Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Thermal applicators
Reexamination Certificate
1999-10-09
2001-07-31
Gibson, Roy (Department: 3739)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Thermal applicators
C607S101000, C607S102000
Reexamination Certificate
active
06267781
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to improved medical device and methods for treating cardiovascular tissues, and more particularly, to such an ablation device and methods for treating valvular annulus, atherosclerosis, or tissues in a patient by delivering therapeutic RF energy through an electrode to the specific lesion sites.
BACKGROUND OF THE INVENTION
An artery is one of the tube-shaped blood vessels that carry blood away from the heart to the body's tissues and organs. An artery is made up of outer fibrous layer, smooth muscle layer, connecting tissue and the inner lining cells. If arterial walls become hardened due to the accumulation of fatty substances, then blood flow can be diminished. Hardening of the arteries, or loss of vessel elasticity, is termed arteriosclerosis while fatty deposit build-up is termed atherosclerosis. Atherosclerosis and its complications are a major cause of death in the United States. Heart and brain diseases are often the direct result of this accumulation of fatty substances that impair the arteries'ability to nourish vital body organs.
Balloon angioplasty is a nonsurgical method of clearing coronary and other arteries, blocked by atherosclerotic plaque, fibrous and fatty deposits on the walls of arteries. A catheter with a balloon-like tip is threaded up from the arm or groin through the artery until it reaches the blocked area. The balloon is then inflated, flattening the plaque and increasing the diameter of the blood vessel opening. The arterial passage is thus widened. As a result of enlarging the hardened plaque, cracks may unfortunately occur within the plaque to expose the underlying fresh tissue or cells to the blood stream.
There are limitations, however, to this technique's application, depending on the extent of the disease, the blood flow through the artery, and the part of the anatomy and the particular vessels involved. Plaque build-up and/or severe re-stenosis recurs within 6 months is up to 30-40 percent of those treated. Balloon angioplasty can only be characterized as a moderate-success procedure. Recently, a newer technique of inserting a metallic stenting element is used to permanently maintain the walls of the vessel treated at its extended opening state. Vascular stents are tiny mesh tubes made of stainless steel or other metals and are used by heart surgeons to prop open the weak inner walls of diseased arteries. They are often used in conjunction with balloon angioplasty to prevent restenosis after the clogged arteries are treated. Stenting technique reduces the probability of restenosis; however, the success rate is still sub-optimal. The underlying fresh tissue or cells still pose as a precursor for vessel reclosures or angio-spasm.
When a clogged artery is widened, the plaque is broken up and the underlying collagen or damaged endothelium is exposed to the blood flow. Collagen has a prothrombotic property that is part of body healing process. Unless the collagen or the damaged endothelium is passivated or modulated, the chance for blood vessel clotting as well as restenosis exists. This same phenomenon occurs in the valvuloplasty where the valvular annulus is enlarged by a balloon, wherein collagen could be denuded and/or endothelium could be damaged. Moderate heat is known to tighten and shrink the collagen tissue as illustrated in U.S. Pat. No. 5,456,662 and U.S. Pat. No. 5,546,954. It is also clinically verified that thermal energy is capable of denaturing the tissue and modulating the collagenous molecules in such a way that treated tissue becomes more resilient (“The Next Wave in Minimally Invasive Surgery” MD&DI pp. 36-44, Aug. 1998). Therefore, it becomes imperative to post-treat walls after the walls are treated with angioplasty, stenting, and/or valvuloplasty procedures.
One method of reducing the size of cellular tissues in situ has been used in the treatment of many diseases, or as an adjunct to surgical removal procedures. This method applies appropriate heat to the tissues, and causes them to shrink and tighten. It can be performed on a minimal invasive fashion, which is often less traumatic than surgical procedures and may be the only alternative method, wherein other procedures are unsafe or ineffective. Ablative treatment device have an advantage because of the use of a therapeutic energy that is rapidly dissipated and reduced to a non-destructive level by conduction and convection, to other natural processes.
RF therapeutic protocol has been proven to be highly effective when used by electrophysiologists for the treatment of tachycardia; by neurosurgeons for the treatment of Parkinson's disease; and by neurosurgeons and anesthetists for other RF procedures such as Gasserian ganglionectomy for trigeminal neuralgia and percutaneous cervical cordotomy for intractable pains. Radiofrequency treatment, which exposes a patient to minimal side effects and risks, is generally performed after first locating the tissue sites for treatment. Radiofrequency energy, when coupled with a temperature control mechanism, can be supplied precisely to the tissue site to obtain the desired temperature for treating a tissue.
The human's circulatory system consists of a heart and blood vessels. In its path through the heart, the blood encounters four valves. The valve on the right side that separates the right atrium from the right ventricle has three cusps and is called the tricuspid valve. It closes when the ventricle contracts during a phase known as systole and it opens when the ventricle relaxes, a phase known as diastole. The pulmonary valve separates the right ventricle from the pulmonary artery. The mitral valve, so named because of its resemblance to a bishop's mitre, is in the left ventricle and it separates the left atrium from the ventricle. The fourth valve is the aortic valve that separates the left ventricle from the aorta. In a venous circulatory system, a venous valve is to prevent the venous blood from leaking back into the upstream side so that the venous blood can return to the heart and the lungs for blood oxygenating purposes.
In either the case of valvuloplasty or valvular dysfunction, the annular organ structure of a heart valve, a valve leaflet, a chordae tendinae, papillary muscles, a venous valve, and the like still needs to be treated and/or tightened so that the valvular function is competent. The current technology for valve repair or valve replacement requires an expensive open-heart surgery that needs a prolonged period of recovery. A less invasive catheter-based valve repair technology becomes an unmet clinical challenge.
Therefore, there is a clinical need to have a less invasive catheter-based approach for treating an annular organ structure of a heart valve, a venous valve, a valve leaflet, a chordae tendinae, papillary muscles, and the like by using high frequency energy for reducing and/or shrinking a tissue mass for tightening and stabilizing the dilated tissue adjacent a valvular annulus or an annular organ structure.
SUMMARY OF THE INVENTION
In general, it is an object of the present invention to provide a method and an improved medical ablation device for generating heat, to treat the atherosclerosis, vascular vessels, other tissues such as intestine, colon, ureter, uterine tube, and other annular organ structure of a heart valve, a venous valve, a valve leaflet, chordae tendinae, papillary muscles, and the like.
It is another object of the present invention to provide a method and a device for monitoring the temperature of the ablated tissue, and to control the temperature by utilizing a temperature control mechanism and/or algorithm. The location of the temperature sensor means is preferably at close proximity of the electrode means of the ablation device.
It is still another object of this invention to provide a method and an device for treating atherosclerosis, vascular walls, or tubular cellular tissues in a patient by applying high frequency current to a pre-implanted stent and consequently to the underlying tissue
Gibson Roy
Quantum Therapeutics Corp.
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