Endoprosthesis with stress reduction features

Abstract

An endoprosthesis configured to transition between a collapsed configuration and an expanded configuration can include a tubular scaffold formed from a single filament woven about a central longitudinal axis and defining a length from a proximal end to a distal end, the tubular scaffold including a plurality of rows of loops and a plurality of rows of rungs arranged in an alternating fashion about the central longitudinal axis; and a polymeric covering extending along the tubular scaffold. Each row of loops and each row of rungs extends longitudinally along the tubular scaffold between the proximal end and the distal end. The tubular scaffold includes a first cutout region extending along a majority of the length of the tubular scaffold, and a second cutout region extending along a majority of the length of the tubular scaffold. The polymeric covering is uninterrupted along the first cutout region and the second cutout region.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 164,766, filed March 23, 2021, the disclosure of which is incorporated herein by reference. Technical Field

[0003] This invention relates to medical devices and methods for manufacturing and / or using medical devices. More particularly, this invention relates to an improved design of an internal prosthesis or stent. Background Technology

[0004] The human body typically includes various cavities, such as the trachea, blood vessels, urinary tract, bile duct, esophagus, or kidneys. These cavities can sometimes be blocked or weakened, or otherwise require structural support. For example, body cavities may be narrowed by tumors, blocked by plaques or stenosis, or weakened by aneurysms. Endoplasmic prostheses or stents have been developed that can be implanted into pathways or cavities within the body. Typically, such endoplasmic prostheses are tubular structures with a circular cross-section; examples include stents, stent grafts, and covered stents.

[0005] Due to their design and device length, current braided or knitted self-expanding internal prostheses can exhibit a high degree of longitudinal flexibility. This can be advantageous for device delivery, particularly in more tortuous anatomical regions, and for reducing post-delivery lumen straightening (which is generally considered less invasive to the target lumen). In some cases, where treatment of benign stenosis is required, stent removal may be necessary, and / or coatings may be used to isolate the treated lumen from nutrient blockages (e.g., extravasation treatment after bariatric surgery, fistula treatment, etc.), bare internal prostheses may include additional coatings. Braided and knitted stents are sometimes used in tracheobronchial lumens to help keep the airway open.

[0006] One problem with using braided and knitted stents within the tracheobronchial lumen is their potential for fracture and / or failure due to fatigue. Forced inhalation / exhalation and / or coughing can cause significant deformation of the body cavities, resulting in corresponding deformation of the stent placed within them. Due to the anatomy of the trachea and bronchi, this deformation can be radially uneven, leading to areas of high stress concentration on the implanted stent. In the trachea, during forceful inhalation / exhalation and / or coughing, the cartilaginous rings are radially compressed, and the smooth muscle tissue caves in, forming sharp folds that create a crescent shape. The implanted stent will deform in a similar manner, resulting in areas of high stress and potentially leading to stent fracture along these sharp folds. While the bronchi experience more even radial compression due to the more uniform distribution of smooth muscle tissue and cartilaginous rings around the lumen, stress concentrations can still occur in the areas surrounding the stent.

[0007] In isolation, these movements generally do not damage the stent. However, over time, repeated exposure to significant deformation can lead to fatigue and / or fracture of the filaments forming the stent. In some cases, fatigue and / or fracture can also result in a loss of coverage integrity. There is a need for alternative prostheses or stents, as well as alternative methods for manufacturing and using them. Summary of the Invention

[0008] In one example, an internal prosthesis configured to transition between a collapsed and expanded form may include a tubular stent formed of a single filament woven around a central longitudinal axis and defining a length from proximal to distal. The tubular stent includes multiple rows of loops and multiple rows of crossbars arranged alternately around the central longitudinal axis; and a polymer overlay extending along the tubular stent. Each row of loops may extend longitudinally along the tubular stent between the proximal and distal ends. Each row of crossbars may extend longitudinally along the tubular stent between the proximal and distal ends. The tubular stent may include a first incision region extending along most of the length of the tubular stent and defining a first proximal end oriented toward the proximal end of the tubular stent and a first distal end oriented toward the distal end of the tubular stent; and a second incision region extending along most of the length of the tubular stent and defining a second proximal end oriented toward the proximal end of the tubular stent and a second distal end oriented toward the distal end of the tubular stent. The polymer overlay may be uninterrupted along the first and second incision regions.

[0009] For any example disclosed herein, the first incision region is formed by removing the middle portion of the first row of rings and the middle portions of several rows of crossbars immediately adjacent to the first row of rings, along most of the length of the tubular support.

[0010] Alternatively or alternatively, for any example disclosed herein, the formation of the first cut region is such that the single filament is discontinuous within the first cut region.

[0011] For any example disclosed herein, additionally or alternatively, the discontinuous single filament includes a first plurality of terminals extending along the first cut region.

[0012] For any example disclosed herein, the second incision region is additionally or alternatively formed by removing the middle portion of the second row of rings and the middle portions of several rows of crossbars immediately adjacent to the second row of rings along most of the length of the tubular support.

[0013] Alternatively or alternatively, for any example disclosed herein, the second cut region is formed such that the single filament is discontinuous within the second cut region.

[0014] Additionally or alternatively, for any example disclosed herein, the discontinuous single filament includes a second plurality of terminals extending along the second slit region.

[0015] In any of the examples disclosed herein, the second incision region is circumferentially spaced from the first incision region.

[0016] For any example disclosed herein, additionally or alternatively, the first proximal end and the second proximal end are disposed distal to the proximal end of the tubular stent. The first distal end and the second distal end are disposed proximal to the distal end of the tubular stent.

[0017] Additionally or alternatively, for any example disclosed herein, the first incision area extends along at least 60% of the length of the tubular stent.

[0018] Additionally or alternatively, for any example disclosed herein, the first incision area extends along at least 75% of the length of the tubular stent.

[0019] Additionally or alternatively for any example disclosed herein, a method of manufacturing an internal prosthesis configured to switch between a collapsed and an expanded form may include: weaving a tubular scaffold from a single filament, the tubular scaffold comprising multiple rows of rings and multiple rows of crossbars arranged in an alternating manner around a central longitudinal axis; heat-setting the tubular scaffold in the expanded form; after the heat-setting step, removing the middle portions of a first row of rings and the middle portions of several rows of crossbars adjacent to the first row of rings along most of the length of the tubular scaffold to form a first incision region; and after the removal step, applying a polymer covering to the tubular scaffold, wherein the polymer covering is uninterrupted along the first incision region.

[0020] Additionally or alternatively to any example disclosed herein, the method may also include: after the heat setting step, removing the middle portion of the second row of rings and the middle portions of several rows of crossbars adjacent to the second row of rings along most of the length of the tubular support to form a second cut area.

[0021] In any of the examples disclosed herein, the second incision region is circumferentially spaced from the first incision region.

[0022] Alternatively or alternatively, for any example disclosed herein, the formation of the first cut region is such that the single filament is discontinuous within the first cut region.

[0023] For any example disclosed herein, additionally or alternatively, the discontinuous single filament includes a first plurality of terminals extending along the first slit region. The first plurality of terminals are embedded within a polymer covering.

[0024] Additionally or alternatively, for any example disclosed herein, an internal prosthesis configured to transition between a collapsed and expanded form may include a tubular scaffold formed of a single filament woven around a central longitudinal axis and defining a length from proximal to distal. The tubular scaffold includes multiple rows of rings and multiple rows of crossbars arranged alternately around the central longitudinal axis; and a polymer overlay extending along the tubular scaffold. Each row of rings may extend longitudinally along the tubular scaffold between the proximal and distal ends. Each row of crossbars may extend longitudinally along the tubular scaffold between the proximal and distal ends. A first row of rings in the multiple rows may be discontinuous along the central region of the tubular scaffold, and several rows of crossbars on circumferentially opposite sides of the first row of rings may be discontinuous along the central region of the tubular scaffold. A second row of rings circumferentially opposite the first row of rings in the multiple rows may be discontinuous along the central region of the tubular scaffold, and several rows of crossbars on opposite sides of the second row of rings may be discontinuous along the central region of the tubular scaffold. The polymer overlay may be continuous along the central region of the tubular scaffold. The polymer cover may be formed of silicone. The intermediate region may extend for at least 60% of the length of the tubular scaffold.

[0025] For any example disclosed herein, additionally or alternatively, in the intermediate region, a single filament comprises multiple discontinuous segments.

[0026] In addition or alternative to any example disclosed herein, multiple discontinuous segments form multiple terminals along the intermediate region, and the multiple terminals are embedded within the polymer cover.

[0027] For any example disclosed herein, the internal prosthesis is otherwise or alternatively biased toward the expansion morphology.

[0028] The above overview of some embodiments, aspects, and / or examples is not intended to describe every disclosed embodiment or implementation of the invention. These embodiments are illustrated more specifically by way of the accompanying drawings and detailed descriptions. Attached Figure Description

[0029] The invention will be more fully understood by taking into consideration the following detailed description in conjunction with the accompanying drawings, wherein:

[0030] Figure 1 This illustrates a prior art knitting support;

[0031] Figure 2 A cross-section of a portion of a patient's trachea in which a knitted stent of prior art is implanted is shown;

[0032] Figure 3 Show Figure 2 Existing technology knitted scaffolds implanted in the middle of the body that withstand forceful inhalation / exhalation and / or coughing;

[0033] Figure 4 Show Figure 1 Existing technology supports that withstand lateral compressive forces;

[0034] Figure 5 Show Figure 1 Existing technology supports that undergo kinking after being subjected to bending forces;

[0035] Figure 6 This illustrates various aspects of the internal prosthesis according to the invention;

[0036] Figure 7 Show Figure 6 All aspects of intraocular prostheses;

[0037] Figure 8 Show Figures 6 to 7 An internal prosthesis subjected to lateral compressive forces;

[0038] Figure 9 Show Figures 6 to 7 The internal prosthesis after being subjected to bending forces;

[0039] Figure 10 Various aspects of the method for manufacturing an internal prosthesis according to the present invention are illustrated;

[0040] Figure 11 Alternative configurations of the internal prosthesis according to the invention are shown; and

[0041] Figure 12 This illustration shows an exemplary placement of the internal prosthesis of the present invention within the trachea.

[0042] While various aspects of the invention are adaptable to numerous modifications and alternatives, their specific details have been shown by way of example in the accompanying drawings and will be described in more detail. However, it should be understood that it is not intended to limit the aspects of the invention to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the invention. Detailed Implementation

[0043] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, wherein the same reference numerals in several views indicate the same elements. The detailed description and drawings are intended to illustrate, not limit, the invention. Those skilled in the art will recognize that the various elements described and / or shown can be arranged in various combinations and configurations without departing from the scope of the invention. The detailed description and drawings illustrate exemplary embodiments of the invention.

[0044] For the purposes of the following definitions, unless otherwise specified in the claims or elsewhere in this specification, these definitions shall apply.

[0045] All numerical values ​​herein are assumed to be modified by the term "about," whether or not explicitly stated otherwise. In the context of numerical values, the term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the referenced value (e.g., having the same function or result). In many instances, the term "about" may include numbers rounded to the nearest significant figure. Unless otherwise specified, the term "about" (e.g., in contexts other than numerical values) may be assumed to have its common and customary definition, as understood and consistent with the context of this specification.

[0046] A reference to a range of numbers represented by an endpoint includes all numbers in that range, including the endpoint (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0047] While some suitable dimensions, ranges and / or values ​​for various components, characteristics and / or specifications are disclosed, those skilled in the art, inspired by the disclosure of this invention, will understand that the desired dimensions, ranges and / or values ​​can be derived from those explicitly disclosed dimensions, ranges and / or values.

[0048] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include a plural indication unless the content expressly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used in the sense that it includes “and / or” unless the content expressly indicates otherwise. It should be noted that, for ease of understanding, certain features of the invention may be described in the singular, even if those features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or contain a singular disclosure unless expressly stated otherwise. For simplicity and clarity, not all elements of the invention will necessarily be shown in every figure or discussed in detail below. However, it should be understood that, unless expressly stated otherwise, the following discussion applies equally to any and / or all of more than one component. Additionally, for clarity, not all cases of some elements or features may be shown in each figure.

[0049] Relative terms such as “proximal,” “distal,” “advance,” “retract,” and variations thereof are generally considered in relation to the positioning, orientation, and / or operation of various elements relative to the user / operator / manipulator of the device, wherein “proximal” and “retract” indicate or refer to being closer to or towards the user, and “distal” and “advance” indicate or refer to being farther from or away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily assigned to facilitate understanding of the invention, and this will be apparent to those skilled in the art. Other relative terms such as “upstream,” “downstream,” “inflow,” and “outflow” refer to the direction of fluid flow in a cavity, such as a body cavity, blood vessel, or within the device. Other relative terms such as “axial,” “circumferential,” “longitudinal,” “transverse,” “radial,” and / or variations thereof generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0050] The term “range” can be understood as the largest measure of the stated or identified dimension, unless the range and dimension in question are preceded by “minimum” or identified as “minimum,” in which case it can be understood as the smallest measure of the stated or identified dimension. For example, “outer range” can be understood as an outer dimension, “radial range” as a radial dimension, “longitudinal range” as a longitudinal dimension, and so on. Each instance of “range” can be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be obvious to a person skilled in the art based on the context of individual use. Generally, “range” can be considered as the largest possible dimension measured according to its intended use, while “minimum range” can be considered as the smallest possible dimension measured according to its intended use. In some cases, “range” can typically be measured orthogonally in a plane and / or cross-section, but as is obvious in the specific context, it can also be measured differently, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc.

[0051] The terms “integral” and “single” should generally refer to an element or multiple elements made or composed of a single structural or base unit / element. Integral and / or single elements should exclude structures and / or features resulting from assembling or otherwise combining multiple discrete structures or elements.

[0052] It should be noted that when the specification refers to "one embodiment," "some embodiments," "other embodiments," etc., it indicates that the described embodiments may include specific features, structures, or characteristics, but each embodiment may not necessarily include that specific feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Moreover, when a specific feature, structure, or characteristic is described in conjunction with an embodiment, whether explicitly described or not, implementing such a specific feature, structure, or characteristic in conjunction with other embodiments is within the knowledge of those skilled in the art, unless the contrary is explicitly stated. That is, even if not explicitly shown in a specific combination, the various individual elements described below are still considered to be combinable or arranged with each other to form other additional embodiments or to supplement and / or enrich the described embodiments, as understood by those skilled in the art.

[0053] For clarity, a distinctive numerical designation (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various described and / or claimed features. It is to be understood that the numerical designation is not intended to be limiting, but merely exemplary. In some embodiments, for brevity and clarity, the numerical designation may be modified and deviated from previously used. That is, a feature identified as a “first” element may later be referred to as a “second” element, a “third” element, etc., or may be omitted entirely, and / or a distinct feature may be referred to as a “first” element. The meaning and / or name in each case will be obvious to a person skilled in the art.

[0054] The accompanying drawings illustrate selected components and / or arrangements of an internal prosthesis or stent. It should be noted that, for simplicity, some features of the internal prosthesis or stent may be omitted or schematically shown in any given drawing. Additional details regarding some components of the internal prosthesis or stent may be shown in more detail in other drawings. It should be noted that, for ease of understanding, certain features of the invention may be described in the singular, even if those features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or contain a singular disclosure unless explicitly stated otherwise. For example, references to “filament,” “unit,” “staff,” or other features may equally refer to all cases and quantities beyond one of said features. Therefore, it should be understood that, unless explicitly stated otherwise, the following discussion applies equally to any and / or all of the more than one component of the internal prosthesis or stent. Additionally, for clarity, not all cases of some elements or features may be shown in each figure.

[0055] In some patients, narrowings may form or develop that partially or completely obstruct body cavities, such as the trachea, esophagus, common bile duct, pancreatic duct, etc., thus requiring treatment. It should be understood that the present invention may relate to features that facilitate and / or allow treatment of body cavities.

[0056] exist Figure 1 The image shows a prior art knitted scaffold 10. Prior art knitted scaffold 10 has been used to treat body cavities. The prior art knitted scaffold 10 may include a plurality of ridges 20 and a plurality of rungs 30 inserted between adjacent ridges 20. The prior art knitted scaffold 10 may be formed from a single continuous filament. When unconstrained, the prior art knitted scaffold 10 may have a generally circular cross-sectional shape and / or extent. For example, as... Figure 2 As seen in the image, when placed within anatomical structures for treatment, the existing knitted scaffold 10 can possess sufficient flexibility to approximate the shape of the body cavity into which it is implanted. Figure 2 A cross-section of a portion of a patient's trachea 80 in which a prior art knitted stent 10 is implanted is shown.

[0057] The trachea 80 is a passageway that allows air to travel between the oral cavity and nasal cavity into the bronchi so that it reaches the lungs during respiration. The trachea 80 may include an anterior wall 84, a posterior wall 86, and a lateral wall 85 extending between the anterior wall 84 and the posterior wall 86. The trachea 80 may have an elongated D-shaped cross-section with a flat posterior wall 86. When implanted, the prior art knitted scaffold 10 can naturally settle into the lumen 81 of the trachea 80, wherein one of the plurality of ridges 20 (e.g., corner ridge 22) is positioned near the flat posterior wall 86.

[0058] Several C-shaped strips of hyaline cartilage 82 prevent the trachea 80 from collapsing. For example... Figure 3 As shown, the posterior wall 86 includes a tracheal muscle 88, which compresses into the lumen 81 of the trachea 80 during coughing to narrow the airway so that air can be expelled from the trachea 80, and the anterior wall 84 includes cartilaginous rings. The trachea 80 is oriented anterior to the esophagus 90, wherein the tracheal muscle 88 is positioned between the lumen 81 of the trachea 80 and the esophagus 90.

[0059] Figure 3 This illustrates how the lumen 81 of the trachea 80 deforms during forceful inhalation / exhalation and / or coughing due to compression of the tracheal muscle 88 into the lumen 81. A sharp fold formed in the lateral angle adjacent to the posterior wall 86 of the lumen 81 creates a crescent shape. The implanted stent 10 will deform in a similar manner, resulting in a high-stress area in the angular ridge 22 and potentially leading to stent fracture along the sharp fold and / or the angular ridge 22.

[0060] Figure 4A side view of a prior art knitted support 10 subjected to lateral force LF (as would occur during inhalation / exhalation and / or coughing) is shown. A portion of the prior art knitted support 10 is deflected inward along a corner ridge 22. As the lateral force LF moves, this portion travels longitudinally along the length of the prior art knitted support 10, as would occur during forceful inhalation / exhalation and / or coughing. Thus, the high-stress area is not limited to a single portion of the knitted support 10, but extends along the length of the knitted support 10.

[0061] In another example, Figure 5 A prior art knitted scaffold 10 is shown, bent almost in two (approximately 180 degrees), to illustrate the kinks that can occur at several bends in an anatomical structure due to the limited flexibility of the prior art knitted scaffold 10. The knit pattern of the scaffold 10 does not allow for stretching on the outside of the bends or compression on the inside of the bends; therefore, the scaffold 10 forms kinks 40 at the bends. Because the knit pattern includes ridges parallel to the extension of the scaffold (such as...), the kinks are caused by the presence of ridges (e.g.,...) extending parallel to the scaffold's length. Figure 1 As seen in the image, there is material buildup at the bend, which causes the support 10 to twist. Figure 5 The kinking tendency shown limits the flexibility and / or bending capability of the prior art knitting support 10.

[0062] Figure 6 Various aspects of an inner prosthesis 100 designed and configured to address the shortcomings of prior art knitted scaffold 10 are shown. The term "inner prosthesis" is used interchangeably with the term "scaffold" herein. For ease of illustration, the inner prosthesis 100 is shown in a flattened shape. The inner prosthesis 100 may include a tubular scaffold 108 formed of a single filament knitted around a central longitudinal axis A and defining a length from a proximal end 102 to a distal end 104.

[0063] The inner prosthesis 100 and / or tubular stent 108 can be configured to switch between a collapsed and an expanded configuration. Compared to the expanded configuration, the collapsed configuration can be a configuration in which the inner prosthesis 100 is axially elongated and / or radially collapsed or compressed. Compared to the collapsed configuration, the expanded configuration can be a configuration in which the inner prosthesis 100 is axially shortened and / or radially expanded. In at least some embodiments, the inner prosthesis 100 and / or tubular stent 108 can be self-expanding. For example, the inner prosthesis 100 and / or tubular stent 108 can be formed of a shape memory material. In some embodiments, the inner prosthesis 100 and / or tubular stent 108 can be mechanically expandable. For example, the inner prosthesis 100 and / or tubular stent 108 can be expanded using an inflatable balloon, an actuating member, or other suitable means. During delivery to the treatment site, the inner prosthesis 100 and / or tubular stent 108 can be disposed in a collapsed configuration within the lumen of the delivery sheath. When removed from the cavity of the delivery sheath, the internal prosthesis 100 and / or the tubular stent 108 can be converted and / or can be converted from a collapsed form to an expanded form.

[0064] The tubular stent 108 may include and / or be formed from multiple units. In some embodiments, the tubular stent 108 may include and / or be formed from a single filament interwoven around the central longitudinal axis of the inner prosthesis 100 and / or the tubular stent 108. In at least some embodiments, the single filament may form and / or define multiple units. In some embodiments, the tubular stent 108 may be woven, knitted, or woven from the single filament. In some embodiments, the single filament may be a thread, yarn, strand, etc. In some embodiments, adjacent portions of the single filament may define openings or gaps through the walls of the tubular stent 108. Alternatively, in some embodiments, the tubular stent 108 may be an integral structure formed from columnar tubular members, such as a single columnar laser-cut nitinol (e.g., nitinol) tubular member, wherein the remaining portion (e.g., unremoved portion) of the tubular member forms the tubular stent 108, defining openings or gaps therebetween.

[0065] The tubular stent 108 may be substantially tubular and / or may include a lumen extending axially through it along its central longitudinal axis A. In some embodiments, the tubular stent 108 may have an axial length of about 40 mm to about 250 mm, about 50 mm to about 225 mm, about 60 mm to about 200 mm, about 80 mm to about 175 mm, about 100 mm to about 150 mm, or another suitable range. In some embodiments, the tubular stent 108 may have a radial external dimension or radial range of about 5 mm to about 30 mm, about 6 mm to about 25 mm, about 8 mm to about 20 mm, about 10 mm to about 15 mm, or another suitable range. Other morphologies are also contemplated. Some suitable, non-limiting materials, such as metallic and / or polymeric materials, are described below for the internal prosthesis 100, the tubular stent 108, and / or its components or elements.

[0066] The tubular stent 108 may include multiple rows of rings 120 and multiple rows of crossbars 130 arranged alternately around a central longitudinal axis A. For example, a row of rings may be positioned between two adjacent rows of crossbars, and a row of crossbars may be positioned between two adjacent rows of rings. The multiple rows of crossbars 130 may be more flexible than the multiple rows of rings 120, thereby providing flexibility to the entire tubular stent 108. In some embodiments, each of the multiple rows of crossbars 130 may extend a greater circumferential distance around the tubular stent 108 than each of the multiple rows of rings 120. Other configurations are also contemplated. In some embodiments, the tubular stent 108, the monofilament, and / or the multiple rows of rings 120 and multiple rows of crossbars 130 may be expanded and heat-formed such that the internal prosthesis 100 and / or the tubular stent 108 self-biased toward the expanded configuration.

[0067] Each row of rings in the multi-row rings 120 extends longitudinally along the tubular support 108 between a proximal end 102 and a distal end 104. In some embodiments, at least some rows of rings in the multi-row rings 120 may extend continuously from the proximal end 102 to the distal end 104. In some embodiments, some rows of rings in the multi-row rings 120 may be discontinuous between the proximal end 102 and the distal end 104. Each row of crossbars in the multi-row crossbars 130 extends longitudinally along the tubular support 108 between a proximal end 102 and a distal end 104. In some embodiments, at least some rows of crossbars in the multi-row crossbars 130 may extend continuously from the proximal end 102 to the distal end 104. In some embodiments, some rows of crossbars in the multi-row crossbars 130 may be discontinuous between the proximal end 102 and the distal end 104.

[0068] In some embodiments, each ring in the multi-row rings 120 may extend about 0.05 mm, 0.10 mm, 0.15 mm, 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, 2 mm, 3 mm, etc., around the circumference of the tubular support 108 (e.g., along an arc). In some embodiments, each crossbar in the multi-row crossbars 130 may extend about 0.10 mm, 0.15 mm, 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, etc., around the circumference of the tubular support 108 (e.g., along an arc). Other configurations are also conceivable.

[0069] The tubular stent 108 may include a first cut-out region 160 extending along a substantial portion of the length of the tubular stent 108. In some embodiments, the first cut-out region 160 may extend along at least 60% of the length of the tubular stent 108. In some embodiments, the first cut-out region 160 may extend along at least 70% of the length of the tubular stent 108. In some embodiments, the first cut-out region 160 may extend along at least 75% of the length of the tubular stent 108. In some embodiments, the first cut-out region 160 may extend along at least 80% of the length of the tubular stent 108. In some embodiments, the first cut-out region 160 may extend along at least 85% of the length of the tubular stent 108. In some embodiments, the first cut-out region 160 may extend along at least 90% of the length of the tubular stent 108. Other morphologies are also contemplated.

[0070] A first incision region 160 may be disposed between the proximal end 102 and the distal end 104 of the tubular stent 108. The first incision region 160 may be defined and continuously extended therefrom by a first proximal end 162 oriented toward the proximal end 102 of the tubular stent 108 and a first distal end 164 oriented toward the distal end 104 of the tubular stent 108. In some embodiments, the first proximal end 162 may be disposed distal to the proximal end 102 of the tubular stent 108. In some embodiments, the first distal end 164 may be disposed proximal to the distal end 104 of the tubular stent 108.

[0071] In some embodiments, the first cut region 160 may be formed by removing a significant portion of the middle portion of the first row ring 122 in the multi-row ring 120 and the middle portions of several rows of crossbars 132 in the multi-row crossbars 130 adjacent to the first row ring 122. In some embodiments, the first row ring 122 in the multi-row ring 120 may be discontinuous along the middle region of the tubular support 108, and the several rows of crossbars 132 located on opposite sides of the first row ring 122 in the circumferential direction of the first row ring 122 may also be discontinuous along the middle region of the tubular support 108.

[0072] The intermediate region of the tubular stent 108 may extend along a substantial portion of the length of the tubular stent 108. In some embodiments, the intermediate region of the tubular stent 108 may extend along at least 60% of the length of the tubular stent 108. In some embodiments, the intermediate region of the tubular stent 108 may extend along at least 70% of the length of the tubular stent 108. In some embodiments, the intermediate region of the tubular stent 108 may extend along at least 75% of the length of the tubular stent 108. In some embodiments, the intermediate region of the tubular stent 108 may extend along at least 80% of the length of the tubular stent 108. In some embodiments, the intermediate region of the tubular stent 108 may extend along at least 85% of the length of the tubular stent 108. In some embodiments, the intermediate region of the tubular stent 108 may extend along at least 90% of the length of the tubular stent 108. Other configurations are also contemplated.

[0073] After heat setting of the tubular support 108, the single filament and / or the multiple rows of rings 120 and multiple rows of crossbars 130, a first cut region 160 may be formed. In at least some embodiments, forming the first cut region 160 may make the single filament discontinuous within the first cut region 160 and / or along the length of the tubular support 108. Similarly, forming the first cut region 160 may make the first row of rings 122 and the several rows of crossbars 132 adjacent to the first row of rings 122 discontinuous within the first cut region 160 and / or along the length of the tubular support 108. In some embodiments, within the intermediate region of the tubular support 108, the single filament may include multiple discontinuous segments 166.

[0074] The discontinuous single filament may include and / or multiple discontinuous segments 166 forming a first plurality of terminals 168 extending along the first cut region 160 and / or the intermediate region. The first plurality of terminals 168 may be adjacent to one of the multiple loops 120 and / or the perimeter of the first cut region 160. For example, the first plurality of terminals 168 may be located within approximately 0.01 mm, 0.02 mm, 0.03 mm, 0.05 mm, 0.07 mm, 0.10 mm, 0.15 mm, 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, etc., of one of the multiple loops 120. Because the tubular stent 108, the single filament and / or the multiple rows of rings 120 and multiple rows of crossbars 130 are heat-set before the formation of the first incision region 160 and / or before removing the middle portion of the first row of rings 122 in the multiple rows of rings 120 and the middle portion of several rows of crossbars 132 adjacent to the first row of rings 122 in the multiple rows of crossbars 130 along most of the length of the tubular stent 108, the tubular stent 108 is prevented from spreading out even when the middle portion is removed and / or the first incision region 160 is formed.

[0075] In some embodiments, the first cut area 160 can be formed by removing several adjacent rows of rings in the multi-row rings 120 and several rows of crossbars immediately adjacent to the adjacent rows of rings. In one example, the first cut area 160 can be formed by removing two adjacent rows of rings, a row of crossbars between the two adjacent rows of rings, and several rows of crossbars on either circumferential side of the two adjacent rows of rings. In another example, the first cut area 160 can be formed by removing three adjacent rows of rings, two rows of crossbars between the three adjacent rows of rings, and several rows of crossbars on either circumferential side of the three adjacent rows of rings. Other configurations are also conceivable.

[0076] In some embodiments, the tubular stent 108 may include a second cut region 180 extending along a substantial portion of the length of the tubular stent 108. In some embodiments, the second cut region 180 may extend along at least 60% of the length of the tubular stent 108. In some embodiments, the second cut region 180 may extend along at least 70% of the length of the tubular stent 108. In some embodiments, the second cut region 180 may extend along at least 75% of the length of the tubular stent 108. In some embodiments, the second cut region 180 may extend along at least 80% of the length of the tubular stent 108. In some embodiments, the second cut region 180 may extend along at least 85% of the length of the tubular stent 108. In some embodiments, the second cut region 180 may extend along at least 90% of the length of the tubular stent 108. Other morphologies are also contemplated.

[0077] A second incision region 180 may be disposed between the proximal end 102 and the distal end 104 of the tubular stent 108. The second incision region 180 may be defined and continuously extended therefrom by a second proximal end 182 oriented toward the proximal end 102 of the tubular stent 108 and a second distal end 184 oriented toward the distal end 104 of the tubular stent 108. In some embodiments, the second proximal end 182 may be disposed distal to the proximal end 102 of the tubular stent 108. In some embodiments, the second distal end 184 may be disposed proximal to the distal end 104 of the tubular stent 108. In some embodiments, the second incision region 180 may be circumferentially spaced from the first incision region. In some embodiments, the second incision region 180 may be disposed on the side of the tubular stent 108 opposite to the first incision region 160 relative to the central longitudinal axis A.

[0078] In some embodiments, the second cut region 180 may be formed by removing a significant portion of the middle portion of the second row ring 124 in the multi-row ring 120 and the middle portions of several rows of crossbars 134 adjacent to the second row ring 124 in the multi-row crossbars 130. The second row ring 124 in the multi-row ring 120 may be circumferentially spaced from the first row ring 122 in the multi-row ring 120. In some embodiments, the second row ring 124 in the multi-row ring 120 may be disposed on the side of the tubular support 108 opposite to the first row ring 122 in the multi-row ring 120 relative to the central longitudinal axis A. In some embodiments, the second row ring 124 in the multi-row ring 120 may be circumferentially opposite to the first row ring 122 in the multi-row ring 120. In some embodiments, the second row of rings 124 in the multi-row rings 120 may be discontinuous along the middle region of the tubular support 108, and several rows of crossbars 134 located on opposite sides of the second row of rings 124 in the circumferential direction of the second row of rings 124 may be discontinuous along the middle region of the tubular support 108.

[0079] The intermediate region of the tubular stent 108 may extend along a substantial portion of the length of the tubular stent 108. In some embodiments, the intermediate region of the tubular stent 108 may extend along at least 60% of the length of the tubular stent 108. In some embodiments, the intermediate region of the tubular stent 108 may extend along at least 70% of the length of the tubular stent 108. In some embodiments, the intermediate region of the tubular stent 108 may extend along at least 75% of the length of the tubular stent 108. In some embodiments, the intermediate region of the tubular stent 108 may extend along at least 80% of the length of the tubular stent 108. In some embodiments, the intermediate region of the tubular stent 108 may extend along at least 85% of the length of the tubular stent 108. In some embodiments, the intermediate region of the tubular stent 108 may extend along at least 90% of the length of the tubular stent 108. Other configurations are also contemplated.

[0080] After heat setting of the tubular support 108, the single filament and / or the multiple rows of rings 120 and multiple rows of crossbars 130, a second cut region 180 may be formed. In at least some embodiments, forming the second cut region 180 may make the single filament discontinuous within the second cut region 180 and / or along the length of the tubular support 108. Similarly, forming the second cut region 180 may make the second row of rings 124 and the rows of crossbars 134 adjacent to the second row of rings 124 discontinuous within the second cut region 180 and / or along the length of the tubular support 108.

[0081] The discontinuous single filament may include and / or multiple discontinuous segments 166 that may form a second plurality of terminals 188 extending along the second cut region 180 and / or the intermediate region. The second plurality of terminals 188 may be adjacent to one of the multiple loops 120 and / or the perimeter of the second cut region 180. For example, the second plurality of terminals 188 may be located within approximately 0.01 mm, 0.02 mm, 0.03 mm, 0.05 mm, 0.07 mm, 0.10 mm, 0.15 mm, 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, etc., of one of the multiple loops 120. Because the tubular stent 108, the single filament and / or the multiple rows of rings 120 and multiple rows of crossbars 130 are heat-set before the second incision region 180 is formed and / or before the middle portion of the second row of rings 124 in the multiple rows of rings 120 and the middle portion of several rows of crossbars 134 in the multiple rows of crossbars 130 adjacent to the second row of rings 124 are removed along most of the length of the tubular stent 108, the tubular stent 108 is prevented from spreading out even when the middle portion is removed and / or the second incision region 180 is formed.

[0082] In some embodiments, the second cut area 180 can be formed by removing several adjacent rows of rings in the multi-row rings 120 and several rows of crossbars immediately adjacent to the adjacent rows of rings. In one example, the second cut area 180 can be formed by removing two adjacent rows of rings, a row of crossbars between the two adjacent rows of rings, and several rows of crossbars on either circumferential side of the two adjacent rows of rings. In another example, the second cut area 180 can be formed by removing three adjacent rows of rings, two rows of crossbars between the three adjacent rows of rings, and several rows of crossbars on either circumferential side of the three adjacent rows of rings. Other configurations are also conceivable.

[0083] like Figure 7As shown, the internal prosthesis 100 may include a polymer cover 150 extending along the tubular support 108. In some embodiments, the polymer cover 150 may be fixedly secured, bonded, or otherwise attached to the entire circumference of the tubular support 108. For example, the polymer cover 150 may be continuously attached to the tubular support 108 around its entire length, width, and / or circumference. In some embodiments, the polymer cover 150 may be fixedly secured, bonded, or otherwise attached to the tubular support 108 wherever it touches. In some embodiments, a portion of the tubular support 108 may be embedded within the polymer cover 150. In some embodiments, the tubular support 108 may be continuously and / or completely embedded within the polymer cover 150.

[0084] In some embodiments, the polymer cover 150 may be continuous along and / or within the first cut region 160. In some embodiments, the polymer cover 150 may be continuous along and / or within the second cut region 180. In some embodiments, the polymer cover 150 may be continuous along the first cut region 160 and the second cut region 180 and / or within the second cut region. In some embodiments, a first plurality of terminals 168 and / or a second plurality of terminals 188 may be embedded within the polymer cover 150, such as... Figure 7 A detailed cross-sectional view is shown. In some embodiments, the polymer cover 150 may be continuous along the middle region of the tubular support 108.

[0085] In some embodiments, the polymer cover 150 may extend along the entire length of the inner prosthesis 100 and / or the tubular stent 108. In some embodiments, the polymer cover 150 may extend along a portion of the length of the inner prosthesis 100 and / or the tubular stent 108. In some embodiments, the polymer cover 150 may extend uninterruptedly between the proximal end 102 and the distal end 104 of the inner prosthesis 100 and / or the tubular stent 108. In some embodiments, the polymer cover 150 may extend continuously from the proximal end 102 of the inner prosthesis 100 and / or the tubular stent 108 to the distal end 104 of the inner prosthesis 100 and / or the tubular stent 108. In some embodiments, all units of a plurality of units may be completely covered by the polymer cover 150. Other morphologies are also contemplated.

[0086] In use, when the internal prosthesis 100 is positioned within a body cavity, the polymer cover 150 can form a substantially continuous outer cover disposed on and / or above the tubular stent 108, thereby creating a barrier, such as a sealing interface, between the lumen 100 of the internal prosthesis 100 and / or the tubular stent 108 and the body cavity wall radially positioned outside the polymer cover 150. The polymer cover 150 can isolate the lumen of the internal prosthesis 100 and / or the tubular stent 108 from the body cavity wall. The polymer cover 150 can prevent tissue from growing inward into the lumen and / or the tubular stent 108 of the internal prosthesis 100, thereby allowing and / or facilitating the removal of the internal prosthesis 100 and / or the tubular stent 108 from the body cavity. Some suitable examples of materials for the polymer cover 150 will be discussed below, including but not limited to PTFE, silicone, etc.

[0087] Figure 8 Showing the experience of similar Figure 4 A side view of the prosthesis 100 and / or tubular stent 108, where the lateral force LF applied to the prior art knitted stent 10 (as it would occur during inspiration / expiration and / or coughing). Figure 8 As seen in the image, a portion of the internal prosthesis 100 and / or the tubular stent 108 and / or some of the multiple rows of rings 120 and multiple rows of crossbars 130 are deflected inward. This portion may travel longitudinally along the length of the internal prosthesis 100 and / or the tubular stent 108, as would occur during forceful inhalation / exhalation and / or coughing. The first incision region 160 and / or the second incision region 180 (not visible) and the polymer covering 150 allow for deflection of the internal prosthesis 100 and / or the tubular stent 108, but do not result in... Figure 4 The same high stress concentration found in the existing knitting support 10 in China. This has been reduced or eliminated. Figure 4 The deformation found in the prior art knitted scaffold 10. Instead of outward stress applied to the monofilaments of the inner prosthesis 100 and / or the tubular scaffold 108, the inner prosthesis 100 and / or the tubular scaffold 108 can collapse in a substantially uniform manner. The polymer cover 150 can be flexible enough to allow the inner prosthesis 100 and / or the tubular scaffold 108 to absorb stress and deform to a flattened orientation. Once the lateral force LF is removed, the inner prosthesis 100 and / or the tubular scaffold 108 can return to its original orientation (e.g., expanded morphology) and maintain the patency of the body cavity.

[0088] In another example, Figure 9 The internal prosthesis 100 and / or tubular stent 108 are shown bent almost in two (approximately 180 degrees) to illustrate the avoidance of Figure 5The kinking seen in the prior art knitted scaffold 10. Testing of the inner prosthesis 100 shows that the first incision region 160, the second incision region 180 (not visible) and / or the polymer cover 150 improve the flexibility and kinking resistance of the inner prosthesis 100 and / or the tubular scaffold 108 compared to the prior art knitted scaffold 10.

[0089] Figure 10 Various aspects of a method for manufacturing an internal prosthesis 100 are illustrated. The method may include knitting a tubular support 108 with monofilaments on a mandrel, the tubular support 108 comprising multiple rows of loops 120 and multiple rows of crossbars 130 arranged alternately around a central longitudinal axis A. In some embodiments, the mandrel may be generally cylindrical and / or have a circular cross-section. Other shapes, cross-sections, and / or configurations are also contemplated.

[0090] The method may include heat-setting the tubular stent 108 on a mandrel. In some embodiments, the method may include heat-setting the tubular stent 108 in an expanded configuration on a mandrel. In some embodiments, the method may include heat-setting the tubular stent 108 in a collapsed configuration at a first temperature on a first mandrel, such that the tubular stent 108 and / or the prosthesis 100 is self-biased toward the collapsed configuration at the first temperature, and heat-setting the tubular stent 108 in an expanded configuration at a second temperature different from the first temperature on a second mandrel, such that the tubular stent 108 and / or the prosthesis 100 is self-biased toward the expanded configuration at the second temperature. Other configurations are also contemplated.

[0091] The method may include, after a heat-setting step, removing a middle portion of a first row of rings in the multi-row rings 120 and a middle portion of several rows of crossbars immediately adjacent to the first row of rings along a majority of the length of the tubular support 108 to form a first cut region 160. In some embodiments, the method may include, after a heat-setting step, removing a middle portion of a second row of rings in the multi-row rings 120 and a middle portion of several rows of crossbars immediately adjacent to the second row of rings along a majority of the length of the tubular support 108 to form a second cut region 180. As discussed herein, the second cut region 180 may be circumferentially spaced from the first cut region 160.

[0092] The method may include, after a removal step, applying a polymer cover 150 to the tubular stent 108, wherein the polymer cover 150 is uninterrupted along and / or within a first incision region 160 and / or a second incision region 180. In some embodiments, the polymer cover 150 may be applied via spraying, dip coating, shrink wrapping, and / or other suitable methods. In some embodiments, the polymer cover 150 may be formed of silicone. In some embodiments, the thickness of the polymer cover 150 may vary along the length of the inner prosthesis 100 and / or the tubular stent 108. In one example, the thickness of the polymer cover 150 may increase along and / or within the first incision region 160 and / or the second incision region 180 compared to the remainder of the inner prosthesis 100 and / or the tubular stent 108. In another example, the thickness of the polymer cover 150 may increase along a first plurality of terminals 168 and / or a second plurality of terminals 188. Other morphologies and / or materials are also contemplated.

[0093] In some embodiments, prior to applying the polymer cover 150 to the tubular support 108, the method may include securing and / or firmly attaching a first plurality of terminals 168 and / or a second plurality of terminals 188 to rings in adjacent rows of the multi-row rings 120. In some embodiments, the first plurality of terminals 168 and / or the second plurality of terminals 188 may be welded (e.g., laser welding, acoustic welding, etc.) to rings in adjacent rows of the multi-row rings 120. Other configurations are also contemplated.

[0094] Figure 11 Alternative configurations of the internal prosthesis 100 are shown. The internal prosthesis 100 may be constructed substantially as described above, but with variations noted below. In some embodiments, the internal prosthesis 100 and / or the tubular stent 108 may include a plurality of incision regions 170 extending along a substantial portion of the length of the tubular stent 108. In some embodiments, the plurality of incision regions 170 may include two incision regions, three incision regions, four incision regions, five incision regions, etc.

[0095] In some embodiments, the plurality of cut regions 170 may extend along at least 60% of the length of the tubular stent 108. In some embodiments, the plurality of cut regions 170 may extend along at least 70% of the length of the tubular stent 108. In some embodiments, the plurality of cut regions 170 may extend along at least 75% of the length of the tubular stent 108. In some embodiments, the plurality of cut regions 170 may extend along at least 80% of the length of the tubular stent 108. In some embodiments, the plurality of cut regions 170 may extend along at least 85% of the length of the tubular stent 108. In some embodiments, the plurality of cut regions 170 may extend along at least 90% of the length of the tubular stent 108. Other configurations are also contemplated.

[0096] Multiple incision regions 170 may be disposed between the proximal end 102 and the distal end 104 of the tubular stent 108. Each of the multiple incision regions 170 may define an orientation toward the proximal end 102 and an orientation toward the distal end 104 of the tubular stent 108. In some embodiments, the proximal end of the multiple incision regions 170 may be located distal to the proximal end 102 of the tubular stent 108. In some embodiments, the distal end of the multiple incision regions 170 may be located proximal to the distal end 104 of the tubular stent 108.

[0097] In some embodiments, the plurality of cut regions 170 may each be formed by removing the middle portion of one row of rings 128 in the plurality of rows of rings 120 and the middle portions of several rows of crossbars 138 in the plurality of rows of crossbars 130 immediately adjacent to the one row of rings 128 along a large portion of the length of the tubular support 108. In some embodiments, the one row of rings 128 in the plurality of rows of rings 120 may be discontinuous along the middle region of the tubular support 108, and the several rows of crossbars 138 located on opposite sides of the one row of rings 128 in the circumferential direction from the one row of rings 128 may be discontinuous along the middle region of the tubular support 108.

[0098] After heat setting of the tubular support 108, the single filament, and / or the multiple rows of rings 120 and multiple rows of crossbars 130, a plurality of cut regions 170 may be formed. In at least some embodiments, forming the plurality of cut regions 170 may cause the single filament to be discontinuous within the plurality of cut regions 170 and / or along the length of the tubular support 108. Similarly, forming the plurality of cut regions 170 may cause a row of rings 128 and several rows of crossbars 138 adjacent to the row of rings 128 to be discontinuous within their respective cut regions 170 and / or along the length of the tubular support 108. In some embodiments, in the middle region of the tubular support 108, the single filament may include multiple discontinuous segments.

[0099] The discontinuous single filament may include and / or multiple discontinuous segments forming multiple terminals that extend along multiple cut regions 170 and / or intermediate regions. The multiple terminals may be adjacent to the perimeter of one and / or multiple cut regions 170 of the multi-row ring 120. For example, the multiple terminals 168 may be located within approximately 0.01 mm, 0.02 mm, 0.03 mm, 0.05 mm, 0.07 mm, 0.10 mm, 0.15 mm, 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, etc., of one of the multi-row rings 120. Because the tubular stent 108, the single filament and / or the multiple rows of rings 120 and multiple rows of crossbars 130 are heat-set before the multiple cut areas 170 are formed and / or before the middle portion of one row of rings 128 in the multiple rows of rings 120 and the middle portion of several rows of crossbars 138 in the multiple rows of crossbars 130 adjacent to the one row of rings 128 are removed along most of the length of the tubular stent 108, the tubular stent 108 is prevented from spreading out even when the middle portion is removed and / or the multiple cut areas 170 are formed.

[0100] In some embodiments, the plurality of incision regions 170 may be circumferentially spaced apart from each other. In some embodiments, the plurality of incision regions 170 may be circumferentially spaced at equal distances around the circumference of the tubular stent 108 and / or the internal prosthesis 100. In some embodiments, the plurality of incision regions 170 may be circumferentially spaced at unequal distances around the circumference of the tubular stent 108 and / or the internal prosthesis 100. The internal prosthesis 100 may include a polymer cover 150 as described herein.

[0101] In some embodiments, the polymer cover 150 may be uninterrupted along and / or within a plurality of cut regions 170. In some embodiments, the polymer cover 150 may be uninterrupted along at least some of the plurality of cut regions 170 and / or within them. In some embodiments, the polymer cover 150 may be uninterrupted along each and / or all of the plurality of cut regions 170 and / or within them. In some embodiments, a plurality of terminals may be embedded within the polymer cover 150. In some embodiments, the polymer cover 150 may be continuous along the central region of the tubular support 108.

[0102] In an alternative configuration, the plurality of cut regions 170 may each be formed by removing the middle portion of only one row of crossbars 130 along a significant portion of the length of the tubular support 108. In some embodiments, the plurality of cut regions 170 may be formed without removing any portion of the multiple rows of rings 120. Thus, the multiple rows of rings 120 may each be continuous from the proximal end 102 to the distal end 104, and each row of crossbars having the formed cut regions may be discontinuous between the proximal end 102 and the distal end 104. Other configurations are also contemplated.

[0103] Figure 12An example placement of the internal prosthesis 100 within the trachea 80 is shown. In some embodiments, a first incision region 160 and / or a second incision region 180 may be provided and / or arranged along the sidewall 85 of the trachea 80. In this position, the internal prosthesis 100 can be sufficiently deflected and / or deformed as the trachea 80 and / or its lumen 81 deforms through the tracheal muscle 88 (not shown) during forceful inhalation / exhalation and / or coughing to alleviate the impact on the prior art knitted support 10 (e.g., Figure 3 The high stress formed at the corner ridge 22 of the internal prosthesis reduces the effects of fatigue and extends the service life of the internal prosthesis 100.

[0104] Materials that may be used for the various components and elements of the internal prosthesis 100 disclosed herein may include those commonly associated with medical devices. For simplicity, the following discussion refers to the internal prosthesis. However, this is not intended to limit the devices and methods described herein, as the discussion is applicable to other elements, components, parts, or devices disclosed herein, such as, but not limited to, tubular stents, polymer caps, and / or their elements or parts.

[0105] In some embodiments, the internal prosthesis and / or its components may be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, combinations thereof, or other suitable materials.

[0106] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), and polyoxymethylene (POM, for example, commercially available from DuPont). Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), and polyether esters (e.g., commercially available from DSM Engineering Plastics) ), ether- or ester-based copolymers (e.g., butyl phthalate / poly(hydrocarbon ether) and / or other polyester elastomers, such as those commercially available from DuPont) ), polyamide (e.g., available from Bayer) Or it can be purchased from Elf Atochem. ), elastomer polyamide, block polyamide / ether, polyether block amide (PEBA, for example, can be listed by trade name) Commercially available), ethylene-vinyl acetate copolymer (EVA), silicone, polyethylene (PE) High-density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g., Polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., Polysulfone, nylon, nylon-12 (such as those available from EMS American Grilon) Perfluoropropyl vinyl ether (PFA), ethylene-vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, polyurethane silicone copolymers (e.g., Aortech Biomaterials'), per ... Or AdvanSourceBiomaterials Biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath may be mixed with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0107] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; low-carbon steels; nickel-titanium alloys such as linearly elastic and / or hyperelastic nickel-titanium alloys; and other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625, such as...). 625, UNS:N06022, such as UNS:N10276, such as other Alloys, etc.), nickel-copper alloys (e.g., UNS:N04400, such as...) 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as...) (etc.), nickel-molybdenum alloys (e.g., UNS:N10665, such as...) ALLOY Other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as...). (etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0108] In some embodiments, the linear elastic and / or non-hyperelastic nickel-titanium alloy may contain nickel in the range of about 50 to about 60% by weight, with the remainder being substantially titanium. In some embodiments, the composition contains nickel in the range of about 54 to about 57% by weight. An example of a suitable nickel-titanium alloy is FHP-NT alloy, commercially available from Furukawa TechnoMaterial Co., Kanagawa Prefecture, Japan. Other suitable materials may include ULTANIUM. TM (Available from Neo-Metrics) and GUM METAL TM (Available from Toyota). In some other embodiments, the desired properties can be achieved using a superelastic alloy, such as a superelastic nitinol.

[0109] In at least some embodiments, part or all and / or a portion thereof of the prosthesis may also be doped with, made of, or otherwise included in a radiopaque material. A radiopaque material is understood to be capable of producing a relatively bright image on a fluoroscopic screen or another imaging technique during medical procedures. This relatively bright image helps the user of the prosthesis determine its position. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marking strips and / or coils may be incorporated into the design of the prosthesis to achieve the same result.

[0110] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the prostheses and / or other elements disclosed herein. For example, the prostheses and / or components or portions thereof may be made of materials that substantially do not distort the image and create a large number of artifacts (i.e., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they may create artifacts in MRI images. The prostheses or portions thereof may also be made of materials that an MRI machine can image. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as...). (etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as...) (etc.), nickel-titanium, etc.

[0111] In some embodiments, the internal prostheses and / or other elements disclosed herein may include a fabric material disposed on or within a structure. The fabric material may consist of a biocompatible material, such as a polymeric material or a biomaterial, suitable for promoting inward tissue growth. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials (such as polyethylene), polypropylene, polyester, polyurethane, and / or mixtures or combinations thereof.

[0112] In some examples, the internal prostheses and / or other elements disclosed herein may comprise and / or be formed from textile materials. Examples of suitable textile materials may include synthetic yarns, which may be flat, shaped, twisted, textured, pre-shrinked, or non-shrinked. Synthetic biocompatible yarns suitable for use in this invention include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefins, polyethylene, polymethyl acetate, polyamide, naphthalic acid derivatives, natural silk, and polytetrafluoroethylene. Furthermore, at least one of the synthetic yarns may be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include those made of or containing stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr based alloys. Yarns may also include carbon fibers, glass fibers, or ceramic fibers. Preferably, the yarn is made of a thermoplastic material, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The yarn may be multifilament, monofilament, or staple fiber. The type of yarn and denier selected can be chosen in terms of how it forms a biocompatible and implantable prosthesis, and especially in terms of the vascular structure with the desired characteristics.

[0113] In some embodiments, the internal prostheses and / or other elements disclosed herein may include suitable therapeutic agents and / or be treated with them. Some examples of suitable therapeutic agents may include anticoagulants (such as heparin, heparin derivatives, urokinase, and PPack (d-phenylalanine-proline-arginine-chloromethyl ketone); antiproliferative agents (such as enoxaparin, angiopeptidase, monoclonal antibodies that can block the proliferation of smooth muscle cells, hirudin, and acetylsalicylic acid); anti-inflammatory drugs (such as dexamethasone, prednisolone, corticosteroids, budesonide, estrogens, sulfasalazine, and mesalazine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vincristine, vinblastine, epothilone, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); and anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone). Ketones, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides; angiogenesis promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); angiogenesis inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, and bifunctional molecules composed of antibodies and cytotoxins); cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0114] It should be understood that the present invention is merely illustrative in many respects. Changes may be made in details, particularly in terms of shape, size, and arrangement of steps, without departing from the scope of the invention. To the appropriate extent, this may include using any of the features used in one example embodiment in other embodiments. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

1. An internal prosthesis configured to switch between a collapsed shape and an expanded shape, the internal prosthesis comprising: A tubular stent, formed by a single filament woven around a central longitudinal axis and defining a length from proximal to distal, the tubular stent comprising multiple rows of rings and multiple rows of crossbars arranged alternately around the central longitudinal axis; as well as Polymer covering extending along the tubular support; Each row of rings extends longitudinally along the tubular support between the proximal and distal ends; Each row of crossbars extends longitudinally along the tubular support between the proximal end and the distal end; The tubular support includes: A first incision region, extending along most of the length of the tubular stent and defining a first proximal end oriented toward the proximal end of the tubular stent and a first distal end oriented toward the distal end of the tubular stent; and The second incision region extends along most of the length of the tubular stent and defines a second proximal end oriented toward the proximal end of the tubular stent and a second distal end oriented toward the distal end of the tubular stent. The polymer coating is continuous along the first and second cut regions.

2. The internal prosthesis of claim 1, wherein the first incision region is formed by removing the middle portion of the first row of rings and the middle portions of several rows of crossbars adjacent to the first row of rings along most of the length of the tubular support.

3. The internal prosthesis according to claim 2, wherein the first incision region is formed such that the single filament is discontinuous within the first incision region.

4. The internal prosthesis of claim 3, wherein the discontinuous single filament comprises a first plurality of terminals extending along the first incision region.

5. The internal prosthesis according to any one of claims 1 to 4, wherein the second incision region is formed by removing the middle portion of the second row of rings and the middle portions of several rows of crossbars adjacent to the second row of rings along most of the length of the tubular support.

6. The internal prosthesis of claim 5, wherein the second incision region is formed such that the single filament is discontinuous within the second incision region.

7. The internal prosthesis of claim 6, wherein the discontinuous single filament comprises a second plurality of terminals extending along the second incision region.

8. The internal prosthesis according to any one of claims 1 to 4, wherein the second incision region is circumferentially spaced from the first incision region.

9. The internal prosthesis according to any one of claims 1 to 4, wherein the first proximal end and the second proximal end are disposed distal to the proximal end of the tubular stent; The first distal end and the second distal end are located on the proximal side of the distal end of the tubular support.

10. The internal prosthesis according to any one of claims 1 to 4, wherein the first incision region extends along at least 60% of the length of the tubular stent.

11. A method of manufacturing an internal prosthesis configured to switch between a collapsed form and an expanded form, comprising: A tubular support woven from a single filament, the tubular support comprising multiple rows of rings and multiple rows of crossbars arranged in an alternating manner around a central longitudinal axis; The tubular support is heat-set in the expanded state; After the heat setting step, the middle portion of the first row of rings and the middle portions of several rows of crossbars adjacent to the first row of rings are removed along most of the length of the tubular support to form the first cut area. as well as Following the removal step, a polymer cover is applied to the tubular support, wherein the polymer cover is continuous along the first cut area.

12. The method of claim 11, further comprising: After the heat setting step, the middle portion of the second row of rings and the middle portions of several rows of crossbars adjacent to the second row of rings are removed along most of the length of the tubular support to form the second cut area.

13. The method of claim 12, wherein the second incision region is circumferentially spaced from the first incision region.

14. The method according to any one of claims 11 to 13, wherein the first cut region is formed such that the single filament is discontinuous within the first cut region.

15. The method of claim 14, wherein the discontinuous single filament comprises a first plurality of terminals extending along the first slit region; The first plurality of terminals are embedded within the polymer cover.

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