A high-precision multifunctional pelvic floor muscle pressure measuring system based on optical fiber sensing

Abstract

The application provides a high-precision multifunctional pelvic floor muscle pressure measuring system based on optical fiber sensing, which comprises a handle, a probe, a plurality of annular balloons, a plurality of FBG pressure sensing arrays, a gas pressure control system, an optical fiber, a tunable laser, an imaging probe and a host computer. The application can accurately measure the overall pressure distribution of different subjects along the vaginal axis by self-adaptive adjustment of the plurality of balloons and omnidirectional layout of the FBG pressure sensing array. The application can not only be used for pelvic floor muscle pressure detection of subjects in a supine position, but also can be used for continuous monitoring of subjects in a moving state, so that various evaluation requirements in the clinic are met, and the application has the advantages of high measurement precision, convenient operation, low maintenance cost and the like.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of gynecological medical devices, and particularly relates to a high-precision multifunctional pelvic floor muscle pressure measuring system based on optical fiber sensing. BACKGROUND

[0002] Pelvic floor muscles (PFM) are a key dynamic stabilizing system that maintains the normal function of pelvic organs, and are divided into three layers from outside to inside: the outer layer includes bulbospongiosus muscle, ischiocavernous muscle, superficial perineal muscle and external anal sphincter; the middle layer is composed of urethral sphincter and deep perineal muscle; and the inner layer is the main device for controlling urine and is composed of levator ani muscle and a pair of coccygeal muscles. According to muscle fiber types, pelvic floor muscles can be divided into two categories: about 70% are type I muscle fibers, which are responsible for maintaining endurance and stability and provide long-term support for pelvic organs; and the rest are type II muscle fibers, which are responsible for rapid and powerful contraction and play a key role in active contraction of pelvic floor muscles, such as processes of urination, defecation and sexual life. When pelvic floor muscles are abnormal, especially when the strength of type I muscle fibers is weakened, pelvic floor dysfunction (PFD) occurs, and clinical manifestations are mainly urinary incontinence, sexual dysfunction and pelvic organ prolapse. These symptoms have a negative impact on quality of life and participation in physical activities. Since the repair capacity of type I muscle fibers is limited, once damaged, the recovery process is relatively slow. Therefore, regular examination and evaluation of PFM conditions are crucial for timely detection of abnormalities and the adoption of preventive measures.

[0003] There are various methods to assess the functional status and contractile strength of PFM, including vaginal palpation, ultrasound, magnetic resonance imaging (MRI), surface electromyography (sEMG), pressure measurement, force measurement, etc. Vaginal palpation is a common method to assess PFM function in physical therapy, but it is greatly influenced by subjective factors and is only used to qualitatively determine whether muscle contraction exists. Available quantitative methods include sEMG, pressure measurement, force measurement, ultrasound, and MRI. These methods measure different aspects of PFM activity and each has its place in physical therapy assessment, but they also have their limitations: sEMG technology can directly record the physiological electrical activity of the pelvic floor muscles, but since this technology requires placing a recording electrode patch in the female vaginal cavity, it can only be used to assess subjects in a non-pregnant state, and factors such as the contact state of the electrode with the vaginal mucosa, the position of the electrode relative to the muscle fibers, the degree of vaginal lubrication, and the thickness of the vaginal tissue can all affect the detection of the sEMG signal. The pressure transducer array used in pressure measurement can obtain the pressure distribution curve along the vaginal axis, but the measurement results can be affected by body position, device displacement, etc., and there is some uncertainty. At the same time, since the measurement values obtained depend not only on the diameter of the probe used, but also on the individual differences in the internal diameter of each subject's vagina, and existing pressure meters lack flexibility in probe specifications, it is difficult to adapt to the individual circumstances of different subjects, so the reliability and universality of the measurement results need to be further improved. Non-invasive detection methods such as ultrasound and MRI improve the comfort of the examination and are suitable for the assessment of certain patient groups, but they cannot replace direct and accurate measurement of pelvic floor muscle contraction. Given the limitations and limitations of using electromyography, pressure measurement, or imaging techniques alone to assess pelvic floor muscle function, combining the advantages of multiple techniques has become a future trend. There is an urgent need for a method that can combine accurate pressure measurement with high-resolution imaging technology, which is expected to comprehensively and objectively evaluate pelvic floor muscle contraction and activity patterns, and provide more reliable data support for clinical diagnosis and functional assessment. SUMMARY

[0004] Technical problem solved: The present application provides a high-precision multifunctional pelvic floor muscle pressure measurement system based on optical fiber sensing, which can accurately measure the overall pressure distribution along the vaginal axis of different subjects through the self-adaptive adjustment of multiple balloons and the omnidirectional layout of the FBG pressure sensing array. The present application not only can be used for pelvic floor muscle pressure detection of subjects in a supine position, but also can be used for continuous monitoring of subjects in an active state, meeting various clinical assessment needs, and having the advantages of high measurement accuracy, convenient operation, and low maintenance cost.

[0005] Technical solution:

[0006] A high-precision multifunctional pelvic floor muscle pressure measurement system based on fiber sensing, comprising a handle, a probe, a plurality of circular ring balloons, a plurality of FBG pressure sensing arrays, a gas pressure control system, an optical fiber, a tunable laser, an imaging probe and a host computer;

[0007] The probe is connected to one end of the handle and extends into the vagina, and the probe comprises a plurality of circular ring balloons stacked in sequence, and the top end of the probe and the sidewall of each circular ring balloon are uniformly attached with a plurality of FBG pressure sensing arrays;

[0008] The FBG pressure sensing array is connected to the tunable laser through the optical fiber, the FBG pressure sensing array measures the pressure exerted by the pelvic floor muscle group at the position, and feeds back the measurement result to the host computer; the imaging probe is connected to the host computer, and the collected image signal is transmitted to the host computer;

[0009] The circular ring balloon is provided with an inflation port, and the gas pressure control system is connected to the circular ring balloon through the inflation pipe and the inflation port of the circular ring balloon, and the inflation pipe and the circular ring balloon are one-to-one corresponding, so that the gas pressure control system independently adjusts the inflation amount of the circular ring balloon;

[0010] The host computer divides the plurality of FBG pressure sensing arrays into a plurality of independent channels by time division multiplexing technology, in each independent channel, the FBG pressure sensing array contained in the independent channel is further wavelength-divided by wavelength division multiplexing technology, and the FBG pressure sensing array is composed into a distributed measurement network; the host computer receives the measurement results sent by the FBG pressure sensing array, and generates an overall pressure distribution curve along the axis of the vagina.

[0011] Further, the upper surface of the circular ring balloon is reserved with a recess for laying the optical fiber.

[0012] Further, an intermediate buffer layer is arranged between the FBG pressure sensing array and the circular ring balloon.

[0013] Further, the intermediate buffer layer adopts a double-layer polyurethane structure, comprising an elastic polyurethane body and a honeycomb polyurethane foam, the honeycomb polyurethane foam is adhered to the surface of the circular ring balloon by using an acrylate adhesive, and the FBG pressure sensing array is fixed on the elastic polyurethane body.

[0014] Further, the intermediate buffer layer comprises a rigid structural member, a fixing plug and a connecting shaft.

[0015] The fixed plug is located inside the annular balloon, the surface of the connecting shaft at both ends has a threaded structure, the first end of the connecting shaft is connected with the fixed plug through the surface of the annular balloon, and the second end is fixed on one surface of the rigid structural member through the thread; the FBG pressure sensor array is fixed on the other surface of the rigid structural member away from the connecting shaft through an adhesive.

[0016] Further, the intermediate buffer layer comprises a sealing ring, which is located at the gap of the annular balloon and sleeved on the first end of the connecting shaft.

[0017] Further, the middle part of the annular balloon is provided with a hollow hose, and the optical fiber and the inflation pipeline are led out from the hollow hose;

[0018] The imaging probe is installed in the hollow hose.

[0019] Further, the outside of the annular balloon is wrapped with a coating layer made of biocompatible material.

[0020] Further, the probe and the handle adopt a split structure.

[0021] The handle adopts a silica gel handle, the optical fiber and the inflation pipeline pass through the center of the handle and are connected with the external host and the inflation control system; the surface of the handle is provided with system control buttons.

[0022] Further, the tail end of the handle adopts an arc-shaped silica gel holder structure, the optical fiber and the inflation pipeline pass through the hole in the middle of the holder and are connected with the host and the inflation control system worn on the waist of the user.

[0023] Beneficial effects:

[0024] Firstly, the high-precision multifunctional pelvic floor muscle pressure measurement system based on optical fiber sensing adopts a plurality of expandable balloon structures, the balloons can be self-adapted to expand according to the individual body shape and pelvic floor muscle condition of the examinee, so that the detector is completely attached to the vaginal wall, thereby ensuring that high-precision pressure measurement data is obtained, and the measurement error problem caused by individual differences in the prior art is effectively solved.

[0025] Secondly, the high-precision multifunctional pelvic floor muscle pressure measurement system based on optical fiber sensing can accurately measure the pressure values at different parts along the vaginal axis by uniformly distributing the FBG pressure sensor array on the surface of each balloon, and fuse these data into an overall pressure distribution curve.

[0026] Third, the high-precision multifunctional pelvic floor muscle pressure measurement system based on optical fiber sensing of the application fully considers the diversity requirements of clinical application, and reasonably designs and integrates two different tail end forms and host configurations according to different use scenarios, greatly improving the use convenience of the system, making the use of the system more humanized and intelligent. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 is a contrast chart before and after the probe expands;

[0028] Figure 2 is a balloon schematic diagram using double-layer polyurethane material as the middle layer;

[0029] Figure 3 is a balloon schematic diagram using rigid material as the middle layer;

[0030] Figure 4 is a structure assembly diagram using rigid material as the middle structure;

[0031] Figure 5 is a schematic diagram of a split structure device;

[0032] Figure 6 is a schematic diagram of a portable structure device;

[0033] Figure 7 is an FBG hybrid multiplexing structure diagram. DETAILED DESCRIPTION

[0034] The following examples enable those skilled in the art to more fully understand the present application, but in no way limit the present application.

[0035] Referring to Figure 5 and Figure 6 , the embodiment of the application discloses a high-precision multifunctional pelvic floor muscle pressure measurement system based on optical fiber sensing, which comprises a handle, a probe, a plurality of circular ring balloons, a plurality of FBG pressure sensing arrays, a gas pressure control system, an optical fiber, a tunable laser, an imaging probe and a host;

[0036] The probe is connected at one end of the handle and extends into the vagina, and the probe comprises a plurality of circular ring balloons stacked in sequence, and a plurality of FBG pressure sensing arrays are uniformly attached to the top end of the probe and the side wall of each circular ring balloon;

[0037] The FBG pressure sensing array is connected with the tunable laser through the optical fiber, the FBG pressure sensing array measures the pressure exerted by the pelvic floor muscle group at the position, and feeds back the measurement result to the host;

[0038] The imaging probe is connected with the host, and transmits the collected image signal to the host;

[0039] The circular ring balloon is provided with an inflation port, and a gas pressure control system is connected with the inflation port of the circular ring balloon through an inflation pipeline, and the inflation pipeline and the circular ring balloon are in one-to-one correspondence, so that the gas pressure control system can independently adjust the inflation amount of the circular ring balloon.

[0040] The host divides the plurality of FBG pressure sensing arrays into a plurality of independent channels through time division multiplexing technology, and in each independent channel, the FBG pressure sensing array contained in the independent channel is further wavelength-divided using wavelength division multiplexing technology, so that the FBG pressure sensing array forms a distributed measurement network; the host receives the measurement results sent by the FBG pressure sensing array, and generates an overall pressure distribution curve along the vaginal axis.

[0041] The application provides a pelvic floor muscle force measuring system based on a combination of an expandable balloon and an FBG pressure sensing array, the FBG pressure sensing array is a fiber core layer in which a periodic refractive index modulation is written, when specific wavelength light is irradiated, Bragg reflection occurs, the wavelength of the reflected light is related to the grating period and the effective refractive index, when the fiber is subjected to strain or temperature change, the effective refractive index changes, and then the reflected wavelength moves, the strain or temperature is measured by accurately measuring the change of the reflected wavelength.

[0042] At present, the FBG pressure sensing array is applied to the field of pressure sensors, and the measurement range can cover 0-5MPa. In clinical diagnosis, the pelvic floor muscle pressure level to be measured and evaluated is usually in the range of 15-50kPa, so the measurement range of the FBG pressure sensing array can cover and meet the measurement requirements of the pelvic floor muscle pressure. In addition, the FBG pressure sensing array has the advantages of measurement accuracy, anti-electromagnetic interference, non-magnetic, high integration, biological compatibility and the like in the field of interventional medicine, and has obvious technical leading nature compared with traditional pressure measurement methods.

[0043] In the embodiment, the selected FBG has the following index parameters: center wavelength 1525-1565 nm, range 1 MPa, resolution 0.1% of full scale (0.1% F.S), and four equally spaced gratings on one fiber, each grating being sensitive to a different wavelength. A tunable laser is selected as the output light source to meet the requirements of wavelength adjustment and power output. The FBG is attached to the side surface of each balloon. At the same time, the balloon at the top end has four FBG pressure sensors evenly distributed on its upper side, three of which are used to measure the muscle strength near the cervical port, and the other is used for FBG temperature compensation. The four FBG sensors on each balloon are connected by a separate optical fiber, and the top balloon uses two optical fibers to connect eight FBGs (FBG pressure sensor array) according to the different positions. To effectively identify and read the 20 FBG sensors, the system uses a hybrid multiplexing technology combining time division multiplexing (TDM) and wavelength division multiplexing (WDM). As shown in Figure 7 the structure, the 20 FBGs are first divided into five independent channels by TDM technology, each channel containing four FBGs. Then, within each channel, WDM technology is used to further divide the FBGs by wavelength, thereby forming a distributed measurement network that can accurately measure the pressure exerted by different pelvic floor muscle groups and obtain the overall pressure distribution curve along the vaginal axis. If a FBG fails, the FBG-containing balloon can be replaced individually without replacing the entire detection device, reducing subsequent maintenance costs.

[0044] In the embodiment, the probe inserted into the body adopts a design of multiple expandable balloons, which can adaptively adjust the size of the probe according to the individual structural differences of different subjects, so that it can perfectly fit the vaginal wall and ensure the accuracy of the measurement. The expandable balloon is made of low-pressure elastic material and is made of biocompatible latex or silicone rubber. In the unexpanded state, each balloon is in a flat oval shape, with a height and diameter of about 2 cm. When compressed air is injected through the inflation port, the balloon can uniformly expand, with a diameter expandable to 4 cm and a height up to 3 cm. Figure 1To expand the contrast chart before and after. Considering the individual differences in the structure of the vagina, the forearm length is 7-9 cm, and the back wall length is 10-12 cm, so the system uses 4 such inflatable balloons in total, which are arranged in order along the longitudinal direction, and the overall structure is a hollow circular ring. Each balloon is provided with a separate inflation port, and according to the real-time feedback of pressure detection, each balloon can be independently controlled to inflate to the appropriate degree, so as to adaptively expand to the appropriate degree and closely fit the vaginal wall of the subject. At the same time, in order to facilitate the wiring of the optical fiber, the upper and lower surfaces of each balloon are provided with consistent recessed structures. For the same subject, the system can remember and store the specific expansion parameters of each balloon during the last detection, and directly call them during the next use, without the need for repositioning and debugging, greatly improving the accuracy and efficiency of the detection.

[0045] To reduce the influence of the strain generated by the balloon during expansion on the FBG sensor, an intermediate buffer layer is added between the balloon and the sensor. The material of the intermediate buffer layer can be selected as polyurethane structure with vibration absorption and buffering effect or rigid material not easy to deform, so that it can effectively absorb and alleviate the deformation caused by balloon expansion, thereby improving the accuracy and reliability of pressure measurement. When a double-layer polyurethane structure is selected, the material close to the balloon layer is honeycomb polyurethane foam, and the other layer is elastic polyurethane body. The area size of the two layers of material is controlled to be about 1cm2, and the two layers of material are tightly attached by using an acrylic adhesive. The structure is as shown in Figure 2 The honeycomb foam layer is used to absorb the strain generated during balloon expansion, and the acrylic adhesive is used to adhere it to the surface of the balloon. The FBG is fixed on the elastic polyurethane body by the same adhesive. By virtue of the excellent elastic properties of the layer of material, the relative displacement of the FBG during balloon inflation and expansion can be effectively avoided, and the accuracy of measurement is ensured. Another scheme is to use a rigid material not easy to deform as an intermediate layer. In this scheme, the intermediate layer includes a rigid material, a fixed plug, and a connecting shaft, and the structure is as shown in Figure 3 and Figure 4 The rigid material is selected as a polyester plate with a size of about 1cm2. The fixed plug is located inside the balloon. The polyester plate and the fixed plug both have a threaded structure. The connecting shaft has a corresponding threaded structure on its two ends. One end passes through the gap in the surface of the balloon and is connected to the plug. A rubber sealing ring is used at the gap to ensure the sealing of the balloon. The other end is fixed to the polyester plate by a threaded connection. Finally, the FBG is fixed on the other side of the polyester plate by an adhesive. The intermediate layer structure composed of the polyester plate and the metal threaded connection can effectively isolate and transmit the deformation stress generated by the balloon during expansion, preventing these strains from affecting the measurement of the FBG sensor.

[0046] In the middle of the balloon, a hollow tube is arranged, which is made of silicon rubber with good elasticity. The fiber bundle and inflation tube of the system are drawn from the tube. The cavity in the center of the tube also has space to accommodate the imaging probe, so as to realize the integration of pressure measurement and image diagnosis.

[0047] In order to improve the biocompatibility of the system and reduce the physiological discomfort of the subject, the outermost layer of the whole device is fully coated with excellent biocompatibility material. Considering the changes in length and width of the detector, the outer coating layer is made of high-elasticity silicone material, which can completely wrap the balloon after inflation. However, in order to avoid excessive stretching and deformation of the silicone during balloon expansion, the silicone outer layer has a certain redundancy in the initial state of the unexpanded balloon, which appears as some wrinkles on the outer surface. This design maximizes the service life of the silicone material and reduces the possibility of probe displacement during detection. At the tail end of the detector, a hollow rubber tube is used to cover the fiber and inflation tube, with a length of about 20-30 cm. The tail end is provided with a standard fiber joint and an inflation tube joint, respectively.

[0048] In actual clinical application, in order to meet the requirements of aseptic operation, the outer layer of the probe can be coated with a condom. At the same time, considering the economic cost factor, the inflatable balloon itself is made of low-cost silicone or silicone rubber material, and the cost of a single balloon is controlled at 10-20 yuan. The manufacturing cost of ordinary FBG sensors is also relatively low, so the entire front-end probe part can be designed as a disposable product, further reducing the risk of cross-infection and providing reliable protection for the health of patients.

[0049] According to different clinical needs, the system is designed with two different tail end shapes and main machine configurations: in the split structure, the tail end adopts an ergonomic handle design, as shown in Figure 5 The shape fits the hand, making it easy for clinicians to control and fix the position and angle of the detector. The fiber bundle and inflation tube are drawn from the hollow position of the handle and connected to the desktop main machine. The handle has control buttons, including inflation, abandonment, detection, and stop functions. The main machine is a computer system with integrated display and data processing functions. In the portable structure, the tail end adopts an arc-shaped silicone holder design, with a length of about 2-3 cm, as shown in Figure 6The design makes the probe position stable during the measurement process, and is suitable for long-term dynamic monitoring. The tail end adopts an arc-shaped silica gel holder design. The optical fiber and the inflation tube pass through the hole in the middle of the holder and are connected with the portable data storage and inflation module for recording detection data during movement. The main machine only has data storage and inflation control modules, and does not have real-time analysis function. After the detection is completed, the data needs to be exported and analyzed to obtain a detailed evaluation report. The two different structure designs can be quickly and seamlessly replaced and switched according to the specific clinical detection requirements, greatly improving the applicability and flexibility of the system.

[0050] The above is only a preferred embodiment of the present application, and the protection scope of the present application is not limited to the above-mentioned embodiments. Any technical solution falling within the concept of the present application shall fall within the protection scope of the present application. It should be noted that, for ordinary skilled persons in the art, some improvements and refinements without departing from the principles of the present application shall be considered as the protection scope of the present application.

Claims

1. A high-precision, multifunctional pelvic floor muscle pressure measurement system based on fiber optic sensing, characterized in that, The high-precision multifunctional pelvic floor muscle pressure measurement system includes a handle, a probe, multiple annular balloons, multiple FBG pressure sensor arrays, a pneumatic control system, an optical fiber, a tunable laser, an imaging probe, and a main unit. The probe is connected to one end of the handle and extends into the vagina. The probe includes multiple annular balloons stacked in sequence. Multiple FBG pressure sensor arrays are uniformly attached to the top of the probe and the sidewall of each annular balloon. The FBG pressure sensing array is connected to a tunable laser via optical fiber. The FBG pressure sensing array measures the pressure applied by the pelvic floor muscle group at its location and feeds the measurement results back to the host. The imaging probe is connected to the host computer and feeds back the acquired image signals to the host computer. The annular balloon is provided with an inflation port. The air pressure control system is connected to the inflation port of the annular balloon through an inflation pipe. The inflation pipe and the annular balloon are in one-to-one correspondence, so that the air pressure control system can independently adjust the inflation amount of the annular balloon. The host computer uses time-division multiplexing technology to divide multiple FBG pressure sensor arrays into several independent channels. Within each independent channel, wavelength division multiplexing technology is used to further divide the wavelengths of the FBG pressure sensor arrays contained in that independent channel, forming a distributed measurement network of FBG pressure sensor arrays. The host computer receives the measurement results sent by the FBG pressure sensor arrays and generates an overall pressure distribution curve along the vaginal axis.

2. The high-precision multifunctional pelvic floor muscle pressure measurement system based on fiber optic sensing according to claim 1, characterized in that, The upper surface of the annular balloon has a recessed portion for laying optical fibers.

3. The high-precision multifunctional pelvic floor muscle pressure measurement system based on fiber optic sensing according to claim 1, characterized in that, An intermediate buffer layer is provided between the FBG pressure sensing array and the annular balloon.

4. The high-precision multifunctional pelvic floor muscle pressure measurement system based on fiber optic sensing according to claim 3, characterized in that, The intermediate buffer layer adopts a double-layer polyurethane structure, including an elastic polyurethane body and a honeycomb polyurethane foam. The honeycomb polyurethane foam is bonded to the surface of the annular balloon using an acrylic adhesive, and the FBG pressure sensor array is fixed on the elastic polyurethane body.

5. The high-precision multifunctional pelvic floor muscle pressure measurement system based on fiber optic sensing according to claim 3, characterized in that, The intermediate buffer layer includes a rigid structural component, a fixing plug, and a connecting shaft; The fixing plug is located inside the annular balloon. The two ends of the connecting shaft have threaded structures. The first end of the connecting shaft passes through the surface of the annular balloon and is connected to the fixing plug. The second end is fixed to one of the surfaces of the rigid structure by threads. The FBG pressure sensing array is fixed to the other surface of the rigid structure away from the connecting shaft by adhesive.

6. The high-precision multifunctional pelvic floor muscle pressure measurement system based on fiber optic sensing according to claim 5, characterized in that, The intermediate buffer layer includes a sealing ring, which is located at the notch of the annular balloon and is fitted onto the first end of the connecting shaft.

7. The high-precision multifunctional pelvic floor muscle pressure measurement system based on fiber optic sensing according to claim 1, characterized in that, The annular balloon has a hollow tube in the middle, from which the optical fiber and inflation tube are led out. The imaging probe is installed inside a hollow flexible tube.

8. The high-precision multifunctional pelvic floor muscle pressure measurement system based on fiber optic sensing according to claim 1, characterized in that, The annular balloon is wrapped with a biocompatible material coating.

9. The high-precision multifunctional pelvic floor muscle pressure measurement system based on fiber optic sensing according to claim 1, characterized in that, The probe and handle adopt a separate structure; The handle is made of silicone, with optical fiber and inflation tubing passing through the center of the handle and connecting to the external host and inflation control system; the surface of the handle is provided with system control buttons.

10. The high-precision multifunctional pelvic floor muscle pressure measurement system based on fiber optic sensing according to claim 1, characterized in that, The handle's tail end adopts an arc-shaped silicone support structure, with optical fibers and inflation tubes passing through a hole in the middle of the support to connect to the main unit and inflation control system worn on the user's waist.

Images