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    公开号:ES2630221T9
    申请号:ES05810308.6T
    申请日:2005-10-06
    公开日:2018-01-02
    发明作者:Peter G. Barthe；Michael H. Slayton；Inder Raj S. Makin；Brian D. O'connor
    申请人:Guided Therapy Systems LLC；
    IPC主号:
    专利说明:

    Procedure and system for the treatment of tissues by ultrasound
    Field of the Invention
    The present invention relates to ultrasound therapy and imaging systems, and in particular to a system for non-invasive treatment of tissues, such as for use in facial elevations and deep tissue tensioning, and / or in tissue treatment. photo-aged, acne and sebaceous glands, and sweat glands.
    Background of the invention
    Thick sagging skin and facial muscles gradually occur over time due to severity and chronic changes in connective tissue generally associated with aging. Invasive surgical treatment to stretch such tissues is common, for example by facial stretching procedures. In these treatments for sagging connective tissue, a part of the tissue is usually removed, and sutures or other fasteners are used to suspend the tissue structures that cause sagging. On the face, the Superficial Muscular Aponeurosis System (SMAS) forms a continuous superficial layer in the muscles of facial expression and under the skin and subcutaneous fat. Conventional face lift operations involve suspension of the SMAS through such suture and restraint procedures.
    Procedures that provide the combination of a specific and precise local heating to a specific temperature region capable of inducing ablation (thermal injury) in the underlying skin and subcutaneous fat have not yet been developed. Attempts have included the use of radiofrequency (RF) devices that have been used to produce heating and contraction of the skin on the face with some limited success, as a non-invasive alternative to surgical stretching procedures. However, RF is a dispersive form of energy deposition. The RF energy is impossible to control precisely within the volume and depth of the heated tissue, because the resistive heating of the tissues by the RF energy occurs along the entire path of the electrical conduction through the tissues. Another restriction of RF energy for the non-invasive tensioning of SMAS is the unwanted destruction of the superimposed layers of fat and skin. The electrical impedance to RF within the fat, which covers the connective suspension structures intended to contract, leads to higher temperatures in the fat than in the target suspension structures. Similarly, medium infrared lasers and other light sources have been used to heat and noninvasively reduce the connective tissues of the dermis, with limited success. However, light is not capable of non-invasive treatment of SMAS, because the light does not penetrate enough to produce local heat. Below a depth of approximately 1 mm, the light energy is dispersed in a multiplied manner and cannot be focused to achieve precise local heating.
    In addition to sagging skin and facial muscle regions, which are a concern for aging individuals, photoaging of human skin is a complex response due to inflammation, oxidative damage, cellular and extracellular changes induced by decades of exposure to sunlight. It is believed that UV wavelengths are primarily responsible. Both primary skin layers, the epidermis and the dermis are affected. Epidermal photoaging includes pigment lesions called ephelids (freckles) and solar lentigines (larger pigmented spots), plus precancerous clonal lesions of keratinocytes called actinic keratosis. The thermal destruction of part or all of the epidermis, the outer cell layer of the skin approximately 0.1 mm thick, is an effective treatment for epidermal photoaging. For example, lasers that vaporize the epidermis are highly effective in a treatment called laser rejuvenation. However, laser rejuvenation creates a significant skin wound with risk of infection and prolonged scarring. Dermal changes in photoaging include solar elastosis (an accumulation of abnormally formed elastin fibers in the upper reticular layer of the dermis), laxity, loss of elasticity, fine and thick wrinkles. Laser rejuvenation at a depth below the dermoepidermal junction can be highly effective in improving dermal photoaging, through a stimulated wound healing process. Deep chemical peels, dermabrasion and other destruction procedures of the epidermis and / or dermis are also effective, and also produce a significant open skin wound with risk of infection and delayed healing.
    Patterns of stimulated thermal damage to the epidermis and / or the dermis are also effective for the treatment of photoaging. Recently, it was reported that "fractional phototermolysis", which uses mid-infrared lasers to produce a microscopic arrangement of thermal injury areas that include both the epidermis and the dermis, was effective and well tolerated for the treatment of photoaging (D. Manstein et al. "Fractional Photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury." Lasers Surg Med., 34: 426-438 (2004)). A major advantage of fractional photothermolysis is that each zone of thermal injury is smaller than can be easily seen with the eye without help, and surrounded by a zone of healthy tissue that initiates a rapid healing response. As Manstein describes, the epidermis is stimulated to heal quickly and without creating an open wound. The microscopic areas of the thermally damaged epidermis are harmlessly released from the surface of the skin after several days to several weeks, leaving a rejuvenated epidermis with less photoaging changes. Repeated treatments can be carried out, which are


    well tolerated, until the desired result is obtained. The microscopic areas of thermal injury with fractional photothermolysis also extend into the dermis. In general, the dermis does not heal as quickly as the epidermis. For weeks or months after treatment, part of the abnormal dermis due to photo-aging is remodeled, leading, however, to the improvement of laxity, wrinkles and skin texture.
    Fractional phototermolysis (FP) is intrinsically limited to regions of approximately 1 millimeter of the skin. The basic concept of producing well-controlled provisions for thermal injury is therefore limited with fractional photothermolysis, to the surface aspects of photoaging. Aging, which also produces the laxity of the skin, and photo-aging involve deeper layers of the dermis. Solar elastosis can spread throughout the dermis, approximately 3 mm deep or more. Laxity and loss of elasticity due to aging are major problems of the dermis.
    A fundamental requirement to produce arrangements of small areas of thermal injury using a radiant energy source that propagates and is absorbed within the tissue, is that the radiant energy source is capable of being properly supplied at the depth of the tissue for which it is You want the layout. Light can be used near the surface of the skin, as in fractional photothermolysis. However, light that propagates more than about 1 mm through the skin is dispersed in a multiplied manner, and can no longer be focused or supplied.
    Acne vulgaris is the most common skin disorder. Acne produces temporary and permanent disfigurement. Acne typically appears on the face, back and / or chest at the beginning of adolescence, that is, when sexual hormonal activity increases in both boys and girls, near puberty. Acne is a disorder of the hair follicles, in which a plug forms within the outflow tract of the hair follicle. Sebum, an oily product of the sebaceous glands attached to each hair follicle, and cellular debris is formed in the plug. Inflammation continues and often hair follicles rupture, leading to great inflammation, pus (a "white spot"), pain, bleeding and / or finally scarring. If the acne lesion consists of an unbroken plug accumulated inside the hair follicle, a "black spot" is formed. If the follicle breaks superficially, a small pustule forms that often heals after a few weeks without scarring. If the follicle breaks inside the middle dermis
    or deep, a painful cystic abscess is formed. Cystic acne usually heals with permanent and disfiguring scars.
    The exact pathophysiology of acne is complex and not fully understood. However, several basic elements are necessary to produce an acne lesion, and acne therapies are based on attacking one or more of these basic elements. First, an active sebaceous gland is necessary. The most potent treatments for acne are oral retinoids such as retinoic acid (Accutane), which inhibit the function of the sebaceous gland. The activity of the sebaceous gland is triggered by androgens and other sex steroid hormones. Women often experience cycle-dependent acne that may respond to treatment with birth control pills that contain small amounts of progestins. Secondly, a plug must be formed in the follicle's outflow tract, called the infundibulum. Bacteria, particularly Proprionobacteria acnes (P acnes) that digest sebum and follicular debris, contribute to the obstruction. Topical retinoids, mild acids and benzoyl peroxide are used in the form of treatments to decrease follicular tamponade. Effective antibiotics against P acnes are administered topically or orally; The prevalence of antibiotic-resistant P acnes is increasing. Third, inflammation is part of the process that breaks the wall of a follicle that contains plugs, which leads to rupture of the follicle with the release of irritating materials on the skin, formation of abscesses and scars. Anti-inflammatory agents, including some antibiotics, are useful in the treatment of acne.
    The most potent treatment for acne today is oral retinoid therapy. Unfortunately, this is a toxic and teratogenic treatment. Unplanned pregnancies in women taking Accutane lead to a high rate of fetal malformations. An aggressive program was implemented to prevent this in the US, but the problem could not be avoided. Systemic retinoid treatment also produces important side effects, including extreme dryness during treatment, risk of hepatitis, bone changes, mood swings and others. The high efficacy and high toxicity of oral retinoids for the treatment of cystic acne strongly suggests that an alternative treatment that targets the sebaceous glands is necessary.
    The sweat glands of the body are divided into apocrine and eccrine glands. Apocrine glands are similar to sebaceous glands, and are present mainly in the armpits. These glands, like the sebaceous glands, secrete an oily protein product in the follicles. Bacterial digestion of apocrine sweat is largely responsible for the "body odor" of the armpits. Similarly, the eccrine sweat glands are present in the depth of the dermis in the palms of the hands, the soles of the feet and the armpits, and are responsible for regulating the temperature resulting from sweating. Excessive activity of these glands also results in copious amounts of abnormal sweating ("hyperhidrosis"), mainly under autonomous neuronal control. Reduction of sweating under the armpits and other regions is a particularly desirable effect within modern society. At present, chemical antiperspirants and deodorants are frequently used as an element of personal hygiene. Antiperspirants are aluminum-based salts that block the ducts of the sweat gland. Deodorant changes the pH of the skin's medium


    minimizing the presence of bacteria (which induce odor). However, the effects with these two components are temporary and it is known that these chemicals irritate the skin in a good percentage of users.
    In addition, there is currently a significant unmet need in the management of excessive sweating and concomitant odor problems as a result of suppurative hydradenitis (irritable infected armpit). This acne-like process in apocine follicles also produces suppurative hydradenitis, which is often a devastating condition in which very painful cysts occur and healing repeatedly in the armpits. The etiology (causes) of this clinical condition is not well understood. However, there are a number of marginally effective approaches to manage this condition. Retinoid drug therapy works marginally, but is associated with severe toxicity. Some prescription formulations of antiperspirants may be used, but they are not particularly effective. These preparations can be applied with the addition of an iontophoretic device. However, it is not known that this technique is more effective than the formulation. The sweat glands can be surgically removed from the armpits and / or the supply to sympathetic nerves can be surgically interrupted. This approach is plagued by its own drawbacks in terms of morbidity, scarring and cost. More and more BOTOX® is used to paralyze nerve connections that induce excessive underarm sweating. However, this is a new approach that has yet to be fully validated. This technique requires multiple injections (painful) and the results last only a few months (3-4 months), therefore, they should be repeated. With this technique you can not get rid of the smell associated with the condition.
    U.S. Pat. No. 5,558,092 discloses procedures and apparatus for carrying out diagnostic ultrasound simultaneously with the application of therapeutic ultrasonic waves. The procedures and apparatus are particularly advantageous in the realization of ultrasonic images of a region of a patient while simultaneously applying therapeutic ultrasonic waves to the region with the purpose of breaking the vesicles administered to that region for purposes such as improved cavitation or fixed release. as the target of a bioactive agent in the region. An operator is able to control vesicle rupture in real time.
    U.S. Pat. No. 5,520,188 discloses a transducer for use in a therapeutic ultrasound and location system. The transducer includes multiple elements that are operated separately. The elements work together to focus a continuous wave ultrasound beam in a focal area that is at a variable distance from the elements. The transducer includes a mechanism to adjust the focal length so that the focal area can move at multiple depths.
    U.S. Pat. No. 6,623,430 discloses a method and apparatus for controlling the safe supply of thermosensitive liposomes containing medication to a region of target tissue using ultrasound. Thermosensitive liposomes containing medications are supplied to a region of interest, the region of interest is located using ultrasound imaging, ultrasound therapy is applied to heat the region of interest, and the temperature of the region is monitored to determine if it has been reached. a designated threshold temperature, which allows the release of medications from liposomes. If the threshold temperature is reached, and the liposomes melt, the treatment stops. If the threshold temperature has not been reached, the application of ultrasound therapy and ultrasound imaging is alternated until the threshold temperature is reached. Ultrasound imaging, temperature control and ultrasonic therapy are preferably carried out with a single transducer.
    Document GB 2,113,099 discloses that a selected part of tissue to be treated is generated in image using an ultrasound imaging system with pulse-echo. This system comprises an ultrasound transducer that is actuated during the generation of images at physiologically tolerable power levels. Once the imaging system is positioned to generate the image of the part of tissue to be treated, the power to which the transducer is operated is increased to a physiologically intolerable level that is sufficient to thermally treat that part. of tissue. After healing, the tissue part is regenerated to determine the effectiveness of the treatment. The apparatus of the preferred embodiment comprises a transducer-lens system for focusing ultrasound on a preselected focal area, an image generating means for displaying images constructed from the echoes of said ultrasound, and a pulsating means that can be selectively actuated at Physiologically tolerable or intolerable power levels to generate images selectively or to produce heat treatment of tissue in the focal area.
    U.S. Pat. No. 5,143,074 discloses an ultrasonic treatment device comprising a power transducer in the form of a spherical cup that serves both as a treatment wave generator and an ultrasound transceiver, in which the transducer is oscillated (motor 2) during treatment to obtain sector type B scan and is excited (circuits 1 to 14) with treatment waves only in a restricted angular scanning sector and with ultrasound waves in the rest of the scanned sector.
    Document DE10219297A1 discloses a procedure and a device for the generation of scar tissue in biological soft tissue through the use of electromagnetic energy, whereby said scar tissue is at least two-dimensional. The device used combines a laser, for the generation of electromagnetic energy, with an ultrasonic transducer for the application of ultrasonic energy with backscatter ultrasound used for


    An A-scan evaluation. Consequently, the optical laser waveguide also forms a transfer path for the sound energy.
    U.S. Pat. No. 4,979,501 discloses a procedure for medically treating a patient suffering from a pathological bone condition of a limb, which comprises the steps of: anesthetizing the patient; fix the affected limb with the pathological bone condition and center its pathological site; treat the pathological site once consecutively and extracorporeally with impact waves of 300 to 600 impacts with a frequency of impacts of 0.5 to 4 per second at a pressure of 700 to 2500 bars and a pulse duration of 0.5 at 4 microseconds over a period of 10 to 120 minutes; and subsequently immobilize the limb for a period of 15 to 90 days.
    Summary of the invention
    Accordingly, the present application provides an ultrasonic treatment system according to an independent claim 1.
    The dependent claims provide features, variations and advantageous embodiments.
    A system for non-invasive tissue treatment is provided, such as for use in facial stretching and deep tissue tensioning. For example, to facilitate facial stretching and deep tissue tensioning, an illustrative treatment system for imaging, control and thermal injury can be configured to treat the SMAS region. According to an illustrative embodiment, the illustrative system is configured for the treatment of the SMAS region first, imaging of the region of interest for the location of the treatment area and surrounding structures, second, ultrasound energy supply to a depth, distribution, timing, and energy level to achieve the desired therapeutic effect, and third, to control the treatment area before, during and after therapy to plan and evaluate the results and / or provide feedback.
    According to an illustrative embodiment, an illustrative treatment system comprises an imaging / therapy probe, a control system and a visualization system. The imaging / therapy probe may comprise various probe and / or transducer configurations. For example, the probe can be configured for a combined dual mode image / therapy transducer, coupled or co-hosted image / therapy transducer, or simply a therapy probe and an image generation probe. The control system and the display system may also comprise various configurations to control the functionality of the probe and the system, including for example a microprocessor with software and a plurality of input / output devices, a system to control the scanning and / or electronic and / or mechanical multiplexing of transducers, a power supply system, control systems, systems for detecting the spatial position of the probe and / or transducers, and user input management systems and recording of treatment results , among others.
    According to an illustrative embodiment, the ultrasound image can be used for safety purposes, such as avoiding damaging vital structures such as the facial nerve (motor nerve), the parotid gland, the facial artery and the trigeminal nerve (for sensory functions ), among others. For example, ultrasound imaging can be used to identify SMAS as the surface layer well defined by the echoes that cover facial muscles. Such muscles can be easily seen and better identified by moving them, and their image can be further enhanced by signal and image processing. According to an illustrative embodiment, ultrasonic therapy through ultrasound focused from a single element is used to treat the SMAS region at fixed and / or variable depths or dynamically controllable depths and positions.
    Brief description of the drawings
    The object of the invention is particularly indicated in the final part of the specification. The invention, however, both as regards the organization and the operating procedure, can be better understood by referring to the following description taken together with the attached drawing figures, in which equal parts may refer to them numbers:
    FIG. 1 illustrates a block diagram of a treatment system according to an illustrative embodiment of the present invention;
    FIG. 2A-2Q illustrate schematic diagrams of an image generation / therapy and ultrasonic control system for treating tissue in accordance with various illustrative embodiments of the present invention;
    FIG. 3A and 3B illustrate block diagrams of an illustrative control system in accordance with illustrative embodiments of the present invention;
    FIG. 4A and 4B illustrate block diagrams of an illustrative probe system in accordance with illustrative embodiments of the present invention;


    FIG. 5 illustrates a cross-sectional diagram of an illustrative transducer, which is not part of the present invention;
    FIG. Figures 6A and 6B illustrate cross-sectional diagrams of an illustrative transducer, which is not part of the present invention;
    FIG. 7 illustrates illustrative transducer configurations for ultrasonic treatment, which are not part of the present invention;
    FIG. 8A and 8B illustrate cross-sectional diagrams of an illustrative transducer according to another illustrative embodiment of the present invention;
    FIG. 9 illustrates an illustrative transducer configured as a two-dimensional arrangement for ultrasonic treatment, which is not part of the present invention;
    FIG. 10A-10F illustrate cross-sectional diagrams of illustrative transducers, which are not part of the present invention;
    FIG. 11 illustrates a schematic diagram of an acoustic coupling and cooling system in accordance with an illustrative embodiment of the present invention;
    FIG. 12 illustrates a block diagram of a treatment system comprising an ultrasonic treatment subsystem combined with additional treatment control and / or treatment image generation subsystems, as well as a secondary treatment subsystem in accordance with an illustrative embodiment of the present invention; Y
    FIG. 13 illustrates a schematic diagram with imaging, therapy or control that is provided with one or more active or passive oral insertions in accordance with an illustrative embodiment of the present invention.
    Detailed description
    The present invention can be described herein in terms of various functional components and processing steps. It should be appreciated that said components and steps can be performed by any number of hardware components configured to perform the specified functions. For example, the present invention may employ various medical treatment devices, visualization and visual imaging devices, input terminals and the like, which can perform a variety of functions under the control of one or more control systems or Other control devices. In addition, the present invention can be practiced in any number of medical contexts and illustrative embodiments related to a method and system for non-invasive and tensioned facial stretching of deep tissue, photoaged tissue, acne and sebaceous glands, and sweat glands, as is described herein, are merely indicative of illustrative applications for the invention. For example, the principles, characteristics and procedures analyzed can be applied to any muscle fascia, gland or other tissue region or any other medical application. In addition, various aspects of the present invention can be suitably applied to other applications.
    In accordance with various aspects of the present invention, a system for tissue treatment is provided. For example, according to an illustrative embodiment, with reference to Figure 1, an illustrative treatment system 100 configured to treat a region of interest 106 comprises a control system 102, an image generation / acoustic coupling therapy probe 104 and a display system 108. The control system 102 and the display system 108 may comprise various configurations to control the probe 102 and the overall functionality of the system 100, such as, for example, a microprocessor with software and a plurality of devices input / output, system and devices to control the electronic and / or mechanical scanning and / or multiplexing of transducers, a system for power supply, control systems, systems for detecting the spatial position of the probe and / or transducers , and / or systems for managing user input and recording treatment results, among others. The imaging / therapy probe 104 may comprise various probe and / or transducer configurations. For example, probe 104 may be configured for a combined dual mode imaging / therapy transducer, coupled or co-hosted image / therapy transducers, or simply a separate therapy probe and an image generation probe.
    According to an illustrative embodiment, the treatment system 100 is configured for the treatment of the first tissue region, imaging of the region of interest 106 for the location of the treatment area and surrounding structures, second, energy supply of ultrasound at a depth, distribution, timing, and energy level to achieve the desired therapeutic effect, and third, to control the treatment area before, during and after therapy to plan and evaluate the results and / or provide feedback.
    Regarding the treatment of face lifts, the SMAS region and connective tissue can be tensed


    permanently by means of heat treatment at temperatures of approximately 60 ° C or more. After ablation, the collagen fibers contract immediately at approximately 30% of their length. The contracted fibers can cause tensioning of the tissue, in which the contraction must occur along the dominant direction of the collagen fibers. Throughout the body, collagen fibers spread in connective tissues along the lines of chronic stress (tension). In the aged face, the collagen fibers of the SMAS region are predominantly oriented along the gravitational tension lines. The contraction of these fibers results in the tensioning of the SMAS in the desired direction for the correction of laxity and sagging due to aging. The treatment comprises the ablation of specific regions of the SMAS region and similar suspensory connective tissues.
    In addition, the SMAS region varies in depth and thickness in different places, for example, between 0.5 mm and 5 mm, or more. On the face, important structures such as nerves, parotid gland, arteries and veins are present above, below or near the SMAS region. Tensioning of the SMAS can be carried out in certain places, such as the preauricular region associated with sagging cheek to create gills, the frontal region associated with flaccid eyebrows, the mandibular region associated with the flaccid neck. The treatment by localized heating of regions of the SMAS or other suspensory subcutaneous connective tissue structures at temperatures of approximately 60 ° C-90 ° C can be adequately carried out, without significant damage to the overlying or distal / underlying tissue. , that is, proximal tissue, as well as the precise supply of therapeutic energy to regions of the SMAS, and obtaining feedback from the region of interest before, during and after treatment.
    It can be initially carried out to further illustrate a method and an illustrative system 200, with reference to Figure 2, the generation of images of a region of interest 206, such as by the generation of images of a region 222 and visualization of images 224 of the region of interest 206 in a viewfinder 208, to facilitate the location of the treatment area and surrounding structures. Next, the ultrasonic energy supply 220 can be adequately provided, at a suitable depth, distribution, timing and energy level to achieve the desired therapeutic effect of thermal injury or ablation to treat the SMAS 216 region, by means of the probe 204 through control through control system 202. Control of the treatment area and surrounding structures before, during and after therapy, that is, before, during and after the supply of ultrasound energy to the region of the SMAS 216 can be provided to plan and evaluate the results and / or provide feedback to the control system 202 and a user of the system.
    The generation of ultrasound images and the provision of images 224 can facilitate fixing as a safe target of the SMAS layer 216. For example, with reference to Fig. 2B, fixing as a specific target for the power supply can be facilitated better to avoid the heating of vital structures such as the facial nerve (motor nerve) 234, the parotid gland 236 (which produces saliva), the facial artery 238 and the trigeminal nerve (for sensory functions) 232, among other regions. In addition, the use of imaging with energy supply set as a target to provide a limited and controlled depth of treatment can minimize the possibility of damaging deep structures, such as the facial nerve below the parotid, which It is typically 10 mm thick.
    According to an illustrative embodiment, with reference to Figure 2C, ultrasound imaging of region 222 of region of interest 206 can also be used to delineate the SMAS layer 216, such as the eco-dense surface layer that covers the facial muscles 218. Such muscles can be seen through the imaging region 222 by moving the muscles 218, for example, by extensional flexing of the muscle layer 218 generally towards the directions 250 and 252. Said imaging of region 222 can be further improved by signal and image processing. Once the SMAS 216 layer is located and / or identified, the SMAS 216 layer is ready for treatment.
    The delivery of ultrasonic energy 220 at a suitable depth, distribution, timing and energy level is provided by probe 204 through operation controlled by control system 202 to achieve the desired therapeutic effect of thermal injury to treat the region. of SMAS 216. During operation, probe 204 can also be scanned mechanically and / or electronically within tissue surface region 226 to treat an extended area. In addition, the spatial control of a treatment depth 220 can be adjusted appropriately at various intervals, such as between a wide range of about 0 to 15 mm, properly set at a few discrete depths, with a limited setting at a fine interval, by example approximately between 3 mm and 9 mm and / or dynamically adjusted during the treatment, to treat the SMAS 216 layer which is typically at a depth between approximately 5 mm and 7 mm. Before, during and after the supply of ultrasound energy to the SMAS 216 region, control of the treatment area and surrounding structures can be provided to plan and evaluate the results and / or provide feedback to the control system 202 and a user of the system.
    For example, according to an illustrative embodiment, with further reference to Figure 2D, ultrasonic imaging of region 222 can be used to control the treatment by observing the amount of contraction of the SMAS layer 216 in the direction of the areas 260 and 262, such as in real time or near real time, during and after the power supply to region 220. The onset of substantially immediate contraction of the SMAS 216 layer is detectable by ultrasound imaging of the region 222 and can


    be further improved by image and signal processing. The control of said contraction may be ideal because it can confirm the intended therapeutic objective of non-invasive stretching and tensioning of the tissue; furthermore, said control can be used for system feedback. In addition to image control, additional processing parameters that can be adequately controlled in accordance with various other illustrative embodiments may include temperature, video, profilometry, image generation and / or strain gauges or any other spatial, temporal and / or parameter. other suitable fabric.
    For example, according to an illustrative embodiment of the present invention, with further reference to Figure 2E, an illustrative control method and system 200 can suitably control the temperature profile or other tissue parameters of the region of interest 206, such as attenuation or speed of sound of the treatment region 222 and properly adjust the spatial and / or temporal characteristics and energy levels of the probe 204 of the ultrasound therapy transducer. The results of said control techniques can be indicated in the viewer 208 in various ways, such as, for example, by one, two or three-dimensional images of the control results 270 or can comprise an indicator 272, such as a success, a failure and / or a type of indication completed / made, or combinations thereof.
    According to another illustrative embodiment, with reference to Figure 2F, the target fixation of the particular region 220 within the SMAS layer 216 can be adequately expanded within the region of interest 206 to include a combination of tissues, such as the skin 210, dermis 212, fatty / adipose tissue 214, SMAS / muscular fascia and / or other suspensory tissue 216, and muscle 218. Treatment of a combination of said tissues and / or fascia can be treated including at least one layer of SMAS 216 or other layers of muscular fascia in combination with at least one muscular tissue, adipose tissue, SMAS and / or other muscular fascia, skin, and dermis, can be adequately achieved by the treatment system 200. For example, the treatment of The SMAS layer 216 can be carried out in combination with the treatment of the dermis 280 by an appropriate adjustment of the spatial and temporal parameters of the probe 204 within the treatment system 200.
    As for the treatment of photo-aged tissue, it is convenient to be able to produce well-controlled arrangements of microscopic areas of thermal injury, not only near the surface of the skin, but in the middle dermis and / or deep dermis. The thermal ablation of the dermis at temperatures greater than about 60 ° C, capable of producing denaturation of the tissue, in such thermal injury arrangements is also convenient. The contraction of the dermis due to thermal action results in skin tightening during laser rejuvenation.
    In contrast to optical or RF approaches, ultrasound energy propagates in the form of a wave with relatively little dispersion, over depths of up to many centimeters in the tissue depending on the frequency of the ultrasound. The size of the focal point attainable with any wave of energy propagation depends on the wavelength. The ultrasound wavelength is equal to the acoustic velocity divided by the ultrasound frequency. The attenuation (absorption, mainly) of the ultrasound by the tissue also depends on the frequency.
    According to an illustrative embodiment, the use of focused, unfocused or unfocused ultrasound for the treatment of components of the epidermis, superficial dermis, dermis, middle dermis and deep dermis of photoaged tissue by adjusting the resistance, depth and type of focus, energy levels and time cadence. For example, focused ultrasound can be used to create precise arrangements of microscopic thermal ablation zones that have several advantages over fractional photothermolysis (FP). At high frequency and with superficial focus or diffraction pattern, ultrasonic ablation can simulate FP but uses a simpler ablation device. Unlike fractional photothermolysis, ultrasound can produce an arrangement of much deeper ablation zones in the skin or even in subcutaneous structures. The detection of changes in the ultrasound reflection can be used for feedback control to detect a desired effect on the tissue and can be used to control the intensity, time and / or position of the exposure.
    To further illustrate the use of ultrasound for the treatment of photo-aged tissue, with reference to Fig. 2G, an illustrative method and system is configured to initially generate images of a region 222 of a region of interest 206 and display said region 224 during the location of the treatment area and surrounding structures. After localization, the ultrasonic energy supply 220 can be provided at a depth, distribution, timing and energy level to achieve the desired therapeutic effect of thermal ablation to treat an epidermis layer 212, a superficial dermis layer 214, a middle dermis layer 216 and / or a deep dermis layer 218. Before, during and after therapy, that is, before, during and after ultrasound power supply 220, the illustrative method and system 200 can control suitably the treatment area and surrounding structures to plan and evaluate the results and / or provide feedback to the control system 202 and / or a user of the system.
    Although an image generation function can be configured within the control system 202 to facilitate the generation of images of a region of interest, according to another illustrative embodiment, an illustrative treatment system 200 can also be configured for therapy only or therapy and control, without image generation functions. In such a case, a known anterior depth of the region of interest, of about 0 to 5 mm or less, is used to achieve treatment areas in the aged skin.


    The probe 204 and / or the transducers can be mechanically and / or electronically scanned in one direction 226 to place the treatment zones 260 over an extended area, such as a line to generate a matrix of closely spaced treatment points. The treatment depth 220 can be adjusted between a range of about 0 to 5 mm, or otherwise to the depth of the deep dermis. The treatment can be limited to a fixed depth or somewhat discrete depths, or it can be adjusted to a fine range, for example from about 0 to 5 mm or to the maximum depth of the deep dermis, or it can be dynamically adjusted during treatment, to the region of treatment of interest 206 which is above the subcutaneous fat region 250.
    In accordance with another illustrative embodiment of the present invention, with reference to Figure 2H, a treated area 260 may extend through the regions of the dermis, and may even extend to the epidermis, 262. In addition, as an area treated increases in depth, its cross section can increase from small size 264 (sub millimeter) in a shallow region near or in the epidermis, to medium size 266 (sub millimeter size to millimeter) in a middle area near or in the middle dermis, up to the large size 268 (millimeter size) in the deep areas near or in the deep dermis. In addition, a single treated area may have a shape that expands in cross-section with depth and / or is composed of the fusion of several smaller treatment areas. The spacing of the treatment zones can be of the order of the size of the treatment zone. The ultrasound beam can be controlled spatially and / or temporarily by changing the position of the transducer, its frequency, depth of treatment, amplitude of actuation and timing through the control system.
    According to another illustrative embodiment of the present invention, with reference to Fig. 2I, an illustrative treatment method and system 200 can be configured to control the temperature profile or other tissue parameters of the region of interest 206, such as attenuation or sound velocity of the treatment region and properly adjust the spatial and / or temporal characteristics and energy levels of the ultrasound therapy transducer. The results of such control techniques may be indicated in the viewfinder 208, such as by displaying one, two or three dimensional images of the control results 270, or they may comprise an indicator 272, such as a success, failure and / or a type of indication completed / made, or combinations thereof. Additional treatment control procedures may be based on one or more of temperature, video, profilometry, imaging and / or strain gauges or any other suitable detection procedure.
    According to another illustrative embodiment, with reference to Figure 2J, an expanded region of interest 280 may suitably include a combination of tissues, such as subcutaneous / adipose fat tissue 250. A combination of said tissues includes at least one of epidermis 212 , superficial dermis 214, middle dermis 216 or deep dermis 218, in combination with at least one of muscle tissue, adipose tissue or other tissues useful for treatment. For example, the treatment 260 of the superficial dermis can be carried out in combination with the treatment 220 of subcutaneous fat 250 by properly adjusting the spatial and temporal parameters of the transducers in the probe 204.
    As for the treatment of acne and sebaceous glands, in patients with acne it is desirable to temporarily or permanently destroy the sebaceous glands. The depth at which these glands are found is approximately 1–7 mm, depending on the thickness of the skin and the site of the body. In accordance with various aspects of the present invention, a method and system for treating acne and sebaceous glands is provided. For example, according to an exemplary embodiment, with reference to Figure 1, an illustrative treatment system 100 configured to treat a region of interest (ROI) 106 comprises a control system 102, an image generation / therapy probe with acoustic coupling 104 and a display system
    108.
    The control system 102 and the viewer 108 may comprise various configurations to control the functionality of the probe 104 and the system 100, including for example a microprocessor with software and a plurality of input / output and communication devices, a system for controlling the electronic and / or mechanical scanning and / or multiplexing of transducers, a system for power supply, control systems, systems for detecting the spatial position of the probe and / or transducers, and / or systems for input management of users and registration of treatment results, among others. The imaging / therapy probe 104 may comprise various probe and / or transducer configurations. For example, probe 104 may be configured for a combined dual mode imaging / therapy transducer, coupled or co-housed image / therapy transducers, a separate therapy probe and a separate image generation probe, or A single therapy probe. According to illustrative embodiments, the image generation transducers can operate at frequencies of approximately 2 to 75 MHz or more, while the therapy energy can be supplied at frequencies of approximately 2 to 50 MHz, with 2 MHz to 25 being typical. MHz
    Referring to Fig. 2A, a method and an illustrative treatment system are configured to initially generate images of a region 222 within a region of interest 206 and display said region 224 in a viewer 208 to facilitate the location of the treatment area and surrounding structures, for example, identification of sebaceous glands 232. After localization, the energy supply of


    ultrasound 220 at a depth, distribution, timing and energy level to achieve the desired therapeutic effect of thermal ablation to treat a sebaceous gland 232. Before, during and / or after therapy, that is, before, during and / or after of the ultrasound power supply, the display of the treatment area and surrounding structures can be carried out to further plan and evaluate the results and / or provide feedback to the control system 202 and to a system operator.
    According to an illustrative embodiment, localization can be facilitated through the generation of ultrasound images that can be used to define the position of a sebaceous gland and / or the depth of the sebaceous glands over a region of interest. It can be seen that said glands extend along the hair follicles and their image can be further improved through signal and image processing. Generations of ultrasound images can also be used for safety purposes, that is, to avoid damaging vital structures. According to other illustrative embodiments, the location can also be carried out without the imaging region 222, but instead may be based on previously known depths of sebaceous glands or other target regions.
    For the ultrasonic power supply, the probe 204 and / or the imaging / therapy transducers can be scanned mechanically and / or electronically, for example along the direction 226, to place treatment zones over an extended area. A treatment depth 220 can be adjusted between a range of approximately 1 to 7 mm and / or the greater depth of the sebaceous glands 232. Such energy supply may appear through a repeated "image and burn" technique, ie , generate images of the target sebaceous gland and then apply ultrasound energy, or by a "bombardment" technique, that is, apply ultrasound energy at known depths over an extended area without initial or continuous image generation.
    With reference to Figure 2B, a treated area 242 may extend over a line, plane or surface, or over an extended area through the depth 240 of the sebaceous gland that typically ranges from about 1 to 7 mm. The probe 204 can be scanned mechanically and / or electronically, for example directionally along 226, to extend the treatment area 242 over a large area. The probe 204 may be further scanned or moved along a longer directional line 228 to further expand the treatment area 242. For any treated area 242, as the treated area 242 increases in depth within the region of interest 206 , the cross-sectional area of the treated area 242 may increase in size from small to medium to large, that is, at greater depths, the size of the treated lesion will increase. In addition, a treated area 242 may have a lesion form that expands in cross-section with depth and / or is composed of the fusion of several smaller treatment areas. For example, a series of "cross-shaped" lesions, a series of wedge-shaped lesions or any properly formed shaped lesion may be placed along the treated area 242.
    The ultrasound beam of the probe 204 can be controlled spatially and / or temporarily by changing the spatial parameters of the transducer, such as placement, distance, depth of treatment and structure of the transducer, as well as changing the temporal parameters of the transducer, such as frequency, amplitude of actuation and timing, managing said control through control system 202. Said spatial and temporal parameters can also be adequately controlled and / or used in open loop and / or closed loop feedback systems within the treatment system 200 As a result of said spatial and / or temporal control, conformal lesions of various shapes, sizes and orientations, specifically set as targets, can be configured along the treatment area 242.
    According to an illustrative embodiment, with reference to Figure 2C, one or more treated areas 242 can be configured to produce heating and damage regions within the treatment layer in spatially defined patterns, such as a discrete location of spaced treatment points. or a two or three dimensional matrix of damaged or destroyed tissue, for example, a matrix of cross-shaped, cigar / ellipsoidal, wedge-shaped, fungus-shaped or any other shaped lesions, instead of heating and destroying the entire volume of the target tissue layer. In such a treatment, in which the surrounding regions are saved from damage, the surrounding undamaged tissue helps rapid healing and recovery.
    According to another illustrative embodiment of the present invention, with reference to Figure 2D, an illustrative control method may comprise the control of the temperature profile or other tissue parameters of the region of interest 206, such as attenuation, speed of sound or mechanical properties such as stiffness and deformation of the treatment region and adequately adjust the spatial and / or temporal characteristics and energy levels of the ultrasonic therapy transducer of the probe 204. The results of such control techniques may be indicated in the viewfinder 208 by means of one, two or three dimensional images of the control results 250, or may simply comprise a success or failure indicator 252, or combinations thereof. Additional treatment control techniques may be based on one or more of temperature, video, profilometry and / or stiffness or strain gauges or any other suitable detection technique.
    According to another illustrative embodiment, with reference to Figure 2E, a treatment system 200 can be configured for treatment over an expanded treatment region of interest 252 that includes a combination of tissues, such as subcutaneous / adipose fat tissue 216 and muscle 218, among others. It can


    treat a multiple of said tissues including sebaceous glands in combination with at least one of epidermis 212, dermis 214, adipose tissue 216, muscular fascia located above muscle tissue 218, mucous membrane, hair bulb 230, hair shaft 234, hair follicle between bulb hair 230 and epidermis 212, blood vessels, apocrine sweat glands, eccrine glands located within dermis 214, fat 216 or muscle 218 and / or any other tissue of interest. For example, a treatment can be carried out in the region 220 of the sebaceous gland 232 in combination with the treatment in a hair region 260 by means of a suitable adjustment of the spatial and / or temporal parameters of treatment of the transducers in the probe 204 .
    As for a non-invasive procedure and system for the treatment of the sweat gland, according to an illustrative embodiment, an ultrasonic transducer probe and a control system are configured to deliver ultrasound energy at a depth and area set as target. / specified in which the population of sweat glands needs to be treated. The ultrasound beam of the transducer probe can be adjusted, modified or controlled spatially and / or temporarily in another way to correspond with the proper treatment of the sweat glands in the region of interest.
    According to illustrative embodiments, the image transducers can operate at frequencies of approximately 2 MHz to 75 MHz or more, while the therapy energy can be supplied at frequencies of approximately 500 kHz to 15 MHz, being typical from 2 MHz to 25 MHz
    With reference to Fig. 2A, sweat glands 230 are generally located within a layer of dermis 214 at a depth close to hair bulbs 236. To treat sweat glands that require treatment at particular anatomical sites, such as, for example , but not limited to, the axillary region (armpit), palms and soles of the feet, an ultrasound transducer probe can be attached to the skin tissue using one of the numerous coupling means, such as water, mineral oils , gels and the like.
    For example, with reference to Fig. 2B, according to an illustrative embodiment, an illustrative process and treatment system are configured to initially generate images of a region 222 within a region of interest 206 and display said region 224 in a viewfinder 208 to facilitate the location of the treatment area and surrounding structures, for example, the identification of sweat glands 230. Upon location, the supply of ultrasonic energy 220 is provided at a depth, distribution, timing and energy level for achieving the desired thermal ablation therapeutic effect to treat a sweat gland 230. Before, during and / or after therapy, that is, before, during and / or after the ultrasound energy supply, visualization can be carried out of the treatment area and surrounding structures to plan and further evaluate the results ados and / or provide feedback to control system 202 and a system operator.
    According to an illustrative embodiment, the location can be facilitated by ultrasound imaging that can be used to define the position of a sweat gland 230 and / or the depth of sweat glands 230 in a region of interest before depositing in a defined pattern in a target region
    220. It can be seen that said glands extend along hair follicles 232 and bulbs 236 and their image can be further enhanced by signal and image processing. Ultrasound imaging can also be used for safety purposes, that is, to avoid damaging vital structures, such as nerve endings 240. According to other illustrative embodiments, location can also be carried out without the region 222 of generation of images, but instead can be based on previously known depths of sweat glands or other target regions and, thus, geometrically and / or electronically configured to selectively deposit energy at a particular known depth below the skin surface 210 in a target region 220.
    The ultrasound beam of the probe 204 can be controlled spatially and / or temporarily by changing the spatial parameters of the transducer, such as placement, distance, depth of treatment and structure of the transducer, as well as changing the temporal parameters of the transducer, such as frequency, drive amplitude and timing, managing said control through control system 202. For example, in some applications, the exposure of temporary energy in one place may vary from about 40 ms to 40 seconds, while the frequency of the The corresponding source may vary appropriately from approximately 500 kHz to 15 MHz. Such spatial and temporal parameters can also be adequately controlled and / or used in open loop and / or closed loop feedback systems within the treatment system 200. As a result of said control spatial and / or temporary, injuries can be configured according of various shapes, sizes and orientations, specifically set as target, within the target region 220.
    According to an illustrative embodiment, the resulting treatment of ultrasound energy supply in the region of sweat glands 230 can be used to achieve selective ablation of regions of the subepidermal region (0.5-10 mm in diameter). For example, one or more treated areas 242 may be configured to produce regions of ablative damage in spatially defined patterns, such as a discrete location of spaced treatment points or a two or three dimensional matrix of damaged or destroyed tissue, for example, a matrix of cross-stitch lesions, in the form of a cigar / ellipsoidal, wedge-shaped, fungus-shaped or any other shaped lesion, instead of heating and destroying the entire volume of the target tissue layer. In a


    Such treatment, in which the surrounding regions are saved from damage, the surrounding undamaged tissue helps rapid healing and recovery.
    According to another illustrative embodiment, a contiguous complete sheet of treatment area can be achieved, whereby all sweat glands within said area are removed. In addition to the selective treatment of the sweat gland regions, according to another illustrative embodiment, the treatment system 200 could be configured to "bombard" the fat layer at a depth of 1-7 mm, for example, it can be ablated up to 90% of the sweat glands in the armpit without any physiological problem.
    According to another illustrative embodiment of the present invention, an illustrative control method may comprise the control of the temperature profile or other tissue parameters of the region of interest 206, such as attenuation, speed of sound or mechanical properties such as stiffness and deformation of the treatment region and properly adjust the spatial and / or temporal characteristics and the energy levels of the ultrasonic therapy transducer of the probe 204. The results of such control techniques can be indicated in the viewfinder 208 by means of images of one, two or three dimensions of the control results 250, or they may simply comprise an indicator 252 of success or failure, or combinations thereof. Additional treatment control techniques may be based on one or more of temperature, video, profilometry and / or stiffness or strain gauges or any other suitable detection technique. The non-thermal effects of an acoustic field can also "impact" sweat producing apocrine and eccrine cells with reduced activity. These effects mentioned herein as examples are, but are not limited to, acoustic cavitation, acoustic transmission, intercellular shear effects, cell resonant effects and the like.
    According to an illustrative embodiment, focused or directive ultrasound energy can be used for the treatment of sweat glands in the armpit (without the combination of pharmacological formulations). For example, a clinical indication would be the use in the management of suppurative Hydradenitis. Ultrasound energy deposited at a selective depth can also be used in combination with a series of pharmaceutical formulations that are currently prescribed for the treatment of hyperactivity of the sweat glands in the axillary region, the palms of the hands and the soles of the feet. . The ultrasound energy supplied to the target region in combination with pharmaceutical agents such as BOTOX® or retinoids can help synergistically treat the region of the sweat glands by, (1) increasing the activity of the agents due to thermal mechanisms and non-thermal, (2) the reduced requirement of the total drug dose, as well as the reduction of drug toxicity, (3) the increase of the local effect of the drug at a site selectively.
    An illustrative control system 202 and display system 208 can be configured in various ways to control the functionality of the probe and the system. With reference to Figs. 3A and 3B, according to illustrative embodiments, an illustrative control system 300 can be configured for the coordination and control of the entire therapeutic treatment process for tissue treatment. For example, the control system 300 may suitably comprise power source components 302, detection and control of components 304, cooling and coupling controls 306, and / or logical control and processing components 308. The control system 300 can be configure and optimize in various ways with more or less subsystems and components to implement the therapeutic system for tissue treatment, and the embodiments in Figs. 3A and 3B are for illustrative purposes only.
    For example, for the power supply components 302, the control system 300 may comprise a
    or more direct current (DC) 303 power supplies configured to provide electrical power for the entire control system 300, including the power required by an electronic amplifier / transducer controller 312. A direct current sensing device can also be provided. 305 to confirm the level of energy entering amplifiers / controllers 312 for security and control purposes.
    The amplifiers / controllers 312 may comprise amplifiers and / or multichannel power controllers
    or single channel. According to an illustrative embodiment for configurations of transducer arrangements, amplifiers / controllers 312 can also be configured with a beam former to facilitate the focus of the arrangements. An illustrative beam former may be electrically excited by an oscillator / digitally controlled waveform synthesizer 310 with related switching logic.
    The power supply components may also include various filtering configurations 314. For example, switchable and / or correspondence harmonic filters can be used at the output of the amplifier / controller 312 to increase the efficiency and effectiveness of the drive. Energy sensing components 316 may also be included to confirm proper operation and calibration. For example, electrical energy and other energy sensing components 316 can be used to control the amount of energy going to an example probe system.
    Various detection and control components 304 can also be properly implemented within the control system 300. For example, according to an illustrative embodiment, the interface control, detection and control components 324 can be configured to operate with various detection systems. movement implemented within the transducer probe 204 to receive and process information such as acoustic information or other spatial and temporal information of a region of interest. Detection components


    and control may also include various controls, interconnections and switches 309 and / or energy detectors
    316. Said detection and control components 304 may facilitate open loop and / or closed loop feedback systems within the treatment system 200.
    Cooling / coupling control systems 306 may be provided to remove residual heat from an illustrative probe 204, provide a controlled temperature at the interface of the surface tissue and deeper into the tissue, and / or provide an acoustic coupling from the probe 204 of the transducer to the region of interest
    206. Said cooling / coupling control systems 306 can also be configured to operate in open loop and / or closed loop feedback arrangements with various coupling and feedback components.
    The control and processing logic components 308 may comprise various system processors and digital control logic 307, such as one or more of microcontrollers, microprocessors, field programmable door arrays (FPGAs), computer boards and associated components, including firmware and control software 326, which is interconnected with user controls and interconnection circuits, as well as input / output circuits and systems for communications, viewers, interface, storage, documentation and other useful functions. System 326 software and firmware control all startup, timing, level adjustment, control, security control and all other system functions necessary to achieve the user-defined treatment objectives. In addition, various control switches 308 can also be properly configured to control operation.
    An illustrative transducer probe 204 can also be configured in various ways and comprise a series of reusable and / or disposable components and parts in various embodiments for ease of operation. For example, the transducer probe 204 can be configured within any type of transducer probe housing or arrangement to facilitate coupling of the transducer to a tissue interface, said housing comprising various shapes, contours and configurations. The transducer probe 204 may comprise any type of correspondence, such as, for example, electrical correspondence, which can be electrically switchable; multiplexer circuits and / or opening / element selection circuits; and / or probe identification devices, to certify the probe handle, electrical correspondence, transducer usage history and calibration, such as one or more serial EEPROM (memories). The transducer probe 204 may also comprise cables and connectors; motion mechanisms, motion sensors and encoders; thermal control sensors; and / or user control and status related switches, and indicators such as LEDs. For example, a movement mechanism in the probe 204 can be used to create multiple lesions in a controlled manner, or the detection of the probe's own movement can be used to create multiple lesions in a controlled manner and / or stop the creation of lesions, example for safety reasons if probe 204 shakes sharply or drops. In addition, an external motion coding arm can be used to hold the probe during use, through which the spatial position and attitude of the probe 104 is sent to the control system to help create lesions in a controlled manner. In addition, other detection functions such as profilometers or other imaging modalities can be integrated into the probe according to various illustrative embodiments. In addition, the therapy contemplated herein can also be produced, for example, by transducers disclosed in US Pat. Serial No. 10 / 944,499, filed on September 16, 2004, entitled METHOD AND SYSTEM FOR ULTRASOUND TREATMENT WITH A MULTI-DIRECTIONAL TRANSDUCER, published with document US2006 / 0058717 A1, and US Application. Serial No. 10 / 944,500, filed on September 16, 2004, and entitled SYSTEM AND METHOD FOR VARIABLE DEPTH ULTRASOUND TREATMENT, published as document US 2006/0058664 A1.
    With reference to Figs. 4A and 4B, according to an illustrative embodiment, a transducer probe 400 may comprise a control interface 402, a transducer 404, coupling components 406, and control / detection components 408, and / or movement mechanism 410. Without However, transducer probe 400 can be configured and optimized in various ways with more or less parts and components to provide ultrasonic energy for a controlled thermal injury, and the embodiment in Figs. 4A and 4B are for illustrative purposes only.
    The control interface 402 is configured to interconnect with the control system 300 to facilitate control of the transducer probe 400. The control interface components 402 may comprise an opening multiplexer / selector 424, switchable electrical correspondence networks 426, Serial EEPROMs and / or other processing components and correspondence and 430 probe usage information and interface connectors
    432
    The coupling components 406 may comprise various devices to facilitate the coupling of the transducer probe 400 to a region of interest. For example, the coupling components 406 may comprise an acoustic and cooling coupling system 420 configured for the acoustic coupling of ultrasound signals and energy. The acoustic cooling / coupling system 420 with possible connections such as collectors can be used to couple the sound to the region of interest, control the temperature at the interface and deeper into the tissue, provide focus with liquid-charged lenses and / or Remove residual heat from the transducer. The coupling system 420 can facilitate said coupling


    through the use of various coupling means, including air and other gases, water and other fluids, gels, solids and / or any combination thereof, or any other means that allows signals to be transmitted between active elements of transducer 412 and a region of interest In addition to providing a coupling function, according to an illustrative embodiment, the coupling system 420 can also be configured to provide temperature control during the application of the treatment. For example, the coupling system 420 can be configured for the controlled cooling of an interface surface or region between the probe of the transducer 400 and a region of interest and beyond by properly controlling the temperature of the coupling means. The appropriate temperature for said coupling means can be achieved in various ways and use various feedback systems, such as thermocouples, thermistors or any other device or system configured for the temperature measurement of a coupling means. Said controlled cooling can be configured to further facilitate the space and / or thermal energy control of the transducer probe 400.
    According to an illustrative embodiment, with additional reference to Fig. 11, acoustic coupling and cooling 1140 can be provided to acoustically couple energy and image signals from transducer probe 1104 to and from region of interest 1106, to provide thermal control in the probe to the interface of the region of interest 1110 and more deeply in the tissue, and to eliminate potential residual heat from the transducer probe in region 1144. Temperature control can be provided at the interface coupling through a thermal sensor 1146 to provide a temperature measuring mechanism 1148 and control through the control system 1102 and a thermal control system 1142. The thermal control may consist of passive cooling, such as by means of heatsinks of heat or by natural conduction and convection, or by active cooling, such as with term refrigerators Peltier electric, coolant or fluid-based systems comprising pump, fluid reservoir, bubble detection, flow sensor, flow / tubing channels 1144 and thermal control 1142.
    With continuous reference to Fig. 4, the control and detection components 408 may comprise various motion and / or position sensors 416, temperature control sensors 418, user control and feedback switches 414 and other similar components to facilitate the control by means of the control system 300, for example, to facilitate spatial and / or temporal control through open loop and closed loop feedback arrangements that control various spatial and temporal characteristics.
    The movement mechanism 410 may comprise manual operations, mechanical arrangements or some combination thereof. For example, a movement mechanism 422 may be suitably controlled by the control system 300, such as through the use of accelerometers, encoders or other position / orientation devices 416 to determine and allow movement and positions of the transducer probe 400 Linear, rotary or variable movement can be facilitated, for example, those that depend on the treatment application and the tissue contour surface.
    Transducer 404 may comprise one or more transducers configured for the treatment of SMAS layers and regions set as target. Transducer 404 may also comprise one or more transduction elements and / or lenses 412. Transduction elements may comprise a piezoelectrically active material, such as lead zirconate titanate (PZT), or any other piezoelectrically active material, such as a material Piezoelectric ceramic, glass, plastic and / or composite materials, as well as lithium niobate, lead titanate, barium titanate and / or lead methanobonate. In addition to, or instead of, a piezoelectrically active material, transducer 404 may comprise any other material configured to generate radiation and / or acoustic energy. Transducer 404 may also comprise one or more correspondence layers configured together with the transduction element such as coupled to the piezoelectrically active material. Acoustic correspondence layers and / or damping can be used as necessary to achieve the desired electroacoustic response.
    According to an illustrative embodiment, the thickness of the transducer element of transducer 404 can be configured to be uniform. That is, a transduction element 412 can be configured to have a thickness that is substantially the same everywhere. According to another illustrative embodiment, the thickness of a transduction element 412 can also be configured to be variable. For example, the transduction element (s) 412 of the transducer 404 can be configured to have a first thickness selected to provide a central operating frequency of about 2 MHz to 75 MHz, such as for generation applications. images.
    The transduction element 412 can also be configured with a second thickness selected to provide a central operating frequency of about 2 to 400 MHz, and typically between 4 MHz and 15 MHz for the therapy application. Transducer 404 can be configured as a single excited broadband transducer with at least two or more frequencies to provide a suitable output to generate a desired response. Transducer 404 can also be configured as two or more individual transducers, in which each transducer comprises one or more transduction elements. The thickness of the transduction elements can be configured to provide central operating frequencies in a desired treatment range.


    Transducer 404 may be composed of one or more individual transducers in any combination of focused, planar or non-focused transducers of a single element, multi-element, or arrangements, including 1-D, 2-D and annular arrangements; linear, curvilinear, sectoral or spherical arrangements; spherical, cylindrical, and / or electronically focused, unfocused and / or augmented sources. For example, with reference to an illustrative embodiment shown in Fig. 5, transducer 500 can be configured as an acoustic arrangement to facilitate phase focusing. That is, transducer 500 can be configured as an arrangement of electronic openings that can be operated by a variety of phases through variable electronic time delay. With the term "operate", the electronic openings of the transducer 500 can be manipulated, operated, used and / or configured to produce and / or supply a power beam corresponding to the phase variation produced by the electronic time delay. For example, these phase variations can be used to deliver unfocused beams, planar beams, and / or focused beams, each of which can be used in combination to achieve different physiological effects in a region of interest 510. Transducer 500 can additionally comprise any software and / or other hardware to generate, produce and / or operate a set of openings in phase with one or more electronic time delays.
    Transducer 500 can also be configured to provide focused treatment to one or more regions of interest using various frequencies. In order to provide the focused treatment, the transducer 500 can be configured with one or more devices of varying depth to facilitate the treatment. For example, transducer 500 can be configured with variable depth devices disclosed in US Pat. 10 / 944,500.
    In addition, transducer 500 can also be configured to treat one or more additional ROI 510 through subharmonic enablement or pulse-echo image generation, as disclosed in US Patent Application 10 / 944,499.
    In addition, any variety of mechanical lenses or variable focus lenses, for example liquid-charged lenses, can also be used to focus and / or blur the sound field. For example, with reference to illustrative embodiments depicted in Figs. 6A and 6B, the transducer 600 can also be configured with an electronic focusing arrangement 604 in combination with one or more transduction elements 606 to facilitate greater flexibility in the treatment of the ROI 610. The arrangement 604 can be configured in a manner similar to the transducer. 502. That is, arrangement 604 can be configured as an arrangement of electronic openings that can be operated by means of a variety of phases through variable electronic time delays, for example, T1, T2 ... Tj. By the term "operate", the electronic openings of arrangement 604 can be manipulated, operated, used and / or configured to produce and / or supply power in a manner corresponding to the phase variation caused by the electronic time delay. For example, these phase variations can be used to deliver unfocused beams, planar beams, and / or focused beams, each of which can be used in combination to achieve different physiological effects in ROI 610.
    The transduction elements 606 may be configured to be concave, convex and / or planar. For example, in an illustrative embodiment depicted in Fig. 6A, transduction elements 606A are configured to be concave in order to provide focused energy for the treatment of ROI 610. Additional embodiments are disclosed in US Patent Application. UU. 10 / 944,500.
    In another illustrative embodiment, depicted in Fig. 6B, transduction elements 606B can be configured to be substantially flat in order to provide a substantially uniform energy to ROI 610. While Figs. 6A and 6B represent illustrative embodiments with transduction elements 604 configured as concave and substantially flat, respectively, transduction elements 604 may be configured to be concave, convex and / or substantially flat. In addition, transduction elements 604 can be configured to be any combination of concave, convex and / or substantially flat structures. For example, a first transduction element may be configured to be concave, while a second transduction element may be configured to be substantially flat.
    With reference to Figs. 8A and 8B, transducer 404 can be configured as single element arrangements, in which a single element 802, for example, a transduction element of various structures and materials, can be configured with a plurality of masks 804, said ceramic masks comprising , metal or any other material or structure to mask or alter the energy distribution of the element 802, creating a set of energy distributions 808. The masks 804 can be directly coupled to the element 802 or separated by a separator 806, such as any material suitably solid or liquid.
    An illustrative transducer 404 can also be configured as an annular arrangement to provide flat, focused and / or unfocused acoustic energy. For example, with reference to Figs. 10A and 10B, according to an illustrative embodiment, an annular arrangement 1000 may comprise a plurality of rings 1012, 1014, 1016 a
    N. The rings 1012, 1014, 1016 to N can be mechanically and electrically isolated in a set of individual elements and can create flat, focused or unfocused waves. For example, such waves may be centered on the axis, such as by corresponding transmission and / or reception delay adjustment procedures, τ1, τ2, τ3… τN. An electronic approach can move properly across various depth positions, and can allow variable resistance or tightness of the beam, while a


    Electronic blur may have varying levels of blur. According to an illustrative embodiment, a lens and / or a convex or concave annular arrangement 1000 can also be provided to help focus or blur so that any differential time delay can be reduced. The movement of the annular arrangement 800 can be implemented in one, two or three dimensions or along any path, such as by the use of probes and / or any conventional robotic arm mechanism, to explore and / or treat a volume or any corresponding space within a region of interest.
    The 404 transducer can also be configured in other annular configurations or not of arrangements for imaging / therapy functions. For example, with reference to Figs. 10C-10F, a transducer may comprise an image generating element 1012 configured with the therapy elements (1014). Elements 1012 and 1014 may comprise a single transduction element, for example, a combined image generating element / Transducer, or separate elements, can be electrically isolated 1022 within the same transduction element or between separate imaging and therapy elements and / or may comprise a 1024 or other correspondence layer separation, or any combination thereof. For example, with particular reference to Fig. 10F, a transducer may comprise an image generating element 1012 having a surface 1028 configured to focus, blur or distribute planar energy, with therapy elements 1014 including a stepped configuration lens configured to focus, blur or distribute planar energy.
    According to various illustrative embodiments, transducer 404 may be configured to provide one, two and / or three dimensional treatment applications to focus acoustic energy to one or more regions of interest. For example, as discussed above, transducer 404 can be conveniently segmented to form a one-dimensional arrangement, for example, a transducer 602 comprising a single arrangement of subtransduction elements.
    According to another illustrative embodiment, transducer 404 can be conveniently segmented into two dimensions to form a two-dimensional arrangement. For example, with reference to Fig. 9, an illustrative two-dimensional arrangement 900 can be suitably segmented into a plurality of two-dimensional portions
    902. The two-dimensional parts 902 can be properly configured to focus the treatment region at a certain depth and thus provide respective slices 904 of the treatment region. As a result, the two-dimensional arrangement 900 can provide a two-dimensional cut of the image site of a treatment region, thus providing a two-dimensional treatment.
    According to another illustrative embodiment, transducer 404 can be properly configured to provide three-dimensional treatment. For example, to provide a three-dimensional treatment of a region of interest, with reference again to Fig. 1, a three-dimensional system may comprise a transducer within the probe 104 configured with an adaptive algorithm, such as, for example, one that uses three-dimensional graphic software, contained in a control system, such as control system 102. The adaptive algorithm is properly configured to receive information on two-dimensional image generation, temperature and / or treatment or other tissue parameter information. related to the region of interest, process the information received and then provide information on the generation of three-dimensional images, temperature and / or the corresponding treatment.
    According to an illustrative embodiment, with reference again to Fig. 9, an illustrative three-dimensional system may comprise a two-dimensional arrangement 900 configured with an adaptive algorithm to properly receive 904 cuts of different image planes of the treatment region, process the information received and then provide volumetric information 906, for example, information on the generation of three-dimensional images, temperature and / or treatment. In addition, after processing the information received with the adaptive algorithm, the two-dimensional arrangement 900 can adequately provide therapeutic heating to the volumetric region 906 as appropriate.
    According to other illustrative embodiments, instead of using an adaptive algorithm, such as three-dimensional software, to provide three-dimensional image generation and / or temperature information, an illustrative three-dimensional system may comprise a single transducer 404 configured within an arrangement of probe to operate from various rotational and / or translational positions relative to a target region.
    To further illustrate the various structures for transducer 404, with reference to Figure 7, ultrasound therapy transducer 700 can be configured for a single approach, an arrangement of approaches, a location of approaches, a linear approach and / or patterns of diffraction. The transducer 700 may also comprise individual elements, multiple elements, annular arrangements, one, two or three dimensional arrangements, broadband transducers and / or combinations thereof, with or without lenses, acoustic components and mechanical and / or electronic focus . Transducers configured as spherically focused individual elements 702, annular arrangements 704, annular arrangements with buffered zones 706, individual elements focused on line 708, linear arrangements 1D 710, curvilinear arrangements 1D concave or convex, with or without elevation approach, arrangements 2-D and 3-D spatial arrangements of transducers can be used to perform therapy and / or acoustic control or imaging functions. For any transducer configuration, the focus and / or blur can be in one plane or two


    through the mechanical approach 720, the convex lens 722, the concave lens 724, the composite or multiple lenses 726, the flat form 728 or the stepped shape, as illustrated in Fig. 10F. Any transducer or combination of transducers can be used for treatment. For example, an annular transducer with an external part dedicated to the therapy and the internal disk dedicated to the generation of broadband images can be used, wherein said image transducer and the therapy transducer have different acoustic lenses and design, as illustrated in Fig. 10C -10F.
    In addition, said transduction elements 700 may comprise a piezoelectrically active material, such as lead zirconanto titanate (PZT), or any other piezoelectrically active material, such as ceramic, crystalline, plastic and / or piezoelectric materials, as well as lithium niobate , lead titanate, barium titanate and / or lead methaiobato. The transduction elements 700 may also comprise one or more correspondence layers configured together with the piezoelectrically active material. In addition to or instead of the piezoelectrically active material, the transduction elements 700 may comprise any other material configured to generate radiation and / or acoustic energy. A means is provided to transfer energy to and from the transducer to the region of interest.
    According to another illustrative embodiment, with reference to Fig. 12, an illustrative treatment system 200 can be configured and / or combined with various auxiliary systems to provide additional functions. For example, an illustrative treatment system1200 for treating a region of interest 1206 may comprise a control system 1202, a probe 1204 and a viewfinder 1208. The treatment system 1200 further comprises an auxiliary image generation mode 1272 and / or the auxiliary control mode 1274 may be based on at least one of photography and other visual optical procedures, magnetic resonance imaging (MRI), computed tomography ( CT), optical coherence tomography (OCT), electromagnetic, microwave or radiofrequency (RF) procedures, positron emission tomography (PET), infrared, ultrasonic, acoustic procedure or any other suitable visualization, location or control procedure of SMAS layers within the region of interest 1206, including improvements in the generation of images / control. Said improvement of the generation of images / control for the generation of ultrasound images through the probe 1204 and the control system 1202 could comprise image generation with M mode, persistence, filtering, color, Doppler and harmonics among others; in addition, an ultrasound treatment system 1270, as a primary source of treatment, can be combined with a secondary source of treatment 1276, including radiofrequency (RF), intense pulsed light (IPL), laser, infrared laser, microwave or any other adequate source of energy.
    According to another illustrative embodiment, with reference to Figure 13, the composite treatment of image generation, control and / or therapy to a region of interest can be further assisted, augmented and / or supplied with passive or active devices 1304 within The oral cavity For example, if the passive or active device 1304 is a second acoustic transducer or reflector acoustically coupled to the cheek lining, tomographic or round-trip acoustic waves that are useful for treatment control can be obtained through the transmission , such as to measure the acoustic speed of sound and attenuation, which depend on the temperature; furthermore, said transducer could be used to treat and / or generate images. In addition, an active, passive or active / passive object 1304 can be used to flatten the skin, and / or it can be used as an image generation grid, marker or lamp, to help determine the position.
    A passive or active device 1304 can also be used to aid cooling or temperature control. Natural air in the oral cavity can also be used as a passive device 1304, so it can be used as an acoustic reflector to aid thickness measurement and control function.

    权利要求:
    Claims (10)
    [1]
    1. An ultrasonic treatment system configured for non-invasive facial stretching and deep tissue tensioning, said ultrasound treatment system comprising:
    a probe system (204) configured for both image generation and therapy, wherein said probe system comprises an image generation and therapy transducer configured for the target administration of ablative ultrasound within the system layer of superficial muscular aponeurosis (SMAS), and in which the image generation and therapy transducer comprises an image generation element and a single therapy element, in which the image generation element is configured to generate the image of a region of interest (206), comprising the SMAS layer (216), in which the individual therapy element is composed of a single-element individual transducer, configured for a single approach and for the target administration of ablative energy ultrasound (220) in said SMAS layer (216) at a depth of up to 15 mm below the skin surface to produce a thermal lesion ica of the tissue and cause the contraction of said SMAS layer (216);
    a control system (202) coupled to said probe system (204), said control system (202) controlling the mechanical scanning of the imaging and therapy transducer and comprising a spatial control and a temporary control, controlling said control spatial and said temporary control said supply set as an ablative ultrasonic energy target (220) to produce said contraction of said at least a portion of said SMAS layer (216);
    a movement mechanism to create multiple lesions in a controlled manner, in which the imaging and therapy transducer within the probe system (204) is mechanically scanned in one direction (226) to place treatment zones (260) on an extended area formed as a line; Y
    a display system (208) coupled to said control system (202) and to said image generating element of said probe system (204), said display system (208) is configured to display images (224) of said region of interest (206).
    [2]
    2. The ultrasonic treatment system according to claim 1, wherein the imaging element has a first thickness, in which the single therapy element has a second thickness and in which the imaging element is configured to generate image with an image generation frequency between 2 MHz to 75 MHz
    and the single therapy element is configured to treat with a treatment frequency between 4MHz and 15MHz.
    [3]
    3. The ultrasonic treatment system according to any one of the preceding claims, wherein the control system comprises a processor configured to execute an operable algorithm to convert the data of the probe system and to visualize a three-dimensional image of said region of interest in said display system (208).
    [4]
    Four. The ultrasonic treatment system according to any one of the preceding claims, wherein the movement mechanism comprises at least one of the group consisting of an accelerometer, an encoder and a position / orientation device.
    [5]
    5. The ultrasonic treatment system according to any one of the preceding claims, wherein the imaging element and the therapy element are integrated into a single dual-function image transducer / therapy element.
    [6]
    6. The ultrasonic treatment system according to any one of the preceding claims, further comprising an auxiliary imaging device (1272), a treatment control device (1274) and a secondary therapy system (1276).
    [7]
    7. The ultrasonic treatment system according to claim 6, wherein said auxiliary imaging device (1272) comprises at least one of a photographic device and an optical mode.
    [8]
    8. The ultrasonic treatment system according to any one of the preceding claims, wherein said probe system (204) is configured for the fixed target delivery of said ablative ultrasonic energy (220) to thermally injure at least a part of skin (210), dermis 212), muscular fascia (216) and fat (214) in addition to said SMAS layer (216) for tissue destruction and to cause contraction of said SMAS layer (216) for any one of a face lift, treatment of photoaged tissue, excessive sweating treatment, hyperhidrosis treatment, sweat gland treatment, acne treatment and sebaceous gland treatment.
    [9]
    9. The ultrasonic treatment system according to any one of the preceding claims, further comprising a tissue parameter control system coupled to said system of

    control (202).
    [10]
    10. The ultrasonic treatment system according to any one of the preceding claims, wherein said supply set as a target of ablative energy (220) is at a fixed depth of up to 5 mm below a skin surface (210 ).






























    +


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    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    US61675204P| true| 2004-10-06|2004-10-06|
    US61675504P| true| 2004-10-06|2004-10-06|
    US616752P|2004-10-06|
    US616755P|2004-10-06|
    US61720304P| true| 2004-10-07|2004-10-07|
    US61729504P| true| 2004-10-07|2004-10-07|
    US617203P|2004-10-07|
    US617295P|2004-10-07|
    PCT/US2005/036377|WO2006042201A1|2004-10-06|2005-10-06|Method and system for ultrasound tissue treatment|
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