Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Thermal applicators
Reexamination Certificate
1998-03-23
2001-11-27
Leubecker, John P. (Department: 3739)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Thermal applicators
C606S169000, C433S216000, C015S022100
Reexamination Certificate
active
06322583
ABSTRACT:
The present invention generally relates to an improved device and methods for medical and dental purposes, and more particularly, to such a device and methods for providing appropriate heat treatment in a patient by delivering thermal energy to the gingivae site, or other tissue, with vibrational massage therapy.
BACKGROUND OF THE INVENTION
The gingivae are the gums and consist of a dense, fibrous connective tissue that attaches to the underlying bone and to the necks of the teeth. Gingivae are covered with a smooth mucous membrane, which is continuous with the mucous membrane of the lips and cheek, and is reflected into the tooth sockets where it is continuous with the periosteum. More teeth are lost by people over 35 because of periodontal disease (socalled pyorrhea) than from any other cause. Over half of our population beyond age 35 has developed some form of this disease. Many of these people are unaware of this condition because it is usually painless and progresses very slowly.
The simplest and most common form of the diseases is an inflammation of the gums known as gingivitis. It begins with a slight swelling along the gum margin of one or more teeth. The gum tissue in the area may have a slightly different color. As the condition grows worse, the puffiness and color change become more pronounced. The “collar” of the gum tissue loses its tight adaptation to the tooth surface, and the tissue bleeds on slight pressure.
If the disturbance is not treated, the gum tissue may gradually separate from the tooth and a pocket may form between the soft gum tissue and the hard tooth surface. The gingivitis, which is more superficial, has now developed into a more deep-seated condition called periodontitis. Bacteria, saliva and food debris collect in the pockets and intensify the destructive process. The bone adjacent to this area disappears, more attaching tissue is lost, and the pocket deepens and widens. Eventually, the tooth loosens, and in the process of chewing, additional irritation can occur.
The dentist may have to surgically remove the gum tissue that has been separated from the tooth during pocket formation. This procedure eliminates areas of stagnation and irritation, and it produces a greater surface area on the tooth, which needs to be kept clean.
Surgery exposes a patient to greater risks, due to infection and other health reasons. 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 ablation, the electrode with a vibration capability is used to simultaneously deliver the 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 catheter to ablate tissue, in which there is the capability for simultaneously delivering radiofrequency energy and vibrational massage therapy.
Therefore, there is a need for an improved medical device and methods using radiofrequency energy to treat gingivae or tumors, while applying vibrational massage therapy.
SUMMARY OF THE INVENTION
In general, it is an object of the present invention to provide a method and an improved medical device for generating heat, to treat gingivae, polyps, prostate, tumors, or cellular tissues. It is another object of the present invention to provide a device in which vibrational massage therapy can be applied to the gingivae, polyps, prostate, tumors, or the targeted cellular tissues, for intimate contact. 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 means is preferably at the proximity of the tip of the medical device. It is still another object of this invention to provide a method and a device for treating gingivae, polyps, prostate, tumors, or cellular tissues in a patient by delivering a therapeutic agent to the targeted site.
Briefly, heat is generated by applying a suitable energy source to a device, which is comprised of an electrode means, 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 can be applied to the canker sore, the gingivae, the polyps, tumors, prostate, or other cellular tissues through the electrode means. 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 and by the delivery duration. The standard RF energy generator means, and its applications through the electrode means to a patient, are well known for those who are skilled in the art.
In a further embodiment, means for generating vibration at the distal section comprises a motor mounted in the cavity of the handle, which has a rotatable motor shaft, an elongated connecting shaft having a first end, to which the electrode means is connected, and a second end connected to the handle, a weight eccentrically mounted on the motor shaft with respect to the motor shaft axis, so as to rotate eccentrically, so that when the motor shaft rotates, the electrode vibrates. In another embodiment, means for generating vibration at the distal section comprises an ultrasonic generating means.
In one embodiment, the device is leak-proof so that the therapeutic agent, in either fluid phase or gel phase, can be forced under a positive pressure to flow inside the lumen of the medical device from its proximal end to the distal end. The fluid is vented through the at least one opening at the proximity of the electrode means to effect the therapeutic purpose to the targeted tissue site.
The method and device of the present invention has several significant advantages over other known systems or techniques to treat the canker sore, the gingivae, the polyps, prostate, tumors, or other cellular tissues. In particular, the device system comprising of the electrode means, using RF energy as a heat source, in this invention, and simultaneously delivering vibrational massage therapy to the targeted tissue sites, results in a more efficient therapeutic effect, which is highly desirable in its intended application on canker sores, the gingivae, the polyps, tumors, prostate, other cellular tissues, or other medical applications.
REFERENCES:
patent: 5176677 (1993-01-01), Wuchinich
patent: 5327501 (1994-07-01), Kato et al.
patent: 5456662 (1995-10-01), Edwards et al.
patent: 5651157 (1997-07-01), Hahn
patent: 5735280 (1998-04-01), Sherman et al.
patent: 5948009 (1999-09-01), Tu
patent: 5977087 (1999-11-01), Pehrson et al.
Gabriel Spera “The Next Wave in Minimally Invasive Surgery” Medical Device & Diagnostic Industry p. 36-44 (Aug. 1998).
Tu Hosheng
Tu Lily Chen
Kearney R.
Leubecker John P.
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