Surgery – Instruments – Electrical application
Reexamination Certificate
1999-12-07
2001-09-04
Leubecker, John P. (Department: 3762)
Surgery
Instruments
Electrical application
C606S047000, C606S049000, C607S102000, C128S898000
Reexamination Certificate
active
06283962
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to an improved device and methods for medical purposes, and more particularly, to such a device and methods for providing appropriate heat treatment in a patient by delivering thermal energy to an endometrosis site, valvular annulus, or other tissues, and a simultaneously continuous sweeping massage therapy.
BACKGROUND OF THE INVENTION
Endometrosis is a condition in which fragments of the lining of the uterus spread to other tissues, such as the wall of the uterus, the ovaries, the peritoneum, or the bowel. The causes of the disease are unknown, but its incidence is higher in women who defer pregnancy. The fragments are benign, but may cause complications if they lodge in a critical location, leading to an organ dysfunction.
There are no definite symptoms of endometrosis, and the condition is found only during a surgical operation for other disorders. When endometrosis is present, symptoms include heavy periods, often more frequent than usual, accompanied by pain (dysmenorrhea); pain during sexual intercourse (dyspareunia); sometimes infertility; and sometimes pain on defecation during a period. The abnormally placed fragments of endometrium pass through the same monthly cycle, as does the normal endometrium. They swell before a period and then bleed. Because there is no outlet for the blood, cysts form. These cysts occasionally rupture, causing severe abdominal pain.
In milder cases, painkilling drugs may lesson the symptoms. However, in severe cases, surgery or laser treatment are currently the only two options. As one of the severe cases, cul-de-sac obliteration implies the presence of retrocervical deep fibrotic endometrosis. The deep fibrotic endometrosis is usually located on the upper vagina, on the superficial anterior rectum, in the rectovaginal space, in the space between the upper vagina and the cervix (cervicovaginal angle), or in one or both uterosacral ligaments. With deep cul-de-sac obliteration, fibrotic endometrosis or adhesions sometimes involve the entire area between the cervicovaginal junction and the rectovaginal septum.
Surgery exposes a patient to greater risks, due to infection and other health reasons. The laser culdotomy, a procedure for the removal of cul-de-sac obliteration, poses a risk of unwanted tissue perforation or tissue vaporization. A less invasive approach using RF therapeutic protocols, 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, when coupled with a temperature control mechanism, can supply precise energy to the device-to-tissue contact site to obtain the desired thermal energy for treatment.
To be more efficient in RF energy ablations, the electrode with a rotational sweeping capability to cover the broad area is used to simultaneously deliver the sweeping massage therapy to the target tissue. Edwards et al. in U.S. Pat. No. 5,456,662 entitled “Method for reducing snoring by RF ablation of the uvula” teaches a medical ablation method for reducing snoring wherein a flexible RF electrode wire is inserted into the uvula, and RF energy is applied to the uvula tissue to cause internal lesions. However, Edwards et al. does not disclose a device to ablate tissues, in which there is the capability for simultaneously delivering radiofrequency energy and rotational sweeping massage therapy.
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 having capability for simultaneously delivering radiofrequency energy and rotational sweeping massage therapy becomes an unmet clinical challenge.
Therefore, there is a clinical need to have a less invasive catheter-based approach for treating the endometrosis, an annular organ structure of a heart valve, a venous valve, a valve leaflet, a chordae tendinae, papillary muscles, tumors, and the like by using high frequency energy with rotational sweeping massage therapy 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 or a catheter for generating heat, to treat endometrosis, cysts, polyps, prostate, tumors, valvular annulus, or cellular tissues. It is another object of the present invention to provide a device in which rotational sweeping massage therapy is applied to the endometrosis, cysts, polyps, prostate, tumors, valvular annulus, or the target cellular tissues, for intimate contact. The “rotational sweeping massage” in this invention implies that the surface of a rotational device (e.g., a plate-like electrode or a cam-type electrode) continuously or intermittently contacts a target tissue with a normal sweeping force by the rotational device. The “target tissue” in this invention indicates the endometrosis, the cysts, the gingivae, the tumor, the prostate, the polyp, the valvular annulus, or other cellular tissues.
It is another object of the present invention to provide a method and a device for monitoring the temperature of the medical device, and to control the temperature by utilizing a temperature control mechanism and/or algorithm. The location of the temperature sensor is preferably at the proximity of the tip portion of the medical device. It is still another object of this invention to provide methods and a device for treating the endometrosis, cysts, polyps, prostate, tumors, valvular annulus, or cellular tissues in a patient by delivering a therapeutic agent to the target site.
Briefly, heat is generated by applying a suitable energy source to a device, including a flexible catheter-type device, which comprises an electrode, in contact with the body tissue. A suitable energy source may consist of radiofrequency energy, microwave energy, ultrasonic energy, alternating current energy, or laser energy. The energy is applied to the endometrosis, cysts, canker sore, gingivae, polyps, tumors, prostate, valvular annulus, or other cellular tissues through the electrode. A DIP (dispersive indifferent pad) type electrode, that contacts the patient, is connected to the Indifferent Electrode Connector on the RF generator. When using an alternating current electrical outlet, the generator should be grounded to avoid electrical interference. Heat is controlled by the power of the RF energy being delivered, by the delivery duration,
Tu Hosheng
Tu Steve Chun-Guang
Leubecker John P.
Quantum Therapeutics Corp.
Ruddy David M.
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