Bilateral pelvic floor muscle function detection device and method

Abstract

The invention discloses a bilateral pelvic floor muscle function detection device and method. The device comprises a pelvic floor probe module and a near-infrared control module, the pelvic floor probe module comprises a probe body, two near-infrared light channels used for synchronously measuring pelvic floor near-infrared light signals on the two sides are arranged in the probe body, and the probe body can be placed in a vaginal cavity or a rectum cavity. Each near-infrared light channel comprises a near-infrared light source used for emitting near-infrared light signals and a light detector used for receiving the near-infrared light signals and converting the near-infrared light signals into electric signals, and the near-infrared light sources and the light detectors in the two near-infrared light channels are used for synchronously collecting the near-infrared light signals of pelvic floor muscles on the two sides of a patient; and the near-infrared control module is used for controlling the work of the near-infrared light channel and processing and transmitting the near-infrared light signal. Near-infrared light signals of pelvic floor muscles on the left side and the right side of a patient can be synchronously measured, and oxygenation and hemodynamics conditions of the pelvic floor muscles on the left side and the right side of the patient are detected.

Description

Technical Field

[0001] The present invention relates to the field of medical rehabilitation, and in particular to a bilateral pelvic floor muscle function detection device and method. Background Art

[0002] Pelvic floor muscle rehabilitation training can effectively help patients restore the function of the pelvic floor muscles, strengthen the pelvic floor support system, and improve pelvic floor function. It is one of the main treatments for pelvic floor dysfunction.

[0003] Initially, the main methods of measuring pelvic floor muscle function included pelvic floor imaging data and pelvic floor pressure data. These methods can directly observe the pelvic floor structure and the intuitive display of the pressure in the pelvic floor, but cannot obtain the activity of the patient's pelvic floor muscles and cannot provide patients with more accurate training guidance. At present, the use of physiological signals to measure pelvic floor muscle function has gradually become the mainstream. The most widely used physiological signal is the surface electromyography signal. The surface electromyography can better reflect the rehabilitation of the patient's pelvic floor muscle function, but the surface electromyography signal can only reflect the patient's muscle strength level, and most of the current electromyography therapeutic devices can only measure single-channel electromyography, reflecting a relatively simple physiological parameter and only reflecting the functional status of the patient's local muscles. With the development of technology, another physiological signal, near-infrared spectroscopy (NIRS), has begun to be used in the field of rehabilitation assessment. In the near-infrared light band of 700nm to 1000nm, the main light-absorbing substances in human tissue are oxygenated hemoglobin (O2Hb) and deoxygenated hemoglobin (HHb). By measuring the light attenuation after the light passes through the tissue, the concentration of O2Hb and HHb in the tissue can be obtained, so as to understand the tissue oxygenation and hemodynamics in the muscle. Based on this, US8977345B2 discloses a technology for monitoring the function of pelvic floor muscles based on near-infrared light, but this technical solution can only monitor the function of the patient's unilateral pelvic floor muscles. In the case that both sides of the patient's pelvic floor muscles may be damaged, the measurement results are prone to deviation and are not accurate enough; on the other hand, this technical solution only has one pelvic floor probe, and an additional special driver is required to control the collection of near-infrared light signals, which will bring operational inconvenience to users and is not flexible enough; at the same time, the probe of this technical solution is not completely sealed, which is easy to cause contamination of the internal parts of the probe during use, and is not safe enough. Summary of the invention

[0004] In order to solve at least one of the problems existing in the prior art, the present invention provides a bilateral pelvic floor muscle function detection device and method, by which the near-infrared light signals of the left and right pelvic floor muscles of the patient can be synchronously measured, and the oxygenation and hemodynamic conditions of the left and right pelvic floor muscles of the patient can be detected, so as to provide more accurate and effective rehabilitation treatment.

[0005] The technical solution adopted by the present invention to solve its technical problem is to provide a bilateral pelvic floor muscle function detection device, including a pelvic floor probe module and a near-infrared control module. Specifically, the pelvic floor probe module includes a probe body, and two near-infrared light channels are arranged in the probe body. The probe body can be placed in the vaginal cavity or the rectal cavity. Each near-infrared light channel includes a near-infrared light source for emitting near-infrared light signals and a light detector for receiving the near-infrared light signals and converting them into electrical signals. The near-infrared light signals of the patient's bilateral pelvic floor muscles are synchronously collected by the near-infrared light sources and light detectors in the two near-infrared light channels.

[0006] The near-infrared control module is used to control the operation of the near-infrared light channel and process and transmit near-infrared light signals.

[0007] Preferably, the pelvic floor probe module further comprises a probe outer handle, which is connected to the probe body. When in operation, the probe outer handle is left outside the body for placing and removing the probe body.

[0008] Preferably, a joint is provided on the outer handle of the probe, and the pelvic floor probe module is connected to the near-infrared control module via the joint.

[0009] Preferably, the near-infrared control module is respectively connected to the connector and the external device to receive external instructions to control the near-infrared light source to send near-infrared light of different wavelengths in time and synchronously collect electrical signals corresponding to the attenuated light intensity values ​​detected by the light detector, extract near-infrared light signals containing tissue oxygenation and hemodynamic information based on the electrical signals, and send the collected near-infrared light signals to the external device.

[0010] Preferably, the near-infrared control module communicates with the external device via wired communication or wireless communication.

[0011] Preferably, the wired communication method is any one of USB communication, serial communication, CAN communication, and RS232 / RS485, and the wireless communication method is any one of Bluetooth, WiFi, and Zigbee.

[0012] Preferably, the two near-infrared light channels are symmetrically arranged on both sides of the probe body, that is, the left and right sides of the probe each include a near-infrared light source and a near-infrared light detector, and the near-infrared light signals of the pelvic floor on the left and right sides can be synchronously measured.

[0013] The near-infrared control module can process and transmit near-infrared light signals.

[0014] Preferably, the near-infrared control module is also used to control the light intensity of the near-infrared light source and / or control the sampling frequency of the near-infrared light source.

[0015] Preferably, the near infrared control module has a button that can control the near infrared control module to turn on and off, including:

[0016] Short press of the button can control the near infrared control module to turn on;

[0017] Long pressing the button can control the near infrared control module to shut down;

[0018] Preferably, the near infrared control module has two working modes, including:

[0019] Standby mode: controlling the two near-infrared light channels to stop working;

[0020] Working mode: Control the two near-infrared light channels to work according to the program settings and send NIRS signals to the outside.

[0021] The present invention also provides a bilateral pelvic floor muscle function detection method, which is implemented by using the bilateral pelvic floor muscle function detection device, and the method comprises the following steps:

[0022] The probe body of the pelvic floor probe module is placed in the vaginal cavity or the rectal cavity, and the near-infrared light sources in the two near-infrared light channels are controlled to emit near-infrared light signals;

[0023] The near-infrared light signal is received by a corresponding light detector after being reflected, scattered and absorbed in human tissue, and the light detector converts the received near-infrared light signal into an electrical signal;

[0024] Based on the electrical signal, a signal of the tissue deoxyhemoglobin concentration (O2Hb) and oxygenated hemoglobin concentration (HHb) information contained in the electrical signal is extracted, and the light attenuation of the near-infrared light signal after passing through the human tissue is calculated by the known modified Beer-Lambert law, so as to obtain the concentration status of O2Hb and HHb in the human tissue and understand the tissue oxygenation and hemodynamics in the human tissue.

[0025] Compared with the prior art, the present invention provides a bilateral pelvic floor muscle function detection device and method, which can insert the pelvic floor probe module deep into the patient's body, detect the functional status of the patient's left and right pelvic floor muscles through near-infrared light technology, and obtain the oxygenation and hemodynamic information of the patient's left and right pelvic floor muscles; at the same time, the near-infrared control module can control, process and transmit near-infrared light signals, so as to facilitate subsequent further analysis of the patient's pelvic floor muscle functional status. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 It is a structural block diagram of a bilateral pelvic floor muscle function detection device provided by an embodiment of the present invention;

[0027] Figure 2 It is a structural schematic diagram of a pelvic floor probe module of a bilateral pelvic floor muscle function detection device provided by an embodiment of the present invention;

[0028] Figure 3 It is a structural schematic diagram of a near-infrared control module of a bilateral pelvic floor muscle function detection device provided by an embodiment of the present invention;

[0029] Figure 4 It is a near-infrared light signal data collection flow chart of a bilateral pelvic floor muscle function detection device in an embodiment of the present invention. DETAILED DESCRIPTION

[0030] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0031] The core of the embodiment of the present invention is to provide a bilateral pelvic floor muscle function detection device, which can collect near-infrared light signals of the patient's bilateral pelvic floor muscles for evaluating the status and function of the patient's bilateral pelvic floor muscles.

[0032] In order to enable those skilled in the art to better understand the solutions of the present invention, the present invention is further described in detail below in conjunction with the accompanying drawings and specific implementation methods.

[0033] Figure 1 A structural block diagram S100 of a bilateral pelvic floor muscle function detection device provided by an embodiment of the present invention is shown in FIG. Figure 1 As shown, the device provided by the embodiment of the present invention includes: a pelvic floor probe module S110, which is placed in the patient's body and acquires near-infrared light signals of the patient's bilateral pelvic floor muscles through a near-infrared light source and a light detector; a near-infrared control module S120, which is used to control the operation of the near-infrared light source and the light detector, and process and transmit near-infrared light data;

[0034] Figure 2 Schematic diagram of the structure of a pelvic floor probe module S110 of a bilateral pelvic floor muscle function detection device provided by an embodiment of the present invention; Figure 2 As shown, the pelvic floor probe module S110 includes a probe housing and two near-infrared light channels (3, 4), specifically:

[0035] According to different positions in the human body, the probe housing can be divided into two parts: a probe body 1 and a probe outer handle 2; the probe body 1 can penetrate into the patient's body and directly reach the location of the pelvic floor muscles, and the probe outer handle 2 is outside the patient's body, which is convenient for placing and removing the probe body 1 and adjusting the position of the pelvic floor probe body 1. A communication line connector 7 is also left at the probe outer handle 2 to facilitate the connection between the near-infrared light channel and the near-infrared control module S120. In some embodiments of the present invention, the probe body 1 is basically cylindrical in shape, of moderate length, and streamlined to better adapt to the shape of the patient's vaginal cavity or rectal cavity.

[0036] In some embodiments of the present invention, the probe body 1 and the probe outer handle 2 are connected in an integrated manner, that is, the probe shell adopts an integrated design, and the shell adopts a material with good biocompatibility, such as stainless steel, resin, PEEK and the like, which can be directly in contact with the human body, can be placed in the human vaginal cavity or rectal cavity and is harmless to the human body, and is suitable for pelvic floor muscle function testing. The diameter selection of the probe body 1 is related to the position where the probe is placed during detection. In some embodiments of the present invention, if the bilateral pelvic floor muscles of the patient are measured through the rectal cavity, the diameter of the probe body 1 is set at about 20 mm; if the bilateral pelvic floor muscles of the patient are measured through the vaginal cavity, it is also necessary to select a pelvic floor probe of corresponding size according to the relaxation of the patient's vaginal cavity, so that the pelvic floor probe fits the vaginal cavity as much as possible, and the diameter of the vaginal cavity pelvic floor probe is usually between 20 mm and 40 mm.

[0037] In the present invention, each of the near-infrared light channels includes a near-infrared light source and at least one light detector, wherein the near-infrared light source can emit near-infrared light of at least two different wavelengths, and the light detector can receive near-infrared light signals that are reflected, scattered, and absorbed in human tissues and finally attenuated, and convert the near-infrared light signals into electrical signals. Among them, by calculating the light attenuation of the near-infrared light signal after passing through human tissues using the modified Beer-Lambert law, the concentration of O2Hb and HHb in human tissues can be obtained, thereby understanding the tissue oxygenation and hemodynamics in human tissues. In addition, the distance between the near-infrared light source and the light detector will affect the acquisition of the light attenuation. When the distance between the two is larger, the near-infrared light will attenuate more during the reflection and scattering process, resulting in deviations in the actual light attenuation through human tissues. In some embodiments of the present invention, the distance between the near-infrared light source and the light detector is twice the maximum depth that the emitted near-infrared light signal can detect. Since the maximum depth that the near-infrared light signal can theoretically detect is between 0.5-1.5 cm, the distance between the near-infrared light source and the light detector can be selected to be between 1-3 cm.

[0038] The near-infrared light channel is placed inside the probe housing 1, and includes a first near-infrared light channel 3 and a second near-infrared light channel 4. The two near-infrared light channels are symmetrically distributed and independent of each other, and respectively collect near-infrared light signals of the left and right pelvic floor muscles.

[0039] The probe housing 1 can be made of non-transparent material with good light isolation properties, with only two small windows (defined as the first window 5 and the second window 6) left on the left and right sides of the probe housing 1, which are colorless and transparent; the first window 5 is set corresponding to the near-infrared light source, used to allow the near-infrared light emitted by the near-infrared light source to pass through the housing and irradiate into the patient's tissue; the second window 6 is set corresponding to the light detector, used to allow the attenuated near-infrared light to pass through the probe housing 1 and be received by the light detector.

[0040] Based on the above embodiment, as a preferred implementation, the pelvic floor probe may be configured as follows, specifically:

[0041] The near-infrared light channel may include a near-infrared light source and a light detector, the near-infrared light source may generate near-infrared light of two wavelengths, and the distance between the near-infrared light source and the light detector is 20 mm. The above implementation can meet the basic requirements of measuring NIRS signals through the near-infrared light channel, and the energy consumed by the operation of the near-infrared light channel is also minimal.

[0042] Figure 3 Schematic diagram of the structure of a near-infrared control module S120 of a bilateral pelvic floor muscle function detection device provided by an embodiment of the present invention; Figure 3 As shown, the near infrared control module S120 includes a main control unit S121, a power supply unit S122, an interface unit S123, a communication unit S124 and a button S125; specifically,

[0043] The main control unit S121 is used to control the near-infrared light source to emit near-infrared light according to a set timing, and synchronously receive an electrical signal corresponding to the attenuated light intensity value detected by the light detector, and extract the tissue deoxyhemoglobin concentration (O2Hb) and oxygenated hemoglobin concentration (HHb) signals contained in the electrical signal, that is, the near-infrared light (NIRS) signal; the power supply unit S122 can provide the near-infrared control module S120 with necessary power and operating voltage so that the near-infrared control module S120 can work normally; the interface unit S123 can be connected to the communication line connector 7 at the probe outer handle 2 of the probe body 1 in the pelvic floor probe module S110, and the main control unit S121 can control the near-infrared light channel inside the pelvic floor probe module through the communication line; the communication unit S124 can be used for communicating with the outside, and can both receive signals from the outside and send the collected NIRS signals to the outside. In some embodiments of the present invention, the communication interface includes but is not limited to USB communication, serial communication, CAN communication, RS232 / RS485 and other wired communication methods and Bluetooth, WiFi, Zigbee and other wireless communication methods; the button S125 can be used to control the power on and off of the near-infrared control module S120, and can also be used to switch the working mode of the near-infrared control module S120.

[0044] The near-infrared control module S120 has two working modes: standby mode and working mode: if the near-infrared control module S120 is in standby mode, the near-infrared light channel will not be controlled to collect the NIRS signal; if the near-infrared control module S120 is in working mode, the NIRS signal will start to be collected, and the NIRS signal will be sent to the outside through the other communication interface. By setting two working modes, it is possible to prevent the near-infrared control module S120 from being directly in working mode as soon as it is turned on, which can reduce the power consumption of the near-infrared control module S120 and avoid the influence of the near-infrared control module S120 collecting invalid NIRS signals when the patient is not ready.

[0045] Based on the above embodiment, as a preferred implementation mode, the working state of the near infrared control module can be switched in two ways, including switching by key state and switching by command. Specifically:

[0046] If the button state is switched, if the button S125 is double-clicked, the near-infrared control module S120 is configured to be in working mode; if the button S125 is single-clicked, the near-infrared control module is configured to be in standby mode;

[0047] If the command is switched through the command, the command comes from the external host computer. If a start command is received, the near infrared control module S120 is configured to the working mode; if an end command is received, the near infrared control module S120 is configured to the standby mode.

[0048] On the basis of the above embodiments, the present invention further provides a bilateral pelvic floor muscle function detection method, which is implemented by using the bilateral pelvic floor muscle function detection device provided by the above embodiments, and the method specifically comprises the following steps:

[0049] Step 1, placing the probe body 1 of the pelvic floor probe module S110 in the vaginal cavity or the rectal cavity, and controlling the near-infrared light sources in the two near-infrared light channels to emit near-infrared light signals;

[0050] Step 2, the near-infrared light signal is received by a corresponding light detector after being reflected, scattered and absorbed in human tissue, and the light detector converts the received near-infrared light signal into an electrical signal;

[0051] Step 3, based on the electrical signal, extract the signal of the tissue deoxyhemoglobin concentration (O2Hb) and oxygenated hemoglobin concentration (HHb) information contained in the electrical signal, calculate the light attenuation of the near-infrared light signal after passing through the human tissue by using the known modified Beer-Lambert law, thereby obtaining the concentration status of O2Hb and HHb in the human tissue, and understanding the tissue oxygenation and hemodynamics in the human tissue.

[0052] As a preferred embodiment, Figure 4 A data collection flow chart provided by an embodiment of the present invention. Figure 4 As shown, specifically:

[0053] At the beginning, the near-infrared control module S120 will be in standby mode and wait for receiving a start command or waiting for a double-click of a button; if the near-infrared control module S120 receives a start command, or the button S125 of the near-infrared control module S120 is double-clicked, it will be configured to the working mode according to the built-in program setting; next, the near-infrared control module S120 will continue to drive the near-infrared light channel inside the pelvic floor probe module S110 to work at a fixed time according to the frequency set by the program and receive the collected near-infrared light intensity value; next, the near-infrared control module S120 converts the near-infrared light intensity value into a near-infrared light (NIRS) signal, wherein the near-infrared light signal refers to the deoxyhemoglobin concentration (O 2Hb) and oxygenated hemoglobin concentration (HHb), where O2Hb and HHb contain the oxygenation and hemodynamic conditions inside the tissue; after completing the signal conversion, the near-infrared control module S120 will send the near-infrared light signal to the outside according to the preset communication method; during the process, if the near-infrared control module S120 receives an end instruction, or the button S125 of the near-infrared control module S120 is clicked, the near-infrared control module S120 is immediately configured to standby mode and stops sending data; if the end instruction is not received and the button S125 is not clicked, the near-infrared control module S120 will continue to collect data at the frequency set inside the program.

[0054] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A bilateral pelvic floor muscle function detection device, characterized in that: It includes a pelvic floor probe module and a near infrared control module; The pelvic floor probe module includes a probe body, in which two near-infrared light channels are arranged. The probe body can be placed in the vaginal cavity or the rectal cavity. Each near-infrared light channel includes a near-infrared light source for emitting near-infrared light signals and a light detector for receiving the near-infrared light signals and converting them into electrical signals. The near-infrared light signals of the patient's bilateral pelvic floor muscles are synchronously collected by the near-infrared light sources and light detectors in the two near-infrared light channels. The near-infrared control module is used to control the operation of the near-infrared light channel and process and transmit near-infrared light signals.

2. A bilateral pelvic floor muscle function detection device according to claim 1, characterized in that: The pelvic floor probe module also includes a probe outer handle, which is connected to the probe body. When working, the probe outer handle is left outside the body for placing and removing the probe body.

3. A bilateral pelvic floor muscle function detection device according to claim 2, characterized in that: The outer handle of the probe is provided with a joint, and the pelvic floor probe module is connected to the near-infrared control module via the joint.

4. A bilateral pelvic floor muscle function detection device according to claim 3, characterized in that: The near-infrared control module is respectively connected to the connector and the external device to receive external instructions to control the near-infrared light source to send near-infrared light of different wavelengths in time-sharing and synchronously collect electrical signals corresponding to the attenuated light intensity values ​​detected by the light detector, extract near-infrared light signals containing tissue oxygenation and hemodynamic information based on the electrical signals, and send the collected near-infrared light signals to the external device.

5. A bilateral pelvic floor muscle function detection device according to claim 4, characterized in that: The near infrared control module communicates with the external device via wired communication or wireless communication.

6. A bilateral pelvic floor muscle function detection device according to claim 1, characterized in that: The two near-infrared light channels are stacked and arranged on both sides of the probe body.

7. The bilateral pelvic floor muscle function detection device according to claim 1, characterized in that: The near-infrared control module is also used to control the light intensity of the near-infrared light source and / or control the sampling frequency of the near-infrared light source.

8. The bilateral pelvic floor muscle function detection device according to claim 1, characterized in that: The near infrared control module includes a button for controlling the near infrared control module to turn on and off, including: Short press the button to turn on the near infrared control module; Long press the button to control the near infrared control module to shut down.

9. A bilateral pelvic floor muscle function detection device according to any one of claims 1 to 8, characterized in that: The near infrared control module has two working modes, including: Standby mode: controlling the two near-infrared light channels to stop working; Working mode: Control the two near-infrared light channels to work according to the program settings and send NIRS signals to the outside.

10. A method for detecting bilateral pelvic floor muscle function, characterized in that: The method is implemented by using the device described in any one of claims 1 to 9, and comprises the following steps: The probe body of the pelvic floor probe module is placed in the vaginal cavity or the rectal cavity, and the near-infrared light sources in the two near-infrared light channels are controlled to emit near-infrared light signals; The near-infrared light signal is received by a corresponding light detector after being reflected, scattered and absorbed in human tissue, and the light detector converts the received near-infrared light signal into an electrical signal; A signal containing information about tissue deoxyhemoglobin concentration and oxygenated hemoglobin concentration contained in the electrical signal is extracted based on the electrical signal, and the light attenuation of the near-infrared light signal after passing through human tissue is calculated, thereby obtaining the concentration conditions of tissue deoxyhemoglobin and oxygenated hemoglobin in the human tissue, and understanding the tissue oxygenation and hemodynamic conditions in the human tissue.

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