Vascular protection and embolic material retriever

Details Vascular protection and embolic material retriever Vascular protection and embolic material retriever

2000-03-31

2001-08-21

Dawson, Glenn K. (Department: 3761)

Surgery

Instruments

Internal pressure applicator

C606S159000, C606S127000

Reexamination Certificate

active

06277139

ABSTRACT:

The present invention relates to a vascular protection and embolic material retriever utilized in conjunction with a guide wire utilized during catheterization of a patient.
BACKGROUND OF THE INVENTION
Vascular disease is the leading cause of death and disability in the world. An estimated 50 million people worldwide suffer from some form of coronary, cerebrovascular and/or peripheral vascular artery disease. Medical technology has advanced dramatically over the years, providing an overall decrease in the cost of care while improving a patient's quality of life. The primary advancement in the treatment of vascular disease has been the advent of catheter-based (or interventional) procedures, which have rapidly gained acceptance—growing from under 325,000 procedures in 1994 to over 1,000,000 in 1997—since they are less invasive and less costly compared to their open surgical counterparts.
Despite the rapid growth in catheter-based procedures, embolic events remain a major clinical problem. Embolic events are typically created by thrombus (blood clot) or plaque which break loose, enter the bloodstream, and become lodged in the artery resulting in the obstruction of blood flow.
Stroke is a form of cardiovascular disease that interrupts blood flow to the brain. A stroke occurs when the carotid artery leading to the brain becomes clogged (ischemic stroke) or bursts (hemorrhagic stroke), preventing oxygen-rich blood from reaching the brain. As a result, brain cells die. Once dead, they do not regenerate which is why damage from a stroke is frequently permanent. Stroke accounts for 10% to 12% of all deaths in industrialized countries. For example, in a population of one million, 1,600 people will have a stroke each year, of which only 55% will survive six months post-stroke, and a third of the survivors will have significant disability. Stroke ranks third in terms of leading causes of death in the United States, behind heart disease and cancer. Strokes cause an estimated 150,000 deaths each year and are the leading cause of long-term disability. Current treatment options include medical management (drug therapy), carotid endarterectomy, or stent-supported carotid angioplasty. Carotid endarterectomy has demonstrated a marked increase in its use during the past two years on the basis of pivotal studies demonstrating a reduction in stroke after carotid revascularization. It is well documented that carotid endarterectomies have a 3% to 6% complication rate, depending if the patient is asymptomatic or symptomatic. Embolization has represented an obstacle to widespread acceptance of stent-supported carotid angioplasty due to the brain's sensitivity to even small amounts of emboli, with clinically significant strokes occurring in the absence of angiographically definable branch vessel occlusions is to compete effectively against the endarterectomy, it must demonstrate equal complication rates. In particular, carotid angioplasty must not lead to an increase in embolization or stroke rates. Industry sources estimate roughly 100,000 carotid endarterectomies were performed in the Unites States alone in 1997. In the same year, approximately 90,000 procedures were performed internationally and these operations are increasing at a faster rate than the United States. The desire among patients to have—and cardiologists to perform—less invasive procedures is evident. Industry estimates indicate that the number of carotid angioplasty procedures in the United states will grow from roughly 3,000 in 1998 to approximately 36,000 procedures in 2002.
The use of an effective emboli capture device or filter could significantly reduce the risk of these often devastating complications, and could potentially become the standard of care—even in low risk cases.
During catheterization of a patient, a guide wire is directed through the patient's blood vessel to the site of interest. For example, the physician may wish to utilize a balloon catheter in order to enlarge a partially obstructed blood vessel at a certain location in the patient's vascular system. To do this, the physician utilizes a guide wire which is directed through the patient's vascular system to the particular site for balloon catheterization. Various medical devices are percutaneously inserted into the patient's blood vessel utilizing the guide wire. The balloon catheter, for example, is mounted at the distal end of an elongated tube. The guide wire is placed in the lumen of the balloon catheter tube such that the balloon catheter can be threaded over the guide wire, through the vascular system and placed at the site of interest by following the guide wire.
In order to enlarge a partially obstructed blood vessel, a physician may use various surgical techniques and biomedical devices or tools including balloon catheters, scrapers or other known medical devices. However, the utilization of these devices sometimes results in a release of an embolus (embolic material) which is an abnormal particle circulating in the blood. In order to reduce complications arising from these medical procedures, physicians sometime utilize filters disposed downstream of the site of interest. As used herein the term “downstream” refers to an item that is spaced a distance apart from a referenced item and in the direction of blood flow through the blood vessel.
U.S. Pat. No. 4,619,246 to Molgaard-Nielsen et al. discloses a collapsible filter basket. The basket includes a woven mesh but does not operate on a guide wire.
U.S. Pat. No. 4,723,549 to Wholey et al. discloses a filter which is expanded based upon inflation of a balloon acting as a donut mounted to expanding frame members of the filter disposed about the guide wire.
U.S. Pat. No. 5,053,008 to Bajaj discloses a filter which is expanded based upon inflation of a tubular balloon.
U.S. Pat. No. 5,108,419 to Reger et al. discloses a filter for capturing particles of plaque which includes a laterally (radially) collapsible bag with a plurality of longitudinally displaced filter cones therein. The bag has a draw string about its mouth which opens and closes the bag both laterally (to deploy or pull-up the conical filters) and longitudinally (to wrap the conical filters and the bag into a small-diameter shape). Each conical filter includes flexible tension supports which carry filter screens or mesh and which open and close based upon the respective longitudinal position of a generally static hub at the end of a guide wire running through the filter basket system. In another embodiment, a single conical filter is utilized with a filter stocking or collapsible bag thereabout. All the tension supports are flexible enough to wrap and twirl within the collapsible bag and wrap the conical filter(s) about the guide wire. Also, a draw string closes the collapsible bag in all embodiments. The flexible tension supports or radial ribs are resilient enough to provide force to spread the conical filter mesh across the lumen of the blood vessel.
U.S. Pat. No. 5,549,626 to Miller et al. discloses a filter deployed from the inside of a hollow tube by axial movement of an inner catheter. The filter is a mesh-like collapsible basket being made of radially expandable materials which can be compressed in the lumen of an outer catheter and radially expand when the basket extends beyond the distal end of the catheter.
U.S. Pat. No. 5,695,519 to Summers et al. discloses a wire, which controllably moves forward and aft, to open and close a generally conical filter by acting on the filter's mouth.
U.S. Pat. No. 5,810,874 to Lefebvre discloses a filter including strips that are radially opened by moving an inboard ring towards an outboard ring. The rings retain forward and aft ends of the strips. The filter can be detached from the guide wire.
U.S. Pat. No. 5,814,064 to Daniel et al. discloses one filter system which utilizes various types of inflatable ribs, tubes or struts and a second filter system wherein the filter material is deployed by longitudinal movement of a push-pull wire relative to a generally sta

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