Galaxy Therapeutics Inc. (Milpitas, CA)

A device for treating an aneurysm in blood vessels includes an occlusion element that is attached to wire, the occlusion element including the cover that covers the neck of an aneurysm as well as an anchoring element inside. The cover may expand from a tube in the compressed form into an expanded shape once extended out of the tube’s distal portion to cover the neck. The cover is comprised of a sphere constructed of mesh material that is folded into a round sphere. The inner anchoring member is connected to and extends from the second side of the cover. It is designed to be in contact with an internal area of the aneurysm. An inner anchoring member could be a cylindrical stem that extends from the central part of the cover.

Aneurysms may be caused by abnormal expansion or weakening of the blood vessel (often an arterial) and may cause various complications. Aneurysms may cause tissue damage, or pressure to the surrounding tissues by bulging blood vessels. This could cause a variety of negative effects within the brain such as diminished vision, speech impairment, and diminished balance. An aneurysm may also result in volumes that are not part of the main blood flow path through the blood vessel. This may result in blood becoming stagnant and result in thromboembolism development because of swirling currents. Aneurysms may rupture and lead to serious internal bleeding.

Aneurysms are treated externally with open surgery. The procedure typically involves closing off the opening or “neck” of the aneurysm with a device such as vascular clamps or an ligament. These open surgeries can be extremely invasive and could cause injury to nearby tissues as well as other negative side negative effects.

Aneurysms can be treated with endovascular procedures. In one procedure that is performed, wires with detachable lengths (e.g. coils) are placed into the internal area of the aneurysm by using a catheter. The coils are designed to fill up the volume of the aneurysm, thereby reducing the flow of blood into the aneurysm, causing stagnation of blood flow. They also stimulate blood clotting in the aneurysm. When there is a large number of cerebral aneurysms filling the aneurysm using multiple coils can lead to an effect of mass that can trigger brain swelling and result in new signs. The use of Stents as an adjunct is another option for aneurysms having a large neck. This helps to retain the coils in the aneurysm. This technique is recommended for being used when treating ruptured aneurysm, due to the necessity of additional anti-thrombotic medications. Another method involves securing the coils within the aneurysm’s mass by using a balloon temporary, that is then inflated inside the bloodvessel. After the coil is secure, the balloon is deflated. Another option is to insert an stent device within the artery. This will allow blood flow to continue beyond the aneurysm. This leads to thrombosis and stagnation within the aneurysm. The main artery’s side branch in which the stent device was positioned may be blocked or “jailed” that could prevent access to the side branch. Sometimes the side branch could become blocked, which could cause stroke. A second anti-thrombotic medication is needed for this procedure. This restricts the use of stents in treating ruptured aneurysms. The stent is generally constructed with a tightly weave. The tight weave improves the effectiveness of the device in diverting blood flow. But, it may restrict or block access to the volume, or the jailed vessel. If the aneurysm fails to clot, the blockage of the aneurysm by the stent device prevents the possibility of placing embolic devices inside the aneurysm. The residual may require additional procedures, such as open surgery or the installation of additional devices.

All procedures that involve filling the volume of the aneurysm suffer from several common shortcomings. The first is that it may require many coils of wire to fill the volume of the aneurysm, which is time consuming and increases the time it takes tocomplete the procedure. Furthermore, the coils can be compacted over time to occupy a smaller percentage of the total volume of aneurysm. If there is enough compacting of the coils may be considered a recurrence of the aneurysm and could require further treatment.

It is advantageous to offer a more effective treatment method and system for an aneurysm.

A device for treating an intravascular aneurysm includes an occlusion device mounted on a wire. The occlusion components include an occlusion cover that covers the neck of the aneurysm, as well as an inner anchoring member. The cover is designed to expand from a compact shape in a tube to an expanded configuration when advanced out of a distal part of the tube to cover the neck of the aneurysm. The cover includes a sphere of mesh material formed into a hemisphereincluding two mesh layers that is formed by folding the top portion of the sphere to the bottom of the sphere. The second layer of the cover is covered by the internal anchoring component. It is designed to meet the interior surface of the aneurysm. The inner anchoring member may be a cylindrical stem extending from a central portion of the cover.

One embodiment refers to an apparatus that treats an intravascular aneurysm. It is comprised of an occlusion device that is attached to a wire. The occlusion components include the cover to cover the neck of an aneurysm, an anchoring piece to be able to contact an internal surface, and a central stem linking the cover with the anchoring members. The occlusion component is attached to the wire that is located on an outside surface of the cover. The anchoring member inside and the cover may expand from a compressed form when positioned inside tubes to expand into an form when moved away from the distal tip. The cover and the inner anchoring member are of a comparable size and diameter. The central stem is less than that of the cover and inside anchoring member.

The invention can be used in other embodiments and of being practiced or being carried out in different ways. Alternative exemplary embodiments relate to other features and combinations of features, as can be generally described in the claims.

Click here to view the patent on USPTO website.


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