Surgery: kinesitherapy – Kinesitherapy – Ultrasonic
Reexamination Certificate
1999-01-28
2001-03-27
Lateef, Marvin M. (Department: 3737)
Surgery: kinesitherapy
Kinesitherapy
Ultrasonic
Reexamination Certificate
active
06206843
ABSTRACT:
FIELD OF THE INVENTION
The present invention concerns an ultrasound system for the administration of ultrasound beams and methods for using this system both for therapeutical and/or cosmetic purposes.
BACKGROUND OF THE INVENTION
Ultrasound is a mechanical wave with a frequency above the audible range that propagates by motion of particles within the medium. The motion causes compressions and refraction of the particles so that a pressure wave travels along with mechanical disturbance.
Ultrasound has been used for several decades for diagnostic purposes, for visualizing soft tissues within the body of the patient. A system which utilizes ultrasound for diagnostic purposes, usually comprises a wave-generating transducer capable of generating an ultrasonic wave, and an ultrasonic receiving transducer capable of receiving the ultrasonic wave. Since the density of the tissue through which the ultrasound wave propagates, has an effect on the speed and attenuation of the wave, if the ultrasound wave passes through tissues having different densities, for example due to a presence of a tumor therein, the wave is distorted, which distortion can be monitored by the receiving transducer. Since ultrasound propagation through air is highly attenuated, the wave-generating transducer should be coupled to the body of the patient to be diagnosed through a specific coupling fluid medium, such as an ultrasonic gel.
U.S. Pat. No. 4,434,799 discloses an ultrasonic apparatus for medical examination wherein the patient organ to be diagnosed, for example a breast, is positioned between an ultrasonic wave-generating transducer and an ultrasonic receiving transducer. In contact with the skin, and at some distance from both the wave-generating transducer and the second receiving transducer, are first and second ultrasonic windows, respectively. The system contains two guiding devices containing a fluid medium, one for guiding ultrasonic waves from the transducer to the first window and from there to the body of the patient, and one for guiding the ultrasonic waves from the body of the patient to the second ultrasonic window and from there to the receiving transducer. This diagnostic apparatus, which emits a non-focused ultrasound wave, enables guiding of the ultrasound wave trough a liquid medium, and eliminates the need to use a coupling gel on the body of the patient, or the need to immerse the body of the patient to be examined in a water tank.
Ultrasound has also been proposed for therapeutical purposes, used in the area of physiotherapy, cardiology, ophthalmology, cancer therapy, and dentistry, Non-focused waves are used, for example, in physiotherapy and focused ultrasonic beams arc used for selectively destroying a living tissue in a desired location, for example, for destroying a malignant tissue. Many times, destruction by a focused ultrasound beam is combined with diagnostic ultrasound imaging which locates precisely the region of the tissue to be destroyed. Several clinical trials for the treatment of benign and malignant tumors of the prostate, bladder, kidney and eye have been conducted by using this method.
Another therapeutical application of the ultrasound, is its use to disintegrate kidney stones where the ultrasound high energy pulses produced by a lithotripter are absorbed in the condensed stone. The stone is slowly broken into small fragments by the energy forces, and is simultaneously monitored by X-ray vision or ultrasound vision. The ultrasound application continues until the broken stone fragments are small enough to be washed through the urinary tract. In practice, the body of the patient, or at least the area containing the organs to be treated, is immersed during the ultrasound administration phase in a water tank.
Ultrasound beams can be focused by using self-focusing radiators or special transducers, lenses or reflectors, or by electrical focusing.
As the ultrasound wave propagates through tissues, part of the energy is absorbed and converted to thermal energy. The thermal elevation of the tissue caused by energy absorption is inversely proportional to the beamed area. The greatest temperature elevation is induced at the focus of the beam, termed “the focal point” where it can be several hundred times more than the overlying tissue. This allows tissue at the focal point to be selectively destroyed while temperature elevation of the surrounding tissue is negligible.
Sharp focusing also allows fast energy delivery so that temperature levels that cause proteins to coagulate and cells to die can be reached in only a few seconds or second parts. The short exposure to sharply focus beams produces sharp temperature gradients and the transition distance between the coagulated cells and damaged cells may be only a few cells wide.
Ultrasound irradiation, where the focal point was at the blood vessel, was demonstrated in vivo to be able to occlude blood vessels and coagulate capillaries and larger arteries. Non-invasive treatment using focused ultrasound is being hindered by the fact that in order for the ultrasound wave to propagate the treated organs of the patient's body has to be immersed in a water tank, which is extremely cumbersome, especially where the patient is handicapped or elderly. Such immersion is almost impossible in cases where the treated area is the face. Even where immersion of the patient's body in a water bank is feasible, it hinders the manipulation of the focused ultrasound beam.
Another concept for solving the problems of the coupling liquid medium placed between the ultrasound transducer and the patient is achieved by immersing the whole ultrasound system within a water tank (Kullervo Hynynen, Science and Medicine, September/October 1996, pp 62-271). This arrangement is also quite cumbersome, not enabling free manipulation of the system.
WO 98/32379 discloses an ultrasonic system capable of providing a focused ultrasonic beam comprising a container holding a liquid medium. The container guides the ultrasonic beam from the ultrasonic generating element to the desired location of administration. The focal point of the focused ultrasonic beam according to WO 98/32379 is always outside of the container, as it is defined that the length of the container is smaller than the ultrasonic focal beam's length. According to this publication the focal point of the ultrasonic beam either immediately outside of the container, and in that case the beam is used to destroy biological tissue on the skin of the treated individual or, alternatively, the ultrasonic focal point may be some distance from the end of the container, and thus destruction of biological tissue is carried out at a desired depth of the body of the treated individual.
At times it is desired to provide pressure on a liquid holding organ such as a blood vessel, a gland a tube, without causing damage to the walls or membranes of the organ. For example it is desired at times to apply pressure on damaged blood vessels in order to stop them from external or internal bleeding; it is desired to apply pressure on gland or ducts, such as saliva, sweat and tear glands, in order to eliminate the excessive secretion therefrom; it is desired to empty and close tubes of the reproducing tract delivering sperm or ova in order to cause reversible sterilization; it is desired to empty blood vessels of their contents prior to their closure by application of energy in order to reduce the heat transport cooling effect of blood. To date, usually the pressure applied to those vessels, tubes or glands, is carried out by applying a mechanical pressure, for example, with the aid of forceps, on the tubes, glands or vessels. Such externally applied mechanical pressure, may not always be precise and controlled, and at times may cause damage such as tearing to the walls of the vessel, furthermore such pressure can not be applied to tissues that are located deeper within the body.
It would be highly desirable to provide a system and method to produce controlled pressure on liquid holding or liquid transferring organs such as
Elman Dmitry
Hassoon Salah
Iger Yoni
Segal Emanuel
Shalhevet David
Browdy and Neimark , P.L.L.C.
Lateef Marvin M.
Mantis Mercader Eleni
Ultra Cure Ltd.
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