IMPLANTABLE CONDUCTS WITH SELF-SEALING WINDOWS AND ASSOCIATED SYSTEMS AND METHODS - Patent application

Abstract

An example of an implantable conduit is disclosed that is tubular in shape and has a lumen and an outer surface. The implantable conduit includes a plurality of overlapping elements, including a first overlapping element and a second overlapping element disposed adjacent to the first overlapping element, defining adjacent pairs of the plurality of overlapping elements. The first overlapping element overlies the second overlapping element, defining an overlapping portion between an inwardly facing surface of the first overlapping element and an outwardly facing surface of the second overlapping element. The implantable conduit also includes a plurality of attachment mechanisms that couple the first overlapping element to the second overlapping element. The inwardly facing surface of the first overlapping element and the outwardly facing surface of the second overlapping element are separable at the overlapping portion by an external force, opening an aperture in the overlapping portion between at least two of the plurality of attachment mechanisms, such that the aperture defines a pathway between the lumen and the outer surface of the implantable conduit. In the absence of the external force, the pathway is sealed.

Description

[Technical field]

[0001] Field This document relates to implantable intraluminal medical devices. For example, this document relates to implantable conduits that can be implanted into body cavities, organs and vessels. [Background technology]

[0002] background In many locations in the human anatomy, a major body conduit (e.g., a major blood vessel) is connected to one or more secondary body conduits (e.g., branch vessels or peripheral vessels) that branch off from the major body conduit. In some cases, the secondary body conduit carries fluid to the major body conduit (e.g., a venous conduit) and in other cases, the secondary body conduit carries fluid from the major body conduit (e.g., an arterial conduit).

[0003] The human vasculature includes many examples of major body conduits with secondary branches. One example of a major body conduit is the aorta. Three major arteries branch off from the aorta in the region of the aortic arch. These three arteries are the brachiocephalic artery, the left common carotid artery, and the left subclavian artery, which carry fluid away from the aorta.

[0004] Bodily conduits and / or the circulatory (or other bodily) systems with which they are associated may suffer from a variety of diseases, defects and conditions, or may otherwise benefit from augmentation with one or more implantable conduits, including grafts, stent-grafts, filters, anastomosis devices, prosthetic valves, etc. Generally, such implantable conduits have a tubular form configured to transport fluids within the body. Summary of the Invention

[0005] Abstract Disclosed herein are examples of implantable conduits that are tubular in shape and have a lumen and an outer surface. According to one example ("Example 1"), the implantable conduit includes a plurality of overlap elements, including a first overlap element and a second overlap element disposed adjacent to the first overlap element, defining adjacent pairs of the plurality of overlap elements. The first overlap element overlies the second overlap element, defining an overlapping portion between an inwardly facing surface of the first overlap element and an outwardly facing surface of the second overlap element. The implantable conduit also includes a plurality of attachment mechanisms that couple the first overlap element to the second overlap element. The inwardly facing surface of the first overlap element and the outwardly facing surface of the second overlap element are separable at the overlapping portion by an external force, opening an aperture at the overlapping portion between at least two of the plurality of attachment mechanisms, whereby the aperture defines a pathway between the lumen and the outer surface of the implantable conduit. In the absence of the external force, the pathway is sealed.

[0006] According to another example ("Example 2") in addition to Example 1, a plurality of overlapping elements are disposed along the length of the implantable conduit, with the overlapping portions extending circumferentially.

[0007] According to another example ("Example 3") in addition to Example 1 or Example 2, the plurality of overlap elements defines a plurality of adjacent pairs of overlap elements and a plurality of overlapping portions, each of the adjacent pairs of overlap elements being separable at a corresponding one of the plurality of overlapping portions to open an aperture defining a pathway between the lumen and the exterior surface of the implantable conduit.

[0008] According to another example ("Example 4") in addition to any of the examples above, the multiple attachment features are elongated strips of material extending longitudinally along the length of the implantable conduit and connecting the first overlap element to the second overlap element.

[0009] According to another example ("Example 5") in addition to any of the examples above, the implantable conduit is configured to close an aperture at the overlapping portion when an external force separating the overlapping elements at the overlapping portion is removed, sealing a pathway between the lumen and the outer surface of the implantable conduit.

[0010] According to another example ("Example 6") in addition to any of the examples above, the attachment mechanism includes an adhesive material.

[0011] According to another example ("Example 7") in addition to any of the examples above, the attachment mechanisms are circumferentially staggered relative to one another around the circumference of the implantable conduit.

[0012] According to another example ("Example 8") in addition to any of the examples above, the implantable conduit further includes a secondary device structure received through the aperture.

[0013] According to another example ("Example 9") in addition to any of the examples above, the implantable conduit defines a varying diameter.

[0014] According to another example ("Example 10") in addition to any of the examples above, the implantable conduit further includes a plurality of stent elements coupled to the plurality of overlap elements.

[0015] According to another example ("Example 11") in addition to any one of Examples 1-10, the multiple overlap elements are defined by a continuous helical length of material edge-over-edge upon itself, or the multiple overlap elements are defined by separate adjacent circumferential rings of material edge-over-edge.

[0016] According to any one of Examples 1-10 plus another Example ("Example 12"), the plurality of overlap elements are defined by a tubular body having a pleated configuration defining a plurality of pleats. A plurality of attachment mechanisms join the overlap elements in the pleated configuration.

[0017] According to another example ("Example 13") in addition to Example 12, the pleats are circumferentially oriented and, optionally, one of the pleats has an aperture formed therein.

[0018] According to one example ("Example 14"), an example of an implantable conduit is also disclosed herein that includes a tube of flexible material having a length, a first end, and a second end. The tube has a plurality of pleats formed along its length. The implantable conduit also includes stiffening elements that reinforce the pleats to resist unfolding when tension is applied along the length of the tube. The tube is configured with fenestrations in the pleats to provide lateral portals along the length of the tube to allow for introduction of a side branch tube therethrough. The pleats are configured to overlap around the side branch tube to resist leakage.

[0019] According to another example ("Example 15") in addition to Example 14, the tube includes a radiopaque marker that indicates the fenestration location.

[0020] According to another example ("Example 16") in addition to Example 14, the stiffening element includes a stent element.

[0021] According to another example ("Example 17") in addition to Example 14, the stiffening element includes a tape.

[0022] According to one example ("Example 18"), an example of an implantable conduit is also disclosed herein that includes a tube of flexible material having a length, a first end, and a second end. The tube has a plurality of pleats formed along its length. The implantable conduit also includes a longitudinal element attached along its length to resist the pleats from unfolding when tension is applied along the length of the tube. The tube is configured to provide fenestrations in the pleats to provide lateral portals along the length of the tube to allow for the introduction of a side branch tube therethrough. The pleats are configured to overlap around the side branch tube to resist leakage.

[0023] According to another example ("Example 19") in addition to Example 18, the longitudinal element includes at least one spine.

[0024] According to another example ("Example 20") in addition to Examples 18 or 19, the longitudinal elements include at least one tape.

[0025] Examples of methods for making an implantable conduit are also disclosed herein. According to one example ("Example 21"), the method includes forming an implantable conduit by rolling a sheet of membrane. The implantable conduit includes a plurality of overlap elements arranged in rows, each overlap element overlapping an adjacent row of overlap elements. The method also includes attaching a plurality of attachment mechanisms to the plurality of overlap elements. The plurality of attachment mechanisms are disposed essentially perpendicular to the overlap elements to maintain the plurality of overlap elements oriented relative to one another, and the implantable conduit is configured to be fenestrated by selectively separating the overlap elements from one another midway to the attachment mechanisms to form apertures at one or more locations along the implantable conduit.

[0026] According to another example ("Example 22"), a method of manufacturing an implantable conduit includes forming apertures at one or more locations in an implantable conduit comprising a sheet of membrane, and folding the implantable conduit to form a plurality of pleats. The apertures are at one or more locations within the pleats, and attach a plurality of attachment mechanisms to the folded implantable conduit. The attachment mechanisms are disposed essentially perpendicular to the pleats and maintain the pleats against a surface of the implantable conduit to maintain the apertures closed, and the apertures at one or more locations within the pleats are configured to be opened in response to selectively unfolding the pleats at least partially from the surface of the implantable conduit intermediate to the attachment mechanisms.

[0027] The foregoing examples are merely illustrative and should not be construed as limiting or narrowing the scope of any inventive concepts otherwise provided by this disclosure. While several examples have been disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive in nature. [Brief description of the drawings]

[0028] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated in and constitute a part of this specification, illustrate embodiments and, together with the description, serve to explain the principles of the disclosure.

[0029] [Figure 1] FIG. 1 shows a side view of an example of an implantable conduit, according to some embodiments.

[0030] [Diagram 2] FIG. 2 shows a side view of an implantable conduit with a longitudinal attachment mechanism, according to some embodiments.

[0031] [Diagram 3] FIG. 3 shows an enlarged view of a portion of the exterior surface of an implantable conduit, according to some embodiments.

[0032] [Figure 4] FIG. 4 shows a side view of another implantable conduit, according to some embodiments.

[0033] [Diagram 5] FIG. 5 shows an exploded view of the implantable conduit of FIG. 4, according to some embodiments.

[0034] [Figure 6] FIG. 6 shows individual overlapping elements of an implantable conduit, according to some embodiments.

[0035] [Figure 7] FIG. 7 shows another individual overlap element of the implantable conduit of FIG. 5, according to some embodiments.

[0036] [Figure 8] FIG. 8 shows an example of a segment of material used to form an implantable conduit, according to some embodiments.

[0037] [Figure 9] FIG. 9 shows an example of the segment of material shown in FIG. 6 partially wrapped (using a manufacturing aid, such as a wrapping mandrel (not shown)) into a tubular shape, according to some embodiments.

[0038] [Figure 10] FIG. 10 is a side view of an implantable conduit including one or more stent elements, according to some embodiments.

[0039] [Figure 11] FIG. 11 is a side view of an implantable conduit having a tapered configuration, according to some embodiments.

[0040] [Figure 12] FIG. 12 shows a side view of another implantable conduit with a longitudinal attachment mechanism, according to some embodiments.

[0041] [Figure 13] FIG. 13 shows a side view of another implantable conduit with a stent element, according to some embodiments.

[0042] [Figure 14] FIG. 14 shows a side view of a segment of material (eg, a tubular segment of material) having multiple apertures for forming an implantable conduit, according to some embodiments.

[0043] [Figure 15] FIG. 15 shows a side view of an implantable conduit formed with a segment of the material of FIG. 14, according to some embodiments.

[0044] [Figure 16] FIG. 16 shows a longitudinal cross-sectional view of a portion of the implantable conduit of FIG. 15 with multiple apertures shown in a closed configuration, according to some embodiments.

[0045] [Figure 17] FIG. 17 shows a longitudinal cross-sectional view of a portion of the implantable conduit of FIG. 15 with multiple apertures shown in an open configuration, according to some embodiments.

[0046] [Figure 18] FIG. 18 shows a side view of a segment of material (eg, a tubular segment of material) having multiple apertures for forming an implantable conduit, according to some embodiments.

[0047] [Figure 19] FIG. 19 illustrates a longitudinal cross-sectional view of a portion of the tube of FIG. 18 with multiple pleats formed upon folding, according to some embodiments.

[0048] Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0049] Detailed Description Definitions and Terminology This disclosure is not intended to be read in a limiting sense, for example, the terms used in this application should be read broadly in the context of the meaning that would be ascribed to such terms by an expert in the field.

[0050] With respect to the term imprecision, the terms "about" and "approximately" may be used interchangeably to refer to measurements including the stated measurement and any measurement reasonably close to the stated measurement. A measurement reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount, as understood and readily ascertained by one of ordinary skill in the relevant art. Such deviations may be attributable, for example, to measurement error, fine-tuning made to optimize performance, and the like. In cases where it is determined that such reasonably small difference values ​​are not readily ascertainable by one of ordinary skill in the relevant art, the terms "about" and "approximately" and similar terms may be understood to mean + or -20% of the stated value.

[0051] Description of Various Embodiments 1 and 2 show an implantable conduit 100 (e.g., a graft, a stent graft, an anastomosis device, a prosthetic valve, or other implantable conduit) according to some embodiments. In various examples, the implantable conduit 100 is implantable within a patient's vascular system during a medical procedure (e.g., using a surgical or percutaneous approach). The implantable conduit 100 includes a cover or covering 102, which may also be described as a wall 102 or a body 102, formed by a plurality of layer elements 104, which may also be described as overlapping elements 104.

[0052] In some examples, the implantable conduit 100, and in particular the body 102, is formed from one or more layers of a biocompatible material, such as one or more layers of a biocompatible polymeric material. Some examples of suitable biocompatible materials include at least one of polyetheretherketone (PEEK), expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene (FEP), copolymers of tetrafluoroethylene (TFE) and perfluoromethylvinylether (PMVE) (also called TFE-PMVE copolymers), urethane, polyester, thermoplastics, thermosets, nylon, polyethylene, expanded polyethylene, ultra-high molecular weight polyethylene (UHMWPE), or various other biocompatible materials. In some examples, suitable materials can include composite membranes, such as expanded polytetrafluoroethylene (ePTFE)-based composite membranes or fibrillated polypropylene-based composite membranes, as well as any composite membrane based on one or more of the biocompatible materials listed above. In addition to membrane materials, the implantable conduit 100 can be made from a variety of fabrics woven, braided or knitted from various types of natural or synthetic fibers, including, but not limited to, PET fibers, polyester fibers, polyamide fibers, PTFE fibers, ePTFE fibers, and the like.

[0053] As shown, the overlap elements 104 are arranged in a row, whereby each overlap element 104 overlaps (e.g., defines an overlapping edge) and defines an overlapping portion 200 with a neighboring or adjacent overlap element 104. In various examples, the overlap elements 104 are arranged essentially axially or along a central longitudinal axis 108 of the implantable conduit 100. The implantable conduit 100 also has a plurality of attachment mechanisms 204 at desired intervals (e.g., at desired circumferential intervals) such that a plurality of overlap elements 104 are arranged along the length of the implantable conduit 100 and one or more (e.g., all of them) of the overlapping portions 200 extend circumferentially. For reference, "circumferential" need not be purely circumferential or extend in a transverse plane relative to the longitudinal axis, but also encompasses a helical orientation. Each attachment feature 204 corresponds to an area where adjacent ones of the overlap elements 104 are bonded, adhered, fastened, fastened, or otherwise coupled to one another. In various examples, the attachment features 204 are disposed along the overlapping portion 200 defined by the overlap elements 104.

[0054] There may be a consistent amount of overlap between the overlap elements 104, or the amount of overlap may vary along the length of the implantable conduit 100. In some instances, the overlap between the overlap elements 104 is any of the following values, or any range between any of the following values: 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% or more of the individual lengths of the overlap elements 104. Stated differently, in some instances, the overlapping portion 200 between adjacent overlap elements 104 may be 10%-20%, 20%-30%, 30%-40%, 40%-50%, 50%-60%, 60%-70%, 70%-80% of the width 202 of the overlap elements 104 (as measured in the longitudinal direction of the implantable conduit 100), or any other suitable value or range therebetween.

[0055] As shown, the implantable conduit 100 has a generally cylindrical or tubular shape having a lumen 110 and an outer surface 112 (e.g., the outer surface of the wall or body 102). The implantable conduit 100 may have a generally constant diameter along all or one or more portions of the length of the implantable conduit, or may have a diameter that varies along all or one or more portions of the length of the implantable conduit, as desired (e.g., one or more portions that are generally tapered or stepped in diameter). The outer shape of the implantable conduit 100 may be irregular (e.g., ridged or wavy) as a result of the overlapping arrangement of the overlapping elements 104. In this regard, the "outer diameter" of the implantable conduit is intended to refer to the average diameter defined by the overlapping elements 104, which in FIG. 1 is generally constant over the portion of the conduit 100 shown. The implantable conduit 100 has a first end 114 and a second end 116 that define a length therebetween.

[0056] Although the implantable conduit 100 is shown with overlap elements 104 along its illustrated length, one or more portions of the implantable conduit 100 may not include overlap elements (e.g., formed as a single, integral, unitary length of material). Additionally, although the overlap elements 104 are shown with a relatively constant size and shape, the overlap elements 104 may vary in size and shape, including the amount of overlap defined by adjacent overlap elements 104.

[0057] In some examples, one or more (e.g., all) of the overlap elements 104 are defined by a continuous, helical length of material that overlaps end-on on itself at a desired pitch. In such examples, each of the overlap elements 104 can be considered a single rotation, or turn, of the material that forms the overlap element 104. In other examples, one or more (e.g., all) of the overlap elements 104 include distinct, adjacent circumferential rings of material that are overlapped end-on, with each of the circumferential rings forming the overlap element 104.

[0058] In examples including overlap elements 104 formed by a continuous helical length of material, each overlap element 104 is continuously connected to an adjacent overlap element 104 since the implantable conduit 100 is made into a continuous length of the body 102. The width 202 of the overlapping portion 200 (the amount of overlap in the longitudinal direction of the implantable conduit 100) can be adjusted by varying the wrap angle Θ of the covering 102 relative to an axis 108 perpendicular to the implantable conduit 100 or transverse to the center of the implantable conduit 100.

[0059] As described above, the attachment mechanism 204 can connect each overlapping element 104. In some examples, the attachment mechanism 204 can be arranged and shaped to extend generally longitudinally rather than circumferentially (e.g., as multiple longitudinally arranged elements connecting the overlapping portions 200), or generally more vertically or circumferentially, or generally helically. The attachment mechanism 204 can be shaped or configured to resist unfolding or dislodging the overlapping portions 200 from one another. In some examples, the attachment mechanism 204 includes at least one adhesive region, filament, suture, tape, bonded region, soldered region, stitch, and / or any other mechanism suitable for connecting the overlapping portions 200 to one another. The attachment mechanism 204 can be arranged axially or longitudinally relative to the body 102 of the implantable conduit 100.

[0060] In some examples, the attachment mechanism 204 is attached to an outer surface of the implantable conduit 100, and in other examples, the attachment mechanism 204 is attached to an inner surface of the implantable conduit 100. In some examples, the attachment mechanism 204 may be an elongated strip, which may include an adhesive material to form an adhesive strip or tape, extending longitudinally along the length of the implantable conduit 100 to bond the first overlap element 104A to the second overlap element 104B. The attachment mechanism 204 helps to hold each of the overlap elements 104 at a predetermined displacement relative to adjacent overlap elements 104 and helps to maintain the orientation of the overlap elements 104 relative to one another. In some examples, the attachment mechanism 204 includes one or more stent elements instead of or in addition to other mechanisms such as adhesive strips or tapes. In some examples, the attachment mechanisms 204 are spaced equidistant from one another (e.g., along the circumference and / or length of the implantable conduit 100). In some instances, one or more attachment mechanisms 204 are positioned at varying distances relative to one another.

[0061] The attachment mechanism 204 can be formed from a variety of materials and in a variety of configurations. The attachment mechanism can be formed from a metal, polymer, or any other suitable biocompatible material that functions to maintain the overlap elements 104 in an assembled position. In some examples, the attachment mechanism 204 includes a polymer adhesive, such as a fluoropolymer, epoxy, polyurethane, acrylate, or the like. The attachment mechanism 204 can be formed from a flexible material (e.g., a compliant and / or elastic material), for example, to facilitate bending of the implantable conduit 100.

[0062] In some examples, the attachment mechanism 204 takes the form of a flexible adhesive strip or tape that includes one or more carrier layers and multiple adhesive layers or components. For example, the flexible adhesive strip can include a carrier layer of expanded polytetrafluoroethylene (ePTFE) and a coating of fluorinated ethylene propylene (FEP). In some examples, the adhesive material can be bonded using a heat treatment (e.g., as a thermoplastic or thermosetting material) or activated in other ways (e.g., UV cured). The attachment mechanism 204 can include bonded / adhesive portions and non-bonded / non-adhesive portions. In some examples, the adhesive material can be present only along certain portions of the attachment mechanism 204 to facilitate selective bonding and / or curing. In other examples, a selective bonding process (e.g., selective thermal bonding) is used to achieve selective bonding and / or curing.

[0063] The overlapping portion 200 and the attachment mechanism 204 of the implantable conduit 100 combine to define an aperture 206, also referred to as an opening, port or fenestration, on the implantable conduit 100. In some examples, the multiple overlap elements 104 define multiple adjacent pairs of overlap elements (e.g., overlap elements 104A and 104B) and multiple overlapping portions 200, each of which is separable at a corresponding one of the multiple overlapping portions 200 to open an aperture 206 that defines a pathway between the lumen 110 and the outer surface 112 of the implantable conduit 100.

[0064] In some examples, one of the overlapping portions 200 can define only one aperture 206 or multiple apertures 206, as desired. In the example shown in FIG. 2, each aperture 206 is defined by a first end 208A of a first overlap element 104A, a second end 208B of an adjacent second overlap element 104B, and one or more attachment features 204. In some examples, the total number and arrangement of apertures 206 depends on the number of attachment features 204 and the number of overlapping portions 200 in the implantable conduit 100. The apertures 206 are configured to be opened or fenestrated by selectively separating two adjacent overlap elements (e.g., the first overlap element 104A and the second overlap element 104B) from one another at a location between or intermediate the attachment features 204. In some instances, markers may be placed at or near the aperture 206 to mark potential fenestration locations for medical imaging.

[0065] In various examples, the implantable conduit 100 is configured such that the overlapping portion 200 has a closed configuration unless deformed or displaced to an open configuration. That is, under normal operating conditions, the overlapping portion 200 prevents fluids or objects from migrating from inside the implantable conduit 100 to outside the implantable conduit 100, and vice versa. In some examples, the implantable conduit 100 is used within a branched body conduit, such as a patient's vascular system, pancreas, liver, or biliary system. The implantable conduit 100 may also be configured to close the aperture 206 in the overlapping portion 200 to seal a pathway between the lumen 110 and the outer surface 112 of the implantable conduit 100 when an external force separating the overlapping elements 104 at the overlapping portion 200 is removed.

[0066] In general, the internal and external pressures on the implantable conduit 100 will vary depending on the location in which the implantable conduit 100 is placed. In various examples, the overlapping portion 200 is configured (e.g., sized, shaped and positioned) to remain sealed in response to a pressure differential across the wall or body 102 of the implantable conduit 100 such that the overlapping portion 200 of the implantable conduit 100 exhibits a closed configuration without the need for additional reinforcement, such as a stent ring or other reinforcement, to maintain the overlapping portion 200 in a closed or sealed configuration.

[0067] In some examples, one or more apertures are configured to be physically opened and fenestrated using a catheter, guidewire, or other fenestration tool (not shown). Regardless of the opening mode, in the absence of an external force, the apertures 206 are configured to self-seal or return to a previously closed or sealed state in use, thus preventing flow therethrough.

[0068] In some instances, in response to application of an external force to the implantable conduit 100, one or more apertures 206 may be opened or fenestrated. In such instances, the external force causes a displacement of the overlap element 104, resulting in wrinkles in the overlapping portion 200. In some instances, when the overlap element 104 is arranged in a helical configuration, the external force may be a rotational force applied in a direction (clockwise or counterclockwise) opposite to the direction of the helical configuration (opposite to the direction of wrapping) of the overlap element 104. Regardless of the opening mode, in various instances, in the absence of an external force, the apertures 206 "self-seal" or return to a previous closed or sealed state following removal of the opening force, thereby preventing the passage of fluids or objects.

[0069] In some examples, the implantable conduit 100 is manufactured by rolling a sheet of membrane to form the implantable conduit 100. The implantable conduit 100 includes a plurality of overlap elements 104 arranged in rows, with each overlap element 104 overlapping an adjacent row of overlap elements 104. A plurality of attachment mechanisms 204 are attached to the plurality of overlap elements 104. The plurality of attachment mechanisms 204 are disposed essentially perpendicular to the overlap elements 104 to maintain the orientation of the plurality of overlap elements 104 relative to one another. As shown, the implantable conduit 100 is configured to be fenestrated to form apertures 206 at one or more locations along the implantable conduit 100 by selectively separating the overlap elements 104 from one another intermediate the attachment mechanisms 204.

[0070] FIG. 3 illustrates a portion of an implantable conduit 300 with multiple overlap elements 302, according to some embodiments, including multiple attachment mechanisms 304 that secure the overlap elements 302. As shown, the attachment mechanisms 304 are circumferentially staggered relative to one another along the circumference of the implantable conduit 300. The attachment mechanisms 304 can couple pairs of overlap elements 302 that are not only circumferentially offset from one another, but also offset from adjacent overlap elements 302 or attachment mechanisms 304 that couple adjacent pairs of overlap elements 302. In this manner, the attachment mechanisms 304 of a pair of overlap elements 302 are not longitudinally aligned with the attachment mechanisms 304 of the next adjacent pair of overlap elements 302. For reference, as used herein, a "pair" of overlap elements is intended to refer to two overlap elements that are coupled to define an overlapping portion, such as overlapping portion 200 (FIG. 1). It should be understood that a single one of the overlap elements 302 may form multiple pairs. In particular, as shown, a single one of the overlap elements 302 forms a "pair" with two different overlap elements 302 (two longitudinally adjacent overlap elements), as shown, for example, in FIG.

[0071] In FIG. 3, for simplicity, the attachment mechanism 304 is shown as a shaded area, but may not be visible in reality. The shaded area may be understood to represent the relative position of the attachment mechanism 304 between the overlap elements 302. The attachment mechanism 304 may be, for example, a layer of adhesive or a thermally bonded area, or some other mechanism that bonds the overlap elements 302. For example, the layer of adhesive may be a coating of a polymeric material, such as fluorinated ethylene propylene (FEP) or other suitable bonding agent. Regardless, the attachment mechanism 304 is located between the overlap elements 302 and may not be visible in FIG. 3. The attachment mechanism 304 generally acts to hold the pair of overlap elements 302 together. As previously referenced, according to some embodiments, an external force is applied to the implantable conduit 300, such as a mechanical force that pushes one or more apertures 308 to open them, such as a mechanical force or an insertion force, such as a catheter or guidewire. In another example, an external force is applied by applying a twisting or twisting force to the implantable conduit 300, causing wrinkles 306 around the zone containing the attachment mechanism 304, resulting in the overlap elements 302 flexing around one or more apertures 308. As shown, the twisting force can result in such an external force causing the pair of overlap elements 302 to wrinkle inwardly and outwardly around the apertures 308, as shown in FIG.

[0072] Regardless of the opening or expansion mechanism used to open one or more apertures 308, in some instances a secondary device structure 310, which can be another implantable conduit (e.g., catheter, guidewire, graft, stent graft) or some other device, is passed or received through the aperture 308 (from outside the implantable conduit 300 to inside the implantable conduit 300 or vice versa, as needed). The secondary device structure 310 can form a branch, or additional flow lumen, extending from the lumen of the implantable conduit 300. For example, when used as a vascular implant, the main implantable conduit 300 can perfuse a main blood vessel, while the secondary device structure 310, which can be another implantable conduit, can perfuse a side vessel that is smaller than the main blood vessel.

[0073] Further, each of the overlap elements 302 has an inwardly facing surface 312 and an outwardly facing surface 314, whereby a pair of two adjacent or adjacent overlap elements 302 are arranged to define an overlapping portion (e.g., overlapping portion 200 of FIG. 2) between the inwardly facing surface 312 of the first overlap element and the outwardly facing surface 314 of the second overlap element. A plurality of attachment mechanisms 304 couple the first overlap element to the second overlap element. Also, the inwardly facing surface 312 of the first overlap element and the outwardly facing surface 314 of the second overlap element are separable at the overlapping portion by an external force to open one or more apertures 308 in the overlapping portion between at least two of the plurality of attachment mechanisms 304, such that the apertures 308 define a pathway between the lumen and the outer surface of the implantable conduit, which pathway is sealed in the absence of the external force.

[0074] 4 and 5 show another implantable conduit 400 configured with a plurality of overlap elements 402 that are separate and distinct tubular members, according to some embodiments, with a plurality of attachment mechanisms 404 connecting the overlap elements 402. As shown, the overlap elements 402 form pairs of overlap elements 402 that share an overlapping portion 406 that defines an aperture 408 that can open in response to an external force. The overlap elements 402, unlike the overlap elements 104 of FIGS. 1 and 2, are separate tubular elements (e.g., not formed continuously), which are aligned along the longitudinal axis 106 to form the implantable conduit 400. There may be any number of attachment mechanisms 404 connecting the overlap elements 402, and they may be configured and arranged in a variety of ways, including any of the ways associated with the attachment mechanisms 204 and 304 described above.

[0075] Figures 6 and 7 show examples of separate and distinct overlap elements 402 that can be used to form an implantable conduit 400, according to some embodiments. Figure 6 shows the attachment mechanism 404 disposed at a first end 604 of the outer surface 600 of one of the overlap elements 402, while Figure 7 shows the attachment mechanism 404 disposed on the inner surface 602 of one of the overlap elements 402, at a second end 606 opposite the first end 604.

[0076] 8 illustrates another example in which the wall or body 102 of the implantable conduit 100 is formed from elements that are spirally wound to form multiple overlapping elements 104, as in the example of FIG. 1 or 2. As shown, multiple attachment features 800 are positioned along the edge of the covering 102 at desired intervals (e.g., equidistant intervals) such that when the covering 102 is wound to form a spiral structure as shown in FIG. 9, the attachment features 800 have a staggered configuration along the longitudinal axis 106 of the implantable conduit 100. The attachment features 800 can be formed in a variety of ways, including, for example, pre-formed on the wall or body 102 (e.g., as an adhesive layer) or formed along the wall or body 102 subsequent to spiral formation (e.g., via thermal bonding).

[0077] FIG. 10 illustrates an implantable conduit 100 with a plurality of stent elements 1000, also described as support members 1000, coupled to a plurality of overlapping elements 104. The stent elements 1000 can be made of a biocompatible metallic or polymeric material, such as stainless steel or Nitinol, among others, as desired. The support members 1000 can have a variety of shapes as desired, such as a wave pattern or a serpentine shape as shown in FIG. 10. In some examples, the plurality of stent elements 1000 have a serpentine or wave arrangement and are formed using a single elongate member (e.g., wire) that is spirally wound around the implantable conduit 100 and attached to the wall 102 or body 102. In such examples, each of the stent elements 1000 can be defined by a single revolution of the elongate member. In some examples, one or more of the stent elements 1000 are formed from separate loops of wire (e.g., as ring-shaped elements). The stent element 1000 can be attached to the exterior or interior surface of the covering 102 (eg, using adhesive, tape, fastening elements such as sutures, or combinations thereof).

[0078] 11-13 show additional implantable conduit variations. As shown in FIG. 11, the implantable conduit 1100 can have a tapered or tapered configuration and includes a narrow or small diameter portion 1102 and a wide or large diameter portion 1104 having a larger diameter than the wide or small diameter portion 1102. The difference in diameter can be a smooth transition, a gradual transition, and a single taper or multiple tapers, as desired. In some instances, the tapered diameter can be achieved by varying the wrap angle of the body or wall 102 in forming the implantable conduit 1100. For example, the narrow portion 1102 can have a first wrap angle Θ1 that is greater than a second wrap angle Θ2 of the wide portion 1104, where each wrap angle is measured relative to an axis 108 perpendicular to the longitudinal axis 106.

[0079] In some instances, the first wrap angle Θ1 may be greater than the second wrap angle Θ2 by about 10 degrees to about 20 degrees, about 20 degrees to about 30 degrees, about 30 degrees to about 40 degrees, or any range therebetween. FIG. 12 illustrates another variation of attachment mechanisms 1200 including multiple attachment mechanisms 1200 extending longitudinally along the implantable conduit 1100 at various circumferential locations around the implantable conduit 1100. The attachment mechanisms 1200 can extend along the inner surface, outer surface, or within a layer of the implantable conduit 1100, as desired. The attachment mechanisms 1200 can be curved to fit the contours of the implantable conduit 1100. FIG. 13 illustrates another variation in which multiple stent elements 1300 are attached to the implantable conduit 1100. The attachment mechanism 1200 and stent element 1300 may have any of the configurations described in connection with any of the previous examples of the implantable conduits 100 , 300 and 400 .

[0080] 14-17 show additional implantable conduit variations. As shown in FIG. 14, according to some embodiments, a tube 1401 of flexible material can be used to form the implantable conduit 1400. As shown, the tube 1401 of flexible material (such as those materials described above for the body or wall 102) can be fenestrated with a plurality of apertures 1402, also referred to as openings or fenestrations, at desired intervals along the length of the implantable conduit 1401. Each of the apertures 1402 is aligned longitudinally with some of the other apertures 1402 and is also aligned axially with some of the other apertures 1402. The implantable conduit 1400 can have any number of apertures 1402 in any number of desired configurations. One or more apertures 1402 can be essentially aligned circumferentially and / or axially along the implantable conduit 1400, as desired.

[0081] The tube 1401 can be folded (e.g., along the transverse dashed lines shown) to define a plurality of overlapping elements 1500 in the form of a plurality of pleats (thus the overlapping elements 1500 may also be referred to as pleats when folded as shown), which at least partially overlap along the length of the implantable conduit 1400 between the first end 114 and the second end 116, as shown in Figure 15. In some instances, the tube 1401 is fenestrated within the pleats to provide lateral portals along the length of the tube 1401, which lateral portals are apertures 1402. Such fenestrations or apertures 1402 allow for the introduction of a side branch tube (e.g., secondary device structure 310 of Figure 3) therethrough. The plurality of overlap elements 1500 are defined by a tubular body having a pleated configuration that defines a plurality of pleats, and the plurality of attachment mechanisms 204 join the overlap elements 1500 in the pleated configuration. The pleats are circumferentially oriented in some examples with the aperture 1402 formed in one of the pleats, although it should be understood that longitudinally oriented pleats could be used as well. As shown, the attachment mechanism 204, or any of the attachment mechanisms described above, are utilized to join the overlap elements 1500 in an overlapping configuration.

[0082] In some examples, the attachment mechanism 204 is a longitudinal or stiffening element, for example, including one or more of at least one spine, tape, and / or stent element, which may reinforce the pleats to resist unfolding upon application of tension along the length of the tube 1401. In other examples, the overlap element is processed (e.g., through heat setting or other processes) to maintain the overlap configuration. As shown in FIG. 16, the overlap element 1500 is in a closed configuration forming the pleats, and an aperture 1402 is formed in the pleat and is closed to prevent passage of fluids or objects between the interior and exterior of the implantable conduit 1400.

[0083] As shown in Figure 17, when an external force is applied as previously disclosed (e.g., by being physically opened and fenestrated using a catheter, guidewire or other fenestration tool), the implantable conduit 1400 can distort and the overlap element 1500 can partially unpleat, thereby allowing the aperture 1402 to assume an open or non-sealing configuration. In the open or non-sealing configuration, solids or fluids can pass through the aperture 1402, as shown by the arrow 1700 in Figure 17.

[0084] In view of the above, the implantable conduit 1400 may be configured to be fenestrated through apertures 1402 in the overlap element 1500 when the overlap element 1500 is partially unpleated. In some instances, the fenestrations or apertures 1402 may be manipulated to an open configuration to provide a lateral portal along the length of the implantable conduit 1400 to allow a secondary device, such as a side branch tube, to pass through the lateral portal. In some instances, the overlap element 1500 or pleats may be configured to overlap around a secondary device (not shown), which may be a side branch tube, to resist leakage.

[0085] In some instances, the attachment mechanism 204, or other configurations described above, may act to allow distortion of the overlap element 1500 to open the apertures 1402 while providing sufficient resistance to such deformation to return to a closed configuration and seal around a secondary device passing through one or more apertures 1402. In some instances, the location of the apertures 1402, or points of fenestration, are indicated by one or more radiopaque markers disposed at or near the location on the tube 1401. Attachment mechanisms and / or support elements as described above may be incorporated to reinforce the overlap element 1500 to help resist undesired deployment (e.g., upon application of tension along the length of the implantable conduit 1400).

[0086] It should be understood that while the attachment mechanism 204 is shown attached to an outer surface of the implantable conduit 1400, in other examples the attachment mechanism 204 may be attached to an inner surface of the implantable conduit 1400. Additionally, instead of the attachment mechanism 204 extending along the length of the implantable conduit 1400, in some examples multiple shorter attachment mechanisms can be used, if desired, and these shorter attachment mechanisms can be arranged in a staggered configuration, for example as previously shown in FIG.

[0087] In some examples, the implantable conduit 1400 is manufactured by forming apertures 1402 at one or more locations in the implantable conduit 1400 comprising a sheet of membrane. The implantable conduit 1400 is folded to form a plurality of overlapping elements or pleats 1500. The apertures 1402 are at one or more locations within the pleats 1500. A plurality of attachment mechanisms 204 are attached to the folded implantable conduit 1400. The attachment mechanisms 204 are disposed essentially perpendicular to the pleats 1500 and maintain the pleats 1500 against a surface of the implantable conduit 1400 and keep the apertures 1402 closed. The apertures 1402 at one or more locations within the pleats 1500 are configured to be opened in response to selectively and at least partially unpleating the pleats 1500 from a surface of the implantable conduit 1400 intermediate the attachment mechanisms 204.

[0088] 18 and 19 illustrate additional implantable conduit features that may be implemented in addition to or as an alternative to any of the exemplary designs described above. As shown in FIG. 18, according to some embodiments, a tube 1800 of flexible material may have alternating sections of bent portions 1804 and stiffer portions 1806. The bent portions 1804 are relatively more flexible (e.g., easier to bend, move, or otherwise deform) than the stiffer portions 1806. The stiffer portions 1806 may be formed by any suitable means, such as by applying an additional layer of material, such as a non-compliant polymeric material, a plastic material, or an adhesive material that hardens when dried, to name a few. In some examples, the stiffer portions 1806 may be stiffened by altering the physical or chemical properties of the bent portions 1804, such as by curing, sintering, or tempering the bent portions 1804, among other methods. Thus, in these examples, the bent portions 1804 and the stiffer portions 1806 are made from the same material. Additionally, the stiffer portion 1806 may have one or more apertures 1802 (also called openings or fenestrations) for fluid flow at desired intervals along the length of the implantable conduit 1800 .

[0089] The tube 1800 can be folded to form a plurality of pleats 1900 by at least partially overlapping the stiffer portions 1806 over the bent portions 1804. FIG. 19 shows the tube 1800 folded such that each crease 1902 is located between the stiffer portions 1806 and the bent portions 1804, such that when the tube 1800 is fully folded, the stiffer portions 1806 are at least partially hidden under the adjacent bent portions 1804. In these embodiments, the stiffer portions 1806 have sufficient stiffness to resist longitudinal compression and / or do not compress longitudinally, thereby maintaining the pleated configuration of the folded tube 1800. In some instances, the pleated configuration is maintained without the use of an attachment mechanism (e.g., 204 shown in FIG. 15) to prevent the folded tube 1800 from unfolding.

[0090] The inventive concepts of this application have been described above generally and with reference to specific embodiments. It will be apparent to one skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of the present disclosure. Thus, it is intended that the embodiments cover the modifications and variations of the present invention provided they come within the scope of the appended claims and their equivalents. The present disclosure further includes the following aspects: Aspect 1 An implantable conduit having a tubular shape and an inner lumen and an outer surface, The implantable conduit comprises: a plurality of overlap elements including a first overlap element and a second overlap element disposed adjacent to the first overlap element, defining adjacent pairs of a plurality of overlap elements, where the first overlap element overlies the second overlap element and defines an overlapping portion between an inwardly facing surface of the first overlap element and an outwardly facing surface of the second overlap element; and a plurality of attachment mechanisms connecting the first overlap element to the second overlap element, wherein an inwardly facing surface of the first overlap element and an outwardly facing surface of the second overlap element are separable at the overlapping portion by an external force to open an aperture at the overlapping portion between at least two of the plurality of attachment mechanisms, such that the aperture defines a pathway between an inner lumen and an outer surface of the implantable conduit, the pathway being sealed in the absence of the external force; An implantable conduit comprising: Aspect 2 2. The implantable conduit of embodiment 1, wherein the plurality of overlapping elements are disposed along a length of the implantable conduit, and the overlapping portions extend circumferentially. Aspect 3 The implantable conduit of any one of the preceding aspects, wherein the plurality of overlap elements define a plurality of adjacent pairs of overlap elements and a plurality of overlapping portions, each of the adjacent pairs of overlap elements being separable at a corresponding one of the plurality of overlapping portions to open an aperture defining a pathway between the lumen and the outer surface of the implantable conduit. Aspect 4 An implantable conduit as described in any one of the preceding aspects, wherein the plurality of attachment mechanisms are elongated strips of material extending longitudinally along the length of the implantable conduit and connecting the first overlap element to the second overlap element. Aspect 5 The implantable conduit of any one of the preceding aspects, wherein the implantable conduit is configured to close an aperture at the overlapping portion and seal a pathway between the lumen and the outer surface of the implantable conduit when an external force separating the overlapping elements at the overlapping portion is removed. Aspect 6 23. The implantable conduit of any one of the preceding aspects, wherein the attachment mechanism comprises an adhesive material. Aspect 7 Aspect 11. The implantable conduit of any one of the preceding aspects, wherein the attachment features are circumferentially staggered relative to one another around a circumference of the implantable conduit. Aspect 8 The implantable conduit of any one of the preceding aspects, further comprising a secondary device structure received through the aperture. Aspect 9: 13. The implantable conduit of any one of the preceding aspects, wherein the implantable conduit defines a varying diameter. Aspect 10 23. The implantable conduit of any one of the preceding aspects, further comprising a plurality of stent elements coupled to the plurality of overlapping elements. Aspect 11 11. The implantable conduit of any one of aspects 1-10, wherein the plurality of overlapping elements are defined by a continuous helical length of material overlapped edgewise upon itself, or the plurality of overlapping elements are defined by separate adjacent circumferential rings of material overlapped edgewise. Aspect 12 11. The implantable conduit of any one of aspects 1-10, wherein the plurality of overlap elements are defined by a tubular body having a pleated configuration defining a plurality of pleats, and the plurality of attachment mechanisms join the overlap elements in the pleated configuration. Aspect 13 13. The implantable conduit of embodiment 12, wherein the pleats are circumferentially oriented, and optionally, one of the pleats has an aperture formed therein. Aspect 14 a tube of flexible material having a length, a first end and a second end, said tube having a plurality of pleats formed along its length; stiffening elements that reinforce the pleats to resist unfolding when tension is applied along the length of the tube; 1. An implantable conduit comprising: the tube is configured with fenestrations in the pleats to provide lateral portals along a length of the tube to permit introduction of a side branch tube therethrough; The pleats are configured to overlap around the side branch tube to resist leakage. Aspect 15 15. The implantable conduit of embodiment 14, wherein said tube comprises a radiopaque marker indicating the location of the fenestration. Aspect 16 The implantable conduit of embodiment 14, wherein the stiffening element comprises a stent element. Aspect 17 The implantable conduit of embodiment 14, wherein the stiffening element comprises a tape. Aspect 18 a tube of flexible material having a length, a first end and a second end, said tube having a plurality of pleats formed along its length; a longitudinal element attached along the length of the tube to resist deployment of the pleats when tension is applied along the length of the tube; 1. An implantable conduit comprising: the tube is configured with fenestrations in the pleats to provide lateral portals along a length of the tube to permit introduction of a side branch tube therethrough; The pleats are configured to overlap around the side branch tube to resist leakage. Aspect 19 The implantable conduit of embodiment 18, wherein the longitudinal element comprises at least one spine. Aspect 20 20. The implantable conduit of embodiment 18 or 19, wherein the longitudinal element comprises at least one tape.

Claims

1. An implantable conduit having a tubular shape and an inner lumen and an outer surface, The implantable conduit comprises: a plurality of overlap elements including a first overlap element and a second overlap element disposed adjacent to the first overlap element, defining adjacent pairs of a plurality of overlap elements, where the first overlap element overlies the second overlap element and defines an overlapping portion between an inwardly facing surface of the first overlap element and an outwardly facing surface of the second overlap element; and a plurality of attachment mechanisms including an elongated strip of material extending longitudinally along a length of the implantable conduit connecting the first overlap element to the second overlap element, whereby an inwardly facing surface of the first overlap element and an outwardly facing surface of the second overlap element are separable at the overlapping portion by an external force to open one or more apertures at the overlapping portion between at least two of the plurality of attachment mechanisms, such that the one or more apertures define a pathway between an inner lumen and an outer surface of the implantable conduit which pathway is sealed in the absence of an external force; An implantable conduit comprising:

2. The implantable conduit of claim 1 , wherein said plurality of overlapping elements are disposed along a length of said implantable conduit, said overlapping portions extending circumferentially.

3. An implantable conduit as described in any one of the preceding claims, wherein the plurality of overlap elements define a plurality of adjacent pairs of overlap elements and a plurality of overlapping portions, each of the adjacent pairs of overlap elements being separable at a corresponding one of the plurality of overlapping portions to open the one or more apertures defining a pathway between the inner lumen and the outer surface of the implantable conduit.

4. The implantable conduit of any one of the preceding claims, wherein the implantable conduit is configured to close the one or more apertures at the overlapping portion and seal a pathway between the inner lumen and the outer surface of the implantable conduit when an external force separating the overlapping elements at the overlapping portion is removed.

5. 2. An implantable conduit according to any one of the preceding claims, wherein the attachment mechanism comprises an adhesive material.

6. 10. An implantable conduit according to any one of the preceding claims, wherein the attachment features are circumferentially staggered relative to one another around the circumference of the implantable conduit.

7. 10. An implantable conduit according to any one of the preceding claims, further comprising a secondary device structure received through said one or more apertures.

8. 10. An implantable conduit according to any one of the preceding claims, wherein the implantable conduit defines a varying diameter.

9. 2. An implantable conduit according to any one of the preceding claims, further comprising a plurality of stent elements coupled to said plurality of overlapping elements.

10. An implantable conduit as described in any one of claims 1 to 9, wherein the plurality of overlapping elements are defined by a continuous helical length of material overlapped edgewise on itself, or the plurality of overlapping elements are defined by separate adjacent circumferential rings of material overlapped edgewise.

11. The implantable conduit of any one of claims 1 to 9, wherein the plurality of overlapping elements are defined by a tubular body having a pleated configuration defining a plurality of pleats, and the plurality of attachment mechanisms join the overlapping elements in the pleated configuration.

12. 12. The implantable conduit of claim 11, wherein said pleats are circumferentially oriented, optionally with said one or more apertures formed in one of the pleats.

13. a tube of flexible material having a length, a first end and a second end, said tube having a plurality of pleats formed along its length; a plurality of stiffening elements extending longitudinally along the length of the implantable conduit and reinforcing the pleats to resist unfolding when tension is applied along the length of the tube; 1. An implantable conduit comprising: the tube is configured with fenestrations in the pleats to provide lateral portals along a length of the tube to permit introduction of a side branch tube therethrough; The pleats are configured to overlap around the side branch tube to resist leakage.

14. 14. The implantable conduit of claim 13, wherein the tube includes a radiopaque marker indicating the location of the fenestration.

15. The implantable conduit of claim 13 , wherein at least one said stiffening element comprises a stent element.

16. The implantable conduit of claim 13 , wherein at least one of the stiffening elements comprises a tape.

17. a tube of flexible material having a length, a first end and a second end, said tube having a plurality of pleats formed along its length; a plurality of longitudinal elements extending longitudinally along a length of the implantable conduit and attached along the length of the tube to resist deployment of the pleats when tension is applied along the length of the tube; 1. An implantable conduit comprising: the tube is configured with fenestrations in the pleats to provide lateral portals along a length of the tube to permit introduction of a side branch tube therethrough; The pleats are configured to overlap around the side branch tube to resist leakage.

18. The implantable conduit of claim 17 , wherein the longitudinal element comprises at least one spine.

19. 19. An implantable conduit according to claim 17 or 18, wherein said longitudinal element comprises at least one tape.

Images