Uncaging stent

Abstract

To provide an uncaging stent.SOLUTION: A stent exhibits strength, modified (or controlled) strength, and / or modified (or controlled) compliance characteristics for expansion and / or implantation, and numerous examples and embodiments of vascular and luminal stents and prostheses are provided. The stent (scaffold) or other luminal prosthesis comprises a circumferential structural element that provides high strength after deployment, allows the scaffold to be uncaged, and / or subsequently allows scaffold or luminal dilation. A circumferential scaffold is typically formed of a non-degradable material and will be modified so as to expand and / or uncage after deployment.SELECTED DRAWING: Figure 4A

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of Provisional Patent Application No. 62 / 622,741 (Attorney Docket No. 32016 - 714 - 110), filed on January 26, 2018; No. 62 / 577,624 (Attorney Docket No. 32016 - 714 - 109), filed on October 26, 2017; No. 62 / 558,273 (Attorney Docket No. 32016 - 714.108), filed on September 13, 2017; and No. 62 / 544,682 (Attorney Docket No. 32016 - 714.107), filed on August 11, 2017, the entire disclosures of which are hereby incorporated by reference into this specification.

[0002] This application is a partial continuation of U.S. Patent Application No. 16 / 039,194, filed on Jul. 18, 2018 (Attorney Docket No. 32016-714.303), which is a continuation of U.S. Patent Application No. 15 / 921,508, filed on Mar. 14, 2018 (Attorney Docket No. 32016-714.302), which is a continuation of U.S. Patent Application No. 15 / 605,601, filed on May 25, 2017, now U.S. Patent No. 9,943,426 (Attorney Docket No. 32016-714.301), which is a continuation of PCT Application No. PCT / US2017 / 032748, filed on May 15, 2017 (Attorney Docket No. 32016-714.601), which claims the benefit of Provisional Patent Application No. 62 / 480,121, filed on Mar. 31, 2017 (Attorney Docket No. 32016-714.106), Provisional Patent Application No. 62 / 430,843, filed on Dec. 6, 2016 (Attorney Docket No. 32016-714.105), Provisional Patent Application No. 62 / 424,994, filed on Nov. 21, 2016 (Attorney Docket No. 32016-714.104), Provisional Patent Application No. 62 / 414,593, filed on Oct. 28, 2016 (Attorney Docket No. 32016-714.103), Provisional Patent Application No. 62 / 374,689, filed on Aug. 12, 2016 (Attorney Docket No. 32016-714.102), and Provisional Patent Application No. 62 / 337,255, filed on Jun. 12, 2016 (Attorney Docket No. 32016-714.101), the entire disclosures of which are incorporated herein by reference. [Background Art]

[0003] Balloon angioplasty has been introduced to open blood vessels, specifically, vessels narrowed as a result of plaque progression or a heart attack. In successful cases, the blood vessel remained open and / or exhibited positive remodeling over time and / or exhibited vasodilatory capacity that mimicked native blood vessel capacity to some extent. However, in other cases, the blood vessel will reocclude within days or months due to various causes such as blood vessel recoil, thrombosis, or other types of plaque morphological progression.

[0004] Metal stents have been developed to provide a structure, often referred to as a scaffold, with sufficient radial strength (resistance to crushing) to address recoil and hold the opened blood vessel over time. Stents are formed from wires, coils, braids, sheets, and / or tubular bodies. Balloon-expandable stents formed from patterned non-degradable metal tubes, wires, or sheets exhibit desirable structural properties such as limited inward recoil, high strength (resistance to crushing or crushing force), and limited axial shortening upon expansion, compared to some previous coiled or braided stents, and are currently the most commonly used.

[0005] Despite their success and widespread adoption, metal stents such as stainless steel alloys, platinum iridium alloys, and cobalt chromium alloy stents suffer from certain drawbacks, such as restricting the lumen or blood vessel, preventing further expansion (after inward recoil) under physiological conditions after implantation, preventing the lumen or blood vessel from expanding further, and thus preventing active remodeling, and / or such stents preventing vasodilation or vasomotion of the treated blood vessel stent segment, which is important for blood vessel healing or normal blood vessel function. This phenomenon is generally referred to as "constraint" or "confining" of the blood vessel. High radial strength is important to support the body lumen in response to implantation and / or to maintain it in an open state in response to stent implantation, and / or high strength is important in preventing the lumen from becoming smaller after implantation. In some cases where shape memory self-expanding alloy stents are used, such stents typically do not exhibit the high radial strength (high crush resistance) of metal stents due to material properties (as a result, the lumen may, in some cases, become smaller after implantation of such stents due to excessive inward recoil of the lumen on the stent and / or due to the lower radial strength of these stents, reducing the likelihood of such stents expanding further after being implanted into the lumen or diseased lumen segment, and / or such stents are less likely to exhibit vasodilation or vasomotion of the stent implantation segment). In some cases, shape memory stents migrate towards the adventitia and penetrate the lumen wall, causing irritation, inflammation of the blood vessel or lumen, and sometimes leading to unwanted negative clinical events and / or restenosis of the body lumen or blood vessel. Also, stents are typically maintained in a crimped configuration using a restraint upon delivery into the blood vessel or lumen, which increases the outer profile of the stent system and makes it less deliverable.Stents of this type are typically pre-programmed to expand to a certain diameter / configuration, which limits sizing to such pre-programmed diameter / configuration, reduces the likelihood of expanding to or maintaining an expanded diameter beyond such pre-programmed diameter, makes stent sizing more difficult, and / or such stents, to name a few, do not expand further beyond such pre-programmed diameter / configuration after deployment.

[0006] To address some of these drawbacks, biodegradable stents or scaffolds made from metal or polymer materials have been developed. By enabling the stent to degrade or be resorbed, the constraining or confining effect will diminish or decrease over time, and the scaffold will ultimately disappear over time. However, current biodegradable stents, specifically polymeric biodegradable stents and corrosive metal stents, have their own drawbacks, including limited ability to resist stent fragmentation and / or over-expand the stent beyond the nominal expanded diameter, and / or having excessive or high initial inward recoil, and / or having additional inward recoil after implantation and after the initial inward recoil. In some cases, they may have insufficient strength to adapt to various lesion types after deployment, and / or have a limited ability to maintain the lumen or blood vessel in an open state after deployment. Biodegradable stents typically have lower radial strength (resistance / strength to fragmentation) than balloon-expandable metallic non-biodegradable stents, typically have bulky strut stents to address some of the mechanical drawbacks such as sub-optimal fragmentation strength, or have thick struts that can cause negative clinical events, which can, to name a few, cause excessive inflammation (at least in part due to degradation of the material and the quality of the degradation products), and / or cause excessive hyperplasia such as neointimal hyperplasia (at least in part due to degradation of the material and the quality of the degradation products).

[0007] Trials have also been conducted to fabricate scaffolds from combinations of polymers and metallic materials. However, such designs exhibit their own drawbacks. Such composite designs may lack sufficient initial crush resistance to effectively open the lumen or maintain it in an open state after stent implantation, or such designs may not allow the stent to disengage, or the stent to disengage along the entire stent section, or the blood vessel to disengage, or the stent to further expand under physiological conditions, or the stent to further expand, and / or not allow the blood vessel to contract after the use of, or after the use of vasodilators and / or vasoconstrictors. Alternatively, some other such designs may not be able to expand to a larger configuration after implantation (and, if applicable, after inward recoil). Still other designs pose a risk of releasing small parts into the bloodstream and have a very large number of separate metal or other non-degradable parts that potentially cause clinical events. One or more of the needs as described above in the following exemplary problems, namely, having a stent with little inward recoil, and / or having a stent whose diameter is substantially maintained after implantation and after initial inward recoil, while having a stent with a little initial inward recoil after expansion, and / or having a non-degradable stent configured to be able to further expand after deployment under physiological conditions (and, if applicable, after inward recoil), and / or having a stent that can expand or further expand after deployment (and, if applicable, after inward recoil) without a pre-programmed temperature-induced setting or without a pre-programmed expansion diameter / configuration setting, and / or having a stent that can expand or further expand after deployment (and, if applicable, after inward recoil) without a pre-programmed temperature, and / or having a stent that can further expand after deployment under physiological conditions (and, if applicable, after inward recoil) without penetrating or substantially penetrating the blood vessel or the lumen wall into the adventitia, and / or having a stent that does not cause excessive inflammation,and / or having a stent that does not penetrate the lumen or the vessel wall after implantation into the adventitia and / or that further expands after any inward recoil and that further expands the lumen or vessel diameter after deployment (implantation), and / or having a stent that is maintained or substantially maintained in a crimped configuration in response to delivery into a blood vessel or lumen without a restraint and that further expands to a larger configuration after deployment after any inward recoil, and / or having a stent that can be expanded to a wide range of diameters and that still allows the blood vessel or lumen to be detached after deployment, and / or having a stent that can be expanded to a wide range of diameters and that further expands to a larger configuration after implantation after any inward recoil, and / or having a stent that can further expand beyond the pre-programmed expansion diameter / configuration after implantation after any inward recoil, and / or having a stent that exhibits vasomotion, vasodilation, or vasoconstriction after implantation, and / or having a stent that has sufficient strength to support a body lumen after deployment, has a slight inward recoil, and the stent exhibits a radial strain of 1% or greater after deployment, and / or having a non-degradable stent having an initial compliance that increases after implantation and having an initial compliance in response to expansion from a crimped configuration to an expanded configuration, and / or having a non-degradable stent having an initial radial strength (burst resistance) that decreases after implantation in response to expansion from a crimped configuration to an expanded configuration, and / or having an expandable configuration with a diameter ranging from 2.0 mm to 4.0 mm, the stent exhibits an initial inward recoil after initial expansion, the stent has an initial diameter after the initial recoil, the stent maintains the initial diameter (or configuration) after the initial inward recoil, the stent responds to a vasodilator sufficient to expand the stent implantation section to a second diameter after implantation, and the second diameter (or configuration) is larger than the initial diameter, and having a balloon-expandable non-degradable stent that can expand from a crimped configuration to an expanded configuration, which remains unmet by current non-degradable stents.,

[0008] Certain concerns within blood vessels and other body lumens after the implantation of a stent or other prosthesis are loss of blood vessel or lumen remodeling or dilation, or loss of blood vessel or compliance or contractility, termed "constriction" or "constraint" of the blood vessel or body lumen above. Blood vessel compliance is necessary for blood vessels or body lumens under physiological conditions such as in response to changes in internal pressure, external pressure, muscle contraction, muscle relaxation, chemical changes, and equivalents. Such changes can result from many sources, such as the body lumen, and / or the presence of natural or artificial substances that can relax or contract muscle, such as smooth muscle cells within the wall of the body lumen, for example. The implantation of a stent within a blood vessel or body lumen will necessarily contribute to a reduction in the overall or "composite" compliance of the body lumen and the stent. The natural compliance of the body lumen and the additional compliance of the stent will each contribute to the complete or overall "composite" compliance, which would necessarily be less than the compliance of the body lumen if the stent were not implanted. Therefore, it is desirable that a stent implanted within a body lumen, specifically within a blood vessel, minimize the reduction in body lumen compliance that naturally occurs as a result of stent implantation. The reduction in compliance may be acceptable over a time period immediately following implantation, but specifically, during that period (depending on the initial period following implantation or implantation), radial strength is desired to maintain the patency of the blood vessel (or body lumen) and prevent further inward recoil after implantation. Such strength is not as necessary or not necessary after the initial period when blood vessel healing occurs and ultimately the strength of the stent becomes unnecessary or less important. During such a healing phase or after such a healing phase, it is highly desirable that the compliance of the blood vessel return to a level at, near, or closer to the natural compliance of the lumen in the absence of the implanted stent.Accordingly, it is an object of the present invention to provide stents, stent scaffolds, and other luminal prostheses that exhibit compliance that increases over time in response to the vascular or other luminal environment after implantation, such that the compliance of the stent scaffold and the complete or composite compliance of the body lumen is increased to a level that is closer to, or approaching, the compliance of the body lumen in the absence of a stent scaffold.

[0009] Loss of compliance is also a problem for valves, rings, and other devices implanted in the cardiac valve annulus. The valve scaffolds may not necessarily require high radial strength, particularly after the initial period of implantation, but are flexible enough that they can conform to the annulus as the annulus deforms during the normal systolic / diastolic cycle, or deform and conform to a deformed annulus resulting from disease progression, and thus it is beneficial to maintain or expand valve function integrity while conforming to physiological conditions or annulus expansion resulting from disease progression.

[0010] What is needed are implants, stents, stent scaffolds, vascular prostheses, external prostheses, and / or other luminal prostheses that address at least some of these drawbacks as well as other drawbacks described herein.

[0011] Related background patents and applications include U.S. Patent Nos. 7,011,678; 5,922,020; 2003 / 0153971; 9,056,157; 2005 / 0222671; 9,265,866; 7,169,173; 8,435,281; 2003 / 0195609; 7,402,168; 7,829,273; 5,695,516; 6,540,777; 8,652,192; 8,128,679; 8,070,794; 6,599,314; 8,961,585; 7,455,687; 7,645,409; 8,202,313; EP 2,229,919; 6,251,134; 6,409,754; 5,766,237; 5,957,975; 5,306,286; 5,961,545; 8,052,743; 9,180,005; 9,192,471; 2008 / 177373; and 2005 / 283229.

Prior Art Documents

Patent Documents

[0012]

Patent Document 1

Summary of the Invention

Means for Solving the Problems

[0013] The present invention provides a number of embodiments and implementations of stents, specifically vascular and lumen stents and prostheses, which exhibit strength, modified (or controlled) strength, and / or modified (or controlled) compliance characteristics upon expansion and / or implantation. In one particular embodiment, metals, metal alloys, and other non-degradable stents may be modified in a number of ways to control their radial strength and compliance both initially upon expansion within a body lumen and subsequently over days, months, and years following initial expansion and / or implantation. Specifically, many of the stents and scaffold designs described and claimed herein will provide a variable (or controlled) compliance with a relatively low initial compliance that increases over time after implantation, and a radial strength with a relatively high initial strength (e.g., having substantial hoop strength or crush resistance) at the time of implantation or initial expansion that decreases (or may be reduced) over time after implantation. The increase in compliance and the decrease in radial strength can occur over a time period of days, weeks, or months after implantation and can be caused by any one or more of several structural transformations in the scaffold that form all or a portion of the prosthesis. In some cases, the compliance can change more abruptly, such as when a locked feature on the scaffold unlocks in response to partial circumferential or full expansion of the scaffold. In other cases, such locked features can be combined with other features and designs that modify the effective compliance of the scaffold in a more stepwise manner over time.

[0014] In a first aspect, the present invention provides an intraluminal prosthesis having improved deployment characteristics when expanded from a crimped configuration to an expanded configuration. The intraluminal prosthesis comprises a scaffold having a plurality of circumferential rings typically formed or patterned from non-degradable materials. The stent pattern comprises one or more of the following, namely, an open cell design, a closed cell design, a helical backbone, an inter-apex ring design, an apex-valley ring design, an offset inter-apex or offset apex-valley ring design, or others. Typically, the stent is formed from a tube, a bent wire, or a flat substrate and formed into a tubular structure. There are several embodiments that provide improved deployment characteristics. In one embodiment, the scaffold contains an axial link that is axially split into two parts, and the two parts are held together during expansion of the stent through geometry or using a degradable or non-degradable polymer or adhesive, and when the stent expands in a physiological environment, the two parts of the axial link separate or move in one or more directions, enabling improved deployment of the scaffold or stent. In another embodiment, the scaffold comprises a series of full circumferential rings and one or more partial circumferential rings, and the partial rings are connected to adjacent full or partial rings by one or more separable axial links. The separable axial links are held together either by geometry or using a degradable or non-degradable polymer or adhesive, and when the stent expands in a physiological environment, the two parts of the axial link separate or move in one or more directions, enabling improved deployment of the scaffold or stent. In another embodiment, more fully described below, the scaffold or stent comprises circumferential rings, some of which contain two aligned struts, and typically the aligned struts are each connected to adjacent circumferential rings through a link or connector.

[0015] In an embodiment, the stent patch is deployed to an expanded configuration under physiological conditions, which include a temperature of about 37°C, an aqueous bath at a temperature of about 37°C, a mammalian body lumen, a mammalian body blood vessel, a mammalian artery, a pressure gradient ranging from 40 mmHg to 200 mmHg, a pressure gradient of 100 mmHg, systolic and / or diastolic pressure, arterial, luminal, or vascular torsion, compression, elongation, and / or bending, vascular movement, a pulsatile artery or a simulated artery, a simulated body blood vessel, or one or more of their combinations.

[0016] In the case of separable axial links, the scaffold is configured to expand from a crimped configuration to an expanded configuration and has attachment points on at least some adjacent circumferential rings, which are typically paired and axially aligned. The attachment points are joined by axially separable circumferential links. Typically, prior to expansion, the axial links will be locked (held from separation) by their geometry, as described in more detail below. When the scaffold is expanded, typically by internal balloon expansion but alternatively by self-expansion, radially, the axial links will undergo a deformation that "unlocks" their initial locking configuration such that the axial links can separate circumferentially. Alternatively, when the scaffold is expanded, the axial links may undergo a deformation that is not sufficient to "unlock" their locking configuration, but after expansion within a physiological environment, the axial links will undergo a deformation sufficient to "unlock" their locking configuration. Alternatively, when the scaffold is expanded, the axial links may undergo a deformation that is not sufficient to "unlock" their locking configuration, but after expansion within a physiological environment, the axial links will separate. In a preferred embodiment, the separable axial links have a geometry that locks the axial links so that they do not separate during expansion of the stent from the crimped configuration to the expanded configuration and are configured to separate after expansion within a physiological environment. Some of the physiological conditions that contribute to further deformation after implantation and unlocking include distortion and compression of the stent within the blood vessel or lumen.

[0017] In another preferred embodiment, the stent patch comprises a structural element having one or more circumferentially separable rings, the rings being configured to deform and / or move, rotate or twist during expansion from a crimped configuration to an expanded configuration and having a geometry configured to prevent the rings from separating. In a preferred embodiment, the separable rings separate through separable axial links joined to the rings. In some cases, the separable axial link sections have geometries configured to mechanically fit or lock together and rotate about a radial, circumferential, and / or axial axis during expansion to counteract, balance, or oppose forces attempting to separate the axial link sections. This rotation cancellation or expansion force opposition prevents the rings from separating during expansion. This geometry can be seen in some embodiments and figures where the axial links comprise a series of bends or interlocking sections. In some cases, the geometry of the separable ring after expansion in a physiological environment is configured to further deform prior to separation. In another embodiment, the geometry of the separable ring after expansion in a physiological environment is configured to separate by forming one or more discontinuities. In another embodiment, the geometry of the separable ring after expansion in a physiological environment is configured to separate by forming one or more discontinuities after degradation of a polymer or adhesive. In another embodiment, the geometry of the separable ring after expansion in a physiological environment is configured to separate without further deformation. In another embodiment, the separable ring has a geometry configured to further deform about an axis comprising one or more of the following axes prior to separation, namely, a radial, axial, or circumferential axis. In another embodiment, the separable ring has a geometry configured to deform to counteract the expansion force of the stent and prevent the ring from separating during expansion.

[0018] In another embodiment, the stent comprises a circumferential ring with struts joined by a crown, and at least some of the circumferential rings comprise two separable struts configured to align and separate after expansion in a physiological environment. Each of the two separable struts may be connected to an adjacent circumferential ring such that after expansion under physiological conditions, the struts separate and open the ring circumferentially, but the separated struts are each connected to an adjacent circumferential ring. In some embodiments, each circumferential ring of the stent contains one or more segments with two aligned struts, and each strut is joined to an adjacent circumferential ring through a link or connector. In one example, the aligned struts and their connectors to the adjacent circumferential rings may be positioned along a line along the circumferential ring extending at an angle to the longitudinal axis of the stent. See FIGS. 54A and B. In some cases, there may be two rows of aligned struts angled along the stent, or three rows of aligned struts each with two struts. During expansion of the stent, the aligned struts are held together through geometry or using adhesives or polymers as described herein, but after expansion in a physiological environment, the struts separate and the scaffolds form one or more segments of the stent that will typically not have ends. In some cases, optionally, some ends may be present. In some embodiments, the aligned struts are joined to adjacent circumferential rings through a link or connector to other aligned struts, but in some embodiments, the aligned struts may be connected to adjacent rings at any location on the ring, typically with an aligned segment on the adjacent ring. Or in some embodiments, instead of aligned struts, segments of overlapping regions (two compartments with mirror-image geometry) may include any segment of the ring-strut, crown, or link in various combinations.

[0019] In another embodiment, the separation region comprises two crowns, respectively, from circumferentially adjacent rings. In another embodiment, the separation region comprises one strut and one crown, respectively, from circumferentially adjacent rings. In yet another embodiment, at least one separation region comprising a strut or a crown from a circumferential ring is connected to a second section on a circumferential ring axially adjacent, and the second section comprises a strut or a crown. In yet another embodiment, the two sections may be regarded as separation regions, and one separation region on one ring is connected to the second separation region on the axially adjacent ring via a link. In one embodiment, the axial length of the separation region is substantially the same as or greater than one of the following, i.e., the strut or crown on a circumferentially adjacent ring is 0.1 times to 2 times the axial length of the strut or crown on one of the circumferentially adjacent rings.

[0020] In a preferred embodiment of any of the embodiments herein, it is desirable to have a stent comprising one or more circumferential rings that separate without having a terminus or having several or more termini or having more than four termini or having four or fewer termini. Embodiments of zero and two termini are shown in FIGS. 35 - 54. This aids in blood vessel healing, minimizes blood vessel irritation, prevents small portions of the structural elements from becoming free in the blood stream, and improves manufacturing.

[0021] Optionally, in addition to physical locking, axially separable circumferential links are retained together, held in close contact, or immobilized by coating, encapsulation, adhesion, or the like, using a biodegradable material that will continue to prevent circumferential separation of the axially separable link until the biodegradable material degrades in a physiological environment and unlocks the axially separable link. Some or all of the separable axially separable links may be coated. However, in other cases, the axially separable circumferential links may not include such coating, encapsulation, adhesive, or other further restraint, and will be held together only by mechanical locking provided by the geometry of the aligned compartments or portions, as described in more detail below. The stent may be a balloon that expands from a crimped configuration, or may be self-expandable to an expanded configuration after removal of the restraint or constriction after being crimped prior to implantation. In yet another embodiment, the stent is a balloon that is expandable to the expanded configuration after an initial self-expansion of the stent within the body lumen.

[0022] At least some of the axial links of the scaffold of the present invention will comprise a first section and a second section. The first and second sections will typically be separated along an axially extending dividing line that will typically have a break, cut, gap, or other discontinuity in the structure of the axial link. "Axially extending" means that the dividing line and the link itself extend from a first attachment point on a first circumferential ring to a second attachment point on an adjacent second circumferential ring, with the attachment points being axially separated. That is, at least the vector of the component or distance between the attachment points extends axially, and the dividing line will extend across that axial distance. However, as will be described in more detail below, the direction of the dividing line at any point along the axial link may be in any orientation, such as axial, circumferential, or any orientation therebetween. Thus, in some embodiments, the dividing line will typically follow a non-linear meandering path that may include curves, bends, linear portions, and combinations thereof. However, typically, the axial link will not extend significantly outside of the cylindrical envelope of the scaffold prior to circumferential expansion. In particular, the sections and regions of the axial link will not radially overlap while the scaffold is in its crimped configuration.

[0023] The first and second sections of the axially separable circumferential link may be circumferentially interlocked to prevent their circumferential separation while the stent is in its crimped configuration. The interlocking may take any one of various forms, and typically, when a circumferential separating force is applied to the axially separable link, at least a portion of one section will curve or bend into a pattern that interferes with or otherwise prevents the circumferential passage or separation of a portion of the other section. However, as the scaffold expands, the geometry of the sections will deform. As the stent expands, several things may contribute to keeping the sections together during expansion. During expansion, the sections may deform and / or the geometry of the two interlocked sections may cause, allow, or provide for rotation of the sections in various directions, circumferentially, axially, or radially, to counteract, balance, or oppose the expansion force and prevent expansion until after expansion under physiological conditions. The deformation may cause the sections of the axially separable link to engage or interfere with each other and prevent separation, but subsequent additional deformation may occur such that any interfering or blocking portions will shift under physiological conditions to allow circumferential separation. The two sections of the axially separable link may contact each other in bends and curves such that the two sections are nested together, similar to each other, or fitting together, forming identical, corresponding, approximate, or similar curves or bends to create a tight fit, mechanical lock, or steric hindrance to impede, resist, delay, or prevent separation of the sections. There may be one or more than one nested or aligned curves or shapes of the two sections along the length of the axially separable link. The sections may be in close contact along a length of the axially separable link or a portion of the integrally joined partial rings that is a part, most, almost all, about 50%, about 70%, about 80%, about 85%, greater than 50%, greater than 70%, greater than 75%, 80%, or greater than 85% of the length.

[0024] The circumferential rings are configured to separate circumferentially at least at the attachment points. In particular, when the scaffold expands circumferentially, both the axial link and the circumferential ring compartments will separate at the attachment points after the compartments are unlocked. After such separation, the opposite ends of each link compartment will remain attached to their adjacent circumferential rings such that the rings remain axially connected but are open circumferentially. In one embodiment, adjacent circumferential rings are axially joined through an axial link, and each axial link includes a separation region that axially divides the axial link into two separable axial links, and after expansion of the stent or scaffold within the physiological environment, the axial link separates into two links that each connect the two adjacent rings.

[0025] Axially separable links in the circumferential direction may extend between virtually any points on adjacent circumferential rings. That is, the attachment points of the axially separable links on the circumferential rings may be at any location on the rings. For example, axially separable links that join rings comprising, or consisting of, struts and crowns may extend between pairs of struts on adjacent rings, between pairs of crowns on adjacent rings, or between a crown on a first ring and a strut on a second ring. Thus, the attachment points may be located at any point among any one or more of the struts and crowns within the circumferential rings. The axially separable links may be connected to one or more of the following on each adjacent ring, namely, the area of the extended region of the ring, the crown region of the ring, the strut region of the ring, the low stress area of the ring, the high stress area of the ring. The scaffold may comprise any number of circumferential rings along its axial length. In one embodiment, when there are an even number of circumferential rings in the scaffold, when the separable axially separable link engages and disengages after expansion of the scaffold in a physiological environment, the scaffold separates into several units, namely, two, three, or four, and the non-separated axially separable links join the circumferential rings within each unit. In a preferred embodiment, the axial length of the separation region is equal to at least the axial length of one ring, i.e., the distance between the rings in the axial direction. In a preferred embodiment, the axial length of the separation region ranges from 0.75 times to 2 times the axial length of one ring or the distance from one ring to an adjacent ring. In one embodiment, when there are an odd number of circumferential rings in the scaffold, when the separable axially separable link engages and disengages after expansion of the scaffold in a physiological environment, the scaffold opens, the separable axially separable link separates, and the scaffold may comprise a single connected component. The scaffold may have rings in a spiral pattern. The scaffold may have some, most, almost all, or all of the circumferential rings joined to adjacent circumferential rings by axially separable links.

[0026] Axially separable circumferential links may also be arranged in various patterns on the scaffold. In some cases, at least some or all of the axially separable links will be arranged along one, two, three, or more axial lines along the length of the scaffold. In other cases, at least some or all of the axially separable links may be arranged along at least one, two, three, or more helical lines along the scaffold.

[0027] The dividing line between the geometries and compartments of the circumferentially separable links can vary widely as long as the two compartments can first interlock or join when the scaffold is crimped and unlock when the scaffold is expanded circumferentially. In many cases, the dividing line will typically have one or more curved regions and will sometimes be non-linear, being completely curved. In many cases, the axially separable links and the dividing line will include both curved and linear regions, and in other cases, the curved segments will have different curved regions. In many cases, the curved segments will include regions of reverse curvature. Employing axially separable links with curves and bends is advantageous in that the flexibility of the stent during crimping and expansion configurations is enhanced.

[0028] In specific embodiments and examples, the two sections of the axially separable link of the scaffold each have a first and a second end, and the dividing line extends in a first axial direction from the first attachment point towards the second end and proceeds in a second axial direction so as to make at least a first direction change and return towards the first end. Such a reversal of direction causes an "overhang" or "undercut" in the pattern of the dividing line that prevents or inhibits the two sections from passing through each other circumferentially when a circumferential opening force is applied to the scaffold. However, when the scaffold deforms, these portions, which first oppose each other in a manner that prevents their biasing, will reorient such that they can pass through each other circumferentially, allowing the axially separable link to unlock, separate, and open circumferentially. Typically, the first direction change traverses an angle of at least about 100°, preferably at least about 120°, more preferably at least about 135°, even more preferably at least about 180°, or greater, and provides sufficient interference so that the sections cannot pass through each other until the scaffold is significantly opened, typically by at least 25% of its initial diameter, frequently by 200% of its initial diameter, and usually by at least 400% of its initial diameter, at which point the axially separable link is able to open.

[0029] In many embodiments, the dividing line and the axially separable link will make a third direction change and proceed again in the first axial direction and, in still more cases, a fourth direction change and proceed back in the second axial direction.

[0030] In other specific cases, the axially separable link and the axially extending dividing line may have an S-shape, a W-shape, a serpentine shape, and combinations thereof.

[0031] In other specific examples, at least some of the axially separable links circumferentially may include nested wedges having a male portion that engages in an interference fit prior to expansion of the scaffold and a female portion.

[0032] The separation region between compartments within the separable axial links may comprise any combination of struts and / or crowns and be configured to deform, twist, rotate, compress, or elongate during expansion to hold the compartments together and subsequently form one or more discontinuities in the circumferential ring upon expansion at physiological conditions (37 °C) or in response to expansion of the stent from a crimped configuration to an expanded configuration in a physiological environment. In one embodiment, the separation region has a geometry configured to deform, twist, rotate, compress, or elongate about a circumferential axis, longitudinal axis, and / or radial axis prior to or in order to form one or more discontinuities in the circumferential ring. In another embodiment, the separation region has a geometry configured to deform, twist, rotate, compress, or elongate prior to or in order to form one or more discontinuities in the circumferential ring after expansion of the stent in a physiological environment. In one embodiment, the compartments may be configured to twist about each other within an area of contact or intimate association to hold the compartments together during expansion and to release, unlock, or disintegrate after expansion under physiological conditions.

[0033] As discussed hereinafter in this specification, the scaffold of the present invention may include a separation region in addition to axially separable circumferential links. The separation region may include a number of biodegradable or non-biodegradable polymeric materials, and other adhesives, glues, sleeves, and the like, which are intended to initially secure the separation region after deployment within a physiological environment. Such biodegradable polymers and other materials described below may also find use in temporarily immobilizing the axially separable circumferential links specifically described herein. Such compartments immobilized using non-biodegradable or biodegradable materials may also be considered separation regions within the scope of this application and related applications. The polymer or adhesive may be placed or located on the stent on the anti-luminal surface, or on the luminal surface or both of the stent, or on one or more surfaces of the stent, or within the separation region, or within the separation region and on the top and / or bottom (anti-luminal or luminal) surfaces of the separation region. There may be additional layers of polymeric material placed or located on the polymer placed on the stent, on the stent on the anti-luminal surface, or on the luminal surface or both of the stent, or on one or more surfaces of the stent, or within the separation region, or within the separation region and on the top and / or bottom (anti-luminal or luminal) surfaces of the separation region. The separable axially links may have a gap between two sections such that the circumferential path of the ring is discontinuous but the degradable polymer coating across or within the gap holds the gap together and provides a continuous circumferential path around the stent. In response to expansion within the physiological environment, the polymer or adhesive degrades, the gap is exposed, providing discontinuity of the circumferential path and an opening of the ring. The sections of the partial ring junctions may have a gap therebetween that is held together by the interlocking shape of the sections, or using a degradable or non-degradable material in the form of a coating, a sleeve across the sections, or an inclusion of material within the gap. In response to expansion of the stent within the physiological environment, the sections unlock, separate, and release or move more freely depending on how the sections are held together.The deployed stent expands substantially uniformly and has sufficient strength to support a body lumen. A non-degradable material, polymer, or adhesive holds the separation regions together during expansion and allows the separation regions after expansion in a physiological environment to move in one or more directions including radially, circumferentially, or axially. In one embodiment, the non-degradable polymer material stretches and allows the movement. In another embodiment, the non-degradable material softens and allows the movement. In one embodiment, the stent has a minimal outward force in the expanded configuration. In another embodiment, the stent has less outward force in the expanded configuration compared to the same stent having a continuous circumferential path (without separation regions). In yet another embodiment, the stent is conformable by the axial and / or circumferential direction of the stent. In yet another embodiment, the stent in the expanded configuration has sufficient strength to support a body blood vessel but does not have sufficient outward force to cause further blood vessel damage after implantation. In yet another embodiment, the stent in the expanded configuration does not cause adventitial damage to the blood vessel.

[0034] In a preferred embodiment, the stent is formed from a non-degradable material and comprises one or more circumferential rings that form a continuous circumferential path around the stent. At least one or more separation regions bisect the circumferential path and create one or more discontinuities in the circumferential path. In a preferred embodiment, the separation regions are pre-formed during or after patterning of the stent. In another preferred embodiment, the separation regions are held together by material or geometry during expansion of the stent from a crimped configuration to an expanded configuration, and the separation regions create one or more discontinuities after expansion under physiological conditions. In a preferred embodiment, the material holding the separation regions together reconnects the bisected circumferential path and renders it continuous prior to creating one or more discontinuities after expansion in a physiological environment. In another embodiment, the geometry of the separation regions holds the circumferential rings intact and allows uniform expansion of the rings from a crimped configuration to an expanded configuration, and then the geometry disengages to create one or more discontinuities in the circumferential rings. In another embodiment, the separation regions comprise one or more of a degradable polymer, coating, or sleeve, adhesive, or one or more bisected structural elements. In another embodiment, the one or more bisected structural elements comprise one or more of the following, namely, key and lock configurations, ball and socket configurations, male and female configurations, or other types of configurations that create discontinuities after expansion of the stent in a physiological environment. In certain cases, it is desired to have separation regions configured to create one or more discontinuities after expansion of the stent in one or more directions to minimize neointimal hyperplasia, reduce torsional stress of the stent, maintain or increase lumen configuration, or reduce elongation or compressive stress of the stent. For example, the separation regions create discontinuities after expansion of the stent in a physiological environment only in the radial direction. In another embodiment, the separation regions create discontinuities after expansion of the stent in a physiological environment only in the radial and / or axial directions relative to the stent longitudinal direction.In another embodiment, the separation region forms a discontinuity after expansion of the stent in the physiological environment only in the radial and / or circumferential directions. In another embodiment, the separation region forms a discontinuity after expansion of the stent in the physiological environment only in the axial direction with respect to the stent longitudinal direction. In another embodiment, the separation region forms a discontinuity after expansion of the stent in the physiological environment only in the circumferential direction. In another embodiment, the separation region can form a discontinuity after expansion of the stent in the physiological environment in the axial, radial, or circumferential directions.

[0035] In another embodiment, the stent patch may be formed from a non-degradable polymer or a metallic material (including a metal or metal alloy), or the stent may be formed from a degradable polymer or a metal (including a metal or metal alloy material).

[0036] In another embodiment, the stent patch may be formed from a non-resorbable shape memory alloy with one or more circumferential rings, at least some of which have at least one separation region that bisects, cuts, or divides the circumferential ring to form a discontinuous circumferential path around the stent, the separation region being held together during expansion of the stent from a crimped configuration to an expanded configuration, the stent expanding substantially uniformly and having sufficient strength to support a body lumen. The separation regions held together may be held together through geometry or using resorbable or non-resorbable polymers or adhesives, any of which may or may not make the discontinuous circumferential path continuous, and may become discontinuous again with the formation of discontinuities after expansion in a physiological environment. For example, using geometry or mechanical interlocking, the separation regions may have gaps or the segments may contact and separate under physiological conditions. Or, if a resorbable material holds the separation regions together, the ring becomes continuous until discontinuities continue to form. Using a non-resorbable material to hold the separation regions together, the ring becomes continuous, but the material may degrade, stretch, or soften, allowing movement in the circumferential, axial, or radial directions. In one embodiment, the stent has a minimal outward force in the expanded configuration. In another embodiment, a stent with discontinuities has less outward force in the expanded configuration compared to the same stent with a continuous circumferential path (without separation regions). In yet another embodiment, the stent is conformable by the axial and / or circumferential direction of the stent. In yet another embodiment, the stent in the expanded configuration has sufficient strength to support a body blood vessel but does not have sufficient outward force to cause further blood vessel damage after implantation. In yet another embodiment, the stent in the expanded configuration does not cause adventitial damage to the blood vessel. In an optional embodiment, the separation regions may be held together prior to expansion of the stent by a resorbable polymer or adhesive, the adhesive or resorbable polymer degrading in a physiological environment to form one or more discontinuities in the circumferential path of the circumferential ring after expansion of the stent.In another embodiment, the stent is restrained in a crimped configuration and is enabled to self-expand to an expanded configuration by removal of the restraint. In yet another embodiment, the stent is a balloon that is expandable to the expanded configuration after an initial self-expansion of the stent within the body lumen. In yet another embodiment, at least some of the rings have one to four separation regions that bisect each of the rings.

[0037] In a preferred embodiment, the stent comprises one or more circumferential rings, the rings comprising structural elements comprising struts and crowns, the rings comprising one or more separation regions, the separation regions being one or more of the following, namely, within a strut, a crown, a strut region, a crown region, adjacent to a strut on a single ring, adjacent to a crown on a single ring, substantially parallel to a strut on a single ring, substantially parallel to a crown on a single ring, instead of a strut in the ring, or instead of a crown in the ring. In a preferred embodiment, the separation regions comprise two adjacent struts within a single ring, two adjacent struts on two circumferentially adjacent rings or partial rings, two adjacent crowns within a single ring, two adjacent crowns on two circumferentially adjacent rings or partial rings, the two adjacent struts or two adjacent crowns being held together during expansion of the stent and separating after expansion of the stent under physiological conditions.

[0038] Sometimes, after the formation of discontinuities in the circumferential rings, it is desirable to connect the stent structure axially. This provides improved support to the body lumen (or blood vessel) and prevents neointimal protrusion between the rings. This can be achieved by separating the circumferential rings joined axially after implantation. In one embodiment, the stent comprises one or more circumferential rings (windings), each ring being joined to an axially adjacent ring, and at least some of the rings having one or more separation regions that discontinue the respective circumferential paths of the rings, the discontinuous paths being held together by a polymer or an adhesive to form one or more discontinuities after expansion of the stent in a physiological environment. In another embodiment, the axially joined rings are joined via one or more axial links, and at least one or more of the axial links are configured to separate after expansion in a physiological environment. In another embodiment, the axially joined rings are joined via one or more axial links, and at least one or more of the axial links are configured to separate after expansion in a physiological environment and after the formation of neointimal hyperplasia to substantially lock the stent in position axially after implantation. In another embodiment, the axially joined rings are joined via one or more axial links, and at least one or more of the axial links are configured to separate after expansion in a physiological environment and after the formation of neointimal hyperplasia sufficient to cover the strut thickness of the stent to substantially lock the stent in position after implantation. In another embodiment, the axially joined rings are joined via one or more axial links, and at least one or more of the axial links are configured to separate after expansion in a physiological environment and after the formation of neointimal hyperplasia sufficient to cover at least 0.25 times the strut thickness of the stent to substantially lock the stent in position axially after implantation.In another embodiment, the axially joined rings are joined via one or more axial links, and at least one or more of the axial links separate after expansion in a physiological environment and after formation of neointimal hyperplasia sufficient to encompass at least 0.1 to 2 times the stent strut thickness, and are configured to substantially lock the stent in position axially after implantation. In another embodiment, one or more axial links are configured to separate before, substantially simultaneously with, or after formation of a discontinuity on an adjacent ring. It is also desirable to substantially hold the stent in position after formation of the discontinuity, provide better structural support to the body lumen (or blood vessel), and minimize or prevent neointimal protrusion through the gaps in the stent structure. In one embodiment, the stent patch includes one or more circumferential rings that are expandable from a crimped configuration to an expanded configuration, the rings having one or more separation regions within each ring, one or more separation regions between each adjacent ring, or one or more separation regions between circumferentially adjacent partial rings, and at least some (or substantially most) of the separation regions form a discontinuity after expansion of the stent and after formation of at least 0.1 to 2 times the thickness of an adjacent strut, crown, or other adjacent stent structural element, and are configured to substantially hold the stent in position circumferentially and / or axially.

[0039] Many or all of the stents or other scaffold designs described herein will be able to adapt or conform over time after deployment to almost all forms of loops and / or vascular geometries, movements, anatomical changes, and distortions. For example, stents and scaffolds having separation regions and / or hinge joints as described herein will possess the ability to adapt to sufficient tensile stress, crush resistance, and geometric distortions such as angles (vascular bending), torsional stress (twisting of the blood vessel about its axis), longitudinal compression and extension, and the like. Such stresses are experienced, for example, by stents and other scaffolds implanted in loops, arteries and veins located within the heart, or the aorta, or peripheral biological structures such as below the knee, or in the superficial femoral artery, and the like. The stents and scaffolds of the present invention are typically able to dynamically conform and respond to both such pulsations of the blood vessel (radial opening and closing) and torsional deformations about the axis of such blood vessel, as well as longitudinal compression.

[0040] In some embodiments, a luminal prosthesis having a circumferential ring with struts sutured by a crown with a separation region formed from a non-degradable material and configured to form a discontinuity after expansion of the prosthesis under physiological conditions has a stress induced by longitudinal compression or extension of the expanded prosthesis prior to the separation region forming the discontinuity. In some cases, the maximum stress induced by longitudinal compression or extension of the expanded prosthesis prior to the separation region forming the discontinuity is reduced by at least 10%, 15%, 25%, 50%, 75%, 85%, or 90% after the formation of the discontinuity. In some cases, the maximum stress induced by longitudinal compression or extension of the expanded prosthesis prior to the separation region forming the discontinuity is reduced by 15% to 95%, preferably 50% to 95%, more preferably 70% to 95% after the formation of the discontinuity.

[0041] In some cases, prior to the separation region forming a discontinuity, the maximum stress as measured by linear elastic finite element analysis induced by 5 - 7% longitudinal compression or extension of the expanded prosthesis ranges from 400e3 to 800e3 PSI, and after the formation of the discontinuity, ranges from 1e3 to 300e3 PSI. Sometimes, prior to the separation region forming a discontinuity, the maximum stress as measured by linear elastic finite element analysis induced by 5 - 7% longitudinal compression or extension of the expanded prosthesis ranges from 300e3 to 1000e3 PSI, and after the formation of the discontinuity, ranges from 1e3 to 250e3 PSI.

[0042] In some embodiments, prior to the separation region forming a discontinuity, the maximum stress induced by torsion applied by the expanded prosthesis decreases by at least 10%, 15%, 25%, 50%, 75%, 85%, or 90% after the formation of the discontinuity. Alternatively, prior to the separation region forming a discontinuity, the maximum stress induced by torsion applied by the expanded prosthesis decreases by 15% - 95%, preferably 50% - 95%, more preferably 70% - 95% after the formation of the discontinuity. In some embodiments, prior to the separation region forming a discontinuity, the maximum stress as measured by linear elastic finite element analysis induced by a torsional displacement of 3.5° / cm of the prosthesis length applied to the expanded prosthesis ranges from 80e3 to 150e3 PSI, and after the formation of the discontinuity, ranges from 1e3 to 65e3 PSI. Alternatively, prior to the separation region forming a discontinuity, the maximum stress as measured by linear elastic finite element analysis induced by a torsional displacement of 3.5° / cm of the prosthesis length applied to the expanded prosthesis ranges from 65e3 to 150e3 PSI, and after the formation of the discontinuity, ranges from 1e3 to 50e3 PSI.

[0043] Sometimes, prior to the formation of a discontinuity in the separation region, the force required to bend the prosthesis by a specified amount in a three-point bending configuration decreases by at least 10%, 15%, 25%, 50%, 75%, 85%, or 90% after the formation of the discontinuity. Alternatively, prior to the formation of a discontinuity in the separation region, the force required to bend the prosthesis by a specified amount in a three-point bending configuration decreases by 15% - 95%, preferably 50% - 95%, more preferably 70% - 95% after the formation of the discontinuity. In some cases, prior to the formation of a discontinuity in the separation region, the force required to bend the center of the prosthesis by about 1 mm in a three-point bending configuration with supports spaced about 11 mm apart ranges from 1 - 4 N, and after the formation of the discontinuity, ranges from 0.1 - 0.8 N. Alternatively, prior to the formation of a discontinuity in the separation region, the force required to bend the center of the prosthesis by about 1 mm in a three-point bending configuration with supports spaced about 11 mm apart ranges from 0.7 - 4 N, and after the formation of the discontinuity, ranges from 0.01 - 0.5 N.

[0044] In some embodiments, prior to the formation of a discontinuity in the separation region, the maximum stress induced by bending the expanded prosthesis to the target radius decreases by at least 10%, 15%, 25%, 50%, 75%, 85%, or 90% after the formation of the discontinuity. Alternatively, prior to the formation of a discontinuity in the separation region, the maximum stress induced by bending the expanded prosthesis to the target radius decreases by 15% - 95%, preferably 50% - 95%, more preferably 70% - 95% after the formation of the discontinuity. Sometimes, prior to the formation of a discontinuity in the separation region, the maximum stress, as measured by linear elastic finite element analysis, required to bend the expanded prosthesis to a target radius of 70 mm ranges from 100e3 - 800e3 PSI, and after the formation of the discontinuity, ranges from 10e3 - 90e3 PSI for an expanded stent diameter of 6 mm.

[0045] Sometimes, prior to the formation of a discontinuity in the separation region, the change in the angle of a curved blood vessel with an expanded physiological implant placed inside it decreases by at least 10%, 15%, 25%, 50%, 75%, 85%, or 90% after the formation of the discontinuity. Alternatively, prior to the formation of a discontinuity in the separation region, the change in the angle of a curved blood vessel with an expanded physiological implant placed inside it decreases by 15% - 95%, preferably 50% - 95%, more preferably 70% - 95% after the formation of the discontinuity. In certain cases, prior to the formation of a discontinuity in the separation region, the change in the angle of a curved blood vessel with an expanded physiological implant placed inside it ranges from 30 - 70 degrees and, after the formation of the discontinuity, ranges from 10 - 25 degrees. In some embodiments, prior to the formation of a discontinuity in the separation region, the maximum stress induced by bending a prosthesis expanded by a given angle decreases by at least 10%, 15%, 25%, 50%, 75%, 85%, or 90% after the formation of the discontinuity. Or, prior to the formation of a discontinuity in the separation region, the maximum stress induced by bending a prosthesis expanded by a given angle decreases by 15% - 95%, preferably 50% - 95%, more preferably 70% - 95% after the formation of the discontinuity.

[0046] In some embodiments, prior to the formation of a discontinuity in the separation region, the maximum stress, as measured by linear elastic finite element analysis, of bending a prosthesis expanded by a given angle of about 7 degrees to a 3.0 mm diameter ranges from 100e3 - 800e3 PSI and, after the formation of the discontinuity, ranges from 10e3 - 90e3 PSI.

[0047] The stent or scaffold may include a drug that will be released in a physiological environment after implantation. The drug may be coated on one or more surfaces of the stent, on the abluminal surface, the luminal surface, or both, contained within one or more polymeric materials coated on any surface of the stent, contained within a top coat on any surface, or contained within a substrate with a polymer on the stent or scaffold. Drugs that may be utilized include the various drugs listed in this application, including, for example, rapamycin, everolimus, analogs, or derivatives, and drugs such as taxol, analogs, or derivatives, including M-tor inhibitors.

[0048] Methods for measuring and quantitatively expressing the strength (radial strength) and compliance of blood vessels and other luminal stents and scaffolds are well known and described in the patent and medical literature.

[0049] Compliance, as the term is used in many of the examples or embodiments, is a dimensionless measure representing the rate of change of the diameter (or configuration) of a luminal structure or a compartment of a luminal structure in response to physiological conditions such as changes in internal pressure within or adjacent to the luminal structure, and usually such a pressure change is 100 mmHg. In some other cases, compliance measurements can be expressed as mm / atm, mm / psi, % / atm, % / psi, or equivalents. The terms "compliance" and "radial compliance" are used synonymously.

[0050] Body lumens, stents, scaffolds, prostheses, and other tubular structures will each have their own compliance. A body lumen having an implanted stent, scaffold, prosthesis, and other tubular structures will also have a compliance that is a composite of the individual compliances of the lumen and the implant, which typically is lower than the lumen and often lower than the implant alone. In many cases or embodiments, the "composite" compliance will be measured to define the compliance characteristics of the stent, however, this can also, in some cases and in many of the embodiments claimed herein, be the stent-alone measured compliance, scaffold, prosthesis, and other tubular structures. In many instances or embodiments throughout this application, the term "radial strain" is used to mean compliance and when the term "compliance" or "composite compliance" is described in this or other paragraphs, it is used synonymously with the term "compliance" (or "composite compliance"). Typically, when radial strain is measured at a 100 mmHg change in pressure, this refers to the compliance (or composite compliance) of the implant, however, compliance can also refer to the rate of change of the diameter of the implant or composite material at a change in pressure other than 100 mmHg, such as about 176 mmHg or other pressures.

[0051] Specifically, the radial compliance of a stent, scaffold, or other lumen prosthesis is measured as the in vitro composite compliance in a simulated blood vessel according to well-known principles and techniques such as those described in ASTM F2477-07R13, which measures compliance at a 100 mmHg change in pressure, however, the test can also provide a method for testing compliance at a change in pressure other than 100 mmHg, such as about 176 mmHg or other pressures. Also, stent compliance can be tested by having a stent implanted in a blood vessel such as a porcine coronary blood vessel and the compliance is measured within the stent deployment section of the blood vessel.

[0052] In a first aspect or embodiment of the present invention, an implant, specifically an intraluminal implant, comprises a scaffold having a plurality of circumferential rings formed or patterned from a non-degradable material, typically a metal or metal alloy, the scaffold being configured to expand from a crimped configuration to an expanded configuration. At least some of the circumferential rings have at least one separation region, the separation region being configured to form at least one discontinuity in the circumferential ring after the scaffold has been expanded within a physiological environment. In a preferred embodiment, after such expansion and exposure to a physiological environment, typically a blood vessel or other body lumen environment, at least two of the circumferential rings remain axially joined after all discontinuities have been formed, typically adjacent rings in the axial direction. Frequently, all of the circumferential rings of such an intraluminal implant will remain axially joined after discontinuities have been formed. For example, the circumferential rings may be joined by axial links, which are typically short structural elements that join a region on one circumferential ring to a region on an adjacent circumferential ring. However, in other embodiments, regions on contiguous adjacent circumferential rings may be joined directly, for example, by welding or otherwise joining crown to crown, strut to strut, or equivalents, as will be described in more detail hereinafter in this application. In a specific embodiment, adjacent crowns on adjacent rings may be joined by welding, coating, joining with wire or other filaments, adhesives, or equivalents. The separation region will often be formed within a strut, crown, or other structural element, but in some cases, the separation region may encompass or comprise the entire structural element. In some embodiments, a lock and key or other type of separation region may extend to form the full or substantially full length of a strut between a pair of abutting crowns. In other embodiments, the male and female components of a lock and key separation region may be curved to form a crown between a pair of abutting or adjacent struts. The separation region may be located anywhere within the structural element. This may be near the approximate center of the structural element, or at or near one or the other end of the structural element.

[0053] The stent prosthesis has at least one separation region that forms a discontinuity after expansion in a physiological environment with placement of the separation region within a circumferential ring such that the discontinuity is formed in the circumferential ring as a non - continuity being formed in a circumferential direction ring. In some cases, this provides a break, gap, complete separation or bisection of the ring into discrete segments such that the ring no longer has a continuous circumferential path around the scaffold. In some embodiments, each circumferential ring has a separation region positioned to provide a gap, break, or separation within each circumferential ring such that, in response to expansion in a physiological environment, a discontinuity is formed and each ring opens or no longer has a continuous circumferential path around the scaffold.

[0054] Bisection typically separates a structural element or a continuous portion or segment of a circumferential ring or an axial link into two or more portions that are not necessarily of equal length. For example, a separation region within a crown or strut in a circumferential ring will bisect the crown or strut into two or more portions. In some cases, the separation region bisects the crown or strut at its center. In other cases, the separation region bisects the crown or strut not at its center.

[0055] In a preferred embodiment, the term "separation region" is a location or region within the scaffold configured to form at least one discontinuity in the scaffold after the scaffold is expanded in a physiological environment. The discontinuity comprises an opening, break, gap, bisection, or the like formed between two adjacent portions or segments of the scaffold components such that the portions or segments are no longer directly connected to each other within the region of the portion or segment, and in some cases were pre - joined. The two adjacent portions or segments of the components may be pre - joined prior to expansion of the stent by any of the methods described elsewhere in this specification or may be formed as a continuous structure.

[0056] In at least most cases, the discontinuity is not formed in the separated region until after the scaffold has been expanded within the physiological environment, typically over a time period ranging from 1 week after stent expansion to 12 months after stent expansion, often from 1 month after expansion to 9 months after expansion, usually from 2 months after expansion to 7 months after expansion. In particular, in the case of balloon-expandable stents and other prostheses, the separated region is expected to remain intact as the scaffold is expanded by the balloon, and the discontinuity will only be fully formed (i.e., release the pre-integrated region of the scaffold) after the scaffold has been deployed within the blood vessel or other physiological environment over the described time period. The discontinuity is usually not formed until after expansion within the physiological environment, but in some cases, one or more rings, typically one or more end rings, may form one or more discontinuities prior to expansion (deployment) of the stent under physiological conditions.

[0057] For example, such an intravascular prosthesis according to the present invention will have a circumferential ring with a circumferential structure having an initial radial compliance, typically a composite compliance as discussed above, prior to the formation of any discontinuity. However, after the formation of the discontinuity, at least some of the circumferential rings will have a radial compliance that is increased relative to the initial radial compliance of at least some of the rings prior to the formation of the discontinuity. For example, the initial radial compliance (or the composite compliance of the scaffold section) of at least some of the circumferential rings of the scaffold according to the principles of the present invention may be 0.1% to 1%, typically 0.1% to 0.5%, while the radial compliance after the formation of the discontinuity will typically be 1.2% to 10%, often 1.2% to 5% or 1.5% to 3%.

[0058] In one example of measuring the composite compliance of a scaffold, a simulated vascular system is used as follows. The scaffold being tested, the simulated blood vessel, the water used to pressurize the simulated blood vessel, and all other test equipment are maintained at room temperature. All diameter measurements are made using a calibrated non-contact system capable of measuring diameters within ±0.01 mm without contacting the scaffold. Suitable measuring instruments include microscopic video measurement systems, laser microscopes, and optical comparators. The pressure measurement of the water used to pressurize the simulated blood vessel is performed using a gauge capable of accurately measuring the fluid gauge pressure within ±0.05 PSI. The pressure measurement is performed when the diameter measurement is made. The length of all connecting tubes used in the setup is less than 10 inches, and any dynamic changes in pressure throughout the simulated blood vessel are eliminated to ensure that they are accurately reflected by the pressure gauge to eliminate any restrictions in the tubes and connectors. The diameter measurement should be performed 30 minutes after the initial pressurization of the simulated blood vessel.

[0059] The simulated blood vessel is an elastomeric silicone tube with a uniform cross-section and uniform material properties throughout its length. For stents smaller than 2.5 mm in diameter, the simulated blood vessel wall thickness is 0.25 ± 0.03 mm. For stents 2.5 mm in diameter and larger, the simulated blood vessel wall thickness is 0.5 mm ± 0.03 mm. The test pressure within the simulated blood vessel is 3.4 ± 1 PSI (or approximately 176 mmHg), and the system will be sufficiently leak-proof to maintain this pressure over the duration of the test. The stent-simulated blood vessel system is fixed to prevent changes in the simulated blood vessel due to length and longitudinal forces that could affect the rest length and diameter of the simulated blood vessel. The stent-simulated blood vessel system is further fixed to prevent changes in diameter due to forces other than internal pressurization.

[0060] The balloon-expandable non-deployable scaffold is deployed in air from an expanded configuration equal to or 0.1 mm smaller than the outer diameter of the simulated blood vessel without pressure. The scaffold is expanded using a balloon or other delivery system suitable for use with the scaffold being tested. The inner diameter (ID) is verified using a non-contact measurement system. Self-expanding scaffolds are deployed in air to their free diameter and the ID is verified using a non-contact measurement system. The simulated artery is selected to have an outer diameter equal to or 0.1 mm larger than the inner diameter of the deployed stent.

[0061] The expanded test scaffold is slid over the outside of the simulated blood vessel and the simulated blood vessel tubing is stretched as needed to temporarily reduce the tube diameter and allow the stent to pass over it. After releasing the tension on the simulated blood vessel, the actual contact between the ID of the scaffold and the outer diameter (OD) of the simulated blood vessel along the entire contact length is verified.

[0062] The interior of the simulated blood vessel tube is connected to an inflation / deflation device (a device used to inflate and deflate an angioplasty balloon during angioplasty) having a gauge capable of providing at least 3.4 psi and measuring the pressure in the tube to within 0.05 psi at such pressure.

[0063] The OD of the stent and the OD of the reference section of the simulated blood vessel away from the stent implantation section are both equal to or twice the diameter of the simulated blood vessel. At distances from the stent and similar distances from any fixture holding the simulated blood vessel, they are measured using a non-contact system. These OD measurements are taken and averaged to obtain a reference simulated blood vessel OD value. These OD measurements are taken and averaged around the mid-length of the scaffold to obtain a reference scaffold OD value. The interior of the simulated blood vessel is pressurized with water up to 3.4 PSI (176 mmHg), and the OD of the scaffold and the simulated blood vessel are measured at the same location used to establish the reference when the pressure reading is maintained at 3.4 PSI. Composite compliance is determined by dividing the OD value measured when the simulated blood vessel is pressurized by the reference OD value, subtracting 1, and multiplying by 100 to determine the composite compliance as a percentage.

[0064] For example, if the applied pressure in the simulated blood vessel increases the diameter of the OD of the test scaffold from 3.50 mm OD to 3.73 mm OD, the composite compliance is ((3.73 / 3.50) - 1) × 100 = 6.6%. As a second example, if the applied pressure in the simulated blood vessel increases the diameter of the OD of the test scaffold from 3.50 mm OD to 3.52 mm OD, the composite compliance is ((3.52 / 3.50 - 1) - 1) × 100 = 0.6%.

[0065] The scaffold composite compliance can be measured before and after the opening of the separation regions that form the discontinuities. To obtain the composite compliance before the formation of the discontinuities, the scaffold is measured as described above while all separation regions remain intact. To obtain the composite compliance after the formation of the discontinuities, the scaffold is treated to open all discontinuities while the scaffold remains on the mock blood vessel. The separation regions may be opened by techniques specific to the nature of the particular separation region. For separation regions immobilized by a polymer sleeve, adhesive, or solvent, the scaffold is exposed to a solvent, enzyme, or other chemical to form the discontinuities without damaging the mock blood vessel. Alternatively, for non-polymer separation regions, the separation regions may be physically separated using mechanical means, a laser cutter, ultrasound, or other energy-based cutter forms the discontinuities. For lock designs or separation regions that open in response to fatigue, the mock artery can be cyclically pressurized at a rate of 5 - 8 Hz until the discontinuities are formed. See Example 5 and Figure 35. If the scaffold collapses while the separation regions are open, the composite compliance will be considered equal to the mock blood vessel compliance without a scaffold.

[0066] The scaffold has an initial fracture strength that decreases upon expansion and formation of discontinuities within the physiological environment. The scaffold has an initial compliance after implantation and the compliance increases after formation of the discontinuities without decreasing the expanded configuration after recoil.

[0067] The radial strength (crushing resistance) is measured using a parallel flat panel (see ISO 25539-2) fixed on an Instron tensile testing machine with a 5 N load cell to enable force and displacement measurements. The bottom plate is flat and remains stationary during the test. The upper plate is mounted on the load cell to record force measurements as a function of displacement. The plates are visually verified to be parallel to each other at the meshing surfaces. Both the bottom and upper plates are rectangular in shape with surfaces that completely cover the test stent in length and diameter. Both plates are configured to remain submerged in a water bath at body temperature maintained at 37 ± 2 °C by a circulation heater. The circulation pump is switched off during force measurement to prevent the current from modifying the results. The upper plate is formed from Delrin and the bottom plate is formed from brass.

[0068] The test scaffold is deployed at its nominal inner diameter using a standard deflator or other delivery system. The deployed test stent is removed from the delivery system, and the diameter of the test stent is verified by a non-contact measurement system. The test stent is then slid onto a 0.035-inch diameter mandrel approximately 50 mm in length before being placed between parallel plates underwater in 37°C water that mimics physiological conditions. The mandrel will prevent the test stent from rolling during initial contact with the parallel plates. The upper plate is then slowly pushed downward using a displacement controller from an Instron tensile testing machine until it comes approximately 1 mm above the stent and the force gauge is set to zero. This is then lowered until it just contacts the test stent and a force of 0.01 N is detected. The stent is then allowed to stabilize in the water bath for 60 seconds. The test cycle is then initiated, and the crushing resistance is measured by reducing the distance between the parallel plates up to a maximum of 50% of the test stent diameter. A force-distance curve is generated during the test. The rate of distance reduction (crosshead speed) is 1.5 mm / min. The load force at 10% of stent deformation (compression) is determined in Newton units. For example, for a 3.0 mm labeled stent that expands to its nominal diameter (3.0 mm), the force required to compress it by 0.3 mm (10% compression) is reported. The load force in Newton (N) units is then divided by the expanded stent length in mm units to normalize the strength in N units to the stent length, and thus the radial strength of the stent is expressed as N / mm of stent length.

[0069] The expanded stent reference radial strength is measured (in N / mm of stent length) and, as described in the crushing resistance method, is measured again (if applicable) after the formation of a discontinuity. For the stent of the present invention, the radial strength decreases after the formation of a discontinuity compared to the reference radial strength before the formation of the discontinuity, and preferably decreases by a range of 10% to 100% of the reference radial strength compared to the reference radial strength.

[0070] The above protocol for measuring composite compliance and radial strength is particularly effective for scaffolds having a nominal diameter of 2 mm to 4 mm and having a dedicated or conventional deployment system in measuring these values. For stents, valves, prostheses, and any other scaffolds having other sizes and deployment systems, including non-standard sizes and non-standard deployment systems, the scaffold should be deployed in accordance with the manufacturer's published instructions for use, and the test apparatus should be adjusted or modified to have the same fit with the deployed scaffold as described above. For the case of the simulated blood vessel for measuring composite compliance, the outer diameter of the simulated blood vessel should be equal to, or at most 0.1 mm larger than, the inner diameter of the deployed scaffold. For the case of the flat plate separation distance for measuring crush resistance, the scaffold OD should be measured with an accuracy of ±0.01 mm via a non-contact method, and a 10% deflection should be calculated from this measurement. All other parts of the test method should be followed as closely as possible.

[0071] In a preferred embodiment, the scaffold of such an endoluminal prosthesis may be separated into compartments after a discontinuity is formed in a circumferential ring. The separation may be along an axial, circumferential, helical, irregular, or other line. For example, two, three, or more compartments may be separated along an axial, helical, or irregular line, allowing the compartments to expand and contract radially and increasing the composite compliance of the scaffold when implanted in a body lumen. In many cases, all or substantially all of the compartments provide an enhanced (or increased) radial compliance while the structural elements of the scaffold remain axially joined together to provide support (or the scaffold) to the lumen (or blood vessel) wall and / or to reduce the risk of removal or otherwise release of the elements after implantation in the vascular system or body lumen and will remain axially joined together along their entire length (or along the entire length of the stent). Other embodiments of the compartments include closed cell compartments and equivalents. In such preferred embodiments, the scaffold (endoluminal prosthesis) forms a tubular body in a crimped configuration and / or an expanded configuration, and the scaffold may be formed from wire, a substantially continuous tube, a sheet, molding, or printing.

[0072] In a closed cell design, such separation regions are typically located such that the circumferential path is no longer continuous. In this case, the discontinuity may be located within the circumferential connectors between the closed cells on the ring or on either side of the closed cells on the ring such that the ring is opened and the circumferential path is completely bisected or separated.

[0073] In other embodiments and / or examples, the scaffold will not be separated into compartments. That is, while at least one, and usually a plurality of discontinuities will be formed in the scaffold, all circumferential rings, struts, crowns, links, and other structural elements (or components) of the scaffold will remain physically connected such that no part (or element) of the scaffold is completely severed from any other part of the remainder of the stent. Such physical connection of all parts of the scaffold, even after the discontinuities are formed, can be an advantage because it reduces the risk that any part of the scaffold will be released into the vascular system or other body lumen.

[0074] In one particular example, the discontinuities in adjacent circumferential rings may be separated along an axial line such that the stent is divided into two or more axially aligned compartments, each extending from a first (usually distal) end of the scaffold to a second (usually distal) end of the scaffold. Such axially aligned compartments of the individual circumferential rings circumferentially separate along an axial (usually straight), helical, or irregular separation line, but after all discontinuities are formed, are axially joined (e.g., by one or more axial links) or remain intact. Such intact axial, helical, or irregular compartments will typically be elongated, having a length corresponding to the overall length of the scaffold in its expanded configuration.

[0075] Such elongated axial, helical, or irregular compartments will usually be completely separated along their entire length, but in other cases, one or two circumferential connections may remain after all discontinuities are formed in the scaffold. Specifically, the elongated compartments may remain joined at one or both ends of the scaffold to reduce "dogboning" or for other purposes.

[0076] In some embodiments, the circumferential ring of the scaffold of the present invention may have a continuous perimeter or periphery, typically a circular perimeter, in which case adjacent continuous rings are typically joined by axial links or by direct connection, for example, by welding, fusing, tying, adhering, or otherwise bonding the crowns together on adjacent circumferential rings. In other cases, at least some of the circumferential rings may have a discontinuous perimeter, joined such that the end regions form a helical scaffold. In specific embodiments and configurations, the axial links will be made of non-degradable metal, metal alloy, or other non-degradable material. Most commonly, such axial links will be patterned from the same tubular component (or material) used to form the scaffold. Thus, many scaffolds will be formed as an integral or monolithic structure from the same metal, metal alloy, or other material that forms the stent.

[0077] Exemplary intraluminal prostheses of the present invention will often comprise a scaffold having repeating structural elements such as circumferential rings, closed cells, or the like. Some or all of the circumferential rings may, for example, comprise a plurality of struts joined by a crown in a similar or the same structure, for example, a similar or the same pattern (although it is also possible to have one or more than one varying among the structure, pattern, and structural elements (thickness, width, shape, etc.)). The separation regions may be located within the struts, the crown, or both. Often, at least one separation region will be located within the struts, and at least 1 to 5 struts within the ring will have a separation region. Alternatively, or in addition, at least one separation region may be located within the crown, and 1 to 5 crowns within the ring may have a separation region. However, often, most or all of the crowns will not include a separation region because as the scaffold expands radially by balloon inflation from a crimped configuration to an expanded configuration, or otherwise, the crown or crown region is subject to high stress. Such high stress can result in premature formation of discontinuities in the scaffold and loss of the structural integrity of the scaffold. The struts are, therefore, a preferred location for the formation of separation regions. The separation regions may also be formed in other regions of the axial link or direct axial connection between adjacent circumferential rings. Separation regions within the axial connectors between adjacent rings will typically not contribute to the radial compliance of the ring or stent retention compartment, or will typically not affect the radial strength of the ring or scaffold after the formation of the discontinuity, and are thus optional. Often, the axial link and axial connector regions will remain intact and free of discontinuities. Thus, in many embodiments of the present invention, the scaffold comprises or consists of a plurality of axially connected circumferential rings, and the rings are connected by a crown and comprise or consist of struts in which the separation regions are formed only in the struts, not in the crown (or crown region) or the axial link or other axial connector regions.Placing a separation region, for example, within a circumferential ring, such as within a strut and / or crown, has the advantage of providing the ability to modify the circumferential properties of the stent at various times after implantation. The circumferential arrangement of the rings is important for the ring structure for various stent properties, such as radial strength (flat plate), composite compliance of the stent deployment compartment, further expansion to a larger diameter after implantation, response to vasodilation, etc. For example, placing a separation region within a circumferential ring structure provides the stent with modified improved properties after a discontinuity is formed after implantation. The need for a lumen stent is essentially time-dependent and varies at different times. Over a short time period after implantation, the stent is required to have a high radial strength to support the blood vessel in an open state, and then, over the next period, after the tissue has reformed and healing has begun or completed, the requirement for high stent strength to maintain the blood vessel in an open state is no longer necessary. In contrast, having a high strength can reduce the physiological function of the blood vessel. Current non-degradable (non-corrosive) stents, such as stainless steel alloy stents, cobalt-chromium alloy stents, and platinum-iridium alloy stents, address the high initial radial strength of the blood vessel directly, but they typically do not respond to the changing blood vessel requirements over time after implantation. The blood vessel no longer requires a high radial strength to maintain the blood vessel in an open state, and having such a high radial strength maintained over time can stimulate the blood vessel and cause further progression of the disease or poor healing. A stent having a separation region within the stent ring that forms a discontinuity in the circumferential ring after implantation, preferably formed from a non-degradable material (the stent can also be formed from a degradable material), provides the stent with modified improved properties after a discontinuity is formed after implantation. Such a stent of the present invention is configured to provide a high initial radial strength after expansion, and such a high initial radial strength then decreases over time after implantation, helping to address the physiological needs of the blood vessel while maintaining the blood vessel in an open state.Similarly, current non-degradable stents typically have a low composite compliance in the stent-retained section that "confines the blood vessel" over the life of the stent, preventing the natural vasomotor ability of the blood vessel, preventing the ability of the blood vessel to respond to vasodilators, or preventing the stent-retained section from further expanding to a larger diameter after implantation. The stent of the present invention, having discontinuities formed within the circumferential ring after implantation, may be configured to have a higher (or increased) composite compliance after expansion, allowing the stent-retained section of the blood vessel to respond to natural fluctuations in blood pressure (vasomotion), allowing the stent (or the stent-retained section) to further expand after initial expansion (and, where applicable, after inward recoil), and maintaining the ability of the blood vessel to respond to vasodilators. The stent of the present invention may be configured to have an increased composite compliance within the stent-retained section immediately after expansion or after a longer time period after implantation.

[0078] There is an advantage in placing a separation region within the struts, which is typically a region of lower stress in the ring and thus undergoes less plastic deformation than the crown. The location and size of the struts are also typically larger than other areas of the stent, such as other curved regions of the crown or ring, and have less torque, providing additional options for more types of separation regions. The struts can typically accommodate more changes on the inside (such as having a separation region) without degrading the functional integrity of the stent, such as being able to expand the stent from a crimped configuration to an expanded configuration. The orientation of the struts changes (opens) as the stent expands and is configured to utilize the strut angle prior to deployment such that the separation regions are held together as the stent expands, enabling a separation region design that allows for the desired direction of movement of the separated strut elements, such as radial, circumferential, and / or axial movement, opening the struts to a certain angle in the expanded stent configuration.

[0079] There can be advantages in the placement of a separation region within the crown. As the ring expands or contracts, the crown typically experiences high bending moments (torques), causing high stresses and plastic deformation. Composite elements that are resistant to high moments (torques) can advantageously be used within the crown region. The movement of deployment within the crown region causes rotation between adjacent struts. For example, joint elements that function to allow such rotation, through ball-socket-like joints or other joints as depicted throughout the present application, can reduce ring stiffness while maintaining adhesion between separate regions of the ring so as to maintain an overall "tubular" shape that conforms to the lumen even after separation. Having a separation region within the crown (inside the crown) can allow for higher composite compliance, as may be desired in certain applications. Additionally, having a separation region within the crown can allow for the use of other materials that were not suitable for stent applications due to their limited mechanical properties such as elongation or brittleness, and the separation region within the crown can allow for expansion of the ring without breakage.

[0080] In the exemplary endoluminal prosthesis, the struts may be joined by a crown so as to define an angle therebetween, typically referred to as the "crimp angle". The crimp angle while the scaffold is in the crimped configuration will typically be small, or even negative at times. The crimp angle will increase as the scaffold expands from the crimped configuration to the expanded stent configuration. Typically, the crimp angle of at least some of the struts joined by the crown ranges from -25° to +25°, and more typically from -15° to +55°. The angle in the expanded configuration will typically range from 35° to 180°, and more typically from 45° to 150°. When present in a strut, the separation region can be located anywhere along the length of the strut, typically in or centered within the middle of the strut, typically bisecting the strut. Similarly, when present in the crown, the separation region can be formed at a point on the crown, typically centered at the middle of the crown, e.g., at the location bisecting the crown, which is typically semi-circular. In a preferred embodiment, the separation region in at least one strut is a pre-formed cut (or gap) that bisects the at least one strut into two separate elements. Examples of separation regions in at least one strut include butt joint designs, key and lock designs, comb designs, and / or others, and the bisected strut elements adjacent to the separation region may have various geometries, shapes, dimensions, patterns that have uniform stent expansion and / or are configured to maintain the structural integrity of the stent in response to expansion. The at least one bisected strut (separation region) is typically held together by one or more materials as described throughout this application.

[0081] In a preferred embodiment, at least some of the separation regions are located over or within these regions such as strut regions that are "low stress regions" of at least some circumferential rings, i.e., regions that experience less stress as the scaffold expands, either by ballooning or by self-expansion. As the scaffold expands from a crimped configuration to an expanded configuration, the low stress regions such as struts will experience less stress than high stress regions such as crowns that deform as a result of concentrated stress as the scaffold expands radially. In certain embodiments, at least some circumferential rings each having one or more separation regions have an initial strength in response to expansion of the stent within a physiological environment, and the initial strength of at least some circumferential rings decreases after formation of the discontinuity. In a preferred embodiment, one or more separation regions are preferably located within the struts, which experience reduced (or minimal) stress as the scaffold expands from a crimped configuration to an expanded configuration, and thus enhance the structural integrity of the expanding scaffold by preventing all or substantially all formation of discontinuities during expansion.

[0082] The separation region within the scaffold of the endoluminal prosthesis may take various forms. For example, the separation region may comprise a pre-formed cut or gap within the crown region and / or within the strut region, whereby the crown and / or strut structural elements are joined, coated thereby, or embedded therein by a material that will degrade in a physiological environment, which is typically a degradable polymer, but sometimes a degradable metal or metal alloy, thereby bisecting the crown and / or the strut into two separate segments, and many specific embodiments will be described in detail below. The degradable material, comprising one or more materials, may in turn be applied to at least one surface of the separation region, to at least one surface of the stent, to all separation region surfaces, and / or to all stent surfaces, and may be provided in various forms and geometries including sleeves, coatings, solder, adhesives, laminates, and the like. In some embodiments, at least one surface, most, or all of the separation region surface or the scaffold surface may be coated or laminated with a degradable material. In a preferred embodiment, the material acts as an adhesive, paste, or attachment element that fills the space between the opposing surfaces of the separation region, and the stent on the anti-luminal side, and the luminal surface, holds the surfaces together, and maintains stent structural integrity in response to stent expansion. In other cases, the degradable material may be located only on or within the separation region, optionally a short distance on both sides thereof, such as 2 mm, 1 mm, 0.5 mm, or the equivalent. In yet another embodiment, a non-degradable material, comprising one or more non-degradable materials, may in addition be applied to at least one separation region surface, and / or in addition be applied to at least one stent surface, and / or in addition be applied to all separation region surfaces, and / or in addition be applied to all stent surfaces. The non-degradable material may be applied before or after the degradable material. In a preferred embodiment, the degradable and / or non-degradable materials disposed on the non-degradable stent are polymeric materials.In another embodiment, the polymeric material (degradable and / or non-degradable) may contain at least one drug and may be coated on at least one surface of the stent, preferably so as to cover at least the anti-luminal surface of the stent.

[0083] In some embodiments, the separation region is made of a non-degradable material that relaxes, expands, becomes more flexible, or softens to create a discontinuity in the circumferential ring such that the ring continues to be joined but exhibits an increased ability to move in various directions at the discontinuity. This separation region may be formed by incorporating a flexible non-degradable material or polymer into the support separation region (gap, break, or interruption). In some embodiments, a degradable or non-degradable material or polymer is coated on the support and covers all or the separation region of the support. In the case of a degradable material, this degrades after expansion of the support under physiological conditions and in some cases releases a drug incorporated in the coating and / or degrades in the separation region to allow the formation of a discontinuity. When the coating is a non-degradable material such as a polymer, the coating may cover the entire support or some regions of the support. The non-degradable material may be selected to cover the separation region, which may be a gap or break in the support such that the non-degradable material softens after expansion of the support under physiological conditions and allows for increased flexibility and movement at the discontinuity.

[0084] In certain embodiments, the degradable material can be applied by spray coating, dip coating, sleeve encapsulation, printing, soldering, adhesion using an adhesive, or the like. The degradable material can be a polymer, metal, or any other degradable material, as described in more detail elsewhere herein. Typically, the degradable material has sufficient strength to hold the separation regions together and immobilize adjacent structural elements within the separation regions while the stent or other prosthesis scaffold expands from a crimped configuration to an expanded configuration within the physiological environment. The degradable material typically degrades after expansion of the stent from the crimped configuration to the expanded configuration. The degradable material may have a thickness substantially the same as the thickness of the adjacent regions of the non-degradable structural elements, i.e., the degradable material will fill the gap or other space between the adjacent structural elements but will not extend across these adjacent regions. However, in other embodiments, the degradable material may have a thickness that extends 5 μm to 30 μm thicker than the thickness of the non-degradable structural elements adjacent to the separation region, may extend across the adjacent region, may extend across at least one surface of the stent, may cover it, or may cover all stent surfaces. The degradable material thickness can be substantially the same for all separation regions or can have different thicknesses, for example, to control the timing of formation of discontinuities.

[0085] In a preferred embodiment, the degradable material substantially uniformly coats the non-degradable structural elements of the stent, i.e., has substantially the same thickness over substantially all of the outer lumen-facing surfaces of the structural elements and has the same thickness with respect to substantially all of the lumen surfaces of the structural elements. However, the degradable material may also have different thicknesses with respect to different surfaces of the scaffold structural elements. Typically, the coating or other cover over the outer lumen-facing and / or lumen surface regions of the scaffold structural elements ranges from 3 μm to 50 μm, and more typically from 5 μm to 30 μm. The degradable material may coat and / or fill only the separation regions, may coat and / or fill the separation regions and the surfaces of adjacent structural elements, may coat and / or fill the separation regions and the surfaces of adjacent structural elements and adjacent rings, or may coat the entire stent and fill all of the separation regions.

[0086] Some or all of the separation regions can be configured to form discontinuities, either substantially simultaneously or at different time periods, as described elsewhere herein. In a preferred embodiment, the degradable material degrades after a period ranging from 1 month to 2 years after implantation, preferably from 2 months to 1 year after implantation, more preferably from 3 months to 9 months after implantation.

[0087] In another preferred embodiment, a non-degradable scaffold having separation regions held together by at least one degradable material has, after expansion and, if applicable, after an initial inward recoil after expansion, an initial stent average volume (or average area), which average area (or average volume) is 0.75% to 0.90% of the initial stent average volume (or average area), substantially the same (maintained) initial average stent volume (or average stent area), or an increased average stent area (or average stent volume) after degradation of the degradable material after implantation of the stent and / or within a period ranging from 1 month to 9 months after implantation in a physiological environment.

[0088] In another embodiment, a non-degradable scaffold (or stent) or other prosthesis comprises a plurality of circumferential rings having one or more separation regions along each path of the circumferential rings. The scaffold has sufficient initial strength to maintain an average stent area (or average stent volume) after expansion and (where applicable) after an initial inward recoil, and the scaffold after the formation of discontinuities exhibits a decrease in that initial strength while substantially maintaining or increasing the stent average area (or average volume) in a physiological environment. Such non-degradable scaffolds are typically stretchable (elastic), usually sufficiently stretchable (elastic) to hold structural elements adjacent to the separation regions together in response to expansion of the scaffold, and / or are sufficiently stretchable (elastic) after deployment, or after deployment and before degradation of a degradable material, or after degradation of a degradable material, to allow the scaffold or scaffold compartments to accommodate or respond to vasomotion or vasodilation. A stent or other prosthesis in such an embodiment may accommodate (or exhibit) an increase in diameter (or a change in diameter) within one or more scaffold compartments (or within the stent deployment compartment) when a vasodilator is used or when a pressure change of about 180 mmHg is applied. Such a change in diameter ranges from 0.05 mm to 0.5 mm, more typically from 0.7 mm to 0.4 mm, after expansion under physiological conditions. In another embodiment, the elastic material adjacent to at least one or more separation regions (including therein, above, around) is a non-degradable material such as a polymeric material such as a polyurethane material. In a preferred embodiment, the non-degradable material has sufficient strength to contain the separation regions together in response to an initial deployment of the stent from a crimped configuration to an expanded configuration, and the elastic non-degradable material allows one or more rings or stent deployment compartments to further expand and / or contract after an initial expansion of the stent and / or after the formation of discontinuities under physiological conditions.

[0089] In yet another embodiment, the separation region may comprise an elastic material disposed above and / or adjacent to a gap, space, or other break formed in a structural element of the ring, typically a strut and / or crown. The elastic material typically remains intact after expansion of the scaffold in a physiological environment, and the elastic material may act as an "expansion joint" that allows expansion, and in some cases contraction, of the ring to increase the radial compliance under physiological conditions. In some embodiments, such an expansion joint is immobilized by a coating, sleeve, adhesive, or other bioabsorbable material in any other form as described elsewhere herein that connects, joins, or holds together adjacent separated regions of the scaffold while the scaffold is deployed. In other embodiments, one or more expansion joints are not immobilized, and the elastic material will provide sufficient strength to remain intact during inflation or other expansion while still providing the desired radial compliance or strength after expansion. The elastic material in the separation region may be utilized alone or in combination with other separation regions that are immobilized during inflation or other expansion by means such as degradable materials.

[0090] In still other exemplary embodiments, the separation region may comprise a "key and lock" junction that is immobilized during expansion but configured to separate after an initial expansion within a physiological environment. In some cases, the key and lock junction may have a comb-like interface that allows for circumferential and / or radial separation but prevents axial separation. In other cases, the key and lock junction will have a smooth or linear interface that allows for circumferential, radial, and / or axial separation. In other cases, the key and lock junction may have a non-linear interface region such as a "sawtooth", "V-shaped", "U-shaped", inverted "V-shaped", inverted "U-shaped", or other surface region interface, and such non-linear surface region interfaces can have one or more surface region interfaces, and the one or more surface region interfaces can have the same or different shapes, sizes, thicknesses, lengths, widths. Such key and lock junctions are typically immobilized during expansion but configured to separate after an initial expansion within a physiological environment and are coated with, embedded in, or joined by a degradable material such as a biodegradable polymer, for example.

[0091] In still other embodiments, the separation region of the present invention may comprise a butt joint that is joined by, coated with, or embedded in a material that degrades within a physiological environment.

[0092] The scaffold of the endoluminal prosthesis of the present invention will comprise a non-degradable material, typically a metal or metal alloy material. The discontinuities formed in the metal scaffold allow the scaffold to expand further after recoiling from the initial expansion. The discontinuities will further typically allow the scaffold to expand to an expanded diameter that is larger than the initial expansion diameter.

[0093] In some embodiments and examples, the circumferential ring may be substantially perpendicular to the longitudinal axis of the scaffold during expansion and / or crimping configurations. In other embodiments and examples, the circumferential ring may be inclined at an angle with respect to the longitudinal axis of the scaffold during one or both of the expansion and crimping configurations. In still further embodiments and examples, the continuous circumferential rings will be joined end-to-end in a continuous spiral pattern where each ring defines a single turn of the helix.

[0094] In another aspect or embodiment, the present invention provides a variably flexible stent (or controllable compliance stent or increased compliance stent), scaffold, or other luminal or valve prosthesis comprising a non-degradable metal or metal alloy scaffold, such as cobalt-chromium alloy, platinum-iridium alloy, and stainless steel alloy, which is expandable from a crimped configuration to a larger configuration. The scaffold preferably has sufficient strength to support the blood vessel lumen after expansion for at least a time period sufficient for the blood vessel to heal and / or at least when the risk of further or additional blood vessel lumen inward recoil (after any initial inward recoil of the stent after initial expansion) is diminished or reduced, over a time period after expansion and / or at least over a time period ranging from 30 days to 6 months after implantation and / or at least over a time period ranging from 60 days to 6 months after implantation. In some embodiments, the stent has an initial strength after expansion (or immediately after expansion or within 24 hours after implantation (expansion) or within 6 months after implantation (expansion) or within 3 months after implantation or within 2 months after implantation), which is sufficient to support the body lumen. The stent is expanded under air or physiological conditions (such as water at 37°C) and then, under physiological conditions, the initial strength decreases to a second strength that is lower than the initial strength, preferably within a period ranging from 3 days to 6 months, preferably the initial strength decreases to a second lower strength within a period ranging from 30 days to 6 months. The decrease in strength to the second strength occurs without mass loss or without degradation of the non-degradable metal or non-degradable metal alloy. The second lower strength, in some embodiments, ranges from 10% to 100% of the initial strength or from 10% to 90% of the initial strength or from 20% to 80% of the initial strength or from 30% to 60% of the initial strength.In some other embodiments, the stent has an initial strength after expansion (or immediately after expansion, or within 1 hour after implantation (expansion), or within 2 hours after implantation), which is sufficient to support the body lumen. The stent is expanded in air or under physiological conditions. Then, the initial strength under physiological conditions typically increases to a first strength that is 5% to 50% greater than the initial strength, preferably 10% to 30% greater than the initial strength. The first strength occurs after the initial strength (or after measurement of the initial strength after implantation (expansion), or 1 hour after implantation, or 2 hours after implantation, or between 1 hour after implantation and 1 month after implantation). The initial strength increases to a greater first strength under physiological conditions. Then, the first strength decreases to a second strength that is lower than the initial strength under the same or similar physiological conditions. The first strength preferably decreases to below the initial strength (second strength) within a period ranging from 15 days to 9 months, preferably within a period ranging from 30 days to 6 months (or within a period ranging from 60 days to 6 months) to a lower second strength (lower than the initial strength). The decrease in strength to the second strength occurs (or takes place) without decomposition of the non-degradable metal or metal alloy (without mass loss). The lower second strength ranges from 10% to 100% of the initial strength, or from 20% to 85% of the initial strength, or from 30% to 65% of the initial strength in some embodiments. Immediately after deployment (or expansion), the scaffold has a complex compliance typically on the order of 0.1% to 1%, usually 0.2% to 0.5%, often on the order of about 0.5%, typically on the order of 0.7%, and in many cases on the order of 1% when measured in a simulated blood vessel (or thin tube). After expansion under physiological conditions (including simulated physiological conditions) or after exposure to vascular conditions, the complex compliance or stent compliance when measured in a simulated blood vessel will increase to at least 1.2%, often to at least 1.5%, and sometimes to at least 2% or more.In other embodiments of the variably flexible stent prosthesis, the composite compliance of the stent, when measured in a simulated blood vessel, can increase by at least 2-fold, often at least 3-fold, and sometimes at least 4, 5, 10-fold or more, when compared to the initial composite compliance when measured in a simulated blood vessel.

[0095] Such variably flexible stent grafts can have various specific design features that provide variable compliance. As will be described in more detail below, for example, a stent graft comprising non-degradable metal or metal enables a scaffold having a separation region that separates or forms a discontinuity after exposure to vascular conditions over a threshold time. For example, some of the separation regions can initially be prevented from separating by a bioabsorbable material that degrades over time when first exposed to vascular conditions. More specifically, the bioabsorbable material can be in the form of a coating, sleeve, adhesive, or any other form suitable for initially connecting, joining, or holding together adjacent separated regions of the scaffold (or of the scaffold separation struts, or of the scaffold separation crowns, or of the scaffold separation structural elements). The bioabsorbable material can degrade over a time period ranging from 30 days to 3 years, often from 3 months to 2 years, and more often from 3 months to 1 year when exposed to vascular conditions. For the purpose of determining whether a stent meets these conditions, the stent can be exposed in vitro to vascular conditions (physiological conditions) as defined elsewhere in this specification that are intended to mimic those experienced when implanted in a human blood vessel or lumen. This can also be tested after in vivo vascular conditions. This can also be tested using in vitro testing under physiological conditions as described in this application. In some other embodiments, one or more rings containing one or more separation regions contain a non-degradable material, preferably an elastic material, preferably a non-degradable polymeric material. The non-degradable material can have sufficient strength to hold such separation regions together or together with another material (such as a degradable material or another non-degradable material, etc.) in response to the expansion of the stent. The elastic non-degradable material can provide the desired radial compliance immediately after expansion, such as in response to the use of nitroglycerin or another vasodilator by expanding one or more stent compartments (or rings or stent retention compartments) containing the elastic material, or within 24 hours after expansion.The elastic non-degradable material in this embodiment controls the desired compliance immediately after initial expansion and / or within 30 minutes after initial expansion (or implantation) and / or within 24 hours after initial expansion (implantation), controls further expansion after initial inward recoil, controls the desired radial strength, and / or controls other mechanical properties of the stent. The stent can additionally comprise one or more rings (identical or different rings containing a separation region containing a non-degradable elastic material) containing one or more separation regions, and one or more additional separation regions contain a degradable material (such as a degradable polymer material). One or more separation regions containing a non-degradable material typically prevent the formation of discontinuities after expansion in a physiological environment, but allow the ring containing the separation region (or stent compartment) to have the desired compliance, or allow further expansion after initial recoil after initial expansion, or allow the response of the stent implantation compartment (or one or more rings) to a vasodilator due to the stretch or elasticity of the non-degradable material. In yet another embodiment, all or substantially all of the separation regions on one or more rings (or all of the separation regions contained on the stent) contain a non-degradable material, which prevents the formation of discontinuities but allows the stent (or one or more rings) to have the desired compliance and / or radial strength, and / or to respond to a vasodilator due to the stretch, elasticity, and / or other material properties of the material.

[0096] In other specific examples and embodiments, the non-degradable metal or metal alloy scaffold may comprise a region reinforced with a reinforcing material that degrades after exposure to vascular conditions over a threshold time period described above or elsewhere. The reinforcing material may comprise a bioabsorbable material that degrades over the time period. For example, the reinforcing material may fill voids within the crown and / or struts of the non-degradable metal or metal alloy scaffold. Still further alternatively, the reinforcing material may coat or cover at least a region of the surface of the non-degradable metal or metal alloy scaffold.

[0097] As described above and / or elsewhere, in addition to exhibiting variable compliance, the variably flexible stent of the present invention holds the vascular lumen in an open state and, for a minimum threshold period of time, typically at least 30 days, more typically at least 60 days, often at least 90 days or longer, and will exhibit sufficient radial strength after expansion and implantation to arrest or prevent vascular recoil after an initial recoil following initial expansion. Typically, for example, with respect to a coronary stent, the stent strength (or the initial stent strength of the expanded stent) measured using, for example, a 10% flat plate compression test is preferably within the range of 0.030 Newtons per millimeter of stent length to 0.14 Newtons per millimeter of stent length, specifically 0.04 Newtons per millimeter of stent length to 0.1 Newtons per millimeter of stent length, often 0.05 Newtons per millimeter of stent length to 0.1 Newtons per millimeter of stent length, when such stent strength is measured using 10% flat plate compression after the stent has been expanded to its nominal stent expansion diameter. Not necessarily, but typically, the radial strength of the stent (scaffold) will decrease after expansion and exposure to vascular conditions as the complex compliance increases from the initial complex compliance (in some other embodiments, decreases before the initial complex compliance increases). (In some other embodiments, the initial radial strength of the expanded stent increases to a first strength greater than the initial strength before decreasing to a second strength less than the initial expanded stent strength.) The decrease in radial strength occurs simultaneously with (or in correspondence with, or at a similar time to, or simultaneously with, or almost simultaneously with) an increase in radial compliance. In most cases, the radial compliance and radial strength of the expanded stent will vary inversely with each other.In many cases, the radial strength of the stent scaffold typically decreases within the range of 20% to 100% of the initial radial strength, measured typically immediately after expansion, or immediately after expansion and exposure to vascular conditions (such as within 1 hour after expansion), and sometimes will decrease within the range of 20% to 80%, or in some cases, while the initial radial strength of the expanded stent increases before substantially decreasing to the initial strength or to a strength lower than the initial strength, the compliance increases from the initial compliance after implantation under physiological conditions, or in some other cases, while the initial radial strength of the expanded stent is substantially maintained, the compliance increases from the initial compliance after expansion under physiological conditions.

[0098] In certain embodiments or forms of the variably flexible stent, the non-degradable metal or metal alloy scaffold has a nominal expansion diameter (the diameter that the stent or other scaffold is intended to be expanded by a balloon), and both the strength and the composite compliance are measured after the stent is expanded to a diameter that is 80% to 120% of the nominal expansion diameter. More generally, the strength and the composite compliance will be measured after the stent is expanded to 100% of the nominal extended diameter.

[0099] In other embodiments, the stent has sufficient strength to support the body lumen after deployment into the expanded configuration, has an inward recoil of 1% to 10% after deployment, exhibits a compliance of 1% or greater than 1% after deployment, and / or when having a stent with sufficient strength to support the body lumen after deployment, has an inward recoil of 1% to 10% after deployment into the expanded configuration, and then the stent exhibits an outward recoil ranging from 3% to 20% after deployment and after said inward recoil under physiological conditions or under the use of a vasodilator.

[0100] In some other embodiments, the composite compliance scale under physiological conditions (including the use of vasodilators) ranges from 0.05 mm to 0.5 mm, preferably from 0.07 mm to 0.4 mm, and more preferably from 0.1 mm to 0.4 mm. Such a scale of diameter change is measured in one or more of the stent deployment section, or the average value of the stent deployment section, or preferably in a region centered on the center of the stent deployment section.

[0101] In other embodiments, the outward recoil scale of the stent under physiological conditions ranges from 0.05 mm to 0.5 mm, preferably from 0.07 mm to 0.4 mm, and more preferably from 0.1 mm to 0.4 mm.

[0102] In another aspect or embodiment, the present invention provides polymeric patches with reinforcing elements, and methods for their use and processing. The endoluminal patch is patterned from a biodegradable polymer and has a circumferential scaffold with an expansion region that deforms as the circumferential scaffold expands from a configuration of a small diameter to a configuration of a larger diameter. In one embodiment, the endoluminal patch of the present invention may comprise a coronary artery stent patch. In another embodiment, the endoluminal patch of the present invention may comprise a vascular stent patch. In yet another embodiment, the stent patch is a non-vascular stent patch. The reinforcing element is coupled to at least some regions of the circumferential scaffold so as to reinforce the circumferential scaffold after the scaffold has been expanded to a configuration of a larger diameter. The reinforcing element may preferably be deformable and may be degradable (including corrosive or erosive) or non-degradable (including non-corrosive and non-erosive). Specifically, the reinforcing element may be malleable or elastic, may comprise metals and metal alloys, may comprise polymers, or may be wholly or partially formed from other materials having mechanical properties capable of reinforcing the expansion region and / or other structures of the stent patch as described herein or in the present application.

[0103] In one embodiment, the circumferential scaffold will typically comprise a stent scaffold of the type patterned from a tube or cylinder, typically formed from a completely or partially biodegradable polymer. The tube or cylinder can be formed by extrusion, dipping, spraying, molding, or printing. The biodegradable polymer tube or cylinder will be patterned using any one of a number of techniques well known in the art for forming stents from polymers, such as laser cutting, photolithography, 3D printing, stereolithography (SLA), and equivalents. The expansion region will typically open as the diameter of the circumferential scaffold expands (or increases), increasing the angle between adjacent, less deformable or non-deformable regions or structural elements, such as struts, and may include joints, hinges, crowns, curves, bends, and / or deformable features or structures or structural elements that can engage adjacent struts, beams, or other less deformable or non-deformable features or structures or structural elements. The stent can also be formed from wire (solid or hollow) or fibers and can be patterned or braided.

[0104] Reinforcing elements may be provided, for example, to improve the stiffness, crush strength, crush resistance strength, radial strength, hoop strength, or equivalents of the circumferential scaffold in response to, or subsequent to, the scaffold being expanded from a crimped configuration to a larger diameter configuration. Specifically, one or more reinforcing elements may be coupled to one or more expansion regions, such as struts and / or links on the circumferential scaffold, and / or other regions, specifically to enhance such strength as measured, for example, by a "plate" or "flat plate" test, as generally known in the art, where the force required to reduce the scaffold diameter expanded by a pre-determined amount (or % such as 10% compressive force (N) or N / mm normalized to stent length) with the circumferential scaffold positioned between parallel spaced plates is measured. Other types of tests for measuring radial strength can also be utilized as generally known in the art (e.g., measured in psi units).

[0105] Most commonly, in another embodiment, at least some of the splices, hinges, crowns, bends, or other expansion regions of the reinforcement element will be coupled to such expansion regions such that, after expansion or opening, they can better resist the closing force (or crushing resistance) than without the addition of the reinforcement element. The expansion region undergoes deformation as the circumferential scaffold expands, and it will be understood that the presence of the reinforcement element will open with the expansion region such that, once opened, the reinforcement element assists the scaffold in resisting the closing force exerted by the blood vessel or other body lumen or body lumen lesion in which the scaffold is implanted. In addition to the deformable expansion region, the circumferential scaffold will also typically include regions that are non-deformable or not very deformable, which generally retain or substantially retain their shape as the circumferential scaffold expands. The reinforcement element may also be coupled to at least some of these non-deformable or not very deformable regions. In many embodiments or most configurations, while the expansion region will be a curved splice, hinge, crown, bend, or the like as described above, the non-deformable region will typically be a strut, straight strut, or other generally linear element of the scaffold, although sometimes it may have non-linear or other shapes such as wavy, S-shaped, M-shaped, V-shaped, wavy-linear, or wavy-nonlinear, and U-shaped. Typically, the expansion of the circumferential scaffold of the endoluminal prosthesis will be achieved by an inflatable balloon or other conventional device, although in other cases the circumferential scaffold may be fabricated from an elastic polymer or other material and be self-expanding, where the expansion is achieved by the release of the circumferential scaffold from a constraint.

[0106] In one embodiment, the reinforcement element increases the stiffness or strength of the reinforced region, reinforced ring or expansion region, and / or the stent.

[0107] In another embodiment, the reinforcing element increases the strength of at least one region of the stent by an amount ranging from 15% to 100%, preferably by an amount ranging from 25% to 150%, more preferably by an amount ranging from 25% to 200%.

[0108] In another embodiment, the reinforcing element increases the strength of the stent by an amount ranging from 0.015 N / mm of stent length to 0.035 N / mm of stent length, preferably by an amount ranging from 0.015 N / mm to 0.05 N / mm of stent length, more preferably by an amount ranging from 0.015 N / mm to 0.09 N / mm of stent length, when measured using a 10% compression flat plate test. For example, a strength of 0.015 N / mm (e.g., using the flat plate test method) for a 3.0 mm stent × 28 mm stent length is equal to a strength of 0.42 N, equal to 0.015 N / mm × 28 mm (stent length).

[0109] In another embodiment, the stent having the reinforcing element has a strength ranging from 0.03 N / mm to 0.06 N / mm of stent length, preferably from 0.025 N / mm to 0.07 N / mm of stent length, more preferably from 0.025 N / mm to 0.09 N / mm of stent length, when measured using a 10% compression flat plate test. For example, a stent length strength of 0.03 N / mm (e.g., using the flat plate test) for a 3.5 mm diameter stent × 18 mm stent length is equal to 0.54 N, equal to 0.03 N / mm × 18 mm of stent length.

[0110] In another embodiment, the reinforcing element reduces the initial inward recoil (or the recoil after expansion or deployment), or reduces the subsequent inward recoil (the recoil after implantation, or the recoil after the procedure is completed, or the recoil within 30 days after implantation, or the recoil within 6 months after implantation, or the initial implantation recoil and the recoil after a 6 - month time period, or the initial implantation recoil and the recoil after 1 day, or the implantation recoil and the recoil after 30 days).

[0111] In another embodiment, the reinforcing element reduces the inward recoil of the stent, after implantation, to an extent in the range of 1% to 10%, preferably to an extent in the range of 1% to 7%, more preferably to an extent in the range of 1% to 5%. In another embodiment, the reinforcing element reduces the subsequent inward recoil of the stent, at various times discussed, to an extent in the range of 0% to 5%, preferably to an extent in the range of 0% to 3%, more preferably to an extent in the range of 0% to 2%.

[0112] In another embodiment, the stent having the reinforcing element has an inward recoil ranging from 1% to 10%, preferably ranging from 1% to 7%, more preferably ranging from 1% to 5%, after expansion or deployment. In another embodiment, the stent having the reinforcing element has a subsequent inward recoil ranging from 0% to 5%, preferably ranging from 0% to 3%, more preferably ranging from 0% to 2%, at various times discussed, and most preferably, the stent has a substantially zero subsequent inward recoil (or the stent substantially maintains its initial recoil after implantation).

[0113] In another embodiment, at least some of the reinforcing elements are coupled to at least some expansion regions on at least some rings of the stent, the stent expands from a crimped configuration to a larger configuration, and the reinforcing elements provide sufficient strength to support the body lumen when in the expanded stent configuration.

[0114] In one embodiment, the reinforcing element may be coupled to the circumferential scaffold in a variety of patterns. The reinforcing element may be attached to some or all of the expansion regions, but is not necessarily attached to any of the regions that are non-deformable or not very deformable. Specifically, the reinforcing element may be attached to one, two, three, or more than one of the expansion regions of the scaffold or scaffold ring. In some embodiments or configurations, the reinforcing element is attached to all of the expansion regions of the scaffold or scaffold ring, and in other preferred embodiments or configurations, the reinforcing element is attached to all but one of the expansion regions of the scaffold or scaffold ring. In other embodiments or configurations, the reinforcing element may be attached to both expansion regions, as well as to some or all of the regions that are non-deformable or not very deformable. In other embodiments or configurations, the reinforcing element may be attached to at least some of the expansion regions that at least partially extend into the non-deformable or not very deformable region. In other embodiments or configurations, the reinforcing element may be attached to at least some of the expansion regions that extend to at least the midpoint of the length of the non-deformable or not very deformable region. In other embodiments or configurations, the reinforcing element may be attached to at least some of the expansion regions that extend substantially the entire length of the non-deformable or not very deformable region. The reinforcing element may be (fully or partially) embedded in the material of the circumferential scaffold, for example, embedded in at least some of the expansion regions (or in any of the surface regions of the expansion regions such as the anti-lumen side surface region, lumen surface region, and / or side surface region). Alternatively, in another embodiment, the reinforcing element may be attached or otherwise disposed on the scaffold such that it is at least partially positioned on top of at least some of the expansion or non-deformable regions.

[0115] The reinforcing element can be coupled (including, or comprising, being embedded in, attached to, or disposed on) to the stent patch after the stent is patterned, and the coupling of the reinforcing element to the patterned stent region can be carried out by various methods, such as press-fitting the reinforcing element onto the stent or stent region, creating or pre-forming grooves or spaces or slots by various means such as lasers or mechanical or chemical means and then press-fitting the reinforcing element onto the stent or stent region, partially dissolving the polymer material or softening the material for press-fitting or insertion and containing the reinforcing element, and / or attaching the reinforcing element by adhering it to the patterned structural surface or region (such as a polymer structure) by various methods. Alternatively, the reinforcing element can be coupled to the stent prior to patterning, such as being coupled to the tube (such as a polymer tube) on which the stent is patterned, and the tube and the reinforcing element are patterned together (or separately) to form the patterned stent using the methods discussed above and / or throughout this application, as well as the patterning means discussed in this application such as laser patterning. The reinforcing element can also be formed using, for example, a tube (such as a polymer tube) that forms the stent using dipping, spraying, or molding, or the reinforcing element can be one or more wires (solid or hollow) that are patterned or woven into the stent, or the reinforcing element can be a wire (solid or hollow) encapsulated by a material (such as the main polymer material) and woven or patterned into the stent. The reinforcing element is coupled as a component, solid wire, tube, or patterned structure.The reinforcing element is coupled to a stent prosthesis as described in the present application and has a discontinuity or separation region while allowing for lumen detachment and / or enabling a scaffold or lumen dilation, and is coupled to a stent structure (such as a polymeric stent material), or the discontinuity or separation region is formed on the reinforcing element (through various means such as laser cutting, dissolution, cutting, etc.) after being coupled to a stent, wire, or tube, and then the discontinuity or separation region is held together by means such as an adhesive, a primary polymer, a different polymer, a sleeve, or other means that hold the stent structure elements together in response to expansion from a crimped configuration to a larger expanded configuration, and are reconnected or held together.

[0116] Typically, a stent including a circumferential scaffold will comprise a plurality of adjacent rings having a curved, bent, hinged, jointed, crown, or other region where the expansion region straightens or opens as the scaffold expands radially, such as a sinusoidal curve, a meandering ring, a zigzag ring, a diamond (Palmaz type) ring, or any other type of radially expandable stent ring known in the art of vascular stents, including open cell designs, closed cell designs, or combinations, or other things known to those skilled in the art. Usually, the individual rings will be oriented in a plane perpendicular to the central axis of the circumferential scaffold when in the crimped or expanded configuration, or perpendicular to the longitudinal axis. However, in other embodiments or examples, the plane of the ring or expansion region or circumferential structural element may be inclined at an angle (e.g., 1° to 85°, or 1° to 45°, or 10° to 75°, or 25° to 75°, or typically 5° to 15°) with respect to the scaffold longitudinal axis, and in some cases, the "ring" or expansion region or circumferential structural element may be formed in a helical structure or joined in a continuous helical arrangement. Adjacent turns of the individual rings or helical stent structures may be joined axially together by axial links between hinges, crowns, beams, struts, and / or other components of the rings or turns. In other examples, the scaffold can be patterned on a stent formed from a wire (solid or hollow in at least some regions) where adjacent rings are connected at one or more locations (or regions). In one example, the stent comprises rings having an orientation that extends to having such an angle with respect to the longitudinal axis of the stent ranging from 1° to 85° since it is perpendicular to the longitudinal axis of the stent, having a helical configuration ring pattern, and at least some of the rings have at least one separation region. In some other examples, a stent such as a valve-containing stent can comprise one or more circumferential rings (or one or more circumferential structural elements). In such examples, the stent can comprise one or more separation regions, hinges, or other structures as described herein.In certain preferred embodiments, the stent comprises one or more circumferential rings, and one or more rings comprise a plurality of struts joined by crowns. Typically, every two struts are joined by a crown, or all crowns join two struts on the ring. At least some, preferably all, rings are joined to adjacent rings by at least one axial link or by joining one or more crown regions of adjacent rings (using solder, adhesive, or fusion of materials).

[0117] In one embodiment, the reinforcing element may be disposed within a compartment centered on the ring or, alternatively, may be disposed to extend substantially around the entire circumferential length of at least some of the rings. However, the reinforcing element is configured to have, or form, at least one cut, discontinuity, or separation region in its circumferential direction or length such that, as the blood vessel or other body lumen remodels during the healing process, the reinforcing element can separate and / or disengage circumferentially or expand incrementally after deployment. In this way, the reinforcing element will be able to provide the desired initial strength and resistance to crushing during deployment and / or the initial period after deployment, but after the biodegradable polymer (such as the main polymer) of the circumferential scaffold has softened and / or the molecular weight of the polymer has decreased and / or the polymer has degraded and / or in response to blood vessel remodeling or other physiological conditions, leave a reinforcing element (not eroded or not completely eroded) that can expand further freely, without inhibiting or preventing the scaffold from disengaging and / or expanding and / or the blood vessel / lumen from expanding after the polymer has been at least partially eroded (including being decomposed or corroded).

[0118] The circumferential scaffold of the present invention may include some or all of the conventional features found in the patterns of conventional stents. For example, the stent pattern may include axial links that hold adjacent rings together and form closed cells of a type well-known in the stent art. In such cases, the reinforcing elements may be coupled to, for example, at least some of the axial links, in which case the plurality of individual reinforcing elements may together form a box structure that is coupled to the generally parallel rings as well as the generally parallel axial links. In one embodiment, the reinforcing element is coupled to at least one axial link having at least one break.

[0119] The reinforcing element can, in one embodiment, be an individual part having a shape or geometry, or substantially having a shape or geometry, or having a smaller shape or geometry, or having a larger shape or geometry, or having a shape or geometry different from the joined structural elements such as crowns, struts, and / or links. Examples of shapes include squares, circles, rectangles, triangles, semi - circles, and other shapes. In these embodiments, the parts are discontinuous or discrete parts (either in contact or not in contact with other adjacent reinforcing elements). The parts can have a debulked end region, a rounded end region, a spherical end region, or other types or geometries that prevent inflammation after the polymeric material has degraded and / or been resorbed. In a preferred embodiment, substantially all of at least some of the ring expansion regions have a reinforcing element part coupled to the expansion region, and the reinforcing element part spans substantially the entire expansion region section or at least a portion of the expansion region section. In another embodiment, substantially all of at least some of the ring expansion regions have a reinforcing element part coupled to the expansion region, the reinforcing element part spans the entire expansion region section, and extends at least partially into a non - deformable or substantially non - deformable section (such as a strut). In a preferred embodiment, the shape and / or geometry of the reinforcing element, the reinforcing element part generally substantially mimics or contours the shape and / or geometry of the joined structural elements. The reinforcing element part can, in one embodiment, be of a size larger in at least one dimension, smaller in at least one dimension, or the same size in at least one dimension relative to the structural element to which the part is joined. The reinforcing element parts coupled to at least some of the structural elements of the biodegradable material enable the stent to further expand (and / or through the introduction of a therapeutic agent such as nitro) after implantation (or after expansion or deployment) while strengthening or enhancing the stent in response to the expansion of the stent to support a body lumen, and / or enable the stent to disengage, and / or enable the blood vessel to exhibit vasomotion or vasodilation.

[0120] In another embodiment, the reinforcing element can be one or more reinforcing element compartments that are coupled to other structural elements such as at least some rings and / or links. For example, the reinforcing element compartment can be coupled to (or span) one crown and one strut on a ring, and / or coupled to (or span) one crown and one strut and one link on a ring, and / or coupled to (or span) a plurality of crowns and struts and a plurality of links on a ring. In another embodiment, the reinforcing element compartment forms a pattern on the stent, and the pattern can be of various shapes, typically a symmetric pattern (although it can also be an asymmetric pattern), and the pattern can include closed and open patterns. When the reinforcing element compartment spans the entire structural element of the ring crown and / or strut, the reinforcing element compartment has at least one cut or discontinuity in the crown and / or strut (the cut or discontinuity is formed before or after coupling to the structural element), enabling the stent to further expand after degradation of the polymeric material, or enabling the stent to disengage, or enabling the blood vessel to have vasomotion, or enabling the blood vessel to have vasodilation after expansion (or after deployment) under physiological conditions (and / or through introduction of a therapeutic agent such as nitro), and the reinforcing element compartment strengthens or enhances the stent by having sufficient strength to support the body lumen after deployment.

[0121] In another embodiment, the reinforcing element can be one or more reinforcing element sections that are coupled to at least some of the rings (or circumferential structural elements), or to substantially all of the rings (or circumferential elements). When the reinforcing element or reinforcing element section spans the entire length of the ring (or circumferential structural element) without a break, discontinuity, or separation region, or spans the entire length of more than one ring without a break, discontinuity, or separation region, or when the reinforcing element spans substantially the entire stent without a break, discontinuity, or separation region, the reinforcing element or reinforcing element section has at least one or more regions along the circumferential path for each ring (e.g., crown or strut), and / or one or more crown regions along the circumferential path of each ring, and / or one or more strut regions along the circumferential path of each ring, and one or more of the regions contains a reinforcing element (or one or more reinforcing elements) having a cross-sectional area ranging from 200 square microns to 4,000 square microns, preferably from 400 square microns to 3,000 square microns, more preferably from 700 square microns to 2,500 square microns, and one or more of the regions allows the one or more rings and / or the stent to further expand after degradation of the polymeric material (or metal degradable material), and / or allows the stent to disengage, and / or allows the blood vessel to have vasomotion, and / or allows the blood vessel to have vasodilation, and / or allows the stent to have a radial strain ranging from 1% to 5% at an expanded diameter of 3.0 mm after (or upon) stent expansion (or deployment) under physiological conditions (and / or through introduction of a therapeutic agent such as nitro), and the reinforcing element section strengthens or enhances the stent by having sufficient strength to support the body lumen after deployment. In another embodiment, the region having the above cross-sectional area spans substantially the entire length of at least some of the rings, or substantially spans the entire stent.In another embodiment, the region having the cross-sectional area spans at least some of the rings, or substantially all of the rings, but does not span at least some of the axial links. In another embodiment, the region has the cross-sectional area, and the width of the reinforcing element ranges from 10% to 50% of the width of the structural element in the region, preferably from 20% to 40%, more preferably from 25% to 35%. In another embodiment, the region has the cross-sectional area, and the thickness of the reinforcing element ranges from 10% to 70% of the thickness of the structural element in the region, preferably from 20% to 50%, more preferably from 30% to 40%. In another embodiment, one or more regions have the cross-sectional area, and the ratio of the thickness to the width of the structural element is from 1.5:1 to 3:1, and the ratio of the thickness to the width of the structural element in the one or more regions reaches 0.7:1.4, preferably reaches 0.8:1. In a preferred embodiment of the present embodiment, the reinforcing element is a non-degradable metal or metal alloy, and the stent frame material (to which the reinforcing element is bonded) is a polymer degradable material. In another preferred embodiment of the present embodiment, the reinforcing element is a non-degradable metal or metal alloy, and the stent frame material is a degradable metal or metal alloy. The stent in this embodiment, which contains a reinforcing element and has a degradable frame material, has sufficient strength to support a body lumen when expanded from a crimped configuration to an expanded configuration, and while the stent radial compliance increases after expansion, the strength of the stent decreases after expansion. In another embodiment, the stent radial strain increases after degradation of the degradable polymer material, and the initial strength after expansion decreases after degradation of the polymer material. In another embodiment of the present embodiment, the reinforcing element combined with the degradable frame stent material has sufficient strength to support a body lumen, and the reinforcing element alone does not have sufficient strength to support a body lumen. In another embodiment of the present embodiment, the reinforcing element combined with the degradable frame stent material has sufficient strength to support a body lumen, and neither the reinforcing element alone nor the stent frame material alone has sufficient strength to support a body lumen.

[0122] In another embodiment, a stent having reinforcing elements, crosslinking elements, separation regions, cuts, and other features described herein exhibits an increase in radial strain (or compliance) after expansion and a decrease in radial strength after such expansion. In another embodiment, the increase in radial strain (or compliance) and the decrease in strength begin (or occur) over a period ranging from one week after stent expansion to nine months after stent expansion, preferably beginning from one month after expansion to six months after expansion, and more preferably beginning from two months after expansion to six months after expansion.

[0123] Most commonly, the reinforcing element will comprise a non-degradable material that is typically a metal (including metal alloys), more typically a malleable metal, that can be opened and deformed with the circumferential scaffold but has a higher strength to resist closure after the scaffold is partially or fully expanded. However, in other embodiments, the reinforcing element may be a polymer having a higher rigidity than the major polymer of the circumferential scaffold (or degradable patterned polymer, or polymer to which the reinforcing element is at least partially bound). The polymeric reinforcing element may be formed from the same or a different polymer that forms the circumferential scaffold. When the reinforcing element is formed from the same polymer, the reinforcing element polymer typically has a higher molecular weight and / or higher crystallinity, or otherwise is a more rigid polymer than the major body polymer of the circumferential scaffold (or degradable patterned polymer, or polymer to which the reinforcing element is at least partially bound), and the reinforcing polymer in this embodiment may be degradable or non-degradable. In yet another embodiment, the reinforcing element may also comprise a degradable metal (including metal alloys) such as magnesium and / or magnesium alloys.

[0124] In yet another embodiment, the stent patch comprises a biodegradable polymer material, and the polymer degradable material degrades in 1 month to 5 years, preferably degrades in 2 months to 3 years, more preferably degrades in 3 months to 2 years, and the reinforcing element is coupled to at least some of the expansion regions of at least some of the rings of the stent. The reinforcing element can be a non-degradable or degradable material, a metal or metal alloy, a polymer (degradable or non-degradable), or other material that strengthens (or enhances) the expansion region (or stent) at the time of stent expansion configuration. Typically, the polymer material degrades faster than the reinforcing element, but can also be configured to degrade simultaneously with (or at the same rate as) the reinforcing element, or slower than the reinforcing element. In another embodiment, the reinforcing element does not degrade or corrode.

[0125] In yet another embodiment, the stent patch comprises a biodegradable metal material such as a magnesium alloy, and the metal degradable material degrades in 1 month to 5 years, preferably degrades in 2 months to 3 years, more preferably degrades in 3 months to 2 years, and the reinforcing element is coupled to at least some of the expansion regions of at least some of the rings of the stent according to any of the embodiments of the present application. The reinforcing element can be a non-degradable or degradable material, a metal or metal alloy, a polymer (degradable or non-degradable), or other material that strengthens (or enhances) the expansion region (or stent) at the time of stent expansion configuration. Typically, the metal material degrades faster than the reinforcing element, but can also be configured to degrade simultaneously with (or at the same rate as) the reinforcing element, or slower than the reinforcing element. In another embodiment, the reinforcing element does not degrade or corrode.

[0126] In still other embodiments, the reinforcing element may be formed from an elastic metal or polymer (including shape memory such as springs and / or NiTi). For example, with respect to a reinforcing element that is curved or bent to conform (or be contoured) to a joint or hinge or expansion region on a polymeric or metallic circumferential scaffold, the reinforcing element will typically be in a closed or constrained configuration when coupled to a corresponding hinge or joint on the circumferential scaffold in a crimped configuration. In this way, the typically metallic reinforcing element will act to serve to open the circumferential scaffold and / or keep it open as it balloons or self-expands to its larger diameter configuration. Also, even after implantation in a blood vessel or other body lumen, the elastic, shape memory, and / or spring-like reinforcing element will typically continue to bias the circumferential scaffold while simultaneously enhancing the strength and crush resistance of the deployed prosthesis such as the prosthesis itself within the lumen, and / or through other reinforcing elements of high rigidity disposed on the same, adjacent, or other expansion regions or structural elements of the circumferential scaffold, such that it will still be at least partially constrained by the polymer (such as the primary polymer) or metal, at least in the region where they are coupled. Optionally, the scaffold may have additional metal, polymer, or other non-elastic (malleable) reinforcing elements, such as hinges or joints, coupled to the same or other expansion regions on the circumferential scaffold. For example, when one or more polymers comprising the scaffold or ring (such as the primary polymer) begin to soften and / or degrade, and / or the molecular weight begins to decrease, and / or the blood vessel or other body lumen heals and reforms over time, the elastic reinforcing element can continue to provide an opening bias and promote expansion of the scaffold. The magnitude of the opening bias is controlled by the elastic material properties (including springs, shape memory) and / or processing, and / or by the degradation of the polymeric material (such as the primary polymer) containing the reinforcing element. The terms "stent" and "scaffold" are used synonymously herein.In another embodiment, a shape memory or spring reinforcement element, typically metallic, having two ends, can be coupled to adjacent struts (non-deformable or substantially non-deformable structural elements), the reinforcement element being configured as an expansion region that connects two adjacent struts (along the length of the struts), the reinforcement element expansion region being in a crimped configuration when the stent is in a crimped configuration and expanding as the stent expands to a deployed configuration. The reinforcement element continues to push open (increasing the angle of the adjacent struts) after deployment of the stent (after inward recoil of the stent from the deployed configuration). The reinforcement element further expands the stent after deployment. The reinforcement element is attached or coupled to a structural element as described throughout this application. In one embodiment, the reinforcement element further expands the stent patch by an average range of 0.05 mm to 1 mm, 0.1 mm to 0.5 mm, preferably 0.1 mm to 0.3 mm, or a corresponding average cross-sectional area, after stent deployment and after stent recoil. In another embodiment, the reinforcement element increases the average diameter or average cross-sectional area of the stent by an average of 2% to 15%, preferably 3% to 10% of the average expanded diameter or average cross-sectional area of the stent, after stent deployment and after inward recoil of the stent. In another embodiment, the stent patch comprises a non-degradable shape memory alloy comprising NiTi or another type of material, the stent having one or more separation regions (and / or one or more hinges), the stent expanding from a crimped configuration to an initial expanded configuration, the one or more separation regions (or hinges) forming a discontinuity, (or allowing the stent to have a radial displacement), allowing the stent to respond to a vasodilator or to conform to a changing lumen (or annulus) configuration.

[0127] In a preferred embodiment, the degradable polymer stent comprises a degradable main polymer (a polymer that substantially forms a polymer scaffold structure, or a polymer that substantially forms a continuous scaffold structure, or a polymer that forms a scaffold structure without substantially accompanying separate regions, or a polymer that forms a scaffold structure excluding at least some separate regions or discontinuities). The degradable polymer stent can comprise more than one polymer in addition to the main polymer (adjacent, blended, mixed, etc.). The reinforcing element is preferably a non-degradable metal and metal alloy having a higher crushing resistance (strength) compared to the main polymer or other additional polymers, and such a reinforcing element is coupled to at least some regions of the scaffold structure elements such as the crown and / or struts, and the reinforcing element has a separation region or discontinuity that allows the stent to detach and / or expand in a physiological environment. The reinforcing element can also be a polymer (degradable or non-degradable) or a corrosive metal and metal alloy.

[0128] In a preferred embodiment, the reinforcing element can have various shapes and geometries, including rods (or solid) or hollow wires, circular, semi-circular, triangular, rectangular, square, oval, or other shapes and geometries. In a preferred embodiment, at least some of the structural elements (such as the crown and / or struts) containing or coupled to the reinforcing element have a cross-sectional area representing 5% to 90% of the cross-sectional area of the structural element, preferably representing 10% to 75% of the cross-sectional area, more preferably representing 15% to 75% of the cross-sectional area of the structural element, and having a reinforcing element. The structural element can be fully embedded, partially embedded, or attached to one or more surface regions of the structural element as described in the present application.

[0129] In another embodiment or aspect of the present invention, the stent has at least one crown region (preferably at least some crown regions, more preferably at least half of the crowns on at least some rings), and / or at least one strut region (preferably at least some strut regions, more preferably at least 1 / 4 of the strut regions on at least some rings) not formed (or partially formed) on at least some rings, and the region is formed or replaced with a reinforcing element, preferably a non-degradable reinforcing element, preferably a metal such as a CoCr alloy, a stainless steel alloy, or other metal or metal alloy, or may also be a non-degradable polymer reinforcing element, and comprises a structural element that is patterned in the structure and comprises a biodegradable polymer material (or a biodegradable metal material). The polymeric stent, in one embodiment, is formed (or formed with a region to be subsequently removed) on at least some rings without at least one crown region and / or without at least one strut region, and the metal reinforcing element has a substantially the same size (or preferably a smaller size) compared to the adjacent polymeric crown region and / or strut region, the reinforcing element is shaped (or bent or curved) to the crown region shape and / or strut region shape, and the two ends of the crown region of the reinforcing element are attached to the strut end regions of the unformed crown.The two ends of the reinforcing element can be attached as butt joints to the two strut ends of the polymeric stent, bonding and joining the two materials together at the joint point, and / or containing both the reinforcing element and the polymeric material joint point region with a sleeve, and / or forming slots in each of the two strut end regions of the polymeric stent (during or after laser patterning), inserting or press-fitting the reinforcing element crown region end into the formed slots, optionally bonding and joining the overlapping regions of the two materials (e.g., 0.05 mm to 1 mm overlapping region), and / or containing the overlapping region with a sleeve (the sleeve can extend beyond the overlapping region), and / or creating or having slots formed in the reinforcing element end region into which the polymeric ends press-fit, and holding both the reinforcing element and the polymeric material joint point, or holding both butt joints together during expansion from a crimped configuration to a larger configuration. Similarly, the reinforcing element can be connected to the unformed polymeric strut ends (or partially formed struts) as discussed above. The reinforcing element strengthens the expansion region and / or the non-deformable or substantially non-deformable region during the expanded stent configuration. The stent is expandable from a crimped configuration to a larger configuration and has sufficient strength to support a body lumen. In one embodiment, the stent polymeric biodegradable material degrades in 3 months to 3 years while the non-degradable reinforcing element remains in the blood vessel wall. The deployed stent disengages from the blood vessel, exhibits vasomotion, exhibits vasodilation, exhibits vasoconstriction, and / or further expands to a larger configuration, and / or has a radial strain ranging from 1% to 10%, preferably from 1% to 7%, more preferably from 1.5% to 7% under physiological conditions. The stent, in one embodiment, comprises a degradable polymeric material with structural elements comprising a crown and struts, at least some of the crown and / or struts not being formed (formed mechanically such as cutting them, or chemically such as removing them using a solvent or other material, etc.), removed, or replaced with a non-degradable metal reinforcing element.The stent is formed from a polymer tube, or from filaments patterned on the stent, or by other methods known to those skilled in the art. The reinforcing element is formed from a tube or wire and can be shaped or patterned into the shape of a structural element that it will replace, such as a crown. In one embodiment, the reinforcing element is formed from a patterned tube, and then the components of the patterned tube are removed (e.g., mechanically) and inserted (or attached) into the location of the unformed polymer structural element (so as to replace it in one embodiment). In another embodiment, the wire reinforcing element is shaped and attached to the structural element being replaced. Other methods of forming the structural element can include various methods such as forming a patterned flat sheet, injection molding, or others. The shape and size of the reinforcing element can vary and will be discussed in more detail throughout the present application.

[0130] In another embodiment, a biodegradable metal stent, such as a magnesium alloy stent, has at least one crown region (preferably at least some crown regions, more preferably at least half of the crowns on at least some rings), and / or at least one strut region (preferably at least some strut regions, more preferably at least 1 / 4 of the strut regions on at least some rings) not formed (or partially formed) on at least some rings, and the region is formed or replaced with a reinforcing element, preferably a non-degradable reinforcing element, preferably a metal such as a CoCr alloy, a stainless steel alloy, or other metal or metal alloy, or may also be a non-degradable polymer reinforcing element, and is patterned in the structure. The metal stent, in one embodiment, is formed (or formed with and then removed) without at least one crown region and / or without at least one strut region on at least some rings, and the metal reinforcing element has a substantially the same size (or preferably a smaller size) compared to the adjacent metal stent crown region and / or strut region, and the reinforcing element is shaped (or bent or curved) to the crown region shape and / or strut region shape, and the two ends of the crown region of the reinforcing element are attached to the strut end regions of the unformed crown.The two ends of the reinforcing element can be attached as butt joints to the two strut ends of the metal stent, bonding and joining both materials at the joint point, and / or containing both the reinforcing element and the metal stent joint region together with a sleeve, and / or forming slots in each of the two strut end regions of the metal stent (during or after laser patterning), inserting or press-fitting the reinforcing element crown region ends into the formed slots, optionally bonding and joining the overlapping regions of the two materials (e.g., a 0.05 mm to 1 mm overlapping region), and / or containing the overlapping region together with a sleeve (the sleeve can extend beyond the overlapping region), and / or creating or having slots formed in the reinforcing element end regions into which the metal stent structural element ends press-fit, and / or laser welding (or fusing) the two materials, holding both the reinforcing element and the metal stent joint together or holding the butt joints together during expansion from a crimped configuration to a larger configuration. Similarly, the reinforcing element can be connected to the unformed metal stent struts (or partially formed struts) as discussed above. The reinforcing element strengthens the expansion region and / or the non-deformable or substantially non-deformable regions during the expansion of the stent configuration. The stent is expandable from a crimped configuration to a larger configuration and has sufficient strength to support a body lumen. In one embodiment, the stent metal biodegradable material degrades or substantially degrades over a time period ranging from 3 months to 3 years, while the non-degradable reinforcing element remains in the blood vessel wall. The deployed stent disengages from the blood vessel, exhibits vasomotion, exhibits vasodilation, exhibits vasoconstriction, and / or further expands to a larger configuration, and / or has a radial strain ranging from 1% to 10%, preferably from 1% to 7%, more preferably from 1.5% to 7% under physiological conditions.In one embodiment, the stent comprises a degradable metallic material comprising a structural element having a crown and struts, wherein at least some of the crown and / or struts are removed, or have been removed, or have been replaced with non-degradable metallic reinforcement elements, and are not formed after formation (such as mechanically by cutting them, or chemically by using a solvent or other material to remove them, etc.). The stent is formed from a metal tube, or from filaments (or wires) patterned onto the stent, or by other methods known to those skilled in the art. The reinforcement element is formed from a tube or wire and can be shaped or patterned to the shape of the structural element it will replace, such as a crown. In one embodiment, the reinforcement element is formed from a patterned tube, and then the components of the patterned tube are removed (e.g., mechanically) and inserted (or attached) into the location of the unformed metal stent structural element (such as to replace it). In another embodiment, the wire reinforcement element is shaped and attached to the structural element being replaced. Other methods of forming the structural element can include various methods such as forming a patterned flat sheet, injection molding, or others. The shape and size of the reinforcement element can vary and are discussed in further detail throughout this application.

[0131] In another aspect or preferred embodiment, it is desirable to have a stent made of a non-degradable high-strength material such as a metallic material in order to have sufficient strength in response to the deployment of the stent within the body lumen (in some cases, a degradable material such as a degradable metallic material having high crush resistance can also be used in this embodiment, and such materials tend to occlude blood vessels over a long period of time and decompose slowly). However, such stents can occlude blood vessels or compartments adjacent to the stent and potentially reduce one or more of the following, namely, the usefulness, safety, and / or effectiveness of the stent, dislodge the blood vessel or stent implantation compartment, exhibit vasodilation within or spanning the stent implantation compartment, exhibit vasoconstriction within or spanning the stent implantation compartment, exhibit further expansion of the stent, and prevent radial distortion across the stent implantation compartment in the range of 1.5% to 5% after deployment from occurring. To address or cope with one or more of the foregoing needs, a non-degradable metallic stent such as an L605 CoCr alloy stent has at least one crown region (preferably at least some crown regions, more preferably less than half of the crown on at least some rings), and / or at least one strut region (preferably at least some strut regions, more preferably at least 1 / 4 of the strut regions on at least some rings) not formed (or partially formed, or formed and then removed) on at least some rings, and the region is patterned into a structure having structural elements formed or replaced with a degradable crosslinking agent such as a degradable polymer material (e.g., a PLLA-based polymer) or a degradable metallic material (e.g., a magnesium alloy).In one embodiment, the non-degradable metal stent is formed (or formed with and then removed) without at least one crown region and / or without at least one strut region on at least some of the rings. The degradable cross-linking element has a substantially the same size (or preferably a smaller size, but may also be a larger size) compared to the adjacent metal stent crown region and / or strut region. The degradable cross-linking element is shaped (or bent or curved) into the crown region shape and / or strut region shape and / or the shape of the stent structural element it replaces. The two ends of the crown region of the degradable cross-linking element are attached to the strut end regions of the unformed crown. The two ends of the degradable cross-linking element can be attached to the two strut ends of the metal stent as a butt joint, bonding and joining the two materials together at the joint, and / or containing both the degradable cross-linking element and the metal stent joint region with a sleeve, and / or forming slots in each of the two strut end regions of the metal stent (during or after laser patterning), inserting or press-fitting or fusing or melting the end of the crown region of the degradable cross-linking element into the formed slots, optionally bonding and joining the overlapping region of the two materials (e.g., a 0.05 mm to 1 mm overlapping region), and / or containing the overlapping region with a sleeve (the sleeve can extend beyond the overlapping region), and / or creating or having slots formed in the end region of the degradable cross-linking element with a larger size into which the ends of the metal stent structural elements are press-fitted, and / or laser welding (or fusing) the two materials to hold both the degradable cross-linking element and the metal stent joint together, or hold the butt joint together, during the expansion of the stent or during the expansion of the stent from a crimped configuration to a larger configuration expanded therefrom. Similarly, the degradable cross-linking element can be connected to the unformed metal stent strut ends (or partially formed struts) as discussed above.The degradable crosslinking element is not very rigid or is not substantially very rigid, and thus weakens the expansion region and / or the non-deformable or substantially non-deformable region during the expansion of the expandable stent configuration. However, the degradable crosslinking element provides one or more than one of the following benefits, i.e., it helps the stent to expand uniformly (or improves the expansion uniformity), provides continuity of circumferential structural elements (such as rings) at least in response to expansion (or over a time period after expansion), provides drug release in the region to prevent neo-intimal hyperplasia, provides partial or complete expansion of the stent circumferential rings in the expansion region, provides lesion coverage and minimizes plaque prolapse, provides a temporary scaffold, and then, as the degradable crosslinking element degrades or corrodes over a period ranging from 1 month to 4 years, preferably ranging from 3 months to 4 years, provides detachment of the stent and / or the blood vessel and provides support to the blood vessel wall. The stent is expandable from a crimped configuration to a larger expanded configuration and has sufficient strength to support the body lumen. The non-degradable stent structural element, in one embodiment, remains substantially intact (or in one embodiment, is substantially retained together or at a substantially fixed position) within the blood vessel wall. The deployed stent detaches from the blood vessel, exhibits vasomotion, exhibits vasodilation, exhibits vasoconstriction, and / or further expands to a larger configuration, and / or under physiological conditions (and / or through the introduction of therapeutic agents such as nitrates), has a radial strain ranging from 1% to 10%, preferably ranging from 1% to 7%, more preferably ranging from 1.5% to 7%. The stent, in one embodiment, comprises a non-degradable metallic material with a structural element comprising a crown and struts, and at least some of the crown and / or struts are not formed (such as being mechanically removed by cutting them, or chemically removed by using a solvent or other material to remove them, or melting them, etc.) or removed or removed after formation and are replaced (or formed) with degradable crosslinks in the region.The stent is formed from a metal tube, a metal sheet, or filaments (or wires) patterned on the stent, or is formed using other methods known to those skilled in the art. The degradable cross-linking element is formed from a tube or filament / wire and can be shaped or patterned, for example, into the shape of a structural element such as a crown that it will replace. In one embodiment, the reinforcing element is formed from a patterned tube, and then the components of the patterned tube are removed (e.g., mechanically) and inserted (or attached or press-fitted) into the location (or region) of the unformed metal stent structural element. In another embodiment, the filament degradable cross-linking element is shaped into the shape of the replacing structural element and attached to the ends as described. Other methods of forming the degradable cross-linking element can include forming a pattern from a flat sheet, using components from the sheet to replace the unformed structural element, injection molding of the degradable cross-linking element, or various other methods such as these. The shape and size of the degradable cross-linking element can vary (smaller than, the same as, or larger than the replaced structural element) as will be discussed in more detail throughout this application.

[0132] In one embodiment, the cross-linking element is degradable. In another embodiment, the cross-linking element is non-degradable but provides one or more than one of the objects of the present invention. The cross-linking element can also be a suture (or wire) that binds the ends of a structural element that is not formed or is partially or completely modified or removed. The suture can bind the ends of the structural element through holes adjacent to each end of the structural element, and the suture (or wire) is screwed through the holes and bound to form the continuity of the unformed structural element (e.g., the suture or wire that bridges two crowns or two struts).

[0133] In another embodiment, the cross-linking element can be formed from a shape memory material or a spring material (which can also be a reinforcing element in other embodiments), and the cross-linking element serves to bias and open at least some of the crowns and further expand after implantation.

[0134] In another embodiment, a non-degradable metal stent (e.g., cobalt-chromium alloy L605 or MP35, etc.) comprises a wire (circular or substantially circular, or elongated, or other shape), and the wire is patterned on the stent. The stent comprises a structural element with a plurality of rings, and each ring comprises a crown and a strut. At least one strut and / or at least one crown on at least some of the rings are removed. The ends of the stent with the struts and / or crowns removed are treated to create a hollow space in the wire. Degradable cross-linking elements are inserted into the hollow space at each end of the wire stent so as to cross-link in the gaps of the removed struts and / or crowns. Optionally, an adhesive or a degradable sleeve is applied to or overlaps the joints so as to hold the joints together as the stent expands from a crimped configuration to a larger configuration, further reinforcing the joint sections. In another embodiment, the degradable cross-linking elements are treated to create a hollow space into which the stent wire structural elements are inserted or press-fitted. Optionally, an adhesive or a sleeve is applied to further hold the joints together.

[0135] In another embodiment, the stent patch is formed as a tube, and the tube comprises a layer of non-degradable material (such as a cobalt-chromium alloy layer) that is either sandwiched between, on top of, or at the bottom of a layer of magnesium alloy. The tubes are patterned on the stent. At least some regions on at least some of the rings (or at least some crown regions and / or strut regions on at least some of the rings) have a non-degradable material (such as a cobalt-chromium alloy layer) that is substantially removed by laser, chemical, or mechanical means, providing a stent that detaches after expansion under physiological conditions. The stent patch can be formed as a sheet in another embodiment, where a degradable layer is on top of or at the bottom of the non-degradable material, and the stent is patterned and treated as described above. The sheet is rolled, attached (or fused), and patterned to form the stent.

[0136] In another embodiment, the stent patch is formed as a wire, and the wire comprises a non-degradable material layer (such as a cobalt-chromium alloy layer) on top of or at the bottom of a degradable polymer or metal material layer (such as a magnesium alloy layer or a PLLA-based polymer). The wire is patterned onto the stent. At least some regions on at least some rings (or at least some crown regions and / or strut regions on at least some rings) are substantially removed by laser, chemical means, or mechanical means to form a degradable cross-linking element connecting two ends of the non-degradable structural element, having a non-degradable material (such as a cobalt-chromium alloy layer), and providing a stent that detaches after expansion under physiological conditions, preferably detaching as the degradable material degrades.

[0137] In another embodiment, the stent patch is formed as a tube, and the tube comprises a non-degradable material layer (such as a cobalt-chromium alloy layer) on top of or inside a degradable polymer material layer (such as a PLLA-based polymer layer). The tube is patterned onto the stent. At least some regions on at least some rings (or at least some crown regions and / or strut regions on at least some rings) have a non-degradable material layer (such as a cobalt-chromium alloy layer) that is substantially removed by laser, chemical means, or mechanical means, and provides a stent that detaches after expansion under physiological conditions. In another embodiment, the stent patch can be formed as a sheet where the degradable layer is on top of or at the bottom of the non-degradable material and the stent is patterned and processed as described above. The sheet is rolled, attached (or fused), and patterned to form the stent.

[0138] In any one of the embodiments of the present application, the stent is tested (expanded) under one or more of the following conditions, i.e., in air, in an aqueous tank, in an aqueous tank at 37 °C, under physiological conditions, in a pulsatile (or systolic) environment, under administration of one or more agents that cause vasodilation or vasoconstriction in the stent placement section, in a tube, in a blood vessel, in a body lumen, under a pressure difference (gradient) ranging from 100 mmHg to 200 mmHg, under a pressure difference (or scale) of 100 mmHg, under a pressure difference (or scale) of about 176 mmHg, or under conditions for testing compliance or strength as described in the present application, or under any other conditions described in the present application. In some cases, all of the conditions described in this paragraph are referred to as physiological conditions.

[0139] In one embodiment, physiological conditions include within ambient air, within an aqueous tank, within an aqueous tank at about 37 °C, in a about 37 °C environment, within a radial distortion tester (compliance tester), within a fatigue tester, within a pulsatile environment, within a pressure or pressure difference environment, within a pulsatile environment that substantially simulates a body lumen or body organ environment, administration of a therapeutic agent such as a vasodilator or vasoconstrictor, within a systolic and / or diastolic environment, within a body lumen, within a body blood vessel, within a body loop, or one or more of the others.

[0140] In a preferred embodiment, the stent patch further comprises at least one coating on at least one surface of the stent patch. The coating comprises, in one embodiment, at least one drug, preferably an m-tor inhibitor. In another embodiment, the stent patch comprises at least one drug. In another embodiment, the stent patch comprises at least two drugs, namely, an m-tor inhibitor and a vasodilator. In yet another embodiment, at least one coating degrades at a rate slower than the degradation rate of the degradable (polymer or metal) material. In another embodiment, at least one coating degrades at a rate faster than the degradable material rate. In yet another embodiment, at least one coating covers at least one surface of the non-degradable stent. In yet another embodiment, at least one degradable coating covers at least one surface of the non-degradable stent. In yet another embodiment, at least one degradable coating covers at least one surface of the non-degradable stent and at least one non-degradable coating covers at least one surface of the non-degradable stent.

[0141] In one embodiment, the stent prosthesis is configured to exhibit, provide, or effect one or more of the following, i.e., to disengage the stent, to disengage the stent deployment section of the lumen or blood vessel, to disengage at least some of the circumferential structural elements (rings) of the stent, to disengage at least some of the rings of the stent, to disengage the blood vessel or blood vessel wall, to exhibit vasomotion, to exhibit vasodilation, to exhibit vasoconstriction, to effect further expansion of the stent to a larger configuration after implantation, and / or the stent has a composite radial strain (or compliance) ranging from 1% to 10%, preferably from 1% to 7%, more preferably from 1.5% to 7%, under physiological conditions (and / or through introduction of a therapeutic agent such as nitro). The stent prosthesis, in this embodiment, exhibits or provides one or more of the following stent states, i.e., upon formation, upon patterning, after treatment or processing after formation (or patterning) of the stent, upon deployment of the stent, in response to deployment of the stent, in response to expansion of the stent, and / or, for example, after deployment or expansion of the stent in a body lumen, one or more of the properties (such as disengaging) described above. The stent prosthesis, in this embodiment, exhibits or provides one or more of the following, i.e., at least some of the circumferential structural elements, at least some of the rings, substantially all of the circumferential structural elements, substantially all of the rings, at least some of the regions, spanning substantially the entire stent or stent section, the stent region, and / or within (or across) the stent section, one or more of the properties (such as disengaging) described above.

[0142] In any one of the embodiments, in addition to cross - linking to one or more structural elements (such as struts and / or crowns, etc.) on at least some of the rings, the cross - linking element can also cross - link to at least one link (or link region).

[0143] In another aspect or another embodiment of the present invention, a non-degradable (which can be a metal (including alloys) or a polymer) stent prosthesis comprises structural elements, which, in one embodiment, comprise a plurality of rings, each ring comprising struts and a crown, and each ring is connected to an adjacent ring at at least one location (or region). At least one strut (or part of a strut or strut region) and / or at least one crown (part of a crown or crown region) on at least some of the rings are not formed (or removed after formation), creating a gap (or discontinuity) between the remaining crown ends (or remaining crown regions) and / or between the remaining strut ends (or remaining strut regions), the gap size ranging from 1 micron to 3 mm, preferably from 2 microns to 2 mm, more preferably from 3 microns to 1 mm, and the gap being measured as a straight line between the remaining struts and / or remaining crowns in the expanded stent configuration (or crimped stent configuration). The ends of the remaining struts and / or crowns can be configured to have different, preferably larger dimensions, geometries, and / or surface areas than adjacent struts and / or crowns, and can have various shapes such as circular, square, semi-circular, rectangular, etc. In one embodiment, at least some of the rings have at least one gap (or discontinuity) along the ring. In another embodiment, at least some of the rings have at least three gaps (or discontinuities) along the ring. In yet another embodiment, at least some of the rings have 1 to 3 gaps (or discontinuities). The stent prosthesis is expandable from a crimped configuration to a larger expanded configuration and has sufficient strength to support a body lumen. The stent, in a preferred embodiment, has a substantially uniform expansion. The stent, in another preferred embodiment, has a maximum circular diameter of 0.7 mm to 1.5 mm in the gap region. The stent, in a further preferred embodiment, has sufficient coating to prevent (or minimize) smooth muscle cell proliferation.The stent patch is configured to exhibit, provide, or perform one or more of the following, namely, disengage the stent, disengage at least some of the circumferential structural elements of the stent, disengage at least some of the rings of the stent, disengage the blood vessel or blood vessel wall, exhibit vasomotion, exhibit vasodilation, exhibit vasoconstriction, further expand the stent to a larger configuration after implantation, and / or the stent has a radial strain ranging from 1% to 10%, preferably from 1% to 7%, more preferably from 1.5% to 7% under physiological conditions (and / or through the introduction of a therapeutic agent such as nitro). In this example, the stent patch exhibits or provides one or more of the above-described properties (such as disengaging) in one or more of the following stent states, namely, when formed, when patterned, after treatment or processing after the formation (or patterning) of the stent, when the stent is deployed, in response to the deployment of the stent, in response to the expansion of the stent, and / or, for example, after the deployment or expansion of the stent in a body lumen. In a preferred embodiment, the remaining end regions of the unformed (or removed) struts and / or crowns are connected to the same or adjacent structural elements on the premise that such connection does not complete the gap (or discontinuity) of the ring and the gap within the ring remains interrupted.

[0144] In another embodiment, the stent prosthesis comprises a plurality of rings comprising struts and crowns, and at least one strut and / or crown region on at least some of the rings is severed (or cut), for example, during laser patterning, but can also be done mechanically or in other ways. The severed regions are expanded from a crimped configuration to a larger configuration that allows for expansion of the stent prosthesis to a larger configuration that is non-traumatic and / or causes contact and / or maintains contact and / or substantially holds the severed regions together, and is geometrically deburred and / or shaped to have sufficient strength to support a body lumen. The stent, in a preferred embodiment, has a substantially uniform pattern when in the expanded configuration. The severed end regions abut, overlap, or have temporary retaining means when in the crimped configuration to allow deployment into the expanded configuration or to allow the stent to have a substantially uniform pattern when in the expanded stent configuration and / or to allow for substantially sufficient coverage to support a body lumen.

[0145] During laser cutting, patterning, or other formation of separation regions and discontinuities within a scaffold, portions of the partially formed scaffold may be temporarily together so that the structure does not prematurely separate after the discontinuity is formed and before the discontinuity is secured by adhesion, coating, sleeve formation, or the like. For example, after a tubular member is laser cut or otherwise patterned to form a circumferential ring including struts and a crown, the ends of the tubular member may be temporarily held by retaining fixtures positioned at each end of the scaffold. Specifically, one, two, three, or more end crowns at each end of the scaffold may be formed to have retaining features such as enlarged ears or similar features that can be gripped by the retaining fixtures. In this way, the retaining fixtures may, for example, first cut or bisect struts and / or crowns within one or more of the circumferential rings, then coat the entire scaffold within a biodegradable sleeve, remove the stent from the fixtures, and subsequently hold the stents together so that as the separation region is formed, the partially formed scaffolds will be held together.

[0146] In another embodiment, a non-degradable (which can be a metal (including an alloy) or a polymer) stent prosthesis comprises circumferential structural elements, which, in one embodiment, comprise a plurality of rings, each ring comprising struts and a crown, and each ring being connected to an adjacent ring at at least one location. At least some of the rings are configured (e.g., patterned and / or treated) to have a gap (or discontinuity) in the ring. For example, the stent can be patterned to have a gap scale that ranges from 1 micron to 3 mm, preferably from 2 microns to 2 mm, more preferably from 3 microns to 1 mm, when measured as a straight line that completes (or connects or provides continuity to) the ring. In a preferred embodiment, there is a maximum circular strut-to-strut (between rings or between the rings of the ring) distance within a region where the gap ranges from 0.9 mm to 2 mm, preferably from 1 mm to 1.5 mm. In one embodiment, at least some of the rings have at least one gap (or discontinuity) along the ring. In another embodiment, at least some of the rings have at least three gaps (or discontinuities) along the ring. In yet another embodiment, at least some of the rings have from 1 to 3 gaps (or discontinuities). The stent prosthesis is expandable from a crimped configuration to a larger configuration and has sufficient strength to support a body lumen. The stent, in a preferred embodiment, has substantially uniform expansion and sufficient vascular coverage to prevent SMC proliferation. The stent prosthesis is configured to exhibit, provide, or effect one or more of the following, namely, dislodging the stent, dislodging at least some of the circumferential structural elements of the stent, dislodging at least some of the rings of the stent, dislodging the blood vessel or blood vessel wall, exhibiting vasomotion, exhibiting vasodilation, exhibiting vasoconstriction, further expansion of the stent to a larger configuration after implantation, and / or the stent having a radial strain that ranges from 1% to 10%, preferably from 1% to 7%, more preferably from 1.5% to 7%, under physiological conditions (and / or through the introduction of a therapeutic agent such as nitro).In this embodiment, the stent patch exhibits, or provides, one or more than one of the following stent properties, i.e., when formed, when patterned, after treatment or processing after stent formation (or patterning), when the stent is deployed, in response to stent deployment, in response to stent expansion, and / or, for example, after deployment or expansion of a stent in a body lumen, one or more than one of the properties (such as detachment) described above.

[0147] In one embodiment, there is a stent patch in which at least some of the rings have at least one gap (or discontinuity) on each ring. In one embodiment, the region (or end region) of the structural element (ring) where there is a gap (or where the gap ends or begins) can be free (not connected to any structural element or any adjacent structural element), or can be connected to other structural elements (such as being connected to a strut and / or crown) at any location along the structural element leading to, adjacent to, or in the end region. The connection to the region can be a substantially linear connection, and / or a crown connection, and / or other connections having various shapes, dimensions, and / or geometries from the region to other structural elements (or adjacent structural elements). Examples of connections (including connection shapes) include Z, S, M, U, W, Y, L, or other types of connections. The dimensions of the connection can be different from or substantially the same as other adjacent structural elements. The connection can also, in other embodiments, have a greater or smaller width and / or thickness. The connection shape and / or dimensions can be substantially the same or different on at least some of the rings.

[0148] In another embodiment, the stent patch comprises a structural element having a plurality of rings, each ring comprising a crown and a strut, and each ring being connected to an adjacent ring in at least one region. At least some of the rings are configured (patterned or otherwise) to have two struts (or two strut regions) and / or two crowns (or two crown regions) that overlap over a length where there are two strut regions and / or crown regions, and having at least one region between the two crowns and / or between the two struts. While the struts and / or crowns are connected at opposite ends, the other end regions form a discontinuity in the ring. The strut and / or crown free end regions can have various shapes and geometries that together constrain or hold the stent patch in response to the deployment of the stent. The strut and / or crown regions can also have grooves or other shapes that hold or constrain the sliding struts and / or crowns in response to the expansion of the stent patch. The stent patch is typically expandable from a crimped configuration to a larger configuration and has sufficient strength to support a body lumen. The stent allows the body lumen to disengage in response to deployment. The stent has sufficient structural element surface area coverage (thickness, width, and / or geometry) in the discontinuity regions to support the body lumen.

[0149] In one embodiment of the examples in the present application, the stent prosthesis comprises a circumferential structural element, the structural element comprising struts and a crown, the stent being configured (e.g., patterned and / or treated) to enable the stent to expand from a crimped configuration to a larger configuration, the stent having sufficient strength in the expanded configuration to support a body lumen, the stent prosthesis being detachable and / or having a radial strain (or compliance) ranging from 1% to 5%, and / or when formed within a body lumen (or under physiological conditions and / or under treatment conditions such as the introduction of nitroglycerin), further expanding in response to and / or after expansion. Examples of the stent prosthesis include one or more than one from the examples comprising reinforcing elements, crosslinking elements, separation regions, struts and / or crowns having gap regions, or others. The stent prosthesis can be degradable, non-degradable, metallic (including alloys), or polymeric over a period ranging from 3 months to 5 years under physiological conditions. The stent prosthesis, in an example, is formed from a tube, patterned onto the stent, or can be formed from one or more than one wire (or filament) and patterned onto the stent. The stent can also be formed from a flat sheet and rolled to form the stent. The flat sheet can be patterned before being rolled to form the stent, or the flat sheet can be rolled to form a tube and then patterned. In one embodiment, the circumferential structural element comprises a plurality of rings, each ring comprising a crown and struts having one or more than one of the configurations described in the present application. In another embodiment, the structural element comprises a crown and struts having one or more than one discontinuity enabling the stent to detach when formed and / or to further expand in response to and / or after deployment when formed.

[0150] In another embodiment of any of the embodiments herein, at least some of the struts and / or crowns have at least one separation region, discontinuity, or break. In another embodiment, at least some of the struts and / or crowns have at least two separation regions, discontinuities, or breaks on the struts and / or crowns. In yet a further embodiment, at least some of the struts and / or crowns will not include a separation region. In yet a further frequent preferred embodiment, at least some of the struts will have a separation region while all of the crowns in the circumferential ring will not include a separation region. Generally, it has been found that positioning a separation region in a strut that does not deform during expansion is preferred over positioning a separation region in a crown that deforms as the scaffold expands.

[0151] In another aspect, or in another embodiment, the present invention provides a non-degradable or slow-degradable prosthesis material having circumferential elements and / or structural elements such as rings with separation regions and / or environmentally responsive separation regions. "Environmentally responsive" means that in response to physiological conditions including vascular conditions and / or other luminal conditions, and / or in response to being placed in ambient temperature or water at 37°C, and / or in response to being placed in buffer solution and / or physiological saline, and / or in response to physiological pressure where the scaffold is exposed after implantation in physiological conditions (e.g., vascular or luminal conditions) and / or within a blood vessel or other body lumen, and / or in response to the scaffold being exposed to a pressure ranging from 30 mmHg to 200 mmHg, preferably ranging from 40 mmHg to 120 mmHg, more preferably ranging from 50 mmHg to 80 mmHg, and / or in response to the scaffold being exposed to a pulsatile pressure range of 30 mmHg to 150 mmHg, preferably a pulsatile pressure range of 30 mmHg to 120 mmHg, more preferably a pulsatile pressure range of 30 mmHg to 90 mmHg, or in response to a therapeutic agent such as the introduction of a vasodilator or vasoconstrictor, the separation region separates, the material such as a degradable polymer material becomes empty, creates a gap, opens, breaks, allows movement in one or more directions, and / or deteriorates.

[0152] In a preferred embodiment among the examples of the present application, the stent can detach in at least some circumferential cross-sections or regions that can detach, detach across stent compartments, and / or expand to a larger diameter (or configuration) under physiological conditions (including physiological environment) in at least some circumferential cross-sections or regions of the stent patch. The larger stent diameter can be larger than the deployed diameter and / or larger than the diameter of the stent after recoil from the deployed expanded configuration. The stent diameter changes and / or increases permanently or temporarily to a larger diameter from the expansion and / or deployed diameter (in one embodiment, after expansion and / or recoil from the deployed diameter, as described in the present application) in response to the pressure and / or pulsatile pressure, while the stent diameter ranges from 0.045 mm to 1 mm, preferably from 0.05 mm to 0.6 mm, more preferably from 0.06 mm to 0.3 mm, or changes to 0.1 - 0.3 mm. The radial strength of the stent after deployment ranges from 12 psi to 30 psi, preferably from 13 psi to 25 psi, more preferably from 15 psi to 25 psi in the same or other embodiments. After expanding the scaffold and / or the flat plate strength of the stent after deployment (10% fracture) ranges from 0.03 N / mm stent length to 0.95 N / mm stent length, preferably from 0.035 N / mm stent length to 0.9 N / mm stent length, more preferably from 0.004 N / mm stent length to 0.085 N / mm stent length in the same or different embodiments. The inward recoil of the scaffold after expansion and / or deployment ranges from 1% to 10%, preferably from 2% to 7%, more preferably from 2% to 5% in the same or different embodiments. The inward recoil of the stent preferably remains substantially the same after deployment. The stent patch preferably expands further to a larger configuration after the introduction of a vasodilator in the body. The stent preferably has a radial strain (or compliance) of 1% to 5% in the expanded configuration.In the same or different embodiments, the radially directed strength of the non-degradable stent after deployment decreases by at least 25%, at least 50%, at least 75%, or 100% of the initial radially directed strength of the scaffold in response to deployment. The time period in the same or different embodiments in which the strength decreases ranges from 1 day to 2 years, preferably from 1 month to 1 year, more preferably from 2 months to 9 months, and even more preferably from 3 months to 9 months. In the same or different embodiments, the radially directed strength of the non-degradable stent after deployment (initial deployment) decreases by an amount in the range of 0% to 25% within 30 days from such initial deployment radially directed strength, and / or decreases by an amount in the range of 10% to 50% within 90 days from such initial deployment radially directed strength, and / or decreases by an amount in the range of 25% to 90% within 180 days from such initial deployment radially directed strength, and / or decreases by an amount in the range of 50% to 100% within 270 days from such initial deployment radially directed strength. The non-degradable stent in this embodiment further comprises at least one degradable polymer and further comprises at least one drug. In a preferred embodiment, at least one drug is contained in the polymer. In another embodiment, or in addition to the previous embodiment, the stent comprises at least one non-degradable polymer. In yet another embodiment, or in addition to the previous embodiment, the stent further comprises a radiopaque marker (degradable or non-degradable).

[0153] In a preferred embodiment throughout the present application after deployment, there is stent detachment, further expansion of the stent after deployment, lumen dilation, and other properties of the stent and / or the lumen, including the entire stent or lumen, at least one part or region of the stent or lumen, at least one circumferential cross-section or region of the stent or lumen, or at least some circumferential cross-sections or regions of the stent or lumen compartments, or one or more than one of the stent implantation compartments.

[0154] In another embodiment, the present invention provides a non-degradable prosthetic material having a circumferential element and / or ring with a separation region. The separation region, when formed and / or patterned (including after patterning), and / or after treatment or processing, and / or before implantation, and / or after implantation, and / or after implantation under physiological conditions, is a region having discontinuity. The discontinuity is completely and / or substantially one or more of the following, namely, being separated, the material becoming empty, having a gap, forming a gap, being open, having a break, forming a break, unlocking, not touching, being non-contact, removal of the material between or adjacent to the separation region, removal of the material holding the separation regions together, the ability of the separation region to move in one or more directions, and / or degradation. In this embodiment, the stent has sufficient strength upon deployment to support a body lumen, and the deployed stent may rebound to a smaller configuration before further expanding to a larger configuration (larger than the recoil configuration and / or larger than the expanded deployed configuration). The stent can expand to a larger configuration within the body lumen and / or under physiological conditions. In another embodiment, the stent detaches, or at least some regions and / or rings, or within the stent retention compartment, detach.

[0155] In another embodiment, one or more circumferential rings containing one or more separation regions may contain at least one or more non-degradable materials (such as non-degradable polymer materials), which prevent the formation of gaps or other discontinuities. One or more circumferential rings containing separation regions with non-degradable materials are configured to expand to a larger diameter or cross-section after initial expansion (and, if applicable, recoil) due to the elasticity and stretch of the non-degradable material under physiological conditions in response to vascular pulsation and / or dilation in response to a vasodilator. Thus, one or more rings, and typically the entire stent implantation section, exhibit the desired compliance after implantation under physiological conditions. The non-degradable material typically has sufficient elasticity in such embodiments and examples to continuously expand and / or contract under physiological conditions, including systolic pulsation of the blood vessel.

[0156] In yet another embodiment, one or more separation regions with non-degradable materials may still form gaps or other discontinuities after initial expansion, preferably after a period ranging from 30 days to 1 year after initial expansion. Although non-degradable, the material may degrade or fatigue over time and / or under physiological conditions, thus allowing the separation region to separate and form gaps or other discontinuities.

[0157] In yet another embodiment, one or more separation regions may be bound by one or more non-degradable materials such as a polymer sleeve or polymer coating, and one or more of the separation regions after the formation of the gaps or other discontinuities remain bound by the non-degradable material even after the formation of the gaps or other discontinuities. For example, the non-degradable material formed as a sleeve or coating can also cover one or more rings of the stent, cover one or more stent surfaces, or cover the entire stent surface. The sleeve or coating that binds the separation region allows one or more rings or stent retention compartments to have the desired compliance, expand further after initial recoil, and / or respond to the introduction of a vasodilator.

[0158] In another embodiment, the intraluminal prosthesis according to the book and / or one aspect and / or preferred embodiment of the present invention is patterned from a non-degradable material such as a non-degradable metal, metal alloy, or rigid non-degradable plastic, and has structural elements such as circumferential elements and / or rings. The scaffold is configured to expand from a crimped configuration to an expanded configuration, and the scaffold has sufficient strength in the expanded configuration to support the body lumen. At least some of the circumferential elements and / or rings will have at least one separation region configured to form a discontinuity in the circumferential element and / or ring immediately or shortly after deployment (initial deployment), and / or over time, and / or after initial expansion in a physiological environment, and / or after exposure to one or more than one of the other conditions disclosed in this application. Such discontinuities allow the scaffold or at least some circumferential cross-sections of the scaffold to expand to at least a larger configuration, preferably further expand after an initial recoil that can occur after deployment, more preferably further expand beyond the initial expansion, and most preferably allow the scaffold to detach or detach in at least some circumferential cross-sections or regions of the stent, preferably detach circumferentially. That is, after the scaffold is first deployed by a balloon or, in some cases, self-expansion from a constraint, the discontinuity preferably allows the portions of the scaffold to separate and the rings to expand with luminal dilation, more preferably with luminal dilation as a result of luminal remodeling. In one embodiment, the ring separation region may be present in the crown region, hinge region, and / or strut region. The stent preferably responds to a vasodilatory stimulus by expanding the lumen in the stent implantation compartment. The stent preferably has a composite radial strain (or compliance) ranging from 1.5% to 7%.

[0159] In another embodiment, the discontinuities formed in the circumferential elements and / or rings will typically be partial or complete breaks, separations, gaps within the structure of the circumferential scaffold that reduce or eliminate the stress area, stiffness, hoop, circumferential, and / or radial strength in the scaffold (or the ring components of the scaffold as described more specifically below and / or herein). Most commonly, the discontinuity will be a complete break that allows the two resulting free ends within the scaffold or ring or circumferential element to move away from each other in response to remodeling or other dilation of the body lumen and / or stent. In one embodiment, there is a discontinuity where the two free ends are contained by a material with a sleeve or coating, and the sleeve or coating material can be non-degradable or degradable such as a polymer, and the sleeve or coating stretches as the free ends move apart. In another embodiment, the discontinuity is contained using a discontinuity geometry (such as a key and lock design and other types of geometries) to hold the structural elements containing the discontinuity together in response to deployment from a crimped configuration to a deployed configuration, and the discontinuity is formed before patterning, during patterning, or after patterning and is held together by the design configuration of the separation region that forms the discontinuity as described above and / or throughout this application. The discontinuity in this case holds the free ends of the structural elements containing the discontinuity together and allows for crimping and / or deployment of the stent while providing sufficient strength after deployment of the stent to support the body lumen. The discontinuity in this case can allow movement of the free ends of the structural elements in one or more directions after deployment, preferably only radially after deployment, more preferably substantially only radially, most preferably mainly radially, or the movement can be in the radial and / or circumferential directions. In one embodiment, at least some of the ring or other portions of the scaffold will have at least one such discontinuity, but more typically each ring will have at least one discontinuity and some or all of the rings may have two or more discontinuities.The individual staging rings may have the same or different numbers of discontinuities, and not all staging rings need to have discontinuities. For example, the rings at or near the ends of the staging may not include discontinuities, e.g., so as to limit the wishbone effect. In further embodiments, at least some of the rings will have some discontinuities ranging from 1 to the same number as the crowns, preferably some discontinuities ranging from 1 to 3 / 4 of the number of crowns on the ring, and / or some discontinuities ranging from 1 to the same number as the struts, preferably some discontinuities ranging from 1 to 3 / 4 of the number of struts on the ring, and / or some discontinuities ranging from 1 to 1 / 2 of the number of crowns on the ring, and / or some discontinuities ranging from 1 to 1 / 2 of the number of struts on the ring, and / or some discontinuities ranging from 1 to 1 / 4 of the number of crowns on the ring, and / or some discontinuities ranging from 1 to 1 / 4 of the number of struts on the ring, and / or some discontinuities ranging from 1 to 10, preferably some discontinuities ranging from 1 to 5, more preferably some discontinuities ranging from 1 to 4, on the ring, and / or a number ranging from 1 to 3, and / or a number ranging from 1 to 2 on the ring.

[0160] In one embodiment, the physiological environment that forms such discontinuities (in other embodiments, the discontinuities are formed independently of the physiological environment) may be characterized by any physical condition associated with the body lumen into which the prosthesis is implanted. For example, the physiological environment or condition may be any one or more of the following: that is, as described in the present application, physiological temperature, for example, 37°C as maintained within the body lumen or within a water bath heated to about 37°C, and / or physiological pressure, and / or pressure, and / or pulsatile pressure, and / or introduction of agents such as vasodilators or vasoconstrictors. Additionally, the physiological environment may include blood or other aqueous media in which the scaffold is embedded, specifically, oxygenated blood that may enhance the corrosion of certain features. In many cases, the physiological environment will, in turn, be able to subject the scaffold embedded with mechanical stress that can fatigue and break specific features formed in the scaffold structure, and will include the pulsation of blood vessels, specifically arteries. Whether due to degradation, corrosion, dissolution, or mechanical stress, in one embodiment, the discontinuities will typically form in 30 days to 6 months, but can also form within several days to 1 year after the initial expansion of the circumferential scaffold and exposure of the expanded scaffold to the environment of the body lumen. In other embodiments, the discontinuities are formed in a water bath at ambient temperature.

[0161] In one embodiment, the separation region may comprise any one of various structures or modifications of the scaffold, including, for example, notches, variations in the granular structure, pre-formed breaks, that are rejoined by, for example, a degradable polymer, an adhesive, a sleeve, a rivet, or the like.

[0162] In one particular embodiment of the separation region, keys and keyholes, and / or keys and locks, and / or balls and sockets, and / or hook junctions are configured to separate and / or form a discontinuity, which are immobilized and / or retained together when formed and / or after formation, and / or before deployment, and / or before expansion, and / or during deployment, and / or during expansion, and after deployment, and / or after additional expansion in a physiological environment. For example, the keys and keyholes, and / or keys and locks, and / or balls and sockets, and / or hook junctions may initially be held together by means such as materials like polymers, cements, adhesives, solders, and / or equivalents that degrade in a physiological environment. The keys and keyholes, and / or keys and locks, and / or balls and sockets, and / or hooks separate or form a gap when the means for holding the junction disintegrates or degrades, or when the keys and keyholes, and / or keys and locks, and / or balls and sockets, and / or hook junctions become free of materials such as polymers, cements, adhesives, solders, etc. in response to, for example, normal pulsations of a blood vessel or other body lumen, or other physiological conditions described throughout this application. In one embodiment, the keys and keyholes, and / or keys and locks, and / or balls and sockets, and / or hook junctions may be substantially held together by the geometry of the junction that sufficiently restricts or substantially restricts movement of the junction in one or more directions to enable the stent to have sufficient strength to support the body lumen after stent deployment and after the stent is deployed (initial deployment). In a preferred embodiment, such junctions remain substantially held together in response to deployment (expansion from a crimped configuration to a larger expanded configuration), and the stent has sufficient strength in the expanded configuration to support the body lumen.In a preferred embodiment, the junction means for holding them together is the geometry of the junction, such as key and keyhole, and / or key and lock, and / or ball and socket, and / or hook type, and / or other types of junctions. The separation region junction can also be a butting junction that connects and / or joins the two ends of the stent structure element and / or ring, and the ends have various shapes and / or cross-sectional shapes (including substantial shape types) such as circular, and / or spherical, and / or square, and / or rectangular, and / or nerve synapse type junction, and / or other types of shapes, and / or substantially such shapes. In one embodiment, deployment means such as a balloon catheter provides for holding discontinuities together in response to deployment of the stent, and the stent is enabled to have controlled movement in one or more directions after deployment, preferably radially after deployment, and the stent has sufficient strength after deployment from a crimped configuration to an expanded larger configuration.

[0163] In another embodiment, the separation region may also comprise a simple butting joint or an overlapping section of the stent structure element, where the structure element is a solid wire (having various shapes such as substantially circular, rectangular, and / or square, and / or nerve synapse, and / or other shapes) and / or a hollow wire / tube structure element (hollow at least in the region adjacent to the separation region) with opposing free ends that are temporarily joined by means such as adhesives and / or connectors and / or polymers and / or solder and / or sleeves that degrade and / or separate and / or break in a physiological environment. Such means can hold the free ends together by placing them between the free ends of the structure element, adjacent to the free ends, covering the free ends, inside the hollow section of the free ends, and / or in all of the above combinations.

[0164] In still other cases or examples, the separation region may comprise notches or thinned sections formed in the circumferential ring and / or circumferential structural elements, which notches or thinned sections preferentially erode or fatigue in a physiological environment and then form a partial or complete separation that allows for the expansion of the circumferential ring. In still other embodiments or examples, the separation region may include a modification of the material of the circumferential ring itself. For example, in a metal ring, the separation region may have modified grain boundaries that are selected to preferentially break and / or erode (including corrosion) in a physiological environment compared to the rest of the circumferential ring. Other examples may be formed starting from an intact circumferential ring, forming one or more cuts in the ring, and then rejoining the cuts using means such as sleeves, adhesives, solder, connectors, coatings, and / or equivalents that are configured to decompose or erode or fatigue or break or separate in a physiological environment. For example, solder, adhesive, and / or polymer may be applied to the resulting joint abutment and / or overlap and / or hollow ends. Alternatively, the connector may comprise a sleeve, ring, coil, or other outer circumferential structure that holds the joint together until such a structure decomposes and / or separates in a physiological environment. In a preferred embodiment, a sleeve or coating comprising a polymer such as parylene can be applied, which allows for the separate free ends of the joint and / or junction to be contained within such a sleeve or coating.

[0165] In another embodiment, the stent comprises a non-degradable metal or metal alloy, the stent has a structure comprising a plurality of rings, the rings comprise struts joined by crowns, at least some of the rings have at least one crown, and approximately three-quarters (preferably at least one and preferably approximately one-half) of the number of crowns are formed and / or patterned to have a crown cross-sectional area that is less than and / or the smallest of the cross-sectional area of adjacent crowns and / or the maximum crown cross-sectional area within the ring. The cross-sectional area can be measured at approximately the apex of the crown and / or at any other point / section on the crown. The cross-sectional area of the smaller (including smallest) crowns ranges from 25% to 90% (preferably 50% to 75%) smaller than the cross-sectional area of adjacent crowns and / or the maximum crown cross-sectional area within the ring. The cross-sectional area of the smaller (including smallest) crowns ranges from 400 square microns to 3,000 square microns, preferably from 400 square microns to 2,500 square microns, more preferably from 400 square microns to 1,500 square microns, and such smaller cross-sectional area crowns allow the crowns to further expand after expansion. The smaller (including smallest) crowns optionally have a sleeve and / or coating and / or solder made of a polymer and / or adhesive and / or other material that holds the crown (and / or the struts joined by the crown) in a crimped or substantially crimped configuration in response to deployment of the stent, and the sleeve and / or coating and / or solder decompose and / or dissolve and / or relax after deployment (expansion) to allow the stent to further expand as the smaller cross-section crowns are allowed to open and / or expand under physiological conditions. The stent has sufficient strength in response to deployment to support a body lumen. In another embodiment, the stent has sufficient strength to support a body lumen in response to deployment, and the stent strength decreases after the sleeve and / or coating and / or adhesive and / or solder dissolve and / or decompose under physiological conditions after deployment.At least 1 / 4 to 3 / 4 of the crown, preferably at least 1 / 2 to 3 / 4 of the crown, more preferably at least 3 / 4 of the crown, has a cross-sectional area ranging from 3,500 square microns to 25,000 square microns, preferably ranging from 4,000 square microns to 10,000 square microns, more preferably ranging from 4,500 square microns to 8,000 square microns. The cross-sectional area measurement in the above examples is of the same type (or the same) non-degradable material (metal or metal alloy material) of structural elements such as stents or crowns. When comparing a crown with a smaller cross-sectional area to a crown with a larger cross-sectional area, it does not contain other materials such as polymers, metals, coatings, etc. on or within the crown. Alternatively, a crown with a smaller cross-sectional area can be achieved by incorporating a material different from the non-degradable metal or metal alloy into the crown region, or having a lower density or weaker material, and / or having one or more of grooves, holes, depressions, crescent shapes, crown shapes, and / or channels within, above, and / or through the crown region. The grooves, holes, depressions, crescent shapes, crown shapes, and / or channels within, above, and / or through the crown region can be filled and / or coated with at least one material comprising a polymer, metal or metal alloy (preferably different from the metal or metal alloy forming the stent), adhesive, and / or solder, and / or other suitable materials. In this example, the smaller cross-sectional area is achieved by having a softer or weaker or lower density material or void in the crown region that effectively reduces the cross-sectional area of the non-degradable metal or metal alloy within the crown compared to the cross-sectional area of the same type of metal or metal alloy in an adjacent crown (even if the total cross-sectional area of the crown may be similar to other crown cross-sectional areas). The material is preferably different from the crown material. The material can remain, dissolve, and / or decompose / erode in the crown region after deployment, allowing the stent to disengage and / or further expand under physiological conditions.The stent according to the deployment has sufficient strength to support the body lumen, and the stent strength does not decrease after deployment, or decreases after deployment, preferably within 30 days after deployment, more preferably within 3 months after deployment and / or within 1 year after deployment. The material has a lower rigidity (preferably 2 to 10 times lower rigidity) than the crown material and is softer, stretchable, and / or lighter than the crown material. The crown can, in one embodiment, have a sleeve and / or coating and / or adhesive containing the crown region and / or struts joined by the crown. In another embodiment, the stent exhibits an increase in radial distortion and / or a decrease in radial strength after expansion. In another embodiment, the increase in radial distortion and / or the decrease in strength begins from 1 week after stent expansion to 9 months after stent expansion, preferably from 1 month after expansion to 6 months after expansion, more preferably from 2 months after expansion to 6 months after expansion. In another embodiment, at least some of the struts have a thinned cross-sectional area as described in this paragraph.

[0166] In another embodiment, a stent formed from a non-degradable metal or metal alloy has one or more regions on at least some of the rings, or other "hollowed-out" structures, such as void regions or "voids" within other structural components of the crown, struts, or stent scaffold where metal has been removed by patterning, cutting (such as laser cutting), polishing, or the like. Optionally, the voids may be completely or partially filled with a degradable or non-degradable filling material that contributes to the strength of the scaffold for at least some time after implantation so that the scaffold has sufficient initial strength to support the body lumen. The filling material can have a higher or lower rigidity than the metal or metal alloy material of the stent, or in some cases, can have equivalent rigidity. The voids may be completely filled, partially completely filled, or in some cases, overfilled such that the filler extends beyond the boundaries of the stent scaffold prior to void formation.

[0167] Such filled voids on the crown region would, for example, deform in response to stent expansion, allowing the compliance and strength of the stent to vary over time. In many embodiments, the filled voids on the crown will enhance the strength of the scaffold upon expansion and implantation, but will also reduce compliance. However, by using a filler material that degrades, softens, or otherwise loses strength when exposed to a blood vessel or other physiological environment, the compliance of the scaffold increases, which in turn will increase the compliance of the stent and the composite or composite compliance of the blood vessel or other body lumen. The strength may decrease simultaneously, but such a decrease in strength is usually acceptable after the blood vessel or other body lumen has been opened and the lumen wall has at least partially healed. Thus, at least some rings of the stent are detachable, further expandable, and / or exhibit vascular reactivity. The thickness of the metal or metal alloy surrounding the cavitation or void region in the crown region (lateral region, lumen surface region, or anti-lumen side surface region) ranges from 10 microns to 50 microns, preferably from 20 microns to 40 microns. The cavitated crown region can have various methods of cavitation, such as where the two lateral regions of the crown region remain intact and the region between the two lateral regions is cavitated, where one lateral region and the lumen surface region remain intact while the other lateral region and the anti-lumen side surface region are cavitated, where the two lateral regions and the lumen surface region remain intact while the anti-lumen side surface region is cavitated, where all surface regions (anti-lumen side, lumen, two lateral) remain intact but the inner core of the crown region is cavitated, and / or where one lateral region, the anti-lumen side surface region, and the lumen surface region remain intact while the core is cavitated from the other lateral region, or other ways such that the crown region allows for stent detachment after expansion. The total cross-sectional area of the non-degradable metal or metal alloy related to one or more than one crown region in at least one section of the crown region ranges from 200 square microns to 4,000 square microns, preferably from 400 to 3,000 square microns, more preferably from 500 to 2,500 square microns.In another embodiment, the cavitation region is filled with another material (degradable or non-degradable), and the expanded material allows for the crown region, ring, and / or stent to disengage, and / or have an increase in radial strain, and / or have an increase in radial strain and a decrease in radial strength. In another embodiment, at least some of the struts along at least some of the rings are cavitated as described in this section.

[0168] Voids may also be formed in the struts and the scaffold ring or other components of the scaffold structure. For example, channels, slots, and the like can be formed over a portion or all of the length of at least some of the rings, including the struts, crown, and any other structural components. Similar to the other voids described above, channels, slots, and the like are herein referred to as "reinforcing materials" to provide sufficient composite material strength to enhance the radial strength of the stent immediately after expansion, and may be partially or fully filled with a second degradable polymer or metallic material that typically degrades after expansion and implantation, and typically enhances compliance while reducing stent strength. The underlying non-degradable material of the struts and the scaffold ring or other components of the scaffold structure is typically from 1,000 μm 2 to 4,000 μm 2 , preferably from 1,500 μm 2 to 3,500 μm 2The degradable reinforcing material having a cross-sectional area within the range and covering all or part of the non-degradable material adds an additional 40 μm to 120 μm to the thickness and / or width of the scaffold base material component. The composite base and the coated reinforcing material have sufficient strength to support the body lumen (and prevent recoil within the blood vessel lumen) in response to expansion. After expansion and implantation, the compliance increases and the strength of at least some of the rings decreases to allow the stent to disengage. The channel depth is typically 40% to 90% of the non-degradable material thickness, preferably 50% to 85%, more preferably 60% to 80%. The width of the channel and the slot is typically 40% to 90% of the non-degradable material width, preferably 50% to 85%, more preferably 60% to 80%. The channel and slot width and thickness can vary along the length of the channel and slot on at least some of the rings. The channel may be disposed on the anti-lumen side surface region, the lumen surface region, and / or both the anti-lumen side and the lumen surface region. The slot will typically penetrate from the anti-lumen side surface to the lumen surface.

[0169] One or more thinning regions may alternatively or also be formed along some or all of the non-degradable scaffold rings or other circumferential elements to increase scaffold compliance and facilitate scaffold detachment after implantation. Such thinning regions may be present in the crown region, in the strut region, or on other components of the ring or other structure that affect circumferential compliance. By "thinned" it is meant that the crown, strut, or other scaffold component has a reference cross-sectional dimension over most of the length of the component, and the reference cross-sectional dimension is reduced in the region referred to as "thinned". The thinning regions can be located in adjacent crowns, alternate crowns, every other crown, or other patterns or configurations so as to achieve sufficient strength to support the body lumen upon deployment and to increase compliance after expansion. Such thinning regions can have a smaller thickness and / or width and / or cross-section relative to a reference dimension sufficient to facilitate detachment after implantation. Without any further modification, the thinning regions will typically provide both lower scaffold strength and increased compliance, at least in the thinning regions of the component. Optionally, the thinning regions can be reinforced by a coating, lamination, or other bonding of a reinforcing material so as to typically degrade after expansion to increase compliance while providing strength in response to expansion. Such biodegradable reinforcing materials can be similar to the fillers described elsewhere in this specification that are typically, but not limited to, degradable polymers or degradable metals. Suitable reinforcing materials will degrade over a time period after implantation or exposure in the vascular environment, typically over a period of 30 days to 3 years, preferably 3 months to 2 years, more preferably 3 months to 1 year.A base non-degradable material (base stent), typically a metal or metal alloy, comprises one or more rings (or circumferential structural elements), typically a plurality of rings, each ring comprising struts and a crown along the length of the ring. The base stent, in some embodiments, does not have sufficient strength to support (or maintain) a body lumen in the absence of a reinforcing material coupled to the base stent, and the reinforcing material has sufficient weight and thickness (such as a polymer coating) to increase the strength of the base strength until it is sufficient to support (or maintain the body lumen in an open state).

[0170] For example, a thinned cross-sectional region along the length of a circumferential ring may be coated, laminated, or otherwise covered with a sufficient amount of reinforcing material to reinforce the stent struts upon expansion, and as the material degrades after expansion and exposure to the vascular or other lumen environment, the stent strength decreases and the compliance increases. The struts are 1,000 μm 2 ~4,000 μm 2 and preferably have a cross-sectional area within the range of 1,500 μm 2 ~3,500 μm 2 and may be formed from a non-degradable base material component. The degradable reinforcing material that coats the non-degradable material adds an additional 40 μm to 120 μm to the thickness and / or width of the strut base material that forms the basic component, and the composite base and coating material has sufficient strength to support the body lumen upon expansion. After expansion and implantation, the compliance increases, the strength of at least some of the rings decreases, and the stent is detached.

[0171] In another embodiment of any of the examples herein, the stent patch exhibits one or more of the following, i.e., (including one or more of the following) detaching after expansion, an increase in radial distortion (or compliance), an increase in radial distortion (or compliance) and a decrease in radial strength, exhibiting vascular reactivity or vasodilation in the stent implantation section, further expanding to a second larger configuration, being able to expand and / or contract after deployment, a change in shape configuration from the deployed shape configuration, a change in displacement of the stent in at least one dimension, having a greater displacement after expansion in at least one direction.

[0172] Suitable stent materials include, but are not limited to, polymers, metals (metals and metal alloys), adhesives, coatings, solders, sleeves, sealants, fixation materials, cements, and energy fixation. Adhesives and fixation materials include, but are not limited to, polyalkyl-2-cyanoacrylates, methyl-2-cyanoacrylate, ethyl-2-acrylate, n-butyl cyanoacrylate, 2-octyl cyanoacrylate, or other cyanoacrylates, epoxies, epoxyamines, ultraviolet curable substances from Loctite, Dymax, Master Bond, or others, acrylics, silicones, hot melts, polyurethanes, Gorilla Glue, TissueGlu, Sylys surgical sealant, or other lysine-based adhesives, fibrin adhesives, adhesives such as beeswax, sealants, and potting compounds. Solders or other fixation materials such as fusible gold materials include Sn97Cu3, Sn50Zn49Cu1, Sn95.5Cu4Ag0.5, Sn90Zn7Cu3, Sn98Ag2, Sn96.5Ag3Cu0.5, Sn91Zn9, Sn85Zn15, Sn70Zn30, Sn89Zn8Bi3, Sn83.6Zn7.6In8.8, Sn86.9In10Ag3.1, Sn95Ag3.5Zn1Cu0.5, Sn86.5Zn5.5In4.5Bi3.5, Sn95Sb5, Sn96.2Ag2.5Cu0.8Sb0.6, Sn90Au10, or other tin or its alloys, In97Ag3, In90Ag10, In50Sn50, In52Sn48, or other indium or its alloys, Zn95Al5, Zn60Sn40, Zn95Sn5, or other zinc or its alloys, B57Sn42Ag1, Bi58Sn52, or other bismuth or its alloys, Au80Sn20, Au98Si2, Au87.5Ge12.5, Au82In18, or other gold or its alloys. Other means of fixation may also be used, such as laser bonding or welding or fusion, or other means of energy fixation (including joining and splicing), polyalkyl-2-cyanoacrylates, methyl-2-cyanoacrylate, ethyl-2-acrylate, n-butyl cyanoacrylate, 2-octyl cyanoacrylate, or other cyanoacrylates, epoxies,UV curable materials from Epoxyamine, Loctite, Dymax, Master Bond, Henkel, or others, acrylics, silicones, hot melts, polyurethanes, Gorilla glue, polyesters, polylactides and their copolymers and mixtures, polytrimethylene carbonates and their copolymers and mixtures, polyvinyl alcohol, polyvinyl acetate, ethylene-vinyl acetate (hot melt adhesives), phenol formaldehyde resins, polyamides, polyester resins, polyethylene (hot melt adhesives), polypropylene, polystyrene, polycarbonates, polychloroprenes, natural rubbers, silicone rubbers, lysine-based adhesives such as TissueGlu, Sylys surgical sealants, or others, fibrin adhesives, beeswax, casein, mussel adhesive proteins, and biologic adhesives such as collagen, their combinations, or solvent-based polymer dispersions or pure adhesives, sealants, and potting compounds equivalent thereto, Sn97Cu3, Sn50Zn49Cu1, Sn95.5Cu4Ag0.5, Sn90Zn7Cu3, Sn98Ag2, Sn96.5Ag3Cu0.5, Sn91Zn9, Sn85Zn15, Sn70Zn30, Sn89Zn8Bi3, Sn83.6Zn7.6In8.8, Sn86.9In10Ag3.1, Sn95Ag3.5Zn1Cu0.5, Sn86.5Zn5.5In4.5Bi3.5, Sn95Sb5, Sn96.2Ag2.5Cu0.8Sb0.6, Sn90Au10, or other tins or their alloys, In97Ag3, In90Ag10, In50Sn50, In52Sn48 or other indiums or their alloys, Zn95Al5, Zn60Sn40, Zn95Sn5, or other zincs or their alloys, B57Sn42Ag1, Bi58Sn52, or other bismuths or their alloys, Au80Sn20, Au98Si2, Au87.5Ge12.5, Au82In18 and other golds or their alloys, their combinations, or solder or fusible gold materials equivalent thereto. Suitable stent materials that are non-degradable in a blood vessel or other physiological environment include, but are not limited to, stainless steels such as 304V, 304L, and 316LV stainless steels, alloy steels such as mild steel, cobalt-based alloys such as cobalt chrome, L605,Platinum-based alloys such as Elgiloy(R), Phynox(R), platinum chromium, platinum iridium, and platinum rhodium, tin-based alloys, rhodium, rhodium-based alloys, palladium, palladium-based alloys, aluminum-based alloys, titanium or their alloys, rhenium-based alloys such as 50:50 rhenium molybdenum, molybdenum-based alloys, tantalum, gold and gold alloys, silver and silver alloys, shape memory metals or alloys, chromium-based alloys, nickel-titanium alloys such as linearly elastic and / or superelastic nitinol, nickel alloys such as nickel-chromium-molybdenum alloys (e.g., INCONEL 625, Hastelloy C-22, Hatelloy C276, Monel 400, Nickelvac 400, and equivalents), nickel-cobalt-chromium-molybdenum alloys such as MP35-N, nickel-molybdenum alloys, platinum-enriched stainless steel, combinations thereof, or equivalents, and other malleable metals such as those of the types commonly employed in the manufacture of stents and prostheses. In other embodiments, the non-degradable material may comprise non-degradable polymers such as polyaryl ether ketone, polyether ether ketone, polyimide, UHMW, HDPE, LDPE, or other polyethylene, polypropylene, polyester, polyethylene terephthalate, polycarbonate, polysulfone, polyphenyl sulfone, polyether sulfone, Ultem, polyether imide, polyurethane, polyamide, nylon 12, nylon 6, nylon 6-6, or other nylon, polyvinyl chloride, PTFE, FEP, ETFE, PFA, PVDF, polyvinyl chloride, acrylonitrile butadiene styrene, delrin, polymethyl methacrylate, polystyrene, polyacrylamide, polyphenyl sulfide, PEBAX, or other materials. In still other embodiments, the non-degradable material is a shape or thermo-memory alloy, shape memory polymer, or superelastic material, typically nickel-titanium alloys, spring stainless steel, Ni50-Mn28-Ga22, copper-aluminum-nickel, zinc, copper, gold, and iron alloys, iron-based alloys such as Fe-Mn-Si, copper-based alloys such as Cu-Zn-Al and Cu-Al-Ni, poly(ε-caprolactone) dimethacrylate, PVDF / PMMA,It may include elastic metals such as PVDF / PVA, PLA / PVAc, or others, or equivalents. Examples of degradable materials such as degradable polymer materials include lactide, caprolactone, trimethylene carbonate, glycolide, poly(L-lactide), poly-DL-lactide, polylactide-co-glycolide (e.g., poly(L-lactide-co-glycolide), poly(L-lactide-co-epsilon-caprolactone) copolymers (e.g., weight ratio of about 50 to about 95% L-lactide to about 50 to about 5% caprolactone), poly(L-lactide-co-trimethylene carbonate), polytrimethylene carbonate, poly-caprolactone, poly(glycolide-trimethylene carbonate), poly(lactide-glycolide-trimethylene carbonate), or equivalents, polyhydroxybutyric acid such as poly(3-hydroxybutyric acid) and poly(4-hydroxybutyric acid), polyhydroxyvaleric acid, polyhydroxybutyric acid / polyhydroxyvaleric acid copolymer (PHV / PHB), polyhydroxyalkanoate, polyorthoester, polyanhydride, polyiminocarbonate, tyrosine-derived polycarbonate, tyrosine-derived polyacrylate, iodinated and / or brominated tyrosine-derived polycarbonate, iodinated and / or brominated tyrosine-derived polyacrylate polyester amide, polycarbonate copolymer, lactone-based polymers such as poly(propylene fumarate-co-ethylene glycol) copolymer (also known as maleic anhydride), polyanhydride ester, polyorthoester, silk elastin polymer, polyphosphazene, aliphatic polyurethane, polyhydroxy acid, polyether ester, polyester, polydepsipeptide, poly(alkylene oxalate), polyaspartic acid, polyglutamic acid polymer, poly-p-dioxanone, poly-beta-dioxanone, asymmetric 3,6-substituted poly-1,4-dioxane-2,5-dione, polyalkyl-2-cyanoacrylate, polydepsipeptide (glycine-DL-lactide copolymer), polydihydropyran, polyalkyl-2-cyanoacrylate, poly-beta-maleic acid (PMLA), polyalkanoate, poly-beta-alkanoic acid, polymers, mixtures, and / or copolymers.Comprising one or more than one of those combinations, or combinations thereof that exceed that.

[0173] In another embodiment, suitable stent materials include polymers and metals (degradable or non-degradable), adhesives, coatings, solder, sleeves, sealants, potting compounds, fixation materials, cements, energy fixatives, elastomers, and other types of materials. Suitable materials include, but are not limited to, polyalkyl-2-cyanoacrylates, methyl-2-cyanoacrylate, ethyl-2-acrylate, n-butyl cyanoacrylate, 2-octyl cyanoacrylate, or other cyanoacrylates such as Gorilla Glue, TissueGlu, Sylys surgical sealant, or other lysine-based adhesives, fibrin adhesives, adhesives such as beeswax. UV curable materials from epoxies, epoxyamines, Loctite, Dymax, Master Bond, or others, degradable sleeve materials, stent materials, and coatings such as acrylics, silicones, hot melts, polyurethanes, polyesters, polylactides and their copolymers and mixtures, lactide, caprolactone, trimethylene carbonate, copolymers of glycolide, poly(L-lactide), poly-DL-lactide, poly(lactide-co-glycolide) (e.g., poly(L-lactide-co-glycolide), poly(L-lactide-co-epsilon-caprolactone) copolymers (e.g., weight ratios of about 50 to about 95% L-lactide to about 50 to about 5% caprolactone), poly(L-lactide-co-trimethylene carbonate), polytrimethylene carbonate, poly-caprolactone, poly(glycolide-trimethylene carbonate), poly(lactide-glycolide-trimethylene carbonate), or equivalents, polyhydroxybutyrates such as poly(3-hydroxybutyric acid) and poly(4-hydroxybutyric acid), polyhydroxyvalerate, polyhydroxybutyrate / polyhydroxyvalerate copolymer (PHV / PHB), polyhydroxyalkanoates, polyorthoesters, polyanhydrides, polyiminocarbonates, tyrosine-derived polycarbonates, tyrosine-derived polyacrylates, iodinated and / or brominated tyrosine-derived polycarbonates, iodinated and / or brominated tyrosine-derived polyacrylate polyester amides, polycarbonate copolymers,Lactone-based polymers such as poly(propylene fumarate-co-ethylene glycol) copolymer (alias maleic anhydride), polyanhydride esters, polyorthoesters, silk elastin polymers, polyphosphazenes, aliphatic polyurethanes, polyhydroxy acids, polyether esters, polyesters, polydepsipeptides, poly(alkylene oxalate), polyaspartic acid, polyglutamic acid polymers, poly-p-dioxanone, poly-beta-dioxanone, asymmetric 3,6-substituted poly-1,4-dioxane-2,5-dione, polyalkyl-2-cyanoacrylate, polydepsipeptide (glycine-DL-lactide copolymer), polydihydropyran, polyalkyl-2-cyanoacrylate, poly-beta-maleic acid (PMLA), polyalkanoates, poly-beta-alkanoic acids, proteins such as elastin, fibrin, collagen, glycoproteins, gelatin, or pectin, polysaccharides such as poly-serine, polycaprolactam, cyclodextrin, chitosan and hyaluronic acid, alginates, polyketals, fatty acid-based polyanhydrides, amino acid-based polyanhydrides, poly(ester anhydrides), polymer mixtures, and / or copolymers, or combinations thereof, or equivalents such as non-degradable adhesives, sealants, and potting compounds. Corrosive solders or fusible metals such as Sn97Cu3, Sn50Zn49Cu1, Sn95.5Cu4Ag0.5, Sn90Zn7Cu3, Sn98Ag2, Sn96.5Ag3Cu0.5, Sn91Zn9, Sn85Zn15, Sn70Zn30, Sn89Zn8Bi3, Sn83.6Zn7.6In8.8, Sn86.9In10Ag3.1, Sn95Ag3.5Zn1Cu0.5, Sn86.5Zn5.5In4.5Bi3.5, Sn95Sb5, Sn96.2Ag2.5Cu0.8Sb0.6, Sn90Au10, or others, indium or its alloys such as In97Ag3, In90Ag10, In50Sn50, In52Sn48 or others, zinc or its alloys such as Zn95Al5, Zn60Sn40, Zn95Sn5, or others, bismuth or its alloys such as Bi57Sn42Ag1, Bi58Sn52, or others. Au80Sn20, Au98Si2, Au87.5Ge12.5,Non-corrosive solder or fusible metal such as gold or its alloy like Au82In18. Degradable and non-degradable polymers include polyesters, polylactides and their copolymers and mixtures, lactide, caprolactone, copolymers of trimethylene carbonate and glycolide, poly(L-lactide), poly-DL-lactide, poly(lactide-co-glycolide) (e.g., poly(L-lactide-co-glycolide), poly(L-lactide-co-epsilon-caprolactone) copolymers (e.g., weight ratio of about 50 to about 95% L-lactide to about 50 to about 5% caprolactone), poly(L-lactide-co-trimethylene carbonate), polytrimethylene carbonate, poly-caprolactone, poly(glycolide-trimethylene carbonate), poly(lactide-glycolide-trimethylene carbonate), or equivalents, polyhydroxybutyric acids such as poly(3-hydroxybutyric acid) and poly(4-hydroxybutyric acid), polyhydroxyvaleric acid, polyhydroxybutyric acid / polyhydroxyvaleric acid copolymer (PHV / PHB), polyhydroxyalkanoates, polyorthoesters, polyanhydrides, polyiminocarbonates, tyrosine-derived polycarbonates, tyrosine-derived polyacrylates, iodinated and / or brominated tyrosine-derived polycarbonates, iodinated and / or brominated tyrosine-derived polyacrylate polyesters amides, polycarbonate copolymers, lactone-based polymers such as poly(propylene fumarate-co-ethylene glycol) copolymer (also known as maleic anhydride), polyanhydride esters, polyorthoesters, silk elastin polymers, polyphosphazenes, aliphatic polyurethanes, polyhydroxy acids, polyether esters, polyesters, polypeptides, poly(alkylene oxalate), polyaspartic acid, polyglutamic acid polymers, poly-p-dioxanone, poly-beta-dioxanone, asymmetric 3,6-substituted poly-1,4-dioxane-2,5-dione, polyalkyl-2-cyanoacrylate, polypeptides (glycine-DL-lactide copolymer), polydihydropyran, polyalkyl-2-cyanoacrylate, poly-beta-maleic acid (PMLA), polyalkanoates, poly-beta-alkanoic acids, elastin, fibrin, collagen, glycoproteins, gelatin,or proteins such as pectin, poly-serine, poly-caprolactam, cyclodextrin, chitosan and hyaluronic acid and other polysaccharides, alginates, polyketals, fatty acid-based polyanhydrides, amino acid-based polyanhydrides, poly(ester anhydrides), polymer mixtures, and / or copolymers, or combinations thereof, or equivalents, polyvinyl alcohol, polyvinyl acetate, ethylene-vinyl acetate (hot melt adhesive), phenolic formaldehyde resin, nylon 12, nylon 6, nylon 6-6, or other polyamides, polyester resins, polyethylene (hot melt adhesive), UHMW, HDPE, LDPE, or others, polychloroprene, polyaryl ether ketone, polyether ether ketone, polypropylene, polystyrene, polyester, polyethylene terephthalate, polycarbonate, polysulfone, polyphenyl sulfone, polyether sulfone, Ultem, polyether imide, polyurethane, polyvinyl chloride, PTFE, FEP, ETFE, PFA, PVDF, polyvinyl chloride, acrylonitrile-butadiene-styrene, polyacetal such as delrin, polymethyl methacrylate, polystyrene, polyacrylamide, polyphenyl sulfide, PEBAX, and / or copolymers, and / or combinations thereof. Silicone rubber, C-flex, poly(n-butyl methacrylate), poly(methacrylate), poly(hexyl methacrylate), and poly(n-butyl methacrylate) mixed with polyvinyl pyrrolidone, Kraton, poly(styrene-ethylene / butylene-styrene) (SEBS), poly(styrene-ethylene / propylene-styrene) (SEPS), poly(acrylic acid-b-styrene-b-isobutylene-b-styrene-b-acrylic acid), poly(styrene-b-isobutylene-b-styrene), polybutadiene, PVDF-HFP poly(vinylidene fluoride-hexafluoropropylene), polyvinyl pyrrolidone, poly(ethylene-co-vinyl acetate), phosphorylcholine, PEBAX, polyurethane elastomer, Tecoflex, Biomer, Pellethane, corethane, silicone rubber, rubber, elastomer, mixture, copolymer, combination thereof,Or an elastic non-absorbent polymer or elastomer such as an equivalent. Shape or thermo-memory alloy, shape memory polymer, or super-elastic material, typically nickel-titanium alloy, spring stainless steel, Ni50-Mn28-Ga22, copper-aluminum-nickel, zinc, copper, gold, and iron alloys, iron-based alloys such as Fe-Mn-Si, copper-based alloys such as Cu-Zn-Al and Cu-Al-Ni, or a non-corrosive elastic metal or metal alloy such as an equivalent. Metals or metal alloys having high initial strength and becoming brittle over time include Ti6Al4V, Ti5Al2.5Sn, or Ti-10V-Fe-3Al, stainless steels such as SAF2507, zinc alloys such as Zn5al, Zn10Al, Zn18Al, Zn30Al, platinum metals and their alloys, tin alloys such as Sn3.9Ag0.6Cu, Sn-3.8Ag-0.7Cu, SnPb, or SnPbAt, aluminum alloys such as Al1.7Fe, Al0.7Cu, A1.5MgScZr, Al6Mg0.2Sc0.15Zr, 3004, 8090, 7075, 6061, or 5056, zirconium alloys such as Zr55Al10Ni5Cu30, magnesium alloys such as AZ31B or MG11li5Al1Zn0.034Sc(LAZ1151), iron alloys such as Fe29.7Mn8.7Al1C, 30HGSA alloy steel, 4140, C45 steel, Fe36Ni, or low-carbon steel, nickel alloys such as Ni21Cr17Mo or Haynes 230. Conventional titanium alloys such as Ti6Al4V, Ti5Al2.5Sn, or Ti-10V-Fe-3Al, stainless steels such as SAF2507, platinum metals and their alloys, aluminum alloys such as Al1.7Fe, Al0.7Cu, A1.5MgScZr, Al6Mg0.2Sc0.15Zr, 3004, 8090, 7075, 6061, or 5056, zirconium alloys such as Zr55Al10Ni5Cu30, alloy steels such as 304V, 304L, and 316LV stainless steel, mild steel, cobalt-based alloys such as cobalt chromium, platinum-based alloys such as L605, Elgiloy(R), Phynox, platinum chromium, platinum iridium, and platinum rhodium, tin-based alloys, rhodium, rhodium-based alloys, palladium, palladium-based alloys, aluminum-based alloys, titanium or their alloys,Rhenium-based alloys such as 50:50 rhenium molybdenum, molybdenum-based alloys, tantalum, gold or their alloys, silver or their silver alloys (degradable), shape memory metals or alloys, chromium-based alloys, nickel-titanium alloys such as linearly elastic and / or superelastic nitinol, nickel-chromium-molybdenum alloys (e.g., INCONEL 625, Hastelloy C-22, Hatelloy C276, Monel 400, Nickelvac 400, and, Nickel alloys such as nickel and equivalents, nickel-cobalt-chromium-molybdenum alloys such as MP35-N, nickel alloys such as Ni21Cr17Mo or Haynes 230, or other nickel-molybdenum alloys, platinum-enriched stainless steels, combinations thereof, or non-corrosive (non-degradable) metals or metal alloys such as equivalents. Corrosive metals or metal alloys (degradable) include nickel, cobalt, tungsten, rhenium, cobalt, iron, zirconium, zinc, tungsten alloys of titanium, magnesium, magnesium alloys, magnesium alloy AZ31, magnesium alloys with less than 20% by weight of zinc or aluminum, less than 3% of iron, silicon, manganese, cobalt, nickel, yttrium, scandium, or one or more impurities of other rare earth metals, or magnesium alloys without or with such impurities, AZ31B or MG11li5Al1Zn0.034Sc (LAZ1151), alloys thereof such as zinc or zinc alloys such as Zn5al, Zn10Al, Zn18Al, Zn30Al, bismuth or its alloys, indium or its alloys, tin or tin-lead, alloys thereof such as Sn3.9Ag0.6Cu, Sn-3.8Ag-0.7Cu, SnPb, or SnPbAt, alloys thereof such as silver or silver-tin alloys, cobalt-iron alloys, iron or 80-55-06 grade ductile cast iron, other ductile cast irons, AISI 1010 steel, AISI 1015 steel, AISI 1430 steel, AISI 8620 steel, AISI 5140 steel, Fe29.7Mn8.7Al1C, 30HGSA alloy steel, 4140, C45 steel, Fe36Ni, low-carbon steel, or alloys thereof such as other steels, fusible alloys (40% bismuth - 60% tin, 58% bismuth - 42% tin, bismuth-tin-indium alloys, etc.), alloys containing one or more of bismuth, indium, cobalt, tungsten, bismuth, silver, copper, iron, zinc, magnesium, zirconium, molybdenum, indium, tin, or other materials, or equivalents.

[0174] In another embodiment or aspect, the present invention provides a non-degradable prosthesis having a ring with an energy-responsive separation region. Such an endoluminal prosthesis comprises a scaffold having a circumferential ring patterned from a non-degradable material, the scaffold being configured to expand from a crimped configuration to an expanded configuration. At least some of the circumferential rings are configured to form one or more discontinuities in the circumferential ring in response to energy applied to the separation region after deployment and / or after implantation of the prosthesis in a body lumen. Such discontinuities allow the scaffold to disengage and / or, if applicable, expand further, typically achieved by balloon expansion, self-expansion, or the like, e.g., beyond an initial expanded diameter after recoil.

[0175] The energy that promotes or causes the discontinuity may be energy associated with the site of implantation or energy from an external source directed at the site of implantation. For example, the separation region may be configured to fatigue in response to the introduction of a drug and / or the pulsation of a blood vessel or other body lumen in which the endoluminal prosthesis is implanted. Alternatively, the separation region may be configured to respond to external energy that causes heat and / or mechanical movement of the separation region, e.g., vibration. Specifically, such a motion-responsive separation region may, in one embodiment, comprise notches, thinned regions, joints, butt joints, key and lock designs, or other local regions or foci that preferentially fatigue and break in response to the applied energy, and / or a pre-formed separation region that interrupts in response to the applied energy. For example, the separation region may comprise a "living hinge" that circulates open and closed, separates, or ultimately fatigues and breaks in response to pulsation or the application of external energy. In yet other embodiments, the separation region may comprise a modified grain boundary in a metal ring where the grains are particularly susceptible to vibration-induced fatigue.

[0176] In other embodiments or examples, the separation region may comprise a pre-formed cut or a pre-formed separation region in a circumferential ring, and these cuts or discontinuities are reconnected using a connector configured to open in response to an applied or endogenous energy (or in response to physiological conditions). Typical forms of externally applied energy include ultrasound, drugs, heat, magnetism, high-frequency energy, high-intensity focused ultrasound (HIFU), and the like.

[0177] In other examples and / or embodiments, the separation region may comprise a circumferential ring and / or keys and lock joints formed in circumferential structural elements, the keys and lock joints being initially immobilized before or during expansion or in response to expansion, but configured to open in response to an applied energy, either external or internal, or physiological conditions. In yet other examples or embodiments, the separation region may comprise rivets or other fasteners that join cuts in circumferential elements, the fasteners being configured to open in response to an applied energy, either external or internal, or in response to physiological conditions.

[0178] In another example and / or a fourth aspect, the present invention provides non-degradable or slow-degradable prostheses having rings with constrained hinges, and methods for their use and processing. The endoluminal prosthesis comprises a scaffold having a circumferential ring pattern from a non-degradable material. The scaffold is configured to deploy from a crimped configuration to an expanded configuration, and the circumferential rings have hinges that open as the scaffold is deployed and / or after deployment. At least some of the hinges on at least some of the rings are configured to contract from expansion during deployment and open in response to a physiological environment or the application of external energy after deployment. Specific physiological environments and external energies capable of releasing the hinges from contraction are fully described above or throughout this application.

[0179] In one embodiment, by initially binding at least some of the hinges of the circumferential ring, the scaffold is first expanded to a diameter appropriate for the body lumen being treated and will possess sufficient strength to rely on the viability of that body lumen while still in its configuration with the bound hinges. However, after deployment and / or over time, the initially bound hinges are released from the binding, reducing the effective circumferential stiffness of the scaffold. That is, adding more hinges or other expansion regions will preferably lower the force required to incrementally open the scaffold beyond its initially expanded configuration. Thus, the endoluminal prosthesis has reduced energy to confine or restrain the treated body lumen, thereby allowing the scaffold to expand and / or the lumen to expand.

[0180] In another embodiment or aspect, the present invention provides non-degradable prostheses having rings with joints or active joints, and methods for their fabrication and use. The endoluminal prosthesis comprises a scaffold having a circumferential ring patterned from a non-degradable material. The scaffold is configured to deploy from a crimped configuration to an expanded configuration, and the circumferential ring typically includes struts connected by joints that open as the scaffold is deployed, typically by balloon expansion. At least some of the joints will be pivoted to allow the scaffold in its expanded configuration to disengage and / or further expand. The pivot or "active joint" may, in some cases, be asymmetric. That is, the joint will allow radial expansion of the circumferential ring but will limit radial contraction of the ring.

[0181] In different embodiments or examples, the shape of the reinforcing element or the crosslinking element can be substantially circular (solid circular wire or hollow circular wire), rectangular, square, oval, or other shapes and geometric forms. The size of the reinforcing element can, in some examples, be substantially the same size / geometric form as the hinge, the expansion region, and / or the struts to which the reinforcing element is attached, while in other examples, the size / geometric form of the reinforcing element can be smaller or larger than the expansion region. In one example, the ends of the reinforcing element are non-traumatic and / or smooth, and / or have a bulbous or rounded shape, and / or have a wider cross-sectional area that reduces trauma to the blood vessel. In one example, the surface finish of the reinforcing element is similar to that of a polished vascular metal stent. In another example, the surface finish is textured.

[0182] In one example of the degradable material, the polymeric body of the circumferential scaffold is configured to substantially degrade under physiological conditions within a period of 1 month to 3 years, preferably 3 months to 2 years, more preferably 6 months to 1 year after deployment of the endoluminal prosthesis. In another example, the reinforcing element is at least partially encapsulated by a material such as a thin polymeric material. Examples include parylene and C-flex materials.

[0183] In another example, the separation region of the non-degradable scaffold is configured to separate over a period of up to 3 years after deployment, typically 1 day to 3 years, 1 month to 3 years, preferably 3 months to 2 years, more preferably 6 months to 1 year. In one example, the separation regions separate over approximately the same time period, and in another example, the separation regions separate over different time periods.

[0184] In another embodiment, the endoluminal prosthesis further comprises at least one coating, preferably a degradable coating, on at least one surface of the stent prosthesis (scaffold prosthesis). In another embodiment, the stent prosthesis further comprises at least one drug on at least one surface of the stent prosthesis. In another embodiment, the stent prosthesis further comprises at least one coating containing at least one drug on at least one surface of the stent prosthesis. In a preferred embodiment, the polymeric material or adhesive that jointly joins or contains or holds the separation regions does not allow movement of the separation regions, or allows some movement, without prematurely forming discontinuities (before or after deployment), and is an extensible type of polymeric or adhesive material (degradable or non-degradable). This also enables consistent performance of the scaffold, improved storage conditions and shelf life for the stent and separation regions, and enables long-term storage under various typical environmental conditions of heat, humidity, and time. The material can withstand temperatures ranging from 5°C to 50°C, preferably from 10°C to 40°C, and a shelf life of 1 month to 3 years, preferably 1 month to 2 years, or 1 month to 18 months. It is at a relative humidity of 10% to 95%, preferably 20% to 70% relative humidity. Examples of materials are described in this application.

[0185] In one embodiment, the endoluminal prosthesis further comprises a radiopaque marker. In a more specific embodiment, the radiopaque marker comprises a non-degradable radiopaque marker. In a preferred embodiment, the non-radiopaque marker comprises a metal or metal alloy.

[0186] In one embodiment, the reinforcing element and / or the separation region and / or the environmentally responsive separation region are formed from non-degradable materials such as non-degradable metals and / or polymers or other materials. The reinforcing element and / or the separation region and / or the environmentally responsive separation region may alternatively be formed, in whole or in part, from degradable metals (such as magnesium and magnesium alloys), or degradable polymers (such as lactide polymers, copolymers, and mixtures thereof), or combinations thereof, such as degradable (corrosive) materials. In one embodiment, the reinforcing element and / or the separation region and / or the environmentally responsive separation region corrode after implantation, disengage the stent or other endoluminal prosthesis, and preferably disengage the stent prosthesis without the formation of unwanted by-products such as hydroxyapatite substances adjacent to the separation region, and are formed from a corrosive material.

[0187] In one embodiment, the intravascular prosthesis is a stent prosthesis having a generally tubular structure, the tubular structure being patterned, the stent prosthesis having a separation region, the stent prosthesis being crimped to a smaller diameter and deployed from the crimped configuration to a larger expanded configuration, the stent in the expanded larger configuration having sufficient strength to support a body lumen and / or not breaking and / or having low recoil. The stent after deployment is configured in this embodiment to do one or more of the following, namely, the stent and / or circumferential structural elements and / or rings are configured to separate, expand, form discontinuities, and / or disintegrate in at least one section and / or region or more after deployment and / or implantation, and / or the stent is modified to include unlocking, disassembling, or containing by a sleeve or material that does not prevent the separation region or the material adjacent to the separation region from detaching, separating at least a portion of the stent structure, expanding, and / or disintegrating, and / or the stent further expands after deployment, and / or the stent further expands after deployment and modification, and / or the stent further expands radially after deployment, and / or the stent expands circumferentially after deployment, and / or the stent further expands after deployment and assisted modification from a source (chemical, energy), and / or the stent is configured to push against the lumen and expand over a period after deployment or implantation, and / or the stent is configured to allow the lumen or blood vessel to expand / enlarge, or combinations thereof. The stent comprises a non-degradable material, or two non-degradable materials, or a degradable material, or two degradable materials, or two degradable materials and one non-degradable material, or a non-degradable material and a corrosive material, or a degradable material and a corrosive material, or a degradable material, and a corrosive material, and a non-degradable material.The stent may further comprise at least one coating on at least one surface of the stent prosthesis, and the coating is a degradable and / or non-degradable coating. The above materials exclude marker materials that may be degradable or non-degradable. The stent may further comprise at least one drug on at least one surface of the stent. The stent can also comprise at least one coating on at least one surface of the stent prosthesis.

[0188] In one embodiment, the stent patch comprises a structure, preferably a generally tubular structure, more preferably a generally tubular patterned structure having a separation region. The stent patch is typically expandable from a crimped configuration to an expanded larger configuration. The stent structure comprises at least one primary or principal material on at least one segment of the stent, preferably the frame material is a degradable material such as a polymeric material, and the stent structure further comprises at least one second material, preferably a material stronger than the frame material, more preferably a metallic material, more preferably a non-degradable metallic material that is in interfacial contact with or bonded to at least the segment of the frame material, preferably the segment is the crown segment of the stent structure. The stent is deployed to the larger expanded configuration. The stent in the expanded deployed configuration has sufficient strength to support a body lumen and / or expands without fragmentation and / or expands with slight recoil. The stent is subject to modification after deployment, the modification including at least partial degradation of the frame material and / or at least partial degradation of the second material and / or corrosion of at least the first material and / or at least partial corrosion of the second material, or combinations thereof. The modified stent comprises one or more discontinuities in at least one ring and / or at least one discontinuity in at least one crown and / or at least one discontinuity in at least one strut, or combinations thereof. In another embodiment, the modified stent has at least one discontinuity in at least a portion of the frame material and / or at least one discontinuity in at least a portion of the second material and / or at least one discontinuity in adjacent portions of the frame and the second material.In another embodiment, the modified stent further expands from a pre-modification configuration to a larger configuration and / or from a deployed configuration to a larger configuration and / or from a "post-deployment recoil" configuration to a larger configuration and / or expands to a larger configuration with respect to any of the foregoing causes within at least one ring of the stent appurtenance and / or expands to a larger configuration within at least one ring of another stent appurtenance where the ring is located about a midportion of the stent length. In another embodiment, at least one discontinuity in at least one ring of the modified stent enables the stent to further expand at the at least one ring under physiological pressure. In another embodiment, the stent appurtenance collapses upon deployment and / or upon modification of at least one ring, crown, and / or strut. In one embodiment, the stent appurtenance after deployment and / or after modification and / or after collapse has a structure and / or has a tubular structure and / or has a tubular patterned structure and / or has a substantially maintained tubular structure and / or has at least a portion of a structure and / or has at least one window and / or has substantially no structure and / or comprises at least one crown structure and / or comprises at least one strut and / or comprises at least one link and / or has strength and / or combinations thereof.

[0189] In certain embodiments, the stent comprises a generally tubular patterned structure (serpentine, diamond, zigzag, and / or other open cell or closed cell structure) comprising a plurality of rings, the rings comprising a crown and struts, with at least some of the rings connected to adjacent rings by at least one link or, in some cases, several adjacent rings connected together at at least one location.

[0190] In an embodiment, the scaffold or ring material comprises a metal and / or a metal alloy. The metal and / or the metal alloy can be non-degradable or degradable / corrosive. The metals herein exclude markers and marker materials that can be a metal or a metal alloy and can be degradable or non-degradable. The corrosive metal or metal alloy corrodes in a cycle ranging from 1 month to 10 years, preferably in a cycle ranging from 3 months to 5 years, and more preferably in a cycle ranging from 3 months to 3 years.

[0191] In an embodiment, the second material (or reinforcing element) has at least two ends, and the ends are deburred, shaped into a sphere such as a "nerve synapse", and / or smoothed to prevent damaging the lumen or blood vessel and / or causing inflammation after the stent collapses and / or after modification. In another embodiment, the stent is configured such that after modification and / or forming a discontinuity and / or destroying a part of the stent, the stress area and / or fatigue area on the stent is reduced after separation of the separation region, so that the separation region and / or does not decompose outside the section configured to decompose.

[0192] In an embodiment, the main or frame material comprises a polymer material. The polymer material can be degradable or non-degradable. In one embodiment, the polymer material degrades in a cycle ranging from 1 month to 10 years, preferably in a cycle ranging from 3 months to 5 years, and more preferably in a cycle ranging from 3 months to 3 years.

[0193] In an embodiment, the main or frame material is non-degradable and / or degradable at a faster rate than the second material (reinforcing element), and / or degradable at a rate substantially the same as the second material, and / or degradable at a slower rate than the second material.

[0194] In an embodiment, the stent is formed in one or more of the following ways in any of the examples and / or embodiments in this application, namely, a tube, a continuous wire or filament, a wire, a hollow wire that is hollow either completely or in certain regions such as low stress regions and / or substantially straight regions, or a braid, or from a mold, or by printing, or by extrusion, or by spraying, or by dipping, or by stamping, or by a combination thereof. The stent has a separated region that is formed before patterning, during patterning, or after patterning, or after a treatment that forms such a separated region and / or discontinuity. Means for retaining such discontinuity are described throughout this application.

[0195] In an embodiment, a second reinforcing material that is bonded to or in interfacial contact with the structural scaffold material is completely embedded inside the frame, or at least one surface or surface region is embedded inside at least one surface or surface region of the frame, or at least two surfaces are embedded inside at least one surface of the frame, or at least three surfaces are embedded inside at least one surface of the frame, or at least one surface of the second material is attached (and / or joined, and / or abutted, and / or adhered, and / or press-fitted) to at least one surface of the frame material. At least one surface of the frame material may be an anti-lumen side surface, a lumen surface, or a side surface of the frame material. The second material may be sandwiched within the frame material. In one embodiment, the second material has a discontinuity, and the second material discontinuity is retained or joined together by the frame material and / or an adhesive and / or a coating.

[0196] In an embodiment, the second reinforcing material may be in the form of one or more components comprising one or more of a wire, a ribbon, a strut, a crown, a link, and / or a filament. The cross-section of the component may have any one of a variety of shapes, including circular or substantially circular, rectangular or substantially rectangular, square or substantially square, vertically elongated or substantially vertically elongated, oval or triangular, or other shapes. The length, number, and location of the components vary and are less than the length of the stent strut or greater than that, less than the length of the stent crown or greater than that, less than the length of the stent link or greater than that, and / or less than the length of the stent ring or greater than that, and may be one or more on at least one or more stent rings. Preferably, the components of the second material are on / within / around at least one stent crown within at least one stent ring and / or on / within / around at least two stent crowns within at least one stent ring, and / or on / within / around substantially all or a part of the stent crowns within at least one stent ring of the stent, and / or on / within / around all except one stent crown on at least one stent ring, and / or on at least one ring, and / or on at least one ring centered on the center of the stent length, and / or on at least one window of the stent patterning structure, and / or on at least one strut or a part of the strut, and / or on at least one link or a part of the link, and / or in other diversities or combinations thereof. In one embodiment, the patterned stent structure comprises a plurality of windows, and each window comprises a reinforcing material comprising at least two crowns and at least four struts. In another embodiment, the window comprises at least four crowns, at least four struts, and at least one or at least two links. In another embodiment, the link may be linear and / or may have a shape such as an S-shaped link, a V-shaped link, an M-shaped link, and / or other link shapes, etc.In an embodiment, at least one structural element (comprising a crown, struts) within each window has a separation region configured to expand and / or have a discontinuity and / or separate. In another embodiment, the structural element comprises a plurality of circumferential rings each comprising one or more windows, and each window has at least one separation region configured to expand and / or have a discontinuity and / or separate.

[0197] In a preferred embodiment, it is desired that the stent after deployment forms a discontinuity in the separation region (or such a discontinuity is formed prior to deployment and retained together using the design geometry or deployment means such as a balloon catheter), or that the stent structure has another type of embodiment of the present application that is substantially maintained after the separation region has collapsed (or separated) and / or has moved in one or more directions. Preferably, the benefit of having a stent structure along the length of the stent length or a portion of the stent length serves to prevent a vulnerable substance under the stent, such as a vulnerable plaque, from rupturing into the blood vessel and causing harm. The stent structure is sufficient to prevent (or retain) a vulnerable substance (such as a vulnerable plaque) within the body lumen. In another embodiment, the stent structure after deployment and / or after collapse and / or after forming a discontinuity is substantially sufficient to support the body lumen. In another embodiment, the stent structure after deployment and / or after collapse and / or after forming a discontinuity is substantially sufficient to support body tissue.

[0198] In one embodiment, at least some of the structural elements of the stent that detach and / or disintegrate and / or have a separation region, when formed under physiological conditions, after treatment (including modification) and / or after deployment, release fixation, release retention, be incomplete, be unhooked, be removed, be detached, be severed, be damaged, be discrete, be pushed, be pushed open, be separated, be pulled apart, create a gap, create a space, collapse, corrode, decompose, fragment, shatter, pulverize, split, decay, be unlatched, be disassembled, deteriorate, degenerate, attenuate, interrupt, be released, and / or include one or more than one of their combinations. The stent structural element, in one embodiment, comprises one or more than one of a ring, a crown, a strut, and / or a link. The stent structural element, in another embodiment, comprises one or more than one of rings, and the ring comprises a crown and / or a strut.

[0199] In an embodiment, the stent prosthesis is deployed to an expanded larger configuration under simulated conditions including physiological conditions and / or air, and / or air at ambient temperature and / or air at 37 °C temperature, and / or water, and / or water at ambient temperature, and / or water at 37 °C, and / or within a body lumen, and / or at body temperature, and / or under intravascular pressure, pulsatile pressure, and / or combinations thereof.

[0200] In an embodiment, the stent patch is deployed to an expanded, larger configuration in air, and / or in air at ambient temperature, and / or in air at 37° C., and / or in water, and / or in water at ambient temperature, and / or in water at 37° C., and / or in a body lumen, and / or at body temperature, and / or in at least one solvent, and / or in at least one solvent or corrosion inducer at ambient temperature, and / or in a solvent or corrosion inducer at 37° C., and / or in a tube, and / or at 1.5 psi to 5 psi, under pressure, under pulsatile pressure, pressurizing the stent, and / or undergoing modification by accelerated fatigue, and / or any of the accelerated conditions, and / or combinations thereof.

[0201] In another embodiment or aspect of the present invention, the non-degradable stent prosthesis has a structure that includes wires, hollow wires (hollow in at least some regions that are formed and / or are hollow after treatment (modification)), and the wires and / or hollow wires are patterned onto a stent, preferably a substantially tubular stent structure, more preferably a substantially tubular patterned stent structure, and the stent is patterned from a tube. The stent prosthesis is expandable from a crimped configuration to a larger or expanded configuration. The stent structure comprises a strong material such as a non-degradable polymer or metal (including metal alloys) such as metallic stainless steel or cobalt chromium. The material is configured to have at least one segment and / or region within at least one ring, and the material collapses (environmental-responsive separation region or separation region) after deployment and / or modification, and / or the material has at least one discontinuity within at least one ring, and / or at least one discontinuity within at least one strut, and / or at least one discontinuity within at least one crown, and / or is configured to have a combination thereof. The discontinuities in the material are held together and do not substantially affect the crimping of the stent and / or its deployment to a larger expanded configuration, and / or the stent prosthesis has sufficient strength in the deployed configuration to support a body lumen, and / or the material has at least one discontinuity within at least one ring, and / or at least one discontinuity within at least one strut, and / or at least one discontinuity within at least one crown, and / or is configured to have a combination thereof. The discontinuities in the material are held together and do not substantially affect the crimping of the stent and / or its deployment to a larger expanded configuration, and / or the stent prosthesis has sufficient strength in the deployed configuration to support a body lumen. The material held together includes holding together, latching, attaching, connecting, pushing together, pulling together, removing gaps, removing spaces, and / or latching the adjacent portions of the material discontinuity.Means for holding together the material discontinuity portions include a sleeve, an adhesive, press-fitting, locking, a coating such as a polymer or metal coating, a gel, solder, and / or a design such as a key and lock design. The stent in the expanded deployment configuration has sufficient strength to support the body lumen and / or expand without fragmentation and / or expand with low recoil. In one embodiment, the stent is modified after deployment, and the modification involves detachment, unlocking, release of retention, incompletion, unlatching, removal of attachment, removal, severance, breakage, discretization, pushing, prying open, separation, pulling apart, creating a gap, creating a space, collapse, corrosion, decomposition, fragmentation, crushing, shattering, splitting, putrefaction, unlocking of locking, disassembly, deterioration, degradation, attenuation, and / or interruption of at least a portion of the material and / or the means for holding together the material discontinuity portions. The modified stent comprises at least one or more than one collapsed material section and / or discontinuity in at least one ring, and / or at least one or more than one collapsed material section and / or discontinuity in at least one crown, and / or at least one or more than one collapsed material section and / or discontinuity in at least one strut, and / or a combination thereof. In another embodiment, the modified stent allows the lumen or blood vessel to expand further after implantation and / or allows the stent to expand further from the pre-modification configuration to a larger configuration and / or expand further from the deployed configuration to a larger configuration and / or expand further from the "post-deployment recoil" configuration to a larger configuration and / or detach and / or expand further to a larger configuration with respect to any of the previous causes in at least one ring of the stent prosthesis and / or expand further to a larger configuration within at least one ring of the stent prosthesis, the ring being located about the middle portion of the stent length.In another embodiment, at least one or more than one disintegration material section (separation region) and / or the discontinuity of at least one ring of the modified stent enables the stent to detach under physiological pressure and / or to further expand at the at least one ring. In another embodiment, the stent prosthesis disintegrates upon deployment and / or after modification of at least one ring, crown, and / or strut. In one embodiment, the stent prosthesis after deployment and / or after modification and / or after disintegration and / or after the material is interrupted has a structure and / or has a tubular structure and / or has a tubular patterned structure and / or has a substantially maintained tubular structure and / or has at least a part of the structure and / or has at least one window and / or has substantially no structure and / or comprises at least one crown structure and / or comprises at least one strut and / or comprises at least one link and / or has strength and / or is a combination thereof.

[0202] In one embodiment, the means for holding the materials together and / or for holding together the material separation region and / or the discontinuity and / or for preventing the stent from disintegrating prior to deployment includes adhesives, metals, polymers, coatings, solders, press-fitting, welding, weaving or braiding the materials, and / or others. In one embodiment, the means decays, decomposes, corrodes, is unlocked, and / or is disengaged at a period ranging from 1 month to 5 years, preferably from 3 months to 3 years, more preferably from 3 months to 1 year. In one embodiment, the stent material decomposes after the means decomposes and / or corrodes and / or is unlocked, etc.

[0203] In another preferred embodiment, the stent prosthesis has a structure, and within the structure, the separation region and / or the discontinuity is located in an area that does not affect radial expansion and / or circumferential expansion, preferably in an area of lower stress such as a strut or a strut region.

[0204] In another embodiment, the stent patch is configured to have a patterned structure, and the structure has key and lock, abutment, two plates, press fit, ratchet, rivet, insert, magnet, or other such separation region discontinuities on at least one strut and / or on at least one crown so as to allow the stent after deployment and / or after deployment and modification to further expand and / or disengage and / or separate as the lumen or blood vessel further expands.

[0205] In another embodiment, the stent patch is configured to have a patterned structure where the structure comprises a plurality of rings, which in one embodiment are serpentine rings, and the rings comprise a crown and struts, and at least one crown and two struts are held in a crimped configuration by a coating and / or a sleeve, and the stent after deployment and modification, including decomposition of the sleeve and / or coating, allows the stent to disengage and / or further expand to a larger configuration and / or allows the lumen or blood vessel to expand.

[0206] In another embodiment, the stent patch is configured to have a patterned structure where the structure comprises a plurality of rings, which in one embodiment are serpentine rings, and the rings comprise a crown and struts, and at least one crown and / or at least one strut on at least one ring has a separation region and / or is configured to disintegrate within at least that section or region under physiological conditions such as after fatigue of one section or region after deployment. The stent structure after disintegration allows the stent to disengage and / or further expand to a larger configuration and / or allows the lumen or blood vessel to expand.

[0207] In another embodiment, the stent prosthesis is configured to have a patterned structure whose structure comprises a plurality of rings, where the rings are, in one embodiment, serpentine rings, and the rings comprise a crown and struts, and at least one crown and / or at least one strut on at least one ring is configured to collapse in a section or region after physiological conditions such as fatigue in at leas...

Claims

[Claim 1] An apparatus, system or method.

Images