CN118976185A - Fiber optic balloon catheter device and balloon expansion state monitoring method - Google Patents
Fiber optic balloon catheter device and balloon expansion state monitoring method Download PDFInfo
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- 238000000034 method Methods 0.000 title claims abstract description 20
- 239000000835 fiber Substances 0.000 title claims description 25
- 239000013307 optical fiber Substances 0.000 claims abstract description 217
- 238000005452 bending Methods 0.000 claims abstract description 85
- 230000003287 optical effect Effects 0.000 claims abstract description 45
- 238000001514 detection method Methods 0.000 claims abstract description 31
- 230000000877 morphologic effect Effects 0.000 claims abstract description 23
- 239000011229 interlayer Substances 0.000 claims abstract description 17
- 230000006355 external stress Effects 0.000 claims abstract description 3
- 210000004204 blood vessel Anatomy 0.000 description 20
- 230000002792 vascular Effects 0.000 description 8
- 230000005855 radiation Effects 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- 208000019155 Radiation injury Diseases 0.000 description 4
- 238000005253 cladding Methods 0.000 description 4
- 238000004891 communication Methods 0.000 description 4
- 238000005259 measurement Methods 0.000 description 4
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- 238000004458 analytical method Methods 0.000 description 2
- 238000002399 angioplasty Methods 0.000 description 2
- 230000005540 biological transmission Effects 0.000 description 2
- 210000004351 coronary vessel Anatomy 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 238000007405 data analysis Methods 0.000 description 2
- 238000013523 data management Methods 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000003384 imaging method Methods 0.000 description 2
- 238000002608 intravascular ultrasound Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012552 review Methods 0.000 description 2
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- 208000031481 Pathologic Constriction Diseases 0.000 description 1
- 208000035965 Postoperative Complications Diseases 0.000 description 1
- 206010057469 Vascular stenosis Diseases 0.000 description 1
- 238000002583 angiography Methods 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 210000001715 carotid artery Anatomy 0.000 description 1
- 239000002872 contrast media Substances 0.000 description 1
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- 210000003141 lower extremity Anatomy 0.000 description 1
- 210000001699 lower leg Anatomy 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 238000002601 radiography Methods 0.000 description 1
- 210000002254 renal artery Anatomy 0.000 description 1
- 210000005077 saccule Anatomy 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
- 230000036262 stenosis Effects 0.000 description 1
- 208000037804 stenosis Diseases 0.000 description 1
- 230000035882 stress Effects 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1018—Balloon inflating or inflation-control devices
- A61M25/10181—Means for forcing inflation fluid into the balloon
- A61M25/10183—Compressible bulbs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1018—Balloon inflating or inflation-control devices
- A61M25/10184—Means for controlling or monitoring inflation or deflation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01B—MEASURING LENGTH, THICKNESS OR SIMILAR LINEAR DIMENSIONS; MEASURING ANGLES; MEASURING AREAS; MEASURING IRREGULARITIES OF SURFACES OR CONTOURS
- G01B11/00—Measuring arrangements characterised by the use of optical techniques
- G01B11/24—Measuring arrangements characterised by the use of optical techniques for measuring contours or curvatures
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01B—MEASURING LENGTH, THICKNESS OR SIMILAR LINEAR DIMENSIONS; MEASURING ANGLES; MEASURING AREAS; MEASURING IRREGULARITIES OF SURFACES OR CONTOURS
- G01B11/00—Measuring arrangements characterised by the use of optical techniques
- G01B11/24—Measuring arrangements characterised by the use of optical techniques for measuring contours or curvatures
- G01B11/255—Measuring arrangements characterised by the use of optical techniques for measuring contours or curvatures for measuring radius of curvature
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3306—Optical measuring means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3327—Measuring
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- Health & Medical Sciences (AREA)
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- Heart & Thoracic Surgery (AREA)
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Abstract
The invention discloses an optical fiber balloon catheter device and a balloon inflation state monitoring method, wherein the optical fiber balloon catheter device comprises: the balloon catheter comprises a catheter and a balloon which is connected to the distal end of the catheter and can radially expand relative to the catheter; the optical fiber microbending sensor is arranged in the interlayer of the balloon and can generate bending deformation under external stress; the optical fiber detection module is connected to the near end of the optical fiber microbend sensor and is used for calculating the bending position of the optical fiber microbend sensor according to the optical phase delay information and calculating the bending radius of the optical fiber microbend sensor according to the optical power attenuation information; the processor is configured to generate a morphological image of the balloon on the display interface at the bend location and bend radius. The mode of detecting the shape of the balloon by the optical fiber microbending sensor in the balloon interlayer can convert the fed back optical signals into the morphological image of the balloon to be displayed on the display interface, and the filling condition of the balloon is fed back in real time.
Description
Technical Field
The invention relates to the technical field of interventional medical instruments, in particular to an optical fiber balloon catheter device and a balloon inflation state monitoring method.
Background
Angioplasty, also known as percutaneous transluminal angioplasty, is an interventional medical procedure used to treat vascular stenosis or obstruction. This procedure can be applied to a variety of blood vessels including coronary arteries, carotid arteries, renal arteries, arteries of the lower extremities, and the like. The procedure is typically performed by arteria crura or radial puncture, inserting a catheter into a blood vessel, and then along the blood vessel to the coronary artery. The balloon at the distal end of the catheter is guided to the stenosis and then inflated to press the plaque against the vessel wall, thereby enlarging the vessel lumen. In some cases, a stent may be placed within the dilated vessel in order to maintain patency of the vessel.
Because the causes of the vascular cavity are various, and the patients have individual differences, the vascular cavity is expanded by balloon inflation or the stent is implanted by balloon inflation, the stent-open state of the blood vessel or the stent is confirmed by auxiliary means to ensure that the blood vessel is fully expanded and the adherence condition of the stent is ensured, or the postoperative complications can be caused, and the blood flow is blocked again.
Currently, intravascular ultrasound and X-ray angiography are common modes. The balloon is required to be deflated and taken out for intravascular ultrasound, then an ultrasound probe is placed in the blood vessel, if the expanding state is not ideal, the balloon is required to be replaced, the steps are repeated, continuous imaging cannot be achieved, and the operation is complex; the X-ray radiography needs to inject contrast agent and uses X-ray imaging, so that the condition in blood vessels, the position and the opening state of a bracket can be observed in real time, but medical staff and patients can be continuously exposed to radiation rays, and the health is affected.
Therefore, there is a need to design an optical fiber balloon catheter device with good safety and simple operation, and a balloon inflation state monitoring method.
Disclosure of Invention
Therefore, the technical problem to be solved by the invention is to overcome the defects of complex operation or poor safety of the balloon inflation form monitoring mode in the prior art, thereby providing the optical fiber balloon catheter device and the balloon inflation state monitoring method.
In order to solve the technical problems, the technical scheme of the invention is as follows:
a fiber optic balloon catheter device, comprising:
A balloon catheter comprising a catheter and a balloon attached to a distal end of the catheter, the balloon being capable of radial expansion relative to the catheter when the lumen is filled;
The optical fiber microbending sensor is arranged in the interlayer of the balloon and extends along the length direction of the balloon; the optical fiber microbending sensor can generate bending deformation when the balloon is subjected to external stress;
the optical fiber detection module is 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 also calculates the bending position of the optical fiber microbend sensor according to the optical phase delay information and calculates the bending radius of the optical fiber microbend sensor at the bending position according to the optical power attenuation information;
And the processor is electrically connected with the optical fiber detection module and is used for generating a simulated morphological image of the balloon on a display interface according to the standard three-dimensional model of the optical fiber microbending sensor in the ideal filling state of the balloon and the calculated bending position and bending radius of the optical fiber microbending sensor.
Further, the balloon comprises an inner balloon and an outer balloon coated outside the inner balloon, and the optical fiber microbending sensor is arranged in an interlayer formed by the inner balloon and the outer balloon; the optical fiber microbend sensor is clung to the inner wall of the outer balloon.
Further, the number of the optical fiber microbend sensors is three or more, the optical fiber microbend sensors of three or more are all linear, the linear extension direction of the optical fiber microbend sensors is the same as the length direction of the balloon, and the optical fiber microbend sensors of three or more are arranged at equal intervals around the circumferential direction of the balloon.
Further, the number of the optical fiber microbending sensors is one and the optical fiber microbending sensors are in a spiral shape, and the optical fiber microbending sensors are arranged in a spiral shape in the interlayer of the balloon.
Further, the number of the optical fiber microbending sensors is two, the optical fiber microbending sensors are all in spiral line type, the spiral directions of the two optical fiber microbending sensors are opposite, and the two optical fiber microbending sensors are arranged in a net shape in the interlayer of the saccule.
Further, the proximal end of the balloon catheter is connected with a catheter seat, and the catheter seat is provided with a balloon filling joint communicated with the inner cavity of the balloon and an optical fiber plug connected with the proximal end of the optical fiber microbending sensor; the balloon filling connector is used for being connected with the balloon expansion pressure pump, and the optical fiber plug is used for being connected with the optical fiber detection module.
Further, the optical fiber detection module and the balloon expansion pressure pump are of an integrated structure, and a display screen for displaying simulated morphological images of the balloon is arranged on the balloon expansion pressure pump.
A balloon inflation status monitoring method based on the optical fiber balloon catheter device, comprising the following steps:
S1, when the balloon is in an ideal filling state, a standard three-dimensional model of the optical fiber microbending sensor in the ideal filling state of the balloon is constructed through the position coordinates of the optical fiber microbending sensor arranged in the balloon interlayer relative to the central axis of the catheter;
S2, after the balloon is inflated, generating optical phase delay information and optical power attenuation information according to an optical signal fed back by the optical fiber microbending sensor; calculating the bending position of the optical fiber microbend sensor according to the optical phase delay information, and calculating the bending radius of the optical fiber microbend sensor at the bending position according to the optical power attenuation information;
S3, generating a simulated morphological image of the balloon on a display interface according to a standard three-dimensional model of the optical fiber microbending sensor in an ideal balloon filling state and the bending position of the optical fiber microbending sensor in the current state and the bending radius corresponding to the bending position of the balloon.
Further, the step of S3 includes:
s31, generating a three-dimensional model of the optical fiber microbending sensor in the current expansion state of the balloon according to a standard three-dimensional model of the optical fiber microbending sensor in the ideal filling state of the balloon and the bending position of the optical fiber microbending sensor in the current state of the balloon and the bending radius corresponding to the bending position;
s32, generating a simulated morphological image of the balloon on a display interface in real time according to the three-dimensional model of the optical fiber microbending sensor in the current expansion state of the balloon.
Further, the simulated morphological image of the balloon generated on the display interface is a two-dimensional image or a three-dimensional image.
The technical scheme of the invention has the following advantages:
1. According to the optical fiber balloon catheter device, the optical fiber microbending sensor extending along the length direction of the balloon is arranged in the interlayer of the balloon, when the balloon is extruded to the inner wall of a blood vessel after being inflated, when a lesion tissue exists on the inner wall of the blood vessel, the corresponding position of the balloon is forced to deform, the optical fiber microbending sensor in the balloon is bent, the optical fiber microbending sensor can cause the change of the front-back phase of light and the attenuation of the light power after being bent, the optical fiber detection module can detect the light phase delay information and the light power attenuation information through the light signals fed back by the optical fiber microbending sensor, and the bending radius of the optical fiber microbending sensor at the bending position is calculated according to the light phase delay information; the processor can generate a simulated morphological image of the balloon on the display interface according to the standard three-dimensional model of the fiber microbending sensor in the ideal filling state of the balloon and the calculated bending position and bending radius of the fiber microbending sensor; at this point the physician may continue to increase the balloon pressure or other means to bring its balloon shape to the target state. Compared with the mode of monitoring the shape of the balloon by using the pressure sensor on the balloon in the prior art, the mode of detecting the shape of the balloon by using the optical fiber microbending sensor has the advantages that the optical fiber microbending sensor can be attached to the inner wall of a blood vessel to the greatest extent under the condition of not contacting a human body, and the measurement precision of the shape of the balloon is higher; meanwhile, the optical fiber microbend sensor is not affected by the temperature difference of the patient. Furthermore, the core diameter of the single optical fiber microbending sensor is usually between 8 micrometers and 10 micrometers, which is far smaller than the size of the pressure sensor, so that a plurality of optical fiber microbending sensors can be arranged under the extremely small volume of the balloon, and the accuracy of the detection result of the shape of the balloon is improved. In addition, because the optical fiber microbending sensor has unique vector bending characteristics, the bending degree of the optical fiber microbending sensor can be identified, and the bending direction of the optical fiber microbending sensor can be monitored at the same time, so that a more accurate three-dimensional model can be built by utilizing optical signals transmitted back by the optical fiber microbending sensor through an algorithm, a doctor can intuitively and continuously observe the state of an intravascular balloon, the doctor can conveniently judge the operation effect and determine the subsequent treatment means, and meanwhile, the radiation injury of X-rays to the doctor and a patient is avoided, or the complex operation flow of intravascular ultrasonic examination is realized.
2. The arrangement mode of the optical fiber balloon catheter device provided by the invention is divided into linear type, spiral type and net type, and the optical fiber balloon catheter device can be suitable for different types of interventional operations; the linear optical fiber microbend sensor has simple structure and low cost, and can be suitable for relatively simple interventional operations under some vascular conditions; the spiral optical fiber microbending sensor is spirally arranged around the circumference of the balloon, so that the cost can be reduced to a certain extent, the balloon morphology monitoring precision can be improved, and the method is suitable for interventional operations with general vascular condition complexity; the net-shaped optical fiber microbend sensor forms a net-shaped structure on the surface of the balloon, can reduce the monitoring blank area to the greatest extent, improves the monitoring accuracy of the balloon morphology, and is suitable for interventional operations with relatively complex vascular conditions.
3. Compared with the method for monitoring the balloon shape by using the pressure sensor on the balloon in the prior art, the method for monitoring the balloon inflation state provided by the invention has the advantages that the optical fiber microbending sensor can be attached to the inner wall of a blood vessel to the greatest extent under the condition of not contacting a human body, and the measurement precision of the balloon shape is higher; meanwhile, the optical fiber microbend sensor is not affected by the temperature difference of the patient. Furthermore, the core diameter of the single optical fiber microbending sensor is usually between 8 micrometers and 10 micrometers, which is far smaller than the size of the pressure sensor, so that a plurality of optical fiber microbending sensors can be arranged under the extremely small volume of the balloon, and the accuracy of the detection result of the shape of the balloon is improved. In addition, because the optical fiber microbending sensor has unique vector bending characteristics, the bending degree of the optical fiber microbending sensor can be identified, and the bending direction of the optical fiber microbending sensor can be monitored at the same time, so that a more accurate three-dimensional model can be built by utilizing optical signals transmitted back by the optical fiber microbending sensor through an algorithm, a doctor can intuitively and continuously observe the state of an intravascular balloon, the doctor can conveniently judge the operation effect and determine the subsequent treatment means, and meanwhile, the radiation injury of X-rays to the doctor and a patient is avoided, or the complex operation flow of intravascular ultrasonic examination is realized. And the filling state of the balloon, other data parameters and the like are automatically stored, and the data can be derived in a wired or wireless transmission mode or accessed into a hospital information system for later data query, review and analysis and the like. The blood vessel state monitoring system has the advantages of convenience in operation, accurate blood vessel state monitoring, visual and continuous display, small harm to doctors and patients, convenience in data management and analysis and the like.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic view of a first embodiment of a fiber balloon catheter device according to an embodiment of the present invention;
FIG. 2 is a schematic view of a second embodiment of a fiber balloon catheter device according to an embodiment of the present invention;
FIG. 3 is a schematic view of a balloon catheter according to an embodiment of the present invention;
FIG. 4 is a schematic view of a balloon catheter according to a second embodiment of the present invention;
FIG. 5 is a schematic view of a balloon catheter according to a third embodiment of the present invention;
Fig. 6 is a schematic diagram of a simulated image of a balloon displayed on a display interface in an embodiment of the present invention.
Reference numerals illustrate: 1. a conduit; 2. a balloon; 3. an optical fiber microbend sensor; 4. a catheter holder; 5. an optical fiber plug; 6. simulated morphology image of balloon.
Detailed Description
The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the description of the present invention, it is to be understood that the terms "proximal" and "distal" are used throughout to refer to proximal and distal with respect to an operator, and that the end of the present invention that is proximal to the physician or operator, i.e., the end at which the operator is located, is "distal" to the physician or operator, i.e., the end at which the balloon is located, when used. The foregoing description of orientations is presented only to facilitate a description of the invention and to simplify the description, and is not intended to indicate or imply that the devices or elements referred to must have a particular orientation, be configured and operate in a particular orientation, and therefore should not be construed as limiting the invention.
In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
An optical fiber balloon catheter apparatus as shown in fig. 1-3 includes a balloon catheter, an optical fiber microbending sensor 3, a catheter hub 4, an optical fiber 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 a catheter seat 4 is connected to the proximal end of the catheter 1. The catheter seat 4 is provided with a guide wire interface and a balloon filling interface. The balloon filling joint is used for being connected with the balloon expanding pressure pump; the catheter 1 is provided with a guide wire cavity and a balloon filling cavity. In use, the guidewire enters along the distal end of the catheter 1, passes out of the guidewire port through the guidewire lumen, and is used to deliver the balloon catheter to the lesion site of the vessel. The balloon 2 is communicated with a balloon filling cavity, the balloon filling cavity is communicated with a balloon filling interface, and the balloon expansion pressure pump is used for injecting filling medium into the inner cavity of the balloon 2 through the balloon filling interface, and the balloon 2 is radially expanded relative to the catheter 1 after the filling medium is injected into the inner cavity.
In some embodiments, balloon 2 comprises an inner balloon and an outer balloon coated outside the inner balloon, and fiber microbending sensor 3 is disposed in an interlayer formed by the inner balloon and the outer balloon; the optical fiber microbending sensor 3 is tightly attached to the inner wall of the outer balloon. The optical fiber microbending sensor 3 extends along the length direction of the balloon 2, and when the balloon 2 is pressed by the pathological tissue in the blood vessel, the optical fiber microbending sensor 3 generates bending deformation at the corresponding position of the bending deformation of the balloon 2.
In some embodiments, as shown in fig. 1, the catheter seat 4 is provided with an optical fiber outlet interface, an optical fiber plug 6 is connected to the optical fiber outlet interface, the proximal end of the optical fiber microbend sensor 3 is connected to an optical fiber plug 5, and the optical fiber plug 5 is used for connecting with an optical fiber detection module. In an alternative embodiment, as shown in fig. 2, the fiber outlet interface may also be provided on the outer wall of the catheter 1 between the balloon 2 and the catheter hub 4.
In the present embodiment, the optical fiber detection module is configured to parse the optical signals from the plurality of optical fiber microbend sensors 3 and generate the optical phase delay information and the optical power attenuation amount information corresponding to the optical fiber microbend sensors 3; the optical fiber detection module also calculates the bending position of the optical fiber microbend sensor 3 according to the optical phase delay information, and calculates the bending radius of the plurality of optical fiber microbend sensors 3at the bending position according to the optical power attenuation information. The processor is electrically connected with the optical fiber detection module, and is used for generating a simulated morphological image 6 of the balloon on the display interface according to a standard three-dimensional model of the optical fiber microbending sensor 3 in an ideal filling state of the balloon and the calculated bending position and bending radius of the optical fiber microbending sensor 3. As shown in fig. 6, the simulated morphological image 6 of the balloon generated on the display interface is a two-dimensional image or a three-dimensional image. Typically, the standard three-dimensional model of the fiber optic microbending sensor 3 in the ideal balloon filling state resembles a cylinder.
Specifically, the optical fiber detection module can monitor the change of the optical wave front phase when the optical fiber is bent, and calculate the specific bending position and even bending direction according to the following formula: ΔΦ bend＝(2πneff/λ)×Leff and L eff＝∑(Lini), where ΔΦ bend is the extra phase delay due to bending; n eff is the equivalent refractive index, taking into account stress and strain effects induced by bending; lambda 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 and n i is the refractive index of the i-th segment. According to the above formula ΔΦ bend＝(2πneff/λ)×Leff, where the extra phase delay ΔΦ bend caused by bending is the data that can be detected by the fiber detection module, the equivalent refractive index n eff and the light source wavelength λ are known data, so that a specific value of the extra effective path length L eff caused by bending can be calculated; Also because the optical fiber microbend sensor 3 can be divided into a plurality of small segments according to its own length, the specific refractive index n i, of each small segment of the optical fiber microbend sensor 3 is known data, and in the case that the specific value of L eff is known, the specific number of the subscript i in L i can be calculated according to the above formula L eff＝∑(Lini), It is thus possible to know on which small section of the optical fiber microbend sensor 3 the bending position of the optical fiber microbend sensor 3 is located, and thus the bending position of the optical fiber microbend sensor 3.
The "guided wave mode" and "radiation mode" in an optical fiber are two basic concepts in fiber optics. Guided wave modes refer to electromagnetic field modes that can propagate axially along the fiber inside the fiber while being constrained by the principle of total reflection, such that the optical energy is confined to propagate within the fiber core. In short, these modes can be transmitted in optical fibers for a long distance without leaking to the outside, and are optical wave forms actually used to carry information in optical fiber communication. Radiation modes are electromagnetic modes that are not effectively totally reflected within and propagate along the fiber, but rather are lost in radiation or leak into the cladding or even the external environment. When the optical fiber is bent, mode coupling in the optical fiber is caused, some guided wave modes become radiation modes, the radiation modes leak into the cladding of the optical fiber to cause optical power loss, and 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 approximated by the following formula: Where Δn is the refractive index difference between the core and cladding of the fiber, n core is the refractive index of the core, α is the bending loss, and λ is the wavelength of light. Since the bending loss α in the formula is the detection amount of the optical fiber detection module, the refractive index difference Δn between the core and the cladding of the optical fiber, the refractive index n core of the core and the optical wavelength λ are all known data, and therefore a specific value of the bending radius R can be calculated according to the above data.
By arranging the optical fiber microbending sensor 3 extending along the length direction of the balloon 2 in the interlayer of the balloon 2, when the balloon 2 is inflated and then the inner wall of a blood vessel is extruded, when the lesion tissue exists on the inner wall of the blood vessel, the corresponding position of the balloon 2 is forced to deform, the optical fiber microbending sensor 3 in the balloon 2 is bent, the optical fiber microbending sensor 3 can cause the change of the front and back phases of light wave and the attenuation of light power after bending, the optical fiber detection module can detect the light phase delay information and the light power attenuation information through the light signals fed back by the optical fiber microbending sensor 3, and calculate the bending position of the optical fiber microbending sensor 3 and the bending radius of the optical power attenuation information at the bending position according to the light phase delay information; the processor can generate a simulated morphological image 6 of the balloon on the display interface according to the standard three-dimensional model of the fiber microbending sensor 3 in the ideal filling state of the balloon and the calculated bending position of the fiber microbending sensor 3 and the bending radius of the bending position, can feed back the filling condition of the balloon 2 in real time, and has the advantages of simple operation, good safety, continuous real-time display of the filling state of the balloon 2 and the like; the physician may then bring his balloon shape to the target state by continuing to increase balloon pressure or other means. The mode of detecting the balloon shape by using the optical fiber microbending sensor 3 can convert the optical signal fed back by the optical fiber microbending sensor 3 into the simulated morphological image 6 of the balloon to be displayed on the display interface of the monitoring equipment, can feed back the filling condition of the balloon 2 in real time, and has the advantages of simplicity in operation, complete monitoring parameters, good safety, capability of continuously monitoring the filling state of the balloon 2 in real time and the like.
Compared with the mode of monitoring the shape of the balloon by using the pressure sensor on the balloon 2 in the prior art, the mode of detecting the shape of the balloon by using the optical fiber microbending sensor 3 has the advantages that the optical fiber microbending sensor 3 can be attached to the inner wall of a blood vessel to the greatest extent under the condition of not contacting a human body, and the measurement precision of the shape of the balloon is higher; meanwhile, the optical fiber microbend sensor 3 is not affected by the temperature difference of the patient; furthermore, the core diameter of the single optical fiber microbending sensor 3 is usually between 8 micrometers and 10 micrometers, which is far smaller than the size of the pressure sensor, so that a plurality of optical fiber microbending sensors 3 can be arranged under the extremely small volume of the balloon 2, so that the accuracy of the detection result of the balloon shape is improved; in addition, because the optical fiber microbending sensor 3 has unique vector bending characteristics, the bending degree of the optical fiber microbending sensor 3 can be identified, and the bending direction of the optical fiber microbending sensor 3 can be monitored at the same time, so that a more accurate three-dimensional model can be built by utilizing the optical signals transmitted back by the optical fiber microbending sensor 3 through an algorithm, a doctor can intuitively and continuously observe the state of the intravascular balloon 2, the doctor can conveniently judge the operation effect and determine the subsequent treatment means, and meanwhile, the radiation injury of X-rays to the doctor and a patient is avoided, or the complex operation flow of intravascular ultrasonic examination is realized.
In some embodiments, the optical fiber detection module, the processor and the balloon inflation pressure pump are in an integrated structure, and the balloon inflation pressure pump is provided with a display screen capable of displaying the simulated morphological image 6 of the balloon. Specifically, the processor, the optical fiber detection module, the control circuit elements required by the balloon expansion pressure pump, and the like can be integrated on the same circuit board positioned in the balloon expansion pressure pump; in this way a compact design of the entire device can be provided. The circuit board is also provided with a storage module and a wired or wireless communication module, the storage module is used for automatically storing the simulated morphological image data and other data of the balloon, and the wired or wireless communication module is used for inquiring, reviewing and analyzing the simulated morphological image data and other data of the balloon by other medical equipment or hospital information systems and the like.
In the present embodiment, the number of the optical fiber microbend sensors 3 is three or more and all are linear, the linear extending 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 equally spaced around the circumferential direction of the balloon 2.
Example two
An optical fiber balloon catheter device as shown in fig. 4 is different from the first embodiment in that the number of optical fiber microbending sensors 3 is one and in a spiral line shape, and the optical fiber microbending sensors 3 are arranged in a spiral shape in the interlayer of the balloon 2.
Example III
An optical fiber balloon catheter device as shown in fig. 5 is different from the first embodiment in that the number of the optical fiber microbending sensors 3 is two and each has a spiral shape, the spiral directions of the two optical fiber microbending sensors 3 are opposite, and the two optical fiber microbending sensors 3 are arranged in a net shape in the interlayer of the balloon 2.
In the first embodiment, the second embodiment and the third embodiment, the arrangement mode of the optical fiber microbending sensor 3 in the balloon 2 is divided into a linear type, a spiral type and a net type, and can be suitable for different types of interventional operations; the linear optical fiber microbend sensor 3 has simple structure and low cost, and can be suitable for relatively simple interventional operations under some vascular conditions; the spiral optical fiber microbending sensor 3 is spirally arranged around the circumference of the balloon 2, so that the cost can be reduced to a certain extent, the form monitoring precision of the balloon 2 can be improved, and the method is suitable for interventional operations with general vascular condition complexity; the net-shaped optical fiber microbend sensor 3 forms a net-shaped structure on the surface of the balloon 2, can reduce the monitoring blank area to the greatest extent, improves the monitoring accuracy of the morphology of the balloon 2, and is suitable for interventional operations with relatively complex vascular conditions.
The invention also provides a balloon inflation state monitoring method based on the optical fiber balloon catheter device, which comprises the following steps:
Step S1, when the balloon 2 is in an ideal filling state, a standard three-dimensional model of the optical fiber microbending sensor 3 in the ideal filling state of the balloon is constructed through the position coordinates of the optical fiber microbending sensor 3 arranged in the interlayer of the balloon 2 relative to the central axis of the catheter 1;
s2, after the balloon 2 is inflated, generating optical phase delay information and optical power attenuation information according to an optical signal fed back by the optical fiber microbending sensor 3; calculating the bending position of the optical fiber microbend sensor 3 according to the optical phase delay information, and calculating the bending radius of the optical fiber microbend sensor 3 at the bending position according to the optical power attenuation information;
and S3, generating a simulated morphological image 6 of the balloon on a display interface according to a standard three-dimensional model of the optical fiber microbending sensor 3 in an ideal balloon filling state and the bending position of the optical fiber microbending sensor 3 and the corresponding bending radius of the bending position of the balloon 2 in the current state.
The step S3 comprises the following steps:
Step S31, firstly, generating a three-dimensional model of the optical fiber microbending sensor 3 in the current expansion state of the balloon 2 according to a standard three-dimensional model of the optical fiber microbending sensor 3 in the ideal balloon filling state and the bending position of the optical fiber microbending sensor 3 in the current state and the corresponding bending radius of the bending position of the balloon 2;
and S32, generating a simulated morphological image 6 of the balloon on a display interface in real time according to the three-dimensional model of the optical fiber microbending sensor 3 in the current expansion state of the balloon 2. Specifically, the simulated morphological image 6 of the balloon generated on the display interface is a two-dimensional image or a three-dimensional image.
Compared with the method for monitoring the balloon shape by using the pressure sensor on the balloon 2 in the prior art, the method for monitoring the balloon inflation state provided by the invention has the advantages that the optical fiber microbending sensor 3 can be attached to the inner wall of a blood vessel to the greatest extent under the condition of not contacting a human body, and the measurement precision of the balloon shape is higher; at the same time, the optical fiber microbend sensor 3 is not affected by the temperature difference of the patient. Furthermore, the core diameter of the single optical fiber microbending sensor 3 is usually between 8 micrometers and 10 micrometers, which is far smaller than the size of the pressure sensor, so that a plurality of optical fiber microbending sensors 3 can be arranged under the extremely small volume of the balloon 2, so as to improve the accuracy of the detection result of the balloon shape. In addition, because the optical fiber microbending sensor 3 has unique vector bending characteristics, the bending degree of the optical fiber microbending sensor 3 can be identified, and the bending direction of the optical fiber microbending sensor 3 can be monitored at the same time, so that a more accurate three-dimensional model can be built by utilizing the optical signals transmitted back by the optical fiber microbending sensor 3 through an algorithm, a doctor can intuitively and continuously observe the state of the intravascular balloon 2, the doctor can conveniently judge the operation effect and determine the subsequent treatment means, and meanwhile, the radiation injury of X-rays to the doctor and a patient is avoided, or the complex operation flow of intravascular ultrasonic examination is realized. The filling state of the balloon 2 and other data parameters can be automatically stored, and the data can be derived through wired or wireless transmission, or can be accessed into a hospital information system for later data query, review and analysis and the like. The blood vessel state monitoring system has the advantages of convenience in operation, accurate blood vessel state monitoring, visual and continuous display, small harm to doctors and patients, convenience in data management and analysis and the like.
It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the invention.
Claims (10)
1. A fiber optic balloon catheter device, comprising:
A balloon catheter comprising a catheter (1) and a balloon (2) connected to the distal end of the catheter (1), the balloon (2) being capable of radial expansion relative to the catheter (1) when the lumen is filled;
An optical fiber microbending sensor (3) which is arranged in the interlayer of the balloon (2) and extends along the length direction of the balloon (2); the optical fiber microbending sensor (3) can generate bending deformation when the balloon (2) is subjected to external stress;
the optical fiber detection module is connected to the proximal end of the optical fiber microbend sensor (3); the optical fiber detection module is configured to analyze an 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 also calculates the bending position of the optical fiber microbend sensor (3) according to the optical phase delay information and calculates the bending radius of the optical fiber microbend sensor (3) at the bending position according to the optical power attenuation information;
And the processor is electrically connected with the optical fiber detection module and is used for generating a simulated morphological image (6) of the balloon on a display interface according to a standard three-dimensional model of the optical fiber microbending sensor (3) in an ideal balloon filling state and the calculated bending position and bending radius of the optical fiber microbending sensor (3).
2. The fiber-optic balloon catheter device according to claim 1, wherein the balloon (2) comprises an inner balloon and an outer balloon coated outside the inner balloon, the fiber-optic microbending sensor (3) being arranged in an interlayer formed by the inner balloon and the outer balloon; the optical fiber microbending sensor (3) is tightly attached to the inner wall of the outer balloon.
3. The optical fiber balloon catheter device according to claim 1, wherein the number of the optical fiber microbending sensors (3) is three or more, the optical fiber microbending sensors (3) of three or more are all linear, the linear extension direction of the optical fiber microbending sensors (3) is the same as the length direction of the balloon (2), and the optical fiber microbending sensors (3) of three or more are equally spaced around the circumferential direction of the balloon (2).
4. The fiber balloon catheter device according to claim 1, characterized in that the number of fiber microbending sensors (3) is one and spiral, the fiber microbending sensors (3) being arranged in a spiral in the sandwich of the balloon (2).
5. The optical fiber balloon catheter device according to claim 1, characterized in that the number of the optical fiber microbending sensors (3) is two, and the optical fiber microbending sensors (3) are in spiral line type, the spiral directions of the two optical fiber microbending sensors (3) are opposite, and the two optical fiber microbending sensors (3) are arranged in a net 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 with a catheter hub (4), the catheter hub (4) being provided with a balloon filling connector communicating with the lumen of the balloon (2) and a fiber plug (5) connected with the proximal end of the fiber-optic microbend sensor (3); the balloon filling connector is used for being connected with a balloon expansion pressure pump, and the optical fiber plug (5) is used for being connected with the optical fiber detection module.
7. The fiber optic balloon catheter device according to claim 6, wherein the fiber optic detection module and the balloon inflation pressure pump are of an integrated structure, and a display screen for displaying simulated morphological images of the balloon is arranged on the balloon inflation pressure pump.
8. A balloon inflation status monitoring method based on the optical fiber balloon catheter device of any one of claims 1-7, comprising:
s1, when the balloon (2) is in an ideal filling state, a standard three-dimensional model of the optical fiber microbending sensor (3) in the ideal filling state of the balloon is constructed through the position coordinates of the optical fiber microbending sensor (3) which is arranged in an interlayer of the balloon (2) and extends along the length direction of the balloon (2) relative to the central axis of the catheter (1);
s2, after the balloon (2) is inflated, generating optical phase delay information and optical power attenuation information according to an optical signal fed back by the optical fiber microbending sensor (3); calculating the bending position of the optical fiber microbending sensor (3) according to the optical phase delay information, and calculating the bending radius of the optical fiber microbending sensor (3) at the bending position according to the optical power attenuation information;
S3, generating a simulated morphological image (6) of the balloon on a display interface according to a standard three-dimensional model of the optical fiber microbending sensor (3) in an ideal balloon filling state and the bending position of the optical fiber microbending sensor (3) and the bending radius corresponding to the bending position of the balloon (2) in the current state.
9. The balloon inflation status monitoring method of claim 8, wherein the step of S3 comprises:
S31, firstly generating a three-dimensional model of the optical fiber microbending sensor (3) in the current expansion state of the balloon (2) according to a standard three-dimensional model of the optical fiber microbending sensor (3) in the ideal expansion state of the balloon and the bending position of the optical fiber microbending sensor (3) in the current state and the corresponding bending radius of the balloon (2) in the bending position;
S32, generating a simulated morphological image (6) of the balloon on a display interface in real time according to the three-dimensional model of the optical fiber microbending sensor (3) in the current expansion state of the balloon (2).
10. The balloon inflation status monitoring method according to claim 8, wherein the simulated morphological image (6) of the balloon generated on the display interface is a two-dimensional image or a three-dimensional image.
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