Uncaging stent

Abstract

To provide an uncaging stent.SOLUTION: A stent (scaffold) or other luminal prosthesis comprising circumferential structural elements provides high strength after deployment and allows the scaffold to uncage, and / or allow a scaffold or luminal expansion thereafter. The circumferential scaffold may be formed from degradable material, or may be formed from non-degradable material, and will be modified to expand and / or uncage after deployment. The scaffold may have a plurality of circumferential rings patterned from a non-degradable material, and may be configured to expand from a crimped configuration to an expanded configuration.SELECTED DRAWING: Figure 25C

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of provisional patent application Ser. No. 62 / 480,121, filed March 31, 2017 (Attorney Docket No. 32016-714.106); Ser. No. 62 / 430,843, filed December 6, 2016 (Attorney Docket No. 32016-714.105); Ser. No. 62 / 424,994, filed November 21, 2016 (Attorney Docket No. 32016-714.104); Ser. No. 62 / 424,994, filed October 28, 2016 (Attorney Docket No. 32016-714.104). This application claims the benefit of Ser. No. 62 / 414,593 (Attorney Docket No. 32016-714.103), filed Aug. 12, 2016; Ser. No. 62 / 374,689 (Attorney Docket No. 32016-714.102), filed May 16, 2016; and Ser. No. 62 / 337,255 (Attorney Docket No. 32016-714.101), filed May 16, 2016, the entire disclosures of which are incorporated herein by reference.

[0002] Balloon angioplasty has been introduced to open blood vessels, particularly those that have become narrowed as a result of plaque progression or heart attack. In successful cases, the vessels have remained open and / or exhibited aggressive remodeling over time and / or exhibited vasodilation capabilities that mimic, to some extent, native vascular capabilities. However, in other cases, the vessels will re-occlude within days or months due to a variety of causes, such as vessel recoil, thrombus formation, or other types of plaque morphology progression.

[0003] Metallic stents have been developed to provide a structure, often referred to as a scaffold, with sufficient radial strength (crush resistance) to counteract recoil and hold the vessel open over time. Stents are formed from wire, coil, braid, sheet, and / or tubular bodies. Balloon-expandable stents formed from patterned, non-degradable metal tubes, wires, or sheets are currently most commonly used because they exhibit desirable structural properties such as limited inward recoil, high strength (crush resistance or crush force), and limited axial shortening upon expansion, compared to some earlier coiled or braided stents.

[0004] Despite their success and widespread adoption, metallic stents, such as stainless steel alloy, platinum-iridium alloy, and cobalt-chromium alloy stents, suffer from certain drawbacks, such as restricting the lumen or vessel, not further expanding (after inward recoil) after implantation under physiological conditions, preventing the lumen or vessel from further expanding and thus inhibiting active remodeling, and / or preventing vasodilation or vasomotion of the treated vascular stent segment, which is important for vascular healing or normal function. This phenomenon is commonly referred to as vascular "restriction" or "trapping." High radial strength is important for supporting and / or holding the body lumen open upon implantation of the stent, and / or high strength is important in preventing the lumen from becoming smaller after implantation. In some cases, shape-memory self-expanding alloy stents are used; however, due to material properties, such stents typically do not exhibit the same high radial strength (high crush force resistance) as metallic stents. (As a result, the lumen may become smaller after implantation of such stents, in some cases due to excessive inward recoil resulting from the inward force of the lumen on the stent and / or due to the lower radial strength of these stents, making such stents less likely to further expand after implantation into the lumen or diseased lumen segment, and / or such stents less likely to exhibit vasodilation or vasomotion of the stented segment.) In some cases, shape-memory stents may migrate toward the adventitia and penetrate the lumen wall, causing irritation, inflammation of the vessel or lumen, and sometimes resulting in unwanted negative clinical events and / or reocclusion of the body lumen or vessel. Furthermore, upon delivery into a vessel or lumen, stents are typically maintained in a crimped configuration using restraints, which increases the 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, making them less likely to expand to or maintain an expanded diameter beyond such pre-programmed diameter, making stent sizing more difficult, and / or such stents do not further expand beyond such pre-programmed diameter / configuration after deployment, to name a few examples.

[0005] To address some of these drawbacks, biodegradable stents made from metal or polymer materials have been developed. By allowing the stent to degrade or resorb, the confining or containment effect fades or diminishes over time, and the scaffolding will eventually disappear over time. However, current biodegradable stents, particularly polymer biodegradable stents and corrodible metal stents, have their own drawbacks, including stent fracture and / or a limited ability to overexpand the stent beyond its nominal expanded diameter, and / or have excessive or high initial inward recoil and / or additional inward recoil after implantation and the initial inward recoil. In some cases, they may have insufficient strength to accommodate various lesion types after deployment and / or a limited ability to hold the lumen or vessel open after deployment. Biodegradable stents typically have lower radial strength (crush resistance / strength) than balloon-expandable metallic non-degradable stents, and typically have bulky, thick strut stents to address some of their mechanical shortcomings, such as suboptimal crush strength, or having thick struts can lead to negative clinical events, such as excessive inflammation (due at least in part to the degradation of the material and the quality of the degradation material) and / or excessive hyperplasia, such as neointimal hyperplasia (due at least in part to the degradation of the material and the quality of the degradation material), to name a few issues.

[0006] Attempts have also been made to create scaffolds from a combination of polymer and metallic materials. However, such designs present their own drawbacks. Such composite designs may lack sufficient initial crush resistance to effectively open or maintain the lumen after stent implantation, or such designs do not dislodge the stent, or dislodge the stent along the entire stent segment, or dislodge the vessel, or do not allow the stent to be further expanded under physiological conditions, and / or the vessel to be constricted using or after the use of vasodilators and / or vasoconstrictors after implantation. Alternatively, some other such designs may not be able to further expand to a larger configuration after implantation (after inward recoil, if applicable). Still other designs have so many separate metallic or other non-degradable components that they risk dislodging small parts into the bloodstream, potentially causing a clinical event. One or more needs as set forth above in the following exemplary problems remain unmet by current non-degradable stents, i.e., having a stent with low inward recoil, and / or having a stent with low initial inward recoil after expansion while the diameter of the stent is substantially maintained after implantation and after the initial inward recoil, and / or having a non-degradable stent configured to be capable of further expanding after deployment under physiological conditions (after inward recoil, if applicable), and / or having a stent that can expand or further expand after deployment (after inward recoil, if applicable) without a pre-programmed temperature trigger setting or without a pre-programmed expansion diameter / configuration setting, and / or having a stent that can expand or further expand (after inward recoil, if applicable) without a pre-programmed temperature, and / or having a stent that can further expand after deployment under physiological conditions (after inward recoil, if applicable) without penetrating or substantially penetrating the vessel or 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 vessel wall after implantation into the adventitia, and / or that further expands after any inward recoil, further expanding the lumen or vessel diameter after deployment (implantation), and / or having a stent that remains or substantially remains in a crimped configuration upon delivery into a vessel or lumen without a restraint, and that further expands after any inward recoil to a larger post-deployment configuration, and / or having a stent that can be deployed to a wide range of diameters and still clear the vessel or lumen after deployment, and / or having a stent that can be deployed to a wide range of diameters and that further expands after any inward recoil to a larger post-implantation configuration, and / or having a stent that can further expand beyond a pre-programmed expanded diameter / configuration after any inward recoil, and / or having a stent that exhibits vasomotion, vasodilation, or vasoconstriction after implantation, and / or a stent having sufficient strength to support a lumen and low inward recoil, wherein the stent exhibits a radial strain of 1% or greater after deployment, and / or a non-degradable stent having an initial compliance upon expansion from a crimped configuration to an expanded configuration whose initial compliance increases after implantation, and / or a non-degradable stent having an initial radial strength (crush resistance) upon expansion from a crimped configuration to an expanded configuration whose initial radial strength decreases after implantation, and / or a balloon-expandable non-degradable stent capable of being expanded from a crimped configuration to an expanded configuration, wherein the expanded configuration has a diameter ranging from 2.0 mm to 4.0 mm, wherein the stent exhibits initial inward recoil after initial expansion, wherein the stent has an initial diameter after initial recoil, and wherein the stent maintains the initial diameter (or configuration) after the initial inward recoil, and wherein the stent is responsive to a vasodilator sufficient to expand the stented section to a second diameter after implantation, wherein the second diameter (or configuration) is greater than the initial diameter;

[0007] A particular concern within blood vessels and other body lumens after implementation of a stent or other prosthetic device is the loss of vascular compliance or contractility, which may result in loss of vascular or lumen remodeling or expansion, or, as referred to above as "confinement" or "restriction" of the blood vessel or body lumen. Vascular compliance is necessary for a blood vessel or body lumen to respond to changes in internal pressure, external pressure, muscle contraction, muscle relaxation, chemical changes, and the like. Such changes may result from many sources, such as the presence of natural or artificial substances that can relax or contract the body lumen and / or muscles, such as smooth muscle cells, within the walls of the body lumen. The implantation of a stent within a blood vessel or body lumen will inevitably contribute to a reduction in the overall or "composite" compliance of the body lumen and stent. The natural compliance of the body lumen and the additional compliance of the stent will each contribute to a total or overall "composite" compliance that would necessarily be less than the compliance of the body lumen if the stent were not implanted. It is therefore desirable for a stent implanted in a body lumen, particularly a blood vessel, to minimize the reduction in body lumen compliance that naturally occurs as a result of the stent's implantation. While reduced compliance may be acceptable for a period of time immediately following implantation, specifically during that period (depending on the initial period at or after implantation), radial strength is desired to maintain vessel (or body lumen) patency and prevent further inward recoil after implantation. Such strength is less or no longer necessary after the initial period, when vessel healing occurs and ultimately stent strength becomes unnecessary or less important. During or after such healing phase, it is highly desirable for the vessel's compliance to return to a level at, approaching, or closer to the natural compliance of the lumen in the absence of the implanted stent.It is therefore an object of the present invention to provide stents, stent scaffoldings, and other luminal prostheses that, after implantation, exhibit increasing compliance over time in response to the vascular or other luminal environment, such that the total or combined compliance of the stent scaffolding and body lumen increases to a level that more closely resembles or approaches the compliance of the body lumen in the absence of the stent scaffold.

[0008] Loss of compliance is also a problem for valves, rings, and other devices implanted in the heart valve annulus. While valve scaffolds may not necessarily require high radial strength, especially after the initial implantation cycle, it is beneficial for them to be flexible enough to conform to the annulus as it deforms during normal systolic and non-systolic cycles, or to deform to conform to deformed annulus due to disease progression, thus maintaining the integrity of valve function, or to expand to conform to annular dilation due to physiological conditions or disease progression, while maintaining the integrity of valve function.

[0009] What is needed are implants, stents, stent scaffoldings, vascular prostheses, external prostheses, and / or other luminal prostheses that address at least some of these shortcomings, as well as others described herein. [Background technology]

[0010] Related background patents and applications include US7011678, US5922020, US2003 / 0153971, US9056157, US2005 / 0222671, US9265866, US7169173, US8435281, US2003 / 0195609, US7402168, US7829273, US5695516, US6540777, US8652192, US8128679, and US8070794. , US6599314, US8961585, US7455687, US7645409, US8202313, EP2229919, US6251134, US6409754, US5766237, US5957975, US5306286, US5961545, US8052743, US9180005, US9192471, US2008 / 177373, and US2005 / 283229. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] U.S. Patent No. 5,306,286 [Patent Document 2] U.S. Patent No. 5,695,516 [Patent Document 3] U.S. Patent No. 5,766,237 [Patent Document 4] U.S. Patent No. 5,922,020 [Patent Document 5] U.S. Patent No. 5,957,975 [Patent Document 6] U.S. Patent No. 5,961,545 [Patent Document 7] U.S. Patent No. 6,251,134 [Patent Document 8] U.S. Patent No. 6,409,754 [Patent Document 9] U.S. Patent No. 6,540,777 [Patent Document 10] U.S. Patent No. 6,599,314 [Patent Document 11] U.S. Patent No. 7,011,678 [Patent Document 12] U.S. Patent No. 7,169,173 [Patent Document 13] U.S. Patent No. 7,402,168 [Patent Document 14] U.S. Patent No. 7,455,687 [Patent Document 15] U.S. Patent No. 7,645,409 [Patent Document 16] U.S. Patent No. 7,829,273 [Patent Document 17] U.S. Patent No. 8,070,794 [Patent Document 18] U.S. Patent No. 8,052,743 [Patent Document 19] U.S. Patent No. 8,128,679 [Patent Document 20] U.S. Patent No. 8,202,313 [Patent Document 21] U.S. Patent No. 8,435,281 [Patent Document 22] U.S. Patent No. 8,652,192 [Patent Document 23] U.S. Patent No. 8,961,585 [Patent Document 24] U.S. Patent No. 9,056,157 [Patent Document 25] U.S. Patent No. 9,180,005 [Patent Document 26] U.S. Patent No. 9,192,471 [Patent Document 27] U.S. Patent No. 9,265,866 [Patent Document 28] US Patent Application Publication No. 2003 / 0153971 [Patent Document 29] US Patent Application Publication No. 2003 / 0195609 [Patent Document 30] US Patent Application Publication No. 2005 / 0222671 [Patent Document 31] US Patent Application Publication No. 2005 / 0283229 [Patent Document 32] US Patent Application Publication No. 2008 / 0177373 Summary of the Invention [Means for solving the problem]

[0012] The present invention provides numerous examples and embodiments of stents, particularly vascular and luminal stents and prostheses, that exhibit strength, modified (or controlled) strength, and / or modified (or controlled) compliance characteristics upon expansion and / or implantation. In one particular example, metal, metal alloy, and other non-degradable stents may be modified in numerous ways to control their radial strength and compliance initially upon expansion within a body lumen and subsequently over the days, months, and years following initial expansion and / or implantation. Specifically, many of the stent and scaffold designs described and claimed herein will provide variable (or controlled) compliance, with an initial compliance that is relatively low and increases over time after implantation, and radial strength that is relatively high (e.g., has substantial hoop strength or crush resistance) upon implantation or initial expansion and decreases (or may be reduced) over time after implantation. The increase in compliance and 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 forms all or part of the prosthesis.

[0013] Methods for measuring and quantitatively expressing the strength (radial strength) and compliance of vascular and other luminal stents and scaffoldings are well known and described in the patent and medical literature.

[0014] Compliance, as the term is used in many of the examples or embodiments, is a dimensionless measurement that represents the rate of change in diameter (or configuration) of a luminal structure or a section of a luminal structure in response to a physiological condition, such as a change in internal pressure within or adjacent to the luminal structure; typically, such a change in pressure is 100 mmHg. In some other cases, compliance measurements may be expressed as mm / atmosphere, mm / psi, % / atmosphere, % / psi, or the like. The terms "compliance" and "radial compliance" are used interchangeably.

[0015] Body lumens, stents, scaffoldings, prostheses, and other tubular structures will each have their own compliance. A body lumen with an implanted stent, scaffolding, prosthesis, and other tubular structure will also have a compliance that is a composite of the individual compliances of the lumen and implant, with the composite typically being lower than the lumen and often lower than the implant alone. In many cases or examples, a "composite" compliance will be measured to define the compliance characteristics of the stent; however, this can also be, in some cases, the stent-only measured compliance, scaffoldings, prostheses, and other tubular structures, in many of the embodiments claimed herein. In many cases or examples throughout this application, the term "radial strain" is used to mean compliance, and is used synonymously with the term "compliance" (or "composite compliance") when the terms "compliance" or "composite compliance" are described herein or elsewhere. Typically, when radial strain is measured at a 100 mmHg change in pressure, this refers to the compliance of the implant (or composite compliance), but compliance can also refer to the rate of change in diameter of an implant or composite at a given change in pressure different from 100 mmHg.

[0016] Specifically, the radial compliance of a stent, scaffolding, or other luminal prosthesis will be measured as an in vitro composite compliance in a simulated vessel according to well-known principles and techniques, such as those described in ASTM F2477-07R13, which measures compliance at a pressure change of 100 mmHg, although testing can also provide the required method for testing compliance at a given pressure change other than 100 mmHg, such as about 176 mmHg or other pressures. Stent compliance can also be tested by having a stent implanted in a vessel, such as a porcine coronary vessel, and compliance measured in the stented section of the vessel.

[0017] In a first aspect or embodiment of the present invention, a prosthesis, particularly an endoluminal prosthesis, comprises a scaffold having a plurality of circumferential rings formed or patterned from a non-degradable material, typically a metal or metal alloy, configured to expand from a crimped configuration to an expanded configuration. At least some of the circumferential rings have at least one separation region configured to form at least one discontinuity in the circumferential ring after the scaffold is expanded in a physiological environment. In preferred embodiments, after such expansion and exposure to a physiological environment, typically a vascular or other body lumen environment, at least two of the circumferential rings remain axially joined after all discontinuities are formed, typically axially adjacent rings. Frequently, all of the circumferential rings of such an endoluminal prosthesis will remain axially joined after the discontinuities are formed. For example, the circumferential rings may be joined by axial links, which are typically short structural elements joining a region on one circumferential ring to a region on an adjacent circumferential ring. However, in other embodiments, regions on successive adjacent circumferential rings may be directly joined, for example, welded or otherwise joined crown to crown, strut to strut, or the like, as will be described in more detail later in this application. In specific embodiments, adjacent crowns on adjacent rings may be joined by welding, wrapping, bonding with wire or other filaments, adhesive, or the like.

[0018] For example, such an endoluminal prosthesis according to the present invention will have circumferential rings with a circumferential structure that, prior to the formation of any discontinuities, have an initial radial compliance, typically a composite compliance as discussed above. However, after the formation of the discontinuities, 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 discontinuities. For example, the initial radial compliance of at least some of the circumferential rings of a scaffold according to the principles of the present invention (or the composite compliance of the scaffold sections) may be 0.1% to 1%, typically 0.1% to 0.5%, while the radial compliance after the formation of the discontinuities will typically be 1.2% to 10%, often 1.2% to 5% or 1.5% to 3%.

[0019] The composite compliance of the scaffold may be measured using a simulated blood vessel system 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 kept at room temperature. All diameter measurements are performed using a calibrated non-contact system capable of measuring diameter to within ±0.01 mm without contacting the scaffold. Suitable measurement instruments include microscopic video measurement systems, laser microscopes, and optical comparators. Pressure measurements of the water used to pressurize the simulated blood vessel are performed using a gauge capable of accurately measuring fluid gauge pressure to within ±0.05 PSI. Pressure measurements are performed at the time the diameter measurements are made. All connecting tubing used in the setup is less than 10 inches in length, and any limitations in the tubing and connectors are eliminated to ensure that any dynamic changes in pressure throughout the simulated blood vessel are accurately reflected by the pressure gauge. Diameter measurements should be performed 30 minutes after the initial pressurization of the simulated blood vessel.

[0020] The simulated 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 diameter, the simulated vessel wall thickness is 0.25 ± 0.03 mm. For stents 2.5 mm diameter and larger, the simulated vessel wall thickness is 0.5 ± 0.03 mm. The test pressure within the simulated vessel is 3.4 ± 1 PSI (or approximately 176 mmHg), and the system will be sufficiently leak-proof to maintain this pressure for the duration of the test. The stent-simulated vessel system is secured to prevent changes in the simulated vessel due to flow and longitudinal forces, which may affect the resting length and diameter of the simulated vessel. The stent-simulated vessel system is also secured to prevent changes in diameter due to forces other than internal pressurization.

[0021] Balloon-expandable, non-degradable scaffolds are deployed in air from an expanded configuration equal to or 0.1 mm smaller than the outer diameter of the simulated vessel without pressurization to an ID after inward recoil. The scaffolds are 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.

[0022] The expanded test scaffold is slid over the outside of the simulated vessel, temporarily reducing the tube diameter and stretching the simulated vessel tubing as needed to allow the stent to be passed over it. After releasing tension on the simulated vessel, actual contact between the ID of the scaffold and the outer diameter (OD) of the simulated vessel along the entire contact length is verified.

[0023] The interior of the simulated vascular tube is connected to an indeflator (an inflation / deflation device used to inflate and deflate angioplasty balloons during angioplasty) capable of providing at least 3.4 psi and having a gauge capable of measuring pressure inside the tube to within 0.05 psi at such pressures.

[0024] The OD of the stent and the OD of a reference section of the simulated vessel away from the stented section are both measured using a non-contact system at a distance from the stent equal to or twice the diameter of the simulated vessel, and at a similar distance from any fixture holding the simulated vessel. These OD measurements are taken and averaged to obtain a baseline simulated vessel OD value. These OD measurements are taken centered around the mid-length of the scaffold and averaged to obtain a baseline scaffold OD value. The interior of the simulated vessel is pressurized with water to 3.4 PSI (176 mmHg), and the ODs of the scaffold and simulated vessel are measured at the same location used to establish the baseline using a non-contact system while the pressure reading is maintained at 3.4 PSI. Composite compliance is determined by dividing the OD value measured when the simulated vessel is pressurized by the baseline OD value, subtracting 1, and multiplying by 100 to determine composite compliance as a percentage.

[0025] For example, if applied pressure in a simulated vessel causes the OD of a test scaffold to increase in diameter from 3.50 mm OD to 3.73 mm OD, the composite compliance is ((3.73 / 3.50)-1) x 100 = 6.6%. As a second example, if applied pressure in a simulated vessel causes the OD of a test scaffold to increase in diameter from 3.50 mm OD to 3.52 mm OD, the composite compliance is ((3.52 / 3.50-1)-1) x 100 = 0.6%.

[0026] The composite compliance of the scaffold can be measured before and after the opening of the separation regions to form discontinuities. To obtain the composite compliance before the formation of discontinuities, the scaffold is measured as described above, while all separation regions remain intact. To obtain the composite compliance after the formation of discontinuities, the scaffold is treated to open all discontinuities, while the scaffold remains on the simulated 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 discontinuities without damaging the simulated blood vessel. Alternatively, for non-polymeric separation regions, the separation regions may be physically separated using mechanical means, a laser cutter, ultrasound, or other energy-based cutters to form the discontinuities. For locking designs or separation regions that open in response to fatigue, the simulated artery can be cyclically pressurized at a rate of 5-8 Hz until discontinuities form. See Example 5 and Figure 35. If the scaffold collapses while the separation region is open, the composite compliance will be considered equal to the simulated vessel compliance without the scaffold.

[0027] Radial strength (crush resistance) is measured using parallel flat panels (reference ISO 25539-2) mounted on an Instron tensile testing machine with a 5 N load cell to allow for force and displacement measurements. The bottom plate is flat and remains stationary during testing. The top plate is mounted on a load cell to record force measurements as a function of displacement. The plates are visually verified to be parallel to each other at the mating surface. Both the bottom and top 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 body temperature water bath, maintained at 37 ± 2°C by a circulating heater. The circulating pump is turned off during force measurements to prevent electrical current from altering the results. The top plate is made of Delrin, and the bottom plate is made of brass.

[0028] The test scaffold is deployed at its nominal inner diameter using a standard indeflator 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 at 37°C, mimicking physiological conditions. The mandrel will prevent the test stent from rolling upon initial contact with the parallel plates. The top plate is then slowly pushed downward using the displacement controller from an Instron tensile tester until it is approximately 1 mm above the stent and the force meter is set to zero. It is then lowered until it just barely touches 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 initiated, and the crush resistance is then measured by reducing the distance between the parallel plates by up to 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 the stent deformation (compression) is determined in Newtons. For example, for a 3.0 mm labeled stent expanded 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 Newtons (N) is then divided by the expanded stent length in mm to normalize the strength in N to the stent length; therefore, the radial strength of the stent is expressed as N / mm of stent length.

[0029] The expanded stent baseline radial strength is measured (in N / mm of stent length) and again after the formation of discontinuities (if applicable) as described in the crush resistance method. For stents of the present invention, the radial strength is reduced after the formation of discontinuities compared to the baseline radial strength before the formation of the discontinuities, preferably by a value in the range of 10% to 100% of the baseline radial strength.

[0030] The above protocol for measuring composite compliance and radial strength is particularly effective for measuring these values ​​in scaffolds with a nominal diameter of 2 mm to 4 mm and with proprietary or conventional deployment systems. For stents, valves, prostheses, and any other scaffolds with other sizes and deployment systems, including non-standard sizes and deployment systems, the scaffold should be deployed according to the manufacturer's published instructions, and the test apparatus should be adjusted or modified to have an identical fit with the deployed scaffold, as described above. For simulated vessels for measuring composite compliance, the outer diameter of the simulated vessel should be equal to or up to 0.1 mm larger than the inner diameter of the deployed scaffold. For flat-plate separation distance measurements for crush resistance, the scaffold OD should be measured via a non-contact method with an accuracy of ±0.01 mm, and a 10% deviation should be calculated from this measurement. All other parts of the test method should be followed as closely as possible.

[0031] In preferred embodiments, the scaffolding of such an endoluminal prosthesis may separate into segments after discontinuities are formed in the circumferential rings. The separation may be along axial, circumferential, helical, irregular, or other lines. For example, two, three, or more segments may separate along axial, helical, or irregular lines, allowing the segments to radially expand and contract, increasing the composite compliance of the scaffold when implanted in a body lumen. In many cases, all or substantially all of the segments will remain axially joined along their entire length (or along the entire stent length) so that the structural elements of the scaffold remain axially joined and provide support (or scaffolding) to the lumen (or vessel) wall, and / or reduce the risk that the elements will become dislodged or otherwise released after implantation in the vasculature or body lumen. Other examples of segments include closed-cell segments and the like. In such preferred embodiments, the scaffold (endoluminal prosthesis) forms a tubular body in a crimped and / or expanded configuration, and the scaffold may be formed from a wire, a substantially continuous tube, a sheet, a molded or by printing.

[0032] In other embodiments and / or examples, the scaffolding will not separate into sections. That is, while at least one, and typically multiple, 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 portion (or element) of the scaffold is completely disconnected from any other portion of the remainder of the stent. Such physical connection of all portions of the scaffold, even after discontinuities are formed, can be advantageous because it reduces the risk of any portion of the scaffold being released into the vasculature or other body lumen.

[0033] In one particular example, discontinuities in adjacent circumferential rings may separate along an axial line such that the stent divides into two or more axially aligned segments, each extending from a first (usually distal) end of the scaffold to a second (usually distal) end of the scaffold. Such axially aligned segments of individual circumferential rings separate circumferentially along axial (usually straight), helical, or irregular separation lines, but remain axially joined (e.g., by one or more axial links) or intact after all discontinuities are formed. Such intact axial, helical, or irregular segments will typically have a length corresponding to the overall length of the scaffold in its expanded configuration, elongating.

[0034] Such elongated axial, helical, or irregular sections will usually be completely separated along their entire length, although in other cases, one or two circumferential connections may remain after all discontinuities have been formed in the scaffold. Specifically, elongated sections may remain spliced ​​at either or both ends of the scaffold to reduce "dog-boning" or for other purposes.

[0035] In some examples, the circumferential rings of the scaffolds of the invention may have a continuous perimeter or circumference, usually a circular perimeter, in which case adjacent consecutive rings are typically joined by axial links or by direct connections, e.g., by welding, fusing, tying, gluing, or otherwise adhering crowns together on adjacent circumferential rings. In other cases, at least some of the circumferential rings may have discontinuous perimeters, with end regions joined to form a helical scaffold. In specific examples and embodiments, the axial links will be comprised of a 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 a unitary or monolithic structure from the same metal, metal alloy, or other material that forms the stent.

[0036] Exemplary endoluminal 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 similar or identical structures, e.g., multiple struts joined by crowns in a similar or identical pattern (although they may have one or more variations in structure, pattern, and structural elements (thickness, width, shape), etc.). Separation regions may be located within the struts, the crowns, or both. Often, at least one separation region will be located within a strut, and at least one to five struts within a ring will have a separation region. Alternatively, or in addition, at least one separation region may be located within a crown, and one to five crowns within a ring may have a separation region. However, often, most or all crowns will not include separation regions because the crown or crown region will be highly stressed as the scaffold is radially expanded by balloon inflation or otherwise from a crimped configuration to an expanded configuration. Such high stresses can result in the premature formation of discontinuities in the scaffold and loss of the scaffold's structural integrity. Struts are therefore preferred locations for the formation of separation regions. Separation regions may also be formed in axial links or other regions of direct axial connection between adjacent circumferential rings. Separation regions in axial connectors between adjacent rings typically will not contribute to the radial compliance of the ring or stented section or affect the radial strength of the ring or scaffold after the formation of the discontinuity, and are therefore optional; in many cases, the axial link and axial connector regions will remain intact, without including discontinuities. Thus, in many embodiments of the present invention, the scaffolding comprises or consists of multiple axially connected circumferential rings, and the rings include or consist of struts connected by crowns, where separation regions are formed only in the struts and not in the crowns (or crown regions) or axial links or other axial connector regions.The placement of separation regions within the circumferential rings, e.g., within the struts and / or crowns, has the advantage of providing the ability to modify the circumferential properties of the stent at various times after implantation. The circumferential arrangement of rings makes the ring structure important for various stent properties, such as radial strength (flat plate), composite compliance of the stented section, further expansion to larger diameters after implantation, and response to vascular dilation, to name a few. For example, the placement of separation regions within the circumferential ring structure provides the stent with modified and improved properties after discontinuities form after implantation. The needs of a luminal stent are inherently time-dependent and differ at different times. For a short period of time after implantation, the stent is required to have high radial strength to support the vessel in an open state, and then, over the next period, after tissue remodeling and healing has begun or completed, the requirement for high stent strength to hold the vessel open is no longer necessary; in contrast, having high strength may compromise the physiological function of the vessel. Current non-degradable (non-corroding) stents, such as stainless steel alloy stents, cobalt-chromium alloy stents, and platinum-iridium alloy stents, address the vessel's immediate initial high radial strength, but they typically do not respond to changing vessel requirements over time after implantation; the vessel no longer requires high radial strength to keep it open. Having such high radial strength maintained over time can irritate the vessel, leading to further progression of disease or poor healing. Stents, preferably made from non-degradable materials (stents can also be made from degradable materials) with separate regions within the stent rings that form discontinuities in the circumferential rings after implantation, provide the stent with modified and improved properties after the discontinuities are formed after implantation. Such stents of the present invention are configured to provide high initial radial strength after expansion, which then decreases over time after implantation, helping to address the vessel's physiological needs while keeping the vessel open.Similarly, current non-degradable stents typically have low composite compliance in the stented section that "confines the vessel" over the life of the stent, inhibiting the vessel's natural vasomotion, inhibiting the vessel's ability to respond to vasodilators, or preventing the stented section from further expanding to a larger diameter after implantation. Stents of the present invention, which have discontinuities formed in the circumferential rings after implantation, may be configured to have a higher (or increased) composite compliance after expansion, allowing the stented section of the vessel to respond to natural fluctuations in blood pressure (vasomotion), allowing the stent (or stented section) to further expand after initial expansion (and inward recoil, if applicable), and maintaining the vessel's ability to respond to vasodilators. Stents of the present invention may be configured to have increased composite compliance in the stented section immediately after expansion or after a longer period of time after implantation.

[0037] There are advantages to placing separation regions within the struts, including that they are typically lower-stress areas of the rings and therefore undergo less plastic deformation than the crowns. The location and size of the struts also typically provide additional options for more types of separation regions because they are larger and have less torque than certain other areas of the stent, such as the crowns or other curved regions of the rings. The struts can typically accommodate more variations within them (such as having separation regions) without reducing 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 is expanded, allowing for a separation region design configured to utilize strut angles prior to deployment that hold the separation regions together in response to stent expansion, releasing the struts to an angle in the expanded stent configuration that allows for the desired direction of movement of the separated strut elements, such as radial, circumferential, and / or axial movement.

[0038] There may be advantages to having a separation region within the crown. As the ring expands or contracts, the crown typically experiences high bending moments (torque), causing high stress and plastic deformation. Joint elements that can withstand high moments (torque) can be advantageously used in the crown region. Deployment motion within the crown region causes rotation between adjacent struts. Joint elements that function to prevent this rotation, for example through ball-and-socket joints or other joints as described throughout this application, can reduce ring stiffness while maintaining intimate contact between the separate regions of the ring so that it maintains an overall "tubular" shape that conforms to the lumen even after separation. Having a separation region within the crown can achieve higher composite compliance, as may be desired in certain applications. Additionally, having a separation region within the crown may enable the use of other materials that would not be suitable for stent applications due to their limited mechanical properties, such as elongation or brittleness, and the separation region within the crown may allow the ring to expand without fracture.

[0039] In the exemplary endoluminal prosthesis, the struts may be joined by crowns to define an angle therebetween, typically referred to as an "included angle." The included angle while the scaffold is in the crimped configuration will typically be small, or even negative at times. The included angle will increase as the scaffold expands from the crimped configuration to the expanded stent configuration. Typically, the included angle in the crimped configuration of at least some of the struts joined by crowns ranges from -25° to +25°, more usually from -15° to +55°. The included angle in the expanded configuration typically ranges from 35° to 180°, more usually from 45° to 150°. When present in a strut, a separation region can be located anywhere along the length of the strut, typically located in or about the center of the strut, and typically bisects the strut. Similarly, when present in a crown, the separation region can be formed at a point on the crown, typically centered about the center of the crown, e.g., a location that bisects the crown, which is typically semicircular. In a preferred embodiment, the separation region in at least one strut is a preformed break (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, sizes, and patterns configured to have uniform stent expansion and / or maintain the structural integrity of the stent upon expansion. The at least one bisected strut (separation region) is typically held together by one or more materials, as described throughout this application.

[0040] In preferred embodiments, at least some of the separation regions are located on or within "low stress regions" of at least some of the circumferential rings, i.e., regions such as strut regions, that experience less stress as the scaffold is expanded, either by a balloon or by self-expansion. As the scaffold expands from a crimped configuration to an expanded configuration, low stress regions such as struts will experience less stress than high stress regions such as crowns, which deform as a result of concentrated stress as the scaffold radially expands. In certain embodiments, at least some of the circumferential rings, each having one or more separation regions, have initial strength in response to expansion of the stent in a physiological environment, and the initial strength of at least some of the circumferential rings decreases after discontinuities form. In preferred embodiments, one or more separation regions are preferably located within the struts, which experience reduced (or minimal) stress as the scaffold is expanded from a crimped configuration to an expanded configuration, thus promoting the structural integrity of the scaffold during expansion by preventing all or substantially all of the formation of discontinuities during expansion.

[0041] The separation region in the scaffold of an endoluminal prosthesis may take various forms. For example, the separation region may comprise a preformed break or gap in the crown region and / or strut region, thereby bisecting the crown and / or strut structural element into two distinct sections joined by, coated with, or embedded in a material that will degrade in a physiological environment, typically a degradable polymer, but sometimes a degradable metal or metal alloy; many specific examples are described in detail below. The degradable material, comprising one or more materials, can be provided in various forms and geometries, including sleeves, coatings, solders, adhesives, laminates, and the like, which 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. In some examples, at least one surface, most, or all of the separation region surface or scaffold surface can be coated or laminated with a degradable material. In preferred embodiments, the material fills the space between the opposing surfaces of the separation region and the abluminal stent and the luminal surface, acting as an adhesive, glue, or attachment element to hold the surfaces together and maintain the structural integrity of the stent upon stent expansion. In other cases, the degradable material can be located only on or within the separation region, optionally a short distance on either side of it, e.g., 2 mm, 1 mm, 0.5 mm, or the like. In yet other embodiments, the non-degradable material comprising one or more non-degradable materials can be additionally applied to at least one separation region surface and / or additionally applied to at least one stent surface and / or additionally applied to all separation region surfaces and / or additionally applied to all stent surfaces. The non-degradable material can be applied before or after the degradable material. In preferred embodiments, the degradable and / or non-degradable material disposed on the non-degradable stent is a polymeric material.In another embodiment, the polymeric material (degradable and / or non-degradable) contains at least one drug, which may be coated onto at least one surface of the stent, preferably to cover at least the abluminal surface of the stent.

[0042] In certain embodiments, the degradable material can be applied by spray coating, dip coating, sleeve encapsulation, printing, soldering, adhering with 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 separated regions together and immobilize adjacent structural elements in the separated regions during expansion of the stent or other prosthetic scaffold from a crimped configuration to an expanded configuration in a physiological environment. The degradable material usually degrades after expansion of the stent from a crimped configuration to an expanded configuration. The degradable material may have a thickness that is substantially the same as the thickness of adjacent regions of non-degradable structural elements, i.e., the degradable material will fill gaps or other spaces between adjacent structural elements but will not extend across these adjacent regions. However, in other embodiments, the degradable material may have a thickness adjacent to the separation region ranging from 5 μm to 30 μm thicker than the thickness of the non-degradable structural element adjacent to the separation region, and may extend across the adjacent region, may extend across or cover at least one surface of the stent, or may cover all stent surfaces. The degradable material thickness may be substantially the same for all separation regions, or may have different thicknesses, for example, to control the timing of discontinuity formation.

[0043] In preferred embodiments, the degradable material coats the non-degradable structural elements of the stent substantially uniformly, i.e., has substantially the same thickness across substantially all abluminal surfaces of the structural elements and has the same thickness along substantially all luminal surfaces of the structural elements, although the degradable material can also have different thicknesses along different surfaces of the scaffolding structural elements. Typically, the coating or other covering over the abluminal and / or luminal surface regions of the scaffolding structural elements ranges from 3 μm to 50 μm, more usually from 5 μm to 30 μm. The degradable material may cover and / or fill only the discrete regions, cover and / or fill the discrete regions and surfaces of adjacent structural elements, cover and / or fill the discrete regions and surfaces of adjacent structural elements and adjacent rings, or cover the entire stent and fill all of the discrete regions.

[0044] Some or all of the separation regions can be configured to form discontinuities at approximately the same time or at different time periods, as described elsewhere herein. In preferred embodiments, the degradable material degrades after a period ranging from 1 month to 2 years after implantation, preferably ranging from 2 months to 1 year after implantation, and more preferably ranging from 3 months to 9 months after implantation.

[0045] In another preferred embodiment, a non-degradable scaffold having separate regions held together by at least one degradable material has an initial average stent volume (or area) after expansion, and if applicable, after initial inward recoil after expansion, which average area (or 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 is 0.75% to 0.90% of the initial average stent volume (or area), substantially the same (maintained) initial average stent volume (or area), or an increased average stent area (or area).

[0046] In another example, a non-degradable scaffold (or stent) or other prosthesis comprises a plurality of circumferential rings having one or more separate regions along the path of each of the circumferential rings. The scaffold has sufficient initial strength to maintain the average stent area (or average stent volume) after expansion and (if applicable) after initial inward recoil, and the scaffold after formation of discontinuities exhibits a decrease in said initial strength while substantially maintaining or increasing the average stent area (or average volume) in a physiological environment. Such non-degradable scaffolds will typically have degradable materials that are stretchable (elastic), usually sufficiently stretchable (elastic) to hold structural elements adjacent the separate regions together in response to expansion of the scaffold, and / or that can be sufficiently stretchable (elastic) to allow the scaffold or scaffold segments to adapt or respond to vasomotion or vasodilation after deployment, or after deployment and before degradation of the degradable material, or after degradation of the degradable material. In such embodiments, the stent or other prosthesis may accommodate (or exhibit) an increase in diameter (or change in diameter) within one or more scaffolding sections (or within the stented section) upon use of a vasodilator or application of a pressure change of approximately 180 mmHg. Such a change in diameter may range from 0.05 mm to 0.5 mm, more typically 0.7 mm to 0.4 mm, after expansion under physiological conditions. In another embodiment, the elastic material adjacent to (including within, on, or around) at least one or more separation regions is a non-degradable material, such as a polymeric material, such as a polyurethane material. In preferred embodiments, the non-degradable material has sufficient strength to contain the separation regions together upon initial deployment of the stent from a crimped configuration to an expanded configuration, and the elastic non-degradable material allows the one or more rings or stented sections to further expand and / or contract under physiological conditions after initial expansion of the stent and / or after formation of discontinuities.

[0047] In yet another example, the separation region may comprise an elastic material disposed in, on, and / or adjacent to gaps, spaces, or other discontinuities formed in the structural elements of the ring, typically the struts 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 the ring to expand, and in some cases, contract, to increase radial compliance under physiological conditions. In some examples, such expansion joints will be immobilized by a bioabsorbable material in the form of a coating, sleeve, adhesive, or any other form as described elsewhere herein that connects, bonds, or holds adjacent separated regions of the scaffold together while the scaffold is deployed. In other examples, one or more expansion joints will not be immobilized, and the elastic material will provide sufficient strength to remain intact during expansion 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 expansion or other expansion by means such as degradable materials.

[0048] In still other exemplary embodiments, the separation region may comprise a "key and lock" junction configured to be immobilized during expansion but separate after initial expansion in a physiological environment. In some cases, the key and lock junction may have a comb-like interface that allows separation in the circumferential and / or radial directions but prevents separation in the axial direction. In other cases, the key and lock junction will have a smooth or linear interface that allows separation in the circumferential, radial, and / or axial directions. In other cases, the key and lock junction has a non-linear interface region, such as a "serrated," "V-shaped," "U-shaped," inverted "V," inverted "U," or other surface region interface, and such non-linear surface region interface 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, and widths. Such key and lock junctions are typically configured to be immobilized during expansion but to separate after initial expansion in a physiological environment, e.g., coated with, embedded in, or joined to a degradable material such as a biodegradable polymer.

[0049] In still other embodiments, the separation regions of the present invention may comprise butt joints that are joined by, coated with, or embedded in a material that degrades in a physiological environment.

[0050] The scaffold of the endoluminal prosthesis of the present invention will comprise a non-degradable material, typically a metal or metal alloy material. Discontinuities formed in the metal scaffold will allow the scaffold to further expand after recoil from initial expansion. The discontinuities will also typically allow the scaffold to further expand to an expanded diameter larger than the initial expanded diameter.

[0051] In some embodiments and examples, the circumferential rings may be substantially perpendicular to the longitudinal axis of the scaffold in the expanded and / or crimped configuration. In other embodiments and examples, the circumferential rings may be inclined at an angle relative to the longitudinal axis of the scaffold in one or both of the expanded and crimped configurations. In still further examples and embodiments, successive circumferential rings will be joined end to end in a continuous helical pattern, with each ring defining a single turn of the helix.

[0052] In another aspect or embodiment, the invention provides a variably flexible stent (or controllably or increased-compliance stent), scaffold, or other luminal or valvular prosthesis comprising a non-degradable metal or metal alloy scaffold, such as cobalt-chromium alloy, platinum-iridium alloy, and stainless steel alloy, that is expandable from a crimped configuration to a larger expanded configuration. The scaffold preferably has sufficient strength to support the vascular lumen after expansion for at least a period of time after expansion (or implantation) sufficient for the vessel to heal, and / or for at least a period of time after expansion when the risk of further or additional vascular lumen inward recoil (after any initial inward recoil of the stent after initial expansion) has subsided or is reduced, and / or for at least a period of time ranging from 30 days to 6 months after implantation, and / or for at least a period of time 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 initial strength is sufficient to support a body lumen, and the stent is expanded in air or under physiological conditions (such as water at 37°C), and then, under physiological conditions, the initial strength decreases to a second strength lower than the initial strength, preferably within a period ranging from 3 days to 6 months, and 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 degradation of the non-degradable metal or non-degradable metal alloy. The second, lower intensity, in some embodiments, ranges from 10% to 100% of the initial intensity, or from 10% to 90% of the initial intensity, or from 20% to 80% of the initial intensity, or from 30% to 60% of the initial intensity.In some other embodiments, the stent has an initial strength after expansion (or immediately after expansion, or within one hour after implantation (expansion), or within two hours after implantation), which initial strength is sufficient to support a body lumen, and the stent is expanded in air or under physiological conditions, and then the initial strength under physiological conditions increases to a first strength that is typically 5% to 50% greater than the initial strength, preferably 10% to 30% greater than the initial strength, and the first strength is increased after the initial strength (or after initial strength measurement after implantation (expansion), or within one hour after implantation). The initial strength increases to a first, higher strength under physiological conditions, and then the first strength decreases to a second, lower strength under the same or similar physiological conditions, preferably within a period ranging from 15 days to 9 months. Preferably, the first strength decreases to a second, lower strength (lower than the initial strength) within a period ranging from 30 days to 6 months (or within a period ranging from 60 days to 6 months). The decrease in strength to the second strength occurs without degradation (mass loss) of the non-degradable metal or metal alloy. In some embodiments, the second, lower strength is 10% to 100% of the initial strength, 20% to 85% of the initial strength, or 30% to 65% of the initial strength. Immediately after deployment (or expansion), the scaffold has a composite compliance as measured in a simulated blood vessel (or thin tube) of as much as 1%, typically as much as 0.7%, often as much as about 0.5%, typically in the range of 0.1% to 1%, and usually 0.2% to 0.5%. After expansion under physiological conditions (including simulated physiological conditions) or exposure to vascular conditions, the composite or stent compliance as measured in the simulated blood vessel will increase to at least 1.2%, often at least 1.5%, and sometimes 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 vessel may increase by at least two-fold, often at least three-fold, and sometimes at least four, five, ten-fold, or more, compared to the initial composite compliance when measured in the simulated vessel.

[0053] Such variably flexible stent prostheses can have a variety of specific design features that provide variable compliance. As described in more detail below, for example, a stent prosthesis comprising a non-degradable metal or metals can enable a scaffold with separated regions that separate or form discontinuities after exposure to vascular conditions for a threshold time. For example, some of the separated regions can be initially prevented from separating by a bioabsorbable material that degrades over time when 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 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) together. The bioabsorbable material can degrade over a time period ranging from 30 days to 3 years, often 3 months to 2 years, and more often 3 months to 1 year, when exposed to vascular conditions. For purposes of determining whether a stent satisfies these conditions, the stent can be exposed in vitro to vascular conditions (physiological conditions), as defined elsewhere herein, intended to mimic those conditions experienced when implanted in a human vessel or lumen. It can also be tested after in vivo vascular conditions. It can also be tested using in vitro tests under physiological conditions, as described herein. In some other embodiments, the 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 with another material (such as a degradable material or other non-degradable material) in response to 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, or within 24 hours after expansion, by expanding one or more stent sections (or rings or stented sections) containing the elastic material.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 desired radial strength, and / or controls other mechanical properties of the stent. The stent can additionally include one or more rings (the same or different rings containing separate regions containing a non-degradable elastic material) containing one or more separate regions, with one or more additional separate regions containing a degradable material (such as a degradable polymeric material). One or more separate regions containing a non-degradable material typically prevent discontinuities from forming after expansion in a physiological environment, but allow the ring containing the separate region (or stent segment) to have the desired compliance, or allow further expansion after initial recoil after initial expansion, or allow the stented segment (or one or more rings) to respond to a vasodilator due to the stretch or elasticity of the non-degradable material. In yet another example, all or substantially all of the separation regions on one or more rings (or all of the separation regions contained on a stent) comprise a non-degradable material that 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 vasodilators due to the stretch, elasticity, and / or other material properties of the material.

[0054] 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 for a threshold time period, as described above or elsewhere. The reinforcing material may comprise a bioabsorbable material that degrades over that 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 cover or coat at least a surface region of the non-degradable metal or metal alloy scaffold.

[0055] In addition to exhibiting variable compliance, as described above and / or elsewhere, the variably flexible stents of the present invention will exhibit sufficient radial strength after expansion and implantation to hold the vessel lumen open and to inhibit or prevent vessel recoil after the initial recoil after initial expansion over some minimum threshold of time, typically at least 30 days, more typically at least 60 days, and often at least 90 days or longer. Typically, for example, for coronary stents, the stent strength (or initial stent strength of an expanded stent) measured using, for example, a 10% flat plate compression test will preferably be in the range of 0.030 Newtons per millimeter of stent length to 0.14 Newtons per millimeter of stent length, particularly 0.04 Newtons per millimeter of stent length to 0.1 Newtons per millimeter of stent length, and often 0.05 Newtons per mm of stent length to 0.1 Newtons per millimeter of stent length, when such stent strength is measured using a flat plate 10% compression after the stent has been expanded to its nominal stent expanded diameter. Typically, but not necessarily, the radial strength of the stent (scaffolding) will decrease after expansion and exposure to vascular conditions as the composite compliance increases from the initial composite compliance (in some other embodiments, the initial composite compliance decreases before increasing) (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 (or corresponding to, or at a similar time, or simultaneously, or nearly simultaneously) with the increase in radial compliance. In most cases, the radial compliance and radial strength of the expanded stent will vary inversely proportional to one another.In many cases, the radial strength of the stent scaffolding will typically decrease within a range of 20% to 100% of the initial radial strength measured immediately after expansion or immediately after expansion and exposure to vascular conditions (such as within 1 hour after expansion), sometimes within a range of 20% to 80%, or in some cases the initial radial strength of the expanded stent will increase before decreasing substantially to or to a strength less than the initial strength, while compliance increases from the initial compliance after implantation in physiological conditions, or in some other cases the initial radial strength of the expanded stent will be substantially maintained, while compliance increases from the initial compliance after expansion in physiological conditions.

[0056] In a particular example or embodiment of a variably flexible stent, the non-degradable metal or metal alloy scaffolding has a nominal expanded diameter (the diameter to which the stent or other scaffolding is intended to be expanded by a balloon), and both the strength and composite compliance are measured after the stent is expanded to a diameter that is 80% to 120% of the nominal expanded diameter. More typically, the strength and composite compliance will be measured after the stent is expanded to 100% of the nominal extended diameter.

[0057] In other embodiments, a stent has sufficient strength to support a body lumen after deployment to an expanded configuration and has an inward recoil of 1% to 10% after deployment, the stent exhibits a compliance of 1% or greater than 1% after deployment, and / or if the stent has sufficient strength to support a body lumen after deployment, has an inward recoil of 1% to 10% after deployment to an expanded configuration, and then the stent exhibits an outward recoil of 3% to 20% after deployment and after said inward recoil under physiological conditions or with the use of a vasodilator.

[0058] In some other embodiments, the composite compliance magnitude 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, more preferably from 0.1 mm to 0.4 mm. Such magnitude of diameter change is measured in one or more of the stented segment, or the average of the stented segment, or preferably in a region centered around the center of the stented segment.

[0059] In another embodiment, the outward recoil magnitude 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.

[0060] In another aspect or embodiment, the present invention provides polymeric prostheses with reinforcing elements, and methods for their use and fabrication. The endoluminal prosthesis comprises a circumferential scaffold patterned from a biodegradable polymer and having an expanding region that deforms as the circumferential scaffold expands from a small diameter configuration to a larger diameter configuration. In one embodiment, the endoluminal prosthesis of the present invention may comprise a coronary stent prosthesis. In another embodiment, the endoluminal prosthesis of the present invention may comprise a vascular stent prosthesis. In yet another embodiment, the stent prosthesis is a non-vascular stent prosthesis. The reinforcing elements are bonded to at least some regions of the circumferential scaffold to strengthen the circumferential scaffold after the scaffold is expanded to the larger diameter configuration. The reinforcing elements are preferably deformable and can be degradable (including erodible or erodible) or non-degradable (including non-erodible and non-erodible). In particular, the reinforcing elements may be malleable or elastic, may comprise metals and metal alloys, may comprise polymers, or may be formed completely or partially from other materials that have mechanical properties capable of reinforcing the expansion region and / or other structures of the stent prosthesis, as described below or herein.

[0061] The circumferential scaffold, in one example, will typically comprise a type of stent scaffolding patterned from a tube or cylinder formed entirely or partially from a 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 many techniques known in the art for forming stents from polymers, such as laser cutting, photolithography, three-dimensional printing, stereolithography (SLA), and the like. The expansion regions will typically comprise joints, hinges, crowns, curves, bends, and / or deformable features or structures or structural elements that may be joined to adjacent struts, beams, or other less deformable or non-deformable features or structures or structural elements such that as the diameter of the circumferential scaffold is expanded (or increased), the expansion regions open up and increase the angle between adjacent less deformable or non-deformable regions or structural elements, e.g., struts. Stents can also be formed from wires (solid or hollow) or fibers and can be patterned or braided.

[0062] Reinforcing elements may be provided to improve the stiffness, crush strength, crush resistance, radial strength, hoop strength, or the like, of the circumferential scaffold, for example, in response to or after the scaffold is expanded from a crimped configuration to a larger diameter configuration. Specifically, one or more reinforcing elements may be coupled to one or more expanded regions and / or other regions, such as struts and / or links, on the circumferential scaffold to promote such strength, specifically as measured by, for example, a "plate" or "flat plate" test, as commonly known in the art, in which the circumferential scaffold is placed between parallel spaced plates and the force required to reduce the expanded scaffold diameter by a predetermined amount (or a % such as 10% compressive force (N) or N / mm normalized to stent length) is measured. Other types of tests that measure radial strength can also be utilized (e.g., measured in psi) as commonly known in the art.

[0063] Most generally, in another embodiment, reinforcing elements will be bonded to joints, hinges, crowns, bends, or other expansion regions such that at least some of such expansion regions are better able to resist closure forces (or crush resistance forces) after expansion or release than without the addition of the reinforcing elements. It will be understood that the expansion regions will undergo deformation as the circumferential scaffold is expanded, and the presence of the reinforcing elements will open along with the expansion regions such that, once released, the reinforcing elements will assist the scaffold in resisting closure forces exerted by a blood vessel or other body lumen or body lumen lesion in which the scaffold is implanted. In addition to the deformable expansion regions, the circumferential scaffold will also typically include non-deformable or less-deformable regions that usually retain or substantially retain their shape as the circumferential scaffold is expanded. Reinforcing elements may also be bonded to at least some of these non-deformable or less-deformable regions. In many examples or most embodiments, the expansion regions will be curved joints, hinges, crowns, bends, or the like, as described above, while the non-deformable regions will typically be struts, straight struts, or other normally linear elements of the scaffold, but may sometimes have nonlinear or other shapes, such as wave-shaped, S-shaped, M-shaped, V-shaped, wavy linear, or wavy nonlinear, and U-shaped. Typically, expansion of the circumferential scaffold of an endoluminal prosthesis will be achieved by an inflatable balloon or other conventional device, but in other cases the circumferential scaffold may be fabricated from an elastic polymer or other material and may be self-expanding, where expansion is achieved by release of the circumferential scaffold from constraints.

[0064] In one embodiment, the reinforcing element increases the stiffness or strength of the reinforced region, reinforced ring or expansion region, and / or the stent.

[0065] In another embodiment, the reinforcing element increases the strength of at least one region of the stent by 15% to 100%, preferably by 25% to 150%, and more preferably by 25% to 200%.

[0066] In another embodiment, the reinforcing element increases the strength of the stent by 0.015 N / mm to 0.035 N / mm of stent length, preferably by 0.015 N / mm to 0.05 N / mm of stent length, and more preferably by 0.015 N / mm to 0.09 N / mm of stent length, when measured using a flat plate test 10% compression. For example, a 0.015 N / mm strength for a 3.0 mm stent (e.g., using the flat plate test method) x 28 mm stent length is equal to 0.015 N / mm x 28 mm (stent length), which is equal to a 0.42 N strength.

[0067] In another embodiment, a stent having reinforcing elements 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, and more preferably from 0.025 N / mm to 0.09 N / mm of stent length, when measured using a flat plate test at 10% compression. For example, a strength of 0.03 N / mm of stent length for a 3.5 mm diameter stent (e.g., using a flat plate test) times 18 mm of stent length is equivalent to 0.03 N / mm times 18 mm of stent length, which is equal to 0.54 N.

[0068] In another embodiment, the reinforcing element increases the initial inward recoil (or recoil after expansion or recoil after deployment) or decreases subsequent inward recoil (recoil after implantation, or recoil after completion of the procedure, or recoil within 30 days after implantation, or recoil within 6 months after implantation, or initial recoil after implantation and recoil after a 6-month time period, or initial recoil after implantation and recoil after 1 day, or recoil after implantation and recoil after 30 days).

[0069] In another embodiment, the reinforcing element reduces the inward recoil of the stent after implantation by a range of 1% to 10%, preferably by a range of 1% to 7%, and more preferably by a range of 1% to 5%. In another embodiment, the reinforcing element reduces the subsequent inward recoil of the stent by a range of 0 to 5%, preferably by a range of 0 to 3%, and more preferably by a range of 0 to 2%, at various time points discussed.

[0070] In another embodiment, a stent having reinforcing elements has an inward recoil after expansion or deployment ranging from 1% to 10%, preferably ranging from 1% to 7%, more preferably ranging from 1% to 5%. In another embodiment, a stent having reinforcing elements has a subsequent inward recoil at various times discussed ranging from 0 to 5%, preferably ranging from 0 to 3%, more preferably ranging from 0 to 2%, and most preferably, the stent has substantially zero inward subsequent recoil (or the stent substantially maintains its initial recoil after implantation).

[0071] In another embodiment, at least some reinforcing elements are coupled to at least some expanded regions on at least some rings of the stent, and the stent expands from a crimped configuration to a larger expanded configuration, and the reinforcing elements provide sufficient strength to support the body lumen in the expanded stent configuration.

[0072] In one example, the reinforcing elements may be coupled to the circumferential scaffold in a variety of patterns. The reinforcing elements may be attached to some or all of the expansion regions, but not necessarily to any of the non-deformable or less-deformable regions. Specifically, the reinforcing elements may be attached to one, two, three, or more of the expansion regions of the scaffold or scaffold ring. In some examples or embodiments, the reinforcing elements are attached to all of the expansion regions of the scaffold or scaffold ring, and in other preferred examples or embodiments, the reinforcing elements are attached to all but one of the expansion regions of the scaffold or scaffold ring. In other examples or embodiments, the reinforcing elements may be attached to both expansion regions and to some or all of the non-deformable or less-deformable regions. In other examples or embodiments, the reinforcing elements may be attached to at least some of the expansion regions that extend at least partially into the non-deformable or less-deformable regions. In other examples or embodiments, the reinforcing elements 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 less-deformable regions. In other examples or embodiments, the reinforcing elements may be attached to at least some of the expansion regions, extending substantially the entire length of the non-deformable or less-deformable regions. The reinforcing elements may be embedded (fully or partially) into the material of the circumferential scaffold, for example, embedded into at least some of the expansion regions (or embedded into any of the surface regions of the expansion regions, such as the abluminal surface region, the luminal surface region, and / or the lateral region). Alternatively, the reinforcing elements may be attached or otherwise positioned on the scaffold such that they are at least partially located on the exterior of at least some of the expansion or non-deformable regions in another example.

[0073] The reinforcing elements can be bonded to the stent prosthesis (including or comprising being embedded, attached, or disposed thereon) after the stent has been patterned, and bonding of the reinforcing elements to the patterned stent region can be accomplished by various methods, such as pressing the reinforcing elements onto the stent or stent region, creating or preforming grooves or spaces or slots by various means such as laser or mechanical or chemical means and then pressing the reinforcing elements onto the stent or stent region, partially dissolving or softening the pressed-in or inserted material to contain the reinforcing elements, and / or adhesively attaching the reinforcing elements to the patterned structure surface or region (such as a polymeric structure), to name a few. Alternatively, the reinforcing elements can be bonded to the stent prior to patterning, such as by bonding the stent to a tube (such as a polymeric tube) on which the pattern will be formed, and the tube and reinforcing elements are patterned together (or separately) to form the patterned stent using the methods discussed above and / or throughout this application, as well as patterning means discussed herein, such as laser patterning. The reinforcing elements can also be formed using, for example, a tube (such as a polymeric tube) using dipping, spraying, or molding to form the stent, or the reinforcing elements can be one or more wires (solid or hollow) that are patterned or woven into the stent, or the reinforcing elements can be wires (solid or hollow) encapsulated by a material (such as a primary polymeric material) and woven or patterned into the stent. The reinforcing elements can be combined as pieces, solid wires, tubes, or patterned structures.The reinforcing elements may have discontinuities or separate regions prior to bonding to a stent prosthesis as described herein to allow lumen detachment and / or scaffolding or lumen expansion, while being bonded to the stent structure (such as a polymeric stent material), or the discontinuities or separate regions may be formed on the reinforcing elements (through various means such as laser cutting, dissolving, cutting, etc.) after bonding to the stent, wire, or tube, and then the discontinuities or separate regions are reconnected or held together by means such as an adhesive, a primary polymer, a different polymer, a sleeve, or other means that hold the stent structural elements together upon expansion from a crimped configuration to a larger expanded configuration.

[0074] Typically, a stent including a circumferential scaffold will comprise multiple adjacent rings, with the expansion regions comprising curved, bent, hinged, jointed, crowned, or other regions of the rings that straighten or open as the scaffold is radially expanded. Most typically, such rings will be sinusoidal, serpentine, zigzag, diamond-shaped (Palmaz-type) rings, or any other type of radially expandable stent ring known in the vascular stent art, including open-cell designs, closed-cell designs, or combinations, or others known to those skilled in the art. Typically, the individual rings will be oriented in a plane that is oriented perpendicular to the central axis of the circumferential scaffold in its crimped or expanded configuration, or perpendicular to the longitudinal axis. However, in other embodiments or examples, the plane of the rings or expansion regions or circumferential structural elements may be inclined at an angle relative to the longitudinal axis of the scaffold (e.g., 1° to 85°, or 1° to 45°, or 10° to 75°, or 25° to 75°, or typically 5° to 15°), and in some cases, the "rings" or expansion regions or circumferential structural elements may be formed in a helical structure or joined in a continuous helical arrangement. Adjacent turns of individual rings or helical stent structures may be joined together axially by hinges, crowns, beams, struts, and / or axial links between other components of the rings or turns. In other examples, the scaffolding can be formed from wire (solid or hollow in at least some regions) and patterned into a stent in which adjacent rings are connected at one or more locations (or regions). In one embodiment, the stent comprises rings having an orientation ranging from perpendicular to the longitudinal axis of the stent to having an angle relative to such longitudinal axis of the stent ranging from 1° to 85°, to having a helically configured ring pattern, at least some of the rings having at least one separate region. In some other embodiments, a stent, such as a valve-containing stent, can comprise one or more circumferential rings (or one or more circumferential structural elements). In such embodiments, the stent comprises one or more separate regions, hinges, or other structures as described herein.In certain preferred embodiments, the stent comprises one or more circumferential rings, each of which comprises a plurality of struts joined by a crown. Typically, every second strut is joined by a crown, or every crown joins two struts on a ring. At least some, and 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 material fusion).

[0075] The reinforcing elements, in one example, may be positioned within compartments about the rings, or alternatively, may be positioned to extend substantially the entire circumferential length of at least some of the rings. However, the reinforcing elements will be configured to have or form at least one break, discontinuity, or separation region in their circumference or length to allow the reinforcing elements to separate and / or break away circumferentially after deployment, or to incrementally expand as the blood vessel or other body lumen reforms during the healing process. In this manner, the reinforcing elements will be able to provide the desired initial strength and resistance to crushing during deployment and / or the initial cycles after deployment, but will not inhibit or prevent the scaffold from detaching and / or expanding and / or the vessel / lumen from expanding after the biodegradable polymer (such as the primary 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 the polymer has at least partially eroded (including being degraded or eroded), leaving the reinforcing elements (uneroded or not fully eroded) free to further expand in response to revascularization or other physiological conditions.

[0076] The circumferential scaffolding of the present invention may include some or all of the conventional features found in conventional stent patterns. For example, the stent pattern may include axial links that hold adjacent rings together to form closed cells of the type well known in the stent art. In such cases, a reinforcing element may be coupled to at least some of the axial links, for example, where multiple individual reinforcing elements may together form a box structure coupled to substantially parallel rings and substantially parallel axial links. In one example, a reinforcing element is coupled to at least one axial link having at least one break.

[0077] In one embodiment, the reinforcing elements can be individual pieces that have a shape or geometry, or that substantially have a shape or geometry, or that have a smaller shape or geometry, or that have a larger shape or geometry, or that have a different shape or geometry from the structural elements to which they are connected, such as crowns, struts, and / or links. Examples of shapes include square, round, rectangular, triangular, semicircular, and other shapes. In these embodiments, the pieces are discontinuous or discrete pieces (either in contact with other adjacent reinforcing elements or not). The pieces can have deburred end regions, rounded end regions, spherical end regions, or other types or geometries that prevent inflammation after the polymer material has degraded and / or resorbed. In a preferred embodiment, substantially all of the expansion regions of at least some rings have reinforcing element pieces connected to them, and the reinforcing element pieces span substantially the entire expansion region section or at least a portion of the expansion region section. In another embodiment, substantially all of the expansion regions of at least some of the rings have a reinforcing element coupled to the expansion region, spanning the entire expansion region section and extending at least partially into the non-deformable or substantially non-deformable section (e.g., strut). In a preferred embodiment, the shape and / or geometry of the reinforcing element generally substantially mimics or contours the shape and / or geometry of the structural element to which it is coupled. In one embodiment, the reinforcing element can be larger in size in at least one dimension, smaller in size in at least one dimension, or the same size in at least one dimension as the structural element to which it is coupled. Reinforcing elements coupled to at least some structural elements of biodegradable material strengthen or augment the stent in response to expansion of the stent to support the body lumen, while allowing the stent to further expand and / or detach and / or allow the blood vessel to exhibit vasomotion or vasodilation under physiological conditions (and / or through the introduction of a therapeutic agent, such as nitroglycerin) after implantation (or after expansion or deployment).

[0078] In another example, the reinforcing element can be one or more reinforcing element segments coupled to at least some of the rings and / or other structural elements, such as links. For example, a reinforcing element segment 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) multiple crowns and struts and multiple links on a ring. In another example, the reinforcing element segments form a pattern on the stent, which is typically a symmetrical pattern (but can also be an asymmetrical pattern) and can be of various shapes, including closed and open patterns. When the reinforcing element section spans the entire structural element of the ring crown and / or strut, the reinforcing element section has at least one break or discontinuity in the crown and / or strut (the break or discontinuity is formed before or after bonding to the structural element), allowing the stent to further expand after degradation of the polymer material, or allowing the stent to detach, or allowing the blood vessel to have vasomotion, or allowing the blood vessel to have vasodilation after expansion (or after deployment) under physiological conditions (and / or through the 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.

[0079] 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 a reinforcing element or reinforcing element section spans the entire length of a ring (or circumferential structural element) without breaks, discontinuities, or separate regions, or when the reinforcing element spans more than one entire ring without breaks, discontinuities, or separate regions, or when the reinforcing element spans substantially the entire stent without breaks, discontinuities, or separate regions, the reinforcing element or reinforcing element section has at least one or more regions along its circumferential path per 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, the one or more regions having a cross-sectional area ranging from 200 square microns to 4,000 square microns, preferably a cross-sectional area ranging from 400 square microns to 3,000 square microns, more preferably Alternatively, the one or more regions may contain a reinforcing element (or one or more reinforcing elements) having a cross-sectional area ranging from 700 square microns to 2,500 square microns, wherein the one or more regions allow the one or more rings and / or stent to further expand after degradation of the polymeric material (or metallic degradable material), and / or allow the stent to detach, and / or allow the blood vessel to have vasomotion, and / or allow the blood vessel to have vasodilation, and / or allow the stent to have a radial strain ranging from 1% to 5% at a 3.0 mm expanded diameter after stent expansion (or deployment) under physiological conditions (and / or through the introduction of a therapeutic agent such as nitro), wherein the reinforcing element section has sufficient strength to support a body lumen after deployment, thereby strengthening or enhancing the stent. In another embodiment, the region having the above cross-sectional area spans substantially the entire length of at least some of the rings or spans substantially the entire stent.In another embodiment, the region having the cross-sectional area spans at least some rings or substantially all rings, but does not span at least some axial links. In another embodiment, the region has the cross-sectional area, and the reinforcing element width ranges from 10% to 50%, preferably from 20% to 40%, and more preferably from 25% to 35% of the width of the structural element in the region. In another embodiment, the region has the cross-sectional area, and the reinforcing element thickness ranges from 10% to 70%, preferably from 20% to 50%, and more preferably from 30% to 40% of the thickness of the structural element in the region. In another embodiment, one or more regions have the cross-sectional area, and the thickness-to-width ratio of the structural element is between 1.5:1 and 3:1, and the thickness-to-width ratio of the structural element in the one or more regions ranges from 0.7:1.4, preferably from 0.8:1. In a preferred embodiment of this embodiment, the reinforcing elements are a non-degradable metal or metal alloy, and the stent frame material (to which the reinforcing elements are bonded) is a polymeric degradable material. In another preferred embodiment of this embodiment, the reinforcing elements are a non-degradable metal or metal alloy, and the stent frame material is a degradable metal or metal alloy. A stent in this embodiment, including the reinforcing elements and having a degradable frame material, has sufficient strength to support a body lumen when expanded from a crimped configuration to an expanded configuration, and the stent's radial compliance increases after expansion, while the stent's strength decreases after expansion. In another embodiment, the stent's radial strain increases after degradation of the degradable polymeric material, and the initial strength after expansion decreases after degradation of the polymeric material. In another embodiment of this embodiment, the reinforcing elements combined with the degradable frame stent material have sufficient strength to support a body lumen, and the reinforcing elements alone do not have sufficient strength to support a body lumen. In another embodiment of this embodiment, the reinforcing element combined with the degradable frame stent material has sufficient strength to support a body lumen, and the reinforcing element alone or the stent frame material alone does not have sufficient strength to support a body lumen.

[0080] In another embodiment, a stent having reinforcing elements, bridging elements, separation regions, discontinuities, and other features described herein exhibits an increase in radial strain (or compliance) and a decrease in radial strength after expansion, hi another embodiment, the increase in radial strain (or compliance) and decrease in strength begin (or occur) over a period ranging from one week after stent expansion to nine months after stent expansion, preferably beginning between one month after expansion and six months after expansion, and more preferably beginning between two months after expansion and six months after expansion.

[0081] Most commonly, the reinforcing elements will comprise a non-degradable material, typically a metal (including a metal alloy), more typically a malleable metal, that has higher strength and can be opened and deformed along with the circumferential scaffold, but resists closure after the scaffold is partially or fully expanded. However, in other examples, the reinforcing elements may be a polymer that has a higher stiffness than the main body polymer of the circumferential scaffold (or the degradable patterned polymer, or the polymer to which the reinforcing elements are at least partially bonded). The polymeric reinforcing elements may be formed from the same or a different polymer than that forming the circumferential scaffold. When the reinforcing elements are formed from the same polymer, the reinforcing element polymer will typically have a higher molecular weight and / or a higher degree of crystallinity, or otherwise be a stiffer polymer than the main body polymer of the circumferential scaffold (or the degradable patterned polymer, or the polymer to which the reinforcing elements are at least partially bonded); the reinforcing polymer in this example may be degradable or non-degradable. In yet another example, the reinforcing elements may also comprise a degradable metal (including a metal alloy), such as magnesium and / or a magnesium alloy.

[0082] In yet another embodiment, the stent prosthesis comprises a biodegradable polymeric material, the polymeric degradable material degrading in 1 month to 5 years, preferably 2 months to 3 years, and more preferably 3 months to 2 years, and a 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) when the stent is in an expanded configuration. Typically, the polymeric material degrades faster than the reinforcing element, but the polymeric material can also be configured to degrade simultaneously (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.

[0083] In yet another embodiment, the stent prosthesis comprises a biodegradable metallic material, such as a magnesium alloy, wherein the metallic degradable material degrades in one month to five years, preferably in two months to three years, and more preferably in three months to two years, and a 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 herein. 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 the stent) when the stent is in its expanded configuration. Typically, the metallic material degrades faster than the reinforcing element, but the metallic material can also be configured to degrade simultaneously (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.

[0084] In still other examples, the reinforcing elements may be formed from elastic metals or polymers (including springs and / or shape memory, such as NiTi). For example, with respect to reinforcing elements that are curved or bent to conform to (or contour to) joints or hinges or expansion regions on a polymeric or metal circumferential scaffold, the reinforcing elements will typically be in a closed or constrained configuration when coupled to the corresponding hinges or joints on the circumferential scaffold in a crimped configuration. In this manner, the typically metallic reinforcing elements will act to help open and / or hold open the circumferential scaffold as it is balloon-expanded or self-expanded 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 elements will typically still be at least partially constrained by the polymer (such as the primary polymer) or metal to continue to bias the circumferential scaffold, simultaneously enhancing the strength and crush resistance of a deployed prosthesis, such as the endoluminal prosthesis itself, and / or open up at least in the regions where they are bonded through other reinforcing elements with higher stiffness located on the same, adjacent, or other expanding regions or structural elements of the circumferential scaffold. Optionally, the scaffold may have additional metal, polymer, or other non-elastic (malleable) reinforcing elements, e.g., hinges or joints, bonded to the same or other expanding regions on the circumferential scaffold. For example, as one or more polymers comprising the scaffold or rings (e.g., primary polymer) begin to soften and / or deteriorate and / or decrease in molecular weight, and / or as the blood vessel or other body lumen heals and remodels over time, the elastic reinforcing elements could continue to provide an opening bias and enhance expansion of the scaffold. The magnitude of the opening bias is controlled by elastic material properties (including spring, shape memory) and / or processing and / or by degradation of the polymeric material (e.g., primary polymer) containing the reinforcing elements. The terms "stent" and "scaffold" are used interchangeably herein.In another embodiment, a shape memory or spring reinforcing element, typically metallic, having two ends can be coupled to adjacent struts (non-deformable or substantially non-deformable structural elements), where the reinforcing element is configured as an expansion region connecting two adjacent struts (along the length of the struts), the expansion region being in a crimped configuration when the stent is in the crimped configuration, and the expansion region expanding as the stent expands to the deployed configuration. The reinforcing element continues to push apart (increase the angle between the adjacent struts) after stent deployment (after the stent recoils inward from the deployed configuration). The reinforcing element further expands the stent after deployment. The reinforcing element is attached or coupled to a structural element as described throughout this application. In one embodiment, the reinforcing element further expands the stent prosthesis 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 stent recoil. In another embodiment, the reinforcing element increases the stent mean expanded diameter or cross-sectional area by 2% to 15%, preferably 3% to 10%, of the stent mean expanded diameter or cross-sectional area after stent deployment and stent inward recoil. In another embodiment, the stent prosthesis comprises a non-degradable shape memory alloy comprising NiTi or other types of material, the stent having one or more separate regions (and / or one or more hinges), the stent expands from a crimped configuration to an initially expanded configuration, and the one or more separate regions (or hinges) form discontinuities (or allow the stent to have radial displacement) and allow the stent to respond to vasodilators or contour to changing lumen (or annulus) configurations.

[0085] In preferred embodiments, the degradable polymer stent comprises a degradable primary polymer (a polymer that forms a substantially polymeric scaffold structure, or a polymer that forms a substantially continuous scaffold structure, or a polymer that forms a scaffold structure without substantially discrete regions, or a polymer that forms a scaffold structure except for at least some discrete regions or discontinuities). The degradable polymer stent can comprise more than one polymer in addition to the primary polymer (adjacent, intermingled, mixed, etc.). The reinforcing elements are preferably non-degradable metals and metal alloys that have higher crush resistance (strength) compared to the primary polymer or other additional polymers. Such reinforcing elements are bonded to at least some regions of the scaffolding elements, such as crowns and / or struts, and have discrete regions or discontinuities that allow the stent to detach and / or expand in a physiological environment. The reinforcing elements can also be polymers (degradable or non-degradable) or corrodible metals and metal alloys.

[0086] In preferred embodiments, the reinforcing elements can have a variety of shapes and geometries, including rods (or solid) or hollow wires, circles, semicircles, triangles, rectangles, squares, ovals, or other shapes and geometries. In preferred embodiments, the cross-sectional area of ​​at least some of the structural elements (such as crowns and / or struts) containing or coupled to the reinforcing elements represents 5% to 90% of the cross-sectional area of ​​the structural element, preferably 10% to 75% of the cross-sectional area, and more preferably 15% to 75% of the cross-sectional area of ​​the structural element. The structural elements can be fully embedded in the structural element, partially embedded, or attached to one or more surface regions of the structural element, as described herein.

[0087] In another embodiment or aspect of the invention, the stent comprises a biodegradable polymeric material (or a biodegradable metallic material) that is patterned into a structure in which at least one crown region (preferably at least some of the crown regions, more preferably at least half of the crowns on at least some of the rings) and / or at least one strut region (preferably at least some of the strut regions, more preferably at least ¼ of the strut regions on at least some of the rings) is not formed (or is partially formed) on at least some of the rings, and the region comprises a reinforcing element, preferably a non-degradable reinforcing element, preferably a structural element formed or replaced with a metal such as a CoCr alloy, a stainless steel alloy, or other metal or metal alloy, or which may also be a non-degradable polymeric reinforcing element. In one embodiment, the polymeric stent is formed (or formed with regions that are then removed) on at least some rings without at least one crown region and / or without at least one strut region, the metal reinforcing elements have substantially the same size (or preferably smaller size) compared to the adjacent polymer crown region and / or strut region, the reinforcing elements are formed (or bent or curved) into the crown region shape and / or strut region shape, and the two ends of the crown region of the reinforcing elements are attached to the strut end regions of the unformed crowns.The two ends of the reinforcing element can be attached to the two strut ends of the polymeric stent as a butt joint, adhesively joining the two materials together at the junction, and / or with a sleeve containing both the reinforcing element and the polymeric material junction region, and / or by forming a slot in each of the two strut end regions of the polymeric stent (during or after laser patterning) and inserting or press-fitting the reinforcing element crown region end into the formed slot, optionally adhesively joining an overlap region of the two materials (e.g., a 0.05 mm to 1 mm overlap region), and / or with a sleeve containing an overlap region (the sleeve can extend beyond the overlap region), and / or by creating or having a slot formed in the reinforcing element end region into which the polymeric end is press-fit, holding the reinforcing element and the polymeric material junction together or holding the butt joint together during expansion from the crimped configuration to the expanded, larger configuration. Similarly, reinforcing elements can be connected to unformed polymeric strut ends (or partially formed struts) as discussed above. The reinforcing elements reinforce the expanded regions and / or the non-deformable or substantially non-deformable regions in the expanded stent configuration. The stent is expandable from a crimped configuration to a larger expanded configuration and has sufficient strength to support a body lumen. In one embodiment, the stent polymer biodegradable material degrades in 3 months to 3 years, while the non-degradable reinforcing elements remain within the vessel wall. After deployment, the stent disengages the vessel, exhibits vasomotion, exhibits vasodilation, exhibits vasoconstriction, and / or further expands to a larger configuration and / or has a radial strain of 1% to 10%, preferably 1% to 7%, more preferably 1.5% to 7%, under physiological conditions. In one embodiment, the stent comprises a degradable polymer material with structural elements including crowns and struts, and at least some of the crowns and / or struts are unformed, disassembled, or removed after formation (e.g., mechanically, such as by cutting them, or chemically, such as by removing them using a solvent or other material) and replaced with non-degradable metallic reinforcing elements.Stents can be formed from polymeric tubes, or from filaments that are patterned into a stent, or by other methods known to those skilled in the art. Reinforcing elements can be formed from tubes or wires and shaped or patterned into the shape of the structural element, such as a crown, that they will replace. In one example, a reinforcing element is formed from a patterned tube, and then components of the patterned tube are removed (e.g., mechanically) and inserted (or attached) into the location of the unformed polymeric structural element (to replace it, in one example). In another example, a wire reinforcing element is molded and attached to the structural element that it replaces. Other methods of forming structural elements 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 are discussed in further detail throughout this application.

[0088] In another embodiment, a biodegradable metal stent, such as a magnesium alloy stent, is patterned into a structure in which at least one crown region (preferably at least some of the crown regions, more preferably at least half of the crowns on at least some of the rings) and / or at least one strut region (preferably at least some of the strut regions, more preferably at least ¼ of the strut regions on at least some of the rings) is not formed (or is partially formed) on at least some of the rings, and the region comprises a reinforcing element, preferably a non-degradable reinforcing element, preferably formed or replaced with a metal such as a CoCr alloy, stainless steel alloy, or other metal or metal alloy, or which may also be a non-degradable polymeric reinforcing element. In one embodiment, the 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 rings, the metal reinforcing elements have substantially the same size (or preferably smaller size) compared to adjacent metal stent crown regions and / or strut regions, the reinforcing elements are formed (or bent or curved) into the crown region shape and / or strut region shape, and the two ends of the crown regions of the reinforcing elements are attached to the strut end regions of the unformed crowns.The two ends of the reinforcing element can be attached to the two strut ends of the metal stent as a butt joint, adhesively joining the two materials together at the junction, and / or containing both the reinforcing element and the metal stent junction 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) and inserting or press-fitting the reinforcing element crown region ends into the formed slots, optionally adhesively joining an overlap region of the two materials (e.g., a 0.05 mm to 1 mm overlap region), and / or containing an overlap region with a sleeve (the sleeve can extend beyond the overlap region), and / or creating or having slots formed in the reinforcing element end regions into which the metal stent structural element ends are press-fit, and / or laser welding (or fusing) the two materials together to hold the reinforcing element and metal stent junctions together or hold the butt joint together during expansion from the crimped configuration to the larger expanded configuration. Similarly, reinforcing elements can be connected to unformed metal stent struts (or partially formed struts), as discussed above. The reinforcing elements reinforce the expanded and / or non-deformable or substantially non-deformable regions in the expanded stent configuration. The stent is expandable from a crimped configuration to a larger expanded 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 three months to three years, while the non-degradable reinforcing elements remain within the vessel wall. After deployment, the stent may detach from the vessel, exhibit vasomotion, exhibit vasodilation, exhibit vasoconstriction, and / or further expand to a larger configuration, and / or have a radial strain ranging from 1% to 10%, preferably ranging from 1% to 7%, more preferably ranging from 1.5% to 7%, under physiological conditions.In one embodiment, the stent comprises a degradable metallic material comprising structural elements including crowns and struts, where at least some of the crowns and / or struts are unformed, detached, or removed after formation (e.g., mechanically, such as by cutting them, or chemically, such as by removing them using a solvent or other material) and replaced with non-degradable metallic reinforcing elements. The stent may be formed from a metallic tube, or from a filament (or wire) that is patterned into a stent, or by other methods known to those skilled in the art. The reinforcing elements may be formed from a tube or wire and shaped or patterned into the shape of the structural element, such as a crown, that they will replace. In one embodiment, the reinforcing elements are formed from a patterned tube, and then components of the patterned tube are removed (e.g., mechanically) and inserted (or attached) into the location of the unformed metallic stent structural element (to replace it, in one embodiment). In another embodiment, a wire reinforcing element is molded and attached to the structural element to be replaced. Other methods of forming the structural elements include various methods, such as forming a patterned flat sheet, injection molding, or others. The shape and size of the reinforcing elements can vary and are discussed in further detail throughout this application.

[0089] 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, to have sufficient strength upon deployment of the stent within a body lumen (in some cases, degradable materials, such as degradable metallic materials with high crush resistance, can also be used in this embodiment, as such materials tend to confine the vessel over time and degrade slowly). However, such a stent will confine the vessel or segment adjacent to the stent and prevent one or more of the following from occurring: potentially reducing the usefulness, safety, and / or effectiveness of the stent; dislodging the vessel or stented segment; exhibiting vessel dilation within or across the stented segment; exhibiting vessel constriction within or across the stented segment; exhibiting further expansion of the stent; or exhibiting radial strain across the stented segment within the range of 1.5% to 5% after deployment. To solve or address one or more of the foregoing needs, a non-degradable metal stent, such as an L605CoCr alloy stent, is constructed by patterning at least one crown region (preferably at least some of the crown regions, more preferably less than half of the crowns on at least some of the rings) and / or at least one strut region (preferably at least some of the strut regions, more preferably at least ¼ of the strut regions on at least some of the rings) into a structure comprising structural elements that are not formed (or are partially formed, or are formed and then removed) on at least some of the rings, and that are formed or replaced with degradable crosslinks, such as a degradable polymeric 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 rings, the degradable bridging elements have substantially the same size (or preferably smaller, but can also be larger) compared to adjacent metal stent crown regions and / or strut regions, the degradable bridging elements are shaped (or bent or curved) into the crown region shape and / or strut region shape and / or the shape of the stent structural element they replace, and the two ends of the crown regions of the degradable bridging elements are attached to the strut end regions of the unformed crowns. The two ends of the degradable bridging elements can be attached to the two strut ends of the metal stent as a butt joint, adhesively joining the two materials together at the junction, and / or containing both the degradable bridging element and the metal stent junction 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) and inserting or pressing or fusing or melting the degradable bridging element crown region ends into the formed slots, optionally adhesively joining an overlap region of the two materials (e.g., a 0.05 mm to 1 mm overlap region), and / or containing an overlap region with a sleeve (the sleeve can extend beyond the overlap region), and / or creating or having slots formed in the larger sized degradable bridging element end region into which the metal stent structural element ends press fit, and / or laser welding (or fusing) the two materials together to hold the degradable bridging element and metal stent junctions together or hold the butt joint together upon stent expansion or during stent expansion from a crimped configuration to a larger expanded configuration. Similarly, degradable bridging elements can be connected to unformed metal stent strut ends (or partially formed struts), as discussed above.The degradable bridging elements are less rigid or substantially less rigid, thus weakening the expanded and / or non-deformable or substantially non-deformable regions in the expanded stent configuration. However, the degradable bridging elements provide one or more of the following benefits: help the stent expand uniformly (or improve expansion uniformity), provide continuity of circumferential structural elements (such as rings) at least in response to expansion (or over a period of time after expansion), provide drug release in the region to inhibit neointimal hyperplasia, provide partial or complete expansion of the stent circumferential rings in the expanded region, provide lesion coverage and minimize plaque prolapse, provide temporary scaffolding, and then provide detachment of the stent and / or vessel as the degradable bridging elements degrade or erode over a period ranging from one month to four years, preferably three months to four years, and provide support to the vessel wall. The stent is expandable from a crimped configuration to a larger expanded configuration and has sufficient strength to support a body lumen. The non-degradable stent structural elements, in one embodiment, remain substantially intact (or, in one embodiment, substantially held together or substantially in place) within the vessel wall. The deployed stent disengages the 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 ranging from 1% to 7%, more preferably ranging from 1.5% to 7% under physiological conditions (and / or through the introduction of a therapeutic agent such as nitro). The stent, in one embodiment, comprises a non-degradable metallic material having structural elements including crowns and struts, wherein at least some of the crowns and / or struts are unformed or dislodged or removed after formation (e.g., mechanically removed, such as by cutting them, or chemically removed, such as by removing them using a solvent or other material or by melting them) and replaced (or formed) with degradable crosslinks in the region.Stents can be formed from metal tubes, metal sheets, or filaments (or wires) patterned into a stent, or formed using other methods known to those skilled in the art. Degradable bridging elements can be formed from tubes or filaments / wires and shaped or patterned into the shape of the structural element they will replace, such as a crown. In one example, a reinforcing element is formed from a patterned tube, and then components of the patterned tube are removed (e.g., mechanically) and inserted (or attached or press-fit) into the location (or area) of the unformed metal stent structural element. In another example, filament degradable bridging elements are shaped into the replacement structural element and attached to the ends, as described. Other methods of forming degradable bridging elements can include various methods, such as forming a pattern from a flat sheet and using components from the sheet to replace the unformed structural element, injection molding the degradable bridging element, or others. The shape and size of the degradable bridging element can vary (smaller, the same, or larger than the replaced structural element), as discussed in more detail throughout this application.

[0090] In one embodiment, the bridging element is degradable. In another embodiment, the bridging element is non-degradable while still achieving one or more of the objectives of the present invention. The bridging element can also be a suture (or wire) that ties together the ends of a structural element, which is not formed, or is partially or completely modified or removed. The suture can be threaded through holes adjacent each end of the structural element to tie together the ends of the structural element, and the suture (or wire) can be threaded through the holes and tied to form a continuity of the unformed structural element (e.g., the suture or wire bridging two crowns or two struts).

[0091] In another embodiment, the bridging elements can be formed from a shape memory material or a spring material (which in other embodiments can also be a reinforcing element), and the bridging elements serve to bias at least some of the crowns open and allow for further expansion after implantation.

[0092] In another embodiment, a non-degradable metal stent (e.g., cobalt chromium alloy L605 or MP35, etc.) comprises a wire (round or substantially round, elongated, or other shape), which is patterned into the stent. The stent comprises a structural element comprising a plurality of rings, each ring comprising a crown and a strut. At least one strut and / or at least one crown on at least some of the rings is removed. The ends of the stent from which the struts and / or crowns were removed are treated to create a hollow space in the wire. Degradable bridging elements are inserted into the hollow space at each end of the wire stent to bridge the gaps between the removed struts and / or crowns. Optionally, adhesive or a degradable sleeve is applied to or overlaps the junctions to further reinforce the junction sections, so that the junctions are held together as the stent expands from the crimped configuration to the larger expanded configuration. In another embodiment, the degradable bridging elements are treated to create a hollow space into which a stent wire structural element can be inserted or press-fit. Optionally, an adhesive or sleeve is applied to further hold the bond together.

[0093] In another embodiment, the stent prosthesis is formed as a tube with a non-degradable material layer (such as a cobalt chromium alloy layer) either sandwiched between, on top of, or on the bottom of magnesium alloy layers. The tubing is patterned into a stent. At least some regions on at least some rings (or at least some crown and / or strut regions on at least some rings) have the non-degradable material (such as a cobalt chromium alloy layer) substantially removed by laser, chemical, or mechanical means to provide a stent that detaches after expansion under physiological conditions. In another embodiment, the stent prosthesis can be formed as a sheet with a degradable layer on top or bottom of the non-degradable material, and the stent is patterned and processed as described above. The sheet is rolled and attached (or fused) to form the patterned stent.

[0094] In another embodiment, the stent prosthesis is formed as a wire, the wire comprising a non-degradable material layer (such as a cobalt chromium alloy layer) on top or bottom of a degradable polymer or metal material layer (such as a magnesium alloy layer or a PLLA-based polymer). The wire is patterned into a stent. At least some regions on at least some of the rings (or at least some crown and / or strut regions on at least some of the rings) are substantially removed by laser, chemical, or mechanical means to provide a stent having the non-degradable material (such as the cobalt chromium alloy layer) forming a degradable bridging element connecting two ends of the non-degradable structural element, which detaches after expansion under physiological conditions, preferably as the degradable material degrades.

[0095] In another embodiment, the stent prosthesis is formed as a tube, with the tubing comprising a non-degradable material layer (such as a cobalt chromium alloy layer) on or inside a degradable polymer material layer (such as a PLLA-based polymer layer). The tubing is patterned into a stent. At least some regions on at least some of the rings (or at least some crown and / or strut regions on at least some of the rings) have the non-degradable material layer (such as a cobalt chromium alloy layer) substantially removed by laser, chemical, or mechanical means to provide a stent that detaches after expansion under physiological conditions. In another embodiment, the stent prosthesis can be formed as a sheet, with a degradable layer on top or bottom of the non-degradable material, and the stent patterned and processed as described above. The sheet is rolled and attached (or fused) to form the patterned stent.

[0096] In one embodiment of any of the embodiments herein, the stent is tested or deployed (expanded) under one or more of the following conditions: in air, in a water bath, in a 37°C water bath, under physiological conditions, in a pulsatile (or constricting) environment, under administration of one or more agents that cause vasodilation or vasoconstriction of the stented segment, in a vessel, in a body lumen, under a pressure differential (gradient) ranging from 100 mmHg to 200 mmHg, under a pressure differential (or magnitude) of 100 mmHg, under a pressure differential (or magnitude) of about 176 mmHg, or under conditions for compliance or strength testing as described herein, or under any other conditions described herein. In some cases, all of the conditions described in this paragraph are referred to as physiological conditions.

[0097] In one example, the physiological conditions comprise one or more of: in an ambient environment, in a water bath, in a water bath at about 37°C, in an about 37°C environment, in a radial strain tester (compliance tester), in a fatigue tester, in a pulsating environment, in a pressure or pressure differential environment, in a pulsating environment that substantially simulates a body lumen or body organ environment, administration of a therapeutic agent such as a vasodilator or vasoconstrictor, in a constriction and / or dilation environment, in a body lumen, in a body vessel, in a body annulus, or others.

[0098] In preferred embodiments, the stent prosthesis further comprises at least one coating on at least one surface of the stent prosthesis. The coating, in one embodiment, comprises at least one drug, preferably an m-tor inhibitor. In another embodiment, the stent prosthesis comprises at least one drug. In another embodiment, the stent prosthesis comprises at least two drugs, i.e., an m-tor inhibitor and a vasodilator. In yet another embodiment, the at least one coating degrades at a rate slower than the degradation rate of the degradable (polymeric or metallic) material. In another embodiment, the at least one coating degrades at a rate faster than the degradable material. In yet another embodiment, at least one coating coats at least one surface of a non-degradable stent. In yet another embodiment, at least one degradable coating coats at least one surface of a non-degradable stent. In yet another embodiment, at least one degradable coating coats at least one surface of a non-degradable stent and at least one non-degradable coating coats at least one surface of a non-degradable stent.

[0099] In one embodiment, the stent prosthesis exhibits, provides, or is configured to perform one or more of the following: dislodge the stent, dislodge the stented section of the lumen or vessel, dislodge at least some circumferential structural elements (rings) of the stent, dislodge at least some rings of the stent, dislodge the vessel or vessel wall, exhibit vasomotion, exhibit vasodilation, exhibit vasoconstriction, further expansion of the stent to a larger configuration after implantation, and / or the stent has a combined radial strain (or compliance) under physiological conditions (and / or through the introduction of a therapeutic agent such as nitro) ranging from 1% to 10%, preferably ranging from 1% to 7%, more preferably ranging from 1.5% to 7%. The stent prosthesis, in this example, exhibits or provides one or more of the properties (e.g., detachment) described above in one or more of the following stent states: when formed; when patterned; after a treatment or processing following stent formation (or patterning); when the stent is deployed; upon stent deployment; upon stent expansion; and / or after stent deployment or expansion, for example, within a body lumen. The stent prosthesis, in this example, exhibits or provides one or more of the properties (e.g., detachment) described above in one or more of the following: at least some circumferential structural elements, at least some rings, substantially all circumferential structural elements, substantially all rings, at least some regions, across substantially the entire stent or stent segments, within (or across) the stent regions and / or stent segments.

[0100] In one embodiment of any of the embodiments, the bridging element may also bridge at least one link (or link region) in addition to bridging one or more structural elements (such as struts and / or crowns) on at least some of the rings.

[0101] In another aspect or embodiment of the invention, a non-degradable (metal (including alloys), but potentially polymeric) stent prosthesis comprises a structural element, which in one embodiment comprises a plurality of rings, each ring comprising struts and crowns, each ring connected to an adjacent ring at at least one location (or region). At least one strut (or portion of a strut or strut region) and / or at least one crown (portion of a crown or crown region) on at least some of the rings is not formed (or is formed and then removed), forming gaps (or discontinuities) 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, and more preferably from 3 microns to 1 mm, measured in 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 a variety of shapes, such as circular, square, semicircular, 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 one to three 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. In a preferred embodiment, the stent has a substantially uniform expansion. In another preferred embodiment, the stent has a maximum circular diameter of 0.7 mm to 1.5 mm in the gap region. In a further preferred embodiment, the stent has a coating sufficient to inhibit (or minimize) smooth muscle cell proliferation.The stent prosthesis is configured to exhibit, provide, or perform one or more of the following: dislodge the stent, dislodge at least some circumferential structural elements of the stent, dislodge at least some rings of the stent, dislodge the vessel or 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 under physiological conditions (and / or through the introduction of a therapeutic agent such as nitro) ranging from 1% to 10%, preferably ranging from 1% to 7%, more preferably ranging from 1.5% to 7%. The stent prosthesis, in this embodiment, exhibits or provides one or more of the above-described properties (such as dislodgement) in one or more of the following stent states: upon formation, upon patterning, after a treatment or processing after stent formation (or patterning), upon stent deployment, upon stent expansion, and / or after deployment or expansion of the stent, for example, within 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, provided that such connections do not complete the gaps (or discontinuities) in the ring, but rather the gaps in the ring remain disconnected.

[0102] 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 by other methods. The severed regions are deburred and / or shaped into a geometry that is atraumatic and / or creates and / or maintains contact and / or substantially holds the severed regions together, allows expansion of the stent prosthesis from the crimped configuration to a larger, expanded configuration, and has sufficient strength to support the body lumen. The stent, in preferred embodiments, has a substantially uniform pattern in the expanded configuration. The severed end regions can abut, overlap, or have temporary retention means in the crimped configuration to enable deployment to the expanded configuration, or to allow the stent to have a substantially uniform pattern in the expanded stent configuration and / or to allow substantially sufficient coverage to support the body lumen.

[0103] During laser cutting, patterning, or other formation of separation regions and discontinuities within a scaffold, portions of the partially formed scaffold may be temporarily held together after the discontinuities are formed and before the discontinuities are fixed by adhesive, coating, sleeve formation, or the like, to prevent the structure from prematurely separating. For example, after a tubular member is laser cut or otherwise patterned to form a circumferential ring including struts and crowns, the ends of the tubular member may be temporarily held by holding fixtures positioned at each end of the scaffold. Specifically, one, two, three, or more terminal crowns at each end of the scaffold may be formed with holding features, such as enlarged ears or similar features, that can be grasped by the holding fixture. In this way, the retention fixture will hold the partially formed scaffold together as the separation regions are formed, for example, by first cutting or bisecting the struts and / or crowns in one or more of the circumferential rings, and then coating the entire scaffold in a biodegradable sleeve, holding the stent together so that the stent can be removed from the fixture and subsequently deployed.

[0104] In another embodiment, a non-degradable (metal (including alloys), but could also be polymeric) stent prosthesis comprises circumferential structural elements, which in one embodiment comprise a plurality of rings, each ring comprising struts and a crown, each ring 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 gaps (or discontinuities) therein. For example, a stent can be patterned to have gap sizes ranging from 1 micron to 3 mm, preferably ranging from 2 microns to 2 mm, and more preferably ranging from 3 microns to 1 mm, when the gaps are measured as straight lines completing (or connecting or providing continuity with) the rings. In preferred embodiments, the gaps have a maximum circular inter-strut (inter-ring or inter-ring) distance within the region ranging from 0.9 mm to 2 mm, preferably ranging 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 one to three 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 preferred embodiments, has substantially uniform expansion, sufficient vascular coverage to inhibit SMC proliferation. The stent prosthesis is configured to exhibit, provide, or do one or more of the following: dislodge the stent, dislodge at least some circumferential structural elements of the stent, dislodge at least some rings of the stent, dislodge the vessel or vessel wall, exhibit vasomotion, exhibit vasodilation, exhibit vasoconstriction, further expansion of the stent to a larger configuration after implantation, and / or the stent has a radial strain under physiological conditions (and / or through the introduction of a therapeutic agent such as a nitroglycerin) ranging from 1% to 10%, preferably ranging from 1% to 7%, more preferably ranging from 1.5% to 7%.The stent prosthesis, in this embodiment, exhibits or provides one or more of the properties described above (such as detachment) in one or more of the following stent states: when formed; when patterned; after a treatment or processing following stent formation (or patterning); when the stent is deployed; upon stent deployment; upon stent expansion; and / or after stent deployment or expansion, for example, within a body lumen.

[0105] In one embodiment, a stent prosthesis has at least one gap (or discontinuity) on each ring. In one embodiment, the region (or end region) of a structural element (ring) where the gap is (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 connected to struts and / or crowns (or connected to other adjacent structural elements, such as connected to struts and / or crowns), at the end region, adjacent to the end region, or anywhere along the structural element leading to the end region. The connection to the region can be a substantially linear connection, a crown connection, and / or other connection 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 type connections. The dimensions of the connection can be different from other adjacent structural elements or can be substantially the same. The connections may also be larger or smaller in width and / or thickness in other embodiments. The connection shapes and / or dimensions may be substantially the same or different on at least some of the rings.

[0106] In another embodiment, a stent prosthesis comprises a structural element comprising a plurality of rings, each ring comprising a crown and a strut, each ring connected to an adjacent ring in at least one region. At least some rings have at least one region between two crowns and / or two struts, configured (patterned or otherwise) to have two struts (or two strut regions) and / or two crowns (or two crown regions), where two strut regions and / or crown regions overlap over a length. The struts and / or crowns are connected at opposite ends, while the other end region forms a discontinuity in the ring. The strut and / or crown free end regions can have various shapes and geometries that constrain or hold the stent prosthesis together as the stent is deployed. The strut and / or crown regions can also have grooves or other shapes that hold or constrain the sliding struts and / or crowns as the stent prosthesis is expanded. A stent prosthesis is typically expandable from a crimped configuration to a larger expanded configuration and has sufficient strength to support a body lumen. The stent allows the body lumen to detach upon deployment. The stent has sufficient structural element surface area coverage (thickness, width, and / or geometry) in the discontinuity areas to support the body lumen.

[0107] In one embodiment of any of the embodiments herein, the stent prosthesis comprises circumferential structural elements, the structural elements comprising struts and crowns, the stent is configured (e.g., patterned and / or treated) to allow the stent to be expandable from a crimped configuration to a larger expanded configuration, the stent has sufficient strength in an expanded configuration to support a body lumen, the stent prosthesis disengages and / or has a radial strain (or compliance) ranging from 1% to 5%, and / or expands upon expansion and / or further after expansion once formed within the body lumen (or under physiological conditions and / or therapeutic conditions such as the introduction of nitroglycerin). Examples of the stent prosthesis include one or more from the embodiments comprising struts and / or crowns with reinforcing elements, bridging elements, separation regions, gap regions, or the like. The stent prosthesis may be degradable, non-degradable, metallic (including alloy), or polymeric, under physiological conditions over a period ranging from 3 months to 5 years. A stent prosthesis, in embodiments, can be formed from a tube and patterned into a stent, or formed from one or more wires (or filaments) and patterned into a stent. A stent can also be formed from a flat sheet and rolled to form a stent. A flat sheet can be patterned before rolling it to form a stent, or a 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 crowns and struts having one or more of the configurations described herein. In another embodiment, the structural element comprises crowns and struts having one or more discontinuities that allow the stent to break away once formed and / or to further expand once formed upon deployment and / or after deployment.

[0108] 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 discontinuity. In another embodiment, at least some of the struts and / or crowns have at least two separation regions, discontinuities, or discontinuities thereon. In yet a further embodiment, at least some of the struts and / or crowns will not include a separation region. In yet a further frequently preferred embodiment, at least some of the struts will have a separation region, while all of the crowns in a circumferential ring will not include a separation region. It has generally been found that locating separation regions in struts that do not deform during expansion is preferable to locating separation regions in crowns that deform as the scaffold expands.

[0109] In another aspect or embodiment, the present invention provides non-degradable or slowly degradable prosthetic materials having structural elements, such as circumferential elements and / or rings, with separation regions and / or environmentally responsive separation regions. "Environmentally responsive" means that the scaffold responds to physiological conditions, including vascular and / or other luminal conditions, and / or responds to being placed in water at ambient temperature or 37°C, and / or responds to being placed in buffer and / or saline, and / or responds to physiological conditions (e.g., vascular or luminal conditions) and / or physiological pressures to which the scaffold is exposed, such as after implantation within a blood vessel or other body lumen, and / or the scaffold responds to pressures ranging from 30 mmHg to 200 mmHg, preferably ranging from 40 mmHg to 120 mmHg, more preferably 50 mmHg. This means that in response to exposure to pressures ranging from 30 mmHg to 80 mmHg, and / or 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 regions will separate, void of material such as a degradable polymeric material, create gaps, open, break, allow movement in one or more directions, and / or degrade.

[0110] The stent, in any preferred embodiment of the present application, is capable of detaching, detaching in at least some circumferential cross sections or regions, detaching across the stent segments, and / or expanding to a larger diameter (or configuration) at physiological conditions (including physiological environments) in at least some circumferential cross sections or regions of the stent prosthesis. The larger stent diameter may 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 in response to the pressure (as described herein), in one embodiment, permanently or temporarily from the expanded and / or deployed diameter to a larger diameter (after recoil from the expanded and / or deployed diameter, if applicable), while the stent diameter changes and / or increases by 0.045 mm to 1 mm, preferably 0.05 mm to 0.6 mm, more preferably 0.06 mm to 0.3 mm, or by 0.1 to 0.3 mm during exposure to the pressure and / or pulsatile pressure. The stent radial strength after deployment, in the same or other embodiments, ranges from 12 psi to 30 psi, preferably 13 psi to 25 psi, more preferably 15 psi to 25 psi. The stent flat plate strength (10% crush) after scaffold expansion and / or deployment 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, and more preferably from 0.004 N / mm stent length to 0.085 N / mm stent length, in the same or a different embodiment. The scaffold inward recoil after scaffold expansion and / or deployment ranges from 1% to 10%, preferably from 2% to 7%, and more preferably from 2% to 5%, in the same or a different embodiment. The stent inward recoil preferably remains substantially the same after deployment. The stent prosthesis preferably further expands to a larger configuration after the introduction of an internal vasodilator. The stent preferably has a radial strain (or compliance) at the expanded configuration ranging from 1% to 5%.In the same or a different embodiment, the radial strength of the non-degradable stent after deployment may decrease by at least 25%, at least 50%, at least 75%, or 100% of the initial radial strength of the scaffold upon deployment. The time period over which the strength decreases in the same or a different embodiment may range from 1 day to 2 years, preferably from 1 month to 1 year, more preferably from 2 months to 9 months, and more preferably from 3 months to 9 months. In the same or a different embodiment, the radial strength of the non-degradable stent after deployment (initial deployment) may decrease by 0% to 25% of such initial deployed radial strength within 30 days, and / or by 10% to 50% of such initial deployed radial strength within 90 days, and / or by 25% to 90% of such initial deployed radial strength within 180 days, and / or by 50% to 100% of such initial deployed radial strength within 270 days. 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, the at least one drug is contained in a 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).

[0111] Preferred embodiments throughout this application after deployment include detachment of the stent, further expansion of the stent after deployment, lumen enlargement, and other properties of the stent and / or lumen, including one or more of the entire stent or lumen, at least one portion 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 segments, or stented segments.

[0112] In another embodiment, the present invention provides a non-degradable prosthetic material having circumferential elements and / or rings with separated regions. The separated regions are regions that have discontinuities when formed and / or patterned (including after patterning), and / or after processing or treatment, and / or before implantation, and / or after implantation, and / or after implantation in physiological conditions. Discontinuities include complete and / or substantial one or more of the following: separation, emptiness of material, gaps, gap formation, openness, discontinuities, disengagement, lack of contact, removal of material between or adjacent to the separated regions, removal of material holding the separated regions together, ability of the separated regions 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 after deployment, the stent may recoil to a smaller configuration before further expanding to a larger configuration (greater than the recoil configuration and / or larger than the deployed expanded configuration). The stent can expand to a larger configuration within the body lumen and / or under physiological conditions. In another embodiment, the stent dislodges or dislodges in at least some regions and / or rings or stented sections.

[0113] In another example, 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 polymeric materials), which prevent the formation of gaps or other discontinuities. One or more circumferential rings containing separation regions comprising a non-degradable material are configured to expand to a larger diameter or cross-section after initial expansion (and recoil, if applicable) due to the elasticity and stretch of the non-degradable material under physiological conditions in response to the vessel and / or expansion in response to a vasodilator. In this way, the one or more rings, and typically the entire stented section, exhibit a desired compliance after implantation under physiological conditions. In such embodiments and examples, the non-degradable material typically has sufficient elasticity to continuously expand and / or contract under physiological conditions, including vascular systole.

[0114] In yet another example, one or more separation regions comprising a non-degradable material may still form gaps or other discontinuities after initial expansion, preferably after cycling 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 regions to separate and form gaps or other discontinuities.

[0115] In yet another example, one or more separate regions may be constrained by one or more non-degradable materials, such as a polymer sleeve or polymer coating, such that one or more of the separate regions remain constrained by the non-degradable material even after the formation of the gap or other discontinuity. 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 constraining the separate regions allows the one or more rings or stented sections to have the desired compliance, further expand after initial recoil, and / or respond to the introduction of a vasodilator.

[0116] In another example, an endoluminal prosthesis according to this and / or an aspect and / or preferred embodiment of the present invention comprises a scaffold having structural elements, such as circumferential elements and / or rings, patterned from a non-degradable material, such as a non-degradable metal, metal alloy, or rigid non-degradable plastic, the scaffold configured to expand from a crimped configuration to an expanded configuration, the scaffold having sufficient strength in the expanded configuration to support a 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 elements and / or rings 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 of the other conditions disclosed herein. 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 any initial recoil that may 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 circumferentially. That is, after the scaffold is initially deployed by a balloon or, in some cases, by self-expanding from a constraint, the discontinuities allow portions of the scaffold to separate and the rings to expand, preferably with lumen expansion, more preferably with lumen expansion as a result of lumen remodeling. In one example, ring separation regions can be present in the crown, hinge, and / or strut regions. The stent preferably responds to vasodilatory stimuli by expanding the lumen in the stented section. The stent preferably has a combined radial strain (or compliance) ranging from 1.5% to 7%.

[0117] In another example, the discontinuity formed in the circumferential elements and / or rings will typically comprise a partial or complete break, separation, gap in the structure of the circumferential scaffold that reduces or eliminates the stress area, stiffness, hoop, circumferential, and / or radial strength in the scaffold (or ring component of the scaffold as described more specifically below and / or herein) and / or separation region. Most commonly, the discontinuity will be a complete break that allows the two resulting free ends in the scaffold or ring or circumferential element to move away from each other in response to reshaping or other expansion of the body lumen and / or stent. In one example, there is a discontinuity where the two free ends are contained by a material comprising a sleeve or coating, which may be non-degradable or degradable, such as a polymer, that stretches as the free ends move apart. In another embodiment, the discontinuities are contained using discontinuity geometries (such as certain key and lock designs and other types of geometries) to hold the structural elements containing the discontinuities together upon deployment from the crimped configuration to the expanded configuration, where the discontinuities are formed before, during, or after patterning and are held together by the design configuration of the separate regions that form the discontinuities as described above and / or throughout this application. The discontinuities, in this case, maintain the free ends of the structural elements containing the discontinuities held together, allowing for crimping and / or deployment of the stent while providing sufficient strength after deployment of the stent to support the body lumen. The discontinuities, in this case, can allow movement of the free ends of the structural elements in one or more directions after deployment, preferably radially only after deployment, more preferably substantially radially only, most preferably primarily radially, or the movement is in the radial and / or circumferential directions. In one example, at least some of the rings 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.Individual scaffold rings may have the same or different numbers of discontinuities, and not all scaffold rings need have discontinuities. For example, rings at or near the ends of the scaffold may be free of discontinuities, e.g., to limit wishbone effects. In further embodiments, at least some rings will have several discontinuities ranging from one to the same number of crowns, preferably from one to three-quarters of the number of crowns on the ring, and / or several discontinuities ranging from one to the same number of struts on the ring, preferably from one to three-quarters of the number of struts on the ring, and / or several discontinuities ranging from one to one-half the number of crowns on the ring, and / or several discontinuities ranging from one to one-half the number of struts on the ring. It may have several discontinuities, and / or may have several discontinuities on the ring ranging from 1 to 1 / 4 of the number of crowns, and / or may have several discontinuities on the ring ranging from 1 to 1 / 4 of the number of posts, and / or may have several discontinuities on the ring ranging from 1 to 10, preferably several discontinuities on the ring ranging from 1 to 5, more preferably several discontinuities on the ring ranging from 1 to 4, and / or a number on the ring ranging from 1 to 3, and / or a number on the ring ranging from 1 to 2.

[0118] In one example, the physiological environment that causes such discontinuities to form (in other examples, the discontinuities form independently of the physiological environment) may be characterized by any physical conditions associated with the body lumen in which the prosthetic device is implanted. For example, the physiological environment or conditions may comprise any one or more of the following: physiological temperature, e.g., 37°C, as maintained within the body lumen or in a water bath heated to about 37°C, and / or physiological pressure, and / or pressure, and / or pulsatile pressure, and / or the introduction of agents such as vasodilators or vasoconstrictors, as described herein. Additionally, the physiological environment may comprise blood or other aqueous medium in which the scaffold is embedded, particularly oxygenated blood, which may promote erosion of certain features. In many cases, the physiological environment will comprise the pulsation of blood vessels, particularly arteries, which may subject the implanted scaffold to mechanical stresses that may in turn fatigue and destroy certain features formed in the scaffold structure. The discontinuities, whether due to degradation, corrosion, dissolution, or mechanical stress, will typically form in 30 days to 6 months in one example, but can also form in a few days to a year after initial circumferential scaffold expansion 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.

[0119] In one embodiment, the separation region may comprise any one of a variety of structures or modifications of the scaffold, including, for example, cutouts, variations in granular structure, pre-formed cuts, which are rejoined by degradable polymers, adhesives, sleeves, rivets, or the like.

[0120] One particular example of the separation region comprises a key and keyhole, and / or a key and lock, and / or a ball and socket, and / or a hook junction that is configured to be fixed and / or held together when formed and / or after formation and / or before deployment and / or before expansion and / or during deployment and / or during expansion, and to separate and / or form a discontinuity after deployment and / or after additional expansion in a physiological environment. For example, the key and keyhole, and / or key and lock, and / or ball and socket, and / or hook junctions may be initially held together by means such as by materials such as polymers, cements, adhesives, solders, and / or the like that degrade in a physiological environment, and the key and keyhole, and / or key and lock, and / or ball and socket, and / or hooks are configured to separate or form gaps once the means holding the junctions collapses or degrades or when the key and keyhole, and / or key and lock, and / or ball and socket, and / or hook junctions are free of the polymer, cement, adhesive, solder, etc. material, for example, in response to normal pulsation of a blood vessel or other body lumen, or other physiological conditions described throughout this application. In one embodiment, the key and keyhole, and / or key and lock, and / or ball and socket, and / or hook junctions may be substantially held together by a junction geometry that limits or substantially limits movement of the junctions in one or more directions sufficiently to allow the stent to deploy and the stent to have sufficient strength to support a body lumen after deployment (initial deployment). In preferred embodiments, such junctions remain substantially held together upon deployment (expansion from a crimped configuration to a larger expanded configuration), and the stent has sufficient strength in the expanded configuration to support a body lumen.In a preferred embodiment, the junction means holding them together is a junction geometry such as a key and keyhole, and / or key and lock, and / or ball and socket, and / or hook type, and / or other type of junction. The separation region junction can also be a butt junction connecting and / or joining two ends of stent structural elements and / or rings, the ends having various shapes and / or cross-sectional shapes (including substantial shape types), such as round, and / or spherical, and / or square, and / or rectangular, and / or neurosynaptic type junctions, and / or other types of shapes, and / or substantially such shapes. In one embodiment, a deployment means such as a balloon catheter provides for holding the discontinuities together upon deployment of the stent, wherein the stent is allowed 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 a larger expanded configuration.

[0121] The separation region may also comprise, in another embodiment, a simple butt joint or overlapping section of a stent structural element, where the structural element is a solid wire (having various shapes, such as substantially circular, rectangular, and / or square, and / or neural synapse, and / or other shapes), and / or a hollow wire / tube structural element (hollow at least in the region adjacent to the separation region) having opposing free ends temporarily joined by means such as adhesives and / or connectors and / or polymers and / or solders and / or sleeves that degrade and / or separate and / or interrupt in a physiological environment. Such means may hold the free ends together by placing them between, adjacent to, covering, inside hollow sections of the free ends, and / or any combination of the above.

[0122] In still other cases or examples, the separation region may comprise cutouts or thinned sections formed in the circumferential ring and / or circumferential structural element that preferentially erode or fatigue in a physiological environment, subsequently forming a partial or complete separation that allows the circumferential ring to expand. 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 selected to preferentially fail and / or erode (including corrode) in a physiological environment compared to the remainder of the circumferential ring. Another example is a joint that may be formed starting with an intact circumferential ring, forming one or more cuts in the ring, and then rejoining the cuts using means such as a sleeve, adhesive, solder, connector, coating, and / or the like that are configured to degrade or erode or fatigue or fail in a physiological environment. For example, solder, adhesive, and / or polymer may be applied to the butting and / or overlapping and / or hollow ends of the resulting fitting. Alternatively, the connector may comprise a sleeve, ring, coil, or other circumscribing structure that holds the fitting together until such structure degrades and / or separates in a physiological environment. In a preferred embodiment, a sleeve or coating comprising a polymer such as Parylene may be applied, which allows the separate free ends of the fitting and / or junction to be contained within such sleeve or coating.

[0123] In another embodiment, a stent comprises a non-degradable metal or metal alloy, the stent comprising a structure comprising a plurality of rings, the rings comprising struts joined by crowns, at least some of the rings having at least one crown, and no more than three-quarters of the crowns (preferably at least one and no more than one-half of the crowns) being shaped and / or patterned to have a crown cross-sectional area that is smaller and / or smallest than the cross-sectional area of ​​adjacent crowns and / or the largest crown cross-sectional area within the ring. The cross-sectional area can be measured approximately at the apex of the crown and / or at any other point / section on the crown. The cross-sectional area of ​​the smaller (including smallest) crown ranges from 25% to 90% smaller (preferably 50% to 75% smaller) than the cross-sectional area of ​​adjacent crowns and / or the largest crown cross-sectional area within the ring. The cross-sectional area of ​​the smaller (including smallest) crowns ranges from 400 to 3,000 square microns, preferably from 400 to 2,500 square microns, and more preferably from 400 to 1,500 square microns, allowing the smaller cross-sectional area crowns to expand further after expansion. The smaller (including smallest) crowns can optionally have sleeves and / or coatings and / or solders made of polymers and / or adhesives and / or other materials that hold the crowns (and / or struts joined by the crowns) in a crimped or substantially crimped configuration upon deployment of the stent, and the sleeves and / or coatings and / or solders degrade and / or dissolve and / or relax after deployment (expansion), allowing the stent to expand further as the smaller cross-sectional crowns are allowed to open and / or expand under physiological conditions. The stent has sufficient strength upon deployment to support a body lumen. In another embodiment, the stent has sufficient strength to support a body lumen upon deployment, and the stent strength decreases after the sleeve, and / or coating, and / or adhesive, and / or solder dissolves and / or degrades under physiological conditions after deployment.The cross-sectional area of ​​at least ¼ to ¾ of the crown, preferably at least ½ to ¾ of the crown, more preferably at least ¾ of the crown, ranges from 3,500 to 25,000 square microns, preferably from 4,000 to 10,000 square microns, more preferably from 4,500 to 8,000 square microns. The cross-sectional area measurements in the above examples do not include other materials, such as polymers, metals, coatings, etc., that may be on or within the crown, for the same type (or same) non-degradable material (metal or metal alloy material) of a structural element, such as a stent or crown, when comparing a crown with a larger cross-sectional area. Alternatively, a smaller cross-sectional area of ​​the crown can be achieved by incorporating a material different from the non-degradable metal or metal alloy, or by having a less dense or weaker material in the crown region, and / or by having one or more grooves, holes, depressions, crescents, crown shapes, and / or channels in, on, and / or through the crown region. The grooves, holes, depressions, crescents, crown shapes, and / or channels in, on, and / or through the crown region can be filled and / or coated with at least one material comprising a polymer, a metal or metal alloy (preferably different from the metal or metal alloy forming the stent), an adhesive, and / or solder, and / or other suitable material. In this embodiment, the smaller cross-sectional area is achieved by having a softer, weaker, or less dense material or voids in the crown region that effectively reduces the cross-sectional area of ​​the non-degradable metal or metal alloy in the crown compared to the cross-sectional area of ​​the same type of metal or metal alloy in the adjacent crowns (or a wider cross-sectional area of ​​the same type of metal or metal alloy). The material is preferably different from the crown material. After deployment, the material can remain in the crown region, dissolve, and / or degrade / erode, allowing the stent to detach and / or further expand under physiological conditions.The stent upon deployment has sufficient strength to support a 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 stiffness (preferably 2-10 times lower stiffness) than the crown material and is softer, more extensible, and / or lighter than the crown material. The crown, in one embodiment, can 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 strain after expansion and / or a decrease in radial strength after expansion. In another embodiment, the increase in radial strain and / or decrease in strength begins one week after stent expansion to nine months after stent expansion, preferably one month after expansion to six months after expansion, more preferably two months after expansion to six months after expansion. In another embodiment, at least some struts have a thinned cross-sectional area as described in this paragraph.

[0124] In another example, 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" structures, e.g., patterned to create void areas or "voids" within the crowns, struts, or other structural components of the stent scaffold where metal has been removed by patterning, cutting (such as laser cutting), grinding, or the like. Optionally, the voids may be fully or partially filled with a degradable or non-degradable filler 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 a body lumen. The filler material may be more or less stiff than, or in some cases have comparable stiffness to, the metal or metal alloy material of the stent. The voids may be fully filled, partially filled, or in some cases overfilled such that the filler extends beyond the boundaries of the stent scaffold prior to void formation.

[0125] Such filled voids on the crown region may deform, for example, in response to stent expansion, allowing the stent's compliance and strength to vary over time. In many embodiments, filled voids on the crown may enhance the strength of the scaffold upon expansion and implantation, but may also reduce compliance. However, by using a filler material that degrades, softens, or otherwise loses strength when exposed to a vascular or other physiological environment, the compliance of the scaffold may increase, which in turn may increase the composite or combined compliance of the stent and vascular or other body lumen. While strength may simultaneously decrease, such a decrease in strength is usually acceptable after the vascular or other body lumen has opened and the luminal wall has at least partially healed. Thus, at least some rings of the stent may detach, further expand, and / or exhibit vasoreactivity. The thickness of the metal or metal alloy surrounding the cavitated or void region in the crown region (side region, luminal surface region, or abluminal surface region) ranges from 10 microns to 50 microns, preferably from 20 microns to 40 microns. The hollowed crown region can be hollowed in various ways, such as leaving two side regions of the crown region intact and hollowing out the region between the two side regions; leaving one side region and the luminal surface region intact while the other side region and the abluminal surface region are hollowed; leaving the two side regions and the luminal surface region intact while the abluminal surface region is hollowed; all surface regions (abluminal, luminal, two sides) remain intact but the inner core of the crown region is hollowed out; and / or leaving one side region, the abluminal surface region, and the luminal surface region intact while the core is hollowed out from the other side region; or other methods that allow the crown region to detach from the stent after expansion. The combined total cross-sectional area of ​​the non-degradable metal or metal alloy for the one or more crown regions 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, and more preferably from 500 to 2,500 square microns.In another embodiment, the hollowed regions are filled with another material (degradable or non-degradable), and the material after expansion allows the crown regions, rings, and / or stent to detach and / or have increased radial strain and / or have increased radial strain and decreased radial strength. In another embodiment, at least some of the struts along at least some of the rings are hollowed as described in this section.

[0126] Voids may also be formed in the struts and other components of the scaffolding rings or other scaffolding structures. For example, channels, slots, and the like may be formed over part or all of the length of at least some of the rings, including the struts, crowns, and any other structural components. As with the other voids described above, the channels, slots, and the like may be partially or completely filled with a second degradable polymeric or metallic material, referred to herein as a "reinforcing material," to provide sufficient composite strength to enhance the radial strength of the stent immediately after expansion; the reinforcing material typically degrades after expansion and implantation, typically reducing stent strength while enhancing compliance. The underlying non-degradable material of the struts and other components of the scaffolding rings or other scaffolding structures is typically less than 1,000 μm. 2 ~4,000μm 2 , preferably 1,500 μm 2 ~3,500μm 2The degradable reinforcement material, having a cross-sectional area within the range of 1 / 2 to 1 / 4, coating all or a portion 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, and the combined base and coating reinforcement material has sufficient strength to support the body lumen upon expansion (and prevent recoil within the vessel lumen), and after expansion and implantation, compliance increases and the strength of at least some of the rings decreases, causing the stent to detach. The channel depth is typically 40% to 90%, preferably 50% to 85%, more preferably 60% to 80% of the non-degradable material thickness, and the channel and slot width is typically 40% to 90%, preferably 50% to 85%, more preferably 60% to 80% of the non-degradable material width. The channel and slot width and thickness can vary along the length of the channels and slots on at least some of the rings. The channels may be disposed on the abluminal surface region, the luminal surface region, and / or on both the abluminal and luminal surface regions. The slots will typically extend from the abluminal surface to the luminal surface.

[0127] Alternatively, or in addition, one or more thinned regions may be formed along some or all of the rings or other circumferential elements of a non-degradable scaffold to increase scaffold compliance and facilitate detachment of the scaffold after implantation. Such thinned regions may be present in crown regions, strut regions, or on other components of the rings or other structures that affect circumferential compliance. By "thinned," we mean that the crowns, struts, or other scaffold components have a nominal cross-sectional dimension throughout the majority of the component's length, and that the nominal cross-sectional dimension is reduced in the region designated as "thinned." Thinned regions can be located within adjacent crowns, alternating crowns, every third crown, or in other patterns or configurations to achieve sufficient strength to support a body lumen upon deployment and increase compliance after expansion. Such thinned regions can have a smaller thickness and / or width and / or cross-section relative to the nominal dimension sufficient to facilitate detachment after implantation. Without any further modification, the thinned region will typically provide both lower scaffold strength and increased compliance, at least in the thinned region of the component. Optionally, the thinned region can be reinforced with a coating, lamination, or other bonding of a reinforcing material to provide strength in response to expansion, while typically degrading after expansion to increase compliance. Such biodegradable reinforcing materials can be similar to the fillers described elsewhere herein, which are typically degradable polymers but may also be degradable metals. Suitable reinforcing materials will degrade over a period of time after implantation or exposure in the vascular environment ranging from 30 days to 3 years, preferably from 3 months to 2 years, and more preferably from 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 crowns along the length of the ring, the base stent in some embodiments not having sufficient strength to support (or maintain) the body lumen in the absence of a reinforcing material bonded to the base stent, the reinforcing material having sufficient weight and thickness (such as a polymer coating) to increase the strength of the base stent until it is sufficient to support (or maintain) the body lumen.

[0128] For example, the thinned cross-sectional areas along the length of the circumferential rings may be coated, laminated, or otherwise covered with sufficient reinforcing material to reinforce the stent scaffolding upon expansion, and as the material degrades after expansion and exposure to the vascular or other luminal environment, the stent strength decreases and compliance increases. 2 ~4,000μm 2 , preferably 1,500 μm 2 ~3,500μm 2 The stent may be formed from a non-degradable base material component having a cross-sectional area in the range of 100 μm to 120 μm, and the degradable reinforcing material coating the non-degradable material adds an additional 40 μm to 120 μm to the thickness and / or width of the scaffold base material forming the base component, wherein the combined base and coating material has sufficient strength to support a body lumen upon expansion, and after expansion and implantation, compliance increases and the strength of at least some of the rings decreases, causing the stent to detach.

[0129] In another embodiment of any of the embodiments herein, the stent prosthesis exhibits one or more of the following (including one or more of the following): detaches after expansion; increases radial strain (or compliance); increases radial strain (or compliance) and decreases radial strength; exhibits vasoreactivity or vasodilation of the stented section; expands further to a second, larger configuration; is capable of expanding and / or contracting after deployment; changes configuration from the deployed configuration; changes displacement of the stent in at least one dimension; has greater displacement after expansion in at least one direction.

[0130] Suitable stent materials include, but are not limited to, polymers, metals (metals and metal alloys), adhesives, coatings, solders, sleeves, sealants, fixation materials, cements, energy fixation, and adhesives and fixation materials include, but are not limited to, cyanoacrylates such as polyalkyl-2-cyanoacrylate, methyl-2-cyanoacrylate, ethyl-2-acrylate, n-butyl cyanoacrylate, 2-octyl cyanoacrylate, or others, epoxies, epoxyamines, UV curable materials from Loctite, Dymax, Master Bond, or others, acrylics, silicones, hot melts, polyurethanes, lysine-based adhesives such as Gorilla Glue, TissueGlu, Sylys surgical sealant, or others, fibrin glue, beeswax, and other adhesives, sealants, and potting compounds. 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 Other fastening materials may also be used, such as solders or low-melting alloy materials, such as 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 B57Sn42Ag1, Bi58Sn52, or others; gold or its alloys, such as Au80Sn20, Au98Si2, Au87.5Ge12.5, Au82In18, or others. Other means for fastening include laser bonding or welding or fusing or other means of energy fastening (including bonding and splicing), cyanoacrylates such as polyalkyl-2-cyanoacrylate, methyl-2-cyanoacrylate, ethyl-2-acrylate, n-butyl cyanoacrylate, 2-octyl cyanoacrylate, or others, epoxies,Epoxyamines, UV curable materials from Loctite, Dymax, Master Bond, Henkel, or others, acrylics, silicones, hot melts, polyurethanes, Gorilla Glue, polyesters, polylactides and their copolymers and blends, polytrimethylene carbonate and their copolymers and blends, polyvinyl alcohol, polyvinyl acetate, ethylene-vinyl acetate (hot melt adhesives), phenol formaldehyde resins, polyamides, polyester resins, polyethylene (hot melt adhesives), polypropylene, polystyrene, polycarbonate, polychloroprene, natural rubber, silicone rubber, lysine-based adhesives such as TissueGlu, Sylys surgical sealant, or others, bioadhesives such as fibrin glue, beeswax, casein, mussel adhesive protein, and collagen, solvent-based polymer dispersions or neat adhesives, sealants, and potting compounds such as Sn97Cu3, Sn50Zn49Cu1, Sn95.5Cu4A g0.5, 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, I Suitable stent materials that are non-degradable within a 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 chromium, L605, Cr ...Platinum-based alloys such as Elgiloy®, Phynox®, platinum-chromium, platinum-iridium, and platinum-rhodium, tin-based alloys, rhodium, rhodium-based alloys, palladium, palladium-based alloys, aluminum-based alloys, titanium or alloys thereof, 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 linear elastic and / or superelastic nitinol, nickel-chromium-molybdenum alloys (e.g., INCONEL 625, Hastelloy C-22, Hattelloy C276, Monel 400, Nickelvac 400, and the like), nickel-cobalt-chromium-molybdenum alloys such as MP35-N, nickel-molybdenum alloys, platinum-enriched stainless steels, combinations thereof, or the like, and other malleable metals of the type commonly employed in stent and prosthetic device manufacturing. In other examples, the non-degradable material may comprise a non-degradable polymer such as polyaryletherketone, polyetheretherketone, polyimide, polyethylene such as UHMW, HDPE, LDPE, or others, polypropylene, polyester, polyethylene terephthalate, polycarbonate, polysulfone, polyphenylsulfone, polyethersulfone, Ultem, polyetherimide, polyurethane, polyamide, nylon such as nylon 12, nylon 6, nylon 6-6, or others, polyvinyl chloride, PTFE, FEP, ETFE, PFA, PVDF, polyvinyl chloride, acrylobutadiene styrene, Delrin, polymethyl methacrylate, polystyrene, polyacrylamide, polyphenylsulfide, PEBAX, or other materials. In still other embodiments, the non-degradable material is a shape or heat memory alloy, a shape memory polymer, or a 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,The degradable material may comprise a resilient material such as PVDF / PMMA, PVDF / PVA, PLA / PVAc, or other or equivalent. Examples of degradable materials, such as degradable polymeric materials, include lactide, caprolactone, trimethylene carbonate, glycolide, poly(L-lactide), poly-DL-lactide, polylactide-co-glycolide (e.g., poly(L-lactide-co-glycolide), copolymers of poly(L-lactide-co-epsilon-caprolactone) (e.g., about 50 to about 95% L-lactide to about 50 to about 5% caprolactone by weight), poly(L-lactide-co-trimethylene carbonate), polytrimethylene carbonate, Polycaprolactone, 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 copolymers (PHV / PHB), polyhydroxyalkanoates, polyorthoesters, polyanhydrides, polyiminocarbonates, tyrosine-derived polycarbonates, tyrosine-derived polyacrylates, iod ... Lactone-based polymers such as iodinated and / or brominated tyrosine-derived polycarbonates, iodinated and / or brominated tyrosine-derived polyacrylate polyesteramides, polycarbonate copolymers, poly(propylene fumarate-co-ethylene glycol) copolymers (also known as fumaric anhydride), polyanhydride esters, polyorthoesters, silk elastin polymers, polyphosphazenes, aliphatic polyurethanes, polyhydroxy acids, polyether esters, polyesters, polydepsipeptides, poly(alginate), ... poly(ethylene oxalate), polyaspartic acid, polyglutaric acid polymers, poly-p-dioxanone, poly-beta dioxanone, asymmetric 3,6-substituted poly-1,4-dioxane-2,5-dionone, polyalkyl-2-cyanoacrylate, polydepsipeptide (glycine-DL-lactide copolymer), polydihydropyran, polyalkyl-2-cyanoacrylate, poly-beta-maleic acid (PMLA), polyalkanoates, poly-beta-alkanoic acids, polymers, blends, and / or copolymers,or a combination thereof.

[0131] In another embodiment, suitable materials include suitable stent materials, including polymers and metals (degradable or non-degradable), adhesives, coatings, solders, sleeves, sealants, potting compounds, fixation materials, cements, energy fixation, elastomers, and other types of materials. Suitable materials include, but are not limited to, cyanoacrylates such as polyalkyl-2-cyanoacrylate, methyl-2-cyanoacrylate, ethyl-2-acrylate, n-butyl cyanoacrylate, 2-octyl cyanoacrylate, or others; lysine-based adhesives such as Gorilla Glue, TissueGlu, Sylys surgical sealant, or others; fibrin glue; beeswax; epoxy; epoxyamine; Loctite; Dymax; Masterbatch; UV curable materials from Bond, or others; degradable sleeve materials, stent materials, and coatings such as acrylics, silicones, hot melts, polyurethanes, polyesters, etc.; polylactides and their copolymers and blends; copolymers of lactide, caprolactone, trimethylene carbonate, glycolide; poly(L-lactide), poly-DL-lactide, polylactide-co-glycolide (e.g., poly(L-lactide-co-glycolide), copolymers of poly(L-lactide-co-epsilon-caprolactone) (e.g., about 50 to about 95% L-lactide to about 50 to about 5% caprolactone by weight); poly(L-lactide-co-trimethylene carbonate), polytrimethylene carbonate, polycaprolactone, 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 copolymers (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 polyesteramides, polycarbonate copolymers,Lactone-based polymers such as poly(propylene fumarate-co-ethylene glycol) copolymer (also known as fumaric anhydride), polyanhydride esters, polyorthoesters, silk elastin polymers, polyphosphazenes, aliphatic polyurethanes, polyhydroxy acids, polyether esters, polyesters, polydepsipeptides, poly(alkylene oxalates), polyaspartic acid, polyglutaric acid polymers, poly-p-dioxanone, poly-beta-dioxanone, asymmetric 3,6-substituted poly-1,4-dioxane-2,5-dionone, polyalkyl-2-cyanoacrylates, polydepsipeptides (glycine-DL-lactide copolymers) ), 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 polyserine, polycaprolactam, cyclodextrin, chitosan, and hyaluronan, non-degradable adhesives, sealants, and potting compounds such as alginates, polyketals, fatty acid-based polyanhydrides, amino acid-based polyanhydrides, poly(ester anhydrides), polymer blends, and / or copolymers, or combinations thereof, or the like. 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 Corrosive solders or low-melting alloys such as .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 solders or fusible alloys such as gold or its alloys, such as Au82In18. Degradable and non-degradable polymers include polyesters, polylactides and their copolymers and blends, copolymers of lactide, caprolactone, trimethylene carbonate, glycolide, poly(L-lactide), poly-DL-lactide, polylactide-co-glycolide (e.g., poly(L-lactide-co-glycolide), copolymers of poly(L-lactide-co-epsilon-caprolactone) (e.g., about 50 to about 95% L-lactide to about 50 to about 5% caprolactone by weight), poly(L-lactide-co-trimethylene carbonate), poly(L-lactide-co-trimethylene carbonate), poly(L-lactide-co-epsilon-caprolactone ...trimethylene carbonate), poly(L-lactide-co-trimethylene carbonate), poly(L-lactide-co-trimethylene carbonate), poly(L-lactide-co-trimethylene carbonate), poly(ethylene carbonate), polytrimethylene carbonate, polycaprolactone, 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 copolymers (PHV / PHB), polyhydroxyalkanoates, polyorthoesters, polyanhydrides, polyiminocarbonates, tyrosine-derived polycarbonates, tyrosine-derived polycarbonates, Lactone-based polymers such as tyrosine-derived polyacrylates, iodinated and / or brominated tyrosine-derived polycarbonates, iodinated and / or brominated tyrosine-derived polyacrylate polyesteramides, polycarbonate copolymers, poly(propylene fumarate-co-ethylene glycol) copolymers (also known as fumaric anhydride), polyanhydride esters, polyorthoesters, silk elastin polymers, polyphosphazenes, aliphatic polyurethanes, polyhydroxy acids, polyether esters, polyesters, polydepsipeptides, poly Poly(alkylene oxalate), polyaspartic acid, polyglutaric acid polymer, poly-p-dioxanone, poly-beta dioxanone, asymmetric 3,6-substituted poly-1,4-dioxane-2,5-dionone, polyalkyl-2-cyanoacrylate, polydepsipeptide (glycine-DL-lactide copolymer), polydihydropyran, polyalkyl-2-cyanoacrylate, poly-beta-maleic acid (PMLA), polyalkanoates, poly-beta-alkanoic acid, elastin, fibrin, collagen, glycoproteins, gelatin,or proteins such as pectin, polysaccharides such as polyserine, polycaprolactam, cyclodextrin, chitosan and hyaluronan, alginates, polyketals, fatty acid-based polyanhydrides, amino acid-based polyanhydrides, poly(ester anhydrides), polymer blends and / or copolymers, or combinations thereof, or the like, polyvinyl alcohol, polyvinyl acetate, ethylene-vinyl acetate (hot melt adhesives), phenol formaldehyde resins, polyamides such as nylon 12, nylon 6, nylon 6-6, or others, polyester resins, polyethylene (hot melt adhesives), UHMW, HDPE, LDPE, or or other materials including polychloroprene, polyaryletherketone, polyetheretherketone, polypropylene, polystyrene, polyester, polyethylene terephthalate, polycarbonate, polysulfone, polyphenylsulfone, polyethersulfone, Ultem, polyetherimide, polyurethane, polyvinyl chloride, PTFE, FEP, ETFE, PFA, PVDF, polyvinyl chloride, acrylobutadiene styrene, polyacetals such as Delrin, polymethyl methacrylate, polystyrene, polyacrylamide, polyphenylsulfide, PEBAX, and / or copolymers and / or combinations thereof. Silicone rubber, C-flex, poly(n-butyl methacrylate), poly(methmethacrylate), poly(hexyl methacrylate), and poly(n-butyl methacrylate) blended with polyvinylpyrrolidone, 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), polyvinylpyrrolidone, poly(ethylene-co-vinyl acetate), phosphorylcholine, PEBAX, polyurethane elastomer, Tecoflex, Biomer, Pellethane, corethane, silicone rubber, rubber, elastomer, blend, copolymer, combination thereof,or equivalents. Shape or heat memory alloys, shape memory polymers, or superelastic materials, typically non-corrosive elastic metals or metal alloys such as 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, or equivalents. Metals or metal alloys that have high initial strength and become brittle over time include stainless steels such as Ti6Al4V, Ti5Al2.5Sn, or Ti-10V-Fe-3Al, SAF2507, and the like; zinc alloys such as Zn5Al, Zn10Al, Zn18Al, and Zn30Al, platinum metal and its alloys, tin alloys such as Sn3.9Ag0.6Cu, Sn-3.8Ag-0.7Cu, SnPb, or SnPbAt, Al1.7Fe, Al0.7Cu, and Al1.5MgScZr. aluminum alloys such as 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; and 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 metal and its alloys; Al1.7Fe, Al0.7Cu, Al1.5MgScZr, Al6Mg0.2Sc0.15Zr; aluminum alloys such as 3004, 8090, 7075, 6061, or 5056; zirconium alloys such as Zr55Al10Ni5Cu30; 304V, 304L, and 316LV stainless steels; alloy steels such as mild steel; cobalt-based alloys such as cobalt-chromium; platinum-based alloys such as L605, Elgiloy®, Phynox, platinum-chromium, platinum-iridium, and platinum-rhodium; tin-based alloys; rhodium; rhodium-based alloys; palladium; palladium-based alloys; aluminum-based alloys; titanium or alloys thereof;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 linear elastic and / or superelastic nitinol, nickel-chromium-molybdenum alloys (e.g., INCONEL 625, Hastelloy C-22, Hatelloy C276, Monel 400, Non-corrosive (non-degradable) metals or metal alloys such as nickel alloys such as Nickelvac 400, 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 equivalents. Corrosive metals or metal alloys (degradable) include nickel, cobalt, tungsten, rhenium, tungsten alloys of cobalt, iron, zirconium, zinc, titanium, magnesium, magnesium alloys, magnesium alloy AZ31, magnesium alloys with less than 20% by weight of zinc or aluminum and without or with less than 3% of one or more of the following impurities: iron, silicon, manganese, cobalt, nickel, yttrium, scandium, or other rare earth metals, AZ31B or MG11li5Al1Zn0.034Sc (LAZ1151), zinc or its alloys such as zinc alloys Zn5al, Zn10Al, Zn18Al, Zn30Al, etc., bismuth or its alloys, indium or its alloys, tin or tin-lead, Sn3.9Ag0.6Cu, Sn-3.8Ag-0.7Cu, SnPb, or SnPbAt, silver or its alloys such as silver-tin alloys, cobalt-iron alloys, iron or 80-55-06 grade ductile cast iron, other ductile cast irons, AISI Includes 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 (such as 40% bismuth-60% tin, 58% bismuth-42% tin, bismuth-tin-indium alloys), 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.

[0132] In another embodiment or aspect, the present invention provides a non-degradable prosthesis having rings with energy-responsive separation regions. Such an endoluminal prosthesis comprises a scaffold having circumferential rings patterned from a non-degradable material, the scaffold configured to expand from a crimped configuration to an expanded configuration. At least some of the circumferential rings will have separation regions configured to form one or more discontinuities in the circumferential rings in response to energy applied to the separation regions after deployment and / or implantation of the prosthesis in a body lumen. Such discontinuities allow the scaffold to detach and / or, if applicable, further expand beyond an initial expanded diameter, e.g., after recoil, typically achieved by balloon expansion, self-expansion, or the like.

[0133] The energy promoting or causing the discontinuity may be energy associated with the site of implantation, or may be 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 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 results in thermal and / or mechanical movement, e.g., vibration, of the separation region. Specifically, such movement-responsive separation regions may, in one example, comprise notches, thinned regions, junctions, butt joints, key-and-lock designs, or other localized areas or focal points that preferentially fatigue and fail in response to applied energy, and / or preformed separation regions that interrupt in response to applied energy. For example, the separation region may comprise a "living hinge" that cycles open and close, separates, or ultimately fatigues and fails in response to pulsation or application of external energy. In yet another embodiment, the isolation region may comprise modified grain boundaries in the metal ring where the grains are particularly susceptible to vibration-induced fatigue.

[0134] In other embodiments or examples, the separation regions may comprise preformed breaks or preformed separation regions in the circumferential ring, and these breaks or discontinuities are reconnected using connectors configured to open in response to applied or endogenous energy (or in response to physiological conditions). Typical forms of externally applied energy include ultrasound, pharmaceutical agents, heat, magnetic, radiofrequency energy, high intensity focused ultrasound (HIFU), and the like.

[0135] In other examples and / or embodiments, the separation region may comprise a key and lock junction formed in the circumferential ring and / or circumferential structural element, which is initially locked before, during, or in response to expansion, but is configured to open in response to applied energy or physiological conditions, either external or endogenous. In yet other examples or embodiments, the separation region may comprise a rivet or other fastener joining the breaks in the circumferential element, which is configured to open in response to applied energy or physiological conditions, either external or endogenous.

[0136] In another embodiment and / or fourth aspect, the present invention provides non-degradable or slowly degradable prostheses having rings with constrained hinges, and methods for their use and fabrication. The endoluminal prostheses include a scaffold having a circumferential ring pattern made of 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 and / or after the scaffold is deployed. At least some of the hinges on at least some of the rings are configured to contract from the expanded configuration during deployment and to open after deployment in response to a physiological environment or the application of external energy. Specific physiological environments and external energy that can release the hinges from contraction are fully described above and throughout this application.

[0137] In one example, by initially constraining at least some of the hinges of the circumferential rings, the scaffold will initially expand to a diameter appropriate for the body lumen being treated and, while still in that configuration with the constrained hinges, will possess sufficient strength to rely on for patency of that body lumen. However, after deployment and / or over time, the initially constrained hinges will be released, lowering 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. In this way, the endoluminal prosthesis will have reduced energy confining or restraining the treated body lumen, thereby allowing the scaffold to expand and / or the lumen to expand.

[0138] 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 includes a scaffold having circumferential rings patterned from a non-degradable material. The scaffold is configured to deploy from a crimped configuration to an expanded configuration, and the circumferential rings include struts connected by joints that open as the scaffold is deployed, typically by balloon expansion. At least some of the joints may be pivoted to allow the scaffold in its expanded configuration to disengage and / or further expand. The pivots or "active joints" may, in some cases, be asymmetric. That is, the joints may allow radial expansion of the circumferential rings but limit radial contraction of the rings.

[0139] In different embodiments or examples, the shape of the reinforcing or bridging elements can be substantially circular (solid round wire or hollow round wire), rectangular, square, oval, or other shapes and geometries. The size of the reinforcing element can, in some examples, be substantially the same size / geometry as the hinge, expansion region, and / or strut to which it is coupled, while in other examples, the size / geometry of the reinforcing element can be smaller or larger than the expansion region. In one example, the ends of the reinforcing element are atraumatic and / or smooth, and / or have a bulbous or rounded shape, and / or a wider cross-sectional area to reduce trauma to the 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.

[0140] In one example of a degradable material, the polymer 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, and more preferably 6 months to 1 year after deployment of the endoluminal prosthesis. In another example, the reinforcing elements are at least partially encapsulated by a material such as a thin polymeric material. Examples include Parylene and C-Flex materials.

[0141] In another embodiment, the separate regions of the non-degradable scaffold are configured to separate at a periodic interval up to 3 years after deployment, typically ranging from 1 day to 3 years, 1 month to 3 years, preferably 3 months to 2 years, and more preferably 6 months to 1 year. In one embodiment, the separate regions separate at approximately the same time period, and in another embodiment, the separate regions separate at different time periods.

[0142] 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 joining or containing or holding the separation regions together is an expandable-type polymer or adhesive material (degradable or non-degradable) that does not allow, or allows some movement of, the separation regions without prematurely forming discontinuities (before or after deployment). This also allows for consistent performance of the scaffold and improved storage conditions and shelf life of the stent and separation regions, allowing for long-term shelf life under a variety of 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 storage period of 1 month to 3 years, preferably from 1 month to 2 years, or from 1 month to 18 months, at a relative humidity of 10% to 95%, preferably from 20% to 70%. Examples of the material are described herein.

[0143] 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.

[0144] In one example, the reinforcing element and / or separation region and / or environmentally-responsive separation region are formed from a non-degradable material, such as a non-degradable metal and / or polymer or other material. The reinforcing element and / or separation region and / or environmentally-responsive separation region may alternatively be formed, in whole or in part, from a degradable (erodible) material, such as a degradable metal (such as magnesium and magnesium alloys), or a degradable polymer (such as lactide polymers, copolymers, and blends thereof), or combinations thereof. In one example, the reinforcing element and / or separation region and / or environmentally-responsive separation region are formed from an erodible material that corrodes after implantation, causing the stent or other endoluminal prosthesis to detach, preferably without the formation of unwanted by-products, such as hydroxyapatite material, adjacent the separation region.

[0145] In one example, the endoluminal prosthesis is a stent prosthesis comprising a substantially tubular structure, the tubular structure being patterned, the stent prosthesis comprising separated regions, 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 fracturing and / or having low recoil. The deployed stent, in this example, is configured to do one or more of the following: the stent and / or circumferential structural elements and / or rings are configured to separate, expand, form discontinuities, and / or collapse in at least one segment and / or region or more after deployment and / or implantation; and / or the stent undergoes modification after deployment or implantation, including unlocking, degrading, or containing with a sleeve or material that does not prevent the separated regions from detaching, causing at least one portion of the stent structure to separate, expand, or and / or collapse, and / or the stent further expands after deployment, and / or the stent further expands after deployment and after correction, 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 after correction with assistance from a source (chemical, energy), and / or the stent is configured to push the lumen and expand for a period after deployment or implantation, and / or the stent is configured to allow the lumen or vessel to expand / dilate, or combinations thereof. The stent comprises a non-degradable material, or comprises two non-degradable materials, or comprises a degradable material, or comprises two degradable materials, or comprises two degradable materials and one non-degradable material, or comprises a non-degradable material and an erodible material, or comprises a degradable material and an erodible material, or comprises a degradable material, an erodible material, and a non-degradable material.The stent may further comprise at least one coating on at least one surface of the stent prosthesis, which may be degradable and / or non-degradable. The above materials exclude marker materials, which 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 may also comprise at least one coating on at least one surface of the stent prosthesis.

[0146] In one embodiment, the stent prosthesis comprises a structure, preferably a substantially tubular structure, more preferably a substantially tubular patterned structure with discrete regions. The stent prosthesis is typically expandable from a crimped configuration to a deployed, larger, expanded configuration. The stent structure comprises at least one main or principal material on at least one section of the stent, preferably 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 interfacing with or bonded to at least the section of the frame material, preferably the section being a crown section 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 crushing and / or expands with low recoil. The stent undergoes modification after deployment, the modification including degradation of at least a portion of the frame material, and / or degradation of at least a portion of the second material, and / or erosion of at least a portion of the first material, and / or erosion of at least a portion 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, and / or combinations thereof. In another example, 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 second material.In another embodiment, the modified stent further expands from the pre-modification configuration to a larger configuration, and / or further expands from the deployed configuration to a larger configuration, and / or further expands from the "post-deployment recoil" configuration to a larger configuration, and / or further expands to a larger configuration for any of the preceding reasons in at least one ring of the stent prosthesis, and / or further expands to a larger configuration in at least one ring of another stent prosthesis, where the ring is centered about the intermediate portion of the stent length. In another embodiment, at least one discontinuity in at least one ring of the modified stent allows the stent to further expand in the at least one ring under physiological pressure. In another embodiment, the stent prosthesis collapses after deployment and / or modification in at least one ring, crown, and / or strut. In one embodiment, the stent prosthesis after deployment and / or modification and / or 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 fenestration, 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.

[0147] In certain embodiments, the stent comprises a substantially tubular patterned structure (serpentine, diamond, zigzag, and / or other open-cell or closed-cell structure) comprising a plurality of rings, the rings comprising crowns and struts, at least some of the rings being connected to adjacent rings by at least one link, or in some cases, several adjacent rings being connected together at at least one location.

[0148] In embodiments, the scaffold or ring material comprises a metal and / or metal alloy. The metal and / or metal alloy may be non-degradable or degradable / corrodible. Metal herein excludes markers and marker materials, which may be metals or metal alloys and may be degradable or non-degradable. Corrosive metals or metal alloys corrode over a period ranging from 1 month to 10 years, preferably from 3 months to 5 years, and more preferably from 3 months to 3 years.

[0149] In an embodiment, the second material (or reinforcing element) has at least two ends, and the ends are deburred, shaped into a "neural synapse"-like ball, and / or smoothed to prevent damaging the lumen or vessel and / or causing inflammation after the stent collapses and / or after modification. In another embodiment, the stent is configured not to degrade outside of the separation region and / or sections configured to degrade after modification and / or after separation of the separation region, forming discontinuities and / or destroying portions of the stent, by reducing stress and / or fatigue areas on the stent.

[0150] In an embodiment, the main or frame material comprises a polymeric material. The polymeric material can be degradable or non-degradable. In one embodiment, the polymeric material degrades over a period ranging from 1 month to 10 years, preferably from 3 months to 5 years, and more preferably from 3 months to 3 years.

[0151] In embodiments, the primary or frame material is non-degradable and / or degradable at a faster rate than the second material (reinforcement element), and / or degradable at substantially the same rate as the second material and / or degradable at a slower rate than the second material.

[0152] In examples, the stent, in any of the examples and / or embodiments herein, is one or more of the following: 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 formed from a mold, or by printing, or by extrusion, or by spraying, or by dipping, or by stamping, or combinations thereof. The stent has discrete regions that are formed before, during, or after patterning, or after procedures that form such discrete regions and / or discontinuities. Means for maintaining the discontinuities are described throughout this application.

[0153] In some embodiments, the second reinforcement material bonded to or interfacing with the structural scaffold material may be completely embedded within the frame, or at least one surface or surface region may be embedded within at least one surface or surface region of the frame, or at least two surfaces may be embedded within at least one surface of the frame, or at least three surfaces may be embedded within at least one surface of the frame, or at least one surface of the second material may be attached (and / or joined and / or abut and / or adhered and / or press-fit) to at least one surface of the frame material. At least one surface of the frame material may be an abluminal surface, a luminal 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 discontinuities, and the second material discontinuities are held together or joined together by the frame material, and / or adhesive and / or coating.

[0154] In examples, the second reinforcing material may be in the form of one or more pieces comprising one or more of wires, ribbons, struts, crowns, links, and / or filaments. The cross-section of the pieces may have any one of a variety of shapes, including circular or substantially circular, rectangular or substantially rectangular, square or substantially square, elongated or substantially elongated, oval or triangular, or other shapes. The length, number, and location of the pieces may vary and may span the length of a stent strut or less, the length of a stent crown or less, the length of a stent link or less, and / or the length of a stent ring or less, at least one or more on at least one or more stent rings. Preferably, the piece of second material is on / in / around at least one stent crown in at least one stent ring, and / or on / in / around at least two stent crowns in at least one stent ring, and / or on / in / around substantially all stent crowns or a portion of stent crowns in at least one stent ring of the stent, and / or on / in / around all but one stent crown on at least one stent ring, and / or on at least one ring, and / or on at least one ring centered in the middle of the stent length, and / or on at least one window of the stent patterned structure, and / or on at least one strut or a portion of a strut, and / or on at least one link or a portion of a link, and / or other varieties or combinations thereof. In one example, the patterned stent structure comprises a plurality of windows, each window 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 example, the links may be straight and / or have shapes such as S-links, V-links, M-links, and / or other link shapes. In an example, at least one structural element (including crowns, struts) in each window has a separation region that is configured to expand and / or have a discontinuity and / or separate. In another example, the structural element comprises a plurality of circumferential rings with one or more windows, each window having at least one separation region that is configured to expand and / or have a discontinuity and / or separate.

[0155] In preferred embodiments, it is desirable to have a stent structure having a separation region in which the deployed stent forms a discontinuity in the separation region (or such discontinuities are formed prior to deployment and held together using the design geometry or deployment means, such as a balloon catheter), or other types of embodiments of the present application in which the stent structure is substantially maintained after the separation region collapses (or separates) and / or moves in one or more directions. Preferably, the benefit of having a stent structure along the stent length or a portion of the stent length is to help prevent vulnerable material underneath the stent, such as vulnerable plaque, from rupturing into the blood vessel and causing harm. The stent structure is sufficient to prevent (or retain) vulnerable material (such as vulnerable plaque) within the body lumen. In another embodiment, the stent structure after deployment and / or collapse and / or after forming discontinuities is substantially sufficient to support the body lumen. In another embodiment, the stent structure after deployment and / or collapse and / or after forming discontinuities is substantially sufficient to support body tissue.

[0156] In one embodiment, at least some structural elements of a stent that breaks away and / or collapses and / or has detached regions may undergo one or more of the following under physiological conditions: unlocking, unretaining, becoming incomplete, unlatching, unattaching, detaching, severing, breaking, scattering, pushing, pushing open, separating, pulling apart, creating gaps, creating spaces, collapsing, corroding, disintegrating, fragmenting, crushing, shattering, splitting, decaying, unlatching, breaking apart, deteriorating, decaying, interrupting, breaking loose, and / or combinations thereof. In one embodiment, the stent structural elements comprise one or more of rings, crowns, struts, and / or links. In another embodiment, the stent structural elements comprise one or more of rings, which comprise crowns and / or struts.

[0157] In embodiments, the stent prosthesis is deployed to a larger expanded configuration under conditions simulating physiological conditions, and / or in air, and / or in air at ambient temperature, and / or in air at 37°C temperature, and / or in water, and / or in water at ambient temperature, and / or in water at 37°C, and / or within a body lumen, and / or at body temperature, and / or within a vessel, under pressure, under pulsatile pressure, and / or combinations thereof.

[0158] In embodiments, the stent prosthesis is deployed to a larger expanded configuration and subjected to modification 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 under pressure, pressurizing the stent under pulsatile pressure at 1.5 psi to 5 psi, and / or accelerated fatigue, and / or any of accelerated conditions, and / or combinations thereof.

[0159] In another embodiment or aspect of the invention, a non-degradable stent prosthesis comprises a structure, the structure comprising a wire, a hollow wire (hollow in at least some regions where it is hollow when formed and / or after treatment (modification)), and the wire and / or hollow wire is patterned into a stent, preferably a substantially tubular stent structure, more preferably a substantially tubular patterned stent structure, the stent being patterned from a tube. The stent prosthesis is expandable from a crimped configuration to a deployed, 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 in at least one ring, which disintegrates after deployment and / or after modification (environmentally responsive separation region or regions), and / or the material is configured to have at least one discontinuity in at least one ring, and / or at least one discontinuity in at least one strut, and / or at least one discontinuity in at least one crown, and / or combinations thereof, where the discontinuities in the material are held together and do not substantially affect the crimping and / or deployment of the stent 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 is configured to have at least one discontinuity in at least one ring, and / or at least one discontinuity in at least one strut, and / or at least one discontinuity in at least one crown, and / or combinations thereof. The discontinuities in the material are held together and do not substantially affect the crimping and / or deployment of the stent to a larger expanded configuration and / or the stent prosthesis has sufficient strength in the deployed configuration to support the body lumen. Material being held together includes holding, latching, attaching, connecting, pushing together, pulling together, eliminating gaps, eliminating spaces, and / or locking adjacent portions of material discontinuities together.The means for holding the material discontinuities together include sleeves, adhesives, press fits, locks, coatings such as polymer or metallic coatings, gels, solders, key and lock designs, and / or the like. The stent, in its expanded, deployed configuration, has sufficient strength to support a body lumen and / or expand without crushing and / or with low recoil. The stent, in one embodiment, undergoes modification after deployment, where the modification includes detaching, unlocking, releasing, becoming unfinished, unlatching, unattaching, removing, severing, breaking, dispersing, pushing, pushing open, separating, pulling apart, creating gaps, creating spaces, collapsing, corroding, disintegrating, fragmenting, crushing, shattering, splitting, decaying, unlocking, disintegrating, deteriorating, degenerating, attenuating, and / or interrupting at least some of the material and / or the means for holding the material discontinuities together. The modified stent comprises one or more collapsed material sections and / or discontinuities in at least one ring, and / or at least one or more collapsed material sections and / or discontinuities in at least one crown, and / or at least one or more collapsed material sections and / or discontinuities in at least one strut, and / or combinations thereof. In another example, the modified stent allows the lumen or vessel to further expand after implantation, and / or allows the stent to further expand to a larger configuration from a pre-modification configuration, and / or further expands to a larger configuration from a deployed configuration, and / or further expands to a larger configuration from a "post-deployment recoil" configuration, and / or dislodges, and / or further expands to a larger configuration for any of the foregoing reasons in at least one ring of the stent prosthesis, and / or further expands to a larger configuration in at least one ring of the stent prosthesis, wherein the ring is centered about a mid-portion of the stent length.In another example, at least one or more collapsed material sections (separation regions) and / or discontinuity in at least one ring of the stent after modification allows the stent to break away under physiological pressure and / or further expand at the at least one ring. In another example, the stent prosthesis collapses after deployment and / or modification and / or collapse and / or material interruption. In one example, the stent prosthesis after deployment and / or modification and / or collapse and / or material interruption has 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 fenestration, and / or is substantially free of 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.

[0160] In one embodiment, the means for holding materials together and / or holding material separation regions and / or discontinuities together and / or preventing the stent from collapsing prior to deployment includes adhesives, metals, polymers, coatings, solders, press fits, welding, weaving or braiding materials, and / or the like. In one embodiment, the means decays, degrades, corrodes, unlocks, and / or unfastens over a period ranging from 1 month to 5 years, preferably 3 months to 3 years, and more preferably 3 months to 1 year. In one embodiment, the stent material degrades, etc., after the means degrades and / or corrodes and / or unlocks.

[0161] In another preferred embodiment, the stent prosthesis comprises a structure in which the separation regions and / or discontinuities are located in areas that do not affect radial and / or circumferential expansion, preferably in areas of lower stress such as struts or strut regions.

[0162] In another embodiment, the stent prosthesis is configured with a patterned structure, the structure having a separation area discontinuity such as a key and lock, abutment, two plates, press fit, ratchet, rivet, insert, magnet, or the like on at least one strut and / or on at least one crown, such that the deployed and / or deployed and modified stent allows the lumen or vessel to further enlarge and / or disengage and / or separate.

[0163] In another embodiment, the stent prosthesis is configured to have a patterned structure, the structure comprising a plurality of rings, which in one embodiment are serpentine rings, the rings comprising crowns and struts, at least one crown and two struts being held in a crimped configuration by a coating and / or sleeve, and the stent after deployment and modification, including degradation of the sleeve and / or coating, allows the stent to detach and / or further expand to a larger configuration and / or allows the lumen or vessel to enlarge.

[0164] In another embodiment, a stent prosthesis is configured to have a patterned structure, the structure comprising a plurality of rings, which in one embodiment are serpentine rings, the rings comprising crowns and struts, and at least one crown and / or at least one strut on at least one ring configured to have a separation region and / or collapse in at least one segment or region after deployment under physiological conditions, such as after fatigue of the segment or region, such that the collapsed stent structure allows the stent to detach and / or further expand to a larger configuration and / or allows the lumen or vessel to enlarge.

[0165] In another embodiment, a stent prosthesis is configured with a patterned structure, the structure comprising a plurality of rings, which in one embodiment are serpentine rings, the rings comprising crowns and struts, and at least one crown and / or at least one strut on at least one ring configured to collapse in at least one segment or region after deployment under physiological conditions, such as after fatigue of the segment or region, such that the collapsed stent structure allows the stent to detach and / or expand to a larger configuration and / or allows the lumen or vessel to enlarge.

[0166] In another embodiment, a stent such as in any of the above embodiments is configured to further expand after implantation using an external energy source, the energy source comprising a magnetic field, infrared heat, inductive heat, ultrasound, and the like.

[0167] In another embodiment of any of the above embodiments, the stent material comprising the stent structure is a shape memory material, and the stent can detach and / or further expand after deployment using a shape memory material such as a nickel titanium alloy (NiTi available under the trademark Nitinol®), which further expands the stent to a larger configuration after deployment, the stent undergoes modification such as having separate regions, the stent collapses or forms a discontinuity in at least one section or region of the stent and / or collapses in at least one ring, and the collapsed stent structure slows further stent expansion and / or stops further expansion of the stent and / or stops causing damage or inflammation to the vessel wall.

[0168] In another embodiment of any of the above embodiments, the stent material additionally comprises a material, such as a platinum alloy, that softens after modification or expansion under physiological conditions, the softening of the material reducing post-deployment stresses on the vessel wall and potentially bringing the compliance of the vessel and stent closer to that prior to the softening of the material.

[0169] In preferred embodiments, the components and / or structures of the stent and / or the structures or portions of the structures after modification and stent collapse are configured to have shapes and / or configurations that avoid releasing such components or structural elements into the bloodstream. Examples include 2D and / or 3D structures, stent windows, structures comprising portions of stent windows, structures comprising at least one crown shape, structures comprising at least one crown and at least one link shape, structures comprising at least one crown, at least two struts, and at least one link shape, structures comprising at least one crown and at least two strut shapes.

[0170] In another embodiment, the stent prosthesis is capable of being deployed from a crimped configuration to a larger expanded configuration under one or more of the deployment conditions in the previous embodiments.

[0171] In another embodiment, the stent can be deployed at a rate of 1-2 atm / sec, allowing the stent to be deployed beyond the target (nominal / intended deployment) diameter without fracture.

[0172] In a preferred embodiment of a corrodible material such as magnesium, the stent is configured to have sections or regions where the material does not degrade (corrode), providing a stent section or region that does not degrade and confine the lumen or vessel, providing a lumen or vessel that is able to expand as a result of not having by-products from the magnesium stent in that section that would cause the stent to confine due to hydroxyapatite by-products that confine the vessel.

[0173] In one embodiment, a stent with separate regions or segments collapses and / or degrades and / or erodes, and / or the stent segments break off and / or unlock, in a period of 1 day to 3 years, 1 month to 3 years after deployment, preferably from a period ranging from 3 months to 1 year.

[0174] In another embodiment, for at least one ring, the number of segments or regions per at least one ring or in at least some of the rings that collapse and / or unlock and / or degrade and / or erode ranges from 1 to 4, preferably from 1 to 3, more preferably from 1 to 2, and the stent has structure after collapse, and / or the stent has no structure after collapse, and / or the stent in the absence of tissue has an unsupported structure or collapses, and / or the stent in the absence of tissue recoils, and / or the stent in the absence of tissue recoils or shrinks.

[0175] In another embodiment, for at least one ring, the number of segments per at least one ring that collapse and / or unlock and / or degrade and / or erode ranges from 1 to 4, preferably from 1 to 3, more preferably from 1 to 2, and the stent has a structure after collapse, and the structure has or does not have sufficient strength to support a body lumen, and / or the stent has no structure after collapse, and / or the stent in the absence of tissue has an unsupported structure, or collapses, and / or the stent in the absence of tissue recoils, and / or the stent in the absence of tissue contracts.

[0176] In another embodiment, for at least one ring, the number of segments per at least one ring that collapse and / or unlock and / or degrade and / or erode ranges from 1 to 4, preferably 1 to 3, more preferably 1 to 2, and the stent has a structure after collapse, and the structure has or does not have sufficient strength to support a body lumen, and / or the stent has no structure after collapse, and / or the stent in the absence of tissue has an unsupported structure, collapses, and / or the stent in the absence of tissue recoils, and / or the stent in the absence of tissue contracts.

[0177] In any one of the preceding embodiments, the lumen or vessel may be disengaged and / or allowed to further expand or dilate when the stent prosthesis comprises reinforcing elements and / or non-degradable materials for stent strength, and / or when the weight of the remaining stent prosthesis non-degradable materials is lighter than the weight of the stent prosthesis comprising both non-degradable and degradable materials. In preferred embodiments, the stent prosthesis weight after degradation (or removal) of the degradable materials (if applicable) ranges from 0.1 mg / mm to 1.5 mg / mm, preferably from 0.1 mg / mm to 1.2 mg / mm, more preferably from 0.2 mg / mm to 0.9 mg / mm, and most preferably from 0.2 mg / mm to 0.6 mg / mm. These weights exclude the weight of the non-degradable radiopaque markers.

[0178] In another embodiment, it is desirable that the conformability of the stent prosthesis (three-point bend test) after the formation of discontinuities, or after the degradation of the degradable material forming the discontinuities (if applicable), be as conformable as possible to avoid potential irritation and inflammation to the vessel wall after implantation. For example, the conformability of the stent prosthesis after the formation or removal of discontinuities (or the degradation of the degradable material) preferably ranges from 0 N / mm to 0.05 N / mm, preferably from 0 N / mm to 0.03 N / mm, and more preferably from 0 N / mm to 0.1 N / mm. In another embodiment, the conformability of the stent after the formation of discontinuities in the deployed configuration (compared to before formation or compared to upon deployment of the stent) is improved by at least 10%, or improved by at least 25%, or improved by at least 50%, or improved by at least 75%. In another embodiment, conformability after formation of the discontinuities is improved (compared to before formation or in response to deployment of the stent) by 10% to 100%, preferably 20% to 75%. In another embodiment, the radial strain of the stent after formation or deployment of the discontinuities ranges from 2% to 5% in simulated bench tests (such as, but not limited to, Example 5). In another embodiment, the radial strain (or compliance) of the stent after formation and / or deployment of the discontinuities is greater than a stent without the discontinuities by a factor ranging from 2 to 10, preferably 2 to 5 (such as, but not limited to, Example 5).

[0179] In another embodiment, the stent or other endoluminal prosthesis is in a detached configuration prior to being deployed from a crimped configuration, and the stent or other endoluminal prosthesis has strength in the deployed configuration to support a body lumen. In another embodiment, the stent or other endoluminal prosthesis is in a circumferentially detached configuration prior to implantation or deployment.

[0180] In another embodiment, a stent or other endoluminal prosthesis is configured to detach after deployment or implantation in a physiological environment, preferably in a circumferential manner or circumferentially by having at least one or more gaps (discontinuities) along the path of at least some, preferably all, of the rings. Optionally, the stent can also open along its longitudinal axis in one or more paths (or lines) through discontinuities formed in various patterns that separate the stent into one or more sections. In one embodiment, the stent does not open along its longitudinal axis or opens along at least a portion of its longitudinal axis.

[0181] In another embodiment, dislodgement of a stent or other endoluminal prosthesis includes one or more of: separation of the stent in at least one region or segment within at least one ring; at least one discontinuity; at least one break; at least one gap; the ability of the stent to further expand after deployment; the ability of the lumen or vessel to actively reshape in the presence of the stent or re-enforcement element or in the presence of the stent; the ability of the stent or other endoluminal prosthesis to further expand after deployment without a stent break, separation, or discontinuity; the ability of the lumen or vessel to actively reshape in the presence of the stent or other endoluminal prosthesis without a discontinuity, break, or separation.

[0182] In one embodiment, an endoluminal prosthesis of the present invention will typically comprise a scaffolding with a circumferential structure, such as a ring, comprising multiple struts joined by crowns, commonly referred to as a zigzag stent, a serpentine stent, a closed-cell design, and the like. According to a further aspect of the present invention, at least some of the struts in at least some of the zigzag or serpentine rings will include at least one separation region configured to form a discontinuity in the circumferential ring and / or break away after expansion of the stent and / or struts in a physiological environment. In these embodiments, the crowns of the rings, or the connected links joining adjacent rings, preferably do not include separation regions. This allows for controlled expansion of the individual rings, as well as the stent as a whole, in response to lumen remodeling.

[0183] In another example, intraluminal prostheses having separation regions within the individual struts of their circumferential rings will form discontinuities after deployment in a target vessel or other body lumen that allow the scaffolding to detach and / or expand beyond its initial expansion. The physiological environment in which the prosthesis is expanded will typically be physiological conditions such as that of a body lumen, such as a vascular environment, which may be mimicked by a 37°C water bath. Within the vascular environment, discontinuities that form in the rings will allow the scaffolding to detach and / or open circumferentially as the vessel and / or lumen actively remodels after placement of a stent or other prosthesis. Discontinuities will typically form 30 days to 6 months after initial expansion of the circumferential scaffold within the physiological environment, although it is possible to have such discontinuities one year to three years after deployment. In one embodiment, discontinuities are formed and / or developed prior to implantation, and such discontinuities still have sufficient strength to allow crimping and / or deployment of the stent from the crimped configuration to the expanded configuration and to support the body lumen. In such cases, the stent or stent structure region may dislodge and / or allow further expansion, at least in the region of the discontinuity in the stent structure.

[0184] In another example, the separation regions within the struts of the circumferential rings may comprise "key and lock" or similar type joints among the struts and / or other structural elements, which are configured to be held together and / or secured during expansion, but to open or release after initial expansion in a physiological environment. In one specific type of key and lock joint, the key and lock will open and allow the joined segments of the struts to separate radially from one another only after the separation regions have freely separated (i.e., mobilized). In another specific example, the key and lock type joint is configured to allow the joined segments of the struts to separate from one another both radially and axially after mobilization. Key and lock type joints may be held together and / or secured by polymers, coatings, sleeve materials, cements, and / or adhesives applied to the abutting surfaces of the joints, with the coatings, cements, sleeves, or adhesives selected to degrade over time in a physiological environment.

[0185] Other examples of suitable adhesives, stent materials, sleeve materials, coatings, and cements include, but are not limited to, polylactide, poly(L-lactide), poly(D-lactide), poly-DL-lactide, polyglycolide, polylactide-co-glycolide (e.g., poly(L-lactide-co-glycolide) with 85% L-lactide to 15% glycolide), copolymers of poly(L-lactide-co-epsilon-caprolactone) (e.g., about 5 Polyhydroxybutyric acid, polyhydroxyvaleric acid, polyhydroxybutyric acid / poly ... Polyhydroxyalkanoates, polyorthoesters, polyanhydrides, polyiminocarbonates, tyrosine-derived polycarbonates, tyrosine-derived polyacrylates, iodinated and / or brominated tyrosine-derived polycarbonates, iodinated and / or brominated tyrosine-derived polyacrylate polyesteramides, polycarbonate copolymers, lactone-based polymers such as poly(propylene fumarate-co-ethylene glycol) copolymers (also known as fumaric anhydride), polyanhydride esters, polyorthoesters, silk elastin polymers, polyphosphazenes, aliphatic polyurethanes, polyhydroxy acids, polyether esters, polyesters, polydepsipeptides, poly(alkylene oxalates), polyaspartic acid, polyglutaric acid polymers, poly-p-dioxanone, poly-beta dioxanone, asymmetric 3,6-substituted poly-1,4-dioxane-2,5-dionone, 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, polyserine, polycaprolactam, cyclodextrin, polysaccharides such as chitosan and hyaluronan, alginate, polyketal, fatty acid-based polyanhydrides, amino acid-based polyanhydrides, poly(ester anhydrides), or the like, and combinations thereof.

[0186] In other examples, key and lock interface types are held together and / or secured by an overlying sleeve or similar external structure that encases the interface and prevents the interface from fully and / or partially releasing and / or opening while the sleeve remains intact and / or remains substantially intact and / or undegraded, but degrades in a physiological environment over time to open and release the interface.

[0187] In still other examples, the separation regions located within the struts of the circumferential ring comprise butt joints, notches, or thinned regions within the struts, preferentially eroding or fatigue within the struts, modified grain boundaries within the struts and the like, or any of the other specific separation regions described elsewhere herein.

[0188] In further specific examples of endoluminal prostheses of the present invention, the scaffold comprises circumferential rings patterned from a metal or other non-degradable material, the scaffold configured to expand from a crimped configuration to an expanded configuration. In these embodiments, at least some of the circumferential rings comprise a plurality of struts joined by crowns, at least some of the struts having at least one separation region pre-formed as a break in the strut structure, for example, formed by laser or otherwise cutting through the struts once or after patterning, secured by a sleeve or adhesive that will degrade in a physiological environment over time.

[0189] While separation region embodiments may be any of those previously described herein, preferred separation region embodiments comprise key-and-lock junctions that hold struts together during expansion and / or substantially hold or immobilize them, and are configured to open after initial expansion in a physiological environment. The key-and-lock junction type, in this embodiment, may be configured to allow joined sections of the struts to separate radially from one another only after the joint is released. Alternatively, the key-and-lock junction may be configured to allow joined sections of the struts to separate both radially and axially from one another after the junction is released, i.e., opened or released from constraint. In both cases, the key-and-lock junction may be initially immobilized by a cement or adhesive or sleeve or coating that holds the adjoining surfaces of the strut sections together or in close proximity and that degrades in a physiological environment. Alternatively, strut sections joined by a key-and-lock junction may be immobilized by an overlying sleeve that degrades in a physiological environment. Such junctions are immobilized, substantially immobilized, held together, substantially and / or held together to limit or substantially limit movement in one or more directions (preferably substantially limiting axial movement) upon deployment from the crimped configuration to the expanded configuration. Immobilization of such junctions may be achieved using materials such as polymers, sleeves, or adhesives, or by configuration of the junction design.

[0190] In preferred embodiments, the stent (scaffold) prosthesis of the present invention is formed from a substantially tubular body (which, in preferred embodiments, is substantially free of holes and / or discontinuities). The stent comprises structural elements capable of radial expansion from a crimped configuration to a larger, deployed configuration. In preferred embodiments, the structural elements comprise a plurality of circumferential rings, the rings comprising struts joined (connected) by crowns. At least some of the rings are connected to adjacent rings. In preferred embodiments, the stent can be crimped onto a balloon delivery system or a delivery system (optionally constrained in the crimped configuration by a sleeve). In preferred embodiments, the stent is a balloon-deployable and / or self-expanding stent. The stent prosthesis can also be formed from wire or fiber (circular or substantially circular, square or substantially square, rectangular or substantially rectangular, and / or other shapes), which are patterned into a stent capable of radial expansion from a crimped configuration to a larger, deployed configuration. Stents can also be formed from hollow or partially hollow wires (having hollow regions within the wire or fiber) or fibers that are patterned into a stent capable of radial expansion from a crimped configuration to a larger, deployed configuration. In preferred embodiments, the stent pattern can be serpentine rings, zigzag rings, diamonds, woven and / or mesh patterns, closed-cell designs, open-cell designs, and / or combinations thereof. Preferably, the stent shape in the deployed configuration is substantially tubular (cylindrical), tapered, hourglass, and / or other shapes. The rings, crowns, struts, and dimensions (length, thickness, angle of curvature, width) are configured to allow the stent to be deployed (expanded) and assume the various shapes described above.

[0191] Those skilled in the art will understand the applicability of the embodiments and / or examples throughout this application to prostheses across a variety of mammalian body applications, including implantation of endoluminal prostheses, extraluminal prostheses, stent prostheses, such as annular prostheses, and / or valves having circular or other shapes within a mammalian body, and / or other types of lumens, conduits, annuli, cavities, sinuses, etc.

[0192] In one example, the stent prosthesis comprises a valve, such as an aortic and / or mitral and / or tricuspid valve, the stent prosthesis comprises an expandable stent prosthesis (balloon expandable or self-expanding), the circumferential structural elements of the stent, such as struts or other types of stents joined by crowns (and / or struts, e.g., including multiple rings), are formed from tubes, wires, sheets, or braided stents formed from one or more wires, and the stent has an open cell design pattern, a closed cell design pattern, or a combination of open and closed cells. The stent prosthesis may be configured with a shape memory alloy such as NiTi, and / or a non-degradable metal or metal alloy such as stainless steel 316L or L605, or other materials described herein, or other, and at least some of the struts (but may also be crowns, circumferential links / connectors, combinations) in at least one ring or at least one section (proximal, intermediate, and / or distal sections, and / or regions within the sections) of the stent may be positioned within, within, or around the body annulus. and / or configured to detach after deployment of a stent prosthesis above or adjacent thereto, and / or configured to have displacement (or movement) in one or more directions or movement patterns, and / or configured to have radial strain, and / or configured to have radial contraction and expansion, or configured to have internal contraction and / or expansion, and / or configured to have internal contraction and / or expansion, and / or configured to have external contraction and / or expansion, having at least one or more junctions, bridging elements, joints, discontinuities, and / or separation regions as described throughout this application, wherein the magnitude of displacement (or radial strain magnitude, or contraction magnitude, or further expansion magnitude, or movement magnitude) ranges from 0.05 mm to 10 mm, preferably ranges from 0.1 to 7 mm, preferably ranges from 0.2 mm to 5 mm, and more preferably ranges from 0.3 mm to 3 mm, and the displacement or radial strain movement is in at least one or more of the following: radial, circumferential, longitudinal, superior, inferior, leaflet closure,the stent prosthesis is in an annulus (or lumen) contracted and / or expanded orientation, or a combination thereof; the stent prosthesis is substantially cylindrical, longitudinal, annular, saddle-shaped, circular, or other shape so as to conform to the biological structure into which the stent prosthesis is implanted; separation regions, junctions, bridging elements, gaps, joints form discontinuities and / or allow at least one or more structural elements to have movement (displacement) in one or more directions, such as circumferential, radial, and / or longitudinal directions (on formation, prior to implantation, and / or after implantation); the stent prosthesis has sufficient strength to support (including hold or maintain) the implantation site (including the annulus, cavity) in an open state and / or to hold (including maintain) structures associated with the implanted stent prosthesis in place (including a valve and / or sheath associated with the stent prosthesis upon deployment or after deployment); the stent prosthesis is configured to expand (from a crimped configuration) to a position where it can be deployed (expanded). the discontinuities and / or movements (displacements) have sufficient strength to support the valve annulus and / or associated stent-valve in an open state and / or in a fixed position in response to expansion to a larger configuration), the discontinuities and / or movements allow for disengagement, displacement, contraction, and / or further expansion of at least one or at least some regions of at least one or at least some sections of the stent-prosthesis or stent-prosthesis structural elements, and / or the discontinuities and / or movements (displacements) allow for expansion and / or contraction of at least one or at least some regions of at least one or at least some sections of the stent-prosthesis or stent-prosthesis structural elements, and / or the discontinuities and / or movements allow the stent and / or at least one or at least some regions of the stent to be less stiff (including being more flexible in at least one or more directions (radial strain) such as circumferentially, radially, longitudinally, or a combination thereof),

[0193] In preferred embodiments, the separation regions, junctions, bridging elements, gaps, and joints are arranged (including positioned) in a pattern that allows the stent (or at least some regions or sections of the stent) to have sufficient strength after deployment and allows at least some regions or sections of the stent prosthesis (including circumferential regions of the stent region) to disengage, be more flexible (radial strain) under physiological conditions, expand and / or contract under physiological conditions, and / or prevent (including minimize, reduce) blood leakage after stent (including valve) implantation. Prevention of blood leakage can be minimized by having the stent present and / or more flexible (including less rigid) in at least some regions, allowing the stent in at least those regions to conform (be more dynamically flexible) to the anatomy into which it is implanted as the anatomy moves or changes shape under physiological conditions. Prevention of blood leakage can occur upon implantation or after implantation. Separation regions, junctions, bridging elements, gaps, and joints can be located in at least some regions of at least one section of the stent prosthesis, such as at least one ring or proximal section of the stent, in an intermediate section of the stent, such as the valve-bearing section, and / or in the distal section of the stent, and / or in all three sections of the stent prosthesis. Optionally, a sheath surrounding at least one region or section of the stent prosthesis can be configured to respond (including contour, expand, or conform) to corresponding discontinuities and / or movement of the stent prosthesis adjacent the sheath region. The sheath can be constructed and / or formed from a stent-like structure having separation regions, junctions, bridging elements, gaps, joints, and / or sheaths that can conform to adjacent stent regions upon expansion and / or contraction or otherwise.In preferred embodiments or examples, the stent prosthesis in at least one ring or in at least some regions (preferably the entire stent) maintains sufficient strength after implantation, and in other examples, the stent prosthesis strength decreases over time after implantation ranging from 30 days to 3 years, preferably ranging from 3 months to 2 years, and more preferably ranging from 6 months to 2 years. In these other examples, either the residual strength is sufficient to perform one or more of the described functions and / or other functions, or the stent prosthesis in at least some regions (or all of the stent) will not have any residual strength over this time period range.

[0194] In one embodiment, a stent prosthesis for valve replacement or repair is provided, wherein the stent is substantially cylindrical or has another shape that conforms to the annulus into which it is implanted, the stent is patterned from a tube, wire, or braided, the stent is balloon-deployable or self-expanding, and the stent is configured to expand from a crimped configuration to a larger expanded configuration and to have sufficient strength in the expanded larger configuration to hold the annulus open (or to support the annulus). The stent prosthesis optionally includes a valve (either bicuspid or tricuspid) coupled thereto. The stent prosthesis optionally includes at least one skirt on at least one surface region, such as the abluminal and / or luminal surface region, of the stent prosthesis that is coupled to the stent prosthesis and / or prosthetic valve. The at least one skirt may also be woven into the abluminal and / or luminal surface region in one embodiment. The at least one skirt, in another embodiment, can be coupled on the abluminal and / or luminal surface region to at least one section of the stent prosthesis, such as a proximal section of the stent prosthesis, a distal section of the stent prosthesis, a middle section of the stent prosthesis, and / or the entire stent section. The at least one skirt, in one embodiment, can have a pouch configured to expand or fill with blood after stent prosthesis implantation.In one embodiment, the stent has at least one section (or region) of the stent having at least one or more of separation regions, discontinuities, bridging elements, junctions, joints, gaps, and is configured to allow, after expansion of the stent prosthesis, disengagement and / or higher displacement in one or more of the following: higher strain, higher displacement, higher contractility and / or expandability, better valve closure, less valve leakage, better adaptation of valve closure as the heart expands, wherein the displacement in the at least one section and / or stent occurs in one or more of the following directions: radial, circumferential, longitudinal, toward the top of the stent, toward the bottom of the stent, and / or other types of directions or movements such as a saddle-shaped direction to accommodate the mitral annulus. At least one or more separation regions, discontinuities, joints, junctions, bridging elements, gaps, etc. are configured (or positioned, or located, or placed) along the desired stent, stent segment, or stent region to provide the required movement (or displacement). Examples of placement locations for such release and / or displacement features include a stent segment (or region) adjacent to the synthetic valve, at least partially attached to the synthetic valve in at least one region, placement within an intermediate section of the stent prosthesis, placement within a distal section of the stent prosthesis, placement within a proximal section of the stent prosthesis, placement on at least one side of at least one section of the stent prosthesis, e.g., placement on the side of one half of at least one section of the stent prosthesis in a cylindrical stent (while the other half of the section does not include such release features), or combinations thereof. At least one segment, in one embodiment, has a magnitude of displacement in at least one direction ranging from 0.1 mm to 10 mm, preferably ranging from 0.2 mm to 7 mm, more preferably ranging from 0.35 mm to 7 mm. The stent prosthesis optionally has support features (such as additional struts joined by crowns in the stent prosthesis rings) that provide additional strength, support, or other mechanical properties to the main stent prosthesis structural elements.The support features may or may not include breakaway features. The stent prosthesis, in this example, has sufficient strength in the expanded configuration to support the annulus (or to maintain the annulus open or to hold the stent in place within the annulus) while providing, after expansion, under physiological conditions, one or more of: higher (or higher, or increased) radial strain (or compliance), higher (or higher, or increased) displacement, higher (or increased) compliance, greater contraction and / or expansion within at least one stent segment (or region) of the stent prosthesis compared to adjacent stented segments (or regions) or stented segments.

[0195] In one example, an implant having a length, width, and thickness is attached (or held in place) adjacent to (or within) a body lumen or annulus, the implant is configured to be coupled with (or attached to) an expandable prosthesis, and at least one of the implant and stent prosthesis is configured to have one or more of separation regions, junctions, joints, hinges, bridging elements, gaps on at least one section or region of the implant and / or stent, allowing at least one section or region of the implant and / or stent to have a greater displacement in one or more directions under physiological conditions than adjacent sections (or regions) of the implant or stent prosthesis.

[0196] In one example, an implant having a length, width, and thickness is attached (or held in place) adjacent to (or within) a body lumen or annulus, the implant is configured to be coupled (or attached) to a prosthetic (or natural) valve, and at least one section or region of the implant is configured to have one or more of a separation area, a junction, a joint, a hinge, a bridging element, a gap, allowing at least one section or region of the implant to have a greater displacement in one or more directions than adjacent sections (or regions) of the implant, the displacement being configured to allow the valve to operate (or function or open and close) under physiological conditions, or to allow (or enhance) the valve to conform (or contour) to the annulus or deformed annulus while retaining valve function.

[0197] In another embodiment, the stent prosthesis is formed from a shape memory material, or from a spring (or coil) material, patterned from one or more wires in a braided pattern, or patterned from a tube in a closed or open cell design, or patterned from a wire in a closed or open cell design, or combinations thereof, the stent is self-expandable from a crimped configuration to a larger expanded configuration and has sufficient strength to support the body annulus, the stent prosthesis is bonded to a valve, the stent has one or more separation regions, junctions, hinges, discontinuities in at least one section distal to, proximal to, or adjacent to the bonded valve, the section after expansion and formation of the discontinuity (or detachment) has a lower outward radial force while the stent is in the expanded configuration but less than the nominal or maximum expanded diametral outward force, preferably 5-15% less than the maximum expanded diametral outward force, and more preferably 15%-75% less than the nominal or maximum expanded diametral outward force.

[0198] In a preferred embodiment, the combined radial strain / compliance of an embodiment of a stent prosthesis having at least one or more separation regions that form a discontinuity after expansion (or vasodilation under pressure or a therapeutic agent such as nitroglycerin) ranges from 1% to 10% or 1% to 5%, preferably from 1.5% to 4%, and / or has a diameter change under physiological or simulated physiological conditions ranging from 0.03 mm to 3 mm, preferably from 0.05 mm to 0.15 mm, or more preferably from 0.07 mm to 0.15 mm, or most preferably from 0.1 mm to 0.3 mm. The pattern of separation regions can be configured, for example, to conform to the anatomy into which the stent prosthesis is implanted and accommodate the forces of such anatomy and / or dynamic movement, thereby comprising one or more planes ranging from and / or between circumferential to axial planes and / or allowing radial movement (and / or expansion, etc.). Those skilled in the art will understand the application of these embodiments to balloon-expandable and / or self-expanding stents, including open-cell designs, closed-cell designs, coil designs, or woven stent patterns, etc. In another example, the stent prosthesis may dislodge and / or allow migration upon or after deployment, and / or expand further and / or have higher radial strain (compliance), and / or the like, by incorporating other means described herein.

[0199] In many cases, implants such as stent prostheses are implanted to open, hold open, hold in place, support, repair and / or replace dysfunctional structures such as valves or the like. In preferred embodiments or examples, stents in such cases are implanted into various biological structures such as arteries, veins, conduits, valve annuli, sinuses, cavities, and / or other mammalian body lumens, which typically experience pressure, pulsatile pressure (systolic and diastolic), movement (or displacement) in one or more planes / directions, shaping and / or reshaping of the lumen or annulus. It is desirable that the implant have sufficient strength at least upon implantation to open, hold open, support, repair and / or replace dysfunctional structures as they are subjected to various physiological conditions such as shaping, expansion and / or contraction, forces from one or more planes / directions, etc., and at the same time, and / or over time after implantation, the implant / stent has the ability to at least partially comply (adapt and / or conform) to the physiological conditions such as movement (displacement), forces, expansion and / or contraction, shaping or reshaping of the lumen, thereby preserving the function of the implant and the integrity of the stent support (or valve contained within the stent).Implant prostheses as described throughout this application allow arteries, veins, ducts, cavities, annuli, and / or other body lumens to at least partially restore (or at least partially accommodate or comply with) some of said movements (displacements), expansions and / or contractions, forces, and / or shaping or reshaping of the lumen, thereby reducing and / or preventing unwanted effects of the implant, thereby reducing and / or preventing unwanted adverse events such as luminal narrowing and / or re-narrowing, restenosis, blood leak, occlusion, thrombus formation, angina, ischemia, aneurysms, etc.; and stents as described throughout this application allow at least one or more regions and / or at least one segment (and / or the entire stent) to detach, move, expand, further expand, further expand from a deployed / expanded configuration, and / or form or reshape from a deployed configuration to a new configuration. , expand and / or contract, have a radial strain (compliance) that more closely matches the natural radial strain (compliance) of the lumen (and / or biological structure into which the stent is implanted), have a higher radial strain (compliance) than immediately after deployment (or in some cases, before forming discontinuities), accommodate at least some of the luminal (annulus, cavity, etc.) physiological conditions (including dynamic movement / displacement, and / or dynamic forces, and / or dynamic expansion and / or contraction, and / or dynamic shaping and / or reshaping), and / or reduce the resistance of the implant (stent) to the physiological conditions at the implant site, and / or protect the body lumen from potentially harmful plaque, such as vulnerable plaque, protect the blood vessel lumen, support the body lumen, and / or provide sufficient stent structure after deployment (or after forming discontinuities) to support the blood vessel lumen. The stent after forming discontinuities may have radial strength after forming discontinuities and / or after deployment, or may not have any radial strength, or maintain sufficient stent structure.

[0200] In preferred embodiments, the stent prosthesis is formed from and / or comprises a non-degradable material with high radial strength (e.g., sufficient to support a body lumen upon deployment of the stent), preferably a metal or metal alloy, but also a polymer or other material with high radial strength upon deployment. In preferred embodiments, the non-degradable material does not degrade within at least 5 years of implantation in a body lumen (or under physiological conditions), preferably does not degrade within at least 10 years of implantation in a body lumen (or under physiological conditions), more preferably does not degrade within at least 20 years of implantation and / or does not degrade within at least 50 years of implantation. Examples of non-degradable metals or metal alloys include, but are not limited to, the following: stainless steel alloys such as 304 stainless steel (including 304V and 304L), 316 stainless steel (including 316L and 316LV), stainless steel alloys having 30% to 80% Fe by weight, L605, MP35, cobalt alloys such as cobalt chromium, including cobalt alloys having 25% to 60% Co by weight, platinum alloys, including platinum alloys having 25% to 40% Pt by weight, metal alloys having chromium in the alloy, including alloys having 15% to 25% chromium by weight, Mo-Re based alloys (including Icon-Nulloy alloy), tantalum and tantalum alloys, gold and gold alloys. Tungsten and tungsten alloys and / or silver and silver alloys are corroding (degradable) metals.

[0201] The terms corrosive and degradable are used interchangeably in this application.

[0202] In another embodiment, the expandable stent has separation regions and / or other configurations as described throughout this application, wherein at least some regions of the stent form discontinuities after deployment, detach in response to or after deployment, expand further, have higher (or increased) radial strain, allow less resistance to the implant site or lumen, and / or have reduced strength after implantation, at least the regions of the separation regions (and / or other configurations) substantially maintain their position within the stent prosthesis structural elements after expansion after deployment of the stent and / or after forming discontinuities, protrude (or move) outward from the stent prosthesis structure, protrude (or move) inward from the stent prosthesis structure, move in a manner (or direction) adjacent to the stent prosthesis, and / or combinations of the above.

[0203] In another embodiment, the stent prosthesis of any of the embodiments described throughout this application, wherein the stent prosthesis upon deployment has sufficient strength to support a body lumen (and / or hold a valve in place while maintaining the body lumen (such as an open valve)), and the strength is substantially maintained after deployment (and / or after forming a discontinuity). In another embodiment, the strength after deployment decreases in a step function (or the strength decreases as a step function after deployment and / or the strength decreases after forming a discontinuity) within 30 days, preferably within 3 months, and more preferably within 1 year. In yet another embodiment, the strength after deployment decreases in a stepwise manner and / or in a linear decay manner within 30 days, preferably within 3 months, and more preferably within 1 year after deployment (and / or after forming a discontinuity). In yet another embodiment, the strength of the stent prosthesis after deployment (and / or after forming discontinuities) decreases, and the decreased strength is sufficient to support the body lumen (and / or hold a structure in place and / or hold a lumen or annulus open). In yet another embodiment, the strength of the stent prosthesis after deployment (and / or after forming discontinuities) decreases and reaches a plateau, and the plateau strength is sufficient to support the body lumen (and / or hold a structure in place and / or hold a lumen or annulus open). In yet another embodiment, the strength of the stent prosthesis after deployment (and / or after forming discontinuities) decreases but does not reach zero. In yet another embodiment, the strength of the stent prosthesis after deployment (and / or after forming discontinuities) decreases to zero within one month, within three months, and / or within one year. In preferred embodiments, a stent having reduced strength compared to its initial strength, but greater than or even zero strength, maintains (or has) sufficient circumferential structure to support a body lumen.

[0204] In another embodiment of any of the embodiments herein, preferably the stent prosthesis comprises and / or is formed from a non-degradable material, such as a non-degradable metal or metal alloy, and the stent prosthesis upon deployment from a crimped configuration to a larger expanded configuration has a low inward recoil, preferably zero to low inward recoil, preferably zero to 6% inward recoil, more preferably zero to 10% inward recoil, when deployed / expanded from the crimped configuration to the expanded configuration / diameter. In another embodiment, the stent prosthesis after deployment (after initial recoil (if applicable)) has substantially zero to 3% inward recoil from the expanded configuration (preferably has substantially zero inward recoil) within 30 days after deployment, preferably within 60 days after deployment, more preferably within 3 months after deployment. In another example, after deployment from the crimped configuration to the expanded, larger configuration (after initial recoil (if applicable)) and / or after forming a discontinuity, the stent prosthesis further expands (naturally or unassisted) to the larger configuration, further expands to a larger configuration larger than the expanded configuration after recoil, and / or further expands to a larger configuration larger than the deployed configuration (before initial recoil). The stent prosthesis, in this example, further expands within 360 days, preferably within 270 days, more preferably within 6 months, more preferably within 3 months, and most preferably within 1 month of deployment and / or implantation. In another embodiment, the stent prosthesis after deployment and / or formation of discontinuities will expand and / or contract by an overall amount of 2% to 15% of its deployed diameter / configuration (after initial recoil (if applicable)), preferably by an overall amount of 3% to 10% of its deployed diameter / configuration (after initial recoil (if applicable), or more preferably by an overall amount of 4% to 15% of its deployed diameter / configuration within one month after deployment, preferably within three months after deployment, more preferably within six months after deployment, and most preferably within one year after deployment.

[0205] In another embodiment, the stent prosthesis has separation regions as described throughout this application (and / or other configurations as described throughout this application), preferably the stent prosthesis comprises and / or is formed from a non-degradable material, such as a non-degradable metal or metal alloy, the stent after deployment forms at least some discontinuities in at least some of the circumferential structural element separation regions, and the stent prosthesis after deployment (and / or after forming the discontinuities) substantially maintains the stent prosthesis structure and / or shape. In another embodiment, the stent prosthesis substantially maintains the stent prosthesis circumferential structure and / or shape. In yet another embodiment, the stent prosthesis after deployment (and / or after forming the discontinuities) substantially maintains the stent prosthesis deployed configuration. In yet another embodiment, the stent prosthesis after deployment (and / or after forming one or more of the discontinuities) has no more than one discontinuity per any ring (or at least some of the rings), preferably no more than two discontinuities per any ring (or at least some of the rings), more preferably no more than three discontinuities per any ring (or at least some of the rings), and more preferably no more than four discontinuities per any ring (or at least some of the rings). A stent prosthesis with separation regions forms discontinuities that, in one embodiment, are substantially linear or spiral or other shaped along the length of the stent prosthesis, along the stent length, in this embodiment, in a linear, spiral, or other configuration, slicing the stent along the longitudinal stent length (while keeping intact one, some, or all axial links connecting (joining) adjacent rings). In another embodiment, the stent prosthesis forms a discontinuity that slices the substantially cylindrical stent structure along (or extending) the length of the stent prosthesis (while keeping intact one, several, or more axial links connecting (joining) adjacent rings) into two structures or sections (such as two circumferential semicircular structures along (or extending) the length of the stent).In another embodiment, the stent prosthesis forms discontinuities that slice the substantially cylindrical stent structure along the length of the stent prosthesis (while keeping intact one, some, or all axial links joining adjacent rings) into three structures (such as three partially circumferential structures extending along the stent length). In another preferred embodiment, the separation regions and / or discontinuities are located on the strut structural elements such that there is no more than one separation region and / or discontinuity per strut (or per number of struts), no separation regions and / or discontinuities on the crown, and / or no separation regions and / or discontinuities in the region joining the strut to the crown. In another preferred embodiment, the separation regions and / or discontinuities are located at least within the strut region of the ring, or substantially in the center of the strut, or along the length of the strut (away from the crown and / or away from the junction point joining the strut to the crown), and / or are located in substantially non-deformable or less deformable regions of the ring, and / or are located in regions of the ring that have less or reduced stress as the stent expands from the crimped configuration to the expanded deployed configuration, and / or are located in substantially non-deformable or less deformable regions on the ring as the stent expands from the crimped configuration to the expanded configuration, and / or are located in regions where the separation regions substantially remain together (or are held together) upon expansion of the stent on the ring from the crimped configuration to the expanded configuration.

[0206] In another example, the separation region has (or defines or comprises) a gap between two opposite ends of the structural element adjacent to the separation region and / or between two adjacent ends of the structural element adjacent to the separation region (e.g., two ends of a non-degradable metal alloy containing, defining, or comprising the separation region). The gap width ranges from 0 to 50 microns, preferably from 0 to 30 microns, more preferably from 0 to 15 microns, more preferably from 0 to 10 microns, and most preferably from 5 microns to 30 microns. The gap can be filled with a coating, such as a degradable polymer coating. The coating can extend beyond the separation region to further hold the separation region in place upon deployment of the stent from a crimped configuration to a larger expanded configuration.

[0207] In a preferred embodiment, the stent prosthesis comprises a structural element, preferably a circumferential structural element comprising a plurality of rings, each ring having struts joined by crowns, each ring connected to adjacent rings (or non-adjacent rings) through (or by) links, or directly joined without links. The stent prosthesis is expandable from a crimped configuration to an expanded configuration to support a body lumen and / or hold the lumen open and / or hold a structure (connected or attached to the stent) in place. The stent prosthesis can have a sheath (preferably circumferentially) surrounding and / or attached to the stent or at least a section of the stent. The stent can hold a structure, such as a valve (synthetic or biological), in place (and / or attached before or after deployment). The stent can also have a means for anchoring the stent or an area within the stent to a body lumen, tissue, etc. The stent may also have tendons or wires attached to some regions of the stent that anchor the stent or pull it inward from at least one region or section. In another embodiment, the stent comprises one circumferential structural element. In another embodiment, the stent prosthesis comprises one ring, the ring comprising struts joined by crowns. In another embodiment, the stent and / or implant comprises a structure that allows expansion from a crimped configuration to a larger expanded configuration.

[0208] In another embodiment, the coating thickness and / or sleeve thickness covering at least a portion of the separation region and / or crown ranges from 3 microns to 100 microns, preferably from 5 microns to 50 microns, and more preferably from 10 microns to 50 microns. The coating, sleeve, material can be degradable or non-degradable, such as a degradable polymer or a non-degradable polymer. In the case of non-degradable polymer embodiments, such as Parylene or C-Flex or polyurethane, in one embodiment, the polymer contains (holds together) the separation region within the polymer, and the separation region and / or discontinuity after deployment is allowed to detach and / or separate within (from) the non-degradable polymer (i.e., the non-degradable polymer continues to encapsulate the separation region and / or discontinuity), but allows the stent and / or stent region to detach and / or further expand and / or become more flexible or have increased compliance after the discontinuity is formed.

[0209] In a preferred embodiment of any of the embodiments herein, the stent prosthesis is capable of expanding from a crimped configuration to a larger expanded configuration without collapse, and / or while maintaining structural integrity, and / or while maintaining regions of separation held together, and / or while maintaining discontinuities held together. The expansion from the crimped configuration to the expanded configuration ranges from deployment to a nominal stent diameter to 3 mm above the nominal stent diameter, preferably from the nominal stent diameter to a diameter 2 mm above the nominal stent diameter, and more preferably from the nominal stent diameter to 1 mm above the nominal stent diameter. The nominal stent diameter includes the nominal delivery system balloon diameter, the beacon delivery system balloon diameter, the nominal delivery system beacon diameter, and / or the beacon delivery system diameter.

[0210] In one example, measurements of any parameter, such as strength compliance, diameter, configuration, recoil, displacement, size, etc., where such measurements are specific measurements of one sample, an average of multiple samples, an average of multiple samples from one lot, an average of multiple samples from multiple lots, and / or measurements from different samples (e.g., test strength), where the samples are constructed to the same or similar specifications. In another example, the measurement is an average of multiple measurements, examples include average lumen area representing a measurement of lumen area, average stent diameter representing a stent diameter measurement, etc. In another example, standard or commonly used test methods known to those skilled in the art can be utilized for various tests of size, size, radial strength, recoil, expansion, contraction, diameter, radial strain (or compliance), resistance, etc., which can also be applicable, for example, to utilize IVUS, OCT, MSCT, QCA, or other measurement devices that measure bench, ex-vivo, and / or in-vivo measurements. Measurements can also be bench, ex-vivo, ex-vivo, or in-vivo. Measurements may also be on the stented section, a section of the stent ring having a separation region, the proximal stent section, the middle stent section, and / or the distal stent section.

[0211] In one embodiment, a stent prosthesis comprises a non-degradable material (such as a polymeric material) patterned on a stent, the stent prosthesis comprising structural elements comprising rings, the rings comprising expansion regions (such as crowns) and struts, at least some reinforcing elements (such as a non-degradable metal) coupled to at least some of the expansion regions of the non-degradable stent, at least some of the rings having at least one separation region, the stent prosthesis expanding from a crimped configuration to a larger expanded configuration and having sufficient strength to support a body lumen, the separation region forming discontinuities on the rings after implantation and allowing the stent to further expand in a physiological environment.

[0212] In embodiments, the metallic stent prosthesis is formed from a tube or wire (solid or hollow in at least some regions of the wire (preferably hollow in the non-deformable regions of the wire)) and patterned into a structure that is expandable from a crimped configuration to an expanded, larger configuration. The stent structure, in one embodiment, comprises a plurality of rings (and at least some rings have one or more separation regions) consisting of strut and crown structural elements, non-deformable elements (or substantially non-deformable elements) such as struts, and deformable elements such as crowns. At least some of the rings are connected to adjacent rings in at least one region, for example, by links. Metal stents can also be formed from patterned sheets that are then rolled into a tube and seamed to form the stent. In yet another embodiment, the stent prosthesis can be formed by 3D printing.

[0213] In another example, the polymeric stent prosthesis is formed from a tube and patterned into a stent by spraying, extruding, dipping, molding, or 3D printing. Alternatively, the stent prosthesis can be formed from one or more fibers or filaments and patterned or woven into a stent.

[0214] In preferred embodiments, the stent prosthesis is configured to detach upon or after deployment, to exhibit vasodilation in a body lumen after deployment, to further expand to a larger configuration after deployment, and / or to have a radial strain across (or on or across or along) substantially all of the stent segments, stent segments, the stent length, the stent circumferential diameter, and / or the stent ranging from 1% to 10%, preferably having a radial strain across (or on or across or along) 1%. In another embodiment, the stent prosthesis is configured to detach upon or after deployment, to exhibit vasodilation in a body lumen after deployment, to further expand to a larger configuration after deployment, and / or to have a radial strain across (or on or across or along) at least one section of the stent, at least one region of the stent, at least some of the stent length, at least some of the stent circumferential diameter, and / or the stent ranging from 1% to 10%, preferably having a radial strain across (or on or across or along) 1% to 7%.

[0215] In preferred embodiments, a stent prosthesis for coronary artery applications is configured to have, in at least some of the rings, and preferably in substantially all of the rings, one or more of the following: reinforcing elements reinforcing the degradable ring structural el...

Claims

[Claim 1] The invention described in the specification.

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