Aortic dissection and aortic false lumen embolization device

Abstract

One embodiment includes a system including a backbone, a first polyurethane shape memory polymer (SMP) foam on the backbone, a second polyurethane SMP foam on the backbone, and a third polyurethane SMP foam on the backbone and between the first and second SMP foams. Other embodiments are described herein.

Description

Technical Field

[0001] Cross - Reference to Related Applications

[0001] Cross - Reference to Related Applications This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 383,665, filed on November 14, 2022, entitled "Aortic Dissection and Aortic False Lumen Embolization Device", the content of which is incorporated herein by reference. This application further claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 356,598, filed on June 29, 2022, entitled "False Lumen / Aortic Dissection Therapeutic Device", the content of which is incorporated herein by reference. This application further claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 510,662, filed on June 28, 2023, entitled "False Lumen / Aortic Dissection Therapeutic Device", the content of which is incorporated herein by reference.

Background Art

[0002]

[0002] Aortic dissection (AD) occurs when damage to the innermost layer of the aorta allows blood to flow between the layers of the aortic wall, separating the layers. This is often associated with the sudden onset of severe chest or back pain, often described as "tearing". Vomiting, sweating, and dizziness may also occur. Other symptoms can result from a reduced blood supply to other organs such as stroke, lower limb ischemia, or mesenteric ischemia. AD can also lead to sudden death from inadequate blood flow to the heart or complete rupture of the aorta.

Summary of the Invention

[0003]

[0003] The features and advantages of embodiments of the present invention will be apparent from the appended claims, the following detailed description of one or more exemplary embodiments, and the corresponding figures. Where appropriate, corresponding or similar elements are indicated by repeating reference labels in multiple figures.

Brief Description of the Drawings

[0004]

Figure 1ABC

[0004] FIG. showing an embodiment of a method for treating AD using an embodiment of an AD system

Figure 1DEF

[0004] FIG. showing an embodiment of a method for treating AD using an embodiment of an AD system

Figure 2

[0005] FIG. showing a "pearls on a string" foam on a backbone in one embodiment

Figure 3

[0006] FIG. showing various cross-sections of implantable foams for embodiments

Figure 4

[0007] FIG. showing various delivery configurations of embodiments

Figure 5

[0008] FIG. showing an embodiment of a method for applying torque to an embodiment of an AD system

Figure 6

[0009] FIG. showing various embodiments of a multi-foam implant

Figure 7

[0010] FIGS. 7A - 7D are FIGS. showing various nested embodiments of foam implants (e.g., counterbores)

Figure 8

Figure 9AB

[0011] FIGS. 9A - 9B are FIGS. showing embodiments of various foam implants having various expanded foam diameters

Figure 9CD

[0011] FIG. 9C shows the spacing between various foams, but is a FIG. showing the connection between the end cap foam and the adjacent foam. FIG. 9D is a FIG. showing an arrangement that is undesirable in at least some examples and is prevented by the embodiment of FIG. 9C

Figure 10

[0012] FIG. showing an embodiment of a foam that may include one or more slidable foams or foam portions

Figure 11

[0013] A diagram showing an embodiment of a foam that may include one or more slidable foams or foam portions together with a UV adhesive and / or a radiation-opaque marker band.

Figure 12A

[0014] A diagram including various embodiments of a foam having a tapered end portion due to a marker band that compresses a portion of the foam.

Figure 12B

[0014] A diagram including various embodiments of a foam having a tapered end portion due to a marker band that compresses a portion of the foam.

Figure 13

Figure 14

[0015] A diagram showing an embodiment of a method utilizing axial shortening / clinching.

Figure 15

[0016] A diagram showing an embodiment of a method utilizing axial shortening / clinching.

Figure 16

[0017] A diagram showing an embodiment utilizing entanglement to occlude voids such as false lumens of AD.

Figure 17

[0018] A diagram showing various embodiments of a system utilizing a peel sleeve for encapsulating a foam.

Figure 18

[0019] A diagram showing various embodiments utilizing a removable delivery wire to facilitate imaging during system delivery.

Figure 19A

[0020] A diagram showing various embodiments using a delivery catheter having a flexible tube for contrast agent injection.

Figure 19BCD

[0020] A diagram showing various embodiments using a delivery catheter having a flexible tube for contrast agent injection.

Figure 20

[0021] A diagram showing various attachment / detachment embodiments for an AD system.

Figure 21

[0022] FIG. is a diagram showing various embodiments that facilitate an AD system with a smaller crimp diameter.

Figure 22ABCD

[0023] FIG. is a diagram showing various fixation embodiments for an AD system.

Figure 22EFGH

[0023] FIG. is a diagram showing various fixation embodiments for an AD system.

Figure 22IJ

[0023] FIG. is a diagram showing various fixation embodiments for an AD system.

Figure 23ABC

[0024] FIG. is a diagram showing various fixation embodiments for an AD system.

Figure 23DE

[0024] FIG. is a diagram showing various fixation embodiments for an AD system.

Figure 24

[0025] FIG. is a diagram depicting an embodiment of a delivery device for an AD system.

DETAILED DESCRIPTION OF THE INVENTION

[0005]

[0026] Reference is now made to the drawings, where like reference numerals are used for like structures. To more clearly show the structures of the various embodiments, the drawings included in this specification are schematic diagrams of the structures. Thus, for example, the actual appearance of a manufactured structure, such as in a photograph, may look different even though it still incorporates the claimed structure of the illustrated embodiment (e.g., walls may not be exactly orthogonal to each other in an actual manufactured device). Further, the drawings may show only the structures useful for understanding the illustrated embodiments. To maintain clarity of the drawings, additional structures known in the art may not be included. For example, not all layers of the device are necessarily shown. The terms “embodiment,” “various embodiments,” etc., indicate that the embodiments so described may include a particular feature, structure, or characteristic, but not all embodiments necessarily include the particular feature, structure, or characteristic. One embodiment may have some, all, or none of the features described for other embodiments. The terms “first,” “second,” “third,” etc., describe a common object and indicate that different examples of the same object are being referred to. The adjectives do not necessarily mean that the objects so described should be in a given order in any manner, whether temporal, spatial, ranking, or otherwise. “Connected” indicates that the elements are in direct physical or electrical contact with each other, and “coupled” indicates that the elements cooperate or interact with each other, but they may or may not be in direct physical or electrical contact. Phrases such as “including at least one of A or B” include situations having A, B, or both A and B.

[0006]

[0027] One embodiment is a shape memory polymer foam embolization implant for treating AD and the false lumen within the aorta. AD presents patient-specific anatomical structures that are difficult and extremely complex to treat. Typically, there are multiple fenestrations / ruptures along the long axis of AD that interact with other blood vessels branching from the aorta (e.g., renal arteries, SMA, celiac artery, etc.). One embodiment can be delivered through a tear or fenestration in the false lumen wall (e.g., proximal tear 103 or distal tear 102) and delivered into the false lumen space as a compressed minimally invasive foam factor. To achieve access to the false lumen space, catheter 104 can be introduced into the femoral artery and guided through the distal exit laceration of the dissected descending aorta portion (Figure 1C). Once delivered to the false lumen anatomical structure, the device expands to volumetrically fill the false lumen space and decompresses the false lumen (Figure 1D). This decompression (through thrombosis) stabilizes the inflow / outflow of the false lumen (Figure 1E). The porous geometric shape of the implanted foam device effectively causes volumetric thrombosis within the false lumen and restricts flow in the complex fenestrated anatomical structure. The expanded material is extremely flexible, reducing the risk of further dissection or rupture of the vascular anatomical structure. The embolization device can be used in combination with other endovascular techniques (e.g., stent 101, graft, etc.) to prepare the AD biological structure for optimal embolization implant delivery.

[0007]

[0028] The cross-section of the implant can be circular, rectangular, or kidney-shaped, as seen in FIGS. 3A - 3D, but is not limited thereto. The implant can be composed of a plurality of individual plugs such as the plug in FIG. 4A. In one embodiment, three, four, five, or more of the plugs in FIG. 4A may be placed in the false lumen. Further, a plurality of plugs may be attached along a carrier member (semi-rigid or flexible). In FIG. 4B, the plugs are connected by a semi-rigid carrier (e.g., polymer, metal, or SMA), filament, coil, etc. In FIG. 4C, the plugs are connected by a flexible carrier (e.g., polymer, metal, or SMA), filament, coil, etc. The carrier member can be composed of any combination of platinum / tungsten / iridium or stainless steel wire, marker band, coil, or beads. The carrier member may be a shape memory alloy or shape memory polymer including nitinol or polyurethane. Other options for flexible carrier members include, but are not limited to, polypropylene, polyethylene, polysulfone, polyurethane, PEEK, polyester (PLLA / PGA), polyanhydride, PDO, PCL, liquid crystal polymer, or any combination thereof.

[0029] The crimped device profile can be terminated proximally with a dome, fillet, or chamfered geometry to facilitate axial device alignment when pulling the device proximally into the delivery catheter during device retrieval. See, for example, FIGS. 7D or 12B.

[0030] Delivery of the flexible carrier member implant, or individual implants, can be performed in a random configuration. Alternatively, the semi-rigid carrier member implant can be delivered using radial torque control with respect to the aorta axis (see, for example, FIGS. 5A - 5D). This allows control of a non-circular device cross-section with respect to the false lumen cross-section (see, for example, FIGS. 3A - 3D). The non-circular device cross-section helps reduce the overall volume of the false lumen after device implantation, and the true lumen can expand when the false lumen is decompressed.

[0008]

[0031] In one embodiment, the radial torque control of the implant section can be selectively deactivated by retracting the locking core wire 501 or the hypodermic tube (Figs. 5A - 5D). The implant section includes an internal locking torque member 503 that engages the locking core wire so as to twist through mechanical interaction (such as lock and key, etc.). In an embodiment of this design, the overall length of the device can be axially torqued until the locking core wire retracts. When the core wire retracts, the most distal implant segment becomes radially flexible and conforms to the delivered biological structure, while the proximal implant segment engaged with the locking core wire can still be torqued (Fig. 5B). The implant section is sequentially disengaged from the locking core wire as the locking core wire retracts until the entire length of all implant sections becomes flexible (Fig. 5C). The locking core wire may be independent of the carrier member 504 that connects the implant section after implantation. The locking core wire may be radiopaque, thereby allowing the axial position of the plug to be identified during implant delivery and before retraction of the radiopaque locking core wire. The implant may be completely radiolucent to minimize subsequent imaging artifacts upon retraction of the radiopaque locking core wire, or may include radiopaque features (such as marker bands, etc.) for device identification via imaging. The marker band may include, for example, a radiopaque metal band surrounding a foam, wire, etc.

[0009]

[0032] In one embodiment, the locking core wire 501 may be a semi-rigid elastic or super-elastic material such as stainless steel or nitinol, or a combination thereof. The locking core wire may be a wire, tube, coil, ground profile wire, or any combination thereof. The internal lock or torque member 503 may be a metal, polymer, etc. For example, the internal lock member may be an SMP foam. The density of the internal lock member SMP foam may be different (e.g., greater) from the density of the general plug SMP foam 502 surrounding the internal lock member. The lock member (regardless of its material composition) may have a square cross-section channel for receiving a lock core wire with a similar square cross-section. Rotation of the lock core wire about its long axis also rotates the internal lock member and its plug SMP foam (which can substantially surround the internal lock member in a plane orthogonal to the long axis of the lock core wire). In other embodiments, the locking core wire may be somewhat flat. For example, it is similar to a "dipstick" used to check the oil in an engine. The locking core wire may be disposed within a channel of an internal locking member having a similar outer shape (thus, rotation of the locking core wire will necessarily rotate the internal locking member). In other embodiments, the internal lock member may be omitted, and the plug foam itself may include slots for receiving a flattened lock wire. Due to the strength of the plug foam, by twisting the locking core wire, the plug foam can be rotated without damaging the plug foam.

[0033] When delivered to the anatomical structure of the false lumen, the device provides acute hemostasis. The implanted shape memory polymer foam serves chronically as a tissue scaffold to promote healing and collagenous scar formation. This contractile collagenous scar tissue promotes contraction of the lesion, further reducing the false lumen volume, and promoting healthy true lumen aorta flow volume (Figure 1F). Over time, the implanted shape memory polymer material degrades, leaving more complete volumes of native tissue within the original false lumen volume.

[0010]

[0034] As an embodiment of any of the foams described in this specification, there is a shape memory polymer foam produced from a partial or total combination of N,N,N’,N’-tetrakis(2-hydroxypropyl)ethylenediamine (HPED), triethanolamine (TEA), hexamethylene diisocyanate (HDI), trimethylhexamethylene diisocyanate (HDI), 1,2,6-hexanetriol (HT), 3-methyl-1,5-pentanediol (MPD), 2-butyl-2-ethylpropanediol (BEP), 2-methyl-2,4-pentanediol, or other aliphatic diisocyanates and aliphatic diols or polyols. Other synthetic monomers include ethylene glycol diol and iodine-containing diols or alcohols containing triiodobenzene.

[0011]

[0035] Embodiments may include one or more implant plugs that are screwed onto a small-gauge backbone (e.g., a wire or coil backbone that includes platinum, iridium, or a combination thereof, or a polymer backbone that includes polyurethane, etc.). FIG. 6A includes an embodiment having three foams 602, 603, 604 along wire 606. Proximal and distal “end caps” 601, 605 are located at either end of the foam. Foams 602, 604 are foam plugs with a smaller diameter compared to foam 603. However, in other embodiments, foams 602, 604 may have the same diameter as 603. Elements 601, 605 may be a band (open cylinder) or a cap (a cylinder with a mostly closed end except for a void for receiving the backbone, similar to a bucket with a hole in the bottom through which the backbone passes). The elements may be radiopaque to assist the clinician in marking the proximal and distal boundaries of the implant. A small backbone may extend through each of the end caps and all of the foams located between the end caps. The wire may form an axis. As shown in FIG. 6E, a plane orthogonal to that axis may intersect the end cap and result in a cross-section having cap 601 that surrounds a portion of foam 602 and that foam portion that surrounds wire 606. The end caps may fix any foam plugs between the two end caps. The foam may be fixed and coupled to the backbone (which may include metal or polymer strands) via an adhesive. However, in other embodiments, one or more foams between the two end caps may be slidably coupled to the backbone. For example, the term “pearls on a string” as shown in FIGS. 2A-2C and 6A-6E addresses embodiments where one or more “pearls” (i.e., foams) slide along the backbone. The embodiments of FIGS. 6A-6E include foams that extend collectively along the backbone by 20, 30, 40, 50, 60, 70, 80, 90, 100 mm or more. The embodiments include foams having an expanded outer diameter of 8, 12, 16, 20, 24, 28, 32, 36, 40, 60 mm or more.FIG. 6C shows four foams on the backbone, while FIG. 6D shows two sets of three foams that can be located on the backbone.

[0012]

[0036] With respect to FIGS. 2A-2C, the embodiments of these figures are similar to the embodiments of FIGS. 6A-6E. One embodiment includes SMP foams 215, 216, 217 between platinum / iridium alloy marker bands 203, 204 and an adhesive 201 (used to round the distal end of the implantable device). The backbone 202 may include a platinum / iridium alloy coil that can be resistant to extension in some embodiments or may have a function of contracting under stimulation in other embodiments. The implantable may be separated from a push rod, guide wire, wire 210, etc. at the collar 205. The wire 210 may have a protrusion that fits within the opening of the collar 205. The hypodermic tube 209 can be used to control the path of the wire 210. A series of hypodermic tubes 211, 212, 213 are coupled to a luer 215, a Touhy Borst adapter 216 having a silicon seal, a stopper slug hypodermic tube 217, a terminal lock coil 214 to assist in delivering the SMP foam to the target implantation position. In various embodiments, preferably, it is another delivery system such as the system described in WO 2022 / 040490 pamphlet.

[0013]

[0037] In embodiments having two or more foams on a backbone, the space or gap between two adjacent foams provides the flexibility of the implant and / or the axial compliance of the implant structure after deployment. See, for example, FIGS. 9C, 10A, 11A, 12B, 13B, 16A. The foam may be delivered in a compressed state (e.g., FIGS. 10B, 11B, 12A, 13A), and its flexibility is limited (as opposed to the relatively increased flexibility when the foam expands). In this less flexible compressed state, the gaps between the foams can promote flexibility and ease of implantation as the device traverses the patient's vasculature. Further, the gaps can facilitate the "interlocking" of implant segments (e.g., FIG. 16B) for stability when finally deployed within the patient. However, in other embodiments, there is no space between the foams, thereby facilitating the function of pulling the foam out of the delivery catheter without snagging the foam on the conduit inlet / outlet orifice. See, for example, FIGS. 7B, 7D, 8A, 9A.

[0038] There are advantages to using foams of various sizes. For example, FIGS. 6B and 6C show proximal and distal smaller foams relative to a larger foam. The smaller foams can provide more space for the end cap to be attached to the backbone. The end cap may include a radiopaque color or beads. The color or cap may fit over a portion of the smaller foam. The smaller foam can be more easily crimped within the end cap. Further, (as opposed to the larger foam) the smaller foam is less likely to finally expand and expand back onto the end cap (compared to the larger foam), which can obscure the radiopaque feature of the end cap.

[0014]

[0039] Figures 7A - 7D address the "nested" embodiment where portions of each end foam are disposed within a larger plug with the portions adjacent. FIG. 7A shows two smaller foams configured to fit into counterbore holes or voids in the larger foam. Foams 703, 704, 705 are threaded onto core wire 702. FIG. 7B shows how a series of nested foams can be formed on a backbone using a counterbore. FIG. 7C shows the implant with the foams compressed, and FIG. 7D shows radiopaque marker band 706. By using a low crimp density foam 704 between high crimp density foams 703, 705, axial and radial flexibility is promoted when the implant is deployed. As used herein, additional radial flexibility increases, for example, the rotational function about axis 701 (shown "out of the page"). Further, despite the varying crimp density, the small and large foams collectively provide a uniform and consistent outer diameter, which helps facilitate pulling the implant into a delivery conduit (i.e., to prevent the larger diameter portion of the foam from being easily pulled into the delivery conduit in the event the implant is initially mispositioned). FIG. 7D shows the expanded implant. Note how marker band 706 compresses portions of the small foams, resulting in those small foams expanding and forming tapered edges towards the end caps (e.g., marker band). This rounding of the proximal and distal edges can, for example, make it easier to deploy or recapture the foam into a delivery conduit (e.g., catheter, hypo tube, etc.). In this embodiment, the region of low crimp density foam is associated with the smaller foams and the region of high crimp density is associated with the larger foams, although in other embodiments the foams can have the same outer diameter when expanded but varying crimp densities.

[0015]

[0040] Regarding figures such as FIGS. 7A - 7C, a legend providing hash patterns for low - crimp density foams and high - crimp density foams is included. For example, FIG. 7C shows a crimped foam. These hash patterns are also seen in expanded foams as described in FIG. 7B. Anyway, the legend is applicable to crimped foams rather than expanded foams. For example, in FIG. 7B, the density of the expanded foam can be the same regardless of the diameter of the part and any different hash patterns added by the drafter. The crimp density (FIG. 7C) is different when compressing its variable diameter to a smaller dimension. Thus, the density of the expanded foam is the lowest density, the crimp of a smaller - diameter plug (e.g., foam 704) can be of intermediate density, and the crimp of a larger - diameter plug (e.g., foam 705) can be of high density. This comment regarding the figures is also applicable to the legends of FIGS. 8A - 11B.

[0016]

[0041] FIGS. 8A - 8B show the embodiments of FIGS. 7A - 7C in more detail. In FIG. 8B, note how the high - crimp density region 804 (adjacent to the low - density region 805) can be based on the density of only the large foam (refer to plane 801) or both the large and small foams (refer to plane 802). Further, FIG. 8B illustrates a uniform outer diameter of the foam that can facilitate exiting from or returning into the delivery conduit. In one embodiment, the entire backbone 803 is radiopaque due to its material composition (e.g., platinum alloy).

[0017]

[0042] Regarding FIG. 8A further, the "nested" section of the smaller - diameter foams can function as a bridge between the larger - diameter plugs in the center for the purpose of eliminating / reducing gaps and facilitating the retraction of the implant by providing continuous foam segments. Thus, the embodiments of FIGS. 8A - 8B provide (1) improved axial flexibility by part 805, (2) a uniform implant diameter as shown in FIG. 8B, and (3) improved implantation performance (minimized foam shear) due to the uniform implant diameter.

[0018]

[0043] Figures 9A-9B show that the large foam has no countersink (compared to the countersink of FIG. 8A), but the large and small foams alternate. Due to the presence of the small foams, the implant still has improved axial and radial flexibility and maintains the uniform implantation diameter (i.e., before expansion) addressed in FIGS. 7A-7D, despite the absence of countersink holes. However, this embodiment is easier to manufacture compared to the embodiments with countersinks. The embodiments of FIGS. 9A-9B provide (1) improved axial flexibility by part 905, (2) a uniform implantation diameter as shown in FIG. 9B, and (3) improved implantation performance (minimized foam shearing) due to the uniform implantation diameter.

[0019]

[0044] One embodiment may include both nested adjacent foams and non-nested adjacent foams. By using either technique, a balance can be achieved between the need to better control the flexibility and axial positioning of the plug. For example, the distal region of the implant can benefit from non-nested fixed foams, while the proximal region of the implant (configured to be implanted near the entrance to a void such as an aortic aneurysm or AD) may have foams that can slide relative to each other and bunch up to better seal the void entrance. This bunching and sealing can be facilitated by using nested foams. Even if the non-nested foams do not slide, their non-nested nature can promote flexibility.

[0020]

[0045] In FIG. 9C, the proximal end of the implant is constructed of an end cap foam 910 (the most proximal foam) nested within a first large-diameter plug 911. This promotes stability and tissue juxtaposition of the proximal portion of the implant after foam expansion. A radiopaque band 912 can be fitted around a portion of the foam 910 to cause a curvature of the surface 913. This can also reduce the expansion of the large proximal foam plug within the tissue space, while leaving the smaller diameter "end cap" foam free to hang within the space. For example, in FIG. 9D, the proximal portion separates from the first large-diameter plug and undesirably moves into the true lumen, thereby obstructing blood flow. To prevent such a situation, the smaller end cap can be fixedly attached to a portion of the first large-diameter plug or backbone.

[0021]

[0046] FIGS. 10A-10B show embodiments that are even more flexible than the embodiments of FIGS. 7A-9B by including voids or gaps between the foams where no foam is present. FIG. 10A shows the implant before the addition of crimping and marker bands (i.e., end caps). In this embodiment, one or more of the SMP foams 1002, 1003, 1004, 1005, 1006 are slidably coupled to a backbone 1001 (e.g., a platinum alloy wire for visualization). In one embodiment, some of the foams may be slidably coupled to the backbone (e.g., the three central foams), while other foams are attached to the backbone (e.g., the two outer foams). In other embodiments, all of the foams are slidably connected to the backbone. In other embodiments, none of the foams are slidably coupled to the backbone (instead, they are fixedly adhered or bonded to the backbone). The foams 1003, 1004, 1005 having a larger expansion diameter may be crimped to the higher density foams located between the more low-density crimped foams 1002, 1006. The gaps located between the foams (e.g., gaps 1009, 1010) serve to facilitate the flexibility of the device during and after implantation. The marker bands 1007, 1009 can be used to more easily visualize the start and end of a series of foams.

[0022]

[0047] Figs. 11A - 11B are similar to Figs. 10A - 10B, but elements such as elements 1102, 1103 are used. The elements may be adhesives and / or marker bands (e.g., 1102, 1103) for fixing one end of one or more foams to the backbone while allowing the opposite end of the foam to slide freely along the backbone. These may be combined with other elements such as radiopaque marker bands 1103, 1104, etc. As a result, the foams are less likely to bunch together (since one end of each foam is statically bonded to the backbone), but bunching may be undesirable in some applications. However, this bunching may be desirable in other applications. For example, bunching of the foams around the entrance to a void (e.g., an aortic aneurysm) may be considered beneficial by some clinicians. The adhesive may include a UV adhesive.

[0023]

[0048] Figs. 12B and 13B show how adhesives and / or marker bands (e.g., 1202, 1203) narrow the foam towards the adhesives and / or marker bands. The adhesives and / or marker bands on both sides of the SMP foam can make the foam appear oval or somewhat spherical (e.g., refer to the foam at the left end of Fig. 12B). In the case of Fig. 12B, proximal fixation of the individual foam sections can make device retrieval more consistent within the delivery catheter without shearing the foam against the core wire. In Fig. 12B, elements 1201, 1202, 1205 may be adhesives and / or marker bands for fixing one end of one or more foams to the backbone while leaving the opposite end of the foam free to slide along the backbone. These may be combined with other elements such as radiopaque marker bands 1203, 1204, etc. Similar to the other embodiments described above, the embodiments of Figs. 12B and 13B may combine more densely crimped foams 1207, 1208, 1209 with less densely crimped foams 1206, 1210.

[0024]

[0049] In one embodiment, the marker band can be fixed to the core wire by direct crimping, caulking, adhesion, or other methods. Thereby, the expansion of the foam (maximum expanded foam volume) can be completed. In this embodiment, one or more foams may be slidably coupled between the marker bands or fixedly attached between the marker bands. By arranging the marker bands with or without using a UV adhesive (see, for example, FIG. 11B), the axial position of the implant can be defined / fixed. In contrast, in other embodiments addressed herein, plugs can aggregate on one side (which can be disadvantageous or advantageous depending on clinical factors), and there are foams that can freely float on the core wire.

[0025]

[0050] Figures 14A - 14B deal with the system and its method of use. In this embodiment, the advantage of flexibility during implantation (due to the spacing between the foams) is combined with the stability after implantation (due to the absence of spacing between the foams). The core wire can be shortened in various ways. For example, the backbone may be formed from a polyurethane shape - memory polymer foam that contracts axially and expands radially when activated. Other ways to shorten the backbone include the following. First, the backbone is a shape - memory polymer filament that contracts axially when exposed to heat, laser irradiation, or some other external stimulus. Second, the backbone is a filament (metal, polymer, or woven fabric) that is pulled through a proximal tightening mechanism (e.g., incorporated into a marker band or as a stand - alone component). The tightening component allows the backbone member to slide proximally, but restricts the distal movement of the filament. At least some of the foam segments along the backbone are slidably coupled to the backbone and are compressed axially together when the backbone filament shortens. Third, the backbone is a filament (metal or polymer) (either incorporated into a marker band or as a stand - alone component) that is pulled through a proximal opening member on the implant. The filament can slide freely proximally and distally within the opening member until the opening is actuated (e.g., a mechanical channel may be closed) to lock the filament in place. Once actuated, the filament can no longer move distally within the aperture member. In some embodiments, the opening member can still move the filament proximally for further axial shortening of the implant after actuation of the opening member. Fourth, in some embodiments, the length of the backbone filament pulled proximally through a tightening member and / or an opening member can be trimmed from the final implant. The filament can be trimmed by a removal mechanism (e.g., a heating element that melts the backbone filament or an electrode that electrolyzes a stainless - steel core filament) that deploys the implant from a proximal delivery push - wire.Alternatively, external core filament trimming energy can be delivered by a delivery catheter (e.g., heat, electrolysis, radiofrequency, laser, or other forms of energy). Fifth, in other embodiments, a filament wire pulled proximally through a clamping or proximal aperture member remains attached to the implant and freely flows within the implanted vascular biological structure while attached to the implant. Sixth, in other embodiments, a filament wire pulled proximally through a clamping or proximal aperture member remains attached to the implant and is pre-shaped into a geometry that reduces the amount of free space occupied by the filament backbone. In one example, the free portion of the proximally pulled filament not contained within a shape memory polymer foam is formed into a coil to increase the surface area to volume ratio within the target vascular anatomical structure.

[0026]

[0051] Accordingly, in FIGS. 14A - 14B, after initial deployment and foam expansion, a flexible core wire is shortened to reduce or eliminate gaps between individual implant segments. Utilizing this feature, the stability of the implant assembly within the aneurysm / lumen space can be readily improved.

[0027]

[0052] FIGS. 15A - 15D address how an axial shortening system can be deployed alone or, for example, after other implants have already been implanted into an anatomical void (e.g., a false lumen). The shortening embodiment can be used to better seal the void entrance. Accordingly, the axial shortening feature of the device can be employed to seal a tear (proximal tear) that serves as a fluid inlet to dissociation. Axial clamping / shortening can also be used to seal the distal tear. The tear seal can be a feature of a false lumen embolization implant or a separate attachment to a lumen embolization device.

[0028]

[0053] Figures 16A - 16B address how the torque feature of, for example, Figure 5 can facilitate entanglement of a plugging device (e.g., shape memory polymer foam, hydrogel). After expansion of the foam, individual implants disposed along a flexible core wire can become entangled, resulting in a more stable (e.g., less likely to move) structure within the aneurysm space. Entanglement can be promoted by applying torque to the assembly during delivery (as previously disclosed). Entanglement may occur randomly as the implant assembly is advanced or filled into the aneurysm space. Also, giving the core wire a predetermined curve or other shape can facilitate entanglement. If the core wire is composed of a shape memory material such as nitinol, the implant assembly can be delivered to the target location in a nominally straight configuration via a catheter, but then assumes a secondary configuration as it is deployed with the blood vessel or aneurysm. The secondary backbone shape may be formed by elastic recovery of an annealed platinum alloy coil.

[0029]

[0054] One embodiment may include a multi - spline device. For example, two backbones may each be fixed to the same single proximal end cap (such as a marker band) and the same single distal end cap (such as a marker band). The backbone may include memory such as shape memory polymer, nitinol. After deployment from the delivery conduit, the backbone may retract axially, arc away from each other, and form a strut / backbone umbrella that better aids in rapidly deploying a number of embodiment elements (e.g., 3 - 5 elements per backbone) into the void.

[0030]

[0055] In FIGS. 17A - 17D, the embodiment may include a thin - wall polymer tube 1704 disposed over a crimped SMP foam implant 1703 to assist in maintaining the outer diameter (OD) compressed during packaging, shipping, and storage. The polymer tube may include polyethylene terephthalate (PET), PEBAX, or another extrudable thermoplastic material. After extrusion, the material may be blown radially with a compressed gas to expand the radial dimensions and result in a thinner wall (e.g., 0.0005 inches - 0.0015 inches). The extruded / blown material may increase the radial strength to help maintain the diameter of the crimped SMP foam. Through any combination of (1) material selection, (2) appropriate material thickness, (3) extrusion under axial strain to axially align the polymer chains, (4) perforation along the axis of the finished tube, and / or (5) other parameters in the draw / blow process, the material sleeve may be biased to longitudinally tear along the axis of the tube, facilitating removal of the sleeve. Use of a strip of thread or suture (or similar high - tensile strength material) 1702 serves to propagate the longitudinal break for removal of the sleeve (FIGS. 17A - 17D). In one embodiment, the peel - away sleeve is utilized only for packaging / storage and may be removed by an operator immediately prior to device introduction to the patient. In other embodiments, the peel - away sleeve may be configured to be part of the delivery and implant release system. In such embodiments, the proximal end of the peel - away tube is fixed to a delivery wire or shaft (e.g., shaft 1701). During device manufacture, the sleeve may be radially contracted over the foam plug or the foam may be radially expanded into the sleeve. In either case, the foam is fixed within the peel - away sleeve while capturing the thread for tearing the tube (FIGS. 17A, 17C). The foam plug (fixed within the peel - away sleeve) may be advanced to a desired anatomical location and released. The peel - away sleeve is removed by retracting proximally the captured suture so as to cut through the wall of the peel - away sleeve (FIGS. 17B, 17D). The peel - away sleeve remains attached to the delivery wire and is removed from the patient along with the delivery system, leaving only the occlusive implant in place.

[0031]

[0056] Embodiments may include an implant with radiopaque markers for monitoring during and after the procedure of device placement via X-ray imaging. Other embodiments include implants without radiopaque features, reducing imaging artifacts by subsequent diagnostic imaging systems such as CT scans. Embodiments of the device can be visualized during and after treatment using ultrasonic or optical coherence tomography (OCT) imaging diagnostic methods. The multi-plug device can be connected to a polymer (biodegradable or bioresorbable) carrier member. These embodiments can be 100% degraded after implantation.

[0032]

[0057] In one embodiment of the method, an embodiment of a non-radiopaque device may be delivered to the false lumen of the AD while a second intravascular ultrasound (IVUS) catheter is positioned within the true lumen of the aorta. By this method, the anatomical structure of the false lumen can be visualized, the positioning of the device can be monitored, and the expansion of the SMP foam can be monitored independently of angiography (as a result, radiation is reduced and the amount of contrast agent injected is reduced). Ultrasonic imaging can be independent of fluoroscopy or used in combination with an X-ray imaging modality.

[0033]

[0058] In other embodiments, the delivery system includes a radiopaque element 1802, such as a platinum-iridium or platinum-tungsten alloy wire, that is screwed through the entire length of the plug implant (single or multiple foam plugs 1801), as seen in FIG. 18A. When multiple SMP foams are used, they are joined to each other via a thread or other backbone. However, in other embodiments, the foams are released from each other when member 1802 is removed. During implant delivery, the wire is visible under fluoroscopy and will serve to define the location of the foam. This radiopaque element can be removed from the implant either as part of the implant release mechanism or independently of device removal from the delivery system (including delivery shaft 1803, FIG. 18B). After retraction, if the implant is completely radiopaque, subsequent X-ray or CT imaging artifacts can be minimized, or the implant can include an additional radiopaque element for device identification in X-ray imaging.

[0034]

[0059] Thus, in FIGS. 18A - 18B, the delivery system includes a radiopaque element, such as a Pt / Ir wire, that can be screwed through the length of the implant. During implant delivery, the wire is visible under fluoroscopy and will serve to define the location of the foam. After release of the foam implant from the delivery catheter, the radiopaque wire is withdrawn, leaving only the foam. This embodiment may be used in combination with the peel-away sleeve delivery / implant release concept of FIGS. 17A - 17D.

[0035]

[0060] In other embodiments, as seen in FIGS. 19A-19D, the flexible tube 1901 passes through one or more of the expandable plugs (e.g., SMP foam, hydrogel) 1902 that are crimped during delivery, using the shaft 1903. The tube 1901 may be stainless steel, nitinol, a polymer extrusion with single or multiple lumens, or a braided or coil-reinforced polymer tube such as polyimide. The contrast agent 1904 is delivered through the tube and visualized. For example, in FIG. 19B, the tube 1901 is filled with contrast agent to visualize the system. The contrast agent injected through the tube makes the tube radiopaque, providing information about the position of the device and the orientation of the plug. A window in the tubing (e.g., laser cut, or a loose portion of the coil / braid) can facilitate the direct delivery of liquid contrast agent into the foam (while being crimped and / or after SMP foam expansion) to improve visualization of the plug (FIG. 19C). Further, the tube window can be positioned between the foam plugs to inject contrast agent into false lumen anatomical structures (FIG. 19D) (while being crimped and / or after SMP foam expansion). The tube can be flushed with sterile saline to remove all air prior to device delivery to the patient. After release of the plug implant, the tube can be withdrawn, leaving only the foam.

[0036]

[0061] Removal of the plug implant from the delivery system may be accomplished using, for example, the pin and loop release mechanism outlined in FIGS. 20A-20D. This mechanism includes, for example, (a) a retaining loop 2001 on the implant side (e.g., SMP foam 2004) that will ultimately be implanted in the patient, (b) a retaining loop 2002 on the delivery system side (which may include the delivery catheter shaft 2006) that will ultimately be removed from the patient, and (c) a retractable core wire 2003 that is removed from the patient. The closed end of the implant and the delivery system retaining loop are positioned to overlap, and the distal portion of the retractable core wire is passed between the two closed loops and advanced into the implant to effectively capture and hold the implant. When the core wire is retracted, the distal tip becomes proximal to the implant retaining loop and the implant is released. The marker band 2005 can assist in visualization.

[0037]

[0062] Embodiments may include large-diameter plug plugs (20 mm and above) with uniform foam density and volume, such as solid cylinders of uniform foam. Other embodiments may have a gradient of foam density as a result of foam synthesis parameters. Other embodiments may have variable foam density due to the foam volume removed from the bulk plug during manufacture (see FIGS. 21A - 21F). The material can be removed as a core along the axis of the foam cylinder, spokes can be removed perpendicular to the cylinder axis, the core can be removed directly from the central foam axis, or combinations thereof. Selectively removing material from the foam volume can result in a higher crimp ratio (i.e., a smaller crimp diameter for an equivalent inflated diameter). The higher the crimp ratio, the greater the volume expansion that the device can achieve after being delivered through a small cross-section delivery catheter for minimally invasive device delivery. Embodiments of the foam plug can still expand fully when material is selectively removed, and other embodiments with significant foam volume removal can incorporate other features (such as shape memory alloy splines) to complement foam expansion once the foam becomes rubbery above its glass transition temperature. At temperatures below the glass transition temperature, the compressed foam material constrains the splines of the shape memory alloy and has sufficient rigidity to maintain a smaller cross-section with a crimped diameter. For example, SMP foam or nitinol wire can be included within the voids (e.g., void 2101) and can help expand the outer foam 2102.

[0038]

[0063] Device features including a tissue adhesive that coats the outer diameter of a plug entanglement, a hook that integrates with the blood vessel wall, and / or a crimp plug that adheres the device to the blood vessel wall are intended to keep the implant device within the target local volume of the false lumen. By controlling the anatomical positioning of the embolization implant within the false lumen space, AD is selectively embolized while avoiding collateral blood vessels that should remain patent and are connected to the AD anatomical structure that should remain open. An alternative embodiment uses a bulk foam plug that is locally positioned with a delivery catheter and held in place until fully expanded. The thrombus integrated with the expanded foam provides adhesion to the local tissue. Once the expanded device is securely held in place, the device is removed and the delivery system is removed from the patient.

[0039]

[0064] For example, FIGS. 22A-22D show an SMP foam 2201 coupled to an inferior vena cava (IVC) filter 2202. The IVC filter (or other anchor member) includes radially expanding barbs on the distal opposing portion of the implant. The portion facing proximal to the implant is composed of SMP foam. The SMP foam plug blocks / suppresses blood flow, and the barbs help stabilize and center the foam within the false lumen. Thereby, the volume of foam required to block or impede blood flow can be reduced.

[0040]

[0065] FIGS. 22E-22H show a method of implanting the system of FIGS. 22A-22D. The user can place the implant under fluoroscopy so that the expanded foam does not block the orifice of the blood vessel with which it communicates. The blood vessel 2203 located distally (below) the plug receives blood fed from the re-entry tear. Blood flow to the blood vessel 2208 starting from above the plug can still receive a limited flow from the blood flowing through the plug. Over time, thrombus and tissue ingrowth are further restricted (and potentially eliminate flow through the plug). During this time, the body accommodates and potentially establishes flow via collateral vessel formation.

[0041]

[0066] Figures 22I - 22J are similar to the system of Figure 22A, but show a system using a stent or backbone system 2204 coupled to the SMP foam 2205. The stent is nominally cylindrical but can conform to the shape of the false lumen. The foam elements are coupled to the stent. The foam may be positioned entirely within the stent, partially within the stent, or entirely outside the stent (but attached to the stent, e.g., via a tether wire or a swaged marker band). The stent serves to stabilize and center the foam within the false lumen and can reduce the volume of foam necessary to block or impede blood flow. The user positions the implant such that the inflated foam does not occlude the opening of the blood vessel contacted under fluoroscopy. The blood vessel 2203 located distal (below) the plug receives the blood fed from the reentry tear. The blood flow to the blood vessel 2208 starting above the plug can still receive a limited flow from the blood flowing through the plug. Over time, thrombus and in - growth of tissue are further restricted (and potentially eliminate the flow through the plug). During this time, the body accommodates and potentially establishes flow via collateral vessel formation. The mesh size of the stent can be adjusted to contribute to occluding the collateral vessels (fine mesh) or to allow the collateral vessels to remain patent even when the stent crosses a vessel bifurcation point (loose mesh).

[0042]

[0067] Figures 23A - 23C show an SMP foam 2305 coupled to the distal end of a backbone support system (e.g., stent 2304). In Figure 23D, the stent is positioned over the blood vessel 2306. Figure 23E discloses a variant of the embodiment of Figure 23A, but there is a plugging device distally coupled to the stent via a tether 2307. The tether 2307 may cross the center of the three foams (Note: Figure 23E shows a cross - sectional view such that the tether crossing the center of the foam is visible).

[0043]

[0068] The following examples relate to further embodiments.

[0069] The first set of examples

[0070] Example 1. A system comprising a backbone, a first polyurethane shape memory polymer (SMP) foam on the backbone, a second polyurethane SMP foam on the backbone, and a third polyurethane SMP foam on the backbone and between the first SMP foam and the second SMP foam.

[0071] The backbone may be rigid or flexible. The backbone may include metals, polymers, suture threads, threads, woven fabrics, and the like.

[0072] Example 2. The system according to Example 1, further comprising first and second radiopaque conduit portions on the backbone, wherein the first, second, and third SMP foams are between the first radiopaque conduit portion and the second radiopaque conduit portion.

[0073] Example 3. The system according to Example 2, wherein at least one of the first, second, or third SMP foams is slidably coupled to the backbone.

[0074] For example, refer to the slidable "pearls on a string" in FIG. 6C.

[0075] Example 4. The system according to Example 3, wherein at least one other of the first, second, or third SMP foams is statically and non - slidably coupled to the backbone.

[0076] Example 5. The system according to Example 1 or 2, wherein at least one of the first, second, and third SMP foams includes a first portion slidably coupled to the backbone and a second portion statically coupled to the backbone.

[0077] Example 6. The system according to any one of Examples 1 - 5, wherein the third SMP foam includes a counterbore portion for surrounding at least a portion of the first SMP foam.

[0044]

[0078] Example 7. The system according to Example 6, wherein the backbone is oriented along a major axis that traverses the first, second, and third SMP foams, the first and second planes are orthogonal to the major axis, the first plane intersects the first and third SMP foams, and the second plane intersects the third SMP foam but does not intersect the first SMP foam.

[0079] Example 8. The system according to Example 2, wherein the backbone is oriented along a major axis that traverses the first, second, and third SMP foams, the plane is orthogonal to the major axis, and the plane intersects the first SMP foam and the first radiopaque conduit portion.

[0080] For example, refer to FIG. 12B.

[0045]

[0081] Example 9. The system according to Example 8, wherein the first SMP foam includes an outer diameter that decreases as the first SMP foam approaches the first radiopaque conduit portion and when the first SMP foam is expanded.

[0082] Example 10. The system according to any one of Examples 1 to 9, wherein the first, second, and third SMP foams each have an expanded primary shape and a compressed secondary shape, the first SMP foam has a first maximum outer diameter in the primary shape, the second SMP foam has a second maximum outer diameter in the primary shape, the third SMP foam has a third maximum outer diameter in the primary shape, and the third maximum outer diameter is greater than at least one of the first maximum outer diameter or the second maximum outer diameter in the first shape.

[0083] For example, refer to FIG. 6A, 7B, or 12B.

[0046]

[0084] Example 11. The first SMP foam has a first maximum outer diameter in its secondary shape, the second SMP foam has a second maximum outer diameter in its secondary shape, the third SMP foam has a third maximum outer diameter in its secondary shape, and the third maximum outer diameter is equal to each of the first and second maximum outer diameters in the secondary shape, the system of Example 10.

[0085] For example, see FIGS. 7C or 12A.

[0047]

[0086] Example 12. The first SMP foam has a first crimp density in its secondary shape, the second SMP foam has a second crimp density in its secondary shape, the third SMP foam has a third crimp density in its secondary shape, and the third crimp density is greater than the first crimp density, the system of Example 11.

[0087] Example 13. The backbone is configured to axially contract in response to a stimulus, the stimulus including at least one of heat, light, moisture, magnetic energy, or combinations thereof, the system according to any one of Examples 1 to 12.

[0088] In one embodiment, the backbone may have first and second configurations. For example, the backbone may include nitinol and deform from a first configuration (generally linear so as to fit within a delivery conduit and be passed through the vasculature) to a second configuration (coiled into a helical shape, a conical shape, and equivalents). During the transition between the first configuration and the second configuration, the backbone may shorten in length from its most proximal tip to its most distal tip.

[0048]

[0089] Example 14. Comprising a mechanical lock coupled to the backbone, the mechanical lock being configured to resist distal movement of the backbone, the system according to any one of Examples 1 to 13.

[0090] Example 15. The mechanical lock is configured to allow proximal movement of the backbone, the system according to Example 14.

[0091] Example 16. The system according to any one of Examples 14 to 15, wherein the mechanical lock includes a cinch.

[0092] Example 17. The system according to any one of Examples 1 to 16, further comprising a further backbone that traverses the first, second, and third SMP foams.

[0093] For example, refer to FIG. 5A.

[0094] Example 18. The system according to Example 17, wherein the further backbone is mainly parallel to the backbone.

[0049]

[0095] Example 19. The third SMP foam includes the first portion and the second portion, the first portion of the third SMP foam is more rigid than the second portion of the third SMP foam, and the further backbone is slidably coupled to the first portion of the third SMP foam. The system according to Example 17 or 18.

[0096] For example, for the more rigid first portion of the third SMP foam, refer to the "internal torque member" in FIGS. 5A to 5D.

[0097] Example 20. A fourth SMP foam is provided between the second SMP foam and the third SMP foam, the fourth SMP foam includes the first portion and the second portion, the first portion of the fourth SMP foam is more rigid than the second portion of the fourth SMP foam, and the further backbone is slidably coupled to the first portion of the fourth SMP foam. The system of Example 19.

[0098] Example 21. In a first orientation, the further backbone is slidably coupled to the first portion of each of the third and fourth SMP foams, and in a second orientation, the further backbone retracts and is slidably coupled to the first portion of the third SMP foam but is no longer slidably coupled to the fourth SMP foam. The system of Example 20.

[0099] For example, refer to FIGS. 5B to 5C.

[0100] Example 22. The first portion of the third SMP foam is the system according to any one of Examples 17 to 21, including the SMP foam.

[0050]

[0101] Example 23. A further backbone is coupled to the first portion of the third SMP foam at a first position, and a cross-section of the further backbone at the first position is non-circular, and the non-circular cross-section is oriented perpendicular to the major axis of the cross-section of the further backbone, the system according to any one of Examples 17 to 22.

[0102] Example 24. The second portion of the third SMP foam surrounds the first portion of the third SMP foam in a plane perpendicular to the major axis of the further backbone, the system according to any one of Examples 19 to 23.

[0051]

[0103] Example 25. The backbone is oriented along a major axis that traverses the first, second, and third SMP foams, a minor axis is perpendicular to the major axis, the third SMP foam includes a continuous outer surface that surrounds the third SMP foam in a plane perpendicular to the major axis, the third SMP foam includes a first void that does not include foam cells, the minor axis intersects the first void, and the minor axis intersects the continuous outer surface of the third SMP foam at least twice, the system according to any one of Examples 1 to 24.

[0104] For example, refer to the void 2101 of the foam 2102 in FIG. 21D.

[0105] Example 26. A further minor axis is perpendicular to the major axis, the first SMP foam includes a second void that does not include foam cells, the further minor axis intersects the second void, and the further minor axis intersects the continuous outer surface of the first SMP foam at least twice, the system according to Example 25.

[0052]

[0106] Example 27. The backbone is oriented along the major axis that traverses the first, second, and third SMP foams, the minor axis is perpendicular to the major axis, the first SMP foam includes a continuous outer surface that surrounds the first SMP foam within a plane perpendicular to the major axis, the first SMP foam includes a first void that does not include foam cells, the minor axis intersects the first void, and the minor axis intersects the continuous outer surface of the first SMP foam at least twice. The system according to any one of Examples 1 to 24.

[0107] Example 28. A further minor axis is perpendicular to the major axis, the first SMP foam includes a second void that does not include foam cells, the further minor axis intersects the second void, and the further minor axis intersects the continuous outer surface of the first SMP foam at least twice. The system according to Example 27.

[0108] Example 29. Including an elastic member, the minor axis intersects the elastic member. The system according to any one of Examples 25 to 28.

[0109] For example, the system may include a nitinol arm contained in the void and assisting in expanding the foam.

[0053]

[0110] Example 30. Comprising a structural support backbone coupled to the second SMP foam, the second SMP foam being between the third SMP foam and the structural support backbone. The system according to any one of Examples 1 to 29.

[0111] For example, see FIG. 23E. The backbone may include an IVC filter and / or a stent.

[0112] In one embodiment, the backbone includes the tether 2307 of FIG. 23E.

[0113] One embodiment has been modified to include a single SMP foam coupled to the backbone, but may include any of the above examples. For example, see FIG. 23D.

[0114] The embodiment has been modified to omit the backbone, but may include any of the above examples. For example, see FIG. 23C.

[0054]

[0115] Example 31. A system comprising a first polyurethane shape memory polymer (SMP) foam and a structural support backbone coupled to the first SMP foam, the structural support backbone including first and second opposing ends, wherein the first SMP foam is coupled to one of the first or second opposing ends.

[0116] For example, see FIGS. 22A or 23C.

[0055]

[0117] Example 32. A method comprising implanting at least a portion of the system according to any one of Examples 1 to 31 into a false lumen of a aortic dissection.

[0056]

[0118] Set of the second example

[0119] Example 1. A system comprising a backbone, a first polyurethane shape memory polymer (SMP) foam on the backbone, a second polyurethane SMP foam on the backbone, and a third polyurethane SMP foam on the backbone and between the first SMP foam and the second SMP foam.

[0120] For example, see first SMP foam 1210, second SMP foam 1206, and third SMP foam 1209. Foam 1206 may be the most distal and configured to emerge from a delivery conduit in front of either of foams 1209, 1210.

[0057]

[0121] Example 2. The system according to Example 1, further comprising first and second radiopaque conduit portions on the backbone, wherein the first, second, and third SMP foams are between the first radiopaque conduit portion and the second radiopaque conduit portion.

[0122] As a result, the user can visualize the start and end of the system.

[0123] Another version of Example 2. The system according to Example 1, comprising first and second radiopaque portions on the backbone, wherein the first, second, and third SMP foams are between the first radiopaque portion and the second radiopaque portion.

[0124] Thus, in certain embodiments, the radiopaque portion need not necessarily be a conduit, and instead may be, for example, beads fixedly coupled (e.g., via welding or an adhesive) to the backbone.

[0125] Another version of Example 2. The system according to Example 1, comprising first and second radiopaque conduit portions on the backbone, wherein the third SMP foam is between the first radiopaque conduit portion and the second radiopaque conduit portion.

[0126] For example, the first and second radiopaque conduit portions on the backbone are attached, for example, to the proximal portions of the first and second SMP foams, and not all of the second foam is between the first radiopaque conduit portion and the second radiopaque conduit portion.

[0058]

[0127] Example 3. The system according to Example 2, wherein at least one of the first, second, or third SMP foams is slidably coupled to the backbone.

[0128] Example 4. The system according to Example 3, wherein at least one other of the first, second, or third SMP foams is statically and non - slidably coupled to the backbone.

[0129] For example, in one embodiment, the end foam may be fixedly connected to the backbone, while the middle foam (or, in an embodiment where there are more than two foams between two outer foams, the middle foams) may slide along the length of the backbone.

[0130] Example 5. The system according to Example 3, wherein at least one of the first, second, and third SMP foams includes a first portion slidably coupled to the backbone and a second portion statically coupled to the backbone.

[0131] For example, the proximal foam may have its proximal end fixed to the backbone. For example, a radiopaque marker may be crimped over the proximal portion of the foam to statically hold the proximal portion of the foam against the backbone. An adhesive may or may not be used to hold the proximal portion of the foam against the backbone. The foam portion may be disposed within or coupled to the radiopaque catheter / marker to taper the proximal portion of the foam and facilitate withdrawal of the foam into the catheter (e.g., by returning the system into the delivery catheter to reposition the system). The distal portion of the proximal foam may slide freely along the backbone. Thus, the foam may expand radially and contract axially as a transition from a secondary form with a smaller diameter to a primary expanded form with a larger diameter.

[0059]

[0132] Example 6. The system according to Example 3, wherein the first SMP foam includes a first portion slidably coupled to the backbone and a second portion statically coupled to the backbone, and the second SMP foam includes a first portion slidably coupled to the backbone and a second portion statically coupled to the backbone.

[0133] Example 7. The system according to Example 5, wherein the third SMP foam includes a first portion slidably coupled to the backbone and a second portion statically coupled to the backbone.

[0134] Example 8. The system according to Example 5, wherein the third SMP foam is slidably coupled to the backbone.

[0135] Example 9. The system according to any one of Examples 2-8, wherein the backbone is oriented along a major axis transverse to the first, second, and third SMP foams, the plane is orthogonal to the major axis, and intersects the first SMP foam and the first radiopaque catheter portion.

[0136] Example 10. The system according to Example 9, wherein the first SMP foam includes an outer diameter that narrows as it approaches the first radiopaque catheter portion and when the first SMP foam is expanded.

[0137] Example 11. The system according to Example 10, wherein a further plane is orthogonal to the major axis and intersects the second SMP foam and the second radiopaque catheter portion.

[0138] Example 12. The system according to Example 11, comprising a third radiopaque catheter portion, wherein another plane is orthogonal to the major axis and intersects the third SMP foam and the third radiopaque catheter portion.

[0139] See, for example, FIG. 12B.

[0060]

[0140] Example 13. The system according to Example 9, wherein the third SMP foam does not directly contact the first SMP foam and does not directly contact the second SMP foam.

[0141] For example, if there is a space between the foams, the flexibility of the system is promoted, thereby facilitating navigation through the vasculature. See, for example, FIG. 12B.

[0061]

[0142] Example 14. Each of the first, second, and third SMP foams has an expanded primary shape and a compressed secondary shape. The first SMP foam has a first maximum outer diameter in the primary shape, the second SMP foam has a second maximum outer diameter in the primary shape, the third SMP foam has a third maximum outer diameter in the primary shape, and the third maximum outer diameter is greater than at least one of the first maximum outer diameter or the second maximum outer diameter in the first shape. The system according to Example 9.

[0143] Example 15. The first SMP foam has a first maximum outer diameter in its secondary shape, the second SMP foam has a second maximum outer diameter in its secondary shape, and the third SMP foam has a third maximum outer diameter in its secondary shape. The third maximum outer diameter is equal to each of the first and second maximum outer diameters in the secondary shape. The system according to Example 9.

[0062]

[0144] Example 16. The first SMP foam includes a polymer including polymerization monomers including hydroxypropyl ethylenediamine (HPED), triethanolamine (TEA), and hexamethylene diisocyanate (HDI). The system according to Example 9.

[0145] Another version of Example 16. The first SMP foam includes a polymer including polymerization monomers including at least one of hydroxypropyl ethylenediamine (HPED), triethanolamine (TEA), or a combination thereof; and at least one of hexamethylene diisocyanate (HDI), trimethylhexamethylene diisocyanate, or a combination thereof. The system according to any one of Examples 1 to 8.

[0063]

[0146] Example 17. The system according to Example 9, further comprising an additional backbone crossing the first, second, and third SMP foams.

[0147] Example 18. At least one of the first, second, or third SMP foams includes an asymmetric cross-section taken parallel to the plane. The system according to Example 17.

[0148] For example, see FIG. 3C. The asymmetric cross-section can assist the user in somehow occluding the false lumen while keeping the passage for the true lumen of AD as wide as possible.

[0149] Example 19. The minor axis is orthogonal to the major axis, the third SMP foam includes a continuous outer surface surrounding the third SMP foam in a further plane orthogonal to the major axis, and includes a first void that does not include foam cells, and the minor axis intersects the first void and intersects the continuous outer surface of the third SMP foam at least twice, the system according to Example 9.

[0150] For example, refer to FIGS. 21A, 21C, and 21E.

[0151] Example 20. The continuous outer surface of the third SMP foam narrows as it slopes proximally, the system according to Example 19.

[0152] Thus, the third SMP foam may be in a "bullet" shape such as foam 1209 in FIG. 12E.

[0064]

[0153] Example 21. A further minor axis is orthogonal to the major axis, the third SMP foam includes a second void that does not include foam cells, the further minor axis intersects the second void, and intersects the continuous outer surface of the third SMP foam at least twice, the system according to Example 19.

[0154] Example 22. The minor axis is orthogonal to the major axis, the first SMP foam includes a continuous outer surface surrounding the first SMP foam in a plane orthogonal to the major axis, and includes a first void that does not include foam cells, and the minor axis intersects the first void and intersects the continuous outer surface of the first SMP foam at least twice, the system according to Example 9.

[0155] Example 23. The continuous outer surface of the first SMP foam narrows as it slopes proximally, the system according to Example 22.

[0156] Example 24. A further minor axis is orthogonal to the major axis, the first SMP foam includes a second void that does not include foam cells, and the further minor axis intersects the second void and intersects the continuous outer surface of the first SMP foam at least twice, the system according to Example 22.

[0157] Example 25. The system of Example 22, including an elastic member and the minor axis intersecting the elastic member.

[0158] For example, the elastic member may be disposed within the void 2101. The elastic member may be an arm attached to the backbone at one end, such as one of the arms of the IVC filter 2202. The elastic member may include a shape memory alloy spline.

[0065]

[0159] Example 26. The system according to any one of Examples 1 - 8, comprising a structural support backbone coupled to the first SMP foam, and the first SMP foam is between the third SMP foam and the structural support backbone.

[0160] In one embodiment, the backbone may include a stent, a multi - arm unit such as an IVC filter, a coil having a helical or conical shape, etc.

[0161] Example 27. The system of Example 26, comprising a tissue adhesive coupled to the structural support backbone.

[0162] In one embodiment, the adhesive is located directly on the foam, instead of or in addition to the mechanical support backbone. For example, any or all of the foams of Figure 12B may include a tissue adhesive applied to a portion of the foam. For example, the adhesive may be disposed on one side of the most proximal foam. That portion of the foam may be loaded with radiopaque particles to indicate its position, whereby the user understands to apply the foam to the aortic wall where the adhesive is located. In this embodiment, when coupled to a torque - guiding backbone (see, e.g., Figure 5C), better control of the position of the adhesive with respect to the aortic wall on the side substantially opposite the false lumen can be achieved.

[0066]

[0163] Example 28. The system of Example 27, wherein the structural support backbone has opposing first and second side walls, and the tissue adhesive is on the first side wall but not on the second side wall.

[0164] For example, the backbone may include a stent in which struts on one sidewall are coated with a tissue adhesive and struts on the opposing sidewall are not coated with a tissue adhesive. In that case, the uncoated sidewall may join the false lumen, and the adhesive-coated sidewall may contact the aortic wall.

[0165] In another embodiment, the tissue adhesive may be replaced with some other type of anchor. For example, only the first sidewall of the stent may include barbs for ingrowth into the aortic wall.

[0166] Example 29. A method comprising implanting at least a portion of the system of Example 9 or 26 into the false lumen of an aortic dissection.

[0167] Example 30. A method comprising implanting at least a portion of the system of Example 9 or 26 into the left atrial appendage (LAA).

[0067]

[0168] Set of the third example

[0169] Example 1. A system comprising a backbone, a first polyurethane shape memory polymer (SMP) foam on the backbone, and a second polyurethane SMP foam on the backbone.

[0170] Example 2. The system of Example 1, comprising first and second radiopaque conduit portions on the backbone, wherein the first and second SMP foams are between the first radiopaque conduit portion and the second radiopaque conduit portion.

[0171] Example 3. The system of Example 2, wherein at least one of the first SMP foam and the second SMP foam is slidably coupled to the backbone.

[0172] Example 4. The system of Example 3, wherein at least the other of the first SMP foam and the second SMP foam is slidably coupled to the backbone.

[0173] Example 5. The system of Example 3, wherein at least one of the first SMP foam or the second SMP foam includes a first portion slidably coupled to the backbone and a second portion statically coupled to the backbone.

[0068]

[0174] Example 6. The first SMP foam includes a first portion slidably coupled to the backbone and a second portion statically coupled to the backbone, and the second SMP foam includes a first portion slidably coupled to the backbone and a second portion statically coupled to the backbone, the system of Example 3.

[0175] Example 7. The backbone is oriented along a major axis that traverses the first SMP foam and the second SMP foam, a plane is orthogonal to the major axis, and intersects the first SMP foam and the first radiopaque conduit portion, the system according to any one of Examples 1-6.

[0176] Example 8. The first SMP foam includes an outer diameter that narrows as it approaches the first radiopaque conduit portion and when the first SMP foam is expanded, the system of Example 7.

[0177] Example 9. A further plane is orthogonal to the major axis and intersects the second SMP foam and the second radiopaque conduit portion, the system of Example 8.

[0178] Example 10. Comprising a third radiopaque conduit portion, wherein another plane is orthogonal to the major axis and intersects the third SMP foam and the third radiopaque conduit portion, the system of Example 9.

[0179] Example 11. The first SMP foam does not directly contact the second SMP foam, the system of Example 10.

[0069]

[0180] Example 12. The first and second SMP foams each have an expanded primary shape and a compressed secondary shape, the first SMP foam has a first maximum outer diameter in the primary shape, the second SMP foam has a second maximum outer diameter in the primary shape, and the first maximum outer diameter is larger than the second maximum outer diameter, the system of Example 1.

[0181] Example 13. The first SMP foam has a first maximum outer diameter in its secondary shape, the second SMP foam has a second maximum outer diameter in its secondary shape, and the first maximum outer diameter is equal to the second maximum outer diameter. The system of Example 1.

[0182] Example 14. The first SMP foam includes a polymer containing polymerization monomers including hydroxypropyl ethylenediamine (HPED), triethanolamine (TEA), and hexamethylene diisocyanate (HDI). The system according to any one of Examples 1 to 13.

[0070]

[0183] Example 15. The backbone is oriented along the major axis that crosses the first and second SMP foams, the minor axis is orthogonal to the major axis, the first SMP foam includes a continuous outer surface surrounding the first SMP foam in a further plane orthogonal to the major axis, the first SMP foam includes a first void that does not include foam cells, the minor axis intersects the first void, and the minor axis intersects the continuous outer surface of the first SMP foam at least twice. The system according to any one of Examples 1 to 14.

[0184] Example 16. The continuous outer surface of the first SMP foam becomes narrower as it inclines proximally. The system of Example 15.

[0185] Example 17. A further minor axis is orthogonal to the major axis, the first SMP foam includes a second void that does not include foam cells, the further minor axis intersects the second void, and the further minor axis intersects the continuous outer surface of the first SMP foam at least twice. The system according to Example 15.

[0186] Example 18. The system includes an elastic member, and the minor axis intersects the elastic member. The system according to Example 15.

[0187] Example 19. It includes a structural support backbone coupled to the first SMP foam and is between the second SMP foam and the structural support backbone. The system according to any one of Examples 1 to 18.

[0188] Example 20. The system according to Example 19, comprising a tissue adhesive coupled to the structural support backbone.

[0189] Example 21. The system according to Example 20, wherein the structural support backbone has a first side wall and a second side wall facing each other, and the tissue adhesive is on the first side wall but not on the second side wall.

[0190] Example 22. A method comprising implanting at least a portion of the system according to any one of Examples 1 to 21 into the false lumen of aortic dissection.

[0191] Example 23. A method comprising implanting at least a portion of the system according to any one of Examples 1 to 21 into the left atrial appendage (LAA).

[0071]

[0192] The above description of the embodiments of the present invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. This description and the following claims include terms such as left, right, top, bottom, upper, lower, upper side, lower side, first, second, etc., but these are used only for purposes of description and should not be construed as limiting. For example, terms specifying relative vertical positions are in a situation where the side surface of a substrate is the "upper" surface of that substrate, and the substrate can be in any orientation such that the "upper" surface of the substrate can actually be lower than the "lower" surface in a standard ground reference frame, yet still within the meaning of the term "upper". As used in this specification and the claims, the term "upper", unless otherwise specified, indicates not only that a first layer "above" a second layer is directly above the second layer and in direct contact with the second layer, but also that a third layer or other structure may exist between the first layer and the second layer above the first layer. Embodiments of the devices or articles described herein may be manufactured, used, or shipped in a certain position and orientation. Those skilled in the art can understand that many modifications and variations are possible in light of the above teachings. Those skilled in the art will recognize various equivalent combinations and substitutions of the various components shown in the figures. Therefore, the scope of the present invention is intended to be defined not by this detailed description but rather by the claims appended hereto.

Claims

1. A backbone, a first polyurethane shape memory polymer (SMP) foam on the backbone, a second polyurethane SMP foam on the backbone, and a third polyurethane SMP foam on the backbone and between the first SMP foam and the second SMP foam, A system comprising the same.

2. The system according to claim 1, further comprising first and second radiopaque conduit portions on the backbone, wherein the first, second, and third SMP foams are between the first radiopaque conduit portion and the second radiopaque conduit portion.

3. The system according to claim 2, wherein at least one of the first, second, or third SMP foams is slidably coupled to the backbone.

4. The system according to claim 3, wherein at least one other of the first, second, or third SMP foams is statically and non - slidably coupled to the backbone.

5. The system according to claim 3, wherein at least one of the first, second, and third SMP foams includes a first portion slidably coupled to the backbone and a second portion statically coupled to the backbone.

6. The first SMP foam includes a first portion slidably coupled to the backbone and a second portion statically coupled to the backbone, and The second SMP foam includes a first portion slidably coupled to the backbone and a second portion statically coupled to the backbone, The system according to claim 3.

7. The system according to claim 5, wherein the third SMP foam includes a first portion slidably coupled to the backbone and a second portion statically coupled to the backbone.

8. The system according to claim 5, wherein the third SMP foam is slidably coupled to the backbone.

9. The backbone is oriented along a major axis transverse to the first, second, and third SMP foams, a plane is orthogonal to the major axis, and the plane intersects the first SMP foam and the first radiopaque conduit portion, The system according to any one of claims 2 - 8.

10. The system of claim 9, wherein the first SMP foam includes an outer diameter that narrows as it approaches the first radiopaque conduit portion and as the first SMP foam expands. **Claim 11** A further plane is orthogonal to the long axis and the further plane intersects the second SMP foam and the second radiopaque conduit portion. The system of claim 10. **Claim 12** Comprising a third radiopaque conduit portion, where another plane is orthogonal to the long axis and the another plane intersects the third SMP foam and the third radiopaque conduit portion. The system of claim 11. **Claim 13** The system of claim 9, wherein the third SMP foam does not directly contact the first SMP foam and does not directly contact the second SMP foam. **Claim 14** The first, second, and third SMP foams each have an expanded primary shape and a compressed secondary shape, the first SMP foam has a first maximum outer diameter in the primary shape, the second SMP foam has a second maximum outer diameter in the primary shape, the third SMP foam has a third maximum outer diameter in the primary shape, and the third maximum outer diameter is greater than at least one of the first maximum outer diameter or the second maximum outer diameter in the first shape. The system of claim 9. **Claim 15** The first SMP foam has a first maximum outer diameter in its secondary shape, the second SMP foam has a second maximum outer diameter in its secondary shape, the third SMP foam has a third maximum outer diameter in its secondary shape, the third maximum outer diameter is equal to each of the first and second maximum outer diameters in the secondary shape. The system of claim 9. **Claim 16** The system of claim 9, wherein the first SMP foam includes a polymer that includes polymerization monomers including hydroxypropyl ethylenediamine (HPED), triethanolamine (TEA), and hexamethylene diisocyanate (HDI). **Claim 17** The system of claim 9, comprising a further backbone that traverses the first, second, and third SMP foams. **Claim 18** The system of claim 17, wherein at least one of the first, second, or third SMP foams includes an asymmetric cross-section taken parallel to the plane.

19. The minor axis is perpendicular to the major axis, the third SMP foam includes a continuous outer surface surrounding the third SMP foam in a further plane perpendicular to the major axis, the third SMP foam includes a first void that does not include foam cells, the minor axis intersects the first void, and the minor axis intersects the continuous outer surface of the third SMP foam at least twice, The system according to claim 9.

20. The continuous outer surface of the third SMP foam narrows as it slopes proximally. The system according to claim 19.

21. A further minor axis is perpendicular to the major axis, the third SMP foam includes a second void that does not include foam cells, the further minor axis intersects the second void, and the further minor axis intersects the continuous outer surface of the third SMP foam at least twice, The system according to claim 19.

22. The minor axis is perpendicular to the major axis, the first SMP foam includes a continuous outer surface surrounding the first SMP foam in a plane perpendicular to the major axis, the first SMP foam includes a first void that does not include foam cells, the minor axis intersects the first void, and the minor axis intersects the continuous outer surface of the first SMP foam at least twice, The system according to claim 9.

23. The continuous outer surface of the first SMP foam narrows as it slopes proximally. The system according to claim 22.

24. A further minor axis is perpendicular to the major axis, the first SMP foam includes a second void that does not include foam cells, the further minor axis intersects the second void, and the further minor axis intersects the continuous outer surface of the first SMP foam at least twice, The system according to claim 22.

25. The system includes an elastic member, and the minor axis intersects the elastic member, The system according to claim 22.

26. Comprising a structural support backbone coupled to the first SMP foam, and the first SMP foam is between the third SMP foam and the structural support backbone, The system according to any one of claims 1 to 8.

27. Comprising a tissue adhesive coupled to the structural support backbone. The system according to claim 26.

28. The structural support backbone has opposing first and second side walls, and The tissue adhesive is on the first side wall but not on the second side wall. The system according to claim 27. **Claim 29** A method comprising implanting at least a portion of the system according to claim 9 or 26 into the false lumen of aortic dissection. **Claim 30** A method comprising implanting at least a portion of the system according to claim 9 or 26 into the left atrial appendage (LAA).

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