JP2016533790A - Medical device integrated with corrugated structural elements for implantation in a luminal structure - Google Patents

Abstract

An expandable skeleton or stent includes a surrounding forming element having a corrugated pattern, wherein the corrugated pattern may include a plurality of straight or non-linear segments. The corrugated pattern distributes stress more uniformly along the surrounding forming element, improves the radial strength of the skeleton, reduces rapid shrinkage after placement, and reduces creep. The framework can be manufactured from a bioabsorbable material. [Selection] Figure 19B

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is based on US patent application Ser. No. 14 / 060,012, filed Oct. 22, 2013, US Provisional Application No. 61 / 895,957 filed Oct. 25, 2013. , And US Provisional Application No. 61 / 968,025, filed March 20, 2014. The contents of each of these previously filed applications are hereby incorporated by reference in their entirety.

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

  A stent is a vascular scaffold that is placed in a lesioned vessel section and supports the vessel wall. During angioplasty, stents are used to repair and reconstruct blood vessels. The placement of the stent in the affected arterial section prevents elastic contraction and arterial occlusion. The stent also prevents local arterial dissection along the media. Physiologically speaking, stents can be placed in any space within the lumen, such as arteries, veins, bile ducts, ureters, gastrointestinal tract, tracheobronchial tree, midbrain aqueduct, or genitourinary system lumens. There is a case. Stents may be placed in the lumen of non-human animals such as primates, horses, cows, pigs, and sheep.

  In general, there are two types of vascular frameworks or stents: self-expanding and balloon-expanding. Self-expanding stents automatically expand and become deployed and expanded when they are released. A self-expanding stent is placed in a vessel by inserting it in a compressed state into an affected area, for example, a stenotic area. Stent compression or crimping can be accomplished using a crimping device (see http://www.machinesolutions.org/sent_crimping.htm, April, 2009). The stent may be compressed using a tube having an outer diameter that is smaller than the inner diameter of the affected tube region. When the compressive force is removed or the temperature rises, the stent expands to fill the lumen. When the stent is released from the restriction in the tube, the stent expands and regains its original shape, which in this process is securely fixed in the tube against the wall.

  Balloon expandable stents are expanded using an inflatable balloon catheter. Balloon expandable stents can be implanted by placing an 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 tube wall and moved through the tube until the catheter reaches the tube portion in need of 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.

  Many stents have common limitations. For example, stents whose body is formed from a polymeric material often have problems of excessive shrinkage and low radial strength. There is a need for improved stent designs that address these issues.

  In one aspect, the present invention provides an expandable framework, such as a stent, for implantation in a body lumen. The skeleton has a compressed or crimped state and an expanded state, and is a plurality of surrounding forming elements, each surrounding forming element having a plurality of wavy shapes consisting of alternating peak and valley shapes , Including a plurality of surrounding forming elements. The plurality of surrounding forming elements form a generally cylindrical shape having a longitudinal axis (or cylinder axis). The plurality of surrounding forming elements include a first surrounding forming element, a second surrounding forming element, and a third surrounding forming element. The first and second surrounding elements are adjacent along the longitudinal direction, and the second and third surrounding elements are adjacent along the longitudinal direction. The first and second surrounding forming elements are connected by a plurality of first connecting elements, and the second and third surrounding forming elements are connected by a plurality of second connecting elements. At least one of the surrounding forming elements has at least one wavy shape with a corrugated pattern. The corrugated pattern has at least six linear segments (eg, 6-64 linear segments, 6-36 linear segments, etc.) that are continuously connected to each other, and when the skeleton is in an expanded state, Each of the at least six linear segments is not collinear with adjacent connecting linear segments. The connecting linear segments may approximate a sinusoidal period when the skeleton is in an expanded state. The lengths of the connecting linear segments may be the same or different from each other. The waveform pattern may also include curved segments. The corrugated pattern may be employed throughout the surrounding forming element and / or for all surrounding forming elements in the skeleton.

  In one embodiment, the skeleton may comprise a bioabsorbable polymer material, such as poly-L-lactide (PLLA). In another embodiment, the skeleton comprises a bioerodible metal.

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

  In one embodiment, the skeleton includes marker dots. The marker dots can be included in or attached to a connecting 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 surrounding forming element are substantially in-phase with the peaks and valleys of the second surrounding forming element. Each of the first connecting elements connects a valley of the first surrounding forming element with a peak of the second surrounding forming element, and the peak of the second surrounding forming element is the second surrounding Adjacent to the trough of the forming element and aligned along the longitudinal direction with the trough of the first surrounding forming element. In a further embodiment, the peaks and valleys of the second surrounding forming element are substantially in phase with the peaks and valleys of the third surrounding forming element, and each of the second connecting elements is one of the On the side, connected by a first connecting element to a crest of the second surrounding forming element connected to the first surrounding forming element and on the other side adjacent to the crest of the third surrounding forming element. The third circumferential forming element peaks are aligned longitudinally with the second circumferential forming element peaks. In another embodiment, each said second connecting element is connected on one side to a valley of said second surrounding forming element adjacent to the peak of said second surrounding forming element, and on the other side, The crest of the third perimeter forming element adjacent to the trough of the third perimeter forming element, the crest of the second perimeter forming element being connected to the first perimeter by the first connecting element. Connected to a surrounding forming element, wherein the valley of the third surrounding forming element is aligned longitudinally with the valley of the second surrounding forming element, each first connecting element comprising: 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 surrounding forming element are substantially in phase with the peaks and valleys of the second surrounding forming element, and each of the first connecting elements is The crest of the first surrounding forming element is connected to the crest of the second surrounding forming element aligned longitudinally with the crest of the first surrounding forming element. In a further embodiment, the peaks and valleys of the second surrounding forming element are substantially in phase with the peaks and valleys of the third surrounding forming element. Each of the second connecting elements is connected on one side to a trough of the second surrounding forming element adjacent to a peak connecting to the first connecting element, and on the other side, the second connecting element Connected to a valley of the third surrounding element that is aligned longitudinally with the valley of the surrounding element. In another embodiment, the crests and troughs of the second surrounding forming element are substantially in phase with the crests and troughs of the third surrounding forming element, and each of the second connecting elements is one of On the side, connected to the second surrounding forming crest adjacent to the second surrounding forming crest, and on the other side aligned longitudinally with the second surrounding forming crest. The crest of the third surrounding forming element is connected to the crest of the second surrounding forming element, and the crest of the second surrounding forming element is connected to the first connecting element.

  In one embodiment of the framework, the peaks and valleys of the first surrounding forming element are substantially in phase with the peaks and valleys of the second surrounding forming element, and each of the first connecting elements is Connecting a crest of the first surrounding forming element with a trough of the second surrounding forming element, wherein the trough of the second surrounding forming element is aligned longitudinally with the crest of the first surrounding forming element Adjacent to the crest of said second surrounding forming element. In a further embodiment, the peaks and valleys of the second surrounding forming element are substantially in phase with the peaks and valleys of the third surrounding forming element, and each of the second connecting elements is one of the On the side, connected to the crest of the second surrounding forming element adjacent to the valley of the second surrounding forming element, and on the other side adjacent to the crest of the third surrounding forming element The third peripheral forming element is connected to the valley of the third peripheral forming element, the valley of the second peripheral forming element is connected to the first peripheral forming element by the first connecting element, and the third peripheral forming element A crest of elements is aligned along the longitudinal direction with a crest of said second surrounding forming elements, and each said first connecting element is along the longitudinal direction of any of said second connecting elements. Not aligned.

  In one embodiment of the skeleton, when the skeleton is in an expanded state, the skeleton comprises at least one continuous helical shape including at least one first coupling element and at least one second coupling element. Has a pattern. Both the at least one first connecting element and the at least one second connecting element connect to the second surrounding forming element at the same peak or valley. In another embodiment of the skeleton, when the skeleton is in an expanded state, the skeleton comprises at least one continuous helix comprising at least one first coupling element and at least one second coupling element. It has the pattern of. In this case, the at least one first coupling element is coupled to the second surrounding forming element at a first coupling position, and the at least one second coupling element is different from the first coupling position. It is connected to the second surrounding forming element at a second connecting position, and the continuous spiral pattern is further connected between the first connecting position and the second connecting position. Part of the surrounding forming element.

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

FIG. 1 shows a cutting pattern of the present frame. FIG. 2A shows the cutting pattern of the present frame including surrounding forming elements having varying lengths. FIG. 2B shows the varying amplitude of the surrounding forming elements. 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 connecting 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 dots. 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 skeleton from various angles. FIG. 5B shows a three-dimensional view of the skeleton from various angles. FIG. 5C shows a three-dimensional view of the skeleton from various angles. FIG. 6 shows a cutting pattern of another embodiment of the present skeleton. FIG. 7 shows the cutting pattern of the present frame including a spiral pattern that repeats alternately. FIG. 8 illustrates the cutting pattern of the present frame including various connecting elements having various shapes. FIG. 9 shows the cutting pattern of the present frame comprising a spiral pattern that alternates with surrounding elements of varying length. FIG. 10A shows a three-dimensional perspective side view of the present frame in the crimped state. FIG. 10B shows a three-dimensional perspective side view of the present frame in the crimped state. FIG. 11A illustrates a cutting pattern of the present skeleton including an alternating spiral pattern. FIG. 11B illustrates a cutting pattern of the present frame that includes an alternating spiral pattern. FIG. 12 illustrates the functionality of the coupling element. FIG. 13 illustrates the geometry of the framework and connecting elements (first and second connecting elements) when expanded. FIG. 14A illustrates the geometry of the connecting element. FIG. 14B illustrates the geometry of the connecting element. FIG. 14C shows various embodiments of how the connecting elements can be attached to adjacent surrounding forming elements. 15A-E illustrate where the connecting elements can be attached along a wavy shape. FIG. 16 shows a radial replacement of the attachment of the connecting element to the adjacent corrugated shape. FIG. 17A1 shows an example of phases 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 a cutting pattern of another embodiment of the present framework in which there are three first connecting elements between two surrounding forming elements. FIG. 19A schematically illustrates a skeleton according to an embodiment of the present invention that includes a corrugated pattern in which the surrounding forming elements are comprised of a plurality of linear segments. FIG. 19B is an enlarged view of the skeleton shown in FIG. 19A. FIG. 19C schematically shows the waveform pattern 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 one embodiment of the present invention, including the waveform pattern shown in FIGS. 19A-19B. FIG. 20B shows a detailed view of a portion of the skeleton in FIG. 20A. FIG. 20C shows a detailed view of a portion of the skeleton in FIG. 20A. FIG. 20D shows a detailed view of a portion of the skeleton in FIG. 20A. FIG. 20E shows a detailed view of a portion of the skeleton in FIG. 20A. FIG. 20F shows a cross section of the marker dot in FIG. 20A. FIG. 20G shows a side view of the skeleton in FIG. 20A. FIG. 21A shows a three-dimensional side view of a portion of an expanded skeleton according to one embodiment of the present invention, including the waveform pattern shown in FIGS. 19A-19B. FIG. 21B shows a three-dimensional side view of a portion of an expanded skeleton according to one embodiment of the present invention, including the waveform pattern shown in FIGS. 19A-19B. FIG. 21C shows a three-dimensional side view of a portion of an expanded skeleton according to one embodiment of the present invention, including the waveform pattern shown in FIGS. 19A-19B. FIG. 22A shows a frame cutting pattern according to one embodiment of the present invention, including the waveform pattern shown in FIGS. 19A-19B. FIG. 22B shows a skeleton cutting pattern according to another embodiment of the present invention, including the corrugated pattern shown in FIGS. 19A-19B. FIG. 23 shows a skeleton cutting pattern according to another embodiment of the present invention, including the waveform pattern shown in FIGS. 19A-19B. FIG. 24 shows a skeleton cutting pattern according to another embodiment of the present invention, including the corrugated pattern shown in FIGS. 19A-19B. FIG. 25A shows a cutting pattern for a skeleton according to another embodiment of the present invention, including the waveform pattern shown in FIGS. 19A-19B. FIG. 25B shows a skeleton cutting pattern according to another embodiment of the present invention, including the waveform pattern shown in FIGS. 19A-19B. FIG. 26A shows a skeleton cutting pattern according to another embodiment of the present invention, including the waveform pattern shown in FIGS. 19A-19B. FIG. 26B shows a skeleton cutting pattern according to another embodiment of the present invention, including the corrugated pattern shown in FIGS. 19A-19B. FIG. 27A shows a three-dimensional view of a skeleton according to an embodiment of the present invention, including the waveform pattern and notch shown in FIGS. 19A-19B. FIG. 27B shows a three-dimensional view of a skeleton according to an embodiment of the present invention, including the waveform pattern and notch shown in FIGS. 19A-19B.

  The present invention relates to an expandable vascular framework, such as a stent. The overall design of the skeleton is a modular design having a pair of surrounding forming elements connected by one or more connecting elements (the terms connecting and connecting are used interchangeably herein). Is based. Using a modular approach, the skeleton can be assembled from surrounding forming elements and connecting elements that vary in length and design. When expanded, the connecting elements form a spiral pattern. The pattern can be helical.

  The vascular framework may be formed from a bioabsorbable polymer, a bioerodible or bioabsorbable 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 (anhydride ester) salicylic acid. Non-limiting examples of bioerodible / bioabsorbable metals include iron, iron-based alloys, magnesium, magnesium-based alloys with or without rare earth elements, such as Mg-Sr alloys, Mg-Sr-Zn alloys, Including 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. Pat. Nos. 7,846,361; 7,897,224 and 8,137,603. US Patent Application Publication No. 2010/0093946. Alexy, et al. BioMed Research International, 2013 Article ID 137985.

  Generally, the skeleton is a cylindrical or tubular object having a tube (or longitudinal) axis that runs in the length direction of the cylinder. The modular geometric design of the present invention exhibits high flexibility and significant radial strength. Generally, the skeleton has a mainly cylindrical body with a plurality of expandable perimeter forming elements. The perimeter forming element may vary in length. At least two surrounding forming elements may be joined to form a pair of surrounding forming elements. There may be one or more connecting elements between the surrounding forming elements forming the pair of surrounding forming elements. The connecting elements can be found in various geometric shapes including linear, curved, or a combination of the two shapes. Each pair of surrounding forming elements is connected to an adjacent pair of surrounding forming elements by at least one connecting element. The number of connecting elements between surrounding forming elements or between surrounding forming element pairs in a pair may vary.

  As used herein, the term “surrounding element” means a structural element that surrounds the present skeleton, which may be cylindrical. In one embodiment, the perimeter forming elements are joined along two imaginary planes that are substantially perpendicular to the cylinder axis of the skeleton. The surrounding forming element may have a plurality of wavy shapes (or may consist of the same shape). A wavy shape is a repeating unit within the surrounding forming element and may have peaks and valleys. The number of wavy shapes per surrounding forming element is 2 to N, for example 2, 3, 4, 5, 6, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 30, 40, 50, 60, etc.

  When the vascular framework is in an expanded state, at least some of the connecting elements connect the surrounding forming elements in pairs and / or the connecting elements connect the surrounding forming elements in adjacent pairs. Thus, a continuous spiral pattern is formed.

  In one embodiment, the continuous spiral pattern is oriented substantially parallel to the cylinder axis of the skeleton. The continuous spiral pattern can take other orientations. The continuous spiral pattern may form a helix, and in certain embodiments, one or more helices, such as a double or triple helix, or 4, 5, 6 or more It can be a spiral of numbers. If more than one helix is present, adjacent helices can be substantially parallel to each other. Adjacent helices may not be parallel to each other. In one embodiment, there are two or more helices equidistant from the frame axis of the skeleton.

  The surrounding forming element may be uniform in shape. Alternatively, the surrounding forming element may be configured from various shapes. For example, the surrounding forming element can be a series of undulating shapes that can 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 a sine wave and a sawtooth. May be formed. The amplitude of the wavy shape can vary within one surrounding forming element or between two surrounding forming elements (the amplitude is a peak deviation of the function from zero). The amplitude and frequency of the wavy shape can also vary. For example, the surrounding forming element may be composed of a sinusoidal pattern having a repetitive pattern such as 2: 1: 2: 1, 2: 1, etc. with varying amplitude. In this case, the ratio of the amplitudes of the wavy shapes is expressed by the indicated ratio. Other ratios such as 3: 1, 4: 1, 5: 1, etc. are possible. The surrounding forming element may be composed of one or more segments, each segment having its own corrugated 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 with 18, 19, 20, 30, 40, 50, 60, etc. The shape of the segment may be linear or curved. Thus, the surrounding forming elements can be assembled in a modular manner from various segments that can be the same or different. In the skeleton, the length of all the surrounding forming elements may be the same. Alternatively, the length of the surrounding forming element may vary, for example, in a number of different ways. For example, the lengths of the perimeter forming elements in a pair may be the same, but the length of the perimeter forming elements closer to one end of the skeleton is longer than the length of the perimeter forming elements closer to the center of the skeleton, Or it may be less than the same length.

  The number of the connecting elements (first connecting element or second connecting element) connecting adjacent surrounding forming elements is 1 to N, for example, 1, 2, 3, 4, 5, 6, 7, 8 , 9, 10, or more, 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 But you can. Similarly, the number of the connecting elements connecting adjacent pairs of surrounding forming elements is 1 to N (for example, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10). The shape of such connecting elements may be linear, curved, S-shaped, inverted S-shaped, Z-shaped, inverted Z-shaped, or any combination thereof. The connecting element can take various angles with respect to the cylinder axis of the framework, for example, 0 to 20 °, 20 to 40 °, 40 to 60 °, or 60 to 80 °. Furthermore, the angles of these connecting elements may be positive or negative with respect to the cylinder axis of the skeleton. Where the connecting elements are curvilinear, they may be irregularities having a curvature present in selected portions of the connecting elements. The degree of curvature can also vary within one connecting element. The number of connecting elements can be employed to modify the flexibility of the framework due to the decrease in flexibility that typically appears when the number of connecting elements increases.

  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 that can be loosened between surrounding forming elements and allows greater expansion of the skeleton. The longer this S-shaped segment is, the more loose it is and the greater the extensibility present in the structure. The S-shaped connecting element may be smooth or square. In another embodiment, the S-shaped connecting element includes at least three substantially straight portions, and the first straight portion is substantially parallel to the barrel axis of the skeleton (eg, , Forming an angle between about 0 degrees and about 20 degrees with respect to the cylinder axis of the skeleton, and the second linear portion is substantially perpendicular to the axis (eg, of the skeleton The third linear portion is substantially parallel to the axis (eg, relative to the cylinder axis of the skeleton), forming an angle between about 70 degrees and about 90 degrees with respect to the cylinder axis. Forming an angle between about 0 degrees and about 20 degrees). In yet 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. (Eg, forming an angle between about 0 degrees and about 20 degrees with respect to the cylinder axis of the skeleton), the second linear portion is substantially perpendicular to the first linear portion. Yes (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 is the first linear portion (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 (eg, 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 surrounding forming elements, the connecting elements are located symmetrically or asymmetrically in a radial position along the periphery of the framework. If the connecting elements are located symmetrically, the radial distance between each pair of connecting elements, eg AB and BC, is equal.

  The radial positions listed here for the connecting element are provided for illustrative purposes only, the connecting element being along the circumference of the framework relative to the tube axis without undue trial and error. It can be arranged by a person skilled in the art at any point. For example, the arrangement of the connecting elements can be determined by dividing 360 ° by n, where n is the number of connecting elements between adjacent surrounding forming elements. When n = 3, the connecting elements may be symmetrically arranged around the stent at approximately 120 ° intervals. If there are two equally spaced connecting elements between adjacent surrounding forming elements, they are located at about 180 ° relative to each other. That is, the two connecting elements are directed opposite to each other.

  The connecting element that connects the surrounding forming elements in each pair for reference purposes only is called the first connecting element. On the other hand, a connecting element that connects the surrounding forming elements in adjacent pairs of surrounding forming elements is called a second connecting element. The first and second coupling elements may have the same shape or may have different shapes. In addition, the shape of the first connecting element that connects the surrounding forming elements in a pair of surrounding forming elements may be the same or may vary in both shape and length. Similarly, the connecting elements that connect adjacent pairs of surrounding forming elements may be the same or may vary in shape and length. As will be discussed further below, the first and second connecting elements are the peripheries in which the vascular framework forms a clearly bent pair outside the surface formed by the perimeter forming elements after expansion. It can be configured to allow expansion without creating a forming element. Thus, the connecting element (eg, second connecting element) between adjacent pairs of surrounding forming elements can extend in response to expansion of the framework. In one embodiment, these connecting elements have an S-shape or are curvilinear.

  When the skeleton is in an expanded state, at least some of the connecting elements that connect the surrounding forming elements in the pair and / or the connecting elements that connect the surrounding forming elements in adjacent pairs are continuous spirals or A spiral pattern is formed. In one embodiment, the spiral or spiral pattern has at least a portion of the first and second coupling elements. In another embodiment, the spiral pattern has at least a portion of the first coupling element. In the third embodiment, the spiral pattern has at least a part of the second coupling element. In a fourth embodiment, the spiral pattern has at least some of the first and second coupling elements and at least some of the surrounding forming elements. In a fifth embodiment, the spiral pattern has at least a part of the first connecting element and at least a part of the surrounding forming element. In a sixth embodiment, the spiral pattern has at least a part of the second connecting element and at least a part of the surrounding forming element.

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

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

  The undulating shape of the surrounding forming element may form peaks and valleys, either to the proximal or distal end of the vascular framework. The first connecting element may couple the surrounding forming elements in a mountain to mountain, mountain to valley, or valley to valley pair. Similarly, the second connecting element may connect the surrounding forming elements between adjacent pairs from mountain to mountain, mountain to valley, or valley to valley. The peak-to-peak, peak-to-valley, or valley-to-valley connection may be on the same cylinder axis or between surrounding 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 in adjacent surrounding forming elements, such as, but not limited to, a peak, a valley, a wavy shaped ascending part, or a descending part.

  The wavy shape of one surrounding forming element in the pair may be in phase or inconsistent with the wavy shape of the other surrounding forming element in the pair. If the two surrounding forming elements are inconsistent, the degree of phase difference can range from greater than 0 ° to 180 °, including but not limited to 5 °, 60 °, Degrees of 90 ° and 120 ° can be included.

  Similarly, the pair of undulations may be either in phase or alternatively inconsistent with the adjacent pair of undulations. If the two surrounding forming elements are inconsistent, the degree of phase difference can range from greater than 0 ° to 180 °, including but not limited to 5 °, 60 °, Degrees of 90 ° and 120 ° can be included.

  The undulating shape of the adjacent surrounding forming elements may be either in-phase or inconsistent. If the two surrounding forming elements are inconsistent, the degree of phase difference can range from greater than 0 ° to 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 framework by the expandable balloon, the surrounding forming element expands in the radial direction and becomes elongated in the peripheral direction. Conversely, when an external compressive force is exerted on the framework, the surrounding forming element contracts in the radial direction and shortens in the circumferential direction. When a radial expansion force is applied to the skeleton, the wavy shape has a smaller amplitude. Conversely, when an external compressive force is exerted on the frame, the wavy shape increases in amplitude.

  In another embodiment, the skeleton has a plurality of polygons. The polygon has an n-plane. Here, n is an arbitrary positive integer. For example, the polygon may have faces in the range of 3-30 (higher order polygons are also included in the design of the present invention). For example, polygons of 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 polygonal faces may or may not be equal. Opposite sides in the polygon may be substantially parallel to each other 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 from a plurality of wavy shapes connected by a plurality of connecting elements. For example, the polygon may be a hexagon formed by two wavy shapes connected by two connecting elements. The hexagon may have a first wave shape and a second wave shape, and the wave shape is connected by the first segment and the second segment. The filaments having the first and second wavy shapes in each hexagon may have different or the same width, length, and thickness. The polygon may be formed from a plurality of wavy shapes without connecting elements. For example, the polygon may be a quadrangle composed of two wavy shapes. In higher order polygons, for example, n = 8-30, the wavy shapes may be connected by a plurality of connecting elements.

  The wavy shape can be one segment or at least two segments (eg, 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 segment may be linear or curved. If the segment is curved, the degree of curvature can vary. The segment may be concave or convex. The segments may include only linear portions that are connected to each other, or may include only curved portions that are connected to each other. Alternatively, the segment may include both straight and curved portions that connect to each other. The segment may have at least one bend disposed at a selected point along its length. For example, the segments may take a stylized shape such as n, C, U, V, etc. The segment may be in the form of a loop. In this case, the loop may be circular or semicircular. The segments can take essentially any suitable configuration. The length, width, and thickness of the pre-wavy segment may or may not be equal. The two wavy shapes of each polygon across each surrounding forming component may be the same or may vary. A wide variety of configurations for the polygons and the various segments representing the faces of the polygons are encompassed by the present invention. For example, the segment representing the polygonal surface may be linear 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 having the opposite wavy shape. The polygon may be convex (ie, all its interior angles are less than 180 °) or non-convex (ie, the polygon includes at least one interior angle greater than 180 °). Good. The polygon may form a continuous, intermittent structure across the skeleton body. The surrounding forming elements (or pairs of surrounding forming elements) may include different or substantially identical polygons. The polygons of the different surrounding forming elements may be different or substantially the same. The surface areas of adjacent polygons may or may not be equal. The surface area of the polygon, i.e., the area encompassed by the face, can be mathematically calculated from the length of the face 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 pairs of surrounding forming elements are shown as 1-4. The surrounding forming elements in the skeleton for pairs 1 to 4 are indicated in parentheses as 1 (5, 6), 2 (7, 8), 3 (9, 10), and 4 (11, 12). ing. Said connecting element (first connecting element) between two surrounding forming elements in one pair 1 is shown as 13-18. On the other hand, the connecting elements (second connecting elements) between adjacent pairs 1 and 2 of surrounding forming elements are designated as 19-21. The framework may include marker dots 22. The polygon formed by the wavy shape of the framework and the connecting elements is illustrated by 23 and 24 boxes.

  Another embodiment of the present skeleton is shown in FIG. 2A. Here, the length of the surrounding forming elements of the present framework varies. The perimeter of the perimeter forming element is A> B> C. However, this order of length is shown for illustrative purposes only. The amplitude of the wavy shape 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 ( FIG. 2B). In the embodiment shown, the perimeter forming elements having 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), BB (33, 34), BB (35 36) and B-A (37, 38). However, many other combinations and distributions are possible. FIG. 2C shows a repetitive sinusoidal pattern in which the amplitude of the wavy shape is constant across the surrounding forming elements. FIG. 2D shows a non-repetitive sine wave pattern. In non-repetitive sinusoidal patterns, the amplitude and / or normal frequency of the wavy shape may vary either symmetrically or randomly along the perimeter of the surrounding forming element.

  The length of the surrounding forming element means the absolute distance of movement along the surrounding forming element starting from an artificial point on the surrounding forming element and returning to the same artificial point.

  A detailed view of a portion of the wavy shape forming two adjacent pairs of surrounding forming elements is shown in FIG. Said surrounding forming elements are shown as 39,40. They are connected by a connecting element (second connecting element), and the connecting element has two linear portions 41, 4101 and an S-shaped portion 42. The wavy shape of the surrounding forming element 40 has amplitudes 43 and 44. In the embodiment shown, 44 is greater than 43.

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

  5A-5C show the framework in an orthogonal view (5A), a side view (5B) and an end view (5C). The surrounding forming elements are labeled 60-64 and 65-70. The connecting elements between the pair of surrounding forming elements are shown as 71, 72, 74, 75 (first connecting elements). On the other hand, the connecting element between two pairs is indicated by 73. The helically shaped design is shown as 76-78, wherein the connecting elements between a pair of surrounding forming elements and the connecting elements between the forming elements forming the pair (first and second connecting elements, respectively) )including. The surrounding forming elements forming the pair are indicated by emphasis lines 63,64.

  FIG. 6 shows a cutting pattern of another embodiment of the present skeleton. 79, 80; 81, 82; 83, 84; 85, 86; 87, 88; 89, 90, and 91, 92 together, the surrounding forming elements are 79- 92. The helical pattern is shown as 93-103 and together with connecting elements (first connecting elements) 94, 96, 98, 100, and 102 between the surrounding forming elements forming a pair, The connection elements (second connection elements) 93, 95, 97, 99, 101, and 103 between the pairs are alternately repeated. In the inset to FIG. 6, a partially compressed view of the skeleton is shown. The surrounding forming elements are indicated by 107 and 107 ′. On the other hand, the connecting elements are indicated by 105 and 106. The present framework shown in the figure includes two or more helical patterns 108-110 that may be substantially parallel to each other.

  FIG. 7 shows a cutting pattern of the present frame having a spiral pattern that repeats alternately. In this embodiment, the spiral pattern includes connecting elements (first connecting elements) 112, 115, 118, 121 between a pair of surrounding forming elements, and portions 113, 117 of the wavy shape of the surrounding forming elements. , 120 and connecting elements (second connecting elements) 111, 114, 116, 119, 122 that connect two adjacent pairs of surrounding forming elements. In this embodiment, the spiral pattern has the following repetitive arrangement starting from one end of the skeleton: a first connecting element, a second connecting element, a part of the wavy shape, a first connecting element, a second And a part of the wavy shape. This repeating arrangement is repeated across the framework. Other repeating arrangements include, but are not limited to, (a) a first connecting element, a portion of the wavy shape, a first connecting element that is repeated n times across the body of the skeleton; (B) a first connecting element repeated n times over the body of the skeleton, a portion of the wavy shape; (c) a second connecting element repeated n times over the body of the skeleton; A portion of a wavy shape; or (d) a second connecting element, a portion of the wavy shape, a second connecting element repeated n times over the body of the skeleton.

  FIG. 8 shows an embodiment in which the connecting elements have various shapes and the distribution of the pattern of the connecting elements varies across the body of the skeleton. Specifically, in the illustrated embodiment, the connecting elements between pairs of surrounding forming elements are straight 124-126 and 130-132, or curved 127-129, 134-136, and 137. ~ 139. One of the curved connecting elements between the pair of surrounding forming elements has both straight and curved portions 127-129. As is apparent from the illustration, the pattern of the connecting elements can vary across the body of the skeleton. Curved shapes 137 to 139, 134 to 136, linear shapes 130 to 132, curved shapes 127 to 129, and linear shapes 124 to 126. Other possible arrangements and geometric shapes are encompassed by the present invention. One skilled in the art can select the arrangement and type of connecting elements that meet the flexibility and spatial requirements required of the blood vessel.

FIG. 9 shows the cutting pattern of this skeleton in a spiral pattern that alternates with surrounding forming elements of varying length. This embodiment illustrates the nature of the modular design of the skeleton, where different length peripheral forming elements and various connecting elements are combined to form a skeleton having two types of spiral patterns. The peripheral forming element has lengths A _n , B _n , and C _n . For example, in one embodiment, the peripheral length 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 spiral pattern at 147 is formed by connecting elements between surrounding forming elements forming a pair (first connecting elements) 148, 150, 152 and connecting elements between pairs of surrounding forming elements (second connecting elements). 149, 151. The other spiral pattern 154 includes connecting elements (first connecting elements) 155, 158 between surrounding forming elements forming a pair, wavy portions 157, 160 of the surrounding forming elements, And a connecting element (second connecting element) 156, 159 between the pair.

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

  FIG. 11A shows a cutting pattern of the present frame having a spiral pattern that alternates alternately. The surrounding forming elements are labeled 458-464, with pairs of surrounding forming elements shown as 458, 459, 460, 461, and 462, 463. In this embodiment, the spiral pattern includes connecting elements (first connecting elements) 451, 455 between a pair of surrounding forming elements, wavy portions 452, 454, 456 of the surrounding forming elements, and the surroundings. It is formed from an alternating pattern of connecting elements (second connecting elements) 453, 457 connecting two adjacent pairs of forming elements. In this embodiment, the spiral pattern has the following repetitive arrangement starting from one end of the skeleton: first connecting element, part of the wavy shape, second connecting element, part of the wavy shape. . The repeating arrangement is repeated across the skeleton. In FIG. 11A, the first and second connecting elements are both linear.

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

  One problem with prior art designs is that the wavy shapes that form adjacent surrounding forming elements are twisted as the framework expands. This design has been improved.

  FIG. 12 illustrates the functionality of the connecting elements between adjacent pairs of surrounding forming elements. 199 and 200 are a pair of surrounding forming elements. Three types of connecting elements, linear 201 and curved 202, 203 are shown. As the skeleton expands, the connecting element 201 is constrained and cannot adjust the expansion of the surrounding forming element, but either the connecting element 203 or 203 is hardly constraining and the surrounding forming elements in adjacent pairs are Adjust expansion without twisting out of faces 197, 198.

  FIG. 13 illustrates the geometry of the skeleton and connecting elements when expanded. The pair of surrounding forming elements is shown as 206,207. The connecting elements (first connecting elements) between the wavy shapes forming the pair of surrounding forming elements are indicated by 208 to 210. The connecting element between the pair is indicated by 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 by 215 and 216. The angle formed by 211, 212, and 213 is indicated by 214. After expansion, the angles 214 ′, 215 ′, and 216 ′ are all increased.

  FIGS. 14A and 14B show various structural geometries of connecting elements that can be between surrounding forming elements in a pair (first connecting element) or between adjacent pairs of surrounding forming elements (second connecting element). FIG. The connecting elements are S-shaped, 217, 217 ′, 401, 404 to 409, linear 218, 410, 218 ′, 413 (bent), concave / convex 219, 219 ′, 411, 412, curved 402, 403, 414. The connecting element may be any point on an adjacent surrounding forming element, for example, a peak (426, 428), a valley (425, 427), or a wave-shaped rise (415, 416, 419, 420, 421, 422, 423, 424, 429, 430, 433) or any point of the descending part (417, 418, 431, 432, 434) may be connected.

  FIG. 14C shows that with one end of a connecting element attached to a wave-like point of a surrounding forming element, the other end of said connecting element is in a directly corresponding peak or valley of an adjacent surrounding forming element, or 2, 3, 4, 5, 6, 7, 8, 9. . . Indicates that it can be attached to a point that is shifted by a wave shape of N (N can be any positive integer) (the shift may be in any direction). In FIG. 14C, the two ends of the connecting element are 480 (crest), 481 (valley); 482 (crest), 483 (valley shifted by one wavy shape); 484 (crest), 485 ( 480 (valley), 487 (mountain).

  15A-E illustrate where the connecting elements can be attached along a wavy shape. Here, the connecting element is shown as a straight line, but this shape is shown for illustrative purposes only, and the connecting element is curved or S-shaped or included in the present invention. Can be any other shape. The embodiment shown here is applicable to both the first and second connecting elements. The barrel axis of the present framework is also shown. The connecting element 220 may be attached to one trough of one wavy shape 221 and a crest of another wavy shape 222 (FIG. 15A). Alternatively, the connecting element 224 can be attached to both sides of the valleys or peaks of the two wavy shapes 223, 225 (FIG. 15B). The connecting element 227 can be attached to two corrugated valleys 226, 228 (FIG. 15C). The connecting element 230 can also be attached to two wavy shaped peaks 229 and valleys 231 (FIG. 15D). The connecting element 234 can also be attached to two wavy shaped raised portions 232, 235 (FIG. 15E). The figure shown here illustrates a connecting element that is attached in a wavy shape in the opposite direction, but the connecting element may be attached in a wavy shape that is radially shifted with respect to the cylinder axis. (FIG. 16) (236-238).

  The proximal and distal ends of the skeleton can be displayed relative to the heart as the proximal ends closest to the aortic valve. The terms peak and valley are arbitrarily defined with respect to the proximal and distal ends of the framework.

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

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

  FIG. 19A schematically illustrates a cutaway view of a skeleton according to one embodiment of the present invention. The skeleton includes three longitudinally adjacent perimeter forming elements 2010, 2020, and 2030. In this case, the pair of surrounding forming elements 2010 and 2020 are connected by the first connecting element 2012. The first connecting element 2012 is linear. The pair of surrounding forming elements 2020 and 2030 are connected by a second connecting element 2022. The second connecting element 2022 is S-shaped. Surrounding elements 2010 and 2030 are shown to include a sawtooth wavy pattern. The pattern is composed of a plurality of linear elements. The surrounding forming element 2020 may include a corrugated pattern 2050 (shaded / darker). This pattern is further illustrated below in connection with FIG. 19B. For illustration purposes, the corrugated pattern 2050 is superimposed on the fictitious sawtooth pattern in FIG. 19A.

  FIG. 19B is an enlarged view of a part 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 corrugated shape (ie, the repeating unit of the corrugated pattern in the surrounding forming element, including one peak and its adjacent valley) is connected in series with each other. Linear segments 2051, 2052, 2053, 2054, 2055, 2056. When the skeleton is in an expanded state, each of the linear segments is not collinear with adjacent linear segments that connect. The linear segments within one wavy shape are approximated together in a sinusoidal period.

  Although the corrugated pattern is shown in FIGS. 19A and 19B to include six straight segments per corrugated shape, a larger number of segments per corrugated shape, eg, 8, 10, 12, 16, 20, 24, 32, 36, 48, 64, etc. may be used. Each of the linear segments can be approximately the same length (variable, less than 10%), or the length can be varied as desired or required. A series of connected curvilinear segments can also be used to form the corrugated pattern. For example, each wavy shape of the present skeleton includes a series of partial wavy shapes or wavelets, as illustrated in FIG. 19D. In this case, the six curvilinear segments constituting the wavy shape are displayed as 2051a, 2052a, 2053a, 2054a, 2055a, and 2056a. (FIG. 19C shows the same waveform pattern as shown in FIG. 19B, with a wavy center line acting as the center line for the surrounding forming elements shown in FIG. 19D). The number of the curved segments forming the waveform pattern may be more than 6, for example, 8, 10, 12, 16, 20, 24, 32, 36, 48, 64, etc. The curvilinear segments within one wavy shape in FIG. 19D are also approximated together with a sinusoidal period.

  Such a corrugated pattern is crystallized by expansion of the skeleton, in particular the skeleton, in contrast to two local stress points (typically at the peaks and valleys) at the wavy shape in conventional skeleton designs. That are formed from a polymer material capable of deriving, make it possible to have additional local stress points. Thus, the corrugated pattern allows stress due to radial expansion of the skeleton to be more evenly distributed along the surrounding forming elements, and a more uniform distribution of induced crystallization of the polymer material. Enable. As a result, a skeleton containing the described corrugated pattern may have higher radial strength, reduced rapid shrinkage after placement, and reduced creep.

  The connecting elements shown in FIGS. 19A and 19B are straight or S-shaped. In other embodiments, the coupling element may also include a corrugated pattern having a plurality of linear or curved segments that are coupled together.

  Although FIGS. 19A and 19B illustrate two successive wavy shaped corrugated patterns at the surrounding forming element 2020, in another embodiment, such corrugated patterns may extend throughout the surrounding forming element 2020. FIG. In other embodiments, all of the surrounding forming elements can be formed from a repetitive corrugated pattern, as illustrated in FIGS.

  FIG. 20A shows an embodiment of the skeleton of the present invention in which each surrounding forming element is composed of a repetitive waveform pattern. 321, 322; 323, 324; 325, 326; 327, 328, and 329, 330, together with a pair of surrounding forming elements, the surrounding forming elements are labeled 321-330. The ridges and valleys of the framework are generally in phase. Three connecting elements are used between each two longitudinally adjacent surrounding forming elements, one for every two wavy shapes in each surrounding forming element. The pair of circumferentially adjacent surrounding elements 321, 322 are connected by a straight (or straight) first circumferential element 332, and the longitudinally adjacent circumferential elements 322, 323 are connected to each other. The pairs are connected by an S-shaped second surrounding forming element 333. The first connecting element 332 connects the mountain 3211 of the surrounding forming element 321 with the valley 3222 of the surrounding forming element 322. The second connecting element 333 connects the valley 3222 with the crest 3234 of the surrounding forming element 323 adjacent to the trough 3232 (the valley 3232 is longitudinally aligned with the trough 3222). The connection pattern repeats across the stent to form a helical shape that includes connection elements 331-340. Two marker dots 1902 and 1904 are located at each end of the skeleton (in the connecting element 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. In FIG. 20D, an enlarged view of a portion of FIG. 20A is shown to further illustrate the repetitive waveform pattern. In this embodiment, two longitudinally adjacent perimeter forming elements are shown as 353, 354. They are connected by connecting elements (first connecting elements) 355 and 356. The linear segments that make up the repetitive waveform pattern are shown as 341-352.

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

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

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

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

  The perimeter forming elements 2210 and 2215 at the proximal end of the skeleton can be connected by straight connecting elements 2212 in a valley-to-valley for each wavy shape. The proximal pair of perimeter forming elements 2210 and 2215 together with the connecting element 2212 form a proximal end zone. The perimeter forming elements 2260 and 2270 at the distal end of the skeleton may be connected by a straight connecting element 2262 in a ridge-to-mountain for each wavy shape. The perimeter forming elements 2260 and 2270 together with the connecting element 2262 form a distal end zone. Although both the proximal end zone and the distal end zone are shown to include two surrounding forming elements that are generally in phase, either or both of the zones can alternatively be a phase change. May include two surrounding forming elements, eg, 180 degrees mismatch, eg, of the embodiment illustrated in FIGS. 25A and 26A. Marker dots 2282 and 2284 are located on the connecting element connecting the proximal pair of surrounding forming elements 2210 and 2215 and the connecting element connecting the distal pair of surrounding forming elements 2260 and 2270, respectively.

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

  FIG. 22B shows a skeleton cutting pattern according to another embodiment of the present invention in which each surrounding forming element is completely constructed from the corrugated pattern described in connection with FIGS. 19A-19B. In this cutting pattern, each surrounding forming element in this pattern has eight wavy shapes (as shown, u1, u2, u3, u4, u5 instead of the six wavy shapes shown in FIG. 22A). , U6, u7, u8) is substantially the same as the pattern shown in FIG. 22A.

  FIG. 23 illustrates a skeleton cutting pattern according to another embodiment of the present invention, including the waveform pattern described in connection with FIGS. 19A-19B. The skeleton includes surrounding forming elements 2310, 2320, 2330, 2340, 2350, 2360, 2370, 2380, which are then connected by connecting elements 2312, 2322, 2332, 2342, 2352, 2362, 2372. Connected. The design pattern between the surrounding forming elements 2300 and 2370 is the pattern between the surrounding forming elements 2200 to 2255 with respect to the connecting element (S-shaped connecting element connecting adjacent pairs of surrounding forming elements in a mountain-valley) in FIG. Is similar. The proximal pair of surrounding forming elements 2310 and 2320 may be connected by a diagonally straight connecting element 2312 (valley-mountain). The distal pair of perimeter forming elements 2370 and 2380 can be connected by a diagonally straight connecting element 2372 (valley-mountain). Marker dots 2385 and 2387 are located on the connecting element connecting the proximal pair of surrounding forming elements 2310 and 2320 and the connecting element connecting the distal pair of surrounding forming elements 2370 and 2380, respectively.

  FIG. 24 illustrates a skeleton cutting pattern according to another embodiment of the present invention, including the waveform pattern described in connection with FIGS. 19A-19B. The skeleton includes surrounding forming elements 2410, 2420, 2430, 2440, 2450, 2460, 2470, which are then connected by connecting elements 2412, 2422, 2432, 2442, 2452, 2462. Each surrounding forming element includes six wavy shapes, and all of the alternately repeating peaks and valleys of these surrounding forming elements are generally in phase with the cylinder axis. Each two longitudinally adjacent surrounding forming elements are connected in a ridge-valley for all other peaks (or valleys) in the surrounding forming element by diagonally straight connecting elements. All of the connecting elements are substantially parallel to each other and together with a portion of the surrounding forming elements form a spiral pattern across the skeleton. For purposes of illustration, for circumferentially adjacent elements 2420, 2430 that are longitudinally adjacent, connecting element 2422 connects peak 2421 and valley 2431 adjacent peak 2433 (peak 2433 extends longitudinally with valley 2421. Aligned.) Similarly, for longitudinally adjacent perimeter elements 2430, 2440, connecting element 2432 connects peaks 2435 and valleys 2445 adjacent to peaks 2443 that are longitudinally aligned with peaks 2435. For this reason, the connecting element 2422, a part of the surrounding forming element 2430 between the valley 2431 and the peak 2435, the connecting element 2432, a part of the surrounding forming element 2440 between the valley 2445 and the peak 2446, and then the connecting element 2242 are continuous. A spiral shape is formed.

  FIG. 25A shows a skeletal cutting pattern according to another embodiment of the present invention in which each surrounding forming element is composed entirely of the corrugated pattern described in connection with FIGS. 19A-19B. The framework includes surrounding forming elements 2510, 2515, 2520, 2525, 2530, 2535, 2540, 2545, 2550, 2555, 2560, 2565, 2570, 2575, 2580, which are then connected elements 2512, 2517, 2522, 2527, 2532, 2537, 2542, 2547, 2552, 2557, 2562, 2567, 2572, 2577. Each surrounding forming element includes six wavy shapes (u1, u2, u3, u4, u5, u6 as shown), and the alternating repeating peaks and valleys of these surrounding forming elements are all the first Except for the surrounding forming element 2510 and the last surrounding forming element 2580, they are generally in phase. The first surrounding forming element 2510 and the last surrounding forming element 2580 are 180 degrees mismatch (or opposite) with respect to the remaining surrounding forming elements. The first two surrounding forming elements 2510, 2515 and the last two surrounding forming elements 2575, 2580 (these surrounding forming elements are ridged for each wavy shape by means of longitudinally aligned linear connecting elements 2512 and 2577. -The remaining longitudinally adjacent surrounding forming element pairs each have a valley-valley (for all two wavy shapes) by means of longitudinally aligned linear connecting elements. Or mountain-mountain). The proximal pair of perimeter forming elements 2510 and 2515 together with the connecting element 2512 form a proximal end zone. The distal pair of perimeter forming elements 2575 and 2580 together with the connecting element 2577 form a distal end zone. Both the proximal end zone and the distal end zone are shown to include two surrounding forming elements that are generally 180 degrees mismatch (or opposite one another), but either or both of the zones May alternatively include two surrounding forming elements that are generally in phase, such as the embodiment illustrated in FIG. 22A.

  In the framework shown in FIG. 25A, the connecting elements together with a part of the surrounding forming elements form a spiral pattern across the framework. For purposes of illustration, with respect to longitudinally adjacent perimeter-forming elements 2525, 2530, connecting element 2527 connects valley 2524 and valley 2531 adjacent to peak 2529 (peak 2529 extends longitudinally with peak 2523). Aligned.) Similarly, for circumferentially adjacent surrounding elements 2530, 2535, connecting element 2532 connects peak 2533 and peak 2534 adjacent to valley 2538 (valley 2538 is longitudinally aligned with valley 2531. ing.). For this reason, the connecting element 2527, a part of the surrounding forming element 2530 between the valley 2431 and the peak 2435, the connecting element 2432, a part of the surrounding forming element 2440 between the valley 2531 and the peak 2533, and then the connecting element 2532 are continuous. A spiral shape is formed. The helical shape includes connecting elements 2537, 2542, 2547, 2552, 2557, 2562, 2567, and a crest of each of the surrounding forming elements and its adjacent valleys that the surrounding forming elements traverse the connecting elements. Followed to include some in between.

  FIG. 25B shows a skeletal cutting pattern according to another embodiment of the present invention in which each surrounding forming element is composed entirely of the corrugated pattern described in connection with FIGS. 19A-19B. In this cutting pattern, each surrounding forming element in this pattern has eight wavy shapes (as shown, u1, u2, u3, u4, u5 instead of the six wavy shapes shown in FIG. 22A). , U6, u7, u8) is substantially the same as the pattern shown in FIG. 25A.

  FIG. 26A shows a skeletal cutting pattern according to another embodiment of the present invention in which each surrounding forming element is composed entirely of the corrugated pattern described in connection with FIGS. 19A-19B. The framework includes surrounding forming elements 2610, 2615, 2620, 2625, 2630, 2635, 2640, 2645, 2650, 2655, 2660, 2665, 2670, 2675, 2680, which in turn are connected elements 2612, 2617, 2622, 2627, 2632, 2637, 2642, 2647, 2652, 2657, 2662, 2667, 2672, 2677. Each surrounding forming element includes six wavy shapes (u1, u2, u3, u4, u5, u6 as shown), and the alternating repeating peaks and valleys of these surrounding forming elements are all the first Except for the perimeter forming element 2610 and the last perimeter forming element 2680, they are generally in phase. The first surrounding forming element 2610 and the last surrounding forming element 2680 are 180 degrees mismatch (or opposite) with respect to the remaining surrounding forming elements. The first two surrounding forming elements 2610, 2615 and the last two surrounding forming elements 2675, 2680 (these surrounding forming elements are each longitudinally aligned with linear connecting elements 2612 and 2617 for each wavy shape, respectively. Each of the remaining longitudinally adjacent surrounding forming element pairs is valley-valley for all two wavy shapes by means of longitudinally aligned linear connecting elements. (Or mountain-mountain). A proximal pair of perimeter forming elements 2610 and 2615 together with a connecting element 2612 form a proximal end zone. The distal pair of perimeter forming elements 2675 and 2680 together with the connecting element 2677 form a distal end zone. Both the proximal end zone and the distal end zone are shown to include two surrounding forming elements that are generally 180 degrees mismatch (or opposite one another), but either or both of the zones May alternatively include two surrounding forming elements that are generally in phase, such as the embodiment illustrated in FIG. 22A.

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

  FIG. 26B shows a skeleton cutting pattern according to another embodiment of the present invention, wherein each surrounding forming element is completely composed of the corrugated pattern described in connection with FIGS. 19A-19B. In this cutting pattern, each surrounding forming element in this pattern has eight wavy shapes (as shown, u1, u2, u3, u4, u5 instead of the six wavy shapes shown in FIG. 22A). , U6, u7, u8) is substantially the same as the pattern shown in FIG. 26A.

  FIG. 27A is a three-dimensional view of a portion of a skeleton according to another embodiment of the present invention, including the waveform pattern described in connection with FIGS. 19A-19B. FIG. 27B is an enlarged rear view of the skeleton shown in FIG. 27A. FIG. 27A shows two surrounding forming elements 2710 and 2720 connected by a straight connecting element 2715 between a crest 2712 of surrounding forming element 2710 and a valley 2722 of surrounding forming element 2720. The valley 2722 is 180 degrees phase shifted from the peak 2712. The perimeter forming element 2710 is also connected to the previous perimeter forming element (not shown) by an S-shaped connecting element 2705. Both connecting elements 2705 and 2715 connect the surrounding forming elements 2710 at the same peak 2712. Connecting element 2715 and peak 2712 connect to form a large angle 2735 that opposes angle 2730 and acute angle 2730. Angle 2735 may be an obtuse angle (greater than 90 degrees and less than 180 degrees), or greater than 180 degrees. A notch is located at the intersection of the connecting element 2715 and the peak 2712 and at an angle 2735 (the notch can be a slight dent or decrease in the thickness of the connecting element or the surrounding forming element, and can be of various shapes. For example, it can be V-shaped, U-shaped, etc.). Such notches facilitate crimping and expansion by allowing the linear segments of the wavy pattern to fold with reduced fatigue or folding at the folding or crimping points. The notches can be arranged on both sides of the surrounding forming element, and can be arranged at other points along the surrounding forming element where the connecting element and the surrounding forming element intersect. The notches can be distributed in any other way along the surrounding forming element. Notches can also be used with the corrugated pattern, eg, conventional perimeter forming elements that do not include the skeleton shown in FIG.

  The framework may further comprise at least one radiopaque marker. The markers can be housed in the marker dots as described herein. The radiopaque markers can take various sizes and shapes. The radiopaque marker can be a high electron density or x-ray refraction marker, such as a metal particle or salt. Non-limiting examples of suitable marker metals include iron, gold, colloidal silver, zinc, and magnesium, either in pure form or as organic compounds. 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. Further embodiments that may be utilized may include naturally encapsulated iron particles, such as ferritin, that can be further crosslinked by a crosslinking agent. Ferritin gels can be constructed by crosslinking with low concentrations (0.1-2%) of glutaraldehyde. The radiopaque marker can be composed of one or more biodegradable polymers, for example, binders such as PLLA, PDLA, PLGA, PEG and the like. In one embodiment with radiopaque markers, the iron-containing compound or iron particles are encapsulated in a PLLA polymer matrix to produce a pasty material. The material can be injected or otherwise deposited into a hollow container contained around the stent. In another embodiment, the marker may be formed from a biodegradable or bioabsorbable material.

  The skeleton may also have a transition zone between the end zone and the body. The transition zone can be formed from a plurality of wavy shapes, each wavy shape having two adjacent connecting elements connected by a loop having a loop width that 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. US Patent Application Publication No. 201110125251. 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, about 60 mm to about 150 mm in length, Or the length can 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 non-vascular), ranging from about 6 mm to about 12 mm (eg, for the iliac femur), from about 10 mm to about 20 mm (eg, for the iliac artery), and from about 10 mm to about 25 mm (eg, for the aorta) obtain.

  The device of the present invention can be used as a self-expanding stent or as described in US Pat. Nos. 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 the specification. In one embodiment, the device is used with a balloon catheter system disclosed in US Pat. No. 7,169,162.

  The framework of the present invention can be used with any suitable catheter. The diameter can range from about 0.8 mm to about 5.5 mm, from about 1.0 mm to about 4.5 mm, from about 1.2 mm to about 2.2 mm, or from 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 skeleton can 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 duct, such as the ureter or urethra, coronary artery, inguinal artery, aortoiliac artery, subclavian artery, mesenteric artery, Or it may be used to treat narrowing or stenosis of any artery, including the renal artery. Other types of vascular occlusions such as those caused by dissecting aneurysms are also encompassed by the present invention. Subjects that can 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 bioabsorbable polymer that provides a wide range of different polymers that can be crystallized. Typically, the bioabsorbable polymer is an aliphatic polyester based on a lactide backbone, such as poly L-lactide (PLLA), poly D-lactide (PDLA), poly D, L-lactide, as a homopolymer or copolymer. It has meso lactide, glycolide, lactone, and an aliphatic polyester formed in a copolymer moiety with comonomers such as trimethylene carbonate (TMC) or ε-caprolactone (ECL). U.S. Patent Nos. 6,706,854 and 6,607,548; European Patent No. 0401844; and Jeon et al. Synthesis and Characterisation of Poly (L-lactide) -Poly (ε-caprolactone) Multiblock Polymers Macromolecules 2003: 36, 5585-5592. The copolymer may be crystallized from glycolide, polyethylene glycol (PEG), ε-caprolactone, trimethylene carbonate, or monomethoxy-terminated PEG (monomethyl-terminated PEG: PEG- It has a full length 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 is a bioabsorbable polymer composition, such as US Pat. Nos. 7,846,361; 7,897,224 and 8,137,603; It is also composed of what is disclosed in pending US Patent Application Publication No. 2010/0093946.

  Based on the presence of the monomer species, the following polymer nomenclature is used.

  In an embodiment of the invention, the composition has a base polymer of poly (L-lactide) or poly (D-lactide). 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 in a molar ratio of 10-20%.

  Another embodiment is a base polymer based on a poly (L-lactide) moiety and / or a poly (D-lactide) moiety attached to the modified copolymer, such as a block copolymer 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- [epsilon] -caprolactone), where the chain length of the lactide is sufficient to achieve cross-moiety crystallization. . Cross-linked crystallization of the composition comprising the copolymer gives improved modulus data in tensile testing and avoids methods that reduce the tensile strength in the polymer blend.

The polymer composition enables the development of a lactidol semi (stereocomplex) crystal structure between L and D moieties, and further improves the mechanical properties of bioabsorbable polymer medical devices. . Formation of the racemic (stereocomplex) crystal structure can result from the following combinations and the like:
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; and
Poly D-lactide-co-PEG and poly L-lactide-co-TMC.

  The poly-lactide racemic composition can be “moldable or bendable at low temperatures” without further heating. The cold bendable skeleton of the present invention does not need to be strung to be flexible enough to be crimped onto a carrier device, and accommodates irregularly shaped organ spaces. Low temperature bendable ambient temperature is defined as room temperature not exceeding 30 ° C. A cold bendable skeleton can provide sufficient flexibility when implanted to allow the skeleton instrument to expand in an organ space, eg, a pulsating vessel cavity. For example, with respect to stents, it is possible to crystallize secondary nested or distally arranged torsional connecting elements, especially when the skeleton is stretched by stretching on the basis of an implantable balloon expansion, which is almost non-crystalline after manufacture. It may be desirable to utilize a polymer composition that provides a functional polymer moiety. Such cold bendable polymer framework embodiments are not brittle and may not be preheated to a flexible state prior to implantation on the contoured surface space in the body. The 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 racemic composition and the non-racemic composition of the embodiments herein are block-type moieties that allow crystallization of cross-linked moieties even when impact modifiers are added to the blend composition. May be processed to have (moiety). Such blends lead to the possibility of designing polymer compositions or blend specific devices by generating either single or double Tg (glass melting transition point).

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

  The usefulness of the polymer implant can be assessed by measuring mass loss, molecular weight reduction, retention of mechanical properties, and / or tissue response. Performance that is more important to the framework is hydrolytic stability, thermal transition, crystallinity, and orientation. Other determinants that negatively affect skeletal performance include, but are not limited to, monomer impurities, cyclic and acyclic oligomers, structural defects, and aging.

  The framework formed from the polymer composition may be clearly amorphous after extrusion or molding. The framework can 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 can be utilized either before secondary or final processing (eg, by laser cutting), or any framework “blank” after such secondary processing. Crystallization (and hence mechanical properties) is also maximized by the introduction of tension, for example, by pulling polymer tubes, hollow fibers, sheets or films, or monofilaments “cold” before further processing. obtain. It has been observed that crystallization contributes to higher stiffness in the framework. Thus, the polymer composition and steric complex of the framework has both non-crystalline and paracrystalline moieties. Initially the semi-crystalline polymer portion can be manipulated by the stretching or expanding action of a given device. In addition, a sufficient amount of amorphous polymer properties is desirable for the flexibility and elasticity of the polymer device. Useful monomer components include lactide, glycolide, caprolactone, dioxanone, and trimethylene carbonate. The skeleton may be constructed to allow relatively uniform exposure to local tissue or circulating bioactive factors and enzymes that circulate and act on the polymer structure during bioresorption.

  The in situ degradation kinetics of the polymer matrix of organ space implants, such as cardiovascular stents, are gradual enough to avoid tissue overload, inflammatory reactions, or other more harmful consequences. In embodiments, the skeleton is manufactured to remain for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, or 36 months.

  A pharmaceutical composition may be included within the polymer, for example, by grafting or coating the active site of the polymer. Polymer embodiments according to the present 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 adhere to the drug in the polymer matrix. The purpose of such additives may be to provide treatment in the cardiovascular system or vascular site that is in contact with the polymer of the medical device, for example with respect to a stent. The type of drug encapsulated or deposited in the polymer can determine the rate of release from the skeleton. For example, the agent or other additive can be attached to the polymer matrix by various known methods, including but not limited to covalent bonds, nonpolar bonds, and esters or similar bioreversible means of attachment. Can be combined.

  In one embodiment, the bioabsorbable implantable medical device comprises a biodegradable and bioabsorbable coating comprising one or more barrier layers, wherein the polymer matrix contains one or more of the aforementioned pharmaceutical substances. It may be covered with. In this embodiment, the barrier layer includes, but is not limited to, polyesters such as PLA, PGA, PLGA, PPF, PCL, PCC, TMC, and any copolymers thereof; polycarboxylic acid, anhydrous Polyanhydrides including maleic acid polymers; polyorthoesters; polyamino acids; polyethylene oxides; polyphosphazenes; polylactic acid, polyglycolic acid, and copolymers and mixtures thereof such as poly (L-lactic acid) (PLLA), poly ( D, L-lactide), poly (lactic acid-co-glycolic acid), 50/50 (DL-lactide-co-glycolide); polydioxanone; polypropylene fumarate; polydepsipeptide; polycaprolactone, and copolymers and mixtures thereof, such as , Poly (D, L-lac Doco-caprolactone) and polycaprolactone co-butyl acrylate; valeric acid polyhydroxybutyrate and blends; polycarbonates such as tyrosine-derived polycarbonates and arylates, polyiminocarbonates, and polydimethyltrimethyl-carbonates; cyano Acrylate; calcium phosphate; polyglycosaminoglycan; macromolecules such as polysaccharides (including hyaluronic acid; cellulose and hydroxypropylmethylcellulose; gelatin; starch; dextran; including alginate and derivatives thereof), proteins, and polypeptides; As well as suitable biodegradable materials, including suitable biodegradable polymers including mixtures and copolymers of any of the foregoing. The biodegradable polymer may be a surface erodible polymer, such as polyhydroxybutyrate and copolymers thereof, polycaprolactone, polyanhydrides (both crystalline and amorphous), maleic anhydride copolymers, and zinc calcium phosphate It can also be. The number of barrier layers that the polymer framework on the device can have depends on the amount of therapeutic need required by the treatment required by the patient. For example, the longer the treatment, the more therapeutic material required over a period of time and the more barrier layers that provide the drug substance in a timely manner.

  In another embodiment, the additive in the polymer composition comprises, for example, a sustained release pharmaceutical agent that inhibits early neointimal hyperplasia / smooth muscle cell migration and proliferation, and maintains duct patency. Long-acting agents or agents that enlarge the diameter of blood vessels, such as vascular endothelial nitric oxide synthase (eNOS), nitric oxide donors and derivatives thereof, such as aspirin or derivatives thereof Nitric oxide-generating hydrogels, PPAR agonists such as PPAR-α ligands, tissue plasminogen activators, statins such as atorvastatin, erythropoietin, darbepoetin, serine proteinase-1 (SERP-1) , And Prabastachi Can be in the form of a multi-component pharmaceutical composition in a matrix containing a secondary biostable matrix that releases steroids, steroids, and / or antibiotics.

  The pharmaceutical composition can be included within the polymer, or it can be coated on the polymer surface after mixing and extrusion by spraying, dipping or painting, or microencapsulated and then the It can be blended into the polymer matrix. U.S. Patent No. 6,020,385. If the pharmaceutical compositions are covalently bound to the polymer blend, they may be bound by hetero- or homo-bifunctional crosslinkers (http://www.piercenet.com/products/browse). .Cfm? FldID = 020306.)

  Pharmaceutical agents that can be included in or coated on the framework include, but 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) inhibiting the growth of antineoplastic / antiproliferative / mitotic inhibitors such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilone, endostatin, angiostatin, angiopeptin, smooth muscle cells; 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-propa-2'-en-1'-yl] -20 rapamycin, (2 ': E, 4'S) -40-0- (4', 5 '.: dihydroxypenta-2'-en-1 '-Yl) rapamycin, 40-0 (2hydroxy) ethoxycarbonylmethyl-rapamycin, 40-0- (3-hydroxypropyl) -rapamycin, 40-0-((hydride 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-nicotinoyloxy) ethyl-rapamycin, 40- 0- [2- (N-25morpholino) 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 ′ ylcarbctoxamido) ethyl) -30 rapamycin, 40-0- (2-ethoxycarbonylaminoethyl) ) -Rapamycin, 40-0- (2-tolylsulfonamidoethyl) -rapamycin, 40-0- [2- (4 ′, 5′-dicarboethoxy-1 ′, 2 ′; 3′-triazole-1 ′ -Yl) -ethyl] rapamycin, 42-epi- (tellazolyl) rapamycin (tacrolimus), and 4 -[3-hydroxy-2- (hydroxymethyl) -2-methylpropanoate] rapamycin (temsirolimus) (WO 2008/086369); (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 inhibitors, platelet inhibitors, and tick antiplatelet peptides; (f) vascular cell growth promoters such as growth factors, transcription activators, and translational promoters; (g) vascular cell growth inhibitors such as growth Factor inhibitors, growth factor receptor antagonists, transcription inhibitors, Translation inhibitor, replication inhibitor, inhibitory antibody, antibody to growth factor, bifunctional molecule consisting of growth factor and cytotoxin, bifunctional molecule consisting of antibody and cytotoxin; (h) protein kinase and tyrosine kinase inhibitor ( (I) prostacyclin analogs; (j) cholesterol-lowering agents; (k) angiopoietin; (l) antibacterial agents such as triclosan, cephalosporins, aminoglycosides, and nitrofurans In; (m) cytotoxic agents, cytostatics, and cell growth influencing agents; (n) vasodilators; and (o) agents that interfere with the mechanism of endogenous vasoactivity, (ii) including antisense DNA and RNA Gene therapy agents and (a) antisense RNA, (b) tRNA or defects Or rRNA to replace the missing endogenous molecule, (c) growth factors such as acidic and alkaline fibroblast growth factor, vascular endothelial growth factor, epidermal growth factor, transforming growth factor a and P, platelet derived endothelial growth factor , 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”) DNA coding for) as well as other agents useful to prevent cell growth.

Other pharmaceutical agents that can be included in the framework include, but are not limited to, acarbose, antigens, β-receptor blockers, non-stereoidal antiinflammatory drugs (NSAIDs), strong Anxiety glucoside, acetylsalicylic acid, virus suppressor, aclarubicin, acyclovir, cisplatin, actinomycin, α and β sympathomimetic (dmeprazole, allopurinol, alprostadil, prostaglandin, amantadine, ambroxol, amlodipine, methotrexate, S-aminosalicylic acid, amitriptyline, amoxicillin, anastrozole, atenolol, azathioprine, valsalazide, beclomethasone, betahistine, bezafibrate, bical Mido, diazepam and diazepam derivatives, budesonide, bufexamac, buprenorphine, methadone, calcium salt, potassium salt, magnesium salt, candesartan, carbamazepine, captopril, cephalosporin, cetirizine, chenodeoxycholic acid, ursodeoxycholic acid, theophylline and theophylline derivatives , Trypsin, cimetidine, clarithromycin, clavulanic acid, clindamycin, clobutinol, clonidine, cotryxazole, codeine, caffeine, vitamin D and vitamin D derivatives, cholestyramine, cromoglycic acid, coumarin and coumarin derivatives, cysteine , Cytarabine, cyclophosphamide, cyclosporine, cyproterone, cytabaline, dapiprazole, deso Guestrel, desonide, dihydralazine, diltiazem, ergot alkaloid, dimenhydrinate, dimethyl sulfoxide, dimethicone, domperidone and domperidone derivatives, dopamine, doxazosin, doxorudrazole, doxorudrazole, , Glycoside antibiotics, desipramine, econazole, ACE inhibitors, enalapril, ephedrine, epinephrine, erythropoietin and erythropoietin derivatives, morphinan, calcium antagonists, irinotecan, modafmil, orlistat, peptide antibiotics, phenytodrosine, rilizole , Sildenafil, topiramate, macrolide antibiotics, estrogens and estrogen derivatives, progestogens and progestogen derivatives, testosterone and testosterone derivatives, androgen and androgen derivatives, etenzamid, etofenamate, clofibrate, fenofibrate, etofylHne , Etoposide, famciclovir, famotidine, felodipine, fenofibrate, fentanyl, fenticonazole, gyrase inhibitor, fluconazole, fludarabine, fluaridine, fluorouracil, fluoxetine, flurbiprofen, ibuprofen, flutamide, fluvastatin, follitropin, formomo Terol, fosfomycin, furosemi , Fusidic acid, galopamil, ganciclovir, gemfibrozil, gentamicin, ginkgo, hypericum perforatum, glibenclamide, urea derivatives as oral antidiabetics, glucagon, glucosamine and glucosamine derivatives, glutathione, glycerol and glycerol derivatives, hypothalamus Hormone, goserelin, gyrase inhibitor, guanethidine, halophanthrin, haloperidol, heparin and heparin derivatives, hyaluronic acid, hydralazine, hydrochlorothiazide and hydrochlorothiazide derivatives, salicylate, hydroxyzine, idarubicin, ifosfamide, imipramine, indomethacin, indamine , Insulin, in Terferon, iodine and iodine derivatives, isoconazole, isoprenaline, glucitol and glucitol derivatives, itraconazole, ketoconazole, ketoprofen, ketotifen, lacidipine, lansoprazole, levodopa, levomethadone, thyroid hormone, lipoic acid and lipoic acid derivatives, lisinopril, lisuride,
Lofepramide, lomustine, loperamide, loratadine, maprotiline, mebendazole, mebevelin, meclozine, mefenamic acid, mefloquine, meloxicam, mepindolol, meprobamate, meropenem, mesalazine, mesuximide, metamizole, metformin, methotrexate, methotrexate, methylphenidone Metoprolol, metronidazole, mianserin, miconazole, minocycline, minoxidil, misoprostol, mitomycin, mizolastine, moexipril, morphine and morphine derivatives, pine rush, nalbuphine, naloxone, thyridine, naproxen, narcotine, natamycin, niostrinfemidipine Niflumic acid, nimodipine, nimorazole, nimustine, nisoldipine, adrenaline and adrenergic derivatives, norfloxacin, novamine sulfone, noscapine, nystatin, ofloxacin, olanzapine, olsalazine, omeprazole, omoconazole, ondanoxanthol Conazole, oxymetazoline, pantoprazole, paracetamol, paroxetine, penciclovir, oral penicillin, pentazocine, pentifylline, pentoxifylline, perphenazine, pethidine, plant extract, phenazone, pheniramine, barbituric acid derivative, phenylbutazone, Phenytoin, pimozide, pindolol, piperazine, piracetam, pirenze , Piribezil, piroxicam, pramipexole, pravastatin, prazosin, procaine, promazine, propiverine, propranolol, propifenazone, prostaglandin, prothionamide, proxyphyrin, quetiapine, quinapril, quinaprilato, ramipril, propanirine, ranipril Rifampicin, risperidone, ritonavir, ropinirole, roxatidine, roxithromycin, ruscogenin, rutoside and rutoside derivatives, sabadilla, salbutamol, salmeterol, scopolamine, selegiline, sertaconazole, sertindole, sertralion, silicate, sildenafil, Simvastatin, sitostero , Sotalol, spaglumic acid, sparfloxacin, spectinomycin, spiramycin, spirapril, spironolactone, stavudine, streptomycin, sucralfate, sufentanil, sulbactam, sulfonamide, sulfasalazine, sulpiride, sultamicillin, sultiam, sumatriptan, squisammethonium chloride , Tacrolimus, taliolol, tamoxifen, taurolidine, tazarotene, temazepam, teniposide, tenoxicam, terazosin, terbinafine, terbutaline, terfenadine, terripressin, tertatrol, tetracycline, terisoline, theobrothiothio, teiothiazine Tiagabine, Chiapride , Propanoic acid derivatives, ticlopidine, timolol, tinidazole, thioconazole, thioguanine, thioxolone, tiropramide, tizanidine, torazolin, tolbutamide, tolcapone, tolnaphthate, tolperisone, topotecan, torasemide, antiestrogen, tramadol, tramazoline, trandolapril, tolanopril Trapidil, trazodone, triamcinolone and triamcinolone derivatives, triamterene, trifluperidol, trifluridine, trimethoprim, trimipramine, triprenamine, triprolidine, triphosphamide, tromantazine, trometamol, tropalpine, troxertin, tulobuterol, tyramine, tyrosuricin, uraciluricin Acid, chenodeoxychol , Valaciclovir, valproic acid, vancomycin, vecuronium chloride, viagra, venlafaxine, verapamil, vidarabine, vigabatrin, villoazine, vinblastine, vincamine, vincristine, vindesine, vinorelbine, vinpocetine, biquidiline, warxanthol, warxantholate, warxanthol, acid Contains zafirlukast, zalcitabine, zidovudine, zolmitriptan, zolpidem, zopricon, zotipine.

  See, for example, US Pat. Nos. 6,897,205, 6,838,528, and 6,497,729.

  The stent may be coded with 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.No. 7,037,772 (U.S. Patent Application Publication Nos. 20070213801, 200701196422, 20070119332, 20070156232, 200701141107, 20070055367, 20070742017, (See also 200601235476 and 20060121012).

  The framework of the present invention can also be formed from a metal such as nickel-titanium (Ni-Ti). The metal composition and method of manufacturing the device is disclosed in US Pat. No. 6,013,854. The superelastic metal for the instrument is preferably a superelastic alloy. A superelastic alloy is generally called a “shape memory alloy”, and after it is deformed to such an extent that a normal metal undergoes permanent deformation, it returns to its original shape. Superelastic alloys useful in the present invention are Elgiloy® and Phynox® spring alloys (Elgiloy® alloys are available from Carpenter Technology Corporation of Reading Pa., And Phynox® alloys are , Metal Impofy of Imphy, France), Carpenter Technology corporation and Latrobe Steel Company of Latrobe, Pa. 316 stainless steel and MP35N alloy available from, and Shape Memory Applications of Santa Clara, Calif. Superelastic Nitinol nickel-titanium alloy available from US Pat. No. 5,891,191.

  The framework of the present invention can be manufactured in a number of ways. The instrument can be formed by removing various portions of the tube wall from the tube to form the pattern described herein. Thus, the resulting device will be formed from one continuous piece of material and will not require the various segments to be connected to one another. Material can be removed from the tube wall using various 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 manufacturing a stent in this manner, a substantially stress-free structure can be created. In particular, the length can be adapted to the length of the diseased portion 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 includes providing a racemic poly-lactide mixture, creating a biodegradable polymer tube of the racemic poly-lactide mixture, and the like. Cutting the tube until a complete skeleton is formed. In this embodiment, the fabrication of the skeleton can be done using molding techniques or extrusion techniques. The molding technique is substantially free of solvent.

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

  The scope of the invention is not limited by what has been particularly shown and described above. Those skilled in the art will recognize that there are suitable alternatives to the materials, configurations, structures, and dimensions of the examples shown. Numerous references, including patents and various publications, are cited and discussed in the description of the invention. Citation and discussion of such references are provided only for clarity of explanation of the invention and no reference is admitted to be prior art to the 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 invention. While particular embodiments of the present invention have been shown and described, it will be apparent 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 (36)

A scaffold for implantation in a body lumen, the framework having a compressed state and an expanded state;
A plurality of surrounding forming elements, each surrounding forming element having a plurality of surrounding forming elements that have a plurality of wavy shapes consisting of alternately repeating peaks and valleys,
The plurality of perimeter forming elements form a generally cylindrical shape having a longitudinal axis;
The plurality of surrounding forming elements include a first surrounding forming element, a second surrounding forming element, and a third surrounding forming element, wherein the first and second surrounding forming elements are along a longitudinal direction. And the second and third surrounding forming elements are adjacent along the longitudinal direction, and the first and second surrounding forming elements are connected by a plurality of first connecting elements, The second and third surrounding forming elements are connected by a plurality of second connecting elements;
At least one of the surrounding forming elements has at least one corrugated shape having a corrugated pattern, the corrugated pattern having at least six linear segments continuously connected to each other; When the skeleton is in an expanded state, each said at least six linear segments are not collinear with adjacent connecting linear segments;
framework.   The skeleton according to claim 1, wherein the waveform pattern includes 6 to 36 linear segments.   The skeleton of claim 1, wherein the at least six connecting linear segments approximate a sinusoidal period when the skeleton is in an expanded state.   The framework according to claim 1, wherein the length of each said at least six connecting linear segments is substantially the same.   The skeleton according to claim 1, wherein the at least one surrounding forming element has a plurality of wavy shapes, and each of the plurality of wavy shapes has a wavy pattern.   2. The framework according to claim 1, wherein each of the plurality of surrounding forming elements has a plurality of wavy shapes, and each of the plurality of wavy shapes of each surrounding forming element has a waveform pattern.   The framework according to claim 1, wherein each of the plurality of surrounding forming elements has a wave shape of 6 to 12.   2. The skeleton according to claim 1, wherein at least one notch is arranged at a position along said one surrounding forming element where the first or second connecting element intersects one of said surrounding forming elements. The framework that is.   The skeleton according to claim 1, wherein the skeleton includes a bioabsorbable polymer material.   The skeleton according to claim 1, wherein the skeleton includes a bioerodible metal.   The skeleton according to claim 1, wherein the plurality of first connecting elements include at least two connecting elements.   The framework according to claim 11, wherein the plurality of first coupling elements include three coupling elements.   The framework according to claim 1, wherein each of the first connecting elements is linear.   The skeleton according to claim 1, wherein each of the first connecting elements has a curved shape.   15. A framework according to claim 14, wherein each first connecting element has an S-shaped segment.   The framework according to claim 1, wherein at least one of the first connecting elements includes a marker dot.   The skeleton of claim 1, wherein peaks and valleys of the first surrounding forming element are substantially in phase with peaks and valleys of the second surrounding forming element, and each of the first connecting elements is Connecting a valley of the first surrounding element to a peak of the second surrounding element, the peak of the second surrounding element being adjacent to the valley of the second surrounding element; A framework that is aligned along the longitudinal direction with the valleys of the first surrounding forming element.   18. The framework of claim 17, wherein the peaks and valleys of the second surrounding forming element are substantially in phase with the peaks and valleys of the third surrounding forming element, and each of the second connecting elements is On one side, a first connecting element is connected to a crest of the second surrounding forming element connected to the first surrounding forming element, and on the other side to a crest of the third surrounding forming element. Connected to the valley of the third surrounding forming element adjacent to each other, and the peak of the third surrounding forming element is aligned longitudinally with the peak of the second surrounding forming element. A skeleton.   19. A skeleton according to claim 18, wherein each said first connecting element has an S-shaped segment and each said second connecting element is straight.   The framework according to claim 18, wherein each of the first connecting elements and each of the second connecting elements extends in substantially the same circumferential direction. The framework of claim 17,
The peaks and valleys of the second surrounding forming element are substantially in phase with the peaks and valleys of the third surrounding forming element;
Each of the second connecting elements connects on one side to a valley of the second surrounding forming element adjacent to the peak of the second surrounding forming element and on the other side the third surrounding forming element A crest of the third surrounding forming element adjacent to the trough of the second surrounding forming element, the crest of the second surrounding forming element being connected to the first surrounding forming element by the first connecting element, and The valleys of the three surrounding forming elements are aligned along the longitudinal direction with the valleys of the second surrounding forming elements;
Each of the first connecting elements is not aligned with any of the second connecting elements along the longitudinal direction.   23. The framework of claim 21, wherein each first coupling element has an S-shaped or Z-shaped segment, and each second coupling element has an S-shaped or Z-shaped segment. A framework that is a thing.   The skeleton of claim 1, wherein peaks and valleys of the first surrounding forming element are substantially in phase with peaks and valleys of the second surrounding forming element, and each of the first connecting elements is A skeleton that connects the peaks of the first surrounding forming element with the peaks of the second surrounding forming element that are aligned longitudinally with the peaks of the first surrounding forming element.   24. The framework of claim 23, wherein the peaks and valleys of the second surrounding forming element are substantially in phase with the peaks and valleys of the third surrounding forming element, and each of the second connecting elements is On one side, connected to the valley of the second surrounding forming element adjacent to the peak connecting to the first connecting element, and on the other side, the valley and longitudinal direction of the second surrounding forming element A skeleton that is connected to the valleys of the third perimeter forming elements that are aligned with each other.   25. A skeleton according to claim 24, wherein each first coupling element is linear and each second coupling element is linear. The skeleton of claim 23,
The peaks and valleys of the second surrounding forming element are substantially in phase with the peaks and valleys of the third surrounding forming element;
Each said second connecting element is connected on one side to the second peripheral forming element crest adjacent to the second peripheral forming element peak and on the other side the second peripheral forming Connected to a crest of the third surrounding forming element aligned longitudinally with the crest of elements, the crest of the second surrounding forming element being connected to the first connecting element framework.   27. A skeleton according to claim 26, wherein each said first connecting element is linear and each said second connecting element is linear.   The skeleton of claim 1, wherein peaks and valleys of the first surrounding forming element are substantially in phase with peaks and valleys of the second surrounding forming element, and each of the first connecting elements is Connecting a crest of the first surrounding forming element with a trough of the second surrounding forming element, wherein the trough of the second surrounding forming element is aligned longitudinally with the crest of the first surrounding forming element A skeleton that is adjacent to a pile of said second surrounding forming elements. The framework of claim 28,
The peaks and valleys of the second surrounding forming element are substantially in phase with the peaks and valleys of the third surrounding forming element;
Each of the second connecting elements connects on one side to a peak of the second surrounding forming element adjacent to the valley of the second surrounding forming element, and on the other side, the third connecting element A trough of the third perimeter forming element adjacent to a peak of the perimeter forming element, the trough of the second perimeter forming element being connected to the first perimeter forming element by the first connecting element; Coupled, and the third circumferential forming element ridge is aligned longitudinally with the second circumferential forming element ridge,
Each of the first connecting elements is not aligned with any of the second connecting elements along the longitudinal direction.   30. The framework according to claim 29, wherein each of the first coupling elements and each of the second coupling elements extends in substantially the same circumferential direction.   2. The framework according to claim 1, wherein the plurality of first connecting elements are arranged such that the first surrounding forming element and the second surrounding forming element are arranged every other mountain or valley of the first surrounding forming element. The framework that is to be connected to.   The skeleton of claim 1, wherein when the skeleton is in an expanded state, the skeleton includes at least one continuous helical shape including at least one of the first coupling elements and at least one of the second coupling elements. A skeleton having a pattern, wherein both the at least one first connecting element and the at least one second connecting element connect with the second surrounding forming element at the same peak or valley. The framework of claim 1,
When the skeleton is in an expanded state, the skeleton has at least one continuous spiral pattern including at least one first coupling element and at least one second coupling element;
The at least one first connecting element is connected to the second surrounding forming element at a first connecting position, and the at least one second connecting element is different from the first connecting position. Connected to the second surrounding forming element at a second connecting position;
The continuous spiral pattern further includes a part of the second surrounding forming element between the first connection position and the second connection position. A framework for implantation in a body lumen, the framework having a compressed state and an expanded state;
A plurality of surrounding forming elements,
Each surrounding element has a plurality of wavy shapes consisting of alternately repeating peaks and valleys, and has the plurality of surrounding forming elements,
Forming a generally cylindrical shape having a longitudinal axis, each of the two surrounding forming elements adjacent along the longitudinal direction being connected by a plurality of connecting elements;
The plurality of surrounding forming elements;
A skeleton having at least one marker dot having a cup-shaped structure having a mouth and a bottom.   35. The framework of claim 34, wherein the at least one marker dot further comprises a hole in the bottom. A framework for implantation in a body lumen, the framework having a compressed state and an expanded state;
A plurality of surrounding forming elements,
Each surrounding element has a plurality of wavy shapes consisting of alternately repeating peaks and valleys, and has the plurality of surrounding forming elements,
Forming a generally cylindrical shape having a longitudinal axis, each of the two surrounding forming elements adjacent along the longitudinal direction being connected by a plurality of connecting elements;
Having a plurality of surrounding forming elements;
At least one of the plurality of surrounding forming elements includes a connecting element and a notch at a position where the surrounding forming elements intersect.

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