JP2012024601A5 - - Google Patents

Description

Method and system for beauty enhancement

  The present invention relates to an ultrasound treatment system, in particular, a non-invasive breast fixation method and system, a cellulite treatment method and system, a vascular disorder treatment method and system, and a skin striatum treatment method and system.

  Severe sagging of the skin and facial muscles occurs gradually over time due to chronic changes in connective tissue associated with gravity and aging. Invasive surgical treatment, for example by cheek lifting, is common to tighten such tissue. In these treatments for connective tissue sagging, a portion of the tissue is usually removed and sutures or other fasteners are used to raise the sagging tissue structure. In the breast, the fascia and ligaments form a layer below the surface of the muscle and the skin and subcutaneous fat. Breast sagging is due to the process of loosening of the support (Cooper) ligament. Surgical tightening of the underlying fascia and ligament is required for surgical correction through breast fixation, or a means commonly known as breast lifting.

  Radio frequency (RF) devices have been used to cause heat and contraction on the skin of the face and breast, which has been somewhat successful as a non-invasive alternative to surgical lifting means. However, RF is a decentralized form of energy storage. Because the resistive heat of tissue due to RF energy occurs along the entire path of electrical conduction through the tissue, it is impossible to control the exact amount and depth of thermal tissue. Another regulation of RF energy for non-invasive tightening of Cooper ligament is unnecessary destruction of the covering fat and skin. The high impedance of RF in the fat covering the support connection structure intended for contraction results in a higher temperature in the fat than in the target support structure. Similarly, mid-infrared lasers and other light sources have been used as a trial for non-invasive heat and contractile connective tissue of the dermis. However, because light does not penetrate deep enough to generate local heat in the Cooper ligament, light cannot provide a non-invasive treatment of the Cooper ligament. Under a depth of about 1 mm, the light energy is diffused in various ways and is not focused to obtain strict local heat.

  Cellulite is a common skin disorder that manifests as irregularities in the shape of the skin, often seen as manifestations of skin depressions. This condition affects 80% of women around the world and tends to gather superficially around the thighs, hips and buttocks.

  Cellulite develops in the body when fat accumulates just below the dermis and is contained in fat bunches (lobules) that can swell. As adipocytes grow larger, the leaflets tend to protrude into the dermis layer and the surrounding tissue is compressed and hardened, trapping fluid and making blood circulation difficult. The reduced elasticity of adipose tissue creates unwanted tension between the layers. As a result, protrusions and indentations at connective tissue anchoring points cause the appearance of cellulite.

  This symptom responds to invasive means such as liposuction with various results. Non-invasive techniques such as massagers and low-frequency diathermy ultrasound show limited results. Previous results with the combination of infrared and RF energy promise some improvement in skin shape, but significant progress is required.

  Varicose veins (peripheral vasodilation) are the underlying clinical manifestations of venous insufficiency. In particular, venous insufficiency of leg veins causes the venous blood to circulate in the opposite direction in the congested leg vein. The veins gradually dilate with increasing venous pressure. Abnormal venous circulation of the leg veins results not only from a decrease in leg muscle muscle tension, but also from the loss of valves normally present in the veins. Furthermore, venous varices in leg veins result from chronic increases in venous pressure. Venous insufficiency appears on the surface or deep veins, and each condition has a series of sequelae. Veins and spider veins are more common in the female group.

  Sclerotherapy, laser and intense pulsed light therapy, radio frequency ablation and surgical ablation are modern techniques used to ablate varicose veins. During sclerotherapy, a sclerosing agent (eg, polidocanol, hypertonic sodium chloride solution, etc.) is injected into the dilated vein. This method requires advanced technology. In the absence of deep vagus veins, treatment is not effective. Furthermore, this technique is significantly more morbid when the drug overflows outside the blood vessel. Percutaneous lasers or intense pulsed light (IPL) are only appropriate for vascular malformations with a small face (etc.). However, intravenous laser therapy inserted into a portion of the varicose vein has been proven to be quite effective for less deep veins because the bare fibers coagulate and plug the vein. RF energy based catheters cauterize veins in a manner similar to laser devices that coagulate diseased blood vessels. Surgical techniques such as saphenous vein ablation are often used to ligate the dilated portion of the vein, but are expensive and can cause many complications.

  Facial capillary tissue proliferative disorders also cause hemangiomas and portwine nevus disorders. These symptoms are usually treated with a laser. However, laser treatment can cause scars, excess / hypopigmentation and other problems after treatment. Therefore, there is a need for more effective and non-invasive methods and systems for vascular treatment.

  Skin striae or striatal diseases are permanent scars that damage the appearance left on the skin, usually caused by excessive stretching, such as during rapid weight gain or during or after pregnancy. These marks occur in 50-90% of all pregnant women and usually appear in the second half of pregnancy, like a bright red or purpleish line. Many are under the abdomen, but are also found on women's thighs, hips, buttocks, breasts and arms. During the postpartum period, the reddish lines generally turn into shallow silver scars.

  Skin hydration with lotions and creams helps reduce the occurrence of skin streaks and their effects, but these are unavoidable in women susceptible to this condition. Several studies have investigated the effect of applying 0.1 percent tretinoin (retioninic acid or retin A) cream to the striatum (Non-Patent Document 1). Although both the length and width of the skin streak have decreased, side effects include dry and itchy skin and moderate to severe erythema. This treatment works best when delivered during the first few days after delivery, but has no known effect on breastfeeding. This is harmful and teratogenic and should never be used during pregnancy.

  Postpartum phototherapy may help reduce the appearance of skin streaks. In order to obtain temporary cosmetic relief, ultraviolet (UVA) exposure may be used to tan bright skin areas where skin streaks appear. In limited cases where the skin streak is darker than the surrounding skin, intense pulsed light may be used to remove the pigment. Pulsed colored lasers are also used.

  The pattern of heat cauterization of the epidermis and / or dermis and / or fibrotic fascia is effective in the treatment of various skin conditions. In recent years, "fractional photothermolysis" using a mid-infrared laser that causes a microscopic array of heat-damaged areas, including both the epidermis and dermis, is effective and well tolerated in treating skin remodeling It was reported. The primary advantage of fractionated photothermolysis is that each area of thermal injury is smaller than is easily seen with the naked eye and is surrounded by areas of healthy tissue that initiate an abrupt healing response. Well-tolerated repeated treatments may be performed until the desired result is obtained. However, as with all light-based treatments, fractional photothermomelting is a technique whereby about 1 mm or more of light propagating through the skin is diffusely diffused and is no longer intensively or effectively transmitted to the treatment area. It has the disadvantage that it is basically limited to an area of 1 mm. Cutaneous striatum involves not only the fibrous fascia, but also both the surface and deep layers of the dermis. Therefore, it is essential to treat not only the surface of the skin but also the deep dermis and fibrotic fascia.

S Kang et al., Topical tretinoin (retinoic acid) improve early stretch marks. Arch Dermatol 1996; 132: 519-526

    In accordance with various aspects of the present invention, methods and systems are provided for noninvasive breast lifting through deep tissue using ultrasound. Exemplary methods and systems comprise a therapeutic ultrasound system configured to provide ultrasound therapy to deep tissue regions, such as regions including fascia and ligaments.

  According to various exemplary embodiments, the therapeutic ultrasound system provides a depth of 1 mm to 4 cm with uniform selective accumulation of ultrasound energy without damaging intervening tissue in the frequency range of 1-15 MHz. Configured to achieve. In addition, therapeutic ultrasound is configured in conjunction with ultrasound imaging or image / monitoring functions and is either configured separately with the image, therapy and monitoring system or in combination with these at all levels. It is.

  In accordance with various aspects of the present invention, methods and systems are provided for non-invasive treatment of cellulite using ultrasound. Exemplary methods and systems comprise a therapeutic ultrasound system for providing ultrasound treatment of a deep tissue section that includes a proximal process to the bottom of the dermis and the dermis of a fatty leaflet. Such an exemplary system delivers uniform ultrasonic therapeutic energy to the area causing the thermal injury, coagulating the proximal processes of the fat lobes, and thus overlapping the skin by removing the fat processes into the dermis Improve the appearance of the surface layer.

The present invention describes non-invasive methods and systems that use ultrasonic energy for the treatment of symptoms due to vascular disorders, such as peripheral limbs and faces. Ultrasonic energy may be used to treat facial and other vascular disorders of the body as well as treating spider veins / congested veins up to several millimeters in diameter and up to 70 mm deep. In one exemplary embodiment, image therapy may be used to locate and then noninvasively cauterize the blood vessel being treated while monitoring the progress of the treatment.

  In other embodiments, the ultrasound system and method comprises a transducer and system configured to transmit ultrasound energy to a surface tissue (eg, skin) portion, whereby energy is transmitted to a vascular malformation (to this). Without limitation, varicose veins, etc.) accumulate at a certain depth, located below the skin surface.

Methods and systems for ultrasonic treatment of skin striatum are provided. Exemplary methods and systems use therapy, therapy and monitoring, using focused, divergent, or defocused ultrasound in various spatial and temporal environments for targeted treatment of skin striatum and surrounding tissue. It is configured to treat skin striae using images and therapy, or therapy, images and surveillance.

  Exemplary methods and systems are configured to provide ablation areas within the treatment area in a spatially defined pattern rather than heating and destroying the entire target layer of tissue. Other exemplary methods and systems are configured to specifically target such ablation areas within the treatment area so that they occur at the same location as the skin striatum.

Exemplary therapeutic ultrasound systems are not only capable of targeting and / or monitoring, but are also capable of substantially allowing uniform and localized accumulation of ultrasound energy. In addition, therapeutic ultrasound can also treat the tissue behind the uniform lesion to avoid the same as to avoid heating, cavitation or other destruction phenomena of interstitial tissue including essential structures. Can be avoided.
For example, the present invention provides the following items.
(Item 1)
An ultrasound system configured for non-invasive breast fusion,
A control system configured for control of the ultrasound therapy system;
An imaging system coupled to the control system, wherein the imaging system is configured for an image of a region of interest, the region of interest including an Cooper ligament;
An ultrasound probe configured to form a uniform lesion within the region of interest to facilitate breast fusion, wherein the control system and the probe are spatially coupled to form the uniform lesion And an ultrasonic probe configured for temporal control, the probe configured to operate in a frequency range of about 1 MHz to about 15 MHz;
An ultrasound system comprising:
(Item 2)
The ultrasound system of claim 1, wherein the ultrasound probe is further configured for spatial and temporal control to form the uniform damage.
(Item 3)
The ultrasound system according to item 1, wherein the ultrasound probe includes a transducer, and the transducer includes at least one of a curved array, an annular array, a linear array, and a planar array.
(Item 4)
The ultrasound system of claim 1, wherein the ultrasound probe includes an array and at least two focusing transducer elements, the array including at least one of a linear array, a planar array, and an annular array.
(Item 5)
The ultrasound system according to item 1, wherein the region of interest further includes at least one of a fascia, a ligament, a support ligament, and a deep tissue region.
(Item 6)
A non-invasive breast fusion method,
Selecting a probe configuration based on spatial and temporal parameters;
Imaging a treatment region comprising at least one of a fascia, a ligament and a Cooper ligament in a deep tissue region;
Verifying the temporal and spatial parameters of the probe;
Confirming acoustic coupling of the probe to the treatment area;
Applying ultrasonic energy to cauterize a portion of the treatment area to facilitate breast fixation;
A method of non-invasive breast fusion comprising:
(Item 7)
7. The method of item 6, wherein the step of applying ultrasonic energy comprises applying uniform ultrasonic energy in the range of about 1 MHz to about 15 MHz.
(Item 8)
An ultrasound system configured for cellulite treatment,
A control system configured for control of the ultrasound therapy system;
An ultrasound probe configured to form a uniform lesion within a region of interest, wherein the region of interest includes a proximal process to the bottom of the dermis, a fat leaflet to the dermis, and to facilitate cellulite treatment An ultrasound probe comprising at least one of the subcutaneous layers;
With
An ultrasound system, wherein the control system and the probe are configured to operate in a frequency range of about 750 kHz to about 20 MHz.
(Item 9)
9. The ultrasound system of item 8, wherein the ultrasound probe is further configured for spatial and temporal control to form the uniform damage.
(Item 10)
9. The ultrasound system of item 8, wherein the uniform damage provides at least one of physically broken adipocyte populations and stretched fiber bonds.
(Item 11)
The transducer probe is further configured to induce at least one of enhancement of lymphatic drainage, removal of lipolysis products, occurrence of heat damage, and coagulation of proximal processes of fat lobes. An ultrasonic system as described in.
(Item 12)
A cellulite treatment method comprising:
Selecting a probe configuration based on spatial and temporal parameters;
Verifying the temporal and spatial parameters of the probe;
Confirming acoustic coupling of the probe to a treatment area, the treatment area comprising at least one of a bottom of the dermis, a proximal protrusion of the fat leaflet to the dermis, and a subcutaneous layer;
Applying ultrasonic energy to ablate a portion of the treatment area to facilitate cellulite treatment;
A cellulite treatment method comprising:
(Item 13)
13. The method of item 12, wherein the step of applying ultrasonic energy comprises applying uniform ultrasonic energy in the range of about 750 kHz to about 20 MHz.
(Item 14)
An ultrasound system configured for vascular treatment,
A control system configured for control of the ultrasound therapy system;
An imaging system coupled to the control system, the imaging system configured to image a region of interest, the region of interest comprising spider veins, congested blood vessels, facial blood vessels, and intravascular occlusions An imaging system including at least one of
An ultrasonic probe configured to form uniform damage in the region of interest to facilitate treatment of a vascular disorder, wherein the control system and the probe operate in a frequency range of about 2 MHz to about 20 MHz An ultrasound probe configured to:
An ultrasound system comprising:
(Item 15)
15. The ultrasound system of item 14, wherein the ultrasound probe is configured for at least one of substantial and complete ablation of the region of interest.
(Item 16)
Item 15. The ultrasound system of item 14, wherein the ultrasound probe is configured for use with a pharmaceutical formulation.
(Item 17)
The ultrasound probe and the pharmaceutical preparation may be site-selectively selected from at least one of increased activity of the pharmaceutical preparation, reduced dose of the pharmaceutical preparation, reduced toxicity of the pharmaceutical preparation, and increased local effect of the pharmaceutical preparation. The ultrasound system of item 16, configured to facilitate one.
(Item 18)
Item 15. The treatment system comprises at least two of an imaging system, a treatment system, and a treatment monitoring system, wherein the at least two systems are used in conjunction with an auxiliary image and treatment monitoring device and a secondary treatment system. Ultrasound therapy system.
(Item 19)
The ultrasonic therapy system according to item 18, wherein the auxiliary image device includes at least one of an imaging device and an optical modality.
(Item 20)
A non-invasive treatment method for vascular disorders,
Selecting a probe configuration based on spatial and temporal parameters;
Imaging a treatment region including at least one of spider veins, congested blood vessels, facial blood vessels and intravascular occlusions;
Verifying the temporal and spatial parameters of the probe;
Confirming acoustic coupling of the probe to the treatment area;
Applying ultrasonic energy to ablate a portion of the treatment area to facilitate vascular treatment;
Including a method.
(Item 21)
21. The method of item 20, wherein the step of applying ultrasonic energy comprises applying uniform ultrasonic energy in the range of about 2 MHz to about 20 MHz.
(Item 22)
An ultrasound system configured for the treatment of skin striatum,
A control system configured for control of the ultrasound therapy system;
An imaging system coupled to the control system, wherein the imaging system is configured for an image of a region of interest, wherein the region of interest includes an image comprising at least one of the epidermis, dermis, deep dermis and fibrotic fascia System,
An ultrasonic probe configured to form uniform lesions in the region of interest to facilitate substantial removal of skin striatum, the control system and the probe having a frequency of about 2 MHz to about 50 MHz An ultrasound probe configured to operate in a range;
An ultrasound system comprising:
(Item 23)
24. The ultrasound system of item 22, wherein the ultrasound probe is further configured for spatial and temporal control to form the uniform damage.
(Item 24)
24. The ultrasound system of item 22, wherein the region of interest has a depth in the range of about 0 to about 10 mm.
(Item 25)
23. The ultrasound system of item 22, wherein the ultrasound probe is configured to treat the region of interest, the region of interest being located in at least one of parallel and perpendicular to a skin striatum.
(Item 26)
24. The ultrasound system of item 22, wherein the ultrasound probe is configured to facilitate the generation of an anisotropic shape of tissue damage.
(Item 27)
The ultrasound probe provides at least two energy effects to the region of interest, the at least two energy effects configured to facilitate a reaction in the region of interest, wherein the at least two energy effects are heat, cavitation, Including at least two of hydrodynamic and resonance-induced tissue effects, the reactions being hemostasis, subsequent revascularization / angiogenesis, interconnected tissue growth, tissue remodeling, pre-existing tissue cauterization, drug 24. The ultrasound system of item 22, comprising at least one of enhanced transmission and activation, stimulation of protein synthesis and increased cell permeability.
(Item 28)
In item 22, the control system includes an imaging system configured to facilitate at least one of a one-dimensional image, a one-dimensional treatment, a two-dimensional image, a two-dimensional treatment, a three-dimensional image, and a three-dimensional treatment. The described ultrasound therapy system.
(Item 29)
A method for treating skin striatum,
Selecting a probe configuration based on spatial and temporal parameters;
Imaging a treatment area comprising at least one of the epidermis, dermis, deep dermis and fibrous fascia;
Verifying the temporal and spatial parameters of the probe;
Confirming acoustic coupling of the probe to the treatment area;
Applying ultrasonic energy to cauterize a portion of the treatment area to facilitate treatment of the skin striatum;
Including a method.
(Item 30)
30. The method of item 29, wherein the step of applying ultrasonic energy comprises applying uniform ultrasonic energy in the range of about 2 MHz to about 50 MHz.
(Item 31)
A method for providing non-invasive treatment of vascular disorders,
Identifying at least one of spider veins, congested blood vessels, facial blood vessels and intravascular occlusions in the region of interest;
Targeting the transmission of ablation ultrasound energy from a transducer probe to the at least one of the spider veins, the congested blood vessel, the facial fascia, and the occlusion within the blood vessel;
The target into the at least one of the spider veins, the congested blood vessel, the facial fascia, and the occlusion in the blood vessel during and after the targeted transmission to continue a treatment plan Monitoring the transmission results;
Including a method.
(Item 32)
A method for providing cellulite treatment,
Identifying at least one of the bottom of the bottom of the dermis, the proximal protrusion of the fat lobule to the dermis and the subcutaneous layer in the region of interest;
Targeting the transfer of ablation ultrasonic energy from a transducer probe to the bottom of the dermis, the proximal protrusion of the fat leaflet to the dermis and the at least one of the subcutaneous layers;
The targeting into the bottom of the dermis, the proximal protrusion of the fat leaflet into the dermis and the at least one of the subcutaneous layers during and after the targeted transmission to continue the treatment plan Monitoring the transmission results;
Including a method.
(Item 33)
A method for providing skin streak treatment,
Identifying at least one of epidermis, dermis, deep dermis and fibrous fascia within the region of interest;
Targeting the transfer of ablation ultrasound energy from a transducer probe to the at least one of the epidermis, the dermis, the deep dermis and the fibrous fascia;
Monitoring the outcome of the targeted transmission into the at least one of the epidermis, the dermis, the deep dermis and the fibrous fascia during and after the targeted transmission to continue a treatment plan When,
Including a method.
(Item 34)
A method for providing non-invasive breast fusion,
Identifying at least one of fascia, ligament and Cooper ligament in the region of interest;
Targeting the transfer of ablation ultrasonic energy from a transducer probe to the at least one of the fascia, the ligament, and the Cooper ligament;
Monitoring the targeted transmission result into the at least one of the fascia, the ligament, and the Cooper ligament during and after the targeted transmission to continue a treatment plan;
Including a method.

The subject matter of the present invention is particularly pointed out in the concluding part of the specification. However, the present invention will be best understood by reference to the following description, in combination with the accompanying drawings, in which like parts are designated with like numerals, both as an arrangement and method of operation.
FIG. 1 is a block diagram of an exemplary ultrasonic treatment system for beauty enhancement according to an exemplary embodiment of the present invention. 2A-2F show cross-sectional views of an exemplary probe system according to an exemplary embodiment of the present invention. 2A-2F show cross-sectional views of an exemplary probe system according to an exemplary embodiment of the present invention. 2A-2F show cross-sectional views of an exemplary probe system according to an exemplary embodiment of the present invention. 2A-2F show cross-sectional views of an exemplary probe system according to an exemplary embodiment of the present invention. 2A-2F show cross-sectional views of an exemplary probe system according to an exemplary embodiment of the present invention. 2A-2F show cross-sectional views of an exemplary probe system according to an exemplary embodiment of the present invention. 3A and 3B show block diagrams of an exemplary control system according to an exemplary embodiment of the present invention. 3A and 3B show block diagrams of an exemplary control system according to an exemplary embodiment of the present invention. 4A and 4B show a block diagram of an exemplary probe system according to an exemplary embodiment of the present invention. 4A and 4B show a block diagram of an exemplary probe system according to an exemplary embodiment of the present invention. FIG. 5 shows a cross-sectional view of an exemplary transducer according to an exemplary embodiment of the present invention. 6A and 6B show cross-sectional views of an exemplary transducer according to an exemplary embodiment of the present invention. 6A and 6B show cross-sectional views of an exemplary transducer according to an exemplary embodiment of the present invention. FIG. 7 illustrates an exemplary transducer configuration for ultrasound therapy according to various exemplary embodiments of the present invention. 8A and 8B show cross-sectional views of an exemplary transducer according to another exemplary embodiment of the present invention. FIG. 9 illustrates an exemplary transducer configured as a two-dimensional array for ultrasound therapy according to an exemplary embodiment of the present invention. 10A-10F show cross-sectional views of exemplary transducers according to other exemplary embodiments of the present invention. 10A-10F show cross-sectional views of exemplary transducers according to other exemplary embodiments of the present invention. 10A-10F show cross-sectional views of exemplary transducers according to other exemplary embodiments of the present invention. 10A-10F show cross-sectional views of exemplary transducers according to other exemplary embodiments of the present invention. 10A-10F show cross-sectional views of exemplary transducers according to other exemplary embodiments of the present invention. 10A-10F show cross-sectional views of exemplary transducers according to other exemplary embodiments of the present invention. FIG. 11 shows a schematic diagram of a sonic coupling and cooling system according to an exemplary embodiment of the present invention. FIG. 12 shows a block diagram of a treatment system that includes a secondary treatment subsystem in an exemplary embodiment of the present invention as well as an ultrasound treatment subsystem that combines additional subsystems and treatment monitoring methods and / or treatment images. . 13A and 13B show schematic views of a treatment area according to an exemplary embodiment of the present invention. 13A and 13B show schematic views of a treatment area according to an exemplary embodiment of the present invention.

  The present invention may be described herein in terms of various functional elements and processing steps. It should be understood that such elements and steps are accomplished by any number of hardware elements configured to perform a particular function. For example, the present invention provides a variety of medical treatment devices, visual image and display devices, input terminals and the like that can perform a variety of functions under the control of one or more control systems or other control devices. Can be used. Furthermore, the present invention may be implemented in any medical field, and the exemplary embodiments relating to the beauty enhancement, imaging system and monitoring system described herein only illustrate exemplary applications of the present invention. . For example, the basic principles, characteristics and methods discussed can be applied to any medical application. Furthermore, various aspects of the present invention can be suitably applied to other applications.

  In various aspects of the invention, methods and systems for enhancing beauty through ultrasonic cautery are provided. For example, as shown in FIG. 1, according to an exemplary embodiment, an exemplary treatment system 100 configured to treat a region of interest 106 includes a control system 102, an image / therapy probe and display with acoustic coupling 104. A system 108 is provided.

  The control system 102 and the display system 108 control the multiplexing of the probe 104 and the entire system 100, eg, a microprocessor, electronic and / or mechanical scanning and / or transducer with software and multiple input / output devices. Systems and devices for power supply systems, monitoring systems, systems for sensing the spatial position of probes and / or transducers, and / or systems for processing user input and recording treatment results, etc. Various configurations for controlling can be provided. The image / therapy probe 104 comprises various probe and / or transducer configurations. For example, the probe 104 may be configured for a combined dual mode image / therapy transducer, a combined or housed image / therapy transducer or simply a separate therapy probe and image probe.

  As used herein, “beauty enhancement” means both essential and / or essential treatment plans for human tissue. Cosmetic enhancement therapies include, but are not limited to, for example, cellulite treatment, vascular disorder treatment, and skin striatum treatment. As used herein, “angiopathy” and the like include, but are not limited to, for example, varicose veins, spider veins, deep vein disorders, facial hemangiomas or ports Includes peripheral vascular deformities such as wine nevus and / or the like.

  According to an exemplary embodiment, the treatment system 100 first images the treatment region and the region of interest 106 of the surrounding structure to obtain the second desired treatment effect, depth, distribution, timing. By transmitting ultrasound energy at the energy level and third, evaluating the plan and results, and / or monitoring the treatment area before, during and after treatment to provide feedback, Configured for treatment of a region of interest.

  In treating the region of interest 106, the system 100 may include one or more breast tissue surface layers, eg, deep tissue regions such as fascia and ligaments and / or regions containing muscle, fat or dermis regions, dermis bottoms and fats. Deep tissue region containing proximal processes to the dermis of the lobule, deep tissue region containing at least one of spider veins, congested veins, facial blood vessels and intravascular occlusions, and / or subcutaneous and / or skin It may be configured to treat fibrous structures (fascia) etc. in the surface layer. As used herein, the term dermis means any part of the dermis and / or epidermis.

  In one or more treatments of these regions of interest, the connective tissue is permanently tightened by heat treatment to a temperature of about 60 ° C. where the tissue immediately shrinks by about 30% of length. Tissue contraction produces the desired tightening for correction of one or more of these regions of interest. In addition to providing accurate transmission of therapeutic energy to the skin striatum and feedback from the region of interest, the skin striated region to a temperature of about 60-90 ° C. without significant damage to the overlap, underlying or surrounding tissue. Treatment with local heating is suitably accomplished via the treatment system 100. Subsequent tightening of the tissue of the ROI 106 results in minimizing aesthetic defects in the target area of the ROI 106 and improving the appearance of the overlapping surface layer of the skin.

  The region of interest 106 is different for each beauty enhancement treatment. For example, ROI 106 includes, for example, fascia, Cooper ligament, support ligament and / or other ligaments. These are typically about 0.5-2.5 cm deep, but differ in depth and thickness at different locations.

  In other embodiments of cellulite treatment, treatment with ROI 106 may cause transducer system 102 to transmit an energy field to, for example, the bottom of the dermis, the proximal process of said fat lobule to said dermis and / or the subcutaneous layer. May be. This energy can have one or more effects such as cauterization of existing tissue, protein synthesis, destruction of adipocyte assembly, stretching of fiber bonds, enhancement of lymphatic drainage, facilitation of lipolysis product removal and / or cellulite. The enhancement of cell permeability for treatment can be promoted.

  In yet another embodiment, the ROI 106 for vascular disorder treatment is, for example, a spider vein, a congested blood vessel, a facial blood vessel, and / or an occlusion within a blood vessel that is several millimeters in size and up to 70 mm deep. ROI 106 includes facial and other vascular disorders of the body.

  In the treatment of skin striatum, the ROI 106 includes connective tissue in which the connective tissue is permanently tightened by heat treatment to a temperature of about 60 ° C. where the tissue immediately shrinks by about 30% of length. The contraction of the tissue results in the desired tightening and reconfiguration for the correction of the skin striatum. In addition to providing accurate transmission of therapeutic energy to the skin striatum and feedback from the region of interest, the skin striated region to a temperature of about 60-90 ° C. without significant damage to the overlap, underlying or surrounding tissue. Treatment with local heating is suitably accomplished via the treatment system 100. Subsequent tightening of the tissue of the ROI 106 results in minimizing skin streaks in the target area of the ROI 106 and improving the appearance of overlapping surface layers of the skin.

In other embodiments, the exemplary transducer 100 first images and displays the treatment region and surrounding region localization region of interest 106 and secondly the desired treatment of thermal ablation to treat cellulite. Deliver focused, divergent, or defocused ultrasonic energy at depth, distribution, timing, and energy level, thirdly evaluate plans and results, and / or control system 102 and / or operator to obtain effects Is configured for treatment of the region of interest by monitoring the treatment area and surrounding structures before, during, and after treatment.

  The exemplary beauty enhancement treatment system 100 is configured to provide a specific treatment that is tailored to fit a specific cosmetic result desired. For example, referring to the exemplary embodiment shown in FIG. 2A, a non-invasive breast fusion system 200 includes a treatment transducer system 202, a control system 204, and a display for providing treatment to a region of interest (ROI) 210. 206.

  The transducer probe 202 may be configured in a probe arrangement for providing therapy. Transducer probe 202 allows for optimal therapy and therapy, such as through a non-invasive configuration and through control by control system 204, for example, to provide a control position for ultrasonic therapy transducer 202. In addition, various mechanical devices may be used. Furthermore, the transducer probe 202 may be configured for one-dimensional, two-dimensional and / or annular arrays and / or three-dimensional therapeutic applications, as described herein.

  The exemplary transducer probe 202 may be configured to be appropriately controlled and / or manipulated in various ways. For example, the transducer probe 202 may be configured for use within any combination of ultrasound therapy, imaging and / or monitoring systems, including ultrasound system therapy, ultrasound imaging systems and / or motion control subsystems. .

  The control system 204 may be configured with one or more subsystems, processors, input devices, displays, and / or the like. Display 206 may be configured to image and / or monitor ROI 210 and / or all specific subregions within ROI 210. Display 206 may be configured for two-dimensional, three-dimensional, real-time, analog, digital, and / or any other image type. Exemplary embodiments of both the control system 204 and the display 206 are described in detail herein.

Tissue region 210 includes a surface layer such as, for example, epidermis and / or dermis, subcutaneous fat, Cooper ligament and / or muscle. Since the Cooper ligament is typically located at a depth of 0.5-2.5 cm, the ROI 210 includes an expanded region of interest. Also, because the Cooper ligament has different depth and thickness at different locations, the transducer system 200 is configured to facilitate imaging and treatment at different tissue depths and locations.
That is, exemplary transducer system 200 may be configured to provide a cross-sectional two-dimensional image of region 207 displayed as image 205, with controlled thermal damage 209 confined within ROI 210. For example, through such space and / or time control, the exemplary treatment system 200 allows the heat damaged area to be processed to any shape and size, and the tissue is treated in a controlled manner. Enable.

  According to an exemplary embodiment, the transducer probe 202 includes various depths including a transfer element having a piezoelectrically active layer that matches a matching layer and / or other material for generating radiation or acoustic energy. Of transducers. In other words, the transducer probe 202 may be configured to operate at a moderate frequency to provide various depths of treatment within the ROI 210. Further, the transducer probe 202 may be configured as a multidirectional transducer. Various configurations of the transducer probe 202 are described in detail herein.

  The exemplary ultrasound transducer probe 202 may be configured in various ways to provide various functions. In one embodiment, the transducer probe 202 may be configured to generate high acoustic energy for therapeutic purposes and at the same time provide the best imaging function. For example, in order to allow optimal control at various treatment depths for the size of the treatment area, exemplary embodiments of the present invention provide each sub-element with sufficient bandwidth for the best distance resolution. There may be a transducer incorporated into the array of sub-elements configured to process the sound with width.

For example, an ultrasound therapy transducer system may be configured for spatial and / or time control by changing the transducer position, drive frequency, focus depth, drive amplitude, and exemplary transducer time. . According to various exemplary embodiments, the transducer probe 202 may change the transducer probe 202 to a reflective surface, or change the angle of energy that is focused or defocused onto the tissue region 205 and / or 207, etc. It may be configured for spatial control and / or configured for time control, such as by controlling changes in frequency, drive amplitude and time of transducer probe 202 via control system 204. As a result, not only the heating conditions, but also the location, shape and size of the treatment area and / or the amount of area or area of interest may be dynamically controlled over time.

  In addition to spatial control, control system 204 and / or transducer probe 202 may also be adjusted via adjustment and optimization of drive amplitude levels, frequency / waveform selection and other energy drive characteristics to control time series and tissue treatment, and the like. And may be configured for time control. Spatial and temporal control can also be facilitated through open loop and closed loop feedback processes, such as by monitoring various position and temporal characteristics.

  According to another exemplary embodiment of the present invention, the control system 204 and / or transducer probe 202 is configured to generate the best acoustic functions while generating high acoustic energy for therapeutic purposes. May be. For example, the exemplary embodiments of the present invention have at least one common inventor and reference in order to be able to be optimally controlled at various treatment depths for treatment site size. Each sub-element is the best distance as described in SYSTEM AND METHODS FOR VARIABLE DEPTH ULTRASOUND TREATMENT filed on September 16, 2004, filed Sep. 16, 2004. A transducer configured in a series of sub-elements configured to process sound waves with sufficient bandwidth for resolution may be provided.

  In accordance with other aspects of the present invention, the exemplary ultrasound treatment system 200 not only acoustically monitors the temperature profile or other tissue parameter monitoring of the treatment area and its general surroundings, but also treats heat, treatment, It may also be configured to provide cooling of the area and / or providing an image. For example, according to an exemplary embodiment, the ultrasound treatment system 200 is based on monitoring temperature or other tissue parameters and / or for appropriately adjusting the spatial and / or temporal characteristics of the ultrasound treatment transducer. It may be configured using dynamic feedback processing based on image information.

  To facilitate image, monitoring, therapy and / or temperature control of the ROI 210, the control system 204 can be configured with various elements and devices. For example, the transducer probe 202 not only forms a controlled heating lesion 209 confined to the top of the muscle near the Cooper ligament, but also appears in the region 207 as shown, for example, in the image 205 in the display 206. Can be configured to provide a cross-sectional two-dimensional image. The therapeutic ultrasound system 200 can be configured not to affect intervening tissue, including not only the posterior tissue of the uniform lesion 209 but also essential structures.

  An exemplary cellulite treatment system therapy is shown in the exemplary embodiment of FIG. 2B. Cellulite transducer system 200 includes a transducer probe 202 connected to a control system 204, and display 206 in combination provides treatment, images and / or temperature or other tissue parameters to monitor region of interest 210. . The region of interest 210 may include surface layers (epidermis / dermis) subcutaneous fat, lobule and muscle. The exemplary transducer system 200 is a cross-sectional two-dimensional image of a region 207 as displayed as an image 205 with a controlled heating lesion 209 approximately confined to the bottom of the dermis at the proximal portion of the fat leaflet. Can be configured to provide. The transducer system 200 may be used to provide an ultrasonic mechanical action to physically destroy adipocyte mass and stretch fiber bonds. This mechanical action will also enhance lymphatic drainage, which stimulates the removal of lipolysis products. That is, the ultrasound may facilitate movement of muscles and soft tissue within the ROI 210, and thus may relax the fat deposit / or facilitate the destruction of the fibrous tissue around the fat deposit. .

Furthermore, the transducer system 200 determines the rate of fat metabolism according to Arrhenius' law Y = A · e ^{−B / T} (where Y is the metabolic reaction yield, A and B are constants, and T is the temperature in Kelvin). To increase, it can be configured to transmit various therapeutic levels of ultrasound. In one exemplary embodiment, the transducer system 200 is configured to provide various therapeutic levels of ultrasound to increase the rate of fat metabolism. That is, according to Arrhenius' law, the yield Y of the metabolic reaction is a function of temperature, and T: Y = A · e− ^{B / T} (A and B are constants and T is the temperature in Kelvin degrees). is there. Thus, ultrasound treatment from the transducer system 200 in the range of about 750 kHz to 20 MHz increases the temperature of the treatment area and thus increases the metabolic reaction yield of that treatment area.

  An exemplary vascular disorder treatment system is shown in the exemplary embodiment of FIG. 2C. The exemplary vascular disorder treatment system 200 includes a transducer / probe 202 connected to a control system 204, and the display 206 in combination provides treatment, images and / or temperature or other tissue parameters.

  Region of interest 210 may include any particular blood vessel or group of blood vessels and / or any portion within a blood vessel. The exemplary transducer system 200 is controlled to be about 0.1-5 mm in diameter to facilitate vessel ablation and about 3-20 mm in diameter to facilitate vessel ablation. It can be configured to provide a cross-sectional two-dimensional image of region 207 to be displayed as image 205 with heat damage. The injury may be any shape to provide vascular cauterization. For example, sphere, ellipse and / or cigar shape damage is effective for ablation purposes. Methods for treating vascular disorders are further described herein.

An exemplary cellulite treatment system 200 is shown in FIGS. Referring to FIG. 2D, an exemplary cellulite treatment system 200 includes an image 222 portion and a display 206 of a region of interest 210 for treatment and surrounding structure localization. The exemplary cellulite system 200 focuses, diverges, or defocuss ultrasonic energy at depth, distribution, timing, and energy level so that the desired therapeutic effect of thermal ablation for treating skin striatum 232 is obtained. Treatment area and surroundings before, during, and after treatment to communicate at least one of 220 and provide feedback to evaluate plans and results and / or to control control system 204 and the operator Configured to monitor the structure. The exemplary probe 202 and / or transducer can be mechanically and / or electronically scanned 226 to place the treatment region in the expansion region, with a treatment depth 220 in the range of about 0-10 mm, Or it can be adjusted at the maximum depth of the skin striatum or deep dermis.

  The tissue region 210 can include surface layers such as, for example, epidermis and / or dermis, subcutaneous fat and / or muscle. The example transducer system 200 can be configured to provide a cross-sectional two-dimensional image 222 of the ROI 210, displayed as an image 224, along with a controlled heating lesion 220.

  To transfer energy to the ROI 210, the transducer probe 202 and / or other transducers can be mechanically and / or electronically scanned 226 to place the treatment region in the expansion zone. In certain embodiments, the treatment depth 220 can be adjusted between a range of about 0-10 mm, or the maximum depth of the skin striae or deep dermis.

In certain embodiments, the image 222 element comprises a display 206 of the ROI 210 to facilitate localization of the treatment area and surrounding structures. The energy 220 may be transmitted to the ROI 210 using a transducer probe 202 configured to transmit focused, divergent, and / or defocused ultrasonic energy 220 with one or more treatment parameters. Various configurations of the transducer probe 202 are disclosed herein. As used herein, the phrase “treatment parameter” refers to, for example, depth, distribution, timing and / or energy to obtain the desired therapeutic effect of heat ablation for treating skin striatum 232. Includes levels.

  As shown in FIG. 2E, according to another aspect of the present invention, an exemplary cellulite treatment system 200 may include a temperature profile or other tissue parameter of interest 210 and / or other tissue parameters of treatment region 220, such as attenuation, speed of sound or stiffness. It may be configured to monitor mechanical properties such as thickness and strain and adjust the spatial and / or temporal characteristics and the energy level of the ultrasonic therapy transducer appropriately. The result of such a monitoring method may be displayed on the display 206 by a 1, 2 or 3D image of the monitoring result 250, or simply a normal or abnormal type display, or a combination thereof. Additional treatment monitoring methods may be based on one or more of temperature, video, profilometry and / or stiffness or strain gauges or other suitable sensor methods.

  As shown in FIG. 2F, according to another exemplary embodiment, an exemplary cellulite treatment system 200 includes an expanded treatment area of interest 252 that includes a combination of tissues such as subcutaneous fat / adipose tissue 216 and muscle 218. It may be configured to provide treatment. Such multiple tissues, including epidermis 212, dermis 214, adipose tissue 216 fascia, muscle 218, hair, glands and skin streaks in combination with at least one of blood vessels in dermis 214 or other relevant tissues, are treated. May be. For example, skin streak treatment 220 may be performed in conjunction with subcutaneous fat 216 treatment by appropriate adjustment of treatment parameters and / or transducers of probe 202.

  As described above, the control systems 102 and 204 may be configured in various ways, using various subsystems and subelements. As shown in FIGS. 3A and 3B, according to an exemplary embodiment, exemplary control system 300 is configured for adjustment and control of the entire therapeutic treatment process based on adjustable settings made by the therapeutic treatment user. can do. For example, the control system 300 may suitably comprise a power supply element 302, a sensor and monitoring element 304, a cooling and coupling control 306 and / or processing and control logic element 308. The control system 300 can be configured and optimized in a variety of ways using subsystems and elements to implement a treatment system for non-invasive breast fixation, and FIGS. 3A and 3B are for illustrative purposes only. It is.

  For example, in the power supply element 302, the control system 300 is configured to provide power for the entire control system 300, including the power required by the transducer electronic amplifier / driver 312. A power source 303 can be provided. A DC current device 305 may be provided to verify the power level sent to the amplifier / driver 312 for safety and monitoring purposes.

  The electronic amplifier / driver 312 may comprise a multi-channel or single channel power amplifier and / or driver. In an exemplary embodiment in a transducer array configuration, the electronic amplifier / driver 312 can also be configured with a beamformer to facilitate array focusing. The exemplary beamformer can be electrically excited by an oscillator / digital control waveform synthesizer 310 using associated switch logic.

  The power supply element can also include a variety of filter configurations 314. For example, a switched harmonic filter and / or matching may be used at the output of the amplifier / driver 312 to increase drive efficiency and effectiveness. A power sensing element 316 may be included to confirm proper scanning and calibration. For example, power and other energy sensing elements 316 may be used to monitor the amount of power delivered to the exemplary probe system.

  Various sensors and monitoring elements 304 may be suitably implemented within the control system 300. For example, according to an exemplary embodiment, monitoring, sensor and interface control element 324 is implemented in transducer probe 104 to receive and process information such as sound or other spatial and temporal information from the region of interest. It may be configured to work with a variety of motion detection systems. Sensors and monitoring elements can also include various controls, interfaces and switches 309 and / or power detectors 316. Such sensors and monitoring elements 304 can facilitate an open / closed loop feedback system within the treatment system 100.

  For example, in such an open loop feedback system, the system user appropriately monitors images and / or other spatial or temporal parameters and then adjusts or modifies them to achieve a specific therapeutic objective Can do. Alternatively, or in combination with an open loop feedback system, an exemplary treatment system is a closed loop where image and / or space / time parameters can be properly monitored within the monitoring element to emit a signal. An equation feedback system can be provided.

During operation of the exemplary treatment system 100, the damage configuration of the selected size, shape, orientation position is determined. Based on this damage configuration, one or more spatial parameters are selected along with appropriate time parameters, and the combination of these parameters results in the desired uniform damage. Actuation of the transducer is then initiated to provide uniform damage or damage. Open and / or closed loop feedback systems are used to monitor spatial and / or temporal characteristics, and / or other tissue parameter monitoring is used to further monitor uniform damage.
The cooling / bonding control system 306 removes waste heat from the exemplary probe 104, provides a controlled temperature to the surface tissue interface and deeper, eg, blood and / or tissue, and / or the transducer probe 104. To provide acoustic coupling to the region of interest 106. Such a cooling / coupling control system 306 can also be configured to operate in both open-loop and / or closed-loop feedback processes using various coupling and feedback elements.

  Processing and control logic elements 308 are only input / output circuits and systems for microcontrollers, microprocessors, field programmable gate arrays (FPGAs), computer boards and communications, displays, interfaces, storage, documentation and other useful functions. A variety of system processors and digital control logic 307 may be provided, such as associated elements including firmware and control software 326 that harmonize with user control and interface circuitry. System software and firmware 326 controls all initial settings, timing, level settings, monitoring, safety monitoring and all other system functions required to achieve the therapeutic objectives defined by the user. Further, the various control switches 308 can be appropriately configured to control operation.

  The exemplary transducer probe 104 may be configured in a variety of ways and may include a number of reusable and / or disposable elements and portions in various embodiments to facilitate operation. For example, to facilitate coupling the transducer to the tissue interface, the transducer probe 104 can be configured in any type of transducer probe housing or process, such a housing can be used for specific therapeutic applications. Of different shapes, outlines and configurations, and such housings may have a variety of shapes, outlines and configurations depending on the particular therapeutic application. For example, in the exemplary embodiment, transducer probe 104 is depressed relative to the tissue interface by partially or completely interrupting blood return and allowing the tissue to be leveled in surface treatment region of interest 106. The transducer probe 104 may be a transducer, such as an electrically switchable electrical match, a multiplexer circuit and / or an aperture / element selection circuit, and / or a probe handle, electrical match, one or more serial EEPROMs (memory), etc. Any type of alignment can be provided, such as a probe identification device to ensure usage history and calibration. The transducer probe 104 may also include indicators such as cables and connectors, operating mechanisms, operational sensors and encoders, heat monitoring sensors and / or user control and status related switches, and LEDs. For example, the operating mechanism in the probe 104 can be used to controllably create multiple damages, or the probe motion sensor itself can controllably create multiple damages and / or, for example, the probe 104 can be activated rapidly. Or it may be used to stop the formation of damage for safety in case of falling. In addition, an externally operated encoder arm is used to maintain the probe during use by being transmitted to the control system to help the spatial position and attitude of the probe 104 controllably create damage. May be. Furthermore, other sensor functions such as a profilometer or other image modality may be integrated into the probe according to various exemplary embodiments.

  As shown in FIGS. 4A and 4B, according to an exemplary embodiment, transducer probe 400 may include a control interface 402, a transducer 404, a coupling component 406 and a monitoring / sensor component 408 and / or an operating mechanism 410. it can. However, the transducer probe 400 can be configured and optimized in a variety of ways with some components and components to provide ultrasonic energy for non-invasive breast fusion, as shown in FIGS. 4B is for exemplary purposes only.

According to an exemplary embodiment of the present invention, transducer probe 400 is configured to transmit energy for different time and / or spatial distributions to provide energy action to the region of interest and to cause a reaction. . These actions can include, for example, heating, cavitation, hydraulic and resonance induced tissue effects. For example, the exemplary transducer probe 400 may be operated under one or more frequency ranges to provide two or more energy effects to the region of interest and to cause one or more reactions. Further, the transducer probe 400 may be configured to deliver planar, defocused , and / or focused energy to a region of interest to provide more than one energy action and cause more than one reaction. Good. These reactions may include, for example, diathermy, congestion, revascularization, angiogenesis, interconnected tissue growth, tissue remodeling, pre-existing tissue cauterization, protein synthesis and / or increased cell permeability. Other exemplary embodiments in ultrasonic therapy, effects and responses thus combined with these are described in “METHOD AND SYSTEM FOR” of US patent application serial number 10 / 950,112 filed on September 24, 2004. "COMBINED ULTRASOUND TREATMENT" is hereby incorporated by reference.

The control interface 402 is configured to coordinate with the control system 300 to facilitate control of the transducer probe 400. Control interface component 402 may include multiplexer / aperture selection 424, switchable electronic matching network 426, serial EEPROMs and / or other processing components and matching and probe usage information 430 , cable 428 and interface connector 432.

  The coupling component 406 may comprise a variety of devices to facilitate coupling the transducer probe 400 to the region of interest. For example, the coupling component 406 may comprise a cooling and acoustic coupling system 420 configured for acoustic coupling of ultrasonic energy and signals. An acoustic cooling / coupling system 420 using possible connections, such as a manifold, focuses the liquid-filled lens to couple the sound to the region of interest, to control the temperature of the interface and deeper, eg, blood and / or tissue. And / or to remove transducer waste heat. The coupling system 420 can be a variety of coupling media including air and other gases, water and other liquids, solids and / or any combination thereof, or other that allows signals to be transmitted between the transducer active element 412 and the region of interest. Such coupling may be facilitated through the use of media. In addition to providing a coupling function, according to an exemplary embodiment, coupling system 420 may be configured to provide temperature control during therapeutic applications. For example, the coupling system 420 may be configured for controlled cooling of the interface surface or region between the transducer probe 400 and the region of interest and beyond the region of interest by appropriate control of the temperature of the coupling medium. The appropriate temperature of such a coupling medium can be obtained in various ways, using various feedback systems such as thermocouples, electrothermal regulators or other devices or systems configured for measuring the temperature of the coupling medium You can do it. Such controlled cooling may be configured to further facilitate space and / or thermal energy control of the transducer probe 400.

According to an exemplary embodiment, as further shown in FIG. 11, acoustic coupling and cooling 1140 acoustically couple energy and image signals from and ROI 110 2 from the transducer probe 1104 to the region of interest 110 2 In order to provide thermal control of the probe 1100 to the region of interest interface (skin) 1110 and deeper, eg blood and / or tissue and deeper eg blood and / or tissue, and from the transducer probe in region 1144 It may be provided to remove any waste heat that may be generated. Temperature monitoring may be provided with a binding interface via a heat sensor 1146 to provide a mechanism for temperature measurement 1148, the control may be provided via the control system 110 6 and thermal control system 1142. Thermal control can be passive cooling, such as through a radiator or natural conduction and convection, or Peltier thermoelectric cooler, coolant or pump, fluid reservoir, bubble detection, flow sensor, flow path / flow tube 1144 and thermal control 1142 It consists of active cooling using a fluid-based system or the like.

  The monitoring and sensor component 408 includes various motion and / or position sensors 416, temperature monitoring sensors 418, user control and feedback switches 414, and open loop and closed loop feedback processes that monitor, for example, various spatial and temporal identifications. Other similar components for facilitating control may be included by the control system 300 for facilitating space and / or time control.

The operating mechanism 410 includes manual operation, mechanical device, or a combination thereof. For example, the motion mechanism driver 3 22 is appropriately controlled by the control system 300, such as through the use of an accelerometer, encoder or other position / orientation position device 416, to determine and provide the motion and position of the transducer probe 400. It's okay. Linear, rotational or various movements are facilitated depending on, for example, the therapeutic application and the required tissue contour.

  Transducer 404 comprises one or more transducers configured to form a uniform lesion of thermal damage in human surface tissue within the region of interest via strict spatial and temporal control of acoustic energy storage. be able to. The transducer 404 can also include one or more transducer elements and / or lenses 412. The transfer element is not only lithium niobate, lead titanate, barium titanate and / or lead metaniobate, but also piezoelectrically active materials such as lead zirconate titanate (PZT), or piezoelectric ceramics, crystals, plastics And / or other piezoelectrically active materials such as synthetic materials may also be included. In addition to or instead of the piezoelectrically active material, the transducer 404 can include other materials configured to generate radiation and / or acoustic energy. The transducer 404 can also include one or more matching layers configured with a transmission element that is coupled to a piezoelectrically active material. An acoustic matching layer and / or damping may be used as necessary to obtain the desired electroacoustic response.

  According to an exemplary embodiment, the thickness of the transmission element of the transducer 404 may be configured to be constant. That is, the transfer element 412 may be configured to have substantially the same thickness throughout. In other exemplary embodiments, the thickness of the transfer element 412 may be configured to vary. For example, the transfer element 412 of the transducer 404 may be configured to have a first thickness selected to provide a central operating frequency of about 2 MHz to 50 MHz, such as for imaging applications. The transfer element 412 may be configured to have a second thickness selected to provide a central operating frequency between about 7 kHz and 50 MHz, and generally between 1 MHz and 25 MHz for therapeutic applications. Transducer 404 may be configured as a single broadband transducer excited at at least two or more frequencies to provide an appropriate output to obtain the desired response. The transducer 404 may be configured as two or more individual transducers, each transducer including one or more transmission elements. The thickness of the transfer element may be configured to provide a central operating frequency in the desired treatment range.

Transducer 404 includes one-dimensional, two-dimensional and annular arrays, straight, curved, fan-shaped or spherical arrays, spherical, cylindrical and / or electronically focused, defocused and / or lens sources, focused, planar or divergent Any combination of single element, multiple element or array transducers, consisting of one or more individual transducers. For example, as shown in the exemplary embodiment shown in FIG. 5, the transducer 500 may be configured as an acoustic array 502 to facilitate phasing. That is, the transducer 500 may be configured as an electronic aperture that may be manipulated with various phases via a variable electronic time delay. The term “operated” means that the electronic aperture of the transducer 500 may be manipulated, driven, used and / or configured to generate and / or transmit an energy beam corresponding to the phase variation caused by the electronic time delay. Means that. For example, these phase variations may be used to transmit defocused beam 508 , planar beam 504, and / or focused beam 506 , where each beam is combined to obtain a different physiological effect in region of interest 510. And may be used. The transducer 500 may additionally comprise any software and / or other hardware for generating, providing or driving the phase aperture array using one or more electronic time delays.

  The transducer 500 may be configured to provide intensive care to one or more regions of interest using a variety of frequencies. To provide intensive care, the transducer 500 may be configured with one or more variable depth devices to facilitate treatment. For example, transducer 500 is a US application 10 entitled “System and Method for Variable Depth Ultrasound” filed on September 16, 2004, having at least a common inventor and common assignee. May be constructed using the variable depth device disclosed in U.S./944,500, which is incorporated herein by reference. Further, the transducer 500 is entitled “Method and System for Ultrasound with a Multi-directional Transducer” filed on September 16, 2004, having at least a common inventor and common assignee with the present application. As disclosed in US patent application Ser. No. 10 / 944,499, which may be configured to treat one or more additional ROIs 510 through the provision of sub-harmonic or pulse echo images. Embedded in the book.

In addition, various mechanical or variable focusing lenses, such as, for example, liquid-filled lenses, may also be used to focus and / or defocus the acoustic field. For example, as shown in the exemplary embodiment shown in FIGS. 6A and 6B, the transducer 600 may be used in conjunction with one or more transfer elements 606 to facilitate increased flexibility in the treatment ROI 610 and the electron focusing array 60. 2 may be used. Array 60 2 may be configured in a similar manner as the transducer 502. In other words, the array 60 2, for _example, T _{1, T} 2. . . Such as T _j, through a variable electronic time delay may be configured as an array of electronic opening which is operated by a variety of phases. The term "manipulated", the electronic aperture arrays 60 2, in a manner corresponding to phase shift caused by the electronic time delay, engineered to produce and / transmit energy, driving is used and / or configurations Means good. For example, these phase variations may be used to transmit a defocused beam, a plane beam, and / or a focused beam, and each beam may be used in combination to obtain a different physiological effect in the ROI 610.

The transmission element 606 may be configured to be concave, convex and / or planar. For example, in the exemplary embodiment shown in FIG. 6A, the transfer element 606 may be configured in a concave shape to provide focused energy for treatment of the ROI 610. A further embodiment is disclosed in US patent application 10 / 944,500 entitled “Variable Depth Transducer System and Method”, which is also incorporated herein by reference.

In another embodiment shown in FIG. 6B, transmission element 60 6, in order to provide a substantially constant energy to ROI610, it may be configured to substantially planar. 6A and 6B illustrate an exemplary embodiment using a transmission element 604 configured to be concave and substantially planar, respectively, while the transmission element 604 may be configured to be concave, convex and / or planar. Further, the transmission element 604 may be configured in any combination of concave, convex, and / or substantially planar structures. For example, the first transmission element may be configured to be concave and the second transmission element may be configured to be substantially planar.

As shown in FIGS. 8A and 8B, the transducer 800 may be configured as a single element array, the single element 802 being configured with multiple masks such as, for example, transmission elements of various structures and materials. Such a mask is made of porcelain, metal or other material or structure to shield or alter the energy distribution from element 802 to form an array of energy distribution 808. Mask 804 may be coupled directly to element 802 or separated by a standoff 806 such as any suitable solid or liquid material.
The exemplary transducer 404 may be configured as an annular array to provide planar, focused and / or defocused acoustic energy. For example, as shown in FIGS. 10A and 10B, according to an exemplary embodiment, the annular array 1000 includes a number of rings 1012, 1014, 1016-N. The rings 1012, 1014, 1016-N are mechanically and electronically separated into a series of individual elements to produce a planar, focused or defocused wave. For example, such waves may have corresponding transmission and / or reception delays t ₁ , t ₂ , t ₃ . . . by a method of adjusting the t _N, you can match the center on the axis. While the electron focus 1020 is appropriately moved along various depth positions to provide variable intensity or beam hardness, the electron defocus can have various defocus amounts. According to an exemplary embodiment, a lens and / or convex or concave annular array 1000 may be provided to aid focusing or defocusing , thereby reducing any time delay. Movement of the annular array 1000 along one, two or three dimensions, or any path, such as through the use of a probe and / or any conventional robot arm mechanism, scans the quantity in the region of interest or any corresponding space. May be implemented to treat.

The transducer 404 may be configured in other annular or non-array configurations for imaging / therapy functions. For example, as shown in FIGS. 10C-10F, the transducer may include an image element 1012 configured with a treatment element 1014. Elements 1012 and 1014 are electronically separated 1022 within the same transmission element or between individual images and treatment elements, including, for example, a single transmission element or individual elements such as combined image / transducer elements. And / or standoffs 1024 or other matching layers, or any combination thereof. For example, as shown in particular in FIG. 10F, the transducer can include an image element 1012 having a surface 1028 configured for focusing, defocusing or planar energy distribution, and the treatment element 1014 can be focused, defocused. Or a stepped component lens configured for planar energy distribution can be included.

  According to other aspects of the invention, the transducer probe 400 may be configured to provide one, two, or three-dimensional therapeutic applications for focused acoustic energy to one or more regions of interest. For example, as described above, the transducer probe 400 may be suitably shaped to form a one-dimensional array, for example, including a single array of secondary transfer elements.

According to other exemplary embodiments, transducer probe 400 may be suitably shaped to form a two-dimensional array. For example, as shown in FIG. 9, an exemplary two-dimensional array 900 may be suitably shaped into a number of two-dimensional segments 902. The two-dimensional segment 902 may be suitably configured to focus on the treatment area at a particular depth, thus providing a respective slice 904 , 907 of the treatment area. As a result, the two-dimensional array 900 can provide a two-dimensional slice of the image location of the treatment area.

  According to other exemplary embodiments, the transducer probe 400 may be suitably configured to provide a three-dimensional treatment. For example, referring again to FIG. 3 to provide a three-dimensional treatment of a region of interest, the three-dimensional system uses an adaptive algorithm that uses three-dimensional graphics software included in a control system such as, for example, control system 300. A transducer probe 400 may be provided that is configured to be used. The adaptive algorithm receives a two-dimensional image, temperature and / or treatment information associated with the region of interest, processes the received information, and then provides a corresponding three-dimensional image, temperature and / or treatment information. Properly configured.

  Referring back to FIG. 9, according to an exemplary embodiment, an exemplary three-dimensional system is a two-dimensional array configured with an adaptive algorithm for properly receiving 904 slices from different image planes of the treatment area. 900 can be used to process the received information and then provide information 906, such as three-dimensional images, temperature and / or treatment information, and the like. Further, after processing the received information using an adaptive algorithm, the two-dimensional array 900 may appropriately provide therapeutic heat to the desired volume region 906.

  Alternatively, rather than using an adaptive algorithm, such as 3D software, to provide 3D images and / or temperature information, the exemplary 3D system has various rotational and / or moving positions relative to the target area. In order to operate from a single transducer 404 may be provided configured in the probe arrangement.

To further illustrate the structure of the various transducers 404, referring to FIG. 7, the ultrasound therapy transducer 700 is configured for single focus, focus array, focus sitting, line focus and / or different patterns. It's okay. The transducer 700 comprises a single element, multi-element, annular array, one, two or three dimensional array, broadband transducer and / or combinations thereof, with / without lenses, acoustic components and mechanical and / or electronic focusing. It's okay. Spherically focused single element 702, annular array 704 with attenuated region 706, linearly focused single element 708, one-dimensional linear array 710, concave or convex with or without high focus 712 Transducers configured as a one-dimensional curve array, a two-dimensional array of transducers 714 and a three-dimensional spatial arrangement may be used to perform therapeutic and / or image and sound monitoring functions. In any transducer configuration, focusing and / or defocusing may be performed in one plane via mechanical focusing 720, convex lens 722, concave lens 724, mixed or multiple lens 726, planar shape 728 or stepped shape, as shown in FIG. 10F. There may be two planes. Any transducer or combination of transducers may be used for therapy. For example, an annular transducer may be used with an outer disk dedicated to therapy and an inner disk dedicated to broadband images, such image and therapy transducers having different acoustic properties, as shown in FIGS. 10C-10F. Has a lens.

Various shapes of treatment lesions are formed using the various acoustic lenses and designs of FIGS. 10A-10F. For example, cigar-shaped lesions may be formed from planar damage from spherically focused and / or planar sound sources. Concave plane sound sources and arrays can form “V-shaped” or elliptical lesions. An electronic array, such as a linear array, can produce a defocused planar or focused acoustic beam that may be used to form a variety of additional lesion shapes at a variety of depths. The array may be used alone or in combination with one or more planar or focusing transducers. Such transducers and arrays used in combination provide a very wide acoustic field and its associated advantages. Fixed focusing and / or various focusing lenses or lenses, etc. may be used to further increase treatment adaptability. Convex lenses with acoustic velocities lower than those of surface tissues such as liquid-filled lenses, gel-filled lenses or solid gel lenses, rubber or synthetic lenses may be used with appropriate power handling capabilities, The profile lens uses and consists of any material or synthetic material that has a velocity that is faster than the velocity of the tissue. The structure and configuration of the transducer sound source can handle specific shape damage as proposed above, but not only the temporal parameters, but other spatial parameters can be further added in every transducer structure and transducer sound source. Such a structure is not limited to a particular shape because it is possible to handle the shape.

Through the operation of the ultrasound system 100, breast fixation methods, cellulite treatments, vascular disorders and / or cellulite treatments provide effective and efficient treatment without causing chronic damage to human tissue. I understand that it can be promoted. For example, the user first selects one or more transducer probe configurations for treatment of the region of interest. The user may select any probe described herein. The treatment area for breast fusion is about 1 mm to 4 cm, about 0 mm to 3.5 cm for cellulite treatment, about 0 mm to 7 cm for vascular disorders, and 0 mm to 1 cm for skin streak treatment. Exemplary transducer probes include, for example, annular arrays, various depth transducers, mechanically operable transducers, cylindrical transducers, linear arrays, one-dimensional arrays, two-dimensional arrays, A curved array, shielded elements, and / or any other transducer configuration described herein may be included. As used herein, the term user may include individuals, employees, doctors, nurses and / or technicians who use any hardware and / or software of other control systems.
Once one or more transducers are selected, the user then images the region of interest to plan a treatment protocol. By imaging the region of interest, the user may use the same treatment transducer probe and / or one or more additional transducers to image the region of interest with high resolution. In certain embodiments, the transducer may be configured to facilitate high-speed imaging for large regions of interest to allow accurate imaging for large regions of interest. In other embodiments, the ultrasound image includes the use of a Doppler flow monitor and / or a color flow monitor. In addition, other means of imaging such as MRI, X-ray, PET, infrared or others may be used individually or in combination for imaging and feedback of surface and vascular tissue of the region of interest.

In other exemplary embodiments, referring to FIG. 12, the exemplary treatment system 200 may be configured and / or used with a variety of auxiliary systems to provide additional functionality. For example, exemplary treatment system 1200 for treating a region of interest 120 2 includes a control system 120 6, the probe 1204 and the display 1208. Treatment system 1200 includes an auxiliary diagnostic imaging subsystem 127 2 and / or auxiliary monitor 127 4 further comprising, photographs and other visual optical, magnetic resonance imaging (MRI), computed tomography (CT), the light buffer tomography (OCT), electromagnetic, microwave or radio frequency (RF) method, positron emission tomography (PET), infrared, ultrasonic, acoustic, or image / including monitoring enhancement, ROI 120 2 vision, May be based on at least one of the other suitable methods of localization, localization or monitoring. Such an image / monitoring enhancement for ultrasonic imaging via probe 1204 and control system 120 6 includes M-mode, persistence, filter, color, etc. Doppler and harmonic imaging, further, the therapeutic ultrasonic therapy system 1270 as one source, radio frequency (RF), a strong pulse light (IPL) laser, infrared laser, microwaves or other suitable energy source including a second therapeutic subsystem 1276 May be used in combination.

  Because the location of Cooper ligament, blood vessels, cellulite and / or skin streak varies from patient to patient (depending on genetic features, weight, age, etc.), images using transducers can track treatment depth within the patient, region of interest Imaging and / or determining the length and / or position of one or more therapeutic targets within a patient (ie, Cooper ligament, blood vessels and / or vascular occlusion, cellulite and / or skin striatum) be able to. This imaging / tracking / decision information may be used to calculate optimal ultrasound treatment parameters to facilitate the desired level of aesthetic results.

  That is, the user may use the image information to facilitate treatment protocol planning. In order to plan a treatment protocol, the user may select one or more spatial and / or temporal characteristics to provide uniform ultrasound energy to the region of interest. For example, the user can, for example, one or more transducers, one or more mechanical and / or electronic focusing mechanisms, one or more transducer elements, one or more transducer placement locations with respect to one or more regions of interest, one or more To control the use of a feedback system, including one or more mechanical arms, one or more transducer orientation positions, one or more treatment temperatures, or one or more coupling mechanisms and / or the like One or more spatial characteristics may be selected.

Further, the user may select one or more time characteristics to control to facilitate treatment of the region of interest. For example, the user may select and / or change treatment time, frequency, power, energy, amplitude and / or the like to facilitate time control. For further information on the selection and control of ultrasound spatial and temporal characteristics, see “Method and System for” filed on Oct. 6, 2005.
Reference is made to US application Ser. No. 11 / 163,148, entitled “Controlled Thermal Injury”, which is incorporated herein by reference.

Once the treatment protocol planning is complete, the treatment protocol may be performed. That is, the transducer system may be used to transmit ultrasonic energy to the treatment area and cauterize selected tissue to facilitate aesthetic treatment. Due to the transfer of energy, the transducer may be driven at a selected frequency, the phase array may be driven by a specific time and / or spatial distribution, the transducer to provide focusing, defocusing and / or planar energy One or more transmission elements may be configured and / or the transducer may be configured and / or driven in any manner created below.

  In one exemplary embodiment for facilitating breast fusion, energy is transmitted at a treatment depth of about 1 mm to 4 cm. The energy can range from 1 MHz to about 15 MHz, but a typical application range is from 2 MHz to 8 MHz. In order to transfer energy in this treatment range, the transducer may be driven at a power level in the range of 10 W to 150 W or higher. Due to the high power and intensive care provided by the transducer, the treatment time of the region of interest may range from 20 milliseconds to 2000 milliseconds or more. These variations may vary from patient to patient and / or region of interest because treatment time and treatment power are interrelated.

  In other exemplary embodiments for facilitating cellulite treatment, energy is transmitted at a treatment depth of about 0 mm to 3.5 cm. The energy can range from 750 kHz to about 10 MHz, but a typical application range is 2 MHz to 10 MHz. In order to transfer energy in this treatment range, the transducer may be driven at a power level in the range of 20W to 200W. These variations may vary from patient to patient and / or region of interest because treatment time and treatment power are interrelated.

In certain exemplary embodiments for treating vascular disorders, ultrasound energy may be transmitted or stored at a selective depth to facilitate vessel ablation. The accumulation of ultrasonic energy is preferably selectable, but is not limited to the surface of skin tissue with a depth of up to 7 mm and a diameter in the range of 0.1-5 mm. The electricity used to transmit the ultrasound source at a location can range, for example, from about 5 W to about 50 W, and the corresponding sound source frequency can range from about 2 MHz to about 5 MHz.
In other exemplary embodiments for treating vascular disorders, ultrasonic energy may be transmitted at a selective depth to facilitate cauterization of intravascular occlusions. The accumulation of ultrasonic energy is preferably selectable, but is not limited to the surface of skin tissue with a depth of up to 70 mm and a diameter in the range of 3-20 mm. The electricity used to transmit the ultrasound source at a location can range, for example, from about 5 W to about 200 W, and the corresponding sound source frequency can range from about 2 MHz to about 20 MHz. If the treatment of the occlusion does not increase blood flow in the region of interest, an exemplary transducer system may be used to further cauterize the occlusion.
Referring to the example and other aspects of the invention for the treatment of skin striatum and the exemplary embodiment shown in FIG. 13A, one or more treatment areas 1340 may be treated in a spatially defined pattern in a treatment volume. Configured to show the inner ablation area. These spatially defined patterns include, for example, a 1, 2 and / or 3 dimensional matrix of individual sitting positions and / or lesions of the treatment site. These spatially defined patterns may be more desirable than heating and destroying the entire tissue. In such treatment, surrounding normal tissue helps with rapid healing and recovery.

  The transducer probe 204 and / or any other transducer (not shown) may be scanned 1326 mechanically and / or electronically to expand the treatment area over a large area, and the transducer probe 204 May be further scanned or moved to further enlarge the treatment area. The treatment area may be located at a depth in the range of about 0-10 mm or at the maximum depth of the skin striae or deep dermis. The treatment area is a two-dimensional matrix that runs parallel and / or perpendicular to the skin streak and / or surrounding tissue to form an anisotropic pattern of tissue damage and / or extended to a bad pattern of skin streak Can be included.

  In another aspect of the invention for the treatment of skin striatum, referring to the exemplary embodiment shown in FIG. 13B, the treatment region 1360 may be extended over the region of the dermis and extended to the epidermis 1360. Good. In addition, the treatment area 1360 increases in depth and its cross section ranges from a narrow area near the epidermis or small size 1364 in the epidermis (about sub-millimeters) to an intermediate zone near the dermis and / or medium size 1366 in the middle of the dermis From about sub-millimeters to millimeters), to a deep zone near the deep dermis and / or a large size 1368 in the deep dermis. Furthermore, a single treatment area has a shape that expands in cross-section with depth and / or consists of a fusion of several small treatment areas. The space of the treatment area may be the size of the treatment area or the level of the area or micro area that may be fused together horizontally.

  Once the treatment protocol is implemented, the tissue region has one or more responses in therapeutic action. For example, in certain embodiments, the tissue responds by causing further contraction of the Cooper ligament and / or other treated tissue. In other embodiments, the tissue responds by formation of lymphatic drainage, cavitation of lipolysis products, heat damage and / or coagulation of the proximal processes of the fatty lobule. As a result, epidermal contraction and / or smoothness also occurs. In other embodiments, occlusion within the blood vessel is no longer obstructed and the blood vessel responds with increased blood flow. In other embodiments, the blood vessels respond to ablation due to disintegration in the body.

In treatment, the steps outlined above may be repeated one or more times to obtain optimal treatment results. Different ablation sizes and shapes can affect recovery time and treatment. For example, generally, the greater the surface area of the treatment site, the faster the recovery. The series of treatments also allows the user to tailor additional treatments depending on the patient's response to ultrasound treatment. The present invention has been described above with reference to various exemplary embodiments. However, one of ordinary skill in the art appreciates that changes and modifications can be made to the exemplary embodiments without departing from the scope of the present invention. For example, the various operational steps as well as the components for performing the operational steps may be related to the operation of the system, depending on the particular application or, for example, deleting, modifying or combining various steps with other steps. Considering any number of cost-related functions, it may be performed in an alternative manner. These and other changes or modifications are intended to be included within the scope of the present invention as set forth in the following claims.

Claims (10)

A system for non-invasive beauty enhancement,
An ultrasonic probe (202), said ultrasonic probe (202) is, under the skin surface showing the cellulite, and in the region of interest (210) within which includes a proximal projection of the fat lobules into the dermis and the dermis, Configured to deliver a first energy field for generating a mechanical energy effect for at least one of destroying a fat mass and extending a fiber bond, and the ultrasound probe (202 ) is to deliver a second energy field to generate a thermal energy application for causing a uniform damage in parts of the region of interest (210) (209) including a proximal projection of the fat lobules into the dermis An ultrasonic probe (202); and a control device (204), the control device (204) comprising the ultrasonic probe (20) 2) coupled to, communicating with, and configured to control delivery of the first energy field and to control delivery of the second energy field.
A system for non-invasive beauty enhancement characterized by: The system for non-invasive beauty enhancement according to claim 1, wherein the ultrasound probe (202) is located below the skin surface showing the cellulite and at the bottom of the dermis, proximal to the fat leaflet into the dermis. A system for non-invasive cosmetic enhancement configured to image within the region of interest (210) comprising at least one of a protrusion and a subcutaneous layer. The system for non-invasive beauty enhancement according to claim 2, wherein the system is coupled to and communicates with the ultrasound probe (202) and the controller (204), and an image (205) of the region of interest (210). ) System for non-invasive beauty enhancement, further comprising a display unit (206) configured to provide. The system for non-invasive cosmetic enhancement according to claim 1, wherein the first energy field is configured for at least one of enhancing lymphatic drainage and removing lipolysis products. A system for non-invasive beauty enhancement. The system for non-invasive beauty enhancement according to claim 1, wherein the second energy field that generates the thermal energy action is Arrhenius' law Y = A · e. ^{-B / T} A system configured to increase the metabolic rate of fat according to (Y is metabolic reaction yield, A and B are constants, and T is the temperature in degrees Kelvin). The system for non-invasive cosmetic enhancement according to claim 1, wherein the second energy field that generates the thermal energy action coagulates the proximal process of the fat leaflet, and thus the fat process to the dermis. A system that improves the appearance of the overlapping surface layer of the skin by removing it. The system for non-invasive beauty enhancement according to claim 1, wherein the ultrasound probe (202) comprises a combination of tissue, such as subcutaneous fat / adipose tissue and muscle, for treatment of an expanded treatment area of interest. Further configured to provide a system. The system for noninvasive beauty enhancement according to claim 1, wherein the ultrasound probe (202) comprises:
  a) an electron focusing array (602) comprising an array of electron apertures manipulated by various phases via a variable electron time delay for delivering a first energy field for generating said mechanical energy action The
  b) A concave transfer element (606) configured to deliver the second energy field that generates the thermal energy effect.
A system that is used in conjunction with the system. 9. A system for non-invasive cosmetic enhancement according to claim 8, wherein the phase diversity is configured to transmit a defocused beam, a planar beam and / or a focused beam, each beam being of interest A system that can be used in combination to obtain different physiological effects in region (106). 10. The system for non-invasive beauty enhancement according to claim 9, wherein the physiological action of the region of interest (106) is the cauterization of tissue present in the region of interest, protein synthesis, destruction of adipocyte populations. A system comprising one or more of: stretching of fiber bonds, enhancement of lymphatic drainage, facilitation of lipolysis product removal and / or enhancement of cell permeability to treat cellulite.