WO2020177472A1

WO2020177472A1 - Diaphragmatic movement assistance device and diaphragmatic movement assistance system

Info

Publication number: WO2020177472A1
Application number: PCT/CN2019/130830
Authority: WO
Inventors: 夏泽洋; 徐桂文; 邓豪; 熊璟
Original assignee: 深圳先进技术研究院
Priority date: 2019-03-05
Filing date: 2019-12-31
Publication date: 2020-09-10
Also published as: CN109998518B; CN109998518A

Abstract

Disclosed are a diaphragmatic movement assistance device (10) and a diaphragmatic movement assistance system. The diaphragmatic movement assistance device (10) comprises an isolation layer (2), and a first driving layer (1) and a second driving layer (3) arranged on two opposite surfaces of the isolation layer (2) in a stacked manner, wherein the first driving layer (1), the second driving layer (3) and the isolation layer (2) are connected together to form a three-layer structural body; the first driving layer (1), the second driving layer (3) and the isolation layer (2) are all elastomers; and the first driving layer (1) and the second driving layer (3) are both internally provided with accommodating cavities for accommodating fluid, and are used for achieving anisotropic deformation along with a change in the pressure of the fluid in the accommodating cavities. The diaphragmatic movement assistance device (10) provides a breathing assistance scheme for a patient, realizes assistance with or replacement of a diaphragmatic movement function of a human body, helps the patient breathe freely, and can provide exercise rehabilitation support for patients with diaphragm atrophy by means of passive assistance with diaphragmatic movement.

Description

Diaphragm movement auxiliary device and diaphragm movement auxiliary system

Technical field

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.

Background technique

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. At present, 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.

technical problem

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.

Technical solutions

The present invention is realized in this way. 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.

In an embodiment of the present invention, 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.

In an embodiment of the present invention, the elastic modulus of the first driving layer and the second driving layer is less than 1 GPa.

In an embodiment of the present invention, the first driving layer and the second driving layer are respectively provided with fluid exchange ports communicating with the containing cavity.

In an embodiment of the present invention, flexible hinges are respectively connected to both ends of the three-layer structure.

In an embodiment of the present invention, a fixing member is installed on one side surface of the flexible hinge.

In an embodiment of the present invention, sensors are installed on the surface of the first driving layer and/or the surface of the second driving layer.

In an embodiment of the present invention, 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. In the case of an abnormal deformation, 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.

Beneficial effect

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.

Description of the drawings

In order to explain the technical solutions in the embodiments of the present invention more clearly, the following will briefly introduce the drawings needed in the embodiments. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative work, other drawings can be obtained based on these drawings.

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.

The details of the labels involved in the above drawings are as follows:

10- Diaphragm movement auxiliary device; 1- First drive layer; 2- Isolation layer; 3- Second drive layer; 4- First fluid exchange port; 5- Second fluid exchange port; 6-Sensor; 7- Flexible hinge ;8-Fixed parts;

20-Signal acquisition module;

30-Data processing module;

40-Motion control module;

50-fluid compressor.

Embodiments of the invention

In order to make the objectives, technical solutions, and advantages of the present invention clearer, the following further describes the present invention in detail with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the present invention, but not to limit the present invention.

It should be noted that when a component is referred to as being "fixed to" or "installed on" another component, it can be directly or indirectly located on the other component. When a component is said to be "connected" to another component, it can be directly or indirectly connected to the other component. The terms "upper", "lower", "left", "right", "front", "rear", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. The indicated orientation or position is based on the orientation or position shown in the drawings, which is only for ease of description and cannot be understood as a limitation of the technical solution. The terms "first" and "second" are only used for ease of description, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features. The meaning of "plurality" means two or more than two, unless otherwise specifically defined.

In order to illustrate the technical solutions of the present invention, detailed descriptions are given below in conjunction with specific drawings and embodiments.

Referring to FIG. 1, 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. Wherein, 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. Inside the 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. In this embodiment, 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.

In a specific application, 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.

In an embodiment of the present invention, 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. Specifically, 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. Among them, 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. In this embodiment, 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. Among them, 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.

In specific applications, the first driving layer 1 and the second driving layer 3 are made of materials with relatively low elastic modulus, and the isolation layer 2 is made of materials with relatively high elastic modulus. By adjusting the first driving layer 1 And the pressure value (inflated body or liquid) in the accommodating cavity of the second driving layer 3, when the pressure in the accommodating cavity of the first driving layer 1 is greater than that of the second driving layer 3, the overall structure will show an "arch" structure ( When the chamber is pressurized, it will extend to both sides; conversely, when the chamber is decompressed, it will shorten). Among them, the isolation layer 2 uses a material with a relatively high elastic modulus to restrain and control the extent of elongation, but the isolation layer 2 will also have a certain degree of elongation.

In an embodiment of the present invention, 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. At this time, the isolation layer 2 can choose soft materials or embed elastic fibers along the elongation direction.

In an embodiment of the present invention, in order to facilitate the adjustment of the pressure in the accommodating cavity of the first driving layer 1 and the second driving layer 3, 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. In this embodiment, 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. Preferably, 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. In specific applications, the first fluid exchange port 4 and the second fluid exchange port 5 are respectively communicated with the fluid compressor 50. Of course, according to actual needs, the first fluid exchange port 4 can be expanded into multiple. Correspondingly, the accommodating cavities in the first drive layer 1 can also be expanded to multiple. The multiple accommodating cavities are independent of each other. Correspond to and communicate with the accommodating cavities of the first drive layer 1 one-to-one; 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. At the same time, in order to maintain design flexibility, each containing cavity is driven separately and controlled in a distributed manner.

In an embodiment of the present invention, 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 When 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.

In order to fix the three-layer structure on the diaphragm of the patient, 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.

In an embodiment of the present invention, in order to facilitate real-time monitoring of the movement state of the diaphragm exercise assisting device 10, a sensor 6 is installed on the diaphragm exercise assisting device 10. Specifically, 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. In a specific application, 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. Among them, the number of installed sensors 6 can be selected according to actual conditions, and is not limited here. Preferably, the sensor 6 is a flexible sensor to adapt to the deformation of the first driving layer 1 and the second driving layer 3.

In another embodiment of the present invention, 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.

In this embodiment, the requirements for the isolation layer 2 are relatively high. When the accommodating cavity of the first drive layer 1 is pressurized, 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. However, since the two ends of the double-layer structure will be fixed inside the human body, 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 . When the design parameters of the double-layer structure are reasonable, it can save cost compared with the three-layer structure.

It is understandable that, in this embodiment, the difference from the three-layer structure of the other embodiments described above is that 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.

In yet another embodiment of the present invention, 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.

In this embodiment, the first driving layer 1 and the second driving layer 3 can form an "arch" structure under the antagonistic action.

It can be understood that in this embodiment, the difference from the three-layer structure of the other embodiments described above is that 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.

Please refer to FIG. 2, based on the same inventive concept, 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. Among them, 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.

In the embodiment of the present invention, 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. Intuitively, by controlling the speed and volume of fluid flowing into or out of the fluid exchange port, 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.

In a specific application, 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. On the other hand, for the motion control of the phrenic exercise assisting device 10, the patient’s own phrenic nerve signals are collected and processed, and then 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. At the same time, 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.

The above descriptions are only optional embodiments of the present invention and are not intended to limit the present invention. Any modification, equivalent replacement and improvement made within the spirit and principle of the present invention shall be included in the protection of the present invention. Within range.

Claims

A diaphragm exercise assisting device, which is characterized by comprising an isolation layer, and a first driving layer and a second driving layer stacked on two opposite surfaces of the isolation layer, the first driving layer, the second driving layer and the The isolation layers 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 are both internally provided for accommodating fluid The containing cavity is used to achieve anisotropic deformation as the fluid pressure in the containing cavity changes.
The diaphragm exercise assisting device according to claim 1, wherein the tension and compression stiffness of the first driving layer and the second driving layer is less than the tension and compression stiffness of the isolation layer.
The diaphragm exercise assisting device according to claim 1, wherein the elastic modulus of the first driving layer and the second driving layer is less than 1 GPa.
The diaphragm exercise assisting device according to any one of claims 1 to 3, wherein the first driving layer and the second driving layer are respectively provided with fluid exchange ports communicating with the containing cavity.
The diaphragm exercise assisting device according to any one of claims 1 to 3, wherein the two ends of the three-layer structure are respectively connected with flexible hinges.
The diaphragm exercise assisting device according to claim 5, wherein a fixing member is installed on one side surface of the flexible hinge.
The diaphragm exercise assisting device according to any one of claims 1 to 3, wherein a sensor is installed on the surface of the first driving layer and/or the surface of the second driving layer.
The diaphragm exercise assisting device according to claim 4, wherein the first driving layer and the second driving layer are each provided with a plurality of independent accommodating cavities, the first driving layer and the second driving layer The driving layer is also respectively provided with a plurality of the fluid exchange ports that correspond to the accommodating cavities one-to-one and communicate with each other, and each of the accommodating cavities adopts independent driving and distributed control.
A diaphragm exercise assisting device, characterized in that it comprises an isolation layer, and a first driving layer stacked on the isolation layer and connected to the isolation layer, and both the first driving layer and the isolation layer are elastomers The inside of 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 the isolation Sensors are installed on the surface of the layer.
A diaphragm exercise assisting device, which is characterized by comprising 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 is an elastomer, and the first driving layer and the second driving layer each have a accommodating cavity for accommodating fluid and are used to achieve anisotropic deformation as the fluid pressure in the accommodating cavity changes, A sensor is mounted on the surface of the first driving layer and/or the surface of the second driving layer.
A diaphragm exercise assisting system, which is characterized by comprising a signal acquisition module, a data processing module, a motion control module, a fluid compressor, and the diaphragm exercise assisting device according to any one of claims 1 to 10. The signal acquisition The module is used to collect the phrenic nerve signal and transmit it 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 receive The decoded data of the neural signal and the data fed back by the sensor are fused, and then an instruction is sent to adjust the fluid pressure input by the fluid compressor to the diaphragm exercise assisting device.