WO2020192699A1 - Mla-oct成像导管、mla-oct成像系统及mla-oct成像方法 - Google Patents

Mla-oct成像导管、mla-oct成像系统及mla-oct成像方法 Download PDF

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WO2020192699A1
WO2020192699A1 PCT/CN2020/081163 CN2020081163W WO2020192699A1 WO 2020192699 A1 WO2020192699 A1 WO 2020192699A1 CN 2020081163 W CN2020081163 W CN 2020081163W WO 2020192699 A1 WO2020192699 A1 WO 2020192699A1
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mla
oct imaging
optical
signal
delay line
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PCT/CN2020/081163
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English (en)
French (fr)
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张林涛
吴振英
冯庆宇
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苏州阿格斯医疗技术有限公司
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Priority to EP20779952.9A priority Critical patent/EP3932287A4/en
Priority to CA3134082A priority patent/CA3134082A1/en
Priority to US17/440,431 priority patent/US20220160231A1/en
Publication of WO2020192699A1 publication Critical patent/WO2020192699A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0033—Features or image-related aspects of imaging apparatus classified in A61B5/00, e.g. for MRI, optical tomography or impedance tomography apparatus; arrangements of imaging apparatus in a room
    • A61B5/004—Features or image-related aspects of imaging apparatus classified in A61B5/00, e.g. for MRI, optical tomography or impedance tomography apparatus; arrangements of imaging apparatus in a room adapted for image acquisition of a particular organ or body part
    • A61B5/0044—Features or image-related aspects of imaging apparatus classified in A61B5/00, e.g. for MRI, optical tomography or impedance tomography apparatus; arrangements of imaging apparatus in a room adapted for image acquisition of a particular organ or body part for the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/07—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0062—Arrangements for scanning
    • A61B5/0066—Optical coherence imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0073—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by tomography, i.e. reconstruction of 3D images from 2D projections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6869—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors
    • A61B2560/0238—Means for recording calibration data
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0233—Special features of optical sensors or probes classified in A61B5/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/046—Arrangements of multiple sensors of the same type in a matrix array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2576/00—Medical imaging apparatus involving image processing or analysis
    • A61B2576/02—Medical imaging apparatus involving image processing or analysis specially adapted for a particular organ or body part
    • A61B2576/023—Medical imaging apparatus involving image processing or analysis specially adapted for a particular organ or body part for the heart

Definitions

  • the invention relates to the technical field of medical endoscopy detection, in particular to an MLA-OCT imaging catheter, an MLA-OCT imaging system and an MLA-OCT imaging method.
  • Coronary artery disease is the number one cause of death worldwide. Due to the accumulation, rupture and thrombosis of atherosclerotic plaques, coronary artery disease can cause chest pain (angina pectoris), myocardial ischemia and sudden cardiac death. For those patients who have not died suddenly or have symptoms of chronic angina, suitable plaque treatment includes PCI (Percutaneous Coronary Intervention). Cardiac interventional experts use PCI to place stents to deal with lesions. However, in recent years, many studies have concluded that the abuse of cardiac stents, or at least overuse, has caused a lot of controversy. Doctors are more cautious and critical when considering only using stents. In addition, since lower-cost drug treatments have been introduced to the market, studies have found that they are also effective.
  • PCI Percutaneous Coronary Intervention
  • the existing commercial intravascular IV-OCT (Intravascular Optical Coherence Tomographic) imaging system includes a host device, an imaging catheter, and a withdrawal controller connecting the two.
  • the proximal end of the withdrawal controller is connected to the interferometer through an optical fiber, and the distal end passes through
  • the catheter connector is connected to the imaging catheter.
  • Host equipment includes lasers, interferometers, photodetectors, data acquisition cards, imaging hosts, image processors, and display terminals.
  • the interferometer carries the most core components of the imaging system: the left side of the interferometer is the laser input, the right is the optical signal output, the upper part is the reference arm containing the adjustable optical delay line (VODL), and the lower part is the retracement controller and Signal arm of imaging catheter.
  • VODL adjustable optical delay line
  • the reference arm of the interferometer of the existing IV-OCT imaging system has a dimmable optical delay line
  • the signal arm has an imaging catheter and a retreat controller
  • the retreat controller has a stepping motor to control the retreat and control high speed Rotating servo motor and fiber optic slip ring.
  • the core of OCT imaging technology is to rely on the imaging catheter located on the signal arm of the interferometer to emit laser light and collect the scattered light returned from human tissues, which interferes with the optical signal of the reference arm of the interferometer for coherent detection.
  • the imaging host is based on the package that detects the interference signal. Network to generate lumen images.
  • the optical path of the reference arm must be very close to the actual optical path of the signal arm in order to obtain high-quality coherent detection.
  • the OCT system has an adjustable optical delay line on the reference arm of the interferometer.
  • the reference arm adjusts the light
  • the delay line is matched to ensure the best interference performance.
  • the main optical paths of the reference arm and the signal arm are both a single optical fiber, corresponding to a single microlens at the tip of the imaging catheter.
  • the annular cavity scanning is completed by the high-speed rotation of a single microlens driven by the servo motor in the retraction controller, the optical fiber slip ring and the torque sleeve outside the inner tube of the imaging catheter.
  • the specific imaging process of the IV-OCT imaging system is: the imaging catheter is sent along the guide wire to the distal end of the intravascular lesion, which exceeds the lesion area by more than 5mm, and then the retracting controller activates the imaging catheter to retract and retreat to the entire lesion area.
  • the retracement process is generally 1-7 seconds, and the retracement distance is 50-150mm.
  • the servo motor (ie, rotating motor) and linear motor (ie, stepping motor) of the retraction controller control the inner tube of the imaging catheter to retreat while rotating at a high speed, which will affect the tissue in the blood vessel. Perform spiral point scanning to collect the scattered light signal returned from each point of the blood vessel tissue.
  • the two motors stop and the scan ends, and the host device returns according to the detected points Scatter light signals to generate complete images of vascular tissue lesions.
  • the imaging catheter to realize this IV-OCT imaging method includes an outer tube, an inner tube and a catheter connector.
  • the inner tube includes an optical fiber and a microlens, and a torque sleeve is provided outside the optical fiber; the distal end of the outer tube is commonly used for PCI interventional surgical catheters Rapid Exchange (Rx) design, the doctor first puts the imaging catheter from the rapid exchange tip on the finger guide wire outside the patient's body, and then pushes the imaging catheter into the diseased target area in the patient's blood vessel along the finger guide wire.
  • Rx Rapid Exchange
  • the outer tube of the imaging catheter does not move, and the guide wire worn on the rapid exchange tip does not move, only the inner tube rotates at a high speed and withdraws.
  • the inner tube rotates unevenly and smoothly, it may collide and rub against the inner wall of the outer tube, causing the outer tube to shake, which will drive the outer tube to quickly exchange the guide wire at the tip to shake.
  • the guide wire may be entangled with the imaging catheter and hurt the patient. This is a potential safety risk of current products.
  • this commercial IV-OCT imaging method is based on mechanically rotating microlenses to scan the luminal tissue laterally, it must ensure that the microlenses at the distal end of the imaging catheter rotate uniformly to obtain accurate images without distortion.
  • the process is: the high-speed rotation of the servo motor located in the retreat controller, the torque sleeve outside the guide tube drives the distal microlens to rotate at a high speed, thereby driving the microlens scanning beam to rotate at a high speed to achieve the lateral ring cavity scanning target At the same time, the scattered light returned from the target tissue of the corresponding ring lumen tube is also collected at high speed.
  • Accurate image generation is based on precise synchronization of the microlens rotation speed, servo motor rotation speed and light source sweep speed. If the rotation of the proximal motor is not synchronized with the rotation of the lens spot, the image will be distorted. Because the catheter follows the body’s own lumen, including but not limited to blood vessels, and is close to the diseased area in the body, these lumens have different shapes and bends. After the imaging catheter is bent, it is easy to cause the rotation of the far and near ends of the imaging catheter to be out of sync. Therefore, the image Distortion is a major challenge for the accuracy of intraluminal IV-OCT imaging.
  • the inner tube of the OCT imaging catheter in the prior art rotates unevenly and smoothly, it may collide and rub against the inner wall of the outer tube, causing the outer tube to shake, which will drive the outer tube to quickly exchange the guide wire at the tip of the tube to shake. Tangle with the imaging catheter and injure the patient.
  • the imaging catheter is bent, it is easy to cause the rotation of the far and near ends to be unsynchronized, resulting in distortion of the image obtained by the OCT imaging of the lumen.
  • the main purpose of the present invention is to provide a novel cavity optical coherence tomography MLA-OCT (Micro-lens Array Optical Coherence Tomography) imaging method, which completely eliminates the current commercial cavity IV -The rotational movement of the imaging catheter inner tube necessary for the OCT imaging method to reduce the risk of injury to the patient during the retraction process of the imaging catheter, and to avoid image distortion caused by the unsynchronized rotation of the far and near ends of the imaging catheter.
  • MLA-OCT Micro-lens Array Optical Coherence Tomography
  • an MLA-OCT imaging catheter includes an inner tube, an outer tube, and a multi-core catheter connector, wherein:
  • the inner tube is located inside the outer tube
  • the inner tube includes an optical fiber bundle and a micro lens array, the optical fiber bundle includes two or more optical fibers, the micro lens array includes two or more micro lenses, and the micro lens array is located at the distal end of the optical fiber bundle;
  • the proximal end of the outer tube is connected with a withdrawal controller for driving the withdrawal of the MLA-OCT imaging catheter through a multi-core catheter connector.
  • the distal end of the outer tube is provided with a quick exchange head end, and the quick exchange head end is provided with a developing ring and a guide wire inlet and outlet.
  • a transparent imaging window is provided at the distal end of the outer tube.
  • the connector of the multi-core catheter has anti-slip patterns.
  • an MLA-OCT imaging system includes: a host device, a withdrawal controller, and the aforementioned MLA-OCT imaging catheter, wherein,
  • the host device includes an optical device and a data processing device.
  • the optical device includes a light source and an interferometer; the signal arm of the interferometer is provided with a retractor controller and an MLA-OCT imaging catheter, and the reference arm of the interferometer is provided with a light source. Delay line; the light source is divided into a beam of sample light and a beam of reference light by the interferometer, the sample light enters the signal arm of the interferometer to reach the human tissue, the MLA-OCT imaging catheter collects the multi-point scattering returned from the human tissue
  • the light is a set of scanning light signals, where each single point scattered light is the first light signal, and the scanning light signal is a collection of the first light signal of each single point.
  • the reference light enters the reference arm of the interferometer and reaches The optical delay line of the interferometer, the light returned by the optical delay line is the second optical signal; the first optical signal and the second optical signal return to the interferometer to interfere to generate an interference signal, which is sent to the data processing device;
  • the retracement controller includes a stepping motor, a first high-speed optical switch, an optical fiber bundle, and an optical fiber array connector; the proximal end of the retracement controller is connected to the interferometer, and the distal end is connected to the MLA-OCT imaging catheter through a multi-core catheter connector When connected, the retraction controller activates the MLA-OCT imaging catheter to move axially to perform axial scanning, so as to establish a spatial image of the tissue.
  • the data processing device includes: a photodetector, a data acquisition card, an imaging host, an image processor, and a display terminal.
  • the host device includes closed-loop monitoring of withdrawal.
  • the reference arm is provided with a second high-speed optical switch and an optical delay line array including two or more optical delay lines; optionally, the reference arm is provided with an optical delay line line.
  • a method for calibrating the MLA-OCT imaging catheter in the MLA-OCT imaging system includes: after the MLA-OCT imaging catheter containing the optical fiber bundle is connected to the withdrawal controller, the data The processing device adjusts the position of the corresponding optical delay line on the reference arm for each optical fiber according to the signal-to-noise ratio of the received interference signal until the signal-to-noise ratio is the highest. At this time, the delay time value of the optical delay line of each optical fiber is Its optical delay line calibration value.
  • an MLA-OCT imaging method using the MLA-OCT imaging system includes the following steps:
  • the MLA-OCT imaging catheter is connected to the withdrawal controller through a multi-core catheter connector;
  • the light source is divided into a beam of sample light and a beam of reference light by the interferometer.
  • the sample light enters the signal arm of the interferometer and reaches the human tissue.
  • the multi-point scattered light collected by the MLA-OCT imaging catheter and returned from the human tissue is one Group of scanning light signals, where each single point scattered light is a first light signal, the scanning light signal is a collection of the first light signal of each single point, and the reference light enters the reference arm of the interferometer and reaches the Optical delay line, the light returned by the optical delay line is the second optical signal; the first optical signal and the second optical signal return to the interferometer to interfere to generate an interference signal and send it to the data processing device;
  • the data processing device adjusts the position of the corresponding optical delay line on the reference arm for each optical fiber according to the received signal-to-noise ratio of each interference signal until the signal-to-noise ratio is the highest.
  • the delay of the optical delay line of each optical fiber is The time value is its optical delay line calibration value, and the optical delay line calibration value is stored in the MLA-OCT imaging system;
  • the MLA-OCT system automatically sets the reference arm length based on the pre-stored optical delay line calibration value to detect the interference signal, and the data processing device generates a two-dimensional lumen cross-sectional image of the human tissue based on all the detected interference signals ;
  • the retraction controller activates the MLA-OCT imaging catheter to move axially to perform axial scanning, so as to establish a three-dimensional image of the human tissue.
  • the invention uses microlens arrays, optical fiber bundles, optical fiber array connectors, optical delay line arrays and high-speed optical switches to achieve multi-point imaging signal acquisition, so that the MLA-OCT imaging catheter can acquire two-dimensional images of the lumen without high-speed rotation.
  • the multi-point scattered light scanning light signal of the cross section is used to generate a lumen tomographic image.
  • the rotational movement of the imaging catheter inner tube is omitted, thereby simplifying the lumen OCT imaging process, greatly improving the safety of the lumen imaging process, and reducing the risk of injury to the patient by the imaging catheter during the imaging process .
  • the MLA-OCT imaging catheter does not have high-speed rotation, it also completely eliminates the phenomenon of image distortion caused by the unsynchronized rotation of the proximal and distal ends of the imaging catheter.
  • Figure 1 (a) A schematic diagram of the structure of the MLA-OCT imaging catheter in a specific embodiment of the present invention
  • FIG. 1(b) A schematic diagram of the MLA-OCT imaging catheter rapid exchange tip according to a specific embodiment of the present invention
  • FIG. 2 Schematic diagram of an MLA-OCT imaging system according to an embodiment of the present invention
  • Figure 3(a) A schematic diagram of the structure of the reference arm of the interferometer in the MLA-OCT imaging system according to a specific embodiment of the present invention
  • FIG. 3(b) Schematic diagram of the signal arm structure of the interferometer in the MLA-OCT imaging system according to an embodiment of the present invention
  • Figure 4 is a schematic diagram of the steps of the MLA-OCT imaging method according to a specific embodiment of the present invention
  • FIG. 1(a) is a schematic diagram of the structure of the MLA-OCT imaging catheter 3 according to a specific embodiment of the present invention, which includes an inner tube 5, an outer tube 4 and a multi-core catheter connector 6.
  • the inner tube 5 is located inside the outer tube 4, the inner tube 5 includes an optical fiber bundle 21 and a distal microlens array 7, the optical fiber bundle 21 includes two or more optical fibers, and the microlens array 7 includes two or more Microlens; the proximal end of the outer tube 4 is connected to the withdrawal controller 2 through a multi-core catheter connector 6, and the distal end of the outer tube 4 enters the body lumen.
  • the optical fiber bundle 21 is a high-density optical fiber bundle
  • the multi-core conduit connector 6 is a high-density multi-core conduit connector.
  • the microlens array 7 is a high-density microlens array, and the microlenses can be selected from ball lenses, cylindrical lenses or silicon lenses.
  • the multi-core catheter connector 6 has anti-slip patterns.
  • the distal end of the outer tube 4 is further provided with a transparent imaging window and a quick exchange head end 8, and the quick exchange head end 8 is provided with a developing ring.
  • the transparent imaging window has a high transmittance to light of a specific wavelength, and mainly has the function of transmitting light; the developing ring cannot be penetrated by X-rays, and under its action, it can show the exactness of the catheter in the body. position.
  • Fig. 1(b) is a schematic structural diagram of the rapid exchange tip 8 of the MLA-OCT imaging catheter 3 according to a specific embodiment of the present invention, wherein the rapid exchange tip 8 has a guide wire insertion port, and the guide wire 9 penetrates the rapid exchange tip 8.
  • the MLA-OCT imaging catheter 3 can be pushed to the diseased target area in the patient's lumen along the guide wire 9.
  • FIG. 2 is a schematic diagram of an MLA-OCT imaging system according to a specific embodiment of the present invention, which includes: a host device 1, an MLA-OCT imaging catheter 3, and a withdrawal controller 2.
  • the host device 1 includes a light source 14, an interferometer 15, a photodetector 16, a data acquisition card 17, an imaging host 18, an image processor and a display terminal 19 and so on.
  • the retreat controller 2 and the MLA-OCT imaging catheter 3 are located on the signal arm of the interferometer 15, and the reference arm of the interferometer 15 is provided with an optical delay line array 13.
  • the proximal end of the retreat controller 2 is connected to the interferometer 15, and the distal end is connected to the MLA-OCT imaging catheter 3.
  • the left side of the interferometer 15 is connected to the light source 14, the right side is connected to the photodetector 16, and the output end of the photodetector 16 is connected
  • the output end of the data acquisition card 17 is connected to the imaging host 18, and the output end of the imaging host 18 is connected to the image processor and the display terminal 19.
  • the light source 14 is divided into a beam of sample light and a beam of reference light by the interferometer 15.
  • the sample light enters the signal arm to reach human tissue
  • the reference light enters the reference arm to the optical delay line of the interferometer 15, MLA-OCT
  • the multi-point backscattered light of human tissue collected by the imaging catheter 3 is a set of scanning light signals, where each single-point scattered light is the first light signal, that is, the scanning light signal is the first light signal of each single point
  • the light returned by the optical delay line is the second optical signal.
  • the first optical signal returns to the interferometer 15 from the signal arm, and the second optical signal returns to the interferometer 15 from the reference arm.
  • the generated optical interference signal is detected by the photodetector 16.
  • the photodetector 16 receives the optical interference signal and converts it into an electrical signal and outputs it to the data acquisition card 17.
  • the card 17 converts the automatically collected electrical signal into a digital signal, and the digital signal is stored in the imaging host 18, and the imaging host 18 analyzes and processes the digital signal, so as to obtain corresponding images in the image processor and the display terminal 19.
  • the data processing device generates a two-dimensional lumen cross-sectional image of human tissue according to the interference signals of all single points, and then the withdrawal controller 2 activates the MLA-OCT imaging catheter 3 to move axially to perform axial scanning, Create a three-dimensional image of human tissue.
  • interference may only occur when the optical paths of the reference arm and the sample arm match within the coherence length of the light source 14.
  • the MLA-OCT imaging system further includes a retracement closed-loop monitoring 20, which is electrically connected to the retracement controller 2, the photodetector 16, and the imaging host 18, for forming MLA-
  • the closed-loop control of the retraction of the OCT imaging catheter 3 prevents the occurrence of forced retraction of the imaging catheter.
  • the light source 14 may be a high-coherence light source such as a laser, or a low-coherence light source such as a superluminescent diode.
  • the optical delay line array 13 is a high-density delay line array.
  • Fig. 3(a) is a schematic diagram of the reference arm structure of the interferometer 15 in the MLA-OCT imaging system according to a specific embodiment of the present invention.
  • the reference arm is provided with a second high-speed optical switch 22 and an optical delay line containing two or more Optical delay line array 13.
  • the optical fiber bundle 21 includes N (N takes an integer greater than 1) optical fibers
  • the second high-speed optical switch 22 is a 1xN high-speed optical switch
  • the optical delay line array 13 includes N optical delay lines .
  • 1xN high-speed optical switch is a functional switch with the function of switching optical paths. 1 represents the number of input optical signal channels, N represents the number of output optical signal channels, and 1xN represents the output signal that can switch the input signal from 1 channel to N channels.
  • the adjustment speed of the optical delay line can exceed the speed of the second high-speed optical switch 22, only one optical delay line may be provided, and the second high-speed optical switch 22 does not need to be provided, thereby simplifying the setting of the reference arm.
  • Fig. 3(b) is a schematic diagram of the signal arm structure of the interferometer 15 in the MLA-OCT imaging system according to a specific embodiment of the present invention.
  • the retreat controller 2 located on the signal arm includes: a stepping motor 10, The first high-speed optical switch 12, the optical fiber bundle 21 and the optical fiber array connector 11; the proximal end of the retreat controller 2 is connected to the interferometer 15, and the optical fiber array connector 11 at the distal end of the retreat controller 2 and the multi-core catheter connector 6 Connected so that the withdrawal controller 2 is connected to the MLA-OCT imaging catheter 3.
  • the optical fiber bundle 21 includes N (N takes an integer greater than 1) optical fibers, the first high-speed optical switch 12 is a 1xN high-speed optical switch, and the optical fiber array connector 11 is an N optical fiber array Connector.
  • the MLA-OCT imaging method includes the following steps:
  • the MLA-OCT imaging catheter 3 is connected to the withdrawal controller 2 through the multi-core catheter connector 6, ready for calibration;
  • the light source 14 is divided into a beam of sample light and a beam of reference light by the interferometer 15.
  • the sample light enters the signal arm of the interferometer 15 and reaches the human body tissue, and the scattered light from the N points returned from the human body tissue is a group Scanning light signal, wherein each single point scattered light is a first light signal, and the scanning light signal is a collection of first light signals of each single point, and the reference light enters the reference arm of the interferometer 15 and reaches the interferometer 15
  • the light returned by the optical delay line is the second optical signal; the first optical signal and the second optical signal are returned to the interferometer 15 for coherent detection to generate an interference signal, and the interference signal is sent to the data processing device;
  • the data processing device adjusts the position of the corresponding optical delay line on the reference arm for each optical fiber according to the received signal-to-noise ratio of each interference signal until the interference signal has the highest signal-to-noise ratio.
  • the delay time value of the optical delay line is its optical delay line calibration value, and the optical delay line calibration value is stored in the MLA-OCT imaging system;
  • the MLA-OCT system automatically sets the reference arm length based on the prestored optical delay line calibration value to detect the interference signal, and the imaging host 18 generates a two-dimensional lumen cross-sectional image of the human tissue according to all the detected interference signals;
  • the withdrawal controller 2 actuates the MLA-OCT imaging catheter 3 to move axially for axial scanning, and the imaging host 18 generates a series of two-dimensional luminal cross-sectional images of the human tissue, thereby obtaining a three-dimensional image of the human tissue Space image.
  • step S1 is: inserting the multi-core catheter connector 6 at the proximal end of the MLA-OCT imaging catheter 3 into the optical fiber array connector 11 on the retraction controller 2 to prepare for calibration;
  • step S3 is: the first high-speed optical switch 12 and the second high-speed optical switch 22 are both 1xN high-speed optical switches, and the two are synchronously linked, that is, the first output signal of the first high-speed optical switch 12 The channel is opened synchronously with the first output signal channel of the second high-speed optical switch 22, and the second output signal channel of the first high-speed optical switch 12 is opened synchronously with the second output signal channel of the second high-speed optical switch 22.
  • the Nth output signal channel of the first high-speed optical switch 12 and the Nth output signal channel of the second high-speed optical switch 22 are opened synchronously.
  • the position M of each two corresponding output signal channels corresponds to a microlens M in the microlens array at the head end of the inner tube 5 of the MLA-OCT imaging catheter 3, an optical fiber bundle 21, and an optical fiber M in the optical fiber array connector 11 ,
  • An optical delay line M of the optical delay line array 13 the imaging host 18 adjusts the position of the optical delay line M according to the signal-to-noise ratio and imaging quality of the received interference signal until the signal-to-noise ratio is the largest and the imaging quality is the best.
  • the delay time value of the optical delay line M is set as the calibration value CV-M of the microlens M/optical fiber M/optical delay line M of the MLA-OCT imaging catheter 3.
  • the output signal channel of the first high-speed optical switch 12 is from 1 to N, synchronously, the output signal channel of the second high-speed optical switch 22 is also from 1 to N, and the calibration value CV corresponding to all lenses/fibers/optical delay lines is obtained.
  • CV-2,..., CV-N set all optical delay lines to their calibration values and store them in the MLA-OCT imaging system.
  • step S3 is: the data processing device adjusts the position of the optical delay line on the reference arm according to the signal-to-noise ratio of the received interference signal until the signal-to-noise ratio is the highest.
  • the delay time of the optical delay line The value of the optical delay line calibration value is the same as the above operation. For each optical fiber, the position of the optical delay line is adjusted once to obtain the corresponding optical delay line calibration value. Finally, the light corresponding to N lenses/N fibers The N calibration values of the delay line are stored in the MLA-OCT imaging system.
  • step S4 is: sending the MLA-OCT imaging catheter 3 along the PCI guiding catheter and the guide wire 9 to the distal end of the luminal lesion 5mm-10mm, the MLA-OCT system is based on the pre-stored optical delay The line calibration value automatically sets the reference arm length. Subsequently, if it is intravascular, the contrast agent is injected to flush out the blood, and the MLA-OCT imaging catheter 3 starts to be withdrawn while imaging; if it is a non-vascular lumen, the MLA-OCT imaging catheter 3 can be directly withdrawn while imaging. During imaging, the MLA-OCT imaging catheter 3 does not need to make any rotational movement.
  • the first high-speed optical switch 12 and the second high-speed optical switch 22 are both 1xN high-speed optical switches.
  • the emission and collection of the first optical signal and the second optical signal are performed by
  • the first high-speed optical switch 12 and the second high-speed optical switch 22 are synchronously linked, and are sequentially connected to the microlens M at the far end of the inner tube 5, the optical fiber M in the optical fiber bundle 21, and the optical delay line M in the optical delay line array 13.
  • the output signal channel of the optical switch 12 and the output signal channel of the second high-speed optical switch 22 are synchronized from 1 to N to obtain the first optical signal of N scanned human tissues, that is, a set of scanning optical signals.
  • the imaging host 18 This generates a two-dimensional lumen cross-sectional image.
  • step S5 the withdrawal controller 2 actuates the MLA-OCT imaging catheter 3 to move axially for axial scanning, and then the imaging host 18 generates a series of two-dimensional luminal cross-sectional images of human tissues. This obtains a three-dimensional image of human tissue.

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Abstract

一种MLA‑OCT成像导管（3）、MLA‑OCT成像导管校准方法、MLA‑OCT成像系统及其成像方法。MLA‑OCT成像导管（3）包括内管（5）、外管（4）和多芯导管连接头（6），内管（5）包括光纤束（21）和微透镜阵列（7）。MLA‑OCT成像系统中，光源（14）通过干涉仪（15）分为样品光和参考光，样品光进入信号臂到达人体组织，参考光进入参考臂到达光延迟线，两处返回的光分别为第一和第二光信号，参考臂设光延迟线装置。MLA‑OCT成像方法包括：数据处理装置根据干涉信号的信噪比，调整光延迟线位置，直到信噪比最高，此时每根光纤的光延迟线的延迟时间值为其光延迟线校准值，并存入MLA‑OCT系统；MLA‑OCT系统基于光延迟线校准值自动设置参考臂臂长，以检测干涉信号；回撤控制器致动MLA‑OCT成像导管（3）轴向移动进行轴向扫描，以建立人体组织的三维空间图像。

Description

MLA-OCT成像导管、MLA-OCT成像系统及MLA-OCT成像方法 技术领域
本发明涉及医疗内窥检测技术领域，尤其涉及一种MLA-OCT成像导管、MLA-OCT成像系统及MLA-OCT成像方法。
背景技术
冠状动脉疾病是全世界导致死亡的头号原因。由于动脉粥样硬化斑块的堆积、破裂和血栓，冠状动脉疾病能引起胸痛(心绞痛)，心肌缺血和心源性猝死。对于那些没有猝死或有慢性心绞痛症状的病人，合适斑块的治疗包括PCI(Percutaneous Coronary Intervention，经皮冠状动脉介入手术)。心脏介入专家通过PCI手术放置支架处理病变，但近年来不少研究结果认为心脏支架被滥用，或至少过度使用引发很多争议，医生在考虑只使用支架时更加谨慎和挑剔。此外由于成本较低的药物治疗已被引入到市场，研究发现它们也是有效的。在治疗病情稳定的冠心病患者时我们已经看到了支架置入术的温和下降。然而目前，三种新的血管成像/测量设备和耗材：1)血管内超声、2)OCT(Optical Coherence Tomography，光学相干层析技术)和3)血流储备分数技术，能准确地帮助医生为每一个病人术前评估是否支架置入及术后评估，在冠心病变检查中起到越来越重要的作用。
现有商用血管内IV-OCT(Intravascular Optical Coherence Tomographic)成像系统包括主机设备、成像导管以及连接两者的回撤控制器，回撤控制器的近端通过光纤与干涉仪相连接，远端通过导管连接头与成像导管相连。主机设备包括激光器、干涉仪、光电探测器、数据采集卡、成像主机以及图像处理器和显示终端等。其中，干涉仪承载成像系统的最核心部件：干涉仪左路是激光输入，右路是光信号输出，上面是包含可调光延迟线(VODL)的参考臂，下面是包括回撤控制器和成像导管的信号臂。
现有的IV-OCT成像系统的干涉仪的参考臂上有可调光延迟线，信号臂上有成像导管和回撤控制器，回撤控制器里有控制回撤的步进电机、控制 高速旋转的伺服电机和光纤滑环。OCT成像技术的核心是依靠位于干涉仪信号臂上的成像导管发射激光并且采集人体组织的返回的散射光，与干涉仪参考臂的光信号干涉做相干检测，成像主机基于检测该干涉信号的包络，生成腔管图像。参考臂光程必须与信号臂的实际光程非常接近，才能得到高质量的相干检测。因为实际产品中，不同成像导管的长度会略有差异，所以OCT系统在干涉仪参考臂上设有一个可调光延迟线，根据信号臂上不同导管长度引起的光程变化，参考臂调整光延迟线来匹配，确保最佳干涉性能。在这里，参考臂和信号臂的主光路都是单根光纤，对应成像导管内管头端的单个微透镜。环腔管扫描由回撤控制器里的伺服电机、光纤滑环和成像导管内管外的力矩套管带动单个微透镜高速旋转完成。
IV-OCT成像系统具体成像过程是：将成像导管沿着导丝送到血管内病变的远端，超出病变范围约5mm以上，然后回撤控制器致动成像导管回撤后退，对整个病变区域进行扫描。回撤过程一般是1-7秒，回撤距离是50-150mm。这期间成像导管的外管不动，回撤控制器的伺服电机(即旋转电机)和直线电机(即步进电机)控制成像导管的内管在高速旋转的同时后退回撤，对血管内组织进行螺旋式点扫描，采集血管组织各点返回的散射光信号，内管后退到设定的产品回撤距离比如50mm时，两个电机停止，扫描结束，主机设备根据检测到的各点返回的散射光信号，生成完整的血管组织病变图像。
实现这种IV-OCT成像方法的成像导管包括外管、内管和导管连接头，内管包括光纤和微透镜，光纤外部设有力矩套管；外管远端是采用PCI介入手术导管常用的快速交换头端(Rapid Exchange,Rx)设计，医生首先在病人体外把成像导管从快速交换头端穿上指引导丝，然后沿着指引导丝在病人血管内把成像导管推送到病变靶区。进行OCT成像的时候，成像导管的外管不动，快速交换头端穿着的导丝也不动，只有内管高速旋转并回撤。如果内管旋转不均匀平稳，可能碰撞摩擦外管内壁，引起外管抖动，从而带动外管快速交换头端的导丝抖动，严重时会发生导丝与成像导管缠绕，伤害病人。这是目前产品的一个潜在安全风险。
其次，这种商用IV-OCT成像方法因为是基于机械旋转微透镜实现侧向扫描腔管组织，它必须保证成像导管远端的微透镜旋转均匀才能获得不失真的精准图像。过程是：位于回撤控制器内的伺服电机的高速转动，通过 导内管外的力矩套管带动远端微透镜高速转动，从而带动微透镜扫描光束高速转动、实现侧向环腔管扫描目标组织，同时，也高速采集到相应的环腔管的目标组织返回的散射光。精准的图像生成基于微透镜转速、伺服电机转速和光源扫频速度的精准同步，如果近端电机旋转与透镜光点旋转不同步，图像就会出现失真。因为导管是顺着人体自腔管，包括但不限于血管，接近体内病变区域，这些腔管形态各异各有弯曲，成像导管弯曲后很容易造成成像导管远近两端旋转不同步，因此，图像失真是腔管IV-OCT成像精准的一大挑战。
发明内容
如上所述，现有技术中的OCT成像导管如果内管旋转不均匀平稳，可能碰撞摩擦外管内壁，引起外管抖动，从而带动外管快速交换头端的导丝抖动，严重时会发生导丝与成像导管缠绕，伤害病人。此外，成像导管弯曲后很容易造成远近两端旋转不同步从而导致腔管OCT成像所获得的图像失真。
为解决上述问题，本发明的主要目的在于提供一种新型腔管光学相干断层MLA-OCT(Micro-lens Array Optical Coherence Tomography，微透镜阵列光学相干断层成像)成像方法，完全排除目前商用腔管IV-OCT成像方法所必须的成像导管内管的旋转运动，以便降低回撤过程中成像导管伤害病人的风险，并且避免因为成像导管远近两端旋转不同步而产生的图像失真。
为实现上述目的，本发明提供的技术方案如下：
在本发明的第一方面，一种MLA-OCT成像导管，其包括内管、外管和多芯导管连接头，其中，
所述内管位于所述外管内部；
所述内管包括光纤束和微透镜阵列，所述光纤束包括两根或以上光纤，所述微透镜阵列包括两个或以上微透镜，所述微透镜阵列位于所述光纤束的远端；
所述外管近端通过多芯导管连接头连接用于驱动MLA-OCT成像导管回撤的回撤控制器。
在所述的MLA-OCT成像导管中，所述外管远端设有快速交换头端， 快速交换头端上设有显影环和导丝出入口。
在所述的MLA-OCT成像导管中，所述外管远端设有透明的成像窗。
在所述的MLA-OCT成像导管中，所述多芯导管连接头具有防滑纹。
根据本发明的另一方面，一种MLA-OCT成像系统，其包括：主机设备、回撤控制器以及如前所述的MLA-OCT成像导管，其中，
所述主机设备包括光学装置和数据处理装置，所述光学装置包括光源和干涉仪；干涉仪的信号臂上设有回撤控制器和MLA-OCT成像导管，干涉仪的参考臂上设有光延迟线；所述光源通过干涉仪分为一束样品光和一束参考光，所述样品光进入干涉仪的信号臂到达人体组织，MLA-OCT成像导管采集的从人体组织返回的多点散射光为一组扫描光信号，其中每个单点散射光为第一光信号，所述扫描光信号为每个单点的第一光信号的集合，所述参考光进入干涉仪的参考臂到达干涉仪的光延迟线，光延迟线返回的光为第二光信号；第一光信号与第二光信号回到干涉仪内发生干涉以产生干涉信号，并发送到数据处理装置；
所述回撤控制器包括步进电机、第一高速光开关、光纤束和光纤阵列连接头；回撤控制器近端与干涉仪连接，远端通过多芯导管连接头与MLA-OCT成像导管连接，回撤控制器致动所述MLA-OCT成像导管轴向移动进行轴向扫描，以建立组织的空间图像。
在所述的MLA-OCT成像系统中，所述数据处理装置包括：光电探测器、数据采集卡、成像主机、图像处理器和显示终端。
在所述的MLA-OCT成像系统中，所述主机设备包括回撤闭环监控。
在所述的MLA-OCT成像系统中，所述参考臂设有第二高速光开关和包含两个或以上光延迟线的光延迟线阵列；可选地，所述参考臂设有一个光延迟线。
根据本发明的另一方面，一种所述MLA-OCT成像系统中的MLA-OCT成像导管的校准方法，其包括：将含有光纤束的MLA-OCT成像导管接入回撤控制器后，数据处理装置根据接收的接收的干涉信号的信噪比，针对每根光纤调整参考臂上对应的光延迟线的位置，直到信噪比最高，此时每根光纤的光延迟线的延迟时间值为其光延迟线校准值。
根据本发明的又一方面，一种应用所述MLA-OCT成像系统的MLA-OCT成像方法，其包括下述步骤：
MLA-OCT成像导管通过多芯导管连接头连接所述回撤控制器；
所述光源通过干涉仪分为一束样品光和一束参考光，所述样品光进入干涉仪的信号臂到达人体组织，MLA-OCT成像导管采集的从人体组织返回的多点散射光为一组扫描光信号，其中每个单点散射光为第一光信号，所述扫描光信号为每个单点的第一光信号的集合，所述参考光进入干涉仪的参考臂到达干涉仪的光延迟线，光延迟线返回的光为第二光信号；第一光信号与第二光信号回到干涉仪内发生干涉以产生干涉信号，并发送到数据处理装置；
所述数据处理装置根据接收的每个干涉信号的信噪比，针对每根光纤调整参考臂上对应的光延迟线的位置，直到信噪比最高，此时每根光纤的光延迟线的延迟时间值为其光延迟线校准值，将光延迟线校准值存入MLA-OCT成像系统；
所述MLA-OCT系统基于预存的光延迟线校准值自动设置参考臂臂长，以检测所述干涉信号，所述数据处理装置根据检测到的所有干涉信号，生成人体组织二维腔管截面图像；
所述回撤控制器致动所述MLA-OCT成像导管轴向移动进行轴向扫描，以建立人体组织的三维空间图像。
发明的效果
本发明采用微透镜阵列、光纤束、光纤阵列连接头、光延迟线阵列和高速光开关来实现多点成像信号采集，使得MLA-OCT成像导管不需要高速旋转便能够采集到腔管的二维截面的多点散射光的扫描光信号，据此生成腔管断层图像。与现有技术比较，省去了成像导管内管的旋转运动，由此简化了腔管OCT成像过程，极大地提高了腔管成像过程的安全性，降低了成像过程中成像导管伤害病人的风险。并且，由于MLA-OCT成像导管没有高速旋转运动，也彻底消除了由于成像导管近远两端旋转不同步造成的图像失真的现象。
附图说明
图1(a)本发明一个具体实施方式的MLA-OCT成像导管结构示意图
图1(b)本发明一个具体实施方式的MLA-OCT成像导管快速交换头 端示意图
图2本发明一个具体实施方式的MLA-OCT成像系统示意图
图3(a)本发明一个具体实施方式的MLA-OCT成像系统中干涉仪参考臂结构示意图
图3(b)本发明一个具体实施方式的MLA-OCT成像系统中干涉仪信号臂结构示意图
图4本发明一个具体实施方式的MLA-OCT成像方法的步骤示意图
符号说明
1主机设备                       12第一高速光开关
2回撤控制器                     13光延迟线阵列
3 MLA-OCT成像导管               14光源
4外管                           15干涉仪
5内管                           16光电探测器
6多芯导管连接头                 17数据采集卡
7微透镜阵列                     18成像主机
8快速交换头端                   19图像处理器和显示终端
9导丝                           20回撤闭环监控
10步进电机                      21光纤束
11光纤阵列连接头                22第二高速光开关
具体实施方式
为了能够使得本发明的技术手段更加清楚明白，达到本领域技术人员可依照说明书的内容予以实施的程度，并且为了能够让本发明的上述目的、特征和优点能够更明显易懂，下面将参照附图更详细地描述本发明的具体实施方式。
需要说明的是，在说明书及权利要求当中使用了某些词汇来指称特定组件。本领域技术人员应可以理解，技术人员可能会用不同名词来称呼同一个组件。本说明书及权利要求并不以名词的差异来作为区分组件的方式，而是以组件在功能上的差异来作为区分的准则。如在通篇说明书及权利要求当中所提及的“包含”或“包括”为一开放式用语，故应解释成“包含但 不限定于”。说明书后续描述为实施本发明的较佳实施方式，然所述描述乃以说明书的一般原则为目的，并非用以限定本发明的范围。本发明的保护范围当视所附权利要求所界定者为准。
图1(a)为本发明一个具体实施方式的MLA-OCT成像导管3结构示意图，其包括内管5、外管4和多芯导管连接头6。其中，内管5位于外管4内部，内管5包括光纤束21和远端的微透镜阵列7，所述光纤束21包括两根或以上光纤，所述微透镜阵列7包括两个或以上微透镜；所述外管4近端通过多芯导管连接头6连接回撤控制器2，外管4远端进入人体腔管。
在一个具体的实施方式中，所述光纤束21为高密度光纤束，所述多芯导管连接头6为高密度多芯导管连接头。
在一个具体实施方式中，所述微透镜阵列7为高密度微透镜阵列，所述微透镜可以选自球透镜、柱透镜或硅透镜。
在一个具体的实施方式中，所述多芯导管连接头6具有防滑纹。
在一个具体的实施方式中，所述外管4远端还设有透明的成像窗和快速交换头端8，快速交换头端8上设有显影环。所述的透明成像窗对特定波段的光具有较高的透过率，主要有传递光的作用；所述显影环不能被X射线所穿透，在其作用下可以显示出导管在体内的确切位置。
图1(b)为本发明一个具体实施方式的MLA-OCT成像导管3的快速交换头端8结构示意图，其中，快速交换头端8具有导丝穿入口，导丝9穿入快速交换头端8，可以沿着导丝9在病人腔管内将MLA-OCT成像导管3推送到病变靶区。
图2为本发明一个具体实施方式的MLA-OCT成像系统示意图，其包括：主机设备1、MLA-OCT成像导管3以及回撤控制器2。其中，主机设备1包括光源14、干涉仪15、光电探测器16、数据采集卡17、成像主机18以及图像处理器和显示终端19等。回撤控制器2和MLA-OCT成像导管3位于干涉仪15的信号臂上，干涉仪15的参考臂上设有光延迟线阵列13。回撤控制器2近端与干涉仪15连接，远端与MLA-OCT成像导管3连接，干涉仪15左路与光源14连接，右路与光电探测器16连接，光电探测器16输出端连接数据采集卡17，数据采集卡17输出端连接成像主机18，成像主机18输出端连接图像处理器和显示终端19。
其中，光源14通过干涉仪15分为一束样品光和一束参考光，所述样 品光进入信号臂到达人体组织，所述参考光进入参考臂到达干涉仪15的光延迟线，MLA-OCT成像导管3采集到的人体组织多点背向散射光为一组扫描光信号，其中每个单点散射光为第一光信号，即所述扫描光信号为每个单点的第一光信号的集合，光延迟线返回的光为第二光信号，第一光信号由信号臂返回到干涉仪15，第二光信号由参考臂返回到干涉仪15，当第一光信号与第二光信号在干涉仪15内发生干涉时，产生的光学干涉信号被光电探测器16探测到，光电探测器16接收到所述光学干涉信号并将其转换成电信号输出到数据采集卡17，数据采集卡17将自动采集到的电信号转换为数字信号，所述数字信号储存到成像主机18中，成像主机18对数字信号进行分析处理，从而在图像处理器和显示终端19获得相应图像。所述数据处理装置根据所有单点的干涉信号，生成人体组织二维腔管截面图像，随后所述回撤控制器2致动所述MLA-OCT成像导管3轴向移动进行轴向扫描，以建立人体组织的三维空间图像。其中，只有当参考臂和样品臂的光程在光源14的相干长度内匹配才可能发生干涉。
在一个具体实施方式中，所述MLA-OCT成像系统还包括回撤闭环监控20，回撤闭环监控20与回撤控制器2、光电探测器16以及成像主机18电连接，用于形成MLA-OCT成像导管3回撤的闭环控制，防止成像导管强行回撤的发生。
在一个具体实施方式中，所述光源14可以为激光等高相干性光源，也可以为超辐射发光二极管等低相干光源。
在一个具体实施方式中，所述光延迟线阵列13为高密度延迟线阵列。
图3(a)是本发明一个具体实施方式的MLA-OCT成像系统中干涉仪15的参考臂结构示意图，所述参考臂设有第二高速光开关22和包含两个或以上光延迟线的光延迟线阵列13。
在一个具体实施方式中，所述光纤束21包括N(N取大于1的整数)根光纤，所述第二高速光开关22为1xN高速光开关，光延迟线阵列13包括N个光延迟线。1xN高速光开关是一种具有切换光路作用的功能开关，1代表输入光信号通道数，N代表输出光信号通道数，1xN表示可以将输入的1个通道信号切换到N个通道的输出信号。
在一个可选的实施方式中，如果光延迟线调整速度能超过第二高速光开关22速度，可以只设置一个光延迟线，不需要设置第二高速光开关22， 从而简化参考臂的设置。
图3(b)是本发明一个具体实施方式的MLA-OCT成像系统中干涉仪15的信号臂结构示意图，如图所示，位于信号臂上的回撤控制器2包括：步进电机10、第一高速光开关12、光纤束21和光纤阵列连接头11；回撤控制器2近端与干涉仪15连接，回撤控制器2远端的光纤阵列连接头11与多芯导管连接头6相连接，从而使得回撤控制器2与MLA-OCT成像导管3连接。
在一个具体实施方式中，所述光纤束21包括N(N取大于1的整数)根光纤，所述第一高速光开关12为1xN高速光开关，所述光纤阵列连接头11为N光纤阵列连接头。
图4为本发明一个具体实施方式的MLA-OCT成像方法的步骤示意图，如图所示，MLA-OCT成像方法包括如下步骤：
S1：MLA-OCT成像导管3通过多芯导管连接头6连接所述回撤控制器2，准备校准；
S2：所述光源14通过干涉仪15分为一束样品光和一束参考光，所述样品光进入干涉仪15的信号臂到达人体组织，从人体组织返回的N点散射光为为一组扫描光信号，其中每个单点散射光为第一光信号，所述扫描光信号为每个单点的第一光信号的集合，所述参考光进入干涉仪15的参考臂到达干涉仪15的光延迟线，光延迟线返回的光为第二光信号；第一光信号与第二光信号回到干涉仪15内进行相干检测以产生干涉信号，所述干涉信号发送到数据处理装置；
S3：所述数据处理装置根据接收的各个干涉信号的信噪比，针对每根光纤调整参考臂上对应的光延迟线的位置，直到该干涉信号的信噪比最高，此时每根光纤的光延迟线的延迟时间值为其光延迟线校准值，将光延迟线校准值存入MLA-OCT成像系统；
S4：所述MLA-OCT系统基于预存的光延迟线校准值自动设置参考臂臂长，以检测所述干涉信号，成像主机18根据检测到的所有干涉信号生成人体组织二维腔管截面图像；
S5：所述回撤控制器2致动所述MLA-OCT成像导管3轴向移动进行轴向扫描，进而成像主机18生成一系列人体组织二维腔管截面图像，由此得到人体组织的三维空间图像。
在一个具体的实施方式中，步骤S1为：MLA-OCT成像导管3近端的多芯导管连接头6插入回撤控制器2上的光纤阵列连接头11，准备校准；
在一个具体的实施方式中，步骤S3为：第一高速光开关12和第二高速光开关22都为1xN高速光开光，两者同步联动，即第一高速光开关12的第1个输出信号通道与第二高速光开关22的第1个输出信号通道同步打开，第一高速光开关12的第2个输出信号通道与第二高速光开关22的第2个输出信号通道同步打开，以此类推，第一高速光开关12的第N个输出信号通道与第二高速光开关22的第N个输出信号通道同步打开。每两个相对应的输出信号通道的位置M对应MLA-OCT成像导管3的内管5头端的微透镜阵列中的一个微透镜M、光纤束21和光纤阵列连接头11中的一根光纤M、光延迟线阵列13的一个光延迟线M，成像主机18根据接收的干涉信号的信噪比和成像质量调整光延迟线M的位置，直到信噪比最大、成像质量最佳，此时的光延迟线M的延迟时间值定为所述MLA-OCT成像导管3的微透镜M/光纤M/光延迟线M的校准值CV-M。第一高速光开关12的输出信号通道从1打到N，同步地，第二高速光开关22的输出信号通道也从1打到N，获得对应所有透镜/光纤/光延迟线的校准值CV-1、CV-2、...、CV-N，设置所有光延迟线于其校准值，并存入MLA-OCT成像系统。
在一个可选的实施方式中，如果光延迟线调整速度能超过第二高速光开关22速度，可以用一个光延迟线来实时对应N个微透镜/N根光纤，参考臂不需要设置第二高速光开关22，此时，步骤S3为：所述数据处理装置根据接收的干涉信号的信噪比，调整参考臂上光延迟线的位置，直到信噪比最高，此时光延迟线的延迟时间值为其光延迟线校准值，同上述操作，针对每根光纤，分别进行一次光延迟线位置的调整，得到对应的光延迟线校准值，最后将该对应N个透镜/N根光纤的光延迟线的N个校准值存入MLA-OCT成像系统。
在一个具体的实施方式中，步骤S4为：将MLA-OCT成像导管3沿PCI指引导管和导丝9送到腔管病变远端5mm～10mm处，所述MLA-OCT系统基于预存的光延迟线校准值自动设置参考臂臂长。随后，如果是血管内，打入造影剂冲开血液，MLA-OCT成像导管3开始边回撤边成像；如果是其它非血管腔管，MLA-OCT成像导管3可以直接边回撤边成像。成 像时，MLA-OCT成像导管3不需要做任何旋转运动，第一高速光开关12和第二高速光开关22都为1xN高速光开关，第一光信号和第二光信号的发射和采集由第一高速光开关12和第二高速光开关22同步联动、依次连接内管5远端的微透镜M、光纤束21中的光纤M和光延迟线阵列13中的光延迟线M，第一高速光开关12的输出信号通道与第二高速光开关22的输出信号通道同步地从1打到N，获得N个扫描的人体组织的第一光信号，即一组扫描光信号，成像主机18据此生成二维腔管截面图像。随后，在步骤S5中，所述回撤控制器2致动所述MLA-OCT成像导管3轴向移动进行轴向扫描，进而成像主机18生成一系列人体组织的二维腔管截面图像，由此得到人体组织的三维空间图像。
尽管以上结合附图对本发明的实施方案进行了描述，但本发明并不局限于上述的具体实施方案和应用领域，上述的具体实施方案仅仅是示意性的、指导性的，而不是限制性的。本领域的普通技术人员在本说明书的启示下和在不脱离本发明权利要求所保护的范围的情况下，还可以做出很多种的形式，这些均属于本发明保护之列。

Claims (10)

  1. 一种MLA-OCT成像导管，其包括内管、外管和多芯导管连接头，其中，
    所述内管位于所述外管内部；
    所述内管包括光纤束和微透镜阵列，所述光纤束包括两根或以上光纤，所述微透镜阵列包括两个或以上微透镜，所述微透镜阵列位于所述光纤束的远端；
    所述外管近端通过多芯导管连接头连接用于驱动MLA-OCT成像导管回撤的回撤控制器。
  2. 根据权利要求1所述的MLA-OCT成像导管，其中，所述外管远端设有快速交换头端，快速交换头端上设有显影环和导丝出入口。
  3. 根据权利要求1所述的MLA-OCT成像导管，其中，所述外管远端设有透明的成像窗。
  4. 根据权利要求1所述的MLA-OCT成像导管，其中，所述多芯导管连接头具有防滑纹。
  5. 一种MLA-OCT成像系统，其包括：主机设备、回撤控制器以及如权利要求1～4中任一项所述的MLA-OCT成像导管，其中，
    所述主机设备包括光学装置和数据处理装置，所述光学装置包括光源和干涉仪；干涉仪的信号臂上设有回撤控制器和MLA-OCT成像导管，干涉仪的参考臂上设有光延迟线；所述光源通过干涉仪分为一束样品光和一束参考光，所述样品光进入干涉仪的信号臂到达人体组织，MLA-OCT成像导管采集的从人体组织返回的多点散射光为一组扫描光信号，其中每个单点散射光为第一光信号，所述扫描光信号为每个单点的第一光信号的集合，所述参考光进入干涉仪的参考臂到达干涉仪的光延迟线，光延迟线返回的光为第二光信号；第一光信号与第二光信号回到干涉仪内发生干涉以产生干涉信号，并发送到数据处理装置；
    所述回撤控制器包括步进电机、第一高速光开关、光纤束和光纤阵列连接头；回撤控制器近端与干涉仪连接，远端通过多芯导管连接头与MLA-OCT成像导管连接，回撤控制器致动所述MLA-OCT成像导管轴向移动进行轴向扫描，以建立组织的三维空间图像。
  6. 根据权利要求5所述的MLA-OCT成像系统，其中，
    所述数据处理装置包括：光电探测器、数据采集卡、成像主机、图像处理器和显示终端。
  7. 根据权利要求5或6所述的MLA-OCT成像系统，其中，所述主机设备包括回撤闭环监控。
  8. 根据权利要求5～7中任一项所述的MLA-OCT成像系统，其中，所述参考臂设有第二高速光开关和包含两个或以上光延迟线的光延迟线阵列；可选地，所述参考臂设有一个光延迟线。
  9. 一种如权利要求5～8中任一项所述的MLA-OCT成像系统中的MLA-OCT成像导管的校准方法，其包括：将含有光纤束的MLA-OCT成像导管接入回撤控制器后，数据处理装置根据接收的干涉信号的信噪比，针对每根光纤调整参考臂上对应的光延迟线的位置，直到信噪比最高，此时每根光纤的光延迟线的延迟时间值为其光延迟线校准值。
  10. 一种应用如权利要求5～8中任一项所述的MLA-OCT成像系统的MLA-OCT成像方法，其包括下述步骤：
    MLA-OCT成像导管通过多芯导管连接头连接所述回撤控制器；
    所述光源通过干涉仪分为一束样品光和一束参考光，所述样品光进入干涉仪的信号臂到达人体组织，MLA-OCT成像导管采集的从人体组织返回的多点散射光为一组扫描光信号，其中每个单点散射光为第一光信号，所述扫描光信号为每个单点的第一光信号的集合，所述参考光进入干涉仪的参考臂到达干涉仪的光延迟线，光延迟线返回的光为第二光信号；第一光信号与第二光信号回到干涉仪内发生干涉以产生干涉信号，并发送到数据处理装置；
    所述数据处理装置根据接收的每个干涉信号的信噪比，针对每根光纤调整参考臂上对应的光延迟线的位置，直到信噪比最高，此时每根光纤的光延迟线的延迟时间值为其光延迟线校准值，将光延迟线校准值存入MLA-OCT成像系统；
    所述MLA-OCT系统基于预存的光延迟线校准值自动设置参考臂臂长，以检测所述干涉信号，所述数据处理装置根据检测到的所有干涉信号，生成人体组织二维腔管截面图像；
    所述回撤控制器致动所述MLA-OCT成像导管轴向移动进行轴向扫 描，以建立人体组织的三维空间图像。
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113413139A (zh) * 2021-06-22 2021-09-21 中山大学中山眼科中心南昌眼科医院 一种基于光学相干弹性成像图像融合装置
CN117146700A (zh) * 2023-10-30 2023-12-01 天津恒宇医疗科技有限公司 一种oct设备光程校准方法、装置和oct设备

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN210043982U (zh) * 2019-03-26 2020-02-11 苏州阿格斯医疗技术有限公司 微透镜阵列光学相干断层成像导管及其成像系统
CN111012369B (zh) * 2019-12-19 2023-07-04 武汉阿格斯科技有限公司 成像导管同步信号控制方法、系统以及控制器和介质
CN114129137B (zh) * 2021-12-02 2022-09-09 深圳先进技术研究院 一种血管内成像系统、装置以及成像方法
CN114203838B (zh) * 2021-12-10 2024-03-29 中国电子科技集团公司第四十四研究所 一种集成侧向探测器的超辐射发光二极管芯片及制备方法

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1780584A (zh) * 2003-04-28 2006-05-31 德州系统大学董事会 导管成像探测器和方法
CN101247753A (zh) * 2005-06-06 2008-08-20 德州系统大学董事会 使用光谱分辨带宽的光学相干层析成像（oct）
US20120158015A1 (en) * 2003-07-15 2012-06-21 The Trustees Of Columbia University In The City Of New York Insertable device and system for minimal access procedure
CN107752985A (zh) * 2017-11-17 2018-03-06 苏州阿格斯医疗技术有限公司 Oct成像方法、oct成像导管及oct系统
US20180084981A1 (en) * 2016-09-23 2018-03-29 Canon Usa Inc. Spectrally encoded endoscopy apparatus and methods
CN109893099A (zh) * 2019-03-26 2019-06-18 苏州阿格斯医疗技术有限公司 Mla-oct成像导管、mla-oct成像系统及mla-oct成像方法

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7417740B2 (en) * 2004-11-12 2008-08-26 Medeikon Corporation Single trace multi-channel low coherence interferometric sensor
DE102005045088B4 (de) * 2005-09-21 2007-05-16 Siemens Ag Optisches Kohärenztomographie-System
AU2007275018A1 (en) * 2006-07-21 2008-01-24 Oncoscope, Inc. Protective probe tip, particularly for use on a fiber-optic probe used in an endoscopic application
JP5236573B2 (ja) * 2009-05-14 2013-07-17 富士フイルム株式会社 光構造計測装置及びその光プローブ
CN104854423B (zh) * 2012-12-06 2018-09-18 周超 空分复用光学相干断层扫描设备及方法
CN104739377B (zh) * 2015-03-20 2018-01-23 武汉阿格斯科技有限公司 血管内同时进行oct成像和压力测量装置、系统及方法
CN204500629U (zh) * 2015-03-20 2015-07-29 武汉阿格斯科技有限公司 血管内同时进行oct成像和压力测量装置及系统
US20160357007A1 (en) * 2015-05-05 2016-12-08 Eric Swanson Fixed distal optics endoscope employing multicore fiber
CN205215191U (zh) * 2015-12-17 2016-05-11 天津求实飞博科技有限公司 一种血管内成像的光学相干层析装置

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1780584A (zh) * 2003-04-28 2006-05-31 德州系统大学董事会 导管成像探测器和方法
US20120158015A1 (en) * 2003-07-15 2012-06-21 The Trustees Of Columbia University In The City Of New York Insertable device and system for minimal access procedure
CN101247753A (zh) * 2005-06-06 2008-08-20 德州系统大学董事会 使用光谱分辨带宽的光学相干层析成像（oct）
US20180084981A1 (en) * 2016-09-23 2018-03-29 Canon Usa Inc. Spectrally encoded endoscopy apparatus and methods
CN107752985A (zh) * 2017-11-17 2018-03-06 苏州阿格斯医疗技术有限公司 Oct成像方法、oct成像导管及oct系统
CN109893099A (zh) * 2019-03-26 2019-06-18 苏州阿格斯医疗技术有限公司 Mla-oct成像导管、mla-oct成像系统及mla-oct成像方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3932287A4 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113413139A (zh) * 2021-06-22 2021-09-21 中山大学中山眼科中心南昌眼科医院 一种基于光学相干弹性成像图像融合装置
CN113413139B (zh) * 2021-06-22 2022-09-16 赵雁之 一种基于光学相干弹性成像图像融合装置
CN117146700A (zh) * 2023-10-30 2023-12-01 天津恒宇医疗科技有限公司 一种oct设备光程校准方法、装置和oct设备
CN117146700B (zh) * 2023-10-30 2024-01-30 天津恒宇医疗科技有限公司 一种oct设备光程校准方法、装置和oct设备

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