Expansion cage

Abstract

A stent is disclosed, in particular a stent (scaffold) or other luminal prosthesis comprising circumferential structural elements which provide a high strength after deployment and allow the scaffold to be stented, and / or allow the scaffold or luminal prosthesis to be expanded thereafter. The circumferential scaffold is typically formed from a non-degradable material and will be modified to expand and / or be stented after deployment.

Description

[0001] This application is a divisional application of Chinese patent application No. 202210542239.6, filed on August 13, 2018, entitled "Spreading Bracket".

[0002] The application filed on August 13, 2018, with application number 202210542239.6 and invention title "Spreading Bracket", is a divisional application of the Chinese patent application filed on August 13, 2018, with application number 201880066645.1 and invention title "Spreading Bracket" (the corresponding PCT application was filed on August 13, 2018, with application number PCT / US2018 / 046561).

[0003] Cross-references to related applications This application claims the benefit of provisional patent application No. 62 / 622,741 (Attorney's Case No. 32016-714-110), filed January 26, 2018; No. 62 / 577,624 (Attorney's Case No. 32016-714-109), filed October 26, 2017; No. 62 / 558,273 (Attorney's Case No. 32016-714.108), filed September 13, 2017; and No. 62 / 544,682 (Attorney's Case No. 32016-714.107), filed August 11, 2017, the entire disclosure of which is incorporated herein by reference.

[0004] This application is a partial continuation of U.S. Patent Application No. 16 / 039,194 (Attorney's No. 32016-714.303), filed July 18, 2018; a continuation of U.S. Patent Application No. 15 / 921,508 (Attorney's No. 32016-714.302), filed March 14, 2018; a continuation of U.S. Patent Application No. 15 / 605,601 (Attorney's No. 32016-714.301), filed May 25, 2017, now U.S. Patent No. 9,943,426; and a continuation of PCT Application No. PCT / US2017 / 032748 (Attorney's No. 32016-714.601), filed May 15, 2017, which claims Provisional Patent Application No. 62 / 4, filed March 31, 2017. Cases 80,121 (Agent Case No. 32016-714.106); Case 62 / 430,843 (Agent Case No. 32016-714.105) filed on December 6, 2016; Case 62 / 424,994 (Agent Case No. 32016-714.104) filed on November 21, 2016; Case 62 / 414 filed on October 28, 2016. The rights to ,593 (Agent Case No. 32016-714.103); 62 / 374,689 (Agent Case No. 32016-714.102) filed on August 12, 2016; and 62 / 337,255 (Agent Case No. 32016-714.101) filed on May 16, 2016, the entire disclosure of which is incorporated herein by reference. Background of the Invention 1. Invention Field Balloon angioplasty has been introduced to open blood vessels, particularly those that have narrowed due to plaque progression or a heart attack. In successful cases, the vessel remains open and / or exhibits positive remodeling over time and / or displays vasodilatory capacity closely resembling that of a natural blood vessel. However, in other cases, the vessel may become blocked again within days or months due to various causes such as vascular retraction, thrombosis, or progression of other types of plaque morphology.

[0005] Metallic stents were developed to provide a structure, often referred to as a skeleton, with sufficient radial strength (compression resistance) to address recoil and keep the vessel open for extended periods. Stents are formed from wires, coils, braids, sheets, and / or tubular structures. Balloon-expandable stents formed from patterned, non-degradable metal tubes, wires, or sheets are currently the most commonly used because they exhibit desirable structural features compared to some earlier coiled or braided stents, such as limited inward recoil, higher strength (compression resistance or comminutedability), and limited axial shortening during expansion.

[0006] Despite the successful and widespread adoption of metallic stents such as stainless steel alloys, platinum-iridium alloys, and cobalt-chromium alloys, they have certain drawbacks, such as occlusion of the lumen or vessel: they do not expand further after implantation under physiological conditions (after inward retraction), thus hindering further expansion of the lumen or vessel and inhibiting active remodeling, and / or these stents inhibit vasodilation or vasomotor activity in the treated stent segment, which is important for vascular healing or normal vascular function. This phenomenon is often referred to as “occlusion” or “caging” of the vessel. High radial strength is important for supporting the body cavity during implantation and / or maintaining the cavity open during stent placement, and / or high strength is important for preventing lumen shrinkage after implantation. In some cases using shape memory self-expanding alloy stents, due to material properties, these stents typically do not exhibit the high radial strength (high resistance to comminutedness) of metallic stents. Therefore, in some situations, excessive inward retraction due to inward forces on the lumen and / or the lower radial strength of these stents can cause the lumen to shrink after implantation, making further expansion less likely after implantation into the lumen or lesion segment, and / or less likely to exhibit vasodilation or vasomotor activity in the stent segment. In some cases, shape memory stents may penetrate the lumen wall and migrate into the adventitia, causing irritation and inflammation of the vessel or lumen, sometimes leading to undesirable negative clinical events and / or re-occlusion of the body cavity or vessel. Furthermore, during delivery to the vessel or lumen, restraints are often used to hold the stent in a coiled configuration, resulting in a larger stent system profile and making delivery difficult. This type of stent is typically pre-programmed to expand to a certain diameter / configuration, which limits size adjustment to this pre-programmed diameter / configuration. It is unlikely that the expanded diameter can be expanded or kept beyond such a pre-programmed diameter. For example, this makes stent size adjustment more difficult, and / or such a stent cannot expand further beyond such a pre-programmed diameter / configuration after being deployed.

[0007] To address some of these drawbacks, biodegradable scaffolds or frameworks made of metallic or polymeric materials have been developed. By allowing the scaffold to degrade or reabsorb, the confinement or cage effect diminishes or decreases over time, and the framework eventually disappears over time. However, current biodegradable scaffolds, particularly polymeric biodegradable scaffolds and corrosive metallic scaffolds, have their own drawbacks, including scaffold fracture, and / or limited ability to over-expand the scaffold beyond its nominal expansion diameter, and / or excessive or high initial inward retraction, and / or additional inward retraction after implantation and initial inward retraction. In some cases, their strength may be insufficient to accommodate various lesion types after deployment, and / or their ability to maintain lumen or vessel patency after deployment is limited. Biodegradable stents typically have lower radial strength (compressive strength / strength) than balloon-expandable non-biodegradable metallic stents. They are often bulky, thick-strut stents designed to address some mechanical drawbacks such as suboptimal compressive strength, or the presence of thick struts may cause negative clinical events, for example, potentially leading to excessive inflammation (at least in part due to material degradation and the amount of degradation material), and / or excessive proliferation such as neovascular intimal hyperplasia (at least in part due to material degradation and the amount of degradation material).

[0008] Attempts have also been made to fabricate the framework using a combination of polymer and metallic materials. However, this design has shown its own limitations. This combination design may lack sufficient initial compressive strength to effectively open the lumen or maintain its openness after stent implantation, or it may fail to uncage the stent, or fail to uncage the stent along the entire stent segment, or fail to uncage the vessel, or fail to further expand the stent under physiological conditions, or fail to allow for the use of vasodilators and / or vasoconstrictors after implantation or for further expansion and / or contraction of the stent after their use. Alternatively, some other such designs will not be able to expand further to a larger configuration after implantation (if, after inward retraction). Other designs have too many individual metal or other non-degradable pieces, which could potentially release small pieces into the bloodstream, potentially leading to clinical events.In the following exemplary cases, one or more of the requirements described above are still not met by current non-degradable stents: stents with less inward retraction, and / or stents with less initial inward retraction after expansion, while the stent diameter is substantially maintained after implantation and after initial inward retraction, and / or non-degradable stents configured to expand further after deployment under physiological conditions (after inward retraction, if present), and / or stents capable of expansion or further expansion (after inward retraction, if present) without a pre-programmed temperature trigger setting or without a pre-programmed expansion diameter / configuration setting. The stent, and / or a stent capable of expanding or further expanding without a programmed temperature (after inward retraction, if present), and / or a stent capable of further expanding after deployment under physiological conditions without penetrating or substantially penetrating the vessel or lumen wall into the adventitia (after inward retraction, if present), and / or a stent that does not cause excessive inflammation, and / or a stent that does not penetrate the lumen or vessel wall after implantation into the adventitia, and / or a stent that further expands after any inward retraction following deployment (implantation), thereby further expanding the lumen or vessel diameter, and / or a stent without approximately When delivered into a blood vessel or lumen in the case of a bundle, the stent retains or substantially retains its coiled configuration and expands further to a larger configuration after any inward retraction following deployment; and / or has a stent that can deploy to a variety of diameters and still expands the blood vessel or lumen after deployment; and / or has a stent that can deploy to a variety of diameters and expands further to a larger configuration after any inward retraction following implantation; and / or has a stent that can expand further beyond a pre-programmed expansion diameter / configuration after any inward retraction following implantation; and / or has a stent that exhibits vasomotor, vasodilation, or vasoconstriction following implantation. The stent, and / or a stent having sufficient strength to support a body cavity after deployment, having less inward retraction and wherein the stent exhibits 1% or greater radial strain after deployment, and / or a non-degradable stent having initial compliance when expanding from a coiled configuration to an expanded configuration, wherein the initial compliance increases after implantation, and / or a non-degradable stent having initial radial strength (compression resistance) when expanding from a coiled configuration to an expanded configuration, wherein the initial radial strength decreases after implantation, and / or a balloon-expandable non-degradable stent capable of expanding from a coiled configuration to an expanded configuration, wherein the expanded configuration includes a diameter of 2.0 mm to 4.0 mm, and wherein the stent exhibits initial inward retraction after initial expansion, and the stent has an initial diameter after the initial retraction, the stent retains the initial diameter (or configuration) after the initial inward retraction, and wherein the stent responds to a vasodilator after implantation sufficiently to expand the stent segment to a second diameter, wherein the second diameter (or configuration) is greater than the initial diameter.

[0009] Following the implantation of stents or other prostheses, a particular concern regarding vessels and other body cavities is the loss or expansion of vascular or luminal remodeling, or the loss of vascular compliance or contractility, referred to above as “cage” or “confining” of the vessel or body cavity. Under physiological conditions, vascular compliance is necessary for vessels or body cavities, such as in response to changes in internal or external pressure, muscle contraction, muscle relaxation, and chemical changes. These changes can arise from numerous sources, including the presence of natural or artificial substances that can relax or contract body cavities and / or muscles (such as smooth muscle cells, for example, smooth muscle cells within the cavity walls). Stent implantation in a vessel or body cavity inevitably leads to a reduction in the overall or “composite” compliance of the cavity and the stent. The natural compliance of the body cavity and the additional compliance of the stent each affect the overall or overall “composite” compliance, which will inevitably be less than the compliance of a body cavity without a stent. Therefore, it is desirable that stents implanted in body cavities, particularly those implanted in vessels, minimize the reduction in body cavity compliance naturally resulting from stent implantation. However, a decrease in compliance may be acceptable for a period immediately following implantation, particularly during periods when high radial strength is required to maintain vascular (or body cavity) patency and prevent further inward retraction after implantation (such as during or in the initial post-implantation period). After the initial period of vascular healing, this strength becomes less necessary or unnecessary, and eventually, the strength of the stent becomes less necessary or important. During or after such a healing phase, it is highly desirable for vascular compliance to recover to, or approach to, or approximate the natural compliance level of the lumen without the implanted stent. Therefore, the object of the present invention is to provide stents, stent frames, and other luminal prostheses that exhibit increased compliance over time in response to the vascular or other luminal environment after implantation, such that the overall or combined compliance of the stent frame and body cavity increases to a level closer to or approximates the compliance level of the body cavity without the stent frame.

[0010] There is also a problem of compliance loss with valves, annulus, and other devices implanted in the heart valve ring. The valve skeleton may not always need high radial strength, especially after the initial stage of implantation. It is beneficial that the skeleton is compliant enough to conform to the valve annulus when it deforms during normal systolic-pause cycles, or that the skeleton deforms to conform to the valve annulus that has deformed due to disease progression, thereby maintaining the integrity of valve function, or that the skeleton enlarges to conform to the valve annulus enlargement due to physiological conditions or disease progression, while maintaining the integrity of valve function.

[0011] What is needed are implants, stents, stent frames, vascular prostheses, external prostheses and / or other luminal prostheses that address these and at least some of the other disadvantages described herein.

[0012] 2. List of background technologiesRelevant background patents and applications include: US7011678; US5922020; US2003 / 0153971; US9056157; US2005 / 0222671; US9265866; US7169173; US8435281; US2003 / 0195609; US7402168; US7829273; US5695516; US6540777; US8652192; US8128679; US8070 794; US6599314; US8961585; US7455687; US7645409; US8202313; EP2229919; US6251134; US6409754; US5766237; US5957975; US5306286; US5961545; US8052743; US9180005; US9192471; US2008 / 177373; and US2005 / 283229. Summary of the Invention

[0014] This invention provides numerous examples and embodiments of stents, particularly vascular and lumen stents and prostheses exhibiting strength, improved (or controllable) strength, and / or improved (or controllable) compliance characteristics after expansion and / or implantation. In one particular example, metallic, metal alloy, and other non-degradable stents can be modified in many ways to control their radial strength and compliance during initial expansion in the body cavity and subsequently over days, months, and years after initial expansion and / or implantation. In particular, many stent and scaffold designs described and claimed in this application will provide variable (or controllable) compliance and radial strength, wherein initial compliance is relatively low and increases over time after implantation, while initial strength is relatively high (e.g., having considerable circumferential strength or compressive strength) at implantation or initial expansion and decreases (or may decrease) over time after implantation. The increase in compliance and the decrease in radial strength may occur over a period of days, weeks, or months after implantation and may be caused by any one or more of many structural transformations in the scaffold forming all or part of the prosthesis. In some cases, such as when locking features on the skeleton unlock in response to partial or full circumferential expansion of the skeleton, compliance may change more abruptly. In other cases, such locking features may be combined with other features and designs that gradually alter the effective compliance of the skeleton over time.

[0015] In a first aspect, the present invention provides an intracavitary prosthesis having improved opening characteristics when expanded from a coiled configuration to an expanded configuration. The intracavitary prosthesis includes a framework having a plurality of circumferential rings, typically formed or patterned from a non-degradable material. The framework pattern includes one or more of the following: open-hole design, closed-hole design, helical trunk, peak-to-peak ring design, peak-to-valley ring design, offset peak-to-peak ring design, or offset peak-to-valley ring design, or others. Typically, the framework is formed from a tube, curved line, or planar substrate and forms a tubular structure. Several embodiments provide improved opening characteristics. In one embodiment, the framework includes axial links axially divided into two parts, which are held together by geometry or the use of degradable or non-degradable polymers or adhesives during framework expansion, and the two parts of the axial links separate or are allowed to move in one or more directions when the framework expands in a physiological environment to provide improved opening of the framework or framework. In another embodiment, the skeleton comprises a series of complete circumferential rings and one or more partial circumferential rings, wherein the partial circumferential rings are connected to adjacent complete or partial rings by one or more separable axial links. The separable axial links are held together by geometry or by a biodegradable or non-biodegradable polymer or adhesive, and when the stent expands in a physiological environment, the two portions of the axial links separate or are allowed to move in one or more directions, providing improved openings for the skeleton or stent. In another embodiment, described more fully below, the skeleton or stent comprises circumferential rings, some of which include two aligned struts, typically each aligned strut being connected to an adjacent circumferential ring by a link or connector.

[0016] In one example, the stent prosthesis deploys to the expanded configuration under physiological conditions, said physiological conditions including one or more of the following: a temperature of about 37°C, a water bath at about 37°C, a mammalian body cavity, a mammalian blood vessel, a mammalian artery, a pressure gradient of 40 mmHg to 200 mmHg, a pressure gradient of 100 mmHg, systolic and / or diastolic blood pressure, torsion of an artery, lumen or vessel, compression, elongation and / or bending, vasomotor activity, a pulsating artery or a simulated artery, a simulated human blood vessel or a combination thereof.

[0017] In the case of separable axial links, the skeleton is configured to expand from a coiled configuration to an expanded configuration and has attachment points on at least some adjacent circumferential rings, wherein these attachment points are typically axially aligned in pairs. These attachment points are engaged by circumferentially separable axial links. Typically, before expansion, the axial links are locked (restricting separation) by their geometry, as described in more detail below. When the skeleton expands radially, typically by internal balloon expansion, but also potentially by self-expansion, the axial links deform in a way that "unlocks" their initially locked configuration, allowing the axial links to circumferentially separate. Alternatively, when the skeleton expands, the axial links may deform in a way insufficient to "unlock" their locked configuration, but after expansion in a physiological environment, the axial links will deform in a way sufficient to "unlock" their locked configuration. Alternatively, when the stent expands, the axial links may deform in a way insufficient to "unlock" their locked configuration, but after expansion in a physiological environment, the axial links will separate. In a preferred example, the separable axial link has geometry locked within the axial link to prevent separation during expansion of the stent from a coiled configuration to an expanded configuration, and the separable axial link is configured to separate after expansion in a physiological environment. Some physiological conditions that lead to further deformation of the stent after implantation and unlocking include torsion and compression of the stent within the blood vessel or lumen.

[0018] In another preferred example, the stent prosthesis includes a structural element comprising one or more circumferentially separable rings, wherein the rings have a geometry configured to deform and / or move, rotate, or twist during expansion from a coiled configuration to an expanded configuration to prevent separation. In a preferred example, the separable rings are separated by separable axial links engaged with the rings. In some cases, the separable axial link segments have a geometry configured to be mechanically fitted or locked together and configured to rotate about a radial axis, a circumferential axis, and / or an axial axis during expansion to offset, balance, or counteract forces attempting to separate the segments of the axial link. This rotation, which offsets or counteracts the expansion forces, prevents the rings from separating during expansion. Such geometry can be seen in many examples and figures, wherein the axial link comprises a series of curved or interlocking segments. In some cases, the separable ring geometry after expansion in a physiological environment is configured to further deform before separation. In another example, the separable ring geometry after expansion in a physiological environment is configured to separate by forming one or more discontinuities. In another example, the separable ring geometry, after expansion in a physiological environment, is configured to separate by forming one or more discontinuities upon degradation of the polymer or adhesive. In another example, the separable ring geometry, after expansion in a physiological environment, is configured to separate without further deformation. In another example, the separable ring has a geometry configured to further deform about one or more axes (including radial, axial, or circumferential axes) prior to separation. In yet another example, the separable ring has a geometry configured to deform to counteract the expansion force of the stent and prevent the ring from separating during expansion.

[0019] In another embodiment, the stent includes circumferential rings comprising struts joined by a coronal portion, wherein at least some of the circumferential rings include two aligned, separable struts configured to separate upon expansion in a physiological environment. Each of the two separable struts can be coupled to an adjacent circumferential ring so that, upon expansion in a physiological condition, the struts circumferentially separate to open the ring, but each separable strut is connected to an adjacent ring. In some embodiments, each circumferential ring of the stent includes one or more segments having two aligned struts, each strut being coupled to an adjacent circumferential ring via a link or connector. In one example, the aligned struts and their connectors to the adjacent circumferential rings may be arranged along a line at an angle to the longitudinal axis of the circumferential ring and the stent. See also Figure 54A and Figure 54BIn some cases, there may be two rows of angled, aligned struts or three rows of aligned struts, each row containing two struts. During strut expansion, the aligned struts are held together by geometry or adhesives or polymers as described herein, but after expansion in a physiological environment, the struts separate and the skeleton opens to form one or more segments of the strut, typically without ends. In some cases, there may be several ends. In some examples, the aligned struts are joined to adjacent circumferential rings by links or connectors of other aligned struts, but in some examples, the aligned struts may be connected to adjacent rings at any location on the ring, typically having aligned segments on the adjacent rings. Or in some examples, segments of overlapping regions (two segments with mirrored geometry) rather than aligned struts may comprise any part of the ring—struts, crowns, or links—in various combinations.

[0020] In another example, the separation region includes two crowns, each originating from a circumferentially adjacent ring. In another example, the separation region includes a strut and a crown, each originating from a circumferentially adjacent ring. In yet another example, at least one separation region including a strut or crown from a circumferential ring is connected to a second segment on an axially adjacent circumferential ring, wherein the second segment includes a strut or crown. In yet another example, the two segments may be considered as separation regions, and a separation region on one ring is connected via a link to a second separation region on an axially adjacent ring. In one example, the axial length of the separation region is substantially the same as one or more of the following: the strut or crown on the circumferentially adjacent ring is 0.1 to 2 times the axial length of the strut or crown on the circumferentially adjacent ring.

[0021] In a preferred embodiment of any example in this application, it is desirable to have a stent comprising one or more circumferential rings, said stent being split without ends, without multiple ends, or without more than four ends, or with no more than four ends. Figures 35-54 illustrate examples with no ends and with two ends. This facilitates vascular healing, minimizes vascular irritation, prevents small structural elements from displacing into the blood flow, and improves fabrication.

[0022] Optionally, in addition to the physical locking, the circumferentially separable axial segments may be additionally restricted, held together, kept in close contact, or secured using a biodegradable material through coating, encapsulation, adhesive, or other means, which will continue to inhibit circumferential separation of the axial segments until the biodegradable material degrades in the physiological environment, thereby unlocking the axial segments. Some or all of the separable axial segments may be encapsulated. However, in other cases, the circumferentially separable axial segments may be unrestricted by such coatings, encapsulation, adhesives, or other further restrictions and will be held together solely by the mechanical locking provided by the geometry of the aligned segments or portions, as described in more detail below. The stent may be a balloon that expands from a coiled configuration, or it may be restricted to the coiled configuration before implantation and allowed to self-expand into the expanded configuration after removal of the restriction or resistance. In another example, after the initial self-expansion of the stent in the body cavity, the stent is a balloon expandable into the expanded configuration.

[0023] At least some of the axial links of the skeleton of the present invention will include a first segment and a second segment. The first and second segments are separated by a dividing line that typically extends axially, and this dividing line typically includes a cleft, cut, gap, or other discontinuity in the axial link structure. By "axial extension," it means that the dividing line and the link itself extend from a first attachment point on a first circumferential ring to a second attachment point on an adjacent second circumferential ring, wherein the attachment points are axially separated. That is, at least one component or vector of the distance between the attachment points will extend axially, and the dividing line will extend across this axial distance. However, as described in more detail below, the direction of the dividing line at any point along the axial link can be in any direction, such as axial, circumferential, or any direction in between. Therefore, in some embodiments, the dividing line will typically follow a non-linear, tortuous path, which may include curves, bends, linear portions, and combinations thereof. However, typically, the axial links do not extend significantly beyond the cylindrical shell of the skeleton before circumferential expansion. In particular, when the skeleton is in its curled configuration, the segments and regions of the axial links do not overlap radially.

[0024] When the stent is in its coiled configuration, the first and second segments of the circumferentially separable axial links can be circumferentially interlocked to inhibit circumferential separation. This interlocking can take any of a variety of forms, and typically, when a circumferential separation force is applied to the axial links, the first and second segments will bend or flex into a pattern that partially interferes with or otherwise inhibits partial circumferential passage or separation of the other segment. However, as the skeleton expands, the geometry of the segments will deform. Several factors may contribute to keeping the segments together during expansion. During expansion, the segments may deform and / or the geometry of the two interlocked segments may cause, allow, or provide for rotating segments in different directions (circumferential, axial, or radial) to deflect, balance, or counteract the expansion force and prevent expansion until after expansion under physiological conditions. This deformation may cause the segments of the axial links to interlock or impede separation and prevent separation, but subsequently, under physiological conditions, additional deformation may occur to allow any interfering or obstructing portions to move to allow circumferential separation. The two segments of the axial link may come into contact with each other in a bend or curve, thus the two segments are nested together, mirror each other, or fitted together with two segments forming the same, corresponding, similar, or identical bends or curves, thereby forming a close fit, mechanical locking, spatial restraint to hinder, resist, delay, or inhibit the separation of the segments. There may be one or more nested or aligned bends or the shapes of the two segments along the length of the axial link. The segments may be in close contact with aligned segments of the partial annular joint along the length of the separable circumferential link, including a portion, a majority, almost all, about 50%, about 70%, about 80%, about 85%, greater than 50%, greater than 70%, greater than 75%, greater than 80%, or greater than 85%, or along the partially annular joint.

[0025] The circumferential rings are configured to be circumferentially separated at least at the attachment point. Specifically, when the skeleton expands circumferentially, after the segment unlocks, the axial link segment and the circumferential ring will separate at the attachment point. After this separation, the opposite ends of each link segment will remain attached to its adjacent circumferential ring, so that the rings remain axially connected but circumferentially open. In one example, adjacent circumferential rings are axially connected by axial links, wherein each axial link includes a separation region that axially divides the axial link into two separable axial links, and after the stent or skeleton expands in a physiological environment, the axial links separate into two links, each connecting the two adjacent rings.

[0026] The circumferentially separable axial links can extend to virtually any point on adjacent rings. That is, the attachment point of the axial link on the circumferential ring can be located anywhere on the ring. For example, the circumferentially separable axial link connecting ring, comprising or consisting of struts and crowns, can extend between strut pairs on adjacent rings, between crown pairs on adjacent rings, or between the crown on the first ring and the strut on the second ring. Therefore, the attachment point can be located at any point on any one or more struts and crowns in the circumferential ring. The axial links can be connected to one or more of the following on each adjacent ring: the expansion region of the ring, the crown region of the ring, the strut region of the ring, the lower stress region, and the higher stress region. The skeleton can contain any number of rings along its axial length. In one example, if the skeleton has an even number of circumferential rings, when the separable axial links disengage after the skeleton expands in a physiological environment, the skeleton separates into several units—two, three, or four—each unit containing circumferential rings connected to unseparated axial links. In a preferred example, the axial length of the separation region is equal to the axial length of at least one ring, i.e., the distance between rings along the axial direction. In a preferred example, the axial length of the separation region ranges from 0.75 times to 2 times the axial length of a ring, or the distance from one ring to an adjacent ring. In one example, if there are an odd number of circumferential rings in the skeleton, the skeleton opens and the separable axial links separate when the skeleton expands and disengages in a physiological environment, and the skeleton may include an integrally connected workpiece. The rings on the skeleton may have a helical pattern. The skeleton may have some, most, almost all, or all of the rings connected to adjacent circumferential rings via separable axial links.

[0027] The circumferentially separable axial links can also be arranged in various forms on the skeleton. In some cases, at least some or all of the axial links will be arranged along one, two, three, or more axes along the length of the skeleton. In other cases, at least some or all of the axial links may be arranged along at least one, two, three, or more helices of the skeleton.

[0028] As long as the two segments are interlocked or joined during the coiling of the skeleton and can be unlocked during circumferential expansion of the skeleton, the geometry of the circumferentially separable links and the boundary lines between the segments can vary widely. Typically, the boundary lines are non-linear, often having one or more curvature regions, and sometimes are completely curved. In many cases, the axial links and boundary lines will include curved and linear regions; in other cases, the curved portions will have regions with different curvatures. Typically, the curved portions will include regions with reverse curvature. Employing axial links with curves and bends enhances the flexibility of the support in coiling and expansion configurations.

[0029] In specific embodiments and examples, each of the two segments of the separable axial link of the skeleton has a first end and a second end, wherein the dividing line extends from the first attachment point along a first axial direction to the second end and forms at least a first deflection back toward the first end. When a circumferential opening force is applied to the skeleton, such a reversal in direction causes an "overhang" or "undercut" in the dividing line pattern, thereby inhibiting or preventing the two segments from passing through each other in the circumferential direction. However, when the skeleton deforms, those segments that were initially opposed in a manner to prevent their bypass will be reoriented so that they can pass through each other circumferentially, allowing the axial link to unlock, separate, and open circumferentially. Typically, the first steering will turn through an angle of at least about 100°, preferably at least about 120°, more preferably at least about 135°, and even more preferably at least about 180° or greater, and will provide sufficient interference to prevent the segments from passing each other, allowing the axial links to open until the skeleton is significantly opened, typically at least 25% of the initial diameter, often 200% of the initial diameter, and typically at least 400% of the initial diameter.

[0030] In many implementations, the dividing line and axial link will form a third turn to travel again in the first axial direction, and in more cases a fourth turn to return in the second axial direction.

[0031] In other specific cases, the axial link and the axially extending boundary line may be S-shaped, W-shaped, serpentine, or a combination thereof.

[0032] In other specific examples, at least some of the circumferentially separable axial links may include nested wedges with male and female portions that are interference-fitted before the skeleton expands.

[0033] The separation region between separable axial link segments may include any combination of struts and / or crowns, and may include geometry that may deform, twist, rotate, compress, or elongate during expansion, after expansion under physiological conditions (37 degrees Celsius), or after the stent expands from a coiled configuration to an expanded configuration under physiological conditions, securing the segments together and subsequently forming one or more discontinuities in the ring. In one example, the separation region includes geometry that deforms, twists, rotates, compresses, or elongates about a circumferential axis, longitudinal axis, and / or radial axis before or in order to form one or more discontinuities in the circumferential ring. In another example, the separation region includes geometry configured to deform, twist, rotate, compress, or elongate in the circumferential ring before or in order to form one or more discontinuities in the circumferential ring after stent expansion in a physiological environment. In one example, the segments may twist against each other in areas of contact or close engagement to hold the segments together during expansion, and are configured to release, unlock, or separate after expansion under physiological conditions.

[0034] As described below, the skeleton of the present invention may include separation regions other than the circumferentially separable axial links. These separation regions may include a variety of biodegradable or non-degradable polymeric materials and other adhesives, glues, sleeves, etc., intended to initially fix the separation regions upon deployment in a physiological environment. Such biodegradable polymers and other materials described below may also be used to temporarily fix the circumferentially separable axial links described more specifically herein. These sections fixed with such non-degradable or biodegradable materials may also be considered separation regions within the scope of this application and related applications. The polymer or adhesive may be placed or located on a support or a support on a proximal surface of the lumen or a lumen, or both; or on one or more surfaces of the support; or within the separation region; or within the separation region and on the top and / or bottom (proximal or lumen) surfaces of the separation region. On top of the polymer on the support, there may be an additional layer of polymeric material that may be placed or located on a support or a support on a proximal surface of the lumen or a lumen, or both; or on one or more surfaces of the support; or within the separation region; or within the separation region and on the top and / or bottom (proximal or lumen) surfaces of the separation region. The separable axial links may have gaps between the two segments to interrupt the circumferential path of the ring, but a coating of a degradable polymer above or within the gap holds the gap together during expansion and provides a continuous circumferential path around the stent. During expansion in a physiological environment, the polymer or adhesive degrades and the gap is exposed, thus providing an interruption in the circumferential path and the opening of the ring. Gaps may exist between the segments of the partial annular joint, held together by the interlocking shape of the segments or by a coating above the segments, a sleeve-like degradable or non-degradable material, or a containing material within the gap. When the stent expands in a physiological environment, the segments are more freely unlocked, separated, opened, or moved depending on how they are held together. An opened stent expands substantially uniformly and has sufficient strength to support the body cavity. Non-degradable materials, polymers, or adhesives hold the separated areas together during expansion and allow the separated areas, after expansion in a physiological environment, to move in one or more directions, including radial, circumferential, or axial. In one example, stretching of the non-degradable polymer material allows this movement. In another example, the softening of the non-degradable material allows for the movement. In one example, the stent has minimal outward force in the expansion configuration. In another example, the stent has lower outward force in the expansion configuration compared to the same stent with a continuous circumferential path (no separation region). In another example, the stent is more compliant in the axial and / or circumferential directions. In yet another example, the stent in the expansion configuration has sufficient strength to support the body vessel but not enough outward force to cause further vascular damage after implantation.In another example, the stent in the expansion configuration does not cause adventitia damage to the blood vessel.

[0035] In a preferred example, the stent is formed of a non-degradable material and includes one or more circumferential rings forming a continuous circumferential path around the stent, wherein at least one or more separating regions bisect the circumferential path, forming one or more discontinuities within the circumferential path. In a preferred example, the separating regions are first formed during or after the patterning of the stent. In another preferred example, the separating regions are held together by material or geometry during the expansion of the stent from a curled configuration to an expanded configuration, wherein the separating regions form the one or more discontinuities after expansion under physiological conditions. In a preferred example, the material connecting the separating regions together connects them into a continuous, equally bisected circumferential path before they form one or more discontinuities after expansion in a physiological environment. In another example, the geometry of the separating regions maintains the integrity of the circumferential rings, allowing the rings to expand uniformly from a curled configuration to an expanded configuration, and then the geometry detaches to form one or more discontinuities within the circumferential rings. In another example, the separating regions include one or more of a degradable polymer: a coating or sleeve, an adhesive, or one or more equally bisected structural elements. In another example, the one or more equally divided structural elements include one or more of the following: a key and lock configuration, a ball-and-socket configuration, a male-female configuration, or other types of configurations that form a discontinuity after expansion within the physiological environment of the stent. In some cases, it is desirable to have a separation region configured to form one or more discontinuous areas after expansion of the stent in one or more directions to minimize the formation of neointimal hyperplasia, reduce torsional stress on the stent, maintain or increase the lumen configuration, or reduce elongation or compressive stress on the stent. For example, the separation region forms a discontinuity after the stent expands only radially within the physiological environment. In another example, the separation region forms a discontinuity after expansion of the stent only in the radial and / or axial length directions within the physiological environment. In another example, the separation region forms a discontinuity after expansion of the stent only in the radial and / or circumferential directions within the physiological environment. In another example, the separation region forms a discontinuity after expansion of the stent only in the axial direction along the length of the stent within the physiological environment. In another example, the separation region forms a discontinuity after expansion of the stent only in the circumferential direction within the physiological environment. In yet another example, the separation region may form a discontinuity after expansion of the stent in the axial, radial, or circumferential directions within the physiological environment.

[0036] In another example, the stent prosthesis may be formed of a non-degradable polymer or a metallic material (including metals or metal alloys), or the stent may be formed of a degradable polymer or a metallic material (including metals or metal alloys).

[0037] In another example, the stent prosthesis may be formed from a non-degradable shape memory alloy, the stent having one or more circumferential rings, at least some of which have at least one separation region that equally divides, cuts, or segments the circumferential rings to form a discontinuous circumferential path around the stent. During expansion of the stent from a coiled configuration to an expanded configuration, the separation regions remain together, wherein the stent expands substantially uniformly and has sufficient strength to support the body cavity. The separated regions held together can be held together by geometry or by degradable or non-degradable polymers or adhesives, any of which may or may not make the discontinuous circumferential path continuous, and may become discontinuous again as discontinuities form after expansion in a physiological environment. For example, the separated regions may have gaps due to geometric results or mechanical interlocking, or the segments may contact and separate under physiological conditions. Alternatively, if a degradable material holds the separated regions together, the ring becomes continuous until a discontinuity subsequently forms. When a non-degradable material holds the separated regions together, the ring becomes continuous, but the material may degrade, stretch, or soften to allow movement in the circumferential, axial, or radial directions. In one example, the stent has minimal outward force in the expansion configuration. In another example, a stent with discontinuities has lower outward force in the expansion configuration compared to the same stent with a continuous circumferential path (no dissociation region). In another example, the stent is more compliant in the axial and / or circumferential directions. In another example, the stent in the expansion configuration has sufficient strength to support the body vessel but not sufficient outward force to cause further vascular damage after implantation. In another example, the stent in the expansion configuration does not cause adventitia damage to the vessel. In an alternative example, the dissociation regions may be held together before the stent is expanded by a biodegradable polymer or adhesive, wherein the adhesive or biodegradable polymer degrades in the physiological environment, forming one or more discontinuities in the circumferential path after the stent is expanded. In another example, the stent is confined in a coiled configuration and is allowed to expand to the expansion configuration by removing this confining. In another example, after the initial self-expansion of the stent in the body cavity, the stent is a balloon expandable to the expansion configuration. In another example, at least some loops have 1 to 4 dissociation regions, dividing each loop equally.

[0038] In a preferred embodiment, the stent includes one or more circumferential rings, wherein each ring includes a structural element comprising struts and a coronal portion, and wherein each ring includes one or more separation regions, wherein the separation regions are located in one or more of the following: struts, coronal portions, strut regions, coronal regions, adjacent to struts on a single ring, adjacent to a coronal portion on a single ring, substantially parallel to struts on a single ring, substantially parallel to a coronal portion on a single ring, replacing struts on a ring, or replacing a coronal portion on a ring. In a preferred embodiment, the separation regions include two adjacent struts in a single ring, two adjacent struts on two circumferentially adjacent rings or partial rings, two adjacent coronal portions in a ring, two adjacent coronal portions on two circumferentially adjacent rings or partial rings, wherein the two adjacent struts or two adjacent coronal portions are held together during stent expansion and separate after the stent expands under physiological conditions.

[0039] Sometimes it is desirable to axially connect the stent structure after the circumferential rings have formed a discontinuity. This helps improve support for the body cavity (or blood vessel) and prevents neointimal protrusion between the rings. This can be achieved by separating the axially connected circumferential rings after implantation. In one example, the stent includes one or more circumferential rings (loops), each ring engaging with an axially adjacent ring, and at least some of the rings having one or more separation regions such that the circumferential path of each ring is discontinuous, the discontinuous path being held together by a polymer or adhesive, and forming one or more discontinuities after the stent expands in the physiological environment. In another example, the axially engaged rings are engaged via one or more axial links, wherein at least one or more of the axial links are configured to separate after expansion in the physiological environment and after neointimal hyperplasia, so as to substantially lock the stent axially after implantation. In another example, the axially connected rings are engaged via one or more axial links, wherein at least one or more of the axial links are configured to dissociate after expansion in the physiological environment and after the formation of new intimal hyperplasia sufficient to cover the strut thickness of the stent, to substantially lock the stent after implantation. In another example, the axially connected rings are engaged via one or more axial links, wherein at least one or more of the axial links are configured to dissociate after expansion in the physiological environment and after the formation of new intimal hyperplasia sufficient to cover at least 0.25 times the strut thickness of the stent, to substantially lock the stent after implantation. In another example, the axially connected rings are engaged via one or more axial links, wherein at least one or more of the axial links are configured to dissociate after expansion in the physiological environment and after the formation of new intimal hyperplasia sufficient to cover 0.1 to 2 times the strut thickness of the stent, to substantially lock the stent after implantation. In another example, one or more axial links are configured to dissociate before, approximately simultaneously with, or after the discontinuity formation on adjacent rings. Following discontinuity formation, the stent needs to be substantially secured in place to provide better structural support for the lumen (vascular vessel) and to minimize or inhibit neointimal protrusion through gaps in the stent structure. In one example, the stent prosthesis includes one or more circumferential rings that can expand from a coiled configuration to an expanded configuration, wherein each ring has one or more separation regions within it, between adjacent rings, or between circumferentially adjacent partial rings, wherein at least some of the separation regions (or substantially most of the separation regions) are configured to form a discontinuity, or other adjacent stent structural element, after stent expansion and after forming 0.1 to 2 times the thickness of the adjacent strut, coronal portion, to substantially secure the stent in the circumferential and / or axial directions.

[0040] Many or all of the stents or other skeleton designs described herein will be able to adapt to or fit most or all forms of annular and / or vascular geometry, movement, anatomical changes, and deformation over time after deployment. For example, as described herein, stents and skeletons with separation regions and / or hinged joints will have sufficient tensile stress, fracture resistance, and the ability to adapt to geometric deformations such as angles (vascular curvature), torsional stresses (vascular twisting around the vessel axis), longitudinal compression, and tension, etc. For example, stents and other skeletons implanted in annular structures, arteries and veins located in the heart, or the aorta, or circumferential anatomy below the knee, or the superficial femoral artery, etc., can withstand such stresses. The stents and skeletons of the present invention are generally able to dynamically conform to and respond to the pulsation (radial opening and closing) of such vessels and torsional deformation and longitudinal compression around the axis of such vessels.

[0041] In some examples, an intracavitary prosthesis formed of a non-degradable material and having a circumferential ring including a strut joined by a coronal portion and having a discontinuous separation region formed after the prosthesis expands under physiological conditions, has stress caused by longitudinal compression or extension of the expanded prosthesis before the discontinuity forms in the separation region. In some cases, the maximum stress caused by longitudinal compression or extension of the expanded prosthesis before the discontinuity forms in the separation region is reduced by at least 10%, 15%, 25%, 50%, 75%, 85%, or 90% after the discontinuity forms. In some cases, the maximum stress caused by longitudinal compression or extension of the expanded prosthesis before the discontinuity forms in the separation region is reduced by 15%-95%, preferably 50%-95%, more preferably 70%-95% after the discontinuity forms.

[0042] In some cases, before the discontinuity forms in the separation region, the maximum stress ranged from 400e3 PSI to 800e3 PSI due to 5%–7% longitudinal compression or extension of the expanded prosthesis, as measured by linear elastic finite element analysis, while after the discontinuity formed, it ranged from 1e3 PSI to 300e3 PSI. Sometimes, before the discontinuity forms in the separation region, the maximum stress ranged from 300e3 PSI to 1000e3 PSI due to 5%–7% longitudinal compression or extension of the expanded prosthesis, as measured by linear elastic finite element analysis, while after the discontinuity formed, the maximum stress ranged from 1e3 PSI to 250e3 PSI.

[0043] In some examples, the maximum stress caused by torsion applied to the expansion prosthesis before the discontinuity forms in the separation region is reduced by at least 10%, 15%, 25%, 50%, 75%, 85%, or 90% after the discontinuity forms. Alternatively, the maximum stress caused by torsion applied to the expansion prosthesis before the discontinuity forms in the separation region is reduced by 15%-95%, preferably 50%-95%, more preferably 70%-95% after the discontinuity forms. In some examples, the maximum stress, as measured by linear elastic finite element analysis, before the discontinuity forms in the separation region is caused by a torsional displacement of 3.5° / cm of the prosthesis length applied to the expansion prosthesis, ranging from 80e3 PSI to 150e3 PSI, and after the discontinuity forms, ranging from 1e3 PSI to 65e3 PSI. Alternatively, before the discontinuity forms in the separation region, the maximum stress measured by linear elastic finite element analysis is caused by a torsional displacement of 3.5° / cm applied to the prosthesis length of the expansion prosthesis, ranging from 65e3 PSI to 150e3 PSI, while after the discontinuity forms, it ranges from 1e3 PSI to 50e3 PSI.

[0044] Sometimes, before the discontinuity forms in the separation region, the force required to bend the prosthesis in a three-point bending configuration is reduced by at least 10%, 15%, 25%, 50%, 75%, 85%, or 90% after the discontinuity forms. Alternatively, before the discontinuity forms in the separation region, the force required to bend the prosthesis in a three-point bending configuration is reduced by 15%-95%, preferably 50%-95%, more preferably 70%-95% after the discontinuity forms. In some cases, before the discontinuity forms in the separation region, the force required to bend the prosthesis center about 1 mm in a three-point bending configuration with stents spaced about 11 mm apart ranges from 0.1 N to 0.8 N. Alternatively, before the discontinuity forms in the separation region, the force required to bend the prosthesis center about 1 mm in a three-point bending configuration with stents spaced about 11 mm apart ranges from 0.7 N to 4 N, and after the discontinuity forms, the required force ranges from 0.01 N to 0.5 N.

[0045] In some examples, the maximum stress caused by bending the expansion prosthesis to the target radius before the discontinuity forms in the separation region is reduced by at least 10%, 15%, 25%, 50%, 75%, 85%, or 90% after the discontinuity forms. Alternatively, the maximum stress caused by bending the expansion prosthesis to the target radius before the discontinuity forms in the separation region is reduced by 15%–95%, preferably 50%–95%, more preferably 70%–95% after the discontinuity forms. Sometimes, the maximum stress ranged from 100e3 PSI to 800e3 PSI when bending the expansion prosthesis to the target radius of 70 mm before the discontinuity forms in the separation region, as measured by linear elastic finite element analysis, while for a 6 mm expansion stent diameter, the maximum stress ranged from 10e3 PSI to 90e3 PSI after the discontinuity forms.

[0046] Sometimes, the change in the angle of the tortuous vessel where the dilatational implant is placed before the discontinuity forms in the separation region is reduced by at least 10%, 15%, 25%, 50%, 75%, 85%, or 90% after the discontinuity forms. Alternatively, the change in the angle of the tortuous vessel where the dilatational implant is placed before the discontinuity forms in the separation region is reduced by 15%-95%, preferably 50%-95%, more preferably 70%-95% after the discontinuity forms. In some cases, the change in the angle of the tortuous vessel where the dilatational implant is placed before the discontinuity forms in the separation region ranges from 30 to 70 degrees, while the change in the angle after the discontinuity forms ranges from 10 to 25 degrees. In some examples, the maximum stress caused by bending the dilatational implant at a given angle before the discontinuity forms in the separation region is reduced by at least 10%, 15%, 25%, 50%, 75%, 85%, or 90% after the discontinuity forms. Alternatively, the maximum stress caused by bending the dilatational implant at a given angle before the discontinuity forms in the separation region is reduced by 15%-95%, preferably 50%-95%, more preferably 70%-95% after the discontinuity forms.

[0047] In some examples, the maximum stress, measured by linear elastic finite element analysis, before the discontinuity forms in the separation region, bends the prosthesis at a given angle of approximately 7 degrees to a diameter of 3.0 mm, ranging from 100e3 PSI to 800e3 PSI, and after the discontinuity forms, ranging from 10e3 PSI to 90e3 PSI.

[0048] The stent or framework may contain a drug that will be released into the physiological environment after implantation. The drug may be coated on one or more surfaces of the stent; on the luminal surface or the lumen surface, or both; contained in one or more polymeric materials coated on any surface of the stent; contained in a coating on any surface; or contained in a polymeric matrix on the stent or framework. Drugs that may be used include the various drugs listed in this application, and include, for example, M-tor inhibitors, including drugs such as rapamycin, everolimus, analogs or derivatives, and paclitaxel, analogs or derivatives.

[0049] Methods for measuring and quantifying the strength (radial strength) and compliance of vascular and other luminal stents and skeletons are well known and described in patents and medical literature.

[0050] In many examples or implementations, the term "compliance" is a non-dimensional measure that expresses the percentage change in diameter (or configuration) of a lumen structure or segment thereof in response to a physiological condition, such as a change in internal pressure within or near the lumen structure, typically in the form of 100 mmHg. In some other cases, compliance measures may be expressed as mm / atm, mm / psi, % / atm, % / psi, etc. The terms "compliance" and "radial compliance" are used interchangeably.

[0051] Body cavities, stents, skeletons, prostheses, and other tubular structures will each have their own compliance. Body cavities with implanted stents, skeletons, prostheses, and other tubular structures will also have compliance, which is a composite of the individual compliances of the lumen and the implant, where the composite is typically lower than that of the lumen and, in many cases, lower than that of the implant alone. In many cases or examples, “composite” compliance will be measured to define the compliance characteristics of a stent, but in some cases it may also be the compliance measured for individual stents, skeletons, prostheses, and other tubular structures in the many examples claimed herein. Throughout many cases or examples of this application, the term “radial strain” is used to mean compliance, and the terms “compliance” or “composite compliance” are used interchangeably with the term “compliance” (or “composite compliance”) when described in this or other paragraphs. Typically, when radial strain is measured under a pressure change of 100 mmHg, the radial strain refers to the compliance (or composite compliance) of the implant. However, compliance can also refer to the percentage change in diameter of the implant or composite under a given pressure change other than 100 mmHg.

[0052] Specifically, the radial compliance of stents, skeletons, or other luminal prostheses will be measured as in vitro composite compliance in simulated blood vessels according to known principles and techniques, such as those described in ASTM F2477-07R13 for measuring compliance under pressure variations of 100 mmHg. However, this test may also provide the methods required to test compliance under given pressure variations other than 100 mmHg (such as approximately 176 mmHg or other pressures). Furthermore, stent compliance can be tested by implanting the stent into a blood vessel, such as a coronary artery, in an animal pig, and compliance can be measured within the stent segment of the vessel.

[0053] In a first aspect or example of the invention, the prosthesis, particularly an intracavitary prosthesis, comprises a skeleton having a plurality of circumferential rings formed or patterned from a non-degradable material (typically a metal or metal alloy), wherein the skeleton is configured to expand from a coiled configuration to an expanded configuration. At least some of the circumferential rings will have at least one separation region, wherein the separation region is configured to form at least one discontinuity in the circumferential ring after the skeleton has expanded in a physiological environment. In a preferred example, after such expansion and exposure to a physiological environment (typically a vascular or other body cavity environment), at least two circumferential rings remain axially engaged after all discontinuities have been formed; these are typically axially adjacent rings. Typically, all circumferential rings of such an intracavitary prosthesis will remain axially engaged after discontinuities have been formed. For example, the circumferential rings may be engaged by axial links, which are typically shorter structural elements that engage a region on one circumferential ring with a region on an adjacent circumferential ring. However, as described in more detail below, in other examples, regions on adjacent circumferential rings may be directly joined, for example, by welding crown to crown, post to post, or otherwise. In certain examples, adjacent crowns on adjacent rings may be joined by welding, wrapping, joining with wire or other threads, adhesives, etc. While separation regions are typically formed within posts, crowns, or other structural elements, in some cases, separation regions may encompass or include the entire structural element. In some examples, lock and key or other types of separation regions may be elongated to form the entire or nearly entire length of a post between a pair of adjacent crowns. In other examples, the male and female components of a lock and key separation region may be bent to form a crown between a pair of mating or adjacent posts. Separation regions may be located anywhere within the structural element. They may be located near the center of the structural element, or at or near one end or the other end of the structural element.

[0054] The stent prosthesis has at least one separation region that forms a discontinuity upon expansion within the physiological environment. This separation region is positioned within a circumferential ring to create the discontinuity. In some cases, it provides a cleft, gap, complete separation, or divides the ring into individual segments, thereby eliminating the continuous circumferential path of the ring around the skeleton. In some examples, each circumferential ring has a separation region that forms a discontinuity upon expansion within the physiological environment, providing a gap, cleft, or separation within each circumferential ring to open or eliminate the continuous circumferential path of each ring around the skeleton.

[0055] Typically, the division method divides a continuous portion or segment of a structural element, circumferential ring, or axial link into two or more separate parts that are not necessarily of equal length. For example, a dividing region in a crown or a strut in a ring divides the crown or strut into two or more equal parts. In some cases, the dividing region divides the crown or strut in the middle of the crown or strut. In other cases, the dividing region divides the crown or strut in a non-middle manner.

[0056] In a preferred example, the term "separation region" refers to a location or area within the scaffold that is configured to form at least one discontinuity within the scaffold after expansion in a physiological environment. This discontinuity includes openings, fissures, gaps, segmented sections, etc., formed between two adjacent portions or segments of the scaffold assembly, in some cases pre-joined so that these portions or segments are no longer directly connected to each other in the region of the portion or segment. The two adjacent portions or segments of the assembly may have been joined prior to scaffold expansion in any of the other ways described herein, or may have already formed a continuous structure.

[0057] At least in most cases, discontinuities form in the dissected area only after expansion within the scaffold and physiological environment, typically between one week and 12 months post-expansion, usually between one month and nine months, and usually between two and seven months. In particular, for balloon-expandable stents and other prostheses, it is expected that the dissected area remains intact when the scaffold is balloon-expanded, and that discontinuities (i.e., the area previously joined by the scaffold) will only fully form after the stent has been in place in the vessel or other physiological environment for a certain period. Although discontinuities typically do not form until after expansion in the physiological environment, in some cases, under physiological conditions, one or more loops (usually one or more distal loops) may form one or more discontinuities before stent expansion (stent deployment).

[0058] For example, such intracavitary prostheses according to the invention will have circumferential rings with circumferential structures that, before any discontinuity is formed, have initial radial compliance, typically the composite compliance discussed above. However, after the discontinuity is formed, the radial compliance of at least some of the circumferential rings will increase relative to the initial radial compliance of at least some of the rings before the discontinuity was formed. For example, the initial radial compliance (or composite compliance of the skeleton segment) of at least some of the circumferential rings of the skeleton according to the principles of the invention may be 0.1% to 1%, typically 0.1% to 0.5%, while after the discontinuity is formed, the radial compliance will typically be 1.2% to 10%, often 1.2% to 15% or 1.5% to 3%.

[0059] In one example, the composite compliance of the skeleton can be measured using a simulated vascular system as follows. The skeleton under test, the simulated vascular system, the water used to pressurize the simulated vascular system, and all other testing equipment are maintained at room temperature. All diameter measurements are performed using a calibrated non-contact system capable of measuring diameters within ±0.01 mm without contact with the skeleton. Suitable measuring instruments include a microscopic video measurement system, a laser microscope, and an optical comparator. Pressure measurements of the water used to pressurize the simulated vascular system are performed using an instrument that can accurately measure fluid gauge pressure within ±0.05 PSI. Pressure measurements are performed concurrently with diameter measurements. All connecting tubing used in this setup is less than 10 inches in length to eliminate any limitations in tubing and connectors, ensuring that any dynamic changes in pressure throughout the simulated vascular system are accurately reflected by the pressure gauge. Diameter measurements should be performed 30 minutes after the initial pressurization of the simulated vascular system.

[0060] The simulated blood vessel is an elastomeric silicone tube with a uniform cross-section and uniform material properties along its entire length. For stents with a diameter less than 2.5 mm, the simulated vessel wall thickness is 0.25 ± 0.03 mm. For stents with a diameter of 2.5 mm and larger, the simulated vessel wall thickness is 0.5 mm ± 0.03 mm. The test pressure within the simulated blood vessel will be 3.4 ± 1 PSI (or approximately 176 mmHg), and the system will have sufficient leak-proof properties to maintain this pressure during testing. The stent-simulated blood vessel system is secured to prevent length changes and variations in the simulated blood vessel caused by longitudinal forces that could affect the stationary length and diameter of the simulated blood vessel. The stent-simulated blood vessel system is further secured to prevent diameter changes caused by forces other than internal pressure.

[0061] The balloon-expandable non-degradable skeleton is deployed in air to an inner diameter (ID) equal to or 0.1 mm smaller than the outer diameter of the simulated vessel in its uninflated state after retracting inward from the expansion configuration. The skeleton is expanded using a balloon or other delivery system suitable for use with the skeleton under test. The inner diameter (ID) is verified using a non-contact measurement system. The expanded skeleton is then deployed in air to its free diameter, and the ID is verified using a non-contact measurement system. A simulated artery is selected such that its outer diameter is equal to or 0.1 mm larger than the inner diameter of the deployed stent.

[0062] The expanded test skeleton slides on the outside of the simulated blood vessel, stretching the simulated blood vessel channel as needed to temporarily reduce the channel diameter to allow the stent to pass over it. After releasing tension on the simulated blood vessel, the actual contact between the skeleton ID and the outer diameter (OD) of the simulated blood vessel along the entire contact length is verified.

[0063] The simulated vascular conduit is internally connected to an indeflator (an inflator / deflator used to inflate and deflate the angioplasty balloon during angioplasty), which is capable of providing at least 3.4 psi and has instruments capable of measuring the pressure in the conduit within 0.05 psi at such pressures.

[0064] The OD of the stent and the OD of the simulated vessel reference portion away from the stent segment were measured using a non-contact system at a distance equal to twice the diameter of the simulated vessel from the stent, and similar to the distance from any fixation holding the simulated vessel in place. Three OD measurements were taken and averaged to obtain the baseline simulated vessel OD value. Three OD measurements were taken near the mid-length of the skeleton and averaged to obtain the baseline skeleton OD value. The interior of the simulated vessel was pressurized with water to 3.4 PSI (176 mmHg), and while maintaining the pressure reading at 3.4 PSI, the OD of both the skeleton and the simulated vessel were measured using a non-contact system at the same location used to establish the baseline. Composite compliance was determined as a percentage by dividing the OD value measured with the simulated vessel under pressure by the baseline OD value, subtracting 1, and multiplying by 100.

[0065] For example, if the pressure applied in the simulated blood vessel causes the OD of the test skeleton to increase from a diameter of 3.50 mm OD to 3.73 mm OD, then the composite compliance is ((3.73 / 3.50) - 1) × 100 = 6.6%. As a second example, if the pressure applied in the simulated blood vessel causes the OD of the test skeleton to increase from a diameter of 3.50 mm OD to 3.52 mm OD, then the composite compliance is ((3.52 / 3.50 - 1) - 1) × 100 = 0.6%.

[0066] The composite compliance of the skeleton can be measured before and after opening the dissociated regions to form discontinuities. To obtain composite compliance before discontinuity formation, the skeleton is measured as described above while all dissociated regions remain intact. To obtain composite compliance after discontinuity formation, the skeleton is processed to open all discontinuities while it remains on the simulated vessel. The dissociated regions can be opened using techniques specific to the nature of the particular dissociated region. For dissociated regions fixed by polymer sleeves, adhesives, or solvents, the skeleton is exposed to solvents, enzymes, or other chemicals to form discontinuities without damaging the simulated vessel. Alternatively, for non-polymer dissociated regions, the discontinuity can be physically separated using mechanical means, laser cutting machines, ultrasound, or other energy-based cutters. For dissociated regions that are locked in place or opened in response to fatigue, the simulated arterial circulation can be pressurized at a rate of 5-8 Hz until discontinuities are formed. See Example 5 and Figure 35. If the skeleton disintegrates when the dissociated regions are opened, the composite compliance is considered equal to the compliance of the simulated vessel without the skeleton.

[0067] The skeletal structure possesses initial compressive strength, which decreases after expansion and discontinuity within the physiological environment. Upon implantation, the skeletal structure exhibits initial compliance, which increases with the formation of discontinuities, while the expanded shape after retraction does not decrease.

[0068] Radial strength (compressive strength) is measured using parallel plates (refer to ISO 25539-2). These parallel plates are fixed to an Instron tensile testing machine equipped with a 5N force sensor to allow for the measurement of force and displacement. The base plate is flat and remains stationary during the test. The top plate is mounted on the force sensor to record force measurements as a function of displacement. Visual verification confirms that the plates are parallel to each other at their mating surfaces. Both the base and top plates are rectangular in shape, their surfaces completely covering the test support in length and diameter. Both plates are configured to be kept immersed in a water bath at body temperature, maintained at 37 ± 2°C by a circulating heater. During force measurements, the circulating pump is shut off to prevent current from altering the results. The top plate is made of delrin, and the base plate is made of brass.

[0069] The test skeleton is unfolded to its nominal inner diameter using a standard inflation / deflation device or other delivery system. The unfolded test skeleton is then removed from the delivery system, and its diameter is verified using a non-contact measurement system. The test stent was then slid onto a 0.035” diameter mandrel approximately 50 mm long and placed between parallel plates immersed in water at 37°C, simulating physiological conditions. The mandrel prevented the test stent from rolling upon initial contact with the parallel plates. The upper plate was then slowly and gently pushed downwards approximately 1 mm above the stent using a displacement controller from an Instron tensile testing machine, and the force gauge was zeroed. It was then lowered until it barely contacted the test stent and a force of 0.01 N was detected. The stent was then allowed to stabilize in the water bath for 60 seconds. The test cycle began, and compressive strength was measured by reducing the distance between the parallel plates to at most 50% of the test stent diameter. Force-distance curves were generated during the test. The rate of distance reduction (crosshead speed) was 1.5 mm / min. The load force at 10% stent deformation (compression) was determined in Newtons. For example, for a 3.0 mm marked stent expanded to a nominal diameter (3.0 mm), a compression of 0.3 N was reported. The force required to measure mm (10% compression) is then divided by the length of the expanded stent in mm to normalize the strength in N relative to the stent length, thus expressing the radial strength of the stent as N / mm stent length.

[0070] The radial strength of the expanded stent baseline (in N / mm stent length) is measured, and measured again after the formation of a discontinuity (if present), as described in the compressive strength method. For the stent of the present invention, the radial strength is reduced after the formation of a discontinuity compared to the radial strength before the formation of a discontinuity, preferably by 10% to 100% of the baseline radial strength.

[0071] The above-described procedures for measuring composite compliance and radial strength are particularly effective for measuring values ​​of skeletons with nominal diameters of 2 mm to 4 mm and featuring dedicated or conventional deployment systems. For stents, valves, prostheses, and any other stents with other sizes and deployment systems (including non-standard sizes and deployment systems), the stent should be deployed according to the manufacturer's published instructions for use, and the test equipment should be adjusted or modified to have the same fit with the deployed skeleton, as described above. In the case of a simulated vessel used to measure composite compliance, the outer diameter of the simulated vessel should be equal to or at most 0.1 mm larger than the inner diameter of the deployed skeleton. In the case of a plate separation distance used to measure compressive strength, the skeleton OD should be measured using 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 much as possible.

[0072] In a preferred example, the skeleton of such an intraluminal prosthesis can be segmented after a discontinuity has been formed in the circumferential ring. The segmentation can be along an axial line, a circumferential line, a spiral line, an irregular line, or other lines. For example, two, three, or more segments can be segmented along an axial line, a spiral line, or an irregular line, allowing the segment to expand and contract radially, which increases the composite compliance of the skeleton when implanted into the body cavity. Typically, all or substantially all of the segments will remain axially engaged along their entire length (or along the entire length of the stent), such that when the discontinuity provides enhanced (or increased) radial compliance, the structural elements of the skeleton remain axially engaged to continue providing support (or skeleton support) to the lumen (or vessel) wall, and / or reducing the risk of displacement or otherwise release of the elements after implantation into the vascular system or body cavity. Other examples of segments include obturator segments, etc. In such a preferred example, the skeleton (intelostomy prosthesis) is formed into a tubular body with a coiled configuration and / or an expanded configuration, and wherein the skeleton can be formed from wire, substantially continuous tubing, sheet, molding, or printing.

[0073] In closed-cell designs, such separation regions are typically located where the circumferential path becomes discontinuous. In this case, the discontinuity can be located in the circumferential connector between closed cells on the ring, or on either side of the closed cell on the ring, so that the ring is opened and the circumferential path is completely divided or separated.

[0074] In other implementations and / or examples, the skeleton will not be segmented. That is, although at least one and usually more discontinuities will be formed in the skeleton, all circumferential rings, struts, crowns, links, and other structural elements (or components) of the skeleton will remain physically connected such that no part (or element) of the skeleton is completely disconnected from the rest of any other part of the scaffold. This physical connection of all parts of the skeleton is advantageous even after discontinuities are formed, as the risk of any part of the skeleton being released into the vascular system or other body cavities is reduced.

[0075] In a specific example, discontinuities in adjacent circumferential rings may be separated along an axial line, such that the support is divided into two or more axially aligned segments, each extending from a first end (typically the end) of the skeleton to a second end (typically the end). These axially aligned segments of the individual circumferential rings are circumferentially separated along an axial line (typically straight), a helix, or an irregular separation line, but remain axially joined or intact (through, for example, one or more axial links) after all discontinuities have been formed. Such intact axial segments, helical segments, or irregular segments will be elongated, typically having a length corresponding to the full length of the skeleton in its expanded configuration.

[0076] While such elongated axial, spiral, or irregular segments will typically be completely separated along their entire length, in other cases, one or two circumferential connections may be retained after all discontinuities have been formed in the skeleton. In particular, elongated segments may be retained at either end or both ends of the skeleton to reduce "dog-boning" or for other purposes.

[0077] In some examples, the circumferential rings of the skeleton of the present invention may have a continuous circumference or perimeter, typically a circular circumference. In this case, adjacent continuous rings are typically joined by axial links or by direct connection, for example, by welding, fusion, binding, gluing, or other means such as adhering the crown to adjacent circumferential rings. In other cases, at least some circumferential rings may have discontinuous circumferences, with end regions joined to form a helical skeleton. In specific examples and embodiments, the axial links will be constructed of non-degradable metals, metal alloys, or other non-degradable materials. Most commonly, such axial links will be patterned from the same tubular components (or materials) used to form the skeleton. Thus, many skeletons will be formed as a monolithic or integral structure from the same metal, metal alloy, or other material forming the support.

[0078] Exemplary intracavitary prostheses of the present invention will typically include a skeleton with repeating structural elements such as circumferential rings, obturators, etc. For example, some or all of the circumferential rings may include similar or identical structures, such as multiple struts joined by the coronal portion in a similar or identical pattern (but may also have different one or more structures, patterns, and structural elements (thickness, width, shape, etc.). Separation regions may be located in the struts, the coronal portion, or both. Typically, at least one separation region will be located in a strut, and at least one to five struts within the ring will have separation regions. Alternatively or additionally, at least one separation region may be located in the coronal portion, and at least one to five coronal portions within the ring may have separation regions. However, typically most or all of the coronal portions will not have separation regions because the coronal portion or coronal region is subjected to higher stresses when the skeleton is inflated by a balloon or otherwise radially expanded from a coiled configuration to an expanded configuration. Such higher stresses can lead to premature formation of discontinuities in the skeleton and loss of structural integrity. Therefore, struts are preferred locations for forming separation regions. Separation regions may also be formed in axial links or other regions directly axially connected between adjacent circumferential rings. Separation regions in the axial connectors between adjacent rings typically do not contribute to the radial compliance of the ring or stent segment, or typically will not affect the radial strength of the ring or skeleton after discontinuity is formed, and are therefore optional. In many cases, the axial links and other axial connector regions will remain uninterrupted and intact. Thus, in many examples of the invention, the skeleton will comprise or consist of multiple axially connected circumferential rings, wherein the rings include or consist of struts connected by the coronal portion, wherein separation regions are formed only in the struts and not in the coronal portion (or coronal region) or in the axial links or other axial connector regions. The advantage of placing separation regions in the circumferential rings, such as struts and / or the coronal portion, is that it provides the ability to alter the circumferential properties of the stent at different points in time after implantation. The circumferential arrangement of the rings makes the ring structure critical for various stent properties such as radial strength (flatness), composite compliance of the stent segment, further expansion to a larger diameter after implantation, response to vasodilation, etc. For example, placing separation regions in the circumferential ring structure provides a stent with altered, improved properties after discontinuity is formed after implantation. The need for luminal stents is inherently time-dependent and varies at different points in time. In the short period after implantation, stents need to have high radial strength to support vascular opening. Then, in the next period, as tissue remodeling and healing begin or are completed, the need for the high stent strength required to maintain vascular opening is no longer necessary; on the contrary, high strength may impair the physiological function of the vessel.While current non-degradable (non-corrosive) stents, such as stainless steel alloy stents, cobalt-chromium alloy stents, and platinum-iridium alloy stents, address the immediate initial high radial strength requirement of blood vessels, they often fail to respond to the changing vascular needs over time after implantation, where the vessel no longer requires high radial strength to maintain patency, and maintaining this high radial strength over time may irritate the vessel and cause further disease progression or poor healing. Stents preferably formed from non-degradable materials (stents can also be formed from degradable materials) and having discontinuous separation regions within the stent rings after implantation provide stents with altered, improved properties after the formation of these discontinuities. Such stents of the present invention are configured to provide high initial radial strength after expansion, which subsequently decreases over time after implantation, thereby helping to address the physiological needs of the vessel while maintaining patency. Similarly, current non-degradable stents often have stent segments with low composite compliance, typically "cageling" the vessel during the stent's lifespan, thereby inhibiting the vessel's natural vasomotor capacity, inhibiting the vessel's ability to respond to vasodilators, or inhibiting further expansion of the stent segment to a larger diameter after implantation. The stent of the present invention, having discontinuities formed within a circumferential ring after implantation, can be configured to have higher (or increased) composite compliance after expansion, thereby allowing the stent segment of the vessel to respond to natural changes in blood pressure (vasomotor activity), allowing the stent (or stent segment) to expand further after initial expansion (and after inward retraction, if present), and maintaining the vessel's ability to respond to vasodilators. The stent of the present invention can be configured to have increased composite compliance in the stent segment shortly after expansion or longer after implantation.

[0079] The advantages of placing the separation region within the strut include that the separation region is typically a lower stress area of ​​the ring, and therefore experiences less plastic deformation than the crown. The strut's location and size also offer additional options for a wider range of separation regions, as they are generally larger and have lower torque than some other areas of the stent, such as the crown of the ring or other curved areas. The strut can often accommodate more variations (such as having a separation region) without compromising the functional integrity of the stent, such as enabling the stent to expand from a coiled configuration to an expanded configuration. The strut's orientation changes as the stent expands (opens), allowing the separation region to be designed to utilize the strut angle before expansion, which is configured to hold the separation region together as the stent expands, and to open the strut to an angle in the expanded stent configuration, allowing desired directions of movement for the separated strut elements, such as radial, circumferential, and / or axial movement.

[0080] Placing the separation region within the coronal can be advantageous. The coronal typically experiences high bending moments (torques) during annular expansion or contraction, leading to high stress and plastic deformation. Engaging elements resistant to these high moments (torques) can advantageously be used in the coronal region. Expansion movement in the coronal region causes rotation between adjacent struts. Engaging elements that release this rotation, such as through ball-and-socket joints or other joints depicted throughout the application, can reduce annular stiffness while maintaining the bonding force between the separable regions of the annulus, allowing them to retain their "tubular" integral shape and conform to the lumen even after separation. Having a separation region within the coronal can achieve greater composite compliance, which may be desirable in some applications. Furthermore, having a separation region in the coronal allows the use of other materials unsuitable for stent applications due to mechanical limitations such as elongation or brittleness, where the separation region in the coronal allows the annulus to expand without breaking.

[0081] In the exemplary intracavitary prosthesis, struts can be coronally joined to define an angle between them, commonly referred to as an "angle". When the skeleton is in a curled configuration, the angle is typically small, sometimes even negative. As the skeleton expands from a curled configuration to an expanded strut configuration, the angle increases. Typically, the angle in a curled configuration with at least some struts coronally joined is in the range of -25° to +25°, more typically in the range of -15° to +55°. The angle in an expanded configuration is typically in the range of 35° to 180°, more typically in the range of 45° to 150°. When present in struts, a separation region can be located anywhere along the length of the strut, typically at or near the middle of the strut, typically bisecting it. Similarly, when present in the coronal, a separation region can be formed at a point on the coronal, typically near the middle of the coronal, for example, at a location that would typically bisect a semi-circular coronal portion. In a preferred example, the separation region in at least one strut is a pre-formed slit (or gap) that divides at least one strut into two separate elements. Examples of the separation regions in at least one support include butt joint designs, key and lock designs, comb designs, and / or others, wherein the equally divided support elements adjacent to the separation regions may have various geometries, shapes, sizes, and patterns, and are configured to have uniform support expansion and / or maintain the structural integrity of the support during expansion. The at least one equally divided support (separation region) is typically held together by one or more materials, as described throughout this application.

[0082] In a preferred example, at least some separation regions are located above or within "low-stress regions" of at least some circumferential rings, i.e., those regions that experience less stress when the skeleton expands via a balloon or by self-expansion, such as strut regions. As the skeleton expands from a coiled configuration to an expanded configuration, low-stress regions (such as struts) will experience less stress than high-stress regions (such as the coronal portion) that deform due to concentrated stress when the skeleton expands radially. In a particular example, at least some circumferential rings, each having one or more separation regions, have initial strength when the stent expands in a physiological setting, wherein the initial strength of at least some circumferential rings decreases after discontinuities form. In a preferred example, one or more separation regions are preferably located within struts, wherein the struts experience reduced (or minimal) stress as the skeleton expands from a coiled configuration to an expanded configuration, thereby enhancing the structural integrity of the skeleton during expansion by suppressing all or substantially all discontinuities during expansion.

[0083] The separation region within the skeleton of an intracavitary prosthesis can take many forms. For example, the separation region may include a pre-formed slit or gap in the coronal and / or strut regions, thereby dividing the coronal and / or strut structural elements into two separate portions, which are joined, covered, or embedded therein by a material that will degrade in the physiological environment. This material is typically a biodegradable polymer, but sometimes a biodegradable metal or metal alloy; many specific examples are described in detail below. The biodegradable material, comprising one or more materials, can then be provided in various forms and geometries, including sleeves, coatings, solders, adhesives, laminates, etc., which can be applied to at least one surface of the separation region, at least one surface of the stent, all separation region surfaces, and / or all stent surfaces. In some examples, at least one, most, or all of the separation region surfaces or skeleton surfaces may be covered or laminated with a biodegradable material. In a preferred example, the material fills all spaces between opposing surfaces of the separation region, as well as the stent proximal and luminal surfaces, and acts as an adhesive, glue, or attachment element to hold the surfaces together to maintain stent structural integrity during stent expansion. In other cases, the degradable material may be located on or only within the separation region, and optionally have a short distance on either side, for example, 2 mm, 1 mm, 0.5 mm, etc. In yet another example, the non-degradable material comprising one or more non-degradable materials may 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 may be applied before or after the degradable material. In a preferred example, the degradable and / or non-degradable material placed on the non-degradable stent is a polymer material. In another example, the polymer material (degradable and / or non-degradable) contains at least one drug substance, which may coat at least one surface of the stent, preferably covering at least the proximal lumen surface of the stent.

[0084] In some examples, the separation region contains a non-degradable material that relaxes, expands, becomes more flexible, or softens to create discontinuities in the circumferential rings, allowing the rings to remain joined but exhibiting enhanced ability to move in all directions at the discontinuities. This separation region can be formed by incorporating a flexible, non-degradable material or polymer into the separation region (gap, crack, or interruption) of the skeleton. In some examples, a degradable or non-degradable material or polymer coats the skeleton, covering the entire skeleton or separation region. In the case of a degradable material, the degradable material degrades after the skeleton expands under physiological conditions, releasing a drug in some cases, which is incorporated into the coating and / or degrades in the separation region to allow for the formation of discontinuities. When the coating is a non-degradable material (such as a polymer), the coating can cover the entire skeleton or some areas of the skeleton. The non-degradable material can be selectively used to cover the separation region, which can be a gap or crack in the skeleton, to allow the non-degradable material to soften after the skeleton expands under physiological conditions and to allow increased flexibility and movement at the discontinuities.

[0085] In certain examples, the biodegradable material may be applied by spraying, dipping, sleeve encapsulation, printing, welding, adhesive bonding, etc. The biodegradable material may be a polymer, metal, or any other biodegradable material, as described in more detail elsewhere herein. Typically, the biodegradable material has sufficient strength to hold the separated regions together to secure adjacent structural elements within the separated regions as the framework of the scaffold or other prosthesis expands from a coiled configuration to an expanded configuration in a physiological environment. The biodegradable material typically degrades after the scaffold expands from a coiled configuration to an expanded configuration. The biodegradable material may have a thickness substantially the same as the thickness of the adjacent regions of the non-biodegradable structural elements, meaning the biodegradable material will fill the gaps or other spaces between adjacent structural elements but will not extend over these adjacent regions. However, in other examples, the biodegradable material may have a thickness adjacent to the separated regions that is 5 μm to 30 μm thicker than the thickness of the non-biodegradable structural elements adjacent to the separated regions, and may extend over said adjacent regions, extending over or covering at least one surface of the scaffold, or covering all scaffold surfaces. The thickness of the biodegradable material may be substantially the same for all separated regions, or may have different thicknesses, for example, to control the timing of discontinuity formation.

[0086] In a preferred example, the biodegradable material substantially uniformly covers the non-degradable structural elements of the scaffold, i.e., has substantially the same thickness on substantially all near-lumen surfaces of the structural elements and substantially all lumen surfaces of the structural elements, but the biodegradable material may also have different thicknesses on different surfaces of the scaffold structural elements. Typically, the coating or other covering on the near-lumen and / or lumen surface areas of the scaffold structural elements ranges from 3 μm to 50 μm, more typically from 5 μm to 30 μm. The biodegradable material may cover and / or fill only the separation areas, may cover and / or fill the separation areas and the surfaces of adjacent structural elements, may cover and / or fill the separation areas and the surfaces of adjacent structural elements and adjacent rings, or may cover the entire scaffold and fill all separation areas.

[0087] As described elsewhere in this document, some or all of the separation regions can be configured to form discontinuities at approximately the same time or at different time intervals. In a preferred example, the degradable material degrades after 1 month to 2 years post-implantation, preferably 2 months to 1 year post-implantation, and more preferably after 3 months to 9 months post-implantation.

[0088] In another preferred example, the non-degradable skeleton having separate regions held together by at least one degradable material will have an initial stent average volume (or average area) after expansion and after initial inward retraction (if present) after expansion, and wherein, in a physiological environment, after the degradation of the degradable material following stent implantation, and / or during a period of 1 to 9 months post-implantation, the average area (or average volume) is 0.75% to 0.90% of the initial stent average volume (or average area), substantially the same as (maintained) the initial average stent volume (or average stent area), or an increase in the average stent area (or average stent volume).

[0089] In another example, a non-degradable skeleton (or stent) or other prosthesis comprises multiple circumferential rings having one or more separation regions along the path of each ring. The skeleton has an initial strength sufficient to maintain the average stent area (or average stent volume) after expansion and initial inward retraction (if present), and exhibits a decrease in said initial strength after discontinuity in a physiological environment, while substantially maintaining or increasing the average stent area (or average volume). Such a non-degradable skeleton will typically have a degradable material that can be stretchable (elastic), typically stretchable (elastic) enough to hold structural elements adjacent to the separation regions together during skeleton expansion, and / or stretchable (elastic) enough to allow the skeleton or skeleton segment to adapt to or respond to vascular movement or vasodilation after deployment, or after deployment and before degradation of the degradable material, or after degradation of the degradable material. When a vasodilator is used, or when a pressure change of approximately 180 mmHg is applied, the stents or other prostheses in these examples may adapt to (or exhibit) an increase (or change) in diameter in one or more skeleton segments (or stent segments). Under physiological conditions, this diameter variation ranges from 0.05 mm to 0.5 mm, and more typically from 0.7 mm to 0.4 mm. In another example, the elastic material adjacent to (including therein, on, and around) at least one or more separation regions is a non-degradable material, such as a polymer material, like polyurethane. In a preferred example, the non-degradable material has sufficient strength to contain the separation regions together as the stent initially unfolds from a coiled configuration to an expanded configuration, and the elastic non-degradable material allows one or more loops or stent segments to further expand and / or contract under physiological conditions after the initial expansion of the stent and / or after the formation of discontinuities.

[0090] In yet another example, the separation region may contain an elastic material disposed within, on, and / or near gaps, spaces, or other fissures formed in the structural elements of the ring (typically struts and / or the crown). The elastic material typically remains intact after the skeleton expands in a physiological setting, and can act as an "expansion joint," allowing the ring to expand and, in some cases, contract to increase radial compliance under physiological conditions. In some examples, this expansion joint will be secured by a coating, sleeve, adhesive, or any other form of bioresorbable material described elsewhere herein, thereby connecting, binding, or holding adjacent separation regions of the skeleton together as the skeleton expands. In other examples, one or more expansion joints will not be secured, and the elastic material will provide sufficient strength to maintain integrity during balloon or other expansion while still providing the desired radial compliance or strength after expansion. The elastic material in the separation region may be used alone or in combination with other separation regions secured during balloon or other expansion by means of means such as biodegradable materials.

[0091] In other exemplary embodiments, the separation region may include a "key and lock" engagement that is fixed during expansion but configured to separate after initial expansion in a physiological environment. In some cases, the key and lock engagement may have a comb-like interface surface that allows separation in the circumferential and / or radial directions but prevents separation in the axial direction. In other cases, the key and lock engagement will have a smooth or straight interface surface that allows separation in the circumferential, radial, and / or axial directions. In still other cases, the key and lock engagement will have non-linear interface surface regions, such as "saw," "v," "u," inverted "v," inverted "u," or other surface region interfaces, wherein the non-linear surface region interfaces may have one or more surface region interfaces, and said one or more surface region interfaces may have the same or different shapes, sizes, thicknesses, lengths, and widths. Such key and lock engagements are typically fixed during expansion but configured to separate after initial expansion in a physiological environment, for example, by being covered, embedded in, or joined with a biodegradable material such as a biodegradable polymer.

[0092] In other examples, the separation region of the present invention may include a mating joint joined, covered, or embedded therein by a material that degrades in a physiological environment.

[0093] The skeleton of the intracavitary prosthesis of the present invention will contain a non-degradable material, typically a metal or metal alloy. Discontinuities formed within the metal skeleton allow for further expansion after initial retraction. These discontinuities will also typically allow for further expansion to a diameter greater than the initial expansion diameter.

[0094] In some implementations and examples, in expansion and / or curling configurations, the circumferential rings may be substantially perpendicular to the longitudinal axis of the skeleton. In other implementations and examples, in one or both of the expansion and curling configurations, the circumferential rings may be tilted at an angle relative to the longitudinal axis of the skeleton. In further examples and implementations, successive circumferential rings will be joined end-to-end in a continuous helical pattern, wherein each ring defines a single turn of the helix.

[0095] In another aspect or example, the present invention provides a variable compliance stent (or a controllable compliance stent, or an enlarged compliance stent), a skeleton, or other lumen or valve prosthesis comprising a non-degradable metal or metal alloy skeleton (such as cobalt-chromium alloys, platinum-iridium alloys, and stainless steel alloys), which can expand from a coiled configuration to a larger expanded configuration. The skeleton has sufficient strength to support the vascular lumen after expansion, preferably for at least a period of time after expansion (or implantation) sufficient for vascular healing, and / or for at least a period of time after expansion where the risk of further or additional vascular lumen retraction (after any initial retraction of the stent following initial expansion) is reduced or decreased, and / or for at least a period of time from 30 days to 6 months after implantation, and / or for at least a period of time from 60 days to 6 months after implantation. In some examples, the stent has initial strength after expansion (or immediately after expansion, or within 24 hours of implantation (expansion), or within 6 months of implantation (expansion), or within 3 months of implantation, or within 2 months of implantation), said initial strength being sufficient to support the body cavity, and subsequently, when the stent expands in air or under physiological conditions (such as water at 37°C), the initial strength decreases under physiological conditions to a second strength below the initial strength, preferably decreasing over a period of 3 days to 6 months, preferably decreasing to a second lower strength over a period of 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. In some examples, the second lower strength is 10% to 100% of the initial strength, or 10% to 90% of the initial strength, or 20% to 80% of the initial strength, or 30% to 60% of the initial strength. In some other examples, the stent has an initial strength after expansion (or immediately after expansion, or within 1 hour, or 2 hours after implantation), which is sufficient to support the body cavity. When the stent expands under air or physiological conditions, the initial strength subsequently increases under physiological conditions to a first strength, typically 5% to 50% greater than the initial strength, preferably 10% to 30% greater. This first strength occurs after the initial strength (or after the initial strength measurement following implantation (expansion), or 1 hour, 2 hours, or between 1 hour and 1 month after implantation), whereby the initial strength increases to a first greater strength under physiological conditions. This first strength then decreases to a second strength, lower than the initial strength, under the same or similar physiological conditions. The first strength preferably decreases to a lower strength (second strength) within a period of 15 days to 9 months, and preferably, within a period of 30 days to 6 months (or 60 days to 6 months). The decrease in strength to the second strength does not involve degradation of the non-degradable metal or metal alloy (no loss of mass) (or occurs in this case).In some examples, the second lower strength is 10% to 100% of the initial strength, or 20% to 85% of the initial strength, or 30% to 65% of the initial strength. Immediately following deployment (or expansion), the stent's composite compliance, measured in the simulated vessel (or tube), is no greater than 1%, typically no greater than 0.7%, frequently no greater than about 0.5%, typically in the range of 0.1% to 1%, and usually 0.2% to 0.5%. Under physiological conditions (including simulated physiological conditions) or after expansion following exposure to vascular conditions, the composite compliance or stent compliance measured in the simulated vessel will increase by at least 1.2%, frequently at least 1.5%, and sometimes at least 2% or more. In other examples of variable compliance stent prostheses, the stent's composite compliance measured in the simulated vessel can increase by at least two times, frequently at least three times, and sometimes at least four times, five times, ten times, or more compared to the initial composite compliance measured in the simulated vessel.

[0096] Such variable compliance stent prostheses can have a variety of specific design features that provide variable compliance. For example, as described in more detail below, stent prostheses comprising non-degradable metals or metals allow for a skeleton with separation regions that separate or form discontinuities after exposure to vascular conditions for a threshold time. For example, separation of some separation regions can initially be prevented by a bioresorbable material that degrades over time upon exposure to vascular conditions. More specifically, the bioresorbable material can be in the form of a coating, sleeve, adhesive, or any other form suitable for initially connecting, binding, or holding together adjacent separation regions of the skeleton (or skeleton separation strut, or skeleton separation coronal, or skeleton separation structural element). When exposed to vascular conditions, the bioresorbable material can degrade over a period of 30 days to 3 years, often 3 months to 2 years, and more often 3 months to 1 year. To determine whether a stent meets these conditions, the stent can be exposed in vitro to vascular conditions (physiological conditions) as defined elsewhere herein, which are designed to simulate those conditions experienced when implanted into a human blood vessel or lumen. The stent can also be tested after in vivo vascular conditions. The stent can also be tested using in vitro tests under the physiological conditions described in this application. In some other examples, one or more rings containing one or more separated regions contain a non-degradable material, preferably an elastic material, and more preferably a non-degradable polymeric material. The non-degradable material may have sufficient strength to hold such separated regions together during stent expansion, or may have this strength in conjunction with another material, such as a degradable material or other non-degradable material. The elastic non-degradable material may provide the desired radial compliance immediately after expansion or within 24 hours after expansion, such as in response to the use of nitroglycerin or another vasodilator by expanding one or more stent segments (or rings, or stent segments) containing the elastic material. In this example, the elastic non-degradable material controls the desired compliance immediately after initial expansion and / or within 30 minutes and / or within 24 hours after initial expansion (implantation), controls further expansion after initial inward retraction, controls the desired radial strength and / or other mechanical properties of the stent. The stent may additionally comprise one or more rings (the same or different from rings containing a non-degradable elastic material) with one or more separation regions, wherein one or more of the additional separation regions contain a degradable material (such as a degradable polymer material). The one or more separation regions containing the non-degradable material typically inhibit the formation of discontinuities after expansion in a physiological environment, but due to the stretching or elasticity of the non-degradable material, allow the ring (or stent segment) containing the separation regions to have the desired compliance, or allow further expansion after initial recoil following initial expansion, or allow the stent segment (or one or more rings) to respond to vasodilators.In yet another example, all or substantially all separation regions on one or more rings (or all separation regions contained in the stent) contain a non-degradable material that inhibits discontinuity formation but allows the stent (or one or more rings) to have the required compliance and / or radial strength, and / or responsiveness to vasodilators due to the tensile, elastic and / or other material properties of the material.

[0097] In other specific examples and embodiments, the non-degradable metal or metal alloy skeleton may include areas 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 include a bioresorbable material that degrades during said time period. For example, the reinforcing material may fill voids in the coronal and / or strut portions of the non-degradable metal or metal alloy skeleton. Alternatively, the reinforcing material may cover or encapsulate at least a surface area of ​​the non-degradable metal or metal alloy skeleton.

[0098] In addition to exhibiting the variable compliance described above and / or elsewhere, the variable compliance stent of the present invention will exhibit sufficient radial strength after expansion and implantation to maintain vascular lumen patency and inhibit or prevent vascular retraction for a certain minimum time threshold after initial retraction following initial expansion. This time threshold is typically at least 30 days, more typically at least 60 days, and often at least 90 days or longer. Typically, for example, coronary artery stents, the stent strength (or the initial stent strength of an expanded stent) measured using, for example, a 10% flat plate compression test will be 0.030 N / mm stent length to 0.14 N / mm stent length, particularly 0.04 N / mm stent length to 0.1 N / mm stent length, and often 0.05 mN / mm stent length to 0.1 N / mm stent length. Preferably, this stent strength is measured using a 10% flat plate compression after the stent has expanded to its nominal stent expansion diameter. Typically, but not necessarily, after dilation and exposure to vascular conditions, as composite compliance increases from the initial composite compliance (in some other examples, the initial composite compliance decreases and then increases), the radial strength of the stent (framework) will decrease (in some other examples, the initial radial strength of the dilated stent increases to a first strength greater than the initial strength, and then decreases to a second strength less than the initial dilated stent strength). The decrease in radial strength as radial compliance increases occurs simultaneously (or correspondingly, or at similar times, or at the same time, or approximately at the same time). In most cases, the radial compliance and radial strength of the dilated stent will change in opposite directions to each other. Typically, the radial strength of the stent skeleton will decrease by 20% to 100% of the initial radial strength, which is usually measured immediately after dilation or shortly after dilation (e.g., within one hour after dilation) and after exposure to vascular conditions. Sometimes the decrease is 20% to 80%, or in some cases, the initial radial strength of the dilated stent increases first and then decreases to approximately the initial strength or a lower strength, while compliance increases from the initial compliance after implantation under physiological conditions. Or in some other cases, the initial radial strength of the dilated stent is essentially maintained, while compliance increases from the initial compliance after dilation under physiological conditions.

[0099] In specific examples or implementations of variable compliance stents, the non-degradable metal or metal alloy skeleton has a nominal expansion diameter (the diameter to which the stent or other skeleton is intended to expand by a balloon), and strength and composite compliance are measured after the stent has expanded to a diameter of 80% to 120% of the nominal expansion diameter. More commonly, strength and composite compliance will be measured when the stent has expanded to 100% of the nominal expansion diameter.

[0100] In other examples, the stent has sufficient strength to support the body cavity after deployment to the expanded configuration, exhibits 1% and 10% inward retraction after deployment, and wherein the stent exhibits 1% or greater compliance after deployment, and / or the stent has sufficient strength to support the body cavity after deployment, and exhibits 1% to 10% inward retraction after deployment to the expanded configuration, and then wherein, under physiological conditions or when using vasodilators, the stent exhibits 3% to 20% outward retraction after deployment and after the inward retraction.

[0101] In some other examples, the magnitude of the combined compliance under physiological conditions (including the use of vasodilators) is on the order of 0.05 mm to 0.5 mm, preferably 0.07 mm to 0.4 mm, and more preferably 0.1 mm to 0.4 mm. This magnitude of diameter variation is measured in one or more stent segments, or at the average of the stent segments, or preferably in a region near the middle of the stent segment.

[0102] In other examples, under physiological conditions, the outward retraction of the stent is on the order of 0.05 mm to 0.5 mm, preferably 0.07 mm to 0.4 mm, and more preferably 0.1 mm to 0.4 mm.

[0103] In another aspect or example, the present invention provides polymeric prostheses with reinforcing elements, and methods of using and manufacturing the same. The endovascular prosthesis includes a circumferential skeleton patterned from a biodegradable polymer and having expansion regions that deform as the circumferential skeleton expands from a small-diameter configuration to a larger-diameter configuration. In one example, the endovascular prosthesis of the present invention may include a coronary stent prosthesis. In another example, the endovascular prosthesis of the present invention may include a vascular stent prosthesis. In yet another example, the stent prosthesis is a non-vascular stent prosthesis. Reinforcing elements are coupled to at least some regions of the circumferential skeleton to reinforce the circumferential skeleton after it has expanded to a larger-diameter configuration. The reinforcing elements will preferably be deformable and may be degradable (including corrosive and erosive) or non-degradable (including non-corrosive and non-erosive). In particular, the reinforcing elements may be malleable or elastic, may comprise metals and metal alloys, may comprise polymers, or may be formed wholly or partially of other materials having mechanical properties that can reinforce the expansion regions and / or other structures of the stent prosthesis, as described below or in this application.

[0104] In one example, the circumferential skeleton will typically comprise a scaffold skeleton type patterned from tubes or cylinders formed wholly or partially from a biodegradable polymer. The tubes or cylinders can be formed by extrusion, impregnation, spraying, molding, or printing. The biodegradable polymer tubes or cylinders will be patterned using any of the many techniques known in the field of polymer-formed scaffolds, such as laser cutting, photolithography, 3D printing, stereolithography (SLA), etc. Expansion regions will typically include joints, hinges, crowns, bends, curves, and / or deformable features or structures or structural elements that can engage with adjacent struts, beams, or other non-deformable or non-deformable features or structures or structural elements such that, as the diameter of the circumferential skeleton expands (or increases), the expansion regions can open to increase the angle between adjacent non-deformable or non-deformable regions or structural elements (e.g., struts). The scaffold can also be formed from wire (solid or hollow) or fiber and can be patterned or woven.

[0105] For example, reinforcing elements can be provided to improve the stiffness, compressive strength, radial strength, circumferential strength, etc., of the circumferential skeleton while or after the support expands from a coiled configuration to a larger diameter configuration. Specifically, one or more reinforcing elements can be coupled to one or more expansion regions and / or other regions, such as struts and / or links on the circumferential skeleton, to enhance strengths, particularly those measured by, for example, the “plate” or “flat plate” test known in the art, in which the circumferential skeleton is placed between parallel, spaced-apart plates, and the force (or % such as 10% compressive force (N) or N / mm, normalized relative to the support length) required to reduce the diameter of the expanded skeleton by a predetermined amount can be measured. Other types of tests can also be used to measure radial strength (e.g., measured in psi), as known in the art.

[0106] Most commonly, in another example, the reinforcing element will be coupled to at least some of the joints, hinges, crowns, bends, or other expansion regions, such that the expansion regions, after expansion or opening, are better resistant to closure forces (or pressure) than without the reinforcing element. It should be understood that as the circumferential skeleton expands, the expansion regions undergo deformation, and the present reinforcing element will open along with the expansion regions, such that once opened, the reinforcing element will help the skeleton resist closure forces imposed by blood vessels or other body cavities or injuries to the implanted skeleton. In addition to deformable expansion regions, the circumferential skeleton will typically also include non-deformable or non-deformable regions that generally retain or substantially retain their shape during circumferential skeleton expansion. The reinforcing element may also be coupled to at least some of these non-deformable or non-deformable regions. In many examples or most embodiments, the expansion regions will be curved joints, crowns, hinges, bends, etc., as described above, while the non-deformable regions will typically be struts, straight struts, or other generally linear skeletal elements, but may sometimes have non-linear or other shapes, such as wavy, S-shaped, M-shaped, V-shaped, wavy linear or wavy non-linear, and U-shaped. Typically, expansion of the circumferential skeleton of an intracavitary prosthesis is achieved using an inflatable balloon or other conventional device. However, in other cases, the circumferential skeleton may be made of an elastic polymer or other material and may be self-expanding, where expansion is achieved by releasing the circumferential skeleton from its constraints.

[0107] In one example, reinforcing elements increase the stiffness or strength of the reinforcing region, reinforcing ring, or expansion region and / or the support.

[0108] In another example, the reinforcing element increases the strength of at least one region of the support by 15% to 100%, preferably by 25% to 150%, and more preferably by 25% to 200%.

[0109] In another example, when measured using a plate test with 10% compression, the reinforcing element increases the strength of the support structure by 0.015 N / mm of the support length to 0.035 N / mm, preferably by 0.015 N / mm to 0.05 N / mm, and more preferably by 0.015 N / mm to 0.09 N / mm. For example, for a 3.0 mm support structure multiplied by a 28 mm support length, a strength of 0.015 N / mm (e.g., using the plate test method) equals 0.015 N / mm multiplied by 28 mm (support length) equals a strength of 0.42 N.

[0110] In another example, when strength is measured using a plate test with 10% compression, the stent with reinforcing elements has a strength of 0.03 N / mm stent length to 0.06 N / mm stent length, preferably 0.025 N / mm stent length to 0.07 N / mm stent length, and more preferably 0.025 N / mm stent length to 0.09 N / mm stent length. For example, for a 3.5 mm diameter stent multiplied by an 18 mm stent length, a strength of 0.03 N / mm stent length (e.g., using a plate test) is equal to 0.03 N / mm multiplied by 18 mm stent length, which equals 0.54 N.

[0111] In another example, the reinforcing element reduces the initial inward retraction (or retraction after expansion or retraction after unfolding) or reduces subsequent inward retraction (retraction after implantation, or retraction after surgery, or retraction within 30 days of implantation, or retraction within 6 months of implantation, or retraction after the initial implantation and a period of 6 months, or retraction after the initial implantation and 1 day, or retraction after implantation and 30 days).

[0112] In another example, after implantation, the reinforcing element reduces the inward retraction of the stent to 1% to 10%, preferably 1% to 7%, more preferably 1% to 5%. In yet another example, at the various time points discussed, the reinforcing element reduces the subsequent inward retraction of the stent to 0% to 5%, preferably 0% to 3%, more preferably 0% to 2%.

[0113] In another example, after expansion or unfolding, the stent with the reinforcing element has 1% to 10%, preferably 1% to 7%, more preferably 1% to 5% inward retraction. In another example, at the various time points discussed, the stent with the reinforcing element has 0% to 5%, preferably 0% to 3%, more preferably 0% to 2% subsequent inward retraction, and most preferably, the stent has substantially zero subsequent inward retraction (or, the stent substantially retains its initial retraction after implantation).

[0114] In another example, at least some reinforcing elements are coupled to at least some expansion regions on at least some rings of the stent, wherein the stent expands from a coiled configuration to a larger expanded configuration, and wherein the reinforcing elements in the expanded stent configuration provide sufficient strength to support the body cavity.

[0115] In one example, the reinforcing element can be coupled to the circumferential skeleton in various patterns. The reinforcing element can be attached to some or all of the expansion regions, without necessarily to any non-deformable or non-deformable regions. Specifically, the reinforcing element can be attached to one, two, three, or more expansion regions of the skeleton or skeleton ring. In some examples or embodiments, the reinforcing element is attached to all expansion regions of the skeleton or skeleton ring, and in other preferred examples or embodiments, the reinforcing element is attached to all but one of the expansion regions of the skeleton or skeleton ring. In other examples or embodiments, the reinforcing element can be attached to two expansion regions and some or all of the non-deformable or non-deformable regions. In other examples or embodiments, the reinforcing element can be attached to at least some expansion regions that at least partially extend into the non-deformable or non-deformable regions. In other examples or embodiments, the reinforcing element can be attached to at least some expansion regions that extend to at least the midpoint of the length of the non-deformable or non-deformable regions. In other examples or embodiments, the reinforcing element can be attached to at least some expansion regions that extend substantially along the entire length of the non-deformable or non-deformable regions. The reinforcing elements may be embedded (fully or partially) in the material of the circumferential skeleton, for example, embedded in at least some of the expanded regions (or any surface region embedded in the expanded regions, such as the near-cavity surface region, the lumen surface region, and / or the side surface region). Alternatively, in another example, the reinforcing elements may be attached or otherwise mounted to the skeleton such that they are at least partially located outside at least some of the expanded or non-deformable regions.

[0116] After the stent is patterned, a reinforcing element can be coupled to the stent prosthesis (including or comprising embedding, attachment, or placement thereon). The coupling of the reinforcing element to the patterned stent region is performed in various ways, such as, by way of example only, press-fitting the reinforcing element to the stent or stent region; creating or pre-forming grooves, spaces, or slots by various means (such as laser, mechanical, or chemical means) and then press-fitting the reinforcing element to the stent or stent region; partially dissolving or softening the polymer material for press-fitting or insertion to include the reinforcing element; and / or adhesively attaching the reinforcing element to a patterned structural surface or region (such as a polymer structure). Alternatively, the reinforcing element can be coupled to the stent prior to patterning, such as coupling to a tube (such as a polymer tube) patterned into a stent, and wherein the tube and reinforcing element are patterned together (or separately) to form a patterned stent using the methods discussed above and / or throughout the application, as well as the patterning means discussed in this application, such as laser patterning. The reinforcing element can also be formed from a tube (such as a polymer tube) that is formed into a scaffold using methods such as impregnation, spraying, or molding. Alternatively, the reinforcing element can be one or more lines (solid or hollow) patterned or woven into the scaffold. The reinforcing element can also be a line (solid or hollow) encapsulated in a material (such as, primarily, a polymer material) and woven or patterned into the scaffold. The reinforcing element is coupled as a sheet, solid line, tube, or patterned structure. The reinforcing element is coupled to the scaffold structure (such as a polymer scaffold material) while having discontinuous or separated regions to expand the lumen and / or allow the skeleton or lumen to enlarge before coupling to the scaffold prosthesis as described in this application. Alternatively, discontinuous or separated regions can be formed on the reinforcing element after coupling to the scaffold, line, or tube (by various means such as laser cutting, dissolution, cutting, etc.), and then the discontinuous or separated regions can be reconnected or held together by means such as adhesives, a primary polymer, different polymers, sleeves, or other means that hold the scaffold structure elements together when expanding from a coiled configuration to a larger expanded configuration.

[0117] Typically, a stent comprising a circumferential framework will include multiple adjacent rings, wherein expansion regions include the curved, bent, hinged, joined coronal or other regions of the rings that straighten or open when the framework expands radially. Most typically, such rings will be sinusoidal rings, serpentine rings, zigzag rings, diamond (Palmaz-type) rings, or any other type of radially expandable stent ring known in the field of vascular stents, including open-aperture designs, closed-aperture designs, or combinations thereof, or other designs known to those skilled in the art. Typically, the individual rings will be oriented in a plane perpendicular to the central axis or longitudinal axis of the circumferential framework in a coiled or expanded configuration. However, in other embodiments or examples, the plane of the ring or expansion region or circumferential structural element may be tilted at an angle relative to the longitudinal axis of the framework (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 form a helical structure or be joined into a continuous helical arrangement. Adjacent rings of the various rings or helical stent structures may be axially joined together by hinges, coronal portions, beams, struts, and / or axial links between other components of the rings or rings. In other examples, the skeleton may be formed from lines (solid or hollow in at least some regions) and patterned into a stent, wherein adjacent rings are connected in one or more locations (or regions). In one example, the stent includes rings having a helical ring pattern with an orientation perpendicular to the longitudinal axis of the stent, at an angle ranging from 1° to 85° to such a longitudinal axis of the stent, wherein at least some rings have at least one separation region. In some other examples, the stent (such as a stent containing a valve) may include one or more circumferential rings (or one or more circumferential structural elements). In such examples, the stent includes one or more separation regions, hinges, or other structures described in this application. In a particularly preferred example, the stent includes one or more circumferential rings, wherein one or more rings include a plurality of struts joined by the coronal portion. Typically, every two struts are joined by the coronal portion, or two struts are joined on each coronal portion of the ring. At least some, preferably all, of the rings are joined to adjacent rings by at least one axial link or by joining one or more crown regions of adjacent rings (using solder, adhesive or fusion material).

[0118] In one example, the reinforcing element may be disposed in a segment surrounding the rings, or may be disposed to extend substantially the entire circumferential length around at least some of the rings. However, the reinforcing element will be configured to have or form at least one gap, discontinuity, or separation region in its circumferential direction or length, such that the reinforcing element may circumferentially separate and / or expand, or gradually expand after deployment as the blood vessel or other body cavity remodels during the healing process. In this way, the reinforcing element will be able to provide the desired initial strength and resistance to collapse during and / or in the initial period after deployment, but will not constrain or inhibit the expansion and / or dilation of the skeleton, and / or the expansion of the blood vessel / lumen, after the softening of the biodegradable polymer (such as the main polymer) of the circumferential skeleton, and / or the reduction of the molecular weight of the polymer, and / or the degradation of the polymer, and / or the at least partial erosion (including degradation or corrosion) of the polymer, allowing the reinforcing element (uneroded or incompletely eroded) to expand freely further in response to vascular remodeling or other physiological conditions.

[0119] The circumferential skeleton of the present invention may include some or all of the conventional features found in conventional support patterns. For example, the support pattern may include axial links that hold adjacent rings together to form a closed loop of a type known in the field of support systems. In this case, for example, reinforcing elements may be coupled to at least some axial links, in which case multiple individual reinforcing elements may be together to 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 slit.

[0120] In one example, the reinforcing element may be a single part having the shape or geometry of a structural element to be coupled, such as a crown, strut, and / or link, or substantially having that shape or geometry, or having a smaller shape or geometry, or having a larger shape or geometry, or having a different shape or geometry. Examples of shapes include squares, circles, rectangles, triangles, semicircles, and other shapes. In these examples, the parts are discontinuous or discrete (in contact with or not in contact with other adjacent reinforcing elements). The parts may have deburred end regions, rounded end regions, spherical end regions, or other types or geometries to prevent inflammation after degradation and / or reabsorption of the polymer material. In a preferred example, at least some rings have reinforcing element parts coupled to said expansion regions in substantially all expansion regions, wherein the reinforcing element parts span substantially the entire expansion region segment or at least a portion of the expansion region segment. In another example, at least some rings have reinforcing element parts coupled to said expansion regions in substantially all expansion regions, wherein the reinforcing element parts span the entire expansion region segment and extend at least partially into non-deformable or substantially non-deformable (e.g., strut) segments. In preferred examples, the shape and / or geometry of the reinforcing element or reinforcing element part generally substantially mimics or matches the shape and / or geometry of the structural element to be coupled. In one example, the reinforcing element part may be larger in at least one dimension, smaller in at least one dimension, or the same size in at least one dimension compared to the structural element to which the part is coupled. The reinforcing element part coupled to at least some structural elements of a biodegradable material allows the stent to expand further under physiological conditions (and / or by the introduction of a therapeutic agent such as nitroglycerin) after implantation (or after expansion or after deployment), and / or allows the stent to expand, and / or allows the vessel to exhibit vasomotor or vasodilation, while reinforcing or strengthening the stent to support the body cavity during stent expansion.

[0121] In another example, the reinforcing element can be one or more reinforcing element segments coupled to at least some rings and / or other structural elements such as links. For example, the reinforcing element segment is coupled to (or spans) a crown and a strut on a ring, and / or coupled to (or spans) a crown and a strut and a link on a ring, and / or coupled to (or spans) multiple crowns and struts and multiple links on a ring. In another example, the reinforcing element segments form a pattern on the support, which is typically a symmetrical pattern (but can also be an asymmetrical pattern), and the pattern can be of various shapes, including closed patterns and open patterns. When the reinforcing element segment spans the entire structural element of the coronal and / or strut, the reinforcing element segment will have at least one gap or discontinuity in the coronal and / or strut (the gap or discontinuity being formed before or after coupling to the structural element) to allow the stent to further expand after the polymer material degrades, or allow the stent to open, or allow the vessel to have vascular movement, or allow the vessel to have vasodilation, under physiological conditions (and / or by the introduction of a therapeutic agent such as nitroglycerin) after expansion (or deployment), the reinforcing element segment strengthens or reinforces the stent by having sufficient strength to support the body cavity after deployment.

[0122] In another example, the reinforcing element may be one or more reinforcing element segments coupled to at least some rings (or circumferential structural elements), or coupled to substantially all rings (or circumferential elements). When the reinforcing element or reinforcing element segment spans the entire length of a ring (or circumferential structural element) without any gaps, breaks, or separations, or spans the entire length of more than one ring without any gaps, breaks, or separations, or when the reinforcing element spans substantially the entire support without any gaps, breaks, or separations, the reinforcing element or reinforcing element segment will have at least one or more regions (e.g., crown or strut) along the circumferential path of each ring, 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, wherein one or more of these regions contain the reinforcing element (or one or more reinforcing element segments). A reinforcing element having a cross-sectional area of ​​200 to 4000 square micrometers, preferably 400 to 3000 square micrometers, and more preferably 700 to 2500 square micrometers, wherein, after stent expansion (or deployment) under physiological conditions (and / or by the introduction of a therapeutic agent such as nitroglycerin), one or more of the aforementioned regions allow the one or more rings and / or the stent to further expand after degradation of the polymer material (or a metal biodegradable material), and / or allow the stent to open, and / or allow the vessel to have vasomotor activity, and / or allow the vessel to have vasodilation, and / or allow the stent to have 1% to 5% radial strain at an expansion diameter of 3.0 mm, the reinforcing element segment strengthening or reinforcing the stent by having sufficient strength to support the body cavity after deployment. In another example, the region having the aforementioned cross-sectional area spans substantially the entire length of at least some rings, or substantially spans the entire stent. In another example, the region having the aforementioned cross-sectional area spans at least some rings, or substantially all rings, but does not span at least some axial links. In another example, the region has the stated cross-sectional area, wherein the width of the reinforcing element is 10% to 50% of the width of the structural element in the region, preferably 20% to 40%, more preferably 25% to 35%. In another example, the region has the stated cross-sectional area, wherein the thickness of the reinforcing element is 10% to 70% of the thickness of the structural element in the region, preferably 20% to 50%, more preferably 30% to 40%. In another example, one or more regions have the stated cross-sectional area, wherein the thickness-to-width ratio of the structural element is 1.5:1 to 3:1, and wherein the thickness-to-width ratio of the structural element in the one or more regions is 0.7:1.4, preferably 0.8:1. In a preferred example of this embodiment, the reinforcing element is a non-degradable metal or metal alloy, and the support frame material (to which the reinforcing element is coupled) is a polymerically degradable material.In another preferred example of this example, the reinforcing element is a non-degradable metal or metal alloy, and the scaffold frame material is a degradable metal or metal alloy. In this example, the scaffold including the reinforcing element and having a degradable frame material has sufficient strength to support the body cavity when expanding from a curled configuration to an expanded configuration, and wherein the radial compliance of the scaffold increases after expansion, while the strength of the scaffold decreases after expansion. In another example, the radial strain of the scaffold increases after the degradable polymer material degrades, and wherein the initial strength after expansion decreases after the polymer material degrades. In another example of this example, the reinforcing element combined with the degradable frame scaffold material has sufficient strength to support the body cavity, wherein a single reinforcing element does not have sufficient strength to support the body cavity. In another example of this example, the reinforcing element combined with the degradable frame scaffold material has sufficient strength to support the body cavity, wherein a single reinforcing element or a single scaffold frame material does not have sufficient strength to support the body cavity.

[0123] In another example, stents having reinforcing elements, bridging elements, separation regions, fissures, and other features described in this application exhibit an increase in radial strain (or compliance) and a decrease in radial strength after expansion. In yet another example, the increase in radial strain (or compliance) and the decrease in strength begin (or occur) within a period from one week to nine months after stent expansion, preferably from one month to six months after expansion, and more preferably from two months to six months after expansion.

[0124] Most commonly, the reinforcing element will comprise a non-degradable material, typically a metal (including metal alloys), and more typically a malleable metal that can open and deform along with the circumferential skeleton, but with higher strength to resist closure after partial or full expansion of the skeleton. However, in other examples, the reinforcing element may be a polymer with a higher stiffness than the main polymer of the circumferential skeleton (or a degradable patterned polymer or polymer to which the reinforcing element is at least partially coupled). The polymer reinforcing element may be formed from the same or different polymers as those forming the circumferential skeleton. When the reinforcing element is formed from the same polymer, the reinforcing element polymer will typically have a higher molecular weight and / or higher crystallinity, or will be a harder polymer than the main polymer of the circumferential skeleton (or a degradable patterned polymer or polymer to which the reinforcing element is at least partially coupled), in which case the reinforcing polymer may be degradable or non-degradable. In yet another example, the reinforcing element may also comprise a degradable metal (including metal alloys), such as magnesium and / or magnesium alloys.

[0125] In yet another example, the stent prosthesis comprises a biodegradable polymer material, wherein the biodegradable polymer material degrades within 1 month to 5 years, preferably within 2 months to 3 years, more preferably within 3 months to 2 years, wherein a reinforcing element is coupled to at least some expansion regions of at least some 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 reinforces (or strengthens) the expansion regions (or the stent) in an expanded configuration. Typically, the polymer material degrades faster than the reinforcing element, but it can also be configured to degrade at the same time (or rate) as the reinforcing element, or at a slower rate. In another example, the reinforcing element does not degrade or corrode.

[0126] In yet another example, the stent prosthesis comprises a biodegradable metallic material, such as a magnesium alloy, wherein the biodegradable metallic material degrades within 1 month to 5 years, preferably within 2 months to 3 years, more preferably within 3 months to within 2 years, wherein, according to any example of this application, a reinforcing element is coupled to at least some expansion regions of at least some 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 reinforces (or strengthens) the expansion regions (or the stent) in a stent expansion configuration. Typically, metallic materials degrade faster than the reinforcing element, but (the metallic material) can also be configured to degrade at the same time (or rate) as the reinforcing element, or degrade more slowly than the reinforcing element. In another example, the reinforcing element does not degrade or corrode.

[0127] In other examples, reinforcing elements may be formed of elastic metals or polymers, including springs and / or shape memory materials such as NiTi. For example, for reinforcing elements that are curved or bent to conform to (or fit) joints or hinges or expansion regions on a polymer or metal circumferential skeleton, the reinforcing element will typically be in a closed or constrained configuration when coupled to a corresponding hinge or joint on the circumferential skeleton in a curled configuration. In this way, reinforcing elements that are typically metallic will help open and / or maintain an open circumferential skeleton when the balloon expands or self-expands to its larger diameter configuration. Furthermore, even after implantation into a blood vessel or other body cavity, elastic, shape memory, and / or spring-like reinforcing elements will typically remain at least partially constrained by the polymer (such as the main polymer) or metal, such that they will continue to bias the circumferential skeleton to an open position, at least in the region to which they are coupled, and simultaneously enhance the strength and compressive strength of the deployed prosthesis, such as an intracavitary prosthesis, and / or by other high-stiffness reinforcing elements mounted on the same, adjacent, or other expansion regions or structural elements of the circumferential skeleton. Optionally, the skeleton may have additional metallic, polymeric, or other non-elastic (stretchable) reinforcing elements coupled to the same or other expansion regions on the circumferential skeleton, such as hinges or joints. For example, as one or more polymers constituting the skeleton or its rings (such as the main polymer) begin to soften and / or degrade and / or their molecular weight begins to decrease and / or as blood vessels or other body cavities heal and remodel over time, the elastic reinforcing elements will be able to continue to provide opening bias to enhance the expansion of the skeleton. The magnitude of the opening bias is controlled by the properties and / or processing of the elastic (including springs, shape memory) material, and / or by the degradation of the polymeric material constituting the reinforcing element (such as the main polymer). The terms "scaffold" and "skeleton" are used interchangeably in this application. In another example, a shape memory or spring-loaded reinforcement element, typically metallic, with two ends, can be coupled to adjacent struts (non-deformable or substantially non-deformable structural elements). The reinforcement element is configured to connect the expansion regions of two adjacent struts (along the length of the struts), wherein the expansion region of the reinforcement element is in a curled configuration when the stent is in such a configuration, and wherein the expansion region of the reinforcement element expands as the stent expands to an unfolded configuration. After the stent unfolds (after the stent retracts inward from the unfolded configuration), the reinforcement element continues to push open (increasing the angle between the adjacent struts). The reinforcement element further expands the stent after unfolding. As described throughout this application, the reinforcement element is attached to or coupled to the structural element. In one example, after the stent unfolds and after the stent retracts, the reinforcement 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 by a corresponding average cross-sectional area.In another example, after stent deployment and inward retraction, the reinforcing element increases the average stent diameter or average cross-sectional area by 2% to 15%, preferably 3% to 10%, of the average expanded stent diameter or average cross-sectional area. In another example, the stent prosthesis comprises a non-degradable shape memory alloy (including NiTi) or other type of material, has one or more separation regions (and / or one or more hinges), and wherein the stent expands from a coiled configuration to an initial expanded configuration, and wherein one or more separation regions (or hinges) form a discontinuity (or allow the stent to have radial displacement), thereby allowing the stent to respond to a vasodilator or anastomosing a changed lumen (or valve annulus) configuration.

[0128] In a preferred example, the biodegradable polymer scaffold comprises a biodegradable master polymer (a polymer that substantially forms the polymeric framework structure, or a polymer that substantially forms the continuous framework structure, or a polymer that substantially forms the framework structure without separation regions, or a polymer that forms the framework structure except for at least some separation regions or discontinuities). In addition to the master polymer, the biodegradable polymer scaffold may comprise more than one polymer (adjacent, blended, mixed, etc.). The reinforcing element is preferably a non-biodegradable metal or metal alloy with higher compressive strength compared to the master polymer or other additional polymers. Such a reinforcing element is coupled to at least some regions of the framework structural elements, such as the coronal and / or struts, wherein the reinforcing element has separation regions or discontinuities, thereby allowing the scaffold to expand and / or dilate in a physiological environment. The reinforcing element may also be a polymer (biodegradable or non-biodegradable) or a corrosive metal or metal alloy.

[0129] In a preferred embodiment, the reinforcing element can have various shapes and geometries, including rods (or solid) or hollow lines, circles, semicircles, triangles, rectangles, squares, ellipses, or other shapes and geometries. In a preferred embodiment, the reinforcing element, or at least some structural elements (such as crowns and / or struts) coupled to the reinforcing element, has a cross-sectional area comprising 5% to 90% of the cross-sectional area of ​​the structural element, preferably 10% to 75%, and more preferably 15% to 75%. As described in this application, the structural element can be fully embedded in the structural element, partially embedded in, or attached to one or more surface regions of the structural element.

[0130] In another example or aspect of the invention, the stent comprises a biodegradable polymeric material (or a biodegradable metallic material) patterned into a structure comprising structural elements, wherein at least one coronal region (preferably at least some coronal regions, more preferably at least half of the coronal portion on at least some rings) and / or at least one strut region (preferably at least some strut regions, more preferably at least ¼ of the strut regions on at least some rings) is not formed (or partially formed) on at least some rings, and said regions are formed or replaced by reinforcing elements, which are preferably non-degradable reinforcing elements, preferably metallic, such as CoCr alloys, stainless steel alloys, or other metals or metal alloys, or may be non-degradable polymeric reinforcing elements. In one example, a polymer scaffold is formed in the absence of at least one coronal region and / or at least one strut region on at least some rings (or where such regions were formed but subsequently removed), wherein a metal reinforcing element has substantially the same size (or preferably smaller size) compared to the adjacent polymer coronal and / or strut regions, and the reinforcing element is shaped (or bent or flexed) into the shape of the coronal region and / or strut region, and the two ends of the coronal region of the reinforcing element are attached to the strut end regions of the unshaped coronal region. The two ends of the reinforcing element can be attached as butt joints to the two strut ends of the polymer scaffold, bonding the two materials together at the joint, and / or enclosing both the reinforcing element and the polymer material joint area with a sleeve, and / or forming slots in the two strut end areas of each polymer scaffold (during or after laser patterning) and inserting or press-fitting the crown region end of the reinforcing element into the formed slots, optionally bonding overlapping areas of the two materials (e.g., 0.05 mm to 1 mm overlap) and / or enclosing the overlapping areas with a sleeve (where the sleeve may extend beyond the overlapping areas), and / or creating or forming slots in the reinforcing element end area press-fitted to the polymer end, thereby holding the reinforcing element and polymer material joint together, or holding the butt joint together, during expansion from a coiled configuration to a larger expanded configuration. Similarly, as described above, the reinforcing element can be attached to unformed polymer strut ends (or partially formed struts). The reinforcing element strengthens the expanded region and / or non-deformable or substantially non-deformable regions in the expanded scaffold configuration. The scaffold can expand from a coiled configuration to a larger expanded configuration and has sufficient strength to support the body cavity. In one example, the biodegradable polymer material of the stent degrades within 3 months to 3 years, while the non-degradable reinforcing element remains in the vessel wall. Under physiological conditions, the deployed stent expands the blood flow, exhibits vasomotor activity, 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%.In one example, the scaffold comprises a structural element made of a biodegradable polymer material, the structural element including a crown and struts, wherein at least some of the crown and / or struts are unformed, detached, or removed after forming (e.g., mechanical removal, such as cutting them, or chemical removal, such as using solvents or other materials) and replaced with a non-degradable metal reinforcement element. The scaffold is formed from polymer tubing or from filaments patterned to form the scaffold, or by other methods known to those skilled in the art. The reinforcement element may be formed from tubing or wire and is shaped or patterned to the shape of the structural element (such as the crown) it will replace. In one example, the reinforcement element is formed from a patterned tubing, and then an assembly of the patterned tubing is removed (e.g., mechanically removed) and inserted (or attached) into the location of the unformed polymer structural element (replacing it in one example). In another example, a wire reinforcement element is shaped to replace and attach to the structural element. Other methods of forming the structural element may include a variety of approaches, such as forming a patterned planar sheet, injection molding, etc. The shape and size of the reinforcement element may vary and are discussed in more detail throughout the application.

[0131] In another example, a biodegradable metal scaffold, such as a magnesium alloy scaffold, is patterned into a structure comprising structural elements, wherein at least one coronal region (preferably at least some coronal regions, more preferably at least half of the coronal region on at least some rings) and / or at least one strut region (preferably at least some strut regions, more preferably at least ¼ of the strut region on at least some rings) is not formed (or partially formed) on at least some rings, and said regions are formed or replaced by reinforcing elements, which are preferably non-degradable reinforcing elements, preferably metallic, such as CoCr alloys, stainless steel alloys, or other metals or metal alloys, or may also be non-degradable polymer reinforcing elements. In one example, a metal scaffold is formed in the absence of at least one coronal region and / or at least one strut region on at least some rings (or where such regions were formed but subsequently removed), wherein the metal reinforcing element has substantially the same size (or preferably smaller size) compared to the adjacent metal scaffold coronal region and / or strut region, and the reinforcing element is shaped (or bent or flexed) into the shape of the coronal region and / or strut region, and the ends of the reinforcing element coronal region are attached to the strut end regions of the unshaped coronal region. The two ends of the reinforcing element can be attached as butt joints to the two strut ends of the metal support, and the two materials can be bonded together at the joint, and / or both the reinforcing element and the metal support joint area can be contained in a sleeve, and / or slots can be formed in the two strut end areas of each metal support (during or after laser patterning) and the crown area end of the reinforcing element can be inserted into or press-fitted into the formed slots, optionally bonding the overlapping areas of the two materials (e.g., an overlap area of ​​0.05 mm to 1 mm) and / or containing the overlapping areas in a sleeve (where the sleeve may extend beyond the overlapping areas), and / or creating or forming slots in the reinforcing element end area to which the metal support structural element end is press-fitted, and / or laser welding (or fusion) the two materials, thereby holding the reinforcing element and the metal support joint together during expansion from a curled configuration to a larger expanded configuration, or holding the butt joint together. Similarly, as described above, the reinforcing element can be attached to the unformed metal support strut end (or a partially formed strut). The reinforcing element reinforces the expanded area and / or the non-deformable or substantially non-deformable area in the expanded support configuration. The stent can expand from a coiled configuration to a larger expanded configuration and has sufficient strength to support the body cavity. In one example, the stent's metallic biodegradable material degrades over a period of 3 months to 3 years, while the non-degradable reinforcing element remains in the vessel wall. Under physiological conditions, the expanded stent opens the vessel, exhibits vasomotor activity, 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%.In one example, the stent comprises a structural element made of a biodegradable metallic material, the structural element including a crown and struts, wherein at least some of the crown and / or struts are unformed, detached, or removed after forming (e.g., mechanical removal, such as cutting them, or chemical removal, such as using solvents or other materials) and replaced with a non-degradable metallic reinforcing element. The stent is formed from a metallic tube or from filaments (or threads) patterned to the stent, or by other methods known to those skilled in the art. The reinforcing element may be formed from a tube or thread and is shaped or patterned to the shape of the structural element (such as the crown) it will replace. In one example, the reinforcing element is formed from a patterned tube, and then an assembly of the patterned tube is removed (e.g., mechanically removed) and inserted (or attached) into the location of the unformed metallic stent structural element (replacing it in one example). In another example, a wire reinforcing element is shaped to replace and attach to the structural element. Other methods of forming the structural element may include various approaches, such as forming a patterned planar sheet, injection molding, etc. The shape and size of the reinforcing element may vary and are discussed in more detail throughout the application.

[0132] In another aspect or preferred example, it is desirable to have stents made of non-degradable, high-strength materials such as metals to provide sufficient strength when the stent is deployed in the body cavity (in some cases, degradable materials such as degradable metals with high compressive strength may also be used in this example; such materials tend to degrade slowly, thus providing long-term vascular coverage). However, after deployment, such stents cover the blood vessel or segment near the stent and prevent one or more of the following from potentially reducing the stent's usability, safety, and / or effectiveness: dilation of the blood vessel or stent segment; vasodilation within or across the stent segment; vasoconstriction within or across the stent segment; further expansion of the stent; or radial strain of 1.5% to 5% on the stent segment. To address or resolve one or more of the aforementioned needs, a non-degradable metal stent, such as an L605 CoCr alloy stent, is configured by patterning it into a structure comprising structural elements, wherein at least one coronal region (preferably at least some coronal regions, more preferably at least half of the coronal region on at least some rings) and / or at least one strut region (preferably at least some strut regions, more preferably at least ¼ of the strut regions on at least some rings) is not formed on at least some rings (or is partially formed, or is removed after formation), and said regions are formed or replaced by degradable bridging elements such as degradable polymeric materials (e.g., PLLA-based polymers) or degradable metallic materials (e.g., magnesium alloys). In one example, a non-degradable metal stent is formed in the absence of at least one coronal region and / or at least one strut region on at least some rings (or where such regions were formed but subsequently removed), wherein a degradable bridging element has substantially the same size (or preferably smaller, but may also be larger) compared to the adjacent coronal and / or strut regions of the metal stent, and the degradable bridging element is shaped (or bent or flexed) into the shape of the coronal region and / or the strut region and / or the shape of an alternative stent structural element thereof, and the two ends of the coronal region of the degradable bridging element are attached to the strut end regions of the unshaped coronal region.The two ends of the biodegradable bridging element can be attached as butt joints to the two strut ends of the metal stent, and the two materials can be bonded together at the joint, and / or both the biodegradable bridging element and the metal stent joint area can be contained in a sleeve, and / or slots can be formed in the two strut end areas of each metal stent (during or after laser patterning) and the crown area end of the biodegradable bridging element can be inserted into, press-fitted into, fused into, or melted into the formed slot, optionally including overlapping areas of the two materials (e.g., an overlap area of ​​0.05 mm to 1 mm) and / or the overlapping area can be contained in a sleeve (where the sleeve may extend beyond the overlapping area), and / or slots can be created or formed in the larger biodegradable bridging element end area to which the metal stent structural element end is press-fitted, and / or the two materials can be laser welded (fused) to hold the biodegradable bridging element and the metal stent joint together, or the butt joint together, during stent expansion or during stent expansion from a rolled configuration to an expanded larger configuration. Similarly, as described above, the biodegradable bridging element can be attached to the unformed metal stent strut end (or a partially formed strut). Degradable bridging elements, when used in expanded stent configurations, exhibit low or very low stiffness, thus weakening the expansion region and / or non-deformable or substantially non-deformable regions. However, degradable bridging elements offer one or more of the following benefits: providing continuity of the circumferential structural elements (such as rings) at least during expansion (or for a period after expansion), which contributes to uniform stent expansion (or improves expansion uniformity); providing drug release in the expanded region to inhibit neointimal hyperplasia; providing partial or complete expansion of the stent circumferential ring in the expanded region; providing lesion coverage and minimizing plaque prolapse; providing temporary scaffold support, subsequently expanding the stent and / or vessel as the degradable bridging elements degrade or corrode over a period of 1 month to 4 years, preferably 3 months to 4 years; and providing support for the vessel wall. The stent can expand from a coiled configuration to a larger expanded configuration and has sufficient strength to support the body cavity. In one example, the non-degradable stent structural elements remain substantially intact within the vessel wall (or in one example remain substantially together, or are substantially in place). Under physiological conditions (and / or by the introduction of a therapeutic agent such as nitroglycerin), the deployed stent opens blood vessels, exhibits vasomotor activity, 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%. In one example, the stent comprises a structural element made of a non-degradable metallic material, the structural element including a coronal portion and a strut, wherein at least some of the coronal portion and / or strut is not formed, detached, or removed after forming (e.g., mechanical removal, such as cutting it, or chemical removal, such as removing it using a solvent or other material or melting it), and is replaced (or formed) in the region by a degradable bridging element.The support is formed from a metal tube, a metal sheet, or from filaments (or threads) patterned into the support, or using other methods known to those skilled in the art. The biodegradable bridging element can be formed from a tube or filament / thread and shaped or patterned to the shape of the structural element (such as a crown) it will replace. In one example, the reinforcing element is formed from a patterned tube, and then components of the patterned tube are removed (e.g., mechanically removed) and inserted (or attached or press-fitted) into the location (or area) of an unformed metal support structural element. In another example, the filament biodegradable bridging element is shaped to replace and attach to the shape of a structural element with the ends described above. Other methods of forming the biodegradable bridging element may include various approaches, such as patterning a planar sheet and using components from that sheet to replace an unformed structural element, injection molding the biodegradable bridging element, etc. The shape and size of the biodegradable bridging element can vary (smaller, the same, or larger than the replaced structural element), as discussed in more detail throughout the application.

[0133] In one example, the bridging element is biodegradable. In another example, the bridging element is non-biodegradable but facilitates one or more of the objectives of the invention. The bridging element may also be a suture (or thread) tethering the two ends of a structural element that is unformed or partially or completely modified or removed. The suture can be used to fasten the two ends of the structural element together through holes adjacent to each end of the structural element, wherein the suture (or thread) passes through the holes and is secured, forming continuity of the unformed structural element (e.g., the suture or thread bridging two coronals or two struts).

[0134] In another example, the bridging element may be formed of a shape memory material or a spring material (or a reinforcing element in other examples), where the bridging element helps to open at least some of the coronal bias for further expansion after implantation.

[0135] In another example, the non-degradable metal stent (such as cobalt-chromium alloy L605 or MP35) comprises a wire (circular or substantially circular, or elliptical or other shapes) patterned into the stent. The stent includes structural elements comprising multiple rings, each ring including a crown and a strut. At least one strut and / or at least one crown on at least some rings is removed. The stent ends where the struts and / or crowns have been removed are treated to form hollow spaces in the wire. Degradable bridging elements are inserted into the hollow spaces at each end of the wire stent to bridge the gaps of the removed struts and / or crowns. Optionally, an adhesive or degradable sleeve is applied to or overlapped at the joint to further reinforce the joint segment such that the joint remains together as the stent expands from a coiled configuration to a larger expanded configuration. In another example, the degradable bridging element is treated to form a hollow space in which the stent wire structural element is inserted or press-fitted. Optionally, an adhesive or sleeve is applied to further hold the joint together.

[0136] In another example, the stent prosthesis is formed as a tube, wherein the tube includes a non-degradable material layer (such as a cobalt-chromium alloy layer) sandwiched between magnesium alloy layers, on top of or under the magnesium alloy layers. The tube is patterned into a stent. At least some regions on at least some rings (or at least some coronal regions and / or strut regions on at least some rings) have a non-degradable material (such as a cobalt-chromium alloy layer) substantially removed by laser, chemical, or mechanical means to facilitate stent expansion under physiological conditions. In another example, the stent prosthesis may be formed as a sheet, wherein a degradable layer is on top of or under the non-degradable material, and the stent is patterned and treated as described above. The sheet is rolled up and attached (or fused) to form a patterned stent.

[0137] In another example, the stent prosthesis is shaped as a line, wherein the line includes a non-degradable material layer (such as a cobalt-chromium alloy layer) on top or bottom of a layer of degradable polymer or metallic material (such as a magnesium alloy layer or a PLLA-based polymer). The line is patterned into a stent. At least some regions on at least some rings (or at least some coronal regions and / or strut regions on at least some rings) have non-degradable material (such as the cobalt-chromium alloy layer) substantially removed by laser, chemical, or mechanical means, thereby forming a degradable bridging element connecting the two ends of the non-degradable structural element, facilitating stent expansion upon expansion under physiological conditions, preferably expansion upon degradation of the degradable material.

[0138] In another example, the stent prosthesis is shaped as a tube, wherein the tube includes a non-degradable material layer (such as a cobalt-chromium alloy layer) on top of or inside a layer of degradable polymeric material (such as a PLLA-based polymer layer). The tube is patterned into a stent. At least some regions on at least some rings (or at least some coronal regions and / or strut regions on at least some rings) have a non-degradable material layer (such as a cobalt-chromium alloy layer) that has been substantially removed by laser, chemical, or mechanical means to facilitate stent expansion under physiological conditions. In another example, the stent prosthesis may be shaped as a sheet, wherein the degradable layer is on top of or under the non-degradable material, and the stent is patterned and treated as described above. The sheet is rolled up and attached (or fused) to form a patterned stent.

[0139] In any example of this application, a stent is tested or deployed (expanded) under one or more of the following conditions: in air, in a water bath, in a water bath at 37°C, under physiological conditions, in a pulsating (or vasoconstrictive) environment, under the administration of one or more agents that cause vasodilation or vasoconstriction of the stent segment, in a tube, in a blood vessel, in a body cavity, under a pressure gradient of 100 mmHg to 200 mmHg, under a pressure gradient (or order of magnitude) of 100 mmHg, under a pressure gradient (or order of magnitude) of about 176 mmHg, or under conditions used to test compliance or strength as described in this application, or under any other conditions described in this application. In some cases, all conditions described in this paragraph are referred to as physiological conditions.

[0140] In one example, physiological conditions include one or more of the following: in ambient air, in a water bath, in a water bath at approximately 37°C, in an environment at approximately 37°C, in a radial strain tester (compliance tester), in a fatigue tester, in a pulsating environment, in a pressure or pressure difference environment, in a pulsating environment that approximates the environment of a body cavity or organ, administration of therapeutic agents such as vasodilators or vasoconstrictors, in a constriction and / or dilation environment, in a body cavity, in a body blood vessel, in a body valve, etc.

[0141] In a preferred example, the stent prosthesis further includes at least one coating on at least one surface of the stent prosthesis. In one example, the coating contains at least one drug, preferably an m-Tor inhibitor. In another example, the stent prosthesis contains at least one drug. In yet another example, the stent prosthesis includes at least two drugs, an m-Tor inhibitor and a vasodilator. In yet another example, at least one coating degrades at a slower rate than the degradation rate of the degradable (polymer or metal) material. In yet another example, at least one coating degrades at a faster rate than the degradation rate of the degradable material. In yet another example, at least one coating covers at least one surface of the non-degradable stent. In yet another example, at least one degradable coating covers at least one surface of the non-degradable stent, and at least one non-degradable coating covers at least one surface of the non-degradable stent.

[0142] In one example, under physiological conditions (and / or by introducing a therapeutic agent such as nitroglycerin), the stent prosthesis exhibits, provides, or is configured to perform one or more of the following: stent expansion, expansion of a stent segment of a lumen or vessel, expansion of at least some circumferential structural elements (rings) of the stent, expansion of at least some rings of the stent, expansion of a vessel or vessel wall, exhibiting vasomotor activity, exhibiting vasodilation, exhibiting vasoconstriction, further expansion of the stent to a larger configuration after implantation, and / or the stent has a composite radial strain (or compliance) of 1% to 10%, preferably 1% to 7%, more preferably 1.5% to 7%. The stent prosthesis in this example exhibits or provides one or more of the properties described above (expansion, etc.) in one or more of the following stent states: during shaping, during patterning, after treatment or processing following stent shaping (or patterning), during stent deployment, after stent deployment, after stent expansion, and / or after stent deployment or expansion in, for example, a body cavity. The stent prosthesis in this example exhibits or provides one or more of the properties described above (such as expansion) in (or above) one or more of the following structures: at least some circumferential structural elements, at least some rings, substantially all circumferential structural elements, substantially all rings, at least some regions spanning substantially the entire stent or the entire stent segment, stent region and / or stent segment.

[0143] In any example, in addition to bridging one or more structural elements (such as struts and / or crowns) on at least some rings, the bridging element may also bridge at least one link (or link region).

[0144] In another aspect of the invention or in another example, the non-degradable (e.g., metallic, including alloys, but also polymeric) stent prosthesis includes structural elements, in one example comprising a plurality of rings, each ring including a strut and a crown, and each ring being connected to an adjacent ring at at least one location (or region). At least one strut (or a portion of a strut, or a strut region) and / or at least one crown (or a portion of a crown, or a crown region) on at least some rings is not formed (or is removed after forming), thereby forming a gap (or discontinuity) between the remaining crown ends (or the remaining crown regions) and / or between the remaining strut ends (or the remaining strut regions), wherein the gap is on the order of 1 micrometer to 3 millimeters, preferably 2 micrometers to 2 millimeters, more preferably 3 micrometers to 1 millimeter, when measured as a straight line between the remaining struts and / or the remaining crown in an expanded stent configuration (or a coiled stent configuration). The ends of the remaining struts and / or coronals can be configured to have different, preferably larger, dimensions, geometry, and / or surface area than the adjacent struts and / or coronals, and can have various shapes, such as circular, square, semi-circular, rectangular, etc. In one example, at least some rings have at least one gap (or discontinuity) along the ring. In another example, at least some rings have at least three gaps (or discontinuities) along the ring. In yet another example, at least some rings have 1 to 3 gaps (or discontinuities). The stent prosthesis can expand from a coiled configuration to a larger expanded configuration and has sufficient strength to support the body cavity. The stent in a preferred example has a substantially uniform expansion. In another preferred example, the stent has a maximum circular diameter of 0.7 mm to 1.5 mm in the gap region. In yet another preferred example, the stent has a coverage area sufficient to inhibit (or minimize) smooth muscle cell proliferation. Under physiological conditions (and / or by the introduction of a therapeutic agent such as nitroglycerin), the stent prosthesis exhibits, provides, or is configured to perform one or more of the following: stent expansion, expansion of at least some circumferential structural elements of the stent, expansion of at least some rings of the stent, expansion of a blood vessel or vessel wall, exhibiting vasomotor activity, exhibiting vasodilation, exhibiting vasoconstriction, further expansion of the stent to a larger configuration after implantation, and / or the stent having a radial strain of 1% to 10%, preferably 1% to 7%, more preferably 1.5% to 7%. The stent prosthesis in this example exhibits or provides one or more of the properties described above (expansion, etc.) in one or more of the following stent states: during shaping, during patterning, after treatment or processing following stent shaping (or patterning), during stent deployment, after stent deployment, after stent expansion, and / or after stent deployment or expansion, for example, in a body cavity. In a preferred example, the unshaped (or removed) strut and / or the remaining end region of the coronal portion are connected to the same or adjacent structural elements, provided that such connection does not complete the gap (or discontinuity) of the rings and the gaps in the rings remain discontinuous.

[0145] In another example, the stent prosthesis comprises multiple rings including struts and a coronal portion, wherein at least one strut and / or coronal portion region on at least some of the rings is cut (or slit) during, for example, laser patterning, but may also be cut mechanically or by other methods. The cut areas are deburred and / or shaped into a non-invasive geometry and / or make contact, and / or maintain contact, and / or substantially hold the cut areas together to allow the stent prosthesis to expand from a coiled configuration to a larger expanded configuration with sufficient strength to support the body cavity. In a preferred example, the stent has a substantially uniform pattern in the expanded configuration. In the coiled configuration, the cut end regions may be adjacent, overlapping, or have temporary holding means to allow unfolding 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 cavity.

[0146] During laser cutting, patterning, or other processes that create separation areas and discontinuities in the skeleton, portions of the partially formed skeleton can be temporarily held together so that the structure does not prematurely separate after the discontinuities are formed and before they are secured by gluing, overlaying, sleeve formation, etc. 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 can be temporarily held by retaining fasteners positioned at each end of the skeleton. In particular, one, two, three, or more terminal crowns at each end of the skeleton can be shaped to have retaining features, such as enlarged ears or similar features that can be gripped by the retaining fasteners. In this way, when separation areas are formed, the retaining fasteners hold the partially formed skeleton together, for example, by first cutting or bisecting the struts and / or crowns in one or more circumferential rings, and then overlaying the entire skeleton in a biodegradable sleeve to hold the skeleton together so that it can be removed from the fasteners and subsequently unfolded.

[0147] In another example, the non-degradable (e.g., metallic, including alloys, but also polymeric) stent prosthesis includes circumferential structural elements, which in one example include multiple rings, each ring including a strut and a crown, and each ring is connected to an adjacent ring in at least one location. At least some rings are configured (e.g., patterned and / or processed) to have gaps (or discontinuities) in the rings. For example, the stent may be patterned to have gaps, wherein the gap is on the order of 1 micrometer to 3 millimeters, preferably 2 micrometers to 2 millimeters, more preferably 3 micrometers to 1 millimeter, when measured as a straight line to complete (or connect or provide continuity) the rings. In a preferred example, the distance between the largest circular struts (or between rings) in the region where the gap is located is 0.9 mm to 2 mm, preferably 1 mm to 1.5 mm. In one example, at least some rings have at least one gap (discontinuity) along the ring. In another example, at least some rings have at least three gaps (discontinuities) along the ring. In yet another example, at least some rings have 1 to 3 gaps (or discontinuities). The stent prosthesis can expand from a coiled configuration to a larger expanded configuration and has sufficient strength to support the body cavity. In preferred examples, the stent has substantially uniform expansion and sufficient vascular coverage to inhibit SMC proliferation. Under physiological conditions (and / or by the introduction of a therapeutic agent such as nitroglycerin), the stent prosthesis exhibits, provides, or is configured to perform one or more of the following: stent expansion, expansion of at least some circumferential structural elements of the stent, expansion of at least some rings of the stent, expansion of the vessel or vessel wall, exhibiting vasomotor activity, exhibiting vasodilation, exhibiting vasoconstriction, further expansion of the stent to a larger configuration after implantation, and / or the stent has a radial strain of 1% to 10%, preferably 1% to 7%, more preferably 1.5% to 7%. The stent prosthesis in this example exhibits or provides one or more of the properties described above (expansion, etc.) in one or more of the following stent states: during shaping, during patterning, after processing or fabrication following stent shaping (or patterning), during stent deployment, after stent deployment, after stent expansion, and / or after stent deployment or expansion in, for example, a body cavity.

[0148] In one example, at least some rings of the stent prosthesis have at least one gap (discontinuity) on each ring. In one example, the region (or end region) of the structural element (ring) at the location of the gap (or the start or end of the gap) can be free (not connected to any structural element or any adjacent structural element), or can be connected to other structural elements, such as to the strut and / or the crown, at or near the end region or anywhere along the structural element leading to the end region (or can be connected to other adjacent structural elements, such as to the strut and / or the crown). The connection to the region can be a substantially straight connection, and / or a coronal connection, and / or other connections from the region to other structural elements (or adjacent structural elements) having various shapes, sizes, and / or geometries. Examples of connections (including connection shapes) include Z, S, M, U, W, Y, L, or other types of connections. The dimensions of the connection can be different from or substantially the same as those of other adjacent structural elements. In other examples, the width and / or thickness of the connection can also be larger or smaller. The shape and / or size of the connections on at least some rings can be substantially the same or different.

[0149] In another example, the stent prosthesis includes structural elements comprising multiple rings, each ring including struts and a crown, and each ring connecting to an adjacent ring in at least one region. At least some rings have at least one region between two crowns and / or between two struts, this region being configured (patterned or otherwise) to have two struts (or two strut regions) and / or two crowns (or two crown regions), wherein the two strut regions and / or crown regions overlap in some length. The struts and / or crowns are connected at opposite ends, while the other end region forms a discontinuity in the ring. The free end regions of the struts and / or crowns may have different shapes and geometries to constrain the stent prosthesis or hold it together when the stent is deployed. The strut and / or crown regions may also have grooves or other shapes to constrain sliding struts and / or crowns when the stent prosthesis expands. Typically, the stent prosthesis can expand from a coiled configuration to a larger expanded configuration and has sufficient strength to support the body cavity. Upon deployment, the stent allows the body cavity to expand. The stent has sufficient structural element surface area coverage (thickness, width, and / or geometry) in the discontinuous region to support the body cavity.

[0150] In any example of this application, the stent prosthesis includes a circumferential structural element comprising a strut and a coronal portion, wherein the strut is configured (e.g., patterned and / or treated) to allow the stent to expand from a coiled configuration to a larger expanded configuration, and wherein the stent, in the expanded configuration, has sufficient strength to support the body cavity, the stent prosthesis expands, and / or has 1% to 5% radial strain (or compliance), and / or further expands within the body cavity during formation, expansion, and / or after expansion (or under physiological conditions and / or under therapeutic conditions such as the introduction of nitroglycerin). Examples of the stent prosthesis include one or more of the following: including reinforcing elements, bridging elements, separation regions, struts and / or coronal portions with gap regions, etc. The stent prosthesis may be a biodegradable or non-biodegradable metal (including alloys) or polymer under physiological conditions for a period of 3 months to 5 years. The stent prosthesis in the examples may be formed and patterned from a tube into a stent, or formed and patterned from one or more lines (or filaments) into a stent. The support structure can also be formed from a flat sheet and rolled up to form the support. The flat sheet can be patterned and then rolled up to form the support, or the flat sheet can be rolled up to form a tube and then patterned. In one example, the circumferential structural element includes a plurality of rings, each ring including a crown and a strut having one or more configurations as described in this application. In another example, the structural element includes a crown and strut with one or more discontinuous sections, thereby allowing the support structure to expand during formation and / or further expand during formation, during unfolding, and / or after unfolding.

[0151] In another example of any example in this application, at least some of the struts and / or crowns have at least one separation region, discontinuity, or crack. In another example, at least some of the struts and / or crowns have at least two separation regions, discontinuities, or cracks in said struts and / or crowns. In a further example, at least some of the struts and / or crowns will have no separation regions. In a further and often preferred example, at least some of the struts will have separation regions, while all the crowns in the circumferential ring will have no separation regions. It has been found that locating the separation regions in struts that generally do not deform during expansion is preferable to locating the separation regions in crowns that deform with skeletal expansion.

[0152] In another aspect or example, the present invention provides non-degradable or slowly degradable prosthetic materials having structural elements such as circumferential elements and / or rings having separation regions and / or environmentally responsive separation regions. “Environmentally responsive” means responsive to physiological conditions including vascular conditions and / or other luminal conditions, and / or responsive to placement in water at ambient temperature or 37°C, and / or responsive to placement in buffer solutions and / or saline, and / or responsive to physiological conditions (e.g., vascular or luminal conditions) and / or physiological pressures to which the skeleton is exposed after implantation into a blood vessel or other body cavity, and / or responsive to pressures of 30 mmHg to 200 mmHg, preferably 40 mmHg to 120 mmHg, more preferably 50 mmHg to 80 mmHg, and / or responsive to pulsating pressures of 30 mmHg to 150 mmHg, preferably 30 mmHg to 120 mmHg, more preferably 30 mmHg to 90 mmHg. A pulsed pressure of mmHg, or in response to the introduction of therapeutic agents such as vasodilators or vasoconstrictors, can cause the separation zone to separate, become vacant, or create gaps, open, rupture, allow movement in one or more directions, and / or degrade.

[0153] In any example of this application, the stent in a preferred embodiment can expand, either by expanding at least some circumferential cross-sections or regions, by expanding over stent segments, and / or by expanding to a larger diameter (or configuration) in at least some circumferential cross-sections or regions of the stent prosthesis under physiological conditions (including physiological environments). The larger stent diameter can be greater than the expanded diameter and / or greater than the stent diameter after retraction from the expanded configuration. In one example, upon exposure to pressure and / or pulsating pressure (as described in this application), the stent diameter temporarily or permanently changes and / or increases to a larger diameter from the expanded and / or deployed diameter (if retraction occurs from the expanded and / or deployed diameter), with the change and / or increase being 0.045 mm to 1 mm, preferably 0.05 mm to 0.6 mm, more preferably 0.06 mm to 0.3 mm, or varying by 0.1 mm to 0.3 mm. In the same or other examples, the radial strength of the expanded stent is 12 psi to 30 psi, preferably 13 psi to 25 psi, more preferably 15 psi to 25 psi. In the same or different examples, after skeleton expansion and / or after expansion, the stent plate strength (10% compression) is 0.03 N / mm stent strength to 0.95 N / mm stent strength, preferably 0.035 N / mm stent strength to 0.9 N / mm stent strength, more preferably 0.04 N / mm stent strength to 0.085 N / mm stent strength. In the same or different examples, the inward recoil of the skeleton after expansion and / or after expansion is 1% to 10%, preferably 2% to 7%, more preferably 2% to 5%. After expansion, the inward recoil of the stent preferably remains substantially the same. After the introduction of a vasodilator into the body, the stent prosthesis is preferably further expanded to a larger configuration. The stent in the expanded configuration preferably has 1% to 5% radial strain (or compliance). In the same or different examples, the radial strength of the deployed non-degradable stent is reduced by at least 25%, at least 50%, at least 75%, or 100% of the initial radial strength of the skeleton at the time of deployment. In the same or different examples, the time period for the strength reduction is 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 different examples, after deployment (initial deployment), the radial strength of the non-degradable stent decreases by 0% to 25% from the initial deployed radial strength within 30 days, and / or by 10% to 50% within 90 days, and / or by 25% to 90% within 180 days, and / or by 50% to 100% within 270 days. In this example, the non-degradable stent also contains at least one degradable polymer and at least one drug.In a preferred example, at least one drug is contained in the polymer. In another example, or in addition to the previous examples, the stent contains at least one non-degradable polymer. In yet another example, or in addition to the previous examples, the stent also contains a radiopaque marker (degradable or non-degradable).

[0154] In a preferred embodiment throughout this application, there is a stent opening after deployment, as well as further expansion of the stent, enlargement of the lumen, and other properties of the stent and / or lumen, which include one or more of the following: the entire stent or lumen, at least a 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 a stent or lumen segment, or a stent segment.

[0155] In another example, the invention provides a non-degradable prosthetic material having circumferential elements and / or rings with separation regions. The separation regions are areas that are discontinuous during formation, and / or during patterning (including after patterning), and / or after processing or treatment, and / or before implantation, and / or after implantation, and / or after implantation under physiological conditions. Discontinuity fully and / or substantially includes one or more of the following: separation, becoming vacant of a material, having a gap, forming a gap, opening, having a slit, forming a slit, unlocking, non-touch, non-contact, removal of material between or adjacent to the separation regions, removal of material holding the separation regions together, the ability of the separation regions to move in one or more directions, and / or degradation. In this example, the stent has sufficient strength to support the body cavity when deployed, and wherein the stent can retract to a smaller configuration after deployment, and then further expand to a larger configuration (greater than the retracted configuration and / or greater than the deployed expanded configuration). The stent can expand to the larger configuration within the body cavity and / or under physiological conditions. In another example, the stent is expanded, or at least expanded in some areas and / or rings or stent sections.

[0156] 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) that inhibit the formation of gaps or other discontinuities. One or more circumferential rings containing separation regions comprising non-degradable materials are configured to expand to a larger diameter or cross-section after initial expansion (and retraction, if present), due to the elasticity and stretching of the non-degradable material in response to vascular pulsation and / or the expansion in response to vasodilators under physiological conditions. In this way, one or more rings, and typically the entire stent segment, exhibit the desired compliance under physiological conditions after implantation. In such embodiments and examples, the non-degradable material typically possesses sufficient elasticity to continuously expand and / or contract under physiological conditions, including vasoconstrictive pulsation.

[0157] In yet another example, after the initial expansion, preferably after a period of 30 days to one year, one or more separation regions containing non-degradable material may still form gaps or other discontinuities. Although the material is non-degradable, it can degrade or fatigue over time or under physiological conditions, thus allowing the separation regions to separate, forming gaps or other discontinuities.

[0158] In yet another example, one or more separation regions may be constrained by one or more non-degradable materials such as polymer sleeves or polymer coatings, wherein the one or more separation regions remain constrained by the non-degradable material even after the formation of a gap or other discontinuity. The non-degradable material formed, for example, as a sleeve or coating, may also cover one or more rings of the stent, cover one or more stent surfaces, or may cover the entire stent surface. The sleeve or coating constraining the separation regions allows one or more rings or stent segments to have desired compliance, further expansion after initial retraction, and / or in response to the introduction of a vasodilator.

[0159] In another example, the intracavitary prosthesis according to this aspect and / or one aspect and / or preferred example of the invention comprises a skeleton having structural elements such as circumferential elements and / or rings, which are patterned from a non-degradable material such as a non-degradable metal, metal alloy, or rigid non-degradable plastic, wherein the skeleton is configured to expand from a coiled configuration to an expanded configuration, and the skeleton has sufficient strength to support the body cavity in the expanded configuration. 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 immediately 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 other conditions disclosed in this application. Such a discontinuity allows the skeleton or at least some of its circumferential cross-sections to expand at least further to a larger configuration, preferably further expanding after an initial retraction that may occur after deployment, more preferably further expanding beyond the initial expansion, and most preferably allowing the skeleton to expand or expand in at least some of the circumferential cross-sections or regions of the support, preferably expanding in the circumferential direction. In other words, after the skeleton has been initially deployed from its constraints by balloon or, in some cases, by self-expansion, intermittently allowing partial movement of the skeleton to separate and allowing annular expansion, preferably accompanied by luminal expansion, more preferably accompanied by luminal expansion due to luminal remodeling. In one example, the annular separation region may be present in the coronal region, hinge region, and / or strut region. The stent preferably responds to vasodilatory stimuli by expanding the lumen within the stent segment. The stent preferably has a composite radial strain (or compliance) of 1.5% to 7%.

[0160] In another example, discontinuities formed in circumferential elements and / or rings will typically include partial or complete cracks, separations, or gaps in the structure of the circumferential skeleton, which reduce or eliminate stress areas, stiffness, circumferential strength, circumferential strength, and / or radial strength in the skeleton (or the ring assembly of the skeleton, as described more specifically below and / or in this application) and / or separation regions. Most commonly, the discontinuity will be a complete crack, which allows two free ends obtained in the skeleton or ring or circumferential element to move apart from each other in response to remodeling or other expansion of the cavity and / or support. In one example, the two free ends of the discontinuity are contained by a material including sleeves or coatings, wherein the sleeve or coating material can be non-degradable or degradable, such as a polymer, wherein the sleeve or coating stretches as the free ends move apart. In another example, the discontinuity is contained by a discontinuous geometry (such as certain key and lock designs and other types of geometry) to hold the structural elements containing the discontinuity together when unfolded from a curled configuration to an expanded configuration, wherein the discontinuity is formed before, during, or after patterning and held together by a design configuration that forms the separating regions of the discontinuity as described above and / or throughout the application. In this case, the discontinuity allows the support to curl and / or unfold while holding the free ends of the structural elements containing the discontinuity together and providing sufficient strength to support the body cavity after the support has unfolded. In this case, the discontinuity may allow the free ends of the structural elements to move in one or more directions after unfolding, preferably only in the radial direction, more preferably substantially only in the radial direction, most preferably the movement is primarily in the radial direction, or the movement is in the radial and / or circumferential directions. In one example, at least some of the rings or other parts of the skeleton will have at least one such discontinuity, but more generally, each ring will have at least one discontinuity, and some or all rings may have two or more discontinuities. Individual skeleton rings may have the same or different numbers of discontinuities, and not all skeleton rings need to have discontinuities. For example, rings at or near the ends of the skeleton may not have discontinuities, for example, to limit the wedge effect.In another example, at least some rings will have 1 to the same number of breaks as the crown, preferably 1 to 3 / 4 of the number of crowns on the ring, and / or will have 1 to the same number of breaks as the struts on the ring, preferably 1 to 3 / 4 of the number of struts on the ring, and / or will have 1 to 1 / 2 of the number of crowns on the ring, and / or will have 1 to 1 / 2 of the number of struts on the ring, and / or will have 1 to 1 / 4 of the number of crowns on the ring, and / or will have 1 to 1 / 4 of the number of struts on the ring, and / or will have 1 to 10 breaks on the ring, preferably 1 to 5 breaks on the ring, more preferably 1 to 4 breaks on the ring, and / or 1 to 3 breaks on the ring, and / or 1 to 2 breaks on the ring.

[0161] In one example, the physiological environment leading to such discontinuity (in other examples, the discontinuity forms independently of the physiological environment) may be characterized by any bodily conditions associated with the body cavity into which the prosthesis is to be implanted. For example, the physiological environment or conditions may include one or more of the following: physiological temperatures such as 37°C in a water bath maintained or heated to approximately 37°C within the body cavity, and / or physiological pressure, and / or pressure and / or pulsating pressure, and / or the introduction of agents such as vasodilators or vasoconstrictors, as described in this application. Additionally, the physiological environment may include blood or other aqueous media, particularly oxygenated blood, into which the skeleton is implanted, which may enhance the corrosion of certain features. Typically, the physiological environment will include the pulsation of blood vessels, particularly arteries, which can subject the implanted skeleton to mechanical stress, which in turn can cause fatigue and rupture of specific features formed in the skeleton structure. In one example, discontinuities caused by degradation, corrosion, dissolution, or mechanical stress will typically form within 30 days to 6 months, but may also form within days to 1 year after the initial expansion of the circumferential skeleton and exposure of the expanded skeleton to the body cavity environment. In other embodiments, it is formed intermittently in a water bath at ambient temperature.

[0162] In one example, the separation region may include any of a variety of structures or modifications in the skeleton, such as notches, changes in grain structure, pre-formed cracks rejoined by degradable polymers, adhesives, sleeves, rivets, etc.

[0163] In a particular example, the separation region includes a key and keyhole, and / or a key and lock, and / or a ball socket, and / or a hook engagement, which are fixed and / or held together during formation, and / or after formation, and / or before unfolding, and / or before expansion, and / or during unfolding, and / or during expansion, and are configured to separate and / or form a gap after unfolding and / or after further expansion in a physiological environment. The key and keyhole, and / or key and lock, and / or ball socket, and / or hook engagement can be initially held together by means such as by materials that degrade in a physiological environment, such as polymers, adhesives, bonding agents, solders, etc., wherein the key and keyhole, and / or key and lock, and / or ball socket, and / or hook are configured, for example, in response to normal pulsation of blood vessels or other body cavities or other physiological conditions described throughout this application, to separate or form a gap once the means of holding the engagement separates or degrades, or once the key and keyhole, and / or key and lock, and / or hook engagement is free of materials such as polymers, adhesives, bonding agents, solders, etc. In one example, the key and keyhole, and / or key and lock, and / or ball joint, and / or hook joint may be substantially held together by a geometry that restricts or substantially restricts movement of the joint in one or more directions, thereby allowing the support to unfold and having sufficient strength to support the body cavity after unfolding (initial unfolding). In a preferred example, such joints are substantially held together during unfolding (expanding from a coiled configuration to a larger expanded configuration), and the support in the expanded configuration has sufficient strength to support the body cavity. In this preferred example, the means of engagement that hold them together are the geometry of the joint, such as key and keyhole, and / or key and lock, and / or ball joint, and / or hook, and / or other types of joints. The separation region junction can also be a butt joint connecting and / or engaging two ends of a stent structural element and / or ring, said ends having various shapes and / or cross-sectional shapes (including generally shape types), such as circular, and / or spherical, and / or square, and / or rectangular, and / or synaptic junctions, and / or other types of shapes, and / or substantially such shapes. In one example, deployment means such as a balloon catheter facilitates holding the discontinuity together during stent deployment, and wherein the stent is allowed controlled movement in one or more directions, preferably in the radial direction, after deployment, and wherein the stent has sufficient strength after deploying from a coiled configuration to a larger, expanded configuration.

[0164] In another example, the separation region also includes overlapping portions of simple mating joints or support structural elements, wherein the structural elements are solid wires (of various shapes, such as substantially circular, rectangular, and / or square, and / or synaptic, and / or other shapes) and / or hollow wire / tube structural elements (at least hollow in the region adjacent to the separation region) with opposing free ends, the free ends being temporarily joined by means such as degradation in a physiological environment and / or separation and / or discontinuous adhesives and / or connectors and / or polymers and / or solders and / or sleeves. Such means can hold the free ends together by placing them between the free ends of the structural elements, near the free ends, to cover the free ends, within the hollow portions of the free ends, and / or combinations thereof.

[0165] In other cases or examples, the separation region may include notches or thinning portions formed in the circumferential ring and / or circumferential structural elements, wherein these notches or thinning portions will preferentially erode or fatigue under physiological conditions, thereby forming partial or complete separation that allows the circumferential ring to expand subsequently. In other embodiments or examples, the separation region may include improvements to the material of the circumferential ring itself. For example, in a metal ring, the separation region may have improved grain boundaries, which are selected to preferentially fracture and / or erode (including corrosion) under physiological conditions compared to the remaining area of ​​the circumferential ring. Other examples are joints whose formation may begin with a complete circumferential ring, forming one or more fissures in the ring, and then rejoined using means such as sleeves, adhesives, solders, connectors, coatings, and / or other means configured to degrade or erode or fatigue or fracture or separate under physiological conditions. For example, solders, adhesives, and / or polymers may be applied to the mating ends and / or overlapping ends and / or hollow ends of the resulting joint. Alternatively, the connector may include a sleeve, ring, coil, or other external structure that holds the joint together until such structure degrades and / or separates in a physiological environment. In a preferred example, a sleeve or coating comprising a polymer such as parylene may be applied, allowing the individual free ends of the joint and / or engagement to be contained within such a sleeve or coating.

[0166] In another example, the stent comprises a non-degradable metal or metal alloy and includes a structure comprising multiple rings, wherein each ring includes a strut joined by a crown, wherein at least some rings have at least one crown, and no more than 3 / 4 of the crowns (preferably at least one and no more than 1 / 2 of the number of crowns) are shaped and / or patterned to have a cross-sectional area smaller than or equal to the cross-sectional area of ​​the adjacent crowns and / or the largest or smallest crown cross-sectional area within the ring. The cross-sectional area can be measured near the peak of the crown and / or any other point / part on the crown. The cross-sectional area of ​​the smaller (including the smallest) crown is 25% to 90% (preferably 50% to 75% smaller) than the cross-sectional area of ​​the adjacent crowns and / or the largest crown cross-sectional area within the ring. The cross-sectional area of ​​the smaller (including the smallest) crown is 400 to 3000 square micrometers, preferably 400 to 2500 square micrometers, more preferably 400 to 1500 square micrometers, such a smaller cross-sectional area allows the crown to expand further after expansion. Smaller (including smallest) coronals may optionally have sleeves and / or coatings and / or solders made of polymers and / or adhesives and / or other materials to hold the coronal (and / or the struts joined by said coronal) in a curled or substantially curled configuration when the stent is deployed, and wherein the sleeves and / or coatings and / or solders degrade and / or dissolve and / or relax after deployment (expansion), thereby allowing the stent to expand further while allowing the smaller cross-section of the coronal to open and / or expand under physiological conditions. The stent has sufficient strength to support the body cavity when deployed. In another example, the stent has sufficient strength to support the body cavity when deployed, wherein the stent strength decreases after the sleeves and / or coatings and / or adhesives and / or solders dissolve and / or degrade under physiological conditions after deployment. The crown has a cross-sectional area of ​​at least 1 / 4 to 3 / 4, preferably at least 1 / 2 to 3 / 4, and more preferably at least 3 / 4, of 3,500 to 25,000 square micrometers, more preferably 4,000 to 10,000 square micrometers, and more preferably 4,500 to 8,000 square micrometers. When comparing a crown with a smaller cross-sectional area to one with a larger cross-sectional area, the cross-sectional area measurements in the above examples are measurements of the same type (or the same) non-degradable material (metal or metal alloy) as the support or structural element such as the crown, excluding other materials such as polymers, metals, coatings, etc., above or within the crown. Alternatively, a crown with a smaller cross-sectional area can be achieved by incorporating different materials from non-degradable metals or metal alloys, or materials with lower density or greater fragility, and / or by having one or more of the following: grooves, holes, indentations, crescent shapes, crown shapes, and / or channels, within, above, and / or through the crown region.Grooves, holes, indentations, crescent shapes, crown shapes, and / or channels within, above, and / or through the coronal region may be filled and / or covered with at least one material, including polymers, metals or metal alloys (preferably different from the metal or metal alloy forming the scaffold), adhesives, and / or solders, and / or other suitable materials. In this example, a smaller cross-sectional area is achieved by having a softer or more fragile or lower-density material or gap in the coronal region that effectively reduces the cross-sectional area of ​​the non-degradable metal or metal alloy in the coronal region compared to the cross-sectional area of ​​the same type of metal or metal alloy in adjacent coronals (or the larger cross-sectional area of ​​the same type of metal or metal alloy) (although the total cross-sectional area of ​​the coronal region may still be similar to the cross-sectional areas of other coronals). This material is preferably different from the coronal material. After unfolding, this material may remain in the coronal region, dissolve, and / or degrade / erode to allow the scaffold to expand and / or further expand under physiological conditions. Upon expansion, the stent possesses sufficient strength to support the body cavity, and the stent strength does not decrease after expansion, or decreases after expansion, preferably within 30 days, more preferably within 3 months, and / or within one year. The material has lower stiffness than the coronal material (preferably 2-10 times lower), and is softer, more stretchable, and / or lighter. In one example, the coronal may have a sleeve and / or coating and / or adhesive comprising the coronal region and / or struts joined by the coronal. In another example, the stent exhibits an increase in radial strain after expansion, and / or a decrease in radial strength after expansion. In another example, the increase in radial strain and / or decrease in strength begins within one week to nine months after stent expansion, preferably one month to six months, more preferably two months to six months. In another example, at least some struts have a reduced cross-sectional area as described in this paragraph.

[0167] In another example, a scaffold formed of a non-degradable metal or metal alloy is patterned such that one or more regions on at least some rings or other structures are "hollowed out" to create void regions or "gaps" within the coronal, strut, or other structural components of the scaffold framework, where the metal has been removed by, for example, patterning, cutting (e.g., laser cutting), grinding, etc. Optionally, the voids may be completely or partially filled with a degradable or non-degradable filler material that contributes to the strength of the framework for at least a period of time after implantation, giving the framework sufficient initial strength to support the body cavity. The filler material may be harder or softer than the metal or metal alloy of the scaffold, or in some cases may have equivalent stiffness. The voids may be completely filled, partially filled, or in some cases overfilled, such that the filler material extends beyond the boundaries of the scaffold framework before the voids are formed.

[0168] For example, such filling voids in the coronal region will deform during stent expansion and allow stent compliance and strength to change over time. In many examples, filling voids in the coronal region will enhance the strength of the scaffold during expansion and implantation, but will also reduce compliance. However, by using filling materials that degrade, soften, or otherwise lose strength upon exposure to blood vessels or other physiological environments, the compliance of the scaffold will increase, thereby increasing the combined compliance of the stent and the blood vessel or other body cavity. Although strength may decrease simultaneously, such strength reduction is generally acceptable after the blood vessel or other body cavity has been opened and the lumen wall has at least partially healed. In this way, at least some rings of the stent are stretched, further expanded, and / or exhibit vascular reactivity. The thickness of the metal or metal alloy surrounding the hollowed-out or voided area in the coronal region (lateral surface region, luminal surface region, or proximal luminal surface region) is 10 to 50 micrometers, preferably 20 to 40 micrometers. The hollowed-out coronary region can be hollowed out in various ways, such as: the two lateral surface regions of the coronary region remain intact while the area between the two lateral surface regions is hollowed out; one lateral region and the luminal surface region remain intact while the other lateral region and the proximal luminal surface region are hollowed out; both lateral surface regions and the luminal surface region remain intact while the proximal luminal surface region is hollowed out; all surface regions (proximal luminum, lumen, and both lateral surfaces) remain intact but the internal core of the coronary region is hollowed out; and / or one lateral region, the proximal luminal surface region, and the luminal surface region remain intact while the core is hollowed out from the other lateral surface region, etc.; allowing the coronary region to allow the stent to expand after expansion. At at least a portion of the coronary region, the total cross-sectional area of ​​the combination of non-degradable metal or metal alloy of the one or more coronary regions is 200 to 4000 square micrometers, preferably 400 to 3000 square micrometers, more preferably 500 to 2500 square micrometers. In another example, the hollowed-out area is filled with another material (degradable or non-degradable), which, upon expansion, allows the crown region, rings, and / or supports to expand, and / or has increased radial strain, and / or increased radial strain and reduced radial strength. In another example, as described in this section, at least some of the supports along at least some of the rings are hollowed out.

[0169] Voids can also be formed in the struts and other components of the scaffold rings or other scaffold structures. For example, channels, slots, etc., can be formed along some or all of the length of at least some rings, including struts, coronals, and any other structural components. As with the other voids described above, channels, slots, etc., can be partially or completely filled with a second biodegradable polymer or metallic material, referred to herein as “reinforcing material,” to provide sufficient combined material strength to enhance the radial strength of the stent immediately after expansion. This reinforcing material typically degrades after expansion and implantation to enhance compliance, while also typically reducing stent strength. The non-degradable material at the base of the struts and other components of the stent rings or other scaffold structures will typically have a thickness of 1000 μm. 2 Up to 4000 μm 2 The cross-sectional area is preferably 1500 μm. 2 Up to 3500 μm 2 The cross-sectional area of ​​the stent, wherein the biodegradable reinforcing material covering all or part of the non-degradable material increases the thickness and / or width of the scaffold base material assembly by an additional 40 μm to 120 μm, and wherein the combined base and covering reinforcing material have sufficient strength to support the body cavity (and prevent vascular lumen retraction) during expansion, and wherein compliance increases and the strength of at least some rings decreases to expand the stent after expansion and implantation. The channel depth is typically 40% to 90% of the thickness of the non-degradable material, preferably 50% to 85%, more preferably 60% to 80%, and the width of the channel and slot is typically 40% to 90% of the width of the non-degradable material, preferably 50% to 85%, more preferably 60% to 80%. The width and thickness of the channel and slot can vary along the length of the channel and slot on at least some rings. The channel can be disposed on the proximal luminal surface region, the luminal surface region, and / or both the proximal luminal surface region and the luminal surface region. The slot typically extends from the proximal luminal surface to the luminal surface.

[0170] One or more thinning regions may alternatively or similarly form along some or all of the rings or other circumferential elements of the non-degradable scaffold to increase scaffold compliance and facilitate scaffold expansion after implantation. Such thinning regions may be present in the coronal region, strut region, or other components of the rings or other structures that affect circumferential compliance. “Thinning” refers to a coronal, strut, or other scaffold component having a baseline cross-sectional size over a substantial portion of the component's length, and a reduction in the baseline cross-sectional size within a region being termed “thinning.” Thinning regions may be located in adjacent coronals, alternating coronals, every three coronals, or other patterns or configurations to achieve sufficient strength to support the body cavity upon expansion and to increase compliance after expansion. Such thinning regions may have a smaller thickness and / or width and / or cross-section relative to the baseline size, sufficient to facilitate expansion after implantation. Without further modification, the thinning regions will generally provide lower scaffold strength and increased compliance in at least the thinned region of the component. Optionally, the thinning regions may be reinforced by overlaying, laminating, or otherwise coupling with reinforcing materials to provide strength upon expansion while generally degrading after expansion to increase compliance. Such biodegradable reinforcing materials can be similar to the filler materials described elsewhere herein, typically biodegradable polymers, but also biodegradable metals. Suitable reinforcing materials will degrade over a period of time following implantation or exposure to the vascular environment, ranging from 30 days to 3 years, preferably 3 months to 2 years, and more preferably 3 months to 1 year. The non-degradable base material (base stent), typically a metal or metal alloy, comprises one or more rings (or circumferential structural elements), typically multiple rings, each ring including a strut and a coronal portion along its length, and in some examples, the base stent lacks sufficient strength to support (or maintain) the body cavity without the presence of reinforcing material coupled to it, the reinforcing material having sufficient weight and thickness (e.g., a polymer coating) to increase the strength of the base to be sufficient to support (or maintain) the body cavity opening.

[0171] For example, the thinned cross-sectional region along the length of the circumferential ring can be covered, laminated, or otherwise encapsulated with sufficient reinforcing material to strengthen the stent framework upon expansion, wherein the stent strength decreases and compliance increases as the material degrades after expansion and exposure to the vascular or other luminal environment. The framework can be formed from a non-degradable base material assembly having a thickness of 1000 μm. 2 Up to 4000 μm 2 The cross-sectional area is preferably 1500 μm. 2 Up to 3500 μm 2The cross-sectional area of ​​the biodegradable reinforcing material covering the non-degradable material increases the thickness and / or width of the skeletal base material component forming the underlying component by an additional 40 μm to 120 μm, and wherein the combined base and covering materials have sufficient strength to support the body cavity upon expansion, and wherein after expansion and implantation, compliance increases and the strength in at least some rings decreases to expand the scaffold.

[0172] In another example of any example of this application, the stent prosthesis exhibits one or more of the following: expands after expansion (which also includes one or more of the following): increased radial strain (or compliance), increased radial strain (or compliance) and decreased radial strength, exhibiting vascular reactivity or vasodilation of the stent segment, further expands to a second larger configuration, is capable of expanding and / or contracting after expansion, changes in shape configuration from the expanded shape configuration, changes in stent displacement in at least one dimension, and greater displacement in at least one direction after expansion.

[0173] Suitable scaffold materials include polymers, metals (metals and metal alloys), adhesives, coatings, solders, sleeves, sealants, fixation materials, bonding agents, and energy fixation materials, including but not limited to the following: adhesives and fixation materials include but are not limited to adhesives, sealants, and potting compounds such as cyanoacrylates, such as polyalkyl-2-cyanoacrylate, methyl 2-cyanoacrylate, ethyl 2-acrylate; n-butyl cyanoacrylate, 2-octyl cyanoacrylate, etc.; epoxy resins; epoxamine; UV-curable materials from Loctite, Dymax, Master Bond, etc.; acrylic resins; silicone resins; hot melt materials; polyurethane; Gorilla Glass; lysine-based adhesives, such as TissueGlu, Sylys surgical sealant, etc.; fibrin glue; beeswax. Other fixing materials can also be used, such as solder or fusible alloys, such as tin or its alloys, such as Sn97Cu3, Sn50Zn49Cu1, Sn95.5Cu4Ag0.5, Sn90Zn7Cu3, Sn98Ag2, Sn96.5Ag3Cu0.5, Sn91Zn9, Sn85Zn15, Sn70Zn30, Sn89Zn8Bi3, Sn83.6Zn7.6In8.8, Sn86.9In10Ag3.1, Sn95Ag3.5Zn1Cu0.5, Sn86.5Zn5.5In. 4.5Bi3.5, Sn95Sb5, Sn96.2Ag2.5Cu0.8Sb0.6, Sn90Au10, etc.; indium or its alloys, such as In97Ag3, In90Ag10, In50Sn50, In52Sn48, etc.; zinc or its alloys, such as Zn95Al5, Zn60Sn40, Zn95Sn5, etc.; bismuth or its alloys, such as B57Sn42Ag1, Bi58Sn52, etc.; gold or its alloys, such as Au80Sn20, Au98Si2, Au87.5Ge12.5, Au82In18.Other fixing methods include laser bonding, welding, or fusion, or other energy-based fixing methods (including bonding or joining), or solvent-based polymer dispersions or pure adhesives, sealants, and potting compounds, such as cyanoacrylates, such as polyalkyl-2-cyanoacrylate, methyl 2-cyanoacrylate, ethyl 2-acrylate; n-butyl cyanoacrylate, octyl 2-cyanoacrylate, etc.; epoxy resins; epoxamine; from Loctite, Dymax, Master UV-curable materials from Bond, Henkel, etc.; acrylic acid; silicone resins; hot melt materials; polyurethane; Gorilla Glass; polyester; polylactide and its copolymers and blends; polytrimethylene carbonate and its copolymers or blends; polyvinyl alcohol; polyvinyl acetate; ethylene-vinyl acetate (hot melt adhesive); phenolic resins; polyamides; polyester resins; polyethylene (hot melt adhesive); polypropylene; polystyrene; polycarbonate; polychloroprene; natural rubber; silicone rubber; lysine-based adhesives, such as TissueGlu, Sylys surgical sealant, etc.; fibroin glue; beeswax; bioadhesives such as casein, mussel adhesive protein and collagen, combinations thereof, etc.; solder or fusible alloy materials, such as tin or its alloys, such as Sn97Cu3, Sn50Zn49Cu1, Sn95.5Cu4Ag0.5, Sn90Zn7Cu3, Sn98Ag2, Sn96.5Ag3Cu0. 5. Sn91Zn9, Sn85Zn15, Sn70Zn30, Sn89Zn8Bi3, Sn83.6Zn7.6In8.8, Sn86.9In10Ag3.1, Sn95Ag3.5Zn1Cu0.5, Sn86.5Zn5.5In4.5Bi3.5, Sn95Sb5, Sn96.2Ag2.5Cu0.8Sb0.6, Sn90Au10, etc.; indium or its derivatives. Alloys, such as In97Ag3, In90Ag10, In50Sn50, In52Sn48, etc.; zinc or its alloys, such as Zn95Al5, Zn60Sn40, Zn95Sn5, etc.; bismuth or its alloys, such as B57Sn42Ag1, Bi58Sn52, etc.; gold or its alloys, such as Au80Sn20, Au98Si2, Au87.5Ge12.5, Au82In18, and combinations thereof, etc.Suitable stent materials that are non-degradable in vascular or other physiological environments include, but are not limited to, metals and metal alloys, such as stainless steels like 304V, 304L, and 316LV stainless steel; steel alloys like mild steel; cobalt-based alloys like cobalt-chromium alloys; L605, Elgiloy®, Phynox®; platinum-based alloys like platinum-chromium alloys, platinum-iridium alloys, and platinum-rhodium alloys; tin-based alloys; rhodium; rhodium-based alloys; palladium; palladium-based alloys; aluminum-based alloys; titanium or its alloys; rhenium-based alloys such as 50:50 rhenium-molybdenum alloys; 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 hyperelastic nickel-titanium alloys; nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., INCONEL 625, Hastelloy C-22, Hatelloy C276, Monel 400, Nickelvac). 400, etc.); nickel-cobalt-chromium-molybdenum alloys, such as MP35-N; nickel-molybdenum alloys; platinum-rich stainless steel; combinations thereof; etc., and other ductile metals commonly used in stent and prosthesis manufacturing. In other examples, non-degradable materials may include non-degradable polymers such as polyaryletherketone; polyetheretherketone; polyimide; polyethylene such as UHMW, HDPE, LDPE, etc.; polypropylene; polyester; polyethylene terephthalate; polycarbonate; polysulfone; polyphenylene sulfone; polyethersulfone; Ultem; polyetherimide; polyurethane; polyamide; nylon such as nylon 12, nylon 6, nylon 6-6, etc.; polyvinyl chloride; PTFE; FEP; ETFE; PFA; PVDF; polyvinyl chloride; acrylamide styrene; Delrin; polymethyl methacrylate; polystyrene; polyacrylamide; polyphenylene sulfide; PEBAX; or other materials. In other examples, non-degradable materials may include elastic metals such as shape or thermal memory alloys, shape memory polymers, or hyperelastic materials, typically nickel-titanium alloys; spring stainless steel; Ni50-MN28-Ga22; copper-aluminum-nickel alloys; alloys of zinc, copper, gold, and iron; iron-based alloys such as Fe-Mn-Si; copper-based alloys such as Cu-Zn-Al and Cu-Al-Ni; poly(α-caprolactone) dimethacrylate; PVDF / PMMA; PVDF / PVA; PLA / PVAc; or others, etc.Examples of biodegradable materials, such as biodegradable polymer materials, include one or more of the following: 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-ε-caprolactone) (e.g., L-lactide to about 50% to about 95% by weight of about 50% to about 5% by weight of caprolactone); poly(L-lactide-co-trimethylene carbonate) Poly(esters), polytrimethylene carbonate, polycaprolactone, poly(glycolic acid-trimethylene carbonate), poly(lactide-glycolic acid-trimethylene carbonate), etc.; polyhydroxybutyrates such as poly(3-hydroxybutyrate) and poly(4-hydroxybutyrate); polyhydroxyvalerate; polyhydroxybutyrate / polyhydroxyvalerate copolymers (PHV / PHB); polyhydroxyalkanoates; polyorthoesters; polyanhydrides; polyimide carbonates; tyrosine-derived polycarbonates; tyrosine-derived polyacrylates; iodinated and / or brominated tyrosine. Acid-derived polycarbonates; iodinated and / or brominated tyrosine-derived polyacrylates and polyamide esters; polycarbonate copolymers, lactone-based polymers, such as poly(propylene fumarate-co-ethylene glycol) copolymers (also known as fumaric anhydride); polyanhydride esters; polyorthesters; silk-elastin polymers; polyphosphazenes; aliphatic polyurethanes; polyhydroxy acids; polyether esters; polyesters; polydepsidpetides; poly(alkylene oxalate); polytetrafluoroethylene (PTFE); poly(hydroxylamine) esters; ... Aspartic acid; polyglutamic acid polymers; poly(p-dioxanone); poly(β-dioxanone); asymmetric 3,6-substituted poly(1,4-dioxane-2,5-dione); polyalkyl-2-cyanoacrylate; polyphenolic peptides (glycine-DL-lactide copolymers); polydihydropyran; polyalkyl-2-cyanoacrylate; poly(β-maleic acid) (PMLA); polyalkanote; poly(β-alkanic acid), polymers, blends and / or copolymers, or combinations thereof.

[0174] In another example, suitable materials include suitable scaffold materials, including polymers and metals (degradable or non-degradable), adhesives, coatings, solders, sleeves, sealants, potting compounds, fixation materials, adhesives, energy-fixing materials, elastomers, and other types of materials, including but not limited to: adhesives such as cyanoacrylates, such as polyalkyl-2-cyanoacrylate, methyl 2-cyanoacrylate, ethyl 2-acrylate; n-butyl cyanoacrylate, octyl 2-cyanoacrylate, etc.; Gorilla Glass; lysine-based adhesives such as TissueGlu, Sylys surgical sealant, etc.; fibrin glue; beeswax.Non-degradable adhesives, sealants, and potting compounds such as epoxy resins; epoxamine; UV-curable materials from Loctite, Dymax, Master Bond, etc.; acrylic resins; silicone resins; hot melt materials; polyurethane; biodegradable sleeve materials, support materials, and coatings such as polyester; polylactide and its copolymers and blends; copolymers of lactide, caprolactone, trimethylene carbonate, and glycolide; poly(L-lactide), poly-DL-lactide, polylactide-co-glycolide (e.g., poly(L-lactide-co-glycolide)); copolymers of poly(L-lactide-co-ε-caprolactone) (e.g., copolymers of about 50% to about 95% L-lactide to about 50% to about 5% caprolactone by weight); poly(L-lactide-co-ε-caprolactone) Ester-co-trimethylene carbonate); polytrimethylene carbonate; polycaprolactone; poly(glycolic acid-trimethylene carbonate); poly(lactide-glycolic acid-trimethylene carbonate), etc.; polyhydroxybutyrates such as poly(3-hydroxybutyrate) and poly(4-hydroxybutyrate); polyhydroxyvalerate; polyhydroxybutyrate / polyhydroxyvalerate copolymer (PHV / PHB); polyhydroxyalkanoate; polyorthoester; polyanhydride; polyimino carbonate; tyrosine-derived polycarbonate; tyrosine-derived polyacrylate; iodinated and / or brominated tyrosine-derived polycarbonate; iodinated and / or brominated tyrosine-derived polyacrylate Acrylates and polyamides; polycarbonate copolymers, lactone-based polymers such as poly(propylene fumarate-co-ethylene glycol) copolymers (also known as fumaric anhydride); polyanhydride esters; polyorthesters; silk-elastin polymers; polyphosphazenes; aliphatic polyurethanes; polyhydroxy acids; polyether esters; polyesters; polydepsidpetides; poly(alkylene oxalate); polyaspartic acid; polyglutamic acid polymers; poly(p-dioxanone); poly-β-dioxanone; asymmetric 3,6-substituted poly-1,4-dioxane-2,5-dione; poly Alkyl-2-cyanoacrylates; polyphenolic peptides (glycine-DL-lactide copolymers); polydihydropyran; polyalkyl-2-cyanoacrylates; poly-β-maleic acid (PMLA); polyalkanote; poly-β-alkanic acid; proteins such as elastin, fibroin, collagen, glycoproteins, gelatin or pectin; polyserine; polycaprolactam; cyclodextrin; polysaccharides such as chitosan and hyaluronic acid; alginates; polyketides; fatty acid-based polyanhydrides, amino acid-based polyanhydrides; poly(ester anhydrides); polymer blends; and / or copolymers; or combinations thereof; etc.Corrosion-prone solders or fusible alloys such as Sn97Cu3, Sn50Zn49Cu1, Sn95.5Cu4Ag0.5, Sn90Zn7Cu3, Sn98Ag2, Sn96.5Ag3Cu0.5, Sn91Zn9, Sn85Zn15, Sn70Zn30, Sn89Zn8Bi3, Sn83.6Zn7.6In8.8, Sn86.9In10Ag3.1, Sn95Ag3.5Zn1Cu0.5, Sn86.5Zn5.5In4.5Bi3.5, Sn95Sb5, Sn96.2Ag2.5Cu0.8Sb0.6, Sn90Au10, etc.; indium or its alloys, such as In97Ag3, In90Ag10, In50Sn50, In52Sn48, etc.; zinc or its alloys, such as Zn95Al5, Zn60Sn40, Zn95Sn5, etc.; bismuth or its alloys, such as Bi57Sn42Ag1, Bi58Sn52, etc. Non-corrosive solders or fusible alloys such as gold or its alloys, such as Au80Sn20, Au98Si2, Au87.5Ge12.5, Au82In18.Degradable and non-degradable polymers include: polyesters; polylactide and its copolymers and blends; copolymers of lactide, caprolactone, trimethylene carbonate, and glycolide; poly(L-lactide), poly-DL-lactide, polylactide-co-glycolic acid (e.g., poly(L-lactide-co-glycolic acid)); copolymers of poly(L-lactide-co-ε-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(glycolic acid-trimethylene carbonate); poly(glycolic acid-trimethylene carbonate), etc.; polyhydroxybutyrates such as poly(3-hydroxybutyrate) and poly(4-hydroxybutyrate); polyhydroxyvalerate; polyhydroxybutyrate / polyhydroxyvalerate copolymers (PHV / PHB); polyhydroxyalkanoates; polyorthoesters; polyanhydrides; polyimide carbonates; tyrosine-derived polycarbonates; tyrosine-derived polyacrylates; iodinated and / or brominated tyrosine-derived polycarbonates; iodinated and / or brominated tyrosine-derived polyacrylates; polyamide esters; polycarbonate copolymers, based on... Polymers of lactones, such as poly(propylene fumarate-co-ethylene glycol) copolymers (also known as fumaric anhydride); polyanhydride esters; polyorthesters; silk-elastin polymers; polyphosphazenes; aliphatic polyurethanes; polyhydroxy acids; polyether esters; polyesters; polydepsidpetides; poly(alkylene oxalate); polyaspartic acid; polyglutamic acid polymers; poly(p-dioxanone); poly(β-dioxanone); asymmetric 3,6-substituted poly-1,4-dioxane-2,5-dione; polyalkyl-2-cyanopropylene. Esters; polyphenolic peptides (glycine-DL-lactide copolymers); polydihydropyran; polyalkyl-2-cyanoacrylates; poly-β-maleic acid (PMLA); polyalkanote; poly-β-alkanic acid; proteins such as elastin, fibroin, collagen, glycoproteins, gelatin or pectin; polyserine; polycaprolactam; cyclodextrin; polysaccharides such as chitosan and hyaluronic acid; alginates; polyketides; fatty acid-based polyanhydrides, amino acid-based polyanhydrides; poly(ester anhydrides); polymer blends; and / or copolymers; or combinations thereof; etc.Polyvinyl alcohol; polyvinyl acetate; ethylene-vinyl acetate (hot melt adhesive); phenolic resin; polyamide, such as nylon 12, nylon 6, nylon 6-6, etc.; polyester resin; polyethylene (hot melt adhesive), UHMW, HDPE, LDPE, etc.; polychloroprene; polyaryletherketone; polyetheretherketone; polypropylene; polystyrene; polyester; polyethylene terephthalate; polycarbonate; polysulfone; polyphenylene sulfone; polyethersulfone; Ultem; polyetherimide; polyurethane; polyvinyl chloride; PTFE; FEP; ETFE; PFA; PVDF; polyvinyl chloride; acrylamide styrene; polyacetal such as Delrin; polymethyl methacrylate; polystyrene; polyacrylamide; polyphenylene sulfide; PEBAX; and / or copolymers, and / or combinations thereof. Elastic, non-absorbable polymers or elastomers such as silicone rubber; C-flex; poly(n-butyl methacrylate); blends of poly(n-butyl methacrylate) with poly(methyl methacrylate), poly(hexyl methacrylate) and polyvinylpyrrolidone; Kraton; poly(styrene-ethylene / butene-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); choline phosphate; PEBAX; polyurethane elastomers; Tecoflex; Biomer; Pellethane; corethane; silicone rubber; rubber; elastomer; blends; copolymers; combinations thereof, etc. Non-corrosion-resistant elastic metals or metal alloys such as shape or heat memory alloys, shape memory polymers or superelastic materials, typically nickel-titanium alloys; spring stainless steel; Ni50-MN28-Ga22; copper-aluminum-nickel alloys; alloys of zinc, copper, gold and iron; iron-based alloys such as Fe-Mn-Si; copper-based alloys such as Cu-Zn-Al and Cu-Al-Ni; and so on.Metals or metal alloys with high initial strength that weakens over time include Ti6Al4V, Ti5Al2.5Sn, or Ti-10V-Fe-3Al; stainless steel such as SAF2507; zinc alloys such as Zn5Al, Zn10Al, Zn18Al, Zn30Al; platinum metal and its alloys; tin alloys such as Sn3.9Ag0.6Cu, Sn-3.8Ag-0.7Cu, SnPb, or SnPbAt; and aluminum alloys such as Al1.7Fe, Al0.7Cu, and Al1.5. MgScZr, Al6Mg0.2Sc0.15Zr, 3004, 8090, 7075, 6061 or 5056; zirconium alloys such as Zr55Al10Ni5Cu30; magnesium alloys such as AZ31B or MG11li5Al1Zn0.034Sc (LAZ1151); ferroalloys such as Fe29.7Mn8.7Al1C, 30HGSA alloy steel, 4140, C45 steel, Fe36Ni or low carbon steel; nickel alloys such as Ni21Cr17Mo or... Haynes 230. Non-corrosion-resistant (non-degradable) metals or metal alloys such as conventional titanium alloys, such as Ti6Al4V, Ti5Al2.5Sn or Ti-10V-Fe-3Al; stainless steel such as SAF2507; platinum metal and its alloys; aluminum alloys such as Al1.7Fe, Al0.7Cu, Al1.5MgScZr, Al6Mg0.2Sc0.15Zr, 3004, 8090, 7075, 6061 or 5056; zirconium alloys such as Zr55Al10Ni5Cu30; 304V, 304L and 316L V stainless steel; steel alloys, such as mild steel; cobalt-based alloys, such as cobalt-chromium alloys; L605, Elgiloy, Phynox; platinum-based alloys, such as platinum-chromium alloys, platinum-iridium alloys, and platinum-rhodium alloys; tin-based alloys; rhodium; rhodium-based alloys; palladium; palladium-based alloys; aluminum-based alloys; titanium or its alloys; rhenium-based alloys, such as 50:50 rhenium-molybdenum alloys; molybdenum-based alloys; tantalum; gold or its alloys; silver or its alloys (degradable); shape memory metals or alloys; chromium-based alloys; nickel-titanium alloys, such as linear elastic and / or hyperelastic nickel-titanium alloys; nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., INCONEL 625, Hastelloy C-22, Hatelloy C276, Monel 400, Nickelvac 400, etc.); nickel-cobalt-chromium-molybdenum alloys, such as MP35-N; nickel alloys, such as Ni21Cr17Mo or Haynes 230Other; nickel-molybdenum alloys; platinum-rich stainless steel; combinations thereof; etc. Corrosion-prone metals or metal alloys (degradable) include nickel, cobalt, tungsten; rhenium, cobalt, iron, zirconium, zinc, titanium tungsten alloys; magnesium, magnesium alloys, magnesium alloy AZ31, magnesium alloys having less than 20% by weight of zinc or aluminum and free from one or more of the following rare earth metals: iron, silicon, manganese, cobalt, nickel, yttrium, scandium or other rare earth metals, or less than 3% of the above impurities; AZ31B or MG11li5Al1Zn0.034Sc (LAZ1151); zinc Or its alloys, such as zinc alloys, such as Zn5Al, Zn10Al, Zn18Al, Zn30Al; bismuth or its alloys; indium or its alloys; tin or its alloys such as 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 its alloys, such as 80-55-06 grade cast ductile iron, other cast ductile iron, AISI 1010 steel, AISI 1015 steel, AISI 1430 steel, AISI 8620 steel, AISI 5140 steel, Fe29.7Mn8.7Al1C, 30HGSA alloy steel, 4140, C45 steel, Fe36Ni, low carbon steel or other steels; molten fusible alloys (such as 40% bismuth-60% tin, 58% bismuth-42% tin, bismuth-tin-indium alloy); alloys containing one or more of bismuth, indium, cobalt, tungsten, silver, copper, iron, zinc, magnesium, zirconium, molybdenum, indium, and tin; or other materials; etc.

[0175] In another example or aspect, the invention provides a non-degradable prosthesis having rings with energy-responsive separation regions. Such an intracavitary prosthesis comprises a skeleton having circumferential rings patterned from a non-degradable material, wherein the skeleton is configured to expand from a coiled 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 expansion and / or after the prosthesis is implanted into the body cavity. Such discontinuities allow the skeleton to expand and / or further expand upon retraction (if present), for example, beyond the initial expansion diameter, which is typically achieved by balloon dilation, self-expansion, etc.

[0176] The energy that promotes or causes intermittent movement can be energy associated with the implantation site or energy from an external source directed towards the implantation site. For example, the separation region can be configured to fatigue in response to the introduction of a drug and / or pulsation of the blood vessel or other body cavity to which the intracavitary prosthesis is implanted. Alternatively, the separation region can be configured to respond to external energy that causes thermal and / or mechanical movement of the separation region, such as vibration. In particular, such a motion-responsive separation region can include, in one example, a notch, thinning region, joint, mating joint, key and lock design, or other localized area or focal point that preferentially fatigues and fractures in response to applied energy, and / or a pre-formed separation region that is intermittent in response to applied energy. For example, the separation region can include a “moving hinge” that cyclically opens and closes in response to pulsation or the application of external energy, and separates or eventually fatigues and fractures. In other examples, the separation region can include improved grain boundaries in a metal ring, where the grain boundaries are particularly susceptible to vibration-induced fatigue.

[0177] In other implementations or examples, the separation region may include a pre-formed gap or pre-formed separation region in a circumferential ring, wherein those gaps or interruptions are reconnected by a connector configured to open in response to applied or endogenous energy (or in response to physiological conditions). Common forms of externally applied energy include ultrasound, pharmaceuticals, heat, magnetism, radiofrequency energy, high-intensity focused ultrasound (HIFU), etc.

[0178] In other examples and / or embodiments, the separation region may include a key and lock engagement formed in a circumferential ring and / or circumferential structural element, wherein the key and lock engagement is initially fixed before, during, or after expansion, but is configured to open in response to applied energy or physiological conditions from external or internal sources. In other examples or embodiments, the separation region may include a rivet or other fastener for engaging the gap in the circumferential element, wherein the fastener is configured to open in response to applied energy from external or internal sources or in response to physiological conditions.

[0179] In another example and / or a fourth aspect, the present invention provides a non-degradable or slowly degradable prosthesis having rings with restraining hinges, and methods of using and manufacturing the same. The intracavitary prosthesis comprises a skeleton having circumferential rings patterned from a non-degradable material. The skeleton is configured to unfold from a coiled configuration to an expanded configuration, and the circumferential rings have hinges that open when and / or after the skeleton is unfolded. At least some hinges on at least some rings are restrained from expanding during unfolding and are configured to open in response to the application of physiological environment or external energy after unfolding. Specific physiological environments and external energies that can release the hinges from restraint have been described in detail above or throughout this application.

[0180] In one example, by initially constraining at least some of the hinges of the circumferential ring, the skeleton will initially expand to a diameter suitable for the cavity to be treated and will have sufficient strength to maintain the patency of the cavity while still in its configuration with constrained hinges. However, after expansion and / or over time, the initially constrained hinges will release from their constraints, which reduces the effective circumferential stiffness of the skeleton. In other words, by adding more hinges or other expansion areas, the force required to gradually open the skeleton (preferably beyond its initial expansion configuration) will decrease. In this way, the intracavitary prosthesis will have reduced energy to cage or confine the cavity being treated, thereby allowing the skeleton to expand and / or the lumen to expand.

[0181] In another example or aspect, the invention provides a non-degradable prosthesis having a ring with joints or movable joints, and methods of manufacturing and using the same. The intracavitary prosthesis includes a skeleton having a circumferential ring patterned from a non-degradable material. The skeleton is configured to unfold from a coiled configuration to an expanded configuration, and the circumferential ring includes struts connected by joints that open when the skeleton is typically expanded by balloon inflation. At least some joints will pivot to allow the skeleton in its expanded configuration to expand and / or further expand. In some cases, the pivot or "movable joint" may be asymmetrical. In other words, the joint will allow radial expansion of the circumferential ring but will restrict radial contraction of the ring.

[0182] In different implementations or examples, the shape of the reinforcing element or bridging element can be substantially circular (solid or hollow circular), rectangular, square, oval, or other shapes and geometries. In some examples, the size of the reinforcing element can be substantially the same as the size / geometry of the hinge, expansion region, and / or strut to which the reinforcing element 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 non-invasive and / or smooth, and / or have a spherical or circular shape, and / or have a large cross-sectional area to reduce trauma to the blood vessel. In one example, the surface finish of the reinforcing element is similar to that of a polished vascular metal stent. In another example, the surface finish is textured.

[0183] In one example of a biodegradable material, the polymeric body of the circumferential skeleton is configured to substantially degrade under physiological conditions over a period of 1 month to 3 years, preferably 3 months to 2 years, and more preferably 6 months to 1 year, after the intracavitary prosthesis has been deployed. 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.

[0184] In another example, the separation regions of the non-degradable skeleton are configured to separate over a period of up to 3 years after unfolding, typically 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 example, the separation regions separate over approximately the same time period, while in another example, the separation regions separate over different time periods.

[0185] In another example, the intracavitary prosthesis further includes at least one coating, preferably a biodegradable coating, on at least one surface of the stent prosthesis (skeleton prosthesis). In another example, the stent prosthesis further includes at least one drug on at least one surface of the stent prosthesis. In yet another example, the stent prosthesis further includes at least one coating containing at least one drug on at least one surface of the stent prosthesis. In a preferred example, the polymeric material or adhesive that bonds, contains, or holds the separated regions together is a stretchable polymeric or adhesive material (biodegradable or non-biodegradable), thereby preventing movement of the separated regions or allowing some movement without premature discontinuity (before or after deployment). This also allows for consistent skeleton performance and improved storage conditions and shelf life for the stent and separated regions, allowing for extended shelf life under different typical environmental conditions of heat, humidity, and time. The material can withstand temperatures from 5°C to 50°C, preferably from 10°C to 40°C, and has a shelf life of 1 month to 3 years, preferably 1 month to 2 years, or 1 month to 18 months. The relative humidity is 10% to 95%, preferably 20% to 70%. Examples of the materials are described in this application.

[0186] In one example, the intracavitary prosthesis also includes radiopaque markings. In a more specific example, the radiopaque markings include non-degradable radiopaque markings. In a preferred example, the radiopaque markings comprise metals or metal alloys.

[0187] In one example, the reinforcing element and / or separation region and / or environmentally responsive separation region are formed of non-degradable materials such as non-degradable metals and / or polymers or other materials. Alternatively, the reinforcing element and / or separation region and / or environmentally responsive separation region may be formed wholly or partially of degradable (corrosive) materials such as degradable metals (e.g., magnesium and magnesium alloys) or degradable polymers (e.g., 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 of a corrosive material that corrodes after implantation to dislodge the stent or other intracavitary prosthesis, preferably dislodges the stent prosthesis without forming unwanted byproducts, such as hydroxyapatite, near the separation region.

[0188] In one example, the intracavitary prosthesis is a stent prosthesis comprising a substantially tubular structure patterned therein, the stent prosthesis including a separation region, and the stent prosthesis being rolled into a smaller diameter and unfolded from a rolled configuration to a larger expanded configuration, wherein the stent in the larger expanded configuration has sufficient strength to support the body cavity and / or will not break and / or has low recoil. In this example, the deployed stent is configured to perform 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 separate at least in one or more portions and / or regions after deployment and / or implantation; and / or the stent undergoes modification including the unlocking, degradation or inclusion of material in or near the separation region after deployment or implantation by a sleeve or material that does not prevent the separation region from expanding, resulting in at least a portion and / or separation, expansion and / or separation of the stent structure; and / or further expansion of the stent after radial deployment; and / or circumferential expansion of the stent after deployment; and / or further expansion of the stent after deployment and after modification assisted by a source (chemicals, energy); and / or the stent is configured to promote luminal expansion for a period of time after deployment or implantation; and / or the stent is configured to allow luminal or vascular dilation / enlargement, or a combination thereof. The stent comprises a non-degradable material, or two non-degradable materials, or a degradable material, or two degradable materials, or two degradable materials and one non-degradable material, or a non-degradable material and a corrosive material, or a degradable material and a corrosive material, or a degradable material, a corrosive material, and a non-degradable material. The stent may also include at least one coating on at least one surface of the stent prosthesis, said coating being a degradable and / or non-degradable coating. The aforementioned materials do not include labeling materials that may be degradable or non-degradable. The stent may also include at least one drug substance on at least one surface of the stent. The stent may also include at least one coating on at least one surface of the stent prosthesis.

[0189] In one example, the stent prosthesis includes a structure, preferably a substantially tubular structure, more preferably a substantially tubular patterned structure with a separation region. The stent prosthesis is typically expandable from a coiled configuration to a larger expanded configuration. The stent structure includes at least one primary or main material on at least a portion of the stent, preferably a biodegradable material such as a polymer, and the stent structure also includes at least one second material, preferably a stronger material than the frame material, more preferably a metallic material, and even more preferably a non-biodegradable metallic material, in contact with or coupled to at least said portion of the frame material; said portion is preferably the coronal portion of the stent structure. The stent expands to a larger expanded configuration. The stent in the expanded, deployed configuration has sufficient strength to support the body cavity and / or expands without fracturing, and / or expands with minimal recoil. After deployment, the stent undergoes modification, wherein the modification includes at least partial degradation of the frame material, and / or at least partial degradation of the second material, and / or corrosion of at least the first material, and / or corrosion of at least part of the second material, or a combination thereof. The modified stent includes one or more interruptions in at least one ring, and / or at least one interruption in at least one coronal portion, and / or at least one interruption in at least one strut, and / or combinations thereof. In another example, the modified stent has at least one interruption in at least a portion of the frame material, and / or at least one interruption in at least a portion of the second material portion, and / or at least one interruption in adjacent portions of the frame and the second material. In another example, the modified stent further expands 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 “deployed-and-retracted” configuration, and / or further expands to a larger configuration with respect to any prior cause in at least one ring of the stent prosthesis, and / or further expands to a larger configuration in other stent prostheses with respect to at least one ring, wherein the ring is located approximately in the middle portion of the stent length. In another example, after modification, at least one interruption in at least one ring of the stent allows the stent to further expand at said at least one ring under physiological pressure. In another example, after deployment and / or modification, the stent prosthesis is separated in at least one ring, coronal portion, and / or strut. In one example, after unfolding and / or modification and / or separation, the stent prosthesis has a structure, and / or has a tubular structure, and / or has a tubular patterned structure, and / or has a substantially retained tubular structure, and / or has at least a partial structure, and / or has at least one window, and / or has substantially no structure, and / or includes at least one coronal structure, and / or includes at least one strut, and / or includes at least one link, and / or has strength, and / or combinations thereof.

[0190] In a particular example, the support includes a generally tubular patterned structure (serpentine, rhomboid, zigzag, and / or other open or closed structure) comprising multiple rings, wherein the rings include a crown and a strut, wherein at least some rings are connected to adjacent rings by at least one link, or in some cases, some adjacent rings are connected together at at least one location.

[0191] In one example, the material of the skeleton or ring includes metals and / or metal alloys. Metals and / or metal alloys can be non-degradable or degradable / corrosive. Metals herein do not include markings and marking materials, which can be metals or metal alloys and can be degradable or non-degradable. Corrosive metals or metal alloys corrode over a period of 1 month to 10 years, preferably over a period of 3 months to 5 years, and more preferably over a period of 3 months to 3 years.

[0192] In one example, the second material (or reinforcing element) has at least two ends, wherein the ends are deburred, shaped into spheres, resembling "neural synapses," and / or smoothed to prevent damage to the lumen or blood vessel after stent separation and / or modification, and / or to cause inflammation. In another example, the stent is configured not to rupture except in the separation area and / or the portion configured for rupture, by reducing stress and / or fatigue areas on the stent after modification and / or after discontinuity formation in the separation region and / or after stent rupture.

[0193] In one example, the primary or framework material includes a polymer material. The polymer material may be biodegradable or non-biodegradable. In one example, the polymer material degrades over a period of 1 month to 10 years, preferably 3 months to 5 years, and more preferably 3 months to 3 years.

[0194] In one example, the primary or frame material is non-degradable, and / or degrades at a faster rate than the second material (reinforcing element), and / or degrades at substantially the same rate as the second material, and / or degrades at a slower rate than the second material.

[0195] In one example, the support in any example and / or embodiment of this application is formed from one or more of the following: tube, continuous wire or thread, thread, hollow wire (completely hollow, or hollow in certain areas such as low-stress areas and / or substantially straight areas), or braid, or die, or by printing, by extrusion, or by spraying, or by impregnation, or by stamping, or a combination thereof. The support has separation regions formed before, during, or after patterning, or such separation regions and / or discontinuities are formed after processing. Means for maintaining said discontinuities are described throughout this application.

[0196] In one example, a second reinforcing material coupled to or in contact with the structural frame material is integrally embedded within the frame, or at least one surface or surface region is embedded within at least one surface or surface region of the frame, or at least two surfaces are embedded within at least one surface of the frame, or at least three surfaces are embedded within at least one surface of the frame, or at least one surface of the second material is attached (and / or joined, and / or adjacent, and / or glued, and / or press-fitted) to at least one surface of the frame material. At least one surface of the frame material can be a proximal surface, a tubular surface, or a side surface of the frame material. The second material can be sandwiched within the frame material. In one example, the second material has a discontinuity, wherein the discontinuity of the second material is held together or joined together by the frame material and / or adhesive and / or coating.

[0197] In one example, the second reinforcing material can be in the form of one or more parts, including one or more of wire, strip, strut, crown, link, and / or thread. The cross-section of the part can have any of the following shapes: circular or substantially circular, rectangular or substantially rectangular, square or substantially square, elliptical or substantially elliptical, egg-shaped or triangular, or other shapes. The length, number, and location of the parts are variable and can be at at least one or more locations on at least one or more support rings, within the range of the length of the support strut or shorter, the length of the support crown or shorter, the length of the support link or shorter, and / or the length of the support ring or shorter. Preferably, the part of the second material is above / among / around at least one support crown in at least one support ring, and / or above / among / around at least two support crowns in at least one support ring, and / or above / among / around substantially all or part of the support crowns in at least one support ring of the support, and / or above / among / around all but one of the support crowns in at least one support ring, and / or on at least one ring, and / or on at least one ring approximately at the middle of the support length, and / or on at least one window of the patterned structure of the support, and / or on at least one strut or part of a strut, and / or on at least one link or part of a link, and / or other variations or combinations thereof. In one example, the patterned support structure includes a plurality of windows, each containing reinforcing material that forms at least two crowns and at least four struts. In another example, the window includes at least four crowns and 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-shaped links, V-shaped links, M-shaped links and / or other link shapes. In one example, at least one structural element (including a crown and a strut) in each window has a separation region configured for expansion and / or for discontinuity and / or separation. In another example, the structural element comprises a plurality of circumferential rings including one or more windows, wherein each window has at least one separation region configured for expansion and / or for discontinuity and / or separation.

[0198] In a preferred example, a stent structure with a separation region is desirable, wherein the stent forms a discontinuity in the separation region after deployment (or such discontinuity is formed before deployment and held together by means of designed geometry or deployment means such as a balloon catheter), or in other types of embodiments of this application, wherein the stent structure is substantially retained after separation (or dissociation) in the separation region and / or movement in one or more directions. The benefit of having a stent structure preferably along the length or a portion of the stent length helps prevent fragile material beneath the stent, such as fragile plaque, from rupturing into the blood vessel and causing damage. The stent structure is sufficient to block (or retain) fragile material (such as fragile plaque) in the body cavity. In another example, the stent structure is substantially sufficient to support the body cavity after deployment and / or after separation and / or after the formation of a discontinuity. In yet another example, the stent structure is substantially sufficient to support body tissue after deployment and / or after separation and / or after the formation of a discontinuity.

[0199] In one example, at least some structural elements of the stent expand and / or separate and / or have separation regions when formed under physiological conditions, after treatment (including modification), and / or after deployment, including one or more of the following: loosening, release, dislodgement, thrombus removal, unattachment, disassembly, breakage, fracture, cracking, pushing, pushing away, separation, pulling apart, creating gaps, creating spaces, disintegration, corrosion, degradation, fragmentation, rupture, pulverization, splitting, decomposition, unlocking, damage, deterioration, degradation, decay, discontinuity, becoming free, and / or combinations thereof. In one example, the stent structural element includes one or more of rings, coronal portions, struts, and / or links. In another example, the stent structural element includes one or more rings, the rings including coronal portions and / or struts.

[0200] In one example, under physiological and / or simulated conditions, including 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 cavity, and / or at body temperature, and / or in a tube, under pressure, under pulsating pressure, and / or combinations thereof, the stent prosthesis expands to a larger configuration of expansion.

[0201] In one example, 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 cavity, 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 of 1.5 psi to 5 psi on the stent, under pressure, under pulsating pressure, and / or under accelerated fatigue, and / or under acceleration under any condition, and / or a combination thereof, the stent prosthesis expands to a larger, expanded configuration and undergoes modification.

[0202] In another example or aspect of the invention, the non-degradable stent prosthesis includes a structure comprising lines, hollow lines (hollow in at least some regions, wherein they are hollow upon formation and / or after processing (modification)), wherein the lines and / or hollow lines are patterned into a stent, preferably a substantially tubular stent structure, more preferably a substantially tubular patterned stent structure wherein the stent is patterned from tubes. The stent prosthesis can expand from a coiled configuration to a larger or expanded configuration. The stent structure comprises a strong material, such as a non-degradable polymer or a metal (including alloys), such as metallic stainless steel or a cobalt-chromium alloy. The material is configured to have at least one portion and / or region in at least one ring, wherein the material will separate after expansion and / or modification (environmentally responsive separation region or separation region); 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 coronal portion, and / or combinations thereof. The discontinuities in the material are held together and substantially do not affect the curling and / or unfolding of the stent to a larger expansion configuration, and / or the stent prosthesis in the unfolded configuration has sufficient strength to support the body cavity; 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 coronal portion, and / or combinations thereof. The discontinuities in the material are held together and substantially do not affect the curling and / or unfolding of the stent to a larger expansion configuration, and / or the stent prosthesis in the unfolded configuration has sufficient strength to support the body cavity. Holding the material together includes holding adjacent portions of the material discontinuities together, latching, attaching, connecting, pressing together, pulling together, removing gaps, removing spaces, and / or locking together. Means for holding the discontinuous portions of the material together include sleeves, adhesives, press fits, locks, coatings such as polymer or metal coatings, gels, solders, and / or designs such as key and lock designs. A stent in an expanded, deployed configuration has sufficient strength to support the body cavity and / or expands without fracturing and / or expands with minimal recoil. In one example, the stent undergoes modification after deployment, wherein the modification includes at least partial and / or means of holding discontinuous portions of the material together by means of expansion, loosening, release, disassembly, thrombus removal, unattachment, disassembly, breakage, fracture, cracking, pushing, pushing away, separation, pulling apart, creating gaps, creating spaces, disintegration, corrosion, degradation, fragmentation, rupture, pulverization, splitting, decomposition, unlocking, damage, deterioration, degradation, decay, and / or discontinuity. The modified stent includes one or more separate material portions and / or discontinuities in at least one ring, and / or at least one or more separate material portions and / or discontinuities in at least one coronal portion, and / or at least one or more separate material portions and / or discontinuities in at least one strut, and / or combinations thereof.In another example, the modified stent allows for further expansion of the lumen or vessel after implantation, and / or allows the stent to expand further to a larger configuration from its pre-modification configuration, and / or from a deployed configuration to a larger configuration, and / or from a "deployed-and-retracted" configuration to a larger configuration, and / or expand, and / or further expand to a larger configuration with respect to any prior cause in at least one ring of the stent prosthesis, and / or further expand to a larger configuration in at least one ring of the stent prosthesis, wherein the ring is located approximately at the midpoint of the stent length. In another example, after modification, at least one or more separate material portions (separation areas) and / or discontinuities of at least one ring of the stent allow the stent to expand and / or further expand at said at least one ring under physiological pressure. In another example, after deployment and / or modification, the stent prosthesis separates in at least one ring, coronal portion, and / or strut. In one example, after unfolding and / or modification and / or separation and / or material discontinuity, the stent prosthesis has a structure, and / or has a tubular structure, and / or has a tubular patterned structure, and / or has a substantially retained tubular structure, and / or has at least a partial structure, and / or has at least one window, and / or has substantially no structure, and / or includes at least one coronal structure, and / or includes at least one strut, and / or includes at least one link, and / or has strength, and / or combinations thereof.

[0203] In one example, means for holding materials together and / or holding separated areas and / or intermittently together and / or preventing the stent from separating before deployment include adhesives, metals, polymers, coatings, solders, press fits, welding, woven or braided materials, etc. In one example, said means decompose, degrade, corrode, unlock, and / or disassemble within a period of 1 month to 5 years, preferably 3 months to 3 years, more preferably 3 months to 1 year. In one example, the stent material degrades after said means have degraded and / or corroded and / or unlocked.

[0204] In another preferred example, the stent prosthesis includes a structure in which the structural separation region and / or discontinuity are located in a region that does not affect radial expansion and / or circumferential expansion, preferably in a low-stress region such as a strut or strut region.

[0205] In another example, the stent prosthesis is configured to have a patterned structure, wherein the structure has discontinuous separation regions on at least one strut and / or at least one coronal portion, such as keys and locks, adjoints, two plates, press fits, ratchet teeth, rivets, inserts, magnets, etc., such that upon deployment, and / or upon deployment and modification, the stent allows for further enlargement, and / or dilation, and / or separation of the lumen or vessel.

[0206] In another example, the stent prosthesis is configured to have a patterned structure comprising multiple rings, wherein in one example the rings are serpentine rings, wherein the rings comprise a coronal portion and struts, wherein at least one coronal portion and two struts are held in a coiled configuration by a coating and / or sleeve, wherein the unfolded and modified stent, including the degradation of the sleeves and / or coating, allows the stent to expand and / or further expand to a larger configuration, and / or allows for the expansion of the lumen or vessel.

[0207] In another example, the stent prosthesis is configured with a patterned structure comprising multiple rings, wherein in one example, the rings are serpentine rings, each ring comprising a coronal portion and a strut, wherein at least one coronal portion and / or at least one strut on at least one ring is configured to have a separation region and / or to separate at least one portion or region after deployment and under physiological conditions (such as after fatigue of said portion or region). The separated stent structure allows the stent to expand and / or further expand to a larger configuration, and / or allows for lumen or vessel dilation.

[0208] In another example, the stent prosthesis is configured with a patterned structure comprising multiple rings, wherein in one example, the rings are serpentine rings, each ring comprising a coronal portion and a strut, wherein at least one coronal portion and / or at least one strut on at least one ring is configured to separate at at least one portion or region after deployment and under physiological conditions (such as after fatigue of said portion or region). The separated stent structure allows the stent to expand and / or further expand to a larger configuration, and / or allows for dilation of the lumen or vessel.

[0209] In another example, the stent in any of the above examples is configured to expand further after implantation using an external energy source, which may include a magnetic field, infrared heat, induced heat, ultrasound, etc.

[0210] In another example of any of the above examples, the stent material constituting the stent structure is a shape memory material, wherein the stent can expand and / or further expand after deployment using a shape memory material such as a nickel-titanium alloy (NiTi, available under the trade name NiTiNO®), and wherein the shape memory material causes the stent to further expand to a larger configuration after deployment, wherein the stent undergoes modifications such as having a separation region, wherein the stent is separated or forms a discontinuity in at least a portion or region of the stent, and / or separated in at least one ring, wherein the separated stent structure slows further stent expansion and / or stops further stent expansion and / or stops damage or inflammation to the vessel wall.

[0211] In another example of any of the above examples, the stent material includes a material that has been modified or further softened under physiological conditions, such as a platinum alloy, wherein the softening of the material reduces stress on the vessel wall after deployment and potentially makes the compliance of the vessel and the stent closer than before the material was softened.

[0212] In a preferred example, the modified parts and / or stent structures and / or structural components separated from the stent are configured to have shapes and / or structures that prevent these parts or structural elements from shifting into the blood flow. Examples include 2D and / or 3D structures, stent windows, structures including partial stent windows, structures including at least one coronal shape, structures including at least one coronal shape and at least one link shape, structures including at least one coronal shape, at least two strut shapes and at least one link shape, and structures including at least one coronal shape and at least two strut shapes.

[0213] In another example, the stent prosthesis can unfold from a curled configuration to a larger expanded configuration under one or more unfolding conditions as in the previous example.

[0214] In another example, the stent can be deployed at a rate of 1-2 atm per second, and the stent can be deployed beyond the marked diameter (nominal diameter / expected deployed diameter) without breaking.

[0215] In a preferred example of a corrosive material such as magnesium, the stent is configured to have portions or areas in which the material does not degrade (corrode), and said portions or areas will not degrade, thereby providing stent portions or areas that do not enclose the lumen or blood vessel, which allow the lumen or blood vessel to expand due to the absence of byproducts from the magnesium stent in said portions, which would cause stent enclosure due to hydroxyapatite byproducts that enclose the blood vessel.

[0216] In one example, the stent, including the separation area or portion, may separate within a period of 1 day to 3 years after deployment, 1 month to 3 years after deployment, preferably 3 months to 1 year, and / or degrade, and / or corrode, and / or the stent may be partially discontinuous, and / or delocked.

[0217] In another example, for at least one ring, the number of separated and / or unlocked and / or degraded and / or corroded portions or regions in each at least one ring or at least some rings is 1 to 4, preferably 1 to 3, more preferably 1 to 2, wherein the stent has a structure after separation, and / or wherein the stent does not have a structure after separation, and / or wherein the stent has an unsupported structure or collapse in the absence of tissue, and / or wherein the stent retracts in the absence of tissue, and / or wherein the stent retracts or shrinks in the absence of tissue.

[0218] In another example, for at least one ring, the number of separated and / or unlocked and / or degraded and / or corroded portions of each at least one ring is 1 to 4, preferably 1 to 3, more preferably 1 to 2, wherein the stent has a structure after separation, the structure having sufficient strength to support the body cavity or having no strength, and / or wherein the stent does not have a structure after separation, and / or wherein the stent has an unsupported structure or collapse in the absence of tissue, and / or wherein the stent retracts in the absence of tissue, and / or wherein the stent contracts in the absence of tissue.

[0219] In another example, for at least one ring, the number of separated and / or unlocked and / or degraded and / or corroded portions of each at least one ring is 1 to 4, preferably 1 to 3, more preferably 1 to 2, wherein the stent has a structure after separation, the structure having sufficient strength to support the body cavity or having no strength, and / or wherein the stent does not have a structure after separation, and / or wherein the stent has an unsupported structure, collapses, in the absence of tissue, and / or wherein the stent retracts in the absence of tissue, and / or wherein the stent contracts in the absence of tissue.

[0220] In any of the foregoing examples, when the stent prosthesis includes reinforcing elements and / or non-degradable materials for stent strength, and / or when the weight of the remaining non-degradable material in the stent prosthesis is less than the weight of the stent prosthesis including both non-degradable and degradable materials, the lumen or vessel is opened and / or allowed to further expand or dilate. In a preferred example, the weight of the stent prosthesis after degradation (removal) of the degradable material (if present) is 0.1 mg / mm to 1.5 mg / mm, preferably 0.1 mg / mm to 1.2 mg / mm, more preferably 0.2 mg / mm to 0.9 mg / mm, and most preferably 0.2 mg / mm to 0.6 mg / mm. These weights do not include the weight of the non-degradable radiopaque markers.

[0221] In another example, after the formation of the discontinuity, or after the degradation of the biodegradable material (if present) to form the discontinuity, it is desirable that the compliance of the stent prosthesis (three-point bending test) be as compliant as possible to avoid potential irritation and inflammation to the vessel wall after implantation. For example, after the formation of the discontinuity, or after removal (or degradation of the biodegradable material), the compliance of the stent prosthesis is preferably 0 N / mm to 0.05 N / mm, more preferably 0 N / mm to 0.03 N / mm, and more preferably 0 N / mm to 0.1 N / mm. In another example, after the formation of the discontinuity in the deployed configuration, the stent compliance is improved (compared to before formation, or compared to when the stent is deployed) by at least 10%, or at least 25%, or at least 50%, or at least 75%. In another example, after the formation of the discontinuity, the compliance is improved (compared to before formation, or compared to when the stent is deployed) by 10% to 100%, preferably 20% to 75%. In another example, in a simulated bending test, the radial strain of the stent is 2% to 5% after the discontinuity is formed or after deployment (as described in Example 5, but not limited to Example 5). In another example, the radial strain (or compliance) of the stent is 2 to 10 times greater, preferably 2 to 5 times greater, than that of a stent without a discontinuity after the discontinuity is formed and / or after deployment (as described in Example 5, but not limited to Example 5).

[0222] In another example, the stent or other endovascular prosthesis is in an expanded configuration before unfolding from a coiled configuration, wherein the stent or other endovascular prosthesis has the strength to support the body cavity in the expanded configuration. In yet another example, the stent or other endovascular prosthesis is in an expanded configuration in the circumferential direction before implantation or unfolding.

[0223] In another example, the stent or other endovascular prosthesis is configured to expand upon deployment or post-implantation in a physiological environment, preferably configured to expand circumferentially through at least one or more gaps (discontinuities) having paths along at least some rings (preferably each ring) in the circumferential direction. Optionally, the stent may also disassemble along its longitudinal axis in various patterns along one or more paths (or lines) through the formed discontinuities, thereby separating the stent into one or more segments. In one example, the stent is not disassembled along its longitudinal axis, or is disassembled at at least a portion of the longitudinal axis of the stent.

[0224] In another example, the deployment of a stent or other endovascular prosthesis includes one or more of the following: dissection, at least one interruption, at least one fissure, or at least one gap of the stent in at least one region or portion of at least one ring; the ability of the stent to expand further after deployment; the ability of the lumen or vessel to actively remodel in the presence of a stent or reinforcing element or in the presence of a stent; the ability of the stent or other endovascular prosthesis to expand further after deployment without stent fissures, dissections, or interruptions; and the ability of the lumen or vessel to actively remodel in the presence of a stent or other endovascular prosthesis without interruptions, fissures, or dissections.

[0225] In one example, the endovascul...

Claims

1. An intracavitary prosthesis, comprising: A skeleton having a plurality of circumferential rings patterned from a non-degradable material, the skeleton being configured to expand from a coiled configuration to an expanded configuration, wherein attachment points on at least some adjacent circumferential rings are joined by circumferentially separable axial links. Wherein, at least some of the axial links include a first segment and a second segment, wherein the first segment and the second segment are separated by an axially extending dividing line, the first segment and the second segment are circumferentially interlocked to prevent circumferential separation when the skeleton is in the curled configuration, and the first segment and the second segment are configured to deform into circumferential unlocking when the skeleton is in the expanded configuration; and The circumferential ring separates at the attachment point, while each segment of the axial link remains attached to the attachment point after the segment is unlocked.

2. The intracavitary prosthesis of claim 1, wherein the circumferentially separable axial links extend between the crown portions on adjacent circumferential rings.

3. The intracavitary prosthesis of claim 1, wherein the circumferentially separable axial link extends between struts on adjacent circumferential rings.

4. The intracavitary prosthesis of claim 1, wherein the circumferentially separable axial link extends between a crown on one of the circumferential rings and a strut on an adjacent circumferential ring.

5. The intracavitary prosthesis of claim 1, wherein at least some of the axial links are arranged axially along the skeleton.

6. The intracavitary prosthesis of claim 1, wherein at least some of the axial links are arranged in a helical pattern along the skeleton.

7. The intracavitary prosthesis of claim 1, wherein at least some of the axial links are arranged along the skeleton in two lines.

8. The intracavitary prosthesis of claim 1, wherein at least some of the axial links are arranged along the skeleton in three lines.

9. An intracavitary prosthesis, comprising: A skeleton having a plurality of circumferential rings patterned from a non-degradable material, the skeleton being configured to expand from a coiled configuration to an expanded configuration, wherein at least some adjacent circumferential rings are joined by circumferentially separable axial links. The circumferentially separable axial link is divided into two parts along the axial engagement line, each part having one or more corresponding bends, curves, straight areas, angles, or any combination thereof, wherein the two parts are configured to assemble together during the expansion of the skeleton and to inhibit separation of the two parts, and the two parts are configured to separate along the axial engagement line after the skeleton has expanded in a physiological environment, thereby allowing the adjacent circumferential rings engaged by the separable axial link to open circumferentially, while the adjacent rings remain axially attached through the two parts.

10. An intracavitary prosthesis, comprising: A skeleton having multiple circumferential rings including struts and crowns, the rings being patterned from a non-degradable material, the skeleton being configured to expand from a coiled configuration to an expanded configuration. Among them, at least some circumferential rings include one or more segments of two aligned struts, each strut being engaged to an adjacent circumferential ring by a link or connector, the two aligned struts remaining together during the expansion of the skeleton but separating after the skeleton expands under physiological conditions.

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