MXPA06005890A - Systems and methods for the destruction of adipose tissue - Google Patents

Abstract

Described is a system and method for the destruction of adipose tissue using an energy applicator such as a HIFU transducer. The system has a scan head containing an energy applicator, a mechanical arm for carrying the weight of the scan head, and a therapy controller such as a computer for controlling the operation of the scan head. The therapy controller may be part of a general purpose computer, and may be used as a robotic controller to automate the procedure. Methods are included for destroying adipose tissue in a quick, non-invasive manner.

Description

SYSTEMS AND METHODS FOR THE DESTRUCTION OF ADIPOSE TISSUE FIELD OF THE INVENTION The present invention relates to systems and methods for the destruction of adipose tissue (fat).

BACKGROUND OF THE INVENTION Body modeling has been developed as a procedure that is quite sought after to reduce a person's weight and restore people to a leaner, thinner physical appearance. The field of cosmetic surgery has expanded considerably with developments in both tools and techniques. A popular procedure for both rapid weight loss and body modeling is liposuction. Liposuction is a method for contouring the body that can dramatically improve the shape and contour of different body areas by modeling and eliminating unwanted fat. More than 200,000 liposuction procedures are performed annually. Innovations and recent advances in the field of liposuction include the tumescent technique and an assisted technique with ultrasonic energy. Traditional liposuction is done by making small incisions in the desired sites, then inserting a hollow tube or cannula under the skin in the fatty layer. The cannula is connected to the vacuum and the fat is sucked under high suction pressure. This procedure indiscriminately removes fat, connective tissue, blood vessels and nervous tissue. The procedure causes bleeding, bruising, trauma, and blood loss, restricting the possible amount of fat removal. The tumescent technique allows the removal of a significantly greater amount of fat during the operation with less blood loss. In tumescent liposuction large amounts of saline and adrenaline solution are injected into a layer of adipose tissue before suctioning. Again a cannula with a suction device is used to remove the fat. This procedure reduces bleeding from traditional liposuction. However, the procedure still removes a significant amount of structural tissue, blood and nerve endings. The most recently approved innovation is Ultrasound-Assisted Lipoplasty (UAL for its acronym in English). UAL uses a titanium cannula that has a tip that vibrates at an ultrasonic frequency. This vibration breaks down the volume of nearby adipose tissue cells and essentially liquefies them for easy removal. UAL uses a low-power suction and extracts the fatty material only in the vicinity of the tip of the cannula. This technique is more refined and less aggressive to the tissues, there is less blood loss, less bruising, less pain, and a significantly faster recovery. The use of ultrasound for surgical procedure is not restricted to UAL. Other researchers have developed high intensity focused ultrasound (HIFU) techniques for cancer therapy. The patent E.U.A. 6,309,355 for Cain et al. , describes a method for generating micro-bubbles in a target tissue and then using an ultrasound source to make the micro-bubbles create a cavitation effect to destroy the surrounding tissue. The preferred embodiment uses a low power ultrasound source (less than 500 kHz) to cause cavitation. A diagnostic instrument is used to determine the location of the individual surgical lesions. The PCT application WO 02/054018 A2 for Eshel et al. , provides a method for lysing adipose tissue in a region of the human body while simultaneously not lysing the non-adipose tissue. The method describes the use of HIFU in the body coupled to a diagnostic imaging system and a computer to track the areas that are being irradiated with HIFU energy. Over the past decade, several innovations in the development of HIFU have been presented. The intensities have been increased to a point at which the boiling occurs in a very short period of time (approximately 1 second) as the bubbles coming from the cavitation form. The bubbles greatly increase the absorption of ultrasound and the rapid concomitant heating of the tissue. The company Haifu (Chongqing, China), has produced a device for therapy for the treatment of solid tumors using ultrasound. The ultrasonic energy is applied at the same time that an applicator is moved inside a bag of water surrounding a tumor-containing tissue. Other treatment regimens are based mainly on thermal mechanisms to necrotize the tissue. Several documents report the creation of tissue cavitation without necessarily increasing tissue temperatures to necrotic levels. These methods apply continuous wave ultrasound regimes (CW for its acronym in English) high intensity tissue to create cavitation bubbles (sometimes referred to as "stable" cavitation), the primary purpose of these bubbles is to increase absorption and reduce heating times. Applying therapy with short pulses of very high intensity which are repeated rapidly in a similar way to pulse wave ultrasound (PW) can create cavitation bubbles with generally short life times (micro-seconds). These bubbles cause significant mechanical damage to the tissue that can be periodically repeated by short pulses (approximately 5-30 seconds) without excessive concomitant tissue heating. Executing the regime parameters carefully can increase mechanical damage through, for example, tangential shear forces, transient cavitation shock waves, or stable cavitation pressures without necessarily heating the tissue to thermal levels of necrosis. HIFU therapy can be applied in various ways and in combinations of ways. Most HIFU regimes are applied by locating the HIFU application at a point and turning on the power for a given time interval, typically 1 to 4 seconds. Intensity levels are typically chosen to heat the tissue at the focal point of the applicator to the point of coagulant necrosis, although others report tissue heating beyond the boiling point of water (100 ° C). After a period of application of sonic energy, the applicator shuts down and moves to a new site; typically a few mm away from the previous application. The applicator does not turn on again until the tissue has a cooling period, which can range from a few seconds to a few minutes. The applicator is turned on again and a new lesion is created. Treating a large volume of tissue can take hours with such a strategy. The following additional references are relevant in the art: 5,769,790; 6,113,558; 5,827,204; 5,143,063; 5,219,401; 5,419,761; 5,618,275; 6,039,048; 6,425,867; 5,928,169; 6,387,380; 6,350,245; 6,241,753; 5,526,815; 6,071,239; 5,143,063; 6, 685, 639 and WO 00/36982. The aforementioned references discuss ultrasound technology relevant to the present invention, and methods for using same to destroy tissue within a person's body. However, there is a notorious difficulty between the antecedent technique. There is no description regarding allowing the patient and the doctor to work together to plan a desired body modeling plan to obtain a result that is accepted by the patient. There are no means in the prior art for storing information accurately from one treatment session to the next in relation to what has been done in a patient. This makes it necessary for all the treatment to be carried out in a single time, which creates the possibility that a patient is subjected to excessive treatment, or that the doctor must guess, either by trial or visual inspection of the adipose tissue regions of a patient, to determine what was done in a previous session. In cases in which the patient has undergone a non-invasive HIFU treatment, the physician is completely lost and unable to determine what appropriate follow-up is desired in the treatment. Also, the ultrasound procedures of the prior art have an inability to treat large volumes of tissue rapidly. Therefore, in terms of volume or mass volume treatment, invasive methods are preferred. Therefore, it is an object of the present invention to provide means by which a patient and a physician can determine an appropriate therapy treatment and obtain a meaning as to the results. obtainable It is a further object of the present invention to provide means for the accurate determination of a volume of adipose tissue in a patient. Still another object of the present invention is to provide means for accurate tracking of the therapy procedures and their effects on a patient so that a patient can extend the course of a desired therapy with respect to time to reduce or eliminate the discomfort and the danger of carrying out a large-scale procedure at once. It is a further object of the present invention to provide means for the accurate mapping of the placement of the surgical lesion within a human body. It is even another object of the present invention to provide means and methods for rapid destruction of adipose tissue in volumes similar to those of invasive procedures. Any one or more of these objectives are solved in the present description.

SUMMARY OF THE INVENTION In the present invention systems and methods for the destruction of adipose tissue are described. In a first embodiment, a system for the application of energy to a body region is presented, the system comprises a scanning head that includes an energy applicator, means for suspending the scanning head in space and a therapy controller coupled to the head. of sweep and suspension means. The therapy controller is adapted to monitor the position and power supply of the scan head while providing addressing to position the scan head. In a second embodiment, a system for producing a map of subcutaneous topographic tissue and close to the complementary surface is presented, the system comprises an apparatus for three-dimensional image formation to produce surface images of a patient's body; an apparatus for tissue imaging to produce subcutaneous images of the patient's body; and a correlative operation device for coupling a plurality of markers of the surface image and the subcutaneous image. In a third embodiment, a system for positioning a medical device is provided, the system comprises; a robotic arm; first control means for controlling the robotic arm; a medical device movably positioned within a therapy head, the therapy head is connected to the robotic arm; and second control means for controlling the movement of the medical device within the therapy head; and an electronic controller in electronic communication with, and for the cooperative operation of, the robotic arm, the first control means, the medical device and the second control means. In yet another embodiment, a system for positioning a medical device is provided, the system comprises; a robotic arm; control means for controlling the robotic arm; a medical device fixedly positioned within a therapy head, the therapy head is connected to the robotic arm; and an electronic controller for translating the movement instructions received from the control means and passing the movement instructions to the robotic arm. In another embodiment, an apparatus is provided for guiding the movement of an energy emitter over the body of a patient, the apparatus comprising; a movable therapy head having at least one energy emitter; a guide ring; and a tracking system for tracking the movement of the guide ring and keeping the therapy head substantially centered within the guide ring. Even in another modality a system is provided to position a medical device, the system comprises: an arm for load balance; a medical device positioned movably within a therapy head, the therapy head is connected to the arm for load balancing; and means for controlling the movement of the medical device within the therapy head. Methods to use the described systems are also provided. In one embodiment, a method for applying energy to a body region is provided, the method comprises the steps of first, providing a treatment plan to a treatment controller, second performing a manual sweep with a scanning head on a body surface in response to the addressing generated by the treatment controller while power is being supplied from said sweep head, third monitor the position of and power supply from the sweep head to produce position data and transfer the position data to the controller treatment; and finally, generate an alert if the manual position and / or the energy supply fall outside the treatment plan. In a second embodiment, a method for performing a lipoplasty procedure is provided, comprising the steps of: (a) determining the suitability of a person for treatment with therapeutic ultrasound; (b) mark the areas that will be treated about the person; (c) positioning the patient for a therapeutic ultrasound procedure; (d) entering the marked areas, by scanning, on a computer; (e) adjusting the therapeutic ultrasound procedure using a software package for procedural planning; (f) activate the therapeutic ultrasound procedure using a computer system controlled through the procedure planning software; (g) recording the progress of the therapy procedure using the procedure planning software; and (h) provide the person with additional post-operative assistance as indicated. In another embodiment, a method for destroying adipose tissue in a patient is provided using therapeutic ultrasound comprising the steps of determining one or more sites of adipose tissue in the patient, placing the patient on a bed for treatment, and irradiating the tissue sites. adipose of the patient with a therapeutic ultrasound transducer. Even in another embodiment, a method for creating a three-dimensional body map is described. The method to create a three-dimensional body map with the sites of adipose tissue volumes comprises the steps of generating a three-dimensional image of the body using a system for forming three-dimensional images, introducing the three-dimensional image of the body into a computer-readable format, creating a three-dimensional body map of the body with a software application for three-dimensional mapping, and perform a body scan with an ultrasound device for diagnosis in electronic communication with the software application for three-dimensional mapping in such a way that the regions of adipose tissue detected by the ultrasound device for diagnosis are placed appropriately on the three-dimensional body map. Even in another embodiment, a method of body modeling is provided using a three-dimensional body map comprising the steps of analyzing a three-dimensional body map with respect to volumes of adipose tissue to be destroyed, determining the amount of adipose tissue that can be destroyed in safely using a body modeling method, subtracting the volume of adipose tissue that is destroyed to produce a second three-dimensional body map, in which a physician and a patient can compare the first three-dimensional body map and any of a plurality of seconds Three-dimensional body maps to select the desired amount of body modeling procedure to be performed. In another embodiment a method for destroying adipose tissue comprising the steps of; determine a volume and area of tissue to be treated; and treat the volume with a pulse wave HIFU (PW) transducer with which a sweep is made across the area in a continuous motion. Even in another embodiment, a method for positioning an ultrasound therapy head in the space using an arm for load balancing is presented, the therapy head comprising a motion controller for a suspended energy applicator within the therapy head. The method comprises the steps of: first applying a force to the therapy head and second, providing electronic addressing to the motion controller.

BRIEF DESCRIPTION OF THE FIGURES Figure 1 illustrates a side view of the present invention. Figure 2 illustrates a scanning head. Figure 3 shows a schematic diagram of a circuit for degassing. Figures 4A-B show the elements of a therapy head. Figure 5 shows an arm with a computer type feeding device. Figures 5A-B illustrate a device for control of guide ring. Figure 6 shows a device for optical control of the guide ring. Figure 7 shows a sliding seal. Figure 8 illustrates a system for three-dimensional volumetric image formation. Figures 9A-C illustrate a method for marking the body of a patient.

DETAILED DESCRIPTION OF THE INVENTION Definitions In the present description reference is made to "therapy controller" as a device responsible for the planning, coordination and operation of the medical procedures used with the present invention. The therapy controller is a computer device. This may be a specially constructed, dedicated computer system or a general purpose computer with sufficient hardware and software resources to provide command and control of the system of the present invention: specifically the control of the therapy head, energy emitter and arm mechanical to the necessary degree. Sometimes reference is made to software for treatment planning, a treatment controller, or a program to perform ultrasound therapy. Each of these elements refers in general terms to the role of the therapy controller as a functional element of the present invention or to a particular subunit of the therapy controller. Also, the term "electronic communication" is used in the present invention to include all forms of signal compilation and electronic power between components, whether hardware or software. Therefore, reference is made to the sending of data, instruction, code, and / or power as electronic communication, whether that shipment is in one way, in two ways, or in response to a request or instruction or demand regarding said power or electrical information. Any intentional movement of electrons between the parts is "electronic communication". With "therapy head" is meant to indicate a housing for containing the energy applicator. The housing may be specially designed to be formed in one piece with the energy applicator by minimizing the volume of the housing, or a housing having additional volume for the incorporation of additional devices. Said devices may include a small motor system for moving the power applicator within the housing, or the use of a fluid reservoir, or for having additional detectors, addressing devices for passing the information to the components positioned outside the head of the head. therapy. In previous descriptions the term "end effector" or "effector" is assigned to the "therapy head". The use of the terms "therapy head", "effector", "scanning head" and "end effector" are considered interchangeable.

Description of the HIFU system The present invention is a system for the application of energy to a body region. The system has three main subsystems: a scanning head, a suspension device and a treatment controller. The sweep head includes an energy applicator and a fluid reservoir. The suspension device is typically a mechanical arm. The third component is a therapy controller in electronic communication with the scan head and means for suspending the scan head. The therapy controller is adapted to monitor the position and / or power supply of the scan head while providing addressing to position the scan head. The PIO system of the present invention has a scanning head 500 which includes an energy applicator 600 (see FIG. 1). The PIO system also has means to suspend the scanning head in space, such as a mechanical arm 200. The suspending means supports most of the weight of the sweeping head 500 and allows either a user to manually reposition the scanning head 500 in the space, or that the scanning head can be move in robotic form through a robotic controller. The suspension means also provide the tracking of information relevant to the site of the scanning head relative to the patient's body. The data can be collected from the scan head 500 as it moves through the space to provide tracking information of the scan head. A therapy controller 250 coupled to the scan head and the suspension means is also present. The therapy controller may be part of a separate 400 computer or smart device. The therapy controller monitors the position and power supply of the scanning head while at the same time providing guidance to a user as to where to move the scanning head relative to the patient's body. The system 10 has a base 100, optionally mounted on a plurality of pivoting wheels 102. A wheel brake 110 can be used to secure the base 100 in place. An optional handle 120 can be used to move the base 100. The base 100 contains a therapy controller 250 as an independent device, or as part of a larger 400 computer. Optional motion generating devices, such as a 232 motor also they may be contained in the base 100. The mechanical arm 200 is anchored to the base 100 through a rod 202. A rotating joint 212 may also contain a rotation encoder 222.

Each arm segment has a corresponding gasket 214, 216, 218 and optional encoder 224, 226, 228. The arm segments 204, 206, 208 extend from the base and support the therapy head (or sweep head) 500. A fastener 260 is used to connect the therapy head 500 to the more distant segment 208 of the mechanical arm 200. The additional joints 240, 210 provide additional degrees of freedom to the therapy head 500 or an optional deployment device 242. Within each segment of arm are contained force generating devices 234, 236, 238 used to move the therapy head 500 in space, or to counterbalance the weight of the therapy head. Next, each of the subsystems is discussed in turn.

Scan head The scan head (also called the therapy head) is a housing that contains an energy applicator, and any additional devices necessary for the effective operation of the energy applicator during a therapeutic procedure. It can be chosen from multiple designs for use in the sweep head subsystem. The therapy head is usually configured as an inverted cup or bell, which has a chamber with an opening at the bottom of the therapy head. The camera can be divided into two sections, forming an upper chamber and a lower chamber, with a seal between them. The upper chamber contains the motor and electronic drive units such as those needed for the manipulation and control of the energy applicator. The lower chamber contains the energy applicator, ultrasound coupling fluid and detectors such as those considered necessary for the proper functioning of the system. Preferably the outer design of the therapy head is ergonomic so that a user can hold the therapy head with one hand while moving it, or orient it against the surface of a patient's skin. The ergonomic fit is to hold and guide, but not to load the weight because the therapy head is designed to be supported by mechanical means. The therapy head (Figure 2) is connected to the mechanical arm 200 by a fastener 260. From the upper end of the therapy head a plurality of connecting lines 531 used to connect the components within the therapy head to the controller are present. therapy 250, electronic controller (computer) 400, and the degassing system 7. The lines maintain electronic and fluid communication between the therapy head 500 and the base unit 100. In the main mode, the therapy head has a chamber upper 504 and lower chamber 502. A fluid tight seal is present separating the two chambers, and there may be one or more through holes. If through holes are present, these are used for mechanical connections 520, 528, electrical communication lines and possibly for fluid flow lines 712. Upper chamber 504 preferably contains a pair of motor drive units 508, 510. The lower chamber 502 contains at least one energy applicator 600. The energy applicator transmits through an aperture 590 that is transparent to the appropriate form of energy used. There are connection means between the motor drive unit and the energy applicator. In addition, there is a plurality of cables connecting the motor drive unit or units, the energy applicator and the fluid circuit with the corresponding elements in the base (the therapy controller and the degassing system 7). At the base 100 a degassing system rests (Figure 3) but has a fluid circuit 712 extending into the lower chamber 502. The fluid circuit has a fluid pump 702, vacuum pump 704, vacuum chamber 706 and an exhaust pipe 726 for the gas. Optional, the degassing system may have a fluid reservoir 708, a cooler 710, a set of inlet or exhaust valves 720, 722 as well as a bypass valve 724 and bypass fluid conduit 718. The detectors 716, 714 are also They can use to monitor the fluid in the circuit. The fluid in the lower chamber 502 is used to assist in coupling the transducer 600 to the patient, and to reduce any cavitation effects near the transducer 600. The therapy head 500 (FIG. 4A) is shown in greater detail below. An energy applicator 600 is present within an enclosure 566. The enclosure has a window 590 to allow radiant energy to pass from the enclosure to a patient. The therapy head 500 is preferably small and light enough for a doctor to move comfortably with one hand. The therapy head 500 can be increased both in size and weight if the practitioner is aided by an articulating arm 200 for loading the weight of the therapy head 500. There is a data connection 572 extending between the therapy head 500 and an external computer 400 or a therapy controller 250. An upper or upper chamber 504 and a lower or lower chamber 502 are present. The therapy head 500 may be mounted on an articulated arm 200 supported by a base 200.

The articulating arm 200 may also have its movements and functions monitored or controlled by a computer 400 or a therapy controller 250. Preferably, the therapy head 500 contains motor transmissions 508, 510 to move the power applicator 600 within the enclosure . The engine transmissions are connected directly, or through a gear assembly (not shown), to a pair of transverse rods 520, 528. The transverse rods in turn drive a pair of slotted actuators 520 ', 528 ' The slotted actuators move through the translation rods leading the power applicator to the intersection of the two slotted actuators. As the translation rods rotate in response to movement from the motors, the slotted actuators carry the energy applicator through the range of motion of the slotted translation rods. The rotation encoders 530 are placed on the translation rods 520, 528 so that the movement of the energy applicator can be accurately measured. In another possible embodiment (Figure 4B), the engine transmission units 508, 510 can be used to control a plate 534a which is magnetically coupled to a plate 534b attached to the energy applicator. The plate is moved by the motors and the energy applicator moves in response. The power applicator is not physically connected to any type of transmission rod or movement device except for the magnetic connection. There is a need for a through hole so that the energy applicator remains in electronic communication with the therapy controller 250 and the computer 400. However, even this through hole can be eliminated using a "wireless" communication device. short range. The lower chamber 502 is fluid tight so that a fluid coupling solution 701 can be introduced into the chamber. The fluid surrounds the energy applicator and provides attachment for the applicator to the patient. Preferably, the energy applicator is a HIFU transducer. The fluid is used to provide coupling so that the ultrasound energy can be transmitted to the outside of the therapy head. The coupler fluid flows in and out of the lower chamber through a pair of supply hoses that are connected to the degassing system in the base 100. Because it is known that HIFU emissions cause cavitation, and that cavitation adversely affects the transmission of ultrasound, it would be desirable to have the fluid degassed while the system is operated. Therefore, the fluid enters the lower chamber on one side of the therapy head and exits on the other. A fluid stream is established as fluid flows in one direction through the lower chamber, and any gas bubbles that may be formed during the HIFU procedure are eliminated instead of allowing them to circulate inside the chamber and interfere potentially with the procedure. The degassing system 7 uses well-established components and procedures to remove gases from a solution. In addition, a coolant can be added to cool the fluid. Refrigerated fluids are less likely to form gas bubbles than warm fluids as an aspect of fluid dynamics. In addition, cold coupling fluids help reduce the temperature in the therapy transducer and allow the HIFU transducer to operate for extended periods of time without heat buildup. The fluid circulation system can use any fluid suitable for ultrasound coupling, as long as the fluid has a relatively low viscosity so that it can be circulated and degassed efficiently. The preferred solution is water. The scanning head or therapy head 500 may also incorporate numerous detectors on the outside of the lower chamber. The opening through which the energy is transmitted is placed against the patient's skin. During a HIFU procedure, a variety of detectors can be used to promote efficient tracking of the therapy head along the patient's surface, as well as to facilitate the safe operation of the device. The therapy head may also have a haptic detector incorporated therein. The haptic detector provides pressure feedback to the user through the first means of control or through a screen or an alert device. The detector measures the pressure that the therapy head exerts on the patient's body and provides the user with either resistance feedback, or graduated pressure information to allow the user to feel the amount of pressure the therapy head is exerting on the patient. The patient's skin during a procedure. The feedback can be used to provide the user with sufficient tactile response capability to prevent the robotic arm from harming the patient. Alternatively, the robotic arm may have a safety limitation placed on the resistance feedback to prevent damage to the patient, or to avoid over-pressure that deforms the contour of a patient's skin during a procedure. Specifically, in cases where the medical device is or comprises a therapy transducer for the treatment of adipose tissue, it is important that the volume of tissue is not overloaded, compressed or deformed to the extent that the focal area of the transducer is already do not rest anymore within the volume of adipose tissue. Because the volume of tissue is "soft" (as opposed to muscle tissue or areas that have bone or hard tissue near the surface) it easily deforms. Therefore, the haptic detector is adjusted in a necessary manner so that it can respond to even small pressures on the patient's skin. This allows a stronger resistance feedback to the user with a minimum of tissue deformation. The haptic detector operates in combination with a charge sensing device that is used to keep the therapy head in contact with the patient's body. The charging device may be part of the force generating mechanism of the robotic arm, or a separate counter-balance device used to counter a portion of the weight of the therapy head while allowing sufficient weight to be transferred through the therapy head. to keep the therapy head coupled with the surface of the skin. A variety of tracking detectors can be used to detect and track the position and orientation of the therapy head as it moves over a patient. The position information can be stored and incorporated into a precision mapping feature if desired. A volumetric tracking program can provide real-time information about the treated tissue (see below). In an alternative embodiment, the scanning head has only a single chamber filled with fluid. The motor assembly can be located either inside the assembly (using motors in fluid-tight housing) or the motor assembly is outside the therapy head. In this embodiment, the motor assembly can be located opposite the therapy head in the distal arm segment 208 of the arm 200. The motor assembly can impart movement to the power applicator 600 via a transmission cable, time band or other mechanical device. In yet another embodiment, the force of the motor can be provided by pressurized fluid pushed through a fluid-driven motor, or a fluid-powered mechanical controller. In this embodiment, the fluid force accumulated in advance in the therapy head can also be used to provide the motive force to move the energy applicator. The energy applicator is preferably an HIFU ultrasound transducer having one or more diagnostic ultrasound elements that can be used to scan the tissue. The "line a" scanner can be centered to look through the focal area of the HIFU transducer, or it can be arranged around the perimeter of the HIFU transducer so that it looks at the tissue near the focal area. The "a" line scans can be performed before, during or after the HIFU scans, and preferably the "a" line image formation is performed concurrently with the therapy transducer, either interspersed with a form pulse wave of the HIFU transducer, or in the form of a continuous sweep through or around the focal area of HIFU. The energy applicator 600, FIG. 4A, is represented by a plurality of elements 602, 604, 606, to represent multiple types of energy applicators that can be combined in a single device and operated cooperatively during a therapy procedure. A transducer receptacle 640 is used to retain the many transducer elements in place in case a component transducer assembly is used. The HIFU transducer can operate in any range of parameters sufficient to cause cell necrosis. In one embodiment, the system of the present invention utilizes an HIFU transducer that operates at a frequency of 1 to 4 MHz, with a pressure of up to 30 MPa, using a pulse repetition frequency (PRF) of 1 KHz or greater. The transducer moves across the surface of a patient's skin at a speed between 4-30 mm / second in a uniform direction. The transducer returns to one side, similar to the return carriage of a manual typewriter. The line spacing of the therapy lines varies from 1 to 3 mm. The scanning head is coupled to a patient using an agent for ultrasound coupling. The coupling agent can be an acoustic gel, or a coupling fluid used in combination with a circulation system within the sweep head. If a line degassed coupling fluid is used, in this case the fluid is circulated through the sweep head and then back to a main unit where the fluid can be degassed or cooled. The fluid passes in front of the energy applicator either through a pad, or by filling a small reservoir 502 that completely bathes the power applicator. The energy applicator then "emits" its energy through an acoustic window or another transmittable window. The window may be integrated in the scan head, or it may be an accessory, such as in the form of a disposable transducer seal.

Means for suspending the scanning head Arm with position encoders One mode of the means for suspending the scanning head in space is an arm with position encoders. This can be an arm designed to carry a load during a medical procedure. The arm comprises a base for securing an articulating arm. The articulating arm has a near end secured in a moveable mode to the base, and a distal end. There is at least one position encoder incorporated in the arm. At the distal end is located a receptacle to carry a • sweep head. Means are also present for balancing the load of the arm when the sweep head engages such that the encoder or position encoders can track the position of the arm in real time. One or more position encoders are used to track the movement of the articulating arm. Preferably, the position encoders are sensitive enough to track position changes as small as 1 m or less. Rotation encoders are preferred and can be included in the joints of the articulating arm so that the movement of each individual arm segment relative to either the base, or other arm segment, or to the therapy head can be traced. The rotation encoders measure the change in the degrees or angle between the arm segments each time the articulating arm moves. By tracking the change in the angle between the moving parts, and knowing the fixed length of each of the arm segments, the position of any joint can be determined using mathematical calculations. If the scanning head or other medical device is secured to the articulating arm through a joint that also has an encoder, then changes in the angle of the joint help to determine exactly the position of the scanning head. Although the rotation encoders are perhaps the simplest and most direct means of tracking the position of the arm, other types of encoders can also be used. The load balance can take either an active form or a passive form. In a passive form, the means for load balancing comprise mechanical structures that provide counter-balancing to changes in the position of the articulating arm during use. The mechanical structures ensure that the arm is always sufficiently balanced to minimize any movement of the therapy head due to the force of gravity, slip joints or hysteresis of the arm. The arm has means for load balancing encompassing known methods and devices for creating or maintaining force. The force generated is used for load balancing and can be active force-generating devices (for example any type of motor) or a passive force generating device (for example a spring and a counterweight, or some type of pressure cylinder) . The exact form of the force generating device or method is not particularly critical because the invention is based on methods and force generating devices that are well established in their respective techniques. The arm is attached to a weight base that has sufficient mass to anchor the arm without considering the position and angle at which the arm moves when the therapy head is attached. Therefore, the arm can be at its maximum extension and at an angle that causes a maximum change in the center of gravity, however, the base must be sufficiently heavy or anchored so that the arm does not lean on itself or it becomes unstable. The joint used to join the arm to the base allows the rotating movement of the arm relative to the base, and / or the inclination and declination of the arm relative to the base. The joint between the base and the proximal end of the arm includes a device for load balancing in the form of a passive or active force generating device or devices. The arm comprises two or more segments, and a mechanism for load balancing between each segment is used either independently (each segment is self-balancing with respect to the other segments of the arm) or in a dependent manner (each segment is balanced in combination with one or more segments adjacent). The load balance for the most distant arm segment must also adjust for the therapy head and any changes in position that it may create during a medical procedure. It should be apparent that in order to maintain the load-balancing characteristic, the weight of the therapy head attached to the distal end of the arm must not exceed the weight-balancing capacity of the load-balancing means. Similarly, the range of arm movement alone should be restricted to prevent the arm from unbalancing. The load balancing mechanism must compensate for both the loading of the therapy head and the change in the center of gravity as the therapy head extends away from the base in a horizontal plane (the configuration with the greatest unbalance). Preferably, the mechanism for load balancing must also compensate for any hysteresis that may accompany arm movement. Therefore, the greater the capacity of the mechanism for load balancing, the greater the permissible range of motion in the articulating arm. Using the arm encoders to determine the position, it is possible to control the range of arm movement based on the weight of the therapy head. The therapy head itself can provide data to the articulating arm in the form of a data chip that can be read by the arm. The data chip may contain information as to the mass of the effector or therapy head, as well as its operational design. It is a lot to say, every time a new therapy head is attached to the distal end of the arm, the arm movement controller is "intelligent" and can resolve what range of motion will be allowed. Therefore, limitations or range of motion "stops" can be implemented in the arm using either the load balancing device in case it is electronically controlled, or the controller can issue an alert when the range of motion is approaching to the acceptable limit. This alert can be an audible tone, warning light or other signal that can be easily communicated to a user. Alternatively, a mechanical stop can be set either manually or automatically to physically inhibit arm movement beyond the balanced range before starting a medical procedure. The data generated by the encoders are transmitted to a controller. The controller is a computer device used to provide the apparatus with a device for position tracking or a closed-loop control mechanism. In passive mode, the controller does not provide active force to the articulating arm, instead it provides a signal to a user as to where the arm should be moved or not. In the passive mode, the means for load balancing can be simple weights and springs that run in line with the articulating arm so that movements in the arm produce a corresponding change in the position of a weight and / or spring or in the arm itself if desired. You can see a four-bar arm as an example. The use of a mechanism for independent passive load balancing is preferred. In this way, each arm segment is balanced simultaneously with all other arm segments when the arm is moved. In a passive dependent mode, a series of springs and weights can again be used, however, it would be more efficient to use a series of gas, hydraulic or pneumatic motors designed to relax when pressure is applied to the distal end of the arm ( or therapy head) or in response to activation of a trigger mechanism. The pressure or force coming from these passive force generating devices is restored once the arm is manually placed in a desired position. The pressure or force in the arm segments prevents the arm from moving again until an operator releases the established pressure or force. Even in another modality, you can use a mechanism for active load balancing that uses any type of active force generating device (such as air / hydraulic cylinders or pneumatic motors). These can operate either independently or dependently based on the commands provided by a user through a robotic controller. An advantage to the active load-balancing mechanism is the manner in which the articulating arm can automatically compensate arm positioning during a procedure while leaving the therapy head in the desired position. For example, when a user wishes to change the rolling bearing, depth or rotational oscillation of the therapy head to fit the local contour of the patient's body, this can be done by moving the therapy head within the joint used to connect the head of the patient. Sweep to the distal end of the arm. Changes in the orientation of the scanning head can cause minute or significant changes to the balance of the articulating arm depending on the size and weight of the scanning head. Using an active load-balancing mechanism, the robotic controller can compensate for changes in the orientation of the scanning head without changing the position of the distal end of the arm. The position encoder of the present invention can be mechanical or optical encoders included incorporated in the arm itself, or these can be one or more feedback devices that are used externally to the arm. Alternative embodiments of the encoder include using one or more optical devices to track the position of the arm as it moves. The arm can incorporate a plurality of optically readable marks that the detectors can easily identify and track. Another alternative is that an individual RF transmitter may be present at the tip of the proximal end, and an RF receiver located at the base, or at an externally fixed location. The RF data can allow the controller to track the movement of the distal end and know where the effector is placed. Said modalities, and any equivalents, are not considered as preferred modalities, but they remain within the scope of the present description. The controller can be a software application or a hardware device (or combination of the two) that receives the data from the encoders and calculates the position of the therapy head. The controller can also calculate the position of each individual segment of the device, and map the movement of the device in space. Because the encoders are in electronic communication with the controller, the data to know where the therapy head is located are essentially in real time. The delay in computer processing of the data is minute and the interval is too small to be detected by the user. Even in the course of performing a medical procedure, no procedure that is currently performed manually by a physician will experience any noticeable or operative delay utilizing the present invention.

In addition to calculating the position of the apparatus in space, the controller can provide movement information to the arm by acting as a robotic controller for any controlled control components of the apparatus. The controller can also receive data from an external supply, or read information from a data file. In this way, the controller can act as a robotic controller to follow instructions in real time from a user or another computer, or to read a data file that provides a map or series of movement commands that the therapy head should follow . Likewise, if the therapy head requires precise activation in particular coordinates, the controller can also handle these operations. The distal end has a therapy head attached thereto. The union must be safe, but it must also be removable in such a way that the therapy head can be removed between procedures, or be interchangeable for different procedures. Likewise, the range of motion between the therapy head and the distal end of the articulating arm can be determined using a rotation encoder on the joint that connects the therapy head with the articulating arm. The joint between the therapy head and the articulating arm can have multiple rotation joints, or a ball joint to allow greater mobility of the therapy head. The encoders in each joint, or an encoder that can precisely match the angle change in a three-dimensional joint, provides the information needed to determine the exact position of the therapy head. Likewise, once the angle and distance from the base are determined, it is a simple matter to include any additional information such as the length of a particular medical device from the last encoder in the chain that goes from the base to the end. distal, and in this way determine the exact three-dimensional coordinate position of the effector or therapy head. Alternatively, the robotic articulating arm can be constructed following the same previous guidelines, or this can be a large device. Again, the base is anchored to the floor or to a wall, or to the top of a counter. The procedure and the types of medical devices used will dictate the size of the robotic articulating arm. Medical devices that require a more robust support structure naturally require an arm that has a greater load-bearing capacity, and a greater stability factor built into the base. Smaller devices can use an arm that can be portable and can be anchored to the surface of a desk using tweezers or similar means.

Arm for load balancing without position encoders Similar to the arm for load balancing previously described, the therapy head can be suspended in space from an arm for load balancing or robotic without the benefit of position encoders. In the present invention, a manual variant of the arm is described in which the arm provides the load-bearing capacity previously described, without the ability to detect and track position. Said arm is both easier to manufacture and to produce, and is easier to maintain, however, it lacks the precision of the previous embodiment. The arm without position encoders can be used primarily as a device for load support, freeing the user from having to load the weight of the therapy head. However, the user must take responsibility for moving and positioning the therapy head while simultaneously maintaining the tracking of the area that the scanning head has previously treated. The arm shown in Figure 5 shares many of the previously described elements. The arm 200 has a base 100 and a plurality of arm segments 204, 206, 208. The arm 200 is secured to the base 100 by a platform 202 and has a plurality of tensioning devices 234, 236, 238 to maintain the position. of the arm when it moves. The therapy head 500 sits on a holder that can oscillate relative to the distal arm segment 208. A user can manipulate the position of the arm using the therapy head as the control means. A user can hold the therapy head and move the therapy head in the space while the arm supports the weight of the therapy head and keeps the therapy head positioned where the user wishes. In this embodiment, the arm lacks the ability to correct the position of the therapy head in accordance with any position that can be provided through the therapy controller. Instead the user has to maintain the proper positioning. Alternatively, one of the arm segments carrying the primary head of the therapy head 500 may use a counterbalance 238 'in place of the force generating device 238. In this embodiment, the robotic force generating devices are replaced with stress generating devices. This offers sufficient strength to overcome joint slip, hysteresis and gravity, but is flexible to the application of additional force such as when the user applies force to move the therapy head. Once the added force is released, the tensioned devices maintain the position of the therapy head.

Addressing systems for the arms The addressing system for the therapy device positioned on the robotic arm preferably consists of two components that work cooperatively. The first control means provide a "macro" level of control to the therapy device, controlling the movement of the robotic arm. The second control means provide a "micro" level of control for the medical device within the therapy head. The command and control of the robotic arm is provided by the first control means (figure 5). The system shown has the same elements previously described with the addition of a computer-like feeding device 244 mounted on the distal arm segment 208. An optional slide gasket 216 'is also present (Figure 7). The first control means 244 provides motion instructions to the motors or other force-generating means of the robotic arm. In addition to the movement instructions for the robotic arm, the first control means can also provide virtual position information to a user through a visual display 242. The first control means can be a variety of different devices that can guide the movement of the robotic arm. In a first modality of the first means of control, a computer feeding device can be used to provide both the virtual positioning of the therapy head, and the movement instructions to the robotic arm. The computer feeding device can be any of a class of power devices normally used to provide motion commands to a pointer (cursor) on a computer screen. These are usually two-dimensional feeding devices such as a mouse, tablet device or trackball. In addition, three-dimensional feeding devices can be used to provide virtual positioning in a three-dimensional visual frame on a computer screen. Said devices are commonly exemplified in control levers, controllers D and the like. Finally, real freedom in motion in a virtual environment can be provided by a six-degree-of-freedom device (DOF), such as a "space-ball" feeding device commonly used in design applications aided by computer (CAD). The feeding device used as the first control means may be an out-of-shelf type of computer feeding device, or a device specially designed to operate with the robotic arm. The device used for the first control means may be interchangeable, so that, depending on the preference of the user or the medical procedure requirements, a feeding device may be used different from one procedure to the next, even when uses the same robotic arm. Although it is preferable that the robotic arm and the feeding device have the same DOF, this is not essential. The feeding device used for the first control means may be interchangeable. That is, it is not necessary that the feeding device be permanently or permanently attached to the robotic arm. The feeding device can be connected through a computer connection interface such as those commonly used for computer feeding devices. Therefore, one power device can have three DOF while the other has six DOF, and yet both can be adapted to instruct and control the robotic arm through a common interface port. Ideally, the robotic arm has six DOFs through the therapy head, and has sufficient mobility and extension to allow the six DOFs to be moved to the therapy head without physically interfering with other objects present during a medical procedure, such as the patient or the user. The movement of the feeding device produces movement instructions in the same way that a computer feeding device produces virtual location information for a cursor or other virtual object that will be displayed on a computer screen. However, in addition to the virtual motion and location information provided by the feeding device, the movement information also results in actual movement instructions for the motors or force generating devices used to control the robotic arm. In this way, the use of a computer feeding device allows a user to manipulate a potentially heavy and troublesome medical device with no greater effort than is necessary to operate a computer feeding device. Unlike some computer feeding devices that are of fixed orientation (such as I-rays or cursor arrows), the orientation of the cursor displayed on the computer screen for the feeding device described in the present invention preferably corresponds to a known orientation of the medical device. For example, the arrow of the cursor can point in the same direction in which the medical device emits energy, or in the opposite direction. Therefore, the movement of the feeding device, and changes in the orientation of the cursor in a virtual environment produce a corresponding change in the position and orientation of the medical device or therapy head. In a manner similar to a normal computer feeding device, the feeding device used with the system of the present invention may have buttons or display scroll wheels or other actuators therein that can be programmed to correspond to operating elements. particular of the system. For example, the buttons on the feeding device can be used to switch between turning the robotic arm motor on and off, activating the medical device either to carry out a therapy treatment or to renew some detector data. An important distinction in the application of the feeding devices for the present description with the general application of said devices is the aspect of re-positioning of said feeding devices. Perhaps it is common knowledge that a computer feeding device can be easily repositioned to compensate for the user's ergonomic desires. For example, you can lift a mouse or joystick and move while the virtual position of the mouse pointer, beam I and the like remains the same. This advantage of the computer feeding device can be adapted to the feeding device used as the first control means for the robotic arm within certain limitations. The advantage can be translated into control of the robotic arm in cases in which the movement of the therapy head, medical device or robotic arm is also suspended while the feeding device is repositioned. However, the advantage can not be translated in cases in which the feeding device is being used to track through a trajectory that can be a real placement of the therapy head, medical device or robotic arm in relation to the patient (cf. below) or an illustration representative of the position of the therapy head, medical device or robotic arm with respect to the patient's body. A representative placement involves either a map or a model of the surface of the patient's skin that is to be used in place of the actual skin surface. In an alternative embodiment of the tracking system, a map of the surface of the patient's skin can be created using a projection image and a camera. A projector projects an image of regularly spaced grid lines on the patient's body, or grid. The lines are projected from a template, the template has a known line spacing. The line spacing can be regular or irregular as long as the distance between each line is known. The projected line image falls on the patient's surface where it can be detected using a camera at an angle outside the projection line. The camera reads the distance between the lines lo and produces a second distance value for one of the sides of a right triangle. Therefore, using simple trigonometry, you can determine the elevation distance between the lines. A tracking system can follow a two-dimensional image of the projected map, in which the actual distances on sloping surfaces are determined by mathematical calculation instead of direct measurement. In this way, the two-dimensional map provides a good approximation of distances and slopes and allows the ultrasound system to adapt to longer (or shorter) slope distances and transmit the appropriate level of energy. Similarly, in another embodiment of the tracking system, a three-dimensional representation of the patient can be used. The three-dimensional representation can be a contoured doll, or a mold obtained from the real patient's body. The three-dimensional representation need not be large or precise as long as it is large enough to encompass the desired treatment area, and accurate enough so that the focal area of the transducer that will be tracked over the actual patient's body is not projected onto muscle tissue or other tissue that should not be treated. In any of these tracking system modalities, it should be appreciated that it is both desirable and beneficial to maintain sufficient accuracy in the tracking model or system using a proxi for the patient's skin surface, such that the actual therapy device continues. treating only undesirable adipose tissue. A transducer for imaging or an "a" scanner transducer may be used to ensure that the therapy is strictly applied to adipose tissue during a therapy session. This allows detection of adipose tissue in real time, and provides detection means for the system to stop, or turn off in the event that the imaging detector detects non-adipose tissue. Even if the user feels that the therapy head is on the appropriate adipose tissue area, the device itself has a safety backup. In a situation of actual placement, re-positioning of the feeding device in the same way could be undesirable for the same reasons above, except that the re-positioning of the feeding device may correspond to a direct change in the placement of the medical device, therapy head or robotic arm. The computer feeding device used as the first control means can be directly mounted on the robotic arm. Preferably, in this case, a feeding device having six DOF can be mounted, and be located substantially close to the therapy head. A user can operate the feeding device by manually manipulating the feeding device (such as with a joystick or space ball) and observe the movement instructions of the feeding device translated as the movement of the robotic arm. In this way, the user is "in the loop" regarding the control and addressing of the robotic arm and can make decisions regarding the angle and positioning of the therapy head without the need to examine a display screen having a virtual representation of the movement of the robotic arm. The user can make adjustments to the positioning of the therapy head in all six DOFs while being a user in the control loop of the robotic arm. A visual display device 242 may be mounted on the robotic arm such that a user can manipulate the therapy head 500 while still observing the deployment device 242. In this manner, a user can evaluate the information and data of the detector. on the screen while simultaneously using the feeding device to guide the movement of the medical device, therapy head or robotic arm. The data supplied by the detector (s) is displayed on the screen and allows the user to manipulate the feeding device to maximize the effectiveness and safety of the medical device or therapy head without being forced to look in several different directions to collect the information necessary to guide the system. In an alternative embodiment, the first control means may be a guide ring 267 placed on the body of a patient (Figure 6). In this embodiment, the guide ring 267 provides data for target selection, and a built-in tracking system is present either in the robotic arm 200, or within the therapy head 500 (or having elements in both). For purposes of illustration, the addressing system may be an optical tracking device that emits light from the emitters 256 in the robotic arm 200. The light is reflected by the reflectors 258 in the guide ring. The reflected light forms a pattern or orientation that optical sensors 262 placed around the therapy head 500 can read. The optical sensors 262 can therefore determine where the center of the guide ring 267 is located, and provide command instructions for movement and orientation to the robotic arm so that the robotic arm moves to keep the therapy head centered within the target ring. The target ring may be transparent in the middle region, or it has an opening. The opening or transparent material must not interfere significantly with any energy that may be emitted by the medical device, nor with the detectors that may be incorporated in the medical device. The ring can be made from a flexible material such that when placed against the patient's body, it fits the contours of the patient, or it can be rigid to provide a definitive reference plane for the user and / or therapy controller. The user of the system can manually move the target ring along the surface of the patient's body while the tracking system follows the movement and angular changes in the target ring. The tracking system provides the appropriate commands and control information to the robotic arm and the therapy head is moved so that the medical device remains, as far as possible, centered within the target ring, and at such angles that the device medical is perpendicular to the general plane of the ring objectified. Alternatively, the user can place the target ring on the patient in one place, and allow the micro controller (the second control means) to treat an area within the center of the guide ring. The objective ring can be manufactured in such a way that it has a side adapted for smooth sliding on the patient's body. This can be treated with a silicone or polymer material to reduce the friction of the device as it moves over the patient. The side facing the tracking system (which faces away from the patient's body) has enough clues or visual markers on it to produce an asymmetric reflection or refraction image. In this way, the tracking system can determine a facing direction, and rotate so that it adapts to the rotation of the target ring so that the medical device or therapy head is properly oriented at all times. The objective ring 267 can be physically attached to the therapy head 500 using similarly capable strain gauges or meters 264 around the perimeter of the therapy head and connected to the target ring (figure 5A-B). Movement of the target ring 267 through the patient's body produces stresses in the strain gauges or meters 264 that can be detected by the electronic controller 400, 250, and correspondingly move the therapy head 500 in response to reduce the effort . In this way, the therapy head can follow the target ring using a physical connection. Alternatively, the therapy head may have a magnetic coil whereby the objective ring has a similar magnetic field.

Changes in the strength or load of an electromagnetic field allow the system to detect the movement and direction of the target ring and compensate accordingly by moving the therapy head in response. Alternatively, the tracking system can be made to follow a detectable route traced or printed on the patient's body. In this embodiment, a user or operator can adjust the therapy head on the patient's body (either in physical contact, or in close proximity to the patient's body). Therefore, the tracking system serves as the first control means and automatically follows the path on the patient's body. The second control means may be a feeding device that a user can control to provide micro control of the position of the medical device while the therapy head follows a path over the patient's body. Alternatively, the electronic controller or the therapy controller may have a program that serves as the second feeding device for moving or oscillating the therapy head or medical device. This movement or oscillation can serve as a "rocking" effect that can sweep an area under the patient's skin on which the transducer has focused while the tracking system is operating. References can be placed on the patient's skin to be followed by the tracking system. It is not necessary to draw a route on the patient's body to be followed by the tracking system if the electronic controller has a program or response designed to track over a surface area defined by discrete reference marks. In this case, the first control means can be used to bring the robotic arm and the therapy head into position within an area defined by the reference markers. The second control means can then intervene and move the therapy head within the reference markers in accordance with its program parameters. The software program that guides the movement of the medical device or therapy head becomes the second means of control. In cases where the surface area to be treated is large, the first and second control means can operate simultaneously in a cooperative manner. That is, the user can guide the robotic arm while the therapy program that functions as the second control means handles the movement of the medical device within the defined treatment area. Even another embodiment combines the tracking system with a feeding device so that a user can use the feeding device to manually direct the robotic arm, therapy head and medical device to follow the path traced on the patient's body. Again, the second control means may be an automated path adjustment instruction that provides for an artificial roll to the movement of the therapy head as the robotic arm tracks the path over the patient's body. Even another modality requires the use of a personalized feeding device of similar design to a computer feeding device, but which is incorporated into the robotic arm during its construction. In this modality, the control means are integrated into the distal end of the robotic arm substantially close to the therapy head. The first integrated control means use technology similar to those of computer feeding devices such as elements for optical tracking, strain gauges, force and torque converters and the like. However, the feeding device is constructed in such a way that it has the same DOF as the arm, and is positioned for ease of use by the user. The second control means provide command and control of movement of the medical device within the therapy head. The second control means are used in cases where the therapy head has a micro-motor assembly, or other force-generating means for movement of the medical device within the therapy head itself. In this way, the robotic arm can be commanded to move the therapy head to a desired position or location relative to the body of a patient, and the second control means can be used for precise placement of the medical device. Therefore, the first control means provide a "macro" level of control, while the second control means provide a "micro" level of control. Alternatively, the second control means may be a software program that provides movement instructions to the micro-motor assembly within the therapy head. Therefore, precise placement of the medical device during a medical procedure can be left to an automated system. This allows the system to place the medical device at precise locations, during precise time intervals, in response to either pre-set parameters, or in response to real-time detector data. In another alternative embodiment of the second control means, a variation of automatic steering or "swing" can be incorporated in the movement instructions transmitted from the first control means to the robotic arm. In this way, the first control means still provide the "macro" level movement commands, but an automatic variation provides a certain "micro" level of movement command that can not be imitated or implemented through the direct translation of the directions of movement received from the first control means. Even in another embodiment, the feeding device used as the first control means can be exchanged between a macro addressing mode and a micro addressing mode. A switch can be used to switch between modes, which allows a user to interact with an individual power device and have both the first and the second control means available. During operation, a user may use the feeding device as the first control means to provide macro positioning of the robotic arm and placement of the therapy head or medical device. Once the therapy head is in the vicinity of the area to be treated, as can best be determined by the macro level addressing, the user can switch to a micro control level. The feeding device now becomes the second control means for fine control of the medical device within the therapy head. Alternatively, fine motor controls attached to the main force generating means used for the robotic arm can provide micro level control while using the same force generating device. This is analogous to the coarse and fine focus found in a light microscope. The application in the use of the motor of the robotic arm would be one of the gear of fine gear for control against ordinary gears, or elements generating fine force against coarse. The robotic arm can also have position or motion encoders integrated in it. The encoders are used to track the position of the therapy device, and the movement of each arm segment during the use of the system. It would be preferable for the robotic arm to have a teaching mode. An operator can use the teaching mode to manually guide the arm through a desired set of motion operations. The electronic controller can "observe" the movement of the arm and memorize the starting position, final position and trajectory taken between the final position and the starting position. The movement can be emorized by the electronic controller and repeated as frequently as desired by retrieving the movement instructions. Multiple motion paths can be saved if desired in the computer's memory. In the mode in which the feeding device is mounted on the arm, a slidable joint (Figure 7) can be incorporated in the arm, to help isolate a certain amount of force or excess torque used on the feeding device. from effecting the movement position of the robotic arm. The sliding joint is designed to help absorb or reduce excess force. For example, rotation force may be applied on the feeding device to cause the therapy head to change its axial rotation. If the user exerts too much rotation force, the feeding device can be pushed to a physical or artificial height. At this point, the excess rotational force can be dissipated in the sliding joint. The axis of rotation of the feeding device can be mounted on a double ring bearing assembly 2163. Once the feeding device reaches its stop, the additional force exceeds a threshold force level and allows the platform to rotate inside the ring of double bearing. Therefore, the foreign rotation force dissipates harmlessly. The sliding seal necessarily has a step so that the data information can be communicated from the feeding device to the electronic controller. The slidable seal may also include a physical opening that serves as a step for any physical connection to the arm, or from the feeding device to the therapy head. In addition to the double bearing ring 2163, the slide seal can also include an additional shaft in which the forces for isolating the arm from undesired forces can be absorbed. In this way, rotational and torque forces can be damped in multiple planes to protect the accuracy of the robotic arm. The forces that exceed the maximum force that can be absorbed by the feeding device, and which are not neutralized by the sliding joint, will be limited by the robotic arm. The robotic arm can detect external forces (those that do not originate from the instructions received from the feeding device) and compensate them by applying opposite forces. This "station maintenance" may be useful in tortuous environments in which the user aggressively handles the feeding device to treat and place the therapy head appropriately. The DOF of the first control means can be separated into elements that are robotic, and elements that are manual. The robotic arm can be constructed with any number of DOF while the therapy head is manually adjusted for the remaining DOF requirement. For example, if the robotic arm is constructed with three DOFs, and the first feeding device is a computer feeding device having three DOFs, then the therapy head can be mounted on a joint that allows for three additional DOFs that are not provided by the robotic arm. The tracking system will still be able to track the location of the medical device by compiling both manual and robotic DOF elements into a single spatial location for both visual representation and for medical procedure tracking purposes. Said system may have the therapy head mounted axially to a feeding device, in which the robotic arm can be adjusted through the feeding device while the therapy head can be manually "pointed" simultaneously. Note that the use of a manual addition to the control means may be a component of any of the first or second control means. If the therapy head has micro position motors for movement of the medical device within the therapy head, the manual contribution to the DOF of the therapy head will be a component of the first control means. The first component in this case may be the command and control of the robotic arm. In this case a user can use the therapy head itself as the feeding device for directing the therapy head and the robotic arm. The micro position control can remain with the therapy controller or electronic controller and move the energy emitter inside the therapy head. Alternatively, if the medical device remains fixed within the therapy head, then the manual contribution to the DOF constitutes the second control means while the command and control of the robotic arm remain exclusively for the first control means. In this case, manual positioning takes the place of an automatic adjustment to the robotic trajectory or artificially induced balancing. It is not necessary that the first feeding device be placed in close proximity to the therapy head. The first and second control devices can be positioned a little beyond the therapy head. For example, in cases where the robotic arm and the therapy head are designed to be operated remotely, then the control means can be positioned near a remote computer in which case the user follows a visual or virtual representation of movement of the therapy head on the patient's body. This alternative modality is reserved for unusual medical procedure in which it is not desirable for the physician to be in close proximity to the patient's body. The motive or motor means of the articulating arm must have a speed limit, such that the arm is not prone to any movement that could cause harm to the patient or operator. The motion controller, therefore, can control the speed of both the re-positioning of the end effector, as well as the speed at which any individual segment of the arm can move through space, thus avoiding or reducing so less the possibility of surprising an operator or observer. Optionally, a deployment device 242 may be placed near the distal end of the arm 208 that provides visual feedback and display of information to a user during a medical procedure.

Therapy controller An electronic controller is used to coordinate the functions of the various elements of the system. The electronic controller may be one or more computers, or other dedicated electronic devices adapted for use with the present system. The electronic controller receives the power information from the first control means, whether these are a computer feeding device, a guide ring or tracking system. The electronic controller then translates the feed information into movement instructions for the robotic arm. A second data path can be implemented that also provides a virtual visual object that will be represented in a deployment device. The data flows of the movement and display data trajectories must be appropriately correlated in such a way that the movement and the visual representation of the movement of the system coincide exactly. The electronic controller must also coordinate the inputs of the second control means. If the second control means operate simultaneously with the first control means, then the electronic controller must coordinate its movements in such a way that the medical device passes over the treatment area of the patient's body in a manner in accordance with the procedure doctor that is being developed. It is imperative that the electronic controller compile exactly the movement commands of the first control means and the second control means so that there is no risk to the patient. If the second control means operate in a time frame separate from the first control means, then the electronic controller need only ensure that command and control of the position of the medical device is appropriately controlled from the appropriate controller. In the same way, the electronic controller must ensure safety towards the patient's body avoiding the unauthorized or inappropriate movement of the medical device on the patient's body. The electronic controller must act as a therapy controller. If a computer is used as the electronic controller, it may have the ability to run pre-loaded software that can function as a controller for the medical device, or it may have an expansion slot such as a PCI bus interface that can accept a or more cards that work as the therapy controller. It is convenient, but not essential that the electronic controller of the present invention be in intimate electronic communication with the therapy controller of the medical device to ensure that the movement and physical placement of the medical device and therapy head are effected in accordance with the procedure of therapy.

The second control means may be a physical device used to provide power, such as a secondary computer power supply device, or the first control means after they are changed to provide fine position control. Alternatively, the second control means may be a software program for providing pre-programmed movement instructions to the medical device within the therapy head. Likewise, the second control means may be a fixed or limited variable motion automatically added to the movement instructions of the first control means, to provide a swing or other continuous state variation to the movement of the robotic arm. The therapy controller of preference has a three-dimensional map (see section 3.0 below) of the treatment area before it actually starts a therapeutic procedure. The therapy controller can monitor the progress of the scan head during a real procedure and compare it with the map of the tissue to be treated. The local progress of the treatment can be handled through a position tracking device used in conjunction with the therapy head of the present invention. From the processing point of view, the position and tracking control of the energy applicator is one way in which the system of the present invention can effectively destroy adipose tissue. Notorious precision can be established in adipose tissue to create lesions of destroyed tissue, or tissue necrosis. Precision is produced using a variety of position detectors and control devices to adjust the position of the energy applicator. The position of the energy applicator 600 within the therapy head 500 can be determined using the motor encoders linked to the micro-motor assembly. By measuring the rotation of each of the motor axes using rotation encoders 530, the amount of movement of the actuators 508, 520, 516 which connect the motors 508, 510 to the power applicator 600 can be determined. This is the first step to isolate the position of the energy applicator. Once the position of the energy applicator 600 within the housing 500 of the scanning head 500 is known, the position of the scanning head 500 relative to the anatomy of the patient must be determined. A series of optical detectors 555? 5552 (FIG. 4A) can be used to accurately measure the physical distance that the scanning head travels over the patient's skin. These optical detectors can also be used to determine the change in rotation (the amount by which the scanning head rotates around its own central axis which is generally perpendicular to the patient's skin), and the angular change (rotation with relation to an axis that is not in the center of the scan head). In addition, encoders may be used in the articulating arm 200 to determine the changes in the position of the scanning head 500 in three dimensions. Therefore, if the sweeping head 500 moves on the side of a person's body, the three-position detector mechanisms are not lost. The computer 400 or the therapy controller 250 can coordinate the data and keep track of the position and dose in a highly organized and accurate manner. Optionally, all data can be tracked on board, using an onboard 532 processor. Splitting the processor tasks can also help reduce the load and accelerate the response time between data reception and signal output towards the operator. If for some reason the scanning head loses traces of the patient's skin, the tracking system allows the return of the scanning head to the patient's skin and ensures proper orientation of the scanning head so that the procedure can begin immediately without involving speculative work to try to determine which fabric has been treated and which fabric has not yet been "treated." Re-positioning involves placing the scanning head in the reference position and aligning the scanning head in accordance with a flank (not shown) around the lower section of the housing The use of any of the three devices to determine and track the position of the power applicator allows a display of the tissue map and an overlay map relating to the display to be displayed on a monitor. current treatment regime, an LCD or other device that can be interpreted appropriately by a user so that the The user can determine where to move the scan head to continue with the procedure. The indicator to facilitate treatment can be as simple as an audible tone of different intensities (a tone to move over a treated area, and a tone to move over an area already treated) for indicator lights, until a fully detailed video display. The screen may be mounted externally to the present system or may be used in conjunction with a computer, device for therapy control, or on a small screen mounted on, or in proximity to, the scanning head. Methods for using the present invention are also described. First, a method for applying energy to a body region is provided. The method comprises first providing a treatment plan to a therapy controller. Second, manually perform a sweep with a sweep head on a body surface in response to the guidelines generated by the therapy control while power is being supplied from the sweep head. Third, monitor the position of a power supply from the scan head to produce position data and transfer the position data to the therapy controller and fourthly generate an alert if the manual position and / or the power supply they fall outside of the treatment plan. Preferably, the method involves manually sweeping the sweep head over the region of the body prior to power delivery to generate a virtual map of the region to be treated. The map is then loaded into the therapy controller. Other treatment parameters must be entered into the therapy controller to the extent possible. This helps to generate a treatment plan based on the virtual map and other treatment data.

System to create a map of three-dimensional volumetric tissue A system is also provided to produce a topographic map and subcutaneous tissue near the matching surface (Figure 8). The system has three components. First an apparatus for three-dimensional image formation 802 for producing surface images of a patient's body. Second, a tissue imaging apparatus 850 for producing subcutaneous images of the patient's body, and third, a co-relative operating device 875 for matching a plurality of markers of said surface images and said subcutaneous images. The apparatus for three-dimensional image formation can be a high-resolution camera system or another optical camera that can make maps with a detailed image of the surface of a patient's skin. It is not necessary that the resolution of skin characteristics be a critical component of the camera system as long as it can accurately track the curvature and shape of the region of interest of the patient's body. The volumetric imaging system may be a 3D ultrasound system or an interpolation 2D ultrasound imaging device. Alternatively, the device for tissue imaging can be an MRI or X-ray device. Preferably, both the visual imaging system and the tissue imaging system produce electronic images that can be manipulated. by a computer. The device for correlative operation can be a general purpose or specialized computer, or an intelligent logic device with similar capacity. The device can also be a software program. The correlative operation handles the coincidence of a plurality of markers between the surface and the subcutaneous images in order to produce an accurate three-dimensional tissue map. The markers used can be easily identifiable natural markers of the patient. However, the preference markers are a plurality of references that can be detected by the two image-forming devices. Once the images are captured and saved electronically, the data of the two images can be correlated using the reference markers. It is not necessary for the two image formation systems to capture images on the same scale, because the correlative operation can also perform a scaling task to ensure that one or both images fit a desired scale before the image is presented. correlation. Once the images are correlated, a new three-dimensional map is produced. The new map has subcutaneous characteristics close to the surface and matching topographical features. The reference marks used by the system can have a variety of parameters that can help to correlate the image maps. For example, the reference mark may include an "up" or "down" indicator so that the image formation system can determine the orientation of the reference mark after the image is captured. By using a plurality of reference marks with orientation data, it is possible to precisely determine the coincidental superimposed position of the second image produced by the system. The preferred reference mark can be detected by both imaging systems (surface and subcutaneous), however this is not necessary. A user can place a plurality of reference marks on the body of a patient that can be detected by one image forming system and not by the other. As long as the user replaces the reference marks with others that the second system can detect, the correlation operation can still be used effectively.

Methods of use The methods described in the present invention are non-invasive. Unlike traditional liposuction procedures, which use a cannula with vacuum, there is no penetration of a patient's skin. The destruction of fat cells or adipose tissue occurs through the accumulation of heat or mechanical rupture caused by cavitation, both effects produced by directed irradiation and preferably by high intensity focused ultrasound (HIFU). Therefore, in a non-invasive procedure for adipose tissue reduction, there is no way to directly visualize how much tissue has been affected. In liposuction, the treating physician can visualize either the amount of fat removed or destroyed, but in a non-invasive procedure, this direct observation is not possible. The user of the present invention has to rely on an ultrasound diagnostic device or other detector to help determine the volume of tissue treated. A common aspect of the methods described in the present invention is an evaluation of the adipose tissue regions to be treated. Current techniques using a "pricked" test can provide a reasonable starting point for the use of both the systems and the methods described in the present invention. The puncture test is used by plastic surgeons to evaluate regions of adipose tissue. A patient P may have local adipose tissue that he wishes to remove. The doctor can evaluate the adipose tissue by drawing a series of contour lines Ci, C2, C3 ... Cx in the patient (Figure 9A).

Method for applying ultrasound energy to a region of the body In one embodiment, the method of the present invention provides a method for applying energy to a body region. The method has four stages. The first stage is to provide a treatment plan to a treatment controller. The second step is to perform a sweep with a sweep head on a body surface in response to the guidelines generated by the treatment control while power is being supplied from the sweep head. The third step is to monitor the position, and the power supply of the sweep head to produce position data and transfer the position data to the treatment controller. The fourth stage is to generate an alert if the position and / or power supply falls outside the treatment plan. In step one, a treatment plan is provided to a treatment controller. In this case, the user identifies the need of the patient to be treated and selects a treatment plan in accordance with the patient's needs. In the preferred application of destroying adipose tissue, the user selects from a possible list of options about how much adipose tissue should be destroyed, the step of tissue destruction, depth, energy flow and other necessary parameters. Probably the user is not familiar with the technical elements that contribute to each treatment plan, but chooses based on the desired result. As such, choose a plan to destroy adipose tissue along a line 12 cm 8 cm wide and 2 cm deep. The program variables that a user can understand are more in line with the result than with the way in which the machine works to achieve the result. Once the treatment plan is selected, the user enters the desired treatment plan in the treatment controller. The treatment controller determines an operating protocol that produces the desired treatment plan. The second stage involves sweeping the patient with the scan head. The scanning head (or therapy head) is active in such a way that the ultrasound energy is transmitted to the patient to destroy adipose tissue. The scan head moves in accordance with the protocol from the treatment controller. Movement can be achieved through manual means or automated means. In a manual mode, the treatment controller provides clues that will be followed by the user. The user moves the scan head through the patient in response to the tracks. In an automated environment, the treatment controller directly controls a device or apparatus, such as a robotic arm, to direct the movement of the scan head. The third step is to monitor the position and energy supplied by the sweeping head. The supply position and information is communicated to the treatment controller in the form of a data feed that is compared to the protocol that is being used by the therapy controller (either through a user, or a robotic device). The therapy controller continuously monitors incoming data against the protocol to ensure patient safety during a procedure. The fourth stage is an alert. If any of the position or power supply is outside the acceptable tolerance of the protocol, the therapy controller uses an alert. The alert can be strictly to be monitored by the user, or this can be an integrated shutoff switch to immediately cease any power transmitter in the scan head. Step one is selected as the start of the procedure, however steps two, three and four are performed continuously to ensure that the appropriate therapy regimen is applied to the patient.

Method to carry out lipoplasty therapy In a second modality, a method for performing a lipoplasty procedure is provided. The method comprises the steps of first, determining the suitability of a person for treatment with therapeutic ultrasound. Second, mark the areas to be treated about the person. Third, position the patient for a therapeutic ultrasound procedure. Fourth, introduce the marked areas, by scanning, into a computer, fifth, adjust the therapeutic ultrasound procedure using a software package for procedural planning. Sixth, activate the therapeutic ultrasound procedure using a computer system controlled through the procedure planning software. Seventh, record the progress of the therapy procedure using the procedure planning software, and finally, provide the person with additional post-operative help as needed. The methods of the present invention are ideally suited to provide the maximum amount of safety, long-term correction to a body modeling procedure with the option for treatment of additional therapy and utilization of drug regimen, while at the same time maintaining a map. virtual patient to ensure that the treatment is effective and safe over the long term. Taken together, the described methods are combined even in another aspect of a method for performing a lipoplasty procedure comprising the steps of: (a) determining a person's suitability for treatment with therapeutic ultrasound; (b) mark the areas that will be treated about a person; (c) positioning the patient for a therapeutic ultrasound procedure; (d) entering the marked areas, by scanning, on a computer; (e) establish the therapeutic ultrasound procedure using a software package of procedure planning; (f) activate the therapeutic ultrasound procedure using a computer system controlled through the procedure planning software; (g) recording the progress of the therapy procedure using the procedure planning software; and (h) provide the person with additional postoperative assistance as required. The following example illustrates the described method.

ETEMPLO 1 Step 1 The patient enters for an initial consultation, as in traditional lipoplasty. If the patient decides to continue with the procedure, dietary supplements, drugs, topical creams, etc. can be provided, which can be formulated specifically to provide some benefit during or after the procedure. Examples include Bromelain and Quercetin taken before the procedure and Arnica Montana taken after the procedure to promote healing and reduce swelling.

Step 2 On the day of the procedure, the doctor marks the patient in a manner similar to what could be done for traditional lipoplasty patients. The ink in the marker pen may contain an additional agent (for example an ultraviolet pigment) to increase the detection capability of the ink on the skin by a detector. This can be particularly useful for dark skin colors.

Step 3 The patient is positioned for the procedure. The patient must be in the same position in which he or she will be during treatment. In most cases, the procedure is performed with the patient lying on a plate, so that this pre-operative step is performed with the patient resting in the prone position. The thickness of the patient's fat can be mapped through the areas to be treated, for example with ultrasound. An ultrasound system for diagnosis can be combined with an image analysis system that detects the strong reflection coming from the boundaries between the fat and the underlying muscle, and record this thickness together with position information. The position information comes from a position detector device attached to the ultrasound transducer. Because only depth information is only needed, the diagnostic ultrasound unit can be replaced with a simpler pulse-echo line system A. Reference marks may be drawn on the patient's body, or may be marked in some other way such as with adhesive paper, to provide reference sites for the position sensing system. This fat thickness map, or a subset thereof can be stored for reference at a subsequent patient visit, for example, to visually demonstrate the actual effects achieved.

Step 4 The pre-procedure body marks are scanned and entered into a computer, also using a position detector system as described above. This can be done by tracing marks with a pen attached to the positioning system, or through the optical detection of the marks in coordination with the positioning system. Ideally, this map of marks that is entered by sweeping the computer can be referenced as the map of fat thickness that can be acquired as described above. The positioning system typically records three to six degrees of freedom (ie, x, "and", z, depth, rotational oscillation, displacement) in all cases.

Step 5 The practitioner can now interact with the procedure planning software provided on a computer with access to the marking and thickness data acquired as indicated above. It is expected that the aesthetic effect of the process can be controlled locally, for example by varying the depth, time or density of treatment to affect more or less tissue. The point of the procedure planning software is to connect these system variables to the desired overall aesthetic effect that will be achieved. For example, the practitioner may decide that an area of fat should be reduced by 2 cm in a central area, decreasing to 1 cm in a region outside the area, "fading" to a zero effect outside of that region. The practitioner does this by identifying the desired effect in a visual representation of the drawn contours, and optionally the fat thickness. Contours and drawn marks can be edited or modified in the treatment planning software. The user can, for example, identify the 2 cm region by clicking inside the corresponding pre-procedure mark with a mouse, or a pointer over it on a touch-sensitive surface, and either writing or selecting from a menu that is region corresponds to 2 cm thick. If it is necessary to modify the contours, these can be altered through the software using media typically found in drawing software such as the Adobe Illustrator program. For example, if the software maintains a Bezier-type representation of drawn contours, "handles", "control points" or "nodes" of Bezier can be provided for interaction and modification by the user as is typical in the drawing software. The 1 cm area is identified in a similar way. The transition regions can be identified, for example by simply choosing a fixed distance on one or both sides of the 2 cm contour for a gradual transition to 1 cm, and the same can be done for the transition from 1 cm to zero. The transition distances can be variable, and in fact can be drawn on the computer with a pointing device, or they can be represented by pre-surgical markings that are scanned to a computer and identified as transition regions for planning software. The user can also inform the therapy controller what effect is desired in a transition region, for example a linear drop or some other form of curve, and what combination of system variables (eg, depth, power, time, density) It must be used to achieve the effect. The depths, transition areas, affected variables, etc., can be displayed visually in different colors or with different marks for easy identification. When the editing and identification procedure is finished, the computer calculates a treatment plan in relation to all the system variables relevant to the desired aesthetic effect.

Step 6 During the course of the actual therapy, the therapy head containing the high intensity ultrasound transducer (s) is connected to a positioning system such as the one described above that follows a system computer to relate the current position of the head of therapy with the computer representation of the treatment plan. The computer then controls the therapy variables to achieve the desired aesthetic effect. In the previous example, as the therapy head moves through the 2 cm region, appropriate power, pulse duration, etc. is applied to the therapy head to achieve 2 cm of affected tissue. As the head moves through the transition region towards the 1 cm area, the power and duration can be reduced in order to affect a variable tissue thickness until the 1 cm effect is achieved. Likewise, this "fading" effect is achieved as the head moves out of the 1 cm area, and the transducers are not allowed to ignite if the head is outside the treatment area. The plan and total record of the treatment can be saved for future reference.

Step 7 After therapy, the patient may be asked to wear a compression garment over the treated areas as is common with traditional lipoplasty procedures, and other medications or nutritional supplements may be given to promote healing or reduce discomfort .

Method for destroying adipose tissue using HIFU In a third embodiment a method is provided for destroying adipose tissue in a patient using therapeutic ultrasound. The method has the steps of: first determining one or more adipose tissue sites in the patient. The second step is to position the patient in such a way that the adipose tissue is arranged in a relatively uniform distribution (preferably looking upwards), and third, to irradiate the adipose tissue sites of the patient with a therapeutic ultrasound transducer. In this method, the site and size of the adipose tissue area to be treated should first be determined. This can be accomplished through traditional means such as "pricking" or "pressing" tests routinely used by plastic surgeons, or it can be determined using a medical examiner such as an ultrasound diagnostic system or the previously described three-dimensional topographic map device. Adipose tissue sites should be located and appropriately identified in terms of depth and size. So while a physician can rely with great comfort on his skill using the puncture test, the limits and depths of adipose tissue should be evaluated as accurately as possible. Therefore a screener is required for image formation of some kind. Once tissue volumes and depths are determined, the skin can be marked with a surgical pen or other device in such a way that the user can clearly identify the areas to be treated.

Next, the patient is oriented in a way that promotes the success of the irradiation step. In this case the patient is oriented on a bed or chair in such a way that the adipose tissue to be treated looks upwards as much as possible. This allows the adipose tissue to settle in an almost uniform distribution around a center, such that the depth of the tissue is preferably symmetric for treatment. Finally, adipose tissue regions are treated. Adipose tissue volumes are treated with a therapeutic ultrasound transducer. The treatment can be applied evenly, if the fabric layer has settled evenly and in a level way in step 2.

Method to create a three-dimensional body map A method to create a three-dimensional body map is also described. The method to create a 3D body map with the adipose tissue volume locations has the steps of: first, generate a three-dimensional image of the body using a system for 3D image formation. Second, enter the 3D image of the body in a computer readable format. Third, create a three-dimensional body map with a software application for three-dimensional mapping, and fourth, capture body data by scanning with an ultrasound device for diagnosis in electronic communication with the software application for three-dimensional mapping in such a way that the regions of adipose tissue detected by the diagnostic ultrasound device are appropriately placed on the three-dimensional body map. The details of the first method are the following. A system for three-dimensional image formation comprises a plurality of cameras that take a photograph of the patient. Instant photography involves all the cameras of the three-dimensional image formation system taking an image simultaneously. Therefore, a visual image of the whole body can be captured from all sides. For this to be done, the patient should probably undress and remain naked or semi-nude at the focal point of the imaging system. The image formation system is similar to those used to develop automotive commercials that show a car from all angles simultaneously. The images from the three-dimensional camera system overlap and coordinate appropriately so that a single comprehensive image of a person's body is generated. The image formation system used is highly accurate and can be converted into a machine-readable form. The cameras in the system for three-dimensional image formation can take normal film images or digital images. However, regardless of the type of image taken, the images must be appropriately superimposed in such a way that a single image of the body results. The image is then converted into a three-dimensional topographic map of the human body and stored in a computer. The procedure is based on the accuracy of the system for three-dimensional image capture to accurately reconstruct the body image. Then the software can appropriately convert the image into a topographic map. Once the topographic map of the human body is generated, the data can be saved for later retrieval. This first image is the pre-operative three-dimensional map of the patient. Once the pre-operative map is prepared, the patient undergoes an ultrasound scan for diagnosis, the scan can be as simple as a scan in line mode "a" or in mode "b" to determine the density and depth of fat in a certain area. However, the preferred mode is a high resolution image forming system so that the details of the fatty layers can be visualized and recorded. The system for diagnostic image formation is in electronic communication with the computer, software and pre-operative map. Using a position location detector, or a precision location controller, the position and direction of the diagnostic scan relative to the body is recorded and superimposed on the pre-operative map. This allows a doctor to generate a volumetric map of a person's fatty deposits. The superimposed image formation allows both the patient and the doctor to observe which areas are available for treatment (either invasive or non-invasive) and also to play with the models by sampling a certain amount of fat to be removed and observing what the appearance will be like. of the patient. This implies the generation of an abstract model using the pre-operative model as the baseline, and any projected changes to the pre-operative model to visualize the final result.

Method to use the three-dimensional body map In another modality, a method for modeling the body using a three-dimensional body map is presented. The method has the steps of first analyzing the three-dimensional body map with respect to volumes of adipose tissue to be destroyed. The second step is to determine the amount of adipose tissue that can be destroyed safely using a body modeling procedure. The third step is to subtract the destroyed adipose tissue volume to produce a second three-dimensional body map, in which the physician and the patient can compare the first three-dimensional body map and any number of second three-dimensional body maps to choose the desired amount of modeling procedure of body that will be played. In this method, a first body map is created using the image forming systems described above in the present invention. The first body map represents the starting point for a patient before any therapy procedures are initiated. The therapy controller can be used to create a second map that shows the contoured body after a volume of adipose tissue is destroyed. By using the controller for therapy in this manner, it is possible for a patient to observe a potential end result of the therapy treatment in numerous types of treatment. Therefore, the patient and the physician can obtain an estimate as to how the patient will look based on the three-dimensional body map of the person after one or more treatments. This information can be used by the doctor and the patient to guide the procedures and determine a safe number of treatments for the desired goal, or to determine the maximum amount of adipose tissue that can be destroyed during a certain number of treatments.

Other methods to destroy adipose tissue In an alternative modality to destroy adipose tissue, a method for destroying adipose tissue is presented having the steps of first determining a volume and area of tissue to be treated, and second treating the volume using a transducer scan of HIFU pulse wave over the area or tissue in a continuous motion. In operation, the step of determining the presence and location of adipose tissue can be very similar to the method previously illustrated and uses a three-dimensional image formation system with a computer to create a pre-operative model. However, current liposuction procedures offer an aspect to rapidly determine regions of adipose tissue using a marker on the patient's skin. In this way, a doctor, using his own experience and practical training, can identify the "problem" areas that a patient wants to be operated on. The doctor uses a marker to delineate the skin area, which represents the region of adipose tissue. Once this is done, the patient can undergo the procedure of creating the three-dimensional pre-operative model as indicated above, however, the cameras have the advantage of being able to detect and incorporate the marked regions on the skin in a topographic map. three-dimensional The ink used in the marker may contain a special pigment or dye that allows the cameras to visualize it under special conditions, for example, the use of a fluorescent marker visible under a special light. The positioning of the patient is presented in a similar way to the previously described procedure. The patient is then treated with a high intensity focused ultrasound device (HIFU) to destroy selected regions of adipose tissue. The HIFU device is particularly designed to incorporate the precision location detector, or the positioning mechanism used in the diagnostic ultrasound step described above. In this way, the address and location of the ultrasound treatment are known and can be superimposed over the preoperative map of the patient. Additional details can be recorded if the electronic high intensity focused ultrasound components are also attached to the image formation system so that each pulse or transition of the HIFU transducer can be recorded and superimposed on the pre-operative map in real time. . In this way, the irradiation step of the procedure can be carried out safely and precisely because the computer can record each individual treatment position. Using a feedback loop between the computer that records the HIFU treatment data, and the HIFU transducer, an increased safety feature can be obtained in the sense that the computer can prevent the HIFU transducer from radiating about a region that has been treated beforehand, or ensuring that there is a certain minimum level of spacing between the lesions. This spacing can be the three-dimensional geometry of the lesions, or a more complicated spacing in time. In cases where a patient can be treated during multiple treatments, the system remembers the location of the previous HIFU lesions and avoids irradiation of the same volume until an adequate space of time has elapsed. The computer system can also control a combination of three-dimensional geometry and time sequence of injuries, as well as incorporate additional parameters regarding strength, size and duration of HIFU treatment.When the irradiation procedure is complete, the patient can be re-screened using the diagnostic imaging device to determine the extent of the success of the procedures as planned. From the post-operative evaluation, the doctor can plan and schedule additional treatments, or modify the program of additional treatments already planned so that they adjust to the needs of the patient in a safe and effective way. Depending on the degree of the treatment performed on the patient, the patient can be discharged with additional medications, or with compression clothing to aid in the healing or modeling of the body.

EXAMPLE 2 This method for destroying adipose tissue involves the use of the aforementioned therapy head with a simultaneous sweep and pulse wave transducer regime. In this method, the patient is prepared in the same manner as previously described. A set of contour lines is drawn to identify the area corresponding to the volume of tissue to be treated (Figure 9A). The lines or grid can be drawn on the contour lines (Figure 9B). The therapy head is used to sweep the tissue area to verify that there is sufficient depth of adipose tissue (Figure 9C). Once this is done, therapy can begin. The therapy is carried out by moving the therapy head on the treatment block at a rate of 3 mm / second to 50 mm / second, using a therapy transducer with a pulse wave mode. The robotic arm can move the transducer, or the user can move the therapy head with the instrument by keeping records of the distances moved during each sweep. You can also use the micro positioning system with the therapy head to sweep through the movement line of the therapy head. This allows a larger area to be treated and therefore a larger volume. This allows the volume of necrotic tissue to increase, reducing the time required to treat the volume, and bringing the non-invasive procedure closer in time to an invasive procedure. In another method for destroying adipose tissue, three general steps are carried out. The first step is to determine an area and volume of tissue to be treated. Second, treat the volume and area of tissue, and finally determine the effectiveness of treatments for volumes and areas. The first step involves determining the volume and area of the tissue to be treated. Currently, plastic surgeons rely on their years of experience to determine the amount of adipose tissue a patient may have. The tactile examination allows doctors to create contour lines around areas of adipose tissue to be removed with liposuction. This same method can be used as a starting point for the doctor to create contour lines. It is necessary to check the depth of the adipose tissue under the contour lines using an ultrasound scan. Once the contour lines are established, the patient should be oriented in such a way that the contour lines that are to be treated are placed in a way that makes the tissue accessible to the therapy head. The therapy head in desirable form has a wide range of motion, but patient orientation is important because many orientations that can be achieved by the therapy head are neither comfortable nor practical for the user of the instrument, or for the user. patient to be treated. In general, the orientation should be with the surface area of adipose tissue facing upwards and usually flat. This allows the adipose tissue to settle in a stable volume without concentrating too much on one side, as opposed to when the patient may be resting to present the volume and surface to be treated in a manner in which the tissue sits irregularly. . The regularity in the depth and volume of the tissue also helps the user to provide a more uniform and effective treatment. After the patient is oriented in a way that leads to user comfort, therapy head and patient, the therapy head is used throughout the area of the contour line in a scan mode for diagnosis. This scanning of the patient to verify the depth of adipose tissue is necessary to provide accurate information to the system and the user so that the therapy head does not destroy tissue that it should not. Put simply, it is necessary to verify that there is sufficient depth of adipose tissue within the contour line area before treatment begins. If insufficient adipose tissue is found, the contour line should be redrawn so that the safety regulations are met. Assuming that the depth and volume of adipose tissue are sufficient to initiate a therapy procedure, the user can begin marking a treatment zone grid on the patient's body. The treatment zone grid in desirable form is at least as large as the area surrounded by the contour lines, and probably extends beyond the contour lines. The grid of the treatment area can be marked on the patient with a surgical marker, a roller device or spray applied ink with a stencil or stencil. Other ways to produce the treatment zone grid are also possible. After the tissue volume has been confirmed and the treatment zone grid is placed, the user can enter the patient data and the desired treatment parameters into the therapy device using the host interface. Various parameters can be entered into the device and the user can accommodate any information that is necessary or desired. Once the machine is properly programmed, the main step of determining the area and volume of tissue to be treated is completed and the user can proceed to the second major step of actually treating the tissue area and volumes. First the user places the therapy head on the patient's body and in alignment with the treatment zone grid. If the therapy head has reference marks on it that can be aligned with the treatment zone grid, the reference marks should be aligned. This allows the therapy head to be positioned exactly for treatment. If there is an easily identifiable pattern, such as a notorious starting site such as a corner or other position in the treatment zone grid, then the user can start at that point. In addition, the therapy controller or the host interface may have a tracking system to determine which areas have been treated so that the user does not need to keep a record of that information. Then, the user identifies a treatment area to be scrutinized with a therapy head. This will be the first area scrutinized and there will be as many areas of sweep as the number of times the area of occupation of the therapy head can fit into the contour line areas. With the therapy head in position, the diagnostic scanner can be run again to check for sufficient depth of tissue. The diagnostic scan can be run interspersed with the therapy scanner, or simply at the end of the therapy block. The therapy block is the area under the therapy head to be treated. The HIFU transducer is coupled in accordance with the parameters coming from the therapy controller. The transducer either mechanically sweeps the block area, moving through a micro positioning system, or the focal region moves electronically using a transducer with electronic HIFU address (such as an in-phase array). The depth of the lesion, density and size can be affected by the scanning speed of the transducer (how fast the focal point moves electronically or mechanically through the tissue). Altering the intensity, PRF or overlap of the treatment lines can also affect the size and shape of the injury. By adjusting one or more of these parameters it is possible to produce both large and small, deep or shallow lesions and allow the user a level of control over the level of necrosis. Therefore, the user can reduce the amount of necrosis and produce a fading effect, such that as the therapy head approaches the adipose tissue limit, the amount of tissue necrosis is reduced. This allows the treatment of desirable tissue without the risk of damaging non-adipose tissue. This also allows the user to enlarge the areas of necrosis in deep adipose tissue areas to generate larger regions of necrosis to produce the desired results. The fading of the lesion and the uniform treatment values - between the contour lines and the treatment density are varied from the uniform treatment value with the vanishing treatment function. Although the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the figures and are described herein in greater detail. However, it should be understood that the invention should not be limited to the particular forms or methods described, but on the contrary, the invention covers all modifications, equivalents and alternatives that fall within the scope of the appended claims.

Claims (65)

1. NOVELTY OF THE INVENTION Having described the present invention, it is considered as a novelty and therefore the content of the following is claimed as property: CLAIMS 1. - A system for the application of energy to a region of the body, said system comprises: a scanning head that includes an energy applicator; means for suspending the scanning head in space; and a therapy controller coupled to the scan head and to the suspending means, said therapy controller is adapted to monitor the position and power supply of the scan head while providing addressing to position the scan head.
2. 2. The system according to claim 1, characterized in that said suspension means also comprise means for tracking the location of said scanning head in the space. 3. - The system according to claim 1, characterized in that said means for suspending said scanning head in the space allow the manual re-positioning of said scanning head in the space. 4. The system according to claim 1, characterized in that said means for suspending said sweep head in the space comprise a robotic arm with the capacity to reposition said sweep head in response to a power guideline. 5. A system according to claim 1, which also comprises a therapy controller coupled to the scan head to monitor the position of the scan head and to determine a treatment region based on the manual positioning of the scan head, said therapy controller is adapted to receive other treatment information from a user. 6. A system according to claim 5, characterized in that the therapy controller is physically separated from the controller and adapted to produce a treatment plan based on the determined treatment region and the other treatment information. 7. - A system according to claim 6, characterized in that the therapy controller is also adapted to transfer said treatment plan to the controller. 8. A system according to claim 1, characterized in that the energy applicator comprises at least one vibrating transducer. 9. A system according to claim 8, characterized in that the energy applicator is mounted so that it can be positioned inside the sweeping head. 10. A system according to claim 9, characterized in that the scanning head comprises a servomotor-controlled energy applicator mounting system that is coupled to the therapy controller, in which the therapy controller can adjust the position of the therapy controller. Energy applicator inside the sweeping head. 11. A system according to claim 1, characterized in that the scanning head comprises a navigation display in electronic communication with the therapy controller, in which the therapy controller can display addressing information for a user. 12. A system according to claim 11, characterized in that the navigation display comprises a video screen, a LED array, discrete lighting elements, and means of communication with said therapy controller. 13. A system according to claim 12, characterized in that the navigation display is mounted on the scan head. 14. A system according to claim 1, characterized in that the suspension means comprise an articulated arm. 15. A system according to claim 14, characterized in that the articulated arm is mounted on an independent base. 16. A system according to claim 15, characterized in that the articulated arm comprises digital encoders to provide tracking of the position of the scanning head. 17. A system according to claim 1, characterized in that said means for suspending said therapy head in space, are a robotic arm. 18. A system for producing a topographic map and a map of subcutaneous tissue near the matching surface, the system comprising: an apparatus for three-dimensional image formation to produce surface images of a patient's body; an apparatus for tissue imaging to produce subcutaneous images of said patient's body; and a co-relative operating device for matching a plurality of markers of said surface images and said subcutaneous images. 19. The system according to claim 18, characterized in that said correlative operation also comprises a computer in electronic communication with said apparatus for three-dimensional image formation and said apparatus for tissue image formation. 20. The system according to claim 18, characterized in that said apparatus for three-dimensional image formation is one or more optical cameras. 21. The system according to claim 20, characterized in that said optical cameras are high definition cameras. 22. - The system according to claim 20, characterized in that said optical cameras provide digital image output. 23. The system according to claim 18, characterized in that said apparatus for tissue image formation is an MRI device. 24. The system according to claim 18, characterized in that said apparatus for tissue image formation is an ultrasound device. 25.- A system to position a medical device, the system includes: a robotic arm; first control means for controlling the robotic arm; a medical device movably positioned within a therapy head, the therapy head is connected to the robotic arm; second control means for controlling the movement of the medical device within the therapy head; and an electronic controller in electronic communication with, and for the cooperative operation of, the robotic arm, the first control means, the medical device and the second control means. 26.- A system to position a medical device, the system includes: a robotic arm; control means for controlling the robotic arm; a medical device positioned in a fixed manner within a therapy head, the therapy head is connected to the robotic arm; and an electronic controller for translating the movement instructions received from said control means, and for transferring said movement instructions to said robotic arm. 27. An apparatus for directing the movement of an energy emitter through the body of a patient, the apparatus comprising: a movable therapy head having at least one energy emitter; a guide ring; and a tracking system for tracking the movement of the guide ring and keeping the therapy head substantially centered within the guide ring. 28.- A system for positioning a medical device, the system includes: an arm for load balancing; a medical device movably positioned within a therapy head, the therapy head is connected to the arm for load balancing; and means for controlling the movement of the medical device within the therapy head. 29.- A method to apply energy to a region of the body, said method comprises: providing a treatment plan to a treatment controller; sweeping with the sweep head on a body surface in response to the guidelines generated by the treatment controller while supplying power from said sweep head; monitoring the position, and power supply, of said sweep head to produce position data and transferring the position data to the treatment controller; and generate an alert if the position and / or energy supply falls outside the treatment plan. 30. A method according to claim 28, characterized in that providing the treatment plan comprises manually sweeping the sweep head on the region of the body before the power supply to generate a volumetric map of the region that is going to to be treated, in which said map is provided to a treatment planner. 31. A method according to claim 29, characterized in that providing the treatment plan also comprises feeding other treatment parameters to the treatment planner, to generate a treatment plan based on the volumetric map and a plurality of other treatment data. . 32.- A method according to claim 30, characterized in that the treatment plan is transferred electronically to the treatment controller before starting the energy data and includes information of both the energy supply position and the energy dose. 33.- A method according to claim 28, characterized in that manually performing a sweep is performed in response to the addressing information provided by the sweep head. 34. A method according to claim 32, characterized in that the addressing information includes at least one of visual information and audible information. 35.- A method according to claim 28, which also comprises automatically positioning an energy applicator within the scan head in response to the data generated by the treatment planner in response to the monitored position of the scan head to eliminate errors in the monitored positioning in relation to the treatment plan. 36. - A method according to claim 34, characterized in that the scanning head is advanced in increments through successive treatment sites, in which the energy application is repositioned while the scanning head is in each location . 37.- A method according to claim 28, characterized in that generating an alert comprises at least one of generating an audible signal, generating a visual signal, reducing the power supply, ceasing the system, or cutting off the energy towards the head sweeping 38.- A method for carrying out a lipoplasty therapy procedure comprising the steps of: (a) determining the suitability of a person for therapeutic ultrasound treatment; (b) mark the areas that will be treated about said person; (c) positioning the patient for a therapeutic ultrasound procedure; (d) entering the marked areas, by scanning, on a computer; (e) adjusting the therapeutic ultrasound procedure using a software package of procedure planning; (f) activate the therapeutic ultrasound procedure using a computer system controlled through the procedure planning software; (g) recording the progress of the therapy procedure using the procedure planning software; and (h) provide the person with additional postoperative assistance as dictated. 39. A method for destroying adipose tissue in a patient using therapeutic ultrasound comprising: (a) determining one or more sites of adipose tissue on the patient: (b) positioning the patient in such a way that said adipose tissue is seated in a relatively uniform distribution; and (c) irradiating the patient's adipose tissue sites with a therapeutic ultrasound transducer. 40. The method according to claim 38, characterized in that the step of determining one or more locations of adipose tissue in the patient (step (a)) also comprises the step of: (al) delineating a skin area using a marker, the delineation conforms to the suspected border area of adipose tissue; (a2) verify the presence of adipose tissue by performing an ultrasound scan for image formation. 41. The method according to claim 39, which also comprises the step of: (a3) recording the position of adipose tissue volumes in a computer. 42. The method according to claim 39, characterized in that the marker of step (al) also comprises a special ink that can be detected by an electronic detector. 43. The method according to claim 38, also comprising the step of: (d) evaluating said one or more adipose tissue locations subsequent to step (c). 44. The method according to claim 38, characterized in that the step of determining one or more locations of adipose tissue in the patient (step (a)) is performed using a system for three-dimensional image formation. 45.- A method for creating a 3D body map with the locations of the volumes of adipose tissue comprising the steps of: (a) generating a 3D image of the body using a system for 3D image formation; (b) enter the 3D image of the body into a computer readable format; (c) create a 3D body map of the body with a software application for 3D mapping; and (d) scanning the body with a diagnostic ultrasound device in electronic communication with the software application for 3D mapping so that the regions of adipose tissue detected by the diagnostic ultrasound device are properly placed on the map of 3D body. 46. The method according to claim 44, characterized in that the step of generating the 3D image of the body also comprises the steps of: (a) positioning a body within a 3D image capture device using a plurality of cameras; (b) build a 3D image using the assembled photographs from the device for 3D image capture. 47.- A method for body modeling using a 3D body map comprising the steps of: (a) analyzing a 3D body map with respect to volumes of adipose tissue to be destroyed; (b) determining the amount of adipose tissue that can be safely destroyed using a procedure for body modeling; (c) subtracting the volume of adipose tissue destroyed in step (b) to produce a second 3D body map; characterized in that a physician and a patient can compare the first 3D body map and any of a plurality of second 3D body maps to choose the desired amount of body shaping procedure to be performed. 48. The method according to claim 46, characterized in that the method for body modeling is liposuction. 49.- The method according to claim 46, characterized in that the method for body modeling is a therapeutic ultrasound operation. 50.- The method according to claim 46, characterized in that the method for body modeling is a drug regimen. 51.- The method according to claim 46, characterized in that the method for body modeling is any combination of one or more of liposuction, therapeutic ultrasound or drug regimen. 52. A method for destroying adipose tissue, comprising the steps of: (A) determining a volume and area of tissue to be treated; (B) treating said volume with a sweep of the pulse wave HIFU transducer over said tissue area in a continuous motion. 53. The method according to claim 51, characterized in that step (a) also comprises the steps of: (Al) delineating a treatment area creating one or more contour lines on the body of a patient; (A2) orienting said treatment area such that said volume of adipose tissue has a substantially symmetric tissue depth; (A3) sweeping said treatment area to verify the depth of adipose tissue; and (A4) mark a treatment zone grid on said treatment area. 54.- The method according to claim 52, characterized in that the step of marking a treatment area grid on a patient is carried out with a surgical marker. The method according to claim 52, characterized in that the step of marking a treatment area grid on a patient is carried out with an ink roller. 56. The method according to claim 52, characterized in that marking a treatment area grid on a patient is effected with a sprayed ink and a screen printing template. 57.- The method for destroying adipose tissue according to claim 51, characterized in that step (B) also comprises: (Bl) placing a therapy head on the body of a patient and in alignment with a treatment zone grid; (B2) identify a treatment area to be scrutinized with a therapy head; (B3) selecting a plurality of treatment parameters; (B4) check the tissue depth and the coupling; and (B5) applying therapeutic ultrasound using a pulse wave HIFU transducer in a linear motion when said transducer is active. 58. The method according to claim 56, which also comprises the step of: (B6) remembering all the previous treatment positions. 59. - The method according to claim 56, further comprising the step of: (B7) repeating any number of steps B1-B6 as frequently as desired. 60.- A method for positng an ultrasound therapy head in the space using an arm for load balancing, the therapy head comprises a motcontroller for a suspended energy applicator within said therapy head, the method comprising the steps of: (A) applying a force to said therapy head; and (B) providing electronic addressing for said motcontroller. 61.- The method according to claim 59, characterized in that the force applied in step (A) is less than the weight of the therapy head. 62. - The method according to claim 59, characterized in that the force applied in step (A) is a manual force. 63. The method according to claim 59, characterized in that the force applied in step (A) is a mechanical force. 64.- The method according to claim 59, characterized in that the electronic addressing in step (B) is received from a computer feeding device. 65. - The method according to claim 59, characterized in that the electronic addressing in step (B) is received from a therapy controller.