Embolization device and a method of using the same

Abstract

Space-occupying devices for treating voids within the body are disclosed. The devices can have multiple elements connected to a flexible leader. The devices can be coated by a binding agent. The devices can also be fillable. Methods of making and using the devices are also disclosed.

Description

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates generally to a device for filling and / or stabilizing the void within an anatomical organ of the body, particularly within the vasculature, and methods for making and using the device. [0003] 2. Description of the Related Art [0004] An aneurysm is an abnormal dilatation of a biological vessel. Aneurysms can alter flow through the affected vessel and often decrease the strength of the vessel wall, thereby increasing the vessel's risk of rupturing at the point of dilation or weakening. FIG. 1 illustrates an abdominal aorta 2 with a sacular aneurysm 4 having an aneurysm wall 6. FIG. 2 illustrates the abdominal aorta 2 with a vascular prosthesis 8 implanted to treat the aneurysm 4, a common aneurysm therapy. Vascular grafts and stent-grafts (e.g., ANEURX® Stent Graft System from Medtronic AVE, Inc., Santa Rosa, Calif.) are examples of vascular prostheses used to treat aneurysms by reconstruc...

AI Technical Summary

Benefits of technology

[0017] A device volume for filling an abnormal void within the body including a bindging agent is disclosed. The device volume is all or part of the volume of the device. The device has a first space-occupying piece, a second space-occupying piece and a binding agent. The first space-occupying piece is flexibly attached to the second space-occupying piece such as a continuous structure, such as a coil. The binding agent attaches the first space-occupying piece and the second space-occupying piece (e.g., each turn of the coil). The binding agent reduces the flexibility of the device volume and increases the pushability to aid in deployment. The flexibility of the device volume of the first space-occupying piece and the second space-occupying piece is restored when the binding agent is exposed to a softening agent.

[0021] A method is disclosed for placing a space-occupying device or a plurality of space-occupying devices, such as the embolization devices disclosed herein, within a void. For example, a catheter having a distal exit is placed at a vascular site. A vascular embolization device is then passed through the catheter and the distal exit and deployed into the vascular site. The device has a flexible leader and at least one non-expandable, space-occupying elements connected to the leader. The method can include selecting a device or devices having the proper volume so that the device(s) is large enough to substantially fill the void, such as an aneurysmal sac within the vasculature, yet small enough to prevent substantial alteration of the natural fluid flow through an adjacent element, for example a vascular prosthesis implanted at or near the vascular site. Furthermore, the method of the present invention may provide for the removal of material within the void, such as the removal of thrombus from the aneurysmal sac and treatment with therapeutic agents prior to, or in conjunction with, the placement of the space-occupying elements.

[0022] A method is also disclosed for filling an abnormal void within the body. The method includes placing a catheter having a distal exit in a void within the body. The method also includes passing a space-occupying device through the catheter and distal exit. The space-occupying device comprising a device volume and a binding agent. The binding agent reduces the flexibility of the space-occupying device. The distal exit of the device is placed at a treatment site at the time of deployment to aid in ejection of the space-occupying device from the delivery catheter.

[0023] The flexibility of the space-occupying device can also increase when the binding agent is exposed to a softening agent. Deploying the device can include exposing the device to a softening agent.

Problems solved by technology

Cragg et al. teach that these solvents can be toxic to tissue and may cause vascular spasms.

Using liquid-solidifying agents in active vessels also carries a high risk that the agents will flow downstream creating emboli or flow into collateral vessels (e.g., lumbar arteries), which may lead to paralysis or other adverse events.

Shifting of the microcoil can lead to recanalization of the aneurysm.

Another disadvantage of microcoils is that they are not easily retrievable.

The expansion of the device after deployment reduces the volumetric precision with which the sac can be filled.

If the volume of the expanded device is too large, the device can press against the inner side of weakened aneurysm wall and outer side of prosthesis, altering flow within the prosthesis and increasing the risk of rupture of the aneurysm.

If the volume of the expanded device is too small, the prosthesis can still alter its position and dislodge or migrate.

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