| Endovascular device for entrapment of participate matter and method for use -> Monitor Keywords |
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Endovascular device for entrapment of participate matter and method for useRelated Patent Categories: Surgery, Instruments, Internal Pressure Applicator (e.g., Dilator), With Emboli Trap Or FilterEndovascular device for entrapment of participate matter and method for use description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060293706, Endovascular device for entrapment of participate matter and method for use. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS REFERENCE TO RELATED APPLICATION [0001] This application is a continuation of U.S. patent application Ser. No. 10/310,149, filed Dec. 5, 2002, entitled "Endovascular Device For Entrapment Of Particulate And Method For Use", which claims priority from provisional application No. 60/335,838, filed on Dec. 5, 2001, entitled "Endovascular Device For Entrapment Of Emboli". FIELD OF THE INVENTION [0002] The present invention relates to an endovascular device and method for use, and in particular, to a device for trapping particulate such as emboli. BACKGROUND OF THE INVENTION [0003] Emboli form, for example, as a result of the presence of particulate matter in the bloodstream. Vascular emboli are a major single causative agent for multiple human pathologies. It is a leading cause of disability and death. Clots or thrombi that become dislodged from the point of origin are termed emboli. [0004] Such particulate matter may originate from a blood clot occurring in the heart. It may be a foreign body, but may also be derived from body tissues. For example, atherosclerosis, or hardening of the blood vessels from fatty and calcified deposits, may cause particulate emboli to form. Moreover, clots can form on the luminal surface of the atheroma, as platelets, fibrin, red blood cells and activated clotting factors may adhere to the surface of blood vessels to form a clot. [0005] Blood clots or thrombi may also form in the veins of subjects who are immobilized, particularly in the legs of bedridden or other immobilized patients. These clots may then travel in the bloodstream, potentially to the arteries of the lungs, leading to a common, often-deadly disease called `pulmonary embolus`. Thrombus formation, and subsequent movement to form an embolus, may occur in the heart or other parts of the arterial system, causing acute reduction of blood supply and hence ischemia. The ischernic damage often leads to tissue necrosis of organs such as the kidneys, retina, bowel, heart, limbs, brain or other organs, or even death. [0006] Since emboli are typically particulate in nature, various types of filters have been proposed in an attempt to remove or divert such particles from the bloodstream before they can cause damage to bodily tissues. [0007] For example, U.S. Pat. No. 6,258,120 discloses a filter device intended to be inserted into the artery of a patient. However, the device has an inherent drawback, which is that the actual trapping of an embolus, for successful operation of the device, may result in blockage of blood flow through the device and hence through the artery. Other disclosed embodiments of the device, which may not be blocked by clots, are not able to filter clots, and may in fact funnel such particulate matter to the blood vessels leading to the brain. None of the disclosed embodiments of the device is anchored to the artery, but instead rely upon conformation to the arterial shape and size to maintain the position of the device, which is not secure. In view of the natural force of blood pressure and elastic recoil of the arterial wall, proper placement and control of position of the device are of paramount importance. If the device moves even slightly, it may even block the artery which it is intended to protect. Such movement may be caused by blood flow for example, as the blood pulse moves through the artery, [0008] U.S. Pat. Nos. 4,873,978, 5,814,064, 5,800,457, 5,769,816, and 5,827,324 describe devices that are intended only for temporary insertion into a blood vessel. Therefore, these devices avoid the difficult issue of simultaneously successfully filtering emboli while also maintaining blood flow through the blood vessel. As such, they do not address the problem of prolonged filtration of the blood. [0009] U.S. Pat. No. 5,234,458 appears to disclose a filter device that is intended to be left in the vessel for a period of time. However, the disclosed filter device lacks a tapered shape, thus introduction and positioning may be unsafe and complex. Such a device does not feature a sufficiently strong anchoring system and the filter does not include a mesh. [0010] The lack of a suitable anchoring system is a general problem with devices disclosed in the background art, as the pulsating blood flow, aortic elasticity and movement may all cause a device inserted into a major blood vessel to become dislodged. Furthermore, those devices which feature rigid structures may create turbulent blood flow at certain locations such as the aortic arch, leading to decreased cerebral blood flow and possible activation of the clotting mechanism. [0011] Therefore, there is a need for a more effective and safer device and method for protecting against particulate such as emboli. SUMMARY OF THE INVENTION [0012] Embodiments of the present invention provide for a device and method for protecting a blood vessel, and hence bodily tissues, against damage caused by particulate such as an embolus. The device is typically a stent, for insertion in a large artery such as the ascending aorta (as shown below), aortic arch or any artery in jeopardy, and is structured as a filter and/or with filtering material. Other configurations can be used. The filtering structure is typically made of at least one layer of mesh, which may be attached to the arterial wall. Typically only part of the device is attached (for example at a reinforcing structure or a ring structure). [0013] In one embodiment, the outer structure is a wire frame. [0014] A device according to an embodiment of the present invention may feature a plurality of layers. The outer layer is typically made of a dilatable and/or otherwise self-expanding tubular structure. This tubular structure is typically anchored to the vascular wall after dilation to the size and shape of the vessel, or to the diameter of the blood vessel. Anchoring components, such as fine pins, maybe employed for anchoring the device to the tissues of the vascular wall. The material of which the device is constructed may optionally be metallic. Other materials may be used. [0015] According to one embodiment, the device includes a first typically outer cage-like structure (such as a stent) for holding an inner net. The net is able to filter the particulate matter. More typically, at least the net is manufactured from a flexible thread such as surgical monofilament sutures suitable for insertion into the body and/or for medical use. Other materials may be used. For example, metallic material, such as titanium, gold, and/or suitable alloys may be used. [0016] The stent is typically constructed so that material of the typically inner and typically more pliable net cannot inadvertently become inserted into the openings of the important branching vessels, if the device is inserted into the aortic arch, for example. The device may feature a plurality of layers, including at least an inner layer and an outer layer. The inner layer is typically constructed of a pliable net, with relatively small openings, so that blood can flow through the net freely, but not emboli. The size of the mesh is typically such that it permits passage of blood and micro-emboli, for example according to the organ system, which is to be protected. The distal part of the net is typically narrowed, and more typically features two layers of the same material. The free edges may be reinforced with, for example, a weave of metallic thread, such as gold. The layers therefore typically form a basket like structure with overlapping layers at one end, which are not sealed, but instead may optionally be opened upon retrograde motion through the distal end of the net structure. Therefore, emboli can be trapped in the net structure, as they typically float in the blood flow, but diagnostic and/or therapeutic catheters may optionally enter the aortic arch (or any other blood vessel in which the device of the present invention is installed) through the distal end of the net. In other words, in such an embodiment, the distal part of the net forms a trap for emboli, with a one-way valve, allowing passage of medical instruments. [0017] A temporary component may be added to the device, for example for use during heart and aortic surgery, with extracorporeal circulation after the device has been inserted to the blood vessel. Such a temporary component may be implemented as, for example, an inner mesh, which is optionally inserted into the device in order to trap micro-emboli during surgery. This mesh with the entrapped contents is then typically removed at the end of the surgical procedure. [0018] The device according to one embodiment of the present invention may be insertable into a blood vessel in a wrapped or compressed form by, for example, using a catheter, according to, for example, the Seldinger Technique. The deployment site may be optionally determined by any number of imaging methods, including but not limited to X-ray fluoroscopy, intravascular ultrasound, or echocardiography, MRI (magnetic resonance imaging), angioscopy, CT (computerized tomography) scan, and/or any other suitable imaging technology. Another optional mode of deployment is surgical, by direct insertion of the catheter carrying the device through a puncture of the targeted vessel in proximity to the deployment site. [0019] The device of the present invention may optionally serve as a platform for carrying physiologic, hematological, biochemical and so forth micro-sensors. Enabling continued monitoring of one or more parameters, such as temperature, blood pressure, heart rhythm, blood flow (`cardiac output`), pH, electrolytes, blood sugar, blood LDL etc. These microprocessors typically transmit the data (for example) wirelessly to an outer monitoring device, as needed. The device can be loaded by coating or small aggregates, to serve as an internal "docking station" to release drugs, hormones, genes and so forth either automatically or by sensor-reactor programming, servomechanism or external control. [0020] The device and method are particularly useful in preventing blockages of flow to the brain, but have other uses as well. Continue reading about Endovascular device for entrapment of participate matter and method for use... 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