Systems and methods for treating aneurysms

Abstract

A device for treating an aneurysm in a blood vessel includes an occlusive element arranged on a wire, the occlusive element including a cover for covering the neck of the aneurysm and an internal anchoring member. The cover is configured to expand from a compressed structure in the tube to an expanded structure to cover the neck of the aneurysm when pushed out from the distal end of the tube. The cover includes a sphere of mesh material formed as a hemisphere, the hemisphere including two layers of mesh formed by folding the top of the sphere into the bottom of the sphere. The internal anchoring member is connected to a second surface of the cover and extends from the second surface of the cover, and is configured to contact the inner surface of the aneurysm. The internal anchoring member can be a cylindrical rod extending from a central portion of the cover.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Application No. 15 / 875,767, filed on January 19, 2018, the entire contents of which are incorporated herein by reference. Background Art

[0003] An aneurysm is an abnormal bulging or weakening of a blood vessel, usually an artery, and can have many complications. The bulging of a blood vessel can 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, the volume formed by the aneurysm is not along the main flow path of blood through the blood vessels. Therefore, it can serve as a location for blood to stagnate and, due to the vortex of the vortex, can contribute to the formation of thromboemboli. If an aneurysm ruptures, it can cause severe internal bleeding.

[0004] Aneurysms can be treated from the outside through open surgery. Such procedures typically involve closing the entrance or "neck" of the aneurysm with a device such as a vascular clamp or ligature. However, such open surgical procedures can be highly invasive and may cause trauma to adjacent tissues and other side effects.

[0005] Aneurysms can also be treated by endovascular procedures. In one procedure, a detachable length of wire (e.g., a coil) is inserted into the interior volume of the aneurysm using a catheter. The coil is intended to fill the volume of the aneurysm to reduce blood flow into the aneurysm, cause stagnation of blood flow and stimulate coagulation within the aneurysm. In the case of large cerebral aneurysms, filling the aneurysm with multiple coils can lead to a mass effect, which may cause brain swelling and become an independent cause of new symptoms. In another procedure, for aneurysms with larger necks, the auxiliary use of stents helps to keep the coils within the aneurysm. This approach is contraindicated in the treatment of ruptured aneurysms due to the need for additional antithrombotic drugs. In another procedure, a temporary balloon expanded in the blood vessel is used to keep the coils in the volume of the aneurysm. Once the mass of the coil is ensured, the balloon is deflated and removed. In yet another procedure, 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 volume. However, the side branches of the aorta where the stent device is placed may be trapped or "imprisoned", which prevents access to the side branches. In other cases, the side branches can become blocked, potentially leading to a stroke. Additionally, such procedures often require the use of additional anti-thrombotic medications, which limits the use of such devices to the treatment setting of a ruptured aneurysm. 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 impedes or blocks volume from entering the aneurysm or imprisoned artery. In situations where the aneurysm cannot coagulate, the occlusion of the aneurysm by the stent device prevents the possibility of placing an embolic device inside the aneurysm. Other procedures may then be required, such as placement of additional stents or open surgery to manage the remnants.

[0006] There are several common disadvantages to all procedures that involve packing the volume of an aneurysm. First, many coils may be required to fill the volume of the aneurysm, which is both time consuming and increases the time required to complete the procedure. Additionally, the coils may become compacted over time to occupy a smaller percentage of the total volume of the aneurysm. Sufficient compaction of the coils may be considered a recurrence of the aneurysm and may require further treatment.

[0007] It would be advantageous to provide improved systems and methods for treating aneurysms. SUMMARY OF THE INVENTION

[0009] One embodiment relates to a device for treating an aneurysm in a blood vessel, the device comprising an occlusive element arranged on a wire, the occlusive element comprising a cover for covering the neck of the aneurysm and an internal anchoring member. The cover is configured to expand from a compressed configuration in the tube to an expanded configuration to cover the neck of the aneurysm when pushed out from the distal end of the tube. The cover includes a sphere of mesh material formed as a hemisphere, the hemisphere including two layers of mesh formed by folding the top of the sphere into the bottom of the sphere. The internal anchoring member is connected to a second surface of the cover and extends from the second surface of the cover, and is configured to contact the inner surface of the aneurysm. The internal anchoring member can be a cylindrical rod extending from a central portion of the cover.

[0010] One embodiment relates to an apparatus for treating an aneurysm in a blood vessel, the apparatus comprising an occlusive element disposed on a wire. The occlusive element comprises: a cover for covering the neck of the aneurysm; an internal anchoring member for contacting the inner surface of the aneurysm; and a central rod connecting the cover and the internal anchoring member. The occlusive element is coupled to the wire on the outer surface of the cover. The cover and the internal anchoring member are configured to expand from a compressed configuration disposed in the tube to an expanded configuration to be positioned within the aneurysm when pushed out from the distal end of the tube. The cover and the internal anchoring member have substantially similar diameters, and wherein the diameter of the central rod is smaller than the diameter of the cover and the internal anchoring member.

[0011] One embodiment relates to a device for treating an aneurysm in a blood vessel, the device comprising an occlusive element arranged on a wire. The occlusive element comprises a cover for covering the neck of the aneurysm and an internal anchoring member. The cover is configured to expand from a compressed configuration in the tube to an expanded configuration to cover the neck of the aneurysm when pushed out from the distal end of the tube. The cover comprises a double-layer mesh comprising an inner layer folded to an outer layer so that the inner surface of the inner layer of the cover comprises a concave surface. The internal anchoring member is directly connected to the inner surface of the cover and extends from the inner surface of the cover, and is configured to contact the inner surface 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 involve other features and combinations of features that may generally be recited in the claims. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

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

[0016] Figures 3A-3E is a deployment according to an exemplary embodiment Figure 1 Schematic side cross-sectional view of a catheter of an aneurysm occlusion 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 5 According to an exemplary embodiment, the catheter is Figure 4 Schematic cross-sectional view of an occlusion 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 an occlusion 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 occlusion device according to an exemplary embodiment.

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

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

[0028] Fig.15is 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 occlusion device according to an exemplary embodiment.

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

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

[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.

[0035] Fig.21 is a schematic side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to another exemplary embodiment.

[0036] Fig. 22 is a schematic side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to another exemplary embodiment.

[0037] Fig.23A is a schematic bottom view of an aneurysm occlusion device according to an exemplary embodiment.

[0038] Fig. 23B is a schematic bottom view of an aneurysm occlusion device according to an exemplary embodiment.

[0039] Fig.24 is a schematic side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to another exemplary embodiment.

[0040] Fig.25 is a schematic side view of an aneurysm occlusion device according to an exemplary embodiment.

[0041] Fig.26A is a schematic side view of an aneurysm occlusion device according to an exemplary embodiment.

[0042] Fig.26B According to an exemplary embodiment Fig.26A Schematic top view of an aneurysm occlusion device.

[0043] Fig. 27 is a schematic side view of an aneurysm with an intravascular device configured to occlude the aneurysm according to another exemplary embodiment.

[0044] Fig.28 is a schematic side view of an aneurysm occlusion device according to an exemplary embodiment.

[0045] Fig.29 is a schematic side view of an aneurysm occlusion device according to an exemplary embodiment.

[0046] Fig.30 is a schematic side view of an aneurysm occlusion device according to an exemplary embodiment.

[0047] Fig.31 is a schematic side view of an aneurysm occlusion device according to an exemplary embodiment.

[0048] Fig.32A is a schematic side view of an aneurysm occlusion device according to an exemplary embodiment.

[0049] Fig.32B is a schematic side view of an aneurysm occlusion device according to an exemplary embodiment.

[0050] Fig.32C is a schematic side view of an aneurysm occlusion device according to an exemplary embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0052] Generally speaking Figures 1 to 14 , an aneurysm occlusion device configured to treat an aneurysm 10 according to some exemplary embodiments is shown. Aneurysm 10 is an outwardly extending bulge in the wall 13 of a blood vessel 12 and has an internal volume 14 in fluid communication with the blood vessel 12 through an opening at a neck 16. Aneurysm 10 may occur at a portion of the wall 13 of the blood vessel 12 that is weakened due to disease or trauma. In one embodiment, aneurysm 10 may 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 occlusion device described herein can be used to treat aneurysms of various sizes and locations. For example, aneurysm 10 may be located between two branches of a blood vessel.

[0053] refer to Figure 1-3E, shows an occlusive device 20 according to an exemplary embodiment, which is arranged in the neck 16 of the aneurysm 10 to interrupt or stop blood flow between the blood vessel 12 and the interior volume 14 of the aneurysm, thereby reducing the possibility of rupture of the aneurysm 10. The occlusive device 20 is configured as a low-profile device to minimize damage to surrounding objects, such as side branches 18 of the blood vessel 12. The occlusive device 20 can be constructed of a biodegradable or bioabsorbable material and can be configured to promote endothelialization.

[0054] The occlusion device 20 includes an inner cover 22 (e.g., a plate, a membrane, etc.) configured to be disposed within the interior volume 14 of the aneurysm 10. When fully expanded, 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 volume 14 of the aneurysm 10 through the neck 16 (e.g., by catheterization) and opened to at least partially occlude the neck 16. As used herein, concave is intended to describe any body that is contoured to have a hollow or cavity along one side. Figure 1 As shown, in one exemplary embodiment, the inner cap 22 can be generally dome-shaped. In another embodiment, the inner cap 22 can have another concave shape (e.g., conical shape) disposed in the neck 16 and opening into the interior volume 14. In one embodiment, the cap 22 can be disc-shaped.

[0055] 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 flexibility of the inner cap 22 enables it to conform to the shape of the inner surface 15 of the aneurysm 10 and more effectively block the flow of blood between the aneurysm 10 and the blood vessel 12. Closely conforming to the shape of the inner surface 15 of the aneurysm 10 also facilitates the adhesion of the inner cap 22 to the tissue of the aneurysm 10 and the formation of new tissue to close the neck 16.

[0056] The inner cover 22 can be sized to fit a particular aneurysm 10. Figure 1-2 As shown, the diameter of the inner cap 22 is larger 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 flexibility of the inner cap 22 allows the inner cap 22 to be larger in size 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 about 5 mm can be used to occlude an aneurysm having a neck diameter of up to 4 mm; an inner cap having a diameter of about 8 mm can be used to occlude an aneurysm having a neck diameter of 4-6 mm; and an inner cap having a diameter of about 12 mm can be used to occlude an aneurysm having a neck diameter of 6-10 mm.

[0057] In one embodiment, the inner cover 22 may be formed of a biocompatible metal or metal alloy, such as platinum, stainless steel, titanium, titanium-nickel alloy (e.g., nitinol). For example, the inner cover 22 may be a concave disk formed of sheet nitinol. The nitinol alloy may be configured to undergo secondary heat setting to form a desired concave shape. According to an exemplary embodiment, the inner cover 22 may have a thickness of less than 100 microns to achieve desired flexibility. In another embodiment, the inner cover 22 may be formed into a relatively dense mesh, such as a 37-micron mesh, which is formed by a plurality of wires or fibers connected together (e.g., welded, soldered, braided, etc.).

[0058] 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 other exemplary embodiments, the inner cover 22 can be formed by a metal or alloy coated with a polymer (e.g., polyparaxylene, PTFE, PFE, etc.) to increase lubricity and biocompatibility and reduce thrombogenicity. 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 may include a laser-drilled nylon sheet to provide a matrix for endothelialization while reducing the volume of the fragment. Another embodiment may involve two photon polymerizations or 3D printing of biocompatible materials to form the inner cover 22 directly on the delivery system, or to cover the skeleton frame attached to the delivery system, thereby allowing the final shape of the inner cover 22 to be customized when processing.

[0059] Reference now Figures 3A-3D , showing the inner cover 22 deployed through the catheter 30 according to an exemplary embodiment. 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 30 is advanced through the neck 16 and enters the interior volume 14 of the aneurysm 10 or a portion of the blood vessel 12 near the neck 16. The push wire 32 is located within a lumen formed in the catheter 30. The catheter 30 can have a single lumen, or the push wire 32 can be located within one of a plurality of 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 coupled to the push wire 36. Reference Figure 3B, the push wire 32 is moved within the lumen relative to the catheter 30 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) to an expanded configuration within the interior volume 14 when it clears the end 34 of the catheter 30. The push wire 32 can be moved relative to the catheter 30 by keeping the catheter 30 stationary while the push wire 32 is advanced (e.g., pushed), by keeping the push wire 32 fixed and retracting the catheter 30 (e.g., unsheathing), or by a combination of movements of the catheter 30 and the push wire 32. The inner cap 22 can be partially deployed within the blood vessel 12 or within the aneurysm 10 together with the distal end 34 of the catheter 30.

[0060] refer to Figure 3C , before fully deploying the inner cap 22 from the catheter 30, the distal end 34 of the catheter 30 is advanced into the interior volume 14 of the aneurysm 10. Figure 3D As 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 in place against the inner surface 15 of the aneurysm. Figure 3E , the distal end 36 of the push wire 32 is separated from the inner cap 22, so that the catheter 30 and the push wire 32 can be withdrawn from the blood vessel 12, while the inner cap 22 remains in the neck 16 or lower portion of the aneurysm 10. The push wire 32 can be removed from the inner cap 22 by any suitable electrical or mechanical cutting device. Alternatively, the inner cap 22 can be removed by retracting the wire 32, causing the inner cap 22 to engage the distal end of the tube 30 and slide off the wire 32.

[0061] In one embodiment, the inner cover 22 can be formed to be biased toward the open, expanded position. In another embodiment, the inner cover 22 can include a mesh supported by rib members or splines that radiate outward from the center of the inner cover 22. In one embodiment, the rib members or splines can be biased toward the open position. In one embodiment, the rib members and splines operate in an inverted umbrella operation and lock in the fully open position once the fully open position is reached.

[0062] Reference now Figure 4-5 , shows an occlusive device 120 according to an exemplary embodiment, which is arranged in the lower portion of the aneurysm 10 to disrupt or stop the blood flow between the blood vessel 12 and the interior volume 14 of the aneurysm, thereby reducing the possibility that the aneurysm 10 will rupture. The occlusive device 120 is configured as a low-profile device to minimize damage to the surrounding body (e.g., the side branches 18 of the blood vessel 12). The occlusive device 120 can be constructed of a biodegradable or bioabsorbable material and can be configured to promote endothelialization.

[0063] The occlusive device 120 includes an inner cover 122 (e.g., a plate, a membrane, etc.) disposed within the interior volume 14 of the aneurysm 10 and similar to the inner cover 22 described above. The occlusive 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 10, proximate the neck 16. The inner anchoring member 140 provides a relatively rigid body that supports the inner cover 122 and reduces the likelihood of the inner cover 122 being displaced from the neck 16 due to fluid pressure of the blood in the blood vessel 12.

[0064] According to an exemplary embodiment, the internal anchoring member 140 includes one or more loops 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 endovascular winding procedures. The internal anchoring member 140 is coupled to the inner cover 122 and includes at least one coil in contact with the inner surface 15 of the aneurysm 10. The loops of the internal anchoring member 140 do not fill the entire internal volume 14 or fill a majority of the internal volume 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 the coil. In another embodiment, the anchoring member 140 includes a large number of loops that substantially fill the internal volume 14. The orientation, number, and size of the loops of the internal anchoring member 140 may vary depending on the size and shape of the aneurysm 10.

[0065] Reference now Figure 5 , according to an exemplary embodiment, the inner cover 122 and the inner anchoring member 140 are shown as being disposed within the catheter 30. The inner cover 122 is coupled to the distal end 36 of the push wire 32 and is received in a collapsed configuration within the lumen of the catheter 30. In the collapsed configuration, the peripheral portion 124 of the inner cover 122 is located upstream (e.g., closer to the distal end 34) than the central portion 126 coupled to the push wire 36 on the 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 disposed within the lumen of the catheter 30 upstream of the inner cover 122.

[0066] Similar to the above reference Figures 3A-3E In the described process, the occlusion device 120 including the inner cap 122 and the inner anchoring member 140 is deployed within the aneurysm 10. With the distal end 34 of the catheter 30 positioned proximate 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 to cause the anchoring member 140 to reach the interior volume 14 and coil therein.

[0067] In one embodiment, the push wire 32 has a circular solid cross-section, while the anchor member 140 has a coiled cross-section (e.g., like a telephone cord) to facilitate coiling 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.

[0068] After coiling of the anchor member 140 is complete, the inner anchor member 140 is pushed out of the catheter and into the interior volume 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 push wire 32 are then retracted until the inner cap 122 abuts against the inner surface 15 of the aneurysm 10 and is held in place by the inner anchor member 140. The distal end 36 of the push wire 32 is separated from the first surface 146 of the inner cap 122 so that the catheter 30 and push wire 32 can be withdrawn from the blood vessel 12 while the inner cap 22 remains in the neck 16 or lower portion of the aneurysm 10 with the inner anchor member 140 coupled to the second surface 146.

[0069] Reference 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 148 can be configured to provide additional support to strengthen the wall of the aneurysm 10. The relatively stiff portion of the inner anchoring member 140 can be used as a frame member to create structure in the interior volume 14 of the aneurysm, while the more compliant portion is used to fill the interior volume 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, such as by changing the thickness of the coil, the radius of the coil, and / or by changing the material used to form the coil.

[0070] The softer portion of the inner anchoring member may include a removable sheath or layer to facilitate positioning of the inner, stiffer portion of the anchoring member 140 within the aneurysm 10. Once the distal end 148 and stiffer portion of the inner anchoring member 140 are positioned, the sheath may be removed.

[0071] In one embodiment, the stiffness 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 region or portion having a different stiffness 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 disposed on an outer shaft connected to the push wire, each external indicator corresponding to a transition from a region having a first stiffness to a region having a second stiffness. In another embodiment, the indicator can be internal, such as an opaque indicator (e.g., a platinum coating) on ​​the internal anchoring member 140 between regions.

[0072] In one embodiment, an anchor member 140 having a variable stiffness may be utilized without the inner cover 122. In such an embodiment, the anchor member 140 fills the interior space 14. In one embodiment, several anchor members 140 may be utilized. In one embodiment, the first anchor member 140 employed has a variable stiffness (e.g., thickness) that is greater than the variable stiffness (e.g., thickness) of the next anchor member employed.

[0073] Reference now Figure 7-10 , shows an occlusive device 220 according to an exemplary embodiment, which is arranged in the lower portion of the aneurysm 20 near or at the neck 26 to interrupt or prevent blood flow between the blood vessel 22 and the interior volume 14 of the aneurysm 20, thereby reducing the possibility of rupture of the aneurysm 20. The occlusive device 220 is configured as a low-profile device to minimize damage to the surrounding body, such as the side branches 28 of the blood vessel 22. The occlusive device 220 can be configured as a biodegradable or bioabsorbable material and can be configured to promote endothelialization.

[0074] The occlusive device 220 includes an inner cover 222 (e.g., a plate, a membrane, etc.) that is disposed within the interior space 14 of the aneurysm 10 and is similar to the inner covers 22, 122 described above. The occlusive device 220 also includes an inner anchoring member 240 that is disposed within the aneurysm 10 and is 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, near or at the neck 16. The occlusive device 220 also includes an outer anchoring member 250 that is disposed within the blood vessel 12, near the aneurysm 10. The outer anchoring member 250 provides a relatively rigid body that supports the inner cover 222 and reduces the likelihood of the inner cover 222 being displaced from the neck 16 due to fluid pressure of the blood in the blood vessel 12.

[0075] Reference 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 endovascular winding procedures. 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.

[0076] Reference Figure 8 According 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 connected 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 oriented perpendicular to the flow of blood 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 with a smaller diameter and does not substantially hinder the blood from passing 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 can vary according to the size and shape of the blood vessel 12.

[0077] Reference 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 through the catheter 30 in a collapsed state, near the aneurysm 10. Once deployed in the blood vessel 12, the stent 258 expands to engage the wall of the blood vessel 12. The stent 258 can be self-expandable or can be expanded using other devices (e.g., an inflatable balloon). All or a portion 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).

[0078] The stent 258 is not intended to occlude the neck 16 of the aneurysm 10, but rather to form a structure to facilitate placement and anchoring of the inner cap 222. Thus, the stent 258 need not be as wide as or wider than the neck 16, but may be a relatively short body (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. In addition, the stent 258 may have a non-dense, relatively open configuration with variable cell morphology that may extend proximally from the neck 16 in the blood vessel 12. In other embodiments, the stent 258 may be a solid member, such as a band formed of a relatively thin thickness of metal or alloy.

[0079] In another embodiment, the outer anchoring member 250 can be a temporary member that is removed with the catheter 30 after the occluding 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 expanded in the vessel 12 near the aneurysm to provide a temporary structure to support the inner cap 222.

[0080] Reference now Fig.10 According to an exemplary embodiment, the inner cover 222, the inner anchor member 240, and the outer anchor member 250 are shown as being arranged within the catheter 30. The outer anchor member 250 is coupled to the distal end 36 of the push wire 32 and is received in the lumen of the catheter 30 in a collapsed configuration. The outer anchor member 250 is coupled to the inner cover 222, which is received in the lumen of the catheter 30 upstream of the outer anchor member 250 in a collapsed configuration. The outer anchor member 250 can be coupled to the inner cover 222, for example, by an adhesive. In the collapsed configuration, the peripheral portion 224 of the inner cover 222 is upstream of the central portion 226 on the first surface 244, and the outer anchor member 250 is coupled to the central portion 226. The inner anchor member 240 is coupled to a second surface 246 of the inner cover 222 opposite to the first surface 242, and is disposed in the lumen of the catheter 30 upstream of the inner cover 222.

[0081] With reference above Figures 3A-3EThe process described is similar, and the occlusion device 220 including the inner cap 222 and the inner anchoring member 240 is deployed within the aneurysm 20. With the distal end 34 of the catheter 30 positioned proximate the neck 16 of the aneurysm 10, the push wire 32 is moved within the lumen relative to the catheter 30. The inner anchoring member 240 is pushed out of the catheter and into the interior volume 14, 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 volume 14. The catheter 30 and / or the push wire 32 are then retracted until the inner cap 222 is in place against the inner surface 25 of the aneurysm 20 and is held in place 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 separated from the outer anchoring member, so that with the inner anchoring member 240 coupled to the second surface 246 and the outer anchoring member 250 disposed in the blood vessel 12, the catheter 30 and the push wire 32 can be withdrawn from the blood vessel 22 while the inner cap 22 remains near or within the neck 16 of the aneurysm 20. In other embodiments, the push wire 32 can be directly coupled to the inner cap 222, and the outer anchoring member 250 can be deployed separately (e.g., separately from another catheter).

[0082] Reference now Figures 11 to 14 , shows an occlusive device 320, according to an exemplary embodiment, disposed in the neck 16 of an aneurysm 10 to disrupt or stop blood flow between the blood vessel 12 and the interior volume 14 of the aneurysm, thereby reducing the likelihood of rupture of the aneurysm 10. The occlusive 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 occlusive device 320 can be configured as a biodegradable or bioabsorbable material and can be configured to promote endothelialization.

[0083] The occluding device 320 includes an inner cover 322 (e.g., a plate, a membrane, etc.) disposed within the interior volume 14 of the aneurysm 10 and similar to the inner covers 22, 122, or 222 described above. The occluding device 320 also includes an outer cover 360 disposed in the blood vessel 12 near the aneurysm 10. The outer cover 360 can be coupled to the inner cover 322 to provide a relatively rigid body to support the inner cover. The outer cover 360 reduces the likelihood that the inner cover 322 will be displaced from the neck 16 due to fluid pressure of the blood in the blood vessel 32. The outer cover 360 can be utilized in place of or in addition to other devices such as the inner anchoring member 140 or the outer anchoring member 250 to secure the inner cover 322 in the neck 16.

[0084] refer to Fig.11According 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 material such as a metal or alloy (e.g., platinum, stainless steel, nickel-titanium alloy, etc.) 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 body 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 disposed in the neck 16, the peripheral portion 362 contacting the wall 13 of the blood vessel 12 around the neck 163 of the aneurysm 10. The central portion 364 can be integrally formed with the inner cover 322, or can be coupled to the inner cover 322 (e.g., by a suitable adhesive). All or part of the outer cover 360 can be coated or covered with a radiopaque material such as 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 location that is smaller in area than the central region of the neck 16 (eg, 90%, 75%, or 50% of the area of ​​the neck). In an embodiment, the central region has a circular shape.

[0085] The outer cover 360 is not intended to occlude 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 does not need to completely cover the neck 16. Therefore, the outer cover 360 can be formed so that a portion of the neck 16 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 peripheral portion 362 of the outer cover 360 extends around the entire neck 16 .

[0086] refer to Fig.13 In another embodiment, the outer cover 360 may include multiple segments or sections, such as radial lobes 366 extending outward from the neck 16. Each lobe 366 may include a central portion 364 disposed within the neck 16 and a peripheral portion 362 extending beyond the neck 16 to contact the wall 13 of the blood vessel 12.

[0087] 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.

[0088] The outer cover 360 can be deployed from the catheter in the same procedure 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 such that within the catheter, the central portion 364 is coupled to the inner cover 322 and positioned upstream of the peripheral portion 362. The inner cover 322 can be as described with reference to Figure 3A Once the inner cap 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 cap 360. The fluid pressure of the blood within the blood vessel 12 forces the outer cap 360 against the wall 13 of the blood vessel 12. In other embodiments, the push wire 32 can be directly coupled to the inner cap 322, and the outer cap 360 can be deployed separately (e.g., separately from another catheter).

[0089] Reference now Figure 15-16 , an occlusive device 420 according to an exemplary embodiment is shown, which is arranged in the lower portion of the aneurysm 10, such as the neck 16. The occlusive device 420 includes an inner cover 422 (e.g., a plate, a membrane, etc.), which is disposed within the interior volume 14 of the aneurysm 10. The occlusive device 420 also includes an inner anchoring member 440 and / or an outer anchoring member 450 disposed within the aneurysm 10. 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 422 and is configured to extend beyond the periphery of the inner cover 422 to contact the inner surface 15 of the aneurysm 10. Thus, the inner anchoring member 440 can be used to facilitate positioning of the inner cap 422 in an aneurysm 10 having a relatively wide neck 16. The struts or arms of the inner anchoring member 440 do not fill the entire interior volume 14 or a majority of the interior volume 14. As the size of the aneurysm 10 decreases as the vessel heals, the "mass effect" of the aneurysm 10 is reduced, 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. The arms of the inner anchoring member 440 can be configured to collapse together for delivery through a microcatheter, similar to the microcatheter 30 described above.

[0090] Still refer to Figure 15 to Figure 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 422 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 such as 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 near the aneurysm 10 through a catheter in a collapsed (e.g., straightened) state. Once deployed in the blood vessel 12, the external anchoring member 450 expands so that at least a portion of the external anchoring member is pressed against the wall of the blood vessel 12. The outer anchoring member 450 can be formed as a single continuous helix, with the loops of the helix formed to have variable properties (e.g., diameter, thickness, flexibility, etc.). For example, the first portion 452 can be formed as a flexible coil with a relatively small diameter, while the second portion 454 can be formed as a larger, relatively rigid coil that provides increased outward radial force to facilitate positioning of the outer anchoring member 450 along the wall of the blood vessel 13.

[0091] refer to Fig.17 According to another exemplary embodiment, a portion of the outer anchoring member 460 can be formed as a double helix. 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 provide support for the inner cap at the neck of the aneurysm.

[0092] refer to FIG. 18A to FIG. 18B According to another exemplary embodiment, the inner cover 470 for the occluding device may be a star-shaped body. The inner cover 470 may be formed (eg, creased, scored, molded) to be folded and collapsed along a predetermined folding line.

[0093] Reference now Fig.19 , an occluding device 480 having an external anchoring member 482 is shown. The external anchoring member 482 is a recaptureable body that can have a variety of shapes (e.g., straight, spiral, multi-spiral, concave, etc.). The external anchoring member 482 is formed as a relatively open structure with a minimal number of segments that form a framework that can position and secure the occluding device 480 while minimizing contact with the vessel wall. The open nature of the external anchoring member 482 has a low risk of imprisoning branch vessels or otherwise altering blood flow through the vessel.

[0094] refer to Fig. 20, an inner anchoring member 494 for an occluding device 490 according to another exemplary embodiment is shown. The inner anchoring member 494 includes a center wire 496 coupled to the cap 492 and one or more outer wires 498 coupled to the center wire 496. The outer wires 498 extend outwardly from the center wire 496 to contact the inner surface 15 of the aneurysm 10. The inner anchoring member 494 is introduced into the aneurysm 10 through the catheter 30 in a collapsed (e.g., straightened) state. Once deployed into the aneurysm 10, the catheter 30 is retracted, allowing the outer wires 498 to expand outwardly so that at least a portion of the outer wires 298 contact the inner surface 15 to position and anchor the cap 492 in the neck 16.

[0095] Reference Fig.21 , an occluding device 520 according to an exemplary embodiment is shown. The occluding device 520 is disposed in or near the neck 16 of the aneurysm 10 to disrupt or prevent blood flow between the blood vessel 12 and the interior volume 14 of the aneurysm 10, thereby reducing the likelihood of rupture of the aneurysm 10. The occluding device 520 is configured as a low profile device to minimize damage to surrounding objects such as side branches of a blood vessel. The occluding device 520 can be configured as a biodegradable or bioabsorbable material and can be configured to promote endothelialization.

[0096] The occluding device 520 includes an inner cover 522 disposed within the interior space 14 of the aneurysm 10. The inner cover 522 is configured to cover the neck 16 of the aneurysm 10. The inner cover 522 is formed of a relatively dense mesh, such as a micron mesh formed by multiple wires or fibers connected together (e.g., welded, soldered, braided, etc.). In this embodiment, the inner cover 522 is a double-layer mesh. The double-layer mesh is first formed into a mesh ball. In some embodiments, the mesh ball is collapsed into the microcatheter 30 for intravascular delivery to the aneurysm 10. When the cover 522 is released from the microcatheter 30, the push wire 32 holds the upper central portion of the mesh ball so that the mesh ball is released and expands into a hemispherical shape. The double-layer cover 522 is formed by a mesh ball, wherein a first upper portion of the ball is wrapped around and enters the second lower portion of the ball, thereby forming a double-layer hemispherical shape, so that the inner surface of the inner cover 522 includes a concave surface, such as Figure 21-22 The expanded shape of the ball depends on the distance between the upper center of the ball and the lower center of the ball, so it can be adjusted by moving the wire.

[0097] The occluding device 520 including the inner cover 522 can be similar to the above reference Figures 3A-3EThe described process is deployed within an aneurysm 20. With the distal end 34 of the catheter 30 positioned proximate the neck 16 of the aneurysm 10, the push wire 32 is moved within the lumen relative to the catheter 30. The inner cover 522 begins to emerge from the end 34 of the catheter 30 to expand into an expanded configuration within the internal volume 14. In one embodiment, the inner cover 522 appears in the form of a mesh ball. The catheter 30 and / or the push wire 32 are then retracted until the inner cover 522 is in place against the inner surface 25 of the aneurysm 10. The double layer of the inner cover 522 is formed by wrapping the top of the sphere onto the bottom, for example by withdrawing the push wire 32 until the top meets the bottom. In other embodiments, the inner cover 522 has been deployed from the catheter 30 in a double layer configuration and does not initially appear spherical.

[0098] Reference now Fig. 22 , shows an occlusion device 520 according to another exemplary embodiment, wherein the occlusion device 520 also includes an external anchoring mechanism 550. The external anchoring member 550 is coupled to and provides support for the inner cap 522, and reduces the possibility that the inner cap 522 will be removed from the neck 16 due to the fluid pressure of the blood in the blood vessel 12. In the illustrated embodiment, the external anchoring mechanism 550 is formed by two or more segments or sections (e.g., radial lobes 566) extending outward from the neck 16. Each lobes 566 can be formed by a single wire loop made of nickel-titanium alloy, polymer, or similar material. In addition to the loop, the lobes 566 can be a solid, substantially flat piece of material extending from the inner cap 522. Each lobes 566 can include a central portion 564 configured to be disposed within the neck 16 and a peripheral portion 562 configured to extend beyond the neck 16 to contact the wall 13 of the blood vessel 12. The wire loop can be formed to have a narrower portion near the central portion 564 and a wider portion near the peripheral portion 562, similar to a paddle shape. In some embodiments, the narrower portion and the wider portion each have a uniform diameter, such as Fig.23A 520 is shown in a bottom view of the occluding device 520. In other embodiments, the diameter of the ring widens continuously between the centralmost portion and the outermost portion, such as Fig. 23B 566. The lobes 566 may have other shapes and sizes in addition to those shown. The occluder 520 may have any position from two to eight lobes 566.

[0099] Return to reference Fig. 22, the lobes 566 of the occluding device 520 are coupled to the inner cap 522 at an angle 570. In some embodiments, the angle 570 formed between the side of the inner cap 522 and the plane of the radial lobes is between 15 and 45 degrees. In this way, the lobes 566 act as a clamp to engage the wall 13 of the blood vessel 12 near the neck 16 and maintain the position of the occluding device 520 in the lower portion of the aneurysm 12, near the neck 16.

[0100] refer to Fig.24 , in an exemplary embodiment, an occlusive device 620 having an inner anchoring member 640 is shown, which is disposed within an aneurysm 10. The inner anchoring member 640 is configured to anchor the inner cover 622 within the lower portion of the aneurysm 10, at or near the neck 16. The inner anchoring member 640 provides a relatively rigid body that supports the inner cover 622 and reduces the possibility of the inner cover 622 being dislodged from the neck 16 due to the fluid pressure of the blood in the blood vessel 12. According to an exemplary embodiment, the inner cover 622 is a double layer formed similar to the inner cover 522. The inner cover 622 has a peripheral portion that contacts the inner surface 15 of the aneurysm 10.

[0101] According to an exemplary embodiment, the internal anchoring member 640 includes one or more loops 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 spring-like and can be similar to the coils commonly used in endovascular coiling procedures. The internal anchoring member 640 is coupled to the inner cover 622 and includes at least one coil that contacts the inner surface 15 of the aneurysm 10. In the illustrated embodiment, the loops of the internal anchoring member 640 do not fill the entire internal volume 14 or a large portion of the internal volume 14. Instead, the internal anchoring member 640 includes only a single set of loops extending from the cover 622 like a rod. In some embodiments, the anchoring member 640 can be a soft mesh coil. In other embodiments, the anchoring member 640 can include a large number of loops that substantially fill the internal volume 14. The orientation, number, and size of the loops of the internal anchoring member 640 can vary depending on the size and shape of the aneurysm 10.

[0102] Alternatively, the inner cover 622 and the inner cover 522 may be implemented using any internal anchoring member as described in the present disclosure. Fig.24 As shown in FIG. 6 , the occlusive device 620 may include any external anchoring member as described in the present disclosure, including but not limited to external anchoring members 250 , 360 , 450 , 460 , 482 , and 550 .

[0103] refer to Fig.25, in an exemplary embodiment, an occlusion device 720 having an internal anchoring member 740 is shown. The internal anchoring member 740 is configured to anchor the inner cap 722 within the lower portion of the aneurysm 10, at or near the neck 16. The internal anchoring member 740 provides a relatively rigid body that supports the inner cap 722 and reduces the likelihood that the inner cap 722 will be dislodged from the neck 16 by the fluid pressure of the blood in the blood vessel 12. According to an exemplary embodiment, the inner cap 722 is double-layered, similar to the inner caps 522, 622. The inner cap 722 has a peripheral portion that contacts the inner surface 15 of the aneurysm 10.

[0104] According to an exemplary embodiment, the internal anchoring member 740 is similar to the internal anchoring member 640 in that the internal anchoring member 740 extends from the approximately central portion of the cover 722 like a rod. In this embodiment, unlike the internal anchoring member 640, the internal anchoring member 740 is a cylindrical rod made of a mesh material sheet. The cylindrical rod can be enclosed at the distal end of the rod that contacts the inner surface 15 of the aneurysm 10. The mesh material can be wrapped around a set of rings forming a coil or can be self-supporting. The internal anchoring member 740 can include a plurality of folds 742 forming a crease-type structure that can shrink when it is pressed against the inner surface 15 of the aneurysm 10. In some embodiments, the mesh material is a very fine, high-density wire mesh. The mesh material can be a combination of nickel-titanium alloy and filaments interlaced with metal. In some embodiments, the top 744 of the internal anchoring member 740 is covered or enclosed.

[0105] Fig.25 The internal anchoring member 740 can be constructed as a unitary structure with the cover 722. For example, the same mesh can be used to form the cover 722, with the cover 722 having an extension of the rod that forms the internal anchoring member 740. In other embodiments, the cover 722 and the internal anchoring member 740 are separate elements that are coupled or molded together.

[0106] Despite Fig.25 Not shown, but the occluding device 720 may include any external anchoring member as described in the present disclosure, including but not limited to external anchoring members 250, 360, 450, 460, 482 and 550.

[0107] refer to Fig.26A -B, in an exemplary embodiment, an inner cover 822 for an occluding device is shown. In this embodiment, the inner cover is a multi-layer inner cover 822. The inner cover 822 includes a plurality of blades 824 that are arranged overlapping each other and are individually movable. The blades 824 are arranged around the central portion of the inner cover 822. Fig.26A In the side view of FIG, the inner cover 822 is shown in a partially retracted configuration with the blades positioned closely around the central portion. Fig.26B 822 is a top view showing the inner cover in an expanded configuration, e.g., when the inner cover 822 is deployed near the neck 16 of the aneurysm 10, the blades 824 are extended or fanned out so that they extend away from the central portion of the inner cover 822. At least a portion of the blades 824 of the inner cover 822 are configured to contact the inner surface 15 of the aneurysm 10 when in the expanded configuration.

[0108] According to an exemplary embodiment, the individual blades 824 of the inner cover 822 are made of a mesh material, such as a biocompatible metal or metal alloy, such as platinum, stainless steel, titanium, titanium nickel alloy (e.g., Nitinol). The blades 824 of the inner cover 822 can be formed of a relatively dense mesh, such as a 37 micron mesh, which is formed of multiple wires or fibers that are connected or molded together. The inner cover 822 can be used in conjunction with an internal anchoring member as described elsewhere herein, including but not limited to the following description and in Fig. 27 -The internal anchoring member and central rod shown in FIG. 32.

[0109] Fig. 27 -32 respectively depict occlusive devices having similar overall structures. For example, each of the embodiments shown therein includes an inner cover (922, 1022, 1122, 1222, 1322, 1422, 1522, 1622) and an inner anchoring member (940, 1040, 1140, 1240, 1340, 1440, 1540, 1640), connected by a central rod (930, 1030, 1130, 1230, 1330, 1430, 1530, 1630). In these embodiments, the inner cover and the internal anchoring member are disks having substantially similar diameters. The central rod can be a cylinder having a diameter that is smaller than the diameter of the inner cover and the internal anchoring member. The inner cover, the internal anchoring member, and the central rod are all made of a mesh material, similar to the occlusive devices described above. In Fig. 27 In some embodiments of -32, the inner cover is made of a higher density mesh and the inner anchoring member is made of a lower density mesh.

[0110] Reference Fig. 27 -32 shows and describes various arrangements and combinations. It is contemplated that the present design is not limited to the embodiments shown, but rather Fig. 27 The various features described in -32 may be used in conjunction with each other in other combinations and arrangements. Fig. 27 Any of the embodiments shown in -32 may also be used Figures 26A-26B The illustrated multi-layer cover 822. The illustrated embodiment may also incorporate any external anchoring member, including but not limited to the external anchoring members described above (250, 360, 450, 460, 482, and 550).

[0111] Reference Fig. 27, in an exemplary embodiment, an occluding device 920 is shown, which is arranged in an aneurysm 10. The occluding device 920 has an inner cover 922 and an inner anchoring member 940 connected by a central rod 930. The central rod 930 can be a cylinder. The inner cover 922 and the inner anchoring member 940 are each generally concave, and the concave surface faces the rod 930 and faces each other. The inner cover 922, the inner anchoring member 940 and the central rod 930 can be constructed separately and connected together. In other embodiments, the three elements are formed by a single sheet and are integral. In this embodiment, the inner cover 922 and the internal anchoring mechanism 940 are both composed of a single layer disc of mesh material.

[0112] Reference Fig.28 , in an exemplary embodiment, an occluder device 1020 is shown. The occluder device 1020 has an inner cover 1022 and an inner anchoring member 1040 connected by a central rod 1030. The inner cover 1022 and the inner anchoring member 1040 are each generally concave, with the concave surface facing the rod 1030 and facing each other. The inner cover 1022, the inner anchoring member 1040 and the central rod 1030 can be constructed separately and coupled together. In other embodiments, the three elements are formed from a single sheet and are integral. Fig.28 The occlusion device 1020 differs from the occlusion device 920 in that the inner cover 1022 and the internal anchoring mechanism 1040 are both made of a double layer of mesh material, which can be formed in a manner similar to the above-mentioned inner cover 522, 622 or 722.

[0113] refer to Fig.29 , in an exemplary embodiment, an occluder device 1120 is shown. The occluder device 1120 has an inner cover 1122 and an inner anchoring member 1140 connected by a central rod 1130. The inner cover 1122 and the inner anchoring member 1140 are each generally concave, with the concave surface facing the rod 1130 and facing each other. The inner cover 1122, the inner anchoring member 1140 and the central rod 1130 can be constructed separately and coupled together. In other embodiments, the three elements are formed of a single sheet and are integral. Fig.29 The occlusion device 1120 differs from the occlusion device 920 in that the inner cover 1122 is formed of a single layer of mesh material and the internal anchoring mechanism 1140 is formed of a double layer of mesh material, which can be formed in a manner similar to the above-mentioned inner cover 522, 622 or 722.

[0114] refer to Fig.30, in an exemplary embodiment, an occluder device 1220 is shown. The occluder device 1220 has an inner cover 1222 and an inner anchoring member 1240 connected by a central rod 1230. The inner cover 1222 and the inner anchoring member 1240 are both generally concave, with the concave surfaces facing the rod 1230 and facing each other. The inner cover 1222, the inner anchoring member 1240 and the central rod 1230 can be constructed separately and coupled together. In other embodiments, the three elements are formed from a single sheet and are integral. Fig.30 The occlusion device 1220 differs from the occlusion device 920 in that the internal anchoring mechanism 1240 is formed of a single layer of mesh material, while the inner cover 1222 is formed of a double layer of mesh material, which can be formed in a manner similar to the above-mentioned inner cover 522, 622 or 722.

[0115] Reference Fig.31 , in an exemplary embodiment, an occluder device 1320 is shown. The occluder device 1320 has an inner cover 1322 and an inner anchoring member 1340, which are connected by a central rod 1330. Fig.31 The occluding device 1320 and Fig.30 The occluder device 1220 of the present invention differs in that the internal anchoring mechanism 1240 is constructed of a single layer of mesh material, while the inner cover 1222 is constructed of a double layer of mesh material, which can be formed in a similar manner to the inner cover 522, 622, or 722, however, in this embodiment, the internal anchoring mechanism 1340 is a single layer end of the central rod 1330 that is flared to form the atraumatic end 1332 of the rod 1330. In addition to the flared internal anchoring mechanism 1340 (shown as part of the occluder device 1320), the occluder device can also include a flared inner cover.

[0116] Figures 32A-32C Other modifications to the occluder device are depicted according to exemplary embodiments. Each of these figures depicts an occluder device having an inner cover and an internal anchoring mechanism connected by a central rod, similar to Figure 27-31 .exist Figures 32A-32C In the embodiment of the embodiment, it is shown that the inner cover and the internal anchoring mechanism can have variations in shape. For example, the inner cover and / or the internal anchoring mechanism can have a flat, uncurved shape. Alternatively, the inner cover and / or the internal anchoring mechanism can have an angled or curved shape. In this alternative embodiment, the inner cover and / or the internal anchoring mechanism can have a substantially flat central portion with an inclined or raised edge. As described above Fig.28 The occluder device 1020 is depicted wherein both the inner cover 1022 and the inner anchoring member 1040 are angled or curved. Fig.32A An occluder device 1420 is depicted wherein the inner cap 1422 and the inner anchoring member 1440 are both straight. Fig.32BAn occluder device 1520 is depicted in which the inner cover 1522 is angled and the inner anchoring member 1540 is straight. Fig.32C An occluder device 1620 is depicted in which the inner cap 1622 is straight and the inner anchoring member 1640 is angled.

[0117] The construction and arrangement of the elements of the aneurysm occlusion device as shown in various exemplary embodiments are illustrative only. Although only some embodiments are described in detail in the present disclosure, it will be readily understood by those skilled in the art who review the present disclosure that many modifications are possible (e.g., changes in the size, dimensions, structure, shape and proportion of various elements, changes in parameter values, changes in mounting arrangements, changes in the use of materials, changes in colors, changes in orientation, 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 may be composed of multiple parts or elements, the position of the element may be reversed or otherwise changed, and the nature or number or position of the discrete element may be changed or varied. It should be noted that the elements and / or components of the system may be composed of any 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 may be made in the design, operating conditions and arrangements of preferred and other exemplary embodiments and medical procedures.

Claims

1. A device for treating an aneurysm in a blood vessel, the device comprising: an occlusive element disposed on the wire, the occlusive element comprising a cap for covering the neck of the aneurysm and an inner anchoring member, wherein the cap is configured to expand from a compressed configuration within the tube to an expanded configuration to cover the neck of the aneurysm when pushed out from the distal end of the tube; wherein the cover comprises a double layer mesh including an inner layer folded over an outer layer such that an inner surface of the inner layer of the cover comprises a concave surface, and wherein the outer layer of the cover is configured to abut an inner surface of the aneurysm adjacent to a neck of the aneurysm; and Wherein, the inner anchoring member is coupled to and extends from the second surface of the cover and is configured to contact an inner surface of the aneurysm.

2. The device according to claim 1, wherein: The inner anchor member includes a cylindrical rod extending from a central portion of the cover.

3. The device according to claim 2, wherein: The cylindrical rod is formed from a sheet of mesh material formed into a cylindrical body.

4. The device according to claim 2, wherein: The cylindrical rod is compressible such that the rod is configured to collapse when pressed against an inner surface of the aneurysm.

5. The device according to claim 4, wherein: The cylindrical rod includes a plurality of folds forming a crease-like structure.

6. The device according to claim 2, wherein: The cylindrical rod is closed at a distal end configured to contact an inner surface of the aneurysm.

7. The device according to claim 2, wherein: The cylindrical rod surrounds one or more loops of coil.

8. The device according to claim 1, wherein: The cover and the inner anchoring member are formed from the same mesh material.

9. The apparatus of claim 1, further comprising an external anchoring member coupled to the cover and configured to be disposed within a blood vessel proximate the aneurysm.

10. A device for treating an aneurysm in a blood vessel, the device comprising: An occlusive element detachably disposed on a push wire, the occlusive element being composed of a cover for covering the neck of an aneurysm, the cover being configured to expand from a compressed structure in the catheter cavity to an expanded structure when pushed out from the distal end of the catheter, wherein the cover comprises a double-layer mesh including an inner layer folded onto an outer layer so that an inner surface of the inner layer of the cover comprises a concave surface, and wherein the cover is configured to abut against an inner surface of the aneurysm adjacent to the neck of the aneurysm and cover the neck of the aneurysm.

11. The device according to claim 10, wherein: The double-layer net is formed by mesh balls.

12. The device according to claim 10 or 11, wherein: The double-layer web includes a plurality of threads or fibers.

13. The device according to claim 12, wherein: The threads or fibers are braided together.

14. The apparatus according to claim 10 or 11, wherein: The cover is configured to be already in a double-layer configuration when it is deployed from the catheter.

15. The apparatus according to claim 10 or 11, wherein: The cover is biased toward the expanded configuration.

16. The apparatus according to claim 10 or 11, wherein: The cover has a thickness of less than 100 microns.

17. The apparatus according to claim 10 or 11, wherein: The cap in the expanded configuration has a cap diameter that is greater than a diameter of the aneurysm neck.

18. The apparatus according to claim 10 or 11, wherein: The occlusive device is configured to promote endothelialization.

19. The apparatus according to claim 10 or 11, wherein: The occlusive device is configured to be biodegradable or bioabsorbable.

20. The apparatus according to claim 10 or 11, wherein: The mesh comprises a dense micron mesh.

21. The apparatus according to claim 10 or 11, wherein: The blocking element is electrically detachable from the push wire.

22. The apparatus according to claim 10 or 11, wherein: The occluding element is mechanically detachable from the push wire.

23. The apparatus according to claim 10 or 11, wherein: The occluding element is configured to slide off the push wire.

24. The apparatus according to claim 10 or 11, wherein: The cover comprises metal.

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