Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2003-04-15
2004-09-14
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S507000
Reexamination Certificate
active
06790204
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to containment and removal of substances including emboli (such as from thrombi, plaque, and other types of material and debris) from blood vessels. The preferred embodiments are particularly advantages for use in the carotid arteries and other arteries above the aortic arch during diagnostic and therapeutic procedures.
2. Description of the Related Art
Human blood vessels often become occluded or completely blocked by plaque, thrombi, deposits, or other substances, which reduce the blood carrying capacity of the vessel. Should the blockage occur at a critical place in the circulatory system, serious and permanent injury, or even death, can occur. To prevent this, some form of medical intervention is usually performed when significant occlusion is detected.
The carotid arteries are the main vessels which supply blood to the brain and face. The common carotid artery leads upwards from the aortic arch, branching into the internal carotid artery which feeds the brain, and the external carotid artery which feeds the head and face. The carotid arteries are first narrowed and may eventually be almost completely blocked by plaque, and may further be complicated by the formation of thrombi (blood clots) on the roughened surfaces of the plaques. Narrowing or blockage of the carotid arteries is often untreatable and can result in devastating physical and cognitive debilitation, and even death.
Various types of intervention techniques have been developed which facilitate the reduction or removal of the blockage in the blood vessel, allowing increased blood flow through the vessel. One technique for treating stenosis or occlusion of a blood vessel is percutaneous balloon angioplasty. A balloon catheter is threaded through the patient's arterial system and inserted into the narrowed or blocked area, and the balloon is inflated to expand the constricted area. The fear of dislodging an embolus from an ulcerative plaque and the severe resulting consequences, however, has prevented the widespread use of angioplasty in the carotid arteries. Because of the potential complications, the options for minimally invasive treatment of the carotid arteries are severely limited.
Carotid endarterectomy is another type of intervention for removal of blockages from the carotid arteries. In endarterectomy, the carotid bifurcation is exposed through an incision in the neck of the patient. Clamps are placed on either side of the occlusion to isolate it, and an incision made to open the artery. The occlusion is removed, the isolated area irrigated and aspirated, and the artery sutured closed. The clamps are removed to reestablish blood flow through the artery. In carotid endarterectomy, the emboli and debris are contained and directed by activating and deactivating the clamps. For example, after the clamps are in place, one on the common carotid artery and one on the internal carotid artery, the particles are contained between the two clamps. After the occlusion is removed, the clamp on the common carotid artery is opened, allowing blood to flow into the previously isolated area toward the clamp on the internal carotid. This blood flow is then aspirated through an external aspiration tube. The common carotid artery is then reclamped, and the clamp on the internal carotid opened. This causes blood to flow into the previously isolated area toward the clamp on the common carotid artery. The flow is then aspirated. The clamp on the internal carotid artery is closed, and the artery is sutured closed. This method allows for the flushing of debris into the area where aspiration occurs.
Alternatively, this method of clamping and unclamping the carotid arteries can be done after the incision in the artery is sutured closed. Using this method, it is hoped that any particles in the internal carotid artery will be forced back to the common carotid artery, then into the external carotid area, where serious complications are unlikely to arise from emboli.
Carotid endarterectomy is not without the serious risk of embolization and stroke caused by particles of the blocking material and other debris moving downstream to the brain, however. There is therefore a need for improved methods of treatment for occluded carotid arteries which decrease the risks to the patient.
SUMMARY OF THE INVENTION
The present invention provides a novel method for containing and removing substances such as emboli from blood vessels. The method is particularly useful in bifurcated vessels, such as the carotid arteries and in other blood vessels above the aortic arch. In one embodiment of the method, there is provided at least one occlusive device such as a balloon or filter, a therapy catheter to treat the occlusion, and a source of aspiration to remove the debris created by the therapy. By utilizing the fluid pressure and flow within the blood vessel, this method can eliminate the need for a separate irrigation catheter and irrigation fluid. Alternatively, irrigation fluid may be provided to flush the area. The minimally invasive treatment allows occlusions to be treated more rapidly and less invasively than known methods, with reduced cost and risk to the patient.
In accordance with one aspect of the present invention, there is provided a method for the treatment of an occlusion in a carotid artery. A main catheter having a first occlusive device on its distal end is inserted into the artery, until the occlusive device is proximal to the occlusion. The first occlusive device is activated to occlude the artery proximal to the occlusion. An inner catheter having a second occlusive device on its distal end is inserted into the artery across the occlusion, until the occlusive device is distal to the occlusion. The second occlusive device is then activated to occlude the artery distal to the occlusion and create a working area surrounding the occlusion. By occlusive device is meant any device which is capable of preventing at least some particles or other debris from migrating downstream. Examples of occlusive devices include inflatable balloons, filters or braids, or other mechanical devices.
According to the foregoing aspect of the invention, a therapy catheter is then inserted into the working area and used to treat the occlusion. Appropriate treatment can include direct drug delivery to the site of the occlusion, angioplasty, cutting, scraping or pulverizing the occlusion, ablating the occlusion using ultrasound or a laser, deploying a stent within the artery, use of a thrombectomy or rheolitic device, or other treatments. Following treatment of the occlusion, the therapy catheter is removed. An aspiration catheter is then delivered to the working area, and the first occlusive device is deactivated to allow blood flow into the working area. Blood flow from collateral vessels prevent the movement of particles and debris downstream where they could cause serious complications. The blood flow also acts as irrigation fluid to create turbulence within the area. Aspiration of the working area is then performed to removed particles and debris. Aspiration can occur simultaneously with the deactivating of the first occlusive device, if desired. Alternatively, either step can be performed first.
In another aspect of the method of the present invention, the occlusive devices are activated and deactivated more than once. After the first occlusive device is deactivated to allow blood flow into the area, the occlusive device is reactivated. The second occlusive device is then deactivated, to allow blood flow in from the distal end of the working area. The second occlusive device is reactivated, and these steps can be repeated any number of times until sufficient irrigation and aspiration of the working area occurs.
In yet another aspect of the method, the first inner catheter with its occlusive device is delivered into one branch of a bifurcated vessel (such as the carotid artery), while a second inner catheter having a third occlusive device on its distal end is delivered in
Bagaosian Celso J.
Ha Hung V.
Muni Ketan P.
Patel Mukund R.
Zadno-Azizi Gholam-Reza
Knobbe Martens Olson & Bear LLP
Medtronic Vascular Inc.
Mendez Manuel
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