阅读说明：本技术 治疗动脉瘤的系统和方法 (Systems and methods for treating aneurysms ) 是由 A·巴德尔丁 E·L·R·佩雷拉 T·J·乌尔夫 O·O·扎达特 于 2019-01-17 设计创作，主要内容包括：用于治疗血管中的动脉瘤的设备,包括布置在线材上的闭塞元件,该闭塞元件包括用于覆盖动脉瘤的颈部的盖以及内部锚固构件。盖被构造成当从管的远端推出时,从管中的压缩构造扩展到扩展构造,以覆盖动脉瘤的颈部。盖包括形成为半球的网状材料的球体,该半球包括通过将球体的顶部折叠到球体的底部中而形成的两层网。内部锚固构件联接至盖的第二表面并从盖的第二表面延伸,并且构造成接触动脉瘤的内表面。内部锚固构件可以是从盖的中央部分延伸的圆柱形杆。(An apparatus for treating an aneurysm in a blood vessel includes an occlusion element disposed on a wire, the occlusion element including a cap for covering a neck of the aneurysm and an internal anchoring member. The cap is configured to expand from a compressed configuration in the tube to an expanded configuration to cover a neck of the aneurysm when pushed out of the distal end of the tube. The cover comprises a sphere of mesh material formed into a hemisphere comprising two layers of mesh formed by folding the top of the sphere into the bottom of the sphere. The internal anchoring member is coupled to and extends from the second surface of the cap and is configured to contact an inner surface of the aneurysm. The inner anchoring member may be a cylindrical rod extending from a central portion of the cap.)

1. Apparatus for treating an aneurysm in a blood vessel, the apparatus comprising:

an occlusion element disposed on the wire, the occlusion element comprising a cap for covering a neck of an aneurysm and an internal anchoring member,

wherein the cap is configured to expand from a compressed configuration in the tube to an expanded configuration to cover a neck of the aneurysm when advanced out of the distal end of the tube;

wherein the cover comprises a ball of mesh material formed into a hemisphere comprising two layers of mesh formed by folding the top of the ball to the bottom of the ball; and is

Wherein the internal anchoring member is coupled to and extends from the second surface of the cap and is configured to contact an inner surface of the aneurysm.

2. The apparatus of claim 1, wherein the internal anchoring member comprises a cylindrical rod extending from a central portion of the cap.

3. The apparatus of claim 2, wherein the cylindrical rod is formed from a sheet of mesh material formed into a cylindrical body.

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

5. The apparatus of claim 4, wherein the cylindrical rod comprises a plurality of folds forming a creased structure.

6. The apparatus of claim 2, wherein the cylindrical rod is enclosed at a distal end configured to contact an inner surface of the aneurysm.

7. The apparatus of claim 2, wherein the cylindrical rod surrounds one or more loops of a coil.

8. The apparatus of claim 1, wherein the cover and the internal anchor member are formed from the same mesh material.

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

10. Apparatus for treating an aneurysm in a blood vessel, the apparatus comprising:

an occlusion element disposed on the wire, the occlusion element comprising a cap for covering a neck of the aneurysm, an internal anchoring member for contacting an inner surface of the aneurysm, and a central rod connecting the cap and the internal anchoring member;

wherein the occlusion element is coupled to the wire on an outer surface of the cap.

Wherein the cap and the internal anchoring member are configured to expand from a compressed configuration disposed in a tube to an expanded configuration to be positioned within the aneurysm when advanced out of the distal end of the tube; and is

Wherein the cap and the inner anchoring member have substantially similar diameters, and wherein the diameter of the central rod is smaller than the diameters of the cap and the inner anchoring member.

11. The apparatus of claim 10, wherein the cover and the inner anchor member each comprise a disc.

12. The apparatus of claim 11, wherein the cover and the internal anchoring member are flat.

13. The apparatus of claim 11, wherein the cap and the internal anchoring member are concave, having a concave surface facing the center rod, such that the center rod extends between an inner surface of the first cap and an inner surface of the internal anchoring member.

14. The apparatus of claim 11, wherein one of the cap and the internal anchoring member is flat, and wherein the other of the cap and the internal anchoring member is concave.

15. The apparatus of claim 10, wherein the cap, the internal anchoring member, and the central rod are formed from a unitary sheet of mesh material.

16. The device of claim 10, wherein the cap, the internal anchoring member, and the central rod are formed from separate pieces of mesh material and are bonded together to form the occlusion element.

17. The apparatus of claim 10, wherein at least one of the cover and the internal anchoring member comprises two layers of mesh material.

18. The apparatus of claim 17, wherein at least one of the cover and the internal anchoring member comprising two layers of mesh material is formed by folding a top portion of a mesh ball into a bottom portion of the mesh ball to form a two-layer hemisphere.

19. The apparatus of claim 10, wherein the center rod comprises a cylinder.

20. The apparatus of claim 10, wherein the cover is made of a mesh material having a first density and the internal anchoring member is made of a mesh material having a second density less than the first density.

Background

An aneurysm is an abnormal bulging or weakening of a blood vessel, usually an artery, and can have many complications. A vessel bulge can damage or apply pressure to surrounding tissue. In the brain, this may lead to various side effects, such as impaired vision, impaired speech, impaired balance ability, and the like. In addition, the volume of aneurysm formation does not follow the main flow path of blood through the blood vessel. Thus, it can serve as a site of blood stasis and, due to the swirling vortex, can contribute to the formation of a thromboembolism. If the aneurysm ruptures, severe internal bleeding can result.

Aneurysms can be treated externally by 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 can result in trauma and other side effects to adjacent tissue.

Aneurysms may also be treated by intravascular procedures. In one procedure, a detachable length of wire (e.g., a coil) is inserted into the interior volume of an aneurysm using a catheter. The coil is intended to fill the volume of the aneurysm to reduce blood flow into the aneurysm, cause stasis of blood flow and stimulate clotting within the aneurysm. In the case of large cerebral aneurysms, filling the aneurysm with multiple coils can lead to a mass effect, possibly causing brain swelling, and become an independent cause of new symptoms. In another procedure, for aneurysms with large necks, the auxiliary use of a stent helps to keep the coil inside the aneurysm. This approach has contraindications in treating ruptured aneurysms due to the need for additional antithrombotic drugs. In another procedure, the coil is held in the volume of the aneurysm using a temporary balloon that expands in the vessel. Once the quality of the coil is ensured, the balloon is deflated and removed. In yet another procedure, a stent device is placed in an artery to facilitate blood flow through an aneurysm. This leads to blood stagnation within the aneurysm and thrombosis within the volume of the aneurysm. However, the side branch of the aorta in which the stent device is placed may become trapped or "banned," which may prevent it from entering the side branch. In other cases, the side branch can become occluded, possibly leading to a stroke. In addition, such procedures often require the use of additional antithrombotic agents, which limits the use of such devices in the treatment environment of ruptured aneurysms. Stent devices are typically formed with a relatively tight weave. While the tight weave increases the effectiveness of the stent device in diverting blood flow, it also hinders or prevents access to the aneurysm or volume of the inhibited artery. In the event that the aneurysm is unable to coagulate, occlusion of the aneurysm by the stent device prevents the possibility of placing an embolic device inside the aneurysm. Other procedures, such as placing other stents or performing open surgery to dispose of the residue, may then be required.

All procedures involving packaging aneurysm volumes suffer from several common drawbacks. 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. Further, the coils may be compacted over time to occupy a smaller percentage of the total volume of the aneurysm. Sufficient compaction of the coil may be considered a recurrence of the aneurysm and may require further treatment.

It would be advantageous to provide improved systems and methods for treating aneurysms.

Summary of The Invention

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

One embodiment relates to a device for treating an aneurysm in a blood vessel, the device comprising an occlusion element disposed on a wire. The occlusion element comprises: a cap for covering the neck of the aneurysm; an internal anchoring member for contacting an inner surface of the aneurysm; and a central rod connecting the cap and the internal anchoring member. The occlusive element is coupled to the wire on an outer surface of the cap. The cap and the internal anchoring member are configured to expand from a compressed configuration disposed in the tube to an expanded configuration for positioning within the aneurysm when advanced out of the distal end of the tube. The cap and the inner anchor member have substantially similar diameters, and wherein the diameter of the central rod is less than the diameters of the cap and the inner anchor member.

One embodiment relates to a device for treating an aneurysm in a blood vessel, the device comprising an occlusion element disposed on a wire. The occlusion element includes a cap for covering the neck of the aneurysm and an internal anchoring member. The cap is configured to expand from a compressed configuration in the tube to an expanded configuration to cover a neck of the aneurysm when pushed out of the distal end of the tube. The lid includes a double-layer web including an inner layer folded over an outer layer such that an inner surface of the inner layer of the lid includes a concave surface. The internal anchoring member is directly coupled to and extends from the inner surface of the cap and is configured to contact the inner surface of the aneurysm.

The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Alternative exemplary embodiments relate to other features and combinations of features that may be recited generally in the claims.

Drawings

These and other features, aspects, and advantages of the present invention will become apparent from the following description, which is briefly described below, the appended claims, and the appended exemplary embodiments shown in the drawings.

Fig. 1 is a schematic cross-sectional side view of an aneurysm, the intravascular device configured to occlude the aneurysm, according to an exemplary embodiment.

Fig. 2 is a schematic cross-sectional bottom view of the aneurysm occlusion device of fig. 1.

Fig. 3A-3E are schematic side cross-sectional views of a catheter deploying the aneurysm occlusion device of fig. 1 according to an exemplary embodiment.

Fig. 4 is a schematic cross-sectional side view of an aneurysm, the intravascular device configured to occlude the aneurysm, according to another exemplary embodiment.

Fig. 5 is a schematic cross-sectional view of the occluding device of fig. 4 inside a catheter according to an exemplary embodiment.

Fig. 6 is a schematic cross-sectional side view of an aneurysm, the intravascular device configured to occlude the aneurysm, according to another exemplary embodiment.

Fig. 7 is a schematic cross-sectional side view of an aneurysm, the intravascular device configured to occlude the aneurysm, according to another exemplary embodiment.

Fig. 8 is a schematic cross-sectional side view of an aneurysm, the intravascular device configured to occlude the aneurysm, according to another exemplary embodiment.

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

Fig. 10 is a schematic cross-sectional view of the occluding device of fig. 7 inside a catheter according to an exemplary embodiment.

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

Fig. 12 is a schematic cross-sectional bottom view of an aneurysm occlusion device according to an exemplary embodiment.

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

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

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

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

Fig. 17 is a schematic bottom view of an outer anchor member for an aneurysm occlusion device according to an exemplary embodiment.

Fig. 18A is a schematic top view of a cap for an aneurysm occlusion device according to an exemplary embodiment.

Fig. 18B is a schematic side view of the lid of fig. 18A in a partially folded configuration.

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

Fig. 20 is a schematic cross-sectional side view of an aneurysm, the intravascular device configured to occlude the aneurysm, according to another exemplary embodiment.

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

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

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

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

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

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

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

Fig. 26B is a schematic top view of the aneurysm occlusion device of fig. 26A according to an exemplary embodiment.

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

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

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

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

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

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

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

Fig. 32C is a schematic side view of an aneurysm occlusion device according to an exemplary embodiment.

Detailed Description

Referring generally to fig. 1-14, an aneurysm occlusion device configured to treat an aneurysm 10 is illustrated, according to some exemplary embodiments. The aneurysm 10 is an outwardly extending bulge in a wall 13 of a blood vessel 12 and has an interior volume 14 in fluid communication with the blood vessel 12 through an opening at a neck 16. An aneurysm 10 may occur at a portion of a wall 13 of a blood vessel 12 weakened by disease or trauma. In one embodiment, the aneurysm 10 may be along an artery, such as a cranial artery (e.g., basilar artery, middle cerebral artery, etc.). As shown, the aneurysm 10 is merely exemplary, and it should be understood that the occluding devices described herein may be used to treat aneurysms of various sizes and locations. For example, the aneurysm 10 may be located between two branches of a blood vessel.

Referring to fig. 1-3E, an occluding device 20 according to one exemplary embodiment is shown, the occluding device 20 being disposed in the neck 16 of an aneurysm 10 to interrupt or stop blood flow between a blood vessel 12 and an interior volume 14 of the aneurysm, thereby reducing the likelihood of rupture of the aneurysm 10. The occluding device 20 is configured as a low profile device to minimize damage to surrounding objects, such as the side branch 18 of the blood vessel 12. The occluding device 20 may be configured as a biodegradable or bioabsorbable material and may be configured to promote endothelialization.

The occluding device 20 includes an inner cover 22 (e.g., a plate, membrane, etc.) configured to be disposed within the interior volume 14 of the aneurysm 10. At full expansion, the outer diameter of the inner cap 22 is greater than the diameter of the neck 16. The inner cover 22 is a thin, flexible, concave body that can deform (e.g., collapse) for insertion through the neck 16 into the interior volume 14 of the aneurysm 10 (e.g., through catheterization) and open to at least partially occlude the neck 16. As used herein, concave is intended to describe any body that is contoured to have a void or cavity along one side. As shown in fig. 1, in one exemplary embodiment, the inner cover 22 may be generally dome-shaped. In another embodiment, the inner cap 22 may have another concave shape (e.g., conical) disposed in the neck 16 and opening into the interior volume 14. In one embodiment, the cover 22 may be disc-shaped.

The inner cover 22 is formed of a flexible (e.g., soft) biocompatible material that can collapse into a microcatheter for intravascular delivery to the aneurysm 10. The flexibility of the inner cover 22 allows 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 cover 22 to the tissue of the aneurysm 10 and the formation of new tissue to close the neck 16.

The inner cover 22 may be sized to fit a particular aneurysm 10. As shown in fig. 1-2, the inner cover 22 has a diameter greater than the diameter of the neck 16 such that a peripheral portion 24 of the inner cover 22 contacts the inner surface 15 of the aneurysm 10. The flexibility of the inner cover 22 allows the inner cover 22 to be relatively large in size relative to the size of the neck 16 without damaging (e.g., rupturing) the aneurysm 10. For example, an inner cap of about 5mm in diameter may be used to occlude an aneurysm having a neck of up to 4mm in diameter; an inner cap having a diameter of about 8mm may be used to occlude an aneurysm having a neck with a diameter of 4-6 mm; and an inner cap of about 12mm diameter can be used to occlude an aneurysm having a neck of 6-10mm diameter.

In one embodiment, the inner cover 22 may be formed from a biocompatible metal or metal alloy, such as platinum, stainless steel, titanium, a titanium-nickel alloy (e.g., nitinol). For example, the inner cover 22 may be a concave disk formed from sheet nitinol. The nitinol alloy may be configured to undergo a second 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 the desired flexibility. In another embodiment, the inner cover 22 may be formed as a relatively dense mesh, such as a 37 micron mesh, formed from a plurality of wires or fibers that are coupled together (e.g., welded, soldered, woven, etc.).

In another embodiment, the inner cover 22 may be formed from a biocompatible polymer, such as Polytetrafluoroethylene (PTFE), modified polyurethane, silicone, or other suitable polymer. In other exemplary embodiments, the inner cover 22 may be formed of a metal or alloy coated with a polymer (e.g., parylene, PTFE, PFE, etc.) to increase lubricity and biocompatibility and reduce thrombogenicity. The inner cover 22 may be formed as a solid sheet or film, or may be a relatively dense mesh. In some embodiments, the inner cover 22 may comprise a laser-drilled nylon sheet to provide a matrix for endothelialization while reducing the volume of the segments. Another embodiment may involve two-pass 3D printing of a photonic polymeric or biocompatible material to form the inner cover 22 directly onto the delivery system, or to cover a skeletal frame attached to the delivery system, allowing the final shape of the inner cover 22 to be customized at the time of processing.

Referring now to fig. 3A-3D, deployment of the inner cover 22 through the catheter 30 is shown according to an exemplary embodiment. Referring to fig. 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 into the interior volume 14 of the aneurysm 10 or a portion of the blood vessel 12 proximate the neck 16. The push wire 32 is located within a lumen formed in the catheter 30. Catheter 30 may have a single lumen or push wire 32 may be located within one of a plurality of lumens formed within catheter 30. The inner cap 22 is coupled to the distal end 36 of the push wire 32 and is received 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 with the push wire 36. Referring to FIG. 3B, the push wire 32 moves within the lumen relative to the catheter 30 until the inner cover 22 begins to emerge from the end 34 of the catheter 30. The inner cover 22 is configured to expand (e.g., due to an internal spring force of the inner cover 22) into an expanded configuration within the interior volume 14 as it clears the end 34 of the conduit 30. The push wire 32 may be moved relative to the catheter 30 by holding the catheter 30 stationary while the push wire 32 is advanced (e.g., pushed), by holding the push wire 32 stationary and retracting the catheter 30 (e.g., unsheathing), or by a combination of the movement of the catheter 30 and the push wire 32. The inner cover 22 may be partially deployed within the blood vessel 12 or within the aneurysm 10 with the distal end 34 of the catheter 30.

Referring to fig. 3C, the distal end 34 of the catheter 30 is advanced into the interior volume 14 of the aneurysm 10 prior to fully deploying the inner cover 22 from the catheter 30. Referring to fig. 3D, as the inner cover 22 is deployed from the catheter 30, the catheter 30 and/or push wire 32 are retracted until the inner cover 22 is seated against the inner surface 15 of the aneurysm. Referring to fig. 3E, the distal end 36 of the push wire 32 is separated from the inner cover 22 such that the catheter 30 and the push wire 32 can be withdrawn from the blood vessel 12 while the inner cover 22 remains in the neck 16 or lower portion of the aneurysm 10. The push wire 32 may be removed from the inner cover 22 by any suitable electrical or mechanical cutting device. Alternatively, the inner cap 22 may be removed by retracting the wire 32, causing the inner cap 22 to engage the distal end of the tube 30 and slide down the wire 32.

In one embodiment, the inner cover 22 may be formed to be biased toward the open, expanded position. In another embodiment, the inner cap 22 may include a mesh supported by rib members or splines radiating outwardly from the center of the inner cap 22. In one embodiment, the rib members or splines may be biased toward the open position. In one embodiment, the rib members and splines operate in an inverted umbrella mode of operation and lock in the fully open position once the fully open position is reached.

Referring now to fig. 4-5, an occluding device 120 is shown according to an exemplary embodiment, the occluding device 120 being deployed in the lower portion of an aneurysm 10 to disrupt or stop blood flow between a blood vessel 12 and an interior volume 14 of the aneurysm, thereby reducing the likelihood that the aneurysm 10 will rupture. The occluding device 120 is configured as a low profile device to minimize damage to the surrounding body (e.g., the side branch 18 of the blood vessel 12). The occluding device 120 may be configured as a biodegradable or bioabsorbable material and may be configured to promote endothelialization.

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

According to an exemplary embodiment, the inner anchor member 140 includes one or more loops of wire coil formed from a suitable biocompatible metal or alloy (e.g., platinum, stainless steel, nitinol, etc.). The metal coil may be similar to coils commonly used in intravascular winding procedures. The inner anchor 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 substantial portion of the internal volume 14. Instead, the inner anchor member 140 may include only a small number of loops. In one exemplary embodiment, the inner anchor member 140 may comprise a single loop of wire. In another embodiment, the anchor member 140 comprises a plurality of loops that substantially fill the interior volume 14. The orientation, number, and size of the loops of the inner anchor member 140 may vary depending on the size and shape of the aneurysm 10.

Referring now to fig. 5, the inner cover 122 and the inner anchor member 140 are shown disposed within the catheter 30 according to an exemplary embodiment. An inner cap 122 is coupled to the distal end 36 of the push wire 32 and is received within the lumen of the catheter 30 in a collapsed configuration. In the collapsed configuration, the peripheral portion 124 of the inner cover 122 is upstream (e.g., closer to the distal end 34) than the central portion 126 that couples the push wire 36 on the first surface 144. The inner anchor member 140 is coupled to a second surface 146 of the inner cap 122 opposite the first surface 142 and is disposed within the lumen of the catheter 30 upstream of the inner cap 122.

Similar to the process described above with reference to fig. 3A-3E, the occluding device 120 including the inner cover 122 and the inner anchor 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 moves intraluminally relative to the catheter 30. The push wire moves to cause the anchor member 140 to reach the interior volume 14 and coil within the interior volume 14.

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 wire) to facilitate coiling within 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.

After completion of the coiling of the anchor member 140, 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 cover 122 begins to emerge from the end 34 of the catheter 30 to expand into the expanded configuration within the interior space 14. The catheter 30 and/or push wire 32 is then retracted until the inner cover 122 abuts 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 detached from the first surface 146 of the inner cover 122 such that with the inner anchor member 140 coupled to the second surface 146, the catheter 30 and the push wire 32 can be withdrawn from the blood vessel 12 while the inner cover 22 remains in the neck 16 or lower portion of the aneurysm 10.

Referring to fig. 6, in an exemplary embodiment, the anchor member 140 may have a variable stiffness. For example, the inner anchor member 140 may be relatively flexible at the proximal end 146 and relatively stiff at the distal end 148. The relatively stiff distal end 148 may be configured to provide additional support to strengthen the wall of the aneurysm 10. The relatively stiff portion of the inner anchor member 140 may serve as a framing member to create a structure in the interior volume 14 of the aneurysm, while the more compliant portion serves to fill the interior volume of the aneurysm and support the inner cover 122. The stiffness of the inner anchor member 140 may be controlled in various ways, such as by varying the thickness of the coil, the radius of the coil, and/or by varying the material used to form the coil.

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

In one embodiment, the stiffness of the inner anchor member 140 may transition smoothly or incrementally along the length of the inner anchor member 140 between the distal end 148 and the proximal end 146. In other exemplary embodiments, the inner anchor member 140 may include two or more distinct regions or portions, each region or portion having a different stiffness or other characteristic. The inner anchor member 140 may include markings or other indicators to delineate the transition from one region to another. In one embodiment, the indicators can be external, such as an indicator disposed on an outer shaft coupled 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 a radiopaque indicator (e.g., a platinum coating) on the inner anchor member 140 between the regions.

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

Referring now to fig. 7-10, an occluding device 220 according to an exemplary embodiment is shown, the occluding device 220 being disposed in the lower portion of the aneurysm 20 proximate to 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 likelihood of rupture of the aneurysm 20. The occluding device 220 is configured as a low profile device to minimize damage to surrounding bodies, such as the side branch 28 of the blood vessel 22. The occluding device 220 may be configured as a biodegradable or bioabsorbable material and may be configured to promote endothelialization.

The occluding device 220 includes an inner cover 222 (e.g., a plate, 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 occluding device 220 also includes an inner anchoring member 240 that is disposed within the aneurysm 10 and similar to the inner anchoring member 140 described above. The internal anchoring member 240 is configured to anchor the internal cover 222 within the aneurysm 20 near or at the neck 16. The occluding device 220 also includes an outer anchor member 250, the outer anchor member 250 being disposed within the vessel 12 proximate the aneurysm 10. The outer anchor member 250 provides a relatively rigid body that supports the inner cap 222 and reduces the likelihood of the inner cap 222 becoming dislodged from the neck 16 due to the fluid pressure of the blood in the vessel 12.

Referring to fig. 7, according to an exemplary embodiment, the outer anchor member 250 includes a loop 252 of a coil formed from a suitable biocompatible metal or alloy (e.g., platinum, stainless steel, nitinol, etc.). The metal coil may be similar to coils commonly used in intravascular winding procedures. In one embodiment, the ring 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 flow of blood through the blood vessel 12. In one embodiment, multiple coils or loops 252 may be used.

Referring to fig. 8, according to an exemplary embodiment, the outer anchor member 250 includes a first loop 254 and a second loop 256. The loops 254 and 256 may be loops of a coil formed from a suitable biocompatible metal or alloy (e.g., platinum, stainless steel, nitinol, etc.). At least one of the loops 254 and 256 is coupled to the inner cap 222 and contacts the wall 13 of the blood vessel 12. First loop 254 extends around the inner circumference of blood vessel 12 such that it is oriented perpendicular to the flow of blood through blood vessel 12. The second ring 256 is oriented parallel to the flow of blood through the blood vessel 12. The second loop 256 is formed of a coil of smaller diameter that does not substantially obstruct the passage of blood through the blood vessel. In other embodiments, the outer anchor member 250 may include more than two loops. The orientation, number and size of the loops may vary depending on the size and shape of the blood vessel 12.

Referring to fig. 9, according to another exemplary embodiment, the outer anchor member 250 includes a stent 258 formed from a suitable biocompatible metal or alloy (e.g., platinum, stainless steel, nitinol, etc.) or a suitable biocompatible polymer. The stent 258 is introduced in a collapsed state through the catheter 30 into the blood vessel 12, adjacent the aneurysm 10. Once deployed into the vessel 12, the stent 258 expands to engage against the wall of the vessel 12. The stent 258 may be self-expandable or may be expanded using other means, such as an inflatable balloon. All or a portion of the stent 258 may 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).

The stent 258 is not intended to occlude the neck 16 of the aneurysm 10, but rather is formed into a structure to facilitate placement and anchoring of the inner cover 222. Thus, the stent 258 need not be as wide as the neck 16 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 anchor member 250 will damage surrounding objects such as the side branch 18 of the blood vessel 12. In addition, the stent 258 may have a relatively open configuration that is not dense, has a variable cell morphology, and may extend proximally in the vessel 12 from the neck 16. In other embodiments, the support 258 may be a solid member, such as a band formed of a metal or alloy having a relatively thin thickness.

In another embodiment, the external anchoring member 250 may 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 external anchoring member may be a balloon that expands in the vessel 12 near the aneurysm to provide a temporary structure to support the inner cover 222.

Referring now to fig. 10, the inner cap 222, the inner anchor member 240, and the outer anchor member 250 are shown disposed within the catheter 30, according to an exemplary embodiment. An outer anchor member 250 is coupled to the distal end 36 of the push wire 32 and is received within the lumen of the catheter 30 in a collapsed configuration. The outer anchor member 250 is coupled to an inner cap 222, the inner cap 222 being received in a collapsed configuration in the lumen of the catheter 30 upstream of the outer anchor member 250. The outer anchor member 250 may be coupled to the inner cap 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 internal 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.

Similar to the process described above with reference to fig. 3A-3E, the occluding device 220, including the inner cover 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 moves intraluminally relative to the catheter 30. The inner anchoring member 240 is pushed out of the catheter and into the interior volume 14, contacting the inner surface 25 of the aneurysm 20 in the interior volume 14. The push wire 32 is further moved until the inner cover 222 begins to emerge from the end 34 of the catheter 30 to expand into the expanded configuration within the interior volume 14. The catheter 30 and/or push wire 32 is then retracted until the inner cover 222 is in place against the inner surface 25 of the aneurysm 20 and held in place by the internal anchoring member 240. The push wire 32 is further moved until the outer anchor member 250 comes out of the catheter 30. The outer anchor member 250 may be, for example, one or more of the rings 252, 254, or 256, or the stent 258. The distal end 36 of the push wire 32 is separated from the outer anchor member such that with the inner anchor member 240 coupled to the second surface 246 and the outer anchor 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 adjacent to or within the neck 16 of the aneurysm 20. In other embodiments, the push wire 32 may be coupled directly to the inner cap 222, and the outer anchor member 250 may be deployed separately (e.g., separately from another catheter).

Referring now to fig. 11-14, an occluding device 320 according to an exemplary embodiment is shown deployed in the neck 16 of an aneurysm 10 to disrupt or stop blood flow between a blood vessel 12 and the interior volume 14 of the aneurysm, thereby reducing the likelihood of rupture of the aneurysm 10. The occluding device 320 is configured as a low profile device to minimize damage to surrounding objects such as the side branch 18 of the blood vessel 12. The occluding device 320 may be configured as a biodegradable or bioabsorbable material and may be configured to promote endothelialization.

The occluding device 320 includes an inner cover 322 (e.g., a plate, membrane, etc.) that is disposed within the interior volume 14 of the aneurysm 10 and is 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 adjacent the aneurysm 10. The outer lid 360 may be coupled to the inner lid 322, providing a relatively rigid body to support the inner lid. Outer cap 360 reduces the likelihood that inner cap 322 will become dislodged from neck 16 by the fluid pressure of the blood in vessel 32. The outer cap 360 may be utilized in place of or in addition to other means, such as the inner anchoring member 140 or the outer anchoring member 250, to secure the inner cap 322 in the neck 16.

Referring to fig. 11, according to an exemplary embodiment, the outer cover 360 is a relatively thin member (e.g., plate, sheet, etc.) formed from a suitable biocompatible material or polymer (e.g., PTFE, etc.) such as a metal or alloy (e.g., platinum, stainless steel, nickel-titanium alloy, 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 body that does not substantially obstruct 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 may be integrally formed with the inner cover 322 or may be coupled to the inner cover 322 (e.g., by a suitable adhesive). All or a portion of outer cover 360 may be coated or covered with a radiopaque material, such as platinum, to allow visualization of outer cover 360 (e.g., during and after placement of outer cover 360). In an embodiment, the outer cap 360 is attached to the inner cap at a central region of less than the area of 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.

The outer cap 360 is not intended to occlude the neck 16 of the aneurysm 10, but rather is formed with structure to facilitate anchoring of the inner cap 322. Thus, the outer cap 360 need not completely cover the neck 16. Accordingly, the outer cap 360 may be shaped such that a portion of the neck 16 is uncovered and/or may be formed from a porous material (e.g., a mesh). Referring to fig. 12, in one embodiment, the outer cap 360 may be a sheet that completely covers the neck 16 such that the peripheral portion 362 of the outer cap 360 extends around the entire neck 16.

Referring to fig. 13, in another embodiment, the outer cap 360 may include a plurality of segments or sections, such as radial lobes 366 extending outwardly from the neck 16. Each lobe 366 may include a central portion 364 disposed within neck 16 and a peripheral portion 362 extending beyond neck 16 to contact wall 13 of vessel 12.

Referring to fig. 14, in another embodiment, the outer cover 360 can include a spiral 368. The inner loop of the screw 368 may form the central portion 364 and the outer loop of the screw 368 may form the peripheral portion 362.

Outer cover 360 may be deployed from the catheter following the same procedure as inner cover 322. Accordingly, outer cap 360 may be configured to be collapsible so that it may be coupled to inner cap 322 and contained within a catheter. Outer cover 360 may be configured such that, within the conduit, central portion 364 is coupled to inner cover 322 and positioned upstream of peripheral portion 362. The inner cover 322 may be deployed as described with reference to fig. 3A-D. Once the inner cap 322 is deployed from the catheter and positioned in the neck 16, the push wire of the catheter may 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 may be coupled directly to the inner cap 322, and the outer cap 360 may be separately deployed (e.g., separately deployed from another catheter).

Referring now to fig. 15-16, an occluding device 420 according to an exemplary embodiment is shown deployed in a lower portion of an aneurysm 10, such as the neck 16. The occluding device 420 includes an inner cover 422 (e.g., a plate, membrane, etc.), the inner cover 422 being disposed within the interior volume 14 of the aneurysm 10. The occluding 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 anchor member 440 includes one or more struts or arms formed from a suitable biocompatible metal or alloy (e.g., platinum, stainless steel, nitinol, etc.). The inner anchor 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 anchor member 440 may be used to facilitate positioning of the inner cover 422 in an aneurysm 10 having a relatively wide neck 16. The struts or arms of the internal anchoring member 440 do not fill the entire internal volume 14 or a substantial portion of the internal volume 14. As the size of the aneurysm 10 shrinks as the blood 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 anchor member 440 may vary depending on the size and shape of the aneurysm 10. The arms of the inner anchor member 440 may be configured to collapse together for delivery through a microcatheter, similar to microcatheter 30 described above.

Still referring to fig. 15-16, the outer anchor 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 vessel 12. The outer anchor member 450 is formed of a suitable biocompatible metal or alloy (e.g., platinum, stainless steel, nitinol, etc.) or a suitable biocompatible polymer. All or a portion of the outer anchor member 450 may be coated or covered with a radiopaque material, such as platinum, to allow visualization of the outer anchor member 450 (e.g., during and after placement of the outer anchor member 450). The outer anchor member 450 is introduced through a catheter in a collapsed (e.g., straightened) state to the vessel 12 proximate the aneurysm 10. Once deployed into the vessel 12, the outer anchor member 450 expands such that at least a portion of the outer anchor member presses against the wall of the vessel 12. The outer anchor member 450 may be formed as a single continuous helix, with the loops of the helix being formed to have variable properties (e.g., diameter, thickness, flexibility, etc.). For example, the first portion 452 may be formed as a flexible coil having a relatively small diameter, while the second portion 454 may be formed as a coil having a larger relative stiffness that provides an increased outward radial force to facilitate positioning of the outer anchor member 450 along the wall of the vessel 13.

Referring to fig. 17, according to another exemplary embodiment, portions of the outer anchor member 460 may be formed as a double helix. According to other exemplary embodiments, the outer anchor member may be formed in a variety of other shapes (e.g., a web, star, etc.) to provide desired flexibility and support for the inner cover at the neck of the aneurysm.

Referring to fig. 18A-18B, according to another exemplary embodiment, an inner cap 470 for an occlusion device may be a star-shaped body. The inner lid 470 may be formed (e.g., creased, scored, molded) to fold and collapse along a predetermined fold line.

Referring now to fig. 19, an occluding device 480 with an outer anchoring member 482 is shown. The outer anchor member 482 is a recapturable body that can have various shapes (e.g., straight, helical, multi-helical, concave, etc.). The outer anchor member 482 is formed as a relatively open structure having a minimum 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 outer anchor member 482 has a low risk of occluding a branch vessel or otherwise altering blood flow through the vessel.

Referring to fig. 20, an internal anchoring member 494 is shown for an occlusion device 490 according to another exemplary embodiment. The internal anchoring member 494 includes a centerline 496 coupled to the cap 492 and one or more external wires 498 coupled to the centerline 496. The outer wire 498 extends outward from the center line 496 to contact the inner surface 15 of the aneurysm 10. The inner anchor 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 withdrawn, allowing the outer wire 498 to expand outward such that at least a portion of the outer wire 298 contacts the inner surface 15 to position and anchor the cap 492 in the neck 16.

Referring to fig. 21, an occluding device 520 is shown according to an exemplary embodiment. 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 the blood vessel. The occluding device 520 may be configured as a biodegradable or bioabsorbable material and may be configured to promote endothelialization.

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 cap 522 is formed from a relatively dense mesh, such as a micro-mesh formed from a plurality of wires or fibers that are coupled together (e.g., welded, soldered, woven, etc.). In this embodiment, the inner cover 522 is a two-layer web. The double net is first formed into a net-like ball. In some embodiments, the mesh ball collapses into the microcatheter 30 for intravascular delivery to the aneurysm 10. When the cap 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-layered cap 522 is formed from a mesh-like ball, wherein a first upper portion of the ball wraps over and into a second lower portion of the ball, thereby forming a double-layered hemispherical shape such that the inner surface of the inner cap 522 includes a concave surface, as shown in fig. 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 and can therefore be adjusted by moving the wire.

The occluding device 520 including the inner cover 522 may be deployed within the aneurysm 20 similar to the process described above with reference to fig. 3A-3E. With the distal end 34 of the catheter 30 positioned proximate the neck 16 of the aneurysm 10, the push wire 32 moves intraluminally relative to the catheter 30. The inner cover 522 initially emerges from the end 34 of the conduit 30 to expand into an expanded configuration within the interior volume 14. In one embodiment, the inner cap 522 is in the form of a mesh ball. The catheter 30 and/or push wire 32 is then retracted until the inner cap 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 globe over the bottom, such as by withdrawing the push wire 32 until the top and bottom meet. In other embodiments, the inner cover 522 has been deployed from the catheter 30 in a double-layered configuration and does not initially appear to be spherical.

Referring now to fig. 22, an occluding device 520 is shown according to another exemplary embodiment, wherein the occluding device 520 further comprises an external anchoring mechanism 550. The outer anchor member 550 is coupled to and provides support to the inner cap 522 and reduces the likelihood that the inner cap 522 will dislodge from the neck 16 due to the fluid pressure of the blood in the vessel 12. In the illustrated embodiment, the external anchoring mechanism 550 is formed from two or more segments or sections (e.g., radial lobes 566) extending outwardly from the neck 16. Each lobe 566 may be formed from a single wire loop made of nitinol, a polymer, or similar material. In addition to the ring, the lobe 566 may be a solid, substantially flat piece of material extending from the inner cover 522. Each lobe 566 may 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 may 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, as shown in the bottom view of the occluding device 520 shown in fig. 23A. In other embodiments, the diameter of the loop widens continuously between the centermost portion and the outermost peripheral portion, as shown in the bottom view of the occluding device 520 shown in fig. 23B. The lobes 566 may have other shapes and sizes besides those shown. The obturator 520 may have anywhere from two to eight lobes 566.

Referring back to fig. 22, the lobe 566 of the obturator 520 is coupled to the inner cap 522 at an angle 570. In some embodiments, the angle 570 formed between the sides of the inner cap 522 and the plane of the radial lobes is between 15 degrees and 45 degrees. In this manner, the lobes 566 act as clips to engage the wall 13 of the blood vessel 12 near the neck 16 and maintain the positioning of the occluding device 520 near the neck 16, below the aneurysm 12.

Referring to fig. 24, in one exemplary embodiment, an occluding device 620 having an internal anchoring member 640 is shown deployed within an aneurysm 10. The internal anchoring member 640 is configured to anchor the inner cap 622 within the lower portion of the aneurysm 10 at or near the neck 16. The internal anchoring member 640 provides a relatively rigid body that supports the inner cap 622 and reduces the likelihood that the inner cap 622 will dislodge from the neck 16 due to the fluid pressure of the blood in the vessel 12. According to an exemplary embodiment, the inner cover 622 is a double layer formed similar to the inner cover 522. The inner cap 622 has a peripheral portion that contacts the inner surface 15 of the aneurysm 10.

According to an exemplary embodiment, the inner anchor member 640 comprises one or more loops of wire coil formed from a suitable biocompatible metal or alloy (e.g., platinum, stainless steel, nitinol, etc.). The metal coil may be spring-like and may be similar to coils commonly used in intravascular coiling procedures. The internal anchoring member 640 is coupled to the inner cap 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 anchor member 640 do not fill the entire internal volume 14 or a substantial portion of the internal volume 14. Instead, the inner anchoring member 640 comprises only a single set of loops extending from the cap 622 just like a rod. In some embodiments, the anchoring member 640 may be a soft mesh coil. In other embodiments, the anchor member 640 can comprise a plurality of loops that substantially fill the interior volume 14. The orientation, number, and size of the loops of the inner anchor member 640 may vary depending on the size and shape of the aneurysm 10.

Alternatively, the inner caps 622 and 522 may be implemented with any internal anchoring member as described in this disclosure. Further, although not shown in fig. 24, the occlusion device 620 can 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.

Referring to fig. 25, in one exemplary embodiment, an occluding device 720 having an internal anchoring member 740 is shown. The inner anchoring member 740 is configured to anchor the inner cover 722 within the lower portion of the aneurysm 10 at or near the neck 16. The internal anchor 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 cover 722 is bi-layered, formed similarly to the inner covers 522, 622. The inner cover 722 has a peripheral portion that contacts the inner surface 15 of the aneurysm 10.

According to an exemplary embodiment, the internal anchor member 740 is similar to the internal anchor member 640 in that the internal anchor member 740 extends like a rod from a generally central portion of the cap 722. In this embodiment, unlike the inner anchor member 640, the inner anchor member 740 is a cylindrical rod made from a sheet of mesh material. The cylindrical shaft may be closed at the distal end of the shaft in contact with the inner surface 15 of the aneurysm 10. The mesh material may be wrapped around a set of loops forming a coil or may be self-supporting. The internal anchoring member 740 may include a plurality of folds 742 that form a crease-type structure that may contract when pressed against the inner surface 15 of the aneurysm 10. In some embodiments, the mesh material is a very fine, high density mesh. The mesh material may be a combination of nitinol and filaments interleaved with metal. In some embodiments, the tip 744 of the inner anchor member 740 is covered or closed.

The internal anchor member 740 of fig. 25 may be constructed as a unitary structure with the cover 722. For example, the same mesh may be used to form the cover 722, the cover 722 having an extension of the shaft forming the internal anchor member 740. In other embodiments, the cap 722 and the internal anchor member 740 are separate elements coupled or molded together.

Although not shown in fig. 25, 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.

Referring to fig. 26A-B, in one exemplary embodiment, an inner cap 822 for an occlusion device is shown. In this embodiment, the inner cover is a multi-layer inner cover 822. Inner cover 822 includes a plurality of vanes 824 arranged to overlap one another and to be individually movable. Vanes 824 are disposed about a central portion of inner cover 822. In the side view in fig. 26A, the inner cover 822 is shown in a partially collapsed configuration with the vanes positioned closely around the central portion. In fig. 26B, which is a top view, the inner cover is shown in an expanded configuration, such as when the inner cover 822 is deployed adjacent the neck 16 of the aneurysm 10, the leaves 824 are extended or fanned out so that they extend away from a 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.

According to an exemplary embodiment, each blade 824 of inner cover 822 is made of a mesh material, such as a biocompatible metal or metal alloy, for example, platinum, stainless steel, titanium-nickel alloy (e.g., nitinol). The vanes 824 of the inner cover 822 may be formed from a relatively dense mesh, such as a 37 micron mesh, formed from a plurality of wires or fibers that are coupled or molded together. The inner cap 822 may be used in conjunction with an internal anchor member as described elsewhere herein, including but not limited to the internal anchor member and central rod described below and shown in fig. 27-32.

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

Various arrangements and combinations are shown and described with reference to fig. 27-32. It is contemplated that the present design is not limited to the embodiments shown, but that the various features described in fig. 27-32 may be used in combination with each other in other combinations and arrangements. In addition, any of the embodiments shown in FIGS. 27-32 may also utilize the multi-layer cap 822 shown in FIGS. 26A-26B. The illustrated embodiment may also incorporate any external anchoring member, including but not limited to the external anchoring members (250, 360, 450, 460, 482, and 550) described above.

Referring to fig. 27, in one exemplary embodiment, an occluding device 920 is shown deployed within an aneurysm 10. The occluding device 920 has an inner cap 922 and an inner anchoring member 940 connected by a central rod 930. The central rod 930 may be a cylinder. Inner lid 922 and inner anchoring member 940 are each generally concave with the concavity facing stem 930 and facing each other. The inner lid 922, the inner anchor member 940 and the central rod 930 may be separately constructed and coupled together. In other embodiments, the three elements are formed from a single sheet and are unitary. In this embodiment, the inner lid 922 and the internal anchoring mechanism 940 are each comprised of a single layer disk of mesh material.

Referring to fig. 28, in an exemplary embodiment, an occluding device 1020 is shown. The occluding device 1020 has an inner cover 1022 and an inner anchoring member 1040 connected by a central rod 1030. Inner cover 1022 and inner anchor member 1040 are each generally concave with the concave surfaces facing stem 1030 and facing each other. Inner cover 1022, inner anchor member 1040, and central rod 1030 may be separately configured and coupled together. In other embodiments, the three elements are formed from a single sheet and are unitary. The occluding device 1020 of fig. 28 differs from the occluding device 920 in that the inner cover 1022 and the internal anchoring mechanism 1040 are each comprised of a double layer of mesh material that may be formed in a similar manner as the inner covers 522, 622, or 722 described above.

Referring to fig. 29, in an exemplary embodiment, an occluding device 1120 is shown. The obturator 1120 has an inner cover 1122 and an internal anchor member 1140 connected by a central rod 1130. The inner cover 1122 and the internal anchor member 1140 are each generally concave with the concavity facing the stem 1130 and facing each other. The inner cover 1122, the internal anchor member 1140 and the central rod 1130 may be separately constructed and coupled together. In other embodiments, the three elements are formed from a single sheet and are unitary. The occluding device 1120 of fig. 29 differs from the occluding device 920 in that the inner cover 1122 is constructed of a single layer of mesh material and the internal anchoring mechanism 1140 is constructed of a double layer of mesh material, which may be formed in a similar manner as the inner covers 522, 622, or 722 described above.

Referring to fig. 30, in an exemplary embodiment, an occluding device 1220 is shown. The obturator 1220 has an inner cap 1222 and an internal anchor member 1240 connected by a central rod 1230. The inner cap 1222 and the inner anchor member 1240 are both generally concave with the concave surfaces facing the stem 1230 and facing each other. The inner cap 1222, the inner anchor member 1240, and the central rod 1230 may be separately configured and coupled together. In other embodiments, the three elements are formed from a single sheet and are unitary. The occluding device 1220 of fig. 30 differs from the occluding device 920 in that the internal anchoring mechanism 1240 is comprised of a single layer of mesh material, while the inner cover 1222 is comprised of a double layer of mesh material, which may be formed in a similar manner as the inner covers 522, 622 or 722 described above.

Referring to fig. 31, in an exemplary embodiment, an occluding device 1320 is shown. The obturator 1320 has an inner cover 1322 and an inner anchor member 1340 connected by a central rod 1330. The occluding device 1320 of fig. 31 differs from the occluding device 1220 of fig. 30 in that the internal anchoring mechanism 1240 is comprised of a single layer of mesh material and the inner cover 1222 is comprised of a double layer of mesh material, which may be formed in a similar manner as the inner covers 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 inner anchoring mechanism 1340 (shown as part of the occluding device 1320), the occluding device may also include a flared inner cover.

Fig. 32A-32C depict other modifications to the occluding device according to exemplary embodiments. Each of these figures depicts an obturator having an inner cap and an internal anchoring mechanism connected by a central rod, similar to fig. 27-31. In the embodiment of fig. 32A-32C, it is shown that the inner cover and the internal anchoring mechanism may have variations in shape. For example, the inner cover and/or the internal anchoring mechanism may have a flat, unbent shape. Alternatively, the inner cover and/or the internal anchoring mechanism may have an angled or curved shape. In this alternative embodiment, the inner cap and/or the internal anchoring mechanism may have a substantially flat central portion with a beveled or raised edge. Fig. 28, as described above, depicts the occluding device 1020 where both the inner cover 1022 and the internal anchoring member 1040 are angled or curved. Fig. 32A depicts the occluding device 1420 where the inner cap 1422 and the inner anchor member 1440 are both straight. Fig. 32B depicts the occluding device 1520 where the inner cap 1522 is angled and the inner anchoring member 1540 is straight. Fig. 32C depicts the occluding device 1620 wherein the inner cover 1622 is straight and the inner anchor member 1640 is angled.

The construction and arrangement of the elements of the aneurysm occlusion device as shown in the various exemplary embodiments is illustrative only. Although only a few embodiments have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter recited herein. For example, elements shown as integrally formed may be constructed of multiple parts or elements, the position of elements may be reversed or otherwise varied, and the nature or number of discrete elements or positions may be altered or varied. It should be noted that the elements and/or components of the system may be constructed of any of a variety of materials that provide sufficient strength, durability, or biocompatibility. Other substitutions, modifications, changes and omissions may be made in the design, operating conditions and arrangement of the preferred and other exemplary embodiments and medical procedures without departing from the scope of the present invention.