M271587 九、新型說明： 【創作所屬之技術領域】 本創作係有關-種超音波肌腱病變治療儀，尤指—種 曰波之機械效應來改進織病變的研究絲，肋改 ^ 治 變的 波深部熱療治療效果不張的現象，此創作提出—全^曰 =的結構與新㈣療參數，而可更有效地達靡療肌鍵^ 【先前技術】 瞻 _ί、ii音波深部熱療(ultrasound diatherray)經常應用於肌 腱火的>口療’例如肩關節鈣化性肌腱炎(calci f ied tendinit丨S以 shoulder) ’或是網球肘(Tennis elb〇w)。超音波深部教療最 吊使用的是1 MHz的連續波，可以有效的將接近骨頭的軟 ’提升其溫度可達攝氏4G至45度，所赠統上認為物理 療用的超音波其主要的物理效應是熱效應，相信可增加纖 ’且可以增加局部組織的微血管血流量，以加強肌腱 組織的灌流。 然而超音波深部熱療的療效近年來卻屢屢遭到質疑，臨床試 驗結果顯示目前並無完善的證據來支持傳統超音波(連續波)對軟 參組織的治療效果；反過來說，近來發現脈衝型超音波㈣細 ultrasoimd)確有療效，1999年肋沈^吐丨從等人的在新英格蘭醫 學f 誌(New English Journal 〇f Medicine)上發表的研究顯示， 在慢性鈣化性肌腱炎的病人身上施以脈波型超音波（2〇%此邙 cycle)的治療後、，無論在肌腱鈣化處鈣質的吸收、疼痛的減少以 及生活功能的改善，接受治療組皆比未受治療的控制組來的好。 根據2001年da Cimha等人研究則顯示··在切斷老鼠的阿基里 斯腱（Achilles tendon)後施予脈波型超音波治療（2〇% duty cycle)，15天後肌腱膠原蛋白的排列比起控制組會有明顯的改 善，連續波型的超音波則無此現象。 、 M271587 近年來許夕研九都顯示，以非熱效應(機械效應）為主的另一 種茸波療法··體外震波治療法（Extrac〇iix)rcal sh^kWaM271587 IX. Description of the new type: [Technical field to which the creation belongs] This creation is related to-a device for treating ultrasonic tendon lesions, especially-a study of the mechanical effects of waves to improve the study of weaving lesions. The phenomenon of deep hyperthermia treatment is not effective. This creation proposes the structure and new treatment parameters of ^^ =, which can more effectively reach the muscle key ^ [previous technology] preview_ii, sonic deep hyperthermia (ultrasound diatherray) Often applied to tendon fire > Oral therapy 'for example shoulder calciformed tendonitis (shoulder)' or Tennis elbow (tennis elbow). The deepest ultrasonic therapy uses 1 MHz continuous wave, which can effectively increase the temperature of soft bones close to bones, and its temperature can reach 4G to 45 degrees Celsius. The physical effect is a thermal effect, and it is believed that it can increase the fiber and the microvascular blood flow of local tissues to enhance perfusion of tendon tissue. However, the efficacy of deep ultrasound hyperthermia has been repeatedly questioned in recent years. Clinical trial results show that there is no perfect evidence to support the therapeutic effect of traditional ultrasound (continuous wave) on soft ginseng tissues. Conversely, pulses have recently been discovered Ultrasound (ultrasonic ultrasound) is indeed effective, and a study published in the New England Journal f Medicine (1999) from the etiology of ribs in 1999 showed that in patients with chronic calcified tendinitis After treatment with pulse wave ultrasound (20% of this cycle) on the body, no matter the calcium absorption in the tendon calcification, the reduction of pain, and the improvement of life function, the treatment group was more than the untreated control The group is good. According to a study by da Cimha et al. In 2001, it was shown that ... after the Achilles tendon of the mouse was cut off, pulse wave ultrasound was applied (20% duty cycle), and the arrangement of tendon collagen after 15 days Compared with the control group, there will be a significant improvement, but the continuous wave type ultrasonic wave does not have this phenomenon. , M271587 In recent years, Xu Xiyan and Jiu Du have shown that another non-thermal effect (mechanical effect) is another kind of fur wave therapy. · Extra shock wave therapy (Extracoiix) rcal sh ^ kWa
Therapy，ESWT)對許多不同位置肌腱病變亦有清楚的療效，包括 肩部肌腱炎、足底筋膜炎與網球肘等。依據臨床經驗顯示， 震波治療數天後會有第-波的症狀_(即時效應）；第二波 狀緩解，發生在-则至數狀後(延遲效應）；細，無論是超 音波或是震波在肌腱喊生的生物效應，以及造成 物理機似今都不妓料。 又王物戎關 在以往«體外震波碎^療(ExtraeQlweal hthotnpsy，or ESWL)的機轉研究已發現··震波、空泡作用 (cavitation effect)與氣泡的關係密不可分；在生物效應方面， 過去震波治療的研究顯示，老鼠皮膚在震波治療後的幾天“内合 明顯的感覺神經末顧少的現象，要到兩、三週後才會漸漸恢復。 震波或超音波治療後肌腱痛覺神經末梢的減少可能和臨床疼 痛症狀的改善有關；針對肌腱炎的研究報告顯示新生血管與肌腱 發炎的疼痛表徵有關，利用藥物讓這些增生血管壞死的治療可以 改善疼痛症狀，然而也有許多研究指出慢性肌腱炎總是發生在肌 腱血液供應最差的位置，而在破壞動物的阿基里斯腱供應血管的 研士則發現，慢性肌腱炎的退化性病理變化與肌腱局部區域缺血 性壞死的變化是一致的。震波研究則發現：新血管在震波治療四 週後就會在肌腱與跟骨骼交界處出現，且會持續存在數週之久， 同時與血管生成有關的一些機制，如：血管内皮生長因子(呢％^ ^ndothelial growth factor或VEGF)、内皮氮氧化物合成梅 (endothelial nitric oxide synthase 或 eNOS)的表現，與内皮 細胞的分裂都會增加。 ^可確認的是血管增生與慢性肌腱炎有密不可分的關係，雖然 ^如之間的相互作用機制不是非常清楚，可能的假說是：肌腱炎 治，的立即效應可能和肌腱上感覺神經末梢的減少有關，而新生 血管是缺血的肌腱組織癒合過程中（延遲效應）的必要因素，但過 M271587 多或未隨癒合進展而消退的血管則是造成疼痛的因素。 傳統超音波治療之所以療效不佳的因素， 解有關’連續型超音波強調的熱效應可能 A病、交的有效作用，脈衝型超音波以及震波的非熱效應 n<^n effect)或稱為機械效應，例如：空泡作用，可能 才是最重要的的治療機轉；脈衝型超音波所使㈣壓力強度、产 療時治療能量與傳統連續波形超音波皆完全㈣。α 、、、工研九么現，般3忍為以機械效應為主的脈衝型超音波合刺 ίίί Jii(fLbr〇blastM^^? ，，產生蛋白質合成、促進細胞分裂，並刺激新生血管生 ^幫助損傷組_修補，此外機械效應可能會對組織產生一些微 =im='trauma) ’這些傷害很可能概慢性發炎退化的肌腱 巧管生新-輪的癒合機制，包括退化組織移除(如触斑）、新 肌腱組織，以及—連_的修補雜，_足成慢性 ^創作JL為-種利用超音波之機械效應來改進肌腱病變的研 ’用以取代傳統的超音波深部熱療治療儀，此創作提出- 白、超音波絲儀的結構與新的治療錄，可更有效 療肌腱病變的效果。 逆J/口 【創作内容】 基於解決以上所述先前技術的缺失，本創作為一種超音 S機械效應，例如：震波波數(pulse number)太少了單 、、古堅力(pressure)太大’一反之，超音波深部熱療的波數太多（連 ’ f f要的目的為建立新-代的慢性肌腱病變治療 计強调聲波療法（震波或超音波）的療效在於其機械效 先所認為的熱效應。而目前聲波的治療儀（震波或超音 鈞·心、1合療參數皆ί達到最佳化的程度，以致於無法產生足 壓力太小，頻率太冑。因此本創狀設計主要貢獻與差別^ 聲波 續 M271587 衝型超音i超參，，，機械效應的產生’包括使用脈 織(如:慢性肌腱炎）的治波間的新治療系統，以改善軟組 括有\、述之目的’本創作之超音波肌腱病變治療儀，其係包 二ΞίΓί:，定接受超音波之人體部位； - d:以疋位須治療的肌腱； 視‘統：聲像該監視系統做一連接’並接收該監 療斗，且該電腦並提供輸入超音波肌腱病變治 -J式產生器’與該電腦相連接 電信號方式號以 -功率放All，用以放大m、為虎強 號，並做-輸出；以及…所傳來之工作頻率與訊 器之輸出信號 一高強度聚焦型超音波換能器，接收功率放大 以對人體肌腱施行超音波之治療工作。 較，者’本創作之超音波肌腱病變治療儀具備一匹 Ιίϊ率，器與高強度聚焦超音波換能器有良ί匹配，使高強 度水,、、、型超音波換能器能有最佳功率之輸出。-° 為進一步對本創作有更深入的說明，乃 說明及創作詳細綱，冀騎t審查·於審查卫作"有所助= 【實施方式】 本創作，建造-套全新概念的超音波肌鍵病變治療強 調超音波的機械效應為主’與現有的超音波深部熱療儀以及體外 M271587 震[波_所，聲^表格所示: 新治療方式 (本創作） 超音波 深部熱療（先 前技術） 頻 率 (kHz) 震波波 數 脈衝重 覆頻率 (Pulse repetition frequency (Hz)) 400〜900間 5〇〇 -2000 100左右 體外 震波治療 (先前技 1000 或 3000 100左 右 連續波 (lxlO6/秒） 連續波 2、 或4 聲波壓 力（Pressure (MPa)) 5 0.5以 下 10 -100 乍之設計^之 聲參數則將由後續生物實驗調整擬定。 、 凊參閱圖-所不，係為本發明之超音波肌腱病冑 能方塊示意圖，其係包括有下列之構件： Μ 二固定平台1 (Stage)，用以固定接受超音波之人體部位； 一，視系統2 (Monitoring System);利用診斷用超音波來確 貫定位將被治療的肌腱； (P〇 3 ’經由一同步裝置3丨(Synchronize與該監視 系，2做一連接，並接收該監視系統2之影像資料，且該電腦3 並提供輸入超音波肌鍵病變治療儀相關設定如：超音波驅動 之頻率、波數、脈衝重覆頻率（Pul纪repetiti〇n M271587 frequency )、壓力、超音波功率等等； 一程式產生器4 (Function Generator)，與該電腦3相連接， 並可將電腦3所設定之信號以電信號方式輸出，以提供不同工 作頻率與訊號； 一功率放大器5 (Power AmpHfier)，用以放大程式產生器4 所傳來之工作頻率與訊號，並做一輸出； ^ 一匹配電路6 (ElectricMatching)，可使功率放大器4與高強 度聚焦型超音波換能器7有良好匹配，使高強度集中超音波轉 換器7能有最佳功率之輸出；以及Therapy (ESWT) also has clear effects on tendonopathy in many different locations, including shoulder tendinitis, plantar fasciitis, and tennis elbow. According to clinical experience, after a few days of shock wave treatment, there will be a first-wave symptom_ (immediate effect); a second wave-like remission occurs from -then to a few-time (delay effect); fine, whether it is ultrasound or The biological effects of shock waves on the tendons, and the physical machines seem to be unreliable. And Wang Wurongguan in the past «ExtraeQlweal hthotnpsy (or ESWL) mechanistic research has found that · the relationship between shock waves, cavitation effects (bubble effects) and air bubbles is inseparable; in terms of biological effects, the past shock wave treatment Studies have shown that within a few days after shockwave treatment, the skin of rats "incorporates a marked decrease in sensory nerve endings, which will gradually recover after two or three weeks. The reduction of tendon painful nerve endings after shockwave or ultrasound treatment" May be related to improvement of clinical pain symptoms; research reports on tendinitis show that neovascularization is related to pain characteristics of tendon inflammation, and the treatment of these proliferative vascular necrosis using drugs can improve pain symptoms, however, many studies have pointed out that chronic tendonitis is always It occurred in the place where the blood supply of the tendon was the worst, and the researcher who damaged the Achilles tendon supply blood vessels of animals found that the degenerative pathological changes of chronic tendinitis were consistent with the changes of ischemic necrosis in the local area of the tendon. Studies have found that new blood vessels can be found in tendons and calcaneus bone after four weeks of shock wave treatment Appear in the boundary, and will persist for several weeks. At the same time, some mechanisms related to angiogenesis, such as: vascular endothelial growth factor (?% ^ Ndothelial growth factor or VEGF), endothelial nitric oxide synthetic plum (endothelial nitric oxide) The expression of synthase or eNOS) will increase with the division of endothelial cells. ^ It can be confirmed that there is an inseparable relationship between angiogenesis and chronic tendinitis. Although the interaction mechanism between ^ is not very clear, the possible hypothesis is: The immediate effect of tendinitis may be related to the reduction of sensory nerve endings on the tendon. New blood vessels are a necessary factor in the process of ischemic tendon tissue healing (delayed effect). However, M271587 is more or has not subsided with the progress of healing. Blood vessels are the factors that cause pain. The reason why traditional ultrasound therapy is ineffective is to explain the thermal effects emphasized by 'continuous ultrasound', which may be effective for A disease and intercourse, non-thermal effects of pulsed ultrasound and shock n < ^ n effect) or mechanical effect, for example: cavitation effect may be the most important treatment mechanism The pulsed ultrasonic wave makes the pressure intensity, treatment energy during labor and the traditional continuous waveform ultrasonic wave completely ㈣. Α ,,, and Industrial Research Institute are nine, and the general 3 is a pulsed ultrasonic wave mainly based on mechanical effects. Acupuncture ίίί Jii (fLbr0blastM ^^?), Which produces protein synthesis, promotes cell division, and stimulates neovascularization ^ helps the injured group_repair, in addition, mechanical effects may produce some micro-imaging of tissue = im = 'trauma)' These injuries are likely to lead to a new-round healing mechanism for chronically inflamed and degenerative tendons, including the removal of degenerative tissues (such as the plaque), new tendon tissues, and --- repairing complexes, _ foot into chronic ^ creation JL To study the use of ultrasonic mechanical effects to improve tendon lesions' to replace traditional ultrasonic deep hyperthermia therapeutic instruments, this creation proposes-the structure of white and ultrasonic instruments and new treatment records can be more effective The effect of treating tendinopathy. Inverse J / Mouth [Creation content] Based on solving the lack of the previous technology described above, this creation is a supersonic S mechanical effect, for example: the number of shock waves is too small, and the pressure is too high 'On the contrary, the ultrasonic wave deep hyperthermia has too many wave numbers (even). The purpose of ff is to establish a new-generation chronic tendon disease treatment plan, emphasizing the efficacy of sonic therapy (shock or ultrasound) because of its mechanical effect. The thermal effect is considered. At present, the parameters of the sonic therapy instrument (shock wave or supersonic heart · heart, 1 combination therapy are optimized to the extent that the foot pressure is too small and the frequency is too high. Therefore, the original design Main contributions and differences ^ Sonic continued M271587 Red ultrasonic supersonic parameters, the generation of mechanical effects, including the use of pulse weaving (such as: chronic tendonitis), a new treatment system between the waves, to improve the soft group including \, The purpose of the description 'The creation of the instrument for treating tendon lesions of the ultrasound, including the two parts of the human body, which are intended to receive ultrasound;-d: the tendon to be treated with a niche; Vision' system: the audiovisual monitoring system does One connection 'and Receive the monitor bucket, and the computer also provides input for ultrasonic tendon disease treatment-J-type generator 'is connected to the computer. The electrical signal mode number is-power amplifier All, which is used to magnify m, be a tiger strong number, and do -Output; and ... the working frequency and the output signal of the transmitter-a high-intensity focused ultrasonic transducer, which receives amplified power to perform ultrasonic treatment on the human tendon. The sonic tendon lesion treatment instrument has a Ιίϊ rate, and the device has a good match with the high-intensity focused ultrasonic transducer, so that high-intensity water ,,, and ultrasonic transducers can have the best power output.-° In order to have a deeper explanation of this creation, it is an explanation and a detailed outline of the creation. Ji Qi t reviewed · Yu reviewed Wei Zuo "helpful = [implementation method] This creation, construction-a set of new concepts of ultrasonic muscle lesions The treatment emphasizes the mechanical effects of ultrasound, and it is based on the existing ultrasonic deep thermotherapy apparatus and the extracorporeal M271587 shock [wave_ 所 ， 声 ^ Table: New treatment method (this creation) Ultrasonic deep thermotherapy (previous technology) Frequency (kHz) Pulse repetition frequency (Pulse repetition frequency (Hz)) 400 to 900 between 500 and 2000 100 external shock treatment (previous technique 1000 or 3000 100 continuous wave (lxlO6 / sec) continuous wave 2 , Or 4 Sonic pressure (Pressure (MPa)) 5 0.5 or less 10 -100 The sound parameters of the design ^ will be adjusted by subsequent biological experiments. 凊 Refer to the figure-No, it is the ultrasonic tendonopathy of the present invention 胄Schematic diagram of the energy block, which includes the following components: Μ 2 fixed platform 1 (Stage), used to fix the parts of the human body that receive ultrasonic waves; First, the monitoring system 2 (Monitoring System); the use of diagnostic ultrasound for consistent positioning The tendon to be treated; (P03 'via a synchronization device 3 丨 (Synchronize makes a connection with the surveillance system, 2 and receives the image data of the surveillance system 2, and the computer 3 provides input ultrasound muscle keys Relevant settings of the disease treatment instrument, such as: ultrasonic drive frequency, wave number, pulse repetition frequency (Pulji repetiti〇n M271587 frequency), pressure, ultrasonic power, etc .; a program generator 4 (Function Generator), connected to the computer 3, and can output the signal set by the computer 3 as an electrical signal to provide different working frequencies and signals; a power amplifier 5 (Power AmpHfier), used to amplify the program generator 4 The working frequency and signal are transmitted and an output is made; ^ A matching circuit 6 (ElectricMatching) can make the power amplifier 4 and the high-intensity focused ultrasonic transducer 7 have a good match, so that the high-intensity concentrated ultrasonic converter 7 can have the best power output; and
一高強度聚焦型超音波換能器7 (High Intensity Focused Ultrasound Transducer)，接收功率放大器4之輸出信號， 以對人體肌腱施行超音波之治療工作。 & 藉由上述之構成及表列之設定參數，而使本創作之超音波肌 腱病變治療儀主要可產生足夠的超音波機械能來治療人體之特定 部位，同時可避免二先前技術過熱或疼痛的副作用。同時本創作 之設計主要貢獻與差別在於強調機械效應的產生，包括使用脈衝 型超音波、降低頻率、增加輸出最大聲壓以及使用較多波數的脈 衝，也就是發展-套聲錄介於震波與治賴傳統超音波間的新 治療系統，以改善各項疾病（如：慢性肌腱炎）的治療效果。 綜上所述，本創作之結構特徵及各實施例皆已詳細揭示，而 可充分顯示出本創作案在目的及功效上均深富實施之進步性，極 具產業之_價值，且為目前市面上前所未見之，依專利法 之精神所述，本創作案完全符合創作專利之要件。 唯以上所述者，僅為本創作之較佳實施例而已，當不能以之 限定本創作所實施之麵，即大凡依本創作巾請專 巧變，修飾，皆應仍屬於本創作專利涵蓋^ 貝審查委員明鑑，並祈惠准，是所至禱。 【圖式簡單說明】 M271587 圖一係為本發明之超音波肌腱病變治療儀之功能方塊示意 圖號說明： 1〜固定平台 2〜監視系統 3〜電腦 31〜同步裝置 4〜程式產生器 5〜功率放大器 6〜匹配電路 7〜高強度聚焦型超音波換能器A High Intensity Focused Ultrasound Transducer 7 (High Intensity Focused Ultrasound Transducer) receives the output signal of the power amplifier 4 to perform ultrasonic treatment on the human tendon. & With the above configuration and listed setting parameters, the ultrasonic tendon lesion treatment instrument of this creation can mainly generate enough ultrasonic mechanical energy to treat specific parts of the human body, and at the same time can avoid overheating or pain of the prior art. Side effects. At the same time, the main contribution and difference of the design of this creation is to emphasize the generation of mechanical effects, including the use of pulsed ultrasound, lowering the frequency, increasing the maximum output sound pressure, and using more pulses of pulses. New treatment system with traditional ultrasound to improve the treatment effect of various diseases (such as chronic tendonitis). In summary, the structural characteristics and various embodiments of this creation have been revealed in detail, and it can fully show that this creation project is deeply implemented in terms of purpose and efficacy, and has great industrial value. As never before seen in the market, according to the spirit of the patent law, this creation case fully complies with the requirements of a creation patent. The above are only the preferred embodiments of this creation. When it is not possible to limit the implementation aspects of this creation, that is, please change and modify according to this creation towel, which should still be covered by this creation patent. ^ Peer reviewer Ming Jian, and pray for the right, is the prayer. [Brief description of the diagram] M271587 Figure 1 is a functional block diagram of the ultrasonic tendon lesion treatment apparatus of the present invention. Description: 1 ~ fixed platform 2 ~ monitoring system 3 ~ computer 31 ~ synchronization device 4 ~ program generator 5 ~ power Amplifier 6 ~ matching circuit 7 ~ high intensity focused ultrasonic transducer