JP6509840B2 - Medical device integrated with a corrugated structural element for implantation within a luminal structure - Google Patents

Description

Cross-Reference to Related Applications This application is related to U.S. Patent Application No. 14 / 060,012 filed October 22, 2013 and U.S. Provisional Application No. 61 / 895,957 filed October 25, 2013 And Priority of US Provisional Application No. 61 / 968,025 filed March 20, 2014. The contents of each of these previously filed applications are incorporated herein in their entirety by this reference.

  The present invention relates to a stent. In particular, the present invention relates to the geometric design of a stent that exhibits high radial strength and flexibility and can be formed of a bioabsorbable polymer.

  A stent is a vascular scaffold that is placed in a diseased vessel section and supports the vessel wall. During angioplasty, stents are used to repair and reconstruct blood vessels. Placement of the stent in the affected arterial area prevents elastic contraction and occlusion of the artery. The stent also prevents local arterial dissection along the media. Physiologically speaking, the stent is placed in any space in the lumen, for example, in the artery, vein, bile duct, ureter, gastrointestinal tract, tracheobronchial tree, midbrain water, or urogenital lumen May be The stent may be placed in the lumen of non-human animals such as primates, horses, cows, pigs and sheep.

  Generally, there are two types of vascular scaffolds or stents: self-expanding and balloon-expandable. Self-expanding stents automatically expand into a deployed and expanded state when they are released. Self-expanding stents are placed in the vessel by inserting them in a compressed state into the affected area, eg, the area of the stenosis. Compression or crimping of the stent can be accomplished using a crimping device (see http://www.machinesolutions.org/stent_crimping.htm, April, 2009). The stent may be compressed using a tube having an outer diameter smaller than the inner diameter of the affected area of the vessel. As the compressive force is removed or the temperature rises, the stent expands and fills the lumen. When the stent is released from the restriction in the tube, the stent expands and regains its original shape, in the process becoming securely anchored in the vessel against the wall.

  Balloon expandable stents are expanded using an expandable balloon catheter. A balloon expandable stent can be implanted by placing the unexpanded or crimped stent on the balloon portion of the catheter. After placing the crimped stent on the balloon portion, the catheter is inserted through a hole in the vessel wall and the catheter is moved through the tube until it reaches the vessel portion requiring repair. The stent is then expanded by inflating the balloon catheter against the inner wall of the tube. Specifically, the stent is plastically deformed by inflating the balloon. This increases the diameter of the stent and expands the stent.

Common limitations exist with many stents. For example, stents in which the body is formed of a polymeric material often suffer from excessive shrinkage and low radial strength. There is a need for an improved stent design that addresses these issues.
As prior art literature information related to the invention of this application, there are the following (including documents cited at the international phase from the international filing date and documents cited at the time of domestic transition to another country).
(Prior art reference)
(Patent document)
(Patent Document 1) US Patent Application Publication No. 2013/0268054
(Patent Document 2) US Patent Application Publication No. 2012/0220934
(Patent Document 3) US Patent Application Publication No. 2013/0261733
(Patent Document 4) US Patent Application Publication No. 2013/0238078
(Patent Document 5) US Patent Application Publication No. 2009/0182404

  In one aspect, the invention provides an expandable scaffold, eg, a stent, for implantation in a body lumen. The framework has a compressed or crimped state and an expanded state, and is a plurality of perimeter forming elements, each perimeter forming element having a plurality of wave-like shapes consisting of alternately repeating peak and valley shapes , Including the plurality of perimeter forming elements. The plurality of perimeter forming elements form a generally cylindrical shape having a longitudinal axis (or cylindrical axis). The plurality of perimeter forming elements have a first perimeter forming element, a second perimeter forming element, and a third perimeter forming element. The first and second perimeter forming elements are adjacent along the longitudinal direction, and the second and third perimeter forming elements are adjacent along the longitudinal direction. The first and second perimeter forming elements are connected by a plurality of first connecting elements, and the second and third perimeter forming elements are connected by a plurality of second connecting elements. At least one of the perimeter forming elements has at least one undulating shape having a corrugated pattern. The corrugated pattern comprises at least six linear segments (e.g. 6 to 64 linear segments, 6 to 36 linear segments etc) connected in series with one another, when the framework is in the expanded state; Each of the at least six straight segments is not co-linear with the adjacent connected straight segments. The connecting linear segments may approximate the period of a sine wave when the skeleton is in the expanded state. The lengths of each of the connected linear segments may be the same or may be different from one another. The waveform pattern may also include curvilinear segments. The corrugation pattern may be employed on the entire surrounding forming element and / or on all the surrounding forming elements in the skeleton.

  In one embodiment, the scaffold may comprise a bioresorbable polymeric material, such as poly-L-lactide (PLLA). In another embodiment, the scaffold comprises a bioerodible metal.

  The plurality of first (or second) connection elements may have at least two connection elements, for example, three first (or second) connection elements. The first connection element may be linear or curved, for example, S- or Z-shaped. Marker dots may be included in the first or second connected element.

  In one embodiment, the framework comprises marker dots. The marker dots may be included in or attached to the linking element. The marker dot may have a cup-shaped configuration having a mouth and a bottom, and may include a hole at the bottom of the cup.

  In one embodiment of the framework, the peaks and valleys of the first perimeter forming element are substantially in-phase with the peaks and valleys of the second perimeter forming element. Each of the first connection elements is for connecting a valley of the first perimeter forming element to a peak of the second perimeter forming element, and a peak of the second perimeter forming element is the second perimeter Adjacent to a valley of the forming element and aligned longitudinally with the valley of the first circumferential forming element. In a further embodiment, the peaks and valleys of the second perimeter forming element are substantially in phase with the peaks and valleys of the third perimeter forming element, and each of the second connection elements is one of On the side, it is connected to the peaks of the second peripheral forming element which are connected to the first peripheral forming element by the first connecting element, and on the other side, adjacent to the peaks of the third peripheral forming element Connected to the valleys of the third perimeter forming element, wherein the peaks of the third perimeter forming element are longitudinally aligned with the peaks of the second perimeter forming element. In another embodiment, each said second connecting element is connected on one side to a valley of said second surrounding element adjacent to a peak of said second surrounding element and on the other side The peaks of the second perimeter forming element are connected to the peaks of the third perimeter forming element adjacent to the valleys of the third perimeter forming element, and the peaks of the second perimeter forming element are connected by the first connecting element. Connected to a perimeter forming element, wherein the valleys of the third perimeter forming element are longitudinally aligned with the valleys of the second perimeter forming element, and each of the first coupling elements is None of the second coupling elements are aligned along the longitudinal direction.

  In one embodiment of the framework, the peaks and valleys of the first perimeter forming element are substantially in phase with the peaks and valleys of the second perimeter forming element, and each of the first connection elements is The peaks of the first perimeter forming element are connected with the peaks of the second perimeter forming element longitudinally aligned with the peaks of the first perimeter forming element. In a further embodiment, the peaks and valleys of the second perimeter forming element are substantially in phase with the peaks and valleys of the third perimeter forming element. Each said second connection element is connected on one side to a valley of said second perimeter forming element adjacent to a peak connected to said first connection element, and on the other side said second Connected to the valleys of said third perimeter forming element aligned longitudinally with the valleys of the perimeter forming element. In another embodiment, the peaks and valleys of the second perimeter forming element are substantially in phase with the peaks and valleys of the third perimeter forming element, and each of the second connection elements is one of On the side, it connects to the peaks of the second perimeter forming element adjacent to the peaks of the second perimeter forming element, and on the other side, aligned along the longitudinal direction with the peaks of the second perimeter forming element Connected to the peaks of the third perimeter forming element, and the peaks of the second perimeter forming element are connected to the first connecting element.

  In one embodiment of the framework, the peaks and valleys of the first perimeter forming element are substantially in phase with the peaks and valleys of the second perimeter forming element, and each of the first connection elements is The peaks of the first perimeter forming element are connected with the valleys of the second perimeter forming element, and the valleys of the second perimeter forming element are longitudinally aligned with the peaks of the first perimeter forming element Adjacent to a peak of the second perimeter forming element. In a further embodiment, the peaks and valleys of the second perimeter forming element are substantially in phase with the peaks and valleys of the third perimeter forming element, and each of the second connection elements is one of On the side is connected to the peaks of the second perimeter forming element adjacent to the valleys of the second perimeter forming element, and on the other side, adjacent to the peaks of the third perimeter forming element Connected to a valley of the third perimeter forming element, the valley of the second perimeter forming element being connected to the first perimeter forming element by the first coupling element, and the third perimeter forming The crests of the elements are longitudinally aligned with the crests of the second perimeter forming element, and each of the first coupling elements is longitudinally along any of the second coupling elements It is not aligned.

  In one embodiment of the scaffold, when the scaffold is in the expanded state, the scaffold comprises at least one continuous spiral comprising at least one of the first coupling element and at least one of the second coupling element. Have a pattern. Both the at least one first connection element and the at least one second connection element connect with the second perimeter forming element at the same peak or valley. In another embodiment of the skeleton, when the skeleton is in the expanded state, the skeleton includes at least one continuous spiral including at least one of the first connection element and at least one of the second connection elements. Have a pattern of In this case, the at least one first connection element is connected to the second peripheral forming element in a first connection position, and the at least one second connection element is different from the first connection position. In the second connection position, the continuous spiral pattern is connected to the second surrounding forming element, and the second spiral pattern further includes the second spiral pattern between the first connection position and the second connection position. Have some of the surrounding forming elements.

  In one embodiment, at least one of the plurality of surrounding forming elements includes a connecting element and a notch at a position where the surrounding forming element intersects.

FIG. 1 shows the cutting pattern of the present framework. FIG. 2A shows the cutting pattern of the present framework comprising perimeter forming elements having varying lengths. FIG. 2B shows the varying amplitude of the surrounding forming element. FIG. 2C shows a repeating sine wave pattern. FIG. 2D shows a non-repetitive sine wave pattern. FIG. 3 shows a detailed view of adjacent surrounding forming elements. FIG. 4A shows details of the coupling element at one end of the framework. FIG. 4B illustrates various embodiments of various coupling elements. FIG. 4C illustrates various embodiments of various coupling elements. FIG. 4D illustrates various embodiments of various coupling elements. FIG. 4E illustrates various embodiments of various coupling elements. FIG. 4F illustrates various embodiments of various coupling elements. FIG. 4G shows a perspective view of the marker dot. FIG. 4H shows cross sections of various embodiments of marker dots. FIG. 4J shows cross sections of various embodiments of marker dots. FIG. 4K shows cross sections of various embodiments of marker dots. FIG. 5A shows a three-dimensional view of the present framework from various angles. FIG. 5B shows a three-dimensional view of the present framework from various angles. FIG. 5C shows a three-dimensional view of the present framework from various angles. FIG. 6 shows the cutting pattern of another embodiment of the present framework. FIG. 7 shows a cutting pattern of the present framework that includes an alternating spiral pattern. FIG. 8 illustrates the cutting pattern of the present framework comprising various connecting elements having different shapes. FIG. 9 shows a cutting pattern of the present framework comprising a spiral pattern alternating with a perimeter forming element of varying length. FIG. 10A shows a three-dimensional perspective side view of the skeleton in a crimped state. FIG. 10B shows a three-dimensional perspective side view of the framework in a crimped state. FIG. 11A illustrates the cutting pattern of the present framework that includes an alternating spiral pattern. FIG. 11B illustrates the cutting pattern of the present framework that includes an alternating spiral pattern. FIG. 12 illustrates the functionality of the linking element. FIG. 13 illustrates the geometry of the present framework and connection elements (first and second connection elements) upon expansion. FIG. 14A illustrates the geometry of the connection element. FIG. 14B illustrates the geometry of the connection element. FIG. 14C shows various embodiments of how the linking elements can be attached to the adjacent surrounding forming elements. Figures 15A-E illustrate where the coupling element can be attached along the undulating shape. FIG. 16 shows radial displacement of the attachment of the coupling element to the adjacent undulating shape. FIG. 17A1 shows an example of the phase in adjacent surrounding forming elements. FIG. 17A2 shows an example of the phase in adjacent surrounding forming elements. FIG. 17B shows an example of the phase in adjacent surrounding forming elements. FIG. 18 shows the cutting pattern of another embodiment of the present framework, in which there are three first connection elements between two surrounding forming elements. FIG. 19A schematically illustrates a framework according to an embodiment of the invention, including a corrugated pattern in which the perimeter forming elements are comprised of a plurality of linear segments. FIG. 19B is an enlarged view of the present framework shown in FIG. 19A. FIG. 19C schematically shows the waveform patterns shown in FIGS. 19A and 19B. FIG. 19D schematically shows a waveform pattern composed of a plurality of curved segments. FIG. 20A shows a cutting pattern according to an embodiment of the invention, including the waveform patterns shown in FIGS. 19A-19B. FIG. 20B shows a detailed view of a portion of this framework in FIG. 20A. FIG. 20C shows a detailed view of a portion of this framework in FIG. 20A. FIG. 20D shows a detailed view of a portion of this framework in FIG. 20A. FIG. 20E shows a detailed view of a portion of this framework in FIG. 20A. FIG. 20F shows a cross section of the marker dot in FIG. 20A. FIG. 20G shows a side view of the present framework in FIG. 20A. FIG. 21A shows a three-dimensional side view of a portion of an expanded framework in accordance with an embodiment of the present invention, including the wave pattern shown in FIGS. 19A-19B. FIG. 21B shows a three-dimensional side view of a portion of an expanded framework in accordance with an embodiment of the present invention, including the wave pattern shown in FIGS. 19A-19B. FIG. 21C shows a three-dimensional side view of a portion of an expanded framework according to an embodiment of the present invention, including the wave pattern shown in FIGS. 19A-19B. FIG. 22A shows a cut pattern of a scaffold according to an embodiment of the present invention, including the wave pattern shown in FIGS. 19A-19B. FIG. 22B shows a cut pattern of a scaffold according to another embodiment of the present invention, including the wave pattern shown in FIGS. 19A-19B. FIG. 23 shows a cut pattern of a scaffold according to another embodiment of the present invention, including the wave pattern shown in FIGS. 19A-19B. FIG. 24 shows a cut pattern of a scaffold according to another embodiment of the present invention, including the wave pattern shown in FIGS. 19A-19B. FIG. 25A shows a cut pattern of a scaffold according to another embodiment of the present invention, including the wave pattern shown in FIGS. 19A-19B. FIG. 25B shows a cut pattern of a scaffold according to another embodiment of the invention, including the wave pattern shown in FIGS. 19A-19B. FIG. 26A shows a cut pattern of a scaffold according to another embodiment of the present invention, including the wave pattern shown in FIGS. 19A-19B. FIG. 26B shows a cut pattern of a scaffold according to another embodiment of the present invention, including the wave pattern shown in FIGS. 19A-19B. FIG. 27A shows a three-dimensional view of a skeleton according to an embodiment of the invention, including the wave patterns and notches shown in FIGS. 19A-19B. FIG. 27B shows a three-dimensional view of a skeleton according to an embodiment of the invention, including the wave patterns and notches shown in FIGS. 19A-19B.

  The present invention relates to expandable vascular scaffolds, such as stents. The overall design of the framework is a modular design having pairs of perimeter forming elements connected by one or more connecting elements (the terms connecting and connecting are used interchangeably herein). It is based. Using a modular approach, the framework can be assembled from surrounding forming elements and connecting elements, which vary in length and design. When expanded, the connecting elements form a helical pattern. The same pattern may be helical.

  The vascular scaffold may be formed of a bioresorbable polymer, a bioerodable or bioresorbable metal, or a combination thereof. Non-limiting examples of bioabsorbable polymers include poly-L-lactide (PLLA), poly-D-lactide (PDLA), poly (D, L-lactide) (PDLLA), poly (desaminotyrosyl-tyrosine) Ethyl ester) carbonate, poly (caprolactone) (PCL), and poly (anhydrous ester) salicylic acid. Non-limiting examples of bioerodible / bioabsorbable metals are iron, iron-based alloys, magnesium, magnesium-based alloys with or without rare earth elements, such as Mg-Sr alloys, Mg-Sr-Zn alloys, It includes Mg-Zn-Zr alloy, Mg-Nd-Zn-Zr alloy, Mg-Zn-Al alloy, Mg-Zn-Ca alloy, metallic glass, for example, zirconium-based metallic glass.

  The framework may be formed from various combinations of metals and polymers. U.S. Patent Nos. 7,846,361; 7,897,224 and 8,137,603. U.S. Patent Application Publication No. 2010/0093946. Alexy, et al. , BioMed Research International, 2013 Article ID 137985.

  Generally, the framework is a cylindrical or tubular body having a cylindrical (or longitudinal) axis which runs along the length of the cylinder. The modular geometric design of the present invention exhibits high flexibility and significant radial strength. In general, the framework comprises an essentially cylindrically shaped body having a plurality of expandable perimeter forming elements. The perimeter forming elements may vary in length. At least two perimeter forming elements may be connected to form a pair of perimeter forming elements. There may be one or more connecting elements between the circumferential forming elements forming the pair of circumferential forming elements. The connecting element may be found in various geometric shapes, including linear, curvilinear, or a combination of the two shapes. Each pair of perimeter forming elements is connected to an adjacent pair of perimeter forming elements by at least one connecting element. The number of links between perimeter forming elements in a pair or between perimeter forming element pairs may vary.

  As used herein, the term "surrounding element" means a structural element that surrounds the perimeter of the present framework, which may be cylindrical. In one embodiment, the perimeter forming element is coupled along two imaginary planes substantially perpendicular to the cylindrical axis of the framework. The perimeter forming element may have a plurality of undulating shapes (or may be of the same shape). The wavy shape is a repeating unit within the perimeter forming element and may have peaks and valleys. The number of wavy shapes per circumferential forming element is 2 to N, for example, 2, 3, 4, 5, 6, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, It may vary by 14, 15, 16, 17, 18, 19, 20, 30, 40, 50, 60, and so on.

  When the vascular framework is in the expanded state, at least a portion of the connecting elements connect the surrounding forming elements in a pair and / or the connecting elements connect the surrounding forming elements in an adjacent pair Form a continuous spiral pattern.

  In one embodiment, the continuous spiral pattern is oriented substantially parallel to the barrel axis of the skeleton. The continuous spiral pattern may take other orientations. The continuous helical pattern may form a helix, and in certain embodiments, one or more helices, eg, double or triple helices, or four, five, six or more It may be a number helix. Where there are double or more helices, adjacent helices may be substantially parallel to one another. Adjacent helices may not be parallel to one another. In one embodiment, there are two or more helices equidistant from the barrel axis of the skeleton.

  The perimeter forming element may be uniform in shape. Alternatively, the perimeter forming element may be configured in various shapes. For example, the perimeter forming element may be a sinusoidal pattern, a sawtooth pattern, a square wave pattern, or any other type of repeating or non-repeating pattern, for example, a combination of sinusoidal and sawtooth patterns, a series of wavy shapes It may be formed from The amplitude of the wavelike shape may vary within one perimeter forming element or between two perimeter forming elements (the amplitude is the peak deviation of the function from zero). The amplitude and frequency of the wave shape may also vary. For example, the surround forming element may be comprised of a sinusoidal pattern having a repeating pattern of 2: 1: 2: 1, 2: 1, etc., of varying amplitude. In this case, the ratio of the amplitude of the wavelike shape is represented by the ratio shown. Other ratios, such as 3: 1, 4: 1, 5: 1, etc. are also possible. The perimeter forming element may be comprised of one or more segments, each segment having its own wavy shape pattern. The number of segments in each surrounding forming element is 1 to N, for example, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, It may vary by 18, 19, 20, 30, 40, 50, 60, etc. The shape of the segments may be linear or curvilinear. To this end, the perimeter forming elements can be assembled in modular fashion from various segments which may be the same or different. In the framework, the lengths of all the surrounding forming elements may be the same. Alternatively, the length of the perimeter forming element may vary, for example, in a plurality of different ways. For example, the lengths of the perimeter forming elements in one pair may be the same, but the length of the perimeter forming elements closer to one end of the framework is longer than the length of the perimeter forming elements closer to the center of the framework, Or, it may be less than the same length.

  The number of connection elements (first connection elements or second connection elements) connecting adjacent surrounding formation elements is 1 to N, for example, 1, 2, 3, 4, 5, 6, 7, 8. , 9, 10 or more numbers, may be in the range of 10-20. The shape of the connecting element may be linear, curved, S-shaped, inverted S-shaped, Z-shaped, inverted Z-shaped, or any other combined shape including, for example, linear and curved sections May be. Similarly, the number of linking elements linking adjacent pairs of perimeter forming elements is between 1 and N (eg 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10) The shape of the connection element may be linear, curved, S-shaped, inverted S-shaped, Z-shaped, inverted Z-shaped, or any combination thereof. The connection element may have various angles, for example, 0 to 20 °, 20 to 40 °, 40 to 60 °, or 60 to 80 °, with respect to the cylindrical axis of the framework. Furthermore, the angles of these connecting elements may be positive or negative with respect to the cylindrical axis of the framework. Where the connecting elements are curvilinear, they may be asperities having curvatures present in selected portions of the connecting element. The degree of curvature may also vary within one connection element. The number of connecting elements may be employed to modify the flexibility of the framework due to the decrease in flexibility that generally occurs when the number of connecting elements is increased.

  When the connecting element is S-shaped, the connecting element may have a substantially S-shaped structure. In one embodiment, the S-shaped connecting element has a doubly bent structure which can be looser between the circumferential forming elements and allow greater expansion of the framework. The longer this S-shaped segment, the more loose and the greater the extensibility present in the structure. The S-shaped connecting elements may be smooth or angular. In another embodiment, the S-shaped connecting element comprises at least three substantially straight portions, the first straight portion being substantially parallel to the cylindrical axis of said skeleton (eg , Forming an angle between about 0 degrees and about 20 degrees with respect to the barrel axis of the framework), the second linear portion being substantially perpendicular to the axis (eg, of the framework) The third straight portion, which forms an angle between about 70 degrees and about 90 degrees with respect to the cylinder axis, is substantially parallel to the axis (eg, with respect to the cylinder axis of the skeleton) Form an angle between about 0 degrees and about 20 degrees). In still another embodiment, the S-shaped connecting element includes at least three substantially straight portions, and the first straight portion is substantially parallel to the cylindrical axis of the skeleton. The second straight portion is substantially perpendicular to the first straight portion (eg, forming an angle between about 0 degrees and about 20 degrees with respect to the barrel axis of the framework) (Eg, the second linear portion forms an angle between about 70 degrees and about 90 degrees with respect to the first linear portion), and a third linear portion includes the first Substantially parallel to a linear portion of (e.g., the third linear portion forms an angle between about 0 degrees and about 20 degrees with respect to the first linear portion) Or perpendicular to the second linear portion (e.g., the third linear portion is the second linear portion It forms an angle of between about 70 degrees and about 90 degrees against).

  When the connecting element is Z-shaped, the connecting element has a substantially Z-shaped structure.

  When there are two or more connecting elements between adjacent circumferential forming elements, the connecting elements are located symmetrically or asymmetrically at radial positions along the periphery of the skeleton. If the connection elements are located symmetrically, the radial distances between each pair of connection elements, for example, A-B and B-C, are equal.

  The radial position listed here for the coupling element is provided for illustration purposes only, the coupling element along the periphery of the framework relative to the barrel axis without undue trial and error. It can be arranged by the person skilled in the art at any point. For example, the arrangement of the connection elements can be determined by dividing 360 ° by n (where n is the number of connection elements between adjacent surrounding forming elements). When n = 3, the linking elements may be symmetrically disposed about the stent at intervals of about 120 °. If there are two equally spaced connecting elements between adjacent circumferential forming elements, they are located approximately 180 ° with respect to each other. That is, the two connection elements are directed opposite to each other.

  For the purpose of reference only, the connecting element connecting the surrounding forming elements in each pair is referred to as a first connecting element. On the other hand, the connecting element connecting the surrounding forming elements in adjacent pairs of the surrounding forming elements is called a second connecting element. The first and second coupling elements may be of the same shape or may have different shapes. In addition, the shape of the first connecting element connecting the peripheral forming elements in the pair of peripheral forming elements may be the same or may vary in both shape and length. Similarly, the connecting elements connecting adjacent pairs of perimeter forming elements may be the same or may vary in shape and length. As discussed further below, the first and second coupling elements are associated with the perimeter where the vascular scaffold forms a distinctly curved pair out of the plane formed by the perimeter forming element after expansion. It can be configured to allow expansion without giving rise to forming elements. Thus, the connection element (e.g., a second connection element) between adjacent pairs of perimeter forming elements can extend in response to the expansion of the framework. In one embodiment, these connecting elements have an S-shape or are curvilinear.

  When the framework is in the expanded state, at least a portion of the connecting elements connecting the surrounding forming elements in the pair and / or the connecting elements connecting the surrounding forming elements in the adjacent pair may be a continuous spiral or Form a spiral pattern. In one embodiment, the spiral or helical pattern comprises at least a portion of the first and second coupling elements. In another embodiment, the helical pattern comprises at least a portion of the first coupling element. In a third embodiment, the helical pattern comprises at least a portion of the second coupling element. In a fourth embodiment, the helical pattern comprises at least a portion of the first and second coupling elements and at least a portion of the perimeter forming element. In a fifth embodiment, the spiral pattern comprises at least a portion of the first coupling element and at least a portion of the perimeter forming element. In a sixth embodiment, the helical pattern comprises at least a portion of the second coupling element and at least a portion of the perimeter forming element.

  The length of the connecting element means the absolute distance of movement moving along the connecting element from one end of the connecting element to the other end of the connecting element.

  The length of the second connection element may be greater than, equal to, or less than the length of the first connection element.

  The undulating shape of the perimeter forming element may form peaks and valleys to either the proximal or distal end of the vascular scaffold. The first connecting element may connect the perimeter forming elements in pairs from mountain to mountain, mountain to valley, or valley to valley. Similarly, the second connection element may connect the perimeter forming element between adjacent pairs of mountains and mountains, mountains and valleys, or valleys and valleys. The mountain-to-peak, peak-to-valley or valley-to-valley connection may be on the same cylinder axis or between perimeter forming elements shifted by 180 °. Other shifts include, but are not limited to, 5 °, 60 °, 90 °, and 120 ° from the same cylinder axis. The connecting element may connect any point of an adjacent perimeter forming element, for example, but not limited to, a peak, a valley, a rising portion of a wave-like shape, or any point in a falling portion.

  The wave-like shape of one of the circumferential forming elements in the pair may be either the same as or out of phase with the wave-like shape of the other circumferential forming element in the pair. If the two surrounding forming elements are not consistent, the degree of retardation may be in the range of more than 0 ° and 180 °, including, but not limited to, 5 °, 60 °, A degree of 90 ° and 120 ° can be included.

  Similarly, the wave shape of one pair may be either in phase or alternatively unmatched with respect to the wave shape of the adjacent pair. If the two surrounding forming elements are not consistent, the degree of retardation may be in the range of more than 0 ° and 180 °, including, but not limited to, 5 °, 60 °, A degree of 90 ° and 120 ° can be included.

  The wavy shape of the adjacent perimeter forming elements may be either in phase or out of phase. If the two surrounding forming elements are not consistent, the degree of retardation may be in the range of more than 0 ° and 180 °, including, but not limited to, 5 °, 60 °, Degrees of 90 °, 120 °, and 180 ° can be included.

  For example, when a radial expansion force is applied to the skeleton by the expandable balloon, the circumferential forming element expands radially and elongates circumferentially. Conversely, when an external compressive force is exerted on the skeleton, the perimeter forming element contracts radially and shortens circumferentially. When a radial expansion force is applied to the skeleton, the wavelike shape decreases in amplitude. Conversely, when an external compressive force is exerted on the skeleton, the undulating shape has a greater amplitude.

  In another embodiment, the scaffold comprises a plurality of polygons. The polygon has an n-face. Here, n is any positive integer. For example, the polygons may have faces in the range of 3 to 30 (higher order polygons are also included in the design of the present invention). For example, polygons having n planes or less, 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 polygons. The faces of the polygon may or may not be equal. The opposite sides of the polygon may be substantially parallel to one another when the skeleton is crimped. The opposite sides of the polygon can take other configurations with respect to each other.

  The polygon may be formed of a plurality of wavy shapes connected by a plurality of connection elements. For example, the polygon may be a hexagon formed of two wavy shapes connected by two connecting elements. The hexagon may have a first undulating shape and a second undulating shape, the undulating shape being connected by the first segment and the second segment. The filaments having the first and second undulating shapes in each hexagon may have different or the same width, length and thickness. The polygon may be formed from a plurality of undulating shapes without connecting elements. For example, the polygon may be a square consisting of two wavy shapes. In higher order polygons, for example n = 8-30, the wavelike shapes may be connected by a plurality of connecting elements.

  The wavy shape may be one segment or at least two segments (e.g. 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20) , 30, 40, 50, 60, N segments). The segments may be straight or curved. If the segments are curvilinear, the degree of curvature may vary. The segments may be concave or convex. The segments may include only linear portions connected to each other, or may include only curvilinear portions connected to each other. Alternatively, the segments may include both straight and curvilinear portions connected to one another. The segments may have at least one bend located at selected points along their length. For example, the segments may have a stylized shape such as n, C, U, V, etc. The segments may be in the form of loops. In this case, the loop may be circular or semicircular. The segments may have essentially any suitable configuration. The lengths, widths, and thicknesses of the segments of the pre-corrugated shape may or may not be equal. The two undulating shapes of each polygon across each perimeter forming component may be identical or may vary. A wide variety of configurations for the polygon and the various segments representing the faces of the polygon are encompassed by the present invention. For example, the segments representing the faces of the polygon may be straight or curved. In one polygon, the length of the segment having one wavy shape may be equal to or longer than the length of the segment of the opposite wave shape. The polygon may be convex (i.e. all its interior angles are less than 180 [deg.]) Or non-convex (i.e. the polygon contains at least one interior angle greater than 180 [deg.]). Good. The polygon may form a continuous, intermittent structure across the body of the skeleton. The perimeter forming elements (or pairs of perimeter forming elements) may comprise different or substantially identical polygons. The polygons of the different perimeter forming elements may be different or substantially identical. The surface areas of adjacent polygons may or may not be equal. The surface area of the polygon, ie the area encompassed by the surface, can be mathematically calculated from the length of the surface of the polygon. http: // mathworld. wolfram. com / PolygonArea. html, April, 2009.

  One embodiment of the framework of the present invention is illustrated in FIG. The pair of perimeter forming elements is shown as 1-4. The perimeter forming elements in the framework for pairs 1-4 are denoted by 1 (5, 6), 2 (7, 8), 3 (9, 10), and 4 (11, 12) in parentheses. ing. The connection element (first connection element) between two surrounding forming elements in one pair 1 is shown as 13-18. On the other hand, said connection element (second connection element) between adjacent pairs 1 and 2 of the surrounding forming element is shown as 19-21. The framework may include marker dots 22. The polygons formed by the wavy shape of the framework and the connecting elements are illustrated by the boxes 23 and 24.

  Another embodiment of the present framework is shown in FIG. 2A. Here, the perimeter forming elements of the present framework vary in length. The perimeter of the perimeter forming element is A> B> C. However, this order of lengths is shown for illustrative purposes only. The wave-like amplitude formed by the surrounding forming elements A, B, C also has a length or height of A ′> B ′> C ′ in the partially crimped or fully crimped state ( Figure 2B). In the embodiment shown, the perimeter forming elements with varying lengths are distributed along the body of the skeleton as follows. 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). However, many other combinations and distributions are also possible. FIG. 2C shows a repeating sinusoidal pattern in which the undulating shape has a constant amplitude across the perimeter forming element. FIG. 2D shows a non-repetitive sine wave pattern. In a non-repetitive sinusoidal pattern, the amplitude and / or normal frequency of the undulating shape may vary either symmetrically or randomly along the perimeter of the perimeter forming element.

  The length of the perimeter forming element means the absolute distance of movement along the perimeter forming element back to the same artificial point starting from the artificial point on the peripheral forming element.

  A detailed view of a portion of the wave-like shape that forms two adjacent pairs of perimeter forming elements is shown in FIG. The perimeter forming elements are shown as 39, 40. They are linked by a linking element (second linking element), said linking element comprising two straight portions 41, 4101 and an S-shaped portion 42. The wavy shape of the circumferential forming element 40 has amplitudes 43 and 44. In the illustrated embodiment, 44 is greater than 43.

  FIG. 4A shows details of the connecting element (first connecting element) at one end of the skeleton. The surrounding forming elements 46, 47 are connected by connecting elements (first connecting elements) 48-55. 4B-4F, for example, along (and interrupting) the side of the straight, multiple segments, or curved or curvilinear connecting element at various points along the connecting element 53. Fig. 7 illustrates various embodiments in which marker dots 54 are attached to the connecting elements 56-59 at the point or on the same side. 4G shows a perspective view of the marker dot 251. FIG. 4H, 4J, and 4K show cross sections of various embodiments of marker dots 252. FIG. The cross section of the framework for the marker dots can take various shapes, including but not limited to the see-through space (FIG. 4H), the inlet 253, the bottom 254, and the bottom It includes a cup-shaped structure (FIG. 4J) having a hole 255 and a cup-shaped structure (FIG. 4K) having an inlet 253a and a bottom 254a.

  5A-5C show the skeleton in orthogonal view (5A), side view (5B) and end view (5C). The perimeter forming elements are labeled 60-64 and 65-70. The connection elements between the pair of perimeter forming elements are shown as 71, 72, 74, 75 (first connection elements). On the other hand, the connection element between the two pairs is indicated at 73. The design of the helical shape is shown as 76-78, and the connecting elements between pairs of peripheral forming elements and connecting elements between peripheral forming elements forming the pairs (first and second connecting elements, respectively) )including. The surrounding forming elements forming the pair are indicated by the highlighting lines 63, 64.

  FIG. 6 shows the cutting pattern of another embodiment of the present framework. 79, 80; 81, 82; 83, 84; 85, 86; 87, 88; 89, 90 and 91, 92 together with the pair of perimeter forming elements, wherein the perimeter forming elements It is displayed at 92. The helical pattern is shown as 93-103 and, together with the connecting elements (first connecting elements) 94, 96, 98, 100 and 102 between the peripheral forming elements forming a pair, It has a pattern of alternately repeating connection elements (second connection elements) 93, 95, 97, 99, 101, and 103 between pairs. In the inset to FIG. 6 a partially compressed view of this framework is shown. The perimeter forming elements are indicated at 107, 107 '. On the other hand, the connected elements are displayed at 105, 106. The present framework shown in the figures includes two or more spiral patterns 108-110, which may be substantially parallel to one another.

  FIG. 7 shows the cutting pattern of the present framework with an alternating spiral pattern. In this embodiment, the helical pattern comprises a connecting element (first connecting element) 112, 115, 118, 121 between a pair of perimeter forming elements and a portion 113, 117 of the undulating shape of the perimeter forming element. , 120, and an alternating pattern of connecting elements (second connecting elements) 111, 114, 116, 119, 122 which connect two adjacent pairs of surrounding forming elements. In this embodiment, the helical pattern comprises the following repeating arrangement starting from one end of the skeleton: a first connection element, a second connection element, a part of the wave-like shape, a first connection element, a second And a part of the wave-like shape. This repeat sequence is repeated across the framework. Other repeating arrangements are not limited to this, but (a) a first connecting element, part of the wave-like shape, a first connecting element, repeated n times over the body of the framework; (B) a first connection element repeated n times over the body of the framework, a part of the wave-like shape; (c) a second connection element repeated n times over the body of the framework, the Or (d) may comprise a second connection element, a part of the wave shape, a second connection element, repeated n times over the body of the framework.

  FIG. 8 shows an embodiment in which the connection elements have various shapes and the distribution of patterns of connection elements varies across the body of the skeleton. Specifically, in the embodiment shown, the connecting elements between pairs of perimeter forming elements are straight 124-126 and 130-132, or curved 127-129, 134-136, and 137 It is -139. One of the curvilinear connection elements between the pair of perimeter forming elements has both straight and curvilinear portions 127-129. As is apparent from the illustration, the pattern of the coupling elements can vary across the body of the skeleton. Curvilinear 137-139, 134-136, linear 130-132, curvilinear 127-129, and linear 124-126. Other potential arrangements and geometries are encompassed by the present invention. One of ordinary skill in the art can select the arrangement and type of linking elements to suit the flexibility and spatial requirements required of the vessel.

FIG. 9 shows the cutting pattern of this scaffold in a spiral pattern alternating with a perimeter forming element of varying length. This embodiment illustrates the nature of the modular design of a framework in which perimeter forming elements of different lengths and various connecting elements are combined to form a framework having a two-fold helical pattern. It said peripheral forming element has a length _A n, _{B n,} and _{C n.} For example, in one embodiment, the perimeter is A>B> C. Specifically, in the order shown in Figure 9, A1 and A0 (140, 144) _is combined with B ₀ ~B 5 (141,143), _then, C _{0 ~C} 6 (142) Combined with In this embodiment, there are two types of spiral patterns 145-147 and 153-154. The helical pattern at 147 is a connecting element (first connecting element) 148, 150, 152 between the pair of peripheral forming elements and a connecting element (second connecting element) between the pair of peripheral forming elements. 149 and 151 are included. Another spiral pattern 154 includes a connecting element (first connecting element) 155, 158 between the pair of peripheral forming elements, a portion 157, 160 of the wavelike shape of the peripheral forming element, and a peripheral forming element. And a connecting element (second connecting element) 156, 159 between the pair.

  10A and 10B show a three-dimensional perspective side view of the skeleton in a crimped or compressed state. The pair of perimeter forming elements is shown as 172, 173. One wave-like shape that forms part of the perimeter forming element 161, 167 is adjacent to the connecting element 162, 166 (second connecting element) between the pair of perimeter forming elements. The connecting elements are located on or follow / overlap the undulating shape of the perimeter forming elements 163, 171 in adjacent pairs, but need not be in contact with the undulating shape. The connection elements (first connection elements) connecting the surrounding forming elements in pairs are shown as 169, 170. This arrangement is also clear in FIG. 10B, where one undulating shape forming part of the perimeter forming elements 175, 186 is adjacent to the connecting element 176, 185 (second connecting element) between the surrounding forming elements. Can be seen. This connection element is located at the top of the wavelike shape of the circumferential forming elements 180, 184 in adjacent pairs, or follows / overlaps the same wavelike shape. The connecting elements (first connecting elements) connecting the surrounding forming elements in pairs are shown as 182. The pair of perimeter forming elements is labeled 183.

  FIG. 11A shows a cutting pattern of the present framework with an alternating spiral pattern. The perimeter forming elements are labeled 458-464, with a pair of perimeter forming elements shown as 458, 459, 460, 461 and 462, 463. In this embodiment, the helical pattern comprises a connecting element (first connecting element) 451, 455 between a pair of perimeter forming elements, a portion 452, 454, 456 of the undulating shape of the perimeter forming element, and a perimeter It is formed of an alternately repeating pattern of connecting elements (second connecting elements) 453 and 457 connecting two adjacent pairs of forming elements. In this embodiment, the helical pattern comprises the following repeating arrangement starting from one end of the skeleton: a first connection element, a part of the wave-like shape, a second connection element, a part of the wave-like shape . The repeat sequence is repeated across the skeleton. In FIG. 11A, the first and second connection elements are both straight.

  FIG. 11B shows the cutting pattern of the present scaffold with another spiral pattern. The perimeter forming elements are labeled 465-472, with a pair of perimeter forming elements shown as 465, 466; 467, 468; 469, 470, and 471, 472. In this embodiment, the spiral pattern comprises connecting elements (second connecting elements) 473, 477 connecting two adjacent pairs of perimeter forming elements, portions 474, 476 of the undulating shape of the perimeter forming elements, An alternating pattern of 478 and connecting elements (first connecting elements) 475 and 479 between pairs of peripheral forming elements is formed. In this embodiment, the helical pattern comprises the following repeating arrangement starting from one end of the skeleton: a second connection element, a part of the wavelike shape, a first connection element, a part of the wavelike shape . The repeat sequence is repeated across the skeleton. In FIG. 11B, both the first and second connection elements are S-shaped.

  One of the problems with prior art designs is that as the framework expands, the undulating shapes forming the adjacent perimeter forming elements twist. This design is improved.

  FIG. 12 illustrates the functionality of the linking element between adjacent pairs of perimeter forming elements. 199 and 200 are a pair of surrounding forming elements. Three types of connecting elements, straight 201 and curved 202, 203 are shown. When the framework expands, the connecting elements 201 are restrictive and can not control the expansion of the surrounding forming elements, but either of the connecting elements 203 or 203 is less restrictive and the surrounding forming elements in adjacent pairs are Adjust the expansion without twisting out of the faces 197, 198.

  FIG. 13 illustrates the geometry of the present framework and connection elements during expansion. The pair of perimeter forming elements is shown as 206,207. The connecting elements (first connecting elements) between the wavelike shapes forming the pair of perimeter forming elements are labeled 208-210. The connected elements between the pairs are indicated at 213. The expanded geometry is illustrated by forming a triangle with 213 using 211, 212. The angles formed with respect to the cylinder axis for 208 and 210 are indicated at 215, 216. The angle formed by 211, 212 and 213 is indicated at 214. After expansion, the angles 214 ′, 215 ′ and 216 ′ all increase.

  FIGS. 14A and 14B show a variety of structural geometries of connecting elements, which may be between surrounding forming elements in a pair (first connecting element) or adjacent pairs of surrounding forming elements (second connecting element) And FIG. The connecting elements are S-shaped, 217, 217 ', 401, 404-409, straight lines 218, 410, 218', 413 (curved), concave / convex 219, 219 ', 411, 412, curved line 402, It may be 403, 414. The connecting element may be any point on an adjacent perimeter forming element, for example, a peak (426, 428), a valley (425, 427) or a wave-shaped rising portion (415, 416, 419, 420, 421, 422, 423, 424, 429, 430, 433) or any point of the lowering portion (417, 418, 431, 432, 434) may be connected.

  FIG. 14C shows that one end of the connecting element, with one end of the connecting element being attached to a point on the undulating shape of the surrounding forming element, directly to the corresponding peak or valley of the adjacent surrounding forming element, or 2, 3, 4, 5, 6, 7, 8, 9. . . N (N may be any positive integer) indicates that it can be attached to shifted points (the shift may be in any direction). In FIG. 14C, the two ends of the connection element are 480 (peaks), 481 (valleys); 482 (peaks), 483 (valleys shifted by one wave shape); 484 (peaks), 485 (peaks). The valleys are shifted by one wavy shape); 486 (valleys), 487 (mountains).

  Figures 15A-E illustrate where the connecting elements can be attached along the undulating shape. Here, the connecting element is shown as being straight, but this shape is shown for illustrative purposes only, and the connecting element is curvilinear or S-shaped or included in the present invention It can be of any other shape. The embodiment shown here is applicable to both the first and second coupling elements. The barrel axis of the framework is also shown. The coupling element 220 may be attached to the valley of one wave shape 221 and to the peak of another wave shape 222 (FIG. 15A). Alternatively, the linking element 224 may be attached to both sides of the valleys or peaks of the two wavy shapes 223, 225 (FIG. 15B). The connection element 227 may be attached to two wave-shaped valleys 226, 228 (FIG. 15C). The linking element 230 can also be attached to two wave-shaped peaks 229 and valleys 231 (FIG. 15D). The connection element 234 can also be attached to the two undulating raised portions 232, 235 (FIG. 15E). Although the figures shown here illustrate the connecting elements being mounted in an oppositely wave-like configuration, the connecting elements can be mounted in a wave-like configuration shifted radially with respect to the cylinder axis (FIG. 16) (236-238).

  The proximal and distal ends of the skeleton may be displayed to the heart as the proximal end closest to the aortic valve. The terms peaks and valleys are optionally defined with respect to the proximal and distal ends of the framework.

  17A1, 17A2 and 17B show examples of phases in adjacent surrounding forming elements. In FIG. 17A1, the circumferential forming elements 239, 240 are in line with one another (compare the cylinder axes for 243 and 244). In FIG. 17A2, the perimeter forming elements 239, 250 are partially inconsistent. In contrast, in FIG. 17B, the circumferential forming elements 242, 247 are 180 ° out of phase with each other (compare 245 and 248).

  FIG. 18 shows the cutting pattern of another embodiment of the present framework. The perimeter forming elements are labeled 301-308, with a pair of perimeter forming elements shown as 301, 302; 303, 304; 305, 306; and 307, 308. The spiral pattern is shown as 309-317 and the perimeter forming a pair with the connecting element (second linking element) 309, 311, 313, 315 and 317 between a pair of perimeter forming elements It has an alternating pattern of connecting elements (first connecting elements) 310, 312, 314 and 316 between the forming elements. The framework shown in the figures comprises two or more helical patterns 318-320.

  FIG. 19A schematically shows a cutaway view of a scaffold in accordance with an embodiment of the present invention. The framework comprises three longitudinally adjacent circumferential forming elements 2010, 2020 and 2030. In this case, the pair of surrounding forming elements 2010 and 2020 is connected by the first connecting element 2012. The first connection element 2012 is linear. The pair of perimeter forming elements 2020 and 2030 is connected by a second connecting element 2022. The second connecting element 2022 is S-shaped. The perimeter forming elements 2010 and 2030 are illustrated as including a sawtooth wavelike shaped pattern. The pattern is composed of a plurality of linear elements. The surround forming element 2020 may include a wave pattern 2050 (shaded / darker). The same pattern is further illustrated below in connection with FIG. 19B. For the purpose of illustration, the wave pattern 2050 is superimposed on an imaginary sawtooth pattern in FIG. 19A.

  FIG. 19B is an enlarged view of a portion of FIG. 19A. The figure further illustrates the detailed structure of the waveform pattern 2050. In the corrugated pattern 2050 shown in FIG. 19B, each wavelike shape (i.e., repeating units of the wavelike shape pattern in the surrounding forming element, including one peak and its adjacent valleys) are connected in series, Linear segments 2051, 2052, 2053, 2054, 2055, 2056. When the skeleton is in the expanded state, each of the straight segments is not collinear with the adjacent straight segments connected. The linear segments in one wavy shape are collectively approximated to the period of a sine wave.

  The wave pattern is shown in FIGS. 19A and 19B as including six straight segments per wave shape, but a greater number of segments per wave shape, eg 8, 10, 12, 16, 20, 24, 32, 36, 48, 64 etc. may be used. The linear segments can each be approximately the same length (variation, less than 10%), or can be varied in length as desired or necessary. A series of connected curvilinear segments can also be used to form the wave pattern. For example, each wavelike shape of the present framework comprises a series of partial wavelike shapes or wavelets as illustrated in FIG. 19D. In this case, the six curvilinear segments constituting the wavy shape are indicated by 2051a, 2052a, 2053a, 2054a, 2055a, and 2056a. (FIG. 19C shows the same waveform pattern as shown in FIG. 19B, with a wavy centerline acting as a centerline for the perimeter forming elements shown in FIG. 19D). The number of curvilinear segments forming the wave pattern may be more than 6, for example 8, 10, 12, 16, 20, 24, 32, 36, 48, 64, and so on. The curvilinear segments in one wave-like shape in FIG. 19D are also approximated to the period of the sine wave.

  Such a corrugation pattern is crystallized by the expansion of said framework, in particular said framework, in contrast to the two local stress points (usually at the peak of the peaks and valleys) in the undulating shape in the conventional framework design. The one formed from an inducible polymer material makes it possible to have further local stress points. Thus, the corrugated pattern allows stresses due to radial expansion of the framework to be more evenly distributed along the perimeter forming element, and a more even distribution of induced crystallization of the polymeric material Make it possible. As a result, scaffolds containing the described corrugated pattern may have higher radial strength, reduced rapid contraction after deployment, and reduced creep.

  The connecting elements shown in FIGS. 19A and 19B are linear or S-shaped. In another embodiment, the connection element may also include a wave pattern having a plurality of straight segments or curved segments connected to each other.

  Although FIGS. 19A and 19B illustrate two continuous undulating shaped wave patterns at the perimeter forming element 2020, in other embodiments such waveform patterns may extend throughout the perimeter forming element 2020. FIG. In another embodiment, the perimeter forming elements may all be formed from a repeating corrugated pattern, as illustrated in FIGS.

  FIG. 20A shows an embodiment of a framework of the invention in which each perimeter forming element is comprised of a repeating wave pattern. The perimeter forming elements are labeled 321-330, with a pair of perimeter forming elements shown as 321, 322; 323, 324; 325, 326; 327, 328 and 329, 330. The peaks and valleys of the framework are generally in phase. Three connecting elements are used between each two longitudinally adjacent surrounding forming elements, one for each of the two undulating shapes in each surrounding forming element. The longitudinally adjacent pair of perimeter forming elements 321, 322 are connected by a straight (or straight) first perimeter forming element 332 and the longitudinally adjacent perimeter forming elements 322, 323 The pairs are connected by an S-shaped second perimeter forming element 333. The first connecting element 332 connects the peaks 3211 of the perimeter forming element 321 with the valleys 3222 of the perimeter forming element 322. The second linking element 333 links the valley 3222 with the peaks 3234 of the perimeter forming element 323 adjacent to the valley 3232 (the valley 3232 is longitudinally aligned with the valley 3222). The connection pattern repeats over the stent to form a helical shape including connection elements 331-340. Two marker dots 1902 and 1904 are located at each end of the framework (at the connection between the first pair of surrounding forming elements and the last pair of surrounding forming elements).

  A detailed view of a portion of the skeleton in FIG. 20A is shown in FIGS. 20B-20E. In FIG. 20D, a magnified view of a portion of FIG. 20A is shown to further illustrate the repeating waveform pattern. In this embodiment, two longitudinally adjacent perimeter forming elements are shown as 353,354. They are linked by linking elements (first linking elements) 355 and 356. The linear segments making up the repetitive waveform pattern are shown as 341-352.

  FIG. 20F shows a cross-sectional view of the marker dot 1904. FIG. The marker dot 1904 takes the form of a cup with a recess in the center to accommodate the radiopaque marker. FIG. 20G is a side view of the skeleton shown in FIG. 20A. The perimeter forming elements are labeled 361-368, forming pairs 374-377. The connection elements (first connection elements) between the circumferential forming elements in the pair are shown as 369, 371, 373. On the other hand, the connecting element between the two pairs of perimeter forming elements is indicated at 370, 372. The helical shape is formed by connecting elements 369-373.

  FIG. 21A shows a three-dimensional side view of a portion of an expanded framework according to an embodiment of the present invention, including the wave pattern described in connection with FIGS. 19A-19B. Three longitudinally adjacent circumferential forming elements are shown as 2110, 2120 and 2130. The circumferential forming elements 2110 and 2120 are connected by a straight first connecting element 2115. The surrounding forming elements 2120 and 2130 are connected by an S-shaped second connecting element 2125. Typical dimensions of the various elements in the framework may be as follows. As shown, the width w1 of the first connection element can be about 100 to 200 μm, for example 140 to 160 μm, and the thickness d1 of the first connection element is about 100 to 200 μm, For example, the width w2 of the S-shaped second connection element 2125 can be 120 to 150 μm, and can be about 100 to 200 μm, for example, 150 to 180 μm, constituting the waveform pattern The width w3 of the linear segments may be about 100 to 250 μm, for example 160 to 200 μm. FIG. 21B is a three dimensional side view of another portion of the expanded framework shown in FIG. 21A. FIG. 21C is yet another three-dimensional view of the expanded framework shown in FIG. 21A, a linking element linking two perimeter forming elements 2140 and 2150 located at one longitudinal end of the framework A marker dot 2148 located at the center of 2145 is shown. The marker dots may be cup-shaped as shown in FIG. 19F.

  FIG. 22A shows a cut pattern of a scaffold according to an embodiment of the present invention in which each perimeter forming element is completely constructed from the wave pattern described in connection with FIGS. 19A and 19B. The framework includes perimeter forming elements 2210, 2215, 2220, 2225, 2230, 2235, 2240, 2245, 2250, 2255, 2260, 2265, and 2270. Each perimeter forming element comprises six wave-like shapes (as shown, u1, u2, u3, u4, u5, u6), and the alternating peaks and valleys of these perimeter forming elements are all approximately the same It is a phase. Then each two longitudinally adjacent perimeter forming elements, among others 2215, 2220, 2225, 2230, 2235, 2240, 2245, 2250, 2255, 2260, 2265 are all other valleys in said perimeter forming element Are connected by S-shaped connecting elements 2217, 2222, 2227, 2232, 2237, 2242, 2247, 2252, 2257.

  The amplitude of the wave-like shape for each of the perimeter forming elements can be the same or different. The S-shaped connecting elements 2217, 2222, 2227, 2232, 2237, 2242, 2247, 2252, 2257 may also vary in length. In one embodiment, the wave-like amplitudes of the two longitudinally adjacent circumferential forming elements and the S-shaped connecting element disposed therebetween are said S-shaped connecting when said stent is crimped The element may be designed such that it can be located within the profile of the undulating shape without bending out of the tubular surface formed by the circumferential forming element.

  The circumferential forming elements 2210 and 2215 at the proximal end of the skeleton may be connected by straight connecting elements 2212, with valleys for each wave shape. The proximal pair of perimeter forming elements 2210 and 2215, together with coupling element 2212, form a proximal end zone. The circumferential forming elements 2260 and 2270 at the distal end of the skeleton may be connected by straight connecting elements 2262 with a peak-to-peak for each wave shape. The perimeter forming elements 2260 and 2270 together with the linking element 2262 form a distal end zone. Although the proximal end zone and the distal end zone are both shown as including two perimeter forming elements that are generally in phase, either or both of the zones may alternatively be phase change For example, two perimeter forming elements may be included, which are 180 degrees mismatched, for example, of the embodiment illustrated in FIGS. 25A and 26A. Marker dots 2282 and 2284 are respectively located at a linking element linking the proximal pair of perimeter forming elements 2210 and 2215 and a linking element linking the distal pair of perimeter forming elements 2260 and 2270.

  In the framework shown in FIG. 22A, the connecting elements between adjacent surrounding forming elements and part of the surrounding forming elements form a helical pattern across the framework. For illustration purposes, for longitudinally adjacent perimeter forming elements 2250, 2255, connecting elements 2252 connect valleys 2251 with peaks 2256 adjacent to valleys 2253 (valleys 2253 longitudinally with valleys 2251 Aligned.). Similarly, for longitudinally adjacent perimeter forming elements 2255, 2260, connecting element 2257 connects valley 2258 with peak 2261 adjacent to valley 2264 (valley 2264 is longitudinally aligned with valley 2258, ing.). Thus, the connecting element 2247, part of the perimeter forming element 2250 between the peak 2246 and the valley 2251, connecting element 2252, part of the perimeter forming element 2255 between the peak 2256 and the valley 2258, and then the connecting element 2258 are continuous It forms a spiral shape.

  FIG. 22B shows a cut pattern of a scaffold according to another embodiment of the present invention, wherein each perimeter forming element is completely constructed from the wave pattern described in connection with FIGS. 19A-19B. This cutting pattern is such that each surrounding forming element in this pattern is replaced with eight wave-like shapes (as shown, u1, u2, u3, u4, u5) instead of the six wave-like shapes shown in FIG. 22A. , U6, u7, u8) are substantially the same as the pattern shown in FIG. 22A.

  FIG. 23 shows a cut pattern of a scaffold according to another embodiment of the invention, including the wave pattern described in connection with FIGS. 19A-19B. The framework includes perimeter forming elements 2310, 2320, 2330, 2340, 2350, 2360, 2370, 2380, and then the perimeter forming elements are connected by connecting elements 2312, 2322, 2332, 2342, 2352, 2362, 2372 It is connected. The design pattern between perimeter forming elements 2300 and 2370 is the pattern between perimeter forming elements 2200-2255 in FIG. 22 with respect to the connecting element (S-shaped connecting element connecting adjacent pairs of perimeter forming elements at a peak-valley) Similar to. The proximal pair of perimeter forming elements 2310 and 2320 may be connected by diagonally straight connecting elements 2312 (valley-peaks). The distal pair of perimeter forming elements 2370 and 2380 may be connected by diagonally straight connecting elements 2372 (valley-peaks). Marker dots 2385 and 2387 are respectively located at the linking element linking the proximal pair of perimeter forming elements 2310 and 2320 and the linking element linking the distal pair of perimeter forming elements 2370 and 2380, respectively.

  FIG. 24 shows a cut pattern of a scaffold according to another embodiment of the invention, including the wave pattern described in connection with FIGS. 19A-19B. The framework comprises perimeter forming elements 2410, 2420, 2430, 2440, 2450, 2460, 2470, which are in turn connected by connecting elements 2412, 2422, 2432, 2442, 2452, 2462. Each perimeter forming element comprises six undulating shapes, and the alternating peaks and valleys of these perimeter forming elements are all approximately in phase with respect to the cylinder axis. Each two longitudinally adjacent circumferential forming elements are connected at an angle with respect to all other peaks (or valleys) in the peripheral forming element by means of a diagonally straight connecting element. The connecting elements are all substantially parallel to one another and, together with part of the perimeter forming element, form a spiral pattern across the skeleton. For illustration purposes, for longitudinally adjacent perimeter forming elements 2420, 2430, connecting elements 2422 connect peaks 2421 and valleys 2431 adjacent to peaks 2433 (peaks 2433 are longitudinal with valleys 2421) Aligned.). Similarly, for longitudinally adjacent perimeter forming elements 2430, 2440, connecting elements 2432 connect peaks 2435 and valleys 2445 adjacent to peaks 2443 that are longitudinally aligned with peaks 2435. Therefore, the connecting element 2422, a part of the circumferential forming element 2430 between the valley 2431 and the peak 2435, the connecting element 2432, a part of the circumferential forming element 2440 between the valley 2445 and the peak 2446, and then the connecting element 2242 are continuous It forms a spiral shape.

  FIG. 25A shows a cut pattern of a framework according to another embodiment of the present invention in which each perimeter forming element is completely constructed from the wave pattern described in connection with FIGS. 19A-19B. The framework includes perimeter forming elements 2510, 2515, 2520, 2525, 2530, 2540, 2545, 2550, 2555, 2560, 2565, 2570, 2575, 2580, and then the perimeter forming elements are connected elements. 2512, 2517, 2522, 2527, 2532, 2537, 2542, 2547, 2552, 2557, 2562, 2567, 2572 and 2577 are linked. Each perimeter forming element includes six wave-like shapes (u1, u2, u3, u4, u5, u6, as shown), and all alternating peaks and valleys of these perimeter forming elements are the first It is generally in phase except for the perimeter forming element 2510 and the last perimeter forming element 2580. The first perimeter forming element 2510 and the last perimeter forming element 2580 are 180 degrees mismatched (or opposite) to the remaining perimeter forming elements. The first two perimeter forming elements 2510, 2515 and the last two perimeter forming elements 2575, 2580 (these perimeter forming elements are peaked for each wavy shape by the longitudinally aligned linear connecting elements 2512 and 2577 The remaining longitudinally adjacent pairs of circumferential formers may be connected to each other by means of the longitudinally aligned linear connecting elements, except for the valleys which may be connected by valleys (valley-valley (2 Or can be connected by The proximal pair of perimeter forming elements 2510 and 2515, together with connecting element 2512, form a proximal end zone. The distal pair of perimeter forming elements 2575 and 2580, together with connecting element 2577, form a distal end zone. Although the proximal end zone and the distal end zone are both shown as including two perimeter forming elements generally 180 degrees out of alignment (or opposite one another), either or both of the zones Alternatively, as in the embodiment illustrated in FIG. 22A, for example, it may include two perimeter forming elements that are generally in phase.

  In the framework shown in FIG. 25A, the connecting elements, together with a part of the perimeter forming element, form a helical pattern across the framework. For illustration purposes, for longitudinally adjacent perimeter forming elements 2525, 2530, connecting elements 2527 connect valleys 2524 with valleys 2531 adjacent to peaks 2529 (peaks 2529 extend longitudinally with peaks 2523) Aligned.). Similarly, for longitudinally adjacent perimeter forming elements 2530, 2535, connecting element 2532 connects peaks 2533 and peaks 2534 adjacent to valley 2538 (valley 2538 is longitudinally aligned with valley 2531 ing.). Therefore, the connecting element 2527, a part of the circumferential forming element 2530 between the valley 2431 and the peak 2435, a connecting element 2432, a part of the circumferential forming element 2440 between the valley 2531 and the peak 2533, and then the connecting element 2532 are continuous It forms a spiral shape. The helical shape is a connection element 2537, 2542, 2547, 2552, 2557, 2562, 2567, and a ridge of the surrounding forming element and its adjacent valley, the surrounding forming element crossing the connecting element Continues to include some between.

  FIG. 25B shows a cut pattern of a framework according to another embodiment of the present invention, wherein each perimeter forming element is completely constructed from the wave pattern described in connection with FIGS. 19A-19B. This cutting pattern is such that each surrounding forming element in this pattern is replaced with eight wave-like shapes (as shown, u1, u2, u3, u4, u5) instead of the six wave-like shapes shown in FIG. 22A. , U6, u7, u8) are substantially the same as the pattern shown in FIG. 25A.

  FIG. 26A shows a cut pattern of a framework according to another embodiment of the present invention, wherein each perimeter forming element is completely constructed from the wave pattern described in connection with FIGS. 19A-19B. The framework includes perimeter forming elements 2610, 2615, 2620, 2625, 2635, 2640, 2645, 2650, 2655, 2660, 2665, 2670, 2675, 2680, and then the perimeter forming elements are connected elements. 2612, 2617, 2622, 2632, 2637, 2642, 2647, 2652, 2657, 2662, 2667, 2672, 2677. Each perimeter forming element includes six wave-like shapes (u1, u2, u3, u4, u5, u6, as shown), and all alternating peaks and valleys of these perimeter forming elements are the first It is generally in phase except for the perimeter forming element 2610 and the last perimeter forming element 2680. The first perimeter forming element 2610 and the last perimeter forming element 2680 are 180 degrees mismatched (or opposite) to the remaining perimeter forming elements. The first two perimeter forming elements 2610, 2615 and the last two perimeter forming elements 2675, 2680 (these perimeter forming elements are each aligned with the longitudinally aligned linear connecting elements 2612 and 2617 for each wavy shape Each of the remaining longitudinally adjacent pairs of circumferential formers are connected by means of the longitudinally aligned linear connecting elements, except for the mountain-valley connected), for all two undulating shapes valley-valley It is connected by (or mountain-mountain). The proximal pair of perimeter forming elements 2610 and 2615, together with coupling element 2612, form a proximal end zone. The distal pair of perimeter forming elements 2675 and 2680, together with coupling element 2677, form a distal end zone. Although the proximal end zone and the distal end zone are both shown as including two perimeter forming elements generally 180 degrees out of alignment (or opposite one another), either or both of the zones Alternatively, as in the embodiment illustrated in FIG. 22A, for example, it may include two perimeter forming elements that are generally in phase.

  The first connection element (2617, in this embodiment), compared to the design pattern shown in FIG. 25, wherein the connection element and part of the perimeter forming element form a continuous spiral shape. 2627, 2637, 2647, 2657, 2667) are longitudinally aligned within them. The second coupling elements (2612, 2622, 2632, 2642, 2652, 2662, 2672) are also longitudinally aligned in them. On the other hand, the first connection element and the second connection element are staggered and offset for one complete wavy shape. Marker dots 2685 and 2687 are respectively located at the linking element linking the proximal end pair of perimeter forming elements 2610 and 2615, and the linking element linking the distal end pair of perimeter forming elements 2675 and 2680, respectively.

  FIG. 26B shows a cut pattern of a framework according to another embodiment of the present invention, wherein each perimeter forming element is completely constructed from the wave pattern described in connection with FIGS. 19A-19B. This cutting pattern is such that each surrounding forming element in this pattern is replaced with eight wave-like shapes (as shown, u1, u2, u3, u4, u5) instead of the six wave-like shapes shown in FIG. 22A. , U6, u7, u8) are substantially the same as the pattern shown in FIG. 26A.

  FIG. 27A is a three dimensional view of a portion of a framework according to another embodiment of the invention, including the wave pattern described in connection with FIGS. 19A-19B. FIG. 27B is an enlarged rear view of the skeleton shown in FIG. 27A. In FIG. 27A, two perimeter forming elements 2710 and 2720 are shown connected by linear connecting elements 2715 between the peaks 2712 of the perimeter forming element 2710 and the valleys 2722 of the perimeter forming element 2720. Valley 2722 is 180 degrees out of phase with peak 2712. The perimeter forming element 2710 also connects to the previous perimeter forming element (not shown) by means of an S-shaped connecting element 2705. Connecting elements 2705 and 2715 both connect perimeter forming element 2710 at the same crest 2712. Coupling element 2715 and crest 2712 couple to form an angle 2730 and a large angle 2735 opposite acute angle 2730. Angle 2735 may be obtuse (greater than 90 degrees, less than 180 degrees), or greater than 180 degrees. The notches are arranged at the intersection of connecting element 2715 and peak 2712 and within angle 2735 (notches can be slight indents or reductions in the thickness of said connecting element or of said peripheral forming element, various shapes For example, V shape, U shape, etc. can be taken.). Such notches facilitate crimping and expansion by allowing the straight segments of the corrugated pattern to fold with reduced fatigue or folding at the folding or crimping point. Notches can also be placed on both sides of the perimeter forming element, and can be located at other points along the perimeter forming element where the connecting element and the perimeter forming element intersect. The notches may be distributed in any other way along the perimeter forming element. Notches may also be used with the conventional circumferentially forming elements not including the corrugated pattern described above, for example, the skeleton shown in FIG.

  The scaffold may further comprise at least one radiopaque marker. The same marker may be contained in the marker dot as described herein. The radiopaque marker can take on various sizes and shapes. The radiopaque marker may be a high electron density or X-ray refractive marker, such as metal particles or salts. Non-limiting examples of suitable marker metals include iron, gold, colloidal silver, zinc and magnesium, either in pure form or as an organic compound. Other radiopaque materials are tantalum, tungsten, platinum / iridium, or platinum. Heavy metals and heavy rare earth elements are useful for various compounds, ferrous salts, organic iodine substances, bismuth or barium salts and the like. Additional embodiments that may be utilized may include naturally encapsulated iron particles, such as ferritin, which may be further crosslinked by a crosslinking agent. Ferritin gels can be constituted by crosslinking with low concentrations (0.1-2%) of glutaraldehyde. The radiopaque marker may be comprised of one or more biodegradable polymers, eg, binders such as PLLA, PDLA, PLGA, PEG and the like. In one embodiment having a radiopaque marker, the iron-containing compound or iron particles are encapsulated in a PLLA polymer matrix to produce a pasty material. The same material may be injected or otherwise deposited in the hollow container contained around the stent. In another embodiment, the marker may be formed of biodegradable or bioresorbable material.

  The framework may also have a transition zone between the end zone and the body. The transition zone may be formed of a plurality of undulating shapes, each undulating shape having two adjacent connecting elements connected by loops having a loop width which varies across the transition zone. The transition zone may have a plurality of polygons in which the surface area of adjacent polygons in the transition zone increases in the circumferential direction. U.S. Patent Application Publication No. 20110125251. The transition zone may take other suitable configurations.

  The dimensions of the framework are about 10 mm to about 300 mm in length, 20 mm to about 300 mm in length, about 40 mm to about 300 mm in length, about 20 mm to about 200 mm in length, and about 60 mm to about 150 mm in length. Or the length may vary from about 80 mm to about 120 mm. The internal diameter (ID) of the stent is about 2 mm to about 25 mm, about 2 mm to about 5 mm (eg, for coronary arteries), about 4 mm to about 8 mm (eg, space for nerves in the CNS, blood vessels And both non-vascular), about 6 mm to about 12 mm (eg, for iliac-femoral), about 10 mm to about 20 mm (eg, for iliac artery), and about 10 mm to about 25 mm (eg, for aorta) obtain.

  The device of the present invention may be used as a self-expanding stent or as US 6,168,617, 6,222,097, 6,331,186, and 6,478,814. It can be used with any balloon catheter stent delivery system, including the balloon catheter stent delivery system described in US patent application Ser. In one embodiment, the device is used with the balloon catheter system disclosed in US Pat. No. 7,169,162.

  The framework of the present invention may be used with any suitable catheter. The diameter may range from about 0.8 mm to about 5.5 mm, about 1.0 mm to about 4.5 mm, about 1.2 mm to about 2.2 mm, or about 1.8 mm to about 3 mm. In one embodiment, the catheter is about 6 French (2 mm) in diameter. In another embodiment, the catheter is about 5 French (1.7 mm) in diameter.

  The scaffold may be inserted into any lumen or body cavity that expands its lumen cross-section. The present invention may be placed in any artery, vein, conduit or other vessel, for example the ureteral or urethra, coronary artery, inguinal artery, aortoiliac artery, subclavian artery, mesenteric artery, Or may be used to treat stenosis or stenosis of any artery, including the renal arteries. Other types of vascular occlusions, such as those resulting from dissociative aneurysms, are encompassed by the present invention. Subjects that may be treated using the frameworks and methods of the present invention are mammals such as humans, horses, dogs, cats, pigs, rabbits, rodents, monkeys and the like.

The framework of the present invention may be formed from at least one bioresorbable polymer that provides a wide range of different polymers that can be crystallized. Typically, the bioresorbable polymer is a homopolymer or copolymer, an aliphatic polyester based on lactide backbone, such as poly L-lactide (PLLA), poly D-lactide (PDLA), poly D, L-lactide, It has meso-lactide, glycolide, lactone, and aliphatic polyester formed into a copolymer moiety with, for example, trimethylene carbonate (TMC) or ε-caprolactone (ε-caprolactone) (ECL). U.S. Patent Nos. 6,706,854 and 6,607,548; European Patent No. 0401844; and Jeon et al. Synthesis and Characterization of Poly (L-lactide) -Poly (ε-caprolactone) Multiblock Copolymers Macromolecules 2003: 36, 5585-5592. The copolymer may be crystallized from the copolymer, and may be glycolide, polyethylene glycol (PEG), ε-caprolactone, trimethylene carbonate, or PEG terminated with monomethoxy group (monomethoxy-terminated PEG: PEG- It has a sufficient length of moiety such as L-lactide or D-lactide that is not sterically hindered by the presence of MME). For example, in certain embodiments, more than 10, 100 or 250 L or D-lactides may be sequentially aligned in the polymer. The stent may be a bioabsorbable polymer composition such as, for example, US Pat. Nos. 7,846,361; 7,897,224 and 8,137,603; It is also composed of those disclosed in co-pending U.S. Patent Application Publication No. 2010/0093946.

  The following polymer nomenclature is used based on the presence of said monomer species.

  In an embodiment of the invention, the composition comprises a poly (L-lactide) or poly (D-lactide) base polymer. Other base polymer compositions include blends of poly (L-lactide) and poly (D-lactide). Other useful base polymer compositions are poly (L-lactide-co-D, L-lactide) or poly (D-lactide-co-) containing D, L-lactide comonomer in a molar ratio of 10-30%. D, L-lactide), and poly (L-lactide-co-glycolide) or poly (D-lactide-co-glycolide) containing glycolide comonomer at a molar ratio of 10-20%.

  Another embodiment is a base polymer based on poly (L-lactide) moieties and / or poly (D-lactide) moieties coupled to the modified copolymer, such as block copolymers or Poly (L-lactide-co-tri-methylene-carbonate) or poly (D-lactide-co-tri-methylene-carbonate) and (L-lactide-co-ε) in the form of blocky random copolymers -Caprolactone) or poly (D-lactide-co-ε-caprolactone) (wherein the chain length of said lactide is sufficient to achieve cross-moiety crystallization). . Crosslinking moiety crystallization of the composition comprising the copolymer provides enhanced modulus data in tensile testing and avoids methods to reduce tensile strength in the polymer blend.

The polymer composition enables the development of a lactide racemate (stereo complex) crystal structure between the L and D moieties and can further improve the mechanical properties of the bioresorbable polymer medical device. . The formation of the racemic (stereo complex) crystal structure may result from the formulation of combinations such as:
Poly L-lactide, poly D-lactide and poly L-lactide-co-TMC;
Poly D-lactide and poly L-lactide-co-TMC;
Poly L-lactide and poly D-lactide-co-TMC;
Poly L-lactide, poly D-lactide and poly D-lactide-co-TMC;
Poly L-lactide-co-PEG and poly D-lactide-co-TMC;
Poly D-lactide-co-PEG and poly L-lactide-co-TMC.

  The poly-lactide racemate composition may be "low temperature formable or bendable" without further heating. The low temperature bendable framework of the present invention does not have to be knocked out to be flexible enough to be crimped on a carrier device, but accommodates irregularly shaped organ spaces. Low temperature bendable ambient temperature is defined as room temperature not exceeding 30 ° C. The cold bendable framework, when implanted, may provide sufficient flexibility to allow the scaffold device to expand in the organ space, eg, a pulsating vessel space. For example, with respect to stents, secondary nested or terminally placed tortuous connecting elements can be crystallized, particularly as the scaffold is pulled by stretching based on balloon dilation for implantation, almost non-crystalline after manufacture It may be desirable to utilize a polymer composition that provides a cationic polymer moiety. Such low temperature bendable polymer framework embodiments are not fragile and may not be preheated to a flexible state prior to implantation on the contour surface space in the body. Low temperature bendability allows these blends to be crimped at room temperature without crazing. Furthermore, the blend can be extended at physiological conditions without crazing.

  The polylactide racemate composition and the non-racemic composition according to the embodiment of the present invention are block-type partial moieties that allow for crosslinking crystallization even when an impact modifier is added to the blend composition. It may be processed to have a (moiety). Such blends lead to the possibility to design polymer compositions or blends specific devices by producing either a single or double Tg (glass melting transition point).

  As understood in the art, the polymer composition of the present invention can be customized to accommodate various needs of the selected medical device. The requirements include mechanical strength, elasticity, flexibility, elasticity, and the rate of degradation under physiological and topographic conditions. Further effects of a particular composition relate to the solubility of the metabolite, the hydrophilicity and the uptake of water, and the optional release rate of the adhering matrix or encapsulated drug.

  The utility of the polymer implant can be evaluated by measuring mass loss, reduction in molecular weight, retention of mechanical properties, and / or tissue response. The more important performances of the framework are hydrolytic stability, thermal transition, crystallinity, and orientation. Other determinants that negatively impact framework performance include, but are not limited to, monomeric impurities, cyclic and noncyclic oligomers, structural defects, and aging.

  The framework formed from the above polymer composition may be apparently non-crystalline after extrusion or molding. The framework may be subjected to controlled recrystallization to induce increased crystallinity and mechanical strength improvement. Further crystallization can be induced by the introduction of tension during instrument placement. Such increased recrystallization may be utilized for any framework "blank" prior to secondary or final processing (e.g., by laser cutting) or after such secondary processing. Crystallization (and hence mechanical properties) can also be maximized by the introduction of tension, for example by drawing "low temperature" polymer tubes, hollow fibers, sheets or films, or monofilaments before further processing obtain. It has been observed that crystallization contributes to higher stiffness in the framework. Thus, the polymer composition and steric complexes of the scaffold have both non-crystalline and para-crystalline moieties. The initially semi-crystalline polymer portion can be manipulated by the stretching or expansion action of a given device. In addition, sufficient amounts of non-crystalline polymer properties are desirable for the flexibility and elasticity of the polymer device. Useful monomer components include lactide, glycolide, caprolactone, dioxanone and trimethylene carbonate. The framework may be constructed to be able to be relatively uniformly exposed to local tissues or circulating bioactive factors and enzymes that act on the polymer structure during circulation and bioresorption.

  The in situ degradation kinetics of the polymer matrix of the organ space implant, eg, a cardiovascular stent, is gradual enough to avoid tissue overload, inflammatory response, or other more deleterious consequences. In embodiments, the scaffold is manufactured to remain for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24 or 36 months.

  The pharmaceutical composition may be contained within the polymer, for example by grafting or coating the active site of the polymer. Embodiments of polymers according to the invention provide for the attachment or inclusion of biohealing factors or other agents in the polymer matrix or polymer coating.

  In another embodiment, the composition may be constructed to structurally encapsulate or attach the agent in the polymer matrix. The purpose of such additives may be, for example, to provide treatment at the cardiovascular system or vascular site in contact with the polymer of the medical device, for a stent. The type that encapsulates or attaches the drug in the polymer can determine the release rate from the scaffold. For example, the agent or other additive may be attached to the polymer matrix by various known methods, including, but not limited to, covalent bonds, nonpolar bonds, and esters or similar bioreversible attachment means. It can be combined.

  In one embodiment, a bioabsorbable implantable medical device is a biodegradable and bioabsorbable coating containing one or more barrier layers, wherein the polymer matrix contains one or more of the aforementioned pharmaceutical substances. It may be covered by In this embodiment, the barrier layer is, but is not limited to, polyesters such as, for example, PLA, PGA, PLGA, PPF, PCL, PCC, TMC, and any copolymers thereof; polycarboxylic acids, anhydrides Polyanhydrides, including maleic acid polymers; polyorthoesters; polyamino acids; polyethylene oxides; polyphosphazenes; polylactic acids, polyglycolic acids, and copolymers and mixtures thereof, such as poly (L-lactic acid) (PLLA), poly (poly (L-lactic acid) D, L-lactide), poly (lactic-co-glycolic acid), 50/50 (DL-lactide-co-glycolide); polydioxanone; polypropylene fumarate; polydepsipeptides; polycaprolactones, and their copolymers and mixtures, for example , Poly (D, L-lac De-co-caprolactone) and polycaprolactone co-butyl acrylate; valerate polyhydroxybutyrate and blends; polycarbonates, such as polycarbonates and arylates derived from tyrosine, polyiminocarbonates, and polydimethyltrimethylcarbonates; cyano Acrylate; calcium phosphate; polyglycosaminoglycans; macromolecules, such as polysaccharides (hyaluronic acid; cellulose and hydroxypropyl methylcellulose; gelatin; starch; dextran; including alginates and their derivatives), proteins, and polypeptides; And suitable biodegradable materials, including suitable biodegradable polymers including mixtures and copolymers of any of the foregoing. The biodegradable polymer is a surface erodible polymer such as polyhydroxybutyrate and its copolymer, polycaprolactone, polyanhydride (both crystalline and noncrystalline), maleic anhydride copolymer, and zinc calcium phosphate It is also possible. The number of barrier layers that the polymer scaffold on the device may have depends on the amount of therapeutic needs required by the treatment required of the patient. For example, the longer the treatment, the more therapeutic substance needed over time, and the more the barrier layer provides the drug substance in a timely manner.

  In another embodiment, additives in the polymer composition, for example, sustained release pharmaceutical agents that inhibit early neointimal hyperplasia / smooth muscle cell migration and proliferation, and maintain the patency of the tube Long-acting drugs to increase blood pressure or drugs that enlarge the blood vessel diameter, for example, vascular endothelial nitric oxide synthase (eNOS), nitric oxide donor and its derivatives such as aspirin or its derivatives Nitric oxide-forming hydrogel, PPAR agonists such as PPAR-α ligands, tissue plasminogen activator, statins such as atorvastatin, erythropoietin, darbepoetin, serine proteinase-1 (SERP-1) , And Pravasati Can be in the form of a multi-component pharmaceutical composition within the matrix, including a secondary biostable matrix that releases a steroid, a steroid, and / or an antibiotic.

  A pharmaceutical composition can be contained within the polymer, or can be coated on the polymer surface after mixing and extrusion by spraying, dipping or painting, or be microencapsulated and then said It can be blended into a polymer matrix. U.S. Patent No. 6,020,385. Where the pharmaceutical composition is covalently linked to the polymer blend, they may be linked by a hetero- or homo-bifunctional crosslinker (http://www.piercenet.com/products/browse See .cfm? FldID = 020306).

  Pharmaceutical agents that can be contained within or coated on the scaffold are not limited to (i) drugs, such as (a) antithrombotic agents, For example, heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine.proline.arginine.chloromethyl ketone); (b) anti-inflammatory agents such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine (C) antineoplastic / antiproliferative / mitotic inhibitors such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilone, endostatin, angiostatin, angiopeptin, inhibiting smooth muscle cell proliferation Possible Clonal antibody, thymidine kinase inhibitor, rapamycin, 40-0- (2-hydroxyethyl) rapamycin (everolimus), 40-0-benzyl-rapamycin, 40-0 (4'-hydroxymethyl) benzyl-rapamycin, 40-0 -[4 '-(1,2-dihydroxyethyl)] benzyl-rapamycin, 40-allyl-rapamycin, 40-0- [3'-(2,2-dimethyl-1,3-dioxolane-4 (S)- Yl-prop-2'-en-1'-yl] -20 rapamycin, (2 ': E, 4'S) -40-0- (4', 5 '.: dihydroxypenta-2'-en-1 '-Yl) rapamycin, 40-0 (2-hydroxy) ethoxycarbonylmethyl-rapamycin, 40- 0- (3-hydroxypropyl)-rapamycin, 40- 0- ( Roxy) hexyl-rapamycin, 40-0- [2- (2-hydroxy) ethoxy] ethyl-rapamycin, 40-0-[(3S) -2,2 dimethyldioxolan-3-yl] methyl-rapamycin, 40-0 -[(2S) -2,3-Dihydroxyprop-1-yl] -rapamycin, 40-0- (2-acetoxy) ethyl-rapamycin, 40-0- (2-nicotinoyl) ethyl-rapamycin, 40- 0- [2- (N-25 morpholino) acetoxyethyl-rapamycin, 40-0- (2-N-imidazolylacetoxy) ethyl-rapamycin, 40-0 [2- (N-methyl-N'-piperazinyl) acetoxy] Ethyl-rapamycin, 39-0-desmethyl-3.9, 40- 0, 0 ethylene-rapamycin, (26R) -26 Hydro-40-0- (2-hydroxy) ethyl-rapamycin, 28-O methylrapamycin, 40-0- (2-aminoethyl) -rapamycin, 40-0- (2-acetaminoethyl) -rapamycin, 40- 0 (2-Nicotinamidoethyl) -rapamycin, 40- 0-(2- (N- methyl-imidazo-2 'ylcarbthoxamido) ethyl)-30 rapamycin, 40-0-(2-ethoxycarbonylaminoethyl) ) -Rapamycin, 40-0- (2-tolylsulfonamidoethyl) -rapamycin, 40-0- [2- (4 ', 5'-dicarbethoxy-1', 2 '; 3'-triazole-1' -Yl) -ethyl] rapamycin, 42-epi- (terlazolyl) rapamycin (tacrolimus), and 4 — [3-hydroxy-2- (hydroxymethyl) -2-methylpropanoate] rapamycin (temsirolimus) (WO 2008/086 369); (d) anesthetics such as lidocaine, bupivacaine and ropivacaine; (E) Anticoagulant, for example, D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compound, heparin, hirudin, antithrombin compound, platelet receptor antagonist, antithrombin antibody, antiplatelet receptor antibody, aspirin Prostaglandin inhibitor, platelet inhibitor, and mite anti-platelet peptide; (f) vascular cell growth promoter such as growth factor, transcriptional activator, and translation promoter; (g) vascular cell growth inhibitor such as growth Factor inhibitors, growth factor receptor antagonists, transcription inhibitors, Translation inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of growth factors and cytotoxins, bifunctional molecules consisting of antibodies and cytotoxins; (h) protein kinases and tyrosine kinase inhibitors ( For example, tyrphostins, genistein, quinoxalines); (i) prostacyclin analogues; (j) cholesterol lowering agents; (k) angiopoietins; (l) antibacterial agents such as triclosanes, cephalosporins, aminoglycosides, and nitrofurans (M) cytotoxic agents, cytostatic agents, and cell growth affecting factors; (n) vasodilators; and (o) agents that interfere with endogenous vasoactive mechanisms, (ii) including antisense DNA and RNA Gene therapeutic agent and (a) antisense RNA, (b) tRNA or defect (C) growth factors such as acidic and alkaline fibroblast growth factors, vascular endothelial growth factor, epidermal growth factor, transforming growth factors a and P, and endothelial growth factor derived from platelets Angiogenic factors including platelet derived growth factor, tumor necrosis factor, hepatocyte growth factor, and insulin-like growth factor, (d) cell cycle inhibitors including CD inhibitors, and (e) thymidine kinase ("TK") ), As well as other agents useful to prevent cell growth.

Other pharmaceutical agents that may be included in the framework include, but are not limited to, acarbose, antigens, beta-receptor blockers, non-steroidal anti-inflammatory drugs (NSAIDs), strong Cardiac glycosides, acetylsalicylic acid, viral inhibitors, aclarubicin, acyclovir, cisplatin, actinomycin, alpha and beta sympathomimetics (dmeprazole, allopurinol, alprostadil, prostaglandin, amantadine, ambroxol, amlodipine, methotrexate, S-aminosalicylic acid, amitriptyline, amoxicillin, anastrozole, atenolol, azathioprine, balsalazide, beclomethasone, bethahistine, bezafibrate, bical Midi, diazepam and diazepam derivatives, budesonide, bufexamac, buprenorphine, methadone, calcium salts, calcium salts, potassium salts, magnesium salts, candesartan, carbamazepine, captopril, cephalosporin, cetirizine, chenodeoxycholic acid, ursodeoxycholic acid, theophylline and theophylline derivatives , Trypsin, cimetidine, clarithromycin, clavulanic acid, clindamycin, clobutynol, clonidine, cotrixazole, codeine, caffeine, vitamin D and vitamin D derivatives, cholestyramine, chromoglycic acid, coumarin and coumarin derivatives, cysteine , Cytarabine, cyclophosphamide, cyclosporin, cyproterone, citabarine, dapiprazole, deso Gestrel, desonide, dihydraladine, diltiazem, ergot alkaloid, dimenhydrinate, dimethylsulfoxide, dimethicone, domperidone and domperidone derivatives, dopamine, doxazosin, doxorubizine, doxiramine, doxiprazole, benzodiazepine , Glycoside antibiotics, desipramine, econazole, ACE inhibitor, enalapril, ephedrine, epinephrine, erythropoietin and erythropoietin derivatives, morphinan, calcium antagonist, irinotecan, modafmil, orlistat, peptide antibiotics, phenytoin, riluzole, risedro And sildenafil, topiramate, macrolide antibiotics, estrogen and estrogen derivatives, progestogen and progestogen derivatives, testosterone and testosterone derivatives, androgen and androgen derivatives, etendamide, etofenamate, clofibrate, fenofibrate, etofylHne Etoposide, famciclovir, famotidine, felodipine, fenofibrate, fentanyl, phenticonazole, gyrase inhibitor, fluconazole, fludarabine, fluarazine, fluorouracil, fluoxetine, flurbiprofen, ibuprofen, flutamide, fluvastatin, follitropin, foritropin Terol, fosfomicin, furosem , Fusidic acid, gallopamil, ganciclovir, gemfibrozil, gentamicin (gentamicin), Ginkgo biloba, Glybenum sativa, glibenclamide, urea derivatives as oral antidiabetic agents, glucagon, glucosamine and glucosamine derivatives, glutathione, glycerol and glycerol derivatives, hypothalamus Hormones goserelin, gyrase inhibitors, guanethidine, halofantrine, haloperidol, heparin and heparin derivatives, hyaluronic acid, hydralazine, hydrochlorothiazide and hydrochlorothiazide derivatives, salicylate, hydroxyzine, idarubicin, ifosfamide, imipramine, indometamin, indolamine , Insulin, in Tarferon, iodine and iodine derivatives, isoconazole, isoprenaline, glucitol and glucitol derivatives, itraconazole, ketoconazole, ketoprofen, ketotifen, lasidipine, lansoprazole, levodopa, levomethadone, thyroid hormones, lipoic acid and lipoic acid derivatives, lisinopril, lisuride,
Lofephramide, lomustine, loperamide, loratadine, mapendiline, mebeverzole, mebevelin, meclozine, mefenamic acid, mefloquine, meloxorol, mepindolol, meprobamate, meropenem, mesoximide, metamizole, metformin, methotrexate, methylphenidate, methylphenidolate Metoprolol, metronidazole, myanserin, miconazole, minocycline, minoxidil, misoprostol, mitomycin, zolastine, moexipril, morphine and morphine derivatives, evening primrose, nalbuphine, naloxone, tilidine, naproxen, nalcotin, natamycin, neostimgine, Niflumic acid, nimodipine, nimorazole, nimustine, nisoldipine, adrenaline and adrenaline derivatives, norfloxacin, novamine sulfone, noscapine, nystatin, ofloxacin, olanzapine, olsalazine, omeprazole, omoconazole, ondansetron, oxacillin, oxoxirin Conazole, oxymetazoline, pantoprazole, paracetamol, paroxetine, penciclovir, oral penicillin, pentazocine, pentyphyrin, pentoxifylline, perphenazine, pethidine, plant extract, phenazone, pheniramine, barbituric acid derivative, phenylbutazone, Phenytoin, pimozide, pindolol, piperazine, piracetam, pirenze N, piribedil, piroxicam, pramipexole, pravastatin, prazosin, purocaine, promazine, propiverine, propranolol, proprifolazone, propifnazone, prostaglandin, prothionamide, proxiphilin, quetiapine, quinapril, quinaprilat, lamipril, lanitidine, provirolabrez, Rifampicin, risperidone, ritonavir, ropinirole, loxatidine, roxithromycin, ruscogenin, rutoside and rutoside derivatives, Sabajira, salbutamol, salmeterol, scopolamine, selegiline, sertaconazole, sertindole, sertralion, silicates, sildenafil, Simvastatin, sitostero , Sotalol, spagulmic acid, sparfloxacin, spectinomycin, spiramycin, spirapril, spironolactone, stavusdine, streptomycin, sucralfate, sufentanil, sulbactam, sulfonamide, sulfasalazine, sulpiride, sultamicillin, sultiam, sumatriptan, squisamethonium chloride, tacrine , Tacrolimus, tarool (taliolol), tamoxifen, taurolidine, tazarotene, temazepam, temipocod, teniposide, tenoxicam, terbinafine, terbutafine, terbutaline, terfenadine, terripresin, tertatrol, tetracycline, teri- sololine, theobromine, theophylline, butyzine, tithioziumateiotithiotiazole Thiagabine with chiapride , Propanoic acid derivatives, ticlopidine, timolol, tinidazole, thioconazole, thioguanine, thioxolone, tyropramide, tizanidine, trazoline, tolbutamide, tolbutamide, tolcapone, tolufatate, tolperisone, toposecone, torosecan, antiestrogens, tramadol, tramadolin, trandolapril, tolrancilil, Trapidil, trazodone, triamcinolone and triamcinolone derivatives, triamterene, trifluperidol, trifluridine, trimethoprim, trimipramine, triprenamine, triprolamine, triphosphamide, tromantadine, tromethamol, troparpine, troquinerin, tulobuterol, tyramycin, urapidil, urapociloldeoxy Acid, chenodeoxycole , Valacyclovir, valproic acid, vancomycin, vecuronium chloride, viagra, venlafaxine, verapamil, vidarabine, vigabatrin, viroazine (viloazine), vinblastine, vincamine, vincristine, vindesine, vinorelbine, vinpocetine, biquidil, warfarin, nicotine acid xanthinol, Zafirlukast, zalcitabine, zidovudine, zolmitriptan, zolpidem, zoplicon, zotipine and the like.

  See, for example, U.S. Patent Nos. 6,897,205, 6,838,528, and 6,497,729.

  The stent may be encoded by at least one antibody. For example, the stent may be coated with an antibody or polymer matrix capable of capturing circulating endothelial cells. U.S. Pat. Nos. 7,037,772 (e.g., U.S. Pat. App. Pub. Nos. 20070213801, 2007019006422, 20070191932, 200702007232, 20070141107, 20070055367, 20070042017, See also 20060135476, 200601021012)).

  The framework of the present invention may also be formed from metals such as nickel-titanium (Ni-Ti). The metal composition and method of making the device is disclosed in US Pat. No. 6,013,854. The superelastic metal for the device is preferably a superelastic alloy. Superelastic alloys are generally referred to as "shape memory alloys" and return to their original shape after being deformed to such an extent that a normal metal undergoes permanent deformation. For superelastic alloys useful in the present invention, Elgiloy (R) and Phynox (R) spring alloys (Elgiloy (R) alloys are available from Carpenter Technology Corporation of Reading Pa .; Phynox (R) alloys are , Metal Imphy of Imphy, France), Carpenter Technology corporation and Latrobe Steel Company of Latrobe, Pa. 316 stainless steel and MP35N alloy available from China, and Shape Memory Applications of Santa Clara, Calif. And a superelastic Nitinol nickel-titanium alloy available from U.S. Patent No. 5,891,191.

  The framework of the present invention can be manufactured in a number of ways. The device may be formed by removing various portions of the tube wall from the tube to form the pattern described herein. Because of this, the resulting device will be formed from one continuous piece of material, and it will not be necessary to connect the various segments together. Material may be removed from the tube wall using a variety of techniques including laser (eg, YAG laser), electrical discharge, chemical etching, metal cutting, combinations of these techniques, or other well known techniques. US Pat. Nos. 5,879,381 and 6,117,165 are hereby incorporated by reference in their entirety. By fabricating the stent in this manner, a substantially stress free structure can be made. In particular, the length may be adapted to the length of the diseased part of the lumen in which the stent is to be placed, thereby avoiding the use of separate stents to cover the entire diseased area.

  In another embodiment, a method of making a tubular stent comprises: preparing a racemic poly-lactide mixture; making a biodegradable polymer tube of the racemic poly-lactide mixture; Cutting the tube until a rigid framework is formed. In this embodiment, the fabrication of the framework may be performed using molding or extrusion techniques. The molding technique is substantially solvent free.

  U.S. Patent Nos. 7,329,277, 7,169,175, 7,846,197, 7,846,361, 7,833,260, 6, Nos. 0254,688, 6,254,631, 6,132,461, 6,821,292, 6,245,103, and 7,279,005 Reference is also made to the specification, which is incorporated in its entirety into the present application. In addition, U.S. Patent Application Nos. 11 / 781,230, 12 / 507,663, 12 / 508,442, 12 / 986,862, 11 / 781,233, Nos. 12 / 434,596, 11 / 875,887, 12 / 464,042, 12 / 576,965, 12 / 578,432, 11/875 No. 892, No. 11 / 781,229, No. 11 / 781,353, No. 11 / 781,232, No. 11 / 781,234, No. 12 / 603,279, No. 11 Nos. 12 / 779,767 and 11 / 454,968 and US Patent Application Publication No. 2001/0029397 are also incorporated in their entirety.

  The scope of the present invention is not limited by what has been particularly shown and described above. One skilled in the art will recognize that there are suitable alternatives to the materials, configurations, structures, and dimensions of the illustrated embodiments. Numerous references, including patents and various publications, are cited and considered in the description of the invention. The citation and discussion of such references is provided solely to clarify the description of the present invention and no references are to be recognized as prior art to the present invention described herein. All references cited and discussed in this specification are hereby incorporated by reference in their entirety. Variations, modifications, and other implementations of what is described herein will occur to those skilled in the art without departing from the spirit and scope of the present invention. While specific embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from the spirit and scope of the invention. The matter set forth in the foregoing description and accompanying drawings is offered by way of illustration only and not as a limitation.

Claims (34)

A scaffold for implantation in a body lumen, the scaffold having a compressed state and an expanded state,
The framework has a plurality of peripheral forming elements, each around forming element has a plurality of undulating shape composed of the shape of the peaks and valleys are alternately repeated,
The plurality of perimeter forming elements form a generally cylindrical shape having a longitudinal axis,
At least one of the wavy shapes has a corrugated pattern comprising at least six linear segments connected directly in series, the at least six linear segments each having substantially the same length Yes,
The framework includes a plurality of first connecting elements connecting the first peripheral forming element and the second peripheral forming element, and a plurality of first connecting elements connecting the second peripheral forming element and the third peripheral forming element. Have two connected elements,
The first and second circumferential forming elements are adjacent along the longitudinal direction, and the second and third circumferential forming elements are adjacent along the longitudinal direction,
At least one perimeter forming element of the first, second and third perimeter forming elements includes at least two continuous wave-like shapes each having the wave-like pattern, and the at least two continuous wave-like shapes Is circumferentially extending between two adjacent first connecting elements or between two adjacent second connecting elements connected with the at least one peripheral forming element;
framework. A framework according to claim 1, wherein the wave pattern comprises 7 to 36 linear segments. The framework of claim 1, wherein the at least six connecting straight segments approximate a sinusoidal period when the framework is in the expanded state.
  The framework of claim 1, wherein the at least one perimeter forming element has a plurality of undulating shapes, each of the plurality of undulating shapes having an undulating pattern.   The framework of claim 1, wherein each of the plurality of perimeter forming elements has a plurality of undulating shapes, and each of the plurality of undulating shapes of each perimeter forming element has an undulating pattern.   The framework of claim 1, wherein each of the plurality of perimeter forming elements has a wavelike shape of 6-12.   The framework according to claim 1, wherein at least one notch is arranged at a position along the one surrounding forming element at which the first or second connecting element and one of the surrounding forming elements intersect. It is a skeleton.   The scaffold according to claim 1, wherein the scaffold comprises a bioresorbable polymeric material.   The framework of claim 1, wherein the framework comprises a bioerodible metal.   The framework of claim 1, wherein the plurality of first coupling elements comprises at least two coupling elements. 11. The framework of claim 10 , wherein the plurality of first coupling elements comprises three coupling elements.   A framework according to claim 1, wherein each said first coupling element is straight.   The framework of claim 1, wherein each first coupling element is curvilinear. The framework according to claim 13 , wherein each first coupling element comprises an S-shaped segment.   The framework of claim 1, wherein the at least one first connection element comprises a marker dot.   The framework of claim 1, wherein the peaks and valleys of the first perimeter forming element are substantially in phase with the peaks and valleys of the second perimeter forming element, and each of the first connecting elements is Connecting the valleys of the first perimeter forming element with the peaks of the second perimeter forming element, the peaks of the second perimeter forming element being adjacent to the valleys of the second perimeter forming element, A framework that is longitudinally aligned with the valleys of the first perimeter forming element. 17. The framework of claim 16 , wherein the peaks and valleys of the second perimeter forming element are substantially in phase with the peaks and valleys of the third perimeter forming element, and each of the second coupling elements is: On one side is connected to the peaks of the second perimeter forming element which are connected to the first perimeter forming element by a first connecting element, and on the other side on the peaks of the third perimeter forming element Connected to a valley of the adjacent third perimeter forming element, wherein the peaks of the third perimeter forming element are longitudinally aligned with the peaks of the second perimeter forming element There is a skeleton. 18. The framework of claim 17 wherein each first coupling element comprises an S-shaped segment and each second coupling element is straight. 18. The framework of claim 17 wherein each first coupling element and each second coupling element extend generally in the same circumferential direction. In the framework according to claim 16 ,
The peaks and valleys of the second perimeter forming element are substantially in phase with the peaks and valleys of the third perimeter forming element,
Each second connecting element is connected on one side to a valley of the second perimeter forming element adjacent to a peak of the second perimeter forming element, and on the other side the third perimeter forming element Connected to a peak of the third perimeter forming element adjacent to a valley of the second perimeter forming element, the peak of the second perimeter forming element being connected to the first perimeter forming element by the first connecting element; The valleys of the three perimeter forming elements are longitudinally aligned with the valleys of the second perimeter forming element,
Each of the first coupling elements is not longitudinally aligned with any of the second coupling elements. 21. The framework according to claim 20 , wherein each first coupling element comprises an S-shaped or Z-shaped segment, and each second coupling element comprises an S-shaped or Z-shaped segment. Skeleton that is a thing.   The framework of claim 1, wherein the peaks and valleys of the first perimeter forming element are substantially in phase with the peaks and valleys of the second perimeter forming element, and each of the first connecting elements is A framework that couples the peaks of the first perimeter forming element to the peaks of the second perimeter forming element aligned longitudinally along the peaks of the first perimeter forming element. The framework of claim 22 , wherein the peaks and valleys of the second perimeter forming element are substantially in phase with the peaks and valleys of the third perimeter forming element, and each of the second connecting elements is One side is connected to a valley of the second perimeter forming element adjacent to a peak connected to the first connection element, and on the other side, the valley and longitudinal direction of the second perimeter forming element A skeleton that is connected to the valleys of the third perimeter forming element aligned along the. 24. The framework of claim 23 , wherein each first coupling element is straight and each second coupling element is straight. In the framework of claim 22 ,
The peaks and valleys of the second perimeter forming element are substantially in phase with the peaks and valleys of the third perimeter forming element,
Each second connecting element is connected on one side to a peak of the second perimeter forming element adjacent to a peak of the second perimeter forming element, and on the other side the second perimeter forming Connected to the peaks of the third perimeter forming element aligned along the longitudinal direction with the peaks of the element, wherein the peaks of the second perimeter forming element are linked to the first connecting element framework. 26. The framework of claim 25 wherein each first coupling element is straight and each second coupling element is straight.   The framework of claim 1, wherein the peaks and valleys of the first perimeter forming element are substantially in phase with the peaks and valleys of the second perimeter forming element, and each of the first connecting elements is The peaks of the first perimeter forming element are connected with the valleys of the second perimeter forming element, and the valleys of the second perimeter forming element are longitudinally aligned with the peaks of the first perimeter forming element A framework that is adjacent to the peaks of the second perimeter forming element. In the framework according to claim 27 ,
The peaks and valleys of the second perimeter forming element are substantially in phase with the peaks and valleys of the third perimeter forming element,
Each said second connecting element is connected on one side to a peak of said second perimeter forming element adjacent to a valley of said second perimeter forming element and on the other side said third one The valleys of the second perimeter forming element are connected to the valleys of the third perimeter forming element adjacent to the peaks of the perimeter forming element, the valleys of the second perimeter forming element being connected to the first perimeter forming element by the first connecting element Connected, the peaks of said third perimeter forming element being longitudinally aligned with the peaks of said second perimeter forming element,
Each of the first coupling elements is not longitudinally aligned with any of the second coupling elements. 29. The framework of claim 28 , wherein each said first coupling element and each said second coupling element extend generally in the same circumferential direction.   The framework according to claim 1, wherein the plurality of first connection elements includes every other one of the first perimeter forming element and the second perimeter forming element in a peak or valley of the first perimeter forming element. A skeleton that is to connect to.   The scaffold according to claim 1, wherein when the scaffold is in the expanded state, the scaffold comprises at least one continuous spiral including at least one of the first connection element and at least one of the second connection elements. A framework having a pattern, wherein both the at least one first connection element and the at least one second connection element are connected to the second perimeter forming element at the same peak or valley. In the framework according to claim 1,
When the scaffold is in the expanded state, the scaffold has at least one continuous spiral pattern including at least one of the first coupling element and at least one of the second coupling element;
The at least one first connection element is connected to the second peripheral forming element in a first connection position, and the at least one second connection element is different from the first connection position It is connected with the said 2nd circumference formation element in the 2nd connection position,
The continuous spiral pattern further includes a portion of the second perimeter forming element between the first connection position and the second connection position. A framework according to claim 1, wherein the at least one perimeter forming element comprises a notch at a location where the linking element and the perimeter forming element intersect. A framework for implantation in a body lumen, the framework having a compressed state and an expanded state,
The framework has a plurality of peripheral forming elements, each peripheral element have a plurality of corrugated shape consisting of the shape of the peaks and valleys are alternately repeated,
The plurality of perimeter forming elements form a generally cylindrical shape having a longitudinal axis,
At least one of the wave shapes has a wave pattern including at least six straight segments connected directly in series;
The framework includes a plurality of first connecting elements connecting the first peripheral forming element and the second peripheral forming element, and a plurality of first connecting elements connecting the second peripheral forming element and the third peripheral forming element. Have two connected elements,
The first and second circumferential forming elements are adjacent along the longitudinal direction, and the second and third circumferential forming elements are adjacent along the longitudinal direction,
At least one of the first, second, and third perimeter forming elements, at least one perimeter forming element, forms at least eight straight, directly connected segments that form one or more corrugated shapes having a corrugated pattern. Including
The at least eight straight segments extend circumferentially between two adjacent first connecting elements or between two adjacent second connecting elements connected with the at least one peripheral forming element It is
framework.

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