Method of using a self-adjusting brace assembly and kit including the brace assembly

Abstract

The present application relates to a method of using a self-adjusting stent assembly and a kit comprising the same. A method of using a self-adjusting stent assembly, comprising: estimating a body lumen diameter associated with a portion of a body lumen in which the stent assembly is to be placed; determining a target expanded stent diameter of the stent assembly to be placed in the portion of the body lumen based on the estimated diameter; selecting a stent assembly for stent implantation of the portion of the body lumen, wherein the stent assembly is configured to expand from an initial diameter to an expanded diameter within an expanded diameter range; wherein the expanded diameter range is from about 9 mm to about 5.5 mm; and wherein the target expanded stent diameter is within the expanded diameter range; and applying a persistent radial force to a wall of the portion of the lumen, wherein the radial force is less than about 0.33 N / mm.

Description

[0001] This application is a divisional application of application No. 201980067943.7, filed on October 16, 2019, having the title “Methods of using a self-adjusting stent assembly and kits including the same”. TECHNICAL FIELD

[0002] The present disclosure relates to stent devices and methods, and in particular to the use of a self-expanding, one-size-fits-all stent assembly for any body lumen diameter within a range of body lumen diameters, kits containing such stent assemblies, and instructions for stent implantation using such stent assemblies. BACKGROUND

[0003] Self-expanding stents generally have a tubular shape that is cut in a pattern that results in a spring-like motion of the stent assembly in the radial direction. The stent is placed in a blood vessel and the spring-like motion acts as a scaffold to support a lesion, hopefully restoring sufficient lumen in the blood vessel. Currently, these devices are designed to fit a specific blood vessel diameter and are used with instructions that generally are within 1-2 mm of the nominal diameter of the designed stent to minimize or avoid damage to the blood vessel wall. However, blood vessel diameters can vary by 5 mm or more. Therefore, the physician or other medical practitioner is required to use various imaging techniques to determine how large a stent assembly is needed. Additionally, the stent assembly can need to be placed in a portion of a blood vessel that has varying blood vessel diameters. In this case, the physician must choose a size that only corresponds to one of the diameters in the blood vessel and place it in that diameter portion of the blood vessel or use a tapered stent assembly to span the portion of the blood vessel having different blood vessel diameters. Often, the physician can choose the wrong stent size, which can result in either a stent that is too large or a stent that is too small. A stent that is too small can result in stent migration or failure to achieve full stent apposition, increasing the risk of thrombosis or migration over the stent edges. A stent that is too large can result in compression of the blood vessel wall and creation of restenosis or perforation.

[0004] SUMMARY

[0005] One aspect of the present disclosure describes in detail a method of using a stent assembly adapted for stent implantation for a range of body lumen sizes, the method comprising: providing stent implantation instructions comprising instructions to: estimate a body lumen diameter associated with a portion of a body lumen where a stent assembly is to be placed; determine a target expanded stent diameter for the stent assembly based on the estimated body lumen diameter; select a stent assembly for stent implantation of the portion of the body lumen based on the target expanded stent diameter, wherein the stent assembly is configured to expand from an initial diameter to one or more expanded diameters within an expanded diameter range while exerting a radial force of about 0.20 N / mm to about 0.33 N / mm, wherein the expanded diameter range is from about 5.5 mm to about 9 mm, and wherein the target expanded stent diameter is within the expanded diameter range; and providing the selected stent assembly in association with the stent implantation instructions. In a preferred embodiment, the stent assembly is implanted in the portion of the body lumen.

[0006] In one embodiment, the stent assembly is configured to expand to all diameters within the expanded diameter range. In another embodiment, the portion of the body lumen where the stent assembly is to be placed includes a lesion; and wherein estimating the body lumen diameter includes: a first estimated body lumen diameter spaced apart from the lesion in a first direction, and a second estimated body lumen diameter spaced apart from the lesion in a second direction, wherein the first direction is opposite the second direction. In another embodiment, the instructions further comprise instructions to: allow a first portion of the stent assembly to expand to a first expanded diameter within the expanded diameter range and allow a second portion of the stent assembly to expand to a second expanded diameter within the expanded diameter range when the portion of the body lumen defines a varying body lumen diameter. In a preferred embodiment, the first expanded diameter is different than the second expanded diameter. In yet another embodiment, the stent assembly comprises: a knitted stent jacket comprising an expandable mesh structure formed of fibers having a diameter between about 7 microns to about 40 microns; and an expandable stent operably associated with the knitted stent jacket, wherein the expandable mesh structure comprises a collapsed state associated with the initial diameter and a deployed state associated with the one or more expanded diameters, wherein the expandable mesh structure defines a pore having a minimum central dimension greater than about 100 microns and not greater than about 300 microns when prior to implantation and when the expandable mesh structure is in the deployed state, wherein the expandable mesh structure has a thickness greater than about 12.5 microns to not greater than about 100 microns.

[0007] In another aspect, the present disclosure includes a method of increasing the endoluminal expansion range of a stent assembly to one or more expanded diameters from about 5.5 mm to about 9 mm under conditions effective to extend the expansion range of the stent (where the applied chronic radial force is from about 0.20 N / mm to about 0.33 N / mm). In a preferred embodiment, the stent assembly includes a knitted stent sheath comprising an expandable mesh formed of fibers having a diameter between about 7 microns and about 40 microns, and an expandable stent operatively associated with the knitted stent sheath, wherein the expandable mesh comprises a collapsed state associated with an initial diameter and a deployed state associated with one or more expanded diameters, wherein the expandable mesh defines pores having a minimum central dimension greater than about 100 microns and not greater than about 300 microns when prior to implantation and when the expandable mesh is in the deployed state, wherein the expandable mesh has a thickness greater than about 12.5 microns to not greater than about 100 microns.

[0008] In another aspect, the present disclosure includes a method of stent implantation comprising: estimating a base reference diameter associated with a portion of a body lumen into which a stent assembly is to be placed; determining a target expanded stent diameter for the stent assembly to be placed in the portion of the body lumen based on the estimated base reference diameter; selecting a stent assembly for stent implantation into the portion of the body lumen, wherein the stent assembly is configured to expand from an initial diameter to one or more expanded diameters within an expanded diameter range, wherein the range of the one or more expanded diameters is from about 5.5 mm to about 9 mm, and wherein the target expanded stent diameter is within the range of the one or more expanded diameters; applying a chronic radial force to a wall forming the portion of the body lumen into which the stent assembly is to be placed, wherein the chronic radial force is less than about 0.33 N / mm. In a preferred embodiment, the stent assembly is implanted into the portion of the body lumen.

[0009] In one embodiment, the method includes implanting the stent assembly into a portion of a body lumen, including allowing the stent assembly to expand to an expanded diameter in a range of expansion diameters, such that the stent assembly exerts a persistent radial force to a wall of the portion of the body lumen into which the stent assembly is to be placed forming the body lumen, and wherein the persistent radial force is greater than about 0.20 N / mm. In a preferred embodiment, the stent assembly is configured to expand to all diameters between about 5.5 mm and about 9 mm. In another preferred embodiment, when the portion of the body lumen defines a varying body lumen diameter, implanting the stent assembly into the portion of the body lumen includes allowing a first portion of the stent assembly to expand to a first expanded diameter in a range of one or more expansion diameters, such that the first portion of the stent assembly exerts a persistent radial force to a wall of the portion of the body lumen into which the stent assembly is to be placed forming the body lumen, and allowing a second portion of the stent assembly to expand to a second expanded diameter in a range of one or more expansion diameters, such that the second portion of the stent assembly exerts a persistent radial force to a wall of the portion of the body lumen into which the stent assembly is to be placed forming the body lumen, and wherein the persistent radial force is greater than about 0.20 N / mm. In another preferred embodiment, the first expanded diameter is different than the second expanded diameter. In another preferred embodiment, the method includes allowing the first portion of the stent assembly to expand to the first expanded diameter and allowing the second portion of the stent assembly to expand to the second expanded diameter occur simultaneously. In another embodiment, the stent assembly includes a knitted stent sheath including an expandable mesh structure formed of fibers having a diameter of about 7 microns to about 40 microns; and an expandable stent operatively associated with the knitted stent sheath, wherein the expandable mesh structure includes a collapsed state associated with an initial diameter and a deployed state associated with an expanded diameter, wherein the expandable mesh structure defines a pore having a minimum central dimension of at least about 100 microns and no greater than about 300 microns prior to implantation and when the expandable mesh structure is in the deployed state, wherein the expandable mesh structure has a thickness of at least about 12.5 microns to no greater than about 100 microns.

[0010] In another aspect, the present disclosure includes a method of stent implantation into a plurality of body lumens, the method comprising positioning a first stent assembly in a contracted state within a first body lumen, expanding the first stent assembly to place the first stent assembly within the first body lumen in a deployed state, wherein the first stent assembly has a first expanded diameter when the first stent assembly is in the deployed state and exerts a first radial force against a first wall forming the first body lumen, positioning a second stent assembly in a contracted state within a second body lumen different from the first body lumen, and expanding the second stent assembly to place the second stent assembly within the second body lumen in a deployed state, wherein the second stent assembly has a second expanded diameter when the second stent assembly is in the deployed state and will exert a second radial force against a second wall forming the second body lumen, wherein the first stent assembly and the second stent assembly are at least substantially identical, and the second expanded diameter is greater than the first expanded diameter, and wherein the second expanded diameter is between about 220% to about 110% of the first expanded diameter, and wherein the second radial force is greater than about 50% of the first radial force.

[0011] In one embodiment, the method comprises expanding the second stent assembly to place the second stent assembly within the second body lumen in a deployed state, expanding a first portion of the second stent assembly to a second expanded diameter within a range of expanded diameters and expanding a second portion of the second stent assembly to a third expanded diameter within the range of expanded diameters when the second body lumen defines a varying body lumen diameter, and wherein the range of expanded diameters is about 9 mm to about 5.5 mm. In another embodiment, each of the first stent assembly and the second stent assembly comprises a knitted stent sheath comprising an expandable mesh structure formed of fibers having a diameter of about 7 microns to about 40 microns and an expandable stent operatively associated with the knitted stent sheath; wherein the expandable mesh structure transitions from a contracted state to a deployed state, wherein the expandable mesh structure defines pores having a minimum central dimension of at least about 100 microns and no greater than about 300 microns prior to implantation and when the expandable mesh structure is in the deployed state, wherein the expandable mesh structure has a thickness of at least about 12.5 microns to no greater than about 100 microns.

[0012] In another aspect, the present disclosure includes a kit comprising: a stent assembly comprising: a knitted stent jacket comprising an expandable mesh structure formed of individual fibers having a diameter of about 7 microns to about 40 microns; and an expandable stent operatively associated with the knitted stent jacket; wherein the expandable mesh structure comprises a contracted state and an expanded state, and wherein the expandable mesh structure defines a lumen having a minimum central dimension of at least about 160 microns in the expanded state, wherein the expandable mesh structure has a thickness of at least about 12.5 microns to no more than about 100 microns, and instructions for use set forth a method of expanding the stent assembly to any expanded diameter within a range of about 5.5 mm to about 9 mm while applying a persistent radial force of about 0.2 N / mm to about 0.33 N / mm.

[0013] In one embodiment, the instructions for use include the following instructions: estimating a body lumen diameter associated with a portion of a body lumen where the stent assembly is to be placed; determining a target expanded stent diameter of the stent assembly based on the estimated body lumen diameter; selecting a stent assembly for stent implantation of the portion of the body lumen based on the target expanded stent diameter, wherein the stent assembly is configured to expand from an initial diameter to any expanded diameter within an expanded diameter range while applying a radial force of about 0.20 N / mm to about 0.33 N / mm; wherein the target expanded stent diameter is within the expanded diameter range; and implanting the stent assembly into the portion of the body lumen. In another embodiment, the stent assembly is configured to expand to all diameters within the expanded diameter range. In yet another embodiment, the instructions for use further include the following instructions: when the portion of the body lumen defines a varying body lumen diameter, allowing a first portion of the stent assembly to expand to a first expanded diameter within the expanded diameter range and allowing a second portion of the stent assembly to expand to a second expanded diameter within the expanded diameter range. In yet another embodiment, the first expanded diameter is different than the second expanded diameter.

[0014] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be limiting.

[0015] In particular, the present application provides the following:

[0016] 1). A method of using a stent assembly adapted for stent implantation of a range of body lumen sizes, the method comprising:

[0017] A stent implantation guideline is provided, including the following guidelines:

[0018] estimating a body lumen diameter associated with a portion of a body lumen where a portion of the stent assembly is to be placed;

[0019] determining a target expanded stent diameter of the stent assembly based on the estimated body lumen diameter;

[0020] selecting the stent assembly for stent implantation of the portion of the body lumen based on the target expanded stent diameter, wherein the stent assembly is configured to expand from an initial diameter to one or more expanded diameters within an expanded diameter range while exerting a radial force of about 0.20 N / mm to about 0.33 N / mm;

[0021] wherein the expanded diameter range is about 5.5 mm to about 9 mm; and

[0022] wherein the target expanded stent diameter is within the expanded diameter range; and

[0023] providing a selected stent assembly associated with the stent implantation guideline.

[0024] 2). The method of 1), wherein the stent assembly is configured to expand to all diameters within the expanded diameter range.

[0025] 3). The method of 1),

[0026] wherein the portion of the body lumen where the stent assembly is to be placed comprises a lesion; and

[0027] wherein the estimated body lumen diameter comprises:

[0028] a first estimated body lumen diameter spaced apart from the lesion in a first direction; and

[0029] a second estimated body lumen diameter spaced apart from the lesion in a second direction;

[0030] wherein the first direction is opposite the second direction.

[0031] 4). The method of 1), wherein the guideline further includes the following guidelines:

[0032] allowing a first portion of the stent assembly to expand to a first expanded diameter within the expanded diameter range and allowing a second portion of the stent assembly to expand to a second expanded diameter within the expanded diameter range when the portion of the body lumen defines a varying body lumen diameter.

[0033] 5). The method of 4), wherein the first expanded diameter is different than the second expanded diameter.

[0034] 6). The method according to any of 1) to 5), wherein the stent assembly comprises:

[0035] a knitted stent jacket comprising an expandable mesh structure formed of fibers having a diameter between about 7 microns to about 40 microns; and

[0036] an expandable stent operatively associated with the knitted stent jacket;

[0037] wherein the expandable mesh structure comprises a collapsed state associated with the initial diameter and a deployed state associated with the one or more expanded diameters, wherein the expandable mesh structure defines a pore having a minimum central dimension greater than about 100 microns and no greater than about 300 microns prior to implantation and when the expandable mesh structure is in the deployed state, wherein the expandable mesh structure has a thickness greater than about 12.5 microns to no greater than about 100 microns.

[0038] 7). A stent implantation method, comprising:

[0039] estimating a base reference diameter associated with a portion of a body lumen where a stent assembly is to be placed;

[0040] determining a target expanded stent diameter of the stent assembly to be placed in the portion of the body lumen based on the estimated base reference diameter;

[0041] selecting the stent assembly for stent implantation of the portion of the body lumen, wherein the stent assembly is configured to:

[0042] expand from an initial diameter to one or more expanded diameters within a range of expanded diameters;

[0043] wherein the range of the one or more expanded diameters is about 5.5 mm to about 9 mm;

[0044] wherein the target expanded stent diameter is within the range of the one or more expanded diameters; and

[0045] applying a persistent radial force to a wall forming the portion of the body lumen where the stent assembly is to be placed, wherein the persistent radial force is less than about 0.33 N / mm.

[0046] 8). The method according to 7), further comprising expanding the stent assembly to an expanded diameter within the range of expanded diameters such that the stent assembly applies the persistent radial force to the wall forming the portion of the body lumen where the stent assembly is to be placed; and

[0047] wherein the persistent radial force is greater than about 0.20 N / mm.

[0048] 9). According to the method described in 7),

[0049] Wherein, when the portion of the body cavity defines a varying body cavity diameter,

[0050] Allowing a first portion of the stent assembly to expand to a first expansion diameter within the range of the one or more expansion diameters, such that the first portion of the stent assembly applies the sustained radial force to the wall forming the body cavity on which the portion of the stent assembly will be placed; and

[0051] Allowing the second portion of the stent assembly to expand to a second expansion diameter within the range of the one or more expansion diameters, such that the second portion of the stent assembly applies the sustained radial force to the wall forming the body cavity where the portion of the stent assembly will be placed; and

[0052] The sustained radial force is greater than approximately 0.20 N / mm.

[0053] 10) The method according to 9), wherein the first expansion diameter is different from the second expansion diameter.

[0054] 11) The method according to 9) or 10), wherein allowing the first portion of the stent assembly to expand to the first expansion diameter and allowing the second portion of the stent assembly to expand to the second expansion diameter occur simultaneously.

[0055] 12) The method according to 7), 8), or 9), wherein the support assembly comprises:

[0056] A knitted support sheath comprising an expandable mesh structure formed of fibers with diameters ranging from about 7 micrometers to about 40 micrometers; and

[0057] An expandable support, which is operatively associated with the knitted support sheath;

[0058] The expandable mesh structure includes a contracted state associated with the initial diameter and an expanded state associated with the expanded diameter, wherein the expandable mesh structure defines a pore with a minimum central size of at least about 100 micrometers and no more than about 300 micrometers before implantation and when the expandable mesh structure is in the expanded state, and wherein the expandable mesh structure has a thickness of at least about 12.5 micrometers and no more than about 100 micrometers.

[0059] 13) A method for increasing the intraluminal expansion range of a stent assembly to one or more expansion diameters from about 5.5 mm to about 9 mm while effectively expanding the expansion range of the stent, wherein the applied sustained radial force is from about 0.20 N / mm to about 0.33 N / mm, wherein the stent assembly comprises:

[0060] a knitted stent jacket comprising an expandable mesh structure formed of fibers having a diameter between about 7 microns to about 40 microns; and

[0061] an expandable stent operatively associated with the knitted stent jacket;

[0062] wherein the expandable mesh structure comprises a collapsed state associated with an initial diameter and a deployed state associated with the one or more expanded diameters, wherein the expandable mesh structure defines a pore having a minimum central dimension greater than about 100 microns and no greater than about 300 microns prior to implantation and when the expandable mesh structure is in the deployed state, wherein the expandable mesh structure has a thickness greater than about 12.5 microns to no greater than about 100 microns.

[0063] 14). A kit comprising:

[0064] a stent assembly comprising:

[0065] a knitted stent jacket comprising an expandable mesh structure formed of individual fibers having a diameter between about 7 microns to about 40 microns; and

[0066] an expandable stent operatively associated with the knitted stent jacket;

[0067] wherein the expandable mesh structure comprises a collapsed state and a deployed state, wherein the expandable mesh structure defines a pore having a minimum central dimension of at least about 160 microns in the deployed state, and wherein the expandable mesh structure has a thickness of at least about 12.5 microns to no greater than about 100 microns; and

[0068] instructions for use setting forth a method for expanding the stent assembly to any expanded diameter ranging from about 5.5 mm to about 9 mm while applying a persistent radial force of about 0.2 N / mm to about 0.33 N / mm.

[0069] 15). The kit of 14), wherein the instructions for use comprise the following instructions for use:

[0070] estimating a body lumen diameter associated with a portion of a body lumen where the stent assembly is to be placed;

[0071] determining a target expanded stent diameter of the stent assembly based on the estimated body lumen diameter;

[0072] selecting the stent assembly for stent implantation of the portion of the body lumen based on the target expanded stent diameter, wherein the stent assembly is configured to expand from an initial diameter to any expanded diameter within an expanded diameter range while exerting a radial force of about 0.20 N / mm to about 0.33 N / mm;

[0073] wherein the target expanded stent diameter is within the expanded diameter range; and

[0074] implanting the stent assembly into the portion of the body lumen.

[0075] 16). The kit of 14) or 15), wherein the stent assembly is configured to expand to all diameters within the expanded diameter range.

[0076] 17). The kit of 14) or 15), wherein the instructions further comprise instructions to:

[0077] allowing a first portion of the stent assembly to expand to a first expanded diameter within the expanded diameter range and allowing a second portion of the stent assembly to expand to a second expanded diameter within the expanded diameter range when the portion of the body lumen defines a varying body lumen diameter.

[0078] 18). The kit of 17), wherein the first expanded diameter is different than the second expanded diameter. BRIEF DESCRIPTION OF DRAWINGS

[0079] In the following description, non-limiting embodiments of examples of the present disclosure are described with reference to the accompanying drawings, which are meant to be non-limiting. In the drawings, like or similar elements are denoted by identical or similar reference signs, and the size of the components and features shown in the drawings can be chosen for convenience or clarity rather than to scale. The drawings are as follows:

[0080] Figure 1 is a perspective view of an enhanced stent apparatus in an open, non-crimped mode according to an example embodiment of the present disclosure;

[0081] Figure 2 is a cross-sectional side view of an enhanced stent apparatus according to an example embodiment of the present disclosure;

[0082] Figure 3 is an illustration of an enhanced stent apparatus in situ in an open mode according to an example embodiment of the present disclosure;

[0083] Figure 4is a perspective view of a reinforced stent device with multiple helical coils in an open mode, according to example embodiments of the present disclosure;

[0084] Figure 5 is a perspective view of a reinforced stent device in a crimped, closed mode, according to example embodiments of the present disclosure;

[0085] Figure 6a is a perspective view of a reinforced stent device with a knitted porous structure in an open mode, according to example embodiments of the present disclosure;

[0086] Figure 6b is a detailed view of a knitted porous structure, according to example embodiments of the present disclosure;

[0087] Figure 7 is a perspective view of a reinforced stent device with a braided porous structure, according to example embodiments of the present disclosure;

[0088] Figure 8 is a perspective view of a reinforced stent device provided with longitudinally non-stretchable wires and horizontally stretchable elastomers, according to example embodiments of the present disclosure;

[0089] Figure 9 is a perspective view of a reinforced stent device, according to example embodiments of the present disclosure, wherein the porous structure is longer than the support element;

[0090] Figure 10 is a perspective view of a reinforced stent device, according to example embodiments of the present disclosure, wherein the porous structure is significantly larger in diameter than the crimped support element, and is folded on itself in order to be inserted into the lumen;

[0091] Figure 11 is a perspective view of a porous structure significantly larger in diameter than an at least partially deflated balloon, according to example embodiments of the present disclosure, wherein the porous structure is folded on itself in order to be inserted into the lumen;

[0092] Figure 12 use of a funnel to reduce the diameter of at least the porous structure, according to example embodiments of the present disclosure, is shown;

[0093] Figure 13 use of a stretchable rubber tube to manufacture a compressed porous structure, according to example embodiments of the present disclosure, is shown;

[0094] Figure 14is a graph showing the fiber thickness versus the percentage of the porous structure surface area of a stent device according to an example embodiment of the present disclosure;

[0095] Figure 15 is a detailed illustration of a threading method for securing a porous structure to a support element according to an example embodiment of the present disclosure;

[0096] Figure 16 is a detailed illustration of a knotting method for securing a porous structure to a support element according to an example embodiment of the present disclosure;

[0097] Figure 17 is a cross-sectional view of an enhanced stent device showing a porous structure folding technique according to an example embodiment of the present disclosure;

[0098] Figure 18 is a schematic diagram showing a method for manufacturing a porous structure according to an example embodiment of the present disclosure;

[0099] Figure 19a is an illustration of a typical aneurysm in the prior art;

[0100] Figure 19b is an illustration of the prior art for treating an aneurysm;

[0101] Figure 19c is an illustration of a technique for treating an aneurysm according to an example embodiment of the present disclosure;

[0102] Figure 20 is a graphical illustration of the reaction force of a prior art stent device by crimping and then expanding according to an example embodiment of the present disclosure;

[0103] Figure 21 is a graphical illustration of the reaction force of a stent device of Figure 1 by crimping and then expanding according to an example embodiment of the present disclosure;

[0104] Figure 22 is a table detailing the reaction force of a stent device of Figure 1 by crimping and then expanding according to an example embodiment of the present disclosure;

[0105] Figure 23 is a flowchart showing a method of operating a device of Figure 1 according to an example embodiment of the present disclosure;

[0106] Figure 24 is a cross-sectional view of a blood vessel according to an example embodiment of the present disclosure;

[0107] Figure 25It is in a contracted state according to the example implementation of this disclosure and Figure 24 The blood vessels extend Figure 1 Cross-sectional view of the support device;

[0108] Figure 26 It is an example implementation of this disclosure that is in an unfolded state and Figure 24 The blood vessels extend Figure 1 Cross-sectional view of the support device;

[0109] Figure 27 It details the exemplary implementation schemes according to this disclosure. Figure 1 A table summarizing information on unidentified patients related to experimental testing of one implementation of a stent assembly;

[0110] Figure 28a This is a cross-sectional view of a slip ring in a reduced profile configuration according to an example embodiment of this disclosure;

[0111] Figure 28b This is a cross-sectional view of a slip ring in its unfolded configuration according to an example embodiment of this disclosure;

[0112] Figure 29 This is a cross-sectional view of a porous structure overgrown with endothelial cells according to an example embodiment of the present disclosure;

[0113] Figure 30 This is a diagram of the current state of the technology, in which endothelial cell clusters separate from the scaffold struts;

[0114] Figures 31a-31d The deployment of a self-expanding stent according to an embodiment of this disclosure is shown;

[0115] Figures 32-35 In situ, in-situ details of typical stent sheath materials in the art are shown; and

[0116] Figure 36 A portion of a knitted support sheath according to an embodiment of the present disclosure is shown;

[0117] Figure 37 An embodiment according to this disclosure is shown. Figure 36 A plan view of the knitted support sheath;

[0118] Figures 38-39 The embodiments shown in this disclosure include Figure 36 Details of the material of the knitted support sheath; and

[0119] Figure 40 The embodiments according to this disclosure are shown in situ. Figure 9 The in-situ details of the material shown.

[0120] Detailed description of example embodiments

[0121] Aspects of the present disclosure address the aforementioned shortcomings of the prior art by providing a so-called universal stent assembly. The universal stent assembly is configured to be suitable for use with a variety of different body lumen diameters, whether the body lumen is a straight body lumen (having a substantially uniform diameter) or a body lumen of varying diameter (having a diameter that varies), or even a branched or bifurcated body lumen. Thus, use of the universal stent assembly eliminates or reduces sizing errors and reduces the number of different sized stent assemblies that need to be available on hand at a patient treatment or prevention site, such as a hospital.

[0122] This application is divided into multiple classification listing sections, which generally include, in order: descriptions of devices (e.g., porous structures, stents, etc.), materials and methods for making the devices, drugs for use with the devices, and methods of using the devices. It should be understood that the section headings are for clarity only and are not intended to limit the subject matter described in each section. Furthermore, some of the subject matter described in a particular section can be addressed in more than one section, and thus, some material can be duplicated between sections.

[0123] INTRODUCTION

[0124] Aspects of the present disclosure successfully address the shortcomings of the prior art by providing a stent assembly that is configured to be expandable to any diameter within a range of diameters to provide a persistent radial force of between about 0.33 N / mm and about 0.20 N / mm.

[0125] According to some embodiments of the present disclosure, the stent assembly reduces risks and errors associated with selecting a particular stent assembly size.

[0126] According to some embodiments of the present disclosure, the stent assembly reduces the number of stent assemblies that need to be kept on hand. This can advantageously allow smaller medical facilities to bear the cost of having on hand stent assemblies for a variety of body lumen sizes, and more generally, to minimize the cost of having on hand a large inventory of different devices for emergency situations.

[0127] According to some embodiments of the present disclosure, the stent assembly provides a known, predetermined radial force expectation for all diameters within the range.

[0128] According to some embodiments of the present disclosure, the stent assembly provides better accommodation of different diameters of a body lumen (e.g., a blood vessel) over the length of the implantation mesh.

[0129] According to some embodiments of the present disclosure, the stent assembly includes fibers having a low diameter that allows each endothelial cell to completely cover and overlap one or more fibers, thereby forming a layer of endothelial cells that adhere to tissue on both sides of the fibers. The endothelial layer thus formed is substantially stable, greatly reducing the tendency to detach and form emboli, which can provide improved patient outcomes.

[0130] According to some embodiments of the present disclosure, the mesh fibers include a material that promotes endothelial cell adhesion, thereby promoting stability of the endothelial layer.

[0131] According to some embodiments of the present disclosure, the mesh is not secondarily treated, e.g., with a chemical coating that can reduce endothelial adhesion. Moreover, the absence of a chemical coating helps to maintain low bulk fibers and fiber junctions, where a first fiber passes over or under a second fiber, which is another feature that contributes to endothelial layer stability. In such embodiments, it is possible to infuse one or more agents into the fibers or into another layer or portion of the stent assembly to provide the benefits of such agents while avoiding the shortcomings of chemical coatings.

[0132] According to some embodiments of the present disclosure, each mesh fiber is spaced apart from adjacent fibers by a distance that minimizes or prevents the risk of a single endothelial cell adhering to more than one fiber, thereby reducing the opportunity for an endothelial cell to dislodge from the stent, e.g., due to natural stent pulsations during blood flow.

[0133] According to some embodiments of the present disclosure, the stent sheath optionally includes a knitted mesh. According to some embodiments of the present disclosure, the stent sheath mesh is optionally formed from a single fiber or a single set of fibers.

[0134] Overview of enhanced stent devices

[0135] In some embodiments of the present disclosure, the present disclosure relates to stent assemblies, such as those set forth in PCT Patent Application PCT / IB2006 / 051874, the disclosure of which is hereby expressly incorporated herein by reference. The methods and kits disclosed herein can be used, for example, with the various stent assemblies disclosed in that PCT application.

[0136] In one example embodiment of the present disclosure, a device is provided that includes a porous structure and an optional underlying support element, e.g., a stent (where underlying means that the porous structure is between the support element and the lumen wall).

[0137] In some example embodiments of the disclosure, a reinforced stent device comprising a porous structure and a stent is used to treat stenosis and / or restenosis. In some example embodiments of the disclosure, the reinforced stent device provides at least one of a plurality of benefits over conventional arterial stents. For example, the reinforced stent device is optionally used to prevent embolization from plaque entering the blood stream, as the porous structure is made with sufficiently small pores (size given below) to keep dislodged plaque in place. In one embodiment of the disclosure, the porous structure is used in place of an embolic protection device during stent implantation. Optionally, a "umbrella" type embolic protection device is not used. Optionally, the porous structure is used in conjunction with an embolic protection device in order to obtain enhanced protection over methods using embolic protection devices during implantation of conventional arterial stents. In one embodiment of the disclosure, the reinforced stent device delivers a wider range of pharmacological assistance to the treatment area than a conventional stent. In some embodiments of the disclosure, the reinforced stent device is optimized to promote endothelial cell growth and / or migration. For the sake of clarity, the porous structure can be a mesh stent sheath as described herein.

[0138] Figure 1 A perspective view of a reinforced stent assembly or stent device 100 in one example embodiment of the disclosure is shown. The support element 102 is designed and configured to expand a blood vessel in a radial manner from a central axis 106 of the reinforced stent device 100. Optionally, the support element 102 is tubular in shape. In some example embodiments of the disclosure, the support element 102 is composed of a flexible biocompatible material. Optionally, the support element 102 is composed of stainless steel, nitinol and / or cobalt-chromium alloy and / or other metal alloys (e.g. magnesium alloys). Optionally, the support element 102 is composed of a biostable or bioabsorbable polymer. In some example embodiments of the disclosure, the support element 102 is a vascular stent, such as those made of and / or polymer.

[0139] In one example embodiment of the disclosure, the support element 102 is covered by at least one porous structure 104. Optionally, the support element 102 serves as a support structure for the porous structure 104, for example to provide radial support and / or to maintain the desired shape of the porous structure 104. Figure 2 A cross-sectional view of the reinforced stent device is shown. In this embodiment, the support element 102 provides structural support for the porous structure 104 that is located on the outside of the support element 102.

[0140] In some example embodiments of the disclosure, the porous structure 104 is placed on the outside of the support element 102, thereby overlapping the gaps in the support element 102 (making the aperture size of the device generally smaller, e.g., 150 microns), as conventional stent structures typically create multiple gaps in the structure of the strut, typically several millimeters. In other example embodiments of the disclosure, the porous structure 104 covers only a portion of the support element 102. For example, only a portion of the support element 102 is covered to avoid restricting luminal flow to the branch vessels.

[0141] In some example embodiments of the disclosure, the porous structure 104 extends beyond at least one end of the support element 102. For example, this can better address the inner surface of the blood vessel at the edge of the enhanced stent device 100, where restenosis is more likely to occur. In example embodiments of the disclosure, the porous structure 104 pads and / or treats the trauma caused by the edge of the support element 102 by extending beyond at least one end of the support element 102. Optionally, the porous structure 104 extends beyond the end of the support element 102 by no more than 1 mm. Optionally, the porous structure 104 extends beyond the end of the support element 102 by more than 1 mm. Optionally, the porous structure 104 extends beyond only one end or both ends of the support element 102 (as shown). Figure 9

[0142] In some example embodiments of the disclosure, the porous structure 104 is attached to the support element 102 to prevent the porous structure 104 from unraveling and / or causing tissue irritation and / or to avoid the porous structure from detaching from the support element during deployment. Optionally, the ends of the porous structure 104 are folded over the ends of the support element 102 and attached, thereby providing a cushion for the edges that can cause trauma. Optionally, the ends of the porous structure 104 are folded over themselves and remain folded due to the pressure between the support element and the lumen. In one embodiment of the disclosure, a process, such as heating, is used to make the fold sharp and / or permanent.

[0143] It should be understood that while in Figure 1 and Figure 2 ​Example configurations of the enhanced stent device are shown in FIGS. 1-3, but other configurations can also be used, including: porous structures 104 on the drug-eluting support elements; drug-eluting porous structures on the support elements 102; drug-eluting porous structures on the drug-eluting support elements; support elements between at least two porous structures (optionally, some or all of the eluting drug); and enhanced stents comprising multiple layers exhibiting different selectable properties, such as degradation time and / or drug elution. It is understood that any of the above configurations include biodegradable and / or bioabsorbable materials. Optionally, the configuration is selected for the specific treatment regimen indicated by the patient's condition.

[0144] In some example embodiments of the disclosure, the porous structure 104 is used to control the local pressure exerted by the enhanced stent device to the body lumen wall. For example, when the porous structure at least partially covers the stent, the pressure exerted per unit area by the enhanced stent device can be varied by increasing or decreasing the coverage area of the porous structure. In some embodiments of the disclosure, the modification of the coverage area needs to take into account factors such as the stiffness of the support elements 102 and the geometry of the support struts of the support elements 120 and / or the coverage area. In one embodiment of the disclosure, pressure control is used to reduce the likelihood of the enhanced stent device causing plaque to dislodge from the lumen wall. In some embodiments of the disclosure, pressure control is used to reduce the tissue trauma typically caused by stent implants, thereby enhancing the protection against stenosis / restenosis. Furthermore, in some embodiments of the disclosure, previous support elements 102 struts that could not be used because they might traumatize the lumen tissue can optionally be used in conjunction with the porous structure 104.

[0145] In some example embodiments of the disclosure, at least one porous structure as described herein is used to treat a bile duct. For example, bile ducts are often clogged by debris (e.g., cholesterol) that restricts flow. Treatment of the bile duct using the enhanced stent device can increase the diameter of the bile duct, improving the operation of the bile duct.

[0146] It is known that different types of body lumens have different surface textures (two body lumens are different from each other), and sometimes different surface textures within one type of lumen. Therefore, in some example embodiments of the disclosure, different porous structures having different surface texture configurations are manufactured and / or used according to the internal surface texture of the lumen being treated. For example, the peaks and valleys in the body lumen mate with the counter peaks and counter valleys of the porous structure (i.e., the counter peaks of the porous structure enter the lumen valleys, and the counter valleys of the porous structure receive the lumen peaks). Optionally, the counter peaks and counter valleys have the same amplitude as the peaks and valleys present in the lumen being treated.

[0147] It is understood that the pore size, the thickness of the porous structure, the thickness of the fibers (or French), and / or the coverage area vary depending on the application. For example, when treating the carotid artery, it is desirable to prevent debris larger than 100 microns from reaching the brain, and thus the porous structure is designed such that when the stent is expanded to a typical diameter of about 8 mm, the majority of the pore size is less than 100 microns. As another example, when treating the coronary artery, larger debris (> 100 microns) is not a problem, and the endotheliazation process and non-restriction of flow to side branches are more important. Thus, for coronary artery applications, the pores in the porous structure are optionally greater than 100 microns and less than 300 microns when the support element 102 is in the expanded position (typically a diameter of about 3 mm). In some embodiments of the present disclosure, the rate at which the porous structure grows endothelial cells can be adjusted by increasing and / or decreasing the thickness of the fibers and the thickness of the porous structure.

[0148] In one example embodiment of the present disclosure, the thickness of the porous structure 104 is less than 100 microns. In some example embodiments of the present disclosure, the thickness of the porous structure is less than 30 microns. Optionally, the thickness of the porous structure is less than 10 microns. For example, the thickness of the porous structure is less than 5 microns or 1 micron. Optionally, the porous structure 104 includes at least one thin, linear fiber. In some example embodiments of the present disclosure, the porous structure 104 includes at least one fiber having a thickness of 40 nm to 40 microns. Optionally, the fiber thickness is similar to or less than the diameter of an endothelial cell to facilitate the growth of endothelial cells between and / or around the at least one fiber. In one example embodiment of the present disclosure, the porous structure 104 is constructed using super-fiber, wherein the super-fiber is made of a plurality of fibers woven together. Optionally, the super-fiber is used to increase the strength of the porous structure 104.

[0149] In one example embodiment of the present disclosure, the fibers of the porous structure 104 are spun and / or knitted and / or woven and / or braided to provide structure to the porous structure 104 and to provide pores 110 in the porous structure 104. Optionally, the porous structure is woven in a uniform pattern. Optionally, the porous structure is constructed such that the fibers are randomly located in the porous structure 104. Optionally, the porous structure 104 is constructed using polymeric fibers. Optionally, a polymeric covering is applied to the porous structure 104 and / or the support element 102. Example porous structure fabrication is described in more detail in the "Fabrication Methods" section below.

[0150] In one example embodiment of the disclosure, the polymer-coated porous structure 104 is optionally made from a closed interlocking design and / or an open interlocking design or a semi-open design similar to the typical support element 102 design. The open interlocking design is advantageous when side branching is required. When treating the junction of two blood vessels, it is sometimes necessary to introduce a stent through the side of the other blood vessel. The open interlocking design allows for this procedure and, when the porous structure is made from a metal mesh, the open interlocking design is used in order to allow for easy side branch stents. Optionally, the use of a biodegradable polymer coating on a non-biodegradable support element 102 will leave an embedded support element 102 after the biodegradable polymer degrades.

[0151] In one example embodiment of the disclosure, the porous structure 104 is crimped to a small diameter while still maintaining its flexibility in order to be able to successfully navigate through a patient's blood vessels to the site where the enhanced stent device 100 is to be implanted. In one example embodiment of the disclosure, the porous structure 104 is expandable so that the porous structure 104 is able to expand along with the support element 102 when the porous structure 104 is deployed at the treatment site within the patient's blood vessel. Optionally, the expansion of the porous structure 104 along the longitudinal axis matches the expansion of the support element 102 along the longitudinal axis.

[0152] In one example embodiment of the disclosure, at least the porous structure 104 is expandable without significantly shortening or lengthening the length of the porous structure 104. For example, in some embodiments, at least the porous structure 104 is expandable with less than about 20% shortening, less than about 15% shortening, less than about 10% shortening, or less than about 6% shortening, or about 6% shortening. Generally, the percentage of shortening is defined as 100 x (change in length ÷ loaded length or final length). Optionally, the expansion of the porous structure 104 is different than the support element 102, for example using a sliding connection as described herein. As described elsewhere herein, in a knitted embodiment of the porous structure 104, the expansion occurs at least in part due to the knitted structure and not necessarily because of the elasticity of the fibers used in constructing the porous structure 104. In one embodiment of the disclosure, at least one fiber comprising the porous structure 104 is provided with slack during manufacturing in order to provide additional fiber material when the porous structure 104 is expanded. Figure 8 A perspective view of an enhanced stent device 900 is shown. According to one example embodiment of the disclosure, the enhanced stent device 900 is provided with non-stretchable wire 902 and stretchable elastomeric fibers 904. This embodiment helps to maintain the length of the overall device 900 while allowing for expandability and flexibility during implantation.

[0153] In one example embodiment of the disclosure, an enhanced stent device is provided that includes at least one expandable support element and an expandable porous structure. The support element is optionally a stent, examples of which are known in the art for use in providing therapy to various body lumens. In one embodiment of the disclosure, the porous structure has a structure similar to a fishing net. In one embodiment of the disclosure, the porous structure is knitted from fibers of about 15-20 microns in diameter, has a coverage area of less than 20% and has a pore size of about 150 x 200 microns. In some embodiments of the disclosure, the porous structure is at least temporarily attached to the support struts of the support element by stitching. Optionally, the stitches are loose to allow the porous structure to slide on the support struts, for example providing the additional expandability described herein with respect to Figure 15 The stitching is optionally biodegradable. In some embodiments of the disclosure, the support element and / or the porous structure are adapted to elute a medicament into the body lumen being treated.

[0154] In some embodiments of the disclosure, different features of the enhanced stent device are selected according to the intended use or treatment to be performed. For example, the pore size is optionally selected according to the need to provide embolic shower protection from debris of a certain size. As another example, the coverage area is optionally selected to modify the local pressure on the lumen being treated. Many of these features are interrelated, for example as described herein and as shown in Figure 14

[0155] In one embodiment of the disclosure, the porous structure 104 is flexible to allow the lumen to naturally change its diameter to cause a change in pressure in the lumen and / or to respond to muscle activity. In some embodiments of the disclosure, the porous structure 104 is divided into multiple semi-independent zones that react differently to stimuli within or from the lumen. Optionally, the multiple zones are used to prevent the lumen from banding across the length of the porous structure 104.

[0156] Example properties and performance of the porous structure

[0157] ​In one embodiment of the present disclosure, the manufacturing techniques described in greater detail below (e.g., providing the individual fibers or portions of the porous structure 104 with a relaxed knit) enable the porous structure 104 to optionally expand up to 10 times its diameter at insertion (insertion diameter described in greater detail below) when deployed. For example, in coronary artery applications, the porous structure 104 can expand from 1 mm to 3 mm in diameter. In other examples, the porous structure 104 can expand from 2 mm to 8 mm in carotid artery applications, and from 0.3 mm to 2.5 mm in cerebral applications. These values are approximate and are merely used for illustration purposes. In one embodiment of the present disclosure, the expansion of the porous structure 104 is achieved in at least one of the following three ways: 1) the knit / braid / weave structure of the porous structure 104 (including fiber relaxation and crimped fibers); 2) the fibers from which the porous structure 104 is made are at least slightly elastic; 3) the sliding connection between the porous structure 104 and the support element 102 (described below) allows the porous structure 104 to shift relative to the support element 102 within certain limits during expansion. In one embodiment of the present disclosure, the fibers from which the porous structure 104 is made include from about 2% to about 80% non-elastic material. In some embodiments of the present disclosure, the elastic material of the fibers from which the porous structure 104 is made allows expansion up to 1000% of its original size.

[0158] In some example embodiments of the present disclosure, the porous structure 104 exhibits high durability when subjected to twisting, turning, compression, and / or elongation, which allows the porous structure 104 to withstand the delivery process through the patient's vasculature to the treatment site. In one embodiment of the present disclosure, the porous structure 104 can be loosely attached to the support element 102 at several locations and folded for insertion into a lumen. The folded porous structure 104 provides a reduced diameter device for easier insertion into a patient's body lumen.

[0159] In some example embodiments of the present disclosure, 20% of the total area of the porous structure 104 includes pores having an approximate diameter of no more than 50 microns, 200 microns, or more than 200 microns in the expanded configuration. It is recognized that during the process of manufacturing the porous structure (e.g., manufacturing with certain manufacturing techniques such as electrospinning and / or knitting), the pores created within the porous structure can overlap. This overlap effectively creates a pore size that is smaller than the specified value. However, in some example embodiments of the present disclosure, the effective nominal pore size is no more than 50 microns, 200 microns, or more than 200 microns in diameter. In some embodiments of the present disclosure, the pore size is selected to promote endothelial cell overgrowth at a certain rate.

[0160] It should be noted that due to the manufacturing of the porous structure 104 and / or the desired performance, the shape of the pores can change at least to some extent. For example, in a knitted porous structure, the pores are most likely to be generally square. Conversely, a woven porous structure can produce square and / or rectangular pores, while a braided porous structure can exhibit quadrilateral pores, as shown in Figure 7 When describing the approximate "diameter" of a pore, it should be recognized that all, some, or none of the pores will be actually circular, square, rectangular, and / or quadrilateral that can be simply area measured using a diameter. Thus, the use of diameter is merely an approximation method of illustrating the pore size. For example, the "diameter" can be the distance between two parallel sides of a quadrilateral, such as a square or rectangle.

[0161] In some sections described below, the pore size described herein is referenced to its size when the porous structure is deployed in the lumen. In other sections, the size refers to the pore size when crimped. At times, the pore size described herein refers to its size in a state between the crimped configuration and the deployed configuration. In the context above, it should be readily apparent which configuration is applicable, however, in the event of ambiguity, the pore size can be considered to be applicable to the expanded configuration, the crimped configuration, or the intermediate configuration. When referring to fiber diameter, it relates to the fiber used to construct the porous structure 104. For example, if the porous structure 104 is constructed from a super- strong fiber comprising a bundle of 10 fibers each having a diameter of 2 microns, the overall super-strong fiber diameter is about 20 microns. Further, it should be understood that reference to fiber diameter is an approximation and merely for convenience and does not mean that the fiber is necessarily circular. Optionally, the fiber size is measured in French, for example, 0.003 Fr.

[0162] Referring to Figure 14 , a graph 1500 is shown relating fiber thickness of a porous structure to the percent coverage area of the support element for a porous structure having a net-like configuration. It can be seen that the general trend is that as the fiber size becomes thinner, the amount of porous structure surface area dedicated to the structure decreases. In one embodiment of the disclosure, it is desirable to have a coverage area of 25% or less. Optionally, the porous structure 104 exhibits a coverage area of less than 20%. In one embodiment of the disclosure, the coverage area of the porous structure is adapted to be minimized while still performing the desired lumen treatment function, such as those described herein. In some embodiments of the disclosure, the coverage area of the porous structure 104 is minimized in order to avoid undesirable clinical side effects. For example, lumen tissue irritation and pyrogenic effects are considerations for minimizing the coverage area of the porous structure 104 and optionally other features, such as pore size, porous structure thickness, and / or fiber thickness.

[0163] In some example embodiments of the present disclosure, the structure to pore ratio of the porous structure 104, the fiber size, and / or the pore size is set so as to allow easy diffusion and promote the growth of endothelial cells through the porous structure 104. Because the diameter of the fibers 2202 used to construct the porous structure 104 is about the size of the endothelial cells 2204 or smaller, as shown in Figure 29 the integrity of the cells grown on the porous structure will be better than that achieved in the prior art. The individual cells will have a strong connection to the vessel wall statistically because of its size being about the same or greater than the fiber diameter, and thus, in one embodiment of the present disclosure, anchor itself in more than one location to its native basal amina intimal layer and be able to achieve better growth conditions. As a result, the chance of late or subacute thrombosis can be reduced as compared to that achieved when treated with the current drug eluting stents. In addition, the porous structure 104 is effective as a thrombus embolization protection device, holds the separated plaque in place, and prevents the plaque from entering the blood stream from the vessel wall. It should be noted that the porous structure 104 is constructed such that the endothelial cells will grow over the porous structure 104 and optional support member 102, taking into account the fiber thickness, porous structure thickness, and / or pore size dimensions, so as to secure the enhanced stent in place and / or isolate the foreign material of the support member 102 and / or porous structure 104 from the blood stream. In one example embodiment of the present disclosure, the overgrowth of the endothelial cell layer on the porous structure 104 is established within a few hours of implantation. In one embodiment of the present disclosure, the overgrowth is completed within this time frame due to the endothelial cell related properties of the porous structure 104 (e.g., total thickness is about the same or less than a single endothelial cell). In some embodiments of the present disclosure, it is contemplated that the average hospital stay of a patient after a stent implantation procedure can be reduced as a result of the speed of endothelialization using the enhanced stent device. In addition, the speed and efficacy of drug therapy can be improved as a result of the rapid endothelialization on at least the porous structure 104 of the enhanced stent device 100.

[0164] Figure 30The disadvantages of using prior art drug eluting stents are shown, where a mass of endothelial cells has detached from the stent struts 2304, exposing "islands" 2302 of the stent. Sometimes, the mass falls off the struts 2304 due to poor adhesion of the endothelial cells to the polymer coating of the struts 2304. The cause of this poor adhesion is that the stent struts 2304 are typically an order of magnitude larger than a single endothelial cell, requiring the creation of large endothelial cell bridges to span the struts. The exposed islands 2302 can serve as seeds for thrombosis development. In some embodiments of the disclosure, the porous structure 104 is configured to reduce the likelihood of endothelial cells falling off the porous structure, thereby reducing the development of late or subacute thrombosis and the chance of the support element 102 being exposed to luminal contents. For example, endothelial cell retention is facilitated, e.g., as described herein, optionally by configuring the porous structure 104 with a thickness of at least one fiber and utilizing a pore size dimension (so as to allow endothelial cells to grow through the pores). Optionally, endothelial cell retention is facilitated by using a thickness of a fiber layer, e.g., those described herein. Optionally, as shown in the linear nature of the single fiber porous structure 104 can reduce the likelihood of large masses of endothelial cells becoming dislodged. In one embodiment of the disclosure, the porous structure 104 (optionally, a drug-soaked porous structure 104) is placed inside a bare metal or drug eluting support element in order to reduce the thrombogenicity of the support element, e.g., by promoting endothelial cell growth thereon and / or by covering a portion of the support element to reduce its exposed surface area. Figure 29

[0165] As suggested above, the use of thin fibers having a thickness similar to or less than the diameter of an endothelial cell enables the growth of an endothelial cell layer on the porous structure 104 while still being tightly constrained to the basal intima layer at at least two points of the endothelial cell layer, one on each side of the porous structure 104. In one embodiment of the disclosure, the anchoring effect of the basal intima layer on the endothelial cell layer reduces the chance of portions of the endothelial cell layer falling off and into the lumen. This effectively reduces the chance of patient embolization and / or also reduces the likelihood of the foreign body (e.g., the stent and porous structure) coming into contact and reacting with the contents of the lumen being treated. If a mass of several endothelial cells falls off the porous structure 104 and thereby exposes a patch of fibers, it is believed that the chance of harm to the patient is reduced because the linear, single endothelial cell width geometry is not as thrombogenic as the Figure 30 Figure 30 ​​In particular, endothelial cell clumps of a diameter of at least a few cell diameters have fallen off. In addition, re-endothelialization on the exposed porous structure 104 will be faster than on the exposed struts 2304, at least because in the case of the porous structure 104, an endothelial cell layer is formed when just one endothelial cell covers the growth on the fiber used to construct the porous structure of endothelial cell size. In contrast, the cover growth of an endothelial cell layer is only completed after multiple endothelial cells have covered the exposed islands.

[0166] In one embodiment of the disclosure, the use of the porous structure 104 for drug elution optionally allows for a reduction in the duration and / or dosage of anti-coagulant use by the patient to reduce the risk of late or sub-acute thrombosis.

[0167] In some example embodiments of the disclosure, the fiber thickness, the porous structure thickness, and / or the pore size are all varied individually depending on the application of the porous structure 104 and the needs of the patient. For example, in coronary arteries, this helps to provide good drug dispersion. In such an example, the fibers comprising the porous structure 104 are optionally positioned closer together in order to allow for more complete delivery of the drug to the patient.

[0168] In some example embodiments, when a large molecule drug, which diffuses poorly into the tissue, is used to fight restenosis, the porous structure can be soaked and / or impregnated with the appropriate drug in order to allow for better diffusion of the drug. Due to side effects and excessive toxicity, the maximum concentration of most drugs used is quite limited, and at the same time, in order to allow for optimal pharmacokinetics in the areas not covered by the stent struts, this concentration is insufficient. The porous structure mesh with better geometric coverage of the stent area provides better and optimal pharmacokinetics for the entire area covered by the stent. For example, when high Dalton large molecule drugs are used, or when liposomes are the carrier of the therapeutic agent, or when the stereochemistry of the drug is large and / or complex, and / or when the drug is hydrophobic, a more uniform drug distribution is highly desirable. In some example embodiments of the disclosure, the pharmacokinetics are also optimized because the drug is on / in the fibers of the porous structure 104 and is covered and sealed in the endothelial layer, which helps to prevent the drug from being washed away by the blood.

[0169] In some example embodiments of the present disclosure, such as in bypass vein grafts, the side branches are not problematic, thus the pore size is optionally made smaller, but not so small as to prevent endothelial cells from growing across it. In another example embodiment of the present disclosure, such as in carotid arteries, the side branches are generally not considered a problem, but capturing debris is a problem. Thus, in some example embodiments of the present disclosure, the pore size of the porous structure 104 is reduced to a diameter of 20 microns or less. In other applications, the pore size can be increased to 50 microns, 100 microns, 200 microns, or even more than 200 microns, depending on the application of the reinforced stent device 100.

[0170] In some example embodiments of the present disclosure, multiple porous structures are used. Optionally, at least one porous structure is located on the interior face of the support element 102 within the lumen of the support element 102. Optionally, more than one porous structure is located on the exterior surface of the support element 102. In some example embodiments of the present disclosure, at least some of the porous structures located on the support element 102 are configured to be "in-phase," where the pores of the porous structures coincide with each other. Optionally, the porous structures are "out-phase," where the pores are configured to not coincide with each other. In one example embodiment of the present disclosure, the "out-phase" configuration is used to improve the contact surface area between the porous structure and the interior surface of the lumen. In one embodiment of the present disclosure, the increased contact surface area can improve the pharmacokinetics, reduce the local pressure exerted by the porous structure 104 on the lumen wall, improve embolic spill protection, and / or achieve other beneficial effects. In some example embodiments of the present disclosure, the porous structure 104 is configured to be the same shape and pattern as the support element 102, but in a smaller scale.

[0171] Example manufacturing materials

[0172] It should be noted that in some example embodiments of the present disclosure, stretchable and / or expandable porous structures 104 are desired. Thus, in some embodiments of the present disclosure, the material selected is: a) stretchable; and / or b) usable to manufacture stretchable porous structures (such as knitted structures). In some example embodiments of the present disclosure, biodegradable (i.e., breakable down by the body) and / or bioabsorbable (i.e., absorbable into the body) materials are used. Additionally, according to some embodiments of the present disclosure, a mixture of materials is used. In one embodiment of the present disclosure, one material is selected because it is thin, but exhibits durability during manufacturing, deployment, and / or use. In one embodiment of the present disclosure, other considerations for the materials to be used are their biocompatibility, toxicity, hemocompatibility, and thrombogenicity.

[0173] Example materials used to manufacture the porous structure 104 include natural based materials such as modified cellulose and / or collagen. In some embodiments of the present disclosure, metal fibers are used to construct the porous structure, which is optionally constructed from stainless steel and / or CoCr and / or CoNi alloys and other possible materials. Optionally, the metal fibers used are coated with at least one polymer. In some embodiments of the present disclosure, the porous structure is manufactured from a shape memory alloy such as Nitinol. Optionally, carbon fibers are added to the porous structure 104 in order to improve the strength characteristics of the porous structure 104. Optionally, glass fibers are added to the porous structure 104 in order to improve the strength characteristics of the porous structure 104. Optionally, durable, absorbable and / or degradable fibers are added to the porous structure 104 in order to improve the strength and durability characteristics of the fibers during manufacturing, which are degraded or absorbed or washed away, leaving a thinner porous structure 104.

[0174] In one embodiment of the present disclosure, some polymeric fibers are selected for constructing the porous structure 104 because they are elastic, biocompatible, hemocompatible, can be made non-adhesive to endothelial tissue, can be selectively bio-stable and / or biodegradable, exhibit the required mechanical strength, are sterilizable, have a high temperature transition zone (solid and non-adhesive at 37°C), are able to contain an effective amount of a drug, and / or can release the embedded drug at a controlled rate. In some example embodiments of the present disclosure, other materials that exhibit some or all of these properties are optionally used to construct the porous structure 104. Optionally, a coating is provided on the porous structure 104, the coating comprising a material that exhibits some or all of these properties.

[0175] The polymeric fibers are optionally made of any of the following materials: thermoplastic polymers such as polyethylene terephthalate (PET), polyolefins, oxidized acrylics, PTFE, polyethylene co-vinyl acetate, polyethylene elastomers, PEO-PBT, PEO-PLA, PBMA, polyurethanes, Carbosil (PTG product), medical grade polycarbonate urethane, nylon, PEEK-Optima, carboxylic acid moieties (including one or more of polyacrylic acid, polymethacrylic acid, maleic acid, helonic acid, taconic acid, and / or combinations of these monomers and / or esters of these monomers), thermoplastic polymers, thermosetic polymers, polyolefin elastomers, polyesters, polyurethanes, polyfluoropolymers, and / or nylons. Optionally, the fibers are composed of elastomers. Optionally, the fibers are composed of fibers coated with a drug and a polymeric coating, the drug and polymeric coating being coated on a metal and / or on a polymeric fiber, mixed to obtain a predetermined drug release profile. Optionally, the fibers are composed of other materials than the example materials listed above. Example polymers optionally used for this purpose are and polymer manufacturing. Optionally, these polymers are selected for at least one of the reasons explained in the paragraphs above. Optionally, the coating is used to facilitate elution of the drug from the porous structure 104.

[0176] In some embodiments of the disclosure, the porous structure is made of absorbable / degradable polymers such as polylactic-co-polyglycolic acid ("PLGA") copolymer or any other degradable copolymer combination such as polycaprolactone ("PCL"), polygluconate, poly lactic acid-polyethylene oxide copolymer, polyhydroxybutyrate, polyanhydrides, polyphosphoesters, polyamino acids, poly-L-lactide, poly-D-lactide, polyglycolide, poly alpha-hydroxy acids, and combinations thereof.

[0177] Example manufacturing methods

[0178] Many of the methods and orientations described herein are designed to provide a porous structure that exhibits at least some expandable properties. The porous structure 104 is optionally adjusted and configured to stretch when it is deployed within the cavity being treated. In some example embodiments of the disclosure, the porous structure 104 is provided with stretchability in order to facilitate positioning of the porous structure 104 relative to the support element 102 or another intermediate layer such as a graft or a cushioning element.

[0179] In one example embodiment of the disclosure, the weaving, braiding, and / or knitting creates some or all of the elasticity of the resulting porous structure due to the structure of the interlaced and / or crimped and / or textured fibers (crimp, relaxation). This can be achieved through the material elongation properties of the porous structure to the stent. In some example embodiments of the disclosure, the porous structure is prepared by combining several interlacing techniques, for example, knitting over a braided porous structure or braiding over a knitted porous structure. In some embodiments of the disclosure, these techniques are used to combine and / or create multiple layers. In some example embodiments of the disclosure, a warp knitted porous structure with "laid in" yarns is used. In some example embodiments of the disclosure, an elastomeric or crimped weft yarn is used to braid the porous structure to obtain radial elasticity.

[0180] In some example embodiments of the disclosure, the porous structure is manufactured by combining several techniques, for example, knitting over a braided porous structure or braiding over a knitted porous structure. In some example embodiments of the disclosure, a weft knitted porous structure with "laid in" yarns is used. In some example embodiments of the disclosure, an elastomeric and / or crimped weft yarn is used to braid the porous structure to obtain radial elasticity. Optionally, the porous structure comprises at least one fiber oriented substantially parallel to the longitudinal axis of the support element.

[0181] In one example embodiment of the disclosure, the manufactured porous structure is added to the support element 102 as a covering. Optionally, the porous structure 104 is used separately from the support element 102, which is optionally not used for stent implantation. In some example embodiments of the disclosure, the porous structure 104 is manufactured directly onto the support element 102.

[0182] In one example embodiment of the disclosure, the porous structure 104 is manufactured by knitting techniques known to those skilled in the art of knitting for non-similar fields, such as clothing and textiles. The knitting of the porous structure 104 is optionally performed by a head with between 20 and 35 needles. Optionally, the head used has between 30 and 45 needles. Optionally, the head used has between 35 and 80 needles. One example of the effect of the head size on the porous structure can be seen in the above mentioned Figure 14 In the above mentioned Figure 14 A head of 22 size and a head of 35 size are plotted in Figure 14 In the above mentioned

[0183] In some embodiments of the disclosure, the shape and / or size of the knitted fabric is controlled by controlling the tension on the fibers used for knitting. For example, to produce a knitted fabric with larger eyelets, the fibers are provided with some slack during knitting. Optionally, the fibers are controlled during knitting so as to obtain circular eyelets when the porous structure 104 is expanded. In one embodiment of the disclosure, the pre-tension on the fibers during knitting is about 10-20 grams. In some embodiments of the disclosure, the post-tension on the fibers during knitting is 15-25 grams. In one example embodiment of the disclosure, the stitch length is between 300 microns and 400 microns. In some embodiments of the disclosure, the knitting machine is operated at a relatively low speed. For example, the knitting machine is operated at 10% of the speed capability using Lamb Knitting Machine Corp. System Model WK6, with special modifications made to the speed operation, measured as a percentage.

[0184] In one example embodiment of the disclosure, the knitted porous structure is manufactured using fibers or super strong fiber yarns having a specific fineness or a range of fineness between 5 microns and 100 microns. Optionally, the knitted porous structure is manufactured using yarns having a fineness of 10-20 microns. Optionally, the yarns are finer than 5 microns. Yarn fineness is often expressed in the textile arts in terms of "Tex". This is the weight (grams) of 1000 meters of yarn. In one example embodiment of the disclosure, the porous structure is manufactured using yarns in the range of 0.3 Tex to 10 Tex. In some embodiments of the disclosure, the specific yarn fineness is selected according to the desired porous structure 104 characteristics. For example, in some embodiments, a 0.5 Tex yarn using a 22 gauge needle will produce a porous structure with about 12% coverage area.

[0185] An example porous structure obtained using the above components and techniques should have 5-50 courses per centimeter. Optionally, 20-45 courses per centimeter are manufactured. Optionally, a porous structure with 30-35 courses per centimeter is manufactured. Figure 5 A knitted porous structure 104 and a support element 102 are shown in a crimped closed position. Figure 6a A knitted porous structure 104 placed on top of a support element 102 is shown in an open position. Figure 6b An example knitted is shown in detail.

[0186] In another example embodiment of the disclosure, the porous structure 104 is manufactured using a weaving technique. Narrow needle looms, as well as conventional narrow looms, can be configured to produce a tubular textile structure. In weaving, at least two layers of warp yarns are interlaced with a crosswise fill yarn.

[0187] By alternating the fill yarn back and forth through the two layers of warp yarns, a tubular shape is created. The dimensions and shape of the fabric are optionally controlled by determining the warp and / or fill yarn density, the interlacing pattern and / or frequency, the yarn tension and / or yarn size and / or elastic properties. The type of fabric used for the porous structure is optionally one of a "plain," "basket," "twill," "sateen," "leno," and / or "jacquard." Optionally, all the fibers of the porous structure are the same. Alternatively, the warp and weft fibers of the fabric are not composed of the same material. Optionally, different materials are used to take advantage of the inherent properties of the different materials, for example, one material can be elastic and another different material can have a high tensile strength. Optionally, the warp fibers are coated and / or drug eluting, while the weft fibers are not coated and / or not drug eluting, or the weft fibers are coated and / or drug eluting, while the warp fibers are not coated and / or not drug eluting.

[0188] In another example embodiment of the disclosure, a weaving technique is used to manufacture the porous structure 104, as described in Knitting Technology, D.J. Spencer, Editor, Woodhead Publishing Limited, Abington Hall, Abington, Cambridge CB1 6AH, England, the disclosure of which is incorporated herein by reference. Weaving machines are optionally used to interlace yarns at various crossing angles. In weaving, a plurality of yarns are fed to an interlacing zone. Interlacing is optionally achieved by rotating a spool of yarn or by a reciprocating needle bed. The dimensions and shape of the woven fabric are optionally controlled by the number of yarns, the interlacing pattern and / or angle, and / or the yarn size and / or elastic properties. Optionally, all the fibers of the porous structure are the same. Optionally, the warp and weft fibers of the woven fabric are not composed of the same material, for example, where the weft fibers are used to provide strength and the warp fibers are used to provide stretchability of the woven fabric.

[0189] In another exemplary embodiment of this disclosure, the porous structure 104 is manufactured via an electrospinning process. Electrospinning is a technique that utilizes a charged polymer solution (or melt) fed through a small opening or nozzle (typically a needle or pipette tip). Due to the charge of the solution, it is drawn as a jet towards a grounded collecting plate (typically a metal screen, plate, or rotating mandrel), typically 5–30 cm away. Optionally, a support element 102 is placed on a delivery conduit that serves as the mandrel. During the jet's propagation, the solvent gradually evaporates, leaving charged polymer fibers accumulated on the grounded target. The charge on the fibers eventually dissipates into the surrounding environment. The resulting product is a nonwoven fibrous porous structure (e.g., a felt) composed of tiny fibers with diameters between approximately 40 nanometers and 40 micrometers, depending on the size of the fibers fed into the system. If the target is allowed to move relative to the nozzle position (e.g., by rotating and / or moving the mandrel along its longer axis), a specific fiber orientation (e.g., parallel alignment or random alignment) can be obtained. In some example embodiments of this disclosure, the porous structure 104 is spun onto a mandrel or support element 102 in a helical winding pattern. Optionally, the porous structure 104 includes a plurality of helical winding patterns constructed by moving the mandrel back and forth, such as... Figure 4 The porous structure 104 is optionally constructed using fibers oriented substantially parallel to the central axis 106. Alternatively, the porous structure 104 is constructed using fibers oriented substantially perpendicular to the central axis 106. Alternatively, the porous structure 104 is constructed using fibers oriented in a combination of any of the orientations described or suggested herein. Depending on the requirements of the patient being treated, the mechanical properties of the porous structure can optionally be altered by changing the fiber diameter and orientation. For example, in some embodiments of this disclosure, a laser is used to cut specific pore sizes and / or ensure that the pores traverse from the outside to the inside of the porous structure 104. Alternatively, a solvent is used to alter the pore size.

[0190] Optionally, portions of the catheter are masked to prevent the porous structure 104 from accidentally covering the delivery catheter. Optionally, the support element 102 is coated with an adhesive and / or a pharmaceutical agent before the porous structure 104 is placed on top of the support element 102. In some example embodiments of this disclosure, the material used to manufacture the porous structure 104 is impregnated with a pharmaceutical agent. Optionally, the pharmaceutical agent is embedded in the material coating the porous structure 104. In one example embodiment of this disclosure, the porous structure 104 includes at least one inner coating adjacent to the support element 102, which exhibits properties different from the outer coating of adjacent patient blood vessels. For example, the inner coating is optionally configured to avoid adhesion to the delivery catheter and / or the support structure. Optionally, the inner coating is configured to adhere to the support element 102 but not to the delivery catheter.

[0191] In some embodiments of this disclosure, the porous structure 104 is designed to be insensitive to shortening and elongation forces as it expands upon unfolding. In some embodiments, this is partly attributed to the knitted nature of the porous structure 104. This property allows the porous structure 104 to be secured to the support element 102 at its ends, rather than at other locations, such as the middle as described in U.S. Application No. 2005 / 0038503 by Greenhalgh et al., the description of which is expressly incorporated herein by reference.

[0192] In some example embodiments of this disclosure, the porous structure is fabricated as a wide-diameter state that is at least partially open. In some example embodiments of this disclosure, the at least partially stretched porous structure is reduced to a smaller diameter after fabrication by heat setting, curling, and / or folding.

[0193] In one embodiment of this disclosure, the diameter of at least partially stretched porous structures is reduced using mechanical methods. Optionally, during the fabrication of the porous structure, a method is used... Figure 12 The funnel-shaped structure 1304 shown is used to reduce the diameter of the knitted porous structure 1302. The knitted porous structure 1302 is pulled down from the knitted area into the narrowed opening, i.e., the funnel-shaped structure 1304. This produces a final porous structure diameter that is controllably smaller than the diameter of the needle bed. Figure 13 This illustrates how to create a porous structure using a stretched rubber tube 1402. In this method, the porous structure 1400 is tightly inserted into a pre-radially stretched tube 1402, and then the tube is relaxed, compressing the porous structure and producing a porous structure with a smaller pore size, the size of which is controlled by the stretch ratio of the rubber tube.

[0194] Reference Figure 17 The illustration shows an embodiment of the porous structure 104 folded in a substantially "n"-shaped manner, the folds serving to reduce the overall diameter of the enhanced stent device 100 for easier insertion and guidance through the patient. Optionally, these folds are oriented in the same direction. In one embodiment of this disclosure, the folded porous structure 104 is at least temporarily secured to the support element 102. Figure 10 The perspective view shows the alternative folded construction.

[0195] Another or alternative embodiment of the folding includes heat-setting the porous structure 104 comprising a polymer to the support structure 102. In one embodiment of this disclosure, heat setting is used when the porous structure 104 comprises at least one polymer material. In one embodiment of this disclosure, the determination of the heat setting conditions is related to the thermal transition temperature of the polymer. Heat setting occurs at the T... g and T mThe process is carried out within a temperature range between [temperature range missing]. Within this range, the polymer becomes amorphous and shrinks onto the support element 102, thereby establishing an overall radius of the reinforced support device 100 that is not much larger than the radius of the support element 102. For example, in some embodiments of this disclosure, the porous structure 104 increases the overall diameter of the support element 102, which has a diameter of 1 mm, by less than 10 micrometers. At T [temperature range missing] m At this point, the polymer transforms into a viscous liquid, loses its mechanical integrity, and adheres to the surface of the support element 102. For example, polyethylene terephthalate (PET) has a T0 of 70°C. g and 265℃ T m Therefore, in one embodiment of this disclosure, the heat setting temperature at a certain point within this range is 200°C. Using temperatures higher than T... m Heat setting at certain temperatures can cause thermal degradation, leading to polymer chain breakage, polymer dissociation, and / or the generation of large amounts of oligomer materials, which alter the mechanical properties of the porous structure 104 and / or release toxic and / or biocompatible materials, thereby causing inflammatory responses in patients. Other example polymers that can be used in heat setting are given in Table 1 below (not an exhaustive list):

[0196] Table 1: Example Polymers and Temperatures Used for Heat Setting (TABLE-US-00001)

[0197] Material Name Tg Tm Set Temperature PP 18℃ 165℃ 140℃ Nylon 6,6 80℃ 256℃ 210℃ PTFE 150℃ 330℃ 300℃ PVA 100℃ 230℃ 190℃ Polyurethane 70℃ 120℃ 100℃ PLLA 60℃ 175℃ 100℃

[0198] Another alternative embodiment of the folding includes using at least one coiled support element 102 in conjunction with the porous structure 104 for coiling. In some embodiments of this disclosure, the porous structure 104 is coiled together with the support element 102. In one embodiment of this disclosure, the coiling of the porous structure 104 and the support element 102 is performed when it is desired to reduce the overall diameter of the enhanced stent device 100. For example, a reduced diameter enhanced stent device 100 allows for easier insertion and guidance of the device to the treatment site. In some embodiments of this disclosure, at least one coiled support element 102 provides relatively stable mechanical properties to the object for more predictable movement during insertion and guidance.

[0199] Optionally, the porous structure 104 is fabricated on a non-curled support element 102. The non-curled support element 102 may be expanded or semi-expanded during manufacturing. In one example embodiment of this disclosure, the porous structure 104 and the support element 102 are curled together. Optionally, excess porous structure 104 material resulting from reducing the profile of the support element 102 during curling is folded together with the support element 102, as... Figure 17As shown. In some example embodiments of this disclosure, the porous structure 104 is prepared on a coiled or partially coiled support structure 102. When fabricating a porous structure for placement on an already coiled support structure, it is conceivable to provide a porous structure that can be sufficiently stretched when implanted into a treatment site within a cavity so as to expand with the radial expansion of the support structure.

[0200] Example methods for coating fibers

[0201] In another exemplary embodiment of this disclosure, manufacturing techniques are used to coat the fibers comprising the porous structure 104 with at least one polymer layer. For example, this is achieved using biocompatible, blood-compatible, biostable, and / or biodegradable polymers soluble in organic solvents. Figure 18 The impregnation technique shown is used to generate an impregnation solution 1906 for coating fibers comprising a porous structure 104. Fibers to be coated are optionally placed in a spool 1902, from which fibers 1904 are drawn to form the porous structure 104. During the manufacturing process, additives such as pharmaceuticals, biological components, enzymes, growth factors, and / or any other additives mentioned herein or known in the art can be incorporated into fibers 1904, for example, by placing these additives in solution 1906 and allowing fibers 1904 to pass through solution 1906. In one embodiment of this disclosure, at least one layer is used to control the release of the pharmaceutical / biological additive. For example, more than one solution tank may be provided for fibers 1904 to pass through during manufacturing. Fibers 1904 are optionally moved to a drying oven 1908, whereby solution 1906 is dried onto fibers 1904. Depending on the pharmaceuticals used, the drying oven 1908 has an operating temperature range of 37-70°C (in some embodiments of this disclosure). In one example embodiment of this disclosure, fiber 1904 is then used by a knitting system 1910 to create a porous structure 104. Optionally, the knitting system 1910 is a system model WK6 from Lamb Knitting Machines. Optionally, the porous structure 104 is coated with a polymer layer after it has been manufactured.

[0202] In some exemplary embodiments of this disclosure, the support element 102 and the porous structure 104 are coated with an additional substance. Optionally, the additional substance is a polymer. Optionally, the additional substance is a drug eluent. Optionally, the coating is hyaluronic acid. Alternatively or additionally, the coating is hyaluronan. Optionally, different nonwoven techniques (such as wet spinning and / or dry spinning) are used to fabricate the porous structure 104. In some embodiments of this disclosure, additional coatings are added to achieve different effects, such as timed release of a drug and / or release of multiple drugs at different times.

[0203] Example methods of mounting a porous structure to a support element

[0204] In some embodiments of the disclosure, the porous structure 104 is at least temporarily secured to the support element 102. Advantages of at least temporarily securing the porous structure 104 to the support element 102 include preventing the fibers from unraveling and / or running out of the porous structure fabric during insertion, delivery, and / or deployment, preventing the porous structure 104 from migrating away and / or sliding relative to the support element 102. Optionally, in many embodiments, the support element 102 and the porous structure 104 are secured together, although in a coaxial and adjacent relationship, without the use of adhesives and / or other securing means.

[0205] In some example embodiments of the disclosure, the support element 102 and the porous structure 104 are attached together by simultaneously curing a polymer support element coating and a porous structure and / or coated porous structure comprising a polymer, thereby adhering the polymer together, when the support element 102 is optionally coated with a polymer. Optionally, pressure and / or heat are used to adhere the polymer-coated support element 102 to the uncoated or polymer-coated porous structure 104, for example when they are both hot. In some example embodiments of the disclosure, the porous structure 104 comprises two components: an outer component and an inner component (relative to the support element 102). When the outer component and the inner component are simultaneously cured, the polymers of both adhere together, thereby securing the porous structure 104 to the support element 102 located between the two components.

[0206] In one example embodiment of the disclosure, the porous structure 104 is secured to the support element 102 so as to avoid migration of the porous structure, but not to limit the expandability of the porous structure 104 and / or the support element 102.

[0207] In some example embodiments of the disclosure, an adhesive is used to bond the support element 102 and the porous structure 104 together. Optionally, the porous structure 104 is glued to the support element 102 using any natural and / or synthetic biocompatible adhesive (for example, cyanocrylate, thermoplastic elastomers, silanes, laminin, albumin and / or fibrinogen and / or PEG-PEG adhesives and / or polyurethane adhesives) and / or any other suitable compatible polymeric material. Optionally, when the porous structure 104 is glued to the support element 102, and wherein the support element 102 is a drug eluting stent, the same polymer used for drug elution is used to attach the porous structure 104 to the support element 102.

[0208] In one embodiment of the disclosure, the porous structure 104 is attached to the support element 102 at multiple points. Optionally, the multiple points define a pattern, such as a straight line or zigzag pattern of points. Optionally, the porous structure 104 is compressed onto the support element 102 to maintain attachment to the support element 102. Optionally, the porous structure is held in place on the support element at least in part by frictional forces. Optionally, the porous structure 104 is sewn and / or mechanically wrapped onto the support element 102. Optionally, heat, pressure, laser welding, UV curing, and / or ultrasonic waves are used as techniques to secure the porous structure 104 to the support element 102. Optionally, a primer (such as parylene) is used on the support element 102 prior to adhering the porous structure 104 to the support element 102 in order to enhance cohesion.

[0209] In some example embodiments of the disclosure, elastic and / or expandable o-rings and / or c-rings are used to hold the porous structure 104 on the support element 102. Optionally, c-rings are used to avoid impeding the expandability of the porous structure 104. Optionally, the rings are used to at least temporarily secure each end of the porous structure 104 to the support element 102 and / or to apply a frictional force to each end of the porous structure 104. Optionally, the rings are coated and / or impregnated with an eluting drug, such as those described herein. Optionally, the rings are constructed of a polymer-based material. In some example embodiments of the disclosure, the porous structure 104 is optionally constrained to the support element 102 using fibers of the porous structure 104. In one example embodiment of the disclosure, a slip ring 2102 is used to secure the porous structure 104 to the support element 102, as shown in Figure 28a and Figure 28b The slip ring 2102 is adapted to expand with the porous structure 104 and the support element 102 when they expand at the luminal treatment site upon deployment. Optionally, the slip ring 2102 is flexible, but rigid enough to secure the porous structure 104 to the support element 102. In one embodiment of the disclosure, the slip ring 2102 is coiled around the enhanced stent device 100 when the enhanced stent device is in a reduced profile configuration, such that the slip ring 2102 at least partially overlaps itself. Upon deployment, as shown in Figure 28bAs shown, the support element 102 and the porous structure 104 are expanded in order to provide therapy to the cavity. In one embodiment of the disclosure, the slip ring 2102 expands with the porous structure 104 and the support element 102 while maintaining enough pressure on the porous structure 104 to keep the porous structure 104 to the support element 102. In one embodiment of the disclosure, the overlapping portion of the slip ring 2102 decreases due to the overall increase in diameter of the slip ring 2102. Optionally, the slip ring 2102 comprises a biodegradable and / or bioabsorbable material. In some embodiments of the disclosure, the thickness of the slip ring 2102 is below 25 microns. Optionally, the thickness of the slip ring 2102 is below 15 microns. Optionally, the thickness of the slip ring 2102 is below 10 microns.

[0210] Referring to Figure 15 One embodiment of the disclosure is shown in which the porous structure 104 is attached to the support element 102 with a slip connection 1602. In one example embodiment of the disclosure, the slip connection is established by attaching at least one loop 1604 of the porous structure 104 to the support element 102 under conditions that prevent both the porous structure 104 and the support element 102 from separating but are loose enough to allow the porous structure 104 to slide relative to the support element 102. In one embodiment of the disclosure, in the slip connection, loose stitches are used to attach the porous structure 104 to the support element 102. In one embodiment of the disclosure, expansion of the porous structure 104 is aided by taking advantage of the slip properties of the connection 1602. For example, the porous structure 104 is secured to the outermost strut 1606 of the support element 102 at an outermost location 1608 of the outermost strut 1606. In one embodiment of the disclosure, on the other side of the support element 102, the porous structure 104 is also attached to the outermost strut at an outermost location of the outermost strut. When the support element 102 and the porous structure 104 are expanded during deployment, the porous structure 104 is given additional expandability relative to the pre-expanded configuration because the slip connection 1602 moves from the outermost location 1608 on the outermost strut 1606 to an innermost location 1610. The distance 1612 (about 1 mm to 6 mm in one embodiment of the disclosure) from the outermost location 1608 to the innermost location 1610 provides additional expandability to the porous structure 104. Optionally, the slip is prevented by securing the porous structure 104 to the strut 1606 at the innermost location 1610 as well as the outermost location 1608. Optionally, the slip is prevented by tightening the connection between the two, for example by providing tighter stitches.

[0211] In some embodiments of the disclosure, the porous structure 104 is tied to the support element 102 using any of a thumb knot, a square knot, a reef knot, or a double surgical knot. Optionally, the porous structure 104 is constrained to the support element 102 using at least one fiber used to construct the porous structure 104. Figure 16 An example method of attaching the porous structure 104 to the support element 102 using knotting is shown. As can be seen, the porous structure 104 is secured to the support element 102 along a plurality of locations along the support element strut 1704 using a knotting fiber 1702. Optionally, the knotting fiber 1702 is threaded through a plurality of eyelets 1706 and across the support element strut 1704, with a knot 1708 tied to secure the porous structure 104 to the support element 102 at at least some of the eyelets.

[0212] As mentioned above, in some embodiments of the disclosure, the porous structure 104 is secured to the support element 102 also serves to reduce the likelihood of run-out and / or unraveling of the porous structure. In an embodiment of the disclosure, run-out and / or unraveling of the porous structure should be avoided at least for the following reasons: to avoid the porous structure protruding into the lumen and / or causing the porous structure to be ineffective for the intended treatment of the lumen. In an embodiment of the disclosure, the porous structure 104 is secured to the support element 102 at the ends of the support element 102, at at least some intersections where the porous structure 104 and the support element 102 overlap, or at both, and / or at each eyelet at both ends. Any of the above-described methods of securing the porous structure 104 to the support element 102 are optionally used to prevent run-out and / or unraveling.

[0213] In an example embodiment of the disclosure, the porous structure 104 is treated to provide temporary enhanced adhesion to the support element 102 during implantation.

[0214] For example, the enhanced stent device 100 is optionally dipped in a liquid that causes the porous structure 104 to adhere to the support element 102. Optionally, the adhesion is due to the surface tension of the liquid. Optionally, the adhesion is due to temporary shrinkage of the porous structure 104 that more tightly secures the porous structure to the support element 102. In some example embodiments of the disclosure, temporary cohesion is used to prevent slippage of the porous structure 104 from the support element 102 due to frictional stresses experienced during navigation of the vasculature during implantation.

[0215] General pharmacological uses

[0216] Optionally or in addition to physically preventing debris from entering the bloodstream, the porous structure 104 optionally contains drugs designed to treat various diseases. In some example embodiments of the present disclosure, drugs are optionally provided including one or more of a drug agent for promoting cell and / or liposome growth and / or other endothelial cell growth factors, anti-proliferative, anti-thrombotic, anti-coagulant, and / or anti-platelet effects, tissue engineering factors, immunomodulators, antioxidants, antisense oligonucleotides, collagen inhibitors, hydrophobic drugs, hydrophilic drugs, and / or endothelial cell seeding substances. The drug treatment provided by the porous structure is optionally used to accelerate the transformation of a vein to an artery. Specific examples of drugs optionally used with the porous structure 104 include: anti-proliferative agents such as sirolimus, zolimus, or zotarolimus paclitaxel and other taxanes, tacrolimus, everolimus, vincritine, viblastine, HMG-CoA reductase inhibitors, doxorubicin, colchicine, dactinomycin, mitomycin C, cycloporine, and / or mycophenolic acid, triazolopyrimidine and derivatives thereof (i.e. coronary vasodilators); intrapide, glucocorticoids such as dexamethasone, methylprednisolone, and / or gamma-interferon; anti-thrombotic agents such as heparin, heparinoid dextran derivatives, dextrose in citrate, coumadin, warfarin, streptokinase, anistreplase, tissue plasminogen activator (tPA), urokinase, and / or abciximab; antioxidants such as probucol; growth factor inhibitors such as tranilast and / or angiopeptin; antisense oligonucleotides such as c-myc and / or c-myb; collagen inhibitors such as halofuginone and / or batimistat; liposomes; gemcitabine (i.e. ); steroids and corticosteroids such as cortisone and prednisone; cortisone, prednisone; sirolimus statins such as lovastatin and / or simvastatin (i.e. ); VEGF; FGF-2; endothelial cell-containing microcarriers; genes; DNA; endothelial cell seeds; and / or endothelial cell-containing hydrogels.

[0217] Generally, drug-eluting stents (i.e., support members) provide drug by embedding the drug on the structure of the stent, particularly on the struts of the stent. The structure is generally minimized in order to provide flexibility and to reduce cost, among other reasons. As a result of minimizing the support member structure, the struts of the structure are generally widely spaced. Thus, when the stent is in place and the drug is released from the stent into the patient, the drug diffuses only from the widely spaced struts. This prevents uniform distribution of the drug over the entire length of the stent. In addition, the stent struts are generally large relative to the endothelial cells, and thus coverage of the endothelial cell layer generally takes about a day or a week, causing the drug elution into the body tissue to be delayed and / or ineffective (for many reasons, including the drug being washed away by intraluminal fluid flow before the endothelial cell layer covers the stent).

[0218] In contrast, covering the stent (including the struts) with a drug-enhanced porous structure as described herein provides a greater surface area in contact with the inner wall of the patient's blood vessel, enabling greater diffusion to occur. The present disclosure optionally uses lower concentrations of drug compared to conventional techniques for drug delivery in stents, because it improves the therapy-rendering surface area. In one embodiment of the present disclosure, the improved delivery of the presently described disclosure allows the use of lower doses of drug to provide the same relative amount of therapy, and reduces the total dose needed to achieve the same result, thus reducing possible side effects. For example, the recommended concentration of taxol on current drug-eluting stents is about 1 μg / mm 2 of stent surface. In contrast, the porous structure 104 optionally uses a concentration of 0.5 μg / mm 2 , because of its increased therapy-rendering surface area. Optionally, the concentration is less than 0.5 μg / mm 2 . As another example, the typical concentration of rapamycin and limus drugs is currently about 140 μg / mm 2 of stent surface. However, using the porous structure 104 described herein, a concentration of 80 μg / mm 2 is optionally used to achieve the same therapeutic effect. In some example embodiments of the present disclosure, as little as 10 μg / mm 2 is optionally used to achieve the same therapeutic effect. In some example embodiments of the present disclosure, the concentration of drug embedded on the porous structure is as much as 15 times less than the conventional concentration currently used.

[0219] In a conventional stent, at the struts, the drug can not be delivered far enough to enter the vessel wall and / or have an effect on the vessel wall, or can be delivered in too great an amount at certain portions of the vessel wall, without being delivered laterally enough to the rest of the inner surface where the drug is needed. The porous structure 104 can deliver the drug in a more locally uniform manner due to the additional surface area with more uniform coverage of the stent surface area. Optionally, there is an axial profile change in the dosage. Because the distribution of the drug into the tissue is controlled by diffusion, and because the amount of dosage concentration on the strut is limited due to excessive toxicity and side effects, it is very helpful to have the drug spread in a more uniform manner to achieve better pharmacokinetics.

[0220] In one embodiment of the disclosure, the drug applied to the patient is located in and / or on the fibers of the porous structure 104. Examples of where and how the drug is optionally located in and / or on the fibers of the porous structure 104 and / or eluted include:

[0221] 1. The drug is deposited within the pores of the porous structure;

[0222] 2. The drug particles are mixed into the fibers of the porous structure as the fibers are generated;

[0223] 3. The drug is applied locally to the porous structure, for example by spraying;

[0224] 4. The porous structure is dipped into a solution containing a drug additive, thereby depositing the additive on and / or in the fibers of the porous structure;

[0225] 5. The drug additive is encapsulated onto the porous structure, optionally using a thermal process;

[0226] 6. The drug additive is grafted onto the porous structure using a plasma treatment;

[0227] 7. The drug additive is etched into the porous structure, for example via sputtering or coating;

[0228] 8. The drug additive is transferred into the porous structure using a concentration difference between the porous structure and a substance containing the additive, for example by adhering microcarriers containing the drug additive to the porous structure, thereby allowing them to migrate into the porous structure;

[0229] 9. Any methods known to a person skilled in the art, such as those described in U.S. Patent Application No. 2004 / 0030377 by Dubson et al., U.S. Patent Application No. 2005 / 0187140 by Hunter et al., U.S. Patent Application No. 2004 / 0236407 by Fieren et al., U.S. Patent No. 6,902,522 by Walsh et al., U.S. Patent No. 6,669,961 by Kim et al., U.S. Patent No. 6,447,796 by Vook et al., U.S. Patent No. 6,369,039 by Palasis et al., U.S. Patent No. 6,939,374 by Banik et al., and U.S. Patent No. 6,919,100 by Narayanan, the contents of which are expressly incorporated herein by reference.

[0230] 10. Eluting drugs from a polymer coating on porous fibers;

[0231] 11. Eluting drugs from polymers with porous structures; and

[0232] 12. Incorporate the drug into a biodegradable polymer.

[0233] Optionally, drug encapsulation occurs before the fabrication of the enhanced scaffold device 100 (e.g., by incorporating drug particles into the porous fiber structure during fiber formation) or during fabrication (e.g., using...). Figure 18 (The impregnation method shown) and / or post-manufacturing (e.g., spraying onto the drug after the device is made). In some example embodiments of this disclosure, a porous structure 104 for drug encapsulation is placed on top of a support element 102 for drug treatment. In some example embodiments of this disclosure, the porous structure 104 is coated with at least one polymer. In some example embodiments of this disclosure, the porous structure is provided with a polymer coating containing the drug eluted from the coating.

[0234] Drugs are optionally encapsulated in porous structure 104 such that they are released into the patient over approximately a predetermined time period. For example, drugs are optionally encapsulated in porous structure 104 for release over a period of one week. Other drugs are optionally encapsulated in porous structure 104 for release over a period of several months. Factors that vary depending on the drug release schedule include the type of material used to construct porous structure 104, the type of drug used, the manner in which porous structure 104 is constructed, and / or the amount of coverage that porous structure 104 provides over support element 102.

[0235] In some example embodiments of this disclosure, 1 microgram of drug per square centimeter of fiber surface area (not the area of ​​the fiber itself, but the area of ​​the tissue it treats) is embedded in the fiber. Optionally, up to 200 micrograms of drug per square centimeter of fiber surface area is embedded in the fiber. Optionally, higher or lower drug concentrations are used depending on the patient's treatment needs and the type of drug used.

[0236] Large and / or complex stereochemical molecules for pharmaceutical applications

[0237] In some example embodiments of this disclosure, the use of a porous structure 104 for enhanced drug delivery allows for the efficient dispersion and delivery of macromolecular and complex stereochemical drugs. Traditionally, macromolecular drugs are not used with drug-eluting stents because they do not diffuse well, and the wide-spaced struts of conventional stents are not conducive to the uniform and / or extensive dispersion of macromolecules as described above. Instead, the use of a device that provides a wider coverage of the vessel wall makes treatment with macromolecular drugs more feasible. This is optionally achieved by providing the porous structure 104 and / or support element 102 with macromolecular drugs for elution and by utilizing the increased vessel wall coverage of the porous structure 104, due to the smaller pore size in some example embodiments. Alternatively or additionally, macromolecular drugs are delivered more efficiently to the patient due to the growth of cells from the body covering the porous structure 104, as the drug is delivered into the tissue rather than being flushed away, for example, in the bloodstream. Optionally, drugs of greater than 700 Daltons, 1,000 Daltons, 3,000 Daltons, or up to 50,000 Daltons are dispersed and uniformly delivered into the patient’s vascular system.

[0238] Optionally, liposomes are eluted from at least one porous structure 104 and / or supporting element 102. Optionally, steroids, statins, anticoagulants, gemcitabine ( ), zolimus or zotacoxetine ), Sirolimus (e.g.) ), paclitaxel / paclitaxel, and / or other large or complex molecular drugs are eluted from at least one porous structure 104 and / or supporting element 102. (See reference) Figure 3 Drug agent 406 is shown to elute from the enhanced stent device 100 and enter the artery 400 from the lumen wall 404. Optionally, agent 406 is eluted from the porous structure after at least some growth of endothelial cells 408 through the enhanced stent device 100 (e.g., a time determined by experimental endothelial cell growth data). As described elsewhere herein, the porous structure 104 is optionally used to capture debris 402 between the outer surface of the enhanced stent device 100 and the lumen wall 404.

[0239] Uses of timed drug release

[0240] In one example embodiment of the disclosure, the drug is eluted from the enhanced stent device into the overlying endothelial tissue, and not just into the interior surface of the lumen being treated. In one example embodiment of the disclosure, drug release is thus optimized by ensuring that only a predetermined amount of drug is lost into the bloodstream and / or other non-treatment medium. In some example embodiments, endothelial cell growth can assist drug therapy by providing a transfer medium for the drug from the implanted stent to the body region being treated, including for example in conjunction with BBB therapy as described below.

[0241] In some example embodiments of the disclosure, the drug is eluted according to the extent of endothelial tissue growth. Optionally, drug therapy is initiated after some endothelial cell growth is present through and / or around the enhanced stent device. Optionally, drug therapy is initiated at implantation regardless of endothelial cell growth. In some example embodiments of the disclosure, the enhanced stent device is adapted and configured to release the drug on a timed basis according to a predetermined treatment schedule. Optionally, the predetermined treatment schedule is adapted to an expected and / or actual endothelial cell growth rate by utilizing a coating having a predetermined rate of degradation. Optionally, release of the drug is determined on a site-by-site basis. For example, if it is estimated that endothelial cell growth requires 8 hours to completely encase the implanted stent, the drug located within the porous structure of the stent optionally has a predetermined 8 hour delay before being released and / or eluted at a low rate to avoid ineffective or undesirable (i.e. toxic overdosing) use of the drug. In one embodiment of the disclosure, endothelial cell coverage of the thin porous structure requires only a few hours, and therefore, the time release needs to be adjusted to match. This can be achieved by coating the porous structure 104 with a "diffusion barrier" layer that inhibits diffusion of the drug for a predetermined period of time. Optionally, this can be achieved by using a controlled degradable matrix. Optionally, drug release occurs after endothelial cells have only partially grown around and / or through the porous structure and / or stent. Optionally, the drug is eluted immediately after insertion and / or implantation into the body lumen. Optionally, it is sufficient for the porous structure 104 to have any biological coverage (e.g. mucus, etc.) for the drug therapy. In some embodiments of the disclosure, the delay is determined according to the material expected to grow over the porous structure 104.

[0242] In one example embodiment of the disclosure, timed release of a drug is accomplished by coating and / or constructing the porous structure 104 and / or the support member 102 with a plurality of biodegradable / absorbable layers. By using layers that provide different performance characteristics (e.g., different drugs, different degradation times, adhesion to the body cavity, surface treatment modifications (e.g., treatments that make it non-stick to the cavity)), the enhanced stent device 100 can be tailored to perform a particular treatment schedule. For example, layer #1 (the outer layer) includes a material that degrades in 2 hours, layer #2 (the inner layer) includes a drug that elutes into the patient's body and degrades in 10 hours, layer #3 (the inner layer) includes a different drug that elutes into the patient's body and degrades in 6 hours, and so on. Naturally, depending on the treatment required by the patient, the performance characteristics of the layers and / or these layers are changed to provide the required treatment. It should be noted that the biodegradable layer can be placed in the outermost position, which is timed for the expected endothelial cell growth, as described above. In this embodiment, the time at which the outermost layer degrades is approximately the same as the time at which the endothelial cell layer coverage growth of the enhanced stent device 100 is complete, which enables the drug from the second layer of the enhanced stent device 100 to elute directly into the endothelial tissue.

[0243] In one example embodiment of the disclosure, the support member 102 elutes a drug, but the treatment is aided by the porous structure 104 that promotes endothelial cell growth on the support member 102. Optionally, the drug located on the support member 102 elutes slowly so as to allow endothelial cell growth. In some embodiments of the disclosure, the rate of elution depends on the local concentration of the drug through the surrounding body tissue and the expected rate of diffusion.

[0244] In some embodiments of the disclosure, a first drug agent is eluted that is designed to promote endothelial cell coverage growth, followed by a second drug agent that is designed to treat a disease in the patient.

[0245] In some embodiments of the disclosure, at least the porous structure 104 is attached to the cavity using an adhesive that is impermeable to the drug in the porous structure 104. However, timed release is achieved by allowing the endothelial layer to cover grow on the porous structure 104 so that the drug elutes into the endothelial layer that is not adjacent to the adhesive. Optionally, the adhesive is biodegradable and / or bioabsorbable and merely delays elution.

[0246] Blood Brain Barrier (BBB) Therapy

[0247] The BBB is a specialized system of capillary endothelial cells that protects the brain from harmful substances in the blood stream while providing the brain with the nutrients needed to perform proper functions. Unlike peripheral capillaries, which allow relatively free exchange of substances across and between cells, the BBB strictly limits transport to the brain by physical (tight junctions) and metabolic (enzymes) barriers. Thus, the BBB often is the limiting factor in determining the rate at which therapeutic drugs penetrate into the brain.

[0248] In some example embodiments of the disclosure, a drug-eluting porous structure is used to deliver a therapy across the BBB. As described herein, the drug therapy is often enhanced by the growth of endothelial cells across and / or around the implanted drug-eluting stent. The use of a porous structure 104 in a cerebral artery allows endothelial cells to grow over the porous structure 104, thus embedding the porous structure 104 into the arterial tissue. The end result, after the previous endothelial cell layer has been absorbed by the body, is that the porous structure 104 containing the cerebral therapy drug is on the other side of the endothelial layer, and thus on the other side of the BBB, with no significant impediment between the porous structure 104 and the brain tissue. Additionally, some example embodiments of the porous structure 104 are sized to fit within the narrow lumens found in the brain. Example drugs suitable for use with the porous structure 104 in therapy across the BBB include gemcitabine (Gemzar®) ) and enzastamin, dopamine and dopamine derivatives, and anti-cancer drugs. In some embodiments of the disclosure, the porous structure 104 elutes an anti-BBB material for reducing the resistance to transport of substances across the BBB.

[0249] Drug therapy of small lumens

[0250] Currently, small lumens such as small coronary arteries or cerebral arteries are treated only with balloon-type catheters. These treatments are short-term, and are not themselves suitable for providing the drug therapy often needed for the lumens. Traditional stent implantation is not commonly performed due to the difficulty in guiding the stent into the small space of these arteries. In one example embodiment of the disclosure, at least a drug-eluting porous structure 104 and optionally a support element are used to treat a lumen with a diameter of less than 2 mm with a drug. Optionally, the support element is a stent. Optionally, the support element is a balloon over which the porous structure 104 is placed. In one example embodiment of the disclosure, a balloon-type catheter is used to insert the porous structure 104 into the small lumen. The balloon is inflated to cause the porous structure 104 to expand, and to promote contact between the porous structure 104 and the lumen wall to be treated. In one embodiment of the disclosure, the porous structure 104 at least partially adheres to the lumen wall. Optionally, a biocompatible adhesive is used to adhere the porous structure 104 to the lumen wall. In several preferred embodiments of the disclosure, the porous structure 104 is self-expanding.

[0251] In some embodiments of the disclosure, the small lumen is treated for a long period of time, which has not been done before. For example, by implanting at least the porous structure of the enhanced stent device 100, the treatment can last for about a month or more. Optionally, the treatment can last for about a week or more.

[0252] Example treatment methods

[0253] In one example embodiment of the disclosure, the enhanced stent device 100 is used to treat, dilate, administer, and / or support a body lumen, such as a blood vessel. In some example embodiments of the disclosure, the enhanced stent device 100 is used to treat a disorder of the carotid artery. In some embodiments of the disclosure, the enhanced stent device 100 is used to treat a disorder of the coronary artery. As described above, the treatment can be provided through the BBB. The stent device 100 can be a self-expandable stent, or any other expansion method is used. Typically, the support member 102 and / or the porous structure 104 are self-expandable. Optionally, for example, a drug is used to treat the patient via the body lumen, as described herein. In some embodiments of the disclosure, the enhanced stent device 100 is used to treat an aneurysm in the brain, for example (described below). In some embodiments of the disclosure, the enhanced stent device 100 is used to prophylactically treat a vulnerable plaque.

[0254] In operation, the enhanced stent device 100 is introduced into the body lumen 400 using techniques known in the art to the area where the enhanced stent device 100 is to be placed, as shown in Figure 3 Optionally, the enhanced stent device 100 can be expanded within the body lumen 400 using self-expanding techniques known in the art. Optionally, the support member 102 and / or the porous structure 104 are constructed of a heat-sensitive shape memory alloy that assumes an expanded shape within the body lumen 400 to provide treatment a certain time after being placed in position when exposed to the natural body temperature of the patient. Alternatively, super-elastic or elastic release is used to place the stent in the treatment area. In some example embodiments of the disclosure, a balloon is used to pre-dilate the body lumen 400 at the treatment area in a procedure of at least two steps (1. pre-dilation, 2. implanting the device 100) before implanting the enhanced stent device 100 at the treatment area. Optionally, only the porous structure 104 is implanted without implanting the entire enhanced stent device 100. In some example embodiments of the disclosure, a balloon is used to post-dilate the body lumen 400 at the treatment area in a procedure of at least two steps (1. implanting the device 100, 2. post-dilation) after implanting the enhanced stent device 100 at the treatment area. This procedure is typically used when the implanted device 100 is a self-expandable stent (e.g. for carotid artery applications).

[0255] In some example embodiments of the present disclosure, the porous structure mesh is filled with a material that temporarily improves the rigidity of the porous structure until it reaches the treatment site in the lumen. In some embodiments of the present disclosure, the material is dissolved by a naturally occurring substance in the body, such as an enzyme. Optionally, the dissolution is timed according to the expected overgrowth of the endothelial cell layer on the porous structure 104. Optionally, the material is a fibrogane. Optionally, the material is an albumin fibrogane helonic acid laminin.

[0256] Example treatment of embolic shower at insertion and / or deployment

[0257] It is common in stent implantation procedures to use an embolic shower protection device that is located downstream of the treatment area only during the stent implantation procedure, the idea being that the protection device will capture debris that is dislodged from the vessel wall during the stent implantation procedure. In one example embodiment of the present disclosure, the need for an embolic shower protection device is avoided using the enhanced stent device 100 having the porous structure 104. The small pore size of the porous structure 104 is designed to capture arterial wall plaque 402 and other debris of a particular size that becomes dislodged between the porous structure 104 and the lumen wall 404 during and / or after the stent implantation procedure. In one example embodiment of the present disclosure, debris having a diameter larger than the pore size is prevented from entering the blood stream in this manner.

[0258] Another advantage of using the implanted porous structure 104 in place of a conventional embolic shower protection device is that the porous structure remains in place after the procedure. That is, debris that becomes dislodged some time after the stent implantation procedure is still able to be captured by the porous structure 104. This is an improvement over the conventional use of embolic shower protection devices that are removed at the end of the stent implantation procedure. Optionally, the enhanced stent device 100 is used during the stent implantation procedure with an embolic shower protection device as a back-up. Optionally, the porous structure 104 filters a particular type of debris, while the support element 102 filters other types of debris.

[0259] It should also be noted that in one example embodiment of the present disclosure, the pore size of the porous structure 104 is designed and configured to allow blood to pass therethrough. This prevents "jailing" of branch blood vessels that prevents important blood components such as red blood cells from entering the branch blood vessels.

[0260] In one example embodiment of the present disclosure, the pore size of the porous structure 104 is larger than the average size of a red blood cell, or about 7 microns, allowing red blood cells to pass without the risk of significant hemolysis.

[0261] In some example embodiments of the present disclosure, the approximate pore size is greater than 20 microns. In some example embodiments of the present disclosure, the approximate pore size is less than 100 microns, thus allowing blood to flow through while keeping large debris (> 100 microns) in place.

[0262] Carotid stent implantation is currently rarely performed due to the high risk of debris migration away during the stent implantation. This migrating debris then travels to the brain, where it often causes severe pathology to the patient. To combat the problem of this migrating debris, in some example embodiments of the present disclosure, a stent is implanted in the carotid artery using an enhanced stent device 100 that includes a porous structure 104.

[0263] Example treatment of an aneurism

[0264] Referring to Figure 19a depicts a typical aneurism volume 2002 emanating from a body lumen 2004. Figure 19b A method currently used to treat aneurisms, known as coil embolization, is shown. Coil embolization is indicated, among other things, for treating cerebral aneurisms. Coil embolization of cerebral aneurisms involves inserting a catheter through the groin, with a small microcatheter being guided through the cerebral arteries to the aneurism itself. A coil 2006 is then deployed into the aneurism, filling the aneurism from the inside and thus disrupting blood flow in the aneurism volume. This effect causes a blood clot to be generated, which is trapped in the aneurism volume 2002 and ultimately transforms into a more solid structure, reducing the risk of aneurism rupture. In some treatments, a stent 2008 is also used in order to prevent the coil 2006 from dislodging from the aneurism volume 2002 and into the blood stream. However, in some cases, portions of the coil 2006 protrude through the stent 2008 and are thus exposed to the blood flow within the lumen 2004. Additionally, safely inserting the coil 2006 into the aneurism volume 2002 can be a complex procedure. Additionally, the generated blood clot can grow through the stent struts, into the blood vessel lumen, potentially constricting the blood vessel lumen to the point of complete occlusion.

[0265] Referring to Figure 19cFigure 2 shows one embodiment of the present disclosure in which the porous structure 104 on the enhanced stent device 100 is used to treat an aneurysm while preventing the coil 2006 from protruding into the lumen 2004. Optionally, a cerebral aneurysm is treated by this method. According to one embodiment of the present disclosure, the porous structure 104 is adapted to have a pore size small enough to prevent the coil 2006 from protruding into the lumen 2004. Optionally, a plurality of porous structures of at least slightly different phases are used in order to prevent at least a portion of the coil 2006 from protruding into the lumen 2004. In some example embodiments of the present disclosure, the coil 2006 is covered with a porous structure (separate from the porous structure 104), resulting in a greater surface area for blood to stick to, enhancing the clot formation within the aneurysm volume 2002. In some embodiments of the present disclosure, the porous structure 104 is manufactured using electrospinning techniques.

[0266] In one example embodiment of the present disclosure, the enhanced stent device 100 is used to treat an aneurysm without the need for a coil 2006. In some embodiments of the present disclosure, the porous structure 104 is adapted to restrict blood flow into the aneurysm volume 2002, thus causing the trapped blood in the aneurysm volume 2002 to clot, which will subsequently solidify and create a strong tissue structure, thus reducing the likelihood of aneurysm rupture or expansion due to increased blood flow thereto. For example, the pore size in the porous structure 104 can be small or widely spaced. Optionally, a plurality of "different phase" porous structures are used together to restrict blood flow into the aneurysm volume 2002. Optionally, the porous structure 104 has pores smaller than 20 microns. Eliminating the need for a coil 2006 is advantageous because it makes the procedure faster, safer, and simplifies the delivery catheter that can be used to perform the procedure.

[0267] In some example embodiments of the present disclosure, the porous structure 104 is shorter than the support element 102. Optionally, a shorter porous structure 104 is used so that only the aneurysm is treated and not the healthy portion of the lumen. Optionally, the shorter porous structure 104 is used to avoid restricting blood flow to the branch vessels. Optionally, the porous structure 104 has a small pore size on the aneurysm side to restrict blood flow through, while the other side has larger pores to avoid restricting blood flow to the branch vessels.

[0268] In some example embodiments of the present disclosure, the porous structure 104 comprises a self-expanding material (e.g., nitinol) that has sufficient radial force to hold itself in place within the lumen. Optionally, the support element 102 is not used at all, and the porous structure 104 provides the necessary treatment of the aneurysm. Optionally, the radial pressure exerted by the porous structure 104 is equal to about 1 atmosphere. Optionally, the pore value diameter for aneurysm treatment is less than 30 microns.

[0269] In some embodiments of the present disclosure, the porous structure 104 also prevents blood clots and / or other embolizing debris from entering the lumen 2004 from the aneurysm volume 2002.

[0270] Example treatment of vulnerable plaque

[0271] Identification of vulnerable plaque regions allows for prophylactic treatment of these regions before they cause problems for the patient. In one embodiment of the present disclosure, the enhanced stent device 100 is used to preferentially treat lumen regions that are predicted to trigger problematic conditions for the patient in the future. For example, plaque often builds up within blood vessels, in some cases breaking off or partially tearing, causing thrombosis. Downstream movement of the plaque or thrombosis is a potential cause of heart attack, stroke, or other maladies in the patient. In some embodiments of the present disclosure, an enhanced stent device including at least a porous structure 104 is implanted at a potentially problematic location within the lumen to prevent plaque rupture and, thus, entry of the plaque into the bloodstream. In some embodiments of the present disclosure, the porous structure 104 elutes at least one drug, such as those described herein, for treating conditions affecting the lumen. In some embodiments of the present disclosure, the porous structure 104 is made of nitinol, which is a self-expandable stent, with sufficient radial force to hold itself in place without a support member 102.

[0272] Example implantation method

[0273] In some example embodiments of the present disclosure, the porous structure 104 is positioned on a catheter for implantation into the lumen separately from or without the support element 102. Treatment with the catheter is optionally provided by implanting the porous structure 104 using the catheter, the porous structure 104 being adapted and configured to provide treatment to the lumen over time. Optionally, a drug or other therapeutic agent is embedded within the porous structure 104, for example as described herein. In one example embodiment of the present disclosure, positioning requires insertion of the catheter at least partially through the interior of the porous structure 104 along the central axis 106. During delivery of the porous structure 104 to the treatment site within the lumen, the porous structure 104 is optionally secured to the catheter during delivery, but not so firmly as to prevent implantation of the porous structure 104 at the treatment site and to prevent leaving the porous structure 104 intact within the lumen while the catheter is withdrawn. For example, the porous structure 104 is optionally adhered to the catheter at selected points using an adhesive such as loctite instant adhesive number 40340, 40840, 46040, or 3411-UV curable adhesive. The strength of the adhesive is sufficient to prevent any attached porous structure 104 from slipping off the catheter during delivery, yet upon self-expansion or other expansion, the bond between the porous structure 104 and the catheter is broken, thereby allowing the porous structure 104 to be implanted at the treatment site within the lumen. In some embodiments of the present disclosure, delivery lasts 6 hours or less. Optionally, delivery lasts 3 hours or less. Optionally, delivery lasts 1 hour or less.

[0274] In some example embodiments of the present disclosure, the catheter is treated with a release agent such as a Parylene-c, silicon coating, and / or (PTFE) coating to help prevent the porous structure 104 from remaining fastened to the catheter after deployment at the treatment site. Optionally, a film is coated onto the catheter that secures the porous structure 104 to the catheter during delivery, but dissolves after a period of time, thereby allowing the porous structure 104 to be removed from the catheter. Optionally, the film includes a layer of albumin fibrinogen and / or hyaluronic acid and / or laminin. Optionally, the film layer is at most a few microns thick. Alternatively, the film layer is 0.1 microns thick.

[0275] In some example embodiments of the present disclosure, the mesh of the porous structure 104 is filled and / or encapsulated with a gel-like material such as fibrin, fibrinogen, and / or hyaluronic acid and / or laminin. The gel material hardens the porous structure 104 for delivery, however, upon prolonged exposure to the conditions within the lumen, the gel dissolves after a period of time, for example hours or days, leaving only the porous structure 104.

[0276] In one embodiment of the disclosure, an adhesive material sensitive to a certain pressure threshold (e.g. 1 atm up to 20 atm) is placed on the porous structure 104 such that when the porous structure 104 is present and pressed against the lumen, the porous structure 104 adheres to the lumen. In one example embodiment of the disclosure, when the porous structure 104 is coated with a pressure sensitive adhesive, it is coated only on the lumen side of the porous structure 104. Optionally, the porous structure 104 is covered with a selective adhesive material (e.g. fibrin sealant, bio-glue, collagen, hydrogel, hydrocolloid or collagen algirate) that has a high affinity to adhere to body tissue, but limited affinity to adhere to other substances such as a delivery catheter.

[0277] Optionally, the porous structure 104 is at least temporarily fastened to the inner surface of the lumen by means of an adhesive. In some example embodiments of the disclosure, the porous structure 104 is at least temporarily attached using at least one barb or pin located on the outer surface of the porous structure 104 facing the inner surface of the blood vessel. Optionally, the adhesive is applied to the outer surface of the porous structure 104 prior to insertion into the lumen. In some example embodiments of the disclosure, once the porous structure 104 is placed at the treatment site within the lumen, the support element 102 is implanted at the same site inside the porous structure 104 relative to the inner surface of the lumen, thereby sandwiching the porous structure 104 between the support element 102 and the lumen.

[0278] In some example embodiments of the disclosure, the porous structure 104 provides mechanical support to the blood vessel wall. Optionally, the support of the porous structure 104 is in addition to the support provided by the support element 102. Alternatively, the support of the porous structure 104 replaces the support provided by the support element 102. In some example embodiments of the disclosure, the support element 102 does not provide support or provides minimal support to the blood vessel wall, but rather supports the porous structure. Optionally, the porous structure 104 provides a pharmacological treatment to the blood vessel without providing support or with minimal support to the blood vessel. Optionally, the porous structure 104 is implanted together with the support element 102, however, the support element 102 degrades in situ leaving the porous structure 104. Optionally, the porous structure 104 prevents the support structure 102 from disintegrating into large pieces, allowing only the release of pieces of the porous structure 102 below a certain threshold size (e.g. below 20 microns in diameter). Optionally, the porous structure 104 is implanted together with the support element 102, however, the porous structure 104 degrades in situ leaving the support element 102. This last configuration is sometimes indicated when the porous structure 104 is made of a polymer containing a drug. Elimination of the polymer and the drug after a certain time has advantages since it reduces the likelihood of long term side effects, such as thrombosis associated with the presence of the polymer and the drug.

[0279] Stent assemblies, with or without sheaths, are used within open vessel lumens of various vascular tissues, including, among others, stenotic coronary arteries, stenotic carotid arteries, and stenotic organ vasculature.

[0280] Prior art trade-off between radial force and stent diameter

[0281] As noted above, self-expanding stents generally have a tubular shape that is cut into a pattern that results in a spring-like motion of the stent assembly in the radial direction. These stents are pre-loaded into a delivery system by crimping them to a small diameter, and then during the procedure, the stent is deployed and gradually expands to the vessel diameter. The stent acts as a support frame based on the stent geometry, and the radial force exerted by the stent on the vessel wall is referred to as the radial force (RF).

[0282] Figure 20 A graphical illustration 2050 of the counteracting forces involved in crimping and then deploying a conventional stent (e.g., change in stent diameter). Generally, line 2052 represents the magnitude of the equivalent linear force required to crimp the stent to a particular diameter within a 4-12 sided polygonal cavity, and line 2054 represents the magnitude of the force exerted by the stent on the vessel wall as the stent diameter increases.

[0283] Generally, the line 2054 passes through a first region 2056 and a second region 2058 during expansion. The first region 2056 is a radial force region that delivers high radial force up to a minimum determined size of the stent and any other stent assembly components (e.g., associated stent sheath) (radial expansion). This region 2056 is designed to initiate expansion of the lesion site or otherwise contact the compromised portion of the body lumen. This region 2056 corresponds to the opening of the stent from 0 to 5 mm with relatively high radial force. The second region 2058 is a conformability region to achieve diameters up to 11 mm with relatively lower radial force. Generally, conventional stents have higher radial force from 0 to 5 mm and then lower radial force from about 6 mm to 11 mm. Conventional stents have very high radial force variation within this region 2058. Thus, the radial force at 5 mm diameter is much greater than the radial force at 9.5 mm diameter. As such, conventional stents generally do not provide a large range of size (i.e., vessel diameter) coverage because the stent is designed to provide support arch coverage proportional to the diameter of the target reference site while avoiding maximum radial force that can compromise the vessel wall. For example, when the second region 2058 includes diameters between 5.5 mm and 9 mm (e.g., a 163% change from the initial diameter), the reduction in radial force is greater than 50% and so high that if the designed expanded stent diameter is + / - 1 to 2 mm compared to the vessel diameter, then inappropriate radial force is applied to the vessel wall. Thus, to help ensure that appropriate radial force is applied to the vessel wall, the physician must select a stent size that is generally within 1-2 mm of the vessel wall. In other words, for conventional stents, the stent has a designed expanded stent diameter that is acceptable within a very small range of vessel diameters. In some applications, the portion of the vessel to be implanted with a stent has different diameters along the length of the portion, with a difference of 5 mm or more. Vessels differ between patients by 5 mm or more, and / or vessels within one patient can differ by 5 mm or more. Thus, there is a wide variety of vessel sizes and different vessel diameters that require implantation of a stent, with each application requiring a different stent size. Generally, the physician can select the wrong stent size, resulting in either undersizing or oversizing. Undersizing can result in stent migration or failure to achieve full apposition of the stent, increasing the risk of thrombosis or migration over the stent edges. Oversizing can result in wall compression and creation of restenosis or perforation. Thus, oversizing and undersizing are undesirable, and the stent devices, methods, and kits described herein avoid these undesirable outcomes and associated risks and costs.

[0284] Example stent implantation using various vessel diameters of one embodiment of a stent device 100

[0285] Figure 21One embodiment including stent device 100 by graphical illustration 2060 of the recoil force by crimping and then expanding (e.g., change in stent diameter). One embodiment of stent device 100 includes an open-cell nickel-titanium stent where the outer porous structure 104 is woven from a single strand of 20 pm diameter PET. Graphical illustration 2060 includes straight lines 2052 and 2054 and second region 2058. Figure 22 including table 2062 detailing the persistent outward force during expansion of one embodiment of stent device 100. For one embodiment of stent device 100 tested, the radial force was determined with a segmented head radial force testing apparatus (Blockwise Engineering LCC, Tempe, AZ, USA). One embodiment of stent device 100 was released directly into the testing apparatus at a starting diameter of 5 mm. The testing was performed at a temperature of 37 ± 2 °C, which approximates body temperature. The diameter of the testing stent assembly apparatus was then increased at a rate of 0.2 mm / s until a diameter of 11 mm (full expansion of one embodiment of stent device 100) while continuously measuring the radial force, which represents the persistent outward force of one embodiment of stent device 100. Afterward, the diameter of the testing apparatus was decreased to 5 mm while continuously measuring the radial force, which represents the radial resistance of one embodiment of stent device 100. All radial force values were normalized by the length of one embodiment of stent device 100. The radial force at the minimum allowed diameter (i.e., 5.5 mm) was defined as 100% and the radial force at the maximum allowed diameter (i.e., 9 mm) was defined as 59%. The radial resistance during compression was approximately twice the persistent outward force with similar progression across the range of diameters tested. In some embodiments, the persistent radial force is the radial force exerted by stent device 100 to the vessel wall over an extended period of time, such as, for example, during the useful or design life of stent device 100.

[0286] It can be seen that one embodiment of the stent device 100 increases from a diameter of 5.5 mm with an outward force of 0.330 N / mm to a diameter of 9 mm with an outward force of 0.195 N / mm, i.e., a 163% increase in diameter with only a 41% decrease in outward force. In other words, when the second expanded diameter is less than the first expanded diameter, the ratio between the first expanded diameter and the second different expanded diameter of the stent device is less than about 1.65 and greater than about 1, and the second radial force is within about 170% of the first radial force. This large range of diameters coupled with generally smaller decreases in outward force results in expansion of the diseased segment while exerting minimal residual radial force on the adjacent healthy segments of the vessel. When used to treat an aneurysm, the stent device 100 exerts an acceptable residual radial force against the lumen wall for any lumen diameter within a range of lumen diameters, such as, for example, a range between about 5.5 mm to about 9 mm. The relevant dimensions for aneurysm treatment typically depend on the dimensions of the parent artery. The stent device 100 is configured to provide sufficient persistent radial force for all diameters within a range including the first expanded diameter to the second expanded diameter. This avoids permanent lesions to the implanted stent and adjacent portions of the vessel. That is, the stent device 100 opens the lesion to its original diameter or baseline reference diameter, prevents collapse, and provides safe coverage of the target lesion / reference site without over forcing on the lumen wall. Furthermore, the stent device 100 accommodates various vessel diameters over a short distance without causing trauma in any area. As such, the stent device 100 is configured to expand to any diameter within a range of diameters including from about 5.5 mm to about 9 mm.

[0287] In some embodiments, the stent device 100 is configured for use in various body indications. For example, the stent device 100 is configured and sized for use in body lumens, including arteries, veins, bronchial lumens, biliary lumens, hepatic lumens, any digestive related lumens, ear-nose-throat related lumens, etc. Generally, the stent device 100 provides similar radial force (e.g., less than 50% decrease) at different final reference standard diameters or baseline reference diameters. Examples of the stent device 100 configured for use in an area, the relevant minimum and maximum reference diameters, the relevant percentage increase in minimum and maximum diameters, and the relevant percentage decrease in radial force are listed in Table 2 (non-exhaustive list):

[0288] Table 2 Example Areas of Use

[0289]

[0290]

[0291] In one example embodiment, as Figure 23As shown, the stent implantation method 2070 includes estimating, at step 2072, a body lumen diameter associated with a portion of a body lumen in which the stent device 100 is to be placed, determining, at step 2074, a target expanded stent diameter for a stent assembly to be placed in the portion of the body lumen based on the estimated body lumen diameter, selecting, at step 2076, a stent device 100 for implanting a stent in the portion of the body lumen, and implanting, at step 2078, the stent assembly 100 in the portion of the body lumen.

[0292] At step 2072, a body lumen diameter associated with a portion of a body lumen in which a stent assembly is to be placed is estimated. Typically, a physician uses imaging techniques to determine an estimated body lumen diameter of the portion of the body lumen in which a stent is required. In some embodiments, the portion of the body lumen in which a stent is to be implanted has, or ideally should have, a substantially uniform vessel diameter (e.g., within 10% variation in diameter). However, in other embodiments, the portion of the body lumen has, or should have, a varying body lumen diameter, which in some cases can be as high as 5 mm or about 160% variation in diameter. Accordingly, in some embodiments, multiple body lumen diameters are estimated during step 2072. As Figure 24 As shown, at step 2072, multiple body lumen diameters are estimated, such as diameters 2080a and 2080b of a portion of a vessel 2082. In some embodiments, the vessel diameter 2080a is associated with a first portion of the body lumen 2082, while the body lumen diameter 2080b is associated with a second portion of the body lumen 2082. In some embodiments, a lesion 2084 causes the body lumen diameter to narrow. In some embodiments, and as described above, the diameters 2080a and 2080b are different, while in other embodiments, the diameters 2080a and 2080b are substantially the same. Typically, the diameters 2080a and 2080b are reference diameters associated with the region in which a stent is to be implanted. This avoids false measurements, as some lumen diameters can appear smaller when the lumen is restricted in any way (e.g., due to a lesion). In some embodiments, the diameter 2080a is spaced apart from the lesion 2084 in a first direction, and the diameter 2080b is spaced apart from the lesion 2084 in a second direction opposite the first direction.

[0293] At step 2074, a target expanded stent diameter for the stent device 100 is determined based on the estimated body lumen diameter. Typically, the target expanded stent diameter for the stent device 100 is uniform with the unaffected region of the body lumen. That is, the target expanded stent diameter is the diameter of the vessel at a location proximate the lesion 2084, or is the diameters 2080a and 2080b. In some embodiments, the expanded diameter of the stent assembly is substantially uniform. However, in some embodiments, and as Figure 24 As shown, there are multiple target expanded stent diameters.

[0294] At step 2076, a stent device 100 is selected for implanting a stent in a portion of a body lumen 2082. In some embodiments, the stent device 100 is selected regardless of whether the target expanded stent diameter is substantially uniform or whether there are multiple target expanded stent diameters within a range of expanded diameters. Further, the stent device 100 is selected when the target expanded stent diameter is any diameter within a range of about 5 mm to about 10 mm. In some embodiments, the stent device 100 is selected when the target expanded stent diameter is any diameter within a range of about 5.5 mm to about 9 mm.

[0295] At step 2078, the stent device 100 is implanted in the portion of the body lumen 2082. As shown, the stent assembly is positioned in a collapsed or crimped state within the portion of the body lumen 2082 (the deployment tool is not shown in FIG. 21). Figure 25 Figure 25 and 26 At step 2080, the stent device 100 is allowed to expand when positioned within the portion of the blood vessel 2082. As shown, the stent assembly expands at the site of the lesion 2084 to open the body lumen. Further, the stent device 100 self-adjusts to the adjacent portions of the body lumen such that the expanded diameter of the stent device 100 is equal to or substantially similar to the estimated body lumen diameters 2080a and 2080b. That is, the stent device 100 self-adjusts and provides the appropriate radial force to the portions of the body lumen adjacent to the lesion 2084. Figure 26

[0296] Although Figures 24-26 ​​The stent device 100 is shown in use in body lumens having different body lumen diameters, but the stent device 100 can also be used in body lumens having substantially uniform blood vessel diameters. For example, the stent device 100 can be used in a body lumen of a first patient having a substantially uniform diameter of about 5.5 mm. Further, the same stent device as the stent device 100 can be used in a body lumen of a second patient having a substantially uniform diameter of about 9 mm (i.e., a substantially uniform diameter). In one embodiment, a substantially identical stent assembly is a stent assembly that is 10% of the size of another stent assembly; a stent assembly that is at least 90% identical in composition; and / or a stent assembly that has the same design but differs slightly due to manufacturing variances and tolerances. The radial force exerted by the stent device 100 is about 0.33 N / mm, while the radial force exerted to the same stent device 100 as the stent device 100 is about 0.195 N / mm, as each radial force (i.e., 0.33 N / mm and 0.195 N / mm) is an acceptable radial force to exert to a body lumen wall, thus the stent device 100 is an all-in-one stent assembly that is configured to expand to any diameter from about 5.5 mm to about 9 mm. In some embodiments, the structure of the stent device 100 allows the stent device 100 to act as a straight stent or a tapered stent. That is, the structure of the stent device 100 is not designed for a predetermined tapering of the expanded diameter, but rather the structure of the stent device 100 accommodates the diameter of the body lumen as the stent device 100 is deployed, even within a body lumen having a non-uniform diameter within the target range of about 5.5 mm to about 9 mm.

[0297] While the lesion 2084 is shown in Figures 24-26 the method 2070 is also applicable to the treatment of an aneurysm. In these cases, the portion of the body lumen to be implanted with the stent includes an aneurysm rather than a lesion. The stent assemblies of the present disclosure can be used for other indications and applications.

[0298] Further, while the stent device 100 described above in the method 2070 is designed for expansion to any diameter from about 5.5 mm to about 9 mm in the common carotid artery, the method 2070 is also applicable for use in each of the regions described in detail above in Table 2. In those cases, for example, when the stent device 100 is designed and sized for use in the aorta, the stent device 100 is configured to expand to any diameter from about 20 mm to about 44 mm, while having a persistent radial force drop equal to or less than about 50% between the expanded diameter of 20 mm and the expanded diameter of 44 mm.

[0299] The stent device 100 and / or method 2070 reduces or eliminates the risk of sizing errors. That is, since the stent device 100 configured for the common carotid artery is configured to expand to a range of diameters including 5.5 mm to 9 mm (and in some cases 5 mm to 10 mm), errors related to undersizing or oversizing of the stent assembly are minimized or prevented. Similarly, and as provided in Table 2, when the stent device 100 is configured for use in the aorta, the stent device 100 is configured to expand to any diameter from about 20 mm to about 44 mm, while having a persistent radial force drop equal to or less than about 50% between the expanded diameter of 20 mm and the expanded diameter of 44 mm. Further, the stent device 100 and / or method 2070 reduces the number of stent assemblies that need to be stored on hand. The stent device 100 and / or method 2070 ensures a known, predetermined radial force expectation for all diameters in the range, and results in a better adaptation to varying diameters over the length of the implant. In this way, there is no longer a need to use stent assemblies that are specifically configured for varying diameters of the vessel, such as tapered stents. Instead, the stent device 100 is configured for use in portions of the body lumen having different diameters, and for use in a range of vessel sizes having generally uniform diameters. The stent device 100 eliminates the compromise of selecting a stent for different body lumen diameters based on the maximum radial force and the desired stent diameter. With the self-adjustment of the stent device 100, the stent assembly automatically achieves optimal expansion and apposition with minimal residual radial force that does not exceed the maximum safe radial force that avoids or minimizes damage to the body lumen wall.

[0300] In some embodiments, and when the external porous structure 104 of a single strand of 20 pm diameter PET is placed to the exterior of the stent, the stent coverage is increased without the need for additional metal struts. This interface increases the target lesion coverage and enables greater flexibility with less metal implantation. The advantage of full coverage with the external porous structure 104 of a single strand of 20 pm PET placed on a nickel-titanium alloy stent allows for a better handling of covering various diameters within the same site, rather than being oversized in certain areas, or indeed undersized in certain areas. In some embodiments, the stent device 100 is composed of or includes a super-elastic memory material such as nickel-titanium alloy or a super-elastic polymer such as, for example, Hytrel® manufactured by SABIC of Riyadh, Saudi Arabia, or a cobalt-chromium stent or other stent material. In some embodiments, the stent device 100 is composed of or includes a super-elastic memory material such as nickel-titanium alloy or a super-elastic polymer such as, for example, Hytrel® manufactured by SABIC of Riyadh, Saudi Arabia, or a cobalt-chromium stent or other stent material.

[0301] In some embodiments, the method 2070 further includes providing implant stent instructions and providing the stent device 100 in association with the instructions. In some embodiments, the implant stent instructions include instructions to estimate a body lumen diameter associated with a portion of a body lumen where a portion of a stent assembly is to be placed; determine a target expanded stent diameter of the stent assembly based on the estimated body lumen diameter; select a stent assembly for implanting a stent in the first portion of the body lumen, wherein the stent assembly is configured to expand from an initial diameter to an expanded diameter in a range of expanded diameters while applying a radial force in a range of about 0.20 N / mm to about 0.33 N / mm; and implant the stent assembly in the portion of the body lumen.

[0302] In some embodiments, the instructions and the stent device 100 are provided as a kit.

[0303] In some embodiments, the stent device 100 includes the porous structure 104 and the support structure 102 as described above. In other embodiments, the porous structure 104 is omitted and the support structure 102 includes or is a single piece cut stent.

[0304] Experimental data related to one embodiment of the stent device 100

[0305] Thirty (30) consecutive eligible patients were enrolled and treated with one embodiment of the stent device 100 having a free diameter of 10.5 mm. All patients had high-grade stenosis of the internal carotid artery and / or symptomatic stenosis. The modified Rankin scale for symptomatic patients was 1.4 ± 0.7. Key inclusion criteria included high-grade stenosis and / or symptomatic stenosis; less than = 1 month of clinical symptoms of carotid stenosis prior to intervention; vessel diameter between 4.7 mm and 9.0 mm. Key exclusion criteria included asymptomatic stenosis < 80%; concurrent acute occlusion of an intracranial artery; intracranial hemorrhage; and prior stent implantation in the body on the same side. The primary efficacy endpoint was the rate of procedural success, defined as successful placement of the stent device 100 in the target vessel with no major procedural complications. The primary safety endpoint was the rate of major adverse events, defined as death, stroke, or myocardial infarction within 30 days of the procedure. Figure 27The characteristics of the patients and lesions are listed in Table 2090. The characteristics of the lesions show a step-in diameter from 8.4 ± 0.6 mm in the common carotid artery (CCA) to 5.8 ± 0.6 mm in the internal carotid artery (ICA). Twenty-one (21) arteries had a lengthened and of these six (6) had a severe tortuosity, while nine (9) arteries were relatively straight. All patients had a pre-interventional duplex ultrasound (DUS) and CT or MRI. Each of the one embodiment of the stent device 100 was implanted by a transfemoral approach using local anesthesia. After placement of a long (i.e. 90 cm) support sheath (6F, Destination, Terumo Europe, Leuven, Belgium) in the common carotid artery, twelve (12 / 30) of the thirty patients used a distal embolization protection device (FilterWire EZ TM Boston Scientific, Natick MA, USA). All patients had an initial stent implantation without pre-dilation. The one embodiment of the stent device 100 was implanted (10 x 40 mm (n = 25) and 10 x 30 mm (n = 5)) into the patients. All patients received 0.5 mg of atropine I.V. (Braun, Germany) and a 5 x 30 mm balloon (Sterling TMBoston Scientific, Natick MA, USA) was performed. All cases were documented at baseline, including stent implantation, post-dilation and removal of the distal filter in two projections using intracranial digital subtraction angiography (DSA) afterwards. A clip-based closure device (StarClose SE of Abbott Vascular, Santa Clara, CA, USA) was used at the puncture site. After the intervention, all patients were transferred to a stroke unit and received neurological monitoring. DUS was repeated after the intervention and after 30 days. In a subgroup, 30-day diffusion-weighted magnetic resonance imaging (DW-MRI) was performed. On the day before the intervention, all patients were premedicated with 500 mg acetylsalicylic acid (ASA) and 300 mg clopidogrel (Sanofi Aventis of Germany). During the intervention, heparin was given between 5,000 and 10,000 IU for an activated clotting time (ACT) of 250 to 300 seconds. From the beginning of the intervention, clopidogrel was taken daily (75 mg, Sanofi Aventis of Germany) for at least 6 weeks, and ASA was taken continuously (100 mg daily). The technical success rate was 100%. In no case was a pre-dilation performed before stent placement. Distal filters were used in twelve of thirty cases (12 / 30). No debris were observed after filter removal. There were no cases of relevant spasm, distal embolization or dissection. The median treatment time from puncture to vessel closure was 37.4 ± 8.7 minutes. The median ACT during the intervention was 266.3 seconds. There were no cases of death or major adverse events (MAE). There were no mild or severe strokes during the intervention or during the 30-day follow-up. No patient developed new neurological symptoms. The modified Rankin scale was 0. After the DUS procedure and after 30 days, all stents were patent and had normalized Doppler velocities. The median peak systolic velocity (PSV) was 75.8 ± 9.1 at day 30. The external carotid artery was patent in all patients. After 30 days, ten of thirty patients (10 / 30) underwent DW-MRI, and no new ipsilateral lesions were detected.

[0306] The high incidence of postoperative embolization using conventional stents (e.g., 2 / 3 of CAS major adverse cardiac and cerebrovascular events (MACCE) at 30 days) justifies the introduction of one embodiment of a stent device 100 that includes a porous structure 104 to provide permanent protection at the time of stent implantation, as it is designed to prevent perioperative and late embolization by capturing potential emboli on the arterial wall, while maintaining perfusion of the external carotid artery and branch vessels.

[0307] In some embodiments, the small pore size of the porous layer 104 provides a neuroprotection effect at 30 days post-CAS with a significant reduction in the incidence and volume of DW-MRI new lesions compared to historical data for conventional stents.

[0308] In terms of clinical outcomes, a retrospective of 550 patients treated with one embodiment of the stent device 100 showed a 1% overall complication rate at 30 days and eliminated post-operative events. In a prospective full referral study of 101 patients treated with one embodiment of the stent device 100, only one perioperative minor stroke was found in a one-year follow-up with no other related complications, one of which was in-stent restenosis. No complications were observed and no minor or major strokes were observed in 30 patients followed.

[0309] The median difference in step was greater than 2 mm. In previous approaches, tapered stents (TS) implanted in a porcine model showed low radial force and reduced intimal hyperplasia, resulting in a significant reduction in restenosis. In clinical trials, TS demonstrated a lower restenosis rate compared to straight stents and were not prophylactic in perioperative events. However, and as noted above, one embodiment of the stent device 100 eliminates and replaces the need for any tapered stent component. One embodiment of the stent device 100 shows excellent compliance with a near flat persistent outward force distribution in the range of 5.5 mm to 9.0 mm (i.e., only about 40% drop in force).

[0310] In this series of otherwise conventional CAS in consecutive patients, one embodiment of the stent device 100 proved that it could be safely implanted relative to the vessel structure, providing a near flat persistent outward force distribution in the range of 5.5 mm to 9.0 mm. Experimental data related to the use of one embodiment of the stent device 100 demonstrated prophylaxis of post-operative embolic events.

[0311] In some embodiments, the support device 100 expands to a final diameter within a final diameter range while maintaining a persistent radial force within a persistent radial force range. In some embodiments, the final diameter ranges from approximately a first final diameter to approximately a second final diameter, the second final diameter being twice the size of the first final diameter. In some embodiments, and for a correspondingly sized support device 100, the final diameter ranges from approximately 10 mm to approximately 20 mm. However, other diameters, such as those listed in Table 2, are considered here. In some embodiments, the persistent radial force ranges from approximately a first persistent radial force to approximately a second persistent radial force, the second persistent radial force being approximately half the first persistent radial force. In some embodiments, the final persistent radial force is inversely proportional to the final diameter. That is, as the final diameter increases, the final persistent radial force decreases. In other words, the second final diameter is twice the size of the first final diameter, and when expanded to the second final diameter, the support device 100 provides approximately 50% (or at least 50%) of the first persistent radial force. However, in other embodiments, an inverse relationship is not required between the final diameter and the final bearing force; instead, the bearing radial force applied by the support device 100 does not decrease by more than 50% over the final diameter range. In some applications, the bearing radial force ranges from about 0.7 N / mm to about 0.35 N / mm, but can be as low as 0.02 N / mm and 0.1 N / mm.

[0312] In some embodiments, and for the scaffold device 100 used in method 2070, the porous structure 104 described herein may be replaced by a polymer scaffold sheath or a polymer graft sheath. In some embodiments, the porous structure 104 is omitted.

[0313] In some embodiments, the stent device 100 is a dual therapeutic stent, a bioresorbable vascular support stent, a bioengineered stent, a drug-eluting stent, and / or a bare metal stent.

[0314] Existing technology support and sheath construction

[0315] like Figure 31a As shown, the stent device 100 includes a freestanding tubular stent 202 without a sheath, here referred to as a bare stent 202. The bare stent 202 typically comprises a metal or polymer tubular structure with large mesh openings 270. The bare stent 202 is shown surrounding a balloon 260, and expands radially outward as the balloon 260 inflates.

[0316] like Figure 31bAs shown, the bare stent 202 has been radially expanded in the vessel lumen 125 to press against the stenotic region 240 of the tissue, thereby radially compressing the stenotic region 240 outward and stenting open the stenotic region 240. After the stent device 100 is deployed, the vessel lumen 125 expands, thereby allowing better circulation through the lumen 125.

[0317] However, the deployment of the bare stent 202 damages the intimal lining 127, thereby causing the formation of scar tissue 242, plaque 244, and new stenotic lesions 240 protruding through the pores 270. Over time, a significant number of recipients of the bare stent 202 develop significant stenotic lesions 240 that occlude the vessel lumen 125, causing what is known as restenosis.

[0318] To prevent restenosis Figure 31c ), a stent assembly 200 has been developed that includes a stent 202 having an internal or external sheath 204 with small pores. The stent assembly 200 is shown in place about the spindle holder 180, which is exposed from the compression sheath 182, with the stent 202 and stent sheath 204 in a substantially tubular alignment. Typically, the sheath is formed of a polymer.

[0319] During expansion, the sheath 204 prevents embolic debris 121 from the plaque along the intimal lining 127 from entering the vessel lumen 125.

[0320] In Figure 31d , the stent assembly 200 is radially expanded in the vessel lumen 125 such that the sheath 204 presses outward against the stenotic tissue 240. After the stent assembly 200 is deployed, the stent sheath substantially prevents the scar tissue 242, plaque 244, and stenotic lesions 240 from protruding through the pores 270. Although restenosis is substantially prevented, the stent sheath 204 creates its own series of problems associated with the formation of emboli 300.

[0321] As noted above, to provide sufficient strength, the stent sheath 204 can be made of interlaced knitted fibers and / or fibers that have been chemically or heat treated, all of which often increase the thickness of the fibers 210 and the bulk of the sheath 204, as seen in Figure 32 .

[0322] Within 48 hours after the stent assembly 200 is implanted, the endothelial cell layer 220 coats the stent sheath fibers 210 and the intimal lining 127, as seen in Figure 32 .

[0323] The endothelial cells 220 have a diameter 222 of about 20 microns and maintain adhesion to the intimal lining 127, but generally do not substantially adhere to the sheath fibers 210.

[0324] The thickness 212 of the fibers 210 in the stent sheath is typically 20 microns, such that endothelial cells 220 straddling the fibers 210 will not attach to the basement membrane layer 127 and will readily dislodge from the fibers 210.

[0325] Additionally, the fibers 210 are typically spaced apart by a distance 218 of less than 20 microns, such that endothelial cells 220 straddling two fibers 210 will attach to both adjacent fibers 210 and will have edge attachment to the basement intimal layer 127 therebetween; again resulting in cells 220 that readily dislodge from the fibers 210.

[0326] The size of the individual endothelial cells 220 that detach from the basement intimal layer 127 is insufficient to be recognized by platelets as a foreign body to aggregate around. However, as Figure 33 seen, the release of multiple interconnected cells 220 occurs during the natural movement of the fibers 210, such as during the regular pulsing of blood in circulation.

[0327] In this case, four endothelial cells 220 have detached from the basement intimal layer 127 and are freely floating in the vessel lumen. Platelets 310 having a diameter 320 that is four to ten times the diameter of the endothelial cells 220 are attracted to the mass comprising at least two endothelial cells 220 and the endothelial cells 220 provide excellent targets of attraction for the platelets 310.

[0328] As Figure 34 seen, a single platelet 310 adheres to a dislodged endothelial cell 220. As Figure 35 seen, additional platelets 310 aggregate around the endothelial cell 220 due to chemotaxis to form a thrombus 300.

[0329] As noted above, the thrombus 300, including the aggregated platelets 310, poses a health threat that can form at any time after implantation of the stent sheath 204, resulting in an estimated 2% of all recipients of the stent sheath 204 eventually developing major organ necrosis and / or death.

[0330] The massive and ongoing threat of thrombus 300 from the stent and sheath assembly 204 Figure 33 ) results in a lifetime of taking a platelet aggregation reducing API. Clopidogrel has many life threatening side effects and there are currently many clinical trials underway for alternative platelet aggregation reducing APIs, including: Ticlopidine, Cangrelor, ARMYDA-2 and Prasugrel.

[0331] (Interventional Cardiology Journal "TCT Annual Meeting: Antiplatelet Drugs"; Vol. 19, p. 193 - April 2006.)

[0332] As noted above, the life-long use of a platelet aggregation reducing API, here clopidogrel, presents problems for many populations.

[0333] For example, many recipients of sheathed stents experience reactions that require the discontinuation of clopidogrel, these reactions include: ulceration, skin rash, and syncope. With the use of high volume sheathed stents, the discontinuation of clopidogrel places the patient at risk for developing a life threatening embolism 300.

[0334] In addition to the risk of embolism 300, there is the risk that the patient must not only discontinue clopidogrel and its attendant risks, but can develop life threatening conditions including myelotoxicity, acquired hemophilia, and TTP.

[0335] Additionally, the patient can have a condition that prevents the administration of clopidogrel, these conditions include: non-response to platelet aggregation reducing API, antithrombin deficiency, hereditary antithrombin deficiency (HD), immunosuppression, low CCR5 Delta 32 homozygous genotype (CCR5), acquired hemophilia, AIDS, HIV.

[0336] Furthermore, almost every person receiving a sheathed stent is at risk. In order to prevent massive bleeding during any surgery, clopidogrel must be discontinued prior to surgery and for a significant period of time after surgery. In this way, a patient who has received a stent and is a candidate for elective surgery, such as a prostatectomy, has no choice: discontinue clopidogrel and risk death from embolism, or take clopidogrel and risk non-embolic bleeding, massive bleeding, and death.

[0337] Optimized stent assembly

[0338] It has been discovered that the particular construction of the stent and sheath described above, as explained in the "Experimental Data" section, appears to provide advantages. The particular features of these constructions will now be addressed.

[0339] Since 1939, single fiber knitted fabrics have been used in pantyhose and include a plurality of interconnected loops that are noted for their strength, elastic properties, and thinness. Single fiber knitted fabrics would be ideal as a low volume sheath 600, if not for the problem that any loop along the edge of the nylon material can flip 180 degrees and form a run.

[0340] Figure 36 A knitted stent sheath 600 is shown that includes knitted fibers 620 that form holes 110. To prevent flipping in the fibers 620, an elastic band 640 has been threaded through the holes 110 at the distal end of the stent sheath 600. Optionally, the elastic band 640 is similarly threaded through loops (not shown) at the proximal end of the stent sheath 600.

[0341] As used herein, any reference to a "knitted material" includes any material manufactured by a knitting process, including, among other things: materials knitted from monofilament, including monofilament or multifilament fibers. Monofilaments can include, among other things, polyethylene, polyvinyl chloride, polyurethane, nylon, stainless steel, nitinol, or any other metal.

[0342] Bio-stable polymers include, among others, any of a polyolefin, a polyurethane, a fluorinated polyolefin, a chlorinated polyolefin, a polyamide, an acrylate polymer, an acrylamide polymer, a vinyl polymer, a polyacetal, a polycarbonate, a polyether, an aromatic polyester, a polyether (ether ketone), a polysulfone, a silicone rubber, a thermoset, and a polyester (ester imide).

[0343] Natural polymers include, among others, any of a polyolefin, a polyurethane, a polyester film, a silicone, a polyester, and a fluorinated polyolefin.

[0344] As Figure 37 seen, the knitted stent jacket 104 includes holes 110 that are maximized such that the fibers 620 provide a small total coverage area where the stent jacket 104 covers the stent 102.

[0345] According to certain embodiments of the present disclosure, the area of the holes 110 in the expanded state is between about 50,000 square microns and about 70,000 square microns. In alternative embodiments, the area of the holes 110 is about between 40,000 square microns and 60,000 square microns. In other embodiments, the area of the holes 110 is between about 30,000 square microns and about 50,000 square microns.

[0346] Because the knitted stent jacket 104 has fibers 620 that exhibit a small total coverage, the crimped stent 102, for example, for insertion into a compression sheath 182 Figure 31c ) is relatively simple.

[0347] Additionally, the small total coverage allows the crimped stent 102 to have a small profile, allowing for easy maneuverability through the lumen 125.

[0348] Furthermore, because the knitted stent jacket 104 has fibers 620 that have a minimal thickness, the stent jacket 104 has substantially minimal impact on the mechanical properties of the stent during delivery and expansion.

[0349] The placement of the jacket 104 on the exterior of the stent 102 can protect the underlying intimal layer 127 from damage during expansion of the stent 102. Additionally, the placement of the jacket 104 on the exterior of the stent 102 can provide substantial protection from debris 121 entering the vessel lumen 125 during expansion of the stent 102, as Figure 31d seen.

[0350] According to some embodiments of the present disclosure, the proximal end portion of the sheath 104 is attached to the proximal aspect of the stent 102 using a process selected from the group consisting of: stitching, gluing, cementing, folding, suturing, riveting, and welding. For example, such attachment allows the stent 102 to be expanded with a different expansion coefficient than the expansion coefficient of the sheath 104, without causing damage to the intima layer 127 of the substrate.

[0351] As seen in the plan view of the knitted stent sheath 600 in Figure 37 The knitted stent sheath 104 includes a small coverage area, for example, about 9%, or about 10%, or about 11%, or about 12% of the surface area of the associated self-expanding stent 102. Generally, the coverage area is less than 16%. Thus, despite the fact that the stent 102 is crimped prior to deployment, the knitted sheath 104 need not be folded to fit into the sheath 182 Figure 31c ) prior to deployment; thereby reducing the bulk and increasing the maneuverability of the stent assembly 200.

[0352] In the present disclosure, the above parameters for the knitted sheath on a self-expanding stent can be readily obtained using a fiber diameter of about 12.5 microns.

[0353] Figure 38 Details of the knitted sheath 600 are shown, wherein the longitudinal length 650 of the aperture 110 is greater than about 160 microns. In other embodiments, the longitudinal length 650 is greater than about 180 microns. In other embodiments, the longitudinal length 650 is greater than about 200 microns.

[0354] According to some embodiments of the present disclosure, the aperture 110 has a transverse length 642 that is greater than about 250 microns. In other embodiments, the transverse length 642 is greater than about 240 microns. In other embodiments, the transverse length 642 is greater than about 230 microns.

[0355] It will be appreciated that the shorter of the longitudinal length 650 and the transverse length 642 defines a minimum central dimension 630 (D) that must be greater than about 230 microns, and preferably greater than 240 microns, and more preferably greater than 250 microns.

[0356] Figure 39The fiber 620 is shown to have a diameter 662 that is optionally in a range between about 7 microns and about 18 microns. In other embodiments, the diameter 662 is in a range between about 10 microns and about 15 microns. In yet other embodiments, the diameter 662 is in a range between about 11 microns and about 14 microns. In yet other embodiments, the diameter 662 is in a range between about 12 microns and about 13 microns. In yet other embodiments, the diameter 662 is in a range between about 12.25 microns and about 12.75 microns. In yet other embodiments, the diameter 662 is about 12.5 microns.

[0357] The substantially inherent advantages of the measured knit sheath 600 become apparent in Figure 40 In Figure 40 Due to the thinness of the fiber 620, the endothelial cells 220 are well adhered and stable with respect to the intima layer 127.

[0358] Due to such spacing, a typical endothelial cell 220 will have sufficient contact with the intima layer 127, as the endothelial cell 220 is prevented from adhering to more than one row of fibers 620 due to the distance between fibers.

[0359] A group of three endothelial cells 220 are seen adhered to a portion of the knit stent sheath 600. The endothelial cells 220 have amoeba-like movement such that at a fiber junction 692, the cell 220 will typically touch down at the junction 692 and move until a substantial portion of the cell 220 is in sufficient contact with the intima layer 127. In the rare case that a cell 228 does not properly anchor into the intima layer 127, that particular single cell 228 alone can be dislodged due to the movement of the fibers 620 during normal pulsations in the blood circulation cycle. The stability of adjacent cells 220 due to being in sufficient contact with the intima layer 127, the plurality of cells 220 will not dislodge with the single cell 228.

[0360] As shown, a single endothelial cell 228 has detached from the intima layer 127. However, the single cell 228 does not have the mass necessary to be recognized by platelets 310 as a subject worthy of adhesion. Thus, no life-threatening embolus 300 associated with platelet aggregation as described above is formed.

[0361] Typically, to ensure the stability of the endothelial cells 220, a patient receiving the stent sheath 100 will be given a platelet aggregation reducing API (such as clopidogrel) for no more than six months, and possibly even less. For example, the patient can receive clopidogrel for no more than five months, no more than four months, no more than three months, no more than two months, or no more than one month.

[0362] Sometimes, a patient receiving the stent sheath 100 will not be given a platelet aggregation reducing API, i.e. the unique properties of the fiber diameter (as shown) and the advantage of the hole minimum center size D alone or in combination completely mitigates the need for a platelet aggregation reducing API. Thus, if a patient is scheduled to undergo an elective surgery during the six month medication period, the clopidogrel can be discontinued without serious fear of platelet aggregation. Figure 30

[0363] Furthermore, if the recipient of the stent sheath 600 has any reaction, including ulceration, rash, syncope, myelotoxicity, and TTP, during the six month medication period, the clopidogrel can be immediately discontinued without serious fear of creating an embolism.

[0364] Furthermore, in the face of patient non-response to clopidogrel, antithrombin deficiency, HD, immunosuppression, low CCR5, acquired hemophilia, AIDS, and HIV, the clopidogrel can be discontinued or not started.

[0365] Experimental data

[0366] Reference is now made to the following chart showing experimental data, which together with the above description, illustrate the present disclosure in a non-limiting manner.

[0367] Optimization of the sheath stent fiber thickness and hole area flat face square reduces the need for an anticoagulant such as clopidogrel.

[0368] Maintaining a small total coverage area provides several additional advantages:

[0369] 1. The crimped stent for insertion is relatively simple;

[0370] 2. The profile of the crimped stent is small;

[0371] 3. The sheath stent has essentially little effect on the mechanical properties of the stent during the delivery and expansion process; and

[0372] 4. In a self-expanding stent, the sheath does not need to be folded during crimping when the stent has a coverage area of about 9%, or about 10%, or about 11%, or about 12%. Generally, the coverage area is less than 16%.

[0373] The following chart provides support that in the present disclosure, using a fiber diameter of about 12.5 microns, the above parameters of sheath coverage on the stent can be easily obtained.

[0374] TABLE-US-00003

[0375]

[0376] ​

[0377] It should be understood that the words and phrases used herein are for descriptive purposes and should not be construed as limiting.

[0378] Unless defined otherwise, all technical and scientific terms and any acronyms used herein have the same meanings as commonly understood by one of ordinary skill in the art in the field of the disclosure. Also, descriptions, materials, methods, and examples are merely illustrative and are not intended to be limiting. Methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure.

[0379] As used herein, the terms "comprising" and "including," or grammatical variants thereof, are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. This terminology encompasses the terms "consisting of" and "consisting essentially of."

[0380] As used herein, "a" or "an" means "at least one" or "one or more." The use of the phrase "one or more" herein does not alter the intended meaning of "a" or "an."

[0381] It is contemplated that many related stent graft materials will be developed during the life of this patent, and the scope of the term stent graft is intended to include all such new technologies in the field.

[0382] As used herein, the term "about" means ±10% of the given value, as appropriate.

[0383] Other objects, advantages and novel features of the present disclosure will become apparent to those skilled in the art from the following example, which is not intended to be limiting. Furthermore, each of the various embodiments and aspects of the present disclosure as described above and as claimed below finds experimental support in the following example.

[0384] It should be appreciated that certain features of the present disclosure, which are, for clarity, described in the context of separate embodiments, can also be provided in combination in a single embodiment. Conversely, various features of the present disclosure, which are, for brevity, described in the context of a single embodiment, can also be provided separately or in any suitable

[0385] While the disclosure has been described in connection with specific embodiments thereof, it will be understood that many modifications, changes, and variations will be clear to those skilled in the art. Accordingly, it is intended to embrace all such modifications, changes, and variations that fall within the spirit and broad scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present disclosure.

Claims

1. A stent assembly comprising: an expandable stent configured to self-expand from an initial diameter to any body lumen diameter to accommodate a diameter of a body lumen when deployed in the body lumen, to an extent that the stent assembly exerts a persistent radial force against a wall of the body lumen, between a first deployed diameter and a second deployed diameter, the second deployed diameter being more than 2 millimeters less than the first deployed diameter, wherein the stent assembly is configured to exert a persistent radial force of 0.20 N / mm to 0.33 N / mm when expanded to any diameter within the range, wherein the stent assembly is not designed for a predetermined tapering of expanded diameters.

2. The support assembly of claim 1, wherein, When the stent assembly is expanded to the first deployed diameter, the stent assembly exerts a radial force that is at least 50% of a radial force exerted by the stent assembly when expanded to the second deployed diameter.

3. The support assembly of claim 1, wherein, The stent assembly is configured to have a first portion that expands to a first expanded diameter and a second portion that expands to a second expanded diameter when the stent assembly is placed in a portion of a body lumen that defines a varying body lumen diameter, the second expanded diameter being different than the first expanded diameter.

4. The support assembly of claim 3, wherein, The stent assembly is configured as a straight stent or a tapered stent, and the stent assembly accommodates a diameter of a body lumen when the stent assembly is deployed in the body lumen, even within a body lumen that is not uniform in diameter.

5. The stent assembly of claim 1, further comprising a knit stent sheath covering the expandable stent.

6. The support assembly of claim 5, wherein, The knit stent sheath controls a local pressure exerted by the expandable stent against a wall of a body lumen in which the stent assembly is implanted.

7. The support assembly of claim 5, wherein, The knit stent sheath comprises an expandable mesh structure.

8. The support assembly of claim 5, wherein, The knit stent sheath is knit from metal monofilaments.

9. The support assembly of claim 1, wherein, The expandable stent is composed of metal.

10. The support assembly of claim 1, wherein, The expandable stent is composed of nitinol.

11. The support assembly of any of claims 1-10, wherein, The first deployed diameter is 9 millimeters and the second deployed diameter is 5.5 millimeters.

12. A stent assembly comprising: an expandable stent configured to self-expand from an initial diameter to at least a first deployed diameter to accommodate a diameter of a body lumen when deployed in the body lumen, to an extent that the stent assembly exerts a persistent radial force against a wall of the body lumen, wherein the stent assembly exerts an acceptable radial force of 0.20 N / mm to 0.33 N / mm to apply to a wall of a body lumen when the stent assembly is expanded to a range between the first deployed diameter and a second deployed diameter that is more than 2 millimeters less than the first deployed diameter, wherein the stent assembly is not designed for a predetermined tapering of expanded diameters.

13. A stent assembly comprising: an expandable stent configured to self-expand from an initial diameter to any body lumen diameter to accommodate a diameter of a body lumen when deployed in the body lumen, to an extent that the stent assembly exerts a persistent radial force against a wall of the body lumen, between a first diameter and a second diameter, wherein the stent assembly is configured to exert a persistent radial force of 0.20 N / mm to 0.33 N / mm when expanded to any diameter within the range, wherein the stent assembly is configured to adapt to a diameter of a body lumen by self-expansion when the stent assembly is deployed in the body lumen, i.e. even within a body lumen of non-uniform diameter, to any diameter within the range between the first diameter and the second diameter, wherein the stent assembly is configured to exert a persistent radial force of 0.20 N / mm to 0.33 N / mm when expanded to any body lumen diameter within the range.

14. The support assembly of claim 13, wherein, When the stent assembly is expanded to the first diameter, the stent assembly exerts a radial force that is at least 50% of the radial force exerted when the stent assembly is expanded to the second diameter.

15. The stent assembly of claim 13, further comprising a knitted stent jacket covering the expandable stent.

16. The support assembly of claim 15, wherein, The knitted stent jacket comprises an expandable mesh structure.

17. The support assembly of claim 15, wherein, The knitted stent jacket is knitted from metal monofilaments.

18. The support assembly of claim 13, wherein, The expandable stent is composed of metal.

19. The support assembly of claim 13, wherein, The expandable stent is composed of Nitinol.

20. The support assembly of any of claims 13-19, wherein, The first diameter is 9 millimeters and the second diameter is 5.5 millimeters.

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