Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-07-23
2001-11-06
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C606S194000, C623S001420
Reexamination Certificate
active
06312421
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to an aneurysm embolization material and to a method for repairing an aneurysm.
An aneurysm is a balloon-like swelling in a wall of a blood vessel. An aneurysm results in weakness of the vessel wall in which it occurs. This weakness predisposes the vessel to tear or rupture with potentially catastrophic consequences for any individual having the aneurysm. Vascular aneurysms are a result of an abnormal dilation of a blood vessel, usually resulting from disease and/or genetic predisposition which can weaken the arterial wall and allow it to expand. Aneurysm sites tend to be areas of mechanical stress concentration so that fluid flow seems to be the most likely initiating cause for the formation of these aneurysms.
Aneurysm in a cerebral circulation tend to occur in an anterior communicating artery, posterior communicating artery, and a middle cerebral artery. The majority of these aneurysms arise from either curvature in the vessels or at bifurcations of these vessels. The majority of cerebral aneurysms occur in women. Cerebral aneurysms are most often diagnosed by the rupture and subarachnoid bleeding of the aneurysm.
Cerebral aneurysms are most commonly treated in open surgical procedures where the diseased vessel segment is clipped across the base of the aneurysm. While considered to be an effective surgical technique, particularly considering an alternative which may be a ruptured or re-bleed of a cerebral aneurysm, conventional neurosurgery suffers from a number of disadvantages. The surgical procedure is complex and requires experienced surgeons and well-equipped surgical facilities. Surgical cerebral aneurysm repair has a relatively high mortality and morbidity rate of about 2% to 10%.
Current treatment options for cerebral aneurysm fall into two categories, surgical and interventional. The surgical option has been the long held standard of care for the treatment of aneurysms. Surgical treatment involves a long, delicate operative procedure that has a significant risk and a long period of postoperative rehabilitation and critical care. Successful surgery allows for an endothehal cell to endothelial cell closure of the aneurysm and therefore a cure for the disease. If an aneurysm is present within an artery in the brain and bursts, this creates a subarachnoid hemorrhage, and a possibility that death may occur. Additionally, even with successful surgery, recovery takes several weeks and often requires a lengthy hospital stay.
In order to overcome some of these drawbacks, interventional methods and prostheses have been developed to provide an artificial structural support to the vessel region impacted by the aneurysm. The structural support must have an ability to maintain its integrity under blood pressure conditions and impact pressure within an aneurysmal sac and thus prevent or minimize a chance of rupture. U.S. Pat. No. 5,405,379 to Lane, discloses a self-expanding cylindrical tube which is intended to span an aneurysm and result in isolating the aneurysm from blood flow. While this type of stent-like device may reduce the risk of aneurysm rupture, the device does not promote healing within the aneurysm. Furthermore, the stent may increase a risk of thrombosis and embolism. Additionally, the wall thickness of the stent may undesirably reduce the fluid flow rate in a blood vessel. Stents typically are not used to treat aneurysms in a bend in an artery or in tortuous vessels such as in the brain because stents tend to straighten the vessel.
U.S. Pat. No. 5,354,295 to Guglielmi et al., describes a type of vasoclusion coil. Disadvantages of use of this type of coil are that the coil may compact, may migrate over time, and the coil does not optimize the patient's natural healing processes.
SUMMARY OF THE INVENTION
One embodiment of the present invention includes a method for treating an aneurysm. The method includes providing a biocompatible polymeric coil, sleeve or hollow string and transporting the string to an aneurysm. The aneurysm is then filled with the coil or string. The coil or string is cut when the aneurysm is substantially filled.
Another embodiment of the present invention includes a kit for treating an aneurysm. The kit includes a biocompatible polymeric string and a catheter for transporting the string to an aneurysm site. The kit also includes a mechanism for cutting the string. The kit optionally includes a biocompatible material for sealing the aneurysm and a balloon for shaping the biocompatible material at the aneurysm neck.
One other embodiment of the present invention includes a biocompatible string, sleeve or coil that comprises a stiff biocompatible core and an outer swellable material, concentrically positioned about the core. A water-soluble material concentrically contacts the outer swellable material and provides a time dependent swelling of the swellable material.
Another embodiment of the present invention includes a method for treating an aneurysm. The method includes providing a biocompatible hollow string or coil and positioning a wire within the hollow string or coil. The wire, string or coil are transported to an aneurysm. The wire is used to guide the string or coil into the aneurysm. The coil, sleeve or hollow string are cut when the aneurysm is substantially filled.
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Hayes Michael J
NeuroVasx, Inc.
Schwegman Lundberg Woessner & Kluth P.A.
Seidel Richard K.
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