WO2020207341A1 - 一种提高皮肤再生效率的软组织扩张器 - Google Patents

一种提高皮肤再生效率的软组织扩张器 Download PDF

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WO2020207341A1
WO2020207341A1 PCT/CN2020/083142 CN2020083142W WO2020207341A1 WO 2020207341 A1 WO2020207341 A1 WO 2020207341A1 CN 2020083142 W CN2020083142 W CN 2020083142W WO 2020207341 A1 WO2020207341 A1 WO 2020207341A1
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soft tissue
vibration device
massage
skin regeneration
expansion
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PCT/CN2020/083142
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English (en)
French (fr)
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方斌
谢芸
单圣周
李青峰
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上海交通大学医学院附属第九人民医院
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Publication of WO2020207341A1 publication Critical patent/WO2020207341A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/02—Devices for expanding tissue, e.g. skin tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive

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  • the invention relates to the technical field of medical devices, in particular to a soft tissue expander for improving skin regeneration efficiency.
  • Soft tissue expanders also known as skin soft tissue expanders (hereinafter referred to as expanders), are often used in plastic surgery and repair and reconstruction, and are widely used in clinical treatment.
  • the expander is a device designed to use the physiological function of expanding and increasing the area of the skin soft tissue under a certain tension.
  • the increased skin and soft tissue obtained after tissue expansion is used to repair the tissue wound or tissue defect to be treated, or to reconstruct the corresponding tissue and organ.
  • the skin soft tissues increased by expansion have similar colors, textures, or hairs to adjacent skin tissues, and no new defects and deformities are generated, so that better plastic surgery and repair and reconstruction effects can be obtained.
  • the structure of a common dilator consists of three parts: a dilatation balloon, a catheter, and an injection bottle. Patients need to gradually increase mechanical tension on the skin through twice a week water injection to complete skin regeneration. Usually such a cycle takes three months to one year. The expansion process is long. The patient's built-in dilator becomes heavier and heavier after water injection. Life brings inconvenience.
  • the present invention provides a soft tissue expander for improving skin regeneration efficiency, which solves the problem of too long skin expansion process in the prior art.
  • a soft tissue dilator for improving skin regeneration efficiency comprising: a dilatation balloon, an injection bottle, and a catheter connecting the expansion balloon and the injection bottle, and a massage vibration device; the massage vibration device is arranged in the cavity of the expansion balloon ; The massage vibration device is controlled remotely.
  • the massage vibration device avoids contact with the injected physiological saline inside the expansion capsule.
  • the massage vibration device is a miniature massage vibration device, which uses a built-in battery or wireless charging for power supply.
  • the massage vibration device is provided with different massage modes, sizes and times. It aims to improve the growth efficiency of the skin with different mechanical stimulation.
  • the water injection bottle includes a casing and a water injection bowl arranged in the casing; the water injection bowl has a hollow cavity inside, and the conduit passes through the casing of the water injection bottle and is connected with The hollow cavities of the water injection bowl are communicated; during use, it is convenient to complete the water injection operation.
  • the pressure sensor is attached to the surface of the massage vibration device. Perceive the pressure change after vibration massage and indirectly judge the effect of skin regeneration.
  • the pressure sensor is a flexible pressure sensor.
  • the massage vibration mode of the massage vibration device is monitored by a physician through a mobile phone app, or is set to remind the patient to start massage regularly.
  • the expansion balloon is made of medical grade medical silicone material.
  • the outer surface of the expansion capsule is provided with a bacteriostatic coating.
  • the antibacterial coating is made of nano silver or nano zinc.
  • the antibacterial coating is an antibiotic coating.
  • the remote control massage vibration device generates vibration, so that the soft tissue on the outer surface of the expander is stimulated by appropriate mechanical force, thereby accelerating the skin regeneration speed, shortening the expansion time, and accelerating the treatment process.
  • the massage vibration device does not come into contact with the liquid in the capsule and is safe.
  • the massage vibration device can be equipped with a pressure sensor to sense the pressure change in the capsule after vibration massage, and indirectly judge the effect of skin regeneration.
  • Fig. 1 is a schematic diagram of a soft tissue expander for improving skin regeneration efficiency of Example 1.
  • the present invention is based on the existing research, and specifically proposes a new skin soft tissue expansion mode, which improves the existing expansion efficiency.
  • the inventor has developed a soft tissue expander that improves the efficiency of skin regeneration through vibration, and uses different vibration methods to reduce slight pain during expansion or discomfort to nerve compression.
  • the improvement of the present invention is that a vibration massage device is added on the basis of the existing soft tissue expander.
  • the massage vibration device is located in the cavity of the expansion capsule and is wrapped with silicone.
  • the vibration massage device can be purchased or customized.
  • Related massager manufacturers or medical equipment development companies can customize similar products.
  • the selected vibration modes include sinusoidal vibration, random vibration, fixed frequency vibration and compound vibration.
  • the motor currently available on the market is a miniature vibration motor wrapped in a plastic shell with a total mass of 1g.
  • the outer plastic shell is 13.4mm long, 5.6mm wide, and 5mm high; the inner motor has a diameter of 4mm; suitable voltage is 3V-3.7V, and current is 100mA.
  • the remote control method belongs to the existing mature technology.
  • a soft tissue dilator 1 for improving the efficiency of skin regeneration includes a dilatation balloon 11, an injection bottle 12, a catheter 13, and a massage vibration device 14.
  • the dilatation balloon 11 and the injection bottle 12 are connected by a catheter 13. Since the expansion balloon 11, the injection bottle 12, and the catheter 13 need to be embedded in the subcutaneous layer, the expansion balloon 11, the injection bottle 12, and the catheter 13 need to be medically Grade medical silicone material to prevent infection.
  • the massage vibration device 14 in this embodiment is arranged inside the expansion capsule 11, and the outside of the massage vibration device 14 is wrapped with a silicone layer (not shown in the figure), which can transmit mechanical force and avoid contact with the inside of the expansion capsule 11. It is safe to contact with other fillings such as normal saline.
  • the massage vibration device 14 uses a miniature massage vibration device, which uses a built-in battery or a wireless charging method for power supply.
  • the micro massage vibration device can be purchased on the market.
  • the micro-massage vibration device used is an implantable micro-vibration motor.
  • the motor currently available on the market is a micro-vibration motor wrapped in a plastic shell with a total mass of 1g.
  • the outer plastic shell is 13.4mm long, 5.6mm wide, and 5mm high; the inner motor has a diameter of 4mm; suitable voltage is 3V-3.7V, and current is 100mA.
  • the vibration mode, intensity, frequency and time of the massage vibration device will be adjusted according to the patient's expansion position, tolerance and expected time, so as to obtain the best expansion effect.
  • the mini-massage vibration device in this embodiment can transmit data such as the massage mode frequency, intensity, time and other real-time data to the mobile phone app or computer terminal, and the patient and the doctor can dynamically monitor changes in the dilator capsule pressure before and after treatment in real time. This will help adjust the vibration scheme and improve the efficiency of skin regeneration.
  • a pressure sensor (not shown in the figure) is also provided in this embodiment; the pressure sensor uses a film sensor on the market (that is, a flexible pressure sensor, commercially available) and is attached to the surface of the massage vibration device. By sensing the pressure change after vibration massage, the effect of skin regeneration can be indirectly judged.
  • a pressure wireless transmission system composed of a mobile phone terminal is taken as an example.
  • the APP is an application program that can be operated and operated based on the mobile phone terminal and remotely controlled by the mobile phone. Therefore, the mobile phone terminal can receive the massage and vibration treatment of the skin in real time
  • the data, as well as the pressure change in the capsule before and after the treatment, and the data change of the pressure sensor can determine the effect state of the expansion treatment on the skin surface to monitor the skin tension in real time. According to the program setting of the APP, a reminder will be sent out every day to remind the patient to perform massage treatment.
  • the wireless communication method in the present invention can adopt existing relatively mature signal transmission methods, such as WIFI, Bluetooth, 3G/4G/5G, 6LoWPAN, LoRa, ZigBee, or other wireless signal transmission methods.
  • the power supply module of the wireless data transmitter may be a rechargeable thin film power supply or a lithium battery.
  • the power supply mode can be solar energy, or the use of collecting human body heat or mechanical energy when the human body moves as the power supply for the electronic monitoring system, or recharging the batteries that power these systems. Therefore, according to the manufacturing process, the wireless data transmitter and the power supply module may not be arranged in the injection bottle, that is, they may be directly integrated on the micro massage vibrator 14.
  • the shape of the dilatation balloon 11 is generally circular or elliptical, which can be set by those skilled in the art as required, which belongs to the content of the prior art. Those skilled in the art can decide whether to install a bacteriostatic coating according to needs.
  • the antibacterial coating is an antibiotic coating, or is made of nano silver or nano zinc, which can effectively prevent infection or inflammation from occurring. In this embodiment, no antibiotic coating is provided on the outer surface of the expansion balloon 1.
  • the above-mentioned pouring kettle 12 includes a housing 121 and a water pouring bowl 122 arranged in the housing 121; the interior of the water pouring bowl 122 has a hollow cavity 123, and the conduit 13 passes through the housing 121 of the pouring kettle 12 and is connected to the hollow of the water pouring bowl 122.
  • the cavity 123 is connected to facilitate the completion of the water injection operation.
  • the vibration strength can be reduced, reducing the compression of the forearm nerve by the expander; at the same time, as described in the massage vibration device
  • the flexible pressure sensor on the surface will monitor the internal pressure of the dilator in real time, which can indirectly reflect the regeneration speed of the skin, provide a basis for judging the effect of skin regeneration, and achieve flexible adjustment of the relevant parameters of the vibration device, thereby reducing the occurrence of related complications , And provide a basis for the end of the expansion in the late expansion period, and further ensure the safety and reliability of the rapid growth of the expanded skin.
  • the skin and soft tissue expander of the present invention can be massaged by vibration. In addition to shortening the time for skin expansion, it also reduces the pain after the expander is filled with water, reduces the discomfort of nerve compression during expansion, and can control the way of massage. If a mobile phone app is used , And the time and cycle of massage can be controlled remotely by the physician. It can remind patients and doctors at the same time whether they have forgotten to massage, and achieve two-way monitoring.

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  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

一种提高皮肤再生效率的软组织扩张器（1），包括：扩张囊（11）、注水壶（12）以及连接该扩张囊（11）和注水壶（12）的导管（13），还包括按摩振动装置（14）；该按摩振动装置（14）设置在该扩张囊（11）的腔内；该按摩振动装置（14）通过远程控制。该软组织扩张器（1）的优点是：在软组织扩张期间，通过远程控制按摩振动装置（14）产生振动，使扩张器（1）外表面的软组织受到适当机械力的刺激，从而加速皮肤再生速度，缩短扩张时间，加速治疗进程。

Description

一种提高皮肤再生效率的软组织扩张器 技术领域
本发明涉及医疗器械技术领域，特别是一种提高皮肤再生效率的软组织扩张器。
背景技术
软组织扩张器，又称皮肤软组织扩张器(以下简称扩张器)，常用于整形和修复重建的外科手术治疗，广泛应用于临床治疗。扩张器是利用皮肤软组织在一定的张力下，有扩张并增加面积的生理功能而设计的器械。利用组织扩张后获得的增加的皮肤软组织，来修复所要治疗的组织创伤或组织缺损，或进行相应的组织器官的重建再造。通过扩张增加的皮肤软组织具有和相邻皮肤组织相近似的色泽、质地、或毛发，不产生新的缺损畸形，从而获得较好的整形美容和修复重建疗效。
普通的扩张器的结构由扩张囊、导管和注水壶三个部分构成。患者需要通过一周两次的注水逐步对皮肤增加机械牵张力，从而完成皮肤再生，通常这样的周期需要三个月到一年，扩张过程漫长，患者内置的扩张器注水后越来越重，对生活带来不便。
因此，设计一种提高皮肤再生效率的软组织扩张器，是十分必要的。
内容
本发明提供一种提高皮肤再生效率的软组织扩张器，解决了现有技术中皮肤扩张过程太长的问题。
本发明所解决的技术问题采用以下技术方案来实现：
一种提高皮肤再生效率的软组织扩张器，包括：扩张囊、注水壶以及连接 所述扩张囊和注水壶的导管，还包括按摩振动装置；所述按摩振动装置设置在所述扩张囊的腔内；所述按摩振动装置通过远程控制。
作为优选的技术方案，所述按摩振动装置的外部使用硅胶封闭之后，再置于所述扩张囊的腔内。这样按摩振动装置则避免了与扩张囊内部的注射生理盐水的接触。
作为优选的技术方案，所述按摩振动装置为微型按摩振动装置，其采用内置电池，或无线充电的方式进行供电。
作为优选的技术方案，所述按摩振动装置设置有不同按摩的模式、大小以及时间。旨在以不同的机械刺激力提高皮肤的生长效率。
作为优选的技术方案，所述注水壶包括外壳，以及设置在所述外壳内的注水碗；所述注水碗的内部具有中空的腔体，所述导管穿过所述注水壶的外壳，并与所述注水碗的中空的腔体相连通；在使用过程中，以便于完成注水操作。
作为优选的技术方案，还包括压力传感器；所述压力传感器贴附在所述按摩振动装置的表面。感知振动按摩后的压力变化，间接判断皮肤再生的效果。其中压力传感器为柔性压力传感器。
作为优选的技术方案，所述按摩振动装置的按摩振动方式通过手机app，由医师进行监控，或设置提醒患者定期开启按摩。
作为优选的技术方案，所述扩张囊由医疗级医用硅胶材料制成。
作为优选的技术方案，所述扩张囊的外表面设有抑菌涂层。
作为优选的技术方案，所述抑菌涂层由纳米银或纳米锌制成。
作为优选的技术方案，所述抑菌涂层为抗生素涂层。
有益效果
(1)在软组织扩张期间，通过远程控制按摩振动装置产生振动，使扩张器外表面的软组织受到适当机械力的刺激，从而加速皮肤再生速度，缩短扩张时间，加速治疗进程。
(2)在机械力的作用下可减少每次注水后短暂的轻微疼痛。
(3)减少扩张晚期在某些特殊部位对神经卡压的不适。
(4)无线传输按摩数据至手机app，可以智能通知医师及患者本人。
(5)按摩振动装置不与囊内液体接触，安全。
(6)按摩振动装置可配有压力传感器，感知振动按摩后囊内的压力变化，间接判断皮肤再生的效果。
附图说明
为了更清楚地说明本发明实施方案或现有技术中的技术方案，下面将对实施方案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方案，对于本领域普通技术人员来讲，在不付出创造性劳动性的前提下，还可以根据这些附图获得其他的附图。
图1为实施例1的提高皮肤再生效率的软组织扩张器示意图。
具体实施方式
为了使本专利实现的技术手段、创作特征、达成目的与功效易于明白了解，下面结合具体图示，进一步阐述本实用新型。
本发明是基于现有的研究，有针对性的提出了一种新型的皮肤软组织扩张模式，提高了现有的扩张效率。本发明人在实践的基础上，研发了一种通过振动提高皮肤再生效率的软组织扩张器，并通过不同的振动方式减缓扩张期间的轻微疼痛或是对神经卡压的不适。
本发明的改进点在于在现有软组织扩张器的基础上增加了振动按摩装置，该按摩振动装置位于扩张囊的腔体内，并且使用硅胶包裹。而且该振动按摩装置可以购买，也可以定制，有相关按摩器生产厂家或是医疗设备开发公司可以定制类似产品，选择的振动方式包括正弦振动、随机振动、定频振动和复合振动。举例：网购可以买到一种微型按摩振动装置，为可植入微型振动电机，目前市场上可参考的电机为外层包裹塑料外壳的微型振动马达，总质量1g。外层塑料外壳长13.4mm、宽5.6mm、高5mm；内层马达直径4mm；适合电压为3V-3.7V，电流为100mA。可以使用但不限于这种规格的产品。其远程控制方式属于现有成熟技术。
下面，进一步详述本发明的方案。
参见图1所示：一种提高皮肤再生效率的软组织扩张器1，包括：扩张囊11、注水壶12、导管13、按摩振动装置14。其中，扩张囊11和注水壶12通过导管13相连通，由于扩张囊11、注水壶12及导管13均需要埋置于皮肤下层，因此，扩张囊11、注水壶12及导管13均需要采用医疗级医用硅胶材料制作，以防止发生感染。本实施例中的按摩振动装置14设置在扩张囊11的内部，并且按摩振动装置14的外部包裹有硅胶层(图中未示出)，这样既能够传送机械力又能避免与扩张囊11内部的生理盐水等其它填充物接触，所以很安全。其中按摩振动装置14使用微型按摩振动装置，其采用内置电池，或无线充电 的方式进行供电。该微型按摩振动装置可以在市场上购买。所使用的微型按摩振动装置为可植入微型振动电机，目前市场上可参考的电机为外层包裹塑料外壳的微型振动马达，总质量1g。外层塑料外壳长13.4mm、宽5.6mm、高5mm；内层马达直径4mm；适合电压为3V-3.7V，电流为100mA。在具体使用时，将根据患者的扩张部位、耐受程度及预期时间调节按摩振动装置的振动模式、强度、频率及时间，从而获得最佳的扩张效果。
本实施例中的微型按摩振动装置，可以将当日的按摩模式频率力度时间等数据实时传输到手机app或是电脑终端，患者与医护可同步实时动态监测到治疗前后扩张器囊内压的变化。这样将有利于调整振动的方案，提高皮肤再生的效率。
本实施例中还设有压力传感器(图中未示出)；该压力传感器使用市场上的薄膜传感器(即柔性压力传感器，市售)，贴附在按摩振动装置的表面。通过感知振动按摩后的压力变化，间接判断皮肤再生的效果。
本发明实施例以手机终端组成的压力无线传输系统为例，APP是应用程序，可基于手机终端进行运行操作，通过手机进行远程控制，因此，手机终端可以实时的接收到皮肤受到的按摩振动治疗数据，以及治疗前后的囊内压力变化，压力传感器的数据变化，能够判断皮肤表面的扩张治疗的效果状态，以实时监测皮肤的张力。根据APP的程序设定，每天会发出提醒，提醒患者进行按摩治疗。
本发明中的无线通讯方式可以采用现有的比较成熟的信号传输方法，如WIFI、蓝牙、3G/4G/5G、6LoWPAN、LoRa、ZigBee或者采用其他的无线信号传输方式。
为了节省注水壶12的空间，无线数据传送器的供电模块可以为可充电的薄膜电源或者为锂电池。其中，供电方式可以是太阳能、或者采用收集人类自身的体热或人体运动时候的机械能作为给电子监测系统供电、或者对为这些系统供电的电池进行再充电。因此根据制作时的工艺，无线数据传送器和供电模块可以不设置在注水壶内，即直接集成于微型按摩振动器14上。
扩张囊11的形状一般为圆形或椭圆形，本领域技术人员根据需要设置，这属于现有技术的内容。本领域技术人员可以根据需要决定是否设置抑菌涂层。其中，抑菌涂层为抗生素涂层，或者由纳米银或纳米锌制成，其能够有效的防止感染或发炎等病症的发生。本实施例在扩张囊1的外表面没有设置抗生素涂层。
上述注水壶12包括外壳121，以及设置在外壳121内的注水碗122；注水碗122的内部具有中空的腔体123，导管13穿过注水壶12的外壳121，并与注水碗122的中空的腔体123相连通，以便于完成注水操作。
当扩张器应用于前臂部皮肤扩张时，我们将根据患者的皮肤条件、耐受程度及预期时间调节按摩振动装置的振动模式、强度、频率及时间，在扩张早、中期明显加快皮肤生长速率，使得原本6-12个月的扩张时间缩短在3个月内，晚期随着扩张器增大可减少振动的力度，减少扩张器对前臂神经卡压的症状；同时，如在所述按摩振动装置的表面的柔性压力传感器将实时监控扩张器的囊内压，可间接反映皮肤的再生速度，为判断皮肤再生的效果提供依据，实现对振动装置相关参数的灵活调节，从而减少相关并发症的发生，并且为扩张晚期结束扩张提供依据，进一步保证扩张皮肤迅速生长的安全性 与可靠性。
本发明的皮肤软组织扩张器能够通过振动按摩，除了可以缩短皮肤扩张的时间，更减少扩张器注水后的疼痛，减少扩张期间对神经卡压的不适，而且能够控制按摩的方式，如果采用手机app，更可以由医师远程控制按摩的时间和周期。可以同时提醒患者及医生，是否有忘记按摩，做到双向监控。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (7)

  1. 一种提高皮肤再生效率的软组织扩张器，包括：扩张囊、注水壶以及连接所述扩张囊和注水壶的导管，其特征在于，还包括按摩振动装置；所述按摩振动装置设置在所述扩张囊的腔内；所述按摩振动装置通过远程控制。
  2. 根据权利要求1所述的一种提高皮肤再生效率的软组织扩张器，其特征在于，所述按摩振动装置的外部使用硅胶封闭之后，再置于所述扩张囊的腔内。
  3. 根据权利要求1或2所述的一种提高皮肤再生效率的软组织扩张器，其特征在于，所述按摩振动装置为微型按摩振动装置，其采用内置电池，或无线充电的方式进行供电。
  4. 根据权利要求1或2所述的一种提高皮肤再生效率的软组织扩张器，其特征在于，所述按摩振动装置设置有不同按摩的模式、大小以及时间。
  5. 根据权利要求1所述的一种提高皮肤再生效率的软组织扩张器，其特征在于，所述注水壶包括外壳，以及设置在所述外壳内的注水碗；所述注水碗的内部具有中空的腔体，所述导管穿过所述注水壶的外壳，并与所述注水碗的中空的腔体相连通；在使用过程中，以便于完成注水操作。
  6. 根据权利要求1所述的一种提高皮肤再生效率的软组织扩张器，其特征在于，还包括压力传感器；所述压力传感器贴附在所述按摩振动装置的表面。
  7. 根据权利要求6所述的一种提高皮肤再生效率的软组织扩张器，其特征在于，所述压力传感器为柔性压力传感器。
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