WO2020037706A1 - 一种足下垂功能性电刺激治疗仪 - Google Patents

一种足下垂功能性电刺激治疗仪 Download PDF

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Publication number
WO2020037706A1
WO2020037706A1 PCT/CN2018/103440 CN2018103440W WO2020037706A1 WO 2020037706 A1 WO2020037706 A1 WO 2020037706A1 CN 2018103440 W CN2018103440 W CN 2018103440W WO 2020037706 A1 WO2020037706 A1 WO 2020037706A1
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Prior art keywords
electrodes
electrode
therapeutic apparatus
control circuit
small
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PCT/CN2018/103440
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English (en)
French (fr)
Inventor
谢春虎
刘昌�
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深圳讯丰通医疗股份有限公司
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Priority to DE212018000201.0U priority Critical patent/DE212018000201U1/de
Priority to US16/611,740 priority patent/US11406821B2/en
Publication of WO2020037706A1 publication Critical patent/WO2020037706A1/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
    • A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • 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
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • 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
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • 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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A61N1/37223—Circuits for electromagnetic coupling

Definitions

  • the invention belongs to the field of electrotherapy equipment, and particularly relates to an integrated foot drop functional electrical stimulation therapy instrument based on a sequence electrode.
  • Foot drop is one of the signs of orthopedic surgery.
  • the patient is seated with both lower limbs naturally dangling. If the foot is in the plantar flexion position and is unable to actively dorsiflexion and varus or valgus at all, the foot is drooping.
  • Common methods for treating foot drop include foot warming therapy, rehabilitation exercise, acupuncture and massage, wearing braces, tibialis anterior and long extensor tendon suspension, posterior tibial tendon transfer for foot drop, and gastrocnemius medial and lateral head forward , Reconstruction of toe extension function, surgical resection, electrical stimulation and so on.
  • Foot drop and foot inversion are a direct manifestation of lower limb dysfunction in patients with hemiplegia.
  • the functional electrical stimulation therapy device in the prior art does not have a waterproof function, the band is separated from the host, the band is not durable and the replacement is cumbersome, the electrode sheet is a hydrogel electrode, and it must be replaced frequently when the life is short. Positioning is also more complicated.
  • the object of the present invention is to provide an integrated foot drop functional electrical stimulation therapy device based on sequence electrodes, which is durable, simple to operate, long in life, and suitable for different people.
  • the present invention provides a functional instrument for treating foot droop, including an upper case, a waterproof ring, a control circuit, a lower case, a bracket integrally formed with the lower case, a serial small electrode, and a large electrode;
  • the large electrodes are embedded in the lower case and the surface of the bracket by an in-mold injection molding process, and the serial small electrodes and the large electrodes are stainless steel metal electrodes.
  • control circuit is connected to a magnetic connector, and the magnetic connector is disposed in the lower case and connected to a charging line through a charging hole of the lower case, and the charging hole is in a closed state when idle.
  • control circuit is connected to the magnetic connector through the magnetic connector circuit board.
  • the inner surface of the upper case is provided with a limiting frame, a first flexible circuit board is affixed inside the limiting frame, a button logo is set on the outer surface of the upper case and the first flexible circuit board, the first flexible circuit board and the control circuit Connected for transmitting user key information to the control circuit.
  • a wire groove is provided on the surface of the bracket for mounting a second flexible circuit board having a pad position, and the second flexible circuit board is connected to the control circuit through the pad position; the serial small electrode has a protrusion connected to the pad position, Thus connected with the control circuit.
  • cover surface is provided with a cover plate groove and a flexible circuit cover plate matched with the cover plate groove, and the wire groove is provided in the cover plate groove.
  • the serial small electrode includes at least 6 small electrodes, and multiple small electrodes are symmetrically distributed.
  • the large electrodes are oblong. Each of the small electrodes in the sequence is square.
  • the control circuit, the small electrode, the human body and the large electrode form an electrical stimulation circuit. .
  • the surface of the lower shell 4 and the bracket 7 is covered with soft glue, and the soft glue is extended to form a band.
  • the front end of the upper shell is provided with hanging ears
  • the strap is provided with Velcro wool and Velcro puncture
  • the Velcro wool is fixed on the upper end of the strap by sewing process
  • the Velcro puncture is fixed on the strap by sewing process.
  • the strap passes through the mounting ears and is fixed with a Velcro after the return. The length of the return is adjusted and fixed by the Velcro.
  • the strap is made of TPE or TPU material.
  • the large electrode can cover the intersection of the common peroneal nerve
  • the small electrode can cover the branch of the common peroneal nerve
  • the back end of the bracket has a positioning fulcrum, which is 1-5 mm away from the small electrode closest to it, and the large electrode 6 is 10-15 mm away from the small electrode closest to it.
  • the present invention has the following advantages:
  • the present invention adopts an integrated waterproof design, which makes the electrodes and straps more durable and easier to operate.
  • the present invention adopts stainless steel electrodes, and the stainless steel has good electrical conductivity, wear resistance and durability, and does not need to be replaced.
  • the present invention uses a sequence electrode, which can cover the neuromuscular of different people.
  • FIG. 1 is a schematic structural diagram of a host of a foot drop functional electrical stimulation therapy apparatus according to an embodiment of the present invention
  • FIG. 2 is a partial enlarged view of a structural composition diagram of a host of a foot drop functional electrical stimulation therapy apparatus according to an embodiment of the present invention
  • FIG. 3 is an overall waterproof design diagram of a foot drop functional electrical stimulation therapy apparatus according to an embodiment of the present invention.
  • FIG. 4 is a schematic diagram of a waterproof structure of a communication interface of a functional electrical stimulation therapy instrument for foot drop according to an embodiment of the present invention
  • FIG. 5 is a schematic diagram of a waterproof structure of a button of a foot drop functional electrical stimulation therapy apparatus according to an embodiment of the present invention
  • FIG. 6 is a schematic structural diagram of a stent of a functional instrument for treating foot droop according to an embodiment of the present invention
  • FIG. 7 is a schematic structural diagram of a bandage of a foot drop functional electrical stimulation therapy apparatus according to an embodiment of the present invention.
  • FIG. 8 is a schematic diagram of a sequence small electrode combination structure of a functional instrument for treating foot droop according to an embodiment of the present invention.
  • FIG. 9 is a schematic diagram of an electrode structure of a foot drop functional electrical stimulation therapy apparatus according to an embodiment of the present invention.
  • FIG. 10 is a schematic diagram of an electrical stimulation circuit of a foot drop functional electrical stimulation treatment apparatus according to an embodiment of the present invention.
  • the electrical stimulation therapy apparatus of the present invention is composed of an upper case 1, a waterproof ring 2, a control circuit 3, a lower case 4, a bracket integrally formed with the lower case, a sequence of small electrodes 5, and a large electrode 6.
  • the serial small electrode 5 is embedded in the bracket 7 by an in-mold injection molding process
  • the large electrode 6 is embedded in the lower case 4 by an in-mold injection molding process.
  • the upper case 1, the waterproof ring 2, and the lower case 4 form a sealed space to realize the waterproof function.
  • the control circuit 3 will not be infiltrated by liquids such as water in the sealed space, which ensures that the electronic components are in the condition of water outside. It can also work normally, and the electronic circuit is waterproofed.
  • the serial small electrode 5 and the large electrode 6 are stainless steel metal electrodes, and the electrodes are waterproofed.
  • the lower shell 4, the bracket 7, and the strap 8 are integrally formed, and the surface is covered with a layer of soft glue to achieve the waterproof function.
  • the control circuit can detect the state of movement of the legs and output electrical stimulation to the sequence of small electrodes 5 and large electrodes 6; the sequence of small electrodes 5 and large electrodes 6 are in contact with the skin of the legs, and assisted walking through electrical stimulation.
  • the control circuit, the serial small electrodes 5, the human body and the large electrodes 6 constitute an electrical stimulation circuit.
  • the electrode is separated from the host (here the host includes an upper case, a control circuit, and a lower case). Connect the electrode to the main unit before use.
  • the electrode is generally a hydrogel electrode.
  • the hydrogel electrode is not durable and needs to be replaced frequently.
  • the present invention uses a stainless steel metal electrode.
  • the stainless steel has good conductivity and wear resistance and does not need to be replaced.
  • the present invention combines the stainless steel electrode with the host.
  • the in-mold injection molding process is integrally injection-molded, that is, the electrodes are embedded in the lower surface of the lower case 4 and the bracket 7 to realize the integration of the electrodes.
  • the band is also separated from the host.
  • the material of the band is generally cloth, which is not easy to clean and not durable.
  • the present invention uses soft rubber (such as TPE, TPU, etc.) as the band.
  • the material is durable, elastic and stretchable, and can be molded into the desired shape.
  • the strap and the bracket are integrally formed by a two-shot injection molding process to realize the integration of the strap and the host.
  • the waterproof ring 2 is located in the middle of the upper shell 1 and the lower shell 4.
  • the waterproof ring 2 is in contact with the side walls of the upper shell 1 and the lower shell 4, respectively.
  • the interference fit is adopted.
  • Soft rubber materials such as rubber are elastic and deformable.
  • the waterproof ring 2 is tightly squeezed between the side walls of the upper and lower shells to achieve waterproofing of the upper and lower shell assembly gaps.
  • the upper and lower shells can be assembled and fixed by buckle, ultrasonic welding, or screws.
  • the large electrode 6 is located at the bottom of the lower case 4 and is embedded in the outer surface of the lower case 4 by an in-mold injection process.
  • the in-mold injection process can use electrodes and the lower case to closely contact together.
  • the control circuit has a charging and communication interface.
  • this interface is MICRO USB or TYPE USB, but it is not waterproof. Therefore, the present invention adopts a magnetic connector, that is, a magnetic connector 13 is provided on the charging interface of the control circuit.
  • the magnetic connector 13 is located inside the lower case 4 and externally connects the charging cable and the charging cable through the lower casing charging hole 15. The terminals are attracted to the magnetic connector 13 to realize the charging function. Because the magnetic connector is solid as a whole, it can be waterproofed during charging or communication.
  • the in-mold injection molding process is used to place the magnetic connector 13 in the mold, and the plastic in the charging hole 15 of the lower shell 4 tightly wraps the magnetic connector 13. There is no assembly gap between the two to prevent water and other liquids. 'S entry. When not charging normally, that is, when idle, the charging hole 15 is in a closed state.
  • the magnetic connector 13 cannot be directly connected to the control circuit 3, and needs to be converted or directly welded with a connecting wire.
  • the external connector requires a small and precise connector and the cost is also small. High, easy to break the reliability of the wire at the direct welding point.
  • the magnetic connector 13 is directly soldered to the magnetic connector circuit board 14, and then the solder pads 141 on the magnetic connector circuit board 14 and the solder pads 31 on the control circuit 3 are soldered together.
  • the magnetic connector circuit board 14 is closely attached to the main board control circuit 3, and the pads of the two are next to each other for soldering.
  • the keys are designed as touch keys, and the touch sensing part is implemented by means of a first flexible circuit board.
  • the flexible circuit board 16 is closely adhered to the inner surface of the upper case 1 with 3M adhesive. Inside the box. In this way, the mechanical gaps avoided are waterproof.
  • the upper case 1 is a complete housing with a smooth outer surface and silk-screened button logos. When operating, touch your finger to the button identification area on the outer surface of the upper case 1. The circular sensing area corresponding to the flexible circuit board 16 can be detected. Related signals.
  • the flexible circuit board 16 can sense the key signal within the range of 1-2 mm of the thickness of the upper shell 1.
  • the large electrode 6 and the lower case 4, the serial small electrode 5 and the bracket 7 are integrally injection-molded.
  • the bracket 7 is made of a soft rubber material with a higher hardness.
  • the lower case 4 is connected to the upper electrode of the serial small electrode 5. Partly constitutes the first deformed area 41, and the part where the upper electrode of the serial small electrode 5 is connected to the middle electrode constitutes the second deformed area 42, and the part where the middle electrode of the serial small electrode 5 is connected to the lower electrode constitutes the third deformed area 43,
  • Each deformed area is made of soft rubber material, so the gaps between the three sets of sequential small electrodes can be bent and deformed, so that the serial small electrodes 5 can adapt to the different leg diameters of the patient to closely contact the leg skin.
  • the soft glue 8 tightly wraps the lower case 4 and the large electrode 6 as well as the serial small electrode 5 and the bracket 7 to form an integrated electrode.
  • the soft glue 8 of FIG. 6 extends downward to form the strap 9 of FIG. 7.
  • the soft glue can be TPE or TPU.
  • the Velcro wool 10 is fixed to the upper end of the strap 9 by a sewing process, and the Velcro puncture 11 It is fixed to the lower end of the strap 9 by sewing process.
  • the strap 9 passes through the mounting ears 12 in FIG. 6 and is fixed by a Velcro after the return. The length of the return is adjusted and fixed by the Velcro to make the strap easily and reliably fixed. On the legs.
  • the serial small electrode 5 and the bracket 7 are integrally injection-molded, and the bracket 7 is made of a soft rubber material.
  • the upper surface of the bracket 7 is provided with a cover plate groove 72 and a flexible circuit cover plate 71 cooperating with the cover plate groove 72.
  • the flexible circuit cover plate 71 is assembled on the cover plate groove 72 to form a closed space that blocks the outer layer of soft rubber.
  • the outer layer of soft glue cannot enter the cover slot 72.
  • the cover groove 72 is also provided with a wire groove 73 for mounting a flexible circuit board 74.
  • the flexible circuit board 74 can be bent and extended freely in the wire groove 73.
  • a single electrode of the serial small electrode 5 has an inward protrusion, and is connected to the control circuit through the pads of the flexible circuit board 74, so that the electrical connection between the serial small electrode 5 and the flexible circuit board 74 can be achieved through a soldering process.
  • the sequence of the small electrodes 5 and the large electrodes 6 is arranged left and right, symmetrical up and down, and is applicable to both left and right legs.
  • the large electrode 6 is oblong and the small electrode is square.
  • the small electrode, the large electrode, the lower leg, and the electrical stimulation generating circuit constitute an electrical stimulation circuit, as shown in FIG. 10. Without this circuit, the stimulation current cannot be formed, and the function of assisting walking dorsiflexion cannot be achieved. In order to achieve the function of dorsiflexion of the foot, the large electrode must cover the junction of the common peroneal nerve, and the small electrode must cover the branch of the common peroneal nerve.
  • the positioning point 21 is located at the rear end of the bracket 7 and is 1-5 mm away from the nearest small electrode, and the large electrode 6 is 10-15 mm away from the nearest small electrode. During use, the positioning point 21 is aligned with the center of the lower edge of the knee metatarsal.
  • the large electrode 6 covers the intersection of the common peroneal nerve, and people with different branches of the common peroneal nerve will be different. Multiple small electrodes 5 can cover the common peroneal as much as possible. A branch of a nerve without too much contact with other nerves.
  • the combination of 6 serial small electrodes any one electrode, any two electrodes, any three electrodes, any four electrodes, any five electrodes, or all six electrodes.
  • the combination of 8 small serial electrodes any one electrode, any two electrodes, any three electrodes, any four electrodes, any five electrodes, any six electrodes, any seven electrodes, or All eight electrodes. Analogically, the combination of other numbers of small electrodes.
  • the present invention adopts an integrated waterproof design, which makes the electrodes and straps more durable and easier to operate.
  • the present invention uses stainless steel electrodes, which have good conductivity and wear resistance, and do not need to be replaced.
  • the present invention uses serial electrodes to cover the nerves of different people muscle.

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Abstract

一种基于序列电极的一体化足下垂功能性电刺激治疗仪，其特征在于：包括上壳(1)、防水圈(2)、控制电路(3)、下壳(4)、与下壳(4)一体成型的支架(7)、序列小电极(5)和大电极(6)；序列小电极(5)和大电极(6)采用模内注塑工艺内嵌于下壳(4)和支架(7)表面，序列小电极(5)和大电极(6)为不锈钢金属电极。上述治疗仪采用一体化防水设计，使得电极与绑带更经久耐用，操作更简单；采用不锈钢电极，不锈钢导电性好耐磨耐用不须更换；采用序列电极，能覆盖不同人群的神经肌肉。

Description

一种足下垂功能性电刺激治疗仪 技术领域
本发明属于电疗设备领域，具体涉及一种基于序列电极的一体化足下垂功能性电刺激治疗仪。
背景技术
足下垂(foot drop)是骨外科体征之一。病人坐位，两下肢自然悬垂，如见足处于跖屈位且完全不能主动背屈与内、外翻，则为足下垂。治疗足下垂的常见方法有足部温热疗法、康复锻炼、针刺与按摩、佩戴支具、胫前肌及趾长伸肌腱悬吊、胫后肌腱转移治疗足下垂、腓肠肌内外侧头前移、重建伸趾功能术、手术切除、电刺激等。足下垂和足内翻是偏瘫患者下肢功能障碍的直接体现，临床上常使用功能性电刺激(FES)助行仪来恢复患者的部分功能性移动能力。中国专利(CN205460479U)公开了一种基于MEMS传感器的可穿戴式足下垂治疗仪，虽然其实现了一体化设计，但是其无法解决由于汗水或其他原因出现水使治疗仪失效的问题以及使用寿命短，也无法解决由于人群个体的神经肌肉群的差异，而无法适用不同人群的问题；中国专利(CN103816613A)公开了一种便携式胫前肌电刺激器，虽然解决了携带方便，但是其防水性差、适用性差、使用寿命短；中国专利(CN101947153A)公开了一种穿戴式智能足下垂矫正器，虽然设计了一体化设计，但是其结构复杂、防水性差、适用性差、使用寿命短；燕铁斌等(“基于行走模式的低频脉冲电刺激瘫痪治疗仪”，燕铁斌等，《中国医疗器械信息》，第16卷第2期，2010年02月25日)公开了 一种基于行走模式的低频率脉冲电刺激瘫痪治疗仪，虽然其声称可以根据个体不同适用不同人群，但是实际并不能有效解决由于人群个体的神经肌肉群的差异，而导致适用不广的问题，而且其设计复杂，防水性差、使用寿命短。
现有技术中的功能性电刺激治疗仪不具有防水功能，绑带与主机是分离的，绑带不耐用且更换繁琐，电极片为水凝胶电极，寿命短须经常更换，电极放置位置的定位也较为复杂。基于现有技术中足下垂功能性电刺激治疗仪存在的各种问题，申请人创造性的发明了一种经久耐用、操作简单、寿命长且适用不同人群的基于序列电极的一体化足下垂功能性电刺激治疗仪。
发明内容
有鉴于此，本发明的目的是提供一种经久耐用、操作简单、寿命长且适用不同人群的基于序列电极的一体化足下垂功能性电刺激治疗仪。
为实现上述目的，本发明提供一种足下垂功能性电刺激治疗仪，包括上壳、防水圈、控制电路、下壳、与下壳一体成型的支架、序列小电极和大电极；序列小电极和大电极采用模内注塑工艺内嵌于下壳和支架表面，序列小电极和大电极为不锈钢金属电极。
进一步的，控制电路连接磁吸连接器，磁吸连接器设置在下壳内并通过下壳的充电孔连接充电线，充电孔空闲时处于密闭状态。
进一步的，控制电路通过磁吸连接器电路板连接磁吸连接器。
进一步的，上壳内表面具有限位框，限位框内贴有第一柔性电路板， 在上壳外表面与第一柔性电路板相对位置设置有按键标识，第一柔性电路板与控制电路相连，用于向控制电路传送用户按键信息。
进一步的，支架表面设置有线槽，用于安装具有焊盘位的第二柔性电路板，第二柔性电路板通过焊盘位与控制电路连接；序列小电极具有与焊盘位连接的凸起，从而与控制电路连接。
进一步的，支架表面设置有盖板槽和与盖板槽配合的柔性电路盖板，线槽设置在盖板槽内。
序列小电极至少包括6个小电极，多个小电极对称分布，大电极呈长圆形，序列小电极中每个小电极呈方形，控制电路、小电极、人体与大电极构成了电刺激回路。
进一步的，下壳4、支架7表面包裹软胶，软胶延长形成绑带。
进一步的，上壳前端设置有挂耳，绑带上设置有魔术贴毛料及魔术贴刺料，魔术贴毛料以车缝工艺固定于绑带的上端，魔术贴刺料以车缝工艺固定于绑带的下端，绑带穿过挂耳，返折后以魔术贴固定，返折的长短通过魔术贴调节固定。
进一步的，绑带由TPE或TPU材料制备。
进一步的，大电极能够覆盖腓总神经的交汇点，小电极能够覆盖腓总神经的分支。
进一步的，支架的后端具有定位支点，与离它最近的小电极相距1-5mm,大电极6与离它最近的小电极相距10-15mm。
对比现有技术，本发明具有以下优点：
1.本发明采用一体化防水设计，使得电极与绑带更经久耐用，操作更简单。
2.本发明采用不锈钢电极，不锈钢导电性好耐磨耐用不须更换。
3.本发明采用序列电极，能覆盖不同人群的神经肌肉。
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获得其他的附图。
图1是根据本发明实施例的一种足下垂功能性电刺激治疗仪的主机结构示意图；
图2是本发明实施例的一种足下垂功能性电刺激治疗仪的主机结构组成图的局部放大图；
图3是本发明实施例的一种足下垂功能性电刺激治疗仪的整体防水设计图；
图4是本发明实施例的一种足下垂功能性电刺激治疗仪的通讯接口防水结构示意图；
图5是本发明实施例的一种足下垂功能性电刺激治疗仪的按键防水结构示意图；
图6是本发明实施例的一种足下垂功能性电刺激治疗仪的支架结构示意图；
图7是本发明实施例的一种足下垂功能性电刺激治疗仪的绑带结构示意图；
图8是本发明实施例的一种足下垂功能性电刺激治疗仪的序列小电极组合结构示意图；
图9是本发明实施例的一种足下垂功能性电刺激治疗仪的电极结构示意图；
图10是本发明实施例的一种足下垂功能性电刺激治疗仪的电刺激回路示意图。
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做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。
如图1和2所示，本发明电刺激治疗仪由上壳1，防水圈2，控制电路3，下壳4以及与下壳一体成型的支架、序列小电极5，大电极6组成。序列小电极5采用模内注塑工艺内嵌于支架7中，大电极6采用模内注塑工艺内嵌于下壳4中。
上壳1，防水圈2，下壳4组成了一个密封的空间以实现防水功能，控制电路3在该密封的空间内不会被水等液体浸入，保证了电子元件在外界有水的情况下也可正常工作，实现了电子电路的防水。序列小电极5和大 电极6为不锈钢金属电极，实现了电极的防水。下壳4、支架7和绑带8一体成型，同时表面包裹一层软胶，实现了防水的功用。控制电路可以检测腿部的运动状态，输出电刺激到序列小电极5和大电极6；序列小电极5和大电极6与腿部皮肤接触，通过电刺激实现辅助行走。控制电路、序列小电极5、人体与大电极6构成了电刺激回路。
现有技术中电极与主机(在此主机包括上壳、控制电路、下壳)是分离的。使用时再将电极连接到主机上。电极一般采用水凝胶电极，水凝胶电极不耐用需要经常更换，本发明采用了不锈钢金属电极，不锈钢导电性好耐磨耐用不须更换，本发明将不锈钢电极与主机结合在一起，采用了模内注塑工艺一体注塑成型，即将电极嵌在下壳4和支架7下表面，实现了电极的一体化。现有技术中绑带与主机也是分离的，绑带的材料一般是布料，不易清洁，不耐用，使用时间长了须更换，本发明采用了软胶(如TPE、TPU等)作为绑带的材料，经久耐用，有弹性可拉伸，可开模成型为想要的形状。在一个实施例中，绑带与支架通过二次注塑一体成型的工艺，实现了绑带与主机的一体化。
如图3所示，防水圈2位于上壳1和下壳4的中间，防水圈2分别与上壳1和下壳4的侧壁接触，采用过盈配合的方式，由于防水圈2为硅胶橡胶等软胶材料，有弹性可变形，防水圈2被紧密地挤压在上下壳的侧壁之间实现了上下壳装配间隙的防水。上下壳的装配固定方式可以是扣位，超声熔接，也可以打螺丝固定。大电极6位于下壳4的底部，采用模内注塑的工艺嵌于下壳4外表面，模内注塑工艺可以使用电极与下壳紧密接触 在一起。
如图4所示，控制电路具有充电和通讯接口。通常来说，此接口是MICRO USB或TYPE C USB，但其无法防水。因此，本发明采用磁吸连接器，也就是控制电路的充电接口上设置有磁吸连接器13，磁吸连接器13位于下壳4内部并通过下壳充电孔位15外接充电线，充电线的端子与磁吸连接器13相吸合，实现充电功能。由于磁吸连接器整体是实芯的，因此在充电或通讯时可实现防水功能。制作时，采用模内注塑工艺，将磁吸连接器13放置于模具内，下壳4的充电孔位15的塑胶紧密包裹住磁吸连接器13，两者间没有装配间隙防止了水等液体的进入。平时不充电，即空闲时，充电孔位15处于密闭状态。
在另一个实施例中，由于结构空间的限制，磁吸连接器13不能直接与控制电路3相连接，需要用连接线进行转接或直接焊接，外加连接器需要小巧精密的连接器且成本也高，直接焊接焊点处线材易断可靠性不高。本发明将磁吸连接器13直接焊接于磁吸连接器电路板14上，再通过磁吸连接器电路板14上的焊盘141与控制电路3上的焊盘31焊接在一起。磁吸连接器电路板14紧贴于主板控制电路3，两者的焊盘挨在一起便于焊接。
如图5所示，在一个实施例中，按键设计为触摸按键，触摸感应部分通过第一柔性电路板的方式实现，柔性电路板16以3M胶紧贴于上壳1的内表面的限位框内。使用这种方式，避免的机械缝隙，具有防水作用。上壳1是一个完整的壳体，外表面光滑，丝印有按键的标识，操作时将手指轻触上壳1外表面的按键标识区，柔性电路板16对应的圆形感应区就 可检测到相关信号。上壳1壳体厚度在1-2mm范围内柔性电路板16都能感应到按键信号。
如图6及图8所示，大电极6与下壳4、序列小电极5与支架7一体注塑，支架7采用硬度较高的软胶材料，下壳4与序列小电极5上部电极的相连部分构成第一变形区41，序列小电极5的上面电极与中间电极相连的部分构成第二变形区42,序列小电极5的中间电极与下面电极相连的部分构成第三变形区43,这三个变形区都是软胶材料，因此这三组序列小电极间的间隙能够弯曲变形，使序列小电极5能适应患者不同的腿径紧密与腿部皮肤接触。软胶8将下壳4及大电极6，以及序列小电极5与支架7紧紧包裹，构成电极的一体化。
图6的软胶8向下延伸形成了图7的绑带9，软胶可以是TPE，也可以为TPU，魔术贴毛料10以车缝工艺固定于绑带9的上端，魔术贴刺料11以车缝工艺固定于绑带9的下端，绑带9穿过图6的挂耳12，返折后以魔术贴固定，返折的长短通过魔术贴调节固定，使绑带能方便可靠地固定于腿部。
如图8所示，序列小电极5与支架7一体注塑成型，支架7为软胶材料。支架7上表面设置有盖板槽72和与盖板槽72配合的柔性电路盖板71，柔性电路盖板71装配于盖板槽72上形成一个封闭的空间，挡住了外层的软胶，使用外层的软胶不能进入盖板槽72内。盖板槽72内还设置有线槽73，用于安装柔性电路板74，柔性电路板74可以在线槽73中自由弯曲伸展。序列小电极5的单个电极都具有向内的凸起，通过柔性电路板74的 焊盘位与控制电路连接，从而通过焊接工艺就可实现序列小电极5与柔性电路板74的电连接。
如图9所示，序列小电极5和大电极6呈左右排列，上下对称，左右腿都适用。大电极6呈长圆形，小电极呈方形。小电极，大电极，小腿，电刺激发生电路构成了电刺激回路，如图10所示。没有此回路就不能形成刺激电流，就无法实现辅助行走足部背屈的功能。为了实现足部背屈的功能，大电极须覆盖腓总神经的交汇点，小电极须覆盖腓总神经的分支。根据人体特征，定位点21位于支架7后端，与最近的小电极相距1-5mm,大电极6与最近的小电极相距10-15mm。使用时将定位点21对准膝盖膑骨下方边缘中央，大电极6覆盖住腓总神经交汇点，而腓总神经的分支不同的人会有差异，多个小电极5可以尽可能覆盖腓总神经的分支而又不过多地接触其它神经。
作为其中一个实施例，6个序列小电极的组合情况：任意一个电极，任意两个电极，任意三个电极，任意四个电极，任意五个电极，或者全部六个电极。
作为其中一个实施例，8个序列小电极的组合情况：任意一个电极，任意两个电极，任意三个电极，任意四个电极，任意五个电极，任意六个电极，任意七个电极，或者全部八个电极。依次类推其它数量的小电极的组合情况。
本发明采用一体化防水设计，使得电极与绑带更经久耐用，操作更简单；本发明采用不锈钢电极，不锈钢导电性好耐磨耐用不须更换；本发明 采用序列电极，能覆盖不同人群的神经肌肉。
尽管已经示出和描述了本发明的实施例，对于本领域的普通技术人员而言，可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型，本发明的范围由所附权利要求及其等同物限定。

Claims (12)

  1. 一种足下垂功能性电刺激治疗仪，包括上壳、防水圈、控制电路、下壳、与所述下壳一体成型的支架、序列小电极和大电极；序列小电极和大电极采用模内注塑工艺内嵌于所述下壳和支架表面，序列小电极和大电极为不锈钢金属电极。
  2. 根据权利要求1所述的治疗仪，其特征在于，所述控制电路连接磁吸连接器，所述磁吸连接器设置在所述下壳内并通过所述下壳的充电孔连接充电线，所述充电孔空闲时处于密闭状态。
  3. 根据权利要求2所述的治疗仪，其特征在于，所述控制电路通过磁吸连接器电路板连接所述磁吸连接器。
  4. 根据权利要求1所述的治疗仪，其特征在于，所述上壳内表面具有限位框，所述限位框内贴有第一柔性电路板，在所述上壳外表面与所述第一柔性电路板相对位置设置有按键标识，所述第一柔性电路板与所述控制电路相连，用于向所述控制电路传送用户按键信息。
  5. 根据权利要求1所述的治疗仪，其特征在于，所述支架表面设置有线槽，用于安装具有焊盘位的第二柔性电路板，所述第二柔性电路板通过焊盘位与所述控制电路连接；所述序列小电极具有与所述焊盘位连接的凸起，通过所述凸起与所述控制电路连接。
  6. 根据权利要求5所述的治疗仪，其特征在于，所述支架表面设置有盖板槽和与所述盖板槽配合的柔性电路盖板，所述线槽设置在所述盖板槽内。
  7. 根据权利要求1所述的治疗仪，其特征在于，序列小电极至少包括6个小电极，所述小电极对称分布，所述大电极呈长圆形，所述小电极呈方形，所述控制电路、小电极、人体与大电极构成了电刺激回路。
  8. 根据权利要求1所述的任一治疗仪，其特征在于，所述下壳4、支架7表面包裹软胶，所述软胶延长形成绑带。
  9. 根据权利要求8所述的治疗仪，其特征在于，所述上壳前端设置有挂耳，所述绑带上设置有魔术贴毛料及魔术贴刺料，魔术贴毛料以车缝工艺固定于所述绑带的上端，魔术贴刺料以车缝工艺固定于所述绑带的下端，绑带穿过挂耳，返折后以魔术贴固定，返折的长短通过魔术贴调节固定。
  10. 根据权利要求9所述的治疗仪，其特征在于，所述绑带由TPE或TPU制备。
  11. 根据权利要求1-10任一权利要求所述的治疗仪，其特征在于，所述大电极能够覆盖腓总神经的交汇点，所述小电极能够覆盖腓总神经的分支。
  12. 根据权利要求1所述的治疗仪，其特征在于，所述支架的后端具有定位支点，所述定位点与最近的小电极相距1-5mm，所述大电极6与最近的小电极相距10-15mm。
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WO2015188889A1 (en) * 2014-06-13 2015-12-17 Fundación Tecnalia Research & Innovation System and method for functional electrical stimulation
CN204233610U (zh) * 2014-11-24 2015-04-01 深圳市讯丰通电子有限公司 可穿戴式足下垂功能性电刺激仪
CN107335140A (zh) * 2017-08-18 2017-11-10 江苏德长医疗科技有限公司 功能性电刺激输出装置及其应用

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