Fiber optic balloon catheter device and balloon expansion state monitoring method

Abstract

The present invention discloses a fiber optic balloon catheter device and a method for monitoring balloon expansion status. The fiber optic balloon catheter device comprises: a balloon catheter including a catheter and a balloon connected to the distal end of the catheter and capable of radially expanding relative to the catheter; a fiber optic microbend sensor disposed in a layer of the balloon and capable of bending and deforming under external stress; a fiber optic detection module connected to the proximal end of the fiber optic microbend sensor, configured to calculate the bending position of the fiber optic microbend sensor based on optical phase delay information and the bending radius of the fiber optic microbend sensor based on optical power attenuation information; and a processor configured to generate a morphological image of the balloon on a display interface based on the bending position and bending radius. By detecting the balloon shape through the fiber optic microbend sensor in the balloon layer, the feedback optical signal can be converted into a morphological image of the balloon and displayed on the display interface, providing real-time feedback on the balloon filling status. The device has the advantages of simple operation, good safety, and the ability to continuously and real-timely display the balloon filling status.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a fiber optic balloon catheter device and a method for monitoring the balloon expansion state. Background Art

[0002] Angioplasty, also known as percutaneous transluminal angioplasty, is an interventional medical procedure used to treat narrowed or blocked blood vessels. This procedure can be performed on a variety of blood vessels, including the coronary arteries, carotid arteries, renal arteries, and arteries in the lower limbs. The procedure is usually performed through a puncture of the femoral or radial artery. A catheter is inserted into the blood vessel and then guided along the blood vessel to the coronary artery. A balloon at the end of the catheter is guided to the stenosis and then inflated, pressing the plaque against the vessel wall, thereby widening the vessel lumen. In some cases, a stent may be placed in the dilated vessel to keep the vessel open.

[0003] Since there are many causes of vascular cavities and individual differences among patients, expanding the vascular cavity by balloon inflation or expanding the stent by balloon inflation requires auxiliary means to confirm the expansion status of the blood vessel or stent to ensure that the blood vessel is fully expanded and the stent is adhered to the wall. Otherwise, postoperative complications may occur and blood flow may be blocked again.

[0004] Currently, commonly used methods include intravascular ultrasound (IVUS) and X-ray angiography. IVUS requires deflation and removal of the balloon, followed by placement of an ultrasound probe within the vessel. If the expansion status is not ideal, the balloon must be replaced and the above steps repeated. This prevents continuous imaging and is complex. X-ray angiography, which requires injection of contrast agent and uses X-rays to visualize the intravascular situation and the position and expansion status of the stent in real time, exposes medical staff and patients to continuous radiation, which can be harmful to their health.

[0005] Therefore, it is necessary to design a fiber optic balloon catheter device with good safety and simple operation and a method for monitoring the balloon expansion state. Summary of the Invention

[0006] Therefore, the technical problem to be solved by the present invention is to overcome the defects of the existing balloon expansion morphology monitoring method, such as complex operation or poor safety, and thus provide a fiber optic balloon catheter device and a balloon expansion state monitoring method.

[0007] In order to solve the above technical problems, the technical solutions of the present invention are as follows:

[0008] A fiber optic balloon catheter device, comprising:

[0009] A balloon catheter comprises a catheter and a balloon connected to the distal end of the catheter, wherein the balloon is capable of expanding in the radial direction of the catheter when the inner cavity is filled;

[0010] an optical fiber microbend sensor disposed in the interlayer of the balloon and extending along the length of the balloon; the optical fiber microbend sensor is capable of bending and deforming when the balloon is subjected to external stress;

[0011] an optical fiber detection module connected to the proximal end of the optical fiber microbend sensor; the optical fiber detection module is configured to analyze the optical signal from the optical fiber microbend sensor and generate optical phase delay information and optical power attenuation information of the optical fiber microbend sensor; the optical fiber detection module further calculates the bending position of the optical fiber microbend sensor based on the optical phase delay information, and calculates the bending radius of the optical fiber microbend sensor at the bending position based on the optical power attenuation information;

[0012] A processor is electrically connected to the optical fiber detection module and is used to generate a simulated morphological image of the balloon on a display interface based on a standard three-dimensional model of the optical fiber microbend sensor under an ideal balloon filling state, and the calculated bending position and bending radius of the optical fiber microbend sensor at the bending position.

[0013] Furthermore, the balloon includes an inner balloon and an outer balloon covering the inner balloon, and the optical fiber microbend sensor is arranged in the interlayer formed by the inner balloon and the outer balloon; the optical fiber microbend sensor is tightly attached to the inner wall of the outer balloon.

[0014] Furthermore, the number of the optical fiber micro-bend sensors is three or more, the three or more optical fiber micro-bend sensors are all linear, the straight extension direction of the optical fiber micro-bend sensors is the same as the length direction of the balloon, and the three or more optical fiber micro-bend sensors are arranged at equal intervals around the circumferential direction of the balloon.

[0015] Furthermore, the number of the optical fiber microbend sensor is one and the optical fiber microbend sensor is in a spiral shape, and the optical fiber microbend sensor is arranged in a spiral shape in the interlayer of the balloon.

[0016] Furthermore, there are two optical fiber microbend sensors, both of which are spiral-shaped, with the spiral directions of the two optical fiber microbend sensors being opposite, and the two optical fiber microbend sensors are arranged in a mesh shape in the interlayer of the balloon.

[0017] Furthermore, the proximal end of the balloon catheter is connected to a catheter seat, and the catheter seat is provided with a balloon filling connector connected to the inner cavity of the balloon, and a fiber optic plug connected to the proximal end of the fiber optic microbend sensor; the balloon filling connector is used to connect to the balloon expansion pressure pump, and the fiber optic plug is used to connect to the fiber optic detection module.

[0018] Furthermore, the optical fiber detection module and the balloon inflation pressure pump are an integrated structure, and the balloon inflation pressure pump is provided with a display screen for displaying a simulated morphological image of the balloon.

[0019] A method for monitoring the balloon expansion state based on the fiber optic balloon catheter device comprises:

[0020] S1. When the balloon is in an ideally filled state, construct a standard three-dimensional model of the optical fiber microbend sensor disposed in the balloon interlayer relative to the central axis of the catheter using the position coordinates of the optical fiber microbend sensor in the balloon interlayer relative to the central axis of the catheter;

[0021] S2. After the balloon is inflated, generating optical phase delay information and optical power attenuation information based on the optical signal fed back by the optical fiber microbend sensor; calculating the bending position of the optical fiber microbend sensor based on the optical phase delay information, and calculating the bending radius of the optical fiber microbend sensor at the bending position based on the optical power attenuation information;

[0022] S3. Generate a simulated morphological image of the balloon on a display interface based on the standard three-dimensional model of the optical fiber microbend sensor in the ideal balloon filling state, the bending position of the optical fiber microbend sensor in the current state of the balloon, and the bending radius corresponding to the bending position.

[0023] Furthermore, the step S3 includes:

[0024] S31, first generating a three-dimensional model of the optical fiber microbend sensor in the current balloon inflation state based on a standard three-dimensional model of the optical fiber microbend sensor in the ideal balloon inflation state, a bending position of the optical fiber microbend sensor in the current balloon inflation state, and a bending radius corresponding to the bending position;

[0025] S32. Generate a simulated morphological image of the balloon in real time on a display interface based on the three-dimensional model of the optical fiber microbend sensor in the current expanded state of the balloon.

[0026] Furthermore, the simulated morphological image of the balloon generated on the display interface is a two-dimensional image or a three-dimensional image.

[0027] The technical solution of the present invention has the following advantages:

[0028] 1. The fiber optic balloon catheter device provided by the present invention comprises a fiber optic microbend sensor extending along the length of the balloon disposed in the interlayer of the balloon. When the balloon is inflated and squeezes the inner wall of the blood vessel, if diseased tissue is present on the inner wall of the blood vessel, the corresponding position of the balloon will be forced to deform, and the fiber optic microbend sensor within the balloon will also bend. The bending of the fiber optic microbend sensor will cause a change in the phase of the light wave and an attenuation of the optical power. The fiber optic detection module can detect the optical phase delay information and the optical power attenuation information from the optical signal fed back by the fiber optic microbend sensor, and calculate the bending position of the fiber optic microbend sensor based on the optical phase delay information and the bending radius of the fiber optic microbend sensor at the bending position based on the optical power attenuation information. The processor can generate a simulated morphological image of the balloon on a display interface based on a standard three-dimensional model of the fiber optic microbend sensor balloon in an ideally filled state, as well as the calculated bending position and bending radius of the fiber optic microbend sensor at the bending position. At this time, the doctor can continue to increase the balloon pressure or use other methods to make the balloon shape reach the target state. Compared to the existing method of monitoring balloon shape using on-balloon pressure sensors, this method of using fiber optic microbend sensors to detect balloon shape offers greater accuracy in balloon shape measurement because the sensors can conform to the inner wall of the blood vessel without contacting the patient. Furthermore, they are not affected by temperature variations in the patient. Furthermore, the core diameter of a single fiber optic microbend sensor is typically between 8 and 10 microns, much smaller than a pressure sensor. This allows multiple sensors to be deployed within the extremely small balloon volume, improving the accuracy of balloon shape detection. Furthermore, due to the unique vector bending properties of fiber optic microbend sensors, their bending degree can be simultaneously detected while also monitoring their bending direction. This allows algorithms to construct a more accurate three-dimensional model using the optical signals transmitted by the sensors. This allows doctors to intuitively and continuously observe the status of the balloon within the vessel, facilitating assessment of surgical effectiveness and subsequent treatment decisions. This approach also avoids X-ray radiation exposure to doctors and patients, nor the complex procedures of intravascular ultrasound examinations.

[0029] 2. In the fiber optic balloon catheter device provided by the present invention, the arrangement of the fiber optic micro-bend sensor in the balloon is divided into linear, spiral and mesh types, which can be applied to different types of interventional surgeries; the linear fiber optic micro-bend sensor has a simple structure and low cost, and can be applied to some interventional surgeries with relatively simple vascular conditions; the spiral fiber optic micro-bend sensor is arranged in a spiral shape around the circumference of the balloon, which can reduce the cost and improve the accuracy of balloon morphology monitoring to a certain extent, and is suitable for interventional surgeries with generally complex vascular conditions; the mesh fiber optic micro-bend sensor forms a mesh structure on the balloon surface, which can minimize the monitoring blank area and improve the accuracy of balloon morphology monitoring, and is suitable for interventional surgeries with relatively complex vascular conditions.

[0030] 3. The balloon inflation status monitoring method provided by the present invention utilizes fiber optic microbend sensors to detect balloon shape. Compared to the prior art method of monitoring balloon shape using pressure sensors on the balloon, the fiber optic microbend sensors achieve greater accuracy in balloon shape measurement because they can conform to the inner wall of the blood vessel without contacting the human body. Furthermore, the fiber optic microbend sensors are not affected by differences in the patient's body temperature. Furthermore, the core diameter of a single fiber optic microbend sensor is typically between 8 and 10 microns, much smaller than the size of a pressure sensor. Therefore, multiple fiber optic microbend sensors can be deployed within the extremely small balloon volume, improving the accuracy of balloon shape detection results. Furthermore, due to the unique vector bending characteristics of the fiber optic microbend sensors, the degree of bend can be determined while also monitoring the bend direction. This allows for an algorithm to construct a more accurate three-dimensional model using the optical signals transmitted by the fiber optic microbend sensors. This allows physicians to intuitively and continuously observe the status of the balloon within the vessel, facilitating their assessment of surgical effectiveness and determining subsequent treatment options. This avoids X-ray radiation hazards to physicians and patients, nor the complex procedures of intravascular ultrasound examinations. Furthermore, the balloon's inflation status and other data parameters are automatically stored and can be exported via wired or wireless transmission or connected to the hospital's information system for later data query and analysis. This system offers advantages such as easy operation, precise vascular status monitoring, intuitive and continuous display, minimal harm to doctors and patients, and convenient data management and analysis. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0032] Figure 1 This is a schematic structural diagram of a first embodiment of the fiber optic balloon catheter device in Example 1 of the present invention;

[0033] Figure 2 This is a schematic structural diagram of a second embodiment of the fiber optic balloon catheter device in Example 1 of the present invention;

[0034] Figure 3 Schematic diagram of the structure of the balloon catheter in Example 1 of the present invention;

[0035] Figure 4 Schematic diagram of the structure of the balloon catheter in Example 2 of the present invention;

[0036] Figure 5Schematic diagram of the structure of the balloon catheter in Example 3 of the present invention;

[0037] Figure 6 Schematic diagram of a simulated image of a balloon displayed on a display interface in an embodiment of the present invention.

[0038] Explanation of the accompanying reference numerals: 1. catheter; 2. balloon; 3. optical fiber microbend sensor; 4. catheter seat; 5. optical fiber plug; 6. simulated morphological image of the balloon. DETAILED DESCRIPTION

[0039] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0040] Throughout the description of the present invention, it is important to understand that the terms "proximal" and "distal" refer to the device relative to the operator. When the present invention is in use, the end closest to the physician or operator is the "proximal end," i.e., the end where the operator is located, and the end away from the physician or operator is the "distal end," i.e., the end where the balloon is located. The aforementioned descriptions of orientations are intended solely to facilitate and simplify the description of the present invention and are not intended to indicate or imply that the device or component referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention.

[0041] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0042] like Figure 1 - Figure 3A fiber optic balloon catheter device is shown, comprising a balloon catheter, a fiber optic microbend sensor 3, a catheter seat 4, a fiber optic detection module and a processor. The balloon catheter comprises a catheter 1 and a balloon 2 connected to the distal end of the catheter 1, and the catheter seat 4 is connected to the proximal end of the catheter 1. The catheter seat 4 is provided with a guidewire interface and a balloon filling interface. The balloon filling connector is used to connect to a balloon expansion pressure pump; the catheter 1 has a guidewire cavity and a balloon filling cavity. When in use, the guidewire enters along the distal end of the catheter 1 and passes through the guidewire cavity and out from the guidewire interface. The guidewire is used to deliver the balloon catheter to the diseased location of the blood vessel. The balloon 2 is connected to the balloon filling cavity, and the balloon filling cavity is connected to the balloon filling interface. The balloon expansion pressure pump is used to inject a filling medium into the inner cavity of the balloon 2 through the balloon filling interface. After the filling medium is injected into the inner cavity, the balloon 2 expands radially relative to the catheter 1.

[0043] In some embodiments, balloon 2 includes an inner layer and an outer layer covering the inner layer. Fiber optic microbend sensor 3 is disposed within the interlayer formed by the inner and outer layers; fiber optic microbend sensor 3 is closely attached to the inner wall of the outer layer. Fiber optic microbend sensor 3 extends along the length of balloon 2. When balloon 2 is squeezed by intravascular diseased tissue, fiber optic microbend sensor 3 bends at a location corresponding to the deformation of balloon 2.

[0044] In some embodiments, as Figure 1 As shown, the catheter seat 4 is provided with an optical fiber outlet interface, the optical fiber outlet interface is connected to the optical fiber plug 6, the proximal end of the optical fiber microbend sensor 3 is connected to the optical fiber plug 5, and the optical fiber plug 5 is used to connect to the optical fiber detection module. In an alternative embodiment, as Figure 2 As shown, the optical fiber outlet interface can also be set on the outer wall of the catheter 1 between the balloon 2 and the catheter seat 4.

[0045] In this embodiment, the optical fiber detection module is configured to analyze the optical signals from the multiple optical fiber microbend sensors 3 and generate optical phase delay information and optical power attenuation information corresponding to the optical fiber microbend sensors 3; the optical fiber detection module also calculates the bending position of the optical fiber microbend sensors 3 based on the optical phase delay information, and calculates the bending radius of the multiple optical fiber microbend sensors 3 at the bending position based on the optical power attenuation information. The processor is electrically connected to the optical fiber detection module, and the processor is used to generate a simulated morphological image 6 of the balloon on the display interface based on the standard three-dimensional model of the optical fiber microbend sensors 3 under the ideal balloon filling state, the calculated bending position of the optical fiber microbend sensors 3, and the bending radius at the bending position. Figure 6 As shown, the simulated morphological image 6 of the balloon generated on the display interface is a two-dimensional image or a three-dimensional image. Generally, the standard three-dimensional model of the optical fiber microbend sensor 3 under the ideal balloon filling state is similar to a cylinder.

[0046] Specifically, the optical fiber detection module can monitor the change in the optical wavefront phase caused by the bending of the optical fiber, and calculate the specific position and even the direction of the bending through the following formula: Δφ bend =(2πn eff / λ)×L eff and L eff =∑(L i n i ), where Δφ bend is the additional phase delay due to bending; n eff is the equivalent refractive index, taking into account the stress and strain effects introduced by bending; λ is the wavelength of the light source; L eff is the additional effective path length caused by bending; L i is the length of the i-th segment, n i is the refractive index of the i-th segment. According to the above formula Δφ bend =(2πn eff / λ)×L eff , where the additional phase delay Δφ caused by bending bend It is the data that can be detected by the optical fiber detection module, the equivalent refractive index n eff and the wavelength λ of the light source are known data, so the additional effective path length L caused by the bend can be calculated eff Because the optical fiber microbend sensor 3 can be divided into multiple small segments according to its own length, the specific refractive index n of each small segment of the optical fiber microbend sensor 3 is i， is known data, in L eff When the specific value of is known, according to the above formula L eff =∑(L i n i ) can be calculated to get L i By obtaining the specific number of the subscript i, it is possible to know on which small section of the optical fiber micro-bend sensor 3 the bending position of the optical fiber micro-bend sensor 3 is located, and thus the bending position of the optical fiber micro-bend sensor 3 is known.

[0047] "Guided modes" and "radiative modes" in optical fibers are two basic concepts in fiber optics. Guided modes refer to electromagnetic field modes that can propagate along the axial direction of an optical fiber while being constrained by the principle of total internal reflection, so that light energy is confined to the core of the optical fiber. Simply put, these modes can be transmitted over long distances in an optical fiber without leaking to the outside world. They are the actual light wave forms used to carry information in optical fiber communications. Radiative modes refer to electromagnetic field modes that cannot be effectively totally reflected inside the optical fiber and propagate along the optical fiber, but are lost in the form of radiation, or leak into the cladding or even the external environment. When an optical fiber is bent, it causes mode coupling in the optical fiber, and some of the guided modes become radiation modes. The radiation modes leak into the cladding of the optical fiber, causing optical power loss. The optical fiber detection module can detect the optical power attenuation of the optical fiber after the optical fiber is bent. The bending radius R can be approximately calculated using the following formula: Where △n is the refractive index difference between the core and cladding of the optical fiber, n core is the refractive index of the fiber core, α is the bending loss, and λ is the wavelength of light. Since the bending loss α in the formula is the detection value of the optical fiber detection module, the refractive index difference △n between the fiber core and the cladding, the refractive index n of the fiber core core and the wavelength λ of light are known data, so the specific value of the bending radius R can be calculated based on the above data.

[0048] By disposing an optical fiber microbend sensor 3 extending along the length of the balloon 2 within the interlayer of the balloon 2, when the balloon 2 is inflated and squeezes the inner wall of the blood vessel, if diseased tissue is present on the inner wall of the blood vessel, the corresponding position of the balloon 2 will be forced to deform, causing the optical fiber microbend sensor 3 within the balloon 2 to bend. The bending of the optical fiber microbend sensor 3 will cause a change in the phase of the light wave and optical power attenuation. The optical fiber detection module can detect optical phase delay information and optical power attenuation information from the optical signal fed back by the optical fiber microbend sensor 3, and calculate the bending position of the optical fiber microbend sensor 3 based on the optical phase delay information and the bending radius of the optical fiber microbend sensor 3 at the bending position based on the optical power attenuation information. The processor generates a simulated morphological image 6 of the balloon on a display interface based on a standard three-dimensional model of the balloon under ideal filling conditions of the optical fiber microbend sensor 3, as well as the calculated bending position and bending radius of the optical fiber microbend sensor 3 at the bending position. This image provides real-time feedback on the filling status of the balloon 2, and has the advantages of simple operation, good safety, and continuous real-time display of the filling status of the balloon 2. The doctor can then continue to increase the balloon pressure or use other methods to adjust the balloon shape to the target state. This method of using the optical fiber micro-bend sensor 3 to detect the shape of the balloon can convert the optical signal fed back by the optical fiber micro-bend sensor 3 into a simulated morphological image 6 of the balloon through a specific algorithm and display it on the display interface of the monitoring device. It can provide real-time feedback on the filling status of the balloon 2 and has the advantages of simple operation, complete monitoring parameters, good safety, and continuous real-time monitoring of the filling status of the balloon 2.

[0049] Compared to the prior art method of monitoring balloon shape using pressure sensors on balloon 2, this method of using fiber optic microbend sensors 3 to detect balloon shape offers greater accuracy in balloon shape measurement because the fiber optic microbend sensors 3 can conform to the inner wall of the blood vessel to the greatest extent possible without contacting the human body. Furthermore, the fiber optic microbend sensors 3 are not affected by differences in the patient's body temperature. Furthermore, the core diameter of a single fiber optic microbend sensor 3 is typically between 8 and 10 microns, much smaller than the size of a pressure sensor. Therefore, multiple fiber optic microbend sensors 3 can be deployed within the extremely small volume of balloon 2, improving the accuracy of balloon shape detection results. Furthermore, due to the unique vector bending characteristics of the fiber optic microbend sensors 3, the degree of bend can be identified while also monitoring the direction of the bend. This allows an algorithm to construct a more accurate three-dimensional model using the optical signals transmitted by the fiber optic microbend sensors 3. This allows doctors to intuitively and continuously observe the status of the intravascular balloon 2, facilitating their assessment of surgical effectiveness and determining subsequent treatment options. This avoids X-ray radiation damage to doctors and patients, nor the complex procedures of intravascular ultrasound examinations.

[0050] In some embodiments, the fiber optic detection module, processor, and balloon inflation pressure pump are integrated into a single structure. The balloon inflation pressure pump is provided with a display screen capable of displaying a simulated image 6 of the balloon. Specifically, the processor, fiber optic detection module, and control circuit components required for the balloon inflation pressure pump can be integrated on a single circuit board within the balloon inflation pressure pump, thereby achieving a compact design for the entire device. The circuit board also includes a storage module and a wired or wireless communication module. The storage module is configured to automatically store the simulated image data and other data of the balloon, while the wired or wireless communication module is configured to transmit the simulated image data and other data of the balloon to other medical devices or hospital information systems for subsequent data query, review, and analysis.

[0051] In this embodiment, the number of optical fiber micro-bend sensors 3 is three or more and they are all linear. The straight extension direction of the optical fiber micro-bend sensor 3 is the same as the length direction of the balloon 2. Three or more optical fiber micro-bend sensors 3 are arranged at equal intervals in the circumferential direction of the balloon 2.

[0052] Example 2

[0053] like Figure 4 The fiber optic balloon catheter device shown is different from the first embodiment in that the number of the fiber optic microbend sensor 3 is one and the fiber optic microbend sensor 3 is spirally arranged in the interlayer of the balloon 2.

[0054] Example 3

[0055] like Figure 5 The fiber optic balloon catheter device shown is different from the embodiment 1 in that there are two fiber optic microbend sensors 3 and both are spiral-shaped. The spiral directions of the two fiber optic microbend sensors 3 are opposite, and the two fiber optic microbend sensors 3 are arranged in a mesh pattern in the interlayer of the balloon 2.

[0056] In Example 1, Example 2 and Example 3, the arrangement of the optical fiber micro-bend sensor 3 in the balloon 2 is divided into linear, spiral and mesh types, which can be applied to different types of interventional surgeries; the linear optical fiber micro-bend sensor 3 has a simple structure and low cost, and can be applied to some interventional surgeries with relatively simple vascular conditions; the spiral optical fiber micro-bend sensor 3 is arranged in a spiral shape around the circumference of the balloon 2, which can reduce the cost and improve the accuracy of balloon 2 morphology monitoring to a certain extent, and is suitable for interventional surgeries with generally complex vascular conditions; the mesh optical fiber micro-bend sensor 3 forms a mesh structure on the surface of the balloon 2, which can minimize the monitoring blank area and improve the accuracy of balloon 2 morphology monitoring, and is suitable for interventional surgeries with relatively complex vascular conditions.

[0057] The present invention also provides a method for monitoring the balloon expansion state based on a fiber optic balloon catheter device, comprising the following steps:

[0058] Step S1: When the balloon 2 is in an ideally filled state, a standard three-dimensional model of the optical fiber microbend sensor 3 in the ideally filled state is constructed using the position coordinates of the optical fiber microbend sensor 3 disposed in the interlayer of the balloon 2 relative to the central axis of the catheter 1;

[0059] Step S2: After the balloon 2 is inflated, optical phase delay information and optical power attenuation information are generated based on the optical signal fed back by the optical fiber microbend sensor 3; the bending position of the optical fiber microbend sensor 3 is calculated based on the optical phase delay information, and the bending radius of the optical fiber microbend sensor 3 at the bending position is calculated based on the optical power attenuation information;

[0060] Step S3: Generate a simulated morphological image 6 of the balloon on the display interface based on the standard three-dimensional model of the optical fiber microbend sensor 3 under the ideal balloon filling state, the bending position of the optical fiber microbend sensor 3 under the current state of the balloon 2, and the bending radius corresponding to the bending position.

[0061] The steps of step S3 include:

[0062] Step S31: First, based on the standard three-dimensional model of the optical fiber microbend sensor 3 in the ideal balloon filling state, the bending position of the optical fiber microbend sensor 3 in the current state of the balloon 2, and the bending radius corresponding to the bending position, a three-dimensional model of the optical fiber microbend sensor 3 in the current state of the balloon 2 is generated;

[0063] Step S32: Generate a simulated balloon image 6 in real time on the display interface based on the three-dimensional model of the optical fiber microbend sensor 3 in the current expanded state of the balloon 2. Specifically, the simulated balloon image 6 generated on the display interface is a two-dimensional image or a three-dimensional image.

[0064] The balloon inflation status monitoring method provided by the present invention utilizes a fiber optic microbend sensor 3 to detect balloon shape. Compared to the prior art method of monitoring balloon shape using a pressure sensor on the balloon 2, the fiber optic microbend sensor 3 can achieve greater accuracy in balloon shape measurement because it can conform to the inner wall of the blood vessel without contacting the human body. Furthermore, the fiber optic microbend sensor 3 is not affected by differences in the patient's body temperature. Furthermore, the core diameter of a single fiber optic microbend sensor 3 is typically between 8 and 10 microns, much smaller than the size of a pressure sensor. Therefore, multiple fiber optic microbend sensors 3 can be deployed within the extremely small volume of the balloon 2, improving the accuracy of balloon shape detection results. Furthermore, due to the unique vector bending characteristics of the fiber optic microbend sensor 3, the degree of bend can be determined while also monitoring its bend direction. This allows an algorithm to construct a more accurate three-dimensional model using the optical signals transmitted by the fiber optic microbend sensor 3. This allows doctors to intuitively and continuously observe the status of the balloon 2 within the blood vessel, facilitating their assessment of surgical effectiveness and determining subsequent treatment options. This avoids X-ray radiation hazards to doctors and patients, nor the complex procedures of intravascular ultrasound examinations. Furthermore, the balloon 2's filling status and other data parameters are automatically stored and can be exported via wired or wireless transmission, or connected to a hospital information system for later data query and analysis. This system offers advantages such as easy operation, precise vascular status monitoring, intuitive and continuous display, minimal harm to doctors and patients, and convenient data management and analysis.

[0065] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. A fiber optic balloon catheter device, characterized in that: include: A balloon catheter comprises a catheter (1) and a balloon (2) connected to the distal end of the catheter (1), wherein the balloon (2) is capable of expanding in the radial direction relative to the catheter (1) when the inner cavity is filled; An optical fiber microbend sensor (3) is arranged in the interlayer of the balloon (2) and extends along the length direction of the balloon (2); The optical fiber microbend sensor (3) is capable of bending and deforming when the balloon (2) is subjected to external stress; an optical fiber detection module connected to the proximal end of the optical fiber microbend sensor (3); the optical fiber detection module is configured to analyze the optical signal from the optical fiber microbend sensor (3) and generate optical phase delay information and optical power attenuation information of the optical fiber microbend sensor (3); the optical fiber detection module further calculates the bending position of the optical fiber microbend sensor (3) based on the optical phase delay information, and calculates the bending radius of the optical fiber microbend sensor (3) at the bending position based on the optical power attenuation information; The optical phase delay information includes an additional phase delay Δφ caused by bending. bend , Δφ bend =(2πn eff / λ)×L eff , L eff =∑(L i n i ); where n eff is the equivalent refractive index, λ is the wavelength of the light source, L eff is the additional effective path length caused by bending, L i is the length of segment i, n i is the refractive index of the i-th segment; the optical power attenuation information includes the bending loss α after the optical fiber is bent, and the bending radius R can be calculated using the following formula: ; where △n is the refractive index difference between the core and cladding of the optical fiber, n core is the refractive index of the fiber core, α is the bending loss, and λ is the wavelength of light; A processor is electrically connected to the optical fiber detection module and is used to generate a simulated morphological image (6) of the balloon on a display interface based on a standard three-dimensional model of the optical fiber microbend sensor (3) in a balloon-filled state, and the calculated bending position and bending radius of the optical fiber microbend sensor (3) at the bending position.

2. The fiber optic balloon catheter device according to claim 1, characterized in that: The balloon (2) comprises an inner balloon and an outer balloon coated outside the inner balloon, and the optical fiber microbend sensor (3) is arranged in a sandwich formed by the inner balloon and the outer balloon; the optical fiber microbend sensor (3) is closely attached to the inner wall of the outer balloon.

3. The fiber optic balloon catheter device according to claim 1, characterized in that: The number of the optical fiber microbend sensors (3) is three or more, the three or more optical fiber microbend sensors (3) are all linear, the linear extension direction of the optical fiber microbend sensors (3) is the same as the length direction of the balloon (2), and the three or more optical fiber microbend sensors (3) are arranged at equal intervals in the circumferential direction around the balloon (2).

4. The fiber optic balloon catheter device according to claim 1, characterized in that: The optical fiber microbend sensor (3) is in one spiral shape and is arranged in a spiral shape in the interlayer of the balloon (2).

5. The fiber optic balloon catheter device according to claim 1, characterized in that: There are two optical fiber microbend sensors (3) and both are spiral-shaped. The spiral directions of the two optical fiber microbend sensors (3) are opposite. The two optical fiber microbend sensors (3) are arranged in a mesh shape in the interlayer of the balloon (2).

6. The fiber optic balloon catheter device according to claim 1, characterized in that: The proximal end of the balloon catheter is connected to a catheter seat (4), and the catheter seat (4) is provided with a balloon filling joint communicating with the inner cavity of the balloon (2), and an optical fiber plug (5) connected to the proximal end of the optical fiber microbend sensor (3); the balloon filling joint is used to be connected to a balloon expansion pressure pump, and the optical fiber plug (5) is used to be connected to the optical fiber detection module.

7. The fiber optic balloon catheter device according to claim 6, characterized in that: The optical fiber detection module and the balloon expansion pressure pump are an integrated structure, and the balloon expansion pressure pump is provided with a display screen for displaying a simulated morphological image of the balloon.

Images