Implantable devices for bifurcated lumens and related systems and methods

Abstract

To provide a good implantable device or the like.SOLUTION: An implantable device comprising: a tubular member; and a stent member supporting the tubular member. The tubular member includes a first end and a second end and defines a primary lumen having a first opening at the first end of the tubular member and a second opening at the second end of the tubular member. The tubular member includes a column disposed within the main lumen to form a secondary lumen, the tubular member defining a plurality of apertures opening into the secondary lumen at a longitudinal position between the first and second ends of the tubular member, the column having a column opening.SELECTED DRAWING: Figure 2A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Provisional Application No. 63 / 176,031, filed April 16, 2021, which is incorporated herein by reference in its entirety for all purposes. [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 conduits carry fluid to the major body conduit (e.g., a venous conduit), and in other cases, the secondary body conduits carry fluid from the major body conduit (e.g., an arterial conduit).

[0003] The human vasculature contains many examples of major body vessels with secondary branches. One example of a major body vessel is the aorta. In the abdominal aorta, multiple arteries branch off from the aorta.

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

[0005] Abstract Examples of implantable devices are disclosed herein.

[0006] According to one example ("Example 1"), an implantable device includes a tubular member having a first end and a second end, wherein the tubular member forms a main lumen having a first opening at the first end of the tubular member and a second opening at the second end of the tubular member, the tubular member including a column disposed within the main lumen to form a secondary lumen, the tubular member defining a plurality of apertures opening into the secondary lumen at longitudinal positions between the first and second ends of the tubular member, the column having column openings; and a stent member supporting the tubular member.

[0007] According to another example ("Example 2"), further to Example 1, the tubular member includes a first graft member defining the main lumen and a second graft member coupled to the first graft member, the second graft member forming the column and defining a secondary lumen between the first graft member and the second graft member.

[0008] According to another example ("Example 3"), further to Example 2, the secondary lumen opens into the main lumen at a proximal opening of the secondary lumen.

[0009] According to another example ("Example 4"), in addition to any of the preceding examples, the secondary lumen is collapsible.

[0010] According to another example ("Example 5"), in addition to any of the preceding examples, the secondary lumen is not supported by a stent.

[0011] According to another example ("Example 6"), in addition to any of the preceding examples, the stent member includes a plurality of stent rings spaced longitudinally along the tubular member.

[0012] According to another example ("Example 7"), in addition to example 6, each of the plurality of apertures is separated from each other by at least one of the plurality of stent rings.

[0013] According to another example ("Example 8"), further to any of the preceding examples, each aperture of the plurality of apertures includes a circular shape or a shape defining a rounded portion and a substantially flat portion.

[0014] According to another example ("Example 9"), in addition to any of the preceding examples, the tubular member includes a plurality of secondary lumens extending longitudinally along at least a portion of the tubular member and circumferentially spaced apart from one another.

[0015] According to another example ("Example 10"), in addition to any of the preceding examples, the implantable device further includes a restraining member receiver positioned to surround at least a portion of the stent member.

[0016] According to another example ("Example 11"), in addition to any of the preceding examples, the tubular member includes a scallop at the first end.

[0017] According to another example ("Example 12"), in addition to any of the preceding examples, the secondary lumen extends along a secondary lumen axis that extends longitudinally at an angle greater than zero relative to the axis of the main lumen.

[0018] According to another example ("Example 13"), an implantable device includes a tubular member having a first end and a second end, wherein the tubular member forms a main lumen with a first opening at the first end of the tubular member and a second opening at the second end of the tubular member, the tubular member including a plurality of columns each defining a secondary lumen, each column of the plurality of columns being circumferentially spaced from one another, each secondary lumen having an aperture defined through the tubular member at a location between the first end and the second end and a column opening proximate the second end of the tubular member, each column operable to collapse under fluid pressure; and a stent member supporting the tubular member.

[0019] According to another example ("Example 14"), a delivery system includes an implantable device including a body and a side branch, wherein the body includes a tubular member and a stent member supporting the tubular member, the tubular member forming a main lumen having a first opening and a second opening, the tubular member having an aperture defined therethrough and forming a secondary lumen having a proximal opening proximal to the second opening of the tubular member; and an elongate member having a first end and a second end, wherein the body of the implantable device is disposed at the first end of the elongate member and the elongate member is positioned along the longitudinal axis of the elongate member. the catheter olive defining a delivery lumen extending along at least a portion of its longitudinal length and operable to allow a side branch to be delivered therethrough; a catheter olive, wherein the body of the implantable device is disposed at a first end of the elongate member such that the body is longitudinally disposed between a forward tip of the catheter olive and the second end of the elongate member; a restraining member disposed around the body and restraining the body in a delivery configuration; and a secondary restraining member disposed around a stent of the body, wherein the secondary restraining member is operable to restrain the body in a partially restrained configuration.

[0020] According to another example ("Example 15"), in addition to Example 14, the delivery system further includes a guide member extending from the delivery lumen of the elongate member, through the proximal opening, through an aperture, through a secondary lumen of the tubular member, and coupled to the catheter olive.

[0021] According to another example ("Example 16"), in addition to example 15, the delivery system further includes an exchange catheter coupled to the guide member and operable to advance along the guide member.

[0022] According to another example ("Example 17"), in addition to Example 16, the delivery system further includes: a first guidewire operable to be delivered through the exchange catheter; a curved catheter operable to be advanced over the first guidewire; and a second guidewire stiffer than the first guidewire, wherein the second guidewire is operable to be advanced through the curved catheter and a side branch is operable to be advanced along the second guidewire to a target site.

[0023] According to another example ("Example 18"), a delivery system includes an implantable device including a body and a side branch, wherein the body includes a tubular member and a stent member supporting the tubular member, the tubular member forming a main lumen having a first opening and a second opening, the tubular member defining a secondary lumen, the tubular member including a column having an aperture defined therethrough and having a column opening proximal to the second opening of the tubular member; and an elongate member having a first end and a second end, wherein the body of the implantable device supports the first opening of the elongate member. the elongate member defining an operable lumen through which a side branch can be delivered; a catheter olive, disposed at the first end of the elongate member such that the body of the implantable device is longitudinally disposed between a forward tip of the catheter olive and the second end of the elongate member; a restraining member disposed around the body and restraining the body in a delivery configuration; and a guide member extending from the lumen of the elongate member, from the proximal opening, through the aperture, and through the secondary lumen of the tubular member and coupled to the catheter olive.

[0024] According to another example ("Example 19"), the delivery system further includes a secondary restraint member disposed about the stent of the main body, the secondary restraint member operable to restrain the main body in a partially restrained configuration.

[0025] According to another example ("Example 20"), in addition to Example 19, the stent member of the main body includes a plurality of stent rings, the secondary restraint member includes a plurality of wires, and one wire of the plurality of wires corresponds to a corresponding stent ring of the plurality of stent rings.

[0026] According to another example ("Example 21"), a method of delivering an implantable device to a target site including a main vessel and a side vessel includes advancing a body of the implantable device to the main vessel of the target site, wherein the body is constrained by a constraining member around an elongate member proximate a first end of the elongate member, the body including a tubular member having a first end and a second end, the tubular member defining a main lumen having a first opening at the first end of the tubular member and a second opening at the second end of the tubular member, and the tubular member has a plurality of columns each defining a secondary lumen extending along at least a portion of the longitudinal length of the tubular member, the tubular member having a plurality of apertures each defined through the tubular member at a location between the first end and the second end of the tubular member, each secondary lumen having a column opening proximal to the second end of the tubular member, the tubular member including a scallop at the first end of the tubular member, the body including a stent member supporting the tubular member and operable to be configured in a delivery configuration and a deployed configuration; positioning the exchange catheter adjacent to the vessel; releasing the body from the restraining member so that the body is operable to expand from a delivery configuration to an expanded configuration; advancing an exchange catheter toward the side branch vessel, wherein the exchange catheter is advanced along a guide member extending from the elongate member from a proximal opening through one of a plurality of secondary lumens of the tubular member, through an aperture at a first end of a plurality of apertures, and is releasably coupled to a catheter olive at the first end of the elongate member; introducing a first guidewire through the exchange catheter so that it extends beyond an aperture at the first end of the exchange catheter; retracting the exchange catheter from around the first guidewire; selecting a target aperture among a plurality of apertures through which a side branch is to be delivered, wherein the first guidewire is retracted after being positioned at or through the target aperture; exchanging the first guidewire for a second, stiffer guidewire; advancing the side branch over the second guidewire to the side branch vessel;and deploying the side branch at the side branch vessel;

[0027] The foregoing examples are merely examples and should not be construed as limiting or otherwise narrowing the scope of the inventive concepts provided by the present disclosure. While multiple examples are 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. [Brief explanation 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 implantable device having a body and multiple side branches extending through the body, according to some embodiments.

[0030] [Figure 2A] FIG. 2A shows a perspective view of a body of an implantable device including a portal and multiple apertures, according to some embodiments.

[0031] [Figure 2B] FIG. 2B shows an end view of the body of FIG. 2A showing the portal opening located at the second end of the body, according to some embodiments.

[0032] [Figure 2C] FIG. 2C shows a perspective view of a body having an aperture with a curved portion and a substantially straight portion, according to some embodiments.

[0033] [Figure 3]FIG. 3 shows a side view of a delivery system for an implantable device, according to some embodiments, including an elongate member, a catheter olive, a guide member, a restraining member, and a delivery handle, wherein the implantable device is positioned around the elongate member.

[0034] [Figure 4A] FIG. 4A shows a perspective view of an implantable device including a restraining member operable to controllably restrain the implantable device, according to some embodiments. [Figure 4B] FIG. 4B shows a perspective view of an implantable device including a restraining member operable to controllably restrain the implantable device, according to some embodiments.

[0035] [Figure 5A] FIG. 5A shows a side view of a guide member extending to a catheter olive, according to some embodiments. [Figure 5B] FIG. 5B shows a side view of the guide member extending to the catheter olive, according to some embodiments. [Figure 5C] FIG. 5C shows a side view of the guide member extending to the catheter olive, according to some embodiments.

[0036] [Figure 6] FIG. 6 shows a perspective view of an exemplary guide member extending through an implantable device, according to some embodiments.

[0037] [Figure 7] FIG. 7 shows a cross-sectional view of an exchange catheter according to some embodiments.

[0038] [Figure 8] FIG. 8 shows a side view of the exchange catheter of FIG. 7 extending from the elongate member within the portal of the implantable device, according to some embodiments.

[0039] [Figure 9] FIG. 9 shows a side view of a delivery handle for an implantable device, according to some embodiments.

[0040] [Figure 10] FIG. 10 shows an end view of an elongate member including multiple delivery lumens, according to some embodiments.

[0041] [Figure 11A] FIG. 11A shows a side view of an implantable device having a main body positioned in the abdominal aortic artery, multiple side branches positioned in the renal arteries, and multiple limbs positioned in the iliac arteries, according to some embodiments. [Figure 11B] FIG. 11B shows a side view of an implantable device having a main body positioned in the abdominal aortic artery, multiple side branches positioned in the renal arteries, and multiple limbs positioned in the iliac arteries, according to some embodiments. [Figure 11C] FIG. 11C shows a side view of an implantable device having a main body positioned in the abdominal aortic artery, multiple side branches positioned in the renal arteries, and multiple limbs positioned in the iliac arteries, according to some embodiments.

[0042] [Figure 12] FIG. 12 is a perspective view of an implantable device showing a side branch extending through a portion of the body, according to some embodiments.

[0043] [Figure 13] FIG. 13 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 14] FIG. 14 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 15]FIG. 15 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 16] FIG. 16 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 17] FIG. 17 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 18] FIG. 18 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 19] FIG. 19 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 20] FIG. 20 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 21] FIG. 21 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 22] FIG. 22 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 23] FIG. 23 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 24] FIG. 24 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 25]FIG. 25 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 26] FIG. 26 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments. [Figure 27] FIG. 27 illustrates a delivery method for delivering an implantable device to a target vessel and a side branch to a side branch vessel, according to some embodiments.

[0044] 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 apparatus 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 INVENTION

[0045] Detailed Description Definitions and Terminology This disclosure is not intended to be read in a restrictive manner, for example, the terms used in this application should be read broadly in the context of the meanings ascribed to such terms by experts in the field.

[0046] With respect to imprecision, the terms "about" and "approximately" may be used interchangeably to refer to a stated measurement, including any measurement that is reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount, as would be understood and readily ascertained by one of ordinary skill in the relevant art. For example, such deviations may be due to measurement error or minor adjustments made to optimize performance. If it is determined that such a reasonably small difference would not be readily ascertainable by one of ordinary skill in the relevant art, then the terms "about" and "approximately," and similar terms, may be understood to mean plus or minus 10% of the stated value.

[0047] Description of Various Embodiments Various aspects of the present disclosure are directed to devices, systems, and methods, including implantable devices. The implantable devices can be placed within a patient to support one or more fluid passageways. The implantable devices can be placed in a main portion of a fluid passageway (e.g., an artery, a vein, a CSF passageway, etc.) and can include side branches extending into side branch passageways within the patient. In certain examples, the implantable devices can be grafts or stent-grafts placed within the vascular system. The devices, systems, and methods can be used to improve or support circulatory function, particularly the function of side branches (e.g., those leading to vital organs such as the kidneys). In one example, a patient may be suffering from an abdominal aortic aneurysm ("AAA"). The AAA may develop near the renal arteries and / or extend into the renal arteries. The implantable devices can be used to help prevent the aneurysm from expanding and rupturing while maintaining perfusion of the main artery and one or more side branch arteries, such as the renal arteries.

[0048] 1 shows a side view of one example of an implantable device 10 having a main body 12 and multiple side branches 14 extending through the main body 12. The implantable device 10 also includes side branches 14 extending from the main body 12. The side branches 14 are separate from the main body (i.e., the side branches 14 are not integrated with the main body 12). Because the side branches 14 are separate structures from the main body 12, the side branches 14 are coupled to the main body 12 to form the implantable device. For example, the main body 12 can be deployed in the abdominal aorta, and the side branches 14 can be deployed in the renal arteries and extend into the main body 12 located in the abdominal aorta.

[0049] As shown in FIG. 2A , in some embodiments, the body 12 of the implantable device 10 includes a tubular member 20 and a stent member 40. As shown, the tubular member 20 has a first end 22 and a second end 24. The tubular member 20 forms a main lumen 26 having a first opening 23 at the first end 22 of the tubular member 20 and a second opening 25 at the second end 24 of the tubular member 20. The tubular member 20 includes a column 28 disposed within the main lumen 26, forming a secondary lumen 30 (see FIG. 2B ). The tubular member 20 defines an aperture 32 into the secondary lumen 30 at a longitudinal position between the first end 22 and the second end 24 of the tubular member 20. The column 28 defines a column opening 34 (see FIG. 2B ) proximal to the second end 24 of the tubular member 20. Stent member 40 supports tubular member 20 such that the implantable device is operable to be configured into and transitioned from a delivery configuration to a deployed configuration.

[0050] In some embodiments, tubular member 20 includes a first graft member 41 defining a main lumen 26 and a second graft member 42 coupled to first graft member 41 to form a column 28 defining a secondary lumen 30 between first graft member 41 and second graft member 42. For example, first graft member 41 may include graft material formed into a tubular shape to define main lumen 26. Second graft member 42 may also optionally include graft material coupled (e.g., by bonding, adhesive, or otherwise) to the first graft member to form secondary lumen 30. The graft materials of first and second graft members 41, 42 may be the same or different materials, as desired. While some materials may offer particular advantages over other materials, a variety of suitable graft materials may be implemented, and generally any suitable graft material may be implemented, including those discussed herein.

[0051] In some embodiments, the secondary lumen 30 extends at least partially along the longitudinal length of the body 12. The secondary lumen 30 of the column 28 opens into the main lumen 26 at a proximal opening of the secondary lumen 30. In some embodiments, the column 28 extends to the second end 24 of the tubular member 20 such that the column opening 34 is located at or flush with the second opening 25 of the tubular member 20. In other embodiments, the column 28 extends toward the second end 24 of the tubular member 20 such that the column opening 34 is longitudinally spaced from the second opening 25 of the tubular member 20. In embodiments including multiple columns 28, the column openings 34 can be located at the same longitudinal length across the tubular member 20, or stated another way, at the same longitudinal position along the tubular member 20, or can be staggered at two or more longitudinally spaced positions along the length of the tubular member 20.

[0052] In some embodiments, the column 28, and therefore the secondary lumen 30, is collapsible. For example, the column 28 may not be supported by a stent member, although supported, collapsible embodiments are contemplated. The lack of support, or the lack of a properly configured support, may allow the column 28 to collapse (collapse radially) and seal the aperture 32, restricting leakage or other passage of fluid (e.g., blood) through the aperture 32. In some embodiments, pressure exerted by a fluid (e.g., fluid pressure, a fluid pressure gradient, and / or pressure exerted by a fluid in motion) causes the column 28 to collapse such that the column seals or seals against the tubular member 20, restricting flow through the secondary lumen 30 and, consequently, the aperture 32.

[0053] As shown in FIG. 2A , the column 28 can be sealed or closed near the first end 22 of the tubular member 20, or in some embodiments not shown, at the first end 22. Thus, the secondary lumen 30 is operable to provide fluid communication between the outer surface of the tubular member 20 between the first and second ends 22, 24 and the main lumen 26, for example, when the column 28 is patent. In some embodiments, the tubular member 20 can include an unsealed (i.e., opening-containing) column 28 near the first end of the tubular member 20. In such embodiments, an elongate member, such as a delivery catheter, can be positioned through the column 28. Referring to FIG. 2B , an end view of the body 12 is shown, with the column opening 34 located proximate the second end 24 of the body 12. In some embodiments, the column 28 extends to the second end 24 of the body 12. As shown, the secondary lumen 30 can be contained within the main lumen 26.

[0054] Referring again to FIG. 2A , the body 12 includes a stent member 40. The stent member 40 can be formed from any suitable material, as described below. The stent member 40 is operable to support the tubular member 20. The stent member 40 can be compressed into a delivery configuration and expanded to an expanded configuration, such as during deployment. The stent member 40 can be a self-expanding stent or a balloon-expandable stent. As shown, the stent member 40 includes a plurality of stent rings 44. Each stent ring 44 circumferentially supports the tubular member 20 at a longitudinal position along the length of the tubular member 20. For example, each stent ring 44 is longitudinally spaced from an adjacent stent ring 44. Each stent ring 44 can include an apex 46 having a first apex 46 a toward the first end 22 and a second apex 46 b toward the second end 24. Various other configurations of the stent member 40 are contemplated herein, including, but not limited to, helical stents (including wavy helical stents, diamond pattern stents, etc.).

[0055] As shown in FIG. 2A , the tubular member 20 includes a plurality of apertures 32 spaced apart along the longitudinal length of the body 12. The apertures 32 may be arranged such that at least one stent ring is located between two longitudinally adjacent apertures 32. For example, the column 28 may include apertures 32 through the tubular member 20 such that the apertures 32 are spaced apart longitudinally along the body 12. All of the apertures are in fluid communication with the secondary lumen 30 of the column 28. The apertures 32 provide access points for secondary branches at various longitudinal lengths along the body 12.

[0056] 2C , the apertures 32 may be formed in a variety of shapes and sizes, including circular profiles, profiles with rounded and substantially flat edges, oval profiles, etc. The various shapes and sizes may be implemented to accommodate various configurations of the side branches 14 from the body 12 at the apertures 32, such as the angle of exit of the side branches 14. In some embodiments not shown, the apertures 32 may be irregularly spaced along the longitudinal length of the column 28. Further, in some embodiments not shown, the apertures 32 may be circumferentially spaced within the column 28. For example, the apertures 32 may be staggered circumferentially and / or longitudinally.

[0057] In some embodiments, the body 12 can include multiple columns 28. For example, the body 12 can include two circumferentially spaced columns 28 for deploying two side branches 14 within side branch lumens of the patient's anatomy. Furthermore, the body 12 can include multiple columns 28 associated with each side branch lumen of the patient's anatomy. For example, if the body 12 is deployed in the abdominal aorta and the side branches 14 are deployed in the renal arteries, each patient can have various circumferential locations where the renal arteries enter the aorta.

[0058] By having multiple columns 28 along which each side branch 14 is deployed, the surgeon can select the appropriate columns 28 that best fit the patient's native anatomy without adding kinks to the vessel when the implantable device 10 is deployed. Thus, in one example, the body 12 may include three columns 28 on one circumferential side of the tubular member 20 and three more columns 28 on the opposite circumferential side of the tubular member 20. Each column 28 is circumferentially spaced from an adjacent column around the tubular member 20. It is contemplated that any number of columns 28 and spacing between columns 28 may be implemented, including one, two, three, four, five, six, seven, eight, or more columns 28, and may be spaced at equal or varying spacings around the tubular member 20. It is further contemplated that a particular spacing may be determined by examining the average circumferential spacing of side branches for a particular implementation in a sample population of patients to determine the spacing of the columns 28. Circumferential spacing of the columns 20 allows clocking of the body 12 within the patient's anatomy, increasing the number of locations for properly positioning the side branch 14 within the side branch vessel. As used herein, the term "clocking" refers to the ability to position a feature at a desired location around a subject. This ability to clock one or more columns 28 can be further advantageous for use with visualization, such as when a procedure is being performed via fluoroscopy. This simplifies placement by providing several entry points when dealing with the two-dimensional plane displayed by the visualization technique and the parallax associated with such visualization. In some embodiments, the columns 28 may be spaced irregularly around the body 12 (e.g., non-uniform spacing between the columns 28). In some embodiments not shown, the columns 28 extend longitudinally at an angle greater than zero relative to the longitudinal axis of the body 12. For example, secondary lumen 30 extends along a secondary lumen axis that extends longitudinally (eg, helically around body 12) at an angle greater than zero relative to the axis of main lumen 26.

[0059] 2A, the body 12 may include a restraining member receiver 50 disposed to surround at least a portion of the stent member 40. For example, in embodiments including multiple stent rings 44, a corresponding restraining member receiver 50 is disposed around each stent ring 44. The restraining member receivers 50 may be formed from a variety of materials, including graft material, fabric, etc. The restraining member receivers 50 are operable to receive a restraining member that can be retracted to partially restrain or collapse the stent rings 44, as described below.

[0060] In some embodiments, the tubular member 20 can include a scallop 52 at the first end 22. The scallop 52 facilitates placement of the tubular member 20 within a lumen, including a side branch lumen, in which a prosthetic side branch 14 does not need to be deployed. For example, when the implantable device 10 is placed within the abdominal aorta and the superior mesenteric artery does not need to have a side branch 14 deployed therein, the scallop 52 can be placed over the entrance to the superior mesenteric artery without blocking or restricting blood perfusion through the superior mesenteric artery (see FIGS. 11A-11C). The scallop 52 can include a variety of shapes, including straight-edge profiles, curved profiles, and combinations thereof.

[0061] 3, a delivery system 100 for delivering and deploying an implantable device 10 is provided. While the delivery system 100 and implantable device 10 may be described with reference to a particular implant procedure site, such as the abdominal aorta, it is understood that the delivery system 100 and implantable device 10 may be implemented in a variety of sites and systems. Furthermore, it is understood that the delivery system 100 may be implemented with other implantable devices not described herein and, therefore, is not limited to use with the particular embodiments disclosed and otherwise discussed herein. However, for purposes of illustration, the delivery system 100 will be discussed with reference to the implantable device 10 discussed herein.

[0062] The delivery system 100 is operable to facilitate placement of the implantable device 10 into the branch lumen, to allow at least partial collapse and re-expansion of the body 12 of the implantable device 10 after deployment, and to allow fenestration of the body 12 at the side branch 14 for implanting the side branch 14 into the side branch lumen.

[0063] The delivery system 100 includes an elongate member 110 (e.g., a delivery catheter), a catheter olive 130, a restraining member 150, a secondary restraining member 170, and a guide member 190. The delivery system also includes a delivery handle 200 for operating, controlling, and otherwise manipulating the delivery system 100 and its various components.

[0064] The elongate member includes a first end 112 and a second end 114, and the body 12 of the implantable device 10 is disposed at the first end 112 of the elongate member 110. Referring to FIG. 10 , the elongate member 110 defines a delivery lumen 116 extending along at least a portion of the longitudinal length of the elongate member 110 and operable to deliver a side branch 14. The delivery lumen 116 is sized to appropriately accommodate the side branch 14 and delivery components. For example, the size of the delivery lumen 116 may be approximately 8 Fr. In other embodiments, the delivery lumen is between about 4 Fr and about 12 Fr. In embodiments in which the implantable device 10 includes two side branches 14, the elongate member may include two delivery lumens 116, one for each side branch 14. Any number of delivery lumens 116 may be implemented for each number of side branches 14 to be deployed. As shown in FIG. 3 , the elongate member 110 can include an opening 118 spaced from the first end 112 of the elongate member. The opening 118 can be located within the main lumen 26 of the body 12 when the body is disposed about the elongate member 110, or can be spaced from the second end 24 of the body 12 (as shown in FIG. 3 ). This allows access to the column 28 and / or aperture 32 for positioning and implanting the side branch 14 with the body 12. The elongate member 110 can further include a restraining member lumen 120. The restraining member lumen 120 is operable to allow control of the restraining member 150 to release the body 12 from a restrained configuration. The elongate member can further include a lockwire lumen 122 and a secondary restraining member lumen 124. The lockwire and restraining wire can extend through the respective lumens 122, 124. In some embodiments not shown, the side branch 14 can be delivered within a separate catheter (not shown).

[0065] The catheter olive 130 is positioned at the first end 112 of the elongate member 110 such that the body 12 of the implantable device 10 is longitudinally disposed between the catheter olive 130 and the second end 114 of the elongate member 110. While an embodiment of the catheter olive 130 is shown in the drawings, it is within the scope of this disclosure that any catheter olive 130 may be implemented. The catheter olive 130 may be implemented to atraumatically advance the delivery system 100 into the patient and, if necessary, dilate the surrounding anatomy. For example, the catheter olive may include a forward tip that initially advances through the patient's anatomy. With reference to FIGS. 5A-5C, the catheter olive 130 may include a guide member holder 132. The guide member 220 is described in more detail below. However, the guide member holder 132 may include a passageway through which the guide member 220 passes (see FIG. 5A). In this embodiment, the guide member 220 can extend through the catheter olive 130 and back through an aperture 32 in another column 28 located on the opposite side. The guide member retainer 132 can be operable to releasably retain a lock wire 230 to which the guide member 220 is coupled (see FIG. 5B). The lock wire 230 can be controlled via the lock wire lumen 122. The guide member retainer can be operable to receive and releasably retain an end of the guide member 220, for example, via a friction fit or other coupling (see FIG. 5C). Various embodiments of the catheter olive 130 can be implemented (e.g., the guide member retainer 132) specifically to couple the guide member 220. Such embodiments include those discussed in U.S. Patent Application Publication No. 2020 / 0046534 to Chung et al., filed August 13, 2019, the contents of which are expressly incorporated herein by reference.

[0066] The restraining member 150 is disposed around the body 12 and restrains the body in the delivery configuration. Any number of restraining members 150 can be implemented and may include knitted, tubular, or any other releasable structure that can be selectively released or actuated to allow expansion of the device. Such structures include those discussed in U.S. Pat. No. 6,224,627, issued June 15, 1998 to Armstrong, and U.S. Pat. No. 7,753,945, issued July 13, 2010 to Bruun, the entire contents of which are expressly incorporated herein by reference. The restraining member 150 is removed, and the body 12 is operable to expand (e.g., self-expanding) or be expanded (e.g., balloon-expandable) to the expanded configuration. The restraining member 150 can be controlled (e.g., released) from the body 12 via a deployment line (not shown) extending through the restraining member lumen 120.

[0067] A secondary restraint member 170 is disposed around the stent member 40 of the body 12. In embodiments including multiple stent rings 44, the delivery system 100 may include multiple secondary restraint members 170 corresponding to each stent ring 44. With reference to FIGS. 4A and 4B , the secondary restraint member 170 is operable to restrain the body 12 in a partially constrained configuration. For example, after the restraint member 150 is removed from the body 12 and the body is expanded to the expanded configuration, tension can be applied to the secondary restraint member 170 to at least partially collapse the body into the partially constrained configuration. The secondary restraint member 170 is disposed within the restraint member receiver 50 of the body 12. Various embodiments of the restraint member receiver 50 can be implemented, including those discussed in U.S. Patent Application Publication No. 2018 / 0036011 to Lehnhardt et al., filed August 7, 2017, the entire contents of which are expressly incorporated herein by reference. The restraint member receiver 50 positions the secondary restraint member 170 around the corresponding stent ring 44, allowing each stent ring 44 to partially collapse after deployment. The secondary restraint member 170 extends through the secondary restraint member lumen 124 (see FIG. 10 ). In some embodiments, as shown in FIG. 4B , for example, the secondary restraint member 170 can be divided into two zones that allow independent control over various portions of the longitudinal length of the main body 12. In this manner, once properly positioned, a first portion of the tubular member 20 corresponding to the first zone 172 of the restraint member can be released to maintain accurate positioning, while the second zone 174 maintains a partially restrained orientation to facilitate placement of the side branch 14. The number of defined zones can include one zone, two zones, or more than two zones.

[0068] In some embodiments, the secondary restraint member 170 can pass through the tubular member 20. To limit leakage through the tubular member after removal, the secondary restraint member 170 can pass through the tubular member 20 within the column 28 (see FIGS. 2A and 2B). Because the secondary restraint member 170 is supported by the elongate member 110, the elongate member 110 can also be positioned within the column 28. When the elongate member 110 and secondary restraint member 170 are removed, the column 28 collapses, sealing any leaks that may form with the secondary restraint member 170. The elongate member 110 can include multiple outlets from the secondary restraint member lumen 124 spaced longitudinally along the elongate member 110 to correspond to the locations of each stent ring 44 and restraint member receiver 50. The secondary restraint member 170 is coupled to a delivery handle 200 to facilitate controlled contraction and expansion of the body 12.

[0069] The secondary restraint member 170 can be implemented to pull the tubular member 20 away from the vessel wall to reposition the body 12, allowing perfusion through a side branch vessel while positioning and delivery of the implantable device 10 is still occurring, or for visualization of the body 12 within the vessel (e.g., via fluoroscopy). For example, the body 12 can have a first diameter corresponding to a delivery configuration and a second diameter corresponding to a deployed configuration, the second diameter being larger than the first configuration. When the secondary restraint member 170 is actuated to restrain the body 12, the body can include an intermediate diameter smaller than the second diameter and larger than the first diameter, corresponding to a partially constrained configuration.

[0070] 5A-6, a guide member 220 is shown extending through the body 12 to the catheter olive 130. The guide member 220 is pre-cannulated through an aperture 32 in the body 12 prior to insertion into the patient. For simplicity, FIG. 6 shows only one aperture 32 of the columns 28 fenestrated with the guide member 220. It is understood that each column 28 includes a corresponding guide member 220 that cannulates one of the apertures 32 associated with that column 28. As shown in FIG. 6, the guide member 220 is pre-cannulated in the aperture closest to the first end 22 of the body 12. Pre-cannulating the aperture 32 of the column 28 provides easier access to the column 28 for delivery of the side branch 14 and facilitates cannulation of the remaining apertures 32 within the column 28. The guide member 220 can include various indicia to identify the column 28 with which it is associated. For example, the guide members 220 may be indicated by varying colors, materials, markings, textures, and the like.

[0071] Referring to FIG. 7 , a cross-sectional view of an exchange catheter 240 is shown. The exchange catheter 240 includes a central lumen 242 extending therethrough having an opening at a first end 244. The first end 244 may include a tapered profile, such as a wedge shape, to facilitate insertion into and / or expansion of a lumen (e.g., a secondary lumen 30 of the column 28). The exchange catheter further defines a peripheral lumen 246. The peripheral lumen 246 extends along the exchange catheter 240 at the first end 244. The peripheral lumen 246 includes a first opening 248 at the first end 244 of the exchange catheter 240 and a second opening 250 spaced from the first end 244 at a location between the ends of the exchange catheter 240. The second opening 250 exits the exchange catheter 240 at the outer surface along the periphery of the exchange catheter (i.e., not at a longitudinal end). The surrounding lumen 246 is operable to house the guide member 220. The guide member 220 thus operates to guide the exchange catheter 240 to a desired location.

[0072] More specifically, Figure 8 shows an exchange catheter 240 being advanced from the elongate member 110 into the body 12. In some embodiments, as shown in Figure 8, the exchange catheter 240 exits the elongate member 110 at an end of the elongate member 110, or in other embodiments, the elongate member 110 includes an opening 118 disposed through a sidewall of the elongate member 110 and exiting the elongate member 110 at a location between the longitudinal ends of the elongate member 110 (see Figure 3). A guide member 220 extends into the secondary lumen 30 of the column 28 and is shown extending through an aperture 32 located proximate the first end 22 of the body 12. The guide member 220 functions as a rail along which the exchange catheter 240 translates through a surrounding lumen 246. A peripheral lumen 246 exits the exchange catheter at the distal end of the tapered portion of the first end 244 such that the exchange catheter 240 is operable to slide into the secondary lumen 30 of the body 12 and expand the column 28. The exchange catheter 240 is operable to be advanced with the sealed end into the end of the column, as shown. The exchange catheter 240 includes a central lumen 242 for advancing various other components of the delivery system 100, as described below.

[0073] FIG. 9 shows a delivery handle 200. The delivery handle 200 includes a first port 202 with a hermetic seal, a second port 204 with a hermetic seal, and at least one knob 206 for controlling the restraining wires 170. The first port 202 can include a guide member 220 extending therethrough for each column 28 on one side of the body 12, and the second port 204 can include a guide member 220 extending therethrough for each column 28 on the other side of the body 12. An exchange catheter 240 can be loaded onto the guide member 220 and then inserted into the respective ports 202, 204. Side branches can also be inserted through the respective ports 202, 204 and advanced to the target site. The body 12 can also be advanced and deployed via the delivery handle 200. For example, the restraining member 150 can be released via the second knob 208. The delivery handle can include a primary access port 210 through which the various components of the delivery system 100 can be delivered and manipulated.

[0074] 11A-11C illustrate various embodiments of the body 12. FIG. 11A illustrates a body 12 that can be at least partially deployed within a second implantable device 300. The second implantable device 300 can include a bifurcated device for deployment within the iliac artery, for example. FIG. 11B illustrates a body 12 having a tapered profile at the second end 24 of the body. The second implantable device 300 can be deployed within a portion of the body 12, such as the tapered portion. FIG. 11C illustrates a body 12 including a bifurcated portion at the second end 24. The bifurcated portion at the second end 24 can be implemented with the second device 300 for implantation within a branched anatomical structure, such as the iliac artery. The delivery sequence of the various implantable devices 10, 300 can be performed in either direction, for example, sequentially from top to bottom or bottom to top within the abdominal aorta. It is understood that when implanting the abdominal aorta, the entire delivery method can be performed via the femoral artery. However, various components etc. may be delivered through a second entry point.

[0075] FIG. 12 is a diagram of the main body 12 including two side branches 14 deployed through the aperture 32 and extending through the column 28 and out of the column opening 34 (see FIG. 2B). The length of the side branches 14 can be selected so that the side branches extend a predetermined distance into the side branch vessel and the side branches 14 extend out through the column opening 34. By extending the side branch opening through the column opening 34, the column 28 remains patent and does not seal at the column opening, allowing perfusion through the side branches 14. In some embodiments, the main body 12 can include an internal stent (not shown) coupled to the tubular member 20 within the main lumen 26. The internal stent can be coupled to the column 28. The internal stent can be constrained in a compressed configuration operable to maintain the column 28 in a patent configuration. When the internal stent is released and expanded, the column 28 collapses and seals, preventing fluid from flowing therethrough. In columns with internally placed side branches 14, the side branches maintain the patency of the column when the internal stent is released.

[0076] Referring now to Figures 13-27, an exemplary method of delivering an implantable device is shown. Figures 13-27 illustrate and will be discussed with reference to an exemplary example of an implantable device being delivered and deployed in the abdominal aorta, with the understanding that the method is limited to the abdominal aorta. Note that certain features may be shown in greater detail in some figures to highlight certain features at certain steps of the procedure, while other features may be hidden to simplify the figures for ease of understanding. However, various combinations of features may be present at certain steps even if not explicitly shown in the figures. The methods shown and described herein can be performed from a single access site.

[0077] 13 shows the body 12 of the implantable device 10 being advanced to a target site (e.g., the abdominal aorta). The body 12 is disposed around the elongate member 110 at the first end 112. The body 12 is restrained in the delivery configuration by the restraining member 150.

[0078] Figure 14 shows body 12 released from restraining member 150 and expanded to an expanded configuration. Figure 15 shows secondary restraint member 170 actuated to partially restrain body 12, allowing for fine tuning of the position of body 12 at the target site.

[0079] 16 shows a body 12 including a column 28 that includes apertures 32 spaced longitudinally along the body 12 that provide access to a secondary lumen 30 of the column 28. A guide member 220 extends into the second opening 25 of the body 12, into the column opening 34, through the column 28, and out the aperture 32 nearest the first end 22 of the body 12 to the catheter olive 130 on which the guide member 220 is retained.

[0080] FIG. 17 shows a guide member 220 that functions as a guide or rail for advancing the exchange catheter 240 into the column 28. As shown, the guide member 220 is positioned within the peripheral lumen 246 of the exchange catheter 240 (see FIGS. 7 and 8). FIG. 18 shows the exchange catheter 240 positioned at the sealed end of the column 28 with a first guidewire 270 advanced through the central lumen 242 (see FIG. 7) of the exchange catheter 240. The first guidewire 270 can be a compliant guidewire with a curved tip. Referring to FIG. 19, the exchange catheter 240 is then removed. In some embodiments, a curved catheter 272 can be inserted over the first guidewire 270. The curved catheter 272 and first guidewire 270 are not engaged with the guide member 220. The curved catheter 272 and first guidewire 270 are oriented so that their curved tips are curved toward a radially outward position. FIG. 20 shows the curved catheter 272 and first guidewire 270 being axially withdrawn from the first end 22 of the body 12. The physician selects the appropriate aperture 32 for accessing the side branch vessel. When the curved catheter 272 is axially retracted, it moves beyond the aperture 32. However, when advanced forward toward the first end 22 of the body 12, the curved catheter 272 and first guidewire 270 engage the aperture 32. Once the aperture 32 is engaged, further advancement of the curved catheter 272 will advance the curved catheter 272 through the aperture 32 (see FIG. 21). The curved catheter 272 is then advanced into the side branch vessel. Once the curved catheter 272 is properly positioned, the first guidewire 270 can be retracted and a second guidewire 274 can be advanced. The second guidewire 274 can be stiffer than the first guidewire 270. The curved catheter 272 is then removed while the second guidewire 274 is retained through the aperture 32 and within the side branch lumen (see FIG. 22).Although the guide member 220 is not shown in all of these figures, it is understood that the guide member 220 may be retained throughout the method in order to restart or repeat the steps if necessary.

[0081] 22, the side branch 14 is advanced to the target site along a second guidewire 274. Figures 23-26 provide a similar procedure for placing a second side branch 14 in a second side branch vessel.

[0082] 27 shows one of the side branches 14 deployed along with the main body 12. Once the side branches 14 are in place, they can be deployed, either individually or individually. The side branches 14 can be released from the restraining member and self-expanded, or can be expanded (e.g., balloon expansion). Once the side branches 14 are deployed, the main body 12 can be finally released (e.g., the secondary restraining member 170 can be released and the delivery system 100 and its components can be removed).

[0083] It is understood that this procedure can be performed in a de novo procedure or as a reintervention. The methodology is substantially the same for both procedures. As previously mentioned, implantable device 10 can be implemented with various other implantable components for engaging other anatomical structures, such as bifurcation devices (as seen in FIGS. 11A-11C).

[0084] A variety of material sets can be implemented for the graft members, including known vascular graft and stent graft materials. Polymers, biodegradable natural materials can be used for specific applications. Also, a variety of manufacturing techniques can be implemented to form the graft members, including extrusion, coating, wrapping, combinations thereof, and the like.

[0085] Biocompatible materials for the graft components described herein can be used. In certain examples, the graft can include a fluoropolymer, such as polytetrafluoroethylene (PTFE) polymer or expanded polytetrafluoroethylene (ePTFE) polymer. In some examples, the graft can be formed from, but is not limited to, polyester, silicone, urethane, polyethylene terephthalate, or another biocompatible polymer, or a combination thereof. In some examples, bioresorbable or bioabsorbable materials can be used, such as bioresorbable or bioabsorbable polymers. In some examples, the graft can include Dacron, polyolefin, carboxymethylcellulose fabric, polyurethane, or other woven, nonwoven, or film elastomers.

[0086] Examples of suitable synthetic polymers include, but are not limited to, nylon, polyacrylamide, polycarbonate, polyformaldehyde, polymethyl methacrylate, polytetrafluoroethylene, polytrifluorochloroethylene, polyvinyl chloride, polyurethane, elastomeric organosilicon polymers, polyethylene, polypropylene, polyurethane, polyglycolic acid, polyester, polyamide, and mixtures, blends, and copolymers thereof, which are suitable as graft materials. In one embodiment, the graft is made from a class of polyesters, such as polyethylene terephthalates, including DACRON® and MYLAR®, and polyaramids, such as KEVLAR®, polyfluorocarbons, such as polytetrafluoroethylene (PTFE) with or without copolymerized hexafluoropropylene (TEFLON® or GORE-TEX®), and porous or non-porous polyurethanes. In another embodiment, the graft comprises an expanded fluorocarbon polymer, particularly PTFE, material. Preferred classes of fluoropolymers include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), copolymers of tetrafluoroethylene (TFE) and perfluoro(propyl vinyl ether) (PFA), homopolymers of polychlorotrifluoroethylene (PCTFE) and its copolymers with TFE, ethylene chlorotrifluoroethylene (ECTFE), copolymers of ethylene-tetrafluoroethylene (ETFE), polyvinylidene fluoride (PVDF), and polyvinyl fluoride (PVF). ePTFE is particularly preferred because of its widespread use in vascular prostheses. In another embodiment, the graft comprises a combination of the above-listed materials. In another embodiment, the graft is substantially impermeable to bodily fluids. A substantially impermeable graft can be made from a material that is substantially impermeable to bodily fluids, or it can be constructed from permeable materials that have been treated or manufactured to be substantially impermeable to bodily fluids (e.g., by layering different types of materials as described above or known in the art).In one embodiment, the body and branch members are made from any combination of the above materials, as described above. In another embodiment, the body and branch members comprise ePTFE, as described above.

[0087] As described above, the stent may be provided in the form of a series of rings arranged generally coaxially along the graft body. In some embodiments, as described, the stent may be generally cylindrical when constrained and / or unconstrained and may include helically arranged corrugations having a plurality of helical turns. The corrugations are preferably aligned to be "in phase" with one another. More specifically, the corrugations include peaks in opposing first and second directions. When the corrugations are in phase, adjacent helical turns are aligned such that the peaks of adjacent helical turns are displaced toward the respective peaks of the corresponding corrugations of the adjacent helical turns. In one embodiment, the corrugations have a sinusoidal shape. In another embodiment, the corrugations are U-shaped. In another embodiment, the corrugations are V-shaped. In another embodiment, the corrugations are oval.

[0088] In various embodiments, the stent can be fabricated from a variety of biocompatible materials, including commonly known materials (or combinations of materials) used in the manufacture of implantable medical devices. Typical materials include 316L stainless steel, cobalt-chromium-nickel-molybdenum alloy ("cobalt-chromium"), other cobalt alloys such as L605, tantalum, nitinol, or other biocompatible metals. In one embodiment, any of the stent grafts described herein is a balloon-expandable stent graft. In another embodiment, any of the stent grafts described herein is a self-expanding stent graft. In another embodiment, the stent is a wire-wound stent. In another embodiment, the wire-wound stent comprises an undulating or repeating undulating pattern of peaks.

[0089] Wire-wound stents can be constructed from reasonably high-strength materials, e.g., materials that resist plastic deformation when stressed. In one embodiment, the stent member comprises a wire helically wound around a mandrel with pins positioned thereon to simultaneously form helical turns and corrugations, as described below. Other constructions can also be used. For example, a flat piece of stock can be formed into the appropriate shape and wound into a cylinder or length of tubing formed into the appropriate shape, or a sheet of material can be laser cut. In another embodiment, the stent is made from a superelastic alloy. Various disclosures exist of the use of superelastic alloys, such as Nitinol, in stents.

[0090] A variety of materials, including various metals and superelastic alloys such as Nitinol, are suitable for use in these stents. The primary requirement for the material is that it have adequate elasticity, even when formed into very thin sheets or small-diameter wires. Various stainless steels that have been treated physically, chemically, or otherwise to create high spring properties are suitable, as are other metal alloys such as cobalt-chromium alloys (e.g., ELGILOY®), platinum / tungsten alloys, and especially the nickel-titanium alloy commonly known as "Nitinol."

[0091] Nitinol is particularly preferred due to its "superelastic" or "pseudoelastic" shape recovery properties, i.e., its ability to withstand significant amounts of bending and flexing and yet return to its original shape without permanent deformation. These metals are characterized by their ability to transform from an austenitic crystalline structure to a stress-induced martensitic structure at a specific temperature and then elastically return to the austenitic shape when the stress is released. These alternating crystalline structures give the alloy its superelastic properties.

[0092] Other suitable stent materials include certain polymeric materials, particularly engineering plastics such as thermotropic liquid crystal polymers ("LCPs"). These polymers are high-molecular-weight materials that can exist in a so-called "liquid crystal state," meaning they possess some of the properties of liquids (i.e., they are flowable) while retaining the long-range molecular order of crystals. The term "thermotropic" refers to a class of LCPs that can be formed by adjusting the temperature. LCPs can be prepared from monomers such as p,p'-dihydroxy-polynuclear aromatic or dicarboxy-polynuclear aromatic compounds. LCPs are easily formed, retain the necessary interpolymer attractive forces at room temperature, and function as the high-strength plastic fabrication required for collapsible stents. They are particularly suitable when reinforced or filled with fibers, such as metal or alloy fibers, as described below. Note that the fibers need not be straight; they may have some preformed shape, such as corrugation, which enhances the physical torsional reinforcement capabilities of the composite.

[0093] Any of a variety of bioactive agents may be implemented with any of the foregoing. For example, any one or more of the device 10 (including portions thereof) may include a bioactive agent. The bioactive agent may be coated onto one or more of the foregoing features for controlled release of the bioactive agent after the device 10 is implanted. Such bioactive agents may include, but are not limited to, thrombogenic agents, such as heparin. Bioactive agents also include, but are not limited to, drugs such as antiproliferative / antimitotic agents including natural products, e.g., vinca alkaloids (e.g., vinblastine, vincristine, and vinorelbine), paclitaxel, epidipodophyllotoxins (e.g., etoposide and teniposide), antibiotics (e.g., dactinomycin (actinomycin D), daunorubicin, doxorubicin, and idarubicin), anthracyclines, mitoxantrone, bleomycin, plicamycin (mithramycin), and mitomycin, enzymes (e.g., L-asparaginase, which metabolizes L-asparagine systemically and deprives cells of the ability to synthesize their own asparagine); G(GP) IIb / IIIa antiplatelet agents such as inhibitors and vitronectin receptor antagonists; antiproliferative / antimitotic alkylating agents such as nitrogen mustards (e.g., mechlorethamine, cyclophosphamide and its analogs, melphalan, chlorambucil), ethylenimines and methylmelamines (e.g., hexamethylmelamine and thiotepa), alkylsulfonates busulfan, nitrosoureas (e.g., carmustine (BCNU) and analogs, streptozocin), trazendacarbazine (DTIC); folic acid analogs (methotrexate, antiproliferative / antimitotic antimetabolites such as pyrimidine analogs (e.g., fluorouracil, floxuridine, cytarabine), purine analogs and related inhibitors (e.g., mercaptopurine, thioguanine, pentostatin, and 2-chlorodeoxyadenosine {cladribine}); platinum coordination complexes (e.g., cisplatin and carboplatin), procarbazine, hydroxyurea, mitotane, aminoglutethimide; hormones (e.g., estrogens); anticoagulants (e.g., heparin, synthetic heparin salts, and other thrombin inhibitors);Antiplatelet agents (e.g., aspirin, clopidogrel, prasugrel, and ticagrelor); vasodilators (e.g., heparin, aspirin); fibrinolytics (e.g., plasminogen activators, streptokinase, and urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab, antimigratory agents anti-inflammatory agents, such as corticosteroids (e.g., cortisol, cortisone, fludrocortisone, prednisone, prednisolone, 6α-methylprednisolone, triamcinolone, betamethasone, and dexamethasone), non-steroidal agents (e.g., salicylic acid derivatives such as aspirin); para-aminophenol derivatives (e.g., acetaminophen); indole and indene acetic acids (e.g., indomethacin, sulindac, and etodalac), heteroaryl acetic acids (e.g., tolmetin, diclofenac, and ketorolac), arylpropionic acids (e.g., ibuprofen and derivatives), anthranilic acids (e.g., mefenamic acid and meclofenamic acid), enolic acids (e.g., piroxicam, tenocin, and thiazolinone); oxicam, phenylbutazone, and oxyfentatrazone), nabumetone, gold compounds (e.g., auranofin, aurothioglucose, and gold sodium thiomalate); immunosuppressants (e.g., cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine, and mycophenolate mofetil); angiogenic agents (e.g., vascular endothelial growth factor (VEGF)), fibroblast growth factor (FGF); angiotensin receptor blockers; nitric oxide donors; antisense oligonucleotides and combinations thereof; cell cycle inhibitors, mTOR inhibitors, growth factor receptor signaling kinase inhibitors; retinoids; cyclin / CDK inhibitors; HMG coenzyme reductase inhibitors (statins); and protease inhibitors.

[0094] Many features and advantages of the present invention have been set forth in the foregoing description, including preferred and alternative embodiments, along with details of the structure and function of the invention. This disclosure is illustrative only and is not intended to be exhaustive. It will be apparent to those skilled in the art that various changes may be made in the structure, materials, elements, components, shape, size, and arrangement of parts within the scope of the principles of the present invention, particularly to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed. These various changes are intended to be encompassed within the spirit and scope of the appended claims. In addition to being directed to the embodiments described above and claimed below, the present invention is also directed to embodiments having different combinations of the features described above and claimed below.

[0095] 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 the present disclosure. Therefore, it is intended that the embodiments cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents. The present disclosure further includes the following embodiments: (Aspect 1) a tubular member having a first end and a second end, the tubular member forming a main lumen having a first opening at the first end of the tubular member and a second opening at the second end of the tubular member, the tubular member including a column disposed within the main lumen forming a secondary lumen, the tubular member defining a plurality of apertures opening into the secondary lumen at longitudinal locations between the first end and the second end of the tubular member, the column having a column opening; and a stent member supporting the tubular member; 1. An implantable device, including: (Aspect 2) The implantable device of embodiment 1, wherein the tubular member includes a first graft member defining the main lumen and a second graft member coupled to the first graft member to form the column, the second graft member defining the secondary lumen between the first graft member and the second graft member. (Aspect 3) 3. The implantable device of embodiment 2, wherein the secondary lumen opens into the main lumen at a proximal opening of the secondary lumen. (Aspect 4) 10. The implantable device of any one of the preceding aspects, wherein the secondary lumen is collapsible. (Aspect 5) 10. The implantable device of any one of the preceding aspects, wherein the secondary lumen is not supported by a stent. (Aspect 6) Aspect 11. The implantable device of any one of the preceding aspects, wherein the stent member comprises a plurality of stent rings spaced longitudinally along the tubular member. (Aspect 7) 7. The implantable device of embodiment 6, wherein each of the plurality of apertures is separated from each other by at least one of the plurality of stent rings. (Aspect 8) Aspect 11. The implantable device of any one of the preceding aspects, wherein each aperture of the plurality of apertures comprises a circle or a shape defining a rounded portion and a substantially flat portion. (Aspect 9) Aspect 10. The implantable device of any one of the preceding aspects, wherein the tubular member includes a plurality of secondary lumens extending longitudinally along at least a portion of the tubular member and circumferentially spaced from one another. (Aspect 10) Aspect 14. The implantable device of any one of the preceding aspects, further comprising a restraining member receiver positioned to surround at least a portion of the stent member. (Aspect 11) Aspect 11. The implantable device of any one of the preceding aspects, wherein the tubular member includes a scallop at the first end. (Aspect 12) Aspect 11. The implantable device of any one of the preceding aspects, wherein the secondary lumen extends along a longitudinally extending secondary lumen axis at an angle greater than zero relative to the axis of the main lumen. (Aspect 13) a tubular member having a first end and a second end, the tubular member forming a main lumen having a first opening at the first end of the tubular member and a second opening at the second end of the tubular member, the tubular member including a plurality of columns each defining a secondary lumen, each column of the plurality of columns being circumferentially spaced from one another, each secondary lumen having an aperture defined through the tubular member at a location between the first end and the second end and a column opening adjacent the second end of the tubular member, each column operable to collapse under fluid pressure; and a stent member supporting the tubular member; 1. An implantable device, including: (Aspect 14) An implantable device comprising a body and a side branch, wherein the body comprises a tubular member and a stent member supporting the tubular member, the tubular member forming a main lumen having a first opening and a second opening, the tubular member having an aperture defined therethrough and forming a secondary lumen having a proximal opening proximal to the second opening of the tubular member; an elongate member having a first end and a second end, wherein the body of the implantable device is disposed at the first end of the elongate member, the elongate member defining a delivery lumen extending along at least a portion of the longitudinal length of the elongate member and operable to deliver a side branch; a catheter olive disposed on the first end of the elongate member such that the body of the implantable device is longitudinally disposed between a forward tip of the catheter olive and the second end of the elongate member; a restraining member disposed about the body and restraining the body in a delivery configuration; and a secondary restraint member disposed about the body stent, wherein the secondary restraint member is operable to restrain the body in a partially restrained configuration; a delivery system comprising: (Aspect 15) A delivery system as described in aspect 14, further comprising a guide member extending from the delivery lumen of the elongate member, from the proximal opening through the aperture, through the secondary lumen of the tubular member, and coupled to the catheter olive. (Aspect 16) 16. The delivery system of embodiment 15, further comprising an exchange catheter coupled to the guide member and operable to be advanced along the guide member. (Aspect 17) a first guidewire operable to be delivered through said exchange catheter; a curved catheter operable to be advanced over the first guidewire; and a second guidewire stiffer than the first guidewire, wherein the second guidewire is operable to be advanced through a curved catheter and the side branch is operable to be advanced along the second guidewire to a target site; 17. The delivery system of embodiment 16, further comprising: (Aspect 18) an implantable device comprising a body and a side branch, wherein the body comprises a tubular member and a stent member supporting the tubular member, the tubular member forming a main lumen having a first opening and a second opening, the tubular member defining a secondary lumen, the tubular member having an aperture defined therethrough and a column having a column opening proximal to the second opening of the tubular member; an elongate member having a first end and a second end, wherein the body of the implantable device is disposed proximal to the first end of the elongate member, the elongate member defining an operable lumen through which a side branch can be delivered; a catheter olive disposed on the first end of the elongate member such that the body of the implantable device is longitudinally disposed between a forward tip of the catheter olive and a second end of the elongate member; a restraining member disposed about the body and restraining the body in a delivery configuration; and a guide member extending from the lumen of the elongate member, from a proximal opening, through the aperture, through the secondary lumen of the tubular member, and coupled to the catheter olive; a delivery system comprising: (Aspect 19) a secondary restraint member disposed about the stent member of the body, wherein the secondary restraint member is operable to restrain the body in a partially restrained configuration; 20. The delivery system of embodiment 18, further comprising: (Aspect 20) A delivery system as described in aspect 19, wherein the stent member of the main body includes a plurality of stent rings, and the secondary restraint member includes a plurality of wires, one of which corresponds to a corresponding one of the plurality of stent rings. (Aspect 21) 1. A method for delivering an implantable device to a target site, including a main vessel and a side vessel, comprising: advancing a body of an implantable device to a main blood vessel at a target site, wherein the body is constrained by a restraining member around an elongate member near a first end of the elongate member, the body including a tubular member having a first end and a second end, the tubular member forming a main lumen having a first opening at the first end of the tubular member and a second opening at the second end of the tubular member, the tubular member having a plurality of columns extending along at least a portion of a longitudinal length of the tubular member, each column defining a secondary lumen, the tubular member having a plurality of apertures each defined through the tubular member at a location between the first end and the second end of the tubular member, each secondary lumen having a column opening proximal to the second end of the tubular member, the tubular member including a scallop at the first end of the tubular member, and the body including a stent member supporting the tubular member and operable to be configured in a delivery configuration and a deployed configuration; positioning the scallop of the tubular member adjacent to a side branch vessel; releasing the body from the restraining member such that the body is operable to expand from a delivery configuration to an expanded configuration; advancing an exchange catheter toward a side branch vessel, the exchange catheter being advanced along a guide member extending from the elongate member, from a proximal opening, through one of a plurality of secondary lumens of the tubular member, through an aperture at a first end of the plurality of apertures, and releasably coupled to a catheter olive at the first end of the elongate member; introducing a first guidewire through the exchange catheter such that the first guidewire extends beyond an aperture at the first end of the secondary lumen; retracting the exchange catheter away from about the first guidewire; selecting a target aperture among a plurality of apertures through which a side branch is to be delivered, wherein the method includes retracting a first guidewire positioned in or through the target aperture; replacing the first guidewire with a second, stiffer guidewire; advancing the side branch with the second guidewire to the side branch vessel; and developing the side branch with the side branch vessel; A method comprising:

Claims

1. a tubular member having a first end and a second end, the tubular member forming a main lumen having a first opening at the first end of the tubular member and a second opening at the second end of the tubular member, the tubular member including a column disposed within the main lumen forming a secondary lumen, the tubular member defining a plurality of apertures opening into the secondary lumen at longitudinal locations between the first end and the second end of the tubular member, the plurality of apertures defined through the tubular member, the plurality of apertures in fluid communication with the column, the column having a column opening defined proximal to the second end of the tubular member; and a stent member supporting the tubular member; 1. An implantable device, including:

2. The implantable device of claim 1, wherein the tubular member includes a first graft member defining the main lumen and a second graft member coupled to the first graft member to form the column, the second graft member defining the secondary lumen between the first graft member and the second graft member.

3. The implantable device of claim 2 , wherein the secondary lumen opens into the main lumen at a proximal opening of the secondary lumen.

4. The implantable device of any one of claims 1 to 3, wherein the secondary lumen is collapsible.

5. The implantable device of any one of claims 1 to 4, wherein said secondary lumen is not supported by a stent.

6. The implantable device of any one of claims 1 to 5, wherein the stent member comprises a plurality of stent rings spaced longitudinally along the tubular member.

7. The implantable device of claim 6 , wherein each of the plurality of apertures is separated from each other by at least one of the plurality of stent rings.

8. The implantable device of any one of claims 1 to 7, wherein each aperture of the plurality of apertures comprises a circular shape or a shape defining a rounded portion and a substantially flat portion.

9. The implantable device of any one of claims 1 to 8, wherein the tubular member includes a plurality of secondary lumens extending longitudinally along at least a portion of the tubular member and circumferentially spaced from one another.

10. The implantable device of any one of claims 1 to 9, further comprising a restraining member receiver positioned to surround at least a portion of the stent member.

11. The implantable device of any one of claims 1 to 10, wherein the tubular member includes a scallop at the first end.

12. The implantable device of any one of claims 1 to 11, wherein the secondary lumen extends along a longitudinally extending secondary lumen axis at an angle greater than zero relative to the axis of the main lumen.

13. a tubular member having a first end and a second end, the tubular member forming a main lumen having a first opening at the first end of the tubular member and a second opening at the second end of the tubular member, the tubular member including a plurality of columns each defining a secondary lumen, each column of the plurality of columns being circumferentially spaced from one another, each secondary lumen having an aperture defined through the tubular member at a location between the first end and the second end and in fluid communication with the column, the columns having a column opening defined proximate the second end of the tubular member, each column operable to collapse under fluid pressure; and a stent member supporting the tubular member; 1. An implantable device, including:

14. an implantable device comprising a body and a side branch, wherein the body comprises a tubular member and a stent member supporting the tubular member, the tubular member forming a main lumen having a first opening and a second opening, the tubular member having an aperture defined therethrough and forming a secondary lumen having a proximal opening proximal to the second opening of the tubular member; an elongate member having a first end and a second end, wherein the body of the implantable device is disposed at the first end of the elongate member, the elongate member defining a delivery lumen extending along at least a portion of the longitudinal length of the elongate member and operable to deliver a side branch; a catheter olive disposed on the first end of the elongate member such that the body of the implantable device is longitudinally disposed between a forward tip of the catheter olive and the second end of the elongate member; a restraining member disposed about the body and restraining the body in a delivery configuration; and a secondary restraint member disposed about the body stent, wherein the secondary restraint member is operable to restrain the body in a partially restrained configuration; a delivery system comprising:

15. 15. The delivery system of claim 14, further comprising a guide member extending from the delivery lumen of the elongate member, from the proximal opening through the aperture, through the secondary lumen of the tubular member, and coupled to the catheter olive.

16. The delivery system of claim 15 , further comprising an exchange catheter coupled to the guide member and operable to be advanced along the guide member.

17. a first guidewire operable to be delivered through said exchange catheter; a curved catheter operable to be advanced over the first guidewire; and a second guidewire stiffer than the first guidewire, wherein the second guidewire is operable to be advanced through a curved catheter and the side branch is operable to be advanced along the second guidewire to a target site; 17. The delivery system of claim 16, further comprising:

18. an implantable device comprising a body and a side branch, wherein the body comprises a tubular member and a stent member supporting the tubular member, the tubular member forming a main lumen having a first opening and a second opening, the tubular member defining a secondary lumen, and including a column having an aperture defined therethrough and having a column opening proximal to the second opening of the tubular member; an elongate member having a first end and a second end, wherein the body of the implantable device is disposed proximal to the first end of the elongate member, the elongate member defining an operable lumen through which a side branch can be delivered; a catheter olive disposed on the first end of the elongate member such that the body of the implantable device is longitudinally disposed between a forward tip of the catheter olive and a second end of the elongate member; a restraining member disposed about the body and restraining the body in a delivery configuration; and a guide member extending from the lumen of the elongate member, from a proximal opening, through the aperture, through the secondary lumen of the tubular member, and coupled to the catheter olive; a delivery system comprising:

19. a secondary restraint member disposed about the stent member of the body, wherein the secondary restraint member is operable to restrain the body in a partially restrained configuration; 20. The delivery system of claim 18, further comprising:

20. 20. The delivery system of claim 19, wherein the stent member of the main body includes a plurality of stent rings, and the secondary restraint member includes a plurality of wires, each wire corresponding to a corresponding one of the plurality of stent rings.

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