WO2008144274A2

WO2008144274A2 - Method, system, and apparatus for line-focused ultrasound therapy

Info

Publication number: WO2008144274A2
Application number: PCT/US2008/063412
Authority: WO
Inventors: David Paul Quigley; Abraham Gal; Michael H. Phillips
Original assignee: Sono Esthetx, Inc.
Priority date: 2007-05-14
Filing date: 2008-05-12
Publication date: 2008-11-27
Also published as: WO2008144274A3

Abstract

A focused ultrasound transducer apparatus (107,107', 115) is provided. The transducer focuses the application of ultrasound energy along a substantially straight line. Systems and methods for using a line-focused ultrasound transducer apparatus (107,107', 115) are also provided, including systems and methods for using the apparatus to perform therapy on human skin, muscle, organ, or bone tissue.

Description

METHOD, SYSTEM, AND APPARATUS FOR LINE-FOCUSED ULTRASOUND

THERAPY

CROSS REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. Provisional Patent

Application Serial No. 60/917,806, entitled "Method and Apparatus for Line-Focused Ultrasound Therapy for Cosmetic and Esthetic Applications," filed on May 14, 2007, and the same is expressly incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to a new therapeutic device, system and method, including a device for treatment of skin, fat, veins, arteries, bone, tissue and internal organs within the body using an ultrasound energy source.

BACKGROUND

Laparoscopic surgery, lasers, and different thermally based techniques have been developed in the last 10 years to reduce the impact and trauma of general surgery and the radical removal of tissue from the patients. The general move in the medical industry and the desire of the patients for a higher quality of life has caused an explosion of less invasive or noninvasive procedures. The beneficial reductions in infections, complications, and costs to healthcare systems of these procedures are well known.

Although scalpels, lasers, radio frequency (RF), infrared, and electromagnetic systems have been somewhat effective in treating different medical applications, the lack of uniformity, the lengthy time to treat, the undesirable side effects, and the lack of significant clinical effect in deep tissue applications indicate that there is room for improvement of these various techniques.

In recent decades, there has been an increase in the number of laser techniques, microwave, radio frequency, cryotherapy, light-based-drug delivery systems, and various other therapeutic ultrasound applications. One of the fastest growing new technologies in this field is focused ultrasound, or FUS. Focused ultrasound use in medical applications has proliferated in many different areas: cardiology, prostate therapy, oncology, female diseases, and many others. The benefits of focused ultrasound are several-fold: it can be non-invasive, resulting in less or no bloodloss, less trauma to the patients, more precise, repeatable therapy, and more cost effective.

Ultrasound has been often accepted and used for imaging and diagnosis of diseases in the body in the medical field. Applications include guiding biopsies, detecting cancer and detecting suspicious tissue. Ultrasound imaging generally relies on the differences in the speed and angle of reflection of high frequency beams applied to various organs and soft tissues. Ultrasound waves are generally emitted from a transducer which also senses these reflections. Imaging ultrasound transducers can make use of the reflection properties of various tissues and surfaces within the body to create an image of the specific tissue or organ for the operator.

For therapy, ultrasound beams can be focused to produce site intensity levels thousands of times higher than diagnostic ultrasound. Focused ultrasound beams produce either thermal effects such as hyperthermia (at site intensity levels generally less than 600W/cm²) or the ablation of tissue (generally found with site intensities from 600 to 2000W/cm²), as well as mechanical effects such as the separation of cells caused by shearing forces (site intensity levels may be well over 3,000-5,000W/cm²), or even the breaking up of solid objects, liquefaction of tissues and cavitation.

In focused ultrasound applications, these effects occur at a distance from the radiating surface by focusing the ultrasonic waves at a specified target within the tissue. This can bring about a rapid temperature rise, or a cavitation effect, or a mechanical effect on the targeted tissue. By modulating and controlling these different tissue effects, a precise and predictable tissue therapy can be achieved based on the medical need. In some medical applications, the intervening and surrounding tissue of the focal zone can be spared using on-off cycle times, and lower power levels. In other applications, it may be clinically advantageous to allow the intervening tissue to be completely treated with the focused ultrasound energy. Lithotriptors for kidney stones and high intensity focused ultrasound systems (HIFU) for the treatment of prostate and fibroid applications are used widely in the world today. The formula generally used for calculating this intensity is:

I is the site intensity (energy flow density) in w/cm², Io is the free-field intensity, at the face of the transducer, for example, a is the attenuation coefficient for the specific tissue that is being treated, F is the ultrasound frequency being applied in Megahertz, 1 is the tissue depth of the beam to the focal point in cm, and Ti is the transducer index handling the focusing effect of the transducer.

In cosmetic medicine, the aging process of skin is inevitable, however, many techniques and treatments are now available to treat some of these age-related disorders. The skin is considered to be an organ of the body just as the heart, lungs, and kidneys - and it is the body's largest organ and covers some 20 square feet and weighing in at almost seven to nine pounds. The skin is comprised of three main layers, each with a distinct form and function for the body. They are the epidermis, the dermis and the subcutis. Below this is the fatty layer and finally the muscle layer of the body. The medical discipline of the cosmetic and esthetic surgery market is concerned with the treating of several diseases, and undesirable body conditions that affect the patients. These conditions include but are not limited to: skin inelasticity, wrinkles, deep lines, acne, scars, keloids, warts, dimpling (cellulite), bulging discoloration, sun spots, age spots, unwanted hair, unwanted tattoos, sagging of tissue, excess tissue, undesirable fat deposits, excessive sweat gland presence, or badly disfigured areas of the body, vein disorders (such as varicose veins, hemorrhoids, spider veins, etc.), open sores, lipomas, melanomas, or cancers of the skin, or obesity. In addition, some patients suffer from over active sweat glands in their face, hands, feet, groin, or armpit regions, often known as hyperhidrosis. The areas of the highest concentration of sweat glands is in the soles of the feet and the hands. There are two sets of nerves which supply these sweat glands, one being the parasympathetic nerves and the other being the sympathetic nerves. For the sweat glands, there is a chemical at the tips of the sympathetic nerves called adrenaline and too much of this chemical present near to the sweat glands can stimulate them to produce excessive amounts of fluid. Then other external stimuli such as smells, spicy foods, stress, exercise, hotter temperatures may combine with this excessive fluid -A- production to be secreted. Several therapies are used currently to destroy the sweat glands such as botox, electric currents such as iontophoresis, and the like. Due to the number of these sweat glands, a need exists for alternative techniques such as those disclosed herein. These current disease or undesirable states are often treated surgically with significant trauma, pain, risk of infection, and sometimes dramatically undesirable results for the patient.

For some vein, organ and cancer therapy applications, one embodiment of the present invention provides both imaging and therapy for this application. Imaging systems using ultrasound generally have multiple transducer surface regions or elements to control and monitor the radiation direction and to sense the source of these reflections. Ultrasound systems like this have been particularly useful in Doppler measurements of internal blood flows. Standard diagnostic ultrasound systems such as those sold by GE, Siemens, Hitachi or Toshiba have this feature. These Doppler systems make use of multiple ultrasound pulses to non-invasively detect and monitor internal movements such as blood flow through arteries and veins. Doppler colorflow indicates relative speeds of motion and assigns a range of colors to indicate this movement - both to (veins - blue color) and away (arteries - red color) from the heart. In the dermis applications of skin rejuvenation, wrinkle removal, cellulite, acne, scar treatments, warts, age spots, tattoo removal, fat reduction, vein treatments and others, the dermis or epidermis may be unaffected by the ultrasound transducer, while the energy is being delivered in therapeutic dosages below in the target zone. Vein disease is quite common and can manifest itself in many different ways throughout the body. Varicose veins tend to be enlarged veins that are swollen and raised above the surface of the skin. These veins can be dark purple or blue in color and can appear to be twisted or bulging beneath the skin. These diseased veins are commonly found on the backs of the calves or on the inside of the legs and they generally develop when valves in the veins that normally allow blood to flow toward the heart stop working properly. As a result, blood pools in the veins and causes them to enlarge. Varicose veins affect approximately 50 percent of people over age 50. They are more common in women than men. Spider veins and hemorrhoids are also types of varicose veins which are either smaller or occur in different places in the body.

For most people, varicose veins, spider veins, and hemorrhoids are common and medically insignificant - but they are a concern for cosmetic reasons. Sometimes however, these veins can cause significant pain and discomfort to the patients, and perhaps lead to even more severe problems in the body. Overall, they can affect up to 15 percent of men or 25 percent of women in the world. In addition, they often affect many women in their first trimester of pregnancy.

Treatments for these veins are varied from the very simple to more invasive surgeries such as the stripping of saphenous veins sometimes called a varicectomy. Besides the risk to the patient of an invasive approach, some surgical techniques such as proximal ligation of the saphenous veins has often been shown to only be effective in about 20 - 80 percent of the patients treated. Some patients elect to have laser or injection therapy, the latter of which includes saline, alcohol or certain medical "foams" intended to either block or cause thrombosis of the diseased vein - a process called sclerotherapy. These endovenous techniques still have much development work to be done and depend substantially on the skill and experience of the surgeon. These types of therapies are minimally invasive, and are often performed under local anesthesia and intravenous sedation. This eliminates the need for and the risk of general anesthesia to the patients.

The formation of a thrombus is usually caused by injury to the wall of the vein vessel, either by heat, or trauma. This causes a slowing or stagnation of blood flow past the point of injury. This can sometimes be termed as intravascular coagulation, where a structureless mass of red blood cells, leukocytes and fibrin accumulate in the insulted or injured area, causing the veins to shut down.

Often in cosmetic or esthetic surgery, there is a need or desire to remove deep lines in the skin of the face, limbs or other body parts. This technique is often performed with open surgery, or needle surgery, or RF needle energy techniques in order to separate one layer of the skin or deeper fascia from another. A needle or fiber can be passed under the dermis and then moved back and forth under deep lines and the tissue can be separated from the lower subcutis tissue in an effort to make these lines disappear. Sometimes the patient is then placed into a mask and this tissue is allowed to heal in a more attractive position for a number of days In deeper tissue, organ, and bone applications, there has been an increase in the use of less invasive or noninvasive technologies in order to reduce patient trauma due to the surgery and decrease the complications of the therapy. Despite these newer techniques, significant problems still arise intra-operatively from blood loss, ischemia, surgical fluid absorption, post-operative bleeding, urine leakage, and the tracking or migration of cancer cells caused by surgery.

SUMMARY

The present invention relates to a new therapeutic device, system and methods including a device for the treatment of cosmetic and esthetic therapy, and other internal organs, bone and tissue within the body using a line-focus ultrasound energy source. The unique nature and benefit of applying this line-focused ultrasound is the uniformity of the results which are particularly important to the patient in these applications. The present invention also relates to use of such a system or methods to simultaneously treat a plane of tissue using line-focused ultrasound energy sources. This is unique in that the "line-focused ultrasound" produces a line or plane of treated tissue instead of a "spot-focused" ultrasound therapy, and the uniformity of the results can be particularly valuable to the surgeon or operator in areas of cosmetic, esthetic, oncology and organ surgery, particularly for organs that are highly vascular and susceptible to bleeding. Various embodiments of the present invention address this and other needs.

In accordance with the present invention, focused ultrasound is generated in a line-focused pattern, whether low, high, or very high intensity in nature. It can be applied non-invasively, with few side effects to treat these conditions. The unique nature and benefit of applying this line-focused ultrasound is the uniformity of the results which are particularly important to the user and patients in certain cosmetic, esthetic, oncologic, organ treatments, soft tissue treatments, bone or bone marrow treatments, venous or arterial applications.

In deeper tissue applications such as fat removal, vein treatments, deep line removal, and organ treatments such as liver, kidney, lung, stomach, pancreas, or bone treatments, the line-focused ultrasound beam intensity may be raised to high intensity or very high intensity in order to create a thermal, cavitational, or mechanical shearing or ripping of the tissue or vessels. These energy dosages can be delivered in either pulsed or continuous beam or modulated duty cycles depending on the application required.

Energy from the line-focused ultrasound transducer embodied in the present invention converges into a sharp and precise line-focus ablation pattern on the targeted tissue which can mechanically disrupt tissue, separate tissue at designated depths, based on layers identified within the body. The temperature rise in the target area created by this embodiment is estimated to be between 40 to 100⁰C to cause the necessary thermal or mechanical, clinical effect. The operating frequency for this embodiment will be in an acoustic range above the range of normal human hearing (i.e., ultrasonic). The chosen frequency of the transducer is determined based on the application of interest with appropriate physics/effectiveness tradeoffs.

In this embodiment, a controller is operatively coupled to the transducer to power the transducer. The controller has a frequency range of 1 to 25 MHz, depending on the application. Ultrasound frequency determines the size and shape of the therapy zone, the effective depth of penetration of the focused ultrasound beam and the degree of change in tissue temperature or focal site intensity. Lower frequency focused ultrasound transducers generally produce longer focal areas that are deeper in the body but have lower degree of change in site intensity. This may be necessary for the deeper tissue and organ treatments or bone therapy. Conversely, the controller may control high frequency focused ultrasound transducers in the range of about 10-25MHz, producing extremely sharp, line-focal zones at a shallow depth in the tissue. The preferred embodiments of the device operate in the range of 1.5 to 25 MHz, and more specifically, in the range of 3.0 to 8 Mhz. Skin and fat applications that typically are quite precise and shallow in depth may require a higher frequency, whereas large organs, deeps tissue, and bone ablation or therapy may require lower frequency transducers.

Focused ultrasound generated in a line-focused pattern, whether low, high, or very high intensity in nature can be applied non-invasively, with little side effects to treat cosmetic, esthetic, or other tissue conditions as disclosed herein. By curving an ultrasound transducer or lens in a circular or ball fashion, all points on the transducer face point come to a focus at a specific spot and produce a rapid and extremely high intensity rise in the focal zone. The unique nature and benefit of applying this line-focused ultrasound is the uniformity of the results which are particularly important to the patient in cosmetic and esthetic applications.

A line-focused ultrasound transducer emitting high or very high intensity ultrasound is likely capable of noninvasively ripping or separating the tissue layers of the skin or the subcutis or other fascia layer between the fat layer and the muscle layer with or without integrated diagnostic ultrasound imaging. The benefits of this type of an approach include less trauma to the patients, no incisions or needles penetrating the skin, and quicker healing times with less chance of infections for the patients. In the treatment of vascular organs or cancer and tumors, for example, this combination of imaging ultrasound, whether conventional and or Doppler ultrasound, with the therapeutic line-focused ultrasound, may be used in diseased tissues in order to cause veins or arteries to close or to treat tissue around the arteries or veins. This integrated approach of applying Doppler ultrasound to identify the location, depth and orientation of the diseased veins that are intact and then applying a line-focus ultrasound ablation or therapeutic pattern is unique to this system. The Doppler system can provide the appropriate information to the user of the transducer as to the specific depth of the artery or vein, or of the diseased tissue to be treated and of its angle or orientation relative to the transducer that can assist the user to be able to apply a therapeutic dose of line-focus ultrasound.

One embodiment of the system includes an applicator containing the barrel shaped, line-focus transducer. In this embodiment, a face housing ensures complete coupling with the skin. The face housing may or may not include vacuum functionality to ensure complete coupling to the skin surface. In addition, the embodiment may have internal and/or external water paths for the inflow and outflow of circulating fluids, or degassed, temperature-controlled water for the purposes of producing an ultrasound coupling medium and for optimizing the temperature of the skin or tissue surface during the process of treating tissue, veins or other deep seated tissues and organs with line-focused ultrasound beams.

Another embodiment of the present invention provides a system that includes a mechanism used to retract or extend the transducer assembly within the housing in order to set the transducer line-focus pattern at a user chosen appropriate depth in the case of a fixed focal length transducer array. Some embodiments of the invention may also include a flexible, or piecewise flexible transducer material that can change its curvature and thus change the focal depth of the line-focus energy beam. Whether mechanical or electrical, these motors, gears, or lever devices will move the transducer in precise increments so that the depth of the line-focus can be accurately placed on the skin, tissue or organ of the patient.

A further embodiment of the present invention couples the line- focused ultrasound transducer inside an operator controlled or directed probe, scope or clamp that can be rigid or flexible in nature. This probe or clamp may be articulated or angled towards and around organs or areas within the body in order to deliver a complete and appropriate therapy to the desired tissue in skin, tissue, an organ, or bone. This probe or clamp might be reusable or disposable, and packaged sterile or sterilizeable. This probe or clamp may also be coupled with a Doppler ultrasound probe or transducer in order to detect blood flow near and along the line of therapy.

A further embodiment of the present invention couples two or more one line-focused ultrasound transducers opposite each other, either directly opposite or slightly askew to create a uniform plane of treated tissue between or among the transducers. These line-focused ultrasound transducers may also be wired and programmed to detect the proximity of the opposing transducer's energy to the face of one or both transducers thus allowing the software and alarms of the control system of the present invention to notify the operator, thus saving the device from causing damage to itself. In this embodiment of the present invention, a sharp blade may be released under spring mechanism to cut in a forward manner the treated tissue between the two opposite, line-focused transducers.

Clinically, the embodiment of the line-focused ultrasound invention herein produces extremely precise tissue therapy, whether at low, high or very high intensity energy applications. This invention is unique in that it can apply an even and uniform line of therapeutic effect in the targeted tissue, more quickly and with less irregularity in the energy deposition than a single-spot focused ultrasound system. Most focused ultrasound systems are spot-focused in nature because the transducers or spoons that deliver the energy are uniformly curved across the whole transducer face, such that all points on the face of the radius have the same focal spot or radius. A line-focused ultrasound transducer is unique in that it is shaped like a half-pipe split lengthwise. In this configuration the transducer creates a "line" of connected focal spots, evenly placed and evenly distributed according to the geometry of the half-pipe transducer. The focused ultrasound from this line-focused transducer can either be delivered as a pulsed, continuous beam, or modulated application depending on the appropriate effect required.

The console/control/user interface system of the embodiment is composed of components such as (but not limited to): an RF generator for the focused ultrasound energy, input output processing boards for signal processing, a digital read out of applicator fluid temperature, and power levels, depth and vein diameter measurements for determining appropriate power levels, a system of dynamic power output control to change therapeutic ultrasound power for each treatment or application, an indication of selected depth of penetration into tissue. The RF generator may have operating characteristics similar to a standard focused ultrasound amplifier. An example of a suitable generator is produced by ENI or T&C Inc. This generator often controls both the frequency of ultrasound delivered as well as the power, which is often measured in watts (W). Output power dramatically influences the therapeutic effect of the transducer. Because it is focused, a transducer that delivers 20-50W of power at the face can create a focal site intensity from 1,600 to 3,000W/cm2 at the focal site causing significant tissue ablation or mechanical shearing effects.

According to one aspect of the present invention, an apparatus is provided, comprising a curved therapeutic ultrasound transducer configured to substantially simultaneously produce a plurality of thermal energy therapy spots in human tissue, wherein the plurality of therapy spots are applied evenly along a line of the human tissue. The apparatus may comprise a lens. The human tissue may be one of skin, adipose tissue, organ tissue, veins, sweat glands, cancerous tissue, and bone. The therapy spots may be applied for one of cosmetic and esthetic therapy. The plurality of therapy spots may comprise a therapy zone and the transducer may comprise a flexible portion configured to change an angle of curvature of the transducer to adjust a focal depth of the therapy zone.

The apparatus may comprise a user-controlled body coupled to the transducer, wherein the user-controlled body directs thermal energy toward a specific portion of the human tissue for accurate therapy. The user-controlled body may comprise one of a rigid probe, an articulating probe, a hand piece, a clamp, a direct visualization lumen, and a channel.

The apparatus may comprise at least one second ultrasound transducer, the second ultrasound transducer comprising at least one of a diagnostic ultrasound transducer and a Doppler ultrasound transducer. The at least one second ultrasound transducer may be located in-line with the therapeutic transducer. The at least one second ultrasound transducer may be separately coupled to the therapeutic transducer.

The apparatus may comprise at least one magnetic and gear driven screw system configured to provide precise vertical or lateral movement of the apparatus to deliver therapeutic line-focused ultrasound.

According to another aspect of the present invention, a method is provided, comprising operating the apparatus of claim 1 to detect and identify at least artery or vein in human tissue that controls blood flow to a targeted area of human tissue or becomes the target itself, providing thermal, cavitational or mechanical shearing energy to treat the targeted area, and providing operator feedback regarding at least one characteristic of the targeted area.

The method may comprise providing operator feedback relating to whether the targeted area includes at least one of treated tissue, necrosed tissue, and cancerous tissue.

According to another aspect of the present invention, a system is provided, comprising the apparatus of Claim 1, a second apparatus configured for patient interface with the apparatus of claim 1, the second apparatus being configured to flatten or smooth human tissue, and a third apparatus, configured to provide vacuum suction through the patient interface to the human tissue, to maintain a contact surface during therapy.

The system may comprise a fifth apparatus configured to engage at least one of an interchangeable probe, a clamp or a hand piece, to adjust the size of the transducer as needed for different therapy applications. The system may comprise an ultrasound permeable material capable of both transmitting the appropriate level of focused ultrasound and holding an ultrasound permeable medium in front of the apparatus of claim 1. The system may comprise a mechanism for circulating at least one type of ultrasound-transmittable medium including at least one of a temperature- controlled degassed water, a Florinert ™, a mineral oil, a liquid, and a gel, which allows ultrasound to pass through the medium, controlling the temperature of the surface, to a targeted area of a patient. The system may comprise a mechanism to position and rotate on an axis a plurality of separate line-focused ultrasound transducers, wherein each of the transducers is capable of applying thermal energy to a single or multiple focal zone which may be shallower or deeper based on the angle of rotation of the mechanism.

According to another aspect of the present invention, a system is provided, comprising an apparatus, which comprises a plurality of line-focused transducers oriented substantially opposite each other, a body configured to hold the line-focused transducers substantially opposite each other, a plurality of handles configured to enable operator control of the body, a hinge mechanism configured to allow the body to engage human tissue, a Doppler ultrasound transducer in-line with at least one of the line-focused transducers, and a blade arranged to pass between the line-focused transducers. The body may be a clamp.

The blade may be one of a single use blade and a multiple-use blade. The line-focused transducers may be at least one of reusable and disposable for sterile surgical use. The apparatus may include at least one of detachable and interchangeable tips, transducers, and clamps for different applications. The apparatus may be usable to create a solid plane of tissue ablation between the line-focused transducers. The body may be configured to squeeze, hold or compress an organ or tissue during activation of the line-focused transducers. The system may comprise a blood flow detector configured to detect blow flow between the line-focused transducers. The system may comprise a controller configured to determine the treated levels of intervening tissue. The blade may be configured to cut treated or ablated tissue between the line-focused transducers. At least one of the line-focused transducers may be configured to detect the presence or proximity of the opposing transducer's focal zone so as not to allow the system to damage itself.

In accordance with another aspect of the present invention , a method is provided, comprising providing an apparatus including a line-focused ultrasound transducer, activating the transducer to subject a target area of human tissue in a human body, the human tissue having a plurality of layers, to an amount of thermal energy to separate layers of the human tissue, and determining if the separated tissue layers should be removed from the human body.

The method may comprise detecting a movement or speed of movement, or lack of movement, of at least a portion of the apparatus over the human tissue. The method may comprise delivering line-focused ultrasound energy to a treated area of a patient and receiving feedback relating to an amount of ultrasound energy delivered to the treated area. The method may comprise providing a dosage control system configured to control dosage levels of focused ultrasound energy in various therapeutic applications. The method may comprise displaying an estimated depth of a focal therapy zone in the tissue to an operator. The method may comprise using diagnostic ultrasound to calculate a volume of tissue to be treated in a designated area of the body prior to applying line-focused ultrasound. The method may comprise using pulsed ultrasound to determine if the apparatus has become detached from the tissue surface of a patient. The method may comprise using ultrasound feedback information to stop or pause therapy so as not to damage the apparatus or a patient surface interface.

Patentable subject matter may include one or more features or combinations of features shown or described anywhere in this disclosure including the written description, drawings, and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a simplified, side-view of a line-focused transducer according to one embodiment of the present invention;

Fig. 2 is length- wise perspective of the embodiment transducer shown in Fig. 1 showing the line-focused ultrasound;

Fig. 3 is sectional view of the present invention shown treating tissue just below the epidermis;

Fig. 4 is perspective view of a surgical handpiece according to one embodiment of the invention that is coupled to the line-focused transducer; Fig. 5 is a simplified perspective of the venous bloodflow in the body, particularly in diseased varicose veins with the patient in a standing position and venous bloodflow moving away from the heart; Fig. 6 is simplified perspective of the same veins in a patient that is sitting or laying prone and the venous bloodflow is returning to the heart normally;

Fig 7. is a simplified perspective of the same veins being treated with one embodiment of the present invention; Fig. 8 is a simplified perspective of the same veins post-treatment with one embodiment of the present invention;

Fig 9 is a simplified perspective of the construction of a deep line or wrinkle in the skin of a patient;

Fig. 10 is a simplified perspective of the deep line or wrinkle being treated with one embodiment of the present invention;

Fig. 11 is a simplified perspective of the same deep line or wrinkle post-treatment with one embodiment of the present invention;

Fig 12. is a sectional, side view of the segmented transducer according to one embodiment of the present invention; Fig. 13 is a sectional side view of a flexible transducer according to one embodiment of the present invention;

Fig. 14 is a sectional side-view of the same flexible transducer in its flexed state with shorter focal length;

Fig. 15 is a sectional side-view of a double transducer according to one embodiment of the present invention;

Fig. 16 is a sectional side detailed view of the transducer depth control mechanism according to one embodiment of the present invention; and

Figs. 17a and b are sectional side-side views of a line-focused transducer mounted within a rigid or flexible probe or clamp; Fig. 18 is a sectional side-view of a double transducer according to one embodiment of the present invention;

Fig. 19 is a sectional side-view of a double transducer with a cutting blade mechanism according to one embodiment of the present invention; and

Fig. 20 is a control diagram depicting integration of Doppler and imaging ultrasound and an applicator with an infra-red movement tracking detection mechanism in accordance with the present invention. DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. With reference to Fig. 1, there is shown a side view of the line-focus ultrasound transducer 107 to demonstrate the physics of focused ultrasound transducer therapy within the body. The transducer 107 may be composed of one or multiple transducer elements 101 in line or parallel to each other, which generate the ultrasonic signal through electrical leads fed through contacts to the back of the element(s) 101. The ultrasound energy generated from the element(s) 101 is then focused through the curved and shaped transducer lens 102 that sharply and precisely focuses the ultrasound energy to a geometric focal line 105. According to an embodiment of the invention, the line-focused transducer elements 101 may be curved, thereby eliminating the need for an additional lens. The line-focused ultrasound beams emanate from the face 108 of the curved lens 102 in either modulated, pulsed, or continuous beams 104 at radius R (103), the value of which depends upon the degree of curvature of the face 108.

The treatment area or therapy area 106 surrounding the line-focus of the transducer 107 is the area where thermal, mechanical, or cavitational effects are caused in the skin, fatty layers, arteries and veins, organs, bones, or other tissues in the body to be treated.

Transducer 107 may be coupled or embedded with a standard diagnostic imaging element, capable of rendering either a quantitative signal or diagnostic image (a gray-scale diagnostic image, for example). This diagnostic imaging may be used concurrently during line-focused ultrasound therapy or prior to the application of line-focused ultrasound energy for the purposes of localizing and orienting the transducer 107 relative to the patient or targeted vessel or tissue. This aids in the provision of an appropriate location, output power levels, depth of penetration, and duty cycle of the transducer 107 therapy.

With reference to Fig. 2, there is shown an embodiment of the present invention in a longitudinal side-view depicting the transducer assembly 107 with its half-pipe, curved or shaped design intended to produce a line-focused ultrasound therapy area or therapeutic region 106 comprised of a continuous line of geometric focal points 100 created by the ultrasound energy beams 104 emanating from lens 102 and caused by the transducer element or elements 101. The material composition of element(s) 101 and lens 102 may be varied depending upon the length and size of the transducer 107, and the particular application of the system. For example, materials such as ceramic, fiberglass, composite material, plastic, aluminum, gold, etc. The transducer 107 can be fabricated to be either disposable or reusable based on the requirements of the market or the application.

In Fig. 3, the transducer 107 is shown as it is being applied to shallow dermis tissue 109, just below the epidermis tissue 201, which remains unaffected by the ultrasound therapy. According to one embodiment of the invention, the transducer 107 emits a line-focused ultrasound beam 104 from lens 102 and element 101 into the dermis region of the body 109. The line-focused therapy area 106 is indicated in Fig. 3 by the rectangular therapy zone 98. The dermis layer 109 is composed of many tissue structures and small blood vessels and capillaries that nourish the skin and which would be the primary targeted region of the skin to be treated. It is possible that the therapy zone may overlap into the subcutis 110 inadvertently, or even intentionally in order to treat the subcutis 110 for certain desired clinical effects. With reference to Fig. 4 there is shown a handpiece assembly or applicator 111, according to one embodiment of the present invention, which incorporates the line-focused ultrasound transducer 107 and a conical housing 112 from which the line-focused ultrasound therapy zone 98 is emitted. There is a dial or other mechanism 113 that the operator can use to adjust the offset or depth of the transducer 107 in the applicator 111 for the purpose of changing the depth of penetration of the line-focused ultrasound therapy zone 106. This depth dimension is visible in the window or display 114 during treatment. This depth calculation is made in real-time with software calculations using an ultrasound reflection and receiving function to determine the distance to the skin or tissue as the first tissue interface and calculating the focal depth set by the curvature of the face 108. Additionally, according to another embodiment of the present invention, the depth setting of the transducer 107 may be communicated electronically to the user console or controller 306 to display to the user or to precondition the system to treatment protocols. In general, console or controller 306 includes a monitor 314, a computer, such as a microcomputer or similar computing device, 315, and an input-output controller 316, which may include a keypad, touch screen, visual display, one or more communications ports or other suitable input or output devices. In some applications, the applicator 111 may have a degassed, cooled water or other ultrasound compatible medium circulation system 307 with inlet and outlet ports and channels to allow for the cooled degassed fluid to flow smoothly around the transducer 107 and in the conical housing 112 between the skin or tissue and the transducer 107. This medium serves three purposes for the treatment: the first is to allow the ultrasound beams 104 to propagate through the conical housing 112 and into the patient, the second is temperature control of transducer 107 if required over longer treatment periods, and the third is to act as a temperature controlled interface between the line-focused ultrasound beam 104 and the epidermis 201 of the skin, or the surface of the tissue. Those of ordinary skill in the art will understand that in all embodiments, either an ultrasound-compatible medium is disposed between the transducer 107 and the therapy area 106, or the transducer 107 is engaged with the therapy area 106, during application of therapy. In other words, while this feature may have been eliminated from the drawings for simplicity, it will be understood that there is no air space between transducer 107 and the therapy area 106 when therapy is being performed.

For example, in some embodiments of the present invention, the handpiece or applicator 111 is coupled with a curved or flat patient interface panel 97 that lays smoothly on the patient's body or tissue for the purpose of smoothing skin or tissue during application or drawing the skin or tissue up into a tight coupling with the conical housing 112. A vacuum/blower system 313 driven with mechanical and electrical subsystems known in the art and vented through the applicator 111 is capable of alternatively drawing in air and expelling air or other gas through one or several holes or ports 96 in the patient interface panel 97. As a result, the vacuum/blower system 313 can draw patient skin and tissue up towards the transducer 107, ensuring a tight interface with the applicator 111 and the skin or tissue. In addition, for some applications this provides a safety margin so that the ultrasound therapy beam 104 does not inadvertently treat bony surfaces in the body. This may be important due to the high attenuation coefficient of ultrasound in bone tissue which may lead to undesirable heating and tissue damage. The blowing function 313 may alternatively expel the ultrasound gel or other coupling media from the port openings 96 in the interface panel 97 in order to clear them periodically during the treatment. This function may take place automatically, for example, during a pause in the movement head of the applicator 111 on the skin or tissue or if the vacuum function 313 senses that there is a break in the contact with the skin or tissue. Additionally, this function may aid cleaning the applicator 111 after usage.

In yet another embodiment of the present invention, the applicator 111 is detachable from a console 306 to allow for different applicators, probes or clamps to be used with the same console 306. Therefore, different size applicators, probes, clamps and transducers can be used for different parts of the body, allowing for faster treatments, large areas to be treated and smaller transducer assemblies for small body parts, organs, bones, vessels and fine, precision work. This detachable applicator 111 may include mechanical, snap-fit valves for the fluid and gas supply connections, electrical contacts, power and signal cables to the transducer 107, as well as other connections as needed.

In another example, the applicator 111 has mechanisms for diagnosing, measuring and monitoring therapy energy delivery based on the actual mechanical speed of movement of the applicator 111 across the skin or tissue surface of the body. The operator can operate the applicator 111 in a diagnostic mode to measure how much tissue surface will be covered in a particular planned treatment. In the case of fat removal applications, the system can indicate to the operator if the area to be covered is clinically acceptable for this patient as too much fat removal may be a problem for the patient's body. In addition, this diagnostic portion of the treatment can also help to characterize the tissue to be treated such as the amount of vascularity in the tissue, or the presence of and foreign objects, bone materials, and the like, which should be avoided during treatment. This is achieved using ultrasound for the characterization of the tissue, and either infrared or visible light technology in the applicator to give spatial reference and velocity information to the operator from a point "0" start point. These visible or infrared emitters and sensors may be combined or used similarly to an optical computer mouse assembly in the applicator to determine degree and direction of movement across the skin. This movement tracking system provides immediate feedback to the operator and to the energy delivery system of the applicator so that the energy can be paused or stopped if the operator movement is not fast enough - thereby delivering too much energy to a particular spot. Similarly, if the operator is moving the probe or applicator across the tissue too quickly to be effective for treatment, an indicator or annunciator on the console is activated. In addition, the system may monitor and track how much energy over tissue volume and time to treat and store these treatment parameters for later reference for each patient.

With reference to Fig. 5, there is shown epidermis 201 that covers visible varicose veins 206, 207, 208 that are bulging or protruding under the skin which is also composed of dermis 202 and subcutis 203. The blood flow in varicose veins 207 actually flows away from the heart (as depicted by the arrows in veins 206, 207, 208) when the patient is in a standing or vertical position. The arrows in veins 206, 207, 208 indicate the direction of the diseased state of a varicose vein. These varicose veins can be supplied by perforating veins 205 from the long saphenous vein 208 that cross the superficial fascia 204.

Patients with varicose veins who stand and experience the backward pressure of gravity and other positive fluid pressures that may be present in the leg see this unhealthy reversal of the blood flow through the varicose veins, where blood might pool up slowly and swirl around in the varicose tributaries 207 or even move away from the heart.

In Fig. 6, the bloodflow of a patient with the same varicose veins as shown in Fig 5 suddenly reverses in the same venous vessels in a patient who is sitting or lying prone. An example of this reversal of blood flow in veins 206, 207, 208 is shown by the direction of the arrows of Fig. 6.

Another embodiment of the present invention, shown in Fig. 7 with inline Doppler ultrasound incorporated or set in-line separately in transducer 107, is able to detect this change in direction of blood flow (depicted in Figs. 5-6) using software and signal processing in the circuitry of the console. The change in bloodflow direction in the varicose veins and tributaries indicates to the operator and the system the depth, direction, location, and orientation of these diseased veins. The varicose tributaries or the long saphenous vein 208 may then be chosen by the operator for treatment, causing these veins to spasm and contract. This in turn cuts off unnecessary blood flow to the diseased veins further downstream and visible through the epidermis 201.

As indicated in Fig. 8, after treatment, the veins 207 have completely contracted and stopped or dramatically reduced the flow of blood through the veins, thus shutting off further bloodflow downstream to the varicose veins 206 that were previously visible under the epidermis 201 and dermis 202. This eliminates pain and clinical risk to these patients from the previously pooling blood.

This treatment may be repeated as necessary to these and other vessels in an effort to completely shut off these veins and promote healing in the patient. This line-focused ultrasound treatment method coupled with diagnostic imaging or Doppler imaging 302 may also be used in other types of blood vessels (arteries, veins, capillaries) and even in organs within the body requiring a similar spasm or collagen shrinkage effect to shut down the flow or cut off supply of lymphatic or other body fluid within these vessels. Fig. 9 depicts epidermis 201 that covers the dermis 202 and the subcutis 203. These three components make up the "skin" of a patient. In addition, there are superficial fascia 204 and other layers such as the fat layer 210 represented in Fig. 9. In certain deep lines 212 in the face or other parts of the body, the epidermis and the dermis are pinched or pulled down or held down in a pinch-point 211 by the subcutis 203 or other tissue layer of the body. This pulling or holding of the tissue in this region of the skin produces the deep lines in a patient's face. A similar phenomena may also occur in other areas or layers of the body as well.

With reference to Fig. 10, there is shown one embodiment of the present invention during use in the skin from a side view, where transducer 107 is emitting line-focused ultrasound beams 104 from the lens 102 and the element 101 to a treatment zone 106 under the deep line 212 through the epidermis 201 and dermis 202 region of the skin to the pinch point 211 between the dermis 202 and the subcutis 203. The line-focused therapy zone 106 is located immediately underneath the pinch- point. The intense ripping effect of the intensity of the line-focused ultrasound beam 104 can rip or sever the tissue and thereby release the pinch point 211 pressure on the tissue, as shown in Fig. 11. This same transducer 107 may also be used to rip or cut treated or ablated tissue in the body, either after line-focused ultrasound therapy or some other treatment modality.

With reference to Fig. 11, there is shown the treated tissue 202, at some point after the treatment method of the present invention according to the embodiment demonstrated in Fig. 10 has occurred, where the epidermis 201 and dermis tissue 202 have separated from the subcutis layer 203 of the skin. Also indicated is the point of tissue separation 213 that has now scarred over leaving the epidermis 201 line-free as shown before the treatment in Fig. 9. This treatment may be repeated as necessary to these and other such lines in an effort to completely relax the deep lines on the patient's face, limbs or body. This line-focused ultrasound treatment method may be coupled with diagnostic imaging or Doppler imaging in order to treat other organs or tissues within the body including arteries, veins, capillaries, connective fascia, muscles, fat, cartilage, tendons, and bone.

In order to accomplish all of these various medical applications in cosmetic and esthetic surgery as well as other organ surgery and tissue separation applications within the body, several other embodiments of the transducer have been designed. In Fig. 12, there is shown a flexible line-focused transducer 115, which allows for variable depth delivery of the line-focused therapeutic ultrasound.

According to one embodiment of the present invention, there is disclosed a flexible lens ultrasonic transducer 115 , based on a flexible lens material of polymer composition, with acoustic properties at the frequency of usage such that, when a side force A (depicted by arrow 116) is applied, transducer 115 deforms to effectively change the focal length of the lens 102. Additionally, the electrical signals applied to the piezoceramic element 101 may be altered in their phase to allow for enhancement of the focusing.

The lens 102 is constructed from a polymer material such as TPX ™ or various epoxies that have ultrasonic properties that are useful for sealing the transducer face while permitting clear transmission of ultrasonic signals.. A piezoceramic 101 is bonded to lens 102, due to the capability of piezocermaic 101 to convert electrical energy into ultrasonic energy. Piezoceramic 101 is sliced, or mounted in such a way that that it can be sliced along the length to make thin slices 101 ', thus resulting in the kerf 115. In the relaxed position, the side force, A (116) is minimal and causes no significant deformation of lens 102, resulting in focal length FLl. Referring to Figs. 13 and 14, a greater side force, Force B (117) is applied, and therefore lens 102 deforms along its radius of curvature and effectively shortens the distance that an ultrasonic beam 104 will converge to focal length FL2. In this embodiment of the present invention, the kerf is the gap separating the pieces of piezoceramic 101 ' from each other. This spacing can be caused by the location of each individual piece of piezoceramic 101 ' or may be the result of cutting a single piece of piezoceramic into multiple slices or segments. Figs. 13 and 14 each show the piezoceramic ultrasound pieces 101', which comprise a suitable material of microcrystalline structure that is chosen for its electromechanical properties for the application. Piezoceramic 101 is bonded to the lens 102 by use of a suitable epoxy or other glues and functions to convert electrical energy to ultrasonic energy. Also shown in Figs. 13 and 14, lens 102 is generally a semi-ridged polymer with mechanical and acoustic properties that enables it to cause a change in the velocity of the ultrasonic waves passing through it as generated by piezoceramic 101. Thus, the ultrasonic waves will converge and form a line of focus. Another embodiment of the present invention shown in Fig. 15, which illustrates two separate line-focused ultrasound transducers 107 and 107' that can rotate outward and inward in directions A and B, from point 118, and still be focused on point 105. Rotating these two transducers on an axis in a mechanical fashion controlled by electrical power suitable for moving and aligning these transducers 107 and 107', a double line-focused point can be produced, or alternatively, the focal depth within the tissue, bones, blood vessels and organs of the body can be changed.

In addition, by crossing the two line-focused transducers,a double line- focused transducer therapy zone comprising a plurality of points 105 may be created for faster area coverage of treated and targeted tissue, bones, blood vessels or organs, with broader window of penetration on the skin surface.

In Fig. 16, a method for adjusting the depth of penetration relative to the surface of the transducer/tissue interface for a line-focused ultrasound beam is shown, according to one embodiment of the present invention. In general, the focusing lens 135 of a treatment transducer 107 is moved by use of a magnetically coupled motor 121, to a drive gear 128, to gears 123 attached to screw threaded shafts 124, which are in turn connected to a focusing lens 135. The position can be sensed by means of a multitude of magnetic or optical sensors 129 embedded into the housing 136 and activated by magnets or optical devices 136 attached to the movable focusing lens 135. Thus, position feedback is achieved. Fig. 16 shows motor 121, a motor of electromechanical, pneumatic, hydraulic, or manual crank type, which is used to couple power to turn drive gear 128 via magnetic coupling 122. This magnetic coupling 122 is used to couple energy from motor 121 to drive gear 128 thus providing a barrier to fluid leakage while allowing power transfer. Fig. 16 shows two different gears, a simple gear 123 which is attached to screw 124, to couple energy from drive gear 128, and a drive gear 128 which is coupled to gear 123 and screw 124 to couple energy from motor 120.

Screw 124 is connected to gear 123 and sensors 129 to move focusing lens 135 nearer or farther from acoustic lens 127. The focusing lens 135 is responsible for shaping the focused beam 105 to create a line focus of ultrasonic energy at a predetermined distance from the focusing lens 135. In the embodiment of Fig. 16, is a position sensor 129 used to indicate the position of the focusing lens 135 inside the housing 119. The sensor(s) may be of magnetic or optical type and number two or more depending upon the number of positions desired. Signals from position sensor 129 may be coupled to the motor control circuitry and/or to indicators or annunciators to indicate position to the system operator. Positioning magnets or optical reflectors 130, are attached to focusing lens 135 such that when the magnet or reflector 130 is in proximity to the position sensor 129, the sensor 129 is activated. Fig. 16 also shows some of the various components that make up the illustrated embodiment of the transducer 107, including a piezo crystal 125, which is attached to focusing lens 135 to transform electrical energy to ultrasonic waves that may be focused by focusing lens 135, and guide 131 for optical reflector 130, which keeps focusing lens 135 in alignment with housing 119, and finally acoustic lens 127 which couples ultrasonic focused beam 105 from coupling fluid 126 to tissue 132. Acoustic lens 127 may be made of various materials including RTV ™, TPX ™, or various other plastic or rubber type materials as found suitable for ultrasonic coupling. Another means for creating coupling to the patient skin surface is coupling fluid 126, a fluid that is suitable for coupling ultrasonic energy from focusing lens 135 to acoustic lens 127. Coupling fluid 126 may be various types of conditioned or unconditioned water. Additionally, coupling fluid 126 may be other suitable liquids such a Florinert ™, various oils such a mineral oil, or other liquids of gels as appropriate.

Fig. 16 also shows transducer 107 emitting focused beam 105 which is caused by focusing lens 135 to converge ultrasonic waves into a concentrated line of energy in tissue 132. A housing 119 is made of various plastics or other suitable materials to hold the assembly rigid and allow ease of use by the operator. Patient tissue 132 is the targeted tissue to be treated by the focused beam 105 of ultrasonic energy.

In Figs. 17a and 17b, one embodiment of the present invention is shown as a hand-held, stationary or automated probe 111 or clamp, coupled to line- focused ultrasound transducer 107. This line-focused transducer 107 produces the focused line of skin, tissue, organ or bone treatment therapy area 106. Fig. 17a shows one embodiment of the invention in the straight and rigid fashion, whereas Fig. 17b shows another embodiment of the invention in a user-controlled curl, bend or articulation as in the case of a flexible probe, scope or clamp 111. The embodiment of Fig. 17b allows the operator to articulate or angle the distal therapy tip of the probe, scope, or clamp around objects or organs within the body for more complete, appropriate or flexible treatment.

With reference to Fig. 18, there is shown a side view of two line- focused ultrasound transducers 107 depicting the arrangement of transducers 107, 107' in an opposite and parallel plane to each other. Each transducer 107, 107' generates ultrasonic signals 104. Ultrasonic signals 104 are sharply and precisely focused to the overlapping target therapy sites 106. The treatment area 106 is the area where thermal, mechanical, or cavitational effects are caused in the skin, fatty layers, arteries and veins, organs, bones, or other tissues in the body to be treated.

With reference to Fig. 19, there is shown an embodiment of the present invention, similar to Fig. 18, with a cutting blade 133 that moves in a parallel fashion 134, through the plane of treated tissues 106. The treatment area 106 may be thermally ablated by transducers 107, 107' emitting ultrasonic signals 104, and cutting blade 133 may not generate much or any blood loss after being severed. With reference to Fig. 20, there is illustrated a line-focused ultrasound treatment system generally in block form as one embodiment of the present invention. An applicator 301 with integrated Doppler flow 302 ultrasound detection capabilities, a line-focused therapeutic transducer 303, a diagnostic, gray-scale imaging transducer 304, and infrared tracking mechanism 305. Diagnostic Doppler ultrasound 302 may be used to detect blood flows in veins and arteries within the patient, in or near the target therapy zone. Imaging transducer 304 may provide real-time diagnostic imaging for the user during line-focused therapy by transducer 303. Infrared tracking 305 may provide user real time comparison information on the volume of treated tissue vs. planned treatments of the same tissue in the body. Fluid circulation system 307 provides temperature control as described above.

As is well known, a power supply 311 provides electrical power to the various system components, which may also include a foot pedal or similar user control 308, used to control operation of applicator 301, an amplifier 309, one or more cooling fans 310, a plasma monitor 312, and a vacuum/blower system 313. A user console or controller 306 generally includes computer 315, monitor 314, controller I/O 316 as described above.

The present disclosure describes patentable subject matter with reference to certain illustrative embodiments. The drawings are provided to facilitate understanding of the disclosure, and may depict a limited number of elements for ease of explanation. No limits on the scope of patentable subject matter are intended to be implied by the drawings. Variations, alternatives, and modifications to the illustrated embodiments may be included in the scope of protection available for the patentable subject matter.

Claims

WHAT IS CLAIMED IS:

1. An apparatus comprising: a curved therapeutic ultrasound transducer configured to substantially simultaneously produce a plurality of thermal energy therapy spots in human tissue, wherein the plurality of therapy spots are applied evenly along a line of the human tissue.

2. The apparatus of claim 1, comprising a lens.

3. The apparatus of claim 1, wherein the human tissue is one of skin, adipose tissue, organ tissue, veins, sweat glands, cancerous tissue, and bone.

4. The apparatus of claim 3, wherein the therapy spots are applied for one of cosmetic and esthetic therapy.

5. The apparatus of claim 1, wherein the plurality of therapy spots comprise a therapy zone and the transducer comprises a flexible portion configured to change an angle of curvature of the transducer to adjust a focal depth of the therapy zone.

6. The apparatus of claim 1, comprising a user-controlled body coupled to the transducer, wherein the user-controlled body directs thermal energy toward a specific portion of the human tissue for accurate therapy.

7. The apparatus of claim 6, wherein the user-controlled body comprises one of a rigid probe, an articulating probe, a handpiece, a clamp, a direct visualization lumen, and a channel.

8. The apparatus of claim 1, comprising at least one second ultrasound transducer, the second ultrasound transducer comprising at least one of a diagnostic ultrasound transducer and a Doppler ultrasound transducer.

9. The apparatus of claim 8, wherein the at least one second ultrasound transducer is located in-line with the therapeutic transducer.

10. The apparatus of claim 8, wherein the at least one second ultrasound transducer is separately coupled to the therapeutic transducer.

11. The apparatus of claim 1, comprising at least one magnetic and gear driven screw system configured to provide precise vertical or lateral movement of the apparatus to deliver therapeutic line-focused ultrasound.

12. A method comprising operating the apparatus of claim 1 to detect and identify at least artery or vein in human tissue that controls bloodflow to a targeted area of human tissue or becomes the target itself, providing thermal, cavitational or mechanical shearing energy to treat the targeted area, and providing operator feedback regarding at least one characteristic of the targeted area.

13. The method of claim 12, comprising providing operator feedback relating to whether the targeted area includes at least one of treated tissue, necrosed tissue, and cancerous tissue.

14. A system comprising: the apparatus in Claim 1, a second apparatus configured for patient interface with the apparatus of claim 1, the second apparatus being configured to flatten or smooth human tissue, and a third apparatus, configured to provide vacuum suction through the patient interface to the human tissue, to maintain a contact surface during therapy.

15. The system of claim 14, comprising a fifth apparatus configured to engage at least one of an interchangeable probe, a clamp or a handpiece, to adjust the size of the transducer as needed for different therapy applications.

16. The system of claim 14, comprising an ultrasound permeable material capable of both transmitting the appropriate level of focused ultrasound and holding an ultrasound permeable medium in front of the apparatus of claim 1.

17. The system of claim 14, comprising a mechanism for circulating at least one type of ultrasound-transmittable medium including at least one of a temperature-controlled degassed water, a Florinert ™, a mineral oil, a liquid, and a gel, which allows ultrasound to pass through the medium, controlling the te :mmppeerraattuurree of the surface, to a targeted area of a patient.

18. The system of claim 14, comprising a mechanism to position and rotate on an axis a plurality of separate line-focused ultrasound transducers, wherein each of the transducers is capable of applying thermal energy to a single or multiple focal zone which may be shallower or deeper based on the angle of rotation of the mechanism.

19. A system comprising: an apparatus comprising a plurality of line-focused transducers oriented substantially opposite each other, a body configured to hold the line-focused transducers substantially opposite each other, a plurality of handles configured to enable operator control of the body, a hinge mechanism configured to allow the body to engage human tissue, a Doppler ultrasound transducer in-line with at least one of the line- focused transducers, and a blade arranged to pass between the line-focused transducers.

20. The system of claim 19, wherein the body is a clamp.

21. The system of claim 19, wherein the blade is one of a single use blade and a multiple-use blade.

22. The system of claim 19, wherein the line-focused transducers are at least one of reusable and disposable for sterile surgical use.

23. The system of claim 19, wherein the apparatus includes at least one of detachable and interchangeable tips, transducers, and clamps for different applications.

24. The system claim 19, wherein the apparatus is usable to create a solid plane of tissue ablation between the line-focused transducers.

25. The system of claim 19, wherein the body is configured to squeeze, hold or compress an organ or tissue during activation of the line-focused transducers.

26. The system of claim 19, comprising a blood flow detector configured to detect blow flow between the line-focused transducers.

27. The system of claim 19, comprising a controller configured to determine the treated levels of intervening tissue.

28. The system of claim 19, wherein the blade is configured to cut treated or ablated tissue between the line-focused transducers.

29. The system of claim 19, wherein at least one of the line- focused transducers is configured to detect the presence or proximity of the opposing transducer's focal zone so as not to allow the system to damage itself.

30. A method comprising: providing an apparatus including a line-focused ultrasound transducer, activating the transducer to subject a target area of human tissue in a human body, the human tissue having a plurality of layers, to an amount of thermal energy to separate layers of the human tissue, and determining if the separated tissue layers should be removed from the human body.

31. The method of claim 30, comprising detecting a movement or speed of movement, or lack of movement, of at least a portion of the apparatus over the human tissue.

32. The method of claim 30, comprising delivering line-focused ultrasound energy to a treated area of a patient and receiving feedback relating to an amount of ultrasound energy delivered to the treated area.

33. The method of claim 32, comprising providing a dosage control system configured to control dosage levels of focused ultrasound energy in various therapeutic applications.

34. The method of claim 30, comprising displaying an estimated depth of a focal therapy zone in the tissue to an operator.

35. The method of claim 30, comprising using diagnostic ultrasound to calculate a volume of tissue to be treated in a designated area of the body prior to applying line-focused ultrasound.

36. The method of claim 30, comprising using pulsed ultrasound to determine if the apparatus has become detached from the tissue surface of a patient.

37. The method of claim 30, comprising using ultrasound feedback information to stop or pause therapy so as not to damage the apparatus or a patient surface interface.