Aortic dissection and aortic false cavity embolization device

Abstract

One embodiment includes a system comprising: a trunk; a first polyurethane shape memory polymer (SMP) foam on the trunk; a second polyurethane SMP foam on the trunk; and a third polyurethane SMP foam on the trunk and between the first SMP foam and the second SMP foam. Other embodiments are described herein.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 383,665, filed on November 14, 2022, and entitled "Aortic Dissection and Aortic False Lumen Embolization Device," the contents of which are hereby incorporated by reference. This application further claims priority to U.S. Provisional Patent Application No. 63 / 356,598, filed on June 29, 2022, and entitled "False Lumen / Aortic Dissection Treatment Device," the contents of which are hereby incorporated by reference. This application further claims priority to U.S. Provisional Patent Application No. 63 / 510,662, filed on June 28, 2023, and entitled "False Lumen / Aortic Dissection Treatment Device," the contents of which are hereby incorporated by reference. Background Art

[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, forcing the layers apart. In most cases, this is associated with the sudden onset of severe chest or back pain, often described as "tearing" in nature. In addition, vomiting, sweating, and dizziness may occur. Other symptoms may result from reduced blood supply to other organs, such as stroke, lower limb ischemia, or mesenteric ischemia. AD can rapidly lead to death due to insufficient blood flow to the heart or complete rupture of the aorta. BRIEF DESCRIPTION OF THE DRAWINGS

[0003] Features and advantages of embodiments of the present invention will become apparent from the appended claims, the following detailed description of one or more exemplary embodiments, and the corresponding drawings.Where considered appropriate, reference numerals have been repeated among the figures to indicate corresponding or analogous elements.

[0004] Figures 1A to 1F Embodiments of methods of treating AD using embodiments of an AD system are shown.

[0005] Figures 2A to 2C Shown is a "pearls on a string" foam on a stem in an example.

[0006] Figures 3A to 3D Various implant foam cross sections are shown for use in the embodiments.

[0007] Figures 4A to 4C Various delivery configurations of embodiments are depicted.

[0008] Figures 5A to 5D Embodiments of methods for applying torque to embodiments of an AD system are depicted.

[0009] Figures 6A to 6E Various embodiments of multi-foam implants are shown.

[0010] Figures 7A to 7D Various foam implant nesting embodiments (eg, countersunk holes) are shown. Figures 8A to 8B The embodiments are shown in more detail.

[0011] Figures 9A to 9B Various foam implant embodiments are shown wherein the foam has different expanded foam diameters. Fig. 9C The spacing between the various foams is depicted, but the end cap foams have connections to adjacent foams. Fig.9D Describes an arrangement that, in at least some circumstances, is undesirable and is caused by Fig. 9C The embodiments prevent this.

[0012] Figures 10A to 10B Foam embodiments are shown that may include one or more slidable foams or foam portions.

[0013] Figures 11A to 11B Foam embodiments are shown that may include one or more slidable foams or foam sections and UV adhesive and / or radiopaque marker bands.

[0014] Figures 12A to 12B and 13A-13B include various embodiments of foams having tapered ends due to the marker hoop compressing portions of the foam.

[0015] Figures 14A to 14B An embodiment of a method utilizing axial shortening / crimping is depicted.

[0016] Figures 15A to 15D An embodiment of a method utilizing axial shortening / crimping is depicted.

[0017] Figures 16A to 16B Embodiments utilizing entanglements to occlude voids, such as the false lumen of AD, are depicted.

[0018] Figures 17A to 17D Various embodiments of systems utilizing a tear-away sleeve surrounding a foam are depicted.

[0019] Figures 18A to 18B Various embodiments are described that utilize a removable delivery wire to facilitate imaging during system delivery.

[0020] Figures 19A to 19D Various embodiments are depicted that use a delivery catheter with a flexible tube for contrast media injection.

[0021] Figures 20A to 20D Various attachment / detachment embodiments for an AD system are depicted.

[0022] Figures 21A to 21F Various embodiments are depicted that facilitate smaller crimp diameter AD systems.

[0023] Figures 22A to 22J Various anchoring embodiments for use in AD systems are depicted.

[0024] Figures 23A to 23E Various anchoring embodiments for use in AD systems are depicted.

[0025] Fig.24 Embodiments of delivery devices for use with AD systems are depicted. DETAILED DESCRIPTION

[0026] Reference will now be made to the figures, wherein similar structures may be provided with similar suffix reference marks. In order to more clearly illustrate the structures of various embodiments, the figures included herein are diagrammatic representations of structures. Therefore, although still in conjunction with the claimed structures of the illustrated embodiments, the actual appearance of the manufacturing structure (e.g., in a photograph) may look different (e.g., in an actual manufacturing device, the walls may not be completely orthogonal to each other). In addition, the figures may only show structures useful for understanding the illustrated embodiments. Additional structures known in the art may not be included to maintain the clarity of the figures. For example, each layer of the device may not necessarily be shown. "Embodiment", "various embodiments", etc. indicate that the embodiments described in this manner may include specific features, structures, or characteristics, but not every embodiment must include specific features, structures, or characteristics. Some embodiments may have some, all, or none of the features described for other embodiments. "First", "second", "third", etc. describe common objects and indicate different instances of similar objects cited. Such adjectives do not mean that the objects described in this manner must be in a given order, whether in time, space, ranking, or in any other way. "Connected" may indicate that elements are in direct physical or electrical contact with each other, and "coupled" may indicate that 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 A, B, or both.

[0027] An embodiment is a shape memory polymer foam embolic implant to treat AD and false lumen in the aorta. AD presents a very complex patient-specific anatomy that is difficult to treat. Typically, there are multiple fenestrations / tears along the length of the AD that interact with other vessels branching from the aorta (e.g., renal arteries, SMA, celiac artery, etc.). An embodiment can be delivered through a tear or fenestration of the false lumen wall (e.g., proximal tear 103 or distal tear 102) and delivered into the false lumen space in a compressed, minimally invasive form factor. To gain access to the false lumen space, a catheter 104 can be introduced into the femoral artery and guided through the distal exit tear ( Figure 1C Once delivered to the false lumen anatomy, the device expands to fill the false lumen space in volume and decompress the false lumen ( Figure 1D This decompression stabilizes the inflow / outflow of the false lumen (via thrombosis). Figure 1E ). The porous geometry of the implanted foam device effectively provides volumetric thrombosis within the false lumen and restricts flow in complex fenestrated anatomies. The expanded material is highly compliant and reduces the risk of further dissection or rupture of the vascular anatomy. The embolic device can be used in conjunction with other intravascular technologies (e.g., stent 101, grafts, etc.) to prepare the AD anatomy for optimal embolic implant delivery.

[0028] like Figures 3A to 3D As seen in FIG. 1 , the cross-section of the implant may be, but is not limited to, circular, rectangular, or kidney-shaped. The implant may include a plurality of separate plugs, such as Figure 4A In an embodiment, Figure 4A 3, 4, 5 or more plugs may be deployed in the false lumen. In addition, multiple plugs may be attached along a carrier member (semi-rigid or flexible). Figure 4B In the invention, the plug is connected by a semi-rigid carrier (e.g., polymer, metal, or SMA), wire, coil, etc. Figure 4C In the embodiment, the plug is connected by a flexible carrier (e.g., polymer, metal or SMA), wire, coil, etc. The carrier component can be composed of any combination of platinum / tungsten / iridium or stainless steel wire, marker hoop, coil or bead. The carrier component can also be a shape memory alloy or shape memory polymer including nitinol or polyurethane. Other flexible carrier component options 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 curled device profile may terminate proximally with a dome, fillet, or chamfer geometry to facilitate axial device alignment when the device is pulled proximally back into the delivery catheter during device retrieval. See, for example, Fig.7D or 12B.

[0030] Delivery of the flexible carrier component implant or individual implants may occur in a random configuration. Alternatively, a semi-rigid carrier component implant may be delivered by radial torque control relative to the aortic axis (e.g., see Figures 5A to 5D ). This allows control of non-circular device cross-sections relative to the false lumen cross-section (see, e.g. Figures 3A to 3D ). A non-circular device cross-section can help reduce the overall false lumen volume after device implantation and allow the true lumen to expand once the false lumen is decompressed.

[0031] In an embodiment, the locking core wire 501 or the hypotube ( Figures 5A to 5D) to selectively disable radial torque control of the implant segment. The implant segment contains an internal locking torque component 503 that engages the locking core wire to enable twisting through mechanical interaction (such as a lock and key). In this design embodiment, the entire length of the device can be twisted axially until the locking core wire is retracted. When the core wire is retracted, the most distal implant segment becomes radially flexible and conforms to the anatomical structure in which it is delivered, but the proximal implant segment that is still engaged with the locking core wire can still be twisted ( Figure 5B As the locking core wire is retracted, the implant segments are sequentially disengaged from the locking core wire until the entire length of all implant segments is flexible ( Figure 5C ). The locking core wire may be independent of the carrier component 504 that connects the implant segments after implantation. The locking core wire may be radiopaque to identify the axial position of the plug during implant delivery and before the radiopaque locking core wire is retracted. When the radiopaque locking core wire is retracted, the implant may be fully radiopaque to minimize subsequent imaging artifacts, or include a radiopaque feature (such as a marker hoop) for identification via an imaging device. The marker hoop may include, for example, a radiopaque metal hoop wrapped around foam, wire, etc.

[0032] In an embodiment, the locking core 501 may be a semi-rigid elastic or superelastic material, such as stainless steel or nitinol, or a combination thereof. The locking core may be a wire, a tube, a coil, a polished contour wire, or any combination thereof. The internal locking or torque component 503 may be a metal, a polymer, etc. For example, the internal locking component may be an SMP foam. The internal locking component SMP foam may have a density that is not equal to (e.g., greater than) the density of the general embolic SMP foam 502 surrounding the internal locking component. The locking component (regardless of its material composition) may have a square cross-sectional channel that receives a locking core having a similar square cross-section. The rotation of the locking core about its long axis will also rotate the internal locking component and its embolic SMP foam (which may substantially surround the internal locking component in a plane orthogonal to the long axis of the locking core). In other embodiments, the locking core may be somewhat planar. For example, similar to a "dipstick" used to check the oil in an engine. Such a locking core may be set into a channel of an internal locking component having a similar profile (and therefore the rotation of the locking core will necessarily rotate the internal locking component). In other embodiments, the internal locking component may be omitted and the embolic foam itself may include a slot for receiving the flat locking wire.Due to the strength of the embolic foam, twisting the locking core wire will cause the embolic foam to rotate without damaging the embolic foam.

[0033] Once delivered to the false lumen anatomy, the device provides acute hemostasis. In the long term, the implanted shape memory polymer foam acts as a tissue scaffold to promote healing and collagen scar formation. This contractile collagen scar tissue promotes lesion contraction to further reduce false lumen volume and promote healthy true lumen aortic flow volume ( Figure 1F ). Over time, the implanted shape memory polymer material biodegrades to leave more full volume of autologous tissue in the original false lumen volume.

[0034] One embodiment of any of the foams described herein includes a shape memory polymer foam made from a combination of some or all of the following: 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-ethylpropylene glycol (BEP), 2-methyl-2,4-pentanediol, or other aliphatic diisocyanates and aliphatic diols or polyols. Other synthetic monomers include ethylene glycol diols and triiodobenzene containing diols or ethanol.

[0035] Embodiments may include one or more implant plugs threaded onto a small gauge backbone (eg, a wire or coil backbone comprising platinum, iridium, or combinations thereof, or a polymer backbone comprising polyurethane, etc.). Fig. 6A An embodiment is included having three foams 602, 603, 604 along line 606. A proximal "end cap" 601 and a distal "end cap" 605 are located on either end of the foam. Foams 602, 604 are foam plugs of smaller diameter than foam 603. However, in other embodiments, foams 602, 604 may be equal in diameter to 603. Elements 601, 605 may be hoops (open cylinders) or caps (cylinders with mostly closed ends except for a void for receiving the trunk, similar to a barrel with a hole in the bottom of the barrel through which the trunk passes). Such elements may be radiopaque to assist the clinician in marking the proximal and distal boundaries of the implant. A small trunk may extend through each of the end caps, as well as all of the foam located between the end caps. The line may form an axis. As Fig. 6E As shown in , a plane orthogonal to the axis may intersect the end caps, resulting in a cross section in which the cap 601 surrounds a portion of the foam 602, and the foam portion surrounds the line 606. The end caps may secure any one or more foam plugs between the two end caps. Such foams may be fixedly 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, Figures 2A to 2CThe term "pearls on a string" as depicted in FIGS. 6A to 6E presents embodiments in which one or more "pearls" (ie, bubbles) slide along a stem. Figures 6A to 6E Embodiments include foams that extend 20mm, 30mm, 40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm or longer along the trunk. Such embodiments include foams with an expanded outer diameter of 8mm, 12mm, 16mm, 20mm, 24mm, 28mm, 32mm, 36mm, 40mm, 60mm or more. Figure 6C Four bubbles on the trunk are shown, but Fig.6D Two groups of three bubbles are shown that may be located on the trunk.

[0036] about FIG. 2A to FIG. 2C , the embodiments of these figures are FIG. 6A to FIG. 6E The embodiment of the present invention is similar. The embodiment includes SMP foam 215, 216, 217 between platinum / iridium alloy marker ferrules 203, 204 and adhesive 201 (for rounding the distal end of the implantable device). The trunk 202 may include a platinum / iridium alloy coil, which may resist stretching in some embodiments, but may have the ability to contract under stimulation in other embodiments. The implant may be separated from the push rod, guide wire, line 210, etc. at the collar 205. The line 210 may have a protrusion to fit within the pores of the collar 205. The hypotube 209 can be used to control the path of the line 210. A series of hypotubes 211, 212, 213 can be connected to the Luer connector 215, the Touhy Borst adapter 216 with a silicon seal, the stop plug hypotube 217, and the terminal locking coil 214 to facilitate the delivery of the SMP foam to the target implantation location. In various embodiments, other delivery systems are also suitable, such as the system described in PCT patent publication WO2022040490.

[0037] In embodiments having two or more foams on the backbone, the space or gap between two adjacent foams provides flexibility of the implant and / or axial compliance of the implant structure after deployment. For example, see Fig. 9C , 10A , 11A, 12B, 13B, 16A. The foam can be delivered in a compressed state (e.g., Fig. 10B , 11B , 12A, 13A), where they have limited flexibility (as opposed to relatively increasing flexibility as the foam expands). In its less flexible compressed state, the gaps between the foams can promote flexibility, which can promote ease of implantation as the device traverses the patient's vasculature. In addition, the gaps can facilitate "tangling" of the implant segments (e.g., Fig. 16B) for stability during final deployment in the patient. However, in other embodiments, there is no space between the foam, thereby facilitating the ability to draw the foam back into the delivery conduit without the foam clogging the conduit inlet / outlet orifices. See, for example Figure 7B , 7D , 8A, 9A.

[0038] The use of foams of variable size has advantages. For example, Figure 6B and 6C The smaller foam is shown proximal and distal to the larger foam. The smaller foam may provide more space for attaching the end cap to the trunk. The end cap may include a radiopaque collar or bead. The collar or cap may fit over a portion of the smaller foam. The smaller foam may be more likely to curl within the end cap. In addition, the smaller foam (as opposed to the larger foam) may eventually expand and is less likely (as compared to the larger foam) to expand back onto the end cap, thereby masking the radiopaque properties of the end cap.

[0039] Figures 7A to 7D A "nested" embodiment is proposed whereby a portion of each end foam is located within an adjacent larger plug. Fig. 7A Two smaller foams are shown, which are configured to fit into the countersunk holes or voids of the larger foam. Foams 703, 704, 705 are threaded onto the core wire 702. Figure 7B Shows how a series of nested bubbles can be formed on a backbone when using countersunk holes. Figure 7C An implant with compressed foam is shown, and Fig.7D A radiopaque marker hoop 706 is shown. The use of low curling density foam 704 between high curling density foams 703, 705 promotes axial flexibility and radial flexibility when the implant is deployed. As used herein, the increased radial flexibility provides an enhanced ability to rotate around, for example, axis 701 (shown as "coming out" from the page). In addition, despite the different curling densities, small and large foams provide a uniform, consistent outer diameter together to help facilitate the possible withdrawal of the implant into the delivery conduit (i.e., to avoid the larger diameter portion of the foam being unable to be easily withdrawn into the delivery conduit if the implant is initially misplaced). Fig.7D The implant is shown after expansion. Note how the marker hoop 706 has compressed a portion of the small bubbles so that when those small bubbles expand, they form edges that taper toward the end cap (e.g., marker hoop). For example, such rounding of the proximal and distal edges can facilitate easy deployment or recapture of the foam into a delivery conduit (e.g., catheter, hypotube, etc.). Although in this embodiment, areas of low curl density foam are associated with smaller bubbles and areas of high curl density foam are associated with larger bubbles, in other embodiments, the foams may have the same outer diameter when expanded, yet have different curl densities.

[0040] About such Figures 7A to 7C The figure includes a legend that provides the hash patterns for low curl density foam and high curl density foam. For example, Figure 7C Curled foam is shown. Those hash patterns can also be seen in expanded foam, such as Figure 7B In any case, this illustration applies to curling foam, not expanding foam. For example, in Figure 7B In the case of a 3D image, the expanding foam will all have the same density, regardless of the part diameter, and regardless of any different hash patterns added by the plotter. When you compress those variable diameters to a smaller size, the curl density ( Figure 7C ) are different. Therefore, the expanded foam has the lowest density, the curl of the smaller diameter plug (e.g., foam 704) may have a medium density, and the curl of the larger diameter plug (e.g., foam 705) may have a high density. This description of the figure also applies to the curl of the larger diameter plug (e.g., foam 705). Figures 8A to 11B Legend for .

[0041] Figures 8A to 8B Shows Figures 7A to 7C but shown in more detail. Figure 8B How can a region of medium to high curl density 804 (adjacent low density region 805) have a density based on only large foam (see plane 801) or both large foam and small foam (see plane 802). In addition, Figure 8B A uniform outer diameter of the foam is shown, which may facilitate exit from or withdrawal into a delivery tube. In an embodiment, the entire trunk 803 is radiopaque due to its material composition (eg, platinum alloy).

[0042] More about Fig. 8A , "nested" sections of reduced diameter foam can be used as a bridge between the central larger diameter plugs, with the goal of eliminating / reducing gaps and providing a continuous foam segment to facilitate implant retraction. Figures 8A to 8B The embodiments provide: (1) improved axial flexibility due to portion 805, (2) Figure 8B and (3) improved retraction performance (minimizing foam shear) due to the uniform implant diameter.

[0043] Figures 9A to 9B Alternating large and small bubbles are shown, but there are no sink holes in the large bubbles (similar to Fig. 8A Due to the presence of the small foam, the implant still has improved axial and radial flexibility and retention despite the lack of countersunk holes. Figures 7A to 7D However, this embodiment may provide for easy manufacturing as compared to the embodiment with a counterbore. Figures 9A to 9BThe embodiments provide: (1) improved axial flexibility due to portion 905, (2) Fig. 9B and (3) improved retraction performance (minimizing foam shear) due to the uniform implant diameter.

[0044] Embodiments may include both nested adjacent foams and non-nested adjacent foams. The ability to use either technology provides the ability to balance the need for flexibility with the need for more controlled axial positioning of the plug. For example, the distal region of the implant may benefit from fixed foams that are not nested with each other, while the proximal region of the implant (configured for implantation near the entrance to the void, such as an aortic aneurysm or AD) may have foams that slide and may gather against each other to better seal the entrance to the void. Aggregation and sealing may be promoted by using nested foams. Even if the non-nested foams do not slide, the lack of nesting may promote flexibility.

[0045] exist Fig. 9C , the proximal end of the implant is configured with an end cap foam 910 (the most proximal foam) nested within a first large diameter plug 911. This facilitates stability and tissue conformation of the proximal portion of the implant after the foam expands. A radiopaque hoop 912 may be fitted around a portion of the foam 910 to induce curvature of surface 913. This may also mitigate expansion of the large proximal foam plug within the tissue space, but leave the smaller diameter "end cap" foam hanging freely within the space. For example, in Fig.9D In the embodiment of the present invention, the proximal portion has been separated from the first large diameter plug and is undesirably moved into the true lumen, thereby obstructing blood flow. To prevent such a scenario, the smaller end cap can be fixedly attached to the first large diameter plug or to a portion of the trunk.

[0046] Figures 10A to 10B An embodiment is shown which, due to the inclusion of voids or gaps (wherein there is no foam between the foams), is relatively Figures 7A to 9B The embodiment has greater flexibility. Fig. 10AThe implant before curling and marking hoop (i.e. end cap) addition is shown. In this embodiment, one or more of SMP foams 1002, 1003, 1004, 1005, 1006 are slidably connected to trunk 1001 (e.g., platinum alloy wire for visualization). In an embodiment, some foams can be slidably connected to the trunk (e.g., three foams in the middle), while other foams are attached to the trunk (e.g., two foams outside). In other embodiments, all of the foams are slidably connected to the trunk. In other embodiments, no foam is slidably connected to the trunk (and fixedly adhered or connected to the trunk instead). The foams 1003, 1004, 1005 of larger expansion diameter can be curled into a higher density foam between the foams 1002, 1006 with lower curling density. The gaps (e.g., gaps 1009, 1010) between the foams help promote the flexibility of the device during and after implantation. Marker collars 1007, 1009 may be used to further facilitate visualization of the beginning and end of a foam series.

[0047] Figures 11A to 11B and Figures 10A to 10B Similar, but including the use of elements such as elements 1102, 1103. These elements may be adhesives and / or marker hoops (e.g., 1102, 1103) to fix one end of one or more foams to the trunk while leaving the opposite end of such foams free to slide along the trunk. These may be connected to other elements (such as radiopaque marker hoops 1103, 1104). As a result, the foams are less likely to gather around each other (because one end of each foam is statically connected to the trunk), which may be undesirable in some applications. However, such gathering may be desirable in other applications. For example, it may be considered beneficial by some clinicians to gather foams around the entrance to a void (e.g., an aortic aneurysm). The adhesive may include a UV adhesive.

[0048] Fig. 12B and 13B 1202, 1203) causes the foam to narrow toward the adhesive and / or marker hoops. The adhesive and / or marker hoops on both sides of the SMP foam can cause the foam to appear oval or slightly spherical (see, e.g., Fig. 12B ). Fig. 12B In the case of , proximal fixation of each individual foam segment enables more consistent retrieval of the device into the delivery catheter without shearing of the foam relative to the core wire. Fig. 12BIn the embodiment, elements 1201, 1202, 1205 may be adhesives and / or marker hoops to secure one end of one or more foams to the trunk while leaving the opposite end of such foams free to slide along the trunk. These may be coupled with other elements such as radiopaque marker hoops 1203, 1204. Similar to the other embodiments presented above, Fig. 12B and 13B Embodiments may have a combination of more densely curled foams 1207 , 1208 , 1209 with less densely curled foams 1206 , 1210 .

[0049] In embodiments, the marker bands may be crimped, crimped, glued or otherwise attached directly to the core wire. This allows the foam to fully expand (maximum expanded foam volume). In such embodiments, one or more foams may be slidably coupled between such marker bands or fixedly attached between such marker bands. Placement of marker bands with or without UV adhesive (e.g., see Fig. 11B ) may define / fix the axial position of the implant. In contrast, other embodiments presented herein have foam that is allowed to float freely on the core wire, which may allow the plug to gather and bunch to one side (depending on clinical factors, this may be a disadvantage or an advantage).

[0050] Figures 14A to 14BA system and a method for using the system are proposed. In this embodiment, the advantages of flexibility during implantation (due to the spacing between the foams) are combined with stability after implantation (due to the lack of spacing between the foams). The core wire can be shortened in various ways. For example, the trunk can be formed by a polyurethane shape memory polymer foam that contracts axially and expands radially when activated. Other ways to shorten the trunk include the following. First, the trunk is a shape memory polymer wire that contracts axially when exposed to heat, laser irradiation, or some other external stimulus. Secondly, the trunk is a wire (metal, polymer, or woven textile) pulled by a proximal tightening mechanism (e.g., incorporated into a marker hoop, or as an independent component). The tightening member allows the trunk component to slide proximally, but limits the wire to move distally. At least some of the foam segments along the trunk are slidably connected to the trunk and compressed together axially when the trunk wire is shortened. Third, the trunk is a wire (metal or polymer) pulled through a proximal aperture component on the implant (either incorporated into a marker hoop, or as an independent component). The wire can slide freely proximally and distally in the aperture part until the aperture is activated (e.g., the mechanical channel can be closed) to lock the wire in place. Once activated, the wire can no longer move distally in the aperture part. In some embodiments, after the aperture part has been activated, the aperture part still allows the wire to move proximally to further shorten the implant axially. Fourth, in some embodiments, the length of the main wire that has been pulled proximally through the tightening and / or aperture part can be trimmed from the final implant. The wire can be trimmed by delivering a separation mechanism (e.g., a heating element that melts the main wire or an electrode that electrolytically degrades the stainless steel core wire) of the push wire deployment implant from the proximal side. Alternatively, the external core wire trimming energy can be delivered by a delivery catheter (e.g., heating, electrolysis, radiofrequency, laser or other forms of energy). Fifth, in other embodiments, the wire that is pulled proximally through the tightening or proximal aperture part remains attached to the implant and flows freely in the implanted vascular anatomical structure while being attached to the implant. Sixth, in other embodiments, the wire pulled proximally through the cinch or proximal aperture component remains attached to the implant and has a pre-formed geometry that mitigates the amount of free space occupied by the wire trunk. In an example, the free segment of the proximally pulled wire not contained within the shape memory polymer foam coil forms a high surface area to volume ratio within the target vascular anatomy.

[0051] Therefore, in Figures 14A to 14B In the present invention, after initial deployment and foam expansion, flexible core wire can be shortened to reduce or eliminate the gap between the independent implant sections. This feature can be used for facilitating the improvement of the stability of the implant assembly in the aneurysm / cavity space.

[0052] Figures 15A to 15DMethods are presented whereby an axial shortening system can be deployed alone or, for example, after other implants have been implanted in an anatomical void (e.g., a false cavity). A shortening embodiment can be used to better seal the void entrance. Thus, the axial shortening feature of the device can be used to seal a tear that serves as a flow entrance to a dissection (proximal tear). Axial tightening / shortening can also be used for distal tear sealing. Tear sealing can be a feature of a false cavity embolization implant, or can be a separate adjunct to a cavity embolization device.

[0053] Figures 16A to 16B How to utilize the torsion characteristic of for example Fig. 5 to facilitate embolic device (for example, shape memory polymer foam, hydrogel) entanglement is proposed.After foam expansion, the independent implant arranged along the flexible core wire can become entangled, produces more stable structure (for example, unlikely migration) in aneurysm space.Can be convenient to entangle (as disclosed above) by torsion assembly during delivery.When implant assembly advances or is inserted in aneurysm space, also may entangle in a random manner.By applying predetermined curve or other shapes in core wire, also may be convenient to entangle.If core wire is made of shape memory material such as nitinol, then implant assembly can be delivered to target position via conduit with nominal straight line structure, but presents secondary structure when being deployed together with blood vessel or aneurysm.Secondary trunk shape also can be formed by the elastic recovery of annealed platinum alloy coil.

[0054] Embodiments may include a multi-spline arrangement. For example, two trunks may each be attached to the same single proximal end cap (such as a marker hoop) and the same single distal end cap (such as a marker hoop). The trunks may include memory materials, such as shape memory polymers, nitinol, etc. After deployment from the delivery conduit, the trunks may be axially retracted and arced away from each other to form an umbrella-like structure of struts / trunks, which better facilitates rapid deployment of a large number of embodiment elements (e.g., 3 to 5 elements per trunk) into a void.

[0055] exist Figures 17A to 17DIn the embodiment, an embodiment may include a thin-walled polymer tubing 1704 placed on a curled SMP foam implant 1703 to help maintain the compressed outer diameter (OD) during packaging, shipping, and storage. The polymer tubing may include polyethylene terephthalate (PET), PEBAX, or another extrudable thermoplastic material. After extrusion, the material may be blown radially with compressed gas to expand the radial dimension and achieve a thinner wall (e.g., 0.0005" to 0.0015"). The extruded / blown material may have high radial strength to help maintain the diameter of the curled SMP foam. By any combination of (1) material selection, (2) appropriate material thickness, (3) extrusion under axial strain to align the polymer chains axially, (4) perforation along the axis of the finished tubing, and / or (5) other parameters during the extrusion / blowing process, one may bias the material sleeve to tear longitudinally along the axis of the tubing to facilitate removal of the sleeve. A thin thread or suture (or similar high tensile strength material) 1702 may be used to help propagate the longitudinal tear for removal of the sleeve ( Figures 17A to 17D ). In one embodiment, the tear-away sleeve is used only for packaging / storage and is removed by the operator immediately prior to introducing the device into the patient. In another embodiment, the tear-away sleeve may be configured as part of a delivery and implant release system. In such embodiments, the proximal end of the tear-away tubing is secured to a delivery wire or shaft (e.g., shaft 1701). During device manufacture, the sleeve may be radially contracted onto the foam plug, or the foam may be radially expanded into the sleeve. In either case, the foam becomes secured within the tear-away sleeve while also capturing the wire ( Fig.17A , 17C The foam plug (secured within the tear-away sleeve) is advanced to the desired anatomical location for release. The tear-away sleeve is removed by proximally retracting the captured suture in a manner that cuts through the wall of the tear-away sleeve. Fig. 17B , 17D ). The tear-away sleeve remains attached to the delivery wire and is removed from the patient along with the delivery system, leaving only the embolic implant in place.

[0056] Embodiments may include implants with radiopaque markers for placement of monitoring devices via X-ray imaging during and after surgery. Other embodiments include implants without radiopaque features to reduce imaging artifacts of subsequent diagnostic imaging systems (such as CT scans). These device embodiments may be visualized using ultrasound or optical coherence tomography (OCT) imaging modalities during and after surgery. Multi-plug devices may be coupled to polymer (biodurable or biodegradable) carrier components. These embodiments may provide 100% degradation after implantation.

[0057] In an embodiment of the method, a non-radiopaque device embodiment may be delivered into the false lumen of the AD while a second intravenous ultrasound (IVUS) catheter is placed in the true lumen of the aorta. This method allows one to visualize the false lumen anatomy, monitor device positioning, and monitor SMP foam expansion independent of angiography (resulting in less radiation and less volume of injected contrast). Ultrasound imaging may be used independent of fluoroscopy, or may be used in conjunction with an X-ray imaging modality.

[0058] In another embodiment, Fig.18A As seen in FIG. 1 , the delivery system includes a radiopaque element 1802, such as a platinum-iridium or platinum-tungsten alloy wire, which passes through the entire length of the embolic implant (a single foam plug or multiple foam plugs 1801). If multiple SMP foams are used, they can be connected to each other via a thread or other backbone. However, in other embodiments, once component 1802 is removed, the foams are detached from each other. During implant delivery, the wire is visible under fluoroscopy and will help to define the location of the foam. The radiopaque element can be withdrawn from the implant as part of the implant release mechanism, or can be independent of the device and delivery system ( Fig.18B , including the delivery shaft 1803) and withdrawn. After retraction, the implant can be completely radiolucent to minimize subsequent X-ray or CT imaging artifacts, or the implant can include additional radiopaque elements for identification of the device in X-ray imaging.

[0059] Therefore, for Figures 18A to 18B , the delivery system includes a radiopaque element, such as a Pt / Ir wire, which can be passed through the length of the implant. During implant delivery, the wire is visible under fluoroscopy and will help define the location of the foam. After the foam implant is released from the delivery catheter, the radiopaque wire is withdrawn, leaving only the foam. This embodiment can be used with Figures 17A to 17D The tear-away sleeve delivery / implant release concept is combined.

[0060] In another embodiment, FIG. 19A to FIG. 19D As seen in FIG. 1 , a flexible tube 1901 passes through one or more of a coiled expansion plug (e.g., SMP foam, hydrogel) 1902 during delivery using a shaft 1903. The tubing 1901 may be stainless steel, nitinol, a single or multi-lumen polymer extrusion, or a braided or coil-reinforced polymer tube (such as polyimide). A contrast agent 1904 may be delivered through the tubing for visualization. For example, in Fig.19BIn FIG. 1 , the tube 1901 is filled with contrast to enable visualization of the system. Contrast injected through the tube will render the tubing radiopaque, providing information about device position and plug orientation. Fenestrations in the tubing (e.g., laser processing or loose sections of coils / braids) can facilitate delivery of liquid contrast directly into the foam (at the time of crimping and / or after expansion of the SMP foam) for improved visualization of the plug ( Fig.19C Additionally, line fenestrations may be located between the foam plugs to allow contrast injection into the false lumen anatomy ( Fig.19D ) (while crimping and / or after the SMP foam expands). Before delivering the device into the patient, the tubing can be flushed with sterile saline to remove all air. After the embolic implant is released, the tubing can be withdrawn, leaving only the foam.

[0061] Separation of the embolic implant from the delivery system can be accomplished using e.g. Figures 20A to 20D 2004). The mechanism includes, for example, (a) a retaining ring 2001 on the implant side (e.g., SMP foam 2004) that is ultimately implanted in the patient, (b) a retaining ring 2002 on the delivery system side (which may include a delivery catheter shaft 2006) that is ultimately removed from the patient, and (c) a retractable core wire 2003 that is removed from the patient. The closed ends of the implant and delivery system retaining rings are positioned to overlap, and the distal portion of the retractable core wire passes between the two closed rings and advances into the implant, effectively capturing and retaining the implant. To release the implant, the core wire is retracted so that the distal tip is proximal to the implant retaining ring. A marking hoop 2005 may assist in visualization.

[0062] Embodiments may include large diameter embolic plugs (20 mm and larger) having uniform foam density and volume, such as in a solid cylinder of uniform foam. Other embodiments may have a gradient in foam density due to foam synthesis parameters. Other embodiments may have variable foam density due to foam volume removed from the block plug during manufacturing (see Figures 21A to 21F). Material may be removed as a core along the axis of the foam cylinder, spokes removed orthogonal to the cylinder axis, a core removed directly from the central foam axis, or a combination thereof. Selective removal of material from the foam volume enables a higher curl ratio (i.e., a smaller curl diameter for an equivalent expanded diameter). A higher curl ratio maximizes the volume expansion that can be achieved after the device is delivered through a small cross-section delivery catheter for minimally invasive device delivery. Embodiments of the foam plug can still be fully expanded by selectively removing material, and other embodiments with significant foam volume removal can incorporate other features (e.g., shape memory alloy splines) that can supplement foam expansion once the foam passes the glass transition temperature and becomes rubbery. Below the glass transition temperature, the compressed foam material is hard enough to constrain the shape memory alloy splines and maintain a curled smaller diameter cross section. For example, SMP foam or nitinol wire may be included in a void (e.g., void 2101) to help expand the outer foam 2102.

[0063] Device features, including plug entanglement, hooks integrally bonded to the vessel wall, and / or tissue adhesives coating the outer diameter of the curled plug that adhere the device to the vessel wall, are intended to maintain the implant device within a targeted local volume of the false lumen. Controlling the anatomical positioning of the embolic implant within the false lumen space allows for selective embolization of the AD while avoiding side branch vessels (which are connected to the AD anatomical structure, which should also remain patent). An alternative embodiment uses a block foam plug that is locally positioned and maintained in place with the delivery catheter until fully expanded, and the thrombus integrally bonded to the expanded foam provides adhesion to the local tissue. Once the expansion device is securely held in place, the device can be detached and the delivery system removed from the patient.

[0064] For example, Figures 22A to 22D 2 depicts SMP foam 2201 coupled to an inferior vena cava (IVC) filter 2202. The IVC filter (or other anchoring component) includes radially expanded barbs on the distal-facing portion of the implant. The proximal-facing portion of the implant is comprised of SMP foam. The SMP foam plug will occlude / inhibit blood flow, and the barbs help stabilize and focus the foam within the false lumen. This can reduce the volume of foam required to occlude or impede blood flow.

[0065] Figures 22E to 22H Shown is the implant Figures 22A to 22DThe method of the system in the embodiment of the present invention. Under fluoroscopy, the user can position the implant so that the expanded foam will not block the orifice of the connecting vessel. The vessel 2203 located distal to (below) the plug will receive blood supplied from the re-entry tear. The blood flow to the vessel 2208 originating from above the plug can still receive limited flow from the blood flowing through the plug. Over time, thrombus and tissue ingrowth will further restrict (and potentially eliminate) flow through the plug. During this time, the body will have time to adapt and potentially establish flow via collateralization.

[0066] Figures 22I to 22J Shown with Fig.22A A system similar to the system of , but using a stent or skeletal system 2204 coupled to an SMP foam 2205. The stent may be nominally cylindrical in shape, but can conform to the shape of the false lumen. The foam element is 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 line or crimped marker hoop). The stent helps stabilize and concentrate the foam within the false lumen, and may reduce the volume of foam required to block or obstruct blood flow. Under fluoroscopy, the user positions the implant so that the expanded foam will not block the orifice of the communicating vessel. The vessel 2203 located distal (below) the plug will receive blood supplied from the reentry tear. The blood flow to the vessel 2208 originating above the plug may still receive limited flow from the blood flowing through the plug. Over time, thrombus and tissue ingrowth will further restrict (and potentially eliminate flow through the plug). During this time, the body will have time to adapt and potentially establish flow via collateralization. The stent mesh size can be tuned to help occlude side branch vessels (fine mesh), or to help them remain patent even when the stent crosses vessel branch points (loose mesh).

[0067] Figures 23A to 23C SMP foam 2305 is shown coupled to the distal end of a bone support system (e.g., stent 2304). Fig.23D , a stent is placed above vessel 2306. Fig.23E Public Fig.23A A variation of the embodiment, but in which several embolic devices are distally coupled to the stent via tethers 2307. Tethers 2307 may cross the middle of the three foams (note: Fig.23E A cross-sectional view is shown so that even though the tether runs across the middle of the foam it is still visible).

[0068] The following embodiments are related to other embodiments.

[0069] First example group

[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; a third polyurethane SMP foam on the backbone and between the first SMP foam and the second SMP foam.

[0071] The backbone can be rigid, or flexible. The backbone can include metal, polymer, suture, thread, woven textile, etc.

[0072] Example 2. The system of Example 1, comprising a first radiopaque tube section and a second radiopaque tube section on the trunk, wherein the first SMP foam, the second SMP foam, and the third SMP foam are between the first radiopaque tube section and the second radiopaque tube section.

[0073] Example 3. The system of any of Examples 1-2, wherein at least one of the first SMP foam, the second SMP foam, and the third SMP foam is slidably coupled to the trunk.

[0074] For example, see Figure 6C Slidable "string of pearls".

[0075] Example 4. The system of Example 3, wherein at least another of the first SMP foam, the second SMP foam, and the third SMP foam is statically and non-slidably coupled to the trunk.

[0076] Example 5. The system of any of Examples 1-2, wherein at least one of the first SMP foam, the second SMP foam, and the third SMP foam comprises a first portion slidably coupled to the backbone and a second portion stationarily coupled to the backbone.

[0077] Example 6. The system of any of Examples 1 to 5, wherein the third SMP foam includes a countersunk portion to enclose at least a portion of the first SMP foam.

[0078] Example 7. The system of Example 6, wherein: the trunk is oriented along a long axis that passes through the first SMP foam, the second SMP foam, and the third SMP foam; the first plane and the second plane are orthogonal to the long axis; the first plane intersects the first SMP foam and the third SMP foam; and the second plane intersects the third SMP foam but not the first SMP foam.

[0079] Example 8. The system of Example 2, wherein: the trunk is oriented along a long axis that traverses the first SMP foam, the second SMP foam, and the third SMP foam; the plane is orthogonal to the long axis; and the plane intersects the first SMP foam and the first radiopaque tubing portion.

[0080] For example, see Fig. 12B .

[0081] Example 9. The system of Example 8, wherein the first SMP foam comprises an outer diameter that narrows as the first SMP foam approaches the first radiopaque tubing portion, and an outer diameter when the first SMP foam expands.

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

[0083] For example, see Fig. 6A , Figure 7B or Fig. 12B .

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

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

[0086] Example 12. The system of Example 11, wherein: the first SMP foam includes a first curl density in its secondary shape; the second SMP foam includes a second curl density in its secondary shape; the third SMP foam includes a third curl density in its secondary shape; the third curl density is greater than the first curl density.

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

[0088] In embodiments, the trunk may have a first configuration and a second configuration. For example, the trunk may include nitinol and transition from a first configuration (which is generally linear to fit in a delivery tube and pass through the vasculature) to a second configuration (which is coiled into a spiral shape, a conical shape, etc.). During the transition between the first configuration and the second configuration, the trunk may decrease in length from its most proximal tip to its most distal tip.

[0089] Example 14. The system of any of Examples 1 to 13, comprising a mechanical lock coupled to the trunk, wherein the mechanical lock is configured to resist distal movement of the trunk.

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

[0091] Example 16. The system of any of Examples 14 to 15, wherein the mechanical lock comprises a tightening device.

[0092] Example 17. The system of any of Examples 1 to 16, comprising an additional backbone traversing the first SMP foam, the second SMP foam, and the third SMP foam.

[0093] For example, see Figure 5A .

[0094] Example 18. The system of Example 17, wherein the additional trunk is primarily parallel to the trunk.

[0095] Example 19. The system of any of Examples 17 to 18, wherein: the third SMP foam includes a first portion and a second portion; the first portion of the third SMP foam is stiffer than the second portion of the third SMP foam; and the additional stem is slidingly coupled to the first portion of the third SMP foam.

[0096] For example, for the harder first portion of the third SMP foam, see Figures 5A to 5D "Internal Torque Components" in.

[0097] Example 20. The system of Example 19, comprising a fourth SMP foam between the second SMP foam and the third SMP foam, wherein: the fourth SMP foam comprises a first portion and a second portion; the first portion of the fourth SMP foam is stiffer than the second portion of the fourth SMP foam; and the additional trunk is slidingly coupled to the first portion of the fourth SMP foam.

[0098] Example 21. The system of Example 20, wherein: in a first orientation, the additional trunk is slidingly connected to a first portion of each of a third SMP foam and a fourth SMP foam; in a second orientation, the additional trunk is retracted and slidingly connected to the first portion of the third SMP foam, but is no longer slidingly connected to the fourth SMP foam.

[0099] For example, see FIG. 5B to FIG. 5C .

[0100] Example 22. The system of any of Examples 17 to 21, wherein the first portion of the third SMP foam comprises SMP foam.

[0101] Example 23. The system of any of Examples 17 to 22, wherein: the additional trunk is coupled to the first portion of the third SMP foam at a first location; the additional trunk has a non-circular cross-section at the first location; the non-circular cross-section is oriented orthogonal to the long axis of the additional trunk.

[0102] Example 24. The system of any of Examples 19 to 23, wherein the second portion of the third SMP foam surrounds the first portion of the third SMP foam in a plane orthogonal to the long axis of the additional backbone.

[0103] Example 25. A system according to any of Examples 1 to 24, wherein: the trunk is oriented along a long axis that traverses the first SMP foam, the second SMP foam, and the third SMP foam; the short axis is orthogonal to the long axis; the third SMP foam includes a continuous outer surface surrounding the third SMP foam in a plane orthogonal to the long axis; the third SMP foam includes a first void, the first void does not include foam cells; the short axis intersects the first void; and the short axis intersects the continuous outer surface of the third SMP foam at least twice.

[0104] For example, see Fig.21D The gaps 2101 in the foam 2102.

[0105] Example 26. A system according to any of Example 25, wherein: the additional short axis is orthogonal to the long axis; the first SMP foam includes a second void, the second void does not include a foam unit; the additional short axis intersects the second void; and the additional short axis intersects the continuous outer surface of the first SMP foam at least twice.

[0106] Example 27. A system according to any of Examples 1 to 24, wherein: the trunk is oriented along a long axis that traverses the first SMP foam, the second SMP foam, and the third SMP foam; the short axis is orthogonal to the long axis; the first SMP foam includes a continuous outer surface surrounding the first SMP foam in a plane orthogonal to the long axis; the first SMP foam includes a first void, the first void does not include foam cells; the short axis intersects the first void; and the short axis intersects the continuous outer surface of the first SMP foam at least twice.

[0107] Example 28. A system according to any of Example 27, wherein: the additional short axis is orthogonal to the long axis; the first SMP foam includes a second void, the second void does not include a foam unit; the additional short axis intersects the second void; and the additional short axis intersects the continuous outer surface of the first SMP foam at least twice.

[0108] Example 29. A system according to any of Examples 25 to 28, wherein: the system includes a resilient member; and the minor axis intersects the resilient member.

[0109] For example, the system may include a nitinol arm that is included in the void and helps expand the foam.

[0110] Example 30. The system of any of Examples 1 to 29, comprising a structural support skeleton coupled to the second SMP foam, wherein: the second SMP foam is between the third SMP foam and the structural support skeleton.

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

[0112] In an embodiment, the backbone includes Fig.23E Tether 2307.

[0113] Embodiments may include any of the above examples, but modified to include a single SMP foam coupled to a skeleton. For example, see Fig.23D .

[0114] Embodiments may include any of the above examples, but modified to omit the stem. Fig.23C .

[0115] Example 31. A system comprising: a first polyurethane shape memory polymer (SMP) foam; a structural support skeleton coupled to the first SMP foam, the structural support skeleton comprising a first relative end and a second relative end; wherein the first SMP foam is coupled to one of the first relative end or the second relative end.

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

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

[0118] Second example group

[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; a third polyurethane SMP foam on the backbone and between the first SMP foam and the second SMP foam.

[0120] See, for example, first SMP foam 1210, second SMP foam 1206, and third SMP foam 1209. Foam 1206 may be distal-most and configured to emerge from the delivery conduit before either of foams 1209, 1210.

[0121] Example 2. The system of Example 1, comprising a first radiopaque tube section and a second radiopaque tube section on the trunk, wherein the first SMP foam, the second SMP foam, and the third SMP foam are between the first radiopaque tube section and the second radiopaque tube section.

[0122] As a result, the user may be able to visualize the beginning and end of the system.

[0123] Another version of Example 2. The system of Example 1, comprising a first radiopaque portion and a second radiopaque portion on the trunk, wherein the first SMP foam, the second SMP foam, and the third SMP foam are between the first radiopaque portion and the second radiopaque portion.

[0124] Thus, in some embodiments, the radiopaque portion is not necessarily a tube, but may instead be a bead that is fixedly coupled (eg, via welding or an adhesive) to the stem, for example.

[0125] Another version of Example 2. The system of Example 1, comprising a first radiopaque tube section and a second radiopaque tube section on the trunk, wherein the third SMP foam is between the first radiopaque tube section and the second radiopaque tube section.

[0126] For example, first and second radiopaque tube sections on the trunk may be attached to proximal portions of the first and second SMP foams such that, for example, not all of the second foam is between the first and second radiopaque tube sections.

[0127] Example 3. The system of Example 2, wherein at least one of the first SMP foam, the second SMP foam, and the third SMP foam is slidably coupled to the trunk.

[0128] Example 4. The system of Example 3, wherein at least another of the first SMP foam, the second SMP foam, and the third SMP foam is statically and non-slidably coupled to the trunk.

[0129] For example, in embodiments, the end foams may be fixedly coupled to the backbone, while the middle foam (or middle foam in embodiments where there are two or more foams between two outer foams) would be able to slide along the length of the backbone.

[0130] Example 5. The system of Example 3, wherein at least one of the first SMP foam, the second SMP foam, and the third SMP foam comprises a first portion slidably coupled to the backbone and a second portion stationarily coupled to the backbone.

[0131] For example, the most proximal foam can have its proximal end fixed to the trunk. For example, a radiopaque marker can be curled on the proximal portion of the foam and hold the proximal portion of the foam stationary against the trunk. An adhesive may be used or not to hold the proximal portion of the foam against the trunk. By positioning a portion of the foam in or connected to a radiopaque conduit / marker, the proximal portion of the foam can be caused to taper and facilitate the withdrawal of the foam into the conduit (e.g., retrieving the system into a delivery conduit to reposition the system). The distal portion of the proximal foam can slide freely along the trunk. Therefore, when the foam is transformed from its smaller diameter secondary form to its larger diameter expanded primary form, the foam can expand radially and contract axially.

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

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

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

[0135] Example 9. A system according to any of Examples 2 to 8, wherein: the trunk is oriented along a long axis that traverses the first SMP foam, the second SMP foam, and the third SMP foam; the plane is orthogonal to the long axis; and the plane intersects the first SMP foam and the first radiopaque tube portion.

[0136] Example 10. The system of Example 9, wherein the first SMP foam comprises an outer diameter that narrows as the first SMP foam approaches the first radiopaque tubing portion, and an outer diameter when the first SMP foam expands.

[0137] Example 11. The system of Example 10, wherein: the additional plane is orthogonal to the long axis; the additional plane intersects the second SMP foam and the second radiopaque tubing portion.

[0138] Example 12. The system of Example 11, comprising a third radiopaque conduit, wherein: the other plane is orthogonal to the long axis; the other plane intersects the third SMP foam and the third radiopaque conduit portion.

[0139] For example, see Fig. 12B .

[0140] Example 13. The system of Example 9, wherein: the third SMP foam does not directly contact the first SMP foam; the third SMP foam does not directly contact the second SMP foam.

[0141] For example, there may be spaces between the bubbles to facilitate flexibility of the system and thereby facilitate navigation through the vascular system. See, for example, Fig. 12B .

[0142] Example 14. The system of Example 9, wherein: each of the first SMP foam, the second SMP foam, and the third SMP foam comprises an expanded primary shape and a compressed secondary shape; the first SMP foam comprises a first maximum outer diameter in its primary shape; the second SMP foam comprises a second maximum outer diameter in its primary shape; the third SMP foam comprises a third maximum outer diameter in its primary shape; and in its primary shape, the third maximum outer diameter is greater than at least one of the first maximum outer diameter or the second maximum outer diameter.

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

[0144] Example 16. The system of Example 9, wherein the first SMP foam comprises a polymer comprising polymerized monomers including hydroxypropyl ethylenediamine (HPED), triethanolamine (TEA), and hexamethylene diisocyanate (HDI).

[0145] Alternative version of Example 16. The system of any of Examples 1 to 8, wherein the first SMP foam comprises a polymer comprising a polymerized monomer comprising: at least one of hydroxypropyl ethylenediamine (HPED), triethanolamine (TEA), or a combination thereof; at least one of hexamethylene diisocyanate (HDI), trimethyl hexamethylene diisocyanate, or a combination thereof.

[0146] Example 17. The system of Example 9, comprising an additional backbone that traverses the first SMP foam, the second SMP foam, and the third SMP foam.

[0147] Example 18. The system of Example 17, wherein at least one of the first SMP foam, the second SMP foam, or the third SMP foam comprises an asymmetric cross-section taken parallel to the plane.

[0148] For example, see Figure 3C The asymmetric cross-section may assist the user in successfully occluding the false lumen while keeping the access to the true lumen of the AD as wide as possible.

[0149] Example 19. The system of Example 9, wherein: the short axis is orthogonal to the long axis; the third SMP foam includes a continuous outer surface that surrounds the third SMP foam in an additional plane orthogonal to the long axis; the third SMP foam includes a first void that does not include a foam unit; the short axis intersects the first void; and the short axis intersects the continuous outer surface of the third SMP foam at least twice.

[0150] For example, see Fig.21A , 21C 、21E.

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

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

[0153] Example 21. The system of Example 19, wherein: the additional minor axis is orthogonal to the major axis; the first SMP foam includes a second void, the second void does not include a foam unit; the additional minor axis intersects the second void; and the additional minor axis intersects the continuous outer surface of the first SMP foam at least twice.

[0154] Example 22. The system of Example 9, wherein: the short axis is orthogonal to the long axis; the first SMP foam includes a continuous outer surface surrounding the first SMP foam in a plane orthogonal to the long axis; the first SMP foam includes a first void, the first void does not include a foam unit; the short axis intersects the first void; and the short axis intersects the continuous outer surface of the first SMP foam at least twice.

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

[0156] Example 24. The system of Example 22, wherein: the additional minor axis is orthogonal to the major axis; the first SMP foam includes a second void, the second void does not include a foam unit; the additional minor axis intersects the second void; and the additional minor axis intersects the continuous outer surface of the first SMP foam at least twice.

[0157] Example 25. The system of Example 22, wherein: the system includes a resilient member; and the minor axis intersects the resilient member.

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

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

[0160] In embodiments, the backbone may include a stent, a multi-arm unit such as an IVC filter, a coil having a spiral or conical shape, or the like.

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

[0162] In embodiments, the adhesive is directly on the foam, instead of or in addition to a mechanical support framework. For example, Fig. 12B Any or all of the foam in the may include a tissue adhesive applied to a portion of the foam. For example, the adhesive may be placed on one side of the most proximal foam. This portion of the foam may be loaded with radiopaque particles to indicate its location so the user knows to apply the foam where the adhesive is positioned to the aortic wall. Such embodiments may be used with a torque inducing trunk (e.g., see Figure 5C ) connection to better control the position of the adhesive relative to the aortic wall primarily opposite the false lumen.

[0163] Example 28. The system of Example 27, wherein: the structural support framework has a first side wall and a second side wall opposite each other; and the tissue adhesive is on the first side wall but not on the second side wall.

[0164] For example, the framework may include a stent having struts on one sidewall coated with tissue adhesive and struts on the opposite sidewall not coated with tissue adhesive. In this case, the uncoated sidewall may dock with the false lumen and the adhesive-coated sidewall may contact the aortic wall.

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

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

[0167] Example 30. A method comprising implanting at least a portion of a system according to any of Examples 9 or 26 in a left atrial appendage (LAA).

[0168] The third sample group

[0169] Example 1. A system comprising: a trunk; a first polyurethane shape memory polymer (SMP) foam on the trunk; a second polyurethane SMP foam on the trunk.

[0170] Example 2. The system of Example 1, comprising a first radiopaque tube section and a second radiopaque tube section on the trunk, wherein the first SMP foam and the second SMP foam are between the first radiopaque tube section and the second radiopaque tube section.

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

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

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

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

[0175] Example 7. The system of any of Examples 1 to 6, wherein: the trunk is oriented along a long axis that traverses the first SMP foam and the second SMP foam; the plane is orthogonal to the long axis; the plane intersects the first SMP foam and the first radiopaque tube portion.

[0176] Example 8. The system of Example 7, wherein the first SMP foam comprises an outer diameter that narrows as the first SMP foam approaches the first radiopaque tubing portion, and an outer diameter when the first SMP foam expands.

[0177] Example 9. The system of Example 8, wherein: the additional plane is orthogonal to the long axis; and the additional plane intersects the second SMP foam and the second radiopaque tubing portion.

[0178] Example 10. The system of Example 9, comprising a third radiopaque tube portion, wherein: the other plane is orthogonal to the long axis; the other plane intersects one of the first SMP foam or the second SMP foam and the third radiopaque tube portion.

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

[0180] Example 12. The system of Example 1, wherein: each of the first SMP foam and the second SMP foam comprises an expanded primary shape and a compressed secondary shape; the first SMP foam comprises a first maximum outer diameter in its primary shape; the second SMP foam comprises a second maximum outer diameter in its primary shape; the first maximum outer diameter is greater than the second maximum outer diameter.

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

[0182] Example 14. The system of any of Examples 1 to 13, wherein the first SMP foam comprises a polymer comprising polymerized monomers including hydroxypropyl ethylenediamine (HPED), triethanolamine (TEA), and hexamethylene diisocyanate (HDI).

[0183] Example 15. A system according to any of Examples 1 to 14, wherein: the trunk is oriented along a long axis that passes through the first SMP foam and the second SMP foam; the short axis is orthogonal to the long axis; the first SMP foam includes a continuous outer surface surrounding the first SMP foam in an additional plane orthogonal to the long axis; the first SMP foam includes a first void, the first void does not include foam cells; the short axis intersects the first void; and the short axis intersects the continuous outer surface of the first SMP foam at least twice.

[0184] Example 16. The system of Example 15, wherein the continuous outer surface of the first SMP foam narrows as it slopes proximally.

[0185] Example 17. The system of Example 15, wherein: the additional minor axis is orthogonal to the major axis; the first SMP foam includes a second void, the second void does not include a foam unit; the additional minor axis intersects the second void; and the additional minor axis intersects the continuous outer surface of the first SMP foam at least twice.

[0186] Example 18. The system of Example 15, wherein: the system includes a resilient member; and the minor axis intersects the resilient member.

[0187] Example 19. The system of any of Examples 1 to 18, comprising a structural support skeleton coupled to the first SMP foam, wherein: the first SMP foam is between the second SMP foam and the structural support skeleton.

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

[0189] Example 21. The system of Example 20, wherein: the structural support framework has a first side wall and a second side wall opposite 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 a system according to any of Examples 1 to 21 in a false lumen of an aortic dissection.

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

[0192] The foregoing description of the embodiments of the present invention has been presented for the purpose of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. This specification and the subsequent claims include terms such as left, right, top, bottom, above, below, upper, lower, first, second, etc., which are used for descriptive purposes only and should not be interpreted as limiting. For example, terms indicating relative vertical positions refer to the situation where one side of a substrate is the "top" surface of the substrate; the substrate can actually be in any orientation so that the "top" side of the substrate can be lower than the "bottom" side in a standard ground reference system and still fall within the meaning of the term "top". The term "on..." as used herein (including in the claims) does not indicate that a first layer "on" a second layer is directly on the second layer and in direct contact with the second layer, unless otherwise specified; there may be a third layer or other structure between the first layer and the second layer on the first layer. The embodiments of the devices or articles described herein can be manufactured, used or transported in a variety of positions and orientations. Those skilled in the relevant art will appreciate that many modifications and variations are possible in view of the above teachings. Those skilled in the art will recognize various equivalent combinations and substitutions for the various components shown in the drawings. It is therefore intended that the scope of the invention be limited not by this detailed description, but rather by the claims appended hereto.

Claims

1. A system comprising: trunk; a first polyurethane shape memory polymer (SMP) foam on the backbone; a second polyurethane SMP foam on said backbone; A third polyurethane SMP foam is on the backbone and between the first SMP foam and the second SMP foam.

2. The system of claim 1, comprising a first radiopaque tubing section and a second radiopaque tubing section on the trunk, wherein a first SMP foam, a second SMP foam, and a third SMP foam are between the first radiopaque tubing section and the second radiopaque tubing section.

3. The system according to claim 2, wherein: At least one of the first SMP foam, the second SMP foam, or the third SMP foam may be slidably coupled to the backbone.

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

5. The system according to claim 3, wherein: At least one of the first SMP foam, the second SMP foam, and the third SMP foam includes a first portion slidably coupled to the backbone and a second portion stationarily coupled to the backbone.

6. The system of claim 3, wherein: The first SMP foam includes a first portion slidably coupled to the backbone and a second portion stationarily coupled to the backbone; The second SMP foam includes a first portion slidably coupled to the backbone and a second portion stationarily coupled to the backbone.

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 stationarily coupled to the backbone.

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

9. A system according to any one of claims 2 to 8, wherein: The backbone is oriented along a long axis that traverses the first SMP foam, the second SMP foam, and the third SMP foam; The plane is orthogonal to the long axis; The plane intersects the first SMP foam and the first radiopaque tube portion.

10. The system according to claim 9, wherein: The first SMP foam includes an outer diameter that narrows as the first SMP foam approaches the first radiopaque tube portion and an outer diameter when the first SMP foam expands.

11. The system of claim 10, wherein: The additional plane is orthogonal to the long axis; The additional plane intersects the second SMP foam and the second radiopaque tubing portion.

12. The system of claim 11, comprising a third radiopaque tube section, wherein: another plane orthogonal to the long axis; The other plane intersects the third SMP foam and the third radiopaque tube portion.

13. The system of claim 9, wherein: The third SMP foam does not directly contact the first SMP foam; The third SMP foam does not directly contact the second SMP foam.

14. The system of claim 9, wherein: each of the first SMP foam, the second SMP foam, and the third SMP foam comprises an expanded primary shape and a compressed secondary shape; The first SMP foam comprises a first maximum outer diameter in its primary shape; The second SMP foam comprises a second maximum outer diameter in its primary shape; The third SMP foam comprises a third maximum outer diameter in its primary shape; In its primary shape, the third maximum outer diameter is greater than at least one of the first maximum outer diameter or the second maximum outer diameter.

15. The system of claim 9, wherein: The first SMP foam comprises a first maximum outer diameter in its secondary shape; The second SMP foam comprises a second maximum outer diameter in its secondary shape; The third SMP foam comprises a third maximum outer diameter in its secondary shape; In its secondary shape, the third maximum outer diameter is equal to each of the first maximum outer diameter and the second maximum outer diameter.

16. The system of claim 9, wherein: The first SMP foam includes a polymer comprising polymerized monomers including hydroxypropyl ethylenediamine (HPED), triethanolamine (TEA), and hexamethylene diisocyanate (HDI).

17. The system of claim 9, comprising an additional backbone traversing the first SMP foam, the second SMP foam, and the third SMP foam.

18. The system of claim 17, wherein: At least one of the first SMP foam, the second SMP foam, or the third SMP foam includes an asymmetric cross-section taken parallel to the plane.

19. The system of claim 9, wherein: The short axis is orthogonal to the long axis; The third SMP foam includes a continuous outer surface that surrounds the third SMP foam in an additional plane orthogonal to the long axis; The third SMP foam includes a first void space, wherein the first void space does not include foam cells; The short axis intersects the first gap; and The minor axis intersects the continuous outer surface of the third SMP foam at least twice.

20. The system of claim 19, wherein: The continuous outer surface of the third SMP foam narrows as it slopes proximally.

21. The system of claim 19, wherein: The additional short axis is orthogonal to the long axis; The third SMP foam includes a second void space, wherein the second void space does not include foam cells; The additional minor axis intersects the second gap; and The additional minor axis intersects the continuous outer surface of the third SMP foam at least twice.

22. The system of claim 9, wherein: The short axis is orthogonal to the long axis; The first SMP foam includes a continuous outer surface surrounding the first SMP foam in a plane orthogonal to the long axis; The first SMP foam includes a first void space, the first void space does not include foam cells; The short axis intersects the first gap; and The minor axis intersects the continuous outer surface of the first SMP foam at least twice.

23. The system of claim 22, wherein: The continuous outer surface of the first SMP foam narrows as it slopes proximally.

24. The system of claim 22, wherein: The additional short axis is orthogonal to the long axis; The first SMP foam includes a second void space, the second void space does not include foam cells; The additional minor axis intersects the second gap; and The additional minor axis intersects the continuous outer surface of the first SMP foam at least twice.

25. The system of claim 22, wherein: The system includes a resilient member; The minor axis intersects the resilient member.

26. The system of any one of claims 1 to 8, comprising a structural support skeleton coupled to the first SMP foam, wherein: The first SMP foam is between the third SMP foam and the structural support skeleton.

27. The system of claim 26, comprising a tissue adhesive coupled to the structural support framework.

28. The system of claim 27, wherein: The structural support frame has a first side wall and a second side wall opposite to each other; The tissue adhesive is on the first side wall but not on the second side wall.

29. A method comprising implanting at least a portion of a system according to any one of claim 9 or claim 26 into the false lumen of an aortic dissection.

30. A method comprising implanting at least a portion of a system according to any one of claim 9 or claim 26 in a left atrial appendage (LAA).

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