Treatment systems and devices for superficial venous insufficiency

Abstract

A system includes an expandable material configured to occupy a space within a blood vessel. The expandable material is shaped to occupy the blood vessel. The expandable material is further configured to block a flow of blood within the blood vessel. The expandable material is further configured to be permanently fixed in the space. The system further includes an introducer configured to confine the expandable material in a compressed state until the expandable material is deployed to the space within the blood vessel. The introducer is further configured to deploy the expandable material to the space from a distal end of the introducer.

Description

PCT APPLICATIONFORTREATMENT SYSTEMS AND DEVICES FOR SUPERFICIALVENOUS INSUFFICIENCYInventor (s):Michel Marinus Petrus Johannes ReijnenWilliam ColonePrepared By:Mahesh Law Group, P.C.Attorney Docket No. LSV 007PCTTREATMENT SYSTEMS AND DEVICES FOR SUPERFICIAL VENOUSINSUFFICIENCYCROSS REFERENCE TO PRIOR APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 634,918, entitled as “TREATMENT SYSTEMS AND DEVICES FOR SUPERFICIAL VENOUS INSUFFICIENCY”, filed April 16, 2024, which is incorporated by reference in its entirety.FIELD OF THE INVENTION

[0002] This disclosure relates to the field of treatment for superficial venous insufficiency, and the like.BACKGROUND

[0003] Superficial venous insufficiency is a type of vein disease caused by faulty valves or walls of the veins. It mostly affects the veins near the surface of the leg. Blood doesn’t flow properly through the vein, which may cause symptoms of discomfort, pain, edema, and various complications. Blood may increase in pressure and damage the surrounding tissues. Eventually, it may lead to venous ulcers.

[0004] Superficial venous insufficiency, leading to varicose veins, is a common disease in the Western world, with a prevalence of 10-30% of the population. Insufficiency of valves in the great and / or small saphenous vein is the most frequent cause of varicose veins. Traditionally these were treated by surgery, ligation of the saphenofemoral or saphenopopliteal junction in junction with stripping of the vein. Currently, this has mostly been replaced with endovenous techniques, related to better outcomes. The most commonly used techniques are laser and radiofrequency ablation. Both are heat-based techniques and consequently require tumescent anesthesia and are related to heat-based complications like pain and nerve damage. Therefore, tumescentless techniques have been developed, including mechano-chemical ablation. This technique uses mechanical damage to the inner layer of the vein, induced with a rotating wire, in combination with sclerosants dispersed into the vessel wall. This technique is related to less postprocedural pain, but the rotating wire may be trapped, causing procedural pain and hematoma. Inaddition, the results depend on the speed of retraction of the device, the speed of injection of the sclerosants, and the percentage of the used sclerosants, making the procedure relatively complex. Due to the maximum dose of sclerosants, the number of veins that can be treated in one session is limited. As an alternative, specially formulated medical adhesives have been developed that can be delivered in the vein to obliterate it. The cyanoacrylate that is used rapidly polymerizes during endovenous treatment to cause occlusion of veins. Cyanoacrylate glue treatment may cause complications such as phlebitis, cellulitis and deep vein thrombosis in rare instances. In addition, it will form a permanent foreign body in the vein.SUMMARY

[0005] The disclosed subject matter is a system, medical device, and method to treat superficial venous insufficiency, otherwise known as varicose veins. The system may include an expandable material configured to fill a volume of a vein to the treated. The expandable material may be positionally fixed in the vein by itself or by one or more anchoring features. The expandable material may be delivered to the volume of the vein to be treated by a catheter or introducer while the expandable material is in a compressed state. The expandable material may expand into an expanded state subsequent to deployment in a target area of the vein.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. 1A illustrates various veins from an anterior view in a vascular system in a subject’s leg.

[0007] FIG. IB illustrates various veins from a posterior view in a vascular system in a subject’s leg.

[0008] FIG. 1C is an illustration of a cross-section of a healthy vein.

[0009] FIG. ID is an illustration of a cross-section of a vein that is insufficient.

[0010] FIG. 2 illustrates a blood vessel that is treated with an embodiment of disclosed subject matter.

[0011] FIG. 3. illustrates another view of a blood vessel that is treated with an embodiment of disclosed subject matter.

[0012] FIG. 4 is a schematic of an embodiment of the disclosed subject matter.

[0013] FIG. 5A is an illustration of a cross-section of an insufficient vein with arrows to indicate a flow of blood.

[0014] FIG. 5B is an illustration of the cross-section of the insufficient vein from FIG. 5A after it is treated with an embodiment of the disclosed subject matter.

[0015] FIG. 6A is an illustration of an embodiment of a disclosed subject matter with a guide wire.

[0016] FIG. 6B is an illustration of an embodiment of disclosed subject matter with a guide wire inside an introducer.

[0017] FIG. 6C is an illustration of an embodiment of the disclosed subject matter that is partially exited from an embodiment of an introducer.

[0018] FIG. 7A is an illustration of an embodiment of the disclosed subject matter comprising and anchoring feature as it is deployed within a vein.

[0019] FIG. 7B is an illustration of the embodiment of the disclosed subject matter from FIG. 7B from a perspective view.

[0020] FIG. 8 is an illustration of the embodiment of the disclosed subject matter comprising and anchoring feature as the anchoring feature is partially exited from an introducer.

[0021] FIG. 9 is an illustration of the disclosed subject matter comprising another embodiment of the anchoring feature as it is deployed within a vein.

[0022] FIG. 10A is an illustration of an embodiment of the disclosed subject matter from a top view comprising anchoring barbs.

[0023] FIG. 10B is an illustration of an embodiment of the disclosed subject matter comprising, a guidewire and anchoring barbs.

[0024] FIG. 11A is an illustration of the disclosed subject matter as the expandable material and anchoring barbs are compressed within the introducer.

[0025] FIG. 11B is an illustration of the disclosed subject matter with anchoring barbs as the disclosed subject matter is partially deployed from an introducer inside of a blood vessel.DETAILED DESCRIPTION

[0026] The disclosed subject matter is a device configured to block the flow of blood in a blood vessel. In an exemplary embodiment, the disclosed subject matter may be configured to treat superficial venous insufficiency, otherwise known as varicose veins. An exemplary embodiment of the disclosed subject matter comprises one or more elongated expandable pieces configured to be inserted into a blood vessel. Once inserted, the expandable pieces may expand to fill up the space within the blood vessel and prevent a flow of blood through the blood vessel.

[0027] An exemplary embodiment of the disclosed subject matter is a system that includes selfexpanding porous polymer cylinders that fill the inside of the insufficient vein. The system may be modular such that two or more polymer cylinders may be used per insufficient vein. The first polymer cylinder may have a fixation or anchoring part that will prevent dislodgement of the polymer cylinder in the deep venous system. For example, the anchoring part may include barbs or hooks. In an exemplary embodiment, the polymer cylinders are tapered such that they have different diameters at the two ends of each polymer, varying from about 4-20 mm.

[0028] In the above-mentioned example embodiment, the attached anchoring part may be a cylinder of polymer foam. The cylindrical polymer foam may include echogenic markers. The cylindrical polymer foam may be shaped at various lengths (about 10-25cm) and diameters. The porosity of the filling body contributes to the compressibility of the system but also promotes thrombus formation and organization inside and around the filling body, as well as rapid remodeling of the vein.

[0029] In various embodiments, the filling body may be biodegradable such that no permanent foreign body will be installed. Optionally, the material may be soaked in sclerosants or sclerosants may be attached to the material. Examples of sclerosants include sodium tetradecyl sulfate, polidocanol, and morrhuate sodium.

[0030] In various embodiments, the disclosed subject matter comprises one or more elongated foam pieces of various shapes configured to be inserted into a blood vessel at a target area of a subject. The one or more foam pieces are further configured to remain stationary at the target area within the blood vessel. The one or more foam pieces are further configured to prevent the flow of blood or any other fluid through the blood vessel.

[0031] In various embodiments, the disclosed subject matter includes an anchoring part configured to prevent movement of the one or more foam pieces within the blood vessel. For example, the anchoring part may comprise one or more barbs configured to penetrate a lumen of the blood vessel in order to prevent movement of the one or more foam pieces.

[0032] In various embodiments, the anchoring portion may comprise an expandable mechanism configured to expand and cause one or more portions of the disclosed subject matter to expand into a lumen of the blood vessel. For example, the one or more foam pieces may be expanded into the blood vessel and become lodged within the blood vessel. The one or more foam pieces may block a portion of the blood vessel by preventing any fluids from flowing through the lumen of the blood vessel. Accordingly, one or more foam pieces may be used to treat superficial venous insufficiency by blocking an insufficient portion of the blood vessel and permanently shutting off all flow of blood in the portion of the blood vessel.

[0033] In various embodiments, the disclosed subject matter may be configured to be inserted into a blood vessel via a delivery introducer and exited from the introducer at a location to be deployed. For instance, disclosed subject matter may be pushed out of a delivery introducer via a guidewire, push disk, or the like. In an example embodiment, the delivery introducer or catheter may be configured to deliver the disclosed subject matter to a target location in a blood vessel from an upstream direction.

[0034] In an example embodiment, the one or more foam pieces may be compressed into the delivery introducer or catheter prior to being exited in the blood vessel. Once the one or more foam pieces are exited within the blood vessel, the one or more foam pieces may self-expand to fill the blood vessel at the target location.

[0035] The target location may be a length of a blood vessel that is determined by a medical practitioner to be insufficient. In various embodiments, the target location may include a length of a blood vessel that should be further blocked in order to treat insufficient portion of the blood vessel. For example, the one or more foam pieces may be delivered to insufficient portion of a blood vessel and an additional portion of the blood vessel in order to prevent further damage due to the insufficient portion of the blood vessel.

[0036] In various embodiments, the anchoring portion may comprise a ring that is configured to expand, causing the ring or at least one of the one or more foam pieces to contact the lumen of the blood vessel and lodge the one or more foam pieces within the blood vessel. In various embodiments, the anchoring part may further include one or more barbs or hooks. In various embodiments the anchoring part may include an expanding element that includes barbs.

[0037] In various embodiments, the anchoring portion may comprise an expanding scaffold that is configured to expand when it is exited from the delivery introducer. For example, the scaffold may include a cylindrical shape configured to contact the length of the inner lumen of a blood vessel. In various embodiments, the scaffold may be configured to be attached to at least one of the one or more foam pieces. For example, the scaffold may be configured to surround at least one of one or more foam pieces. In various embodiments the scaffold may be configured to be inserted within at least one of the one or more foam pieces and cause at least one or more foam pieces to expand into the inner lumen of the blood vessel.

[0038] Referring to Fig. 1 A and Fig. IB, Fig. 1A is an illustration 100 of various veins in a vascular system in a subject’s leg from an anterior view. Fig. IB is an illustration 120 of various veins from a posterior view in a vascular system in a subject’s leg. The subject may be a human being, as shown in Figs. 1 A and IB, or various animals, such as mammals, that have circulatory systems with blood vessels that facilitate blood circulation similar to a human being.

[0039] Various embodiments of the disclosed subject matter may be configured for treatment of the great saphenous vein (GSV) 105, which runs along the length of the thigh and leg and drains into the femoral vein 110. Likewise, some embodiments of the disclosed subject matter may be configured for treatment of the small saphemous vein (SSV) 122, which runs up the leg’s posterior surface, enters the popliteal fossa 126, and drains into the popliteal vein 124.

[0040] Referring to Figs. 1C and ID, Fig. 1C is an illustration 140 of a cross-section of a healthy vein. The healthy vein may include valves that allow blood or other fluids to flow in only one direction. The illustration 140 includes valves 142 that restrict the flow of blood in an upward direction 144. Veins that are damaged or insufficient may include valves that are not fully functional.

[0041] Fig. ID is an illustration 160 of a cross-sectional view of an insufficient vein. The illustration 160 shows damage in a vein that may be treated. For comparison, the relatively straight structure shown in the illustration 140 of Fig. 1C is curved and twisted in the illustration 160 of Fig. ID. In various cases, the valves 162 in the damaged vein may not function properly, such as not closing all the way or allowing some blood to flow in the wrong direction 164.

[0042] Referring to Fig. 2, Fig. 2 is an illustration 200 of a blood vessel treated with an embodiment of disclosed subject matter. As shown in the illustration 200, two pieces of expandable material are inserted into a portion of a vein. A first piece 210 is inserted at an upstream location in the vein, and a second piece 205 is inserted at a downstream location in the vein. The first piece 210 and second piece 205 are inserted such that they are touching one another.

[0043] The first piece 210 and second piece 205 include an expandable material that is configured to fill the entire space of the vein at the location where the first piece 210 and second piece 205 are deployed. In various embodiments, the expandable material may be deployed at any location in a blood vessel that is insufficient to treat the insufficiency. In various embodiments, the expandable material may be further deployed along a length of healthy blood vessels in order to prevent further damage to the circulatory system.

[0044] In various embodiments, the deployed expandable material comprises one or more pieces. For example, the disclosed subject matter may comprise a single piece. In another example, the disclosed subject matter may comprise three or more pieces of expandable material. Each piece of expandable material may be shaped to various lengths. In various embodiments, the expandable material may include a length of between about 1 cm and about 5 cm. In various embodiments, the expandable material includes a length of between about 5 cm and about 10 cm. In various embodiments, the expandable material may include a length of between about 10 cm and 15 cm. In various embodiments, the expandable material may include a length of between about 10 cm and 20 cm. In various embodiments, the expandable material may be include a length of between about 20 cm and 25 cm. In various embodiments, the expandable material may include a length of between about 25 cm and 30 cm. In various embodiments, the expandable material may include a length of between about 30 cm and 40 cm.

[0045] In various embodiments, the expandable material is configured to include a central wire that runs along the length of the expandable material. Once the expandable material is positioned in the vein, the central wire may prevent compression of the expandable material in a longitudinal direction. In an example embodiment, the central wire is made of a bioresorbable material.

[0046] In various embodiments, the expandable material that comprises a rod-shaped expandable material, a bar-shaped expandable material, a cylinder-shaped expandable material, or other shaped expandable materials that are disclosed herein. The expandable material 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.

[0047] Referring to Fig. 3, Fig. 3 is an illustration 300 of another view of a blood vessel 320 that is treated with an embodiment of disclosed subject matter. As shown in illustration 300, theblood vessel 320 is filled with three pieces of expandable material that effectively block call flow of fluid through the blood vessel 320. Blocking the blood vessels, as shown in the illustration 300, may be a treatment for superficial venous insufficiency.

[0048] As shown in illustration 300, the blood vessel 320 is filled with three pieces of expandable material: a first piece 305, a second piece 310, and a third piece 315. The disclosed subject matter may be modified based on the shape of one or more blood vessels to be filled. Accordingly, the length, diameter, number of pieces, overall shape, and the like of the expandable material may be modified and adjusted based on the shape, size, and length of a blood vessel to be filled.

[0049] For example, if a treatment for superficial venous insufficiency calls for filling 40 cm of a vein that is 6 mm in diameter at an upstream end of the portion to be filled and 8 mm in diameter at a downstream end of the portion to be filled, various pieces of expandable material may be shaped to fill formation portion of the vein. For instance, three portions of 13.3 cm pieces of expandable material may be fabricated to fill the aforementioned portion of the blood vessel to be treated. In some instances, the various pieces of expandable material may have different diameters based on their volume of vessel to fill.

[0050] Diameters of the expandable material may be configured to fill an inner volume within a blood vessel when the expandable material is fully expanded. Accordingly, the expandable material may be configured to expand to fill a volume that is greater than the inner volume of the blood vessel to ensure that the expandable material fills the entire volume without leaving any gaps. Thus, the expandable material may be configured to expand to a diameter that is greater than the diameter of the lumen of the target area of the blood vessel.

[0051] In the aforementioned example, with an upstream blood vessel diameter of 6 mm and a downstream diameter of 8 mm, each piece of the expandable material may be configured to have a diameter of greater than 8 mm to ensure that the entire volume of the target area of the blood vessel is filled. In various embodiments, the first piece may have a greater diameter than the other pieces. For example, the first piece 305 of expandable material may have a diameter of 10 mm if it is allowed to fully expand, the second piece 310, we have a diameter of 9 mm it isallowed to fully expand, and the third piece 315 may have a diameter of 9 mm if it is allowed to fully expand.

[0052] Referring to Fig. 4, Fig. 4 is a schematic 400 of an embodiment of the disclosed subject matter. As shown in the schematic 400, the disclosed subject matter may be a device that includes one or more pieces. Each of the pieces may be delivered separately or concurrently to a target location in a blood vessel such as a vein. For instance, a first piece of the device may be configured to be delivered prior to a second piece 440 from an upstream direction and a vein.

[0053] In embodiments where the device is configured to be delivered from an upstream direction, only the first piece 435 may be required to be anchored to prevent movement of the entire device because subsequent pieces that are delivered after the first piece 435 would be pushed based on the flow of blood to the vein. Accordingly, and as shown in the schematic 400, the first piece 435 includes an anchoring part 405 to stabilize the movement of the first piece 435. The anchoring part 405 may include various anchoring elements such as anchoring barbs 410 that are configured to at least partially pierce a lumen of the blood vessel. Attached to the anchoring part 405 may be an expanding material 415.

[0054] The second piece 440 may include an expandable material 420 that can be deployed at an upstream direction from the first piece 435 whereby the second piece 440 would be blocked from flowing from the deployment location by the first piece 435.

[0055] In an exemplary embodiment, each piece of expandable material may have a substantially cylindrical shape with a substantially circular cross-section extending along the cylindrical shape's length. The diameter of each piece of expandable material may be a length 425 that passes through a center axis 445 of the piece and has endpoints on the circumference of the circular cross-section of the cylinder. In various embodiments, one or more of the pieces may be tapered such that the diameter at one end of the piece is larger or smaller than the diameter at another end. The tapering of the various pieces may be modified based on the size and shape of the target area of the vein or other blood vessel. For example, a vein will typically increase in size along a downstream direction for the flow of blood. Thus, a diameter on the downstream end of the piece may be configured to be larger in diameter than the upstream end of the piece.

[0056] The term upstream, as used herein, refers to a direction of flow that opposes the flow of blood through a blood vessel. The term downstream, as used herein, refers to a direction that coincides with blood flow in a blood vessel. The term upstream direction, as used herein, refers to a vector or direction from a point in a blood vessel directed along the blood vessel against the flow of blood. For instance, delivering one more pieces from an upstream direction may refer to delivering one more pieces to a target location from a direction that is upstream from the target location.

[0057] Referring to Figs. 5A and 5B. Fig. 5A is an illustration 500 of a cross-section 505 of an insufficient vein with arrows to indicate a flow of blood. Fig. 5B is an illustration 550 of the cross-section 555 of the insufficient vein from Fig. 5A after the insufficient vein is treated with an embodiment of the disclosed subject matter. As shown in the illustration 500, insufficient veins may be characterized by one or more of blood vessel walls 510 that are relatively twisted as compared to substantially straight blood vessel walls of a healthy vein.

[0058] A flow of blood through the insufficient vein may be turbulent or meandering through the blood vessel, as indicated by the arrow 515, which will represent a flow of blood. The valves 520 and insufficient vein may be defective in one or more ways. For instance, the valves 520 may be damaged such that they do not close all the way, or the valves 520 may not open and close at the correct times to regulate the flow of blood in one direction.

[0059] The illustration 550 shows the same insufficient vein from Fig. 5A after treatment with an embodiment of the disclosed subject matter. As shown in the cross-section 555, the blood vessel is filled with an expandable material 565 that is configured to expand and fill the entire volume within the blood vessel. After the deployment to the target area within the blood vessel, the expandable material 565 expands until it makes contact with the blood vessel walls 560.

[0060] In various embodiments, the disclosed subject matter includes an anchoring portion 575 that stabilizes the expandable material 565 and prevents movement downstream within the blood vessel. The anchoring portion 575 shown in the cross-section 555 comprises an expandable ring with barbs 580 that are configured to pierce a lumen of the blood vessel wall 560 and prevent movement of the expandable material 565. The expandable ring may include various materials, such as shape memory alloys that are configured to expand when exposed to a specific change intemperature. An example of a shape memory alloy is nitinol, which is an alloy made from nickel and titanium.

[0061] In various embodiments of the anchoring portion 575 that are not shown in the illustration 550, the anchoring portion may comprise an expandable stent or scaffold, an expandable balloon, one or more hooks, a disk, or other device or mechanism that prevents movement of the expandable material downstream of the target location within the blood vessel.

[0062] Referring to Figs. 6A, 6B, and 6C, Fig. 6A is an illustration 600 of an embodiment of a disclosed subject matter with a guidewire 610. Fig. 6B is an illustration 630 of an embodiment of disclosed subject matter with a guidewire 640 inside an introducer 645. Fig. 6C is an illustration 660 of an embodiment of the disclosed subject matter that is partially exited from an embodiment of an introducer 670.

[0063] The guidewire 610 may be configured to move expandable material 605 in a blood vessel. In an exemplary embodiment, the expandable material 605 may be delivered to the target location from an upstream direction in a vein or other blood vessel. The guidewire 610 may be used to push or pull the expandable material 605 to the target location in the blood vessel.

[0064] As shown in Fig. 6B, the expandable material may be deployed from a catheter or introducer 645. The guidewire 640 may be used to exit or otherwise deploy the expandable material 635 from the catheter or introducer 645. In various embodiments, the guidewire 640 may be positioned down a central axis of the expandable material 635. The introducer 645 may comprise a cylindrical sheath or cover that is open on a distal end 650 of the introducer 645. The introducer 645 may be positioned at a target area in a blood vessel by the guidewire 640 at which point the expandable material 635 may be exited from the introducer 645 into the blood vessel.

[0065] As shown in Fig. 6C, the expandable material 665 may expand when it is exited from the introducer 670. The expandable material 665 is configured to expand until it fills a volume of the target area of the blood vessel. Accordingly, the expandable material 665 may effectively block fluid flow within the target area and permanently close off blood flow in the area of the subject’s body. Once the expandable material 665 is fully exited from the introducer 670, the guidewire 675 may be retracted from the expandable material 665. The guidewire 675 andintroducer 670 may be extracted from the blood vessel via the same path that the introducer and guidewire 675 were inserted into the target location. For instance, if the device was deployed to the target area from an upstream direction, the device may be extracted from the target area via the same upstream direction.

[0066] Referring to Fig. 7A and Fig. 7B, Fig. 7A is an illustration 700 of an embodiment of the disclosed subject matter comprising an anchoring feature 710 as it is deployed within a vein 720. Fig. 7B is an illustration 750 of the embodiment of the disclosed subject matter of Fig. 7A from a perspective view. The anchoring feature 710 may stabilize and prevent movement of the expandable material 705. In an exemplary embodiment, the disclosed subject matter may be deployed to the target location of a vein 720 from an upstream direction such that a distal end 730 of the device is directed toward a downstream direction of the vein 720. The flow of blood in a downstream direction through the blood vessel is indicated by the arrow 725.

[0067] The anchoring feature 710 may be positioned on a distal end of the disclosed subject matter. In various embodiments the anchoring feature 710 may be positioned at various other positions of the disclosed subject matter. For instance, the anchoring feature 710 may be positioned in the middle or proximal end of the disclosed subject matter. As shown in the illustration 700, the anchoring feature 710 may include a scaffold or stent configured to expand to touch the walls 715 of the vein 720 at a target location. By expanding into the walls of the vein 720, the anchoring feature may effectively immobilize any portion of the device attached to the anchoring feature 710 and block any portion of the device, including additional expandable materials that are deployed upstream from the anchoring feature 710.

[0068] In the embodiment of the disclosed subject matter shown in Fig. 7A, the anchoring feature 710 is deployed proximal to an expandable material 705. The expandable material 705 is configured to expand until it meets the walls 715 to fill a volume of space within the vein 720.

[0069] In an example embodiment, the anchoring feature 710 may include one or more anchoring hooks 755 that are configured to pierce or otherwise latch onto the walls 715 of the vein 720. The anchoring hooks 755 may be distributed in various configurations, such as radially, as shown in Fig. 7B, or longitudinally along a length of the expandable material 705.

[0070] Referring to Fig. 8, Fig. 8 is an illustration 800 of the embodiment of the disclosed subject matter comprising an anchoring feature 815 as the anchoring feature 815 is partially exited from an introducer 810. The anchoring feature 815 may comprise various materials, including stainless steel, metal alloys, or biocompatible plastics such as polycarbonate, polyethylene, polypropylene, polyethylene terephthalate, polyvinyl chloride, polymethyl methacrylate, polyether ether ketone, and polylactic acid.

[0071] Some metal materials that may be included in the anchoring feature 815 include titanium, gold, and platinum. Some metal alloys include tantalium, stainless steel, and nitinol. In various embodiments, anchoring feature 815 may include one or more shape memory alloys. An example of a shape memory alloy is nitinol. A shape memory alloy in the anchoring feature 815 may be configured to automatically expand to a preconfigured shape at a specific temperature. For example, the shape memory alloy may be configured to approximate the inner lumen of a vein when the shape memory alloy is exposed to the body temperature of a subject.

[0072] As shown in the illustration 800, the anchoring feature 815 is partially exited from the introducer 810. The portion of the anchoring feature 815 outside of the introducer 810 is an expanded state. The portion of the anchoring feature 815 inside the introducer 810 is in a compressed state. Similarly, the expanding material 805 is in a compressed state when it is inside the introducer 810 and expands when it is exited from the introducer 810.

[0073] Referring to Fig. 9, Fig. 9 is an illustration 900 of the disclosed subject matter comprising another embodiment of the anchoring feature 915 as it is deployed within a vein 910. The anchoring feature 915 in the illustration 900 is embedded within the first piece of expanding material 905. Accordingly, the anchoring feature 915 may cause the expanding material surrounding the anchoring feature 915 to press into the walls 920 of the vein 910 more forcefully than the expanding material would press into the walls 920 without the anchoring feature 915.

[0074] Similar to the illustration 700 shown in Fig. 7, the anchoring feature 915 is positioned at a distal end 935 of the disclosed device to treat insufficient veins. When the device is deployed to the vein 910 from an upstream direction, the distal end 935 will be the end that is directed toward the natural flow of blood as indicated by the arrow 930. The anchoring feature 915 is appended to the distal end 935 of the first piece of expanding material 905. Accordingly, the first piece ofexpanding material 905 is secured in the vein 910 at the target position. Subsequently deployed pieces of expanding material, such as the second piece of expanding material 925 may be safely deployed as they will be pressed by the natural flow of blood in the direction of the first piece of expanding material 905, which is securely in place.

[0075] Referring to Figs. 10A and 10B, Fig. 10A is an illustration 1000 of an embodiment of the expanding material from a top view comprising anchoring barbs 1010. Fig. 10B is an illustration 1050 of an embodiment of the disclosed subject matter comprising a guidewire 1065 and anchoring barbs 1060. The illustration 1000 shows a distal end 1005 of the expanding material. Three anchoring barbs 1010 are equally distributed around a circumference of the cylindrically shaped expanding material, as seen from the top view.

[0076] The anchoring barbs 1010 may be configured to pierce a lumen of a blood vessel when the anchoring barbs 1010 are deployed. In various embodiments, the anchoring barbs 1010 may be in a retracted state when the expanding material and any other portions of the disclosed medical device are in a compressed state such as when the expanding material is compressed within the introducer 645. The anchoring barbs 1010 may extend from the retracted state by various mechanisms. For example, an inner end 1015 of the anchoring barbs 1010 that generally points toward the central axis 1020 of the expanding material, may be attached to a portion of the expanding material such that the anchoring barbs 1010 are extended out of the expanding material when the expanding material is in an expanded state.

[0077] As shown in the illustration 1050, the anchoring barbs 1060 may be oriented such that the outer end 1070 of the anchoring barbs 1060 is directed in a distal direction relative to the inner end 1075 of the anchoring barbs 1060. The distal direction, as used herein, may be the direction toward a distal end 1080 of the expanding material or other portion of the disclosed subject matter.

[0078] Referring to Fig. 11 A and Fig .1 IB, Fig. 11 A is an illustration 1100 of the disclosed subject matter as the expanding material 1105 and anchoring barbs 1115 are compressed within the introducer 1120. Fig. 1 IB is an illustration 1150 of the expandable material 1155 with anchoring barbs 1160 as the expandable material 1155 is partially deployed from an introducer 1165 inside of a vein. In an exemplary embodiment, the anchoring barbs 1115 may beconfigured to extend from the expanding material 1 105 when the expanding material is exited or deployed from the introducer 1120. For example, an end of the anchoring barbs may be attached to a portion of the expanding material 1105 such that the anchoring barbs 1115 extend in the direction of the arrows 1125 when the expanding material 1105 transforms from a compressed state into an expanded state.

[0079] As shown in the illustration 1100, the anchoring barbs 1115 may be oriented in the compressed state such that an outer end 1070 is oriented in a distal direction compared to an inner end 1075 of the anchoring barbs 1115. When the expandable material 1155 and anchoring barbs 1160 transform into an expanded state, the anchoring barbs 1160 may maintain the same orientation, which may prevent movement in a distal direction when the anchoring barbs 1160 pierce a wall 1170 of a vein 1175.

[0080] A central wire 1180 may be positioned to run down a length of the expandable material 1155. The purpose of the central wire 1180 is to prevent compression of the expandable material 1155 in a longitudinal direction. In an example embodiment, the central wire 1180 comprises a bioresorbable material such as polyglycolide.

[0081] In an example embodiment, the central wire 1180 may prevent the expandable material 1155 from being compressed in the longitudinal direction when deployed with a push-pull system. The push-pull system is a deployment process of pushing the expandable material 1155 while simultaneously pulling the introducer 1165.

[0082] An exemplary embodiment is a system for treating a superficial venous insufficiency. The system includes an expandable material configured to occupy a space within a blood vessel. The expandable material is shaped to occupy the blood vessel. The expandable material is further configured to block a flow of blood within the blood vessel. The expandable material is further configured to be permanently fixed in the space. The system further includes an introducer configured to confine the expandable material in a compressed state until the expandable material is deployed to the space within the blood vessel. The introducer is further configured to deploy the expandable material to the space from a distal end of the introducer. The system may further include an anchoring portion configured to prevent movement of the expandable material within the blood vessel. The anchoring portion may include a scaffold that is configured toexpand into a lumen of the blood vessel when the scaffold is deployed from the introducer. The anchoring portion may further include one or more hooks that are configured to pierce the lumen of the blood vessel. The expandable material may include one or more pieces configured to be deployed separately to the space within the blood vessel. The expandable material may include sclerosants. The expandable material may include thermoset polycarbonate polyurethane. The system may further include a central wire configured to prevent compression of the expandable material in a longitudinal direction.

[0083] Another general aspect is a medical device for treating superficial venous insufficiency. The medical device includes an expandable material configured to occupy a space within a blood vessel. The expandable material is shaped to occupy the blood vessel. The expandable material is further configured to block the flow of blood within the blood vessel. The expandable material is further configured to be permanently fixed in the space. The expandable material is further configured to be delivered by an introducer to the space. The medical device further includes an anchoring portion configured to prevent movement of the expandable material within the blood vessel. The anchoring portion may include a scaffold configured to expand into a lumen of the blood vessel when the scaffold is deployed from the introducer. The anchoring portion may further include one or more hooks that are configured to pierce the lumen of the blood vessel.The expandable material may include one or more pieces configured to be deployed separately to the space within the blood vessel. The expandable material may include sclerosants. The expandable material may include thermoset polycarbonate polyurethane. The medical device may further include a central wire configured to prevent compression of the expandable material in a longitudinal direction.

[0084] An exemplary embodiment is a method for treating a superficial venous insufficiency. The method includes delivering an expandable material in a compressed state to a space in a blood vessel. The method further includes deploying the expandable material from a distal end of an introducer to the space. The expandable material is configured to expand from the compressed state to an expanded state subsequent to being deployed from the introducer. The expandable material is shaped to occupy the blood vessel when the expandable material is in the expanded state. The expandable material is further configured to block a flow of blood within the blood vessel. The expandable material is further configured to be permanently fixed in the space.The expandable material may include an anchoring portion configured to prevent movement of the expandable material within the blood vessel. The anchoring portion may include a scaffold configured to expand into a lumen of the blood vessel when the scaffold is deployed from the introducer. The anchoring portion may further include one or more hooks that are configured to pierce the lumen of the blood vessel. The expandable material may include one or more pieces configured to be deployed separately to the space within the blood vessel. The expandable material may include sclerosants. The deploying may include pushing the expandable material from the introducer where the expandable material includes a central wire that is configured to prevent compression of the expandable material in a longitudinal direction during the pushing.

[0085] 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 a superficial venous insufficiency, the system comprising: an expandable material configured to occupy a space within a blood vessel, the expandable material shaped to occupy the blood vessel, the expandable material further configured to block a flow of blood within the blood vessel, the expandable material further configured to be permanently fixed in the space; and an introducer configured to confine the expandable material in a compressed state until the expandable material is deployed to the space within the blood vessel, the introducer further configured to deploy the expandable material to the space from a distal end of the introducer.

2. The system of claim 1, further comprising an anchoring portion configured to prevent movement of the expandable material within the blood vessel.

3. The system of claim 2, wherein the anchoring portion comprises a scaffold configured to expand into a lumen of the blood vessel when the scaffold is deployed from the introducer.

4. The system of claim 3, wherein the anchoring portion further comprises one or more hooks that are configured to pierce the lumen of the blood vessel.

5. The system of claim 4, wherein the expandable material comprises one or more pieces configured to be deployed separately to the space within the blood vessel.

6. The system of claim 1, wherein the expandable material comprises sclerosants.

7. The system of claim 6, wherein the expandable material comprises thermoset polycarbonate polyurethane.

8. The system of claim 1, further comprising a central wire configured to prevent compression of the expandable material in a longitudinal direction.

9. A medical device for treating superficial venous insufficiency, the medical device comprising:an expandable material configured to occupy a space within a blood vessel, the expandable material shaped to occupy the blood vessel, the expandable material further configured to block a flow of blood within the blood vessel, the expandable material further configured to be permanently fixed in the space, the expandable material further configured to be delivered by an introducer to the space.

10. The medical device of claim 9, further comprising an anchoring portion configured to prevent movement of the expandable material within the blood vessel.

11. The medical device of claim 10, wherein the anchoring portion comprises a scaffold configured to expand into a lumen of the blood vessel when the scaffold is deployed from an introducer.

12. The medical device of claim 11, wherein the anchoring portion further comprises one or more hooks that are configured to pierce the lumen of the blood vessel.

13. The medical device of claim 12, wherein the expandable material comprises one or more pieces configured to be deployed separately to the space within the blood vessel.

14. The medical device of claim 9, wherein the expandable material comprises sclerosants.

15. The medical device of claim 14, wherein the expandable material comprises thermoset polycarbonate polyurethane.

16. The medical device of claim 9, further comprising a central wire configured to prevent compression of the expandable material in a longitudinal direction.

17. A method for treating a superficial venous insufficiency, the method comprising: delivering an expandable material in a compressed state to a space in a blood vessel; and deploying the expandable material from a distal end of an introducer to the space, the expandable material configured to expand from the compressed state to an expanded state subsequent to being deployed from the introducer, the expandable material shaped to occupy the blood vessel when the expandable material is in the expanded state, theexpandable material further configured to block a flow of blood within the blood vessel, and the expandable material further configured to be permanently fixed in the space.

18. The method of claim 17, wherein the expandable material comprises an anchoring portion configured to prevent movement of the expandable material within the blood vessel.

19. The method of claim 18, wherein the anchoring portion comprises a scaffold, the scaffold configured to expand into a lumen of the blood vessel when the scaffold is deployed from the introducer.

20. The method of claim 19, wherein the anchoring portion further comprises one or more hooks that are configured to pierce the lumen of the blood vessel.

21. The method of claim 20, wherein the expandable material comprises one or more pieces configured to be deployed separately to the space within the blood vessel.

22. The method of claim 17, wherein the expandable material comprises sclerosants.

23. The method of claim 17, wherein the deploying comprises pushing the expandable material from the introducer; and wherein the expandable material comprises a central wire that is configured to prevent compression of the expandable material in a longitudinal direction during the pushing.

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