Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
2000-03-07
2001-10-02
Schaetzle, Kennedy (Department: 3762)
Surgery
Instruments
Cutting, puncturing or piercing
C606S167000
Reexamination Certificate
active
06296651
ABSTRACT:
FIELD OF THE INVENTION
The present invention pertains generally to surgical devices and procedures. More particularly, the present invention pertains to a device and method for treating occlusions in the coronary artery which inhibit blood flow to the heart.
BACKGROUND
Many medical complications are created by the total or even partial blockage of blood vessels of the body. For example, it is relatively common for stenotic segments to develop in the arterial vessels which supply blood to the heart. These stenotic segments may partially or fully occlude the vessels, thereby decreasing cardiac capacity and/or causing myocardial infarction.
Numerous methods and devices have been developed to treat or remove stenotic segments which occur within the internal vessels of the body. For example, an angioplasty procedure is commonly used to treat the blockages in vessels. Typically, angioplasty generally involves inflation of a tubular balloon within the stenotic segments which occlude a particular vessel. Inflation of the balloon dilates the stenotic segment and fully or partially restores the flow of blood within the involved vessel.
Atherectomy is another procedure which has been developed to clear stenotic segments from occluded vessels. In an atherectomy procedure, a rotatable cutting tool is advanced through the stenotic segments which occlude a particular vessel. The rotating cutter severs the material forming the stenotic segment, and allows the severed stenotic material to be removed by operation of a vacuum or other means.
Unfortunately, stenotic segments can develop in areas where angioplasty and atherectomy techniques can not be utilized. For example, the development of a stenotic segments within a vessel which is internal to an organ, presents special problems which may not be suited for treatment by traditional angioplasty and atherectomy procedures. Specifically, stenotic segments can develop within the internal vessels of the heart. Because these vessels provide blood and oxygen to the myocardial tissue, occlusions which develop within these internal vessels present a serious risk to the health of the patient. As indicated above, the size and location of many of these vessels makes treatment with traditional methods and devices, such as angioplasty and atherectomy, difficult and generally ineffective.
In light of the above, it is an object of the present invention to provide a device and method for treating occlusions in the internal vessels of an organ. Another object of the present invention is to provide a device and method for treating an occlusion in a coronary artery which inhibits blood flow to the myocardial tissue of the heart. Still another object of the present invention is to provide a device for treating occlusions in the coronary artery which is relatively simple to manufacture, easy to use, and comparatively cost effective.
SUMMARY
The present invention is directed to a device and method adapted for creating one or more new pathways from a vessel into an organ for the flow of blood. More specifically, the present invention is a device for creating one or more channels from the coronary artery into the cardiac muscle of the heart to enhance the flow of blood from the coronary artery into the cardiac muscle. This enhances cardiac capacity and inhibits myocardial infarction.
Structurally, the present invention includes a positioning catheter, anchoring means and a cutting catheter. The positioning catheter is formed with a deployment lumen. The deployment lumen includes a plurality of deployment apertures which extend through the catheter into the deployment lumen.
The anchor means secures the positioning catheter within the vessel around a circumference of the vessel, so that the cutting catheter can precisely create the perfusion channel. In one version, the anchor means is a cylindrical sleeve attached to the positioning catheter. The sleeve has a distal sleeve end and a proximal sleeve end which are adapted to move relative to each other. Functionally, the movement of the distal sleeve end towards the proximal sleeve end causes the sleeve to expand radially outward. Alternately, in a second version of the present invention, the anchor means is an inflatable balloon attached to the positioning catheter.
The cutting catheter is designed to incise and dilate the tissue of the cardiac muscle. Preferably, the cutting catheter includes a cutting catheter body having a plurality of spaced apart cutting blades. The blades extend radially around the cutting catheter body and are aligned with the longitudinal axis of the cutting catheter body. The blades may be fixedly attached to the surface of the cutting catheter body or each blade may be retractable into the cutting catheter body. In cases where the blades are retractable, each blade is preferably spring-loaded, or otherwise biased, to move from a first position where the blades are substantially contained within the cutting catheter to a second position where the blades extend from the surface of the cutting catheter body. This feature causes the blades to extend from the cutting catheter when the cutting catheter body extends from the positioning catheter.
The cutting catheter may be formed to include a cutting catheter lumen for receiving a cutting guidewire. Generally, the cutting guidewire is formed from a resilient and flexible metal, such as stainless steel, and has a sharpened distal end. The cutting guidewire is insertable through the cutting catheter lumen to allow the sharpened distal end of the cutting guidewire to be selectively extended from the cutting catheter. The cutting guidewire can also be formed with a cutting guidewire lumen so that a medication can be released into the muscle. Alternately, a contrast medium can be released from the cutting guidewire lumen and/or a pressure measurement can be taken with the cutting guidewire lumen to ensure that the cutting catheter is properly positioned in the cardiac muscle.
Operationally, the positioning catheter is first advanced into the coronary artery which supplies blood to the cardiac muscle. The advancement of the positioning catheter continues until a distal end of the positioning catheter is located within boundaries of the heart itself and the deployment aperture of the positioning catheter is located adjacent to the site where a new perfusion channel is to be formed. With the positioning catheter positioned at the proper location, the anchoring means is expanded to contact the artery to anchor the positioning catheter within the artery.
Subsequently, the cutting guidewire is inserted through the deployment lumen and one of the deployment apertures into the myocardial tissue. A contrast medium can be released or a pressure measurement can be taken to ensure that the cutting guidewire is properly positioned. Next, the cutting catheter is inserted into the deployment lumen over the cutting guidewire. This causes the blades to adopt the first position where each blade is positioned within the cutting catheter body. The cutting catheter is then advanced through the deployment lumen. As a distal end of the cutting catheter emerges from one of the deployment apertures, the spring-loaded blades adopt the second position where each blade extends from the surface of the cutting catheter body. Further, advancement of the cutting catheter and the cutting guidewire forces the cutting catheter to bore a channel through the myocardial tissue. The boring of the channel is aided by the blades which incise the myocardial tissue to accommodate the advancing cutting catheter.
At any time during advancement of the cutting catheter, the cutting guidewire may be advanced through the cutting catheter lumen in the myocardial tissue, thereby boring a path, or pilot hole, for subsequent advancement of the cutting catheter. The process of alternately advancing the cutting guidewire and cutting catheter may be repeated until one or more channels through the myocardial tissue have reached the desired depth.
Once the cutting catheter has been fully advanced, the cutting
Lary Banning Gray
Radisch, Jr. Herbert R.
Droesch Kristen
Interventional Technologies Inc.
Nydegger & Associates
Schaetzle Kennedy
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