201236673 六、發明說明： [0001] 【發明所屬之技術領域】 本發明係有關於一種麩A ° Q穴位電刺激與體感覺誘發 電位分析之评估系統，尤敌B > 〜X心一種藉以於人體的神經 穴位經電刺激器來治療疼痛电A 、陶愚處’且同時經由體感覺誘 發電位分析單元來針對患處仕# — 作疼痛減緩狀況的評估分析 ，進而達到有效治療的目的。 [0002] 〇 【先前技術】 按，就醫學的醫療物皙1 U 罵基礎不同，其中、西醫立足 點也就有別。首先，娜西醫，由於西醫以物質的粒子 層次為基礎，所以它治病就著眼於人想、的生理側重於 人體的生㈣構，西醫是從人_生理結私手來解決 疾病過程中人體的魏和代謝異”問題；歸納中醫治 療人體功能性病變’ ^西醫擅長，具有瞧的優勢；相 反，中醫處理人艘的器質性病變不如西醫f利。 [0003] 而-般人體某部位疼痛、酸痛大都藉由中醫的推拿 〇 、針灸、電療或復健等方式來H而往往所治療的成 果只有當事者長可得知’且均為以感覺來做論判，無醫 學根據也無法得知患部確實改善；而西醫方面檢測人體 神經疼痛則藉由誘發電位，而其分為腦幹聽覺誘發電位 檢查（BAEP)、視覺誘發電位檢查（VEp)和體 感覺誘發電位檢查（S S E P);而在腦神經科學的臨 床診斷方面，常利用誘發電位來診斷神經傳導功能是否 正常’而臨床上常用的體感覺誘發電位（S e p )是經 由機械、電刺激肢體或脊椎引發之反應，其傳導路徑是 100108689 表單編號A0101 第3頁/共12頁 1002014722-0 201236673 沿著脊髓背柱、再經腦幹、視丘到達大腦體感覺皮質區 ，而體感覺誘發電位檢查可評估周邊神經的近端乃至中 柩神經的整個傳導路徑，是西醫臨床神經生理檢查相當 成熟的一項重要評估指標。 [0004] [0005] 另外，如脊柱侧彎是小兒骨科的常見疾病，由於脊 柱畸形矯正手術自身涉及範圍廣，尤其在脊柱後凸、先 天脊柱側彎、重度脊柱侧彎以及應已存在神經系統功能 障礙等情況，而誘發電位是神經系統對特異性外界刺激 的反應，是檢測神經通路功能的重要方法，具有持續、 客觀以及可定量的優點，而且無需患兒配合。軀體感覺 誘發電位（S E P )用於術中監測是一項進步，自從1 9 7 5年臨床上首次嘗試應用體感誘發電位監測脊髓功 能缺陷以來，在歐美發達國家現已廣泛用於有截癱風險 的手術，並取得相當豐碩的成果。 而刺激人體指、趾皮神經或肢體大的混合神經幹中 的感覺纖維，在肢體神經、脊椎的皮膚表面和腦感覺投 射區相應的頭皮上記錄到的電位變化，這就是體感誘發 電位，體感透發電位最先是由D aws ο η ( 1 9 5 1 )在一次偶爾的對遺傳性陣攣性痛病的周圍神經進行單 次刺激時成功地記錄到的。S E P如同V E P、A E P 一樣，是一種最常用的誘發電位。它在鑒別感覺障礙是 功能性或器質性上有重要意義。體感誘發電位可以根據 刺激電極放置部位、刺激頻率、潛伏期長短等特點進行 分類；同樣，按照刺激頻率的不同，體感誘發電位可以 分為瞬態感誘發電位和穩態體感誘發電位兩種。 100108689 表單編號A0101 第4頁/共12頁 1002014722-0 201236673 [0006] 該瞬態體感誘發電位為單次的脈沖刺激可以誘發出 瞬態體感誘發電位，瞬態體感誘發電位目前在臨床上應 用較多；而穩態體感誘發電位則為將連續的刺激脈沖施 加於受試者，可以誘發出穩態體感誘發電位。早在1 9 74年，Namero w等就記錄到了穩態體感誘發電 位波形，並且通過濾波，將起始刺激所誘發的慢電位全 部濾去，僅剩下與連續脈沖頻率相一致的一串震盪電位 ，再通過平均技術把震盪電位縮合成一個波形。 _ [0007] 有鑑於此，本發明人秉持多年該相關行業之豐富設 Ο 計開發及實際製作經驗，係將中西醫的醫療技術合併， 藉以相互整合醫術處理之特性，來達成有效改善疼痛病 理的功效，藉此以期具有更佳實用價值性之目的者。 【發明内容】 [0008]201236673 VI. Description of the Invention: [0001] Technical Field of the Invention The present invention relates to an evaluation system for acupoint A-Q acupoint electrical stimulation and somatosensory evoked potential analysis, especially B > The nerve acupoints of the human body are treated by an electric stimulator to treat the pain electric A and Tao Yu's, and at the same time, through the somatosensory evoked potential analysis unit, the evaluation of the pain relief state is performed for the purpose of effective treatment. [0002] 〇 [Prior Art] According to the medical medical material 皙 1 U 骂 different foundations, among them, the Western medicine standpoint is different. First of all, Naxi Medical, because Western medicine is based on the particle level of matter, it treats the disease with a focus on human physiology and focuses on the human body. The Western medicine is to solve the disease process from the human body. The problem of Wei and metabolism is different; inductive Chinese medicine treatment of human functional diseases' ^ Western medicine is good at, has the advantage of sputum; on the contrary, Chinese medicine treatment of human vessels is not as good as Western medicine. [0003] And - a certain part of the human body pain Most of the soreness is caused by traditional Chinese medicine, such as massage, acupuncture, electrotherapy or rehabilitation. The results of treatment are often only known to the person concerned, and they are judged by feelings. It is known that the affected part does improve; while Western medicine detects human neuralgia by evoked potential, which is divided into brainstem auditory evoked potential test (BAEP), visual evoked potential test (VEp) and somatosensory evoked potential test (SSEP); In the clinical diagnosis of cranial neuroscience, evoked potentials are often used to diagnose whether the nerve conduction function is normal' and the commonly used somatosensory evoked potentials (S ep ) It is a mechanical or electrical stimulation of the limb or the spine. The conduction path is 100108689. Form No. A0101 Page 3 of 12 1002014722-0 201236673 Along the spinal dorsal column, the brain stem, and the hypothalamus reach the cerebral sensory cortex. Area, and the sensory evoked potential test can evaluate the entire conduction path of the proximal nerve and even the middle sacral nerve. It is an important evaluation index for the clinical neurophysiological examination of Western medicine. [0004] [0005] In addition, such as the spine side Bending is a common disease in pediatric orthopedics. Because of the wide range of spinal deformity correction surgery, especially in kyphosis, congenital scoliosis, severe scoliosis, and the presence of nervous system dysfunction, the evoked potential is the nervous system. Response to specific external stimuli is an important method for detecting the function of neural pathways. It has the advantages of continuous, objective and quantifiable, and does not require the cooperation of children. Somatosensory evoked potential (SEP) is an improvement for intraoperative monitoring. The first clinical trial in 1978, the application of somatosensory evoked potentials to monitor spinal cord dysfunction It has been widely used in the developed countries of Europe and America for surgery with paraplegia risks, and has achieved quite fruitful results. It stimulates the sensory fibers in the mixed nerve trunk of the human body, the toe skin nerve or the limbs, in the skin of the limb nerves and the spine. Surface and brain sensory projection area corresponding to the change in potential recorded on the scalp, this is the somatosensory evoked potential, the somatosensory transmission potential is first caused by D aws ο η (1 9 5 1 ) in an occasional hereditary herd Sexually painful peripheral nerves were successfully recorded in a single stimulation. SEP, like VEP and AEP, is one of the most commonly used evoked potentials. It is important in identifying functional or organic sensations. The evoked potentials can be classified according to the characteristics of the placement of the stimulating electrodes, the stimulation frequency, and the length of the incubation period. Similarly, according to the stimulation frequency, the somatosensory evoked potentials can be divided into transient evoked potentials and steady-state somatosensory evoked potentials. 100108689 Form No. A0101 Page 4 / Total 12 Page 1002014722-0 201236673 [0006] The transient somatosensory evoked potential can induce transient somatosensory evoked potentials by a single pulse stimulation, and transient somatosensory evoked potentials are currently in clinical practice. More applications are applied; while the steady-state somatosensory evoked potential is a continuous stimulation pulse applied to the subject, and a steady-state somatosensory evoked potential can be induced. As early as in 1997, Namero w recorded the steady-state somatosensory evoked potential waveform, and filtered to filter out all the slow potentials induced by the initial stimulus, leaving only a string consistent with the continuous pulse frequency. The oscillating potential is then condensed into a waveform by an averaging technique. _ [0007] In view of this, the inventors have been adhering to the rich experience in the development and practical production of the related industries for many years, and have merged the medical technology of Chinese and Western medicines to integrate the characteristics of medical treatment to achieve effective improvement of pain pathology. The efficacy of this, in order to have a better practical value for the purpose. SUMMARY OF THE INVENTION [0008]
本發明之主要目的即是為提供一種結合穴位電刺激 與體感覺誘發電位分析之砰估;參統，其主要係藉以於人 體的神經穴位經電刺激器考讀秦參廣奏處，且同時經由 體感覺誘發電位分析單元來針對患處作疼痛減緩狀況的 評估分析；藉此，以可真正實際了解患者之治療效果與 成效的目的。 [0009] 為達上述目的，本發明提供一種結合穴位電刺激與 體感覺誘發電位分析之評估系統，其特徵與功效如下： [0010] 其主要包含有一針對人體神經穴位進行電療刺激治 療疼痛的神經穴位電刺激器，及一檢測人體感覺神經的 體感覺誘發電位分析單元，及一將神經穴位電刺激器所 100108689 傳輸之訊號轉換輸入與將體感覺誘發電位分析單元之訊 表單編號A0101 第5頁/共12頁 1002014722-0 201236673 號轉換輸入的轉換單元，及一接收轉換單元輸出、輸入 訊號而做分析的評估單元；藉此，以可經由神經穴位電 刺激器來治療疼痛患處，且同時經由體感覺誘發電位分 析單元來針對患處作疼痛減緩狀況的評估分析，達到真 正實際了解患者之治療效果與成效，且可經由評估分析 的資料而適時修正給予的治療電壓或方式，讓疼痛治療 效果達到最佳的改善成果者。 [0011] [0012] [0013] [0014] 本發明提供一種結合穴位電刺激與體感覺誘發電位 分析之評估系統進一步於人體穴位貼敷電極片來進行神 經穴位電刺激器治療疼痛患部，而於頭部戴掛電極帽來 作體感覺誘發電位分析的檢測者。 【實施方式】 為令本發明之技術手段、發明目的及達成功效有更 完整及清楚的揭露，茲於下詳細說明之，並請一併參閱 揭示之圖式及元件符號。 首先，請參閱第一圖所示，為本發明提供一種結合 穴位電刺激與體感覺誘發電位分析之評估系統整體流程 架構示意圖，其主要包含有： 一神經穴位電刺激器（1 )，為針對人體神經穴位 進行電療刺激治療疼痛的構件，其神經穴位電刺激器（ 1 )由一組對應貼附在人體穴:位上的電極片（1 1 )來 形成電極導通，而可施以電療刺激治療疼痛； 一體感覺誘發電位分析單元（2)，為檢測人體感 覺神經的構件，其體感覺誘發電位分析單元（2 )由一 100108689 表單編號A0101 第6頁/共12頁 1002014722-0 [0015] 201236673 [0016] [0017] Ο [0018]The main object of the present invention is to provide an evaluation of the combination of acupoint electrical stimulation and somatosensory evoked potential analysis; the system is mainly used to test the nerve acupoints of the human body through the electric stimulator to read the Qinshen Guangshi, and at the same time The somatosensory evoked potential analysis unit is used to evaluate the pain relief condition of the affected area; thereby, the purpose of the patient's treatment effect and effectiveness can be truly understood. [0009] In order to achieve the above object, the present invention provides an evaluation system combining acupoint electrical stimulation and somatosensory evoked potential analysis, the features and effects of which are as follows: [0010] It mainly includes a nerve for acupuncture treatment of pain in a human acupuncture point An acupoint electrical stimulator, and a somatosensory evoked potential analysis unit for detecting a human sensory nerve, and a signal conversion input for transmitting a nerve acupoint electrical stimulator 100108689 and a form of a sensory evoked potential analysis unit A0101 Page 5 / Total 12 pages 1002014722-0 201236673 conversion input conversion unit, and an evaluation unit that receives the conversion unit output and input signals for analysis; thereby, the painful affected area can be treated via a neuro-acupoint electrical stimulator, and at the same time The somatosensory evoked potential analysis unit is used to evaluate and analyze the pain relief status of the affected area, to achieve a truly practical understanding of the patient's treatment effect and effectiveness, and to timely correct the treatment voltage or mode of administration by evaluating the analyzed data, so that the pain treatment effect can be achieved. The best improvement. [0014] [0014] The present invention provides an evaluation system combining acupoint electrical stimulation and somatosensory evoked potential analysis to further apply a nerve acupoint electrical stimulator to treat a painful affected part. The head was attached to the electrode cap for the detection of the sensory evoked potential analysis. DETAILED DESCRIPTION OF THE INVENTION For a more complete and clear disclosure of the technical means, the object of the invention, and the effect of the present invention, the details of the present invention are described in detail below. First, referring to the first figure, the present invention provides a schematic diagram of an overall process architecture of an evaluation system combining acupoint electrical stimulation and somatosensory evoked potential analysis, which mainly comprises: a neuro-acupoint electro-stimulator (1) for The acupoints of the human body are subjected to electrotherapy to stimulate the pain. The nerve acupoint electrical stimulator (1) is formed by a set of electrode sheets (1 1 ) attached to the acupuncture points of the human body to form an electrode conduction, and the electrotherapy stimulation can be applied. The treatment of pain; the integrated sensory evoked potential analysis unit (2), which is a component for detecting human sensory nerves, the somatosensory evoked potential analysis unit (2) is composed of a 100108689 form number A0101, page 6 of 12 pages 1002014722-0 [0015] 201236673 [0017] [0018] [0018]
電極帽（2 1)來對應戴掛於頭部而作體感覺誘發電位 分析的檢測； 一轉換單元（3 )，為可將神經穴位電刺激器（1 )所傳輸之訊號轉換輸入與將體感覺誘發電位分析單元 (2) 之訊號轉換輸入的轉換單元（3); 一評估單元（4)，為將輸出訊號傳輸給轉換單元 (3) ，而讓轉換單元（3)將輸出訊號傳遞給神經穴 位電刺激器（1 )來進行電刺激療程，及接收體感覺誘 發電位分析單元（2)傳遞給轉換單元（3)之輸入訊 號，且將輸出、輸入訊號作分析評估的構件者。 請一併參閱第一圖所示，於使用時，下列所述為可 實施中的其一設定值，於架構圖中該神經穴位電刺激器 (1 )之電極片（1 1 )對應貼抵在人體疼痛和部處的 穴位，以藉由評估單元（4)輸出訊號給轉換單元（3 )，而讓轉換單元（3)傳輸電壓訊號給神經穴位電刺 激器（1 )來執行電療，一般而言，神經穴位電刺激器 (1 )主要是在疼痛周圍用按摩的方式來獲得止痛的效 果，在臨床上常使用高頻低強度脈衝電刺激到皮膚，主 要參數範圍刺激頻率10〜200Hz、刺激波寬1 〇 0〜2 0 0 u s和常以輸出波形連續波為主，而針灸式 神經穴位電刺激器（1 )刺激點放在穴位上，讓我們人 體本身產生出腦内啡，來達到止痛效應，參數範圍刺激 頻率2〜100Hz、刺激波寬100〜200//S和 輸出波形常以脈衝波等為主；當人體接受神經穴位電刺 激器（1 )改善疼痛感時，再藉由體感覺誘發電位分析 100108689 表單編號A0101 第7頁/共12頁 1002014722-0 201236673 單元（2)之電極帽（2 1 )對應戴掛在人體頭部，擷 取腦波訊號，腦波訊號相對於體表其他訊號來講是屬於 比較弱的訊號，腦波的訊號大小約為1 0 — 5〜1 0 — 4 伏特，因此，由體感覺誘發電位分析單元（2)内之腦 波放大器（2 2 )來放大訊號，而放大器電路本身的雜 訊電壓、雜訊電流及電阻的熱雜訊等都會被多次放大， 所選用的放大器元件必須具有高的訊雜比及高的輸入阻 抗，接著，腦波放大器（2 2)將放大後訊號回傳給轉 換單元（3)，且經轉換單元（3)將所獲得以經電療 後的腦波訊號傳輸給評估單元（4)，讓評估單元（4 )針對輸出、輸入訊號作分析評估，以獲得此神經穴位 電刺激器（1 )所施以治療疼痛的電壓是否可真正得到 改善舒緩患部者。 [0019] 藉此，以可經由神經穴位電刺激器（1 )來治療疼 痛患處，且同時經由體感覺誘發電位分析單元（2)來 針對患處作疼痛減緩狀況的評估分析，達到真正實際了 解患者之治療效果與成效，且可經由評估分析的資料而 適時修正給予的治療電壓或方式，讓疼痛治療效果達到 最佳的改善成果者。 [0020] 以上所舉者僅係本發明之部份實施例，並非用以限 制本發明，致依本發明之創意精神及特徵，稍加變化修 飾而成者，亦應包括在本專利範圍之内。 [0021] 綜上所述，本發明實施例確能達到所預期之使用功 效，又其所揭露之具體構造，不僅未曾見諸於同類產品 中，亦未曾公開於申請前，誠已完全符合專利法之規定 100108689 表單編號A0101 第8頁/共12頁 1002014722-0 201236673The electrode cap (2 1) is used for detecting the sensory evoked potential analysis corresponding to wearing the head; a conversion unit (3) is for converting the signal transmitted by the nerve acupoint electrical stimulator (1) into the body a conversion unit (3) for sensing the signal conversion input of the evoked potential analysis unit (2); an evaluation unit (4) for transmitting the output signal to the conversion unit (3), and letting the conversion unit (3) transmit the output signal to The nerve acupoint electrical stimulator (1) is used for performing an electrical stimulation treatment, and the receiver sensory evoked potential analysis unit (2) transmits the input signal to the conversion unit (3), and the output and input signals are used as components for analysis and evaluation. Please refer to the first figure together. In use, the following is a set value that can be implemented. In the architecture diagram, the electrode piece (1 1 ) of the nerve acupoint electrical stimulator (1) is correspondingly attached. In the human body pain and the acupuncture points in the body, the signal is output to the conversion unit (3) by the evaluation unit (4), and the conversion unit (3) transmits a voltage signal to the nerve acupoint electrical stimulator (1) to perform electrotherapy. In other words, the nerve acupoint electrical stimulator (1) mainly uses massage to obtain analgesic effect around the pain. In the clinic, high-frequency low-intensity pulse electrical stimulation is often used to the skin, and the main parameter range stimulation frequency is 10 to 200 Hz. The stimulation wave width is 1 〇0~2 0 0 us and the output waveform is continuous wave, and the acupuncture-type nerve acupoint electrical stimulator (1) is placed on the acupuncture point, so that the human body itself produces endorphins. To achieve the analgesic effect, the parameter range stimulation frequency is 2~100Hz, the stimulation wave width is 100~200//S, and the output waveform is often pulsed wave; etc.; when the human body receives the nerve acupoint electrical stimulator (1) to improve the pain, then borrow Somatosensory evoked potential Analysis 100108689 Form No. A0101 Page 7 / Total 12 Page 1002014722-0 201236673 The electrode cap (2 1 ) of the unit (2) is worn on the head of the human body, and the brain wave signal is extracted. The brain wave signal is compared with other signals on the body surface. In other words, it is a relatively weak signal. The signal size of the brain wave is about 10 - 5 to 1 0 - 4 volts. Therefore, it is amplified by the brain wave amplifier (2 2 ) in the somatosensory evoked potential analysis unit (2). The signal, and the noise voltage of the amplifier circuit itself, the noise current and the thermal noise of the resistor are amplified multiple times. The selected amplifier component must have a high signal-to-noise ratio and a high input impedance. Then, the brainwave amplifier (2) returning the amplified signal to the conversion unit (3), and transmitting the brain wave signal obtained after the electrotherapy to the evaluation unit (4) via the conversion unit (3), and letting the evaluation unit (4) target The output and input signals are analyzed and evaluated to obtain whether the voltage applied to the nerve acupoint electrical stimulator (1) can actually improve the soothing affected part. [0019] Thereby, the painful affected area can be treated via the neuro-acupoint electrical stimulator (1), and at the same time, the somatosensory evoked potential analysis unit (2) is used to evaluate the pain-mitigating condition of the affected part, and the actual actual understanding of the patient is achieved. The therapeutic effect and effectiveness, and the treatment voltage or mode of administration can be timely corrected by evaluating the analyzed data to achieve the best improvement effect of the pain treatment effect. The above are only some of the embodiments of the present invention, and are not intended to limit the present invention, and are modified according to the inventive spirit and features of the present invention, and should also be included in the scope of this patent. Inside. [0021] In summary, the embodiments of the present invention can achieve the expected use efficiency, and the specific structure disclosed therein has not been seen in similar products, nor has it been disclosed before the application, and has completely complied with the patent. The law of the law 100108689 Form number A0101 Page 8 / Total 12 pages 1002014722-0 201236673
與要求，爰依法提出發明專利之申請，想請库予 並賜准專利， 則實感德便。 【圖式簡單說明】 [0022] 第一圖：本發明整體流程架構示意圖 【主要元件符號說明】 [0023] (1 ) 神經穴位電刺激器 [0024] (11) 電極片 [0025] (2 ) 體感覺誘發電位分析單元 [0026] (21) 電極帽 [0027] (22) 腦波放大器 [0028] (3 ) 轉換單元 ^ [0029] (4 ) 評估單元 100108689 表單編號A0101 第9頁/共12頁 1002014722-0And the request, the application for the invention of a patent in accordance with the law, would like to ask the library and grant the patent, it is really sensible. BRIEF DESCRIPTION OF THE DRAWINGS [0022] First: Schematic diagram of the overall flow architecture of the present invention [Description of main component symbols] [0023] (1) Neuro-acupoint electrical stimulator [0024] (11) Electrode sheet [0025] (2) Somatosensory evoked potential analysis unit [0026] (21) Electrode cap [0027] (22) Brain wave amplifier [0028] (3) Conversion unit ^ [0029] (4) Evaluation unit 100108689 Form number A0101 Page 9 of 12 Page 1002014722-0