201016196 六、發明說明： 【發明所屬之技術領域】 本發明涉及動脈硬化的治療領域，尤其涉及用於降低血管斑塊 的系統。 【先前技術】 心血管疾病是全世界疾病和死亡率的主要成因。心血管疾病的 發病原因是由於一段時間於冠狀動脈内形成了斑塊，這就導致流入如 腦及心肌等特定器官内的血液流動減少。在某些情況下，血液流動的 減少可能引起短暫性的腦缺血、小腿肚抽筋或心絞痛等症狀。如果動 脈的堵塞更加明顯，可能損傷大腦、腿或心肌甚至致命。 治療（心藏）血管疾病和避免進一步損傷組織的方法是藉由侵 入性消除斑塊。通常是藉由侵入性手術完成。另一個種可選擇的方法 是藉由氣球血管修復術，該手術涉及利用導管插入術進入血管。在這 個手術過程帽可以進行經皮雕舰θ支架置人術。纽塊的特性 排除利用血管修復術治療時，可以在血管或心臟手術過程中，在斑塊 區域周圍移植新血管，藉峨過斑塊。在—些病人中，血管修復術和 遶道手術都不能實施’比如當病人的年齡偏大或身體較弱時，或者當 :塊經不起任何的治療一在這樣的情況下，病人必須f試藉由醫藥 s理來控_病’比如藉由使㈣物。因為動脈魏的手術治療是侵 ^性，所絲斜會舰紐麵顺，並科合所有㈣人，因此， 需要-種較少侵人性的方法用於降低韻除動脈_塊形成。 用於治雜織和血管㈣需錄侵人性方法通常是心 =管’已触_過’例如美國專利第5,657,76 成!專=，524,62°號的專利。_ ’這些方法並《合:: 減少斑塊，更別提用在血管系統中。 ，肖赠計畫及控制治療 201016196 【發明内容】 本發明涉及一種用於減少血管斑塊的方法和系統。 為了達到目的，術語“心節律”係指從一次心跳開始到下一次心跳 開始過程中產生的全部或任何與血液流動有關的事件。心臟的每次單 一“跳動”涉及三主要階段：心房收縮，心室收縮和完全心臟舒張。 根據本發明，提供了一種非侵入性減少動脈斑塊的方法，其包 括下面的步驟： 對哺乳動物身體的至少一部分進行成像以產生一影像； β 在該影像中確定至少一斑塊的所在地； 確定該斑塊的基部所在地，該基部的所在地為目標所在地； 精確的確定與動物體内的心節律相關的該目標所在地的相關位 置； 將來自一來源的一超音能量波束發送到相關位置内的焦點，以 預定方式提高該目標所在地的溫度； 監測目標所在地的溫度；以及 當該目標所在地達到預定設置溫度時’中止發送超音能量波。 與本發明相關的方法包括顯示該影像和該目標所在地的步驟。 ^ 本方法還包括用於治療該血管斑塊之治療計畫的準備步驟。超音能量 波的頻率調整到0.8Hertz和大約4Hertz之間。例如，超音能量波束 的焦點為少於約15mm3。該超音能量波的強度通常調整成大於約 500WW。另外’超音能量波的發送持續時間通常係根據溫度的變 化而調整。一般，超音能量波束的發送持續時間調整到約8〇ms至乜 之間。 ’ 根據本發明的另一特點，提供一種用於減少血管斑塊的系統， 包括： ’ 用於對哺乳動物身體的至少一部分成像的成像裝置； 用於將解讀該影像的解讀裝置，以定位出至少一灰管斑塊和該 血管斑塊的基部，用以確定斑塊的所在地； Λ 5 201016196 用於監測關於心節律之該目標所在地的相對位置的監測裝置； 用於將預定強度的超音能量波發送到該目標所在地的至少一可 替換超音波發送裝置； 用於監測該目標所在地的溫度的溫度監測裝置；以及 當目標所在地達到預定設置溫度時關閉超音能量波發送的裝 置。 監測裝置為一心電圖(electrocardiogram; ECG)機器。超音波發送 裝置為尚頻超音波（High Frequency Ultrasound; HFU)裝置。成像裝 置為核磁共振成像（Magnetic Resonance Imaging; MRJ)裝置。201016196 VI. Description of the Invention: [Technical Field] The present invention relates to the field of treatment of arteriosclerosis, and more particularly to a system for reducing vascular plaque. [Prior Art] Cardiovascular disease is a major cause of disease and mortality worldwide. The cause of cardiovascular disease is due to the formation of plaques in the coronary arteries for a period of time, which leads to a decrease in blood flow into specific organs such as the brain and myocardium. In some cases, a decrease in blood flow may cause transient cerebral ischemia, calf cramps, or angina. If the occlusion of the artery is more pronounced, it may damage the brain, leg or heart muscle and even be fatal. The treatment (nursing) of vascular disease and the avoidance of further damage to the tissue is to eliminate plaque by invasiveness. It is usually done by invasive surgery. Another alternative is balloon vascular prosthesis, which involves catheterization into the blood vessel. In this surgical procedure, the cap can be used for percutaneous engraving. Characteristics of the New Blocks When vascular repair is used, new blood vessels can be transplanted around the plaque area during vascular or cardiac surgery. In some patients, vascular prosthetics and bypass surgery cannot be performed 'such as when the patient is older or weaker, or when the block cannot withstand any treatment. In such a case, the patient must try Controlling _ disease by medicine, for example, by making (four) things. Because the surgical treatment of arterial Wei is invasive, the slanting of the ship will be smooth, and all of the (four) people will be combined. Therefore, a less invasive method is needed to reduce the arterial _ block formation. For the treatment of weaving and blood vessels (4), the method of recording invasiveness is usually a heart = tube 'has been touched', for example, the patent of US Patent No. 5,657,76 to !, 524, 62 °. _ ‘ these methods and “combined:: reduce plaque, not to mention in the vascular system. BRIEF SUMMARY OF THE INVENTION The present invention is directed to a method and system for reducing vascular plaque. To achieve this, the term "heart rhythm" refers to all or any event related to blood flow that occurs during the start of a heartbeat and the beginning of the next heartbeat. Each single "beating" of the heart involves three main phases: atrial contraction, ventricular contraction, and complete diastole. According to the present invention, there is provided a method of non-invasively reducing arterial plaque comprising the steps of: imaging at least a portion of a mammalian body to produce an image; beta determining a location of at least one plaque in the image; Determining the base of the plaque, the location of the base being the target location; accurately determining the relevant location of the target location associated with the heart rhythm in the animal; transmitting a supersonic energy beam from a source to the relevant location The focus is to increase the temperature of the target location in a predetermined manner; to monitor the temperature of the target location; and to 'send the transmission of the ultrasonic energy wave when the target location reaches the predetermined set temperature. A method associated with the present invention includes the steps of displaying the image and the location of the target. ^ The method also includes a preparation step for a treatment plan for treating the vascular plaque. The frequency of the ultrasonic energy wave is adjusted between 0.8 Hertz and approximately 4 Hertz. For example, the focus of the ultrasonic energy beam is less than about 15 mm3. The intensity of the ultrasonic energy wave is typically adjusted to be greater than about 500 WW. In addition, the transmission duration of the ultrasonic energy wave is usually adjusted in accordance with changes in temperature. Typically, the transmission duration of the ultrasonic energy beam is adjusted to between about 8 〇ms and 乜. According to another feature of the invention, a system for reducing vascular plaque is provided, comprising: 'an imaging device for imaging at least a portion of a mammalian body; an interpreting device for interpreting the image to locate At least one gray tube plaque and a base of the blood vessel plaque to determine the location of the plaque; Λ 5 201016196 a monitoring device for monitoring the relative position of the target site of the heart rhythm; for supersonics of predetermined intensity An at least one replaceable ultrasonic transmitting device that transmits an energy wave to the target location; a temperature monitoring device for monitoring the temperature of the target location; and means for turning off the transmission of the ultrasonic energy wave when the target location reaches a predetermined set temperature. The monitoring device is an electrocardiogram (ECG) machine. The ultrasonic transmitting device is a High Frequency Ultrasound (HFU) device. The imaging device is a Magnetic Resonance Imaging (MRJ) device.
成像裝置和解讀裝置能夠識別成像體的血管系統内斑塊，並確 定血管的MRI影像内斑塊的基部。hfu裝置適用於將hpu發送到經 成像和解讀裝置辨別作為目標所在地的斑塊的基部^溫度監測裝置能 經由熱成像以監測目標所在地處的組織的溫度，從而確定發送 完成。 ' 依據本發_祕可麟治賴動脈、腸f、大腿或冠狀動脈 内的斑塊。根據本發_其他實施例，ECG朗裝置適躲在該治 療過程中監測心節律並處理來自該監測到ECG的信號。 控制裝置根據從ECG監峨置巾接收的資料控制成像的時 間和肺的發送，使得丽發送和讀雜在心動週期内的特定 點被觸發。 控制裝置適用於引導超音波發送裝置發射超音能量波，並確定： 發送的特定角度或所在地； 發射的超音能量波的強度；以及 用於發送超音能量波的持續時間。 上述參數係取決域躲置所赠之哺社小和所在地。 該治療計畫 於較發送超音崎脖數的治療計畫。該系統 =裝置’祕從自動_單元及/錢過人為干預以接收 發送麵到斑塊的基部會引起目標所在地的組織溫度升高。目 6 201016196 標組織的MRI監測偵測到溫度升高。當溫度升高足夠時，停止 * 治療。可在相同目標但用另一發送角度以重複HFU治療。也可在相 同斑塊内或在不同斑塊内的多目標所在地重複HPU治療。 對於每個目標’持續發送HFU，直到已經發送足夠的治療量而 導致結疤和斑塊退化為止。 【實施方式】 第1圖顯示非侵入性減少血管斑塊的系統。利用超音波發送裝 置對病人10進行治療，通常是藉由高頻超音波（High FreqUency ® tHtrasomKi;卿）發送裝置2〇。在進行治療過程中，病人1〇同時用 心電圖（electrocardiogram; ECG)監測裝置30和核磁共振成像 (Magnetic Resonance Imaging; 裝置 4〇 進行監測。ecg 監測裝 置30和MRI裝置4〇的輪出傳送至處理裝置5〇，其包括影像識別裝 置60和影像顯示裝置70。控制器提供輸出給轉向單元8〇，該 轉向單元80藉由轉向和控制丽發送裝置以引導能量的發送。 /在此過程中，病人10位於治療臺上的舒適位置在此位置病人 *、v頁保持靜止不動ϋ/自療過程是非侵人性，所以可以不需要任何 鎮靜處理而實施’且並不會引s病人的不適。治療台位於裝置 ❹ ^内’使得在治療過程中可取得MRI影像ώ定位目標碰，並監測 治療的進度。在灰管壁的斑塊背面上，顧裝置4〇必須能提供快速 而詳細的動脈影像，使得斑塊的基部能被精確辨別。^^裝置4〇提 供能在奈米級解析度的情況下看到組織的影像，如1.5、3或7 Tesla _裝置，可用於本發明實施例中以提供這些精確影像。 在治療過程中還可以利用ECG監測裝置30對病人10進行監 測。ECG監測裝置30可以為標準的12引線ECG或可以利用較少引 ^來實施如同在^^裝置4〇内或附近所使用的全部其他元件，ECG _、裝置30必須不包括任何含鐵的材料。病人的心臟跳動導致心臟 所有動脈都在運動’如同每次心臟收縮時動脈都在擴張。ecg用 ;吏系統補償這個運動。為了獲得有用的影像所以對應病人 7 201016196 的、臟跳動以取得影像，使得每個影像是在每個心跳週期的相 同點取得。例如’在心臟放鬆時，裝置可以安排在心臟舒張時取 得影像。類似的’使用ECG監測裝置30使HFU治療的發送對應到 心跳週期。當目標所在地使用MRI影像確認之後，HFU治療被用於 該目標所在地。為了在治療過程中確定正確的目標所在地，在心動週 期中取得MRI影像的時間點係與發送HPU治療的時間點相同。根據 這個方式’用MRI所確認的目標所在地是與發送HFU治療所到達的 所在地相同。 ECG資料在治療過程中傳送到處理裝置5〇。處理裝置5〇解讀 ECG資料並提供指令給MRI裝置40和HFU控制器80。處理裝置50 也會從MRI裝置40中接收資料，並且包括影像識別裝置6〇和影像 顯不裝置70。影像識別裝置60可以經由解讀影像内的信號，來 辨別動脈内的斑塊。另一方式是，臨床醫生可以在視覺上辨別在Mjy 影像的影像顯示裝置70上的斑塊。在一些實施例中，影像識別裝置 60識別斑塊’並且臨床醫生利用影像顯示裝置7〇來驗證該識別。影 像識別裝置60及/或臨床醫生識別每個斑塊的基部之所在地，而該所 在地為HFU治療的目標。 在處理裝置50及/或臨床醫生識別一個或多個目標所在地之 後，會提出治療計畫。單一斑塊可以包括一目標所在地或沿斑塊之基 部的數個目標所在地。除此之外，一個體可以具有多個斑塊。在一些 情況下，治療計畫將包括發送HFU到全部識別出的斑塊基部上。在 其他情況下’希望選擇性的僅處理一些斑塊基部或部分斑塊基部而留 下未處理的其他斑塊基部。因此，治療計畫包括決定有哪些將要處理 的斑塊以及將這些所在地變為目標所在地。對於每個目標所在地，也 必須確定HFU裝置20對病人10的理想排列。這將取決於目標所在 地以及如個別病人詳細分析的因素。 以下的參數係取決於MRI裝置40所描繪之斑塊的大小和所在 地： 發送的特定角度或所在地； 8 .201016196 發射超音能量波的強度；以及 用於發送超音能量波的持續時間。 在一些情況中，可藉由單一角度的靜止HFU波束來實施治療。 另一方式是，可以更好地利用多於一個治療角度的靜止HPU波束將 HFU發送到目標所在地。在一些情況下，jjpu可隨波束藉治療角度 的弧線旋轉而發送。在其他情況下，HFU可藉由治療角度的多個弧 線來發送。這點可以憑藉多焦變換器來實現。該方法包括替換該波束 來源的步驟。該替換可以為線性的或有角度的。藉由利用一個以上的 ❹ 治療角度來發送治療，極小化發送到目標所在地外面之組織上的能 量，並因此可降低或消除對其他組織的損傷風險。對於每個治療角度 和每個治療所在地，必須選擇目標溫度。因此治療計畫包括關於哪些The imaging device and the interpretation device are capable of identifying plaques within the vasculature of the imaging volume and determining the base of the plaque within the MRI image of the blood vessel. The hfu device is adapted to transmit the hpu to the base of the plaque as the target location by the imaging and interpretation device. The temperature monitoring device can detect the temperature of the tissue at the target location via thermal imaging to determine the completion of the transmission. ' According to this hair _ secret Kelin treatment of the artery, intestine f, thigh or coronary artery plaque. According to other embodiments of the present invention, the ECG device is adapted to monitor the heart rhythm during the treatment and to process signals from the monitored ECG. The control device controls the time of imaging and the transmission of the lungs based on the data received from the ECG monitoring towel so that the ray transmission and reading are triggered at specific points within the cardiac cycle. The control device is adapted to direct the ultrasonic transmitting device to emit the ultrasonic energy wave and determine: a specific angle or location of the transmission; the intensity of the transmitted ultrasonic energy wave; and the duration for transmitting the ultrasonic energy wave. The above parameters are determined by the domain to hide the donation and the location. The treatment plan is based on a treatment plan that sends a number of supersonics. The system = device 'secret' from the automatic unit and / / money to intervene to receive the sending surface to the base of the plaque will cause the tissue temperature of the target location to rise. Head 6 201016196 MRI monitoring of the target tissue detected an increase in temperature. When the temperature rises enough, stop * treatment. The HFU treatment can be repeated at the same target but with another delivery angle. HPU treatment can also be repeated within the same plaque or at multiple target sites within different plaques. The HFU is continuously sent for each target until a sufficient amount of treatment has been sent resulting in scarring and plaque degradation. [Embodiment] Fig. 1 shows a system for non-invasively reducing vascular plaque. The patient 10 is treated with an ultrasonic transmitting device, typically by means of a high frequency ultrasonic (High FreqUency® tHtrasomKi; qing) transmitting device. During the course of treatment, the patient is simultaneously monitored by electrocardiogram (ECG) monitoring device 30 and magnetic resonance imaging (Magnetic Resonance Imaging; device 4〇. ecg monitoring device 30 and MRI device 4〇 are transferred to the treatment. The device 5 includes an image recognition device 60 and an image display device 70. The controller provides an output to the steering unit 8〇, which diverts and controls the MN transmission device to guide the transmission of energy. The patient 10 is located in a comfortable position on the treatment table. At this position, the patient*, v page remains stationary and the self-treatment process is non-invasive, so it can be performed without any sedation treatment and does not induce the patient's discomfort. The station is located inside the device 使得 ^ so that the MRI image can be obtained during the treatment, the target is touched, and the progress of the treatment is monitored. On the back of the plaque on the gray wall, the device must provide a fast and detailed image of the artery. So that the base of the plaque can be accurately identified. ^^ Device 4〇 provides images that can be seen in the case of nanometer resolution, such as 1.5, 3 Or a 7 Tesla® device that can be used in embodiments of the present invention to provide these accurate images. The patient 10 can also be monitored during the treatment using the ECG monitoring device 30. The ECG monitoring device 30 can be a standard 12-lead ECG or can be utilized With less guidance to implement all other components used in or near the device 4, the ECG_, device 30 must not include any iron-containing material. The patient's heart beat causes all the arteries of the heart to move as The arteries are expanding each time the heart contracts. The ecg system compensates for this movement. In order to obtain useful images, the dirty beats of the patient 7 201016196 are taken to obtain images so that each image is at the same point in each heartbeat cycle. Obtained. For example, 'when the heart is relaxed, the device can arrange to obtain images when the heart is dilated. Similar 'use ECG monitoring device 30 to make the transmission of HFU treatment correspond to the heartbeat cycle. HFU treatment is used after the target location is confirmed using MRI images. At the target location. In order to determine the correct target location during treatment, MRI is obtained during the cardiac cycle. The time point of the image is the same as the time point at which the HPU treatment is sent. According to this method, the target location confirmed by MRI is the same as the location where the HFU treatment is delivered. The ECG data is transmitted to the treatment device during the treatment. The device 5 interprets the ECG data and provides instructions to the MRI device 40 and the HFU controller 80. The processing device 50 also receives data from the MRI device 40 and includes an image recognition device 6 and an image display device 70. The image recognition device 60 The plaque in the artery can be discerned by interpreting the signal in the image. Alternatively, the clinician can visually discern the plaque on the image display device 70 of the Mjy image. In some embodiments, image recognition device 60 identifies the plaque ' and the clinician utilizes image display device 7 to verify the identification. The image recognition device 60 and/or the clinician identifies the location of the base of each plaque, which is the target of HFU therapy. After the treatment device 50 and/or the clinician identifies one or more target locations, a treatment plan is presented. A single plaque can include a target location or a number of target locations along the base of the plaque. In addition to this, one body can have multiple plaques. In some cases, the treatment plan will include sending HFUs to all of the identified plaque bases. In other cases, it is desirable to selectively treat only some of the plaque base or part of the plaque base while leaving other untreated plaque bases. Therefore, the treatment plan includes determining which plaques are to be treated and turning those locations into destinations. The ideal alignment of the HFU device 20 to the patient 10 must also be determined for each target location. This will depend on where the target is located and factors such as individual patient analysis. The following parameters depend on the size and location of the plaque depicted by MRI device 40: the particular angle or location of the transmission; 8. 201016196 The intensity of the transmitted ultrasonic energy wave; and the duration used to transmit the ultrasonic energy wave. In some cases, treatment can be performed by a single angle of stationary HFU beam. Alternatively, the HFU can be better transmitted to the target location using more than one treatment angle of the stationary HPU beam. In some cases, jjpu can be sent as the beam is rotated by the arc of the treatment angle. In other cases, the HFU can be sent by multiple arcs of the treatment angle. This can be achieved with a multifocal converter. The method includes the step of replacing the source of the beam. This replacement can be linear or angular. By using more than one treatment angle to deliver treatment, the energy delivered to the tissue outside the target site is minimized, and thus the risk of damage to other tissues can be reduced or eliminated. The target temperature must be selected for each treatment angle and location of each treatment. So the treatment plan includes which
目標所在地需要處理、發送_的角度、是否利用多角度發送HFU 到目標所在地進行治療以及對於每次發送HPU到目標所在地後最終 溫度是多少的詳細内容。超音能量波的發送可以是間歇性地連續性 地或脈衝式的，在每次脈衝之後或-㈣脈衝之㈣換超音波發送的 來源發送角度可以固定或在每次脈衝或一串列脈衝之後改變。可以 根據臨床醫生編輯的料方針由處理裝置Μ，或結合處理裝置％的 臨床醫生做出這些決定。 ▲在治療肖朗-歸上贿腦可以是_贼靜止的。當治 療計畫需要在練肖度祕線發送jjPU時，治療是在 裝置主動移動af發送《然而，由於動脈的運動所以動脈的册U 治療的旋轉發送可只在每派、輯_的特定時㈣p巾才提供。因 :台療的弧線可以利用一系列的小弧線形成，在每次心臟跳動 時’藉由一系列小弧線旋轉發送HPU來進行治療。例如，在第一次 心跳時’可以在第-角度開始進行治療並旋轉 。隨著下次心跳，可在第二角度重新治療並旋“第Hi 多個J 丨連貫的第二小弧線。因此該治療將連續旋轉經過許 ^個小弧線，直到這些小弧_成治療計畫的弧料止。另一方式 疋’在HFU治療期間，可以在角度的弧線上發送靜止治療而不用 .201016196 f轉。例如’在第-次心跳時’可以在第_角度發送靜止肺波束 來進仃治療。腦裝置可被輕微的調整，例如lmm,並在第二次心 ，時’由靜止HFU裝置在第二角度魏治療，第二角度可靠近第一 角度。HFU裝置可以持續地調整連續的治療角度，直到在一系列角 度上發送治療以形成治療角度的弧線為止。 另方式疋在尺寸與樣式上調整至目標_^管的多焦變換器，或 具有一個以上以連績方式發送能量之變換器的弧線。 處理裝置根據治療計畫織令傳給帛來控制册卩發送裝置2〇 的HFU控制器80。當HPU發送裝置2〇位於_裝置4〇内時必 須不包括任何含鐵的材料。在治療過程中，jjPU發送裝置2〇的治療 表面與病人1G體表直接接觸，或藉由如凝膠貼片的中間媒介物質而 與病人的脖頸、鼠鎮部或胸部接觸。當使用凝膠片的時候，能夠施壓 來校正病人體表和血管内的目標所在地之間的距離。因此凝踢貼片適 合使用於需要在一治療弧線上旋轉發送HFU的治療計畫中，從而當 裝置繞目標所在地旋轉時，裝置和目標所在地之間的距離 維持疋咼頻超曰波發送裝置20為活動式，且病人可以被精確的 定位並調整肖度，以便直接將HFU精確地發制目標所在地。高頻 超音發送裝置20和目標所在地之間的最大距離最好小於約6cm。可 在產生治療计畫時考慮這個最大距離。 發射超音波的HFU發送裝置20發送超音波至斑塊基部的目標 所在，，使目標所在地的溫度升高。HFU焦點的大小最好小於約 15mm3 ’此HFU焦點的大小可以利用頻率大約在〇 8至4Hertz、聚焦 強度大約在500至3000W/cm2的HFU波而達成。HFU發送裝置2〇 根據處理裝置50的指令將HFU在重複的短暫區間内發送至目標所在 地内的特定點上，該等區間係關聯至藉ECG所探測到的心動週期内 的一特定點。每次HFU發送持續時間可以約80ms至約is。每次Hpu 發送的適當持續時間係取決於各個病人的心跳速率。每次HFu發送 的持續時間可以為適合大多數或全部病人的短持續時間，而不考慮病 人的心跳速率。另一方式是，每次HFU發送的持續時間可以取決於 •201016196 所量測到的心跳速率，針對個別病人來決定。最後，每次HpU發送 的持績時間可以在治療各個病人過程中變化，以響應所測量到的心跳 速率。 HFU發送裝置20連續地將HFU發送到目標所在地，直到組織 達到冶療计畫所需的溫度為止。在一些實施例中，目標所在地的最大 所需溫度約攝氏80度。目標所在地的溫度係藉由處理裝置％根據 裝置4G所提供的影絲蚊。為了朗溫度的升高，系統可以 週期地在治療過程中獲取_影像。例如，系統可以在每次發送 之後取得—聰難。另―^妓，個MRI 可以在發送 ® 過程中被取得。例如，一 MRI影像可以在最初的治療令被轉， 然後在幾次HFU脈衝之後重現。然後複數個讓影像可在監測過程 中重現。目標所在地的MR!影像信號係以對應到組織溫度的方式改 變。處理裝置50包括可以解讀目標所在地之河^影像變化的裝置， 藉以確定組織的溫度。當達到所需溫冑時，處理裝置50赫HFU控 制器80間歇性地發送hfu。 第2圖顯不了本發明實施例中治療的方法。治療開始於步驟 1〇〇。在步驟102中’取得冠狀血管的影像。該影像用於識別步驟1〇4 中斑塊基部的斑塊和目標所在地。根據應影像，在步驟1〇6中藉 參 ά處理裝置及/或通過臨床醫生製作治療計畫^在步驟〗⑽中，画 治療藉由靜止超音波束或旋轉超音波束而施加於金管壁内的精確位 置。目標所在地的MRI成像在步驟11〇巾被實施。成像步驟根據步 驟112中製作的治療計畫來確定是否達到所需溫度。如果沒有達到， 重複卿治療步驟108、MRI成像步驟11〇 #麵影像處理步驟 112 ’直到達到所需溫度為止。 ，步驟114中決定是否治療計畫需要進一步確定治療角度或治 療角度弧線。如果需要進-步計畫治療角度或治療角度弧線，則在步 驟116中’調整丽發射裝置的開始所在地和起始角度，並在步驟 1〇8中再-次將卿治療以一個新的角度施加於同一目標所在地。 在步驟110和步驟112中重複贿雜和影像處理’直到利用新的 201016196 hfu裝置角度達到所需溫度為止。 當沒有進一步治療計畫給目標所在地時，則在步驟118中作出 關於另-個目標所在地的進-步治療計畫的決定。如果沒有治療計畫 給其它目標所在地時’則該治療會在步驟122中結束。然而，如果有 計畫進一步的治療所在地’則在步驟12〇中調整裝置的所在地， 以發送HFU到新目標所在地，而且針對新目標所在地重複該處理過 程。重複該處理’直到所有的計畫目標所在地已經處理完成為止。 ▲藉由施加HFU於斑塊的基部，使血管壁内的目標組織的溫度升 f。這種溫度的升高會導致組織發炎，錢形成結症，足以減少或損 ® 壞主動脈血管内自養管(vasava_m)，該主動脈血管内自養管係提供 給斑塊的血管。據信，對斑塊基部處的血管壁的血管化損壞會導致斑 塊最後退化。13為HFU非雜確，可以财地職量魏到斑塊的 基部而不損壞血管壁。按照這個方式，HPU治療可用以非侵入性減 少或消除斑塊。 本發明實施例的利用目標超音波治療以非侵入性治療動脈粥樣 硬化疾病，因而避免存在於侵入性治療中的風險。除此之外，藉由避 免手術，使得治療過程對於病人和臨床醫生來說更簡單，且可以更加 快速地實施並使病人的病痛減輕又能較快速且較容易康復。此外，提 φ 供一治療選項給無法承受手術干預的病人。雖然本發明的一些實施例 適用於大動脈，但是治該療也可以用來減少體内其他位置的動脈硬 化’包括冠狀動脈。 影像導引心臟剝離方法和系統有潛力可以用於下述的血管應用 中： ‘ 用以消除動脈硬化，包括移除動脈粥樣硬化斑塊，通常是在大 腿、頸動脈、腎臟或冠狀動脈内。還可以用於消除血栓溶解，該企栓 溶解包括顱内血栓形成、血液透析分流内的血栓形成、左心耳（LAA ) 内的血栓形成、靜脈血栓形成以及肺栓塞。又可以進一步用以消除身 體狀況中典型的血管閉塞，如出血、穿刺的密封、靜脈曲張、假性動 脈瘤、大腦内的血管畸形、器官的貧血切除、出血食道靜脈曲張，以 12 201016196 及用於分割共用單一胎盤的雙胞胎。 影像導引〜聰離方法和系統有潛力可以延伸驗下面的非血 管應用： ，紐癌症有_情形’包括前列腺癌、乳癌、肝細胞癌、腎 膀職、胰龜及腎_癌。還可簡於其他非血管應用而 ，心|±癌症’如良性攝護腺肥大、子宮肌瘤及纖維瘤（胸，肝臟）。 另外’影像導引心臟剝離方法和系統可以用於治療青光眼，疼 痛治療’大_魏爾礙轉（_症，帕金赫合症），碎石術The target location needs to be processed, the angle of transmission, the multi-angle transmission of the HFU to the target location for treatment, and the details of the final temperature after each transmission of the HPU to the target location. The transmission of the ultrasonic energy wave may be intermittently continuous or pulsed, and the source transmission angle after each pulse or - (four) pulse (four) change ultrasonic transmission may be fixed or in each pulse or a series of pulses. Then change. These decisions can be made by the treatment device according to the guidelines edited by the clinician, or by the clinician in combination with the treatment device. ▲ In the treatment of Xiao Lang - returning to the brain can be _ thief still. When the treatment plan needs to send jjPU in the secret line, the treatment is sent by the device actively moving af. However, due to the movement of the artery, the rotation of the arterial U treatment can be sent only at the specific time of each pie. (d) p towel is provided. Because: The arc of the treatment can be formed by a series of small arcs, which are treated by a series of small arc rotations to send the HPU every time the heart beats. For example, at the first heartbeat, treatment can be initiated and rotated at the first angle. With the next heartbeat, the second angle can be re-treated and rotated "the second small arc of the Hi multiple J 丨 coherent. Therefore the treatment will be continuously rotated through a small arc until these small arcs into treatments The arc of the painting is stopped. Another way 疋 ' During HFU treatment, the static treatment can be sent on the arc of the angle without using .201016196 f. For example, 'in the first heartbeat' can send the stationary lung beam at the _ angle The brain device can be slightly adjusted, for example, lmm, and in the second heart, 'the second angle is treated by the stationary HFU device, and the second angle can be close to the first angle. The HFU device can be continuously Adjust the continuous treatment angle until the treatment is sent at a series of angles to form an arc of the treatment angle. Another way is to adjust the size and pattern to the multi-focus transducer of the target tube, or have more than one way of succession The arc of the transducer that transmits the energy. The processing device transmits the HFU controller 80 to the recording device 2〇 according to the treatment plan weaving order. When the HPU transmitting device 2 is located in the device 4, it must not Including any iron-containing material. During the treatment, the treatment surface of the jjPU transmitter device is in direct contact with the patient's 1G body surface, or with the patient's neck or mouse town or by an intermediate medium such as a gel patch. Chest contact. When a gel piece is used, pressure can be applied to correct the distance between the patient's body surface and the target location within the blood vessel. Therefore, the squeezing patch is suitable for use in a therapeutic device that needs to rotate and transmit HFU on a therapeutic arc. In the drawing, when the device rotates around the target location, the distance between the device and the target location maintains the chirp-frequency super-chopper transmitting device 20 in a movable manner, and the patient can be accurately positioned and adjusted to directly shift the HFU. The target location is accurately generated. The maximum distance between the high frequency ultrasonic transmitting device 20 and the target location is preferably less than about 6 cm. This maximum distance can be considered when generating the treatment plan. The ultrasonic transmitting HFU transmitting device 20 transmits the ultrasonic wave to The target of the base of the plaque is to raise the temperature of the target location. The size of the HFU focus is preferably less than about 15mm3 'The size of this HFU focus can be This is achieved with HFU waves having a frequency of approximately 至8 to 4 Hertz and a focusing intensity of approximately 500 to 3000 W/cm2. The HFU transmitting device 2 transmits the HFU to the specific location within the target location in accordance with the instruction of the processing device 50 in a repeated short interval At the point, the intervals are associated with a specific point within the cardiac cycle detected by the ECG. Each HFU transmission duration may be from about 80 ms to about is. The appropriate duration of each Hpu transmission depends on each patient's Heart rate. The duration of each HFu transmission may be a short duration suitable for most or all patients, regardless of the patient's heart rate. Alternatively, the duration of each HFU transmission may depend on •201016196 The measured heart rate is determined for individual patients. Finally, the duration of each HpU transmission can be varied during the treatment of each patient in response to the measured heart rate. The HFU transmitting device 20 continuously transmits the HFU to the target location until the tissue reaches the temperature required for the treatment plan. In some embodiments, the maximum desired temperature of the target location is approximately 80 degrees Celsius. The temperature at the target location is based on the mosquito screen provided by the device 4G by the processing device %. In order to increase the temperature, the system can periodically acquire images during the treatment. For example, the system can be acquired after each transmission - it is difficult. In addition, an MRI can be obtained during the Send ® process. For example, an MRI image can be rotated at the initial treatment order and then reproduced after several HFU pulses. Then multiple images can be reproduced during the monitoring process. The MR! image signal at the target location is changed in a manner that corresponds to the tissue temperature. The processing device 50 includes means for interpreting changes in the image of the target location to determine the temperature of the tissue. The processing device 50 Hz HFU controller 80 intermittently transmits hfu when the desired temperature is reached. Figure 2 shows a method of treatment in an embodiment of the invention. Treatment begins in step 1〇〇. In step 102, an image of the coronary blood vessel is taken. This image is used to identify the plaque at the base of the plaque in step 1〇4 and the target location. According to the image, in step 1〇6, the reference treatment device and/or the clinician can make a treatment plan. In step (10), the treatment is applied to the gold tube by the stationary ultrasonic beam or the rotating ultrasonic beam. The precise location within the wall. MRI imaging of the target location is performed in step 11 wipes. The imaging step determines if the desired temperature is reached based on the treatment plan made in step 112. If not, repeat the treatment step 108, the MRI imaging step 11 〇 #面影像处理步骤 112 ' until the desired temperature is reached. In step 114, it is determined whether the treatment plan needs to further determine the treatment angle or the treatment angle arc. If it is desired to plan the treatment angle or the treatment angle arc, then in step 116, 'adjust the starting position and starting angle of the MN launcher, and in step 1 〇8, the treatment will be treated at a new angle. Applied to the same target location. The bribe and image processing are repeated in steps 110 and 112 until the desired temperature is reached using the new 201016196 hfu device angle. When there is no further treatment plan for the target location, then a decision is made in step 118 regarding the further treatment plan for the other target location. If there is no treatment plan for other target locations, then the treatment will end in step 122. However, if there is a plan for further treatment location, then the location of the device is adjusted in step 12 to send the HFU to the new target location and the process is repeated for the new target location. This process is repeated 'until all the project target locations have been processed. ▲ The temperature of the target tissue in the vessel wall is raised by f by applying HFU to the base of the plaque. This increase in temperature can lead to inflammation of the tissue, which is sufficient to reduce or damage the vascular avascular tube (vasava_m), which is supplied to the plaque by the autologous vascular line. It is believed that vascularized damage to the vessel wall at the base of the plaque results in the final degradation of the plaque. 13 is not a miscellaneous HFU, it can be used to the base of the plaque without damaging the blood vessel wall. In this manner, HPU treatment can be used to non-invasively reduce or eliminate plaque. The use of target ultrasound therapy in embodiments of the present invention treats atherosclerotic disease non-invasively, thereby avoiding the risk of being present in invasive treatment. In addition, by avoiding surgery, the treatment process is simpler for the patient and the clinician, and can be performed more quickly and the patient's pain is alleviated faster and easier to recover. In addition, a treatment option is provided for patients who cannot undergo surgical intervention. While some embodiments of the invention are applicable to the aorta, this treatment can also be used to reduce arterial stiffness at other locations in the body, including coronary arteries. Image-guided cardiac ablation methods and systems have the potential to be used in vascular applications as described below: 'To eliminate arteriosclerosis, including removal of atherosclerotic plaque, usually in the thigh, carotid artery, kidney or coronary artery . It can also be used to eliminate thrombolysis, including intracranial thrombosis, thrombosis in the hemodialysis shunt, thrombosis in the left atrial appendage (LAA), venous thrombosis, and pulmonary embolism. It can further be used to eliminate typical vascular occlusion in physical conditions, such as bleeding, puncture sealing, varicose veins, pseudoaneurysm, vascular malformation in the brain, anemia of the organ, and bleeding esophageal varices, with 12 201016196 and To divide the twins sharing a single placenta. The image-guided method and system have the potential to extend the following non-vascular applications: New Zealand cancer has _the situation including prostate cancer, breast cancer, hepatocellular carcinoma, kidney, pancreatic tortoise and kidney cancer. It can also be simpler than other non-vascular applications, heart |± cancers such as benign prostatic hypertrophy, uterine fibroids and fibroids (chest, liver). In addition, the image-guided cardiac exfoliation method and system can be used to treat glaucoma, pain treatment, 'large _ Weier dysfunction (_ disease, Parkin Hehe syndrome), lithotripsy
泌尿’膽> 輸精管切除術，滑膜切除術（風濕性關節炎〉，皮膚損 傷修復（心臟__，淋巴引流，皮纽理）以及 顫動（maze轉）的叙。 々纖維性 還可以用於基因標靶和藥物輸送的應用。 由於本發明可以具體為各獅式而不脫離其獅，所以可以理 解為上述實施例並不侷限於前面所描述的任意細節，除非另作說明， 但寧願寬泛地解讀為本發明意'圖保言蔓之範脅。在不脫離本發明精神和 範圍的情況下可以做出關於本發明内容的任何修飾或變更。是以，凡 有在相同之發明精神下所作有關本發明之任何修飾或變更，皆仍應包 括在本發明意圖保護之範疇。 ’ 【圖式簡單說明】 第1圖為減少血管斑塊的非侵入性系統；以及 第2圖為本發明實施例中治療的方法。 【主要元件符號說明】 10病人 2〇 岗頻超音波（High Frequency Ultrasound; HFU)發送裝置 30 心電圖(electrocardiogram; ECG)監測裝置 40 核磁共振成像（Magnetic Resonance Imaging; MRI)裝置 50處理裝置 13 201016196 60影像識別裝置 70影像顯示裝置 80HFU轉向單元 100〜122步驟Urinary 'biliary> vasectomy, synovectomy (rheumatoid arthritis), skin damage repair (heart __, lymphatic drainage, piline) and tremor (maze). 々 fiber can also be used For the application of gene targeting and drug delivery. Since the present invention can be specifically for each lion without departing from its lion, it can be understood that the above embodiments are not limited to any of the details described above, unless otherwise stated, but rather The invention is to be construed as broadly construed, and the invention may be modified or modified without departing from the spirit and scope of the invention. Any modifications or alterations made to the present invention are still included in the scope of the present invention. ' [Simple Description of the Drawings] Figure 1 is a non-invasive system for reducing vascular plaques; Method of treatment in the embodiment of the invention [Description of main components] 10 patient 2 High Frequency Ultrasound (HFU) transmitting device 30 Electrocardiogram (electrocardiog Ram; ECG) monitoring device 40 Magnetic Resonance Imaging (MRI) device 50 processing device 13 201016196 60 image recognition device 70 image display device 80HFU steering unit 100 to 122 steps