WO2022233103A2 - 一种用于吞咽障碍治疗的方法 - Google Patents

一种用于吞咽障碍治疗的方法 Download PDF

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WO2022233103A2
WO2022233103A2 PCT/CN2021/113390 CN2021113390W WO2022233103A2 WO 2022233103 A2 WO2022233103 A2 WO 2022233103A2 CN 2021113390 W CN2021113390 W CN 2021113390W WO 2022233103 A2 WO2022233103 A2 WO 2022233103A2
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electrical stimulation
catheter
treating dysphagia
patient
stimulation waveform
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PCT/CN2021/113390
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French (fr)
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窦祖林
金兴
温红梅
万桂芳
崔丰曦
安德连
张雪
贺子桐
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深圳市理康医疗器械有限责任公司
窦祖林
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Publication of WO2022233103A2 publication Critical patent/WO2022233103A2/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system

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  • the present invention relates to the technical field of medical device application, in particular to a method for treating swallowing disorders.
  • Neurogenic dysphagia is a common complication of neurological disorders with limited treatment options. Therefore, it is imperative to translate basic research on neurostimulation into clinical applications.
  • Electrical stimulation technology is one of the commonly used treatments for swallowing disorders, and its safety and effectiveness have been recognized by doctors and patients.
  • the commonly used electrical stimulation methods for swallowing disorders include neuromuscular electrical stimulation therapy, induction electrotherapy and transcranial direct current stimulation (tDCS) with central effect, but these electrical stimulation methods cannot directly act on the pharyngeal mucosa, muscles and peripheral nerves. Treatment effects are limited.
  • PES pharyngeal electricalstimulation
  • the information of the pharyngeal mucosa stimulated by PES will be transmitted to the nucleus tractus solitarius of the brainstem and the higher center of the swallowing-related cortex, and then analyzed and processed by the central pattern generator in the dorsal medulla of the bilateral medulla, and then passed through V, VII, IX, X , XI, XII induced swallowing reflex activity on cranial nerves.
  • PES influences motor signal output from the swallowing cortex. The results showed that after stimulation, the delivery time of the bolus was shortened, and the leakage and aspiration were reduced.
  • the waveform parameters of PES are as follows: waveform: square wave, frequency: 1Hz or 5Hz (5Hz is better), pulse width: 0.2ms, voltage is 289V.
  • the waveform parameters are still within the range of neuromuscular electrical stimulation parameters, and its role is to activate muscles by stimulating the intact peripheral motor nerves, and it also has a partial effect on the central nervous system, but the effect is limited.
  • Fig. 2 from Rodr ⁇ guez-FernándezL, Rebollo-RoldánJ, Jiménez-RejanoJJ, Güeita-Rodr ⁇ guezJ (2016).
  • Strength-duration curves of the common fibularnerve show hypoexcitability in people with functional ankle instability, PM&R), it can be known that to better excite nerves or muscles, sufficient pulse duration and intensity are required, while the pulse duration of the PES waveform is relatively small, so a higher treatment intensity is required. Excessive treatment intensity may cause mucosal redness, bleeding, or electric shock due to electrode movement, bringing unnecessary risks to treatment.
  • the technical problem to be solved by the present invention is to provide a method for treating dysphagia.
  • the technical scheme adopted in the present invention is: a method for the treatment of dysphagia, comprising,
  • An electrical stimulation waveform that induces the patient's swallowing reflex is applied in the patient's pharyngeal cavity through the catheter electrode, and the positive half cycle of the electrical stimulation waveform is composed of a combination of square waves and triangular waves;
  • the intensity of electrical stimulation was gradually increased until the patient's tolerance threshold was triggered, and then the next round of electrical stimulation was repeated to the patient's pharynx.
  • the negative half cycle of the electrical stimulation waveform is a pulse, and the pulse is used to reduce the electrolytic effect caused by the DC component.
  • the frequency of the stimulation waveform applied by the catheter electrode is in the range of 0.1-40 Hz;
  • the frequency of the stimulation waveform applied by the catheter electrode is 5 Hz.
  • the pulse width of the stimulation waveform applied by the catheter electrode is in the range of 1-50ms;
  • the pulse width of the stimulation waveform applied by the catheter electrode is 10 ms.
  • the treatment time is in the range of 1-30 minutes.
  • the treatment time is 10 minutes.
  • the catheter electrode includes a catheter and at least a pair of conductive electrodes
  • the catheter material includes but is not limited to silica gel, TPU and nylon
  • the conductive electrode material includes but is not limited to stainless steel and conductive silicone.
  • the length of the catheter of the catheter electrode is 150 cm, the diameter is 3.2 cm, and the catheter is marked every 1 cm.
  • the electrical stimulation waveform is generated by an electrical stimulation device, and the electrical stimulation device includes a power supply module, a high voltage generation module, a waveform generation module, an intensity control module and a load detection module.
  • the beneficial effect of the present invention is that: an electrical stimulation waveform composed of a square wave and a triangular wave is applied in the pharyngeal cavity of the patient through the catheter electrode, and the current is directly applied to the pharyngeal mucosa, muscles and nerves.
  • the central pattern generator of swallowing is stimulated through the sensory ascending pathways of the glossopharyngeal nerve and the vagus nerve related to swallowing nerves, which excites the swallowing-related cortex and induces neuroplasticity.
  • the current/voltage intensity required to use the electrical stimulation waveform is smaller. Since the electrical stimulation waveform has sufficient pulse width and duration, it needs to excite nerves and muscles with a relatively small intensity, which is more reliable in application.
  • Fig. 1 is the method flow chart for the treatment of dysphagia of the present invention
  • Fig. 2 is the intensity-time curve of stimulating excitatory tissue of the present invention
  • FIG. 3 is a schematic diagram of the mechanism of action of an electrical stimulation waveform of the present invention.
  • FIG. 4 is a schematic diagram of the electrical stimulation waveform parameters of the present invention.
  • Fig. 5 is the bipolar waveform schematic diagram of the present invention.
  • FIG. 6 is a schematic diagram of the catheter electrode of the present invention.
  • the first embodiment of the present invention is: a method for treating dysphagia, comprising the steps of:
  • the pharyngeal electrode can be positioned intuitively through the laryngoscope swallowing function evaluation (FEES) for the initial intubation, and a single electrode ring in the double electrode ring is indwelled at the ostium of the piriform sinus under the laryngoscope.
  • FEES laryngoscope swallowing function evaluation
  • the best effect of pharyngeal EMG is within 1cm. Most of the pharyngeal electrodes are placed at a distance of 13-18cm from the nostrils.
  • S30 Gradually increase the electrical stimulation intensity until the patient's tolerance threshold is triggered, and then repeat the next round of electrical stimulation to the patient's pharyngeal cavity.
  • the controller routinely sets the 5Hz current to gradually increase from 0.5mA by 0.5mA/time until the patient feels the stimulation, which is the perception threshold (the patient feels the stimulation at first), and then continues to increase until the patient feels pain and discomfort and does not want the intensity to increase again, which is the tolerance threshold , and measure 3 times with an interval of 5 min after zeroing and take the average value.
  • the duration of electrical stimulation was 10 ms.
  • the intensity of the stimulus was receptive threshold + 75% (tolerance threshold - receptive threshold). Stimulate 10min every day.
  • FIG. 3 is a schematic diagram of the action mechanism of the electrical stimulation waveform of the present invention.
  • an electrical stimulation waveform composed of a square wave and a triangular wave in a positive half cycle is applied to the pharyngeal cavity of the patient through the catheter electrode.
  • the current is directly applied to the mucous membrane, muscles and nerves of the pharynx, mainly through the tongue.
  • the sensory ascending pathways of the swallowing nerves such as the pharyngeal nerve and the vagus nerve, stimulate the central pattern generator of swallowing, excite the swallowing-related cortex, and induce neuroplasticity.
  • a pulse in order to increase the comfort of the treatment, a pulse can be applied in the negative half cycle of the waveform, which is used to reduce the electrolytic effect caused by the DC component.
  • the triangular wave combined waveform, triangular wave and square wave as shown in Figure 4.
  • the electrical stimulation waveform can be a unipolar stimulation pulse or a bipolar stimulation pulse.
  • the main function of the negative half-cycle waveform of the bipolar stimulation pulse is to reduce the electrolytic effect caused by the DC component.
  • the frequency of the stimulation waveform applied by the catheter electrode is in the range of 0.1-40 Hz; preferably, the frequency of the stimulation waveform applied by the catheter electrode is 5 Hz.
  • the comparison of 1-40 Hz in previous pharyngeal electrical stimulation experiments found that 5 Hz had the greatest impact on cortical excitability, and cortical excitability was closely related to changes in swallowing function. The lower swallowing reflex is not obvious enough. Most patients can complete multiple complete and large swallowing movements at 5Hz. If the stimulation frequency continues to increase, most patients will experience throat muscle spasm.
  • the pulse width of the stimulation waveform applied by the catheter electrode is in the range of 1-50ms; preferably, the pulse width of the stimulation waveform applied by the catheter electrode is 10ms.
  • the pulse width of pharyngeal electrical stimulation in the previous study was 0.2ms, which resulted in a relatively large stimulation intensity, greater than 20mA, prone to local swelling, bleeding, vomiting, etc.
  • the pulse width was 10ms, the stimulation intensity of most patients could be significantly reduced to below 10mA.
  • the treatment time is in the range of 1-30 minutes. Preferably, the treatment time is 10 minutes.
  • Previous studies have shown that 10 minutes of pharyngeal electrical stimulation every day has a good therapeutic effect. Long-term stimulation will cause fatigue. Healthy people and patients enrolled in the pre-experiment will experience a decrease in swallowing frequency and amplitude after 7-10 minutes of stimulation.
  • the catheter electrode includes a catheter and at least a pair of conductive electrodes
  • the catheter material includes but is not limited to silica gel, TPU and nylon
  • the conductive electrode material includes but is not limited to stainless steel and conductive silicone.
  • the length of the catheter of the catheter electrode is 150 cm, the diameter is 3.2 cm, and the catheter is marked every 1 cm.
  • the electrical stimulation waveform is generated by an electrical stimulation device, and the electrical stimulation device includes a power supply module, a high voltage generating module, a waveform generating module, an intensity control module and a load detection module.

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Description

一种用于吞咽障碍治疗的方法 技术领域
本发明涉及医疗设备应用技术领域，尤其是指一种用于吞咽障碍治疗的方法。
背景技术
神经源性吞咽障碍是一种常见的神经系统疾病的并发症，治疗方法有限。因此，将神经刺激的基础研究转化为临床应用成为当务之急。
电刺激技术是吞咽障碍的常用治疗手段之一，其安全性和有效性已经被广大医生和患者认可。吞咽障碍常用电刺激方法有神经肌肉电刺激治疗、感应电疗法和对中枢作用的经颅直流电刺激(tDCS)等，但这些电刺激方法都不能直接作用到咽部粘膜、肌肉及周围神经上，治疗效果有限。
有研究者尝试通过咽部电刺激(pharyngealelectricalstimulation,PES)改善吞咽功能，PES是一种周围神经调控技术，即将电脉冲通过悬置在咽部表面的导管电极输送到咽部粘膜而发挥作用。目前，PES确切的作用机制尚未完全阐明，但其作用外周途径已基本清楚，主要是通过PES激活粘膜内的感觉神经，包括V、VII、IX、X对颅神经。PES刺激咽部粘膜的信息会被传送至脑干的孤束核、吞咽相关皮层高级中枢，再由双侧延髓背侧的中枢模式发生器进行分析及处理，后通过V、VII、IX、X、XI、XII对颅神经引起吞咽反射活动。通过这些复杂的神经调控，PES影响吞咽皮质运动信号输出。结果显示：刺激后患者的食团运送时间均缩短，渗漏、误吸减少。
PES的波形参数如下：波形：方波，频率：1Hz或5Hz(5Hz效果更佳)，脉宽：0.2ms，电压为289V。该波形参数仍在神经肌肉电刺激参数范围内，其作用是通过刺激完整的外周运动神经来激活肌肉，对中枢神经也有部分作用，但作用有限。另外，根据强度/时间曲线(如图2，来源于Rodríguez-FernándezL，Rebollo-RoldánJ，Jiménez-RejanoJJ，Güeita-RodríguezJ(2016).Strength-duration curves of the common fibularnerve show hypoexcitability in people with functional  ankle instability，PM&R)可以得知，若要更好的兴奋神经或肌肉，需要足够的脉冲持续时间和强度，而PES波形的脉冲持续时间比较小，因此需要采用更高的治疗强度。而过高的治疗强度可能会造成粘膜红肿、出血或因电极移动带来的电击感，给治疗带来不必要的风险。
发明内容
本发明所要解决的技术问题是：提供一种用于吞咽障碍治疗的方法。
为了解决上述技术问题，本发明采用的技术方案为：一种用于吞咽障碍治疗的方法，包括，
将导管电极使进行消毒后插入患者的咽腔内；
通过导管电极在患者的咽腔内施加一种引起患者吞咽反射的电刺激波形，该电刺激波形的正半周由方波和三角波结合而成；
逐渐增强电刺激强度，直到触发患者的耐受阈值时停止，然后对患者的咽腔重复进行下一回合的电刺激。
进一步的，电刺激波形的负半周为一个脉冲，该脉冲用于减少直流分量带来的电解效应，脉冲的形式包含但不限于正半周由方波和三角波结合的波形、三角波及方波。
进一步的，导管电极施加的刺激波形的频率在0.1-40Hz范围内；
进一步的，导管电极施加的刺激波形的频率为5Hz。
进一步的，导管电极施加的刺激波形的脉宽在1-50ms范围内；
进一步的，导管电极施加的刺激波形的脉宽为10ms。
进一步的，治疗时间在1-30分钟范围内。
进一步的，治疗时间为10分钟。
进一步的，导管电极包含导管及至少一对导电电极，导管的材料包含但不限于硅胶、TPU和尼龙；导电电极的材料包含但不限于不锈钢和导电硅胶。
进一步的，导管电极的导管长度为150cm，直径为3.2cm，导管每隔1cm印有标记。
进一步的，电刺激波形由电刺激设备产生，该电刺激设备包含电源模块、 高压产生模块、波形产生模块、强度控制模块和负载检测模块。
本发明的有益效果在于：通过导管电极在患者的咽腔内施加一种正半周由方波和三角波结合而成的电刺激波形，是将电流直接施加在咽部粘膜、肌肉及神经上，主要通过舌咽神经和迷走神经等有关吞咽神经的感觉上行通路刺激吞咽中枢模式发生器，兴奋吞咽相关皮层，诱导神经可塑性。使用该电刺激波形需要的电流/电压强度更小，该电刺激波形由于有足够的脉宽持续时间，因此需要兴奋神经和肌肉的强度比较小，在应用上安全性更加可靠。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图示出的机构获得其他的附图。
图1为本发明的用于吞咽障碍治疗的方法流程图；
图2为本发明的刺激兴奋性组织的强度-时间曲线；
图3为本发明的电刺激波形作用机制模式图；
图4为本发明的电刺激波形参数示意图；
图5为本发明的双极性波形示意图；
图6为本发明的导管电极示意图。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明的一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
需要说明，本发明中涉及“第一”、“第二”等的描述仅用于描述目的，而不能理解为指示或暗示其相对重要性或者隐含指明所指示的技术特征的数量。 由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。另外，各个实施例之间的技术方案可以相互结合，但是必须是以本领域普通技术人员能够实现为基础，当技术方案的结合出现相互矛盾或无法实现时应当认为这种技术方案的结合不存在，也不在本发明要求的保护范围之内。
请参阅图1，本发明的第一实施例为：一种用于吞咽障碍治疗的方法，包括步骤，
S10、将导管电极使进行消毒后插入患者的咽腔内；
首先需使用消毒湿巾(Tristel Trio)对导管(Nu-Tek)依次进行三次消毒，消毒后为避免消毒液刺激性气味需用无菌注射用水再次擦拭；用湿棉签对患者鼻腔进行清洁后，用导管从鼻腔按鼻饲管置管方式置管，初次插管通过喉镜吞咽功能评估(FEES)可直观定位咽腔电极，双电极环中的单个电极环在喉镜下留置在梨状窦口1cm内时咽腔肌电信号效果最佳。咽腔电极放置位置目前多数在在距离鼻孔13-18cm。
S20、通过导管电极在患者的咽腔内施加一种引起患者吞咽反射的电刺激波形，该电刺激波形的正半周由方波和三角波结合而成；
S30、逐渐增强电刺激强度，直到触发患者的耐受阈值时停止，然后对患者的咽腔重复进行下一回合的电刺激。
控制器常规设置5Hz电流由0.5mA按0.5mA/次逐渐增强直到患者感受到刺激，为感受阈(患者最初感受到刺激)，之后继续增强到患者感到疼痛不适不想强度再增加，为耐受阈，归零后间隔5min测量3次取平均值。电刺激持续的时间为10ms。刺激的强度为感受阈+75％(耐受阈-感受阈)。每天刺激10min。如图3为本发明的电刺激波形作用机制模式图。
本实施例中，通过导管电极在患者的咽腔内施加一种正半周由方波和三角波结合而成的电刺激波形，是将电流直接施加在咽部粘膜、肌肉及神经上，主要通过舌咽神经和迷走神经等有关吞咽神经的感觉上行通路刺激吞咽中枢模式发生器，兴奋吞咽相关皮层，诱导神经可塑性。
其中，如图5所示，为了增加治疗的舒适性，可以在波形负半周施加一个脉冲，该脉冲用于减少直流分量带来的电解效应，脉冲的形式包含但不限于正 半周由方波和三角波结合的波形、三角波及方波，如图4所示。电刺激波形可以是单级性刺激脉冲，也可以是双极性刺激脉冲。双极性刺激脉冲的负半周波形的主要作用是减少直流分量带来的电解效应。
其中，导管电极施加的刺激波形的频率在0.1-40Hz范围内；优选地，导管电极施加的刺激波形的频率为5Hz。既往咽腔电刺激实验1-40Hz进行对比发现5Hz对皮层兴奋性影响最大，皮层兴奋性和吞咽功能改变密切相关，预实验频率主要设置在0.1-10Hz之间，0.1Hz范围内多数患者喉镜下吞咽反射不够明显，5Hz时多数患者能完成多次完整及大幅度吞咽动作，刺激频率继续升高多数患者会出现咽喉部肌肉痉挛。
其中，导管电极施加的刺激波形的脉宽在1-50ms范围内；优选地，导管电极施加的刺激波形的脉宽为10ms。既往咽腔电刺激研究脉宽为0.2ms，导致刺激强度相对较大，大于20mA，容易出现局部红肿、出血、呕吐等，预实验时脉宽10ms下多数患者刺激强度可明显降低到10mA以下，而且存在可调控阈值，避免出血、红肿等高强度电刺激副作用。
其中，治疗时间在1-30分钟范围内。优选地，治疗时间为10分钟。既往研究表明每天咽腔电刺激10分钟治疗效果好，长时间刺激会产生疲劳性，预实验入组的健康人及患者在刺激7-10分钟后会出现吞咽频率及幅度下降。
其中，如图6所示，导管电极包含导管及至少一对导电电极，导管的材料包含但不限于硅胶、TPU和尼龙；导电电极的材料包含但不限于不锈钢和导电硅胶。
其中，导管电极的导管长度为150cm，直径为3.2cm，导管每隔1cm印有标记。
其中，电刺激波形由电刺激设备产生，该电刺激设备包含电源模块、高压产生模块、波形产生模块、强度控制模块和负载检测模块。
以上所述仅为本发明的实施例，并非因此限制本发明的专利范围，凡是利用本发明说明书及附图内容所作的等效结构或等效流程变换，或直接或间接运用在其他相关的技术领域，均同理包括在本发明的专利保护范围内。

Claims (11)

  1. 一种用于吞咽障碍治疗的方法，其特征在于：包括，
    将导管电极使进行消毒后插入患者的咽腔内；
    通过导管电极在患者的咽腔内施加一种引起患者吞咽反射的电刺激波形，该电刺激波形的正半周由方波和三角波结合而成；
    逐渐增强电刺激强度，直到触发患者的耐受阈值时停止，然后对患者的咽腔重复进行下一回合的电刺激。
  2. 如权利要求1所述的用于吞咽障碍治疗的方法，其特征在于：电刺激波形的负半周为一个脉冲，该脉冲用于减少直流分量带来的电解效应，脉冲的形式包含但不限于正半周由方波和三角波结合的波形、三角波及方波。
  3. 如权利要求2所述的用于吞咽障碍治疗的方法，其特征在于：导管电极施加的刺激波形的频率在0.1-40Hz范围内；
  4. 如权利要求3所述的用于吞咽障碍治疗的方法，其特征在于：导管电极施加的刺激波形的频率为5Hz。
  5. 如权利要求4所述的用于吞咽障碍治疗的方法，其特征在于：导管电极施加的刺激波形的脉宽在1-50ms范围内；
  6. 如权利要求5所述的用于吞咽障碍治疗的方法，其特征在于：导管电极施加的刺激波形的脉宽为10ms。
  7. 如权利要求1所述的用于吞咽障碍治疗的方法，其特征在于：治疗时间在1-30分钟范围内。
  8. 如权利要求7所述的用于吞咽障碍治疗的方法，其特征在于：治疗时间为10分钟。
  9. 如权利要求1所述的用于吞咽障碍治疗的方法，其特征在于：导管电极包含导管及至少一对导电电极，导管的材料包含但不限于硅胶、TPU和尼龙；导电电极的材料包含但不限于不锈钢和导电硅胶。
  10. 如权利要求9所述的用于吞咽障碍治疗的方法，其特征在于：导管电极的导管长度为150cm，直径为3.2cm，导管每隔1cm印有标记。
  11. 如权利要求1所述的用于吞咽障碍治疗的方法，其特征在于：电刺激 波形由电刺激设备产生，该电刺激设备包含电源模块、高压产生模块、波形产生模块、强度控制模块和负载检测模块。
PCT/CN2021/113390 2021-05-06 2021-08-19 一种用于吞咽障碍治疗的方法 WO2022233103A2 (zh)

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