Treatment systems and devices for a damaged blood vessel

Abstract

A system for treating the false lumen of a dissection is disclosed. The system includes an expandable material configured to occupy space within the aortic dissection where the expandable material is shaped to occupy the aortic dissection. The system includes a catheter configured to deliver the expandable material to the aortic dissection. A system may further be directed to treatment of a saccular aneurysm.

Description

TREATMENT SYSTEMS AND DEVICES FOR A DAMAGED BLOOD VESSELCROSS REFERENCE TO PRIOR APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 588,790, entitled as “TREATMENT SYSTEMS AND DEVICES FOR A DAMAGED BLOOD VESSEL”, filed October 9, 2023, which is incorporated by reference in its entirety.FIELD OF THE INVENTION

[0002] This disclosure relates to the field of treatment for aneurysms, aortic dissections, and the like.BACKGROUND

[0003] An aortic dissection is a medical condition characterized by a tearing in an inner layer of the arterial wall. Blood may then fill the layer in between the intima and adventitial layer of the artery. The thoracic aorta is a predominant anatomical location of dissections. An aortic dissection that is left untreated may lead to further tearing of the aorta, blood loss, and possibly death. On the long-term they may cause aneurysmal dilatation of the aorta. Aortic dissections can be classified as either occurring in the ascending aorta, which is part of the aorta that transports blood as the blood leaves the heart, and the descending aorta, which is downstream in the aorta from the right subclavian, right common carotid, left subclavian and left common carotid arteries. There is an unmet need in the art for safer, easier, dedicated and less costly treatments for all types of aortic dissections.

[0004] A saccular aneurysm is a swelling or bulging in an artery that may result from trauma, iatrogenic injury, but can also spontaneously occur. It is the most common type of aneurysm in the brain. It is characterized by a round sac that protrudes from a main artery that supplies blood to the brain. There is a need in the art for safer, easier, and less costly treatments for saccular aneurysms.SUMMARY

[0005] Disclosed is a system for treating a damaged blood vessel. The system includes an expandable material that is configured to expand to fill a space within the blood vessel. The system may include a catheter that is configured to deliver the expandable material to the blood vessel. The expandable material may be shaped based on the space to be filled. In embodiments, the expandable material may be shaped to be deployed in layers where each layer supports or reinforces other layers of expandable material after deployment in the space within the blood vessel. The layer may be shaped based on the shape of the space in the blood vessel. Various combinations of various shaped expandable materials may be deployed to fill the space. The various shapes include, but are not limited to bar shapes, rod shapes, solid cylinder shapes, hollow cylinder shapes, cube shapes, sphere shapes, corkscrew shapes and combinations thereof. In embodiments, the expandable material may be configured to be deployed in an aortic dissection or an aneurysm.

[0006] The system may include a catheter that is configured to deliver the expandable material to the space in the blood vessel. In embodiments, the catheter may be configured to deploy the expandable material from a downstream direction of blood flow through the blood vessel.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] FIG. 1 is an illustration of the main arteries as they facilitate the flow of blood from the heart of a human subject.

[0008] FIG. 2 is an illustration of an aortic dissection in the descending aorta in the circulatory system of a human subject.

[0009] FIGS. 3A-3B are illustrations of embodiments of expandable material that may be deployed in an aortic dissection.

[0010] FIG. 4 is an illustration of expandable material that has been deployed in an aortic dissection.

[0011] FIGS. 5A-5B are illustrations of embodiments of expandable material that may be deployed in an aortic dissection or aneurysm.

[0012] FIG. 6 is an illustration of a cylindrical shaped expandable material that may be deployed in an aortic dissection.

[0013] FIG. 7 is an illustration of three layers of the cylindrical shaped expandable material as they are deployed in an aortic dissection.

[0014] FIG. 8 is an illustration of a tapered embodiment of three layers of the cylindrical shaped expandable material as they are deployed in an aortic dissection.

[0015] FIG. 9 is an illustration of a corkscrew-shaped expandable material that may be deployed in an aortic dissection.

[0016] FIG. 10 is an illustration of the corkscrew -shaped expandable material as it is deployed in an aortic dissection.

[0017] FIG. 11 is an illustration of an embodiment of a catheter that may deploy various embodiments of the disclosed expandable material.

[0018] FIG. 12 is an illustration of another embodiment of the catheter that may deploy various embodiments of the disclosed expandable material.

[0019] FIG. 13 is an illustration of a saccular aneurysm that is filled with an embodiment of the disclosed expandable material.DETAILED DESCRIPTION

[0020] The disclosed subject matter is an expandable material that may be used to fill an expanding blood vessel such as an aneurysm or the false lumen of an aortic dissection. The expandable material may be shaped to advantageously take up space within the expanded blood vessel. In various embodiments, a plurality of pieces of expandable materials may be simultaneously deployed into a single expanded blood vessel such as an aneurysm or an aortic dissection.

[0021] In various embodiments, the plurality of pieces of expandable material may be shaped to complement one another to more effectively fill the expanded blood vessel. For example, aplurality of rod shaped pieces of expandable material may be deployed into an aortic dissection to more effectively seal the aortic dissection than with a single piece of expandable material.

[0022] In an exemplary embodiment, the plurality of pieces of expandable material may comprise substantially cubic or spherical shaped pieces of expandable material. The plurality of cubic or spherical shaped pieces of expandable material may be deployed into the expanded blood vessel to more effectively seal the expanded blood vessel than a single piece of expandable material. Various shapes of expandable material may be useful based on a shape of the expanded blood vessel.

[0023] For example, the expandable serial may comprise a rod or bar shaped material with a length that is approximately equal to a distance from an inflow of blood into an aortic dissection and an outflow of blood from the aortic dissection. The multitude of rod or bar shaped pieces of expandable materials may be deployed into the aortic dissection where each rod or bar shaped expandable material occupies a space spanning the length of the aortic dissection.

[0024] In an exemplary embodiment, the expandable material may comprise a substantially cylindrical shape. The substantially cylindrical shaped expandable material may be configured to deploy with a plurality of cylindrical shaped expandable materials such that multiple layers of cylinders are nested within one another. For example, a cylindrical shaped expandable material with a hollow center may comprise an outside layer. Other layers of cylindrical shaped expandable materials may be nested within the outside layer. Each subsequent layer of cylindrical shaped spendable material may be nested within the previous outside layer. The innermost cylindrical shaped expandable material may comprise a solid center.

[0025] In various embodiments the various pieces of expandable material may comprise different shapes. The different shaped expandable materials may be shaped to advantageously fit within an expanded blood vessel depending on the shape of the blood vessel. For example, the plurality of rod or bar shaped expandable materials that span a length of an aortic dissection may be configured to be of different lengths because different portions of the aortic dissection may have different lengths. For instance, an outside portion of the aortic dissection may have a shorter length than an inner portion.

[0026] In another example of different shaped expandable materials advantageously fitting within the expanded blood vessel, the plurality of nested cylindrically shaped expandable materials may be tapered such that an innermost layer of cylindrically shaped expandable material may have a longer length than each subsequent layer of cylindrical material going from the innermost layer to an outermost layer. Accordingly, the sizes of expandable material may complement one another in the goal of filling the space within an expanded blood vessel such as an aneurysm or aortic dissection.

[0027] The various pieces of expandable material may be deployed to a damaged blood vessel via a catheter. In various embodiments the catheter may be guided to the expanded blood vessel such as an aneurysm or aortic dissection via a guidewire. In an exemplary embodiment, the expandable material may be deployed through a proximal end of a catheter via a mechanism of pulling each expandable material out of catheter through the proximal on an inside of the expanded blood vessel. In various embodiments, the catheter may comprise a funnel shape whereby the funnel and the catheter facilitates deployment of the expandable material through the funnel. For example, expandable material may gradually expand as it works its way through the funnel. Thus, a cross-section of the expandable material may be partially or fully expanded as it leaves the catheter.

[0028] An exemplary embodiment of the disclosed subject matter is an expandable material for filling a saccular aneurysm. A saccular aneurysm is a common type of intracranial aneurysm characterized by a circular- shaped bulge in an artery leading to the brain. A piece of expandable material may be shaped and sized to fit within the bulge of the saccular aneurysm in order to minimize its danger to the human patient.

[0029] Referring to Fig. 1, Fig. 1 is an illustration 100 of the main arteries as they leave the heart 105 of a human subject. The various arrows in the illustration 100 represent a flow of blood through the arteries. The first arrow represents a flow of blood that leaves the heart of a human subject. The blood then flows through the ascending aorta. After that, blood flows over an arch whereby the aorta branches into the innominate artery, left common carotid, and left subclavian arteries which supply blood to the head and upper body. A flow of blood may then pass through the descending aorta where it enters the abdominal aorta area. After that, blood may branch intothe left renal and right renal arteries. And after that, the aorta bifurcates into the left iliac and right iliac arteries.

[0030] An aortic dissection occurs where an inner layer of the blood vessel ruptures and blood spills into one or more middle layers. This may commonly happen in the ascending aorta or descending aorta. In both cases the aortic dissection is a potentially life-threatening condition.

[0031] Referring to Fig. 2, Fig. 2 is an illustration 200 of an aortic dissection in the descending aorta in the circulatory system of a human subject. The aortic dissection includes a tear in the inner lumen of the artery that allows an inflow of blood, at an inflow tear 205, into the middle layers of the blood vessel to create the aortic dissection. The blood continues to flow and reenters the artery through an outflow tear 210 in the blood vessel.

[0032] The area of the aorta that supports a flow of blood within the inner lumen of the aorta is referred to as the true lumen 215. The area of the aorta at the aortic dissection in between the inner layer and middle layers of the aorta is referred to as the false lumen 220.

[0033] Access to the aortic dissection may be made from a downstream location whereby a catheter is guided against the flow of blood from the bottom of the illustration 200 to the outflow tear 210 to enter the aortic dissection. Access from the upstream location may be made through the right or left subclavian aorta and entering the inflow tear 205 of the aortic dissection.

[0034] In an exemplary embodiment, the disclosed catheter is configured to access the aortic dissection from a downstream location. In one example, the catheter is deployed in the aortic dissection whereby one or more pieces of expandable material are pushed out of the catheter and allowed to expand within the aortic dissection. In one instance of use, the one or more pieces of expandable material are pulled out of the catheter through a proximate end of the catheter.

[0035] Referring to Figs. 3A-3B, Fig. 3 A is an illustration 300 of a rod shaped expandable material that may be deployed into an aortic dissection to fill the aortic dissection. Fig. 3B is an illustration 350 of a bar shaped expandable material 310 that may be similarly deployed into an aortic dissection to fill it. The rod shaped expandable material 305 may be configured to have a length that is substantially equal to the length of the distance between the inflow and outflow tears in the aortic dissection. Accordingly, a plurality of rod shaped expandable materials 305may be deployed to an aortic dissection whereby each of the rod shaped expandable materials 305 traverses a length of the aortic dissection.

[0036] The bar shaped expandable material 310 is characterized by the rounded shape on the ends of the bar shaped expandable material 310. The bar shaped expandable material may be used similarly to the rod shaped expandable material 305. In an exemplary embodiment, a crosssection of the rod shaped expandable material 305 or bar shaped expandable material 310 may be between about 25 and 50 mm.

[0037] In various embodiments, the expandable material that comprises the rod shaped expandable material 305, bar shaped expandable material 310, or other shaped expandable materials that are disclosed herein may comprise a foam material with spongelike properties. In an exemplary embodiment, the foam comprises biocompatible thermoset polycarbonate polyurethane. In various embodiments, the expandable material comprises a polytetrafluoroethylene (PTFE) liner at a top and bottom where there would be more likely to be exposed to a flow of blood to prevent thrombosis. Various materials for the expandable material include but are not limited to polyester, polytetrafluoroethylene (PTFE or ePTFE), and polyethylene terephthalate (PET). In various embodiments, radiopaque markers may be appended to the expandable material.

[0038] In various embodiments, the expandable material may be bioresorbable. A bioresorbable material is a material that can be safely degraded and absorbed by the body after fulfilling its intended function. In various embodiments, the expandable material may be a biostable material that does not undergo significant changes in its properties or functions due to the effects of the physiological environment. In various embodiments, the expandable material may be coated with prothrombotic agents that promote or favor blood clotting. In various embodiments, the expandable material may be coated with anti-inflammatory agents. The expandable material may be further coated with other agents that promote healing of the arterial wall. The expandable material may include any combination of the materials disclosed herein.

[0039] Referring to Fig. 4, Fig. 4 is an illustration 400 of expandable material that is been deployed in an aortic dissection. As shown in the illustration 400, the aortic dissection is filled with three layers of an expandable material. The 3 layers each comprise a rod shaped expandablematerial. A first rod shaped expandable material 405 is positioned nearest the true lumen. Next, the second rod shaped expandable material 10 is layered against the first rod shaped expandable material 405. And the third rod shaped expandable material 415 is furthest away from the true lumen and conforms to the inner lumen of the aortic dissection.

[0040] In various embodiments, the top and bottom ends of the rod shaped expandable materials, such as the top end 420 of the first rod shaped expandable material 405, may be tipped with PTFE to prevent thrombosis from exposure to blood flowing through the artery. In various embodiments, the lengths of each of the rod shaped expandable materials are normalized to an approximate length of the aortic dissection as measured from the inflow tear 425 to the outflow tear 430. In the exemplary embodiment shown in the illustration 400, the length of the various expandable materials are adjusted based on the dimensions of the aortic dissection. As shown in the illustration 400, the first rod shaped expandable material 405 is slightly longer than the second rod shaped expandable material 410 which in turn is slightly longer than the third rod shaped expandable material 415.

[0041] The two-dimensional view of the expanded material as deployed in the aortic dissection shown in the illustration 400 does not depict a third dimension, which could also be adjusted. For example, the length and width of the rods could be adjusted based on the shape of the aortic dissection and the specific needs of the patient. The number of rods necessary to fill the space of the aortic dissection may vary based on the three-dimensional shape of the aortic dissection. In one example, the expandable material may be adjusted in size, such as by cutting the expandable material before deployment into the damaged blood vessel.

[0042] In an example of deployment, each rod-shaped expandable material may be deployed from a catheter and allowed to expand inside the aortic dissection. In another embodiment, the catheter may deploy the rod-shaped expandable material in a manner that allows the expandable material to expand before deployment into the aortic dissection but also be delivered in a compressed state. For example, a delivery catheter may be deployed via a guidewire, entering through the inflow (car 425 and passing through the outflow tear 430. The expandable material may then be deployed and pulled back into the aortic dissection.

[0043] Referring to Figs. 5A-5B, Figs. 5A-5B are illustrations of embodiments of expandable materials that may be deployed in an aortic dissection or aneurysm. Fig. 5A illustrates a substantially cubic shaped expandable material 500 that may be deployed to an aortic dissection. A plurality of the substantially cubic shaped expandable material 500 may be deployed to a single a or aortic dissection in order to fill all space in the aortic dissection.

[0044] Fig. 5B illustrates a substantially spherical- shaped expandable material 550 that may be deployed to an aortic dissection. In various embodiments, a combination of the cubic shaped expandable material 500 and spherical-shaped expandable material 550 may be deployed to a single aortic dissection. In an exemplary embodiment, one or more of the cubic shaped expandable materials 500 or spherical-shaped expandable materials may include a radiopaque markers that enhance visualization of the expandable materials. In various embodiments, the cubic shaped expandable material and / or spherical- shaped expandable materials may have a diameter of between about 6-20mm.

[0045] Referring to Fig. 6, Fig. 6 is an illustration 600 of a cylindrical shaped expandable material that may be deployed in an aortic dissection. The cylindrical shaped expandable materials may be deployed in concentric rings where an outermost cylindrical shaped expandable material surrounds the next outermost cylindrical shaped expandable material and so on.

[0046] The illustration 600 shows an outside layer 605, a middle layer 610, and an inside layer 615. In an exemplary embodiment, the outside layer 605 is deployed first and allowed to expand. Once the outside layer is fully expanded, the middle layer 610 is deployed inside the outside layer. And once the middle layer 610 is deployed and allowed to fully expand, the inside layer 615 is deployed inside the middle layer 610.

[0047] In various embodiments, the cylindrical-shaped expandable material shown in Fig. 6 may comprise any number of layers. For example, the cylindrical-shaped expandable material may include anywhere from one layer to ten layers. The various layers may be deployed starting with the outerside layer 605 first, and then working inward such that each subsequent next outermost layer is deployed. In an example embodiment, the various layers of the cylindricalshaped expandable material may be shaped differently with varying lengths and widths. Thelength of the expandable material, as used for Fig. 6, may refer to the distance from one end of the cylindrical-shaped expandable material to the other.

[0048] For example, the distance from the top end of the cylindrical-shaped expandable material to the bottom end of the cylindrical-shaped expandable material. The width of the cylindrical-shaped expandable material may be the distance from the inner radius of each cylindrical-shaped expandable material to the outer radius. In cases where the cylindrical-shaped expandable material is solid rather than hollow, the width may refer to the diameter of the cylindrical-shaped expandable material. For example, the outside layer 605 and middle layer 610 shown in the illustration are hollow cylindrical- shaped expandable materials, and the inside layer 615 is a solid cylindrical- shaped expandable material. The various lengths and widths of expandable material may be tailored based on the needs of the patient. For example, the space to be filled in a damaged blood vessel may vary for each patient, and the lengths and widths of the different layers of the cylindrical-shaped expandable material may be adjusted accordingly to fit the space to be filled.

[0049] Referring to Fig. 7, Fig. 7 is a partial sectional illustration 700 of three layers of the cylindrical shaped expandable material as they are deployed in an aortic dissection 702. The outer layer 715 and the middle layer 710 arc illustrated as sections in order to illustrate the positions of all lavers in an embodiment of the disclosed subject matter. As shown in the illustration 700, the multitude of cylindrical shaped expandable materials have been deployed to the aortic dissection 702 in order to fill the space within the aortic dissection. In various embodiments, each layer of the cylindrical shaped expandable materials are delivered separately beginning with the outer layer 715 and working inward. For instance, the middle layer 710 may be delivered after the outer layer 715. The inner layer 705 may be delivered subsequent to delivery of the middle layer 710.

[0050] In one example of deployment, a catheter is guided to the aortic dissection 702 whereby a cylindrical shaped expandable material is pulled from the catheter and allowed to expand within the aortic dissection 702. Subsequent cylindrical shaped expandable materials may be deployed within the first cylindrical shaped expandable material. The plurality of expandable materials may expand and conform to a shape of the aortic dissection. Every patient with anaortic dissection may have a different shape of aortic dissection. Accordingly, the expandable material may fill in irregular shapes and surfaces within the aortic dissection.

[0051] In embodiments, one or more of the layers may be shaped based on a shape of the aortic dissection 702. For example, a length of one or more of the layers, measured from the top to the bottom of the illustration 700, may be adjusted to conform to a length of the aortic dissection, measured from the inflow tear 720 to the outflow tear 725. Length of the various layers may be further adjusted based on order of layering, as shown in Fig 8.

[0052] Referring to Fig. 8, Fig. 8 is an illustration 800 of a tapered embodiment of three layers of the cylindrical shaped expandable material as they are deployed in an aortic dissection. The cylindrical shaped expandable materials may be deployed via pin and pull deployment or zipper deployment from the catheter. In various embodiments, the aortic dissection may have the largest cross-sectional area in the middle of the aortic dissection and a smaller cross-sectional area at the ends of the aortic dissection near the inflow tear 805 and outflow tear 810.

[0053] The illustration 800 shows a partial sectional view of the cylindrical shaped expandable materials to more clearly show how the cylindrical shaped expandable materials are concentrically aligned with one another. An inner layer 815 of the cylindrical shaped expandable materials has the longest length compared to the other layers. A middle layer 820 of the cylindrical shaped expandable materials is shorter in length than the inner layer 815. And the outer layer 825 of the cylindrical shaped expandable materials has the shortest length. The tapered lengths of the cylindrical shaped expandable materials may help accommodate various shapes of the aortic dissection.

[0054] In various embodiments, other non-cylindrically shaped expandable materials may be arranged in a similarly tapered manner. For example, the rod shaped expandable material or bar shaped pieces of expandable material may be arranged in a tapered fashion to accommodate a shape of the aortic dissection. Similarly, the corkscrew-shaped expandable material shown in Figs. 9-10 may be configured to be deployed with a cylinder shape expandable material that is positioned along the center axis of the corkscrew-shaped expandable material. The cylinder shape expandable material may be configured to have a different length in the corkscrew-shaped expandable material to accommodate a shape of the aortic dissection.

[0055] Referring to Fig. 9, Fig. 9 is an illustration 900 of a corkscrew-shaped expandable material 910 that may be deployed in an aortic dissection. The corkscrew-shaped expandable material 910 may comprise a wire within the expandable material to control its shape. In an exemplary embodiment, the wire may comprise a shape memory wire such as nitinol that conforms to a preset shape when the wire reaches a temperature. Other variations in embodiments of the expandable material may also comprise a shape memory wire such as nitinol. The shape memory wire 905 is indicated by the dashed lines in the illustration 900 to indicate that it is covered by the expandable material.

[0056] The corkscrew-shaped expandable material 910 may be compressed or straightened out within the catheter before deployment. After deployment, the shape memory wire 905 may cause the corkscrew-shaped expandable material 910 to take its corkscrew shape. In various embodiments, the corkscrew-shaped expandable material 910 may be configured to contain one or more expandable materials along the center axis of its corkscrew shape which travels down the middle of the corkscrew.

[0057] In embodiments, radiopaque markers may be placed at various locations on the outside of the corkscrew-shaped expandable material 910. These radiopaque markers may communicate the shape of the corkscrew-shaped expandable material 910, allowing a medical practitioner to view or obtain a relatively accurate depiction of the three-dimensional space occupied by the corkscrew-shaped expandable material 910. In embodiments where the corkscrew-shaped expandable material 910 is packed in a straightened state and expands into its corkscrew shape, the radiopaque markers may be positioned on the expandable material in a simple linear pattern. Accordingly, the use of radiopaque markers on the corkscrew-shaped expandable material 910, which is initially compressed in a straightened state, allows for straightforward setup and manufacturing for marker placement.

[0058] Referring to Fig. 10, Fig. 10 is an illustration 1000 of the corkscrew-shaped expandable material 1005 as it is deployed in an aortic dissection 1015. As shown in the illustration 1000, a cylindrical shaped expandable material 1010 is deployed inside the corkscrew-shaped expandable material 1005. In an exemplary embodiment, the corkscrew-shaped expandable material 1010 is configured to be deployed before the cylindrical shaped expandable material1010. Once the corkscrew-shaped expandable material 1005 expands and attains its corkscrew shape, the cylindrical shaped expandable material 1010 may be deployed along the center axis of the corkscrew-shaped expandable material.

[0059] In an embodiment, the corkscrew-shaped expandable material 1005 may be deployed with various other shapes of expandable material. For example, the corkscrew-shaped expandable material 1005 may be deployed alongside a layered expandable material as shown in Figs. 7 and 8. Various combinations of the corkscrew-shaped expandable material 1005 and other shapes of expandable material may be deployed based on the shape of the damaged blood vessel and the needs of the patient. For example, the shape of the damaged blood vessel may be abnormally shaped and may require a combination of expandable materials to fit the desired shape. The space of the damaged blood vessel may therefore influence the arrangement and deployment of the various expandable materials. In embodiments, the corkscrew-shaped expandable material 1005 may be deployed alongside the cubic-shaped expandable material 500 shown in Fig. 5A or the spherical-shaped expandable material 550 shown in Fig. 5B.

[0060] Referring to Fig. 11, Fig. 11 is an illustration 1100 of an embodiment of a catheter 1105 that may deploy various embodiments of the disclosed expandable material. The catheter 1105 includes a distal end 1115 and a proximal end 1120. The catheter 1105 may be directed to the location of an aortic dissection or other type of expanding blood vessel by a guidewire 11 10. The expandable material may be compressed and inserted into the catheter to be deployed.

[0061] In various embodiments, expandable material that is delivered to the aortic dissection in the catheter is deployed through the proximal end 1120 of the catheter 1105. For example, once the catheter 1105 is guided to the aortic dissection by the guidewire 1110, expandable material may be pushed or pulled out of the catheter 1105 and allowed to expand within the aortic dissection or other damaged vessel.

[0062] The catheter 1105 may be configured to be deployed in a downstream direction of blood flow to the aortic dissection or aneurysm. For example, the catheter may be configured to be deployed into a blood vessel upstream from the damaged portion of the blood vessel. The catheter could then be guided by the guidewire 1110 to the damaged portion of the blood vessel, and subsequently delivered through the damaged portion of the blood vessel. For instance, if thedamaged portion of the blood vessel is an aortic aneurysm, the catheter may be guided by the guidewire 1110 through one end of the aortic aneurysm to another. For example, the catheter could be deployed through the inflow tear 205 to the outflow tear 210, whereupon the catheter would deploy the expandable material.

[0063] Referring to Fig. 12, Fig. 12 is an illustration 1200 of another embodiment of the catheter that may deploy various embodiments of the disclosed expandable material. The exemplary embodiment of the catheter 1205 shown in the illustration 1200 has a funnel shape. Expandable materials that are compressed in the catheter may be gradually decompressed by traveling through the funnel.

[0064] For example, expandable materials may be pushed or pulled in the direction from the compressed end 1210 to the expanded end 1215 to gradually expand the expandable materials before being fully deployed from the catheter 1205. Thus, the expansion of the expandable materials may be more carefully controlled.

[0065] In the example shown in the illustration 1200, the catheter 1205 may be configured to deliver multiple expandable materials. For example, the catheter 1205 may be configured to carry a first expandable material 1220, a second expandable material 1225, and a third expandable material 1230. The one or more expandable materials carried by the catheter 1205 may be delivered according to the relative positions to which the expandable materials are packed. For example, and as shown in the illustration, the first expandable material 1220, second expandable material 1225, and third expandable material 1230 may be packed into the catheter 1205 in a tapered formation, whereby the first expandable material 1220 extends further to the compressed end 1210 of the catheter 1205 than the second expandable material 1225, and the second expandable material 1225 extends further into the compressed end 1210 of the catheter than the third expandable material 1230. The layered expandable materials may then be delivered and decompressed into the damaged portion of the blood vessel, in positions relative to one another that they were compressed into the catheter 1205. In various embodiments, the corkscrew-shaped expandable material 1005 may be deployed alongside the cubic-shaped expandable material 500 shown in Figure 5A or the spherical-shaped expandable material 550 shown in Figure 5B.

[0066] Referring to Fig. 13, Fig. 13 is an illustration 1300 of a saccular aneurysm 1305 that is filled with an embodiment of the disclosed expandable material. The saccular aneurysm 1305 is characterized by a substantially round shape of an expanded portion of a blood vessel. It commonly occurs in the lower cranial area of the circulatory system.

[0067] In an exemplary embodiment, a single piece of the expandable material 1310 may be deployed to the saccular aneurysm 1305 and allowed to expand to fill up the saccular aneurysm 1305. A plurality of expandable materials may be deployed to the saccular aneurysm 1305. Once expanded, the expandable material 1310 may prevent blood from entering the saccular aneurysm 1305 and prevent it from further expanding. In various embodiments, the expandable material may have a cross-sectional length of between about 1 cm and 2 cm.

[0068] A system for treating an aortic dissection is disclosed. The system includes an expandable material configured to occupy space within the aortic dissection where the expandable material is shaped to occupy the aortic dissection. The system includes a catheter configured to deliver the expandable material to the aortic dissection. The material may be bioresorbable, or not, and coated with prothrombotic and / or anti-inflammatory agents and / or other agents that promote healing of the arterial wall. The expandable material may include two or more separate pieces of expandable material that are shaped to concurrently occupy the space in the aortic dissection. At least one of the pieces of expandable material may be shaped as a rod. At least one of the pieces of expandable material may be shaped as a bar. At least one of the pieces of expandable material may be configured to expand to substantially cover and length of the aortic dissection as measured from a blood inflow position to a blood outflow position of the aortic dissection. A length of each piece of expandable material may be less than a length of the aortic dissection as measured from a blood inflow position to a blood outflow position of the aortic dissection when the piece of expandable material is fully expanded. At least one of the pieces of expandable material may have a substantially cubic shape. At least one of the pieces of expandable material may have a substantially spherical shape. The expandable material may include a cylindrical shaped piece. The expandable material may include a plurality of cylindrical shaped pieces. The plurality of cylindrical shaped pieces may be configured to be deployed in layers where an outside layer includes a cylindrical shaped material with a hollow center. The plurality of cylindrical shaped pieces may include one or more inside layers that arenested inside the outside layer. The lengths of the cylinder shaped pieces, as measured along a flow of blood to the aortic dissection, are tapered such that the lengths decrease from an insight cylindrical shaped piece to an outside cylindrical shaped piece. At least one of the pieces of expandable material may have a substantially corkscrew shape. At least one of the pieces of expandable material may include a substantially cylindrical shape. The expandable material with a substantially corkscrew shape may be configured to corkscrew around expandable material with the cylindrical shape. The expandable material with a substantially corkscrew shape may be configured to be deployed in the aortic dissection before the expandable material with the cylindrical shape is deployed. The expandable material with a substantially corkscrew shape may include a nitinol wire surrounded by the expandable material. The catheter may be configured to access the aortic dissection from a downstream direction of blood flow through the aortic dissection. The expandable material may be configured to be deployed from a proximal end of the catheter. The catheter may include a funnel shape with a first end comprising a radius that is larger than a second end of the catheter. The expandable material may be configured to be deployed through the first end of the catheter.

[0069] Another general aspect is a system for treating an aneurysm. The system includes an expandable material configured to occupy space within the aneurysm where the expandable material is shaped to occupy a saccular aneurysm. The system can be used with or without an adjunctive stent to ensure stabilization of the material in the aneurysm. The system further includes a catheter configured to deliver the expandable material to the aneurysm.

[0070] Many variations may be made to the embodiments described herein. All variations, including combinations of embodiments, are intended to be included within the scope of this disclosure. The description of the embodiments herein can be practiced in many ways. Any terminology used herein should not be construed as restricting the features or aspects of the disclosed subject matter. The scope should instead be construed in accordance with the appended claims.

Claims

CLAIMS:

1. A system for treating an aortic dissection, the system comprising: an expandable material configured to occupy a space within the aortic dissection, the expandable material shaped based on the shape of the aortic dissection; and a catheter configured to deliver the expandable material to the aortic dissection.

2. The system of claim 1, wherein the expandable material comprises two or more separate pieces of expandable material that are shaped to concurrently occupy the space in the aortic dissection.

3. The system of claim 2, wherein at least one of the pieces of expandable material is shaped as a rod.

4. The system of claim 2, wherein at least one of the pieces of expandable material is shaped as a bar.

5. The system of any one of claims 3 or 4, wherein at least one of the pieces of expandable material are configured to expanded to substantially cover a length of the aortic dissection as measured from a blood inflow position to a blood outflow position of the aortic dissection.

6. The system of claim 2, wherein a length of each piece of expandable material is less than a length of the aortic dissection as measured from a blood inflow position to a blood outflow position of the aortic dissection when the piece of expandable material is fully expanded.

7. The system of claim 6, wherein at least one of the pieces of expandable material has a substantially cubic shape.

8. The system of claim 6, wherein at least one of the pieces of expandable material has a substantially spherical shape.

9. The system of claim 1, wherein the expandable material comprises a bioresorbable material.

10. The system of claim 1 , wherein the expandable material comprises a biostable material.

11. The system of claim 1, wherein the expandable material comprises prothrombotic agents.

12. The system of claim 1, wherein the expandable material comprises anti-inflammatory agents.

13. The system of claim 1, wherein the expandable material comprises a cylindrical shaped piece.

14. The system of claim 13, wherein the expandable material comprises a plurality of cylindrical shaped pieces.

15. The system of claim 14, wherein the plurality of cylindrical shaped pieces are configured to be deployed in layers; wherein an outside layer comprises a cylindrical shaped material with a hollow center; and wherein the plurality of cylindrical shaped pieces comprise one or more inside layers that are nested inside the outside layer.

16. The system of claim 15, wherein lengths of the plurality of cylindrical shaped pieces, as measured along a flow of blood through the aortic dissection, are tapered such that the lengths decrease from an inside cylindrical shaped piece to an outside cylinder shaped piece.

17. The system of claim 1, wherein the expandable material has a substantially corkscrew shape.

18. The system of claim 17, wherein the expandable material comprises a substantially cylindrical shape.

19. The system of claim 18, wherein the expandable material with the substantially corkscrew shape is configured to corkscrew around the expandable material with the cylindrical shape.

20. The system of claim 19, wherein the expandable material with the substantially corkscrew shape is configured to be deployed in the aortic dissection before the expandable material with the cylindrical shape is deployed.

21. The system of claim 20, wherein the expandable material with the substantially corkscrew shape comprises a nitinol wire surrounded by the expandable material.

22. The system of any of claims 1-21, wherein the catheter is configured to access the aortic dissection from a downstream direction of blood flow through the aortic dissection.

23. The system of claim 22, wherein the expandable material is configured to be deployed from a proximal end of the catheter.

24. The system of any of claims 1-21, wherein the catheter comprises a funnel shape with a first end comprising a radius that is larger than a second end of the catheter.

25. The system of claim 24, wherein the expandable material is configured to be deployed through the first end of the catheter.

26. A system for treating an aneurysm, the system comprising: an expandable material configured to occupy a space within the aneurysm, the expandable material shaped to occupy a saccular aneurysm; and a catheter configured to deliver the expandable material to the aneurysm.

Images