WO2020177472A1 - 一种膈运动辅助装置及膈运动辅助*** - Google Patents

一种膈运动辅助装置及膈运动辅助*** Download PDF

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Publication number
WO2020177472A1
WO2020177472A1 PCT/CN2019/130830 CN2019130830W WO2020177472A1 WO 2020177472 A1 WO2020177472 A1 WO 2020177472A1 CN 2019130830 W CN2019130830 W CN 2019130830W WO 2020177472 A1 WO2020177472 A1 WO 2020177472A1
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layer
driving layer
diaphragm
driving
assisting device
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PCT/CN2019/130830
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English (en)
French (fr)
Inventor
夏泽洋
徐桂文
邓豪
熊璟
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深圳先进技术研究院
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Publication of WO2020177472A1 publication Critical patent/WO2020177472A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4688—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor having operating or control means
    • A61F2002/4692—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor having operating or control means fluid

Definitions

  • the present invention relates to the technical field of medical equipment, in particular to a diaphragm exercise assisting device and a diaphragm exercise assisting system.
  • Diaphragm is a membranous muscle that separates the chest and abdomen in the body cavity of humans or mammals. It is also called “diaphragm” or “diaphragm”. It helps the lungs to inhale and exhale air through the diaphragm. It is an important respiratory muscle of the body , Accounting for 60% to 80% of all respiratory muscle functions. For medical problems due to diaphragm injury or dysfunction, there are mainly surgical treatments and auxiliary treatments with medical equipment. Surgical treatment has limitations. For example, diaphragm folding is usually only suitable for patients with unilateral diaphragm palsy.
  • the auxiliary equipment is mainly diaphragmatic pacing device, which uses pulse current to stimulate the phrenic nerve or diaphragm to cause muscle contraction, but there is a potential risk of diaphragmatic spasm and heart rate changes, and it is not suitable for severe functional failure and those with other pacing devices. Be applicable.
  • the existing diaphragm function auxiliary device is mainly based on the acquisition and processing of phrenic nerve signals, and realizes diaphragm pacing by compensating the stimulation current to act on the diaphragm.
  • This method has high requirements for the completeness of the diaphragm function, and is not suitable for people with diaphragm injury or severe failure, and electrical stimulation will cause a certain degree of damage to the skeletal muscle, which is not conducive to sports rehabilitation.
  • the purpose of the present invention is to provide a diaphragm exercise assisting device, which aims to solve the technical problem of narrow application range of the existing diaphragm function assisting device.
  • a diaphragm exercise assisting device includes an isolation layer, and a first drive layer and a second drive layer stacked on two opposite surfaces of the isolation layer.
  • the first drive layer and the second drive layer The driving layer and the isolation layer are connected together to form a three-layer structure.
  • the first driving layer, the second driving layer and the isolation layer are all elastomers, and the first driving layer and the second driving layer have internal functions. It is used in the accommodating cavity containing the fluid and used to achieve anisotropic deformation as the pressure of the fluid in the accommodating cavity changes.
  • the tension and compression stiffness of the first driving layer and the second driving layer are less than the tension and compression stiffness of the isolation layer.
  • the elastic modulus of the first driving layer and the second driving layer is less than 1 GPa.
  • the first driving layer and the second driving layer are respectively provided with fluid exchange ports communicating with the containing cavity.
  • flexible hinges are respectively connected to both ends of the three-layer structure.
  • a fixing member is installed on one side surface of the flexible hinge.
  • sensors are installed on the surface of the first driving layer and/or the surface of the second driving layer.
  • the first driving layer and the second driving layer are each provided with a plurality of the accommodating cavities independent of each other, and the first driving layer and the second driving layer are respectively provided with There are two fluid exchange ports that correspond to the accommodating cavities one-to-one and communicate with each other, and each of the accommodating cavities adopts separate driving and distributed control.
  • Another object of the present invention is to provide a diaphragm exercise assisting device, comprising an isolation layer, and a first driving layer stacked on the isolation layer and connected to the isolation layer, the first driving layer and the isolation layer All are elastomers.
  • the first drive layer has a containing cavity for containing fluid and is used to achieve anisotropic deformation as the pressure of the fluid in the containing cavity changes.
  • the surface of the first drive layer and/ Or a sensor is installed on the surface of the isolation layer.
  • Another object of the present invention is to provide a diaphragm exercise assisting device, including a first driving layer, and a second driving layer stacked on the first driving layer and connected to the first driving layer.
  • the first driving layer and the second driving layer are both elastomers, and the first driving layer and the second driving layer each have a containing cavity for accommodating fluid, and are used to realize each of them as the pressure of the fluid in the containing cavity changes.
  • a sensor is installed on the surface of the first driving layer and/or the surface of the second driving layer.
  • Another object of the present invention is to provide a diaphragm movement assisting system, including a signal acquisition module, a data processing module, a motion control module, a fluid compressor, and the diaphragm movement assisting device as described above, and the signal acquisition module is used for The phrenic nerve signal is collected and transmitted to the data processing module for signal decoding.
  • the data processing module is used to transmit the decoded signal to the motion control module, and the motion control module is used to decode the received nerve signal.
  • the decoded data is fused with the data fed back by the sensor, and then an instruction is sent to adjust the fluid pressure input by the fluid compressor to the diaphragm movement assisting device.
  • a diaphragm exercise assisting device implementing the present invention has the following beneficial effects: the present invention designs a bionic diaphragm exercise assisting device, which provides patients with a breathing assistance program, realizes the assistance or replacement of the human diaphragm movement function, and helps patients Breathing freely and passively assisting the movement of the diaphragm can provide exercise rehabilitation support for patients with diaphragm atrophy, and its application range is wide.
  • a phrenic movement assisting system implementing the present invention has the following beneficial effects: the present invention realizes autonomous control of the phrenic movement assisting device by collecting signals based on the phrenic nerve, decoding them into control instructions, and assisting patients to breathe freely; The received information is transmitted to the motion control module for data fusion to complete the closed-loop control of the movement of the diaphragm exercise assisting device, and achieve functional indicators such as breathing rate, breathing depth, and breathing ratio required by the patient.
  • Figure 1 is a schematic structural diagram of a diaphragm exercise assisting device provided by an embodiment of the present invention
  • Fig. 2 is a structural block diagram of a diaphragm movement assisting system provided by an embodiment of the present invention.
  • an embodiment of the present invention provides a diaphragm exercise assisting device 10, which includes an isolation layer 2, a first driving layer 1, and a second driving layer 3.
  • the first driving layer 1 and the second driving layer 3 are stacked on two opposite surfaces of the isolation layer 2.
  • the first driving layer 1, the second driving layer 3 and the isolation layer 2 are connected together to form a three-layer structure.
  • the first driving layer 1, the second driving layer 3 and the isolation layer 2 are all elastomers, that is, the first driving layer 1, the second driving layer 3 and the isolation layer 2 can all be elastically deformed under the action of external force.
  • first driving layer 1 and the second driving layer 3 there are accommodating cavities for accommodating fluid (gas or liquid), and the accommodating cavities of the first driving layer 1 and the second driving layer 3 are independent and not connected to each other.
  • the first driving layer 1 and the second driving layer 3 are used to achieve anisotropic deformation as the fluid pressure in the containing cavity changes, thereby assisting or replacing the movement function of the human diaphragm.
  • the deformation of the three-layer structure is powered by the pressure of the accommodating cavity of the first driving layer 1 and the second driving layer 3, by designing the accommodating cavity structure of the first driving layer 1 and the second driving layer 3 , Can achieve its anisotropic deformation, using deformation (movement) to provide assistance for the movement of the diaphragm with insufficient strength.
  • the embodiment of the present invention designs a bionic diaphragm movement assisting device, which provides a breathing assistance scheme for the patient, realizes the assistance or replacement of the human diaphragm movement function, helps the patient to breathe freely, and passively assists the movement of the diaphragm. Atrophy patients provide sports rehabilitation support, which has a wide range of applications.
  • the first driving layer 1 and the second driving layer 3 may be in a strip shape or a rod shape, and the isolation layer 2 may be in a sheet shape.
  • the first driving layer 1 and the second driving layer 3 are adhered to two opposite surfaces of the isolation layer 2.
  • the first driving layer 1 and the second driving layer 3 can be made of silicone elastomer (Ecoflex), and the isolation layer 2 can be embedding a polyurethane elastomer (Polyurethane) in the silicone elastomer.
  • the tension and compression stiffness of the first driving layer 1 and the second driving layer 3 is less than the tension and compression stiffness of the isolation layer 2, which can be achieved by adjusting the load-bearing cross-sectional area or changing the elastic modulus of the material.
  • the first driving layer 1 and the second driving layer 3 and the isolation layer 2 have different deformability, and can be made of materials with different elastic moduli.
  • the first drive layer 1 and the second drive layer 3 are more flexible than the isolation layer 2, and the isolation layer 2 can limit the expansion and contraction movement of the first drive layer 1 and the second drive layer 3 within a certain range.
  • the first driving layer 1 and the second driving layer 3 can achieve antagonistic movement under a certain degree of limitation of the isolation layer 2, thereby realizing the rising and falling of the middle of the three-layer structure.
  • the middle part of the three-layer structure rises (corresponding to exhalation) as shown in Figure 1 A, and the middle part of the three-layer structure falls (corresponding to the breathing) as shown in Figure 1 B.
  • the first driving layer 1 and the second driving layer 3 are made of materials with relatively low elastic modulus
  • the isolation layer 2 is made of materials with relatively high elastic modulus.
  • the elastic modulus of the first driving layer 1 and the second driving layer 3 is less than 1 Gpa, that is, the first driving layer 1 and the second driving layer 3 are made of soft materials with an elastic modulus less than 1 GPa , So that the elastic modulus of the first driving layer 1 and the second driving layer 3 is relatively close to the elastic modulus of the human soft tissue organs.
  • the isolation layer 2 can choose soft materials or embed elastic fibers along the elongation direction.
  • the first driving layer 1 and the second driving layer 3 are respectively provided with their accommodating cavities.
  • a connected fluid exchange port which is used for fluid inflow and outflow.
  • the end of one end of the first drive layer 1 is provided with a first fluid exchange port 4 communicating with the containing cavity, and the end of the first drive layer 1 away from the first fluid exchange port 4 is closed;
  • the end of one end of the second drive layer 3 is provided with a second fluid exchange port 5 communicating with the containing cavity, and the end of the second drive layer 3 away from the second fluid exchange port 5 is closed.
  • the first fluid exchange port 4 and the second fluid exchange port 5 are arranged at the ends of the first drive layer 1 and the second drive layer 3 close to each other.
  • the first fluid exchange port 4 and the second fluid exchange port 5 are respectively communicated with the fluid compressor 50.
  • the first fluid exchange port 4 can be expanded into multiple.
  • the accommodating cavities in the first drive layer 1 can also be expanded to multiple. The multiple accommodating cavities are independent of each other.
  • the second fluid exchange ports 5 can be expanded into multiple, correspondingly, the accommodating cavities in the second drive layer 3 can also be expanded into multiple,
  • the cavities are independent of each other, and the second fluid exchange ports 5 and the accommodating cavities of the second driving layer 3 are in one-to-one correspondence and communicate with each other.
  • each containing cavity is driven separately and controlled in a distributed manner.
  • the first driving layer 1, the second driving layer 3 and the isolation layer 2 are connected together to form a three-layer structure, and the ends of the two ends of the three-layer structure are respectively connected with flexible hinges 7
  • the flexible hinge 7 realizes the ascending and descending movement at the middle part of the three-layer structure, it can play a role in providing support for bending deformation.
  • a fixing member 8 is installed on one side surface of the flexible hinge 7.
  • the fixing member 8 is fixedly connected to the inner wall of the human abdominal cavity, thereby fixing both ends of the three-layer structure On the corresponding position of the human body.
  • a sensor 6 is installed on the diaphragm exercise assisting device 10.
  • the sensor 6 is installed on the surface of the first driving layer 1 and/or the surface of the second driving layer 3, for example, the sensor 6 is installed only on the surface of the first driving layer 1, or only on the surface of the second driving layer 3.
  • the sensor 6 is installed, or the sensor 6 is installed on the surface of the first driving layer 1 and the surface of the second driving layer 3 at the same time.
  • the sensor 6 can be installed on the upper surface and/or the lower surface of the first driving layer 1, and can also be installed on the upper surface and/or the lower surface of the second driving layer 3.
  • the number of installed sensors 6 can be selected according to actual conditions, and is not limited here.
  • the sensor 6 is a flexible sensor to adapt to the deformation of the first driving layer 1 and the second driving layer 3.
  • the diaphragm exercise assisting device 10 is a double-layer structure, which includes an isolation layer 2, and a first driving layer 1 stacked on the isolation layer 2 and connected to the isolation layer 2.
  • a driving layer 1 and isolation layer 2 are both elastomers, the first driving layer 1 has a containing cavity for containing fluid inside, and the first driving layer 1 is used to achieve anisotropic deformation as the fluid pressure in the containing cavity changes
  • a sensor 6 is installed on the surface of the first driving layer 1 and/or the surface of the isolation layer 2, for example, a sensor 6 is installed on the surface of the first driving layer 1 away from the isolation layer 2 or on the surface of the first driving layer 1 close to the isolation layer 2. 6. Or a sensor 6 is installed on the surface of the isolation layer 2 away from the first driving layer 1, or a sensor 6 is installed on the surface of the isolation layer 2 close to the first driving layer 1.
  • the requirements for the isolation layer 2 are relatively high.
  • the isolation layer 2 will restrict the elongation of the lower surface of the first drive layer 1 to a certain extent.
  • the effect makes the upper and lower surfaces of the first driving layer 1 have different elongation amplitudes, thereby forming an "arch" structure.
  • the double-layer structure is elongated as a whole, but the elongation range of the upper and lower surfaces of the first driving layer 1 is different, thus forming an "arch" structure .
  • the design parameters of the double-layer structure are reasonable, it can save cost compared with the three-layer structure.
  • the diaphragm exercise assisting device 10 is a two-layer structure, including an isolation layer 2 and a first driving layer 1. Layer structure. Other structures and characteristics are the same as those in the above-mentioned embodiment, and will not be repeated here.
  • the diaphragm exercise assisting device 10 is a two-layer structure, which includes a first driving layer 1, and a second driving layer 1 stacked on the first driving layer 1 and connected to the first driving layer 1.
  • the driving layer 3, the first driving layer 1 and the second driving layer 3 are both elastomers, the first driving layer 1 and the second driving layer 3 both have accommodating cavities for accommodating fluid, and the first driving layer 1 and The second driving layer 3 is used to achieve anisotropic deformation as the fluid pressure in the containing cavity changes, and sensors 6 are installed on the surface of the first driving layer 1 and/or the surface of the second driving layer 3.
  • the first driving layer 1 and the second driving layer 3 can form an "arch" structure under the antagonistic action.
  • the diaphragm exercise assisting device 10 is a two-layer structure, including a first driving layer 1 and a second driving layer. 3 Two-layer structure. Other structures and characteristics are the same as those in the above-mentioned embodiment, and will not be repeated here.
  • an embodiment of the present invention also provides a diaphragm movement assist system, which includes a signal acquisition module 20, a data processing module 30, a motion control module 40, a fluid compressor 50, and any of the above The diaphragm exercise assisting device 10 described in an embodiment.
  • the signal acquisition module 20, the data processing module 30, the motion control module 40, and the fluid compressor 50 are electrically connected in sequence.
  • the fluid compressor 50 is connected to the fluid exchange port of the diaphragm exercise assisting device 10, and the sensor 6 of the diaphragm exercise assisting device 10 It is electrically connected to the motion control module 40.
  • the signal acquisition module 20 is used to collect the human phrenic nerve signal and transmit it to the data processing module 30 for signal decoding. Then the data processing module 30 is used to transmit the decoded signal to the motion control module 40, and the motion control module 40 is used to The decoded data of the received neural signal is fused with the data fed back by the sensor 6, and then an instruction is sent to adjust the fluid pressure input by the fluid compressor 50 to the diaphragm exercise assisting device 10.
  • the phrenic nerve signal is collected and decoded into control instructions to realize autonomous control of the phrenic exercise assisting device 10 and assist the patient to breathe freely; the sensor 6 transmits the detected information to the exercise control module 40 for data fusion , To complete the closed-loop control of the movement of the diaphragm exercise assisting device 10 to achieve functional indicators such as breathing rate, breathing depth, and breathing ratio required by the patient.
  • the drive layer is antagonistic, and the overall structure can mimic the physiological movement of the diaphragm in a predetermined pattern to achieve the rise and fall of the middle part.
  • the diaphragm exercise assisting device 10 is installed in the diaphragm muscle part of the patient's body so that it is located between the thoracic cavity and the abdominal cavity, and plays a role of isolating the thoracic cavity and the abdominal cavity. With the coordinated movement of the first driving layer 1 and the second driving layer 3 of the diaphragm exercise assisting device 10, it can imitate the movement form of the natural diaphragm.
  • the motion control module 40 sends instructions to adjust the fluid pressure output of the fluid compressor 50, and integrates the feedback of the sensor 6 Information, real-time adjustment of the fluid pressure of the accommodation cavity of the drive layer, and control of the movement trajectory of the diaphragm movement assisting device 10, so that the diaphragm movement assisting device 10 can assist or replace the natural diaphragm functionally.
  • the pressure output range of the fluid compressor 50 can be set through the information fed back by the sensor 6, so as to protect the patient.

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Abstract

一种膈运动辅助装置（10）及膈运动辅助***，该膈运动辅助装置（10）包括隔离层（2），以及层叠设置于隔离层（2）的两相对表面的第一驱动层（1）和第二驱动层（3），第一驱动层（1）、第二驱动层（3）和隔离层（2）连接在一起形成三层结构体，第一驱动层（1）、第二驱动层（3）和隔离层（2）均为弹性体，第一驱动层（1）和第二驱动层（3）内部均具有用于容纳流体的容纳腔且用于随着容纳腔内流体压力的改变实现各项异性变形。该膈运动辅助装置（10）为患者提供呼吸辅助的方案，实现对人体膈肌运动功能的辅助或代替，帮助患者进行自由呼吸，并且通过被动辅助膈肌运动，可以为膈肌萎缩患者提供运动康复支持。

Description

一种膈运动辅助装置及膈运动辅助*** 技术领域
本发明涉及医疗器械技术领域，特别涉及一种膈运动辅助装置及膈运动辅助***。
 背景技术
膈是人或哺乳动物体腔中分隔胸腹两腔的膜状肌肉，亦称“膈膜”、“横膈膜”，通过膈的一张一弛，帮助肺吸入与呼出气体，是机体重要的呼吸肌，占所有呼吸肌功能的60%～80%。对于由于膈肌损伤或功能障碍的医学问题，主要有手术治疗和医疗设备辅助治疗。手术治疗具有局限性，如膈肌折叠术通常只适用于单侧膈肌麻痹患者。目前，辅助设备主要是膈肌起搏装置，其采用脉冲电流刺激膈神经或膈肌引起肌肉收缩，但有潜在的膈肌痉挛、心率改变的风险，且对严重功能衰竭和安放有其它起搏装置者不适用。
现有的膈肌功能辅助装置主要是基于对膈神经信号的采集、处理，通过补偿刺激电流作用于膈肌，实现膈肌起搏。这种方法对膈肌功能完备性具有很高的要求，对于膈肌损伤或者严重衰竭者并不适用，并且电刺激会对骨骼肌造成一定程度的损伤，不利于运动康复。
 技术问题
本发明的目的在于提供一种膈运动辅助装置，旨在解决现有的膈肌功能辅助装置适用范围窄的技术问题。
 技术解决方案
本发明是这样实现的，一种膈运动辅助装置，包括隔离层，以及层叠设置于所述隔离层的两相对表面的第一驱动层和第二驱动层，所述第一驱动层、第二驱动层和所述隔离层连接在一起形成三层结构体，所述第一驱动层、第二驱动层和隔离层均为弹性体，所述第一驱动层和第二驱动层内部均具有用于容纳流体的容纳腔且用于随着所述容纳腔内流体压力的改变实现各项异性变形。
在本发明的一个实施例中，所述第一驱动层和第二驱动层的拉压刚度小于所述隔离层的拉压刚度。
在本发明的一个实施例中，所述第一驱动层和第二驱动层的弹性模量小于1GPa。
在本发明的一个实施例中，所述第一驱动层和第二驱动层分别设置有与其容纳腔连通的流体交换口。
在本发明的一个实施例中，所述三层结构体的两端分别连接有柔性铰链。
在本发明的一个实施例中，所述柔性铰链的一侧表面上安装有固定件。
在本发明的一个实施例中，所述第一驱动层的表面和/或所述第二驱动层的表面安装有传感器。
在本发明的一个实施例中，所述第一驱动层和第二驱动层内均设置有多个相互独立的所述容纳腔，所述第一驱动层和第二驱动层还分别设置有多个与所述容纳腔一一对应且相互连通的所述流体交换口，每一所述容纳腔采用单独驱动和分布式控制。
本发明的另一目的在于提供一种膈运动辅助装置，包括隔离层，以及层叠设置于所述隔离层上且与所述隔离层连接的第一驱动层，所述第一驱动层和隔离层均为弹性体，所述第一驱动层内部具有用于容纳流体的容纳腔且用于随着所述容纳腔内流体压力的改变实现各项异性变形，所述第一驱动层的表面和/或所述隔离层的表面安装有传感器。
本发明的又一目的在于提供一种膈运动辅助装置，包括第一驱动层，以及层叠设置于所述第一驱动层上且与所述第一驱动层连接的第二驱动层，所述第一驱动层和第二驱动层均为弹性体，所述第一驱动层和第二驱动层内部均具有用于容纳流体的容纳腔且用于随着所述容纳腔内流体压力的改变实现各项异性变形，所述第一驱动层的表面和/或所述第二驱动层的表面安装有传感器。
本发明的再一目的在于提供一种膈运动辅助***，包括信号采集模块、数据处理模块、运动控制模块、流体压缩机，以及如上述所述的膈运动辅助装置，所述信号采集模块用于对膈神经信号进行采集并传递给所述数据处理模块进行信号解码，所述数据处理模块用于将解码后的信号传递给所述运动控制模块，所述运动控制模块用于对接收的神经信号解码后的数据与传感器反馈的数据进行融合，进而发送指令调节所述流体压缩机输入所述膈运动辅助装置的流体压力。
实施本发明的一种膈运动辅助装置，具有以下有益效果：本发明设计了一种仿生膈运动辅助装置，其为患者提供呼吸辅助的方案，实现对人体膈肌运动功能的辅助或代替，帮助患者进行自由呼吸，并且通过被动辅助膈肌运动，可以为膈肌萎缩患者提供运动康复支持，其适用范围广。
 有益效果
实施本发明的一种膈运动辅助***，具有以下有益效果：本发明通过基于膈神经信号的采集，解码转化为控制指令实现对膈运动辅助装置的自主控制，辅助患者自由呼吸；通过传感器将检测到的信息传递给运动控制模块进行数据融合，完成闭环控制膈运动辅助装置的运动，实现患者所需的呼吸率、呼吸深度、呼吸比等功能指标。
 附图说明
为了更清楚地说明本发明实施例中的技术方案，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是本发明实施例提供的膈运动辅助装置的结构示意图；
图2是本发明实施例提供的膈运动辅助***的结构框图。
上述附图所涉及的标号明细如下：
10-膈运动辅助装置；1-第一驱动层；2-隔离层；3-第二驱动层；4-第一流体交换口；5-第二流体交换口；6-传感器；7-柔性铰链；8-固定件；
20-信号采集模块；
30-数据处理模块；
40-运动控制模块；
50-流体压缩机。
 本发明的实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
需说明的是，当部件被称为“固定于”或“设置于”另一个部件，它可以直接或者间接位于该另一个部件上。当一个部件被称为“连接于”另一个部件，它可以是直接或者间接连接至该另一个部件上。术语“上”、“下”、“左”、“右”、“前”、“后”、“竖直”、“水平”、“顶”、“底”、“内”、“外”等指示的方位或位置为基于附图所示的方位或位置，仅是为了便于描述，不能理解为对本技术方案的限制。术语“第一”、“第二”仅用于便于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明技术特征的数量。“多个”的含义是两个或两个以上，除非另有明确具体的限定。
为了说明本发明所述的技术方案，以下结合具体附图及实施例进行详细说明。
请参阅图1，本发明实施例提供了一种膈运动辅助装置10，包括隔离层2、第一驱动层1和第二驱动层3。其中，第一驱动层1和第二驱动层3层叠设置于隔离层2的两相对表面上，第一驱动层1、第二驱动层3和隔离层2连接在一起形成三层结构体，第一驱动层1、第二驱动层3和隔离层2均为弹性体，即第一驱动层1、第二驱动层3和隔离层2在外力作用下均能发生弹性变形。在第一驱动层1和第二驱动层3内部均设有用于容纳流体（气体或液体）的容纳腔，且第一驱动层1和第二驱动层3的容纳腔相互独立、不连通。该第一驱动层1和第二驱动层3用于随着容纳腔体内的流体压力的改变实现各向异性变形，进而辅助或代***膈肌运动功能。在本实施例中，三层结构体的形变是由第一驱动层1和第二驱动层3的容纳腔压力提供动力，通过对第一驱动层1和第二驱动层3的容纳腔结构设计，可实现其各项异性变形，利用变形（运动）为力量不足的膈肌的运动提供辅助。
本发明实施例设计了一种仿生膈运动辅助装置，其为患者提供呼吸辅助的方案，实现对人体膈肌运动功能的辅助或代替，帮助患者进行自由呼吸，并且通过被动辅助膈肌运动，可以为膈肌萎缩患者提供运动康复支持，其适用范围广。
在具体应用中，第一驱动层1和第二驱动层3可呈条状或棒状，隔离层2可呈片状。第一驱动层1和第二驱动层3粘接于隔离层2的两相对表面上。第一驱动层1和第二驱动层3可以选用有机硅弹性体（Ecoflex），隔离层2可以是在有机硅弹性体中嵌入聚氨酯弹性体（Polyurethane）。
在本发明的一个实施例中，第一驱动层1和第二驱动层3的拉压刚度小于隔离层2的拉压刚度，可通过调节承载的横截面积或改变材料的弹性模量实现。具体地，第一驱动层1和第二驱动层3与隔离层2具有不同的变形能力，可选用不同弹性模量的材料制成。其中，第一驱动层1和第二驱动层3的伸缩性强于隔离层2，该隔离层2在一定范围内可限制第一驱动层1和第二驱动层3的伸缩运动。在本实施例中，第一驱动层1和第二驱动层3在隔离层2的一定程度限制下可实现拮抗运动，进而实现三层结构体中部的上升与下降。其中，三层结构体的中间部位上升（对应呼）如图1中的A所示，三层结构体的中间部位下降（对应吸）如图1中的B所示。
在具体应用中，第一驱动层1和第二驱动层3采用弹性模量相对较低的材料制成，隔离层2采用弹性模量相对高一些的材料制成，通过调节第一驱动层1和第二驱动层3的容纳腔中的压力值（充气体或液体），当第一驱动层1的容纳腔内的压力大于第二驱动层3时，整体结构会呈现“拱形”结构（对容纳腔加压时，会向两侧伸长；反之，对容纳腔减压则缩短）。其中，隔离层2选用相对高弹性模量的材料可以起到约束作用并控制伸长的幅度，但隔离层2也会有一定程度上的伸长。
在本发明的一个实施例中，第一驱动层1和第二驱动层3的弹性模量小于1Gpa，即第一驱动层1和第二驱动层3采用弹性模量小于1GPa的软体材料制成，使得第一驱动层1和第二驱动层3的弹性模量与人体软组织器官的弹性模量比较接近。此时，隔离层2可以选择软体材料也可以选择沿伸长方向嵌入弹性纤维。
在本发明的一个实施例中，为了便于调节第一驱动层1和第二驱动层3的容纳腔内的压力，在第一驱动层1和第二驱动层3的一端分别设置有与其容纳腔连通的流体交换口，该流体交换口用于供流体流入与流出。在本实施例中，第一驱动层1的一端的端部设置有与其容纳腔连通的第一流体交换口4，而第一驱动层1远离第一流体交换口4的一端呈封闭设置；第二驱动层3的一端的端部设置有与其容纳腔连通的第二流体交换口5，而第二驱动层3远离第二流体交换口5的一端呈封闭设置。优选地，第一流体交换口4和第二流体交换口5设置于第一驱动层1和第二驱动层3相互靠近的一端的端部。在具体应用中，第一流体交换口4和第二流体交换口5分别与流体压缩机50连通。当然，根据实际需要，第一流体交换口4可扩展为多个，相应地，第一驱动层1内的容纳腔也可扩展为多个，多个容纳腔相互独立，第一流体交换口4与第一驱动层1的容纳腔一一对应并相互连通；第二流体交换口5可扩展为多个，相应地，第二驱动层3内的容纳腔也可扩展为多个，多个容纳腔相互独立，第二流体交换口5与第二驱动层3的容纳腔一一对应并相互连通。同时，为了保持设计的灵活性，每个容纳腔都是单独驱动，并呈分布式控制的。
在本发明的一个实施例中，第一驱动层1、第二驱动层3和隔离层2连接在一起形成三层结构体，在该三层结构体的两端的端部分别连接有柔性铰链7，该柔性铰链7在三层结构体的中间部位实现上升和下降运动时，可以起到提供弯曲变形支持的作用。
为了将三层结构体固定安装于患者体内膈肌部位，在柔性铰链7的一侧表面上安装有固定件8，该固定件8与人体腹腔内壁固定连接，进而将三层结构体的两端固定于人体的对应位置上。
在本发明的一个实施例中，为了便于实时监测膈运动辅助装置10运动的状态，在膈运动辅助装置10上安装有传感器6。具体地，在第一驱动层1的表面和/或第二驱动层3的表面安装有传感器6，例如只在第一驱动层1的表面安装传感器6，或者只在第二驱动层3的表面安装传感器6，或者同时在第一驱动层1的表面和第二驱动层3的表面安装传感器6。在具体应用中，传感器6可安装于第一驱动层1的上表面和/或下表面，也可以安装于第二驱动层3的上表面和/或下表面。其中，安装的传感器6的数量可根据实际情况进行选择，在此不做限定。优选地，传感器6为柔性传感器，以适应第一驱动层1和第二驱动层3的变形。
在本发明的另一个实施例中，膈运动辅助装置10为双层结构体，其包括隔离层2，以及层叠设置于隔离层2上且与隔离层2连接的第一驱动层1，该第一驱动层1和隔离层2均为弹性体，第一驱动层1内部具有用于容纳流体的容纳腔，且第一驱动层1用于随着容纳腔内流体压力的改变实现各项异性变形，该第一驱动层1表面和/或隔离层2的表面安装有传感器6，如在第一驱动层1远离隔离层2的表面或在第一驱动层1靠近隔离层2的表面安装有传感器6，或在隔离层2远离第一驱动层1的表面安装有传感器6，或在隔离层2靠近第一驱动层1的表面安装有传感器6等。
在本实施例中，对隔离层2的要求较高，当对第一驱动层1的容纳腔加压时，隔离层2会对第一驱动层1下表面的伸长起到一定程度的限制作用，使得第一驱动层1的上下表面伸长的幅度不同，从而形成“拱形”结构。但由于该双层结构体的两端会固定于人体内部，所以双层结构体整体上是伸长的，只是第一驱动层1的上下表面的伸长幅度不同，从而形成“拱形”结构。在双层结构体设计参数合理的情况下，其相对于三层结构体可以节省成本。
可以理解的是，在本实施例中，其与上述其它实施例的三层结构体的不同之处在于：膈运动辅助装置10为双层结构体，包括隔离层2和第一驱动层1两层结构。而其它结构与特性与上述实施例相同，在此不再赘述。
在本发明的又一个实施例中，膈运动辅助装置10为双层结构体，其包括第一驱动层1，以及层叠设置于第一驱动层1上且与第一驱动层1连接的第二驱动层3，该第一驱动层1和第二驱动层3均为弹性体，第一驱动层1和第二驱动层3内部均具有用于容纳流体的容纳腔，且第一驱动层1和第二驱动层3用于随着容纳腔内流体压力的改变实现各项异性变形，在该第一驱动层1的表面和/或第二驱动层3的表面安装有传感器6。
在本实施例中，第一驱动层1与第二驱动层3在拮抗作用下可以形成“拱形”结构。
可以理解的是，在本实施例中，其与上述其它实施例的三层结构体的不同之处在于：膈运动辅助装置10为双层结构体，包括第一驱动层1和第二驱动层3两层结构。而其它结构与特性与上述实施例相同，在此不再赘述。
请结合图2，基于同一发明构思，本发明实施例还提供了一种膈运动辅助***，其包括信号采集模块20、数据处理模块30、运动控制模块40、流体压缩机50，以及如上述任一实施例所述的膈运动辅助装置10。其中，信号采集模块20、数据处理模块30、运动控制模块40和流体压缩机50依次电性连接，流体压缩机50与膈运动辅助装置10的流体交换口连接，膈运动辅助装置10的传感器6与运动控制模块40电性连接。信号采集模块20用于对人体膈神经信号进行采集并传递给数据处理模块30进行信号解码，之后数据处理模块30用于将解码后的信号传递给运动控制模块40，运动控制模块40用于对接收的神经信号解码后的数据与传感器6反馈的数据进行融合，进而发送指令调节流体压缩机50输入膈运动辅助装置10的流体压力。
本发明实施例通过基于膈神经信号的采集，解码转化为控制指令实现对膈运动辅助装置10的自主控制，辅助患者自由呼吸；通过传感器6将检测到的信息传递给运动控制模块40进行数据融合，完成闭环控制膈运动辅助装置10的运动，实现患者所需的呼吸率、呼吸深度、呼吸比等功能指标。在直观上，通过控制经过流体交换口流入或流出流体的速度与体积使得驱动层在拮抗作用的同时，整体结构可以呈预定规律模仿膈肌的生理运动实现中间部位的上升和下降。
在具体应用中，将膈运动辅助装置10安装于患者体内膈肌部位，使其位于胸腔与腹腔之间，起到隔离胸腔与腹腔的作用。随着膈运动辅助装置10的第一驱动层1和第二驱动层3的协同运动配合，使得其能够模仿天然膈肌的运动形式。另一方面，对于膈运动辅助装置10的运动控制，采用对患者自身膈神经信号的采集与处理，再通过运动控制模块40发送指令调节流体压缩机50的流体压力输出，同时整合传感器6反馈的信息，对驱动层的容纳腔的流体压力进行实时调节，控制膈运动辅助装置10的运动轨迹，使得膈运动辅助装置10在功能上实现对于天然膈的辅助或替代。同时，可通过传感器6反馈的信息设定流体压缩机50压力输出范围，实现对患者的保护。
以上所述仅为本发明的可选实施例而已，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、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (11)

  1. 一种膈运动辅助装置，其特征在于，包括隔离层，以及层叠设置于所述隔离层的两相对表面的第一驱动层和第二驱动层，所述第一驱动层、第二驱动层和所述隔离层连接在一起形成三层结构体，所述第一驱动层、第二驱动层和隔离层均为弹性体，所述第一驱动层和第二驱动层内部均具有用于容纳流体的容纳腔且用于随着所述容纳腔内流体压力的改变实现各项异性变形。
  2. 如权利要求1所述的膈运动辅助装置，其特征在于，所述第一驱动层和第二驱动层的拉压刚度小于所述隔离层的拉压刚度。
  3. 如权利要求1所述的膈运动辅助装置，其特征在于，所述第一驱动层和第二驱动层的弹性模量小于1GPa。
  4. 如权利要求1至3任一项所述的膈运动辅助装置，其特征在于，所述第一驱动层和第二驱动层分别设置有与其容纳腔连通的流体交换口。
  5. 如权利要求1至3任一项所述的膈运动辅助装置，其特征在于，所述三层结构体的两端分别连接有柔性铰链。
  6. 如权利要求5所述的膈运动辅助装置，其特征在于，所述柔性铰链的一侧表面上安装有固定件。
  7. 如权利要求1至3任一项所述的膈运动辅助装置，其特征在于，所述第一驱动层的表面和/或所述第二驱动层的表面安装有传感器。
  8. 如权利要求4所述的膈运动辅助装置，其特征在于，所述第一驱动层和第二驱动层内均设置有多个相互独立的所述容纳腔，所述第一驱动层和第二驱动层还分别设置有多个与所述容纳腔一一对应且相互连通的所述流体交换口，每一所述容纳腔采用单独驱动和分布式控制。
  9. 一种膈运动辅助装置，其特征在于，包括隔离层，以及层叠设置于所述隔离层上且与所述隔离层连接的第一驱动层，所述第一驱动层和隔离层均为弹性体，所述第一驱动层内部具有用于容纳流体的容纳腔且用于随着所述容纳腔内流体压力的改变实现各项异性变形，所述第一驱动层的表面和/或所述隔离层的表面安装有传感器。
  10. 一种膈运动辅助装置，其特征在于，包括第一驱动层，以及层叠设置于所述第一驱动层上且与所述第一驱动层连接的第二驱动层，所述第一驱动层和第二驱动层均为弹性体，所述第一驱动层和第二驱动层内部均具有用于容纳流体的容纳腔且用于随着所述容纳腔内流体压力的改变实现各项异性变形，所述第一驱动层的表面和/或所述第二驱动层的表面安装有传感器。
  11. 一种膈运动辅助***，其特征在于，包括信号采集模块、数据处理模块、运动控制模块、流体压缩机，以及如权利要求1至10任一项所述的膈运动辅助装置，所述信号采集模块用于对膈神经信号进行采集并传递给所述数据处理模块进行信号解码，所述数据处理模块用于将解码后的信号传递给所述运动控制模块，所述运动控制模块用于对接收的神经信号解码后的数据与传感器反馈的数据进行融合，进而发送指令调节所述流体压缩机输入所述膈运动辅助装置的流体压力。
PCT/CN2019/130830 2019-03-05 2019-12-31 一种膈运动辅助装置及膈运动辅助*** WO2020177472A1 (zh)

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