Pre-strained stent element

Abstract

Various aspects of the present invention relate to devices, systems, and methods comprising a self-expanding implantable prosthesis having a shrinking configuration and an unfolding configuration. The self-expanding implantable prosthesis may include a self-expanding scaffold element having an enlarged diameter and a graft component attached to at least a portion of the self-expanding scaffold element and having an enlarged diameter smaller than that of the self-expanding scaffold element in the unfolding configuration.

Description

[0001] This application is a divisional application of application No. 201880008988.2, filed on July 29, 2019, entitled "Prestrained Support Element". Background Technology

[0002] Medical stents, grafts, and stent grafts have a variety of uses, including expanding body cavities with constricted diameters, such as blood vessels. Blood vessels may become diseased, constricted, or otherwise damaged due to the effects of lesions such as atherosclerosis or cancerous tumors. Atherosclerosis refers to lesions within arteries, including the buildup of plaque, which obstructs blood flow through the vessels. Over time, the size and thickness of the plaque increase, eventually leading to clinically significant narrowing of the arteries, or even complete occlusion. When used to expand a constricted body cavity, a medical stent provides a tubular support structure within the cavity. Furthermore, non-limiting examples of stent and graft / stent graft applications include endovascular repair of aneurysms and abnormal widening or enlargement of a portion of a body cavity that involves weakened cavity walls. Summary of the Invention

[0003] Various aspects of the present invention relate to self-expanding implantable prostheses having a shrinking configuration and an unfolding configuration. The self-expanding implantable prosthesis may include a self-expanding scaffold element having an enlarged diameter and a graft component, the graft component being attached to at least a portion of the self-expanding scaffold element and having an enlarged diameter smaller than that of the self-expanding scaffold element in the unfolding configuration. Furthermore, in the unfolding configuration, the self-expanding scaffold element may apply a radial expansion force (expansion force) to the graft component. The yield strength of the graft component may be greater than the radial expansion force (expansion force), and it is configured to radially hold the self-expanding scaffold element at the enlarged diameter of the graft component when a second radial expansion force greater than the radial expansion force of the self-expanding scaffold element is applied.

[0004] This application also relates to a self-expanding implantable prosthesis having a self-expanding scaffold element with a manufacturing diameter from 7 mm to 32 mm and a graft component with an expansion diameter from 5 mm to 27 mm. The self-expanding scaffold element may include a self-expanding diameter at least 2% to 25% larger than the expansion diameter of the graft component. Furthermore, the expansion scaffold element may be at least partially attached to the graft component. Additionally, when the self-expanding implantable prosthesis is fully deployed, the self-expanding scaffold element may continue to exert an outward force on the graft component without expanding beyond the expansion diameter of the graft component.

[0005] Various aspects of the invention also relate to a self-expanding implantable prosthesis comprising a self-expanding scaffold element having a neutral diameter from 22 mm to 58 mm and a graft component having an expansion diameter from 20 mm to 53 mm and attached to the self-expanding scaffold element. The self-expanding scaffold element and the graft component can be configured to decrease in size from a fully expanded configuration to a delivery configuration for introduction into a patient. Furthermore, the self-expanding diameter of the self-expanding scaffold element can be at least 2% to 25% larger than the expansion diameter of the graft component, and the graft component is configured to hold the self-expanding scaffold element within the expansion diameter of the graft component.

[0006] Various aspects of the present invention also relate to a self-expanding implantable prosthesis having a shrinking configuration and an unfolding configuration. The self-expanding implantable prosthesis may include a self-expanding scaffold element having an enlarged diameter and a diameter constraint portion coupled to at least a portion of the self-expanding scaffold element. The diameter constraint portion may be configured to limit a portion of the self-expanding scaffold to an enlarged diameter smaller than the enlarged diameter of the self-expanding scaffold element in the unfolding configuration. In the unfolding configuration, the self-expanding scaffold element may apply a radial expansion force to the graft component. Furthermore, the graft component may include a yield strength greater than the radial expansion force and is configured to radially hold the self-expanding scaffold element within the enlarged diameter of the graft component when a second radial expansion force greater than the radial expansion force of the self-expanding scaffold element is applied.

[0007] Various aspects of the present invention also relate to self-expanding implantable prostheses having a shrinking configuration and an expanding configuration. A self-expanding implantable prosthesis may include a self-expanding scaffold element having a manufacturing diameter and an expansion diameter, and a graft component attached to the self-expanding scaffold element having an expansion diameter smaller than the expansion diameter of the self-expanding scaffold element in the expanding configuration. Furthermore, the self-expanding scaffold may be configured to exhibit plastic strain in response to being reduced to the shrinking configuration and in response to being in the expanding diameter.

[0008] Various aspects of the present invention also relate to methods of manufacturing a self-expanding implantable prosthesis having a shrinkage configuration and an expansion configuration. The methods may include reducing the self-expanding scaffold element from its manufacturing diameter to the expansion diameter of the graft component. The methods may also include attaching the self-expanding scaffold element to the graft component at the expansion diameter of the graft component. Furthermore, the methods may include inducing plastic strain in the self-expanding scaffold element by shrinking the self-expanding implantable prosthesis to a shrinkage configuration.

[0009] Various aspects of the present invention also relate to methods of treating target sites in a patient's blood vessels using a self-expanding implantable prosthesis having a shrinking configuration and an expanding configuration. The method may include positioning the self-expanding implantable prosthesis at the target site. The self-expanding implantable prosthesis may include a self-expanding stent element having a manufacturing diameter and an expansion diameter, and includes a graft component attached to the self-expanding stent element and having an expansion diameter smaller than the expansion diameter of the self-expanding stent element in the expanding configuration. The graft component may be coupled to the self-expanding stent element to reduce the self-expanding stent element from its manufacturing diameter to the expansion diameter of the graft component. The self-expanding stent may be configured to exhibit plastic strain in response to shrinking to the shrinking configuration and plastic strain at the expanding diameter. The method may also include expanding the self-expanding implantable prosthesis from the shrinking configuration to the expanding configuration.

[0010] According to one example (“Example 1”), a self-expanding implantable prosthesis having a shrinking configuration and an unfolding configuration includes: a self-expanding scaffold element having an enlarged diameter; and a graft component attached to at least a portion of the self-expanding scaffold element and having an enlarged diameter smaller than that of the self-expanding scaffold element in the unfolding configuration; wherein, in the unfolding configuration, the self-expanding scaffold element applies a radial expansion force to the graft component; the graft component has a yield strength greater than the radial expansion force and is configured to radially hold the self-expanding scaffold element within the enlarged diameter of the graft component when a second radial expansion force greater than the radial expansion force of the self-expanding scaffold element is applied.

[0011] According to another example (“Example 2”) further referring to Example 1, the graft component is constructed to resist plastic deformation when a second radial expansion force is applied.

[0012] According to another further example (“Example 3”) compared to any of Examples 1-2, the enlarged diameter of the self-expanding scaffold element is 2% to 25% larger than the enlarged diameter of the graft component.

[0013] According to another further example (“Example 4”) compared to any of Examples 1-3, the graft component is a continuous structure attached to a self-expanding scaffold element, thereby forming a flow cavity for a self-expanding built-in prosthesis.

[0014] According to another further example (“Example 5”) compared to any of Examples 1-4, the self-expanding support element includes a plurality of corrugations (sections) formed by pillars connecting the vertices.

[0015] According to another example (“Example 6”) that is further than Example 5, the vertex includes an inner arc surface and an outer arc surface, and the graft component is configured to reduce tensile stress in the inner arc surface of the vertex.

[0016] According to another example (“Example 7”) that is further than Example 5, the vertex includes an inner arc surface and an outer arc surface, and the graft component is constructed to maintain compression (state) on the inner arc surface of the vertex.

[0017] According to another example (“Example 8”) that is further than Example 7, the expansion scaffold element and the graft component are reduced to a shrinkage structure, while the inner arc surface of the vertex remains in a compressed (state) after expansion to an unfolded structure.

[0018] According to another example (“Example 9”) compared to any of Examples 1-8, the self-expanding support element is thermally shaped to the manufacturing diameter.

[0019] According to another example (“Example 10”) that is further than Example 9, the manufacturing diameter of the self-expanding scaffold element is 15% to 20% larger than the enlarged diameter of the graft component.

[0020] According to another further example (“Example 11”) compared to any of Examples 1-10, the manufacturing diameter of the self-expanding scaffold element is about 1 mm to 3 mm larger than the enlarged diameter of the graft component.

[0021] According to another example (“Example 12”) compared to any of Examples 1-11, the self-expanding scaffold element and graft component are constructed to a reduced diameter compressed to 4 French (a French unit) to 26 French.

[0022] According to another example (“Example 13”) that is further than Example 12, the enlarged diameter of the graft component is 2 mm to 53 mm.

[0023] According to another further example (“Example 14”) compared to any of Examples 1-3, the self-expanding scaffold element has a manufacturing diameter of 7 mm to 32 mm, and the graft component has an expansion diameter of 5 mm to 27 mm.

[0024] According to another example further than Example 14 (“Example 15”), the graft component is constructed to resist radial expansion forces greater than the outward forces from the self-expanding scaffold element without expanding beyond the expansion diameter of the graft component, and the radial expansion forces are between 3 standard atmospheres (atm) and 6 standard atmospheres.

[0025] According to one example (“Example 16”), a self-expanding built-in prosthesis includes: a self-expanding scaffold element having a manufacturing diameter of 7 mm to 32 mm; and a graft component having an expansion diameter of 5 mm to 27 mm; wherein the self-expanding diameter of the self-expanding scaffold element is at least 2% to 25% larger than the expansion diameter of the graft component; wherein the self-expanding scaffold element is at least partially attached to the graft component; and wherein, when the self-expanding built-in prosthesis is fully deployed, the self-expanding scaffold element continues to exert an outward force on the graft component without expanding beyond the expansion diameter of the graft component.

[0026] According to another example further than Example 16 (“Example 17”), the graft component is constructed to resist radial expansion forces greater than the outward forces from the self-expanding scaffold element without expanding beyond the expansion diameter of the graft component, and the radial expansion forces are between 3 standard atmospheres (atm) and 6 standard atmospheres.

[0027] According to another further example (“Example 18”) compared to any of Examples 16 to 17, the self-expanding scaffold element includes multiple corrugations formed by struts, the apexes including an inner arc surface and an outer arc surface, and the graft component is configured to maintain compression of the inner arc surface of the apex.

[0028] According to another example further than Example 18 (“Example 19”), before the graft component is attached to the self-expanding scaffold element, the self-expanding scaffold element is reduced from the manufacturing diameter to the self-expanding diameter, and the attachment sets the inner arc surface of the vertex to be in a compressed (state).

[0029] According to one example (“Example 20”), a self-expanding implant includes: a self-expanding stent element having a neutral diameter of 22 mm to 58 mm; and a graft component having an expansion diameter of 20 mm to 53 mm and attached to the self-expanding stent element; wherein the self-expanding stent element and the graft component are configured to decrease from a fully expanded configuration to a delivery configuration for introduction into a patient; and wherein the self-expanding diameter of the self-expanding stent element is at least 2% to 25% larger than the expansion diameter of the graft component, and the graft component is configured to maintain the self-expanding stent element within the expansion diameter of the graft component.

[0030] According to another example (“Example 21”) that further compares to Example 20, the self-expanding scaffold element is oversized relative to the graft component in its fully deployed configuration, in order to exert an outward force on the graft component.

[0031] According to another example (“Example 22”) that is further than Example 20, the graft component is constructed to resist radial expansion forces greater than the outward forces from the self-expanding scaffold element without expanding beyond the expansion diameter of the graft component, and the radial expansion forces are between 3 standard atmospheres (atm) and 6 standard atmospheres.

[0032] According to one example (“Example 23”), a self-expanding internal prosthesis having a shrinking configuration and an unfolding configuration includes: a self-expanding scaffold element having an enlarged diameter; and a diameter constraint portion coupled to at least a portion of the self-expanding scaffold element, the diameter constraint portion being configured to constrain the portion of the self-expanding scaffold to an enlarged diameter smaller than the enlarged diameter of the self-expanding scaffold element in the unfolding configuration; wherein, in the unfolding configuration, the self-expanding scaffold element applies a radial expansion force to a graft component; the graft component has a yield strength greater than the radial expansion force, and is configured to radially maintain the self-expanding scaffold element at the enlarged diameter of the graft component when a second radial expansion force greater than the radial expansion force of the self-expanding scaffold element is applied.

[0033] According to another example (“Example 24”) that is further than Example 23, the diameter constraint portion is a filament woven through the various parts of the self-expanding support element.

[0034] According to one example (“Example 25”), a self-expanding internal prosthesis having a shrinkage configuration and an expansion configuration includes: a self-expanding scaffold element having a manufacturing diameter and an expansion diameter; and an implant component attached to the self-expanding scaffold element and having an expansion diameter smaller than the expansion diameter of the self-expanding scaffold element in the expansion configuration; wherein the self-expanding scaffold configuration exhibits plastic strain in response to being reduced to the shrinkage configuration and in response to being in the expansion diameter.

[0035] According to one example (“Example 26”), a method of manufacturing a self-expanding built-in prosthesis having a shrinkage configuration and an expansion configuration, the method comprising: reducing a self-expanding scaffold element from a manufacturing diameter to an expansion diameter of a graft component; attaching the self-expanding scaffold element to a graft component with the graft component at the expansion diameter; and inducing plastic strain in the self-expanding scaffold element by reducing the self-expanding built-in prosthesis to the shrinkage configuration.

[0036] According to one example (“Example 27”), a method of treating a target site in a patient’s blood vessel with a self-expanding implant having a shrinking configuration and an expanding configuration, the method comprising: disposing the self-expanding implant at the target site, the self-expanding implant including a self-expanding stent element having a manufacturing diameter and a ligation diameter, a graft member attached to the self-expanding stent element and having an expansion diameter smaller than the expansion diameter of the self-expanding stent element in the expanding configuration, and wherein the graft member is coupled to the self-expanding stent element to reduce the self-expanding stent element from the manufacturing diameter to the expansion diameter of the graft member, and the self-expanding stent configuration exhibits plastic strain in response to reduction to the shrinking configuration and in response to being in the expanding diameter; and expanding the self-expanding implant from the shrinking configuration to the expanding configuration.

[0037] Although several embodiments have been disclosed, other embodiments of the invention will become apparent to those skilled in the art from the following detailed description of illustrative embodiments shown and described. Therefore, the drawings and detailed description are to be considered illustrative in nature and not restrictive. Attached Figure Description

[0038] Figure 1A An example self-expanding support element of the same manufacturing diameter as various aspects of this application is shown.

[0039] Figure 1B A self-expanding built-in prosthesis consistent with various aspects of this application is shown, which includes attachment to, for example Figure 1A The graft assembly shown is a self-expanding scaffold element.

[0040] Figure 1C A self-expanding built-in prosthesis consistent with various aspects of the present invention is shown, such as Figure 1B As shown, it is located on its decreasing diameter.

[0041] Figure 2A Another example of a self-expanding support element with a manufacturing diameter, consistent with various aspects of this application, is shown.

[0042] Figure 2B The diameter constraint portion consistent with various aspects of this application is shown, and as follows: Figure 2A The first construction of the self-expanding support element shown.

[0043] Figure 2C The diameter constraint portion consistent with various aspects of this application is shown, and as follows: Figure 2A The second construction of the self-expanding support element shown.

[0044] Figure 3An example self-expanding built-in prosthesis in a shrink-fit configuration, consistent with various aspects of this application, is shown.

[0045] Figure 4 Another example of a self-expanding built-in prosthesis consistent with various aspects of this application is shown.

[0046] Figure 5 An example of a self-expanding built-in prosthesis consistent with various aspects of this application is shown, comprising a graft component and a self-expanding scaffold element, wherein portions of the self-expanding scaffold element are detached from the graft component.

[0047] Figure 6 A graph consistent with various aspects of this application is shown.

[0048] Figure 7 A self-expanding built-in prosthesis consistent with all aspects of this application is shown.

[0049] Figure 8 Another self-expanding built-in prosthesis consistent with various aspects of this application is shown.

[0050] While the disclosed subject matter is adaptable to various modifications and alternatives, specific embodiments have been illustrated by way of example in the accompanying drawings and are described in detail below. However, it is not intended to limit this application to the specific embodiments described. Rather, this application is intended to cover all modifications, equivalents, and alternatives falling within the scope of the disclosed subject matter as characterized by the appended claims.

[0051] As used herein with respect to measurement ranges (such as those just disclosed above), the terms “approximately” and “about” may be used interchangeably to refer to a measurement that includes the stated measurement and also includes any measurement that is reasonably close to the stated measurement but may differ by a reasonably small amount, such that a person skilled in the art would understand and readily determine that it is attributable to measurement error, differences in measurement and / or manufacturing equipment calibration, human error in reading and / or setting the measurement, adjustments to optimize performance and / or structural parameters to account for differences in measurements associated with other components, specific implementation schemes, imprecise adjustments and / or manipulations of the object by humans or machines, etc.

[0052] Similarly, although illustrative methods may be represented by one or more figures (e.g., flowcharts, communication flows, etc.), the figures should not be construed as implying any requirement for the various steps disclosed herein, or a particular order in or between them. However, as may be explicitly described herein and / or understood from the nature of the steps themselves (e.g., the performance of some steps may depend on the results of previous steps), some embodiments may require certain steps and / or a certain order between certain steps. Additionally, a “set,” “subset,” or “group” of items (e.g., inputs, algorithms, data values, etc.) may include one or more items, and similarly, a subset or subgroup of items may include one or more items. “Multiple” means more than one. Detailed Implementation

[0053] Various aspects of this application relate to medical devices (or self-expanding built-in prostheses) comprising a self-expanding stent element attached to a graft component. In some cases, the stent graft can be delivered to a target site via a catheter. Therefore, the stent graft can be minimized to fit the delivery configuration. Minimizing the delivery pattern / profile (e.g., the diameter of the stent graft within the delivery configuration) facilitates access to the treatment site and reduces the risk of access site complications.

[0054] Figure 1A An example self-expanding support element 100 with a manufacturing diameter of 102 is shown, consistent with various aspects of the present invention. Figure 1A The diagram illustrates a self-expanding support element 100 with a manufacturing diameter 102. In some cases, the self-expanding support element 100 may be heat-shaped to the manufacturing diameter 102. Furthermore, the self-expanding support element 100 may be a wire-wound support with multiple vertices (e.g., as shown in reference). Figure 4 (Discussed in more detail). The self-expanding stent element 100 can form part of the self-expanding built-in prosthesis 104, such as Figure 1B As shown.

[0055] Figure 1B A self-expanding internal prosthesis 104 is shown, comprising a graft component 106 attached to at least a portion of a self-expanding scaffold element 100. In some cases, the graft component 106 is a continuous structure attached to the self-expanding scaffold element 100, thereby forming a flow cavity in the self-expanding internal prosthesis 104. Figure 1B As shown, the self-expanding implant 104 is shown in its deployed configuration. In the deployed configuration of the self-expanding implant 104, the graft component 106 is disposed below the expansion diameter 108 of the graft component 106. In some cases, the expansion diameter 108 of the graft component 106 in the deployed configuration of the self-expanding implant 104 can be from about 5 mm to 27 mm.

[0056] The manufacturing diameter 102 of the self-expanding scaffold element 100 may be approximately 1 mm to 5 mm larger than the expansion diameter 108 of the graft component 106 in the deployment configuration of the self-expanding implant 104 (e.g., 2 mm to 5 mm, 5 mm to 13 mm, 35 mm to 53 mm, or any size between these). In other cases, the manufacturing diameter 102 of the self-expanding scaffold element 100 may be 2% to 20% larger than the expansion diameter 108 of the graft component 106 in the deployment configuration of the self-expanding implant 104. The expansion diameter of the graft component 106 may be smaller than the expansion diameter 110 of the self-expanding scaffold element 100. For example, the expansion diameter 108 of the graft component 106 may be from 5 mm to 27 mm, while in other cases, the expansion diameter 108 of the graft component 106 may be from 20 mm to 53 mm. In either case, the manufacturing diameter 102 of the self-expanding scaffold element 100 is 2% to 20% larger than the expansion diameter 108 of the graft component 106.

[0057] In certain circumstances, when the self-expanding implant 104 is in its deployed configuration, the self-expanding scaffold element 100 may be configured to apply a radial expansion force (expansion force) along the graft component 106. The graft component 106 may have a yield strength greater than the radial expansion force applied by the self-expanding scaffold element 100. Furthermore, the graft component 106 may be configured to radially maintain the self-expanding scaffold element 100 within the expansion diameter of the graft component 106 when a second radial expansion force greater than the radial expansion force of the self-expanding scaffold element 100 is applied.

[0058] The second radial expansion force is sufficient to enlarge the graft component 106 to the enlarged diameter without plastically deforming it to a diameter larger than the enlarged diameter. The second radial expansion force depends on the diameter of the self-expanding scaffold element 100 and / or the graft component 106. For example, a larger diameter graft component 106 may be less resistant to the expansion force than a smaller diameter graft component 106. In some cases, the second radial expansion force is between 3 atmospheres (atm) and 6 atmospheres (atm). In some cases, the graft component 106 may have a yield strength such that the second radial expansion force can be applied for 10 seconds, 20 seconds, or 30 seconds without the diameter of the graft component 106 enlarging by more than 0.5 mm. In some cases, the graft element 106 does not enlarge by more than 0.1 mm, 0.2 mm, 0.3 mm, or 0.4 mm in response to the force applied to it.

[0059] In some cases, the graft component 106 is configured to resist plastic deformation (and / or fracture and breakage) upon application of a second radial expansion force. For example, the graft component 106 may be configured to maintain the self-expanding implanted prosthesis 104 within the expansion diameter 108 of the graft component 106 in response to the second radial expansion force. The graft component 106 mitigates the expansion of the self-expanding implanted prosthesis 104 rather than allowing the self-expanding implanted prosthesis 104 to expand in response to the second radial expansion force.

[0060] Furthermore, the manufacturing diameter 102 of the self-expanding scaffold element 100 can be from 7 mm to 32 mm, while the expansion diameter 108 of the graft component 106 is from 5 mm to 27 mm. In some cases, the manufacturing diameter 102 of the self-expanding scaffold element 100 can be from 22 mm to 58 mm, and the expansion diameter 108 of the graft component 106 is from 20 mm to 53 mm (1 mm to 5 mm smaller than the manufacturing diameter 102 of the self-expanding scaffold element 100). In some cases, after plastic deformation from the manufacturing diameter 102, the expansion diameter 110 of the self-expanding scaffold element 100 is 2% to 25% larger than the expansion diameter 108 of the graft component 106.

[0061] Figure 1C A self-expanding built-in prosthesis 104 consistent with various aspects of this application is shown, such as Figure 1A As shown, it is in its reduced diameter of 112. With the reduced diameter of 112, the self-expanding in-situ prosthesis 104 can be configured in a delivery configuration for insertion into a patient. Furthermore, the self-expanding scaffold element 100 and graft component 106 are configured with a reduced diameter of 112 between approximately 4 French frenzies and approximately 24 French frenzies. Depending on the diameter of the self-expanding scaffold element 100 and graft component 106, other reduced diameters are also possible. In some cases, the diameter of the self-expanding in-situ prosthesis 104 is reduced to the point that the self-expanding scaffold element 100 undergoes plastic strain.

[0062] In some cases, the size of the self-expanding implanted prosthesis 104 can be reduced beyond the plastic strain initiation (amount) in the self-expanding stent element 100. For example, the self-expanding implanted prosthesis 104 can be reduced beyond the plastic strain initiation (amount) of the self-expanding stent element 100 to 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, or 5 mm (depending on the diameter of the self-expanding implanted prosthesis 104). The self-expanding stent element 100 of the self-expanding implanted prosthesis 104 can be configured to... Figure 1C The delivery structure shown unfolds to Figure 1BThe expansion structure shown maintains plastic strain after expansion. The self-expanding built-in prosthesis 104 can be delivered from the delivery (or shrinkage) structure to the expansion structure at the target site within the patient's vascular system to treat the target site.

[0063] The manufacturing diameter 102 of the self-expanding scaffold element 100 can be considered as the diameter to which the self-expanding scaffold element 100 would expand if no plastic strain (deformation) were induced and if it were not attached to the graft component 106. The self-expanding scaffold element 100 can be reduced from its manufacturing diameter 102 to attach the graft component 106 thereto. The manufacturing diameter 102 of the self-expanding scaffold element 100 can be considered as a neutral, nominal, self-expanding, or non-biased diameter. For example, the manufacturing diameter 102 of the self-expanding scaffold element 100, i.e., a neutral or nominal diameter, can be neutral or nominal such that if the self-expanding scaffold element 100 does not undergo plastic deformation, it will return to that manufacturing diameter 102, i.e., a neutral or nominal diameter.

[0064] In some cases, heat-setting all or part of the self-expanding scaffold element 100 to a diameter larger than the expansion diameter 108 of the implant component 106 can pre-strain (pre-deform) the self-expanding scaffold element 100. Pre-straining of the self-expanding scaffold element 100 can neutralize or offset the effects of plastic deformation occurring during compression / loading, which will free the self-expanding implanted prosthesis 104 from... Figure 1B The unfolded structure shown is reduced to Figure 1C The delivery structure shown.

[0065] Figures 1A to 1C The illustrative components shown are not intended to limit the scope of use or function of the various embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or requirement associated with any individual component or combination of components shown. Furthermore, in the embodiments, in Figures 1A to 1C Any one or more components shown in any of them may be integrated with various other components shown herein (and / or components not shown), all of which are considered to be within the scope of the disclosed subject matter.

[0066] Figure 2A Another example of a self-expanding support element 200 with a manufacturing diameter of 202 is shown, consistent with various aspects of this application. The manufacturing diameter 202 of the self-expanding support element 200 can be from 2 mm to 13 mm or 35-53 mm or any value between therewith. In some cases, the self-expanding support element 200 may be heat-shaped to the manufacturing diameter 202 of the self-expanding support element 200. Furthermore, the self-expanding support element 200 may be a wire-wound support with multiple vertices (e.g., as referenced). Figure 4 (Discussed in more detail). Furthermore, the self-expanding scaffold element 200 can form part of an implantable scaffold graft device 204, such as... Figure 2B As shown.

[0067] Figure 2B The diameter constraint portion 206, consistent with various aspects of this application, is shown, and as shown... Figure 2A The first configuration of the self-expanding support element 200 shown is such that it is positioned below the first expansion diameter 208 and the second expansion diameter 210 of the diameter constraint portion 206. (As shown) Figure 2B As shown, the diameter constraint portion 206 is a filament woven through (braided through) various parts of the self-expanding scaffold element 200. The filament can be a material similar to that of a continuous graft component. In other cases, the diameter constraint portion 206 can be a continuous graft component that differs from the wire structure (e.g., as...). Figure 1B (As shown). In any case, the diameter constraint 206 may be configured such that the implantable scaffold graft device 204 includes more than one diameter. In some cases, either the first expansion diameter 208 or the second expansion diameter 210 of the diameter constraint 206 includes an expansion diameter from 5 mm to 27 mm. More specifically, the manufacturing diameter 202 of the self-expanding scaffold element 200 may be about 1 mm to 5 mm larger than either the first expansion diameter 208 or the second expansion diameter 210 of the diameter constraint 206.

[0068] In some cases, the self-expanding support element 200 may have a self-expanding diameter that is at least 2% to 25% larger than the first expansion diameter 208 and the second expansion diameter 210 of the diameter constraint 206 when it is attached thereto. The self-expanding diameter of the self-expanding support element 200 can be considered as the diameter to which the self-expanding support element 200 would expand if it were not attached to the diameter constraint 206. The self-expanding support element 200 may be reduced from its manufacturing diameter 202 to attach the diameter constraint 206 thereto. Furthermore, as referenced above... Figure 1C The implantable stent graft device 204 can be reduced to a delivery configuration for implantation in a patient. In some cases, reducing the implantable stent graft device 204 to a delivery configuration and / or reducing the self-expanding stent element 200 from a manufacturing diameter 202 can plastically deform the self-expanding stent element 200 such that it can be configured to expand to a self-expanding diameter, which is at least the first expansion diameter 208 and the second expansion diameter 210 of the diameter constraint portion 206.

[0069] Furthermore, the self-expanding scaffold element 200 can be configured such that when the implantable scaffold graft device 204 is fully deployed (e.g., Figure 2B As shown, the self-expanding support element 200 can be configured to continue applying an outward force to the diameter constraint portion 206 without expanding beyond the first expansion diameter 208 and the second expansion diameter 210 of the diameter constraint portion 206. Furthermore, in some cases, the diameter constraint portion 206 can be configured to resist a radial expansion force greater than the outward force from the self-expanding support element 200 without expanding beyond the first expansion diameter 208 and the second expansion diameter 210. The radial expansion force can depend on the diameter of the self-expanding support element 200 and / or the diameter of the diameter constraint portion 206. For example, a larger diameter diameter constraint portion 206 may have less resistance (drag) to the expansion force than a smaller diameter diameter constraint portion 206. In some cases, the radial expansion force is between 3 and 6 standard atmospheres (atm).

[0070] Figure 2C It shows the attachment to, such as Figure 2A The second configuration of the diameter constraint portion 206 of the self-expanding support element 200 shown. (As shown) Figure 2C As shown, the diameter constraint portion 206 is a thread structure woven through various parts of the self-expanding scaffold element 200. In other cases, the diameter constraint portion 206 can be a continuous graft component different from the thread structure (e.g., such as...). Figure 1B (As shown). The diameter constraint portion 206 can be attached to the self-expanding support element 200 such that the diameter constraint portion 206 includes a single expansion diameter 212.

[0071] Figure 3 Example self-expanding implantable prostheses 300 and 302 in a reduced-size configuration, consistent with various aspects of this application, are shown. Each self-expanding implantable prosthesis 300 and 302 includes a graft component and a pre-stressed scaffold component. The pre-stressed scaffold component of the self-expanding implantable prosthesis 300 and 302 may include a reduced wire diameter to allow for the illustrated low-profile (low-profile) reduced-size (delivery) configuration. The wire diameter of the scaffold of the implantable prosthesis can contribute to its structural strength. Forces can be applied when reducing the implantable prosthesis to a reduced-size (delivery) configuration, and the forces acting on the implantable prosthesis when implanted can limit the size of the wire diameter. Pre-stressing the scaffold component of the self-expanding implantable prosthesis 300 and 302 enhances the scaffold component's ability to withstand radial forces applied to the self-expanding implantable prosthesis 300 and 302. Furthermore, compared to devices of the same size design that do not have a pre-strained support component if the wire diameter is equal, the reduced wire diameter of the pre-strained support component of the self-expanding built-in prosthesis 300, 302 optimizes the shrinkage (delivery) construction, thereby allowing the self-expanding built-in prosthesis 300, 302 to be reduced to a smaller shrinkage (delivery) construction.

[0072] See below for reference. Figure 6In more detail, pre-strained scaffold components can also optimize the unfolded diameter, radial force, and fatigue life, and reduce stiffness due to the reduced wire diameter. Furthermore, pre-strained scaffold components can also increase compressive resistance (radial force) because the pre-strained state and / or the pre-strained scaffold component has a larger manufactured (or relaxed) scaffold diameter than the unfolded diameter after the graft component is attached.

[0073] Figure 4 Another example of an implantable scaffold graft device 400 consistent with various aspects of this application is shown. The self-expanding implantable scaffold graft device 400 includes a self-expanding scaffold element 402 and a graft component 404. (As...) Figure 4 As shown, if the self-expanding scaffold element is not constrained by the graft component 404, the self-expanding scaffold element expands beyond the diameter of the graft component 404.

[0074] The self-expanding scaffold element 402 may have a manufacturing diameter of 7 mm to 32 mm, while the expansion diameter of the graft component 404 is 5 mm to 27 mm. In some cases, the manufacturing diameter of the self-expanding scaffold element 402 may be 22 mm to 58 mm, while the expansion diameter of the graft component 404 is 20 mm to 53 mm, or 1 mm to 5 mm smaller than the manufacturing diameter of the self-expanding scaffold element 402. More specifically, the manufacturing diameter of the self-expanding scaffold element 402 may be about 1 mm to 3 mm larger than the expansion diameter of the graft component 404. Furthermore, the self-expanding scaffold element 402 includes a self-deploying diameter (e.g., if the self-expanding scaffold element 402 is not attached to the graft component 404), which is 2% to 25% larger than the expansion diameter of the graft component 404. When the implantable scaffold graft device 400 is fully deployed, the self-expanding scaffold element 402 may be configured to apply an outward force to the graft component 404 without causing the graft component 404 to expand beyond its expansion diameter. Furthermore, in some cases, the graft component 404 may be configured to resist radial expansion forces greater than those from the self-expanding scaffold element 402 without expanding beyond the expansion diameter of the graft component 404. The radial expansion force may depend on the diameter of the self-expanding scaffold element 402 and / or the graft component 404. For example, a larger diameter graft component 404 may be less resistant to expansion forces than a smaller diameter graft component 404, wherein the radial expansion force is between 3 and 6 atmospheres.

[0075] The self-expanding support element 402 may include multiple corrugations (sections). For example... Figure 4As shown, the self-expanding support element 402 includes multiple rows 406, 408, 410, 412 forming multiple corrugations (sections). Although highlighted on two sets of corrugations, each of the multiple corrugations is formed by struts (supports) 414, 418 interconnected at vertices 416, 420. Vertices 416, 420 include inner arc surfaces 422, 426 (inner portions of the vertex) and outer arc surfaces 424, 428 (outer portions of the vertex).

[0076] In some cases, the graft component 404 may be attached to the self-expanding scaffold element 402 and configured to reduce tensile stress in the inner arcuate surfaces 422, 426 of the vertices 416, 420. In some cases, reducing the implantable scaffold graft device 400 to a delivery configuration and / or reducing the self-expanding scaffold element 402 from a manufacturing diameter to attach the graft component 404 thereto allows for plastic deformation of the self-expanding scaffold element 402, such that the inner arcuate surfaces 422, 426 of the vertices 416, 420 are positioned under compression. After the self-expanding scaffold element 402 has undergone plastic deformation, the self-expanding scaffold element 402 and the graft component 404 are unfolded to a fully unfolded configuration. Because the self-expanding scaffold element 402 is maintained in a configuration smaller than its manufacturing diameter, the tensile stress in the inner arcuate surfaces 422, 426 of the vertices 416, 420 is reduced. The inner arc surfaces 422 and 426 under tension are more likely to crack or break than those under non-tension or compression. Therefore, reducing the tension (tensile force) within the inner arc surfaces 422 and 426 of the apex 416 can improve the fatigue resistance and reliability of the self-expanding support element 402.

[0077] Furthermore, the graft component 404 may be attached to the self-expanding scaffold element 402 and configured to maintain compression of the inner arc surfaces 422, 426 of the vertices 416, 420. In some cases, tensile stress can be reduced by maintaining the inner arc surfaces 422, 426 of the vertices 416, 420 in a compressed state. However, for illustrative purposes, the plurality of corrugated rows 410 of the self-expanding scaffold element 402 are shown as not attached to the graft component 404. The compression of the attached inner arc surface 426 compared to the unattached inner arc surface 422 is shown by the difference in lengths 430, 432 between the struts 414, 418, because the length 432 between the struts 418 of the attached inner arc surface 426 is less than the length 430 between the struts 414 of the unattached inner arc surface 422, due to the attached inner arc surface 426 being in a compressed state.

[0078] In some cases, the graft component 404 is configured to maintain the compression of the inner arc surfaces 422, 426 of the apexes 416, 420 in a fully expanded (expanded) configuration. Furthermore, the graft component 404 is configured to maintain the compression of the inner arc surfaces 422, 426 in response to a radial expansion force greater than the outward force from the self-expanding scaffold element, without expanding beyond the expansion diameter of the graft component 404. Additionally, the self-expanding scaffold element 402 may be manufactured with a smaller diameter to attach the graft component 404 thereto. Furthermore, as referenced above... Figure 1C and Figure 3 The implantable scaffold graft device 400 can be reduced to a delivery configuration for implantation into a patient. As described above, reducing the implantable scaffold graft device 400 allows for plastic deformation of the self-expanding scaffold element 402, such that the inner arc surfaces 422, 426 of the vertices 416, 420 are positioned in a compressed state.

[0079] The manufacturing diameter of the self-expanding support element 402 can be considered to be a neutral, nominal, self-expanding, or non-biased diameter. For example, the neutral or nominal diameter of the self-expanding support element 402 can be neutral or nominal such that if the self-expanding support element 402 does not undergo plastic deformation, it will return to that neutral or nominal diameter.

[0080] Maintaining the inner arc surfaces 422 and 426 of vertices 416 and 420 in a compressed state can mitigate the failure of the self-expanding scaffold element 402. Tensile forces in the inner arc surfaces 422 and 426 of vertices 416 and 420 can cause them to fracture, negatively impacting the fatigue life of the self-expanding scaffold element 402. Furthermore, maintaining the inner arc surfaces 422 and 426 of vertices 416 and 420 in a compressed state promotes the uniform expansion of the self-expanding implantable scaffold graft device 400 from its delivery configuration to its fully expanded (expanded) configuration. Additionally, compressing or reducing the self-expanding implantable scaffold graft device 400 to its delivery configuration allows for plastic deformation of the self-expanding scaffold element 402, thereby enabling the graft component 404 to maintain the inner arc surfaces 422 and 426 of vertices 416 and 420 in a compressed state.

[0081] Figure 5 An example implantable scaffold graft device 500 consistent with various aspects of this application is shown, comprising a graft component 504 and a self-expanding scaffold element 502, wherein portions 506 of the self-expanding scaffold element 502 are detached from the graft component 504. For illustrative purposes, portions of the self-expanding scaffold element 502 are shown detached from the graft component 504. All aspects of the self-expanding scaffold element 502 are attachable to the graft component 504.

[0082] Multiple portions of the self-expanding scaffold element 502 are shown detached from the graft component 504. The self-expanding scaffold element 502 may include a self-expanding diameter (e.g., if the self-expanding scaffold element 502 is not attached to the graft component 504) that is 2% to 25% larger than the expansion diameter of the graft component 504. The manufacturing diameter of the self-expanding scaffold element 502 may be 5 mm to 27 mm (or 5 mm to 53 mm), while the expansion diameter of the graft component 504 is 5 mm to 27 mm, or the diameter of the self-expanding scaffold element 502 is 1 mm to 5 mm larger (2% to 25%) than that of the graft component 504. In some cases, the manufacturing diameter of the self-expanding scaffold element 502 may be 22 mm to 58 mm, while the expansion diameter of the graft component 504 is 20 mm to 53 mm, or 1 mm to 5 mm smaller than the manufacturing diameter of the self-expanding scaffold element 502. More specifically, the manufacturing diameter of the self-expanding scaffold element 502 may be larger than the expansion diameter of the graft component 504. Furthermore, and in some cases, the self-expanding scaffold element 502 may be excessively large relative to the graft component 504 in its fully expanded configuration, in order to exert an outward force on this graft component 504.

[0083] Furthermore, the self-expanding scaffold element 502 can be reduced from a manufacturing diameter to the expansion diameter of the graft component 504 for attachment thereto. This reduction in the self-expanding scaffold element 502, or the reduction of the self-expanding scaffold element 502 to a delivery configuration (e.g., as...), is beneficial. Figure 1C and Figure 3 As shown, the self-expanding scaffold element 502 is configured to expand to its self-expanding diameter, but is held to the expansion diameter of the graft component 504 by being attached to the graft component 504.

[0084] When the implantable scaffold graft device 500 is fully deployed, the self-expanding scaffold element 502 may be configured to exert an outward force on the graft component 504 without causing the graft component 504 to expand beyond its expansion diameter. Furthermore, in some cases, the graft component 504 may be configured to resist a radial expansion force greater than the outward force from the self-expanding scaffold element 502 without expanding beyond the expansion diameter of the graft component 504 (e.g., the manufacturing diameter of the graft component 504). The radial expansion force may depend on the diameter of the self-expanding scaffold element 502 and / or the graft component 504. For example, a larger diameter graft component 504 may have less resistance (drag) to expansion forces than a smaller diameter graft component 504, wherein the radial expansion force is between 3 and 6 atmospheres. For example, in some cases, the radial expansion force is sustained for 1, 2, 5, 10, 20 or 30 seconds between 3 and 6 standard atmospheres, without increasing the diameter of the implantable scaffold graft device 500 to more than about 0.5 mm.

[0085] The manufacturing diameter of the self-expanding support element 502 can be considered a neutral, nominal, self-expanding, or non-biased diameter. In some cases, the self-expanding support element 502 can be plastically deformed by reducing the self-expanding support element 502 from its manufacturing or nominal diameter. For example, the neutral or nominal diameter of the self-expanding support element 502 can be neutral or nominal such that if the self-expanding support element 502 is not plastically deformed, it will return to that neutral or nominal diameter.

[0086] Figure 5 The illustrative components shown are not intended to limit the scope of use or function of the various embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or requirement associated with any individual component or combination of components shown. Furthermore, in the embodiments, in Figure 5 Any one or more components shown in any of these embodiments may be integrated with various other components (and / or components not shown) shown herein, all of which are considered to be within the scope of the disclosed subject matter. For example, graft component 504 may be configured to maintain the inner arc surface of the apex of the self-expanding scaffold element 502 in a compressed state, as referenced above. Figure 4 The subject of discussion.

[0087] Figure 6A graph consistent with various aspects of this application is shown. This graph includes curves (plotted lines) 600, 602, and 604 of an implanted prosthesis having graft components and scaffold components, wherein the scaffold components have different diameters. Curve 600 shows the radial force applied to an implanted prosthesis with a pre-strained scaffold element having a wire diameter of 0.0185 inches (in.) at various implanted prosthesis diameters. The pre-strained scaffold is manufactured with a diameter 4 mm larger than the expansion diameter of the graft component. Curve 602 shows the radial force applied to an implanted prosthesis with a pre-strained scaffold element having a wire diameter of 0.0195 inches (in.) at various implanted prosthesis diameters. The pre-strained scaffold is manufactured with a diameter 2 mm larger than the expansion diameter of the graft component. Curve 604 shows the radial force applied to an implanted prosthesis with a non-pre-strained scaffold element having a wire diameter of 0.0205 inches (in.) at various implanted prosthesis diameters.

[0088] The slopes of curves 600 and 602 (pre-strained) are less than that of curve 604 (unpre-strained). Pre-straining the support components enhances their ability to withstand radial forces applied to the self-expanding built-in prostheses 300 and 302. Therefore, compared to the built-in prosthesis of curve 604 (unpre-strained, but with a larger line diameter), the built-in prostheses of curves 600 and 602 (pre-strained) can be reduced to approximately the same or smaller (delivery) configuration. In some cases, the built-in prostheses of curves 600 and 602 (pre-strained) can be reduced to an even smaller delivery configuration.

[0089] Furthermore, when using smaller diameter stent wires, at fully expanded diameters, the built-in prostheses (pre-strained) of curves 600 and 602 can resist radial compression approximately equally to the built-in prostheses (unpre-strained) of curve 604. Additionally, the pre-strain of the stent frame increases material strain (material deformation) and causes the self-expanding stent element 200 to plastically deform into a reduced (delivery) structure under the compressive / load of the built-in prosthesis. Plastic deformation can result in residual compressive stresses at the surfaces of the stent components (e.g., inner arc surfaces 422, 426). Furthermore, after the built-in prosthesis expands, the stent component does not expand beyond the graft diameter, which limits the amount of tensile load applied to the compressively, plastically deformed element, thereby mitigating associated fatigue failure modes.

[0090] Figure 6 The illustrative components shown are not intended to limit the scope of use or function of the various embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or requirement associated with any individual component or combination of components shown. Furthermore, in the embodiments, in Figure 6Any one or more components shown in any of them may be integrated with various other components shown herein (and / or components not shown), all of which are considered to be within the scope of the disclosed subject matter.

[0091] Figure 7 A self-expanding implantable prosthesis 700 consistent with various aspects of this application is shown. The self-expanding implantable prosthesis 700 may include a self-expanding scaffold element 702 and an implant component 704. The self-expanding implantable prosthesis 700 may taper (conical) such that the diameter of one end of the self-expanding implantable prosthesis 700 is smaller than the diameter of the other end of the self-expanding implantable prosthesis 700, wherein the diameter of the middle portion decreases between them.

[0092] As discussed in more detail above, the self-expanding scaffold element 702 can be plastically deformed from a manufacturing diameter (larger than the expansion diameter). The self-expanding scaffold element 702 can be configured to exhibit plastic deformation. The graft component 704 can be attached to the self-expanding scaffold element 702 such that the expansion diameter of the self-expanding scaffold element 702 (or the diameter resulting from the tapering of the self-expanding implant 700) is 2% to 25% larger than the expansion diameter of the graft component 704 (or the diameter resulting from the tapering of the self-expanding implant 700) after the self-expanding scaffold element 702 has been plastically deformed from its manufacturing diameter (larger than the expansion diameter).

[0093] Figure 7 The illustrative components shown are not intended to limit the scope of use or function of the various embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or requirement associated with any individual component or combination of components shown. Furthermore, in the embodiments, in Figure 7 Any one or more components shown in any of them may be integrated with various other components shown herein (and / or components not shown), all of which are considered to be within the scope of the disclosed subject matter.

[0094] Figure 8 Another self-expanding implantable prosthesis consistent with aspects of this application is shown. The self-expanding implantable prosthesis 800 may include a self-expanding scaffold element 802 and a graft component 804. The self-expanding implantable prosthesis 800 may include portions of different sizes such that the diameter of each end of the self-expanding implantable prosthesis 800 is smaller than the diameter of the intermediate portion therebetween. The self-expanding implantable prosthesis 800 may have… Figure 8 The shape of the dog bone shown.

[0095] As discussed in more detail above, the self-expanding scaffold element 802 can be plastically deformed from a manufacturing diameter (larger than the expansion diameter). In some cases, only the end of the self-expanding implant 800 can be constructed in this manner. In other cases, the entire self-expanding implant 800 can be configured to plastically deform the self-expanding scaffold element 802. The self-expanding scaffold element 802 can be configured to exhibit plastic deformation. The graft component 804 can be attached to the self-expanding scaffold element 802 such that the expansion diameter of the self-expanding scaffold element 802 (or the diameter resulting from the tapering of the self-expanding implant 800) is 2% to 25% larger than the expansion diameter of the graft component 804 (or the diameter resulting from the tapering of the self-expanding implant 800) after the self-expanding scaffold element 802 has been plastically deformed from its manufacturing diameter (larger than the expansion diameter).

[0096] Figure 8 The illustrative components shown are not intended to limit the scope of use or function of the various embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or requirement associated with any individual component or combination of components shown. Furthermore, in the embodiments, in Figure 8 Any one or more components shown in any of them may be integrated with various other components shown herein (and / or components not shown), all of which are considered to be within the scope of the disclosed subject matter.

[0097] The graft components discussed herein can be made of any material suitable for use as grafts in selected body cavities and resistant to expansion beyond the desired size as discussed herein. Graft components can be made of the same or different materials. Furthermore, graft components can comprise multilayer materials that can be the same or different materials. Many graft materials are known, especially those known for use as vascular graft materials. In one embodiment, the materials can be used in combination and assembled together to include a graft. Graft materials for scaffold grafts can be extruded, coated, or formed from a wrapped film, or a combination thereof. Polymers, biodegradable materials, and natural materials can be used for specific applications.

[0098] Examples of synthetic polymers suitable for use as graft materials include, but are not limited to, nylon, polyacrylamide, polycarbonate, polyoxymethylene, polymethyl methacrylate, polytetrafluoroethylene, polychlorotrifluoroethylene, polyvinyl chloride, polyurethane, elastomeric silicone polymers, polyethylene, polypropylene, polyurethane, polyglycolic acid, polyesters, polyamides, and mixtures, blends, and copolymers thereof. In one embodiment, the graft is made of a class of polyesters, polyfluorinated hydrocarbons, and porous or non-porous polyurethanes, such as polyethylene terephthalate, including DACRON® and MYLAR®, and polyarylamides, such as KEVLAR®, and the polyfluorinated hydrocarbons such as polytetrafluoroethylene (PTFE) with or without copolymerized hexafluoropropylene (TEFLON® or GORE-TEX®). In some cases, the graft comprises expanded fluoropolymer (particularly PTFE) materials as described in British Patent Nos. 1,355,373, 1,506,432, or 1,506,432, or in U.S. Patent Nos. 3,953,566, 4,187,390, or 5,276,276, all of which are incorporated herein by reference in their entirety. Included in this class of preferred fluoropolymers are polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), tetrafluoroethylene (TFE), and perfluoro(propyl vinyl ether) copolymers (PFA), homopolymers of polychlorotrifluoroethylene (PCTFE), copolymers thereof with TFE, ethylene-chlorotrifluoroethylene (ECTFE), ethylene-tetrafluoroethylene (ETFE) copolymers, polyvinylidene fluoride (PVDF), and polyvinyl fluoride (PVF). ePTFE is particularly preferred due to its widespread use in vascular prostheses. In some embodiments, the graft comprises a combination of the materials listed above. In some cases, the graft is substantially impermeable to bodily fluids. Such substantially impermeable grafts may be made of materials substantially impermeable to bodily fluids or may be made of permeable materials that have been processed or manufactured (e.g., by layering different types of materials described above or known in the art) to be substantially impermeable to bodily fluids.

[0099] Other examples of graft materials include, but are not limited to, vinylidene fluoride / hexafluoropropylene hexafluoropropylene (HFP), tetrafluoroethylene (TFE), vinylidene fluoride, 1-hydropentafluoropropylene, perfluoro(methyl vinyl ether), trifluorochloroethylene (CTFE), pentafluoropropylene, trifluoroethylene, hexafluoroacetone, hexafluoroisobutylene, fluorinated poly(ethylene-co-propylene) (FPEP), poly(hexafluoropropylene) (PHFP), poly(trifluorochloroethylene) (PCTFE), poly(vinylidene fluoride) (PVDF), poly(vinylidene fluoride-co-tetrafluoroethylene) (PVDF-TFE), poly(vinylidene fluoride-co-hexafluoropropylene) (PVDF-HFP), poly( Poly(tetrafluoroethylene-co-vinyl alcohol) (PTFE-VAL), poly(tetrafluoroethylene-co-vinyl acetate) (PTFE-VAC), poly(tetrafluoroethylene-co-propylene) (PTFEP), poly(hexafluoropropylene-co-vinyl alcohol) (PHFP-VAL), poly(ethylene-co-tetrafluoroethylene) (PETFE), poly(ethylene-co-hexafluoropropylene) (PEHFP), poly(vinylidene fluoride-co-trifluorochloroethylene-ethylene) (PVDF-CTFE), and combinations thereof, as well as other polymers and copolymers described in U.S. Publication 2004 / 00663805, the entire contents of which are incorporated herein by reference for all purposes. Other polyfluoropolymers include tetrafluoroethylene (TFE) / perfluoroalkyl vinyl ethers (PAVE). PAVE can be perfluoromethyl vinyl ether (PMVE), perfluoroethyl vinyl ether (PEVE), or perfluoropropyl vinyl ether (PPVE), as substantially described in U.S. Publication 2006 / 0198866 and U.S. Patent No. 7,049,380, the entire contents of which are incorporated herein by reference for all purposes. Other polymers and copolymers include: polylactide, polycaprolactone-glycolic acid, polyorthoesters, polyanhydrides; polyamino acids; polysaccharides; polyphosphazenes; poly(ether-ester) copolymers or blends thereof, such as PEO-PLLA; polydimethylsiloxane; poly(ethylene-vinyl acetate); acrylate-based polymers or copolymers, such as poly(hydroxyethyl methacrylate); polyvinylpyrrolidone; fluorinated polymers such as polytetrafluoroethylene; cellulose esters; and any polymers and copolymers described in U.S. Publication 2004 / 0063805, the entire contents of which are incorporated herein by reference.

[0100] As discussed herein, graft components can be attached to a self-expanding scaffold element using a connecting member, typically a flat band or strap, having at least one generally flat surface. In some cases, the strap member is made of expanded PTFE (ePTFE) coated with an adhesive. The adhesive can be a thermoplastic adhesive. In some cases, the thermoplastic adhesive can be fluorinated ethylene propylene (FEP). More specifically, the FEP-coated side of the ePTFE may face and contact the outer surfaces of the self-expanding scaffold and the graft component, thus attaching the self-expanding scaffold to the graft component. Materials and methods for attaching scaffolds to grafts are discussed in Martin's U.S. Patent No. 6,042,602, which is incorporated herein by reference for all purposes.

[0101] The scaffold elements discussed in this article can be made from a variety of biocompatible materials. These materials may include 316L stainless steel, cobalt-chromium-nickel-molybdenum-iron alloys (“cobalt-chromium”), other cobalt alloys such as L605, tantalum, nitinol, or other biocompatible metals. In some cases, as discussed in detail above, the scaffold (and graft) may be self-expanding. The prosthesis may be balloon-expandable.

[0102] Wire-wound supports (wire-wound supports) can be made of materials with considerable strength, i.e., materials that resist plastic deformation when stressed. In some cases, the support comprises a wire spirally wound around a mandrel with pins arranged on it, thus simultaneously forming a helical bend (coil) and corrugations (corrugated sections), as described below. Other constructions are also possible. For example, flat raw materials can be shaped into suitable forms and wound into cylinders or formed into tubes of a suitable shape and length, or laser-cut sheets of material can be used. In some cases, the support is made of a superelastic alloy. There are many disclosures regarding the use of superelastic alloys, such as nitinol, in supports. See, for example, U.S. Patent No. 4,503,569 to Dotter, No. 4,512,338 to Balko et al., No. 4,990,155 to Wilkoff, No. 5,037,427 to Harada et al., No. 5,147,370 to MacNamara et al., No. 5,211,658 to Clouse, and No. 5,221,261 to Termin et al.

[0103] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the invention. For example, although the embodiments discussed above specify particular features, the scope of the invention also includes embodiments having different combinations of features and embodiments that do not include all of the stated features. Therefore, the scope of the invention is intended to cover all such alternatives, modifications, and variations falling within the scope of the claims, as well as all their equivalents.

Claims

1. A self-expanding internal prosthesis, comprising: A self-expanding support element having a self-expanding diameter, the self-expanding support element comprising multiple waveforms formed by multiple pillars, the multiple waveforms defining multiple inner arc surfaces and multiple outer arc surfaces, the self-expanding support element having undergone plastic deformation by reducing the manufacturing diameter of the self-expanding support element. as well as A graft component having an expansion diameter attached to the self-expanding scaffold element, wherein, prior to attachment of the self-expanding scaffold element to the graft component, the self-expanding scaffold element is reduced from its manufacturing diameter to its self-expanding diameter to maintain the plurality of inner arc surfaces in compression after the plastic deformation of the self-expanding scaffold element, such that the self-expanding diameter of the self-expanding scaffold element is at least 2% to 25% larger than the expansion diameter of the graft component; When the self-expanding built-in prosthesis is fully deployed, the self-expanding scaffold element continues to exert an outward force on the graft component without expanding beyond the expansion diameter of the graft component.

2. The self-expanding built-in prosthesis as described in claim 1, characterized in that, The manufacturing diameter of the self-expanding scaffold element is from 7 mm to 32 mm, and the graft component has an expansion diameter of 5 mm to 27 mm.

3. The self-expanding built-in prosthesis as described in claim 1, characterized in that, The self-expanding scaffold element has a neutral diameter of 22 mm to 58 mm, the graft component has an expansion diameter of 20 mm to 53 mm, and the self-expanding scaffold element and the graft component are configured to decrease from a fully expanded configuration to a delivery configuration for introduction into the patient.

4. The self-expanding built-in prosthesis as described in claim 1, characterized in that, The graft component is configured to resist radial expansion forces greater than the outward forces from the self-expanding scaffold element, without expanding beyond the expansion diameter of the graft component, and the radial expansion forces are between 3 and 6 standard atmospheres.

5. The self-expanding built-in prosthesis as described in any one of claims 1 to 4, characterized in that, The graft component and the self-expanding scaffold element are connected within the expansion diameter of the graft component.

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