Bifurcation stent graft with patient-specific fenestration

Abstract

Devices, systems, and methods for patient-specific, custom-designed fenestrated implants. Various examples involve abdominal aortic stent-grafts with custom-designed fenestration features for perfusion of the renal arteries, mesenteric arteries, and / or celiac trunk arteries.

Description

[0001] Cross-reference related applications

[0002] This application claims priority to U.S. Application No. 18 / 937,748, filed November 5, 2024, and claims the benefit of Provisional Application No. 63 / 596,983, filed November 8, 2023, the entire contents of which are incorporated herein by reference for all purposes. Background Technology

[0003] Custom-designed implantable prostheses (e.g., stent grafts for aneurysm repair) are typically patient-specific devices tailored to the specific anatomy of an individual. In this context, a “custom” approach is not achieved through a unique combination of existing devices and is generally manufactured based on the patient’s anatomy to treat vascular regions that typically include one or more collateral vessels (e.g., in the case of the aorta, treatment of thoracic, abdominal, proximal, and suprenal aneurysms, and aortic arch repair). While customization can broadly involve simply altering the size of the implantable prosthesis (e.g., the diameter along the length of the implantable prosthesis), as discussed in this patent specification, customization involves providing openings in the implantable prosthesis that are customized to fit the specific anatomical structure (one or more) of that patient or group of patients. Summary of the Invention

[0004] Customized fenestrations in implantable prostheses provide healthcare providers with patient-specific device options. In some embodiments, the fenestration is reinforced by additional material, such as additional material on the surface of the implantable prosthesis, or additional material forming external and / or internal tubing (e.g., membrane tubing). In some embodiments, one or more fenestrations are marked or otherwise associated with radiopaque material, such as rings, marking patterns, or other radiopaque indicators. In some embodiments, removable guidewire tubing, cannulation fibers, cannulation wires, or other features are placed in one or more fenestrations to facilitate pre-cannulation of the fenestrations during device delivery (e.g., pre-cannulation with one or more guidewires). In some embodiments, the implantable prosthesis includes a substantial, unsupported length to provide sufficient area for the setting of customized, patient-specific fenestration features (e.g., formed in a remote location, such as at the manufacturing site, or formed on-site at the implantation site). In some embodiments, an in-body prosthesis delivery system component (e.g., a restraint sleeve component) associated with the in-body prosthesis may be modified to better accommodate the orientation and positioning of one or more openings (e.g., intermediate unfolding techniques, such as multiple releasable seams for unfolding one or more portions of the in-body prosthesis to one or more intermediate diameters smaller than the final fully unfolded diameter).

[0005] According to one example (“Example 1”), an embedded prosthesis article includes: a body including a crown portion, a hip portion, and an intermediate portion located between the crown portion and the hip portion, the crown portion and the hip portion being supported by one or more frame elements, while the intermediate portion is not supported by any frame element; a first leg extending from the hip portion of the body; and a second leg extending from the hip portion of the body adjacent to the first leg.

[0006] According to another example (“Example 2”), further, in Example 1, the intermediate portion is configured for one or more patient-specific fenestration features subsequently formed.

[0007] According to another example (“Example 3”), further, in Example 1, one or more frame elements have an undulating shape that defines a maximum amplitude, and the height of the middle portion is at least twice the maximum amplitude, or alternatively, at least five times the maximum amplitude, or alternatively, at least ten times the maximum amplitude.

[0008] According to another example (“Example 4”) that goes further than Example 3, in Example 3, one or more patient-specific fenestration features are located at preselected locations corresponding to one or more abdominal aortic branch vessels of a particular patient.

[0009] According to another example (“Example 5”) that goes further than any of the preceding examples, the coronal portion is configured to anchor the built-in prosthesis in the abdominal aorta at a location above the renal artery.

[0010] According to another example (“Example 6”), an implantable prosthesis includes: a body including a crown portion, a hip portion, and an intermediate portion located between the crown portion and the hip portion, the crown portion and the hip portion being supported by one or more frame elements, the intermediate portion having one or more fenestration features associated with the intermediate portion, the one or more fenestration features including an orifice for a graft element passing through the intermediate portion and a port liner extending through the orifice; a first leg extending from the hip portion of the body; and a second leg extending from the hip portion of the body adjacent to the first leg.

[0011] According to another example (“Example 7”) that goes further than Example 6, the middle section is not supported by any frame elements.

[0012] According to another example (“Example 8”) that goes further than Example 6, the middle section is supported by frame elements formed to not obstruct the window opening feature.

[0013] According to another example (“Example 9”) that goes further than Example 6 or 8, the intermediate portion is supported by one or more frame elements having undulating shapes with varying amplitudes and / or frequencies to accommodate the opening features, and the undulating shapes of one or more frame elements of the intermediate portion are different from those of one or more frame elements supporting the crown portion and the hip portion.

[0014] According to another example (“Example 10”) that goes further than any of Examples 6 to 9, the port liner is a tubular member formed of a thin film material and does not have any frame elements.

[0015] According to another example (“Example 11”) that goes further than any of Examples 6 to 9, the orifice and / or port liner is reinforced by one or more of the following: polymer ring elements, fiber elements, wire elements, and combinations thereof.

[0016] According to another example (“Example 12”) that goes further than any of Examples 6 to 11, the windowing feature includes one or more of the following nontransparent markings: circumferential markings, dot markings, immersion markings and combinations thereof.

[0017] According to another example (“Example 13”), a method of manufacturing an embedded prosthesis includes: acquiring patient-specific branch vessel location data; and forming one or more fenestration features in an unsupported intermediate portion of the embedded prosthesis article based on the patient-specific branch vessel location data.

[0018] According to another example (“Example 14”) that goes further than Example 13, the method also includes providing a frame element for supporting the middle portion, the frame element being configured not to obstruct one or more window features.

[0019] According to another example (“Example 15”) that goes further than the example of claim 13 or 14, the built-in prosthesis article is manufactured prior to obtaining patient-specific branch vessel location data.

[0020] According to another example (“Example 16”) that goes further than any of Examples 13 to 15, forming one or more window features includes: forming an orifice through a graft element in the intermediate portion, setting a port liner through the orifice, and attaching the port liner to the graft element in the intermediate portion.

[0021] According to another example (“Example 17”) that goes further than any of Examples 13 to 16, forming one or more windowing features includes associating a translucent mark selected from one or more of the following with the windowing feature: circumferential mark, dot mark, immersion mark, and combinations thereof.

[0022] According to another example (“Example 18”) that goes further than any of Examples 13 to 17, forming one or more fenestration features includes forming fenestration features corresponding to at least three aortic branch vessels of a particular patient.

[0023] According to another example (“Example 10”) that goes further than Example 18, the aortic branch vessels include the first renal artery, the second renal artery, the mesenteric artery and / or the celiac trunk artery.

[0024] According to another example (“Example 10”) that goes further than any of Examples 13 to 19, forming one or more window features includes reinforcing the orifice with one or more of the following: polymer ring elements, fiber elements, wire elements, and combinations thereof.

[0025] The various examples mentioned in this patent specification should not be construed as limiting or otherwise narrowing the scope of the inventive concept provided in any other manner. While several examples have been disclosed, other embodiments will become apparent to those skilled in the art from the description and drawings, which illustrate and describe illustrative examples. Therefore, the drawings and detailed descriptions should be considered illustrative rather than restrictive in nature. Attached Figure Description

[0026] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and, together with the description, serve to explain the principles of the present disclosure.

[0027] Figure 1 illustrates a built-in prosthesis according to some embodiments.

[0028] Figure 2 shows an enlarged view of a portion of the built-in prosthesis of Figure 1 according to some embodiments.

[0029] Figures 3 to 5 An example of the radiopaque markings of the built-in prosthesis shown in Figure 1 is illustrated.

[0030] Figure 6 An embedded prosthesis article according to some embodiments is shown.

[0031] Figure 7 A method for manufacturing the built-in prosthesis of FIG1 is shown according to some embodiments.

[0032] Figure 8 Another manufacturing method for the built-in prosthesis of FIG1 is shown according to some embodiments.

[0033] Figure 9 An internal prosthesis construction according to some embodiments is shown.

[0034] Figure 10 Another built-in prosthesis construction according to some embodiments is shown.

[0035] Figure 11 Another built-in prosthesis construction according to some embodiments is shown. Detailed Implementation

[0036] Definitions and Terms

[0037] This disclosure should not be read in a restrictive manner. For example, the terms used in this application should be understood broadly in the context of the meanings that those skilled in the art would assign to them.

[0038] Regarding imprecise terminology, the terms "about" and "approximately" are used interchangeably to refer to measurement results that include the measured value and also any measured value that is reasonably close to the measured value. A measurement result that is reasonably close to the measured value has a reasonably small deviation from the measured value, as understood and readily determined by one of ordinary skill in the art. For example, such deviation may be attributed to measurement errors, differences in the calibration of measuring and / or manufacturing equipment, human error in reading and / or setting the measured value, minor adjustments to performance and / or structural parameters to account for measurement differences related to other components, specific implementation scenarios, imprecise adjustments and / or operations performed on the object by personnel or machines, and / or the like. If the value of such a reasonably small difference is not readily determined by one of ordinary skill in the art, the terms "about" and "approximately" may be understood as plus or minus 10% of the value.

[0039] As used herein, the terms “fenestration” or “fenestration feature” are intended to refer to one or more openings of sufficient size in an implanted prosthesis to allow substantial perfusion or flow from the implanted prosthesis to one or more branch vessels (e.g., any of those described herein).

[0040] Overview

[0041] The various designs described in this patent specification relate to an internal prosthesis 100, which includes one or more graft components and one or more support components coupled to the graft component(s). As shown in FIG1, the internal prosthesis 100 includes a body 102. The body 102 is end-branched, having a large proximal entrance and two distal exits defined by two legs, such as a short leg and a long leg. Although not shown, the body 102 may alternatively be configured to have a single large proximal entrance and a single large distal exit, for example, without defining separate legs or branches at the distal end. As shown, the body 102 branches into a first leg 104 and a second leg 106. The first leg 104 is positioned adjacent to the second leg 106. As shown, the legs extend in substantially the same general direction, although branched legs or other arrangements are also considered. While the first leg and the second leg 104, 106 may have different lengths, they may also have the same length. In some embodiments, one or both of the legs 104, 106 may be short-headed, or even have an opening without any substantial length extending from the body 102.

[0042] As shown in the figure, the implantable prosthesis 100 is configured for endovascular implantation and treatment of the abdominal aorta (e.g., using a catheter delivery system, not shown). However, configurations for treating other vessels (e.g., the aortic arch) are also contemplated. In various examples, the implantable prosthesis 100 is used to treat aortic aneurysms. Generally, in some embodiments, the implantable prosthesis 100 is configured to facilitate the guidance of blood through the aorta while protecting the aortic wall from further pressure from the blood flow. In other words, the implantable prosthesis 100 is used to support blood flow to relieve pressure on damaged, weakened, or diseased portions of vessels, such as the aorta. For example, legs 104, 106 may be configured to be guided into (directly or via an extended graft) the iliac artery, with the body located within the abdominal aorta. The implantable prosthesis 100 includes a frame component composed of one or more frame elements (e.g., circumferential and / or helical stent windings, braids, knits, or other stent forms) and a graft component composed of one or more graft elements (e.g., squeezed, wrapped, braided, knitted, or otherwise constructed). Examples of suitable materials for the frame and graft components are described in subsequent sections.

[0043] As shown in the figure, the body 102 includes a coronal portion 200, a intermediate portion 202, and a hip portion 204. The coronal portion 200 typically includes one or more coronal portion frame elements (e.g., circumferential and / or helical stent supports) configured to anchor the coronal portion 200, and therefore more generally, the in-situ prosthesis 100, into a vascular system (e.g., the abdominal aorta). According to some examples, the one or more coronal portion frame elements may be uniformly spaced apart from each other (e.g., uniformly spaced individual circumferential rings, or uniformly spaced helical coils). The coronal portion 200 also includes a coronal portion graft element. The intermediate portion 202 also includes an intermediate graft element 210, but as shown, it has no frame element and is also referred to as stentless or not supported by any secondary frame elements. Similar to the coronal portion frame elements, according to some examples, one or more hip portion frame elements may be uniformly spaced apart from each other (e.g., uniformly spaced individual circumferential rings, or uniformly spaced helical coils). Although shown as uniformly spaced, any combination of uniform and non-uniform spacing between the various frame elements in any of the different portions described above or below is contemplated.

[0044] The intermediate portion 202 has a substantial height in the axial direction, which is substantially greater than the spacing between the frame elements of the crown and hip portions. In some examples, one or more frame elements of the crown and hip portions 202, 204 have an undulating shape defining a maximum amplitude, and the height of the intermediate portion 202 is at least twice the maximum amplitude, or alternatively, at least five times the maximum amplitude, or alternatively, at least ten times the maximum amplitude, although a variety of sizes are considered. For example, the height of the intermediate portion 202 can be 1 cm, 2 cm, 10 cm, 15 cm, 20 cm, or any value or range between any of the foregoing values, although any of a variety of sizes are considered.

[0045] The intermediate graft element 210 may be provided with additional material or thickness to make it more resistant to collapse, bending, indentation, etc. The hip portion 204 also includes one or more hip portion frame elements (e.g., circumferential and / or spiral support members) configured to support the hip portion graft element. Similarly, the first leg 104 includes frame elements and graft elements, and the second leg includes frame elements and graft elements. One or more of the various frame elements described above may be continuously formed, integrally formed, interconnected, or formed as separate, non-connected components as needed. Similarly, one or more of the various graft elements described above may be continuously formed, integrally formed, interconnected, or formed as separate components as needed.

[0046] In various examples, the body 102 is configured to be tailored to and anchored therein (e.g., within the abdominal aorta), and includes one or more fenestration features 300 formed at tailored locations corresponding to one or more branch vessels (e.g., the aorta) of the patient or patient group. These fenestration features are pre-selected based on the patient's anatomy, such as at locations corresponding to one or more abdominal aortic branch vessels of a particular patient. For example, the body 102 may be anchored above the location where a renal artery (RA) branches from the aorta and includes fenestration features 300 for allowing perfusion of these renal arteries. In some examples, the body 102 is anchored above or near the superior mesenteric artery and / or celiac trunk artery and includes fenestration features 300 for allowing perfusion of one or both of these aortic branch vessels. For example, the fenestration features 300 may be configured for the first renal artery, second renal artery, mesenteric artery, and / or celiac trunk artery, etc.

[0047] As shown in the figure, one or more window features 300 may be located within the intermediate portion 202. As described in more detail below, the intermediate portion 202 may remain without any frame elements, or it may have custom frame elements added to it, corresponding to the positioning of the window features 300 (see Figure 202). Figure 11 (For example, the position / construction of the frame elements is not determined until the positioning of the window feature 300 is determined.) The intermediate portion 202 may be supported by one or more frame elements formed not to obstruct the window feature 300. For example, as Figure 11 As shown, frame elements with customized shapes, such as varying amplitudes and / or frequencies in their undulating shape (crests and troughs), can be used to accommodate the window feature 300. The frame elements can be positioned relatively close to the window feature 300, thereby also providing support for the window feature 300. Furthermore, as... Figure 9 As shown, the intermediate portion 202 can be lengthened or its overall area adjusted (e.g., by removing the presence of one or more rows of stents or by lengthening the overall length of the intermediate portion 202). By adjusting the overall area of ​​the intermediate portion 202, the intermediate portion 202 can be configured to accommodate or have more or fewer fenestration features 300 and / or locations, including locations corresponding to those vascular branches mentioned herein.

[0048] Window features

[0049] Figure 2 is a close-up or enlarged view of a fenestration feature 300, wherein Figure 2 illustrates a first fenestration feature 300a of one or more fenestration features 300. Fenestration features 300 are typically patient-specific because they are positioned and constructed to support a particular patient or a particular patient group characterized as being within a range of common anatomical features (e.g., vessels and branch vessels with similar positioning and size at the desired treatment site). Various fenestration features 300 can be constructed similarly, and therefore can be cumulatively described for the first fenestration feature 300a (although fenestration features with different constructions, i.e., different sizes, shapes, support methods, e.g., nitinol frames, unsupported, etc.), are also considered. As shown in Figure 2, the first fenestration feature 300a includes an orifice 310 formed into the intermediate graft element 210 at a patient-specific location corresponding to a branch vessel (e.g., a branch of the aorta, such as the renal artery). The first fenestration feature 300a includes a port liner 320 received within the orifice 310 and coupled within the boundary of the orifice 310. Typically, the port liner 320 can be formed as a cylindrical tube of material or otherwise formed as a tubular member. The port liner 320 can be formed from any of a variety of materials, including any graft material described herein. As shown, the port liner 320 extends through an orifice 310, defining an inner portion 322 inside the orifice 310 and an outer portion 324 outside the orifice 310. While the port liner 320 can have both an inner portion 322 and an outer portion 324, in some embodiments, the port liner 320 extends only from the outer surface (having only the outer portion 324), or the port liner 320 extends only from the inner surface (having only the inner portion 322). The port liner 320 can be flexible and formed as a straight cylinder (e.g., it can be freely flexed or bent, but is not formed with bends or curves). If desired, the port liner 320 may have one or more portions that are more flexible or more resistant to flexure than other portions, and / or the port liner 320 may have pre-formed bends(one or more), tapers(one or more), or other shapes. In some embodiments, the port liner 320 has a lumen 320a. The lumen 320a may be adapted to receive a guide wire. As shown in FIG2, the port liner 320 may be adapted to receive placement of a lateral branch component 320b (e.g., a stent graft implant for perfusing one or more branch vessels).

[0050] In some embodiments, the total length of the port liner is between 1 and 10 mm, such as about 5 mm, although various lengths are considered. While the port liner is shown as being associated with each opening of the various window features 300, it should be understood that this is not necessarily the case in all embodiments, and window features 300 without port liner components are also considered, such as... Figure 10As shown. Additionally or alternatively, various reinforcements may be provided to enhance the window feature (e.g., orifice 310 and / or port liner 320), including one or more of the following: polymer ring elements, fiber elements, wire elements, and combinations thereof. In other words, the port liner 320 may be without any structural reinforcement (e.g., support, ring, or other reinforcement), or may be structurally reinforced by one or more structural reinforcement elements, such as... Figure 4 The area is generally indicated by the dashed line feature. In some embodiments, the port liner 320 is reinforced by a foldable reinforcing element.

[0051] Typically, the port liner 320 can assist in any of a variety of functions. For example, the port liner 320 can partially extend into a branch vessel aligned with the orifice 310. The port liner 320 can be used as an additional sealing material to assist in sealing with the branch vessel. Additionally or alternatively, the port liner 320 can be used as an anchoring point and / or sealing feature when used with a branch-in-plant prosthesis. For reference, any of a variety of branch-in-plant prostheses are considered, including branch stent-grafts. Examples of suitable branch stent grafts include, for example, a suitably constructed GORE® VIABAHN® VBX cyst-expandable in-plant prosthesis.

[0052] One or more windowing features 300 may optionally also include transmissive markings. For example, Figure 3 A circumferential nontransmissive line mark 340 is shown that surrounds, demarcates, encloses, or otherwise is adjacent to the aperture 310. Figure 4 Transmissive markings 342 are shown in the form of multiple points or discrete markings (e.g., four) surrounding the aperture 310. Figure 5 An opaque marking 344 is shown in the form of an impermeable material associated with the port liner 320, either impregnated or otherwise. While some examples are shown, any of a variety of opaque marking constructions are contemplated. For example, the window feature 300 may include an opaque marking selected from one or more of the following: circumferential markings, dot markings, impregnated markings, and combinations thereof.

[0053] For example, in various embodiments, the implantable prosthesis is formed to include up to one, two, three, four, or five or more fenestration features 300 in the intermediate portion 202, such as customized, patient-specific fenestration features corresponding to one or two renal arteries (RA), the superior mesenteric artery, the celiac trunk, and / or one or more accessory renal arteries. In some embodiments, the implantable prosthesis may be fenestrated or include fenestration features adapted to perfuse multiple renal arteries (e.g., three), the superior mesenteric artery, and related treatment methods may include, for example, placing the implantable prosthesis below the celiac trunk vessels.

[0054] Methods for creating customized window features

[0055] Figure 6 An implantable prosthesis article 100a is shown, which is either a precursor to the implantable prosthesis 100 of FIG. 1 before the formation of the fenestration feature 300, or an finished medical device for implantation. The implantable prosthesis article 100a includes a crown portion 200, a middle portion 202, a hip portion 204, and first and second legs 104, 106, as described above in conjunction with FIG. 1. As shown, the middle portion 202 of the implantable prosthesis article 100a does not have one or more fenestration features to be subsequently formed. In other words, the middle portion 202 may be completely devoid of fenestration features, or it may have a number of fenestration features that preclude one or more fenestration features to be subsequently formed in the middle portion. Specifically, the implantable prosthesis article 100a represents the manufacturing state of the implantable prosthesis 100 before the formation of the fenestration feature 300. For reference, the fenestration feature 300 may be formed at a remote location (e.g., a manufacturing or preparation location) or at a surgical location, before or after implantation, or at other locations as needed. The fenestration feature 300 may be formed by a manufacturer, healthcare provider, or other suitable entity. As described below, the fenestration feature 300 can be formed immediately after the collection of patient anatomical data, or after a period of time (e.g., hours, days, months, years) after the collection of patient anatomical data.

[0056] Figure 7 A first method for forming (also known as manufacturing) a custom-designed implantable prosthesis 100 is illustrated. In various examples, the method includes forming one or more fenestration features in the unsupported intermediate portion of the implantable prosthesis article based on acquired patient-specific branch vessel location data. Any number of fenestration features can be formed depending on the specific device application. For example, the method may include forming fenestration features corresponding to at least one branch vessel (e.g., aortic branch vessels), at least two such branch vessels, at least four such branch vessels, at least five such branch vessels, and so on, for a particular patient.

[0057] like Figure 7As shown, the method includes fabricating an in-situ prosthesis 100a. This can be completed months, weeks, days, hours, or immediately before subsequent steps, i.e., assessment of the patient's anatomy. This may require acquiring patient-specific branch vessel location data. For example, patient anatomical data can be collected during this step (e.g., using CT scans, ultrasound, or other appropriate assessment techniques). Once the anatomical data has been collected, whether for an individual patient or a group of patients, one or more fenestration features 300 are custom-formed in the intermediate portion 202 of the in-situ prosthesis 100a. For example, using the anatomical data, fenestration features 300 can be formed in the intermediate portion 202 at locations corresponding to one or more branch vessels, including any of those previously described. As part of forming one or more fenestration features 300, the method may also include attaching a port liner 300 to a graft element of the intermediate portion 202. For example, after forming an orifice (e.g., orifice 310) through the graft element of the intermediate portion 202, the port liner 300 can be disposed through the orifice, and then the port liner can be attached to the graft element of the intermediate portion 202. If desired, a radiopaque marking (e.g., radiopaque marking 342) may be associated with a window feature (orifice and / or port lining), including those selected from one or more of the following: circumferential markings, dot markings, impregnation markings, and combinations thereof.

[0058] If needed, a custom frame can be added in an optional step in a manner that does not interfere with the functionality of the windowing feature 300. Figure 11 The advantage of the aforementioned process is that by prefabricating the in-body prosthesis 100a (e.g., days, weeks, months, etc.) before collecting patient-specific data and / or forming the fenestration feature, the delivery cycle in the process of providing a custom-made in-body prosthesis can be significantly shortened.

[0059] Figure 8 An alternative method for forming a custom-built-in prosthesis 100 is shown. For example... Figure 8 As shown, the aforementioned anatomical data is collected prior to the formation of the implanted prosthesis 100a. The implanted prosthesis 100a is then manufactured, with a fenestration feature 300 prepared in the intermediate portion 202. The fenestration feature 300 can be formed as part of the manufacturing of the implanted prosthesis 100a (e.g., as part of a single manufacturing process). Alternatively, the fenestration feature 300 can be incorporated into the implanted prosthesis 100a months, weeks, days, or hours after its manufacture.

[0060] Material

[0061] The materials used for the graft components associated with the body and branch components can include any material suitable for use as a graft within a selected body cavity. The graft components for the body and(one or more) branch components can be composed of the same or different materials. The graft components can include multiple layers of material, which can be the same or different materials. While graft components can have multiple layers of material, they can have a layer formed as a tube (innermost tube) and an outermost layer formed as a tube (outermost tube).

[0062] Many graft materials are known, especially those that can be used as vascular grafts. Graft materials can be extruded, coated, or formed from wrapping membranes, or a combination thereof.

[0063] Polymers, biodegradable materials, and natural materials can be used for implanted prostheses in specific applications. In particular, biocompatible materials for various graft components associated with the body and branch components described herein are considered. In some cases, graft components may include expanded polymers, such as expanded polyethylene (ePE). In some examples, graft components may include fluoropolymers, such as polytetrafluoroethylene (PTFE) polymers or expanded polytetrafluoroethylene (ePTFE) polymers. In some cases, graft components may be formed from, but not limited to, polyethylene, polyester, silicone, polyurethane, polyethylene terephthalate, or another biocompatible polymer or combinations thereof. In some cases, bioresorbable or bioabsorbable materials, such as bioresorbable or bioabsorbable polymers, may be used. In some cases, the graft may include polyester, polyolefin, carboxymethyl cellulose fabric, polyurethane, or other woven, nonwoven, or film elastomers.

[0064] Biocompatible materials can be used for various frame or scaffold components associated with the body and branch components described herein. For example, nickel-titanium alloy (NiTi) can be used as a material for frames or scaffolds (and any frames discussed herein), but other materials, such as, but not limited to, stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or any other suitable biocompatible material and combinations thereof, can be used as frame materials. The hyperelasticity and flexibility of NiTi can enhance the conformability of the scaffold. Furthermore, the shape of NiTi can be set to a desired shape. That is, NiTi can be shaped such that when the frame is unconstrained, such as when the frame is deployed from the delivery system, the frame tends to self-expand into the desired shape.

[0065] notify

[0066] The invention described above has been presented in both general and specific terms. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of this disclosure. Therefore, it is intended that the embodiments cover modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.

Claims

1. An implantable prosthesis, comprising: The body includes a crown portion, a hip portion, and an intermediate portion located between the crown portion and the hip portion, the crown portion and the hip portion being supported by one or more frame elements, while the intermediate portion is not supported by any frame element; The first leg extends from the hip portion of the body; as well as The second leg extends from the hip portion of the body adjacent to the first leg.

2. The implantable prosthesis product according to claim 1, characterized in that, The intermediate portion is configured to serve as one or more patient-specific fenestration features for subsequent formation.

3. The implantable prosthesis product according to claim 1, characterized in that, The one or more frame elements have an undulating shape that defines a maximum amplitude, and the height of the middle portion is at least twice the maximum amplitude, or alternatively, at least five times the maximum amplitude, or alternatively, at least ten times the maximum amplitude.

4. The implantable prosthesis product according to claim 3, characterized in that, The one or more patient-specific fenestration features are located at preselected locations corresponding to one or more abdominal aortic branches of a specific patient.

5. The implantable prosthesis article according to any one of the preceding claims, characterized in that, The coronal portion is configured to anchor the built-in prosthesis in the abdominal aorta at a position above the renal artery.

6. An implantable prosthesis, comprising: The body includes a crown portion, a hip portion, and an intermediate portion located between the crown portion and the hip portion, the crown portion and the hip portion being supported by one or more frame elements, the intermediate portion having one or more fenestration features associated with the intermediate portion, the one or more fenestration features including an orifice for a graft element passing through the intermediate portion and a port liner extending through the orifice; The first leg extends from the hip portion of the body; as well as The second leg extends from the hip portion of the body adjacent to the first leg.

7. The built-in prosthesis according to claim 6, characterized in that, The middle section is not supported by any frame element.

8. The built-in prosthesis according to claim 6, characterized in that, The middle section is supported by frame elements formed to not obstruct the window opening feature.

9. The built-in prosthesis according to claim 6, characterized in that, The intermediate portion is supported by one or more frame elements having undulating shapes with varying amplitudes and / or frequencies to accommodate the opening feature, the undulating shapes of the one or more frame elements of the intermediate portion being different from the one or more frame elements supporting the crown portion and the hip portion.

10. The implanted prosthesis according to any one of claims 6 to 9, characterized in that, The port liner is a tubular member formed of a thin film material and does not have any frame elements.

11. The implanted prosthesis according to any one of claims 6 to 9, characterized in that, The orifice and / or the port liner is reinforced by one or more of the following: polymer ring elements, fiber elements, wire elements, and combinations thereof.

12. The implanted prosthesis according to any one of claims 6 to 11, characterized in that, The windowing features include one or more of the following non-transparent markings: circumferential markings, dot markings, immersion markings, and combinations thereof.

13. A method for manufacturing an implantable prosthesis, comprising: Acquire patient-specific branch vessel location data; as well as Based on the patient-specific branch vessel location data, one or more fenestration features are formed in the unsupported intermediate portion of the built-in prosthesis.

14. The method according to claim 13, characterized in that, It also includes a frame element for supporting the middle portion, the frame element being configured not to obstruct the one or more window features.

15. The method according to claim 13 or 14, characterized in that, The implanted prosthesis is manufactured prior to acquiring the patient-specific branch vessel location data.

16. The method according to any one of claims 13 to 15, characterized in that, Forming the one or more window features includes: forming an opening through the graft element in the intermediate portion, disposing a port liner through the opening, and attaching the port liner to the graft element in the intermediate portion.

17. The method according to any one of claims 13 to 16, characterized in that, Forming one or more windowing features includes associating a translucent mark selected from one or more of the following with the windowing feature: circumferential mark, dot mark, immersion mark, and combinations thereof.

18. The method according to any one of claims 13 to 17, characterized in that, Forming one or more fenestration features includes forming fenestration features corresponding to at least three aortic branch vessels of a particular patient.

19. The method according to claim 18, characterized in that, The aortic branches include the first renal artery, the second renal artery, the mesenteric artery, and / or the celiac trunk artery.

20. The method according to any one of claims 13 to 19, characterized in that, Forming the one or more window features includes reinforcing the orifice with one or more of the following: polymer ring elements, fiber elements, wire elements, and combinations thereof.

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