Multi-directional hinged support

Abstract

The expandable multidirectional articulation stent is radially expanded from a compressed configuration to an expanded configuration. The stent includes an elongate connector and radially expandable rings (e.g., at least a first ring, a second ring, and a third ring) aligned in series along a common axis and defining a common lumen of the stent extending through the rings. The connector extends between the rings, the rings comprise a first group and a second group, the first group comprises a first elongated connector and a second elongated connector, and the second group comprises a third elongated connector and a fourth elongated connector. The first and second elongate connectors couple the first ring to the second ring to form a first hinge axis extending through the first and second connectors, the bracket being curved in a first direction about the first hinge axis, the second set comprises a third elongated connector and a fourth elongated connector, and the third elongated connector and the fourth elongated connector connect the second ring to the third ring to form a second hinge axis extending through the third connector and the fourth connector. The bracket is curved in a second direction about the second hinge axis. The first group is axially and circumferentially offset from the second group.

Description

Priority requirements

[0001] This disclosure claims priority to U.S. Provisional Patent Application Serial No. 63 / 512,877, filed July 10, 2023, the disclosure of which is incorporated herein by reference. Technical Field

[0002] This disclosure relates to expandable endoluminal devices for use within body channels or catheters, and more specifically, to implantable stents comprising one or more elongated connectors such that the implantable stent is configured to hinge in at least one or more selected directions with relatively reduced force. Background Technology

[0003] A common approach to treating narrowed or aneurysmed blood vessels or other blocked channels is the use of expandable prostheses, such as stents, configured to be deployed in an expandable configuration within the blood vessel or channel to maintain its openness or continuity. Stents can also be used as fixation devices to anchor medical devices within a blood vessel or channel. Stents can be bare, coated, or covered. Covers can be made of biocompatible materials such as polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePFTE). An example covered stainless steel stent is the iCAST / V12 balloon expandable stent manufactured by Atrium Medical Systems.

[0004] In many surgical procedures, stents are configured to be delivered to a target site, expand, and securely implanted. For example, in the endovascular repair of open-pore aneurysms (FEVAR) procedure, multiple stents can be placed within pre-formed openings or orifices in the main implant or end-effector to create a connection between the main implant and the target branch vessel or catheter. In vascular applications, one or more covered stents may protrude a few millimeters into the aortic main implant or end-effector. Once deployed and secured, one or more stents form a closed lumen space for blood to flow from the main implant or end-effector into the target vessel. Stents can also reinforce the vessel wall to maintain a patent lumen or access.

[0005] For certain target sites and surgical procedures, deployed stents need to be configured with bending, folding, articulation, or twisting to conform to the shape of a specific vessel, channel, or opening between adjacent vessels or channels. Importantly, the stent should be able to be configured with bending, folding, articulation, or twisting as needed without kinking or deforming to the point of restricting fluid flow through the stent lumen. In some cases, stents can be formed from flexible materials, allowing them to be easily bent into many desired configurations. However, stents formed from flexible materials may not be strong enough to reinforce the walls of the vessel or channel, or to resist collapse when exposed to normal anatomical forces. Therefore, stents formed partially or entirely from highly flexible materials may not maintain the openness or continuity of fluid flow through the channel or vessel when deployed at the target site, and may not be suitable for certain surgical procedures. For example, stents formed from flexible materials may have relatively low radial and / or axial stiffness.

[0006] Stents made of highly flexible materials may also be unsuitable for delivery using balloon catheters. Balloon-expandable stents are constructed to be rolled onto the balloon of a balloon catheter. During delivery, the balloon-expandable stent should provide sufficient retention to the catheter to prevent displacement before expansion at the target site. In particular, the balloon-expandable stent should demonstrate the ability to be accurately delivered and positioned without significant shortening or “watermelon seeding” should the stent accidentally slip from the proximal or distal end of the balloon. The stent should also be designed to have predictable recoil characteristics after deployment to maintain proper apposition. For example, a stent placed in a fenestration must be strong enough to resist migration of the associated endoplasm and not collapse due to shear forces. Stents made of highly flexible materials may not remain in place when rolled onto a balloon catheter or deployed within a fenestration.

[0007] Many different stent designs are known to those skilled in the art. Known stent designs may include combinations of different types of frame structures, such as helical coils, meshes, grids, or interconnected rings. Such frame structures may be made of, for example, stainless steel and / or cobalt-chromium. In a common design, a stent may comprise a series of cylindrical rings aligned in series along a central longitudinal axis or a common axis. These rings may be secured to each other by multiple elongated connectors, such as longitudinally extending struts. A stent formed by rings and elongated connectors may have sufficient radial strength to support the vessel wall but may not be flexible enough to be deployed in curved or bent configurations. There are also designs in which the connectors are attached by a compression fit, allowing the connectors more degrees of freedom of movement. In other examples, stent designs include drilling in the stent struts to make them more flexible. However, alternative stent designs are needed that are flexible enough to adopt certain curved, bent, articulated, or twisted configurations when needed, while maintaining sufficient rigidity to roll over into a balloon catheter, support or reinforce the vessel or channel, and resist migration from the target site or deployment location. Summary of the Invention

[0008] According to one aspect of this disclosure, an expandable multidirectional articulated support configured to radially expand from a compression configuration to an expansion configuration includes a plurality of radially expandable rings aligned in series along a common axis and defining a common lumen of the support extending through the plurality of rings. The plurality of rings includes at least a first ring, a second ring, and a third ring aligned in series. The support also includes a plurality of elongated connectors extending between the plurality of rings. Each connector includes a first set of at least two elongated connectors extending between the first and second rings, forming a first hinge axis, and the support is configured to bend about the first hinge axis in a first direction. The connectors also include a second set of at least two elongated connectors extending between the second and third rings, forming a second hinge axis, and the support is configured to bend about the second hinge axis in a second direction. The first set of elongated connectors is axially and circumferentially offset from the second set of elongated connectors.

[0009] According to another aspect of this disclosure, an expandable support configured to radially expand from a compression configuration to an expansion configuration includes a plurality of radially expandable rings aligned in series along a common axis and defining a common lumen of the support extending through the plurality of rings. The support also includes a plurality of elongated connectors extending between the plurality of rings, the plurality of elongated connectors including at least a first pair of elongated connectors extending between a particular ring and an adjacent ring, and a second pair of elongated connectors extending between the particular ring and the adjacent ring. Each pair of elongated connectors is spaced less than 90 degrees from each other around the perimeter of the support, and the first pair of elongated connectors and the second pair of elongated connectors are circumferentially spaced greater than 90 degrees.

[0010] Non-limiting illustrative examples of embodiments of this disclosure will now be described in the following numbered items: Item 1: An expandable multidirectional articulated bracket configured to radially expand from a compression configuration to an expansion configuration, the expandable bracket comprising: a plurality of radially expandable rings, the plurality of radially expandable rings being aligned in series along a common axis and defining a common lumen of the expandable bracket extending through the plurality of rings, wherein the plurality of rings includes at least a first ring, a second ring, and a third ring aligned in series; and a plurality of elongated connectors extending between the plurality of rings, including (i) a first group comprising a first elongated connector and a second elongated connector, the first connector and the second connector connecting the first ring. (ii) A second set of connectors including a third and a fourth elongated connectors, the second ring being connected to the third ring to form a first hinge axis extending through the first and second connectors, the expandable support being configured to bend about the first hinge axis in a first direction, and (ii) a second set of connectors including a third and a fourth elongated connectors, the third and fourth connectors connecting the second ring to the third ring to form a second hinge axis extending through the third and fourth connectors, the expandable support being configured to bend about the second hinge axis in a second direction, wherein the first set of elongated connectors is axially and circumferentially offset from the second set of elongated connectors.

[0011] Item 2: The expandable bracket according to Item 1, wherein the first set of elongated connectors is positioned such that the bending force required to bend the bracket a predetermined distance in a first direction at the first hinge axis is less than the bending force required to bend the bracket a predetermined distance in a second direction at the first hinge axis.

[0012] Item 3: The expandable bracket according to Item 1, wherein the second set of elongated connectors is positioned such that the bending force required to bend the bracket a predetermined distance in the second direction at the second hinge axis is less than the bending force required to bend the bracket a predetermined distance in the first direction at the second hinge axis.

[0013] Item 4: The expandable support as described in Item 1, wherein the first elongated connector and the second elongated connector are adjacent to each other and circumferentially spaced apart by at least 90 degrees around the perimeter of the support.

[0014] Item 5: The expandable support as described in Item 1, wherein the first set of elongated connectors is circumferentially offset between 60 and 90 degrees from the second set of elongated connectors around the perimeter of the support.

[0015] Item 6: The expandable support as described in Item 1, wherein the first elongated connector and the second elongated connector are circumferentially spaced apart from each other by less than 90 degrees around the perimeter of the support or circumferentially spaced apart from each other by at least 90 degrees around the perimeter of the support.

[0016] Item 7: An expandable support as described in Item 6, wherein the first set of elongated connectors includes a fifth elongated connector and a sixth elongated connector, the fifth elongated connector and the sixth elongated connector being circumferentially spaced from each other about a common axis of the support in a manner symmetrical with respect to the first elongated connector and the second elongated connector.

[0017] Item 8: The expandable support as described in Item 6, wherein the third elongated connector and the fourth elongated connector are either circumferentially spaced apart from each other by less than 90 degrees around the perimeter of the support or circumferentially spaced apart from each other by at least 90 degrees around the perimeter of the support.

[0018] Item 9: The expandable support as described in Item 1, wherein the plurality of elongated connectors include at least one of a curved portion, a bent portion, a straight portion, or a pigtail-shaped portion.

[0019] Item 10: The expandable stent as described in Item 1, wherein at least one of the plurality of rings or the plurality of elongated connectors comprises a biocompatible alloy, a biocompatible polymer, or a bioabsorbable material.

[0020] Item 11: The expandable support as described in Item 1, wherein at least one of the plurality of rings or the plurality of elongated connectors comprises stainless steel, cobalt-chromium alloy or nickel-titanium alloy.

[0021] Item 12: The expandable support as described in Item 1 further includes a cover over at least a portion of the plurality of rings, wherein the cover comprises polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE).

[0022] Item 13: The expandable support as described in Item 1, wherein each of the plurality of rings includes a plurality of linear segments connected end-to-end to form the peaks and valleys of the ring.

[0023] Item 14: An expandable support as described in Item 13, wherein at least one of the plurality of elongated connectors is connected to one of the plurality of rings at approximately the midpoint of the linear segment of the ring between the peak and the valley of the ring.

[0024] Item 15: An expandable support as described in Item 13, wherein the plurality of elongated connectors are arranged to form two axially extending helices passing through the plurality of rings, and wherein: the first elongated connector and the second elongated connector are circumferentially offset from the third elongated connector and the fourth elongated connector by at least one linear segment; and the connection points on the second ring for the first elongated connector and the second elongated connector are circumferentially offset from the connection points on the second ring for the third elongated connector and the fourth elongated connector extending to the third ring.

[0025] Item 16: An expandable support as described in Item 13, wherein at least one of the plurality of elongated connectors is connected to one of the plurality of rings at a point on the linear segment closer to the other of the peak or valley of the ring than to the peak or valley of the ring.

[0026] Item 17: An expandable support as described in Item 13, wherein at least one of the elongated connectors includes an inclined segment tilted relative to the common axis of the support, one end of the inclined segment connecting the elongated connector to the linear segment.

[0027] Item 18: An expandable support as described in Item 17, wherein each of the first elongated connector and the second elongated connector includes a first end connected to a linear segment of the linear section of the first ring and a second end connected to a linear segment of the linear section of the second ring, wherein the linear segment of the second ring is not axially aligned with the linear segment of the first ring to which the first end is attached.

[0028] Item 19: The expandable stent of Item 1 further includes at least one rigid segment, the rigid segment comprising: a plurality of radially expandable rings of the rigid segment, the radially expandable rings being aligned in series along the common axis and defining a portion of a common lumen of the stent; and a plurality of elongated connectors extending between the rings of the plurality of rings of the rigid segment, wherein at least three elongated connectors extend between each ring of the plurality of radially expandable rings of the rigid segment and an adjacent ring, each elongated connector being separated from each adjacent elongated connector by no more than 120 degrees.

[0029] Item 20: An expandable stent configured to radially expand from a compression configuration to an expansion configuration, the expandable stent comprising: a plurality of radially expandable rings, the plurality of radially expandable rings being aligned in series along a common axis and defining a common lumen of the expandable stent extending through the plurality of rings; and a plurality of elongated connectors extending between the plurality of rings, the plurality of elongated connectors comprising at least a first pair of elongated connectors extending between a first ring in the plurality of rings and a second ring in the plurality of rings adjacent to the first ring, and a second pair of elongated connectors extending between the first ring and the second ring, wherein each pair of elongated connectors is spaced apart from each other by less than 90 degrees around the perimeter of the expandable stent, and the first pair of elongated connectors and the second pair of elongated connectors are circumferentially spaced apart by more than 90 degrees.

[0030] These and other features and characteristics disclosed herein, as well as the methods of operation and function of related structural elements, and the economy of combination and manufacture of components, will become more apparent from consideration of the following description and appended claims with reference to the accompanying drawings, all of which form part of this specification, wherein the same reference numerals denote corresponding components in the various figures. However, it should be clearly understood that the drawings are for illustrative and descriptive purposes only and are not intended to be construed as limiting the scope of this disclosure or any invention. As used in the specification and claims, the singular forms “a,” “an,” and “the” include plural indicators unless the context clearly indicates otherwise. Attached Figure Description

[0031] Figure 1A This is a side view of a support in an expanded configuration according to one aspect of this disclosure; Figure 1B This is a two-dimensional plan view of a support including a flexible portion and a rigid portion, according to one aspect of this disclosure; Figure 1C This is a side view of a covered support in a compressed configuration according to one aspect of this disclosure; Figure 1D This is a side view of a support in a compressed configuration according to one aspect of this disclosure; Figure 1E yes Figure 1D A side view of the front semicircular portion of the bracket (where the rear semicircular portion of the bracket has been removed for clarity). Figure 1F yes Figure 1D The bracket passes through the cross-section of the connector.

[0032] Figure 2A This is a plan view of the flexible portion of the support according to one aspect of this disclosure; Figure 2B This compares the bending response of a conventional stent (in this case, the iCAST / V12 stent design, sold by Atrium Medical Corporation) with... Figure 1B A graph showing the bending response of the flexible portion of the support in its expanded configuration; Figure 3 According to one aspect of this disclosure, bending about the hinge axis is included. Figure 1B Side view of the flexible part of the support; Figure 4A This is a plan view of another flexible portion of the support according to one aspect of this disclosure; Figure 4B It compares the bending response of conventional stents with Figure 4A A graph showing the bending response of the flexible portion of the support in its expanded configuration; Figure 5 This is a plan view of another flexible portion of the support according to one aspect of this disclosure; Figure 6 This is a plan view of another flexible portion of the support according to one aspect of this disclosure; Figure 7 This is a plan view of another flexible portion of the support according to one aspect of this disclosure; Figure 8A This is a plan view of another flexible portion of the support according to one aspect of this disclosure; Figure 8B It compares the bending response of conventional stents with Figure 8A A graph showing the bending response of the flexible portion of the support in its expanded configuration; Figure 9 This is a plan view of another flexible portion of the support according to one aspect of this disclosure; Figure 10A-10D This is a plan view of different elongated connectors extending between the expandable rings of the support, according to various aspects of this disclosure; Figure 11A-11D This is a plan view of an additional embodiment of an elongated connector extending between expandable rings of a support, according to one aspect of this disclosure; Figure 12 This is a plan view of an expandable ring of a support structure connected together by struts according to one aspect of this disclosure; Figure 13 This is a plan view of the expandable rings of the supports directly connected together according to one aspect of the invention; Figure 14 This is a flowchart illustrating a method for deploying a support according to one aspect of this disclosure; Figure 15A It is a computer-generated representation of a conventional support bending during a cantilever test; Figure 15B It is a computer-generated representation showing the flexible portion of a support, including the features of this disclosure, bending during a cantilever test; Figures 16A-16E The photograph shows a prototype support including the features of this disclosure, which is bent or twisted to demonstrate the enhanced flexibility provided by the support design disclosed herein. Figure 17 This is a plan view of another flexible portion of the support according to one aspect of this disclosure; Figure 18 This is a plan view of another flexible portion of the support according to one aspect of this disclosure; Figure 19 This is a plan view of another flexible portion of the support according to one aspect of this disclosure; and Figure 20 The image is a cross-sectional front view of a support according to one aspect of this disclosure, showing the support in an initial or 0-degree position, a 90-degree position, a 180-degree position, a 270-degree position, and a 360-degree position. Detailed Implementation

[0033] These illustrations generally depict illustrative and non-limiting aspects of the apparatuses, components, and methods of this disclosure. While these descriptions present various aspects of these apparatuses and components, they should not be construed as limiting this disclosure in any way. Furthermore, those skilled in the art should understand that modifications, concepts, and applications of aspects of this disclosure are to be included, but not limited to, the descriptions and illustrations herein.

[0034] Furthermore, for the purposes described below, the terms “end,” “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” “radial,” and their derivatives will refer to this disclosure as oriented as they are in the accompanying drawings. The term “proximal” refers to an end of a device configured for user manipulation, or, for an implanted device, the side or end of the device being closest to the implantation site during deployment. The term “distal” refers to the end of the device opposite the proximal end, which may be the end of the device furthest from the part intended for user manipulation. For an implanted device, the “distal” end of the device is the end of the device furthest from the implantation site. However, it should be understood that this disclosure may take various alternative variations and sequences of steps unless expressly specified to the contrary. It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following description are merely exemplary aspects of this disclosure. Therefore, specific dimensions and other physical characteristics associated with the aspects disclosed herein should not be considered limiting. To facilitate understanding of this disclosure, the accompanying drawings and description illustrate its preferred aspects, from which various aspects of this disclosure, its structure, construction and operation, as well as its many advantages, can be understood and appreciated.

[0035] For the purposes of this disclosure, the term “about” refers to a range of ±10% of the stated value.

[0036] Referring to the accompanying drawings, this disclosure relates to an expandable stent 10 having a multidirectional articulation mechanism that allows the stent 10 to be articulated, bent, or flexed in multiple directions and / or allows different portions of the stent 10 to be articulated, bent, or flexed in multiple directions. As is common with expandable stents known in the art, the stent 10 of this disclosure can be radially expanded using, for example, an expandable catheter (such as an extension or balloon catheter). While expandable stents 10 are commonly used in endovascular procedures such as fenestrated endovascular aortic repair (FEVAR), branch endovascular aortic repair (BEVAR), chimney endovascular aortic repair (ChEVAR), peripheral, coronary, biliary, or other stent procedures, it should be understood that the arrangement of the stent 10 disclosed herein is not limited to use with endovascular procedures. For example, the stent designs disclosed herein can be adapted to any number of medical applications and procedures in which the stent structure can be used to maintain fluid flow through a body lumen and / or to position a medical device within a body lumen. For example, medical devices including implantable grafts, drug delivery devices, filters, shunts, and similar medical devices can all be modified to include the arrangement of expandable rings, elongated connectors, and / or struts of this disclosure. Furthermore, the stent designs of this disclosure can be deployed in structures other than blood vessels, such as the small intestine, large intestine, bile duct, or any other anatomical location.

[0037] like Figure 1A-1FAs shown, the stent 10 of this disclosure may include a tubular structure that may be coated, covered, partially covered, fully encapsulated, partially encapsulated, or uncovered. In some examples, the members, teeth, rings, and / or struts of the flexible portion 12 and / or rigid portion 14 of the stent 10 may be cut from a continuous tube by an automated cutting process (e.g., laser cutting). In some cases, portions of the stent 10 may also be formed by joining individual elongated members together and / or attaching them to other elements of the stent 10 to form a tubular structure. For example, elongated members may be joined together or attached to other elements of the stent 10 by ultrasonic welding, laser welding, or other suitable joining processes. Furthermore, multiple teeth or elongated members of the stent 10 may be woven together to form portions of the stent 10. The dimensions of the stent 10 (such as the longitudinal length L1 of the stent 10) are... Figure 1A (shown in the figure), the length L2 of the flexible portion 12, the length L3 of the rigid portion 14 of the bracket 10, and the compression diameter D2 of the bracket 10 (in the figure). Figure 1D and 1E (as shown in the diagram), the expansion diameter D1 of the support 10 (in Figure 1A (as shown in the figure) can be selected based on various considerations including, but not limited to, the intended deployment location of the support 10, the intended delivery components and technologies and / or the intended usage.

[0038] As described in detail herein, the articulation mechanism of this disclosure refers to a portion of the support 10 having reduced bending or flexural stiffness in a selected direction compared to other portions of the support 10 and / or compared to conventional support designs, while maintaining sufficient radial and axial stiffness (e.g., fracture strength) to meet its intended purpose. Reduced bending stiffness can involve a reduction in the force required to bend, fold, or articulate the support 10 in a given direction. It should be noted that those skilled in the art will understand the types of motion between bending, folding, and articulation, making these terms interchangeable herein. Reduced bending stiffness can be relative to a variety of aspects, such as those just mentioned. For example, for bending in a selected direction, the support 10 can have portions designed to have reduced bending stiffness such that the support 10 can bend at these portions in a selected direction (e.g., about the bending axis of two radially connected connectors 16 passing through adjacent tubular segments connecting the support 10) with reduced force, wherein the adjacent tubular segments are separated from each other by a gap circumferentially offset by 90 degrees from the bending axis, as in other portions requiring greater force. In another aspect, reduced bending stiffness can be relative to the perimeter of the support 10. For example, within a selected perimeter, the stent 10 may have reduced bending stiffness in one bending direction than in another. As will be described in further detail below, reduced bending stiffness can be achieved by creating a hinge axis, which reduces the force required to hinge the stent 10 about the hinge axis compared to hinged on a different axis than the hinge axis described herein. When the stent 10 is deployed in a body lumen and exposed to normal bodily forces at the deployment location, the stents 10 disclosed herein are configured to have sufficient radial stiffness to maintain the patency of the body passage or blood vessel. Each stent 10 disclosed herein is also configured to have sufficient axial stiffness to substantially maintain the length of the stent 10 during manufacturing (e.g., easier processing to manufacture stents with increased success rates), during delivery (e.g., increased fracture strength to accommodate forces encountered during delivery to the target site), and / or during deployment (e.g., lower and more predictable shortening).

[0039] As used herein, and interchangeably, "bending stiffness" or "flexural stiffness" refers to the resistance of a structural member to flexure, such as flexure that occurs when a load is applied at the free end of a structural member in a direction perpendicular to the axial direction, as in a tip-loaded cantilever beam. A bracket 10 with high bending stiffness requires a greater force to displace one end of the bracket 10 a specified distance compared to a more flexurally compliant bracket 10. The bending stiffness of slender members such as beams or brackets can be measured by a cantilever bending test. Those skilled in the art will recognize that a bracket with high bending stiffness is more likely to kink when forced to bend compared to a more flexurally compliant bracket. The force applied to the bracket 10 that causes it to bend can depend on a variety of factors. For example, as those skilled in the art of bracket manufacturing will understand, the material of the bracket 10 or its components can contribute to bending stiffness, and subsequently to the force required to bend the bracket 10. As will be described in further detail below, the configuration of the components of the bracket 10 can also contribute to bending stiffness, particularly when said configuration allows for a relatively reduced force to bend the bracket 10.

[0040] Conversely, "radial stiffness" refers to the resistance to deformation when a radially inward force is applied to the sidewall of the stent 10. When a radially inward force (e.g., a radially inward force from a constricting or collapsing channel or blood vessel) is applied to the sidewall of the stent 10, a stent 10 with low radial stiffness can deform, compress, or collapse. The stent 10 of this disclosure is configured to have sufficient radial stiffness to prevent radial collapse or radial compression when the body channel in which the stent is deployed contracts around the stent 10, thereby maintaining fluid flow through the lumen of the stent 10. The radial forces that the stent 10 may experience during normal use can be determined by those skilled in the art of stent manufacturing and will vary based on the intended deployment location and / or the use of the stent 10. Therefore, based on the principles of this disclosure, those skilled in the art can modify the geometry, materials, and other characteristics of the stent 10 disclosed herein to obtain sufficient radial stiffness so that the stent 10 meets its intended purpose.

[0041] As used herein, "axial stiffness" refers to resistance to compression or tension along a given axis. In a particular manner, the axial stiffness along the primary longitudinal axis of the stents 10, 110 (e.g., the central axis of the lumen of the stent 10) can be referred to as fracture strength, particularly with respect to resistance to compression along the primary longitudinal axis. The stents 10, 110 of this disclosure are constructed to have sufficient axial stiffness or fracture strength to prevent significant changes in the overall length of the stents 10, 110 during the aforementioned stages. The axial forces that the stents 10, 110 may experience during normal use can be determined by those skilled in the art of stent manufacturing and will vary based on the intended deployment location and / or use of the stents 10, 110. Therefore, based on the principles of this disclosure, those skilled in the art can modify the geometry, materials, and other characteristics of the stents 10, 110 disclosed herein to obtain sufficient axial stiffness or fracture strength so that the stents 10, 110 meet their intended purpose.

[0042] In some examples, the support 10 of this disclosure includes multiple hinge mechanisms, such as hinge mechanisms between different rings of the support 10, which allow the support 10 to hinge, flex, or bend in different directions with relatively reduced forces.

[0043] As will be described in further detail below, the articulation mechanism may correspond to a hinge axis passing through the support 10 based on the articulation mechanism being positioned circumferentially and / or longitudinally along the support 10. Including multiple articulation mechanisms or sections provides a support 10 with multi-directional articulation capability, meaning that different sections of the support 10 are configured to bend more easily in different selected directions, allowing the support 10 to be deployed in various positions and configurations. Therefore, the support 10 can be configured to adopt a non-linear shape, for example, when deployed at a target location where the support 10 needs to adapt to a bending, folding, or articulating configuration. As used herein, "more easily bent" means that the bending force required to bend or articulate the support 10 a predetermined distance in one direction is less than the bending force required to bend or articulate the support 10 in another direction. That is, the support 10 can bend more easily due to the relatively reduced force. Therefore, for a support 10 with multiple articulation mechanisms, the support 10 is more easily bent in multiple directions. In particular, the multi-directional articulation mechanism allows the support 10 to bend or flex in multiple directions without kinking, thereby preventing restriction of fluid flow through the lumen of the support 10. By avoiding or resisting kinking, the stent 10 can be deployed in various or multiple bending or folding configurations without restricting fluid flow through the stent 10 or reducing the stent 10's ability to keep the blood vessel open.

[0044] To provide radial stiffness, axial stiffness, and kink resistance, the bracket 10 disclosed herein includes various geometric arrangements of expandable rings 18, elongated connectors 16, and / or struts, said geometric arrangements being positioned to provide adequate support for the rings 18 to prevent the bracket 10 from collapsing (e.g., maintaining radial and axial integrity), while allowing easy bending in selected directions or multiple directions (e.g., maintaining flexibility). The hinge points of the bracket 10 can be selectively positioned for different rings 18 (e.g., by circumferentially offsetting the rings 18), resulting in a multi-directional hinged bracket 10 that provides enhanced bracket flexibility in multiple directions or in any desired direction, and, compared to conventional bracket designs, reduces the bending stiffness of the bracket 10 in these multiple directions, and allows the bracket 10 to hinge or bend in all directions, as each direction can be achieved through the corresponding positioning of the elongated connectors 16 around the rings 18. Furthermore, the bracket 10 disclosed herein is configured to provide predictable recoil characteristics after deployment, thereby maintaining appropriate wall attachment capability. In particular, the stent 10 of this disclosure placed in the fenestration should be strong enough to resist the migration of the associated endoplasmic implant and should not collapse due to shear forces.

[0045] The stent 10, including the multi-directional articulation mechanism disclosed herein, can also be configured to address certain difficulties encountered during conventional stent delivery. As previously mentioned, balloon-expandable stents are typically delivered using a balloon catheter, with the stent 10 coiled onto the catheter. During delivery, the stent 10 should be configured to maintain adequate stent retention on the catheter to prevent displacement during placement. Furthermore, the balloon-expandable stent 10 should be configured to be precisely delivered and positioned without significant shortening. The stent 10 of this disclosure is configured to bend or flex in multiple directions, allowing it to be easily and tightly coiled onto the balloon-expandable catheter, reducing the likelihood of the stent 10 being dislodged or slipping off the catheter during placement.

[0046] Figure 1A-1F An exemplary, non-limiting expandable support 10 is shown, which is provided with a multi-directional hinge mechanism according to the present disclosure. The support 10 is configured to retract radially or compress into a configuration (e.g., Figure 1D and 1E Radial expansion to radial expansion configuration (e.g., Figure 1AThe support 10 includes a first or proximal end 2 and a second or distal end 4. The support 10 may include one or more flexible segments or flexible portions 12 configured to be hinged about a hinge axis at predetermined locations. As used herein, a “flexible portion” may refer to a portion of the support 10 having a configuration that allows multidirectional hinged connections between selected rings 18, such that the support 10 is more easily bent in the selected directions than a configuration without the present disclosure. In contrast, conventional supports previously described are typically flexurally rigid (e.g., having high bending stiffness) and resistant to bending in any direction and / or require substantially equal forces to bend in any direction, where such forces are greater than the forces that the support 10 might require to bend about the hinge axis. According to the present disclosure, the flexible portions 12 may be arranged such that different portions or segments of the support 10 are more easily bent in different directions, resulting in the multidirectional hinged support of the present disclosure that is easily bent in multiple directions. That is, the stent 10 can be configured with a stent design such that the flexible portion 12 bends in a predetermined direction at a predetermined location along the stent 10, and bends in one or more directions due to the reduced force required for the stent 10 to bend in the predetermined direction at the predetermined location and in one or more directions. Multi-directional articulation allows the stent 10 to be deployed in a wide range of locations and configurations, such as conforming to the geometry of a portion of the body lumen in which the stent 10 will be deployed. Upon deployment, the stent 10 is configured to maintain the desired radial structure by providing radial stiffness, such that fluid flow through the lumen of the stent 10 is unimpeded when the stent 10 is exposed to normal body forces at the deployment location. As previously stated, “radial stiffness” refers to resistance to radial deformation. A stent 10 with adequate radial stiffness is able to resist collapse and / or maintain its shape and cross-sectional area, even when external forces (e.g., forces generated by a restricted or collapsed blood vessel or artery) contract around the stent 10. In particular, the stent 10 disclosed herein should be robust enough that fluid flow through the lumen of the stent 10 will not be significantly reduced or blocked even when the body channel or blood vessel in which the stent 10 is deployed begins to contract or collapse, such as when intimal hyperplasia and / or connective tissue remodeling and / or inflammatory cell infiltration may occur after stent placement.

[0047] The support 10 may also include one or more rigid segments or rigid portions 14 (such as...) Figure 1BAs shown), it is connected to and axially aligned with the flexible portion 12. As used herein, a “rigid portion” of the support 10 refers to a part of the support 10 having a configuration selected to resist bending in many directions, and / or refers to a portion or section of the support 10 where similar forces are required to bend the support 10 in different directions. A rigid portion may generally correspond to the rigid design of a conventional support with rings and connectors, where the rigid design extends throughout the conventional support. Instead, the support 10 may selectively incorporate one or more rigid portions 14 throughout the support to prevent or reduce bending at these sections of the support 10. Figure 1B A non-limiting example of a bracket 10 including a flexible portion 12 and a rigid portion 14 is shown. The flexible portion 12 includes a plurality of axial or elongated connectors 16 or struts arranged to resist bending. For example, the rigid portion 14 may include a greater number of elongated connectors 16 relative to a segment of the flexible portion 12. Conversely, as will be described in further detail below, the flexible portion 12 includes fewer elongated connectors 16 arranged to resist bending in one or more first directions by requiring a greater force (e.g., a force similar to that of the rigid portion 14) before bending occurs, while allowing bending in one or more second directions other than the first directions when a reduced force is applied relative to the force required to bend the flexible portion 12 in the first directions.

[0048] The flexible portion 12 and rigid portion 14 of the scaffold 10 are typically formed of the same material. For example, the flexible portion 12 and rigid portion 14 may comprise members, teeth, rings, and / or struts formed of a suitable metallic material (e.g., stainless steel or cobalt-chromium alloy). The flexible portion 12 and / or rigid portion 14 may also comprise biocompatible polymers, absorbable polymers, bioabsorbable materials, and / or other biomaterials known in the art. Portions 12, 14 of the scaffold 10 may also be formed of a hyperelastic material. An exemplary hyperelastic material commonly used in the scaffold field is a nickel-titanium alloy (e.g., NITINOL). As known in the art, NITINOL also has shape memory properties, which allow a memorized shape to be imprinted on a structure containing NITINOL, such that when the material is activated (e.g., by being heated to a specific temperature (e.g., body temperature)), these structures will return to the memorized shape or configuration. However, the present invention does not require shape memory properties. Instead, NITINOL and similar materials may also be used with the scaffold 10 disclosed herein to utilize the hyperelasticity and enhanced flexibility of these materials, which may be beneficial for certain uses of the scaffold 10 disclosed herein. As described above, the material used for the elongated connector 16 can limit the force required to bend the bracket 10 in a given direction, and this force can vary based on the bending direction.

[0049] In many cases, the flexible portion 12 and rigid portion 14 of the stent 10 are formed by laser cutting a selected geometric pattern from a single tubular structure. In this case, the flexible portion 12 and rigid portion 14 of the stent 10 are integrally formed and differ only in the orientation of the elongated connector 16 and other geometric features of the stent 10. In other examples, the flexible portion 12 and rigid portion 14 may be formed as separate structures, joined together using, for example, ultrasonic welding, adhesives, stitching, or other commonly used joining techniques, as known in the field of stent manufacturing.

[0050] Continue to refer to Figure 1A-1F In a non-limiting embodiment of the invention shown, the support 10 may include a plurality of radially expandable rings 18 aligned in series along a common axis X1 to define a common lumen 20 of the support 10 extending through the rings 18. Within the support 10, the flexible portion 12 and the rigid portion 14 may include the rings 18. The rings 18 may be circular, defining a cylindrical shape for the lumen 20. In other examples, one or more rings 18 may be shaped as elliptical, triangular, square, rectangular, polygonal, or any other convenient regular or irregular shape, such that the lumen 20 has a corresponding cross-sectional shape along the axis X1. The rings 18 may be a completely annular member that completely surrounds the lumen 20 of the support 10, or may include gaps or openings located at one or more locations around the perimeter of the rings 18. The gaps or openings of the plurality of rings 18 of the support 10 may be aligned along the length axial direction of the support 10 or may be offset from each other.

[0051] In some examples, ring 18 includes multiple segments 22 connected end-to-end to form a generally repeating pattern of peaks 24 and valleys 26 of ring 18. Segments 22 can be linear, arcuate, serpentine, or other configurations. As used herein, “generally repeating” segments 22 can refer to repeating units, but can accommodate minor interruptions in the repeating pattern. Minor interruptions in the repeating pattern can be, for example, changes or substitutions to the repeating segments 22 of ring 18 that do not affect the expansion of ring 18. For example, some segments 22 can be formed by curved portions (e.g., instead of connected straight segments). Furthermore, some segments 22 can be longer or shorter than other segments 22 of ring 18. Therefore, Figure 1A-1F The arrangement of segments 22 of the ring 18 shown is not intended to be limited to a strict and precise repeating pattern of segments 22. For example, a ring 18 that includes repeating segments 22 but has one or more minor breaks in the repeating pattern is considered to be within the scope of this disclosure.

[0052] Figure 1A-1FEach ring 18 comprises sixteen segments 22, each ring 18 defining eight peaks 24 and eight valleys 26. However, the number of segments 22, peaks 24, and valleys 26 is not intended to be limiting, and a ring 18 may have any number of segments 22 within the scope of this disclosure (e.g., fewer than sixteen or more than sixteen segments 22). Furthermore, in some examples, different rings 18 of the support 10 may include different numbers of segments 22. For example, a ring 18 near the middle of the support 10 may include sixteen segments 22, while a ring 18 near the ends 2, 4 of the support 10 may include more segments (e.g., up to twenty or more segments 22 per ring 18). Although the rings 18 may be provided in various configurations and orientations, for simplicity, as used herein, the peaks 24 of a ring 18 refer to the portion of the ring 18 closer to the proximal end 2 of the support 10. The valleys 26 refer to the portion of the ring 18 closer to the distal end 4 of the support 10. When the support 10 is in a radially compressed (e.g., coiled) configuration ( Figure 1D and 1E The ring 18 is radially compressed, meaning that the diameter D2 of the ring 18 is relatively small, and the amplitude of the ring 18 (e.g., the axial distance between the peaks 24 and valleys 26 of the ring 18) is relatively large compared to the radially expanded configuration. For example, the diameter D2 of the support 10 in the compressed state can be from about 1.5 mm to about 4.0 mm. The amplitude of the ring 18 in the compressed state can be from about 2 mm to about 4 mm. When the support 10 transitions from a radially compressed state to a radially expanded state (e.g., ... Figure 1A As shown, when the stent 10 expands, the diameter D1 of the ring 18 increases, while the amplitude between the peak 24 and the valley 26 of the ring 18 decreases. For example, when the stent 10 expands, the diameter D1 of the ring 18 of the stent 10 can increase by 2.0 mm, 4.0 mm, 8.0 mm or more. For example, the amplitude of the ring 18 in the expanded state can be from about 1.0 mm to about 4.0 mm.

[0053] The ring 18 of the support 10 can be arranged in various configurations, as known in the art. In some examples, such as Figure 1A-1F As shown, rings 18 are arranged in a "peak-valley" configuration, wherein the peak 24 of the first ring 18 is axially aligned or substantially aligned with the valley 26 of the second ring 18 immediately adjacent to the first ring 18. As used herein, the first ring is "immediately adjacent" to the second ring when there are no other rings between the first and second rings. It should be understood that other structural elements (e.g., elongated connectors, struts, portions of coverings) may exist between the first and second rings. As used herein, "axial alignment" means that points on the different rings 18 of the bracket 10 are collinear (i.e., on the same line) along a line parallel to the common axis X1 of the bracket 10.

[0054] In other examples, rings 18 can be arranged in a "peak-to-peak" configuration, where the peaks 24 of a particular ring 18 are axially aligned with the peaks 24 of the adjacent ring 18. Therefore, compared to a "peak-valley" configuration, a "peak-to-peak" configuration allows rings 18 to be arranged such that lines can pass through the peaks 24 of a series of rings 18 parallel to axis X1. Lines passing through the valleys 26 of the series of rings 18 are also parallel to axis X1. In other examples, the peaks 24 and valleys 26 of a particular ring 18 (or rings thereof) can be circumferentially offset (e.g., misaligned) from the peaks 24 and valleys 26 of the adjacent rings 18, such that a particular ring 18 is referred to as offset from the adjacent ring 18 (e.g., in an offset configuration). In some examples, all rings 18 of the support 10 can be arranged in the same orientation (e.g., all rings 18 are peak-to-peak or all rings 18 are peak-valley). In other examples, the support 10 may include some portions or segments of a ring 18 having a peak-to-peak arrangement, other portions or segments of a ring 18 having a peak-to-valley arrangement, other portions or segments of a ring 18 having circumferentially offset (e.g., not circumferentially aligned) from the peaks and valleys of the adjacent ring, or any combination thereof.

[0055] In some examples, the stent 10 is a covered stent. For example, all or part of the stent 10 may be covered by a cover 42. Exemplary covered stents 10 incorporating the features of this disclosure are... Figure 1C It is shown in a compressed configuration. For example... Figure 1CAs shown, the cover 42 surrounds the entire flexible portion 12 of the stent 10. In some examples, the cover 42 may cover both the flexible portion 12 and the rigid portion 14 of the stent 10 (if present). In other examples, only some segments or portions of the stent 10 may be covered, while other segments or portions of the stent 10 are exposed. For example, only the rigid portion 14 of the stent 10 may be covered by the cover 42, while the flexible portion 12 is exposed, and vice versa. In other examples, the cover 42 may partially surround both the flexible portion 12 and the rigid portion 14 of the stent 10, while segments or portions near the ends 2, 4 of the stent 10 are exposed. The cover 42 may be formed of a sheet or membrane, for example, a biocompatible material. The sheet or membrane may be configured to protect the vessel wall defining a body passage or blood vessel from the edges of the ring 18 and other elements of the stent 10. In some examples, the cover 42 may be formed of a low-friction material configured to protect the stent 10 and reduce or prevent biomaterial adhesion to portions of the stent 10. For example, the cover 42 may be formed of a low-friction and / or hygroscopic material, such as expanded polytetrafluoroethylene (ePTFE). In some examples, the material of the cover 42 is elastic and capable of stretching without breaking when the stent 10 expands. However, the elasticity of the material of the cover 42 should not be so strong as to cause the stent 10 to contract back to a compressed state from an expanded state. In some examples, the cover 42 may be designed to perform auxiliary functions, such as providing hemostasis. Furthermore, the cover 42, ring 18, and / or elongated connector 16 of the stent 10 may be coated, covered, and / or impregnated with a therapeutic agent (e.g., heparin).

[0056] The determination of whether ring 18 is peak-to-peak, peak-to-valley, or offset is generally based on whether the support 10 is covered or exposed, and if covered, based on the material properties of the cover 42. Specifically, since the peak 24 of a ring 18 tends to rotate away from the valley 26 immediately adjacent to the ring 18 when the support 10 expands, a support 10 with rings 18 arranged peak-to-valley can cause the cover 42 to stretch when the ring 18 expands and rotates or twists. This movement of the peaks 24 and valleys 26 is acceptable if the support 10 is exposed or if the cover material is flexible or elastic. However, for a support 10 comprising a cover 42 formed of a rigid material that is not easily stretched, rotation of the peaks 24 away from the valleys 26 can cause the cover 42 to tear. In this case, using rings 18 arranged in a peak-to-peak or offset configuration can extend the service life of the support 10.

[0057] The flexible portion 12 and rigid portion 14 of the support 10 also include elongated struts or connectors 16 extending between the rings 18. For example... Figure 1BAs shown, the elongated connector 16 may include a proximal or first end 28 connected at a connection point to one of the rings 18 and a second end 30 immediately adjacent to the ring 18 at another connection point. The elongated connector 16 may include one or more straight segments, such as straight segment 32. In some examples, the elongated connector 16 may also include bent portions, folded portions, pigtail portions, or combinations thereof, configured to bend or unfold as the support 10 transitions between a compressed state and an expanded state. For example, as... Figure 1B As shown, the elongated connector 16 may include bent portions 34 near the ends 28, 30 of the elongated connector 16. Straight sections 32 are disposed between the bent portions 34 of the elongated connector 16. (As shown in the bracket 10...) Figure 1B As shown, elongated connectors 16 can have different shapes. In a first type of elongated connector 16, the bent portion 34 extends from the end of the straight section 32 in the same direction, forming a generally C-shape or a reverse C-shape. In a second type of elongated connector 16, the bent portion 34 extends from the end of the straight section 32 in the opposite direction, thus forming a generally S-shape or a reverse S-shape. Moreover, although in Figure 1B Not shown, but some or all of the elongated connectors 16 may be branched, connecting to a particular ring 18 at two or more different connection points. The elongated connectors 16 of the flexible portion 12 or rigid portion 14 of the support 10 may generally be identical, or may have different shapes or widths to give the support 10 different structural features. For example, narrower elongated connectors 16 (e.g., connectors 16 with smaller widths) may be used in areas of the support 10 intended to be more flexible. Wider elongated connectors 16 may be used in areas of the support 10 intended to be more rigid. In some examples, the width of the elongated connectors 16 extending between the ring 18 and immediately adjacent to the ring 18 may differ. For example, the elongated connectors 16 at the 0-degree and 180-degree positions around the ring 18 may be wider, while the elongated connectors 16 at the 90-degree and 270-degree positions of the ring 18 may be narrower, resulting in the support 10 being less rigid at the 90-degree and 270-degree positions than at the 0-degree and 180-degree positions.

[0058] In some examples, the ends 28, 30 of the elongated connector 16 are connected to the linear segments 22 of the ring 18 near the midpoint of these linear segments 22 (e.g., at approximately equal distances between the peaks 24 and adjacent valleys 26 of the ring 18). In other examples, the elongated connector 16 may be connected to the ring 18 closer to the peaks 24 or valleys 26 of the ring 18. For example, as Figure 11A-11D As shown, the first end 28 of the elongated connector 16 can be connected near the peak 24 of the ring 18, and the second end 30 of the elongated connector 16 can be connected to the valley 26 adjacent to the ring 18.

[0059] The number and position of the elongated connectors 16 generally affect the bending (i.e., flexural) stiffness of the bracket 10 or bracket segment, and in particular, affect the direction of bending force by reducing the bending stiffness of the bracket 10 or bracket segment. That is, a smaller bending force is generally required to bend the bracket 10 about a hinge axis H perpendicular to the gap axis G, which passes through the portion of the flexible portion 12 excluding the elongated connectors 16. Specifically, for the flexible portion 12 including the first and second elongated connectors 16 located at 0 degrees and 180 degrees, the flexible portion 12 will bend more easily about the axis H extending along the diameter of the bracket 10, such that the bracket 10 deforms most along the axis G through the gap between adjacent rings 18 offset from the hinge axis H by 90 (or 270) degrees. For example, as Figure 1B As shown in the flexible portion 12, to provide appropriate bending stiffness that allows the bracket 10 to bend in a predetermined direction when a reduced force is applied, the elongated connectors 16 extending between a specific ring 18 and an adjacent ring 18 can be spaced approximately 180 degrees around the perimeter of the bracket 10. However, it should be understood that for a bracket 10 comprising a pair of connectors 16 forming a hinge point, the elongated connectors 16 can be spaced less precisely by 180 degrees because the hinge point is located between the elongated connectors 16 of the specific pair. Furthermore, as those skilled in the art will understand, when adjacent tubular segments of the bracket 10 are connected by only two connectors 16, a hinge axis can be formed through these two connectors 16 even if the two connectors 16 are not radially opposite. This will result in a larger gap on one side of a pair of connectors 16 and a smaller gap on the opposite side of the connectors 16, thereby creating a preferred bending direction, wherein the bracket 10 bends more easily around the hinge axis when the larger gap is located at the inner diameter of the bending bracket 10 compared to when the smaller gap is located at the inner diameter of the bending bracket 10.

[0060] In some examples, for each elongated connector 16 extending from a particular ring 18 to an adjacent ring 18, the generally straight segment 32 is axially and circumferentially offset from any other elongated connector 16 extending from the particular ring 18. The rigid portion 14 of the support 10 includes elongated connectors 16 arranged similarly to those of the aforementioned conventional supports. For example, the rigid portion 14 of the support 10 may include a plurality of elongated connectors 16 extending between the particular ring 18 and the adjacent ring 18. The plurality of elongated connectors 16 may be equidistantly spaced (e.g., spaced 90 degrees apart) around the perimeter of the support 10 (i.e., circumferentially equidistant relative to adjacent elongated connectors 16). The elongated connectors 16 of the rigid portion 14 of the support 10 may be as follows: Figure 1B The axial and circumferential offsets, or axial alignments, are shown to impart additional rigidity.

[0061] Figure 2A(Top view, 2D configuration) and Figure 3 (Side view, 3D configuration) shows a detailed view of an exemplary flexible portion 12 of the expandable support 10. Figure 2A The flexible portion 12 of the support 10 includes elongated connectors 16a, 16b, and 16c located on opposite sides of the support 10 (e.g., separated by 180 degrees). Although the elongated connectors 16a, 16b, and 16c of the flexible portion 12 (extending between adjacent rings 18a and 18b, 18b and 18c, and 18c and 18d, respectively) are axially offset and slightly circumferentially offset from each other, the elongated connectors 16a, 16b, and 16c are generally positioned on the same side of the support 10 along the entire axial length of the flexible portion 12. Specifically, as Figure 2A As shown, the elongated connectors 16a, 16b, and 16c (extending between each ring 18a and 18b, 18b and 18c, and 18c and 18d respectively) are located or approximately located at 0 degrees and 180 degrees on each ring 18a, 18b, 18c, and 18d.

[0062] As used in this article, the “position” on rings 18a, 18b, 18c, and 18d refers to the position from the initial or 0-degree position around the ring to the final position which is only less than 360 degrees. Figure 20 The arcuate distances around rings 18a, 18b, 18c, and 18d, as shown in the diagram. For convenience, "position" or arcuate distance is described herein as measured in degrees. "Position" or arcuate distance can also be measured or described based on a position on a clock face (e.g., 12 o'clock, 3 o'clock, 6 o'clock, etc.) or based on multiple linear segments 22 of ring 18 separating the first elongated connector 16a from the second elongated connector 16b. For example, in... Figure 2A In the first elongated connector 16a, one of the first elongated connectors 16a is separated from the other by a ring length comprising eight linear segments 22. The ring length is the shortest distance along the ring between possible connection points, for example, from the middle of the first straight segment 32 to the adjacent second straight segment 32. The ring length is represented by a line R1.

[0063] like Figure 2AAs shown, there are no elongated connectors at the 90-degree and 270-degree positions, such that the flexible portion 12 includes areas or quadrants completely devoid of elongated connectors, as indicated by shapes S2a and S2b. The configuration of the elongated connectors 16a, 16b, and 16c in the flexible portion 12 allows the support 10 to be more easily (within the flexible portion 12) hinged or bent in the 90-degree and 270-degree directions, while maintaining greater bending stiffness in the 0-degree and 180-degree directions. Specifically, the flexible portion 12 allows the support 10 to be hinged or bent with reduced force in the 90-degree and 270-degree directions, while requiring increased force in the 0-degree and 180-degree directions. In one embodiment, the hinge axis is created by placing the elongated connectors 16a, 16b, and 16c at the 0-degree and 180-degree positions. Therefore, the support 10 can be hinged or bent with less force around the hinge axis, rather than hinged or bent around it. The portions of rings 18a, 18b, 18c, and 18d in the areas without elongated connectors 16a, 16b, and 16c (shown by shapes S2a and S2b) have greater freedom of movement than other areas of the bracket 10. This means that these portions of rings 18a, 18b, 18c, and 18d can move toward or away from each other, which helps to improve the hinge capability of the flexible portion 12 compared to conventional bracket designs. Figure 3 The diagram shows the bending of the flexible portion 12 of the bracket 10, which illustrates the elongated connectors 16a, 16b (particularly). Figure 3 The slender connector 16c) is configured to be bent or flexed to form a hinge axis. Figure 3 In this specific case shown, the hinge axis can be a line extending through the elongated connector 16c and perpendicular to the image plane. Therefore, the elongated connector 16c is positioned at 0 degrees and 180 degrees (e.g., the front and rear of the illustrated bracket 10) and configured to bend with reduced force in directions of 90 degrees and 270 degrees (e.g., towards the top and bottom of the page toward the image). However, Figure 2A The positioning of the elongated connectors 16a, 16b, and 16c is not intended to be restrictive. Rather, as shown in the exemplary flexible portion 12 in other figures, the elongated connectors 16 forming the flexible portion 12 of the bracket 10 can be arranged in various configurations to obtain the desired amount and orientation of bracket flexibility, thereby adapting the bracket 10 to different applications and deployment locations. Furthermore, the positioning and configuration of the elongated connectors 16a, 16b, and 16c can vary along the length of the bracket 10 (e.g., offset circumferentially along the axial direction), thereby providing the bracket 10 with the aforementioned multidirectional hinge mechanism.

[0064] like Figure 2A and Figure 3As shown, the flexible portion 12 includes a repeating pattern of radially expandable rings, which, for convenience, are designated herein as a first ring 18a, a second ring 18b, a third ring 18c, and a fourth ring 18d. The first ring 18a, second ring 18b, third ring 18c, and fourth ring 18d are aligned in series along a common axis X1 of the support 10. Those skilled in the art will understand that the term "axis" refers to the path connecting the centers of the rings 18 forming the support 10, even when the support 10 is curved along its length such that the "axis" is not always straight. The number of rings 18a, 18b, 18c, and 18d is not intended to limit the invention. Rather, in some examples, the support 10 may include a repeating pattern of fewer or more rings. For example, the support 10 may include a repeating pattern of two or three rings. In some examples, each ring of the support 10 may be different from any other ring. In other examples, all rings of the support 10 may be identical.

[0065] exist Figure 2A and Figure 3 In the example shown, Figure 2A and Figure 3 The elongated connectors 16a, 16b, and 16c shown are not identical in shape. Conversely, some elongated connectors (in...) Figure 2A (In the accompanying drawings, denoted by reference numerals 16a and 16c) are symmetrical about a vertical axis including a curved portion 34, which extends in the same direction from the linear segments 22 of the rings 18a and 18b. Specifically, as shown... Figure 2A As shown, the elongated connector 16a extending between the first ring 18a and the second ring 18b extends from the linear segment 22 of the rings 18a and 18b in the upward direction ( Figure 2A Extending upwards (as indicated by the middle arrow A1). As... Figure 2A As shown, the elongated connector 16a extends between the axially aligned linear segments 22 of the first ring 18a and the second ring 18b.

[0066] In contrast, the elongated connector 16b extending between the second ring 18b and the third ring 18c is asymmetrical about the vertical axis. Instead, the first end 28 of the elongated connector 16b extends upward from the linear segment 22 of the first ring 18a (as shown by arrow A1), and the second end 30 of the elongated connector 16b extends downward from the linear segment 22 of the third ring 18c (as shown by arrow A2). Unlike the elongated connectors 16a and 16c, the elongated connector 16b is not connected between the axially aligned linear segments of the rings 18b and 18c. Instead, the linear segment 22 of the second ring 18b (on which the elongated connector 16b is attached) is circumferentially offset by one linear segment 22 from the linear segment 22 of the third ring 18c (on which the elongated connector 16b is attached).

[0067] Figure 4AThis is a detailed view of another exemplary flexible portion 12 of the support 10, which includes elongated connectors 16a, 16b, 16c positioned to create a multi-directional hinge mechanism. As in the previous example, the flexible portion 12 includes two symmetrical elongated connectors 16a extending between a first ring 18a and a second ring 18b, two asymmetrical elongated connectors 16b extending between a second ring 18b and a third ring 18c, and two symmetrical elongated connectors 16c extending between a third ring 18c and a fourth ring 18d. The flexible portion 12 may include multiple sets of four rings 18a, 18b, 18c, 18d connected in series to create a support 10 with elongated flexible regions. As in the previous example, the elongated connectors 16a, 16b, 16c (extending between each of rings 18a and 18b, 18b and 18c, and 18c and 18d, respectively) are positioned on opposite sides of the respective rings 18a, 18b, 18c, 18d, spaced approximately 180 degrees apart. Due to the positioning of the elongated connectors 16a, 16b, and 16c, the same repeating pattern exists along the length of the flexible portion 12. The flexible portion 12 may alternatively include multiple sets of three rings 18a, 18b, and 18c connected in series, as will become more apparent below.

[0068] In such Figure 4A In the example of the bracket 10 shown in this disclosure, the bracket 10 differs from the previous examples because the elongated connectors 16a, 16b, 16c (extending between rings 18a and 18b, 18b and 18c, 18c and 18d, respectively) are not as tightly bundled together as in the previous examples. That is, when viewed along the axial direction, the elongated connectors 16a, 16b, 16c are not circumferentially aligned. Instead, they are... Figure 2A and Figure 3 Compared to the elongated connectors 16a, 16b, and 16c of the bracket 10 shown, they are circumferentially offset by a very small amount when viewed axially. Figure 4A The elongated connectors 16a, 16b, and 16c in the exemplary bracket 10 are offset from each other by a large amount (e.g., from approximately 45 degrees to approximately 70 degrees) in the circumferential direction when viewed axially. Therefore, Figure 4A The elongated connectors 16a, 16b, and 16c in the bracket 10 are axially offset circumferentially along the length of the bracket 10. In a particular exemplary embodiment, Figure 4A The bracket 10 may include an elongated connector 16a located at 0 degrees and 180 degrees, an elongated connector 16b located at 90 degrees and 270 degrees, and an elongated connector 16c located at 0 degrees and 180 degrees. In this way, the elongated connectors 16a, 16b, and 16c can be offset circumferentially and axially. The elongated connectors 16a, 16b, and 16c ( Figure 4AThis configuration (as shown) allows the flexible portion 12 of the support 10 to preferentially hinge at different hinge points depending on the direction of bending of the support 10 (e.g., to reduce force). As mentioned above regarding... Figure 3 As discussed, the bracket 10 can generate a hinge axis as a line extending through elongated connectors 16, which are offset from each other by 180 degrees in the circumferential direction. Through this hinge axis, the bracket 10 can be configured to bend or hinge about the hinge axis with reduced force. Therefore, for example... Figure 2A and Figure 3 as well as Figure 4A The elongated connectors 16a and 16c shown, and the bracket 10, can be bent or hinged with reduced force in the 90-degree and 270-degree directions. When stress is applied in the approximate directions of 0 degrees and 180 degrees by introducing the elongated connector 16b located at the 90-degree and 270-degree positions, Figure 4A The support 10 in the middle will also be more easily bent. Therefore, in the previous example (e.g., in...) Figure 2A and Figure 3 In the case of the flexible portion 12 of the bracket 10, the bracket 10 is more easily bent in only two directions (e.g., at 90 degrees and 270 degrees) and maintains greater bending stiffness in other directions (e.g., at 0 degrees and 180 degrees) along the entire length of the flexible portion 12 of the bracket 10, because the elongated connectors 16a, 16b, and 16c are all in or approximately in the 0-degree and 180-degree positions. Depending on whether the elongated connectors 16a and 16c generate a hinge axis or whether the elongated connector 16b generates a hinge axis, Figure 4A The bracket 10 can be more easily bent in four directions (e.g., in the 0, 90, 180 and 270 degree directions).

[0069] More precisely, and to illustrate yet another exemplary embodiment of positioning the elongated connectors 16a, 16b, 16c to strategically reduce the forces acting on the bending or hinged bracket 10, Figure 4A The flexible portion 12 of the support 10 includes a first ring 18a, a second ring 18b, a third ring 18c, and a fourth ring 18d. Rings 18a, 18b, 18c, and 18d are arranged in series along the common axis X1 of the support 10. An elongated connector 16a extending between the first ring 18a and the second ring 18b is separated by the ring length or approximately 180 degrees of eight linear segments 22 comprising rings 18a and 18b, and is located at 0 and 180 degree positions. Similarly, an elongated connector 16b extending between the second ring 18b and the third ring 18c is separated by the ring length or approximately 180 degrees of eight linear segments 22, and is located near 90 and 270 degree positions. Figure 4AAs shown in shape S4a, the elongated connector 16a is circumferentially offset or spaced from the second ring 18b by the length of the ring, which includes three linear segments 22, or spaced at approximately 45 degrees. Figure 4A As shown in shape S4b, the elongated connector 16c is circumferentially offset from the elongated connector 16b along the third ring 18c by the ring length comprising four linear segments 22, or by approximately 67.5 degrees.

[0070] Figure 5 Another example of the flexible portion 12 of the bracket 10 shown in this disclosure includes an elongated connector 16 arranged to form a multidirectional hinge mechanism. Figure 5 As shown by lines L2 and L3 in the diagram, Figure 5 The elongated connector 16 of the flexible portion 12 is arranged to form two helices extending along the length axis of the flexible portion 12 of the support 10. More specifically, as Figure 5 As shown, the flexible portion 12 of the support 10 includes a plurality of expandable rings 18 aligned in series along the common axis X1 of the support 10. Each ring 18 includes a plurality of linear segments 22 connected end-to-end to form peaks 24 and valleys 26 of the ring 18. Figure 5 Each ring 18 includes eight peaks 24 and eight valleys 26. The rings 18 are arranged in a peak-valley configuration. However, it should be understood that the helical configuration is not intended to limit the invention. In other examples, the elongated connector 16 between the rings 18 may be located at any of eight or more connection points between the rings 18 and adjacent rings 18.

[0071] Figure 5 The flexible portion 12 also includes two elongated connectors 16 extending between each ring 18 and the adjacent ring 18. As in the previous example, the elongated connectors 16 between each ring 18 and the adjacent ring 18 are spaced approximately 180 degrees apart on opposite sides of the support 10. Furthermore, in Figure 5 In the example of the bracket 10 shown, the elongated connectors 16 are all symmetrical elongated connectors 16, identical in shape, and extend upward from the linear segment 22 of the ring 18. There are eight different positions for the mating elongated connectors 16 between the ring 18 and the adjacent ring 18, allowing the pair of elongated connectors 16 to be positioned as follows: Figure 5 Positions 1-8 are shown. A bracket 10 with fewer peaks 24 and valleys 26 per ring 18 element will have fewer potential hinge connection positions. A bracket 10 including rings 18 with more than eight peaks 24 and eight valleys 26 will have more potential hinge connection positions. Figure 5 The elongated connector 16 shown is generally C-shaped. However, as mentioned above, this shape is for illustrative purposes only, and different shapes may be used in exemplary embodiments. For example, as Figure 1BAs shown, the elongated connector 16 can also be in a reverse S-shape. In another example, the elongated connector 16 can also be in a symmetrical shape, such as an S-shape and / or a reverse C-shape. In another example, the support 10 can include one or more of any of these shapes for the elongated connector 16 (e.g., Figure 1B The bracket 10 shown includes an elongated connector 16 that presents a C-shape and an inverted S-shape.

[0072] As mentioned above, Figure 5 The elongated connector 16 is arranged to form two helices (lines L2, L3) extending along the perimeter and length of the flexible portion 12. To provide a helical configuration, as... Figure 5 As shown, the elongated connector 16 extending from any ring 18 in the proximal direction (e.g., toward the proximal end 2 of the bracket 10) and the elongated connector 16 extending from that particular ring 18 in the distal direction (e.g., toward the distal end 4 of the bracket 10) are circumferentially offset by a ring length including a linear segment 22, such that each hinge or connector position appears to have moved one step upward from the previous hinged position. Therefore, as Figure 5 As shown, in the spiral configuration, the connection point of the elongated connector 16 extending from a specific ring 18 (in) Figure 5 (As shown by reference numeral 36 in the attached figure) is circumferentially offset from another connection point 36 on the adjacent linear segment 22 of the particular ring 18. For example, as Figure 5 As shown, line L4, which extends through connection point 36 on ring 18, is circumferentially offset (e.g., does not intersect or overlaps) from line L5, which extends through adjacent connection point 36 on the same ring 18.

[0073] Figure 6 This is another example of the flexible portion 12 of the support 10 disclosed herein. Figure 6 The flexible portion 12 includes elongated connectors 16d and 16e located on one side of the support 10, forming a clustered skeleton of elongated connectors 16d and 16e extending axially through the flexible portion 12. Figure 6 Other areas of the bracket 10 shown in the medium shape S6a do not have elongated connectors 16d, 16e. This design allows the flexible portion 12 of the bracket 10 to be freely hinged in one direction (e.g., away from the cluster of elongated connectors 16) and to bend to accommodate sharp corners without twisting.

[0074] like Figure 6 As shown, the flexible portion 12 includes a plurality of expandable rings 18a, 18b, 18c, and 18d aligned in series along a common axis X1. For illustrative purposes, Figure 6The support 10 shown also includes additional expandable rings 18e and 18f. The rings 18a, 18b, 18c, 18d, 18e, and 18f include multiple linear segments 22 connected end-to-end to form the peaks 24 and valleys 26 of the rings 18a, 18b, 18c, and 18d (e.g., a total of 16 linear segments 22 for each ring 18a-f). Figure 6 The rings 18a, 18b, 18c, and 18d are arranged in a peak-valley configuration. The flexible portion 12 also includes elongated connectors 16d and 16e extending between each ring 18a, 18b, 18c, 18d, 18e and the distal adjacent rings 18b, 18c, 18d, 18e, and 18f, respectively. The elongated connectors 16a, 16b, and 16c are positioned on opposite sides of the ring 18 or circumferentially separated by 180 degrees within a given ring 18 (e.g., as shown). Figure 2A , 3 Unlike the previous examples shown in bracket 10 of 4A and 5, in Figure 6 The elongated connectors 16d and 16e, which extend between each ring 18a, 18b, 18c, 18d, 18e and the distal adjacent rings 18b, 18c, 18d, 18e, 18f, are separated in the first direction only by the ring length (e.g., about 45 degrees) comprising three linear segments 22. Figure 6 The slender connectors 16d and 16e are separated in the second direction by a ring length comprising thirteen linear segments 22, or separated by approximately 315 degrees. Figure 6 Other areas or regions of the rings 18a, 18b, 18c, 18d shown by shape S6a do not have elongated connectors 16d, 16e. In contrast, in the previous example (e.g.) Figure 2A , 3 As shown in Figures 4A and 5), two elongated connectors 16a, 16b, 16c extending between each ring 18a, 18b, 18c, 18d and immediately adjacent to rings 18a, 18b, 18c, 18d are separated by approximately 180 degrees in both directions on opposite sides of rings 18a, 18b, 18c, 18d. Figure 6 In the example of the bracket 10 shown, the portions of rings 18a, 18b, 18c, 18d, 18e, and 18f in the areas without elongated connectors 16d and 16e (shown by shape S6a) have greater degrees of freedom of movement compared to other areas of the bracket 10. This means that these portions of rings 18a, 18b, 18c, and 18d can move more freely toward or away from each other, which contributes to the enhanced hinge capability of the flexible portion 12 compared to conventional bracket designs. In this way, Figure 6The bracket 10 shown with the configuration of elongated connectors 16d, 16e can achieve a variable hinge direction, wherein the positions of the elongated connectors 16d, 16e can provide a pivot point with a certain range of motion (e.g., adapting to hinges in multiple dimensions in multiple planes), and the range of motion requires a reduced force rather than the hinge axis when the elongated connectors 16d are separated by 180 degrees (e.g., adapting to hinges in two main and opposite directions, which are coplanar).

[0075] like Figure 6 As shown, there are four elongated connectors 16d, 16e extending from, for example, the second ring 18b. Two elongated connectors 16d, 16e extend into the first ring 18a in the proximal direction (i.e., towards the proximal end 2 of the bracket 10). Two elongated connectors 16d, 16e extend into the third ring 18c in the distal direction (i.e., towards the distal end 4 of the bracket 10). Moreover, two elongated connectors 16d, 16e are connected to the same linear segment 22 of the second ring 18b. Figure 6 In the example shown, the elongated connectors 16d and 16e are symmetrical, but they are not identical in shape (although they may be identical in other examples of the bracket 10 of this disclosure). Instead, the elongated connector 16d extends upward from the linear segment 22 of the rings 18a, 18b, 18c, and 18d. Figure 6 (As shown by the middle arrow A1), the elongated connector 16e extends downward from the linear segment 22 of rings 18a, 18b, 18c, and 18d. Figure 6 (As indicated by the middle arrow A2).

[0076] Figure 7 Another non-limiting example of the flexible portion 12 of the stent 10 according to this disclosure is shown. Similar to... Figure 6 , Figure 7 The flexible portion 12 includes a cluster arrangement of elongated connectors 16d and 16e. Figure 7 In the configuration, the support 10 is freely hinged in multiple directions and can be roughly similar to Figure 6 The bracket 10 is formed with sharp corners without kinking. As in the previous example, elongated connectors 16d, 16e can be arranged in any number of locations to achieve the desired flexibility of the flexible portion 12 of the bracket 10. Figure 7 The elongated connectors 16d and 16e shown in the example are symmetrical, but not identical. Instead, elongated connector 16d includes linear segments 22 from rings 18a, 18b, 18c, and 18d in the upward direction ( Figure 7 The curved portion 34 extends from the middle arrow A1, and the elongated connector 16e includes linear segments 22 extending from the rings 18a, 18b, 18c, and 18d in the downward direction (…). Figure 7(As shown by the middle arrow A2) Extended curved portion 34.

[0077] like Figure 7 As shown, the flexible portion 12 includes a plurality of expandable rings 18a, 18b, 18c, 18d, 18e, and 18f arranged in series along a common axis X1. The rings 18a, 18b, 18c, 18d, 18e, and 18f are arranged in a peak-valley configuration. As in the previous example, two elongated connectors 16d and 16e extend between a ring (e.g., the first ring 18a) and an adjacent ring (e.g., the second ring 18b). Furthermore, as... Figure 6 As shown, the two elongated connectors 16d and 16e are separated by the ring length of three linear segments 22, including ring 18a, at approximately 45 degrees. Figure 7 Other areas of rings 18a, 18b, 18c, 18d, 18e, and 18f, as shown by shapes S7a and S7b, do not have elongated connectors 16d and 16e. As a result, the areas shown by shapes S7a and S7b have greater degrees of freedom of movement compared to other areas of the bracket 10. This means that these portions of rings 18a, 18b, 18c, and 18d can move more freely toward or away from each other, which helps to improve the hinge capability of the flexible portion 12 compared to conventional bracket designs.

[0078] and Figure 6 different, Figure 7 The elongated connectors 16d and 16e of the flexible portion 12 are not all located only on one side of the support 10 forming the cluster-like skeleton. Instead, in Figure 7 In the figure, elongated connectors 16d and 16e extending between the first ring 18a and the second ring 18b are located on the side of the bracket 10 opposite to the elongated connectors 16d and 16e extending between the second ring 18b and the third ring 18c. As shown, for each pair of adjacent rings 18 having a common ring 18 (e.g., the first pair is rings 18a and 18b, and the second pair is rings 18b and 18c), the elongated connectors 16d and 16e extending between the first pair of rings 18 are circumferentially and axially offset from the elongated connectors 16d and 16e between the second pair of rings 18. Thus, the elongated connectors 16d and 16e extending from ring 18b in one direction (e.g., toward the proximal end 2 of the bracket 10) are separated from the elongated connectors 16d and 16e extending in another direction (towards the distal end 4 of the bracket 10) by a ring length including the six linear segments 22 of ring 18b (approximately 112.5 degrees). As in the previous example, the pattern of spaced-out elongated connectors 16 can continue along the entire length of the flexible portion 12 of the support 10.

[0079] Figure 8AAnother exemplary flexible portion 12 of the support 10 of this disclosure is shown, which includes a plurality of expandable rings 18a, 18b, 18c, 18d, 18e, 18f aligned in series along a common axis X1. Figure 8A The flexible portion 12 includes four elongated connectors 16f, 16g extending between each ring 18a, 18b, 18c, 18d, 18e and the distal adjacent rings 18b, 18c, 18d, 18e, 18f of the flexible portion 12. The elongated connectors 16f, 16g are arranged in pairs. A “pair” of elongated connectors 16f, 16g connects to adjacent linear segments 22 of rings 18a, 18b, 18c, 18d, 18e, 18f. Specifically, the first pair includes two elongated connectors 16f connected to adjacent linear segments 22, and the second pair includes two elongated connectors 16g connected to a second set of adjacent linear segments 22 of rings 18a, 18b, 18c, 18d, 18e, 18f. The first and second pairs of elongated connectors 16f, 16g are circumferentially offset within a given pair of rings 18a-f. This design allows the flexible portion 12 of the support 10 to hinge freely in multiple directions and form sharp corners without twisting.

[0080] like Figure 8A As shown, the first pair of connectors 16f and the second pair of connectors 16g are positioned on opposite sides of rings 18a, 18b, 18c, 18d, 18e, and 18f, such that these pairs are separated by the length of the ring, which includes seven linear segments 22 of rings 18a, 18b, 18c, 18d, 18e, and 18f, or separated by approximately 135 degrees. As in the previous example, the elongated connectors 16f and 16g include a bent portion 34. Furthermore, some of the elongated connectors 16f and 16g are bent upwards (…). Figure 8A (As indicated by the middle arrow A1), while the other slender connectors 16f and 16g bend downwards ( Figure 8A(As indicated by the middle arrow A2). The elongated connector 16f is located on the linear segment 22 adjacent to the linear segment 22 of its paired elongated connector 16f, such that the paired elongated connectors 16f are separated by less than about 25 degrees in the first direction. These elongated connectors 16f are separated from the adjacent elongated connectors 16g of another pair (connecting the same two rings) by the ring length of seven linear segments 22 (separated by approximately 135 degrees in the second direction). Each pair of connectors 16c, 16d includes a symmetrical upward-facing connector and a symmetrical downward-facing connector. The bracket 10 also includes regions represented by shapes S8a and S8b that do not contain elongated connectors 16c, 16d, and therefore have greater degrees of freedom of movement compared to other regions of the bracket 10. This means that these portions of rings 18a, 18b, 18c, 18d can move more freely toward or away from each other, which helps improve the articulation capability of the flexible portion 12 compared to conventional bracket designs. In some examples, the regions represented by shapes S8a, S8b may not extend along the entire length of the bracket 10. Conversely, some portions of the support 10 may include regions S8a, S8b, while other portions of the support 10 include additional elongated connectors 16f, 16g and / or elongated connectors 16f, 16g located at different positions around the perimeter of the support 10. Similarly, as in the previous example, connectors 16f, 16g may also be arranged at any number of other locations around rings 18a, 18b, 18c, 18d, 18e, 18f to achieve the desired flexibility of the support. In another way of observing the paired elongated connectors 16f, 16g, Figure 8A The support 10 can be roughly similar to the one mentioned above. Figure 2A , 3 The bracket 10 described in 4A and 5. Specifically, paired elongated connectors 16f, 16g are circumferentially separated by 180 degrees between two rings 18, or positioned on opposite sides of the bracket 10. Figure 2A , 3 The support 10 in 4A and 5 is the opposite. Figure 8A The bracket 10 in the middle allows the elongated connectors to be paired. The paired elongated connectors 16f and 16g can also form a corresponding hinge axis, around which the bracket 10 can be bent or hinged with reduced force.

[0081] Figure 9Another exemplary flexible portion 12 of the stent 10 of this disclosure is shown, comprising a plurality of expandable rings 18a, 18b, 18c, 18d aligned in series along a common axis X1. As shown, the stent 10 may utilize a repeating pattern of expandable rings 18a-d. Thus, a series of rings 18a-d may repeat, wherein a ring 18d from the proximal group (e.g., closer to the proximal end 2) is adjacent to a ring 18a from the distal group (e.g., closer to the distal end 4). As in the previous example, the expandable rings 18a, 18b, 18c, 18d are formed by linear segments 22 arranged end-to-end, defining peaks 24 and valleys 26 of the rings 18a, 18b, 18c, 18d. Figure 9 The rings 18a, 18b, 18c, and 18d are in a peak-to-peak configuration, with the peak 24 of one ring axially aligned with the peak 24 of the other ring.

[0082] and Figure 8A The paired slender connectors 16f and 16g are the same. Figure 9 The flexible portion 12 includes four elongated connectors 16h and 16i extending between each ring 18a, 18b, 18c, 18d and adjacent rings 18b, 18c, 18d, 18a. The elongated connectors 16h and 16i are arranged in pairs, with the first pair comprising two elongated connectors 16h connected to adjacent linear segments 22 of specific rings 18a, 18b, 18c, 18d, and the second pair comprising two elongated connectors 16i connected to a second set of adjacent linear segments 22 of specific rings 18a, 18b, 18c, 18d. Figure 8A As shown, this design allows the bracket 10 to hinge freely in multiple directions and form sharp corners without kinking. Figure 9 In the exemplary embodiment shown, the paired elongated connectors 16h, 16i can be circumferentially offset by 180 degrees between a given pair of rings 18a-d, or positioned on opposite sides of the bracket 10. In this way, the elongated connectors 16h, 16i can create a hinge axis. Figure 9 The bracket 10 can be bent or hinged about the hinge axis. As in the previous example, the connectors 16h, 16i can also be arranged in any number of other locations around the rings 18a, 18b, 18c, 18d to achieve the desired flexibility of the bracket.

[0083] like Figure 9As shown, pairs of elongated connectors 16h and 16i are positioned on opposite sides of rings 18a, 18b, 18c, and 18d, such that the pairs of elongated connectors connecting the same two rings are separated by a ring length comprising seven linear segments 22 of rings 18a, 18b, 18c, and 18d, or approximately 135 degrees. That is, one elongated connector 16h is separated from the closer elongated connector 16i by the ring length. However, when considering the distance between a pair of elongated connectors 16h and a pair of elongated connectors 16i, these pairs can be separated by 180 degrees or by a ring length comprising eight linear segments 22. Figure 9 The elongated connectors 16h and 16i differ from the previous examples because they include inclined segments 38 to accommodate the peak-to-peak configuration of rings 18a, 18b, 18c, and 18d. More specifically, Figure 9 The elongated connectors 16h and 16i include bent portions 34 located at a first end 28 and a second end 30 of the connectors 16h and 16i. The connectors 16h and 16i also include two straight sections 32 separated by an inclined section 38. Furthermore, each pair of elongated connectors 16h and 16i includes an upward-facing connector (made by...). Figure 9 (as shown by arrow A2 in the image) and the downward-facing connector (by...) Figure 9 (As shown by arrow A2 in the image).

[0084] Figure 17-19 An additional example of the bracket 10 is shown, which includes elongated connectors 16h, 16i having inclined sections 38 extending between rings 18a, 18b, 18c, 18d. Similar to... Figure 9 The support 10 can be used in a manner where rings 18a-d can be repeated in groups. Although Figure 17-19 The slender connectors 16h and 16i are roughly similar in shape to Figure 9 The connectors 16h and 16i, including the inclined section 38, are included. Figure 17-19 The bracket 10 differs from previous examples in the positioning and orientation of the elongated connectors 16h and 16i. For example, as Figure 17 As shown, the bracket 10 includes a pair of elongated connectors 16h and a pair of elongated connectors 16i extending between each ring 18a, 18b, 18c, 18d and the distal adjacent rings 18b, 18c, 18d, 18a. However, Figure 17 The bracket 10 and Figure 9 The bracket 10 is different because... Figure 17 In this configuration, pairs of elongated connectors 16h and 16i on adjacent rings 18a, 18b, 18c, and 18d are connected to adjacent linear segments 22. Specifically, connector 16h extending between the first ring 18a and the second ring 18b is connected to the adjacent linear segment 22 of connector 16h extending between the second ring 18b and the third ring 18c. Figure 17 The other paired elongated connectors 16h and 16i are positioned with a similar construction.

[0085] Figure 18 Another example of a bracket 10 including elongated connectors 16j and 16k is shown, which include inclined sections 38. The elongated connector 16j includes a curved portion 34 extending upward from the linear section 22 (e.g., Figure 18 (As shown by the middle arrow A1). The elongated connector 16k includes a curved portion 34 extending downward from the linear segment 22 (as shown by the middle arrow). Figure 18 (As indicated by the middle arrow A2). Figure 18 The bracket 10 differs from the previous example because... Figure 18 In this configuration, two elongated connectors 16j and 16k extend from a single linear segment 22. For example, as... Figure 18 As shown, some elongated connectors 16k having an upwardly curved portion 34 extending between the first ring 18a and the second ring 18b, and elongated connectors 16j having a downwardly curved portion 34 extending between the second ring 18b and the third ring 18c, are connected to the same linear segment 22 of the second ring 18b. Similarly, some elongated connectors 16j having a downwardly curved portion 34 extending between the first ring 18a and the second ring 18b, and elongated connectors 16k having an upwardly curved portion 34 extending between the second ring 18b and the third ring 18c, are connected to the same linear segment 22 of the second ring 18b. Figure 18 As shown, this configuration of the elongated connectors 16j and 16k extending from the same linear segment 22 continues throughout the support 10.

[0086] Figure 19 Another exemplary bracket 10 is shown, which includes a pair of elongated connectors 16h, 16i extending between rings 18a, 18b, 18c, 18d and adjacent to rings 18b, 18c, 18d, 18a. As in the previous example, connectors 16h, 16i include a sloping section 38. Figure 19 The bracket 10 and Figure 9 The bracket 10 is different because... Figure 19 In this context, the inclined sections 38 used for different connectors 16h and 16i are inclined in different directions. For example, as... Figure 19 As shown, a pair of elongated connectors 16h and a pair of elongated connectors 16i extend between the first ring 18a and the second ring 18b. Figure 19 As indicated by arrow A3, the elongated connectors 16h and 16i between the first ring 18a and the second ring 18b are inclined in the upward direction. A pair of elongated connectors 16h and a pair of elongated connectors 16i also extend between the second ring 18b and the third ring 18c. However, as... Figure 19As shown by arrow A4, the elongated connectors 16h and 16i between the second ring 18b and the third ring 18c are inclined in the downward direction. Figure 19 As shown, the arrangement of the upwardly and downwardly tilted connectors in the elongated connectors 16h and 16i can continue between the other rings 18b, 18c, and 18d of the bracket 10.

[0087] Non-limiting examples of elongated connector configurations As previously mentioned, the elongated connectors 16, 16a, 16b, 16c, and 16d can be constructed in various shapes and configurations to achieve the required flexibility and expansion of the support 10. Figure 10A-10D Different variations of the elongated connector 16 used in some of the aforementioned flexible portions 12 of the support 10 are shown. In the presence of the rigid portion 14 of the support 10, Figure 10A-10D The elongated connector 16 shown can also be used for the rigid portion 14 of the bracket 10.

[0088] Figure 10A The slender connector 16 in the middle is vertically symmetrical with the curved portion 34 at the first end 28 of the connector 16, another curved portion 34 at the second end 30 of the connector 16, and the generally straight section 32 extending between the first end 28 and the second end 30 of the connector 16. Figure 10A The curved portions 34 in the middle all originate from the linear segments 22 of the expandable rings 18a and 18b in the same direction (e.g., from...). Figure 10A The linear segment 22, indicated by arrow A1, extends in the upward direction. Furthermore, Figure 10A The slender connector 16 extends from the middle of the linear segment 22 of the rings 18a and 18b.

[0089] Figure 10B An elongated connector 16 is shown, which is symmetrical and includes bent portions 34 located at the ends 28, 30 of the connector 16. The bent portions 34 extend downward from the linear segments 22 of the rings 18a, 18b, as shown. Figure 10B As shown by arrow A2 in the diagram.

[0090] Figure 10C and 10D An elongated connector 16 is shown that is asymmetrical (e.g., not vertically symmetrical) and extends between expandable rings 18a, 18b. Figure 10C and 10D The elongated connector 16 includes a bent portion 34 at a first end 28 of the connector 16, a bent portion 34 at a second end 30 of the connector 16, and a generally straight section 32 extending between the ends 28 and 30 of the connector 16. Figure 10CIn the example shown, the bent portion 34 at the first end 28 of the connector 16 extends upward from the linear segment 22 of the first expandable ring 18a (by... Figure 10C (As shown by arrow A1 in the diagram) extends, and the bent portion 34 at the second end 30 of the connector 16 extends downward from the linear segment 22 of the second expandable ring 18b (by...). Figure 10C (As shown by arrow A2 in the diagram). The connection points 36a and 36b between the linear segments 22 of rings 18a and 18b are not axially aligned. Instead, the connection point 36a between the first ring 18a and connector 16 is circumferentially offset by a linear segment 22 from the connection point 36b between connector 16 and the second ring 18b. Figure 10D The slender connector 16 in the middle is Figure 10C A mirror image of the elongated connector 16. Specifically, as... Figure 10D As shown, the bent portion 34 at the first end 28 of the connector 16 extends downward from the linear segment 22 of the first ring 18a. Figure 10D (As shown by arrow A2 in the diagram) extends, and the bent portion 34 at the second end 30 of connector 16 extends upward from the linear segment 22 of the second ring 18b (as shown by arrow A2 in the diagram). Figure 10D (As shown by arrow A1 in the image) extends.

[0091] Figure 11A-11D Additional examples of elongated connectors 16 that can be used in the flexible portion 12 and / or rigid portion 14 of the support 10 of this disclosure are shown. Figure 11A-11D The elongated connector 16 shown can be used as an elongated connector 16 in any flexible portion 12 and rigid portion 14 of the bracket 10 described herein. Figure 11A-11D The elongated connector 16 shown is an extended form of the elongated connector 16, which extends from a point near the peak 24 of a ring 18a to a point near the valley 26 of an adjacent ring 18b.

[0092] Unlike the previous example, Figure 11A-11D The elongated connector 16 in the middle does not connect to the middle of the linear segment 22 of the rings 18a, 18b (e.g., at approximately equidistant points between the peaks 24 and valleys 26 of the rings 18a, 18b), and does not extend from the middle of the linear segment 22 of the rings 18a, 18b. Instead, Figure 11A-11D The elongated connector 16 in the middle is connected to a point on the linear segment 22 closer to the peak 24 or valley 26 of the rings 18a, 18b. For example, as Figure 11AAs shown, rings 18a and 18b are arranged in a peak-valley configuration. The elongated connector 16 includes a bent portion 34 at a first end 28 of the connector 16, a bent portion 34 at a second end 30 of the connector 16, and a generally straight section 32 extending between the first end 28 and the second end 30. The bent portion 34 on the first end 28 extends upwards from the linear section 22 of the first ring 18a. Figure 11A (As indicated by the middle arrow A1) extends and is located near the peak 24 of the first ring 18a. The curved portion 34 at the second end 30 of the connector 16 extends upward from the linear segment 22 of the second ring 18b (as indicated by the middle arrow A1). Figure 11A (As shown by arrow A2 in the diagram) extends and is located near the valley 26 of the second ring 18b. Figure 11B Showing something similar Figure 11A The connector is a symmetrical, elongated connector 16, but with a bent portion 34 that extends downward from the linear segment 22 (in...). Figure 11B (Indicated by arrow A2).

[0093] Figure 11C and 11D Showing with Figure 10C and 10D The asymmetrical elongated connector in the middle is compared to the asymmetrical elongated connector 16, which extends in length. Figure 11C In the middle, the bent portion 34 at the first end 28 of the connector 16 extends from the linear segment 22 of the first ring 18a in the upward direction (by... Figure 11C (As indicated by arrow A1 in the diagram). The first end 28 of connector 16 connects to the linear segment 22 of the first ring 18a near the peak 24 of the ring 18a. The bent portion 34 at the second end 30 of connector 16 extends from the linear segment 22 of the second ring 18b in the downward direction (…). Figure 11C (As shown by arrow A2 in the diagram). The second end 30 of connector 16 is connected to the linear segment 22 of the second ring 18b near the valley 26 of the second ring 18b. Figure 11D yes Figure 11C The mirror image shows the curved portion 34 at the first end 28 of the elongated connector 16 extending downward from the linear segment 22 of the first ring 18a. Figure 11D (Arrow A2) extends, and the curved portion 34 at the second end 30 of the elongated connector 16 extends upward from the linear segment 22 of the second ring 18b ( Figure 11D The arrow A1 in the diagram extends from it.

[0094] Reference Figure 12In some examples, the flexible portion 12 or rigid portion 14 of the support 10 includes a strut 40 extending between the valley 26 of the ring 18a and the peak 24 immediately adjacent to the ring 18b. The strut 40 may be used as an alternative to or replacement for the elongated connector 16, wherein the strut 40 is configured to be hinged to allow the support 10 to bend without kinking. In other examples, the support 10 may include the elongated connector 16 and the strut 40 to provide the required flexibility to the support.

[0095] like Figure 12 As shown in the example, the flexible portion 12 and / or rigid portion 14 of the support 10 includes a first ring 18a and a second ring 18b with a peak-valley configuration. The strut 40 is connected to the valley 26 of the first ring 18a and extends axially from the valley 26 of the first ring 18a to the peak 24 of the second ring 18b. In some examples, although in Figure 12 Not shown, but the flexible portion 12 may include two struts 40 located between each ring 18a, 18b. The two struts 40 may be spaced approximately 180 degrees apart on opposite sides of the support 10, similar to the configuration of the elongated connector 16 in the aforementioned example. When used with the flexible portion 12, the struts 40 provide a flexible, non-kinked location for the support 10 and may also provide increased stiffness (e.g., fracture strength) and support for selected areas of the flexible portion 12. Instead of the elongated connector 16 described above, or in addition to the elongated connector 16, the rigid portion 14 of the support 10 may also include struts 40 to enhance the rigidity of the rigid portion 14. For example, similar to... Figure 1C The rigid portion 14 may include four struts 40 located between each expandable ring 18a, 18b, the struts 40 being equally spaced about 90 degrees around the ring 18. In other examples, the rigid portion 14 may include more than four struts 40 between each expandable ring 18a, 18b, or fewer than four struts 40 between each expandable ring 18a, 18b.

[0096] Non-limiting example of a flexible portion of a directly connected ring Reference Figure 13 In some examples, the flexible portion 12 or rigid portion 14 of the support 10 includes rings, such as a first ring 18a and a second ring 18b, which are directly connected together without elongated connectors or struts. Instead, the valley 26 of the first ring 18a may be directly connected to the peak 24 of the adjacent second ring 18b and / or integrally formed with the peak 24 of the adjacent second ring 18b.

[0097] For example, such as Figure 13As shown, the expandable support 10, configured to radially expand from a contracted or compressed (e.g., rolled) configuration to an expanded configuration, includes a plurality of radially expandable rings, such as a first ring 18a and a second ring 18b, whose dimensions and configurations are similar to the foregoing example. As in the previous example, rings 18a, 18b include a plurality of linear segments 22 connected end-to-end to form peaks 24 and valleys 26 of rings 18a, 18b. Figure 13 Rings 18a and 18b are arranged in a peak-valley configuration. For example... Figure 13 As shown, one of the valleys 26 of the first ring 18a is directly connected to the peak 24 of the second ring 18b, thereby connecting the first ring 18a to the second ring 18b. Figure 13 In the example shown, the other valleys 26 of the first ring 18a are separated from the peaks 24 of the second ring 18b by a distance or gap G1.

[0098] As in the previous examples, rings 18a and 18b can be joined together in various configurations to provide the desired flexibility and / or allow the support 10 to bend in various directions without kinking. For example, the flexible portion 12 of the support 10 may include two connection points, where each ring 18a is directly connected to the second ring 18b. The connection points may be located, for example, on opposite sides of rings 18a and 18b, spaced approximately 180 degrees apart. The peaks 24 and valleys 26 of other portions of rings 18a and 18b may be separated by a gap G1. In some examples, the connection points for directly joining rings 18a and 18b together may be located only on one side of the support 10 along its entire axial length, forming a clustered skeleton, similar to... Figure 6 The example shown. In other examples, the connection point between the rings 18a, 18b of the support 10 can be positioned to create a helix extending axially along the flexible portion 12 of the support 10 (e.g. Figure 5 (as shown), or positioned in any other convenient configuration that provides bending or flexing at the desired location and direction along the length of the support 10.

[0099] In some examples, the rigid portion 14 of the support 10 (if present) may also include integral or directly connected rings 18a, 18b. For example, the rigid portion 14 of the support 10 may include a first ring 18a having valleys 26 directly connected to the peaks 24 of a second ring 18b at four or more equidistant connection points. In other examples, the rigid portion 14 of the support 10 may include a first ring 18a having valleys 26 directly connected to the peaks 24 of a second ring 18b at fewer than four equidistant connection points. In one specific example, the rigid portion 14 may include four connection points located between adjacent rings 18a, 18b, these connection points being spaced approximately 90 degrees apart, similar to... Figure 1C The rigid portion 14 shown.

[0100] Non-restrictive examples of deployment methods Reference Figure 14 This document illustrates a method for deploying a stent 10 including the features described herein. The deployment method can be applied to any stent 10 embodiment of this disclosure. As shown in step 110 of the method, surgery is prepared by removing the selected stent 10 from its packaging and removing the protective sheath covering the stent 10 during storage. The stent 10 is initially provided in a compressed state, such as rolled onto a balloon-type expandable catheter. As previously described, the stent 10 of this disclosure is configured to be easily bent or hinged in one or more directions based on the positioning of the elongated connector 16 and / or other connections between the rings 18 of the stent 10. The stent 10 can be selected for a specific surgical procedure and target deployment site depending on how the stent 10 needs to be bent or hinged during deployment. For example, a stent 10 having an elongated connector 16 forming a clustered skeleton of a flexible portion 12 extending axially through the stent 10 (such as...) Figure 6 (As shown) It is easier to bend without kinking in a range of directions away from the clustered skeleton. The stent 10 with the elongated connector of the clustered skeleton is able to bend around the sharp corners without kinking by bending in directions within this range. The stent 10, which is easy to bend with reduced force and can bend around the sharp corners without kinking, can be used in surgical procedures where the stent is located within a branch artery or where the stent 10 extends from one body passage to another through an opening. Other uses of the stent that is easy to bend around the sharp corners can also be readily determined by those skilled in the art. In other examples, the stent 10 is configured with a multidirectional articulation mechanism that is easy to bend in a number of selected directions (e.g., by generating a multidirectional articulation mechanism that can bend in a number of selected directions). Figure 9 (The hinge axis in the middle). A multi-directional hinged bracket 10 can be selected for deployment positions where the bracket 10 is exposed to multiple different bending forces and / or bending or twisting in multiple directions. Those skilled in the art will also readily determine the use of a bracket that is easier to bend in multiple directions but does not require bending around sharp corners. Figure 4A , 5 An exemplary support 10, configured to bend in multiple directions, is shown in Figures 9 and 9.

[0101] In step 112 of the method, a delivery assembly is provided, comprising a catheter or sheath and a guidewire, for advancing the stent 10 through the patient's vascular system or other lumen to a deployment location. The deployment location can be any desired location within the patient's vascular system or other lumen. For example, the stent 10 can be deployed in a blood vessel or artery. In some examples, the stent 10 is deployed within an endoplasty. As previously described, stents with specific articulation and bending characteristics can be selected for specific desired surgical procedures and deployment locations.

[0102] The stent 10 is coiled onto the balloon catheter and can be inserted into the delivery catheter. To deploy the stent 10, in step 114 of the method, a guidewire is introduced through a vascular system or other lumen to the desired deployment location. Once the guidewire is in place, in step 116 of the method, the delivery catheter, the balloon catheter, and the stent assembly mounted thereon are advanced onto the guidewire to the deployment location.

[0103] In step 118 of the method, once the stent 10 is in the desired deployment position, the balloon catheter dilates. As previously described, the radial outward dilation of the expandable portion of the balloon catheter causes the expandable ring 18 of the stent 10 to dilate outward. After dilation, the guidewire can be removed and the stent 10 can be in a curved, bent, or articulated configuration, as required by the surgical procedure and deployment site.

[0104] Example The following non-limiting embodiments are provided to illustrate the general principles of embodiments according to this disclosure. This disclosure and any claimed embodiments should not be considered as limited to the specific examples presented.

[0105] Preset Example 1 As mentioned above, Figure 2A The flexible portion 12 of the illustrated support 10 includes pairs of elongated connectors 16a, 16b, and 16c, which respectively connect rings 18a and 18b, 18b and 18c, and 18c and 18d. Figure 2A As shown, each of a pair of elongated connectors 16a, 16b, and 16c is located on opposite sides of the bracket 10, approximately 180 degrees apart. When positioned at 0 degrees and 180 degrees (e.g., the 0-degree position can be arbitrarily designated around the perimeter of the ring, and subsequent measurements can be based on this 0-degree position), the bracket 10 is configured to more easily hinge with reduced force in the 90-degree and 270-degree directions, while maintaining greater bending stiffness in the 0-degree and 180-degree directions.

[0106] Figure 2B It shows that the calculations performed through finite element analysis (FEA) make... Figure 2A The flexible portion 12 of the bracket 10 shown and Figure 3 The diagram shows the force required to bend the flexible portion 12 of the support 10 by 2.0 mm. Figure 2A The bending of stent 10 in this study is compared to the bending of a conventional stent (such as the iCAST / V12 stent sold by Atrium Medical Corporation) having four equidistant connectors extending between each ring and adjacent rings of a conventional stent. The connectors in a conventional stent are separated by 90 degrees. For example, a conventional stent may include at least four connectors located between a pair of rings circumferentially separated by 90 degrees.

[0107] like Figure 2B As shown, changing the design of a conventional bracket with four connectors resulted in a significant reduction in the bending force required to bend the bracket by 2.0 mm. Figure 2A When the bracket 10 shown is bent about the hinge axis in a selected direction (e.g., a 90-degree direction), the force is 8% of the force required to bend a conventional bracket, or 92% less than the force required to bend a conventional bracket in the same direction. In the bracket 10 (in... Figure 2A (As shown in the image) when not bending around the hinge axis, Figure 2A The support 10 still has the required reduced force. For example, to bend the support 10 by 45 degrees relative to the hinge axis, this force is 51% of the force required to bend a conventional support, or the bending force is reduced by 49%. In the support 10 (in... Figure 2A (As shown in the figure) When bent 90 degrees relative to the direction of the hinge axis, the force is 48% of the force required to bend a conventional bracket, or the bending force is reduced by 52%.

[0108] Preset Example 2 As mentioned above, Figure 4A The flexible portion 12 of the support 10 includes pairs of elongated connectors 16a, 16b, and 16c that respectively connect a first ring 18a to a second ring 18b, a second ring 18b to a third ring 18c, and a third ring 18c to a fourth ring 18d. The two elongated connectors 16a are located at approximately 0 degrees and approximately 180 degrees from the support 10 connecting the first ring 18a to the second ring 18b. The two elongated connectors 16b connect the second ring 18b to the third ring 18c, and these two connectors 16b are located at approximately 90 degrees and approximately 270 degrees. The two elongated connectors 16c are located at approximately 0 degrees and approximately 180 degrees from the support 10 connecting the third ring 18c to the fourth ring 18d. This configuration of connectors 16a, 16b, and 16c provides a bracket 10 that is easier to hinge when subjected to stress in any of the 0, 90, 180, and 270 degree directions, depending on which of the elongated connectors 16a, 16b, and 16c bends or hinges.

[0109] Figure 4B This demonstrates the bending effect compared to conventional stents (such as the iCAST / V12 stent sold by Atrium Medical Corporation), calculated by finite element analysis. Figure 4A The graph shows the force required for the bracket 10 to bend 2mm. This graph illustrates how, by modifying the design of a conventional bracket with four connectors, the force required for... Figure 4A The support 10 achieves a significant reduction in bending force as a whole, rather than specifically around a given hinge axis. In having Figure 4A When the flexible portion 12 of the support 10 is bent at 0 degrees, the force is 12% of the force required to bend a conventional support, or the bending force is reduced by 88%. Figure 4A When the flexible portion 12 of the support shown bends at a 45-degree angle, the force is 11% of the force required to bend a conventional support, or the bending force is reduced by 89%. Figure 4A When the stent 10 bends 90 degrees, the force is 16% of the force required to bend a conventional stent, or the bending force is reduced by 84%. As described above, Figure 4A The support 10 is configured to be more easily hinged in multiple directions. Therefore, the result is that... Figure 4A The reduction in force at the hinge of the bracket 10 is roughly similar around all angles.

[0110] Preset Example 3 As mentioned above, Figure 8A The flexible portion 12 of the support 10 includes four elongated connectors 16f, 16g located between the first ring 18a and the second ring 18b. The elongated connectors 16f, 16g are paired, with one pair of elongated connectors 16f positioned at approximately 0 degrees and the other pair of elongated connectors 16d positioned at approximately 180 degrees. The paired elongated connectors 16c, 16d between the second ring 18b and the third ring 18c are circumferentially offset at 90-degree and 270-degree positions. This configuration of the elongated connectors 16c, 16d also ensures that the support 10 is more easily hinged when subjected to stress in any of the 0-degree, 90-degree, 180-degree, and 270-degree directions, depending on which elongated connector 16f, 16g bends or hinges, and in other directions, the proximity to and access to the hinge point.

[0111] Figure 8B This explains how finite element analysis calculations can achieve... Figure 8A The diagram shows the force required to bend the bracket 10 up to a distance of 2 mm. (See diagram for reference.) Figure 8B As shown, used to make Figure 8A The forces required to bend the stent 10 as a whole in the 0°, 45°, 90°, 135°, and 180° directions without specifically bending it around a given hinge axis are similar, requiring a force between 0.2N and 0.25N to bend the stent by 1.5mm. In contrast, bending a conventional stent (such as the iCAST / V12 stent sold by Atrium Medical Corporation) in any of the 0°, 90°, 180°, or 270° directions requires a force close to 0.5N. As described above, Figure 8A The support 10 is configured to be more easily hinged in multiple directions. Therefore, the result is that... Figure 8A The reduction in force at the hinge of the bracket 10 is roughly similar around all angles.

[0112] Preset Example 4 Figure 15A and 15B It is a more conventional control stent ( Figure 15A ) and multi-directional articulated supports including the features disclosed herein ( Figure 15B The visual representation was created by using finite element analysis to approximate the characteristics of the support during the cantilever bending test.

[0113] Conventional stents ( Figure 15A This is a standard stainless steel bracket that includes four elongated connectors positioned at 0 degrees, 90 degrees, 180 degrees, and 270 degrees between each ring and adjacent rings. It includes multi-directional hinges. Figure 15B The support structure includes two connectors located between each ring and the adjacent ring, these two connectors being separated by several linear segments of the ring, and as... Figure 1A , 1B Positioned as shown in 4A. Note that, Figure 15A and 15B The brackets in the series include the same ring structure and configuration, and differ only in the positioning and number of elongated connectors between the rings.

[0114] To create the FEA representation, the bracket design was modeled when expanded to an 8mm diameter, and then cantilever bending simulation was performed up to a distance of 19mm. Figure 15A This indicates that when subjected to this cantilever force, the conventional support begins to twist to the point where the lumen diameter and cross-sectional area decrease.

[0115] Including the same ring element structure incorporating a multi-directional hinge mechanism Figure 15B When the flexible portion of the stent is subjected to cantilever forces, the bending transition is smooth and there is no kinking. These visual representations indicate that the addition of a multi-directional articulation mechanism allows the stent to produce smooth bending, thereby allowing the stent to conform to the blood vessel in any direction.

[0116] Work Example Figures 16A-16E These are photographs of prototype brackets including the hinge mechanism of the present invention, such as... Figure 1A , 1B The flexible portion of the support shown in 1C and 4A. Figure 16A and 16B As shown, the prototype support is easier to bend in one direction to create a bend along the length of the support. Figure 16C The prototype support is shown to bend in both directions and bend to conform to the sharp corners without kinking. Figure 16D The prototype support is shown bent into a U-shape. Figure 16E A prototype support of this disclosure is shown, including features of the present disclosure that include torsion around a rod.

[0117] While various non-limiting embodiments of this disclosure have been described in detail for illustrative purposes, based on aspects currently considered most practical and preferred, it should be understood that such details are for that purpose only, and that this disclosure is not limited to the disclosed aspects but, on the contrary, is intended to cover modifications and equivalent arrangements falling within the spirit and scope of the appended claims. For example, it should be understood that this disclosure contemplates that, to the extent possible, one or more features of any aspect may be combined with one or more features of any other aspect.

Claims

1. An expandable multi-directional hinged bracket, the expandable multi-directional hinged bracket being configured to radially expand from a compressed configuration to an expanded configuration, the expandable bracket comprising: A plurality of radially expandable rings are aligned in series along a common axis and define a common lumen of the expandable stent extending through the plurality of rings, wherein the plurality of rings includes at least a first ring, a second ring, and a third ring aligned in series; as well as A plurality of elongated connectors extending between the plurality of rings, including (i) a first group comprising a first elongated connector and a second elongated connector, the first connector and the second connector connecting the first ring to the second ring to form a first hinge axis extending through the first connector and the second connector, the expandable support being configured to bend about the first hinge axis in a first direction, and (ii) a second group comprising a third elongated connector and a fourth elongated connector, the third connector and the fourth connector connecting the second ring to the third ring to form a second hinge axis extending through the third connector and the fourth connector, the expandable support being configured to bend about the second hinge axis in a second direction, wherein the first group of elongated connectors is axially and circumferentially offset from the second group of elongated connectors.

2. The expandable stent according to claim 1, wherein, The first set of elongated connectors is positioned such that the bending force required to bend the bracket a predetermined distance in a first direction at the first hinge axis is less than the bending force required to bend the bracket a predetermined distance in a second direction at the first hinge axis.

3. The expandable stent according to claim 1, wherein, The second set of elongated connectors is positioned such that the bending force required to bend the bracket a predetermined distance in the second direction at the second hinge axis is less than the bending force required to bend the bracket a predetermined distance in the first direction at the second hinge axis.

4. The expandable stent according to claim 1, wherein, The first elongated connector and the second elongated connector are adjacent to each other and circumferentially spaced at least 90 degrees around the perimeter of the bracket.

5. The expandable stent according to claim 1, wherein, The first set of elongated connectors is circumferentially offset from the second set of elongated connectors by 60 to 90 degrees around the perimeter of the bracket.

6. The expandable stent according to claim 1, wherein, The first elongated connector and the second elongated connector are either circumferentially spaced from each other by less than 90 degrees around the perimeter of the bracket or circumferentially spaced from each other by at least 90 degrees around the perimeter of the bracket.

7. The expandable stent according to claim 6, wherein, The first set of elongated connectors includes a fifth elongated connector and a sixth elongated connector, which are circumferentially spaced from each other about the common axis of the bracket in a manner symmetrical with respect to the first elongated connector and the second elongated connector.

8. The expandable stent according to claim 6, wherein, The third and fourth elongated connectors are either circumferentially spaced from each other by less than 90 degrees around the perimeter of the bracket, or circumferentially spaced from each other by at least 90 degrees around the perimeter of the bracket.

9. The expandable stent according to claim 1, wherein, The plurality of elongated connectors include at least one of a curved portion, a bent portion, a straight portion, or a pigtail-shaped portion.

10. The expandable stent according to claim 1, wherein, At least one of the plurality of rings or the plurality of elongated connectors comprises a biocompatible alloy, a biocompatible polymer, or a bioabsorbable material.

11. The expandable stent according to claim 1, wherein, At least one of the plurality of rings or the plurality of elongated connectors comprises stainless steel, cobalt-chromium alloy, or nickel-titanium alloy.

12. The expandable support of claim 1, further comprising a cover over at least a portion of the plurality of rings, wherein the cover comprises polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE).

13. The expandable stent according to claim 1, wherein, Each of the plurality of rings includes multiple linear segments connected end-to-end to form the peaks and valleys of the ring.

14. The expandable stent according to claim 13, wherein, At least one of the plurality of elongated connectors is connected to one of the plurality of rings at approximately the midpoint of the linear segment of the ring between the peak and the valley of the ring.

15. The expandable stent according to claim 13, wherein, The plurality of elongated connectors are arranged to form two axially extending helices passing through the plurality of rings, wherein: The first and second elongated connectors are circumferentially offset from the third and fourth elongated connectors by at least one linear segment; and The connection points on the second ring for the first elongated connector and the second elongated connector are circumferentially offset from the connection points on the second ring for the third elongated connector and the fourth elongated connector extending to the third ring.

16. The expandable stent according to claim 13, wherein, Compared to one of the peaks or valleys of the ring, at least one of the plurality of elongated connectors is connected to one of the rings at a point on the linear segment closer to the other of the peaks or valleys of the ring.

17. The expandable stent according to claim 13, wherein, At least one of the elongated connectors includes an inclined segment that is tilted relative to the common axis of the bracket, one end of the inclined segment connecting the elongated connector to the linear segment.

18. The expandable stent according to claim 17, wherein, Each of the first elongated connector and the second elongated connector includes a first end connected to a linear segment of the linear section of the first ring and a second end connected to a linear segment of the linear section of the second ring, wherein the linear segment of the second ring is not axially aligned with the linear segment of the first ring attached to the first end.

19. The expandable support according to claim 1, further comprising at least one rigid segment, the rigid segment comprising: The rigid segment comprises a plurality of radially expandable rings, which are aligned in series along the common axis and define a portion of the common lumen of the support. as well as A plurality of elongated connectors extending between the rings of the plurality of rings of the rigid segment, wherein at least three elongated connectors extend between each ring and an adjacent ring in the plurality of radially expandable rings of the rigid segment, and each elongated connector is separated from each adjacent elongated connector by no more than 120 degrees.

20. An expandable support, the expandable support being configured to radially expand from a compressed configuration to an expanded configuration, the expandable support comprising: A plurality of radially expandable rings are aligned in series along a common axis and define a common lumen of the expandable support extending through the plurality of rings; as well as A plurality of elongated connectors extending between the plurality of rings, the plurality of elongated connectors including at least a first pair of elongated connectors extending between a first ring and a second ring immediately adjacent to the first ring in the plurality of rings, and a second pair of elongated connectors extending between the first ring and the second ring. Each pair of elongated connectors is spaced less than 90 degrees apart from each other around the perimeter of the expandable support, and the first pair of elongated connectors and the second pair of elongated connectors are circumferentially spaced more than 90 degrees apart.

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