Surgery: kinesitherapy – Kinesitherapy – Ultrasonic
Reexamination Certificate
1998-08-03
2001-03-27
Lateef, Marvin M. (Department: 3737)
Surgery: kinesitherapy
Kinesitherapy
Ultrasonic
C601S003000, C601S046000, C600S437000, C600S439000, C606S041000, C606S169000, C606S170000, C606S171000, C604S022000, C607S002000, C607S076000
Reexamination Certificate
active
06206842
ABSTRACT:
The present invention generally relates to an improved ultrasonic ablation device and methods for treating hemorrhoids, polyps, vascular tissues, and natural conduit obstructions in a patient by delivering ultrasonic energy to the target tissue sites in association with therapeutic pressure management.
BACKGROUND OF THE INVENTION
One method of modifying cellular tissues in situ requires heating the tissues, and causing them to shrink and tighten. It is often less traumatic than surgical procedures and may be the only alternative method, wherein other procedures may be unsafe, complicate, or ineffective. Ablative treatment devices have an advantage because of using a destructive energy that is rapidly dissipated and reduced to a non-destructive level by conduction and convection, to forces of circulating fluids and other natural processes.
The destructive energy used includes microwave energy, radiofrequency energy, ultrasonic energy, cryogenic means, laser energy, and tissue destructive substances. They have been used to destroy malignant, benign, and other types of cells and tissues from a wide variety of anatomic sites and organs. Tissues treated include isolated carcinoma masses and, more specifically, organs such as the prostate, glandular and stromal nodules characteristic of benign prostate hyperplasia. These devices typically include a catheter or cannula which is used to carry a radiofrequency electrode or microwave energy antenna, through a duct, to the area of treatment, and applying energy diffusely through the duct wall into the surrounding tissues in the targeted directions.
Of particular interest to the present invention are ultrasonic energy therapeutic protocols, which have been proven to be highly effective. The traditional radiofrequency ablation provides therapeutic energy by heat conduction while the ultrasonic ablation can provide a deeper energy penetration by remote energy transmissions. By heating the tissues deeply, and causing them to shrink and tighten, the loosen tissue can be tightened and restored to its healthy state. Ultrasonic energy, when coupled with a temperature control mechanism, can be supplied to the device-to-tissue contact site and deep into the tissue zone precisely to obtain the desired tissue treatment. Ultrasonic energy is conveyed to the tissue by heat conduction and remote penetration.
To be more efficient in ultrasonic energy ablation, an ultrasonic transducer means with a vibration capability can be used to simultaneously deliver the massage therapy to the target tissues. The electric toothbrush with vibration has been disclosed in the following patents: Suyama in U.S. Pat. No. 4,944,296, Ng in U.S. Pat. No. 5,283,921, Hwang in U.S. Pat. No. 5,381,576, Okada in U.S. Pat No. 5,421,726, Mei in U.S. Pat. No. 5,617,603, and Hahn in U.S. Pat. No. 5,651,157. All the above patents disclose the advantage of an electric toothbrush with vibration. However, they do not teach using an ablation means with vibration capability to treat the tissues for therapeutic purpose.
On the other hand, Imran in U.S. Pat. No. 5,281,218 entitled “Catheter having needle electrode for radiofrequency ablation” teaches a method using a needle electrode that is attached onto a catheter for radiofrequency ablation. Though a needle-like electrode is beneficial to ablate a tissues point, it is not disclosed that the particular needle electrode could possibly combine pressure therapy and ultrasonic energy for proper contact with the target tissues. The “pressure therapy” is defined in this invention as applying appropriate pressure onto the tissues by a medical device.
Hemorrhoid is a varicose dilatation of a vein of the superior or inferior hemorrhoidal plexus, resulting from a persistent increase in venous pressure. The external hemorrhoid is a varicose dilatation of a vein of the inferior hemorrhoidal plexus, situated distal to the pectinate line and covered with modified anal skin. The internal hemorrhoid is a varicose dilatation of a vein of the superior hemorrhoidal plexus, originating above the pectinate line, and covered by mucous membrane. A more serious case of hemorrhoid, prolapsed hemorrhoid, is an internal hemorrhoid that has descended below the pectinate line and protruded outside the anal sphincter. One of the worst cases, strangulated hemorrhoid, is an internal hemorrhoid which has been prolapsed sufficiently and for long enough time for its blood supply to become occluded by the constricting action of the anal sphincters.
Taylor in U.S. Pat. No. 5,578,047 teaches a hemorrhoid-removing device. Tuffel in U.S. Pat. No. 4,938,221 teaches a hemorrhoid inflammation-reducing device. Bidoia in U.S. Pat. No. 5,203,863 teaches an instrument for the ligation of hemorrhoids. None of them discloses a medical device by using a suitable energy to treat a dilated vein to shrink it. On the other hand, an alternative for hemorrhoid treatment is by surgically removing the dilated vein by a laser or other means. For a dilated vein, RF energy or other suitable energy can be applied for treating the tissues of the vascular walls, and causing them to shrink and tighten.
Marcus et al. in U.S. Pat. No. 5,295,484 and Castellano et al. in U.S. Pat. No. 5,606,974 teach a catheter system having ultrasonic device for intracardiac ablation of arrhythmias. However, neither discloses a medical device having ultrasonic energy and pressure/vibrational therapy to treat the hemorrhoid tissues effectively.
Therefore, there is a need for an improved medical device and methods using the ultrasonic energy to treat a dilated vein or tissue, such as hemorrhoids or tumors, while simultaneously applying pressure and/or 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 the hemorrhoids, dilated vascular vessels, or other cellular tissues. It is another object of the present invention to provide a medical device so that vibrational massage therapy can be applied to the hemorrhoids, or the target cellular tissues, for intimate contact. It is another object of the present invention to provide a device utilizing ultrasonic transducer means for tissue treatment. It is still 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 close proximity of the ultrasonic transducer means of the medical device. It is still another object of this invention to provide a method and a device for treating hemorrhoids, dilated vascular vessels, or cellular tissues in a patient by applying appropriate pressure to the tissues.
In summary, heat is generated by supplying a suitable energy source to a device, that is comprised of an energy delivery or electrode means, in contact with the body tissues. 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 hemorrhoids or cellular tissues through the energy delivery or electrode means. A DIP (dispersive indifferent pad) type pad or electrode, which contacts the patient, is connected to the Indifferent Electrode Connector port on the ultrasonic energy generator. The generator should usually be grounded to avoid electrical interference. Heat is controlled by the power of the ultrasonic energy delivered and by the delivery duration. The standard ultrasonic energy generator means, and its applications through the ultrasonic transducer means, to a patient are well known for those who are skilled in the art. More detailed information can be found in U.S. Pat. No. 5,295,484.
The present invention comprises at least one ultrasonic transducer mounted on a distal end portion of a device. The ultrasonic transducer may be a single crystal transducer or a phased array crystal transducer. Ultrasonic trans
Tu Hosheng
Tu Lily Chen
Lateef Marvin M.
Lin Jeoyuh
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