Systems and methods for treating aneurysms

Abstract

A system and method can be used to treat an aneurysm in a blood vessel. The system and method can use a catheter. The catheter includes a tube, a wire disposed in the tube; and a closure element. The closure element is disposed on the wire. The closure element is configured to fit in the tube and slide out of an opening at the distal end of the tube in response to movement of the wire in the tube. The closure element is configured to open to a radius greater than the radius of the tube and cover the neck of the aneurysm.

Description

[0001] This application is a divisional application of the Chinese patent application with application number 201680012003.4, application date February 23, 2016, and title “System and method for treating aneurysm”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to and the benefit of U.S. Application No. 62 / 120,456, filed on February 25, 2015, the entire contents of which are incorporated by reference in their entirety. Background Art

[0004] An aneurysm is an abnormal bulge or weakening of a blood vessel (usually an artery) and can have a variety of complications. The bulge of a blood vessel may damage or exert pressure on surrounding tissue. In the brain, this can lead to various side effects such as impaired vision, impaired speech, impaired balance, etc. In addition, an aneurysm creates a space (volume) that is not along the main flow route of blood through the blood vessels. Therefore, it can serve as a location for blood to stagnate and, due to swirling vortexes, may contribute to the formation of thromboemboli. If aneurysms rupture, they can cause severe internal bleeding.

[0005] Aneurysms can be treated externally through open surgery. This approach typically involves closing the entrance or "neck" of the aneurysm with a device such as a vascular clip or bandage. However, this open surgical approach can be highly invasive and may cause trauma to adjacent tissues and other side effects.

[0006] Aneurysms can also be treated by endovascular methods. In one method, a detachable length of wire (e.g., a coil) is inserted into the internal space of the aneurysm using a catheter. The coil is intended to fill the space of the aneurysm to reduce blood flow into the aneurysm, cause blood flow stagnation and stimulate coagulation within the aneurysm. In the setting of cerebral aneurysms, filling the aneurysm with multiple coils can lead to a mass effect, which may cause brain swelling and may be an independent cause of new symptoms. In another method, for aneurysms with larger necks, the auxiliary use of stents helps to keep the coils within the aneurysm. This method is disabled in the treatment of ruptured aneurysms due to the need for additional antithrombotic drugs. In another method, the coil is kept in the space of the aneurysm with a temporary balloon that is expanded in the blood vessel. Once a certain mass of coils is fixed, the balloon is deflated and removed. In another method, a stent device is placed in the artery to promote blood flow through the aneurysm. This leads to blood stagnation within the aneurysm and thrombosis within the aneurysm space. However, the side branches of the aorta in which the stent device is placed may become restricted or "caged," which blocks access to the side branches. In other cases, the side branches may clot, potentially leading to a stroke. In addition, this approach typically requires the use of additional anti-thrombotic drugs, which limits the use of such devices in the setting of ruptured aneurysm treatment. Stent devices are typically formed with a relatively tight braid. While the tight braid increases the effectiveness of the stent device in diverting blood flow, it also blocks or blocks access to the space of the aneurysm or to the clogged artery. In the event that the aneurysm is not clotted, the closure of the aneurysm by the stent device prevents the possibility of placing an embolic device within the aneurysm. Additional methods may then be required to deal with the remnant, such as placement of additional stents or open surgery.

[0007] There are several common disadvantages to all methods involving packing the aneurysm space. First, many coils of wire may be required to fill the aneurysm space, which is time consuming and increases the time required to complete the method. In addition, the coils may compact over time, occupying a smaller percentage of the total volume of the aneurysm. A sufficiently large compaction of the coils may be considered a recurrence of the aneurysm and further treatment may be required.

[0008] It would be advantageous to provide an improved system and method for treating aneurysms. Summary of the invention

[0009] One embodiment relates to a catheter for treating an aneurysm in a blood vessel. The catheter includes: a tube, a wire disposed in the tube, and a closure element. The closure element is disposed on the wire. The closure element is configured to fit in the tube and slide out of an opening at a distal end of the tube in response to movement of the wire in the tube. The closure element is configured to open to a radius greater than the radius of the tube and cover the neck of the aneurysm.

[0010] One embodiment is directed to a method of treating an aneurysm in a blood vessel. The method includes providing a distal portion of a tube to a neck region of the aneurysm, and sliding a wire attached to a closure element in the tube so that the closure element leaves the tube at the neck region. The method also includes separating the closure element from the wire after the closure element leaves the tube.

[0011] One embodiment relates to a closure system for treating an aneurysm in a blood vessel. The closure system comprises: a wire, and a closure element disposed on the wire. The closure element is configured to be compressed into a cone shape and expand into a disc or concave shape to cover the neck of the aneurysm.

[0012] The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Alternative exemplary embodiments are directed to other features, and combinations of features generally recited in the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] These and other features, aspects, and advantages of the present invention will be apparent from the following brief description, the appended claims, and the accompanying exemplary embodiments illustrated in the accompanying drawings, which are briefly described hereinafter.

[0014] Figure 1 is a schematic cross-section side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to an exemplary embodiment.

[0015] Figure 2 yes Figure 1 Schematic cross-sectional bottom view of an aneurysm closure device.

[0016] Figures 3A-3E According to the exemplary embodiment Figure 1 Schematic side cross-sectional view of a catheter of an aneurysm closure device.

[0017] Figure 4 is a schematic cross-sectional side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to another exemplary embodiment.

[0018] Figure 5According to an exemplary embodiment, the catheter is Figure 4 Schematic cross-sectional view of a closure device.

[0019] Figure 6 is a schematic cross-sectional side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to another exemplary embodiment.

[0020] Figure 7 is a schematic cross-sectional side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to another exemplary embodiment.

[0021] Figure 8 is a schematic cross-sectional side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to another exemplary embodiment.

[0022] Fig. 9 is a schematic cross-sectional side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to another exemplary embodiment.

[0023] Fig.10 According to an exemplary embodiment, the catheter is Figure 7 Schematic cross-sectional view of a closure device.

[0024] Fig.11 is a schematic cross-sectional side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to another exemplary embodiment.

[0025] Fig.12 is a schematic cross-sectional bottom view of an aneurysm closure device according to an exemplary embodiment.

[0026] Fig.13 is a schematic cross-sectional bottom view of an aneurysm closure device according to an exemplary embodiment.

[0027] Fig.14 is a schematic cross-sectional bottom view of an aneurysm closure device according to an exemplary embodiment.

[0028] Fig.15 is a schematic cross-sectional side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to another exemplary embodiment.

[0029] Fig.16 is a schematic cross-sectional side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to another exemplary embodiment.

[0030] Fig.17 is a schematic bottom view of an outer anchoring member for an aneurysm closure device according to an exemplary embodiment.

[0031] Fig.18A is a schematic top view of a cover for an aneurysm closure device according to an exemplary embodiment.

[0032] Fig.18B yes Fig.18A Schematic side view of a cover in a partially folded configuration.

[0033] Fig.19 is a schematic side view of an intravascular device configured to occlude an aneurysm according to another exemplary embodiment.

[0034] Fig. 20 is a schematic cross-sectional side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to another exemplary embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0036] In general, reference Figure 1-14 , an aneurysm closure device configured to treat an aneurysm 10 is shown according to several exemplary embodiments. Aneurysm 10 is a protrusion extending outward in the wall 13 of a blood vessel 12 and has an interior space 14 that is in fluid communication with the blood vessel 12 through an opening at a neck 16. Aneurysm 10 can occur in a portion of a blood vessel 12 where the wall 13 is weakened due to disease or trauma. In one embodiment, aneurysm 10 can be along an artery, such as a cranial artery (e.g., basilar artery, middle cerebral artery, etc.). As shown, aneurysm 10 is exemplary only, and it should be understood that the closure device as described herein can be used to treat aneurysms of various sizes and locations. For example, aneurysm 10 can be located between two branches of a blood vessel.

[0037] refer to Figure 1-3E , according to an exemplary embodiment, a closure device 20 is shown disposed in the neck 16 of an aneurysm 10 to disrupt or stop the flow of blood between the blood vessel 12 and the interior space 14 of the aneurysm, thereby reducing the likelihood that the aneurysm 10 will rupture. The closure device 20 is configured as a low profile device to minimize damage to surrounding bodies, such as side branches 18 of the blood vessel 12. The closure device 20 can be configured as a biodegradable or bioabsorbable material and can be configured to promote endothelialization.

[0038] The closure device 20 includes an inner cover 22 (e.g., a plate, a membrane, etc.) disposed within the interior space 14 of the aneurysm 10. The outer diameter of the inner cover 22 is greater than the diameter of the neck 16. The inner cover 22 is a thin, flexible concave body that can be deformed (e.g., collapsed) to be inserted into the interior space 14 of the aneurysm 10 through the neck 16 (e.g., by a catheter) and opened to at least partially close the neck 16. As used herein, a concave body is intended to describe any object whose contour has a depression or recess along one side. Figure 1 As shown, in an exemplary embodiment, the inner cap 22 can be generally dome-shaped. In another embodiment, the inner cap 22 can have another concave surface (e.g., conical) disposed in the neck 16 and leading to the interior space 14. In one embodiment, the cap 22 can be disc-shaped.

[0039] The inner cap 22 is formed of a flexible (e.g., soft) biocompatible material that can be collapsed into a microcatheter for intravascular delivery to the aneurysm 10. The softness of the inner cap 22 allows it to conform to the shape of the inner surface 15 of the aneurysm 10 and more effectively block blood flow between the aneurysm 10 and the blood vessel 12. Close conformity to the shape of the inner surface 15 of the aneurysm 10 also helps the inner cap 22 adhere to the tissue of the aneurysm 10 and form new tissue to close the neck 16.

[0040] The size of the inner cover 22 can be set to fit a particular aneurysm 10. Figure 1-2 As shown, the diameter of the inner cap 22 is greater than the diameter of the neck 16, so that the peripheral portion 24 of the inner cap 22 contacts the inner surface 15 of the aneurysm 10. The softness of the inner cap 22 allows the inner cap 22 to be oversized relative to the size of the neck 16 without damaging (e.g., rupturing) the aneurysm 10. For example, an inner cap having a diameter of approximately 5 mm can be used to close an aneurysm having a neck diameter of up to 4 mm; an inner cap having a diameter of approximately 8 mm can be used to close an aneurysm having a neck diameter of 4-6 mm; and an inner cap having a diameter of approximately 12 mm can be used to close an aneurysm having a neck diameter of 6-10 mm.

[0041] In one embodiment, the inner cover 22 can be formed by a biocompatible metal or metal alloy, such as platinum, stainless steel, titanium, titanium-nickel alloy (e.g., nitinol). For example, the inner cover 22 can be a concave disk formed by sheet-cut nitinol. The nitinol alloy can be configured to perform secondary heat setting to form the desired concave shape. According to an exemplary embodiment, the inner cover 22 can have a thickness of less than 100 microns to achieve desired flexibility. In another embodiment, the inner cover 22 can be formed into a relatively dense mesh, such as a 37-micron mesh formed by multiple wires or fibers that are connected together (e.g., welded, soldered, braided, etc.).

[0042] In another embodiment, the inner cover 22 can be formed by a biocompatible polymer, such as polytetrafluoroethylene (PTFE), modified polyurethane, silicone or other suitable polymers. In another exemplary embodiment, the inner cover 22 can be formed by a metal or alloy coated with a polymer (such as polyparaxylene, PTFE, PFE, etc.) to increase lubricity and biocompatibility and reduce thrombosis. The inner cover 22 can be formed as a solid sheet or film, or can be a relatively dense net. In some embodiments, the inner cover 22 can include a laser-drilled nylon sheet to provide a matrix for endothelialization while reducing the volume of this segment. Another embodiment can include two-photon polymerization or 3-D printing of a biocompatible material to form the inner cover 22 directly on the delivery system, or to cover the skeleton frame attached to the delivery system, allowing the final shape of the inner cover 22 to be customized during treatment.

[0043] Now, refer to Figures 3A-3D , according to an exemplary embodiment, the inner cover 22 is shown deployed using the catheter 30. Figure 3A , a catheter 30 including a push wire 32 is advanced through a blood vessel 12 to the location of an aneurysm 10. The distal end 34 of the catheter is advanced through the neck 16 and into the interior space 14 of the aneurysm 10, or to a portion of the blood vessel 12 proximal to the neck 16. The push wire 32 is positioned within a lumen formed in the catheter 30. The catheter 30 can have a single lumen or the push wire 32 can be positioned within one of several lumens formed within the catheter 30. The inner cover 22 is coupled to the distal end 36 of the push wire 32 and is housed within the lumen in a collapsed configuration. In the collapsed configuration, the peripheral portion 24 of the inner cover 22 is upstream (e.g., closer to the distal end 34) than the central portion 26 to which the push wire 36 is coupled. Reference Figure 3B , the push wire 32 is moved relative to the catheter 30 within the lumen until the inner cap 22 begins to emerge from the end 34 of the catheter 30. The inner cap 22 is configured to expand (e.g., due to the internal spring force of the inner cap 22) into an expanded configuration within the interior space 14 when it clears the end 34 of the catheter 30. The push wire 32 can be moved relative to the catheter 30 by holding the catheter 30 stationary and advancing the push wire 32 (e.g., pushing), by holding the push wire 32 stationary and retracting the catheter 30 (e.g., pulling out), or by a combination of movement of the catheter 30 and the push wire 32. The inner cap 22 can be partially deployed, wherein the distal end 34 of the catheter 30 is located within the blood vessel 12 or within the aneurysm 10.

[0044] refer to Figure 3C , before the inner cap 22 is fully deployed from the catheter 30, the distal end 34 of the catheter 30 is advanced into the interior space 14 of the aneurysm 10. Figure 3DAs the inner cap 22 is deployed from the catheter 30, the catheter 30 and / or the push wire 32 are retracted until the inner cap 22 is seated against the inner surface 15 of the aneurysm. Figure 3E , the distal end 36 of the push wire 32 is disengaged from the inner cap 22, so that the catheter 30 and the push wire 32 can be removed from the blood vessel 12, while the inner cap 22 remains in the neck 16 of the aneurysm 10. The push wire 32 can be separated from the inner cap 22 by any suitable electrical or mechanical cutting device. Alternatively, the inner cap 22 can be removed by pulling the wire 32 from the cap 22, causing the cap 22 to engage the distal end of the tube 30 and slide off the wire 32.

[0045] In one embodiment, the inner cover 32 can be formed to be biased toward the open position. In another embodiment, the inner cover 32 can include a mesh supported by rib members or splines that radiate outward from the center of the inner cover 32. In one embodiment, the rib members or splines are biased toward the open position. In one embodiment, the rib members and splines operate in a reverse umbrella operation, locking in the fully open position once the fully open position is reached.

[0046] Now, refer to Figure 4-5 , shows a closure device 120 disposed in the neck 16 of an aneurysm 10 according to an exemplary embodiment to disrupt or stop the flow of fluid between the blood vessel 12 and the interior space 14 of the aneurysm, thereby reducing the likelihood that the aneurysm 10 will rupture. The closure device 120 is configured as a low-profile device to minimize damage to surrounding objects, such as the side branches 18 of the blood vessel 12. The closure device 120 can be configured as a biodegradable or bioabsorbable material and can be configured to promote endothelialization.

[0047] The closure device 120 includes an inner cover 122 (e.g., a plate, a membrane, etc.) disposed within the interior space 14 of the aneurysm 10 and similar to the inner cover 22 described above. The closure device 120 also includes an inner anchoring member 140 disposed within the aneurysm 10. The inner anchoring member 140 is configured to anchor the inner cover 122 within the aneurysm within the neck 16. The inner anchoring member 140 provides a relatively rigid object that supports the inner cover 122 and reduces the likelihood that the inner cover 122 will be displaced from the neck 14 by fluid pressure of blood in the blood vessel 12.

[0048] According to an exemplary embodiment, the internal anchoring member 140 includes a loop or multiple loops of coils formed of a suitable biocompatible metal or alloy (e.g., platinum, stainless steel, nickel-titanium alloy, etc.). The metal coil may be similar to the coils commonly used in endovascular winding processes. The internal anchoring member 140 is coupled to the inner cover 122 and includes at least one coil that contacts the inner surface 15 of the aneurysm 10. The loops of the internal anchoring member 140 do not fill the entire internal space 14 or most of the internal space 14. Instead, the internal anchoring member 140 may include only a small number of loops. In an exemplary embodiment, the internal anchoring member 140 may include a single loop of coils. In another embodiment, the anchoring member 140 includes a large number of loops that substantially fill the internal space 14. The orientation, number, and size of the loops of the internal anchoring member 140 may vary according to the size and shape of the aneurysm 10.

[0049] Now, refer to Figure 5 , according to an exemplary embodiment, an inner cover 122 and an inner anchoring member 140 are shown disposed within a catheter 30. The inner cover 122 is coupled to the distal end 36 of the push wire 32 and is contained within the lumen of the catheter 30 in a collapsed configuration. In the collapsed configuration, a peripheral portion 124 of the inner cover 122 is upstream (e.g., closer to the distal end 34) than the central portion 126, and the push wire 36 is coupled to a first surface 144. The inner anchoring member 140 is coupled to a second surface 146 of the inner cover 122 opposite the first surface 142 and is disposed within the lumen of the catheter 30 upstream of the inner cover 122.

[0050] With reference Figures 3A-3E Similar to the above process, the closure device 120 including the inner cap 122 and the inner anchoring member 130 is deployed in the aneurysm 10. When the distal end 34 of the catheter 30 is positioned close to the neck 16 of the aneurysm 10, the push wire 32 is moved within the lumen relative to the catheter 30. The push wire is moved so that the anchoring member 40 reaches the interior space 14 and forms a loop in the interior space.

[0051] In one embodiment, the push wire 32 has a circular solid cross-section and the anchor member 140 has a coiled cross-section (e.g., like a telephone wire) to facilitate curling in the interior space 14. In one embodiment, the push wire 32 and the anchor member 140 have a circular solid cross-section. In one embodiment, the push wire 32 and the anchor member have a coiled solid cross-section.

[0052] After the winding of the anchoring member is complete, the inner anchoring member 140 is pushed out of the catheter and into the interior space 14, where it contacts the inner surface 15 of the aneurysm 10. The push wire 32 is further moved until the inner cap 122 begins to emerge from the end 34 of the catheter 30 to expand into an expanded configuration within the interior space 14. The catheter 30 and / or the push wire 32 are then retracted until the inner cap 122 bears against the inner surface 15 of the aneurysm 10 and is secured by the inner anchoring member 140. The distal end 36 of the push wire 32 is disengaged from the first surface 146 of the inner cap 122, allowing the catheter 30 and the push wire 32 to be pulled out of the blood vessel 12 while the inner cap 22 remains in the neck 16 of the aneurysm 10 and the inner anchoring member 140 is coupled to the second surface 146.

[0053] refer to Figure 6 In one exemplary embodiment, the anchoring member 140 can have a variable stiffness. For example, the inner anchoring member 140 can be relatively flexible at the proximal end 146 and relatively stiff at the distal end 148. The relatively stiff distal end 146 can be configured to provide additional support to strengthen the wall of the aneurysm 10. The stiffer portion of the inner anchoring member 140 can be used as a frame member to create structure in the interior space 14 of the aneurysm, while the more flexible portion is used to fill the interior space of the aneurysm and support the inner cover 122. The stiffness of the inner anchoring member 140 can be controlled in a variety of ways, for example, by changing the thickness of the coil, the radius of the coil, and / or by changing the material used to form the coil.

[0054] The more flexible portion of the inner anchor member may include a removable sheath or layer to facilitate positioning of the stiffer portion of the inner portion of the anchor member 140 within the aneurysm 10. Once the distal end 148 and stiffer portion of the inner anchor member 140 are positioned, the sheath may be removed.

[0055] In one embodiment, the hardness of the internal anchoring member 140 can smoothly or incrementally transition between the distal end 148 and the proximal end 146 along the length of the internal anchoring member 140. In other exemplary embodiments, the internal anchoring member 140 may include two or more different regions or portions, each having a different hardness or other characteristics. The internal anchoring member 140 may include markings or other indicators to depict the transition from one region to another. In one embodiment, the indicator can be external, such as an indicator provided on an outer shaft coupled to the push wire, each external indicator corresponding to the transition from a region having a first hardness to a region having a second hardness. In another embodiment, the indicator can be internal, such as a radiopaque indicator (e.g., a platinum coating) located on the internal anchoring member 140 between regions.

[0056] In one embodiment, an anchor member 140 having a variable hardness may be used without an inner cover 122. In such an embodiment, the anchor member 140 fills the interior space 14. In one embodiment, a plurality of anchor members 140 may be used. In one embodiment, the first anchor member 140 employed has a variable hardness (e.g., thickness) that is greater than the variable hardness (e.g., thickness) of the next anchor member employed.

[0057] Now, refer to Figure 7-10 , shows a closure device 220 according to an exemplary embodiment, which is disposed in the neck 26 of the aneurysm 20 to disrupt or stop the flow of blood between the blood vessel 22 and the interior space 24 of the aneurysm 20, thereby reducing the possibility of rupture of the aneurysm 20. The closure device 220 is configured as a low-profile device to minimize damage to surrounding objects, such as the side branches 28 of the blood vessel 22. The closure device 220 can be configured as a biodegradable or bioabsorbable material and can be configured to promote endothelialization.

[0058] The closure device 220 includes an inner cover 222 (e.g., a plate, a membrane, etc.) disposed within the interior space 14 of the aneurysm 10 and similar to the inner cover 22 described above, and an inner anchoring member 240 disposed within the aneurysm 10 and similar to the inner anchoring member 140 described above. The inner anchoring member 240 is configured to anchor the inner cover 222 within the aneurysm 20 within the neck 16. The closure device 220 also includes an outer anchoring member 250 disposed within the blood vessel 12 proximate the aneurysm 10. The outer anchoring member 250 provides a relatively rigid object that supports the inner cover 222 and reduces the likelihood that the inner cover 222 will be displaced from the neck 14 by the fluid pressure of the blood in the blood vessel 12.

[0059] refer to Figure 7 According to an exemplary embodiment, the external anchoring member 250 includes a loop 252 of a coil formed of a suitable biocompatible metal or alloy (e.g., platinum, stainless steel, nickel-titanium alloy, etc.). The metal coil can be similar to the coils commonly used in the endovascular winding process. In one embodiment, the loop 252 is coupled to the inner cover 222 and contacts the wall 13 of the blood vessel 12. In one embodiment, the loop 252 is oriented perpendicular to the blood flow through the blood vessel 12. In one embodiment, multiple coils or loops 252 can be used.

[0060] refer to Figure 8According to an exemplary embodiment, the external anchoring member 250 includes a first ring 254 and a second ring 256. The rings 254 and 256 can be rings of coils formed by suitable biocompatible metals or alloys (e.g., platinum, stainless steel, nickel titanium alloy, etc.). At least one of the rings 254 and 256 is coupled to the inner cover 222 and contacts the wall 13 of the blood vessel 12. The first ring 254 extends around the inner circumference of the blood vessel 12 so that it is perpendicular to the direction of blood flow through the blood vessel 12. The second ring 256 is oriented parallel to the blood flow through the blood vessel 12. The second ring 256 is formed by a coil having a relatively small diameter and does not substantially hinder the blood flow through the blood vessel. In other embodiments, the external anchoring member 250 may include more than two rings. The orientation, number, and size of the rings may vary according to the size and shape of the blood vessel 12.

[0061] refer to Fig. 9 According to another exemplary embodiment, the external anchoring member 250 includes a stent 258 formed of a suitable biocompatible metal or alloy (e.g., platinum, stainless steel, nickel-titanium alloy, etc.) or a suitable biocompatible polymer. The stent 258 is introduced into the blood vessel 12 close to the aneurysm 10 in a collapsed state via the catheter 30. Once deployed into the blood vessel 12, the stent 258 opens to compress the wall of the blood vessel 12. The stent 258 can be self-expandable or can be expanded with another device (such as an inflatable balloon). All or part of the stent 258 can be coated or covered with a radiopaque material (e.g., platinum) to allow visualization of the stent 258 (e.g., during and after placement of the stent 258).

[0062] The stent 258 is not intended to close the neck 16 of the aneurysm 10, but rather to form a structure that facilitates the placement and anchoring of the inner cap 222. Thus, the stent 258 need not be the same width as or wider than the neck 16, but can be a relatively short object (e.g., shorter than the width of the neck 16 of the aneurysm 10). The relatively short length of the stent 258 reduces the likelihood that the outer anchoring member 250 will damage surrounding objects, such as the side branches 18 of the blood vessel 12. Further, the stent 258 can have a non-dense, relatively open configuration having a variable cell morphology that can extend from the neck 16 in the blood vessel 12 toward the center of the body. In other embodiments, the stent 258 can be a solid member, such as a band formed of a relatively thin thickness of metal or alloy.

[0063] In another embodiment, the outer anchoring member 250 can be a temporary member that is removed with the catheter 30 after the closure device 320 has been placed in the neck 16 of the aneurysm and has been coupled to the wall of the aneurysm 10. For example, the outer anchoring member can be a balloon that is inflated in the vessel 12 proximate the aneurysm to provide a temporary structure that supports the inner cap 222.

[0064] Now, refer to Fig.10 , according to an exemplary embodiment, an inner cover 222, an inner anchoring member 240, and an outer anchoring member 250 are shown disposed within a catheter 30. The outer anchoring member 250 is coupled to the distal end 36 of the push wire 32 and is contained in a collapsed configuration within the lumen of the catheter 30. The outer anchoring member 250 is coupled to the inner cover 222, which is contained in a collapsed configuration within the lumen of the catheter 30 upstream of the outer anchoring member 250. The outer anchoring member 250 can be coupled to the inner cover 222 using, for example, an adhesive. In the collapsed configuration, the peripheral portion 224 of the inner cover 222 is upstream of the central portion 226, and the outer anchoring member 250 is coupled to the central portion 226 on a first surface 244. The inner anchoring member 240 is coupled to a second surface 246 of the inner cover 222 opposite the first surface 242, and is disposed within the lumen of the catheter 30 upstream of the inner cover 222.

[0065] With reference Figures 3A-3E Similar to the process described above, the closure device 220 including the inner cap 222 and the inner anchoring member 230 is deployed within the aneurysm 20. The distal end 34 of the catheter 30 is positioned proximate the neck 26 of the aneurysm 20, and the push wire 32 is moved relative to the catheter 30 within the lumen. The inner anchoring member 240 is pushed out of the catheter and into the interior space 24, where it contacts the inner surface 25 of the aneurysm 20. The push wire 32 is moved further until the inner cap 222 begins to emerge from the end 34 of the catheter 30 to expand into an expanded configuration within the interior space 24. The catheter 30 and / or the push wire 32 are then retracted until the inner cap 222 abuts against the inner surface 25 of the aneurysm 20 and is secured by the inner anchoring member 240. The push wire 32 is moved further until the outer anchoring member 250 emerges from the catheter 30. The outer anchoring member 250 can be, for example, one or more rings 252, 254 or 256, or a stent 258. The distal end 36 of the push wire 32 is disengaged from the external anchoring member, so that the catheter 30 and the push wire 32 can be removed from the blood vessel 22, while the inner cap 22 remains in the neck 26 of the aneurysm 20, the inner anchoring member 240 is coupled to the second surface 246, and the external anchoring member 250 is disposed in the blood vessel 12. In other embodiments, the push wire 32 can be coupled directly to the inner cap 222, and the external anchoring member 250 can be deployed separately (e.g., from another catheter).

[0066] Now, refer to Figure 11-14, shows a closure device 320 according to an exemplary embodiment, which is disposed in the neck 16 of the aneurysm 10 to disrupt or stop the flow of blood between the blood vessel 12 and the interior space 14 of the aneurysm, thereby reducing the likelihood that the aneurysm 10 will rupture. The closure device 320 is configured as a low-profile device to minimize damage to surrounding objects, such as the side branches 18 of the blood vessel 12. The closure device 320 can be configured as a biodegradable or bioabsorbable material and can be configured to promote endothelialization.

[0067] The closure device 320 includes an inner cover 322 (e.g., a plate, a membrane, etc.) disposed within the interior space 14 of the aneurysm 10 and similar to the inner cover 32 described above. The closure device 320 also includes an outer cover 360 disposed in the blood vessel 12 proximal to the aneurysm 10. The outer cover 360 can be coupled to the inner cover 322 to provide a relatively rigid object to support the inner cover. The outer cover 360 reduces the likelihood that the inner cover 322 will be displaced from the neck 34 by the fluid pressure of the blood in the blood vessel 32. The outer cover 360 can be used instead of other devices, or in addition to other devices, to secure the inner cover 322 in the neck 16, such as the inner anchoring member 140 or the outer anchoring member 250.

[0068] refer to Fig.11 According to an exemplary embodiment, the outer cover 360 is a relatively thin member (e.g., a plate, a sheet, etc.) formed of a suitable biocompatible metal or alloy (e.g., platinum, stainless steel, nickel-titanium alloy), or a polymer (e.g., PTFE, etc.). According to an exemplary embodiment, the outer cover 360 has a thickness of less than 2 mm. According to a preferred embodiment, the outer cover 360 has a thickness of less than 1 mm. The outer cover 360 is a low-profile object that does not substantially hinder blood flow through the blood vessel 12. The outer cover 360 includes a peripheral portion 362 and a central portion 364, the peripheral portion 362 contacts the wall 13 of the blood vessel 12 surrounding the neck 16 of the aneurysm 10, and the central portion 364 is disposed in the neck 16. The central portion 364 can be formed integrally with the inner cover 322, or can be coupled to the inner cover 322 (e.g., with a suitable adhesive). All or part of the outer cover 360 can be coated or covered with a radiopaque material (e.g., platinum) to allow visualization of the outer cover 360 (e.g., during and after placement of the outer cover 360). In an embodiment, the outer cover 360 is attached to the inner cover at a central region having an area that is less than the neck 16 (e.g., 90%, 75%, or 50% of the area of ​​the neck). In one embodiment, the central region has a circular shape.

[0069] The outer cover 360 is not intended to close the neck 16 of the aneurysm 10, but rather to form a structure that facilitates anchoring of the inner cover 322. Therefore, the outer cover 360 need not completely cover the neck 16. Therefore, the outer cover 360 can be formed so that a portion of the neck 160 is not covered and / or can be formed of a porous material (e.g., a mesh). Fig.12 In one embodiment, the outer cover 360 may be a sheet that completely covers the neck 16 , such that the outer peripheral portion 362 of the outer cover 360 extends around the entire neck 16 .

[0070] refer to Fig.13 In another embodiment, the outer cover 360 may include a plurality of segments or sections such as radial blades 366 extending outward from the neck portion 16. Each blade 366 may include a central portion 364 disposed within the neck 16 and a peripheral portion 364 extending beyond the neck 16 to contact the wall 13 of the blood vessel 12.

[0071] refer to Fig.14 In another embodiment, the outer cover 360 may include a spiral body 368. The inner ring of the spiral body 368 may form the central portion 364, and the outer ring of the spiral body 368 may form the peripheral portion 362.

[0072] The outer cover 360 can be deployed from the catheter in the same process as the inner cover 322. Thus, the outer cover 360 can be configured to be collapsible so that it can be coupled to the inner cover 322 and accommodated within the catheter. The outer cover 360 can be configured within the catheter with the central portion 364 coupled to the inner cover 322 and positioned upstream of the peripheral portion 362. Figures 3A-3D As described above, the inner cover 322 can be deployed. Once the inner cover 322 is deployed from the catheter and positioned in the neck 16, the push wire of the catheter can be further advanced to deploy the outer cover 360. The fluid pressure of the blood in the blood vessel 12 pushes the outer cover 360 toward the wall 13 of the blood vessel 12. In other embodiments, the push wire 32 can be directly coupled to the inner cover 322, and the outer cover 360 can be deployed separately (e.g., from another catheter).

[0073] Now, refer to Figure 15-16, a closure device 420 disposed in the neck 16 of an aneurysm 10 is shown according to an exemplary embodiment. The closure device 420 includes an inner cover 422 (e.g., a plate, a membrane, etc.) disposed within the interior space 14 of the aneurysm 10. The closure device 420 also includes an inner anchoring member 440 disposed within the aneurysm 10, and / or an outer anchoring member 450. The inner anchoring member 440 is configured to anchor the inner cover 422 within the aneurysm 10 in the neck 16. According to an exemplary embodiment, the inner anchoring member 440 includes one or more struts or arms formed of a suitable biocompatible metal or alloy (e.g., platinum, stainless steel, nickel-titanium alloy, etc.). The inner anchoring member 440 is coupled to the inner cover 122 and is configured to extend beyond the periphery of the inner cover 422 to contact the inner surface 15 of the aneurysm 10. Therefore, the inner anchoring member 140 can be used to help position the inner cover 422 in an aneurysm 10 having a relatively wide neck 16. The struts or arms of the inner anchoring member 140 do not fill the entire interior space 14 or a majority of the interior space 14. The "mass effect" of the aneurysm 10 is reduced because the size of the aneurysm 10 is allowed to shrink as the vessel heals, thereby reducing the pressure exerted by the aneurysm on the surrounding tissue. The orientation, number, and length of the arms of the inner anchoring member 440 can vary depending on the size and shape of the aneurysm 10. Similar to the microcatheter 30 described above, the arms of the inner anchoring member 440 can be configured to collapse together for delivery via a microcatheter.

[0074] Still refer to Figure 15-16 , the external anchoring member 450 includes a first portion 452 (e.g., a distal portion) disposed at the neck 16 and coupled to the inner cap 420 and a second portion 454 (e.g., a proximal portion) disposed in the blood vessel 12. The external anchoring member 450 is formed of a suitable biocompatible metal or alloy (e.g., platinum, stainless steel, nickel-titanium alloy, etc.) or a suitable biocompatible polymer. All or part of the external anchoring member 450 may be coated or covered with a radiopaque material (e.g., platinum) to allow visualization of the external anchoring member 450 (e.g., during and after placement of the external anchoring member 450). The external anchoring member 450 is introduced into the blood vessel 12 proximal to the aneurysm 10 through a catheter in a collapsed (e.g., straightened) state. Once deployed into the blood vessel 12, the external anchoring member 450 opens so that at least a portion of the external anchoring member is compressed against the wall of the blood vessel 12. The outer anchoring member 450 can be formed as a single, continuous helical shape, with the loops of the helix having variable properties (e.g., diameter, thickness, flexibility, etc.). For example, the first portion 452 can be formed as a flexible coil having a relatively small diameter, while the second portion 454 can be formed as a relatively stiff coil that provides increased outward radial force to help position the outer anchoring member 450 along the wall 13 of the blood vessel 12.

[0075] refer to Fig.17 According to another exemplary embodiment, a portion of the outer anchoring member 460 can be formed into a double helix shape. According to other exemplary embodiments, the outer anchoring member can be formed into a variety of other shapes (e.g., web-shaped, star-shaped, etc.) to provide the desired flexibility and support of the inner cap at the neck of the aneurysm.

[0076] refer to Figures 18A-18B According to another exemplary embodiment, the inner cover 470 for the closure device may be a star-shaped body. The inner cover 470 may be formed (eg, corrugated, scored, molded) to fold and collapse along a predetermined folding line.

[0077] Now, refer to Fig.19 , a closure device 480 is shown with an external anchoring member 482. The external anchoring member 482 is a recapturable object that can be of various shapes (e.g., straight, spiral, multi-spiral, coven, etc.). The external anchoring member 482 is formed as a relatively open structure with a minimal number of segments that forms a framework that can position and secure the closure device 480 while minimizing contact with the vessel wall. The open nature of the external anchoring member 482 has a low risk of imprisoning a branch vessel or otherwise altering blood flow through the vessel.

[0078] refer to Fig. 20 , an inner anchoring member 494 for a closure device 490 is shown according to another exemplary embodiment. The inner anchoring member 494 includes a center line 496 coupled to the cap 492 and one or more outer lines 498 coupled to the center line 496. The outer lines 498 extend outwardly from the center line 496 to contact the inner surface 15 of the aneurysm 10. The inner anchoring member 494 is introduced into the aneurysm 10 in a collapsed (e.g., straightened) state through the catheter 30. Once deployed into the aneurysm 10, the catheter 30 is pulled back, allowing the outer lines 498 to expand outwardly so that at least a portion of the outer lines 298 contact the inner surface 15 to position and anchor the cap 492 in the neck 16.

[0079] The construction and arrangement of the elements of the aneurysm closure device as shown in various exemplary embodiments are only schematic. Although only a few embodiments are described in detail in the present disclosure, it can be easily understood by those skilled in the art who browse the present disclosure that many modifications are possible (e.g., changes in the size, dimensions, structure, shape and proportion of various elements, parameter values, mounting arrangements, use of materials, colors, orientations, etc.) without substantially departing from the novel teachings and advantages of the subject matter described herein. For example, an element shown as being integrally formed can be composed of multiple parts or elements, the position of the element can be reversed or otherwise changed, and the nature or quantity, or position of the discrete element can be changed or changed. It should be noted that the elements and / or components of the system can be composed of any one or more of a variety of materials that provide sufficient strength, durability or biocompatibility. Without departing from the scope of the present invention, other substitutions, modifications, changes and omissions can be made in the design, operating conditions and arrangements of preferred and other exemplary embodiments and medical methods. Specific implementation plan

[0080] Embodiment 1: A catheter for treating an aneurysm in a blood vessel, the catheter comprising:

[0081] Tube;

[0082] a wire disposed within the tube; and

[0083] A closure element is disposed on the wire, wherein the closure element is configured to fit within the tube and slide out of an opening at the distal end of the tube in response to movement of the wire within the tube, wherein the closure element is configured to open to a radius greater than a radius of the tube and cover a neck of the aneurysm.

[0084] Embodiment 2. A catheter according to embodiment 1, wherein the closure element has a closed umbrella-like shape within the tube and has an open umbrella shape when being inspected.

[0085] Embodiment 3. A catheter according to embodiment 2, wherein the closure element is a mesh material.

[0086] Embodiment 4. A catheter according to embodiment 1, wherein the closure element is provided on a portion of the wire that is a distance from the distal end of the wire.

[0087] Embodiment 5: The catheter according to embodiment 1 further comprises:

[0088] A cutting element is arranged to cut the wire after the closing element is opened.

[0089] Embodiment 6. A catheter according to embodiment 1, wherein the wire segment between the distal end of the wire and the closure element is flexible so that the wire segment can be wrapped within the inner surface of the aneurysm.

[0090] Embodiment 7. A catheter according to embodiment 1, wherein the closure element is configured to allow the wire to slide off after opening.

[0091] Embodiment 8: The catheter according to embodiment 1 further comprises:

[0092] An anchor member is coupled to the closure element, and the anchor member is disposed on the blood vessel side of the neck.

[0093] Embodiment 9. The catheter according to embodiment 8, wherein the anchoring member is a stent.

[0094] Embodiment 10. A catheter according to Embodiment 8, wherein the anchoring member comprises an annular element.

[0095] Embodiment 11. A catheter according to embodiment 8, wherein the anchoring member includes a disc element that extends beyond the neck region and is stiffer than the closure element.

[0096] Embodiment 12, a method for treating an aneurysm in a blood vessel, the method comprising:

[0097] providing a distal portion of the tube to a neck region of the aneurysm;

[0098] sliding a wire attached to a closure element in the tube so that the closure element exits the tube at the neck region; and

[0099] After the closing element has left the tube, the closing element is separated from the wire.

[0100] Embodiment 13. A method according to embodiment 12, wherein after the closure element leaves the tube, the closure element is expanded, wherein the radius of the closure element is larger than the radius of the tube and engages the inner wall of the aneurysm and covers the neck of the aneurysm.

[0101] Embodiment 14. A method according to embodiment 12, wherein the detachment is performed by pulling the wire back through the tube so that the closure element engages the distal end of the tube and is pulled off the wire.

[0102] Embodiment 15. The method according to embodiment 12 further comprises:

[0103] A distal portion of the wire is provided into the aneurysm such that the distal end of the wire is wrapped within an inner wall of the aneurysm, wherein the closure element is disposed on a portion of the wire that is located at a greater distance from an end of the wire in the aneurysm than the distal portion is from an end of the wire.

[0104] Embodiment 16. The method according to embodiment 15 further comprises:

[0105] An anchoring element is provided in the blood vessel at a location associated with the neck.

[0106] Embodiment 17: A closed system for treating an aneurysm in a blood vessel, the closed system comprising:

[0107] line; and

[0108] A closure element is disposed on the wire, wherein the closure element is configured to be compressed into a cone shape and expand into a disk or concave shape to cover the neck of the aneurysm.

[0109] Embodiment 18. A closure system according to embodiment 17, wherein the closure element is disposed at a location on the wire that is a distance from a distal end of the wire.

[0110] Embodiment 19. The closure system according to embodiment 17 further comprises a cutting device for separating the wire from the closure element.

[0111] Embodiment 20: A closed system according to embodiment 17, further comprising an anchoring element device for engaging the blood vessel.

Claims

1. A device for treating an aneurysm in a blood vessel, the device comprising: a push wire; a closure element, which is detachably coupled to the push wire and comprises an inner cover and an outer anchoring member, the inner cover comprising a central portion configured to cover the neck of the aneurysm and a peripheral portion configured to contact the inner surface of the aneurysm so that the closure element as a whole remains near the neck and away from the top of the aneurysm; an outer anchoring member coupled to the inner cover and configured to be disposed in the blood vessel near the aneurysm and on the blood vessel side of the neck to fix the inner cover to the neck, the outer anchoring member comprising a plurality of radial blades extending from the central portion of the inner cover, wherein each of the radial blades includes a central portion and a peripheral portion, the peripheral portion being configured to extend beyond the neck of the aneurysm; and wherein the inner cover and the outer anchoring member are each configured to be collapsible to advance through the inner cavity of a catheter, and wherein the inner cover and the outer anchoring member are each configured to be expandable when deployed from the inner cavity of the catheter.

2. The apparatus of claim 1, wherein the plurality of radial blades comprises at least 3 radial blades.

3. The apparatus of claim 2, wherein the plurality of radial blades consists of three radial blades.

4. The apparatus of claim 2, wherein said at least three radial blades are circumferentially arranged in an equally spaced manner.

5. The device of claim 1, wherein a peripheral portion of each of the plurality of radial blades is configured to contact a blood vessel wall.

6. The device of claim 1, wherein the inner cover has a concave shape.

7. The device of claim 1, wherein the inner cover is disc-shaped.

8. The device of claim 1, wherein the inner cover comprises a mesh of threads or fibers.

9. The device of claim 1, wherein the inner cover comprises metal.

10. The device of claim 1, wherein the inner cover comprises a 3-D printed material.

11. The device of claim 1, wherein the inner cover has a conical shape.

12. The device of claim 1, wherein the inner cover has a diameter between 5 mm and 12 mm.

13. The device of claim 1, wherein the inner cover has a thickness of less than 100 microns.

14. The device of claim 1, wherein the inner cover comprises a nickel-titanium alloy.

15. The device of claim 1, wherein the inner cover comprises platinum.

16. The device of claim 1, wherein the inner cover comprises a laser drilled sheet.

17. The device of claim 1, wherein said push wire is configured to be mechanically disengaged from said inner cover.

18. The apparatus of claim 1, wherein said push wire is configured to be electrically disconnected from said inner cover.

19. The device of claim 1, wherein the inner cover comprises silicone.

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