WO2016180290A1 - 应用于oct内窥扫描成像的球囊导管、使用方法及oct成像系统 - Google Patents

应用于oct内窥扫描成像的球囊导管、使用方法及oct成像系统 Download PDF

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Publication number
WO2016180290A1
WO2016180290A1 PCT/CN2016/081352 CN2016081352W WO2016180290A1 WO 2016180290 A1 WO2016180290 A1 WO 2016180290A1 CN 2016081352 W CN2016081352 W CN 2016081352W WO 2016180290 A1 WO2016180290 A1 WO 2016180290A1
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Prior art keywords
oct
balloon
inner tube
balloon catheter
scanning imaging
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PCT/CN2016/081352
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English (en)
French (fr)
Inventor
常健
刘辉
高端贵
李常青
冷德嵘
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南京微创医学科技有限公司
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Publication of WO2016180290A1 publication Critical patent/WO2016180290A1/zh

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    • 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
    • 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
    • A61M25/1006—Balloons formed between concentric tubes
    • 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
    • A61B1/00147—Holding or positioning arrangements
    • A61B1/00148—Holding or positioning arrangements using anchoring means
    • 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
    • A61B1/00131—Accessories for endoscopes
    • 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
    • A61B1/00147—Holding or positioning arrangements
    • 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
    • A61B1/04—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 combined with photographic or television appliances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/14—Arrangements specially adapted for eye photography

Definitions

  • the present invention relates to a balloon catheter, particularly a balloon catheter for use in optical coherence tomography, methods of use thereof, and an OCT endoscopic scanning imaging system having the balloon catheter.
  • OCT Optical Coherence Tomography
  • OCT Compared with other CT, ultrasound, MRI and other imaging methods, OCT has a very high resolution, compared with the traditional laser confocal microscope, OCT imaging depth has obvious advantages.
  • Most of the core technologies of traditional optical probes use fiber bundles for light transmission and imaging, or CCD technology for imaging.
  • Such endoscopic probes can only detect lesions on the surface of tissues.
  • the symptoms of early cancer occur 1-3 mm below the epidermis.
  • the depth of the traditional optical endoscopic probe is not enough.
  • Endoscopic OCT technology is an OCT branch technology that was born and flourished with the development of OCT technology in the past decade. Its core goal is to miniaturize OCT optical imaging equipment without reducing the resolution.
  • the lumen provides a high resolution OCT image.
  • This technology greatly expands the application field of OCT technology, making OCT inspection objects have involved various digestive tract lumens, large digestive tract lumens (such as esophagus, rectum), small digestive tract lumens (such as biliary tract), etc. .
  • Barrett's esophagus is a pathological phenomenon in which the stratified squamous epithelium in the lower esophagus is replaced by a single columnar epithelium. It is closely related to the occurrence of esophageal cancer and is a major precancerous lesion of esophageal adenocarcinoma.
  • the diagnosis is mainly based on endoscopy, while endoscopy has delays, sampling errors and other limitations, and optical coherence tomography (OCT) system has the advantages of fast imaging speed, high resolution and easy image recognition.
  • OCT optical coherence tomography
  • the balloon has good transparency and a certain expansion force to the normal esophagus.
  • OCT optical probe scanning the common dilatation balloon is guided and supported by the guide wire.
  • the filling medium is generally liquid, and the inner tube has a labeled developing ring. When filling, the inner tube will bend and the optical probe is scanned. There are problems such as incomplete imaging in the process, so there is a need for improvement.
  • the inner tube is specially designed for the OCT probe.
  • the inner tube has an inner diameter of 1.4mm and the inner tube has an outer diameter of 1.65mm.
  • the concentricity of the inner tube with the balloon deviates from no more than 500 micrometers at a nominal use atmospheric pressure, preferably, the nominal use atmospheric pressure is 3-5 atmospheres, and the inner tube is concentric with the balloon Degree deviates from no more than 500 microns at 3 atmospheres;
  • the membrane sleeve is located at the junction of the balloon and the double lumen tube, and controls the floating of the inner tube inside the lumen to ensure that the center of the balloon does not deviate from the center of the balloon to solve the eccentric problem;
  • the soft head is a solid structure. Wherein, one end of the double lumen tube is connected to the handle, the other end is connected to the inner tube and the balloon, and the other end of the balloon is connected with the soft head.
  • the balloon catheter of the present invention can pass through a 0.055 in OCT optical microprobe.
  • the balloon has an ink printing scale, the line width is ⁇ 0.1mm, and the direction of the probe scanning can be discriminated, which does not affect the scanning judgment of the normal image and can also distinguish the scanning position on the display screen.
  • the balloon front end seal Blocking can prevent the body fluid from affecting the optical scanning, prevent the corrosion of the body fluid to the precision equipment, and at the same time, the sealing material is a soft structure, which will not scratch the tissue and the cavity of the measured object during the operation, and enhance the equipment. safety. .
  • the soft head has a solid structure and can prevent body fluid from entering.
  • the nominal atmospheric pressure is 3-5 atmospheres.
  • the nominal atmospheric pressure is 3 atmospheres, and the concentricity of the inner tube and the balloon deviates by no more than 500 microns at 3 atmospheres.
  • the balloon is used at a pressure of 3 atmospheres. At normal pressure, the normal esophagus will not be damaged. At the same time, the heat setting process and welding process of the balloon can ensure that the concentricity of the inner tube and the balloon does not exceed 500 microns at the rated 3 atmospheres, which is convenient for optical imaging.
  • the balloon catheter further comprises a membrane sleeve located at the junction of the balloon and the dual lumen tube.
  • the double lumen tube is connected to the handle by UV glue, and the other components are connected by a welding process.
  • the inner tube length is fixed according to the length of the balloon, and the length thereof is shorter than the balloon, and when the balloon is welded with the soft head, the balloon is pushed down by a certain distance, It is flush with the inner tube and fixed after welding, so that the balloon has an elongation margin when filling, so as to match the stretching of the inner tube and keep it concentric.
  • the method of welding and fixing the balloon can prevent the inner tube from being directly inserted into the balloon without being fixed. Due to the movement of the patient and the organ cavity and the excessive insertion of the catheter into the balloon, the relative movement of the catheter and the balloon is caused. The problem of optical probe eccentricity.
  • the balloon has a folding curl temperature of 40° to 45° and a setting time of 4 to 5 hours.
  • the process can maintain the concentricity while maintaining the memory of the balloon. characteristic.
  • the handle material can be polycarbonate
  • the double lumen material can be block polyether amide
  • the balloon and inner tube materials can be nylon and its modified polymer
  • the soft head can be block polyether.
  • Amide. Another object of the present invention is to provide a method of using a balloon catheter for high-resolution OCT endoscopic scanning imaging, the steps comprising: first entering an endoscope through a natural cavity of a human body; and then having an OCT fiber optic probe Insert the balloon catheter into the forceps and push the balloon to the position to be scanned; then tighten the handle wire cavity connector to the connector on the OCT device, tighten the inflation port and the automatic air pump connector, and click the inflation button on the device software. Inflate, after the inflation is finished, click the scan button on the software to scan the image. After the scan is finished, click the inhalation button, and finally withdraw the balloon catheter after the end of inhalation.
  • Another object of the present invention is to provide an OCT endoscopic scanning imaging system, including a frequency sweeping laser module, an interference module, a detector module, a data acquisition module, a data processing module, an image display module, an actuator, an OCT micro probe, and a charging device. a deflation device, the balloon catheter, wherein
  • the frequency sweeping laser module comprises a high speed swept laser, a fiber isolator and a fiber coupler, and the optical signal output from the swept laser is isolated from the subsequent optical path to prevent the optical signal returned by the subsequent optical path from interfering with the normal operation of the laser; the interference module A fiber-optic Mach-Zehnder interferometer (MZI) or a fiber-optic Michelson interferometer structure can be used.
  • MZI Mach-Zehnder interferometer
  • Michelson interferometer structure can be used.
  • the Mach-Zehnder interferometer structure is mainly composed of two fiber couplers, two fiber circulators and two fiber polarization controllers, the first of which A fiber coupler generally uses an asymmetric fiber coupler to output most of the laser light to the microprobe of the sample arm; a fiber circulator is placed in both the reference arm and the sample arm to collect the light reflected or scattered back from the two arms. Signal; the second fiber coupler can use a symmetric 2 ⁇ 2 fiber coupler (ie, a split ratio of 50/50) to generate an optical interference signal and reduce the DC common mode signal.
  • the fiber polarization controller is symmetrically placed on the reference arm. In the sample arm, it is used to adjust the polarization state of the two arms to obtain the best optical interference signal.
  • the Michelson interferometer structure consists of a symmetrical 2 ⁇ 2 fiber coupler, a fiber circulator, and two optical polarization controllers.
  • the swept laser first passes through the fiber circulator and enters the fiber coupler, from the reference arm and sample.
  • the optical signal reflected or scattered back by the arm generates an interference signal through the same fiber coupler.
  • the fiber polarization controller is symmetrically placed in the reference arm and the sample arm to adjust the polarization state of the two arms for optimal optics. Interference signal.
  • the Mach-Zehnder Interferometer MZI
  • MZI Mach-Zehnder Interferometer
  • the Mach-Zehnder Interferometer has the advantages of structural symmetry, simple dispersion management, and high detection sensitivity.
  • the advantage of the Michelson interferometer is that it is simple in structure and does not introduce a positive mode dispersion (PMD).
  • the optical path difference between the two arms determines the free spectral region where the optical clock occurs ( FSR), which also determines the maximum imaging depth of the OCT image;
  • the detector module can use a high-speed balanced photodetector, which is mainly used to convert the interference optical signal output from the interference module into an electrical signal;
  • the data acquisition module is a high-speed mode
  • the data acquisition card is mainly used for converting an analog electrical signal into a digital electrical signal, and providing the digital signal to a data processing module for digital signal processing;
  • the data processing module is a chip with digital signal processing capability (such as CPU, GPGPU, DSP, FPGA, etc.) are mainly used to process the original signal and convert it into a final image signal;
  • the image display module is mainly used for displaying an image signal and is responsible for post-processing and measurement work of the image;
  • the actuator is rotated by the optical fiber
  • the connector, the motor and the electric translation stage are composed, and the rotary motor in the actuator drives the OCT micro
  • the software reconstructs the acquired rotation scan data and the translation stage movement data to generate a 3D image;
  • the OCT micro probe is mainly used to enter the internal organs of the human body.
  • the balloon catheter is used to expand the internal organ conduit of the human body, eliminate wrinkles and stabilize the OCT microprobe at the center of the balloon;
  • the deflation device is mainly used to expand the balloon catheter.
  • the OCT microprobe comprises a spring tube capable of providing sufficient torque to keep a probe of a certain length synchronized at both ends when rotating, and the spring tube is interspersed with a single mode fiber that transmits an optical signal; a lens assembly for collecting light propagating through an optical fiber at a predetermined working distance, the lens assembly comprising a glass rod and a self-focusing lens, by changing a bonding distance between the glass rod and the single-mode optical fiber
  • the gluing of the autofocus lens and the glass rod increases the clear aperture of the autofocus lens, thereby increasing the numerical aperture and lateral resolution of the OCT probe.
  • the OCT microprobe may also include a mirror, a support stainless steel tube, and a slotted stainless steel tube, the end faces of which are glued with optical glue.
  • one end of the single-mode fiber has a fiber optic standard connector, and the connector can be connected to the optical fiber rotating end of the OCT system, the single-mode fiber is sleeved in the spring tube (covered with a PTFE film), and the spring tube can effectively protect the single The mode fiber reduces the resistance of the probe when rotating, and makes the overall scanning of the OCT micro-probe more smooth and smooth.
  • the optical fiber standard connector has a supporting stainless steel tube, which supports the OCT micro-probe when scanning, so that the whole The probe rotates more smoothly when rotated.
  • the other end of the single-mode optical fiber is a beveled surface, and is glued to one end surface of the glass rod which is also beveled.
  • the inclination of the glued surface effectively reduces the interference of the reflected light on the signal light, and can change the bonding distance between the glass rod and the single-mode optical fiber.
  • the other end of the glass rod is glued to the self-focusing lens at an angle of 0° and then encapsulated in a slotted stainless steel tube. By changing the length of the autofocus lens, the working distance of the OCT probe is changed to achieve the specified working distance.
  • the numerical aperture of the OCT probe can be increased by increasing the length of the glass rod, thereby improving the lateral resolution, that is, the use of the glass rod not only increases the working distance of the micro probe, but also increases the micro
  • the numerical aperture of the probe, and the increase of the numerical aperture also leads to an increase in lateral resolution.
  • this design also greatly shortens the length of the self-focusing lens, ensuring the cornering of the micro-probe, so that the entire micro-probe can pass.
  • the endoscopic forceps and the catheter directly enter the human esophagus.
  • the mirror can change the forward light into a lateral direction, and the mirror is a cylindrical mirror, which can change the astigmatism effect of the protective sleeve outside the OCT probe on the concentrated beam.
  • the self-focusing lens is glued to the glass rod, wherein the surface of the self-focusing lens in contact with the air is coated with an anti-reflection film, which can reduce the reflection of light between the optical surfaces and increase the light transmission performance, thereby reducing the optical surface.
  • the influence of reflected light on the signal light improves the sensitivity of the OCT micro-probe.
  • the surface of the autofocus lens in contact with air can be processed into a 4°-8° slope. This design can further reduce the interference signal formed by light passing through this surface. .
  • the angle of the glued slope of the single mode fiber and the glass rod is 4 to 12 degrees.
  • the reflecting surface of the mirror is packaged in a stainless steel tube toward the slot of the stainless steel tube.
  • the mirror here can be based on the inner and outer diameters of the inner cylindrical tube and the inner tube.
  • the refractive index of the material is designed to be a cylindrical mirror.
  • the charge and discharge device is applied to the OCT endoscopic scanning imaging system, that is, includes a frequency sweeping laser module, an interference module, a detector module, a data acquisition module, a data processing module, an image display module, an actuator, and a balloon catheter.
  • the OCT micro probe, and the charging and discharging device, the charging and discharging device is an automatic charging and discharging device, the automatic charging and discharging device comprises: a control and display module, a gas pump, a gas filling solenoid valve, a gas discharging solenoid valve, and a pressure Sensor, explosion-proof pressure sensor, mechanical pressure switch.
  • the automatic charging and deflation device is applied to an OCT endoscopic scanning imaging system to realize automatic charging and discharging and precise air pressure control, wherein the air pump is connected to the throttle valve through a gas filling solenoid valve and a bleed solenoid valve, the throttle valve Connected to the foregoing balloon, the pressure sensor is plural, wherein at least one pressure sensor is connected to the balloon, and at least one pressure sensor is disposed between the throttle valve and the inflation solenoid valve and the deflation solenoid valve, the explosion-proof pressure sensor and the ball
  • the capsule is connected, the mechanical pressure switch is connected to the balloon, and the control and display module can set the balloon air pressure and inflation time, collect pressure, control the air pump to start and stop, and control the working state of the solenoid valve;
  • the use of the automatic charge and discharge device includes:
  • the balloon pressure and inflation time are set in the control and display module, and the air pump is inflated until the set air pressure value;
  • the balloon pressure and deflation time are set in the control and display module, and the air pump inhales until the set pressure value;
  • the system is over-pressure protected by an explosion-proof pressure sensor, the air pump is turned off when the balloon exceeds the set air pressure, and the pressure is released by the mechanical pressure switch when the balloon exceeds the set air pressure.
  • the automatic charging and discharging device realizes automatic inflation and inhalation, and has the function of setting different air pressure parameters, and can charge and deflate the balloon of different specifications, and the device reaches the set air pressure during inflation of the balloon. After the value, the inflation is stopped and the overvoltage protection function is provided.
  • the achievable effect is: firstly, the doctor's manual filling and deflation operation of the balloon is eliminated, the time for the doctor to charge and deflate is shortened, the safety is improved, and the risk of overfilling and exploding the balloon is avoided; secondly, Accurate air pressure control ensures that the shape consistency of the balloon after inflation is ensured.
  • optical imaging is sensitive to the shape of the scanned object supported by the balloon, the repeatability of multiple scans of the same scanned object is better.
  • the doctor can compare the scanned image data; again, in the emergency case, the doctor can perform other operations while automatically deflated.
  • the OCT endoscopic scanning imaging system comprises an optical clock module composed of the interference module, the detector module and an optical clock conversion circuit module, wherein the interferometer module can adopt all-fiber Mach-Zehnder interference Instrument (MZI) structure, mainly composed of two fiber couplers, of which The two couplers are symmetric 2 ⁇ 2 fiber couplers, which are first divided into two paths of light at the first fiber coupler, and the two paths of light respectively pass through two fixed optical paths of the first optical fiber and the second optical fiber. Interference occurs at the two fiber couplers.
  • the detector module can employ a high-speed balanced photodetector, which is mainly used to convert an interference optical signal output from the interference module into an electrical signal.
  • MZI Mach-Zehnder interference Instrument
  • the optical interference signal generated from the MZI is converted into an electrical signal by a balanced photodetector, and then passed through an optical clock conversion circuit module, that is, sequentially passed through a wide-band 90-degree phase shifter, a zero-crossing comparator, an exclusive OR gate, an OR gate, and an optical clock.
  • the signal output module converts to an optical clock signal that is uniform over the frequency domain and variable in frequency domain.
  • the wide-band 90-degree phase shifter is mainly used to shift the phase of the MZI electrical signal by 90 degrees, which can increase the available spectral interval width of the original signal, enrich the spectrum distribution resources of the sampling clock signal, and optimize the acquired sampling clock signal.
  • the zero-crossing comparator is mainly used for zero-crossing comparison between the original MZI electrical signal and the phase-shifted MZI electrical signal to be converted into a digital signal, and the zero point of the MZI signal is evenly distributed in the frequency domain, so the number generated after the zero-cross comparison is generated. The rising or falling edge of the signal is also evenly distributed in the frequency domain.
  • the XOR gate is mainly used to combine two digital clock signals to obtain two clock signals in one free spectral region (FSR). Increasing the FSR increases the maximum imaging depth of the OCT and reduces the jitter generated by the optical signal.
  • the optical clock signal needs to fill in some false clock signals in the blank through an OR gate to ensure that the high speed analog capture card can work normally.
  • the OR gate implements the function of combining the real optical clock signal with the fake clock signal.
  • the optical clock signal output module is mainly used to deliver the combined real optical clock signal and the fake clock signal to the data acquisition module.
  • a method for processing an OCT signal in an OCT endoscopic scanning imaging system using a general purpose image processor comprising (1) data acquisition; (2) data transmission; (3) data processing; and (4) Pass to the image display library in four steps.
  • GPGPU general purpose image processor
  • the invention obtains FD-OCT raw data through an external collection device
  • the FD-OCT raw data obtained in the data acquisition step is placed in the computer system or embedded system memory, and the data is stored in the system memory in frame units, when certain conditions are met (such as data accumulation) One or more frames), this data can be passed through the data bus (such as PCI) Express) is transferred to the device memory of the general-purpose image processor; because the bus transfer speed is relatively slow, the general-purpose image processor performs parallel processing of the OCT raw data that was last transferred to the device memory while the data is being transferred.
  • the method has high-efficiency parallel signal processing capability, can realize real-time digital signal processing, greatly improves transmission efficiency, and saves bus resources;
  • the processed data is placed in the memory of the image display library, and the image display library can be directly called, no need to transmit through the bus, which greatly improves the transmission efficiency, saves the bus resources, and is efficient.
  • Parallel signal processing capability for real-time digital signal processing, high portability, seamless integration with popular image display libraries, and improved flexibility of software display (eg, image processing via a general-purpose image processor) Post-processing) enables lower hardware and software development costs.
  • Figure 1 is a schematic view showing the structure of a balloon catheter of the present invention
  • Figure 2 is a balloon with a membrane sleeve
  • Figure 3 is the imaging effect of the inner tube and the balloon eccentricity of about 500 microns
  • Figure 4 is the imaging effect of the inner tube and the balloon eccentricity is less than 500 microns.
  • Figure 5 is the imaging effect of the inner tube and the balloon eccentricity of more than 500 microns
  • Figure 6 shows the concentricity scan results of a product on the market.
  • Figure 7 is a schematic view of an OCT endoscopic scanning imaging system with a balloon catheter of the present invention.
  • FIG. 8 is a diagram showing the physical components of the OCT micro-probe of the present invention.
  • 9a and 9b are enlarged cross-sectional views of key parts of the OCT microprobe of the present invention.
  • FIG. 10 is a schematic structural view of the charging and discharging device of the present invention.
  • FIG. 11 is a flow chart showing the operation of the charging and discharging device of the present invention.
  • Figure 12 is a schematic view of an optical clock module of the present invention.
  • Figure 13 is a schematic diagram showing the process of generating an optical clock signal of the present invention.
  • FIG. 14 is a schematic diagram of an OCT endoscopic scanning imaging system with an optical clock module of the present invention.
  • Figure 15 is a FD-OCT signal processing step of the present invention.
  • 16 is a schematic diagram of parallel generation of GPGPU data transmission and signal processing according to the present invention.
  • Figure 17 is a schematic view showing the overall implementation of the present invention.
  • Figure 18 is a graph showing the relationship between the working distance, the bonding distance and the lateral resolution curve of the OCT microprobe of the present invention.
  • Figure 19 is a view showing the esophagus of a healthy animal of the present invention.
  • Figure 20 is a partial enlarged view of the eczema scan of a healthy animal of the present invention.
  • Figure 21 is a 3D image of a healthy animal's esophagus of the present invention.
  • SE squamous epithelial layer
  • LP lamina propria
  • MM muscle mucosa
  • SM submucosa
  • MP intrinsic base layer
  • MZI electrical signal with 90 degree phase shift after wide frequency 90 degree phase shifter, 92, MZI electrical signal without phase shift, 93, digital signal of signal 91 undergoing zero crossing, 94, signal 92 Zero-compared digital signal, 95, false clock signal, 96, digital signal 93 and 94 are combined by XOR gate,
  • a balloon catheter of an OCT endoscopic scanning imaging system includes a handle 12, one interface of the handle 12 is a host interface 14, and the other interface is a ventilation interface 13; the double lumen tube 11 can allow OCT optics.
  • the probe passes; the balloon 10, the front end of the balloon 10 is sealed and the balloon has a scale, and the front end sealing is a solid welded structure, and the blocking is sleeved inside the inner tube, when the device moves in the cavity, the cavity Body Rubbing with the inner tube and the balloon, the contact soft head is not touched, and even if it comes into contact with the soft head, the frictional force tends to press the soft head into the inner tube; the inner tube 9, the inner tube 9 and the balloon 10 are concentric
  • the degree of deviation from the rated atmospheric pressure does not exceed 500 microns; the membrane sleeve 15, as shown in Figure 2, the membrane sleeve is located at the junction of the balloon and the double lumen tube, controlling the floating of the inner tube inside the lumen, thereby ensuring The
  • the material of the handle 12 is polycarbonate
  • the material of the double lumen tube 11 and the soft head 8 is block polyether amide
  • the material of the balloon 10 and the inner tube 9 is nylon and its modified polymer.
  • the balloon 10 has an ink printing scale with a line width of ⁇ 0.1 mm, which can distinguish the direction of the probe scanning, and does not affect the scanning judgment of the normal image, but also can distinguish the scanning position on the display screen.
  • the double lumen tube 11 is printed with a scale so that the doctor can judge the position of the scan.
  • the double lumen tube 11 for the OCT balloon catheter can pass the 0.055 inOCT optical probe.
  • the probe beam from the probe needs to pass through the inner tube wall to reach the object to be measured.
  • the OCT probe needs to be rotated inside the inner tube to detect the object under test.
  • the inner tube 9 has an inner diameter of 1.4 mm and an outer diameter of 1.65 mm, and is specifically designed for the OCT probe.
  • This inner tube thickness is most suitable for OCT probe imaging, which can ensure that the light energy attenuation is small under this thickness, and the inner tube strength is ensured, and the imaging unevenness and unclearness caused by the deformation of the probe and the inner tube are not caused. The problem.
  • the length of the inner tube is fixed according to the length of the balloon, and the length thereof is shorter than the balloon.
  • the balloon is welded to the soft head, the balloon is pushed down by a certain distance to make it
  • the inner tube is flush and fixed and welded, so that the balloon has an elongation margin when filling, thereby matching the inner tube to stretch and maintain concentricity.
  • the balloon In optical imaging, the balloon needs to be opened to open the cavity of the object to be measured, so that the image is completely formed. If the air pressure is low, the surface of the balloon will form wrinkles, which will inevitably affect the imaging effect, but if the air pressure is too high, it may be Damage and damage to the object being tested, therefore, in order to ensure that the device is not used correctly The object is damaged and destroyed, and the balloon is fully filled without wrinkles.
  • this indicator can also limit the length of the balloon and the length of the inner tube. The process of the balloon of the present application ensures that the concentricity of the inner tube from the balloon does not exceed 500 microns at 3 atmospheres for optical imaging.
  • FIG. 6 shows a standard circle with an eccentricity of about 500 microns.
  • Figures 4 and 5 show images scanned with an inner tube and balloon eccentricity of less than 500 microns and an eccentricity of more than 500 microns. From the above two figures, the eccentricity of less than 500 microns can meet the full imaging requirements. In contrast, the general product on the market does not control this indicator, and can not meet the requirement that the concentricity of the inner tube and the balloon deviate from 500 micrometers at 3 atmospheres. We select a product on the market as a comparison, and its imaging The effect is shown in Fig. 6, in which the upper right corner area is incompletely imaged and cannot meet the actual scanning requirements.
  • the endoscope enters the human body through the natural cavity of the human body.
  • an OCT endoscopic scanning imaging system includes a frequency sweeping laser module, an interference module, a detector module, a data acquisition module, a data processing module, an image display module, an actuator, an OCT micro probe, and a gas discharge and gas discharge.
  • the swept laser module comprises a high speed swept laser, an optical isolator and a fiber coupler, and the optical signal output from the swept laser is isolated from the subsequent optical path to prevent the optical signal from being returned by the subsequent optical path.
  • the interfering laser operates normally; the interference module may be a fiber-optic Mach-Zehnder interferometer (MZI) or a fiber-optic Michelson interferometer structure.
  • MZI Mach-Zehnder interferometer
  • the Mach-Zehnder interferometer structure is mainly composed of two fiber couplers, two fiber circulators and two fiber polarization controllers.
  • the first fiber coupler generally uses an asymmetric fiber coupler to drive most of the laser.
  • a microprobe that is output to the sample arm; a fiber optic circulator is placed in both the reference arm and the sample arm to collect optical signals reflected or scattered back from the two arms; the second fiber coupler can be coupled using a symmetric 2 ⁇ 2 fiber
  • the device ie, the split ratio is 50/50
  • the fiber polarization controller is symmetrically placed in the reference arm and the sample arm to adjust the polarization state of the two arms to obtain the most Good optical interference signal.
  • the Michelson interferometer structure consists of a symmetrical 2 ⁇ 2 fiber coupler, a fiber circulator, and two optical polarization controllers. The swept laser first passes through the fiber circulator and enters the fiber coupler, from the reference arm and sample.
  • the optical signal reflected or scattered back by the arm generates an interference signal through the same fiber coupler.
  • the fiber polarization controller is symmetrically placed in the reference arm and the sample arm to adjust the polarization state of the two arms for optimal optics. Interference signal.
  • the Mach-Zehnder Interferometer has the advantages of structural symmetry, simple dispersion management, and high detection sensitivity.
  • the advantage of the Michelson interferometer is that it is simple in structure and does not introduce a positive mode dispersion (PMD).
  • the commonality of both is that the optical path difference between the two arms determines the free spectral region where the optical clock occurs ( FSR), which also determines the maximum imaging depth of the OCT image; the detector module can use a high-speed balanced photodetector, which is mainly used to convert the interference optical signal output from the interference module into an electrical signal; the data acquisition module is a high-speed mode
  • the data acquisition card is mainly used for converting an analog electrical signal into a digital electrical signal, and providing the digital signal to a data processing module for digital signal processing;
  • the data processing module is a chip with digital signal processing capability (such as CPU, GPGPU, DSP, FPGA, etc.) are mainly used to process the original signal and convert it into a final image signal;
  • the image display module is mainly used for displaying an image signal and is responsible for post-processing and measurement work of the image; the actuator is rotated by the optical fiber
  • the connector, the motor and the electric translation stage are mainly used to drive the mechanical spiral scan of the OCT micro
  • the OCT microprobe is mainly used to enter internal organs of the human body to transmit the swept laser and collect optical signals backscattered from the biological tissue; the balloon catheter is used to expand the internal organs of the human body to eliminate wrinkles.
  • the OCT microprobe is stabilized at the center of the balloon; the charge and deflation device is primarily used to expand the balloon catheter.
  • the spring tube 2 is covered with a single mode fiber 1, which is a spring tube 2 can mention Provide sufficient torque to keep the probe of a certain length synchronized at the far and near ends when rotating.
  • the spring tube 2 effectively protects the fragile fiber while reducing the resistance when the probe rotates; the end of the glass rod 3 is at a zero angle from the autofocus lens 4.
  • the surface is glued, and the other end is obliquely glued to the single-mode optical fiber 1.
  • the working distance of the OCT probe can be changed by changing the bonding distance between the two end faces of the glass rod 3 and the single-mode optical fiber 1 to achieve the expected working distance, thereby improving the OCT probe.
  • the numerical aperture and the lateral resolution; the mirror 5 is a cylindrical mirror and is enclosed in the slotted stainless steel tube 6.
  • the reflecting surface of the mirror 5 faces the slot of the slotted stainless steel tube 6, which can reduce the light source through the cylindrical shape. The effect of astigmatism on the imaging.
  • an OCT microprobe of an OCT endoscopic scanning imaging system comprising a single mode fiber 1, a spring tube 2, a glass rod 3, a self-focusing lens 4, a mirror 5, a slotted stainless steel tube 6 And supporting the stainless steel tube 7, the end faces of these optical elements are glued with optical glue.
  • the mirror 5 is placed in the slotted stainless steel tube 6, and then placed on the tooling point A/B glue, and then the UV glue is spotted under the microscope to assemble the glass rod 3 and the self-focusing lens 4;
  • the optical fiber 1 is inserted into the spring tube 2, and the assembled glass rod 3 and the self-focusing lens 4, the single-mode optical fiber 1 and the spring tube 2 are assembled using a point UV glue, and finally the assembled spring tube assembly is loaded into the slot.
  • the edge gap is filled with A/B glue.
  • the single-mode fiber 1 is externally sheathed with a stainless steel spring tube 2 (coated with a PTFE membrane), which effectively protects the fragile fiber while reducing the resistance of the probe when rotating, making the micro-probe scan smoother and smoother.
  • the main function of the supporting stainless steel tube 7 is to support the OCT probe during scanning, so that the entire probe is rotated more smoothly, and the notch of the slotted stainless steel tube 6 allows the beam to be irradiated onto the sample to be tested through the slot.
  • the antireflection film can reduce the reflection of light between the optical surfaces and increase the light transmission performance, thereby reducing the influence of the reflected light of the optical surface on the signal light. Therefore, in this embodiment, the length of the self-focusing lens can be changed.
  • the working distance of the OCT probe is to achieve the best lateral resolution under the specified working distance.
  • the surface of the autofocus lens 4 in contact with the air is coated with an anti-reflection film.
  • the surface of the autofocus lens in contact with the air can be processed into 4 °-8° bevel, this design can further reduce the interference signal formed by light passing through this surface.
  • FIG. 9b is: whether the self-focusing lens 4 makes the angle of inclination of the plane, and the plane of the exit is shown in Figure 9b. Tilted 4°-8° design, this design minimizes the unwanted light signal reflected back from this surface and improves the imaging quality of the OCT probe.
  • one end of the glass rod 3 is glued to the zero-degree angle of the self-focusing lens 4, which improves the sensitivity and resolution of the micro-probe.
  • the other end of the glass rod 3 has a certain inclination angle with the bonding surface of the single-mode optical fiber 1.
  • the inclination angle of the bonding surface can be 8°, and the inclination of the bonding surface effectively reduces the reflected light to the signal light.
  • the numerical aperture of the OCT probe is increased to increase the lateral resolution, and the working distance of the OCT probe can be changed by changing the bonding distance of the two end faces to achieve the desired working distance. Since the mirror 5 is mounted at an angle of 45°, the incident light and the reflected light are perpendicular to each other to cause light interference.
  • the front end of the micro probe is mounted with a 40° angle mirror 5, and the mirror 5 is encapsulated in the slotted stainless steel tube 6 and the reflective surface Facing the slotted opening of the slotted stainless steel tube 6, and in order to reduce the influence of the astigmatism of the light source through the cylindrical inner tube on the imaging, the mirror here in this embodiment is based on the inner and outer diameters of the inner cylindrical tube and the inner tube material. Designing a cylindrical mirror with refractive index, the mirror can change the forward light into a lateral direction, and the mirror is a cylindrical mirror, which can change the astigmatism caused by the protective sleeve outside the OCT probe to the concentrated beam. influences.
  • An OCT endoscopic scanning imaging system is similar to Embodiment 3 or 4, except that the charging and discharging device is an automatic charging and discharging device, as shown in FIG. 10, the automatic charging and discharging device includes: a power source The part, the control and display part and the air pump and the control system part thereof, the air pump and the control system part thereof comprise: an air pump, a pneumatic solenoid valve, a deflation solenoid valve, a throttle valve, a pressure sensor, an explosion-proof pressure sensor, and a mechanical pressure switch.
  • a power source The part, the control and display part and the air pump and the control system part thereof, the air pump and the control system part thereof comprise: an air pump, a pneumatic solenoid valve, a deflation solenoid valve, a throttle valve, a pressure sensor, an explosion-proof pressure sensor, and a mechanical pressure switch.
  • the pressure sensor of the present application is plural, wherein at least one pressure sensor is connected to the balloon, and at least one pressure sensor is disposed between the throttle valve and the inflation solenoid valve and the deflation solenoid valve, and the pressure sensor functions to charge and discharge
  • the pipeline air pressure and balloon pressure are monitored in real time during the gas process.
  • the pressure sensor is composed of two pressure sensors 103 and 105, and cooperates with the plurality of solenoid valve assemblies in the present application to form a pressure detecting system for the charging and discharging process.
  • the specific structure is: between the air pump 101 and the pressure sensor 103.
  • the gas filled solenoid valve 102 and the deflation solenoid valve 107 are separated by a throttle valve 104, and the pressure sensor 105 is connected to the balloon.
  • Two pressure sensors 103 and 105 are arranged, and after being separated by the throttle valve 104, the pressure sensor 105 is directly connected to the balloon, and the acquired data is more accurate, and for the pressure sensor 103, the pipeline can be monitored.
  • the air pressure is proofed with 105 air pressure, and in the process of charging and discharging gas, after the inflation solenoid valve 102 and the bleed air valve 107 are opened, before the throttle valve 104 is opened, the air pressure of the air pump can be monitored for early warning.
  • the role of the pressure such as pressure problems can be automatically controlled to close the solenoid valve in time, to prevent excessive pressure on the balloon and even the patient's body cavity caused unnecessary damage, greatly enhancing the safety of the system.
  • the pressure sensors 103 and 104 are connected to the air pump through the electromagnetic valve, and the electromagnetic pump isolates the air pump and the external air pressure to interfere with the pressure monitoring.
  • the pressure monitoring system of the present application further includes an explosion-proof pressure sensor connected to the balloon.
  • the function of the explosion-proof pressure sensor is to monitor the air pressure in real time during the charging and discharging process, and the monitoring data is independent of the pressure sensor when the monitoring data is Exceeding the preset upper limit of the air pressure will activate the pressure relief mechanism. If the monitoring data remains unchanged for a long time, it will prevent the air pump from continuing to pressurize.
  • the pressure monitoring system of the present application is divided into a pressure sensor and an explosion-proof pressure sensor, which realizes multiple monitoring of the air pressure by setting a plurality of sensors, and enhances the stability of the system; in addition, different sensors are disposed at different positions. The proofreading can also be performed between the sensors.
  • the electromagnetic valve is also isolated between the sensors to avoid the interference of the charging and discharging device and the pressure relief device on the pressure measurement, and the accuracy of the pressure measurement is improved.
  • the plurality of pressure sensors cooperate with the solenoid valve stroke pressure.
  • the use process of the automatic charging and discharging device includes:
  • Inflation process Firstly, the user sets the parameters of the balloon 10 air pressure, inflation time and the like, and issues an inflation command.
  • the control system reads the data of the pressure sensors 103 and 105. If it is less than the air pressure set by the user, the air pump 101 is activated to open the inflation.
  • the solenoid valve 102 and the throttle valve 104 read the feedback values of the pressure sensors 103 and 105 in real time during the inflation process until the set air pressure value is charged, the air pump 101 is turned off, and the throttle valve 104 and the gas filling solenoid valve 102 are closed;
  • Deflating process Firstly, the user sets parameters such as the balloon 10 air pressure and deflation time, and the control system reads the data of the pressure sensor 105. If it is greater than the air pressure set by the user, the air pump 101 is activated, and the deflation solenoid valve 107 is opened. The throttle valve 104 reads the feedback value of the pressure sensor 105 in real time during the deflation until the set air pressure value is reached, the gas 101 pump is turned off, and the throttle valve 104 and the deflation solenoid valve 107 are closed.
  • the control system reads the data of the pressure sensor 105. If it is greater than the air pressure set by the user, the air pump 101 is activated, and the deflation solenoid valve 107 is opened.
  • the throttle valve 104 reads the feedback value of the pressure sensor 105 in real time during the deflation until the set air pressure value is reached, the gas 101 pump is turned off, and the throttle valve 104 and the deflation solenoid valve 107 are closed.
  • the system monitors the feedback value of the explosion-proof pressure sensor 106 in real time. If the user's air pressure upper limit setting value is exceeded, the software program protection is immediately performed, the air pump 101 is turned off, and the alarm is given; the mechanical pressure switch 108 is hardware protected. If the set value is exceeded, the switch is opened and the pressure is released for protection.
  • the pressure relief protection mechanism is realized by the automatic control function to guide the entire charging and discharging device system. It monitors the trigger through the explosion-proof pressure sensor and is implemented in three ways: First, software protection, that is, when the explosion-proof pressure sensor detects the pressure overrun , will turn off the air pump inflation function, and close the pneumatic solenoid valve, If necessary, the throttle valve and the deflation solenoid valve will be opened by the air pump to actively pump the air pressure. During this process, the pressure sensor will cooperate with the pressure monitoring. When the pressure is normal, the solenoid valve and the air pump will be closed to end the software protection pressure relief. In case of excessive pressure relief, the hardware is protected. After the explosion-proof pressure switch detects the pressure limit, the mechanical switch will automatically open for pressure relief protection.
  • the pressure relief valve protects when the equipment cannot operate normally. Manual pressure relief can also be achieved by opening the switch on the pressure relief valve.
  • the application combined with the explosion-proof pressure sensor provides software protection, hardware protection and pressure relief valve protection triple protection path for the system over-voltage risk, and achieves the effect of strengthening the safety and stability of the system and improving the accuracy of the pressure relief system.
  • the automatic charging and discharging device of the present application has the following advantages:
  • the user can set the required pressure value and inflation time on the control and display module at any time, and upload relevant parameters to the data system in real time.
  • the system will monitor and operate the system according to the new parameters in real time. All kinds of emergencies in the situation are timely and strained to enhance system security.
  • the precise air pressure control makes the shape consistency of the balloon inflated, which makes the image data obtained by scanning the object multiple times more relevant and easier to compare.
  • the air pump does not change or change the air pressure for a long time, it is very likely that the balloon is ruptured or leaking. If the pump continues to inflate or pumping gas, it may cause damage to the patient's body cavity. Therefore, if the pressure system monitors the length of the pump When the air is inflated or deflated, the air pressure has not changed or changed little, and the protection mechanism is automatically activated to close the air pump and strengthen the system safety.
  • This application can realize the rapid opening and closing of the electromagnetic valve by means of automatic control, reduce the interference of the charging and discharging gas to the monitoring system, and increase the accuracy of the monitoring system.
  • Inflating and pumping in this application are two different channels, which can be quickly switched between charging and discharging. Especially in the process of pressure relief protection, rapid pumping can prevent excessive inflation. Damage to the balloon and the patient's body cavity enhances system safety.
  • This application adopts an automatic charge and discharge air pump, which has a large inflation pressure range.
  • the pressure range is generally controlled at 1 to 5 atmospheres.
  • the pressure pressure range that can be provided by manual pressure supply is much smaller than the pressure range of the present application.
  • an optical clock module used in an OCT endoscopic scanning imaging system includes an interference module, a detector module, and an optical clock conversion circuit module, the optical clock conversion circuit module including a wide frequency 90 degree phase shifting , zero-crossing comparators, and circuits consisting of XOR gates, OR gates, and optical clock signal output modules.
  • the interference module uses the all-fiber Mach-Zehnder interferometer (MZI)
  • MZI all-fiber Mach-Zehnder interferometer
  • the structure is mainly composed of two fiber couplers, wherein the second coupler is a symmetric 2 ⁇ 2 fiber coupler, which is first divided into two paths of light at the first fiber coupler, and the two paths of light respectively pass through two fixed lights. The first fiber and the second fiber of the path interfere with each other at the second fiber coupler.
  • the detector module is composed of a high-speed balanced photodetector and is mainly used for converting an interference optical signal output from the interference module into an electrical signal.
  • the MZI electrical signal converted by the detector module is partially transmitted to the broadband 90-degree phase shifter, and the other portion is transmitted to the zero-crossing comparator, and the phase shift of the electrical signal transmitted to the broadband 90-degree phase shifter is 90 degrees.
  • the comparator is mainly used for zero-crossing comparison of signals in which phase shift occurs and phase shift has not occurred to be converted into a digital signal.
  • the XOR gate is mainly used to combine two digital clock signals to obtain two clock signals in one free spectral region (FSR), which increases the maximum imaging depth of the OCT without increasing the FSR, and reduces the optical The jitter produced by the signal. Since the swept laser always has some idle time between two adjacent scans, the optical clock signal needs to fill in some false clock signals in the blank through an OR gate to ensure that the high speed analog capture card can work normally, or The gate implements the function of combining a real optical clock signal with a false clock signal.
  • the optical clock signal output module is mainly used for transmitting the combined real optical clock signal and the fake clock signal to the data acquisition module.
  • 91 is an MZI electrical signal that undergoes a 90-degree phase shift after a wide-band 90-degree phase shifter
  • 92 is an MZI electrical signal in which no phase shift occurs
  • 93 is a zero-cross comparison of the MZI signal 91 in which phase shift occurs.
  • the subsequent digital signal, 94 is a digital signal after the zero-comparison of the MZI signal 92 without phase shift, because the zero point of the MZI signal is evenly distributed in the frequency domain, so the rising edge or falling of the digital signal generated after the zero-crossing comparison The edges are also uniformly distributed in the frequency domain, 96 is a signal in which the uniformly distributed digital signals 93 and 94 are combined by XOR gates, 95 is a false clock signal, and 95 and 96 are combined to form an optics after the OR gate merge. Clock signal.
  • an OCT endoscopic scanning imaging system is similar to Embodiment 3-5 except that the frequency sweeping laser module, the optical clock module, the data acquisition module, the data processing module, the image display module, and the execution are performed.
  • the optical interference signal generated from the MZI is converted into an electrical signal by a balanced photodetector, and then passed through a Converted into an optical clock that is uniform in the frequency domain and variable in the time domain by a circuit consisting of a wide-band 90-degree phase shifter, a zero-crossing comparator, and an exclusive OR gate
  • the signal, or gate combines the real optical clock signal with the false clock signal for normal operation of the high speed analog acquisition card.
  • the frequency sweeping laser module comprises a high speed swept laser, an optical isolator and a fiber coupler, and the optical signal output from the swept laser is isolated from the subsequent optical path, preventing the optical signal returned by the subsequent optical path from interfering with the normal operation of the laser, and A small portion of the swept laser output is output to the optical clock module, and most of the laser continues to output;
  • the optical clock module includes an interference module, a detector module, and an optical clock conversion circuit module, which are mainly used to obtain uniformity and time in the frequency domain.
  • the data processing module is a chip with digital signal processing capability (such as CPU, GPGPU, DSP, FPGA, etc.), and is mainly used for processing and converting the original signal into a final image signal; the image display module is mainly used for displaying an image signal.
  • the actuator is light
  • the rotary connector, the motor and the electric translation stage are mainly used for driving the mechanical spiral scan of the OCT micro probe to obtain an OCT image
  • the OCT micro probe is mainly used for entering the internal organs of the human body to transmit the swept laser and collecting from the biological tissue.
  • Backscattered optical signal the balloon catheter is used to expand the internal organ conduit of the human body, eliminate wrinkles and stabilize the OCT microprobe at the center of the balloon;
  • the charge and discharge device is primarily used to expand the balloon catheter.
  • An OCT endoscopic scanning imaging system is similar to Embodiment 3-6 except that the general image processor is used to process the OCT signal as shown in FIG. 15 , including sequentially connected (1) data acquisition; (2) Data transmission; (3) data processing and (4) several steps of passing to the image display library, wherein the data transmission is relatively slow due to the bus transmission speed, and the general image processor will transmit the data to the last time while the data is being transmitted.
  • the OCT raw data in the device memory is processed in parallel, and its parallel transmission and processing are shown in Figure 16.
  • the data processing process is divided into three steps: one-dimensional digital resampling, one-dimensional fast Fourier transform (FFT), and calculation of amplitude. And normalization, wherein one-dimensional digital re-sampling step realizes fast one-dimensional cubic interpolation by two linear texture searching to improve the accuracy of resampling.
  • FFT fast Fourier transform
  • a scheme for processing an OCT signal by using a general-purpose image processor includes (1) data acquisition, (2) data transmission, (3) data processing, and (4) delivery to an image display library. Steps.
  • the invention obtains FD-OCT raw data through an external collection device
  • the FD-OCT raw data obtained in the data acquisition step is placed in the computer system or embedded system memory, and the data is stored in the system memory in frame units, when certain conditions are met (such as data accumulation) One or more frames), this data can be transferred to the device memory of the General Purpose Image Processor (GPGPU) via a data bus (such as PCI Express); due to the relatively slow bus transfer speed, general image processing while transmitting data
  • GPGPU General Purpose Image Processor
  • PCI Express General Purpose Image Processor
  • the parallel signal transmission/processing model can be effectively used. Improve the data processing speed of the general image processor.
  • Data processing as shown in Fig. 15, the digital signal processing performed in the general image processor is divided into three steps: one-dimensional digital resampling, one-dimensional fast Fourier transform (FFT), and calculation of amplitude and normalization.
  • Digital resampling can be realized by the texture search function built in the image processor (GPU).
  • the texture search function built in the image processor can automatically realize two-dimensional linear interpolation for interpolation, and the image processor's texture search module has special interpolation.
  • Hardware optimization faster interpolation than general general image processor, especially for non-equidistant interpolation in OCT signal processing; by precisely setting the search point in one dimension, it can be realized by the texture search function built in the image processor.
  • One-dimensional line interpolation One-dimensional line interpolation.
  • fast one-dimensional cubic interpolation is realized by two linear texture search, so as to improve the accuracy of resampling.
  • the texture search module specially optimizes non-equidistant interpolation, this method is more than direct cubic interpolation.
  • the general-purpose image processor is implemented with less computation and higher computational efficiency; the FFT can be implemented by a common commercial image processor-based numerical calculation library (such as nVidia's cuFFT library or OpenCL FFT library); the amplitude is calculated and normalized. You can write your own image processor program. For example, you can use the CUDA library provided by nVidia to write the corresponding kernel function to achieve fast traversal of 2D data to achieve amplitude and normalization calculation.
  • the processed data is placed in the memory of the image display library, and the image display library can be directly called, no need to transmit through the bus, which greatly improves the transmission efficiency, saves the bus resources, and is efficient.
  • a microprobe for OCT imaging scanning of a human esophagus inserts the microprobe from the proximal guidewire lumen of the balloon into the balloon inner tube 9, and connects the balloon handle ventilation interface 13 to An automatic inflation pump (not shown) inflates the balloon 10 to a rated air pressure to expand the esophagus.
  • the balloon 10 and the inner tube 9 are made of an optically transparent material and have excellent transparency. Light performance.
  • the balloon 10 functions to expand the esophagus to reduce esophageal wrinkles and to secure the OCT microprobe within its working distance.
  • the balloon 10 expands to a radius of between about 8 and 10 mm, which is the radius after the esophagus is fully deployed.
  • a relatively large working distance (approximately 8-10 mm) is a must for the OCT microprobe.
  • the OCT micro-probe needs to select a long self-focusing lens, which is not easy to bend, and causes inconvenience when used in a body cavity, and the lens may be broken when excessively bent, which has a safety hazard. Therefore, by setting the glass rod to change the working distance of the self-focusing lens, making it a multi-section structure, the micro-probe can ensure better cornering, so that the entire micro-probe can enter a narrow channel when the working distance is large.
  • the glass rod 3 is specially designed.
  • changing the bonding distance of the glass rod 3 and the single-mode optical fiber 1 can change the working distance of the micro-probe.
  • the micro-probe is used for the human esophagus, and the working distance is about 8 -10mm, by the calculation and testing of the glass rod 3 and the single-mode fiber 1 on both sides of the glue distance should be less than 0.3mm.
  • the design of the glass rod 3 not only enables the OCT micro-probe to work over a long working distance range, but also changes the numerical aperture and lateral resolution of the micro-probe, thereby increasing the bonding distance between the glass rod and the single-mode fiber. The distance increases the numerical aperture and increases the lateral resolution of the microprobe.
  • D is the clear aperture of the optical component
  • WD is the working distance
  • NA is the numerical aperture.
  • the numerical aperture is proportional to the aperture (D) of the optical component, due to the processing process of the self-focusing lens itself.
  • the defect has a clear aperture of only about 80% of its diameter.
  • the pass-through aperture that can be actually used by directly connecting the self-focusing lens through a single-mode fiber has only a self-focusing lens.
  • the diameter of the self is less than 10%.
  • the present invention incorporates the glass rod, and the light is diffused and transmitted in the glass rod.
  • the glass rod is expanded to light, and the aperture of the light that is actually used when the optical fiber passes through the self-focusing lens is increased.
  • ⁇ is the incident light wavelength is a fixed value
  • ⁇ X is proportional to the numerical aperture (N.A), that is, the larger the numerical aperture, the higher the lateral resolution (the smaller the value).
  • the use of the glass rod 3 not only increases the working distance of the microprobe, but also increases the numerical aperture of the microprobe, and the increase of the numerical aperture also leads to an increase in lateral resolution, and this design is also extremely large.
  • the length of the self-focusing lens is shortened to ensure the bending of the micro-probe, so that the entire micro-probe can still directly enter the human esophagus through the endoscopic forceps together with the balloon catheter.
  • This effective design allows the lateral resolution of the probe to be approximately 10-30 microns and the working distance to be 8-10 mm.
  • the relationship between the working distance and the lateral resolution of the microprobe is shown in Figure 18.
  • the diameter of the entire microprobe is less than 1.5 mm.
  • a self-focusing lens with a diameter of 1.0 mm is used.
  • the diameter of the whole microprobe is less than 1.3 mm.
  • the diameter of the entire microprobe is less than 1.0 mm; if the diameter is 0.5 mm Self-focusing lens, the entire microprobe has a diameter of less than 0.7 mm.
  • the application enables the OCT microprobe to be applied to a narrow space with a large working distance, a large numerical aperture and a high resolution.
  • Figure 19 is a section of a healthy animal esophagus obtained by an OCT balloon catheter endoscope with an image size of 1200 lateral scans x 4096 longitudinal scans, a scan rate of 0.2 cm/3 s, and a scale of 1 mm.
  • Figure 20 is a partial enlarged view of the esophageal image of the healthy animal of Figure 19, the distinguishable layers including 81: squamous epithelial layer (SE), 82: lamina basement (LP), 83: muscle mucosa (MM), 84: mucosa Lower layer (SM) and 85: intrinsic base layer (MP).
  • Figure 21 is a 3D image of a healthy animal's esophagus produced by OCT endoscopic scanning imaging system for lumen surface and depth scan, and then software reconstruction of the scan data.

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Abstract

一种可以配合内窥镜、OCT光学探头使用的球囊导管，OCT成像系统及使用方法。所述球囊导管包括手柄（12）、双腔管（11）、球囊（10）、内管（9）、软头（8）等几部分，内管（9）与所述球囊（10）的同心度在额定使用大气压下偏离不超过500微米，不会对正常食管造成破坏，同时又能保证内管与球囊的同心度，便于光学成像。

Description

应用于OCT内窥扫描成像的球囊导管、使用方法及OCT成像系统 技术领域
本发明涉及一种球囊导管，特别是用于光学相干断层扫描中的球囊导管，其使用方法，以及具有所述球囊导管的OCT内窥扫描成像系统。
背景技术
光学相干断层成像(Optical Coherence Tomography，简称OCT)，已广泛应用在眼科诊断领域，这项技术是建立在光学、电子学以及计算机技术科学的基础上，是集光电及高速数据采集和图像处理等多项前沿学科为一体的新型成像技术，OCT凭借其具有高分辨率、高速成像等优点而备受人们的关注，并在生物医学与临床诊断领域开始得到重视和应用。
与现有的CT、超声、MRI等其他成像方式相比，OCT具有极高的分辨率，与传统的激光共聚焦显微镜相比，OCT的成像深度具有明显的优势。传统光学探头的核心技术大多采用光纤束进行光传导并进行成像，或者采用CCD技术进行成像，此类内窥探头仅能探测组织表面的病变，然而早期癌症的症状发生在表皮以下1-3毫米的深度，因此传统光学内窥探头就显得力不从心。目前也有通过超声原理进行医学成像的内窥探头，虽然可获得生物组织表层以下较深的组织信息，但分辨率仅为毫米量级，对早期的癌症易造成漏诊。
内窥式OCT技术是近十年伴随OCT技术发展而诞生并蓬勃发展的一项OCT分支技术，其核心目标是在不降低分辨率的前提下将OCT光学成像设备微型化，为人体内部脏器管腔提供高分辨率OCT图像。这项技术极大的扩展了OCT技术的应用领域，使得OCT检查对象已经涉及到各种消化道管腔，大消化道管腔(如食道，直肠)，小消化道管腔(如胆道)等。
Barrett食管是指食管下段的复层鳞状上皮被单层柱状上皮所替代的一种病理现象，它与食管癌的发生密切相关，是一种主要的食管腺癌的癌前病变，本病的诊断主要根据内镜检查，而内镜检查存在延迟，采样存在误差等种种局限，而光学相干断层扫描(OCT)系统具有成像速度快、分辨率高和图像易识别等优点，内窥式OCT系统中的一个关键部件则是OCT微探头。它可以将与现有 临床上使用内窥镜或微创技术结合，伸入人体内部脏器，采集并收集来自生物组织的背向散射光，而球囊具有透明度好同时又能对正常食道有一定的扩张力，因此作为OCT光学探头扫描的首选，然而普通的扩张球囊是由导丝导引及支撑，充盈介质一般为液体，且内管上有标记的显影环，充盈时内管会弯曲，光学探头在扫描的过程中会出现成像不完全等问题，因此有改进的需要。
发明内容
本发明的目的是提供一种能够在内窥镜下使用，同时又能满足OCT光学探头扫描的球囊导管，所述球囊导管包括：手柄，所述手柄的一个接口为主机接口，另一接口为通气接口；双腔管，所述双腔管可以允许OCT光学探头通过；球囊，所述球囊的前端封堵且球囊上有刻度；内管，所述内管长度根据所述球囊的长度定长，且其长度短于所述球囊，所述球囊与所述软头焊接时，将所述球囊下推一定距离，使其与内管平齐并固定后焊接，由于内管太厚会影响扫描图像的清晰度，太薄则会影响探头的旋转以及同心度，所述内管专门为OCT探头设计，内管内径为1.4mm，内管外径为1.65mm，所述内管与所述球囊的同心度在额定使用大气压下偏离不超过500微米，优选地，所述额定使用大气压为3-5个大气压，所述内管与所述球囊的同心度在3个大气压下偏离不超过500微米；膜套，所述膜套位于球囊与双腔管接合处，控制内管在管腔里面的浮动，从而保证与球囊的中心不发生偏离解决偏心问题；软头，所述软头为实心结构，其中，所述双腔管一端与所述手柄连接，另一端与所述内管及所述球囊连接，所述球囊与所述内管另一端与所述软头连接。
传统的球囊导管需要导丝支撑及导引，导丝直径一般为0.018in、0.035in、0.014in、0.038in，本发明的球囊导管可以通过0.055in的OCT光学微探头。所述球囊上有油墨印刷刻度，线条宽度≤0.1mm，能够辨别探头扫描的方向，既不会影响正常图像的扫描判断同时也能在显示屏上分辨出扫描位置，所述球囊前端封堵，能够防止体液进入对光学扫描造成影响，防止体液对精密设备的腐蚀，同时封堵材料为软性结构，不会在操作过程中划伤被测对象的组织和腔道，增强了设备的安全性。。所述软头为实心结构，能够防止体液进入。
优选地，额定使用大气压为3-5个大气压。
优选地，所述额定使用大气压为3个大气压，所述内管与所述球囊的同心度在3个大气压下偏离不超过500微米。球囊的使用额定压力为3个大气压， 在较低压力下不会对正常食管造成破坏，同时球囊的热定型工艺和焊接工艺可保证在额定的3个大气压下内管与球囊的同心度偏离不超过500微米，便于光学成像。
优选地，所述球囊导管还包括膜套，所述膜套位于球囊与双腔管接合处。
优选地，所述双腔管通过UV粘胶与所述手柄相连接，其他各部件均采用焊接工艺连接。
优选地，所述内管长度根据所述球囊的长度定长，且其长度短于所述球囊，所述球囊与所述软头焊接时，将所述球囊下推一定距离，使其与内管平齐并固定后焊接，使得球囊在充盈时有一个伸长余量，从而匹配内管的拉伸并保持同心。球囊的焊接固定方式在一定程度上能够避免在内管不经固定直接插入球囊的结构中，由于病人及器官腔体移动及导管过分插入球囊时，导致导管与球囊相对运动引发的光学探头偏心的问题。
优选地，所述球囊的折叠卷曲温度在40°～45°，定型时间为4～5h，相比于常规的球囊折叠工艺，此工艺在保证同心度的同时又能保持球囊的记忆特性。
优选地，本发明中手柄材料可采用聚碳酸酯，双腔管材料可采用嵌段聚醚酰胺，球囊和内管材料可采用尼龙及其改性聚合物，软头可采用嵌段聚醚酰胺。本发明另一目的是提供一种应用于高分辨率OCT内窥扫描成像的球囊导管的使用方法，步骤包括：首先将内窥镜通过人体自然腔道进入人体；然后将带有OCT光纤探头的球囊导管插入钳道，并且将球囊推送至需扫描的位置；再将手柄导丝腔接头与OCT设备上的接头拧紧，充气接口与自动充气泵接头拧紧，点击设备软件上的充气按钮进行充气，充气结束后点击软件上的扫描按钮进行图像扫描，扫描结束后点吸气按钮，最后在吸气结束后将球囊导管撤回。
本发明的另一目的是提供一种OCT内窥扫描成像系统，包括扫频激光模块、干涉模块、探测器模块、数据采集模块、数据处理模块、图像显示模块、执行机构、OCT微探头、充放气设备、所述球囊导管，其中，
所述扫频激光模块包括高速扫频激光器、光纤隔离器与光纤耦合器，将从扫频激光器输出的光学信号与后续光路隔离，防止后续光路返回的光学信号干扰激光器正常工作；所述干涉模块可采用光纤式马赫—曾德尔干涉仪(MZI)或光纤式迈克尔逊(Michelson)干涉仪结构。其中马赫—曾德尔干涉仪结构主要由两个光纤耦合器、两个光纤环形器以及两个光纤偏振控制器组成，其中第一 个光纤耦合器一般采用非对称式光纤耦合器，将大部分激光输出至样品臂的微探头；在参考臂与样品臂中均放置一个光纤环形器以收集从两个臂反射或散射回的光学信号；第二个光纤耦合器可采用对称式2×2光纤耦合器(即分光比为50/50)以产生光学干涉信号并降低直流共模信号，光纤偏振控制器被对称的放置在参考臂与样品臂中，用于调整两个臂的偏振状态以获得最佳的光学干涉信号。迈克尔逊干涉仪结构则由一个对称式2×2光纤耦合器、一个光纤环形器以及两个光学偏振控制器组成，扫频激光首先经过光纤环形器后在进入光纤耦合器，从参考臂与样品臂反射或散射回的光学信号在经过同一个光纤耦合器产生干涉信号，光纤偏振控制器被对称的放置在参考臂与样品臂中，用于调整两个臂的偏振状态以获得最佳的光学干涉信号。马赫—曾德尔干涉仪(MZI)的优点在于结构对称、色散管理简单、探测灵敏度高。迈克尔逊(Michelson)干涉仪的优点在于结构简单、且不会引入偏正模色散(PMD)，两者的共同之处在于两个臂中间的光程差决定了发生光学时钟的自由光谱区(FSR)，也最终决定了OCT图像的最大成像深度；探测器模块可采用高速平衡光电探测器，主要用于将从干涉模块输出的干涉光学信号转换成电学信号；所述数据采集模块是高速模数采集卡，主要用于将模拟电学信号转换成数字电学信号，并将数字信号提供给数据处理模块进行数字信号处理；所述数据处理模块是具有数字信号处理能力的芯片(如CPU，GPGPU、DSP、FPGA等)，主要用于对原始信号进行处理并转化为最终的图像信号；所述图像显示模块主要用于显示图像信号并负责图像的后处理以及测量工作；所述执行机构由光纤旋转连接器、电机以及电动平移台组成，执行机构中的旋转电机驱动OCT微探头进行旋转扫描，同时电动平移台驱动执行机构往某一方向移动，这时软件将获取到的旋转扫描数据及平移台移动数据进行重建，即产生3D图像；所述OCT微探头主要用于进入人体内部脏器以传输扫频激光并采集从生物组织中背向散射的光学信号；所述球囊导管用于扩张人体内部脏器管道，消除皱褶并将OCT微探头稳定于球囊中心；所述充放气设备主要用于扩张球囊导管。
优选地，所述OCT微探头包括弹簧管，此弹簧管能提供足够的扭力，使一定长度的探头在旋转时保持远近两端同步，并且此弹簧管中穿插有传递光信号的单模光纤；透镜组件，使通过光纤传播的光聚集在预定的工作距离处，所述透镜组件包括玻璃棒和自聚焦透镜，通过改变玻璃棒与单模光纤的胶合距离可 以改变OCT微探头的工作距离，同时能够提高OCT探头的横向分辨率；通过自聚焦透镜与玻璃棒的胶合，增大自聚焦透镜的通光孔径，进而提高OCT探头的数值孔径和横向分辨率，并优化探头的物理尺寸。所述OCT微探头还可包括反射镜、支撑不锈钢管和开槽不锈钢管，这些光学元件端面用光学胶水胶合。
其中，所述单模光纤一端带有光纤标准接头，此接头可与OCT系统的光纤旋转端相连接，所述单模光纤套在弹簧管中(覆有PTFE膜)，弹簧管可以有效保护单模光纤，降低了探头旋转时的阻力，使所述OCT微探头整体扫描更平稳顺畅，所述光纤标准接头带有支撑不锈钢管，此不锈钢管在OCT微探头进行扫描时起支撑作用，使整个探头旋转扫描时更加平稳。所述单模光纤的另一端为斜面，与同样也为斜面的玻璃棒一端端面胶合，胶合面的倾斜有效降低了反射光对信号光的干扰，可以通过改变玻璃棒与单模光纤的胶合距离来改变OCT微探头的工作距离以达到所要求的预期工作距离。所述玻璃棒的另一端与所述自聚焦透镜以0°角端面胶合后封装于开槽不锈钢管内，通过改变自聚焦透镜的长度，从而改变OCT探头的工作距离，实现在指定工作距离的条件下获得最佳横向分辨率，而通过增加所述玻璃棒长度能够增大OCT探头的数值孔径，从而提高横向分辨率，即玻璃棒的使用不仅增加了微探头的工作距离，并且增大了微探头的数值孔径，而数值孔径的增加也导致横向分辨率的提高，同时这一设计也极大的减短了自聚焦透镜的长度，保证了微探头的过弯性，使得整个微探头可以通过内镜钳道与导管一起直接进入人体食道。所述反射镜可以将前向的光线变为侧向，且所述反射镜为柱面反射镜，可以改变OCT探头外的保护套管对聚集光束造成的散光影响。所述自聚焦透镜与所述玻璃棒胶合，其中自聚焦透镜与空气接触的面镀有增透膜，可降低光线在光学面之间的反射及增加透光性能，从而降低了由于光学面的反射光对信号光的影响，提高了OCT微探头的灵敏度，所述自聚焦透镜与空气接触的面可加工成4°-8°斜面，此设计可进一步降低光线通过此面所形成的干扰信号。所述单模光纤与玻璃棒的胶合斜面的角度为4°～12°。所述反射镜的反射面朝向不锈钢管开槽口封装于不锈钢管内，为了降低光源通过圆柱形内管的散光对成像的影响，此处的反射镜可以根据圆柱形内管的内外径以及内管材料的折射率而设计柱面反射镜，当添加该反射镜后，在光线入射反射镜的时候不仅会对光线的光路进行反射而改变，同时由于反射镜特殊设计的镜面会对光线进行汇聚，从而抵消内管的散光影响，校正光 斑的形状，达到提高成像质量的目的。
优选地，充放气设备应用于所述OCT内窥扫描成像系统，即包括扫频激光模块、干涉模块、探测器模块、数据采集模块、数据处理模块、图像显示模块、执行机构、球囊导管、OCT微探头，以及充放气设备、所述充放气设备为自动充放气设备，所述自动充放气设备包括：控制和显示模块、气泵、充气电磁阀、放气电磁阀、压力传感器、防爆压力传感器、机械压力开关。所述自动充放气设备应用于OCT内窥扫描成像系统可实现自动充放气及精确的气压控制，其中，气泵通过充气电磁阀以及放气电磁阀与该节流阀相连，该节流阀与前述球囊相连，该压力传感器为多个，其中至少一压力传感器与球囊相连，至少一压力传感器设置在节流阀与充气电磁阀、放气电磁阀之间，该防爆压力传感器与球囊相连，该机械压力开关与该球囊相连，控制和显示模块能够设定球囊气压和充气时间、采集压力、控制气泵启停、控制电磁阀工作状态；
该自动充放气设备的使用过程包括：
充气过程，在控制和显示模块设定球囊气压和充气时间，气泵充气直到设定的气压值；
放气过程，在控制和显示模块设定球囊气压和放气时间，气泵吸气直到设定的气压值；
在所述充放气过程中，系统通过防爆压力传感器进行过压保护，当球囊超过设定气压时关闭气泵以及当球囊超过设定气压时通过机械压力开关泄压。
所述自动充放气设备实现了自动充气和吸气，且具有设定不同气压参数的功能，可对不同规格的球囊进行充放气，设备在给球囊充气过程中达到设定的气压值后停止充气，且具有过压保护功能。其可实现的效果在于：首先，免去了医生对球囊手动充放气的操作，缩短了医生充放气的时间，并提高了安全性，避免了球囊过充爆炸的风险；其次，精确的气压控制使球囊充气后的形状一致性得到保证，由于光学成像对于球囊撑起的被扫描物体的形状敏感，这就对同一个被扫描对象进行多次扫描的重复性较好，医生可对于扫描后的图像数据进行比对；再次，在紧急情况处理时，可实现自动放气的同时医生做其他的操作。
优选地，所述OCT内窥扫描成像系统包括由所述干涉模块、所述探测器模块和光学时钟转化电路模块组成的光学时钟模块，其中，干涉仪模块可采用全光纤式马赫-曾德尔干涉仪(MZI)结构，主要由两个光纤耦合器构成，其中第 二个耦合器为对称式2×2光纤耦合器，首先在第一光纤耦合器处分成两路光，该两路光分别经过两段固定光程差的第一光纤和第二光纤，在第二光纤耦合器处发生干涉。探测器模块可采用高速平衡光电探测器，主要用于将从干涉模块输出的干涉光学信号转换成电学信号。从MZI产生的光学干涉信号由一个平衡光电探测器转换为电学信号后，经过光学时钟转化电路模块，即依次经过宽频90度移相器、过零比较器、异或门、或门以及光学时钟信号输出模块而转换为在频域上均匀、在时域上变频率的光学时钟信号。其中，宽频90度移相器主要用于将MZI电学信号的相位移动90度，可增加原始信号的可用的频谱区间宽度，丰富采样时钟信号的频谱分布资源，对获取的采样时钟信号进行优化。过零比较器主要用于对原始MZI电学信号和移相后的MZI电学信号进行过零比较以转换为数字信号，而MZI信号的零点在频域上均匀分布，因此过零比较后产生的数字信号的上升沿或下降沿也在频域上均匀分布，异或门主要用于将两个数字时钟信号进行合并，以获得在一个自由光谱区(FSR)中产生两个时钟信号，这样在不增加FSR前提下增加了OCT最大成像深度，减少了由光学信号产生的抖动(jitter)。而且由于扫频激光器在两个相邻扫描之间总是存在一些空闲时间，光学时钟信号还需要通过一个或门在空白处填入一些假的时钟信号以保证高速模数采集卡可以正常工作，或门实现了将真实光学时钟信号与假的时钟信号合并的功能，光学时钟信号输出模块主要用于将合并后的真实光学时钟信号与假的时钟信号输送到数据采集模块。通过在OCT内窥扫描成像系统中使用所述的光学时钟模块，可降低对数据采集与处理系统的要求，并减少冗余信息的采集，减轻存储系统的负担，从而提高整个OCT系统的集成度，进而降低系统成本，且还可以提高图像信号的信噪比，减少探测灵敏度衰减，从而提高图像的清晰度。
优选地，利用通用图像处理器(GPGPU)在OCT内窥扫描成像系统中处理OCT信号的方法，该方法包括(1)数据采集；(2)数据传输；(3)数据处理；和(4)传递至图像显示库四个步骤。
其中，(1)数据采集，本发明通过外部采集设备获取FD-OCT原始数据；
(2)数据传输，在数据采集步骤获得的FD-OCT原始数据被放置在计算机系统或嵌入式系统内存中，这些数据在系统内存中以帧为单位存放，当满足一定条件后(如数据积累够一帧或多帧)，这些数据可以通过数据总线(如PCI Express)传输至通用图像处理器的设备内存中；由于总线传输速度相对较慢，在传输数据的同时，通用图像处理器将上一次传输至设备内存中的OCT原始数据进行并行处理。该种方法具有高效的并行信号处理能力，可实现实时数字信号处理，极大的提高了传输效率，节省了总线资源；
(3)数据处理，在通用图像处理器中进行的数字信号处理分为三步：一维数字重采样、一维快速傅立叶变换(FFT)以及计算幅值并归一化。其中一维数字重采样步骤中通过两次线性纹理查找实现快速一次一维三次插值以提高重采样的精度；
(4)传递至图像显示库，处理好的数据放置于图像显示库的内存中，图像显示库可以直接调用，无需再通过总线传输，极大的提高了传输效率，节省了总线资源，具有高效的并行信号处理能力，实现实时数字信号处理，可移植性高，由于与流行的图像显示库可以无缝结合，也提高了软件显示的灵活性(例如：还可以通过通用图像处理器对图像进行后处理)，可实现较低的硬件与软件开发成本。
附图说明
图1是本发明的球囊导管结构示意图；
图2是加入膜套的球囊
图3是内管与球囊偏心程度在500微米左右的成像效果
图4是内管与球囊偏心程度小于500微米左右的成像效果
图5是内管与球囊偏心程度超过500微米左右的成像效果
图6是市面上某产品同心度扫描结果
图7是本发明的具有球囊导管的OCT内窥扫描成像系统示意图；
图8是本发明的OCT微探头实物部件图；
图9a和9b是本发明的OCT微探头关键部位放大剖面图；
图10是本发明的充放气设备结构示意图；
图11是本发明的充放气设备工作流程图；
图12是本发明的光学时钟模块示意图；
图13是本发明的光学时钟信号发生过程示意图；
图14是本发明的具有光学时钟模块的OCT内窥扫描成像系统示意图；
图15是本发明的FD-OCT信号处理步骤；
图16是本发明的GPGPU数据传输与信号处理并行发生示意图；
图17是本发明的整体实施结构示意图；
图18是本发明的OCT微探头工作距离、胶合距离与横向分辨率曲线关系图；
图19是本发明的健康动物食管扫描图；
图20是本发明的健康动物食管扫描图局部放大图；
图21是本发明的健康动物食管3D图像。
附图标号说明
1、单模光纤，2、弹簧管，3、玻璃棒，4、自聚焦透镜，5、反射镜，6、开槽不锈钢管，7、支撑不锈钢管，8、软头，9、内管，10、球囊，11、双腔管，12、手柄，13、通气接口，14、主机接口，15、膜套，
81、鳞状上皮层(SE)，82、固有层(LP)，83、肌粘膜(MM)，84、粘膜下层(SM)，85、固有基层(MP)，
91、经宽频90度移相器后发生90度相位移动的MZI电学信号，92、未发生相位移动的MZI电学信号，93、信号91进行过零比较后的数字信号，94、信号92进行过零比较后的数字信号，95、假的时钟信号，96、数字信号93和94经异或门合并之后的信号，
101、气泵，102、充气电磁阀，103、压力传感器，104、节流阀，105、压力传感器，106、防爆压力传感器，107、放气电磁阀，108、机械压力开关。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
下面结合附图和实施方式对本发明作进一步说明，但本发明绝不限于下述实施例。
实施例1
如图1所示，一种OCT内窥扫描成像系统的球囊导管，包括手柄12，手柄12的一个接口为主机接口14，另一接口为通气接口13；双腔管11，可以允许OCT光学探头通过；球囊10，球囊10的前端封堵且球囊上有刻度，其前端封堵是一实心焊接结构，其阻塞套设在内管之内，当设备在腔体内移动时，腔体 与内管和球囊进行摩擦，不会接触到该封堵软头，即使接触到软头，摩擦力会趋向于将软头压入内管；内管9，内管9与球囊10的同心度在额定使用的大气压下偏离不超过500微米；膜套15，如图2所示，所述膜套位于球囊与双腔管接合处，控制内管在管腔里面的浮动，从而保证与球囊的中心不发生偏离，解决偏心问题；软头8，为实心结构，其中，双腔管11一端与手柄12连接，另一端与内管9及球囊10的一端连接，球囊10与内管9的另一端与软头8连接，双腔管11通过UV粘胶与手柄12相连，其他各部分均通过焊接的方式相连。
手柄12材料为聚碳酸酯，双腔管11和软头8材料为嵌段聚醚酰胺，球囊10和内管9材料为尼龙及其改性聚合物。
球囊10上有油墨印刷刻度，线条宽度≤0.1mm，能够辨别探头扫描的方向，既不会影响正常图像的扫描判断同时也能在显示屏上分辨出扫描位置。双腔管11上印有刻度，因此，医生能够判断扫描的位置。
传统的球囊导管需要导丝支撑及导引，导丝直径一般为0.018in、0.035in、0.014in、0.038in，本实施例中OCT球囊导管用的双腔管11可以通过0.055inOCT光学探头。进行光学成像时，探头发出的探测光束需要穿过内管壁进而达到被测对象，此外，OCT探头成像时还需要在内管内转动，以便对被测对象全面探测。在这一过程中，如果内管壁过厚，由于探测光在穿过内管壁的时候会造成衰减，导致探测光能量损失，造成成像不清晰；如果内管壁过薄，由于OCT探头会在内管内部高速转动，太薄的管壁会导致探头卡顿，内管变形，使得成像不均匀，因此本申请对内管的内径和外径进行了限定，以此确定内管的厚度，本实施例中内管9内径为1.4mm，外径为1.65mm，专门为OCT探头设计。这一内管厚度对于OCT探头成像最为合适，能够保证在这一厚度之下光能量衰减较小，同时保证内管的强度，不会因探头卡顿、内管变形导致成像不均匀和不清晰的问题。
所述内管长度根据所述球囊的长度定长，且其长度短于所述球囊，所述球囊与所述软头焊接时，将所述球囊下推一定距离，使其与内管平齐并固定后焊接，使得球囊在充盈时有一个伸长余量，从而匹配内管的拉伸并保持同心。
在进行光学成像时，需要球囊撑开被测对象所在的腔道，以便成像完全，如果气压较低，球囊表面会形成褶皱，这必然会影响成像效果，但是如果气压过高，可能会对被测对象造成损伤和破坏，因此，为了保证设备使用时不对被 测对象造成损伤和破坏，同时保证球囊能够完全充盈不产生褶皱，申请人优选了额定使用大气压为3个大气压，所述内管与所述球囊的同心度在3个大气压下偏离不超过500微米。另外，这一指标也能对球囊的长度以及内管长度起到限定作用。本申请球囊的工艺能保证其在3个大气压下内管与球囊的同心度偏离不超过500微米，以便于光学成像。
若内管与球囊的同心度偏离不超过500微米，则成像效果较好，若内管与球囊若偏离程度超过500微米，则呈现出的图像显示不全。图3为偏心度在500微米左右的一个标准圆，图4和图5分别为内管与球囊偏心程度小于500微米和偏心程度超过500微米时扫描出来的图像。从以上两幅图来看，偏心程度小于500微米则能够符合成像完全的要求。相比之下，市面上一般产品对该指标没有加以控制，不能达到内管与球囊的同心度在3个大气压下偏离不超过500微米的要求，我们选取市面上一个产品作为对比，其成像效果如图6所示，其中右上角区域成像不完全，不能满足实际扫描要求。
实施例2
一种如实施例1中所述的球囊导管的使用方法，步骤包括：
1.内窥镜通过人体自然腔道进入人体。
2.将带有OCT光纤探头的球囊导管插入内窥镜钳道。
3.将球囊推送至需扫描的部位。
4.将手柄导丝腔接头与OCT设备上的接头拧紧，充气接口与自动充气泵接头拧紧。
5.点击设备软件上的充气按钮进行充气。
6.充气结束后点击软件上的扫描按钮进行图像扫描。
7.扫描结束后点吸气按钮。
8.吸气结束后将球囊导管撤回内窥镜。
实施例3
如图7所示，一种OCT内窥扫描成像系统，包括扫频激光模块、干涉模块、探测器模块、数据采集模块、数据处理模块、图像显示模块、执行机构、OCT微探头、充放气设备、以及图1所示的球囊导管，其中，
所述扫频激光模块包括高速扫频激光器、光纤隔离器与光纤耦合器，将从扫频激光器输出的光学信号与后续光路隔离，防止后续光路返回的光学信号干 扰激光器正常工作；所述干涉模块可采用光纤式马赫—曾德尔干涉仪(MZI)或光纤式迈克尔逊(Michelson)干涉仪结构。其中马赫—曾德尔干涉仪结构主要由两个光纤耦合器、两个光纤环形器以及两个光纤偏振控制器组成，其中第一个光纤耦合器一般采用非对称式光纤耦合器，将大部分激光输出至样品臂的微探头；在参考臂与样品臂中均放置一个光纤环形器以收集从两个臂反射或散射回的光学信号；第二个光纤耦合器可采用对称式2×2光纤耦合器(即分光比为50/50)以产生光学干涉信号并降低直流共模信号，光纤偏振控制器被对称的放置在参考臂与样品臂中，用于调整两个臂的偏振状态以获得最佳的光学干涉信号。迈克尔逊干涉仪结构则由一个对称式2×2光纤耦合器、一个光纤环形器以及两个光学偏振控制器组成，扫频激光首先经过光纤环形器后在进入光纤耦合器，从参考臂与样品臂反射或散射回的光学信号在经过同一个光纤耦合器产生干涉信号，光纤偏振控制器被对称的放置在参考臂与样品臂中，用于调整两个臂的偏振状态以获得最佳的光学干涉信号。马赫—曾德尔干涉仪(MZI)的优点在于结构对称、色散管理简单、探测灵敏度高。迈克尔逊(Michelson)干涉仪的优点在于结构简单、且不会引入偏正模色散(PMD)，两者的共同之处在于两个臂中间的光程差决定了发生光学时钟的自由光谱区(FSR)，也最终决定了OCT图像的最大成像深度；探测器模块可采用高速平衡光电探测器，主要用于将从干涉模块输出的干涉光学信号转换成电学信号；所述数据采集模块是高速模数采集卡，主要用于将模拟电学信号转换成数字电学信号，并将数字信号提供给数据处理模块进行数字信号处理；所述数据处理模块是具有数字信号处理能力的芯片(如CPU，GPGPU、DSP、FPGA等)，主要用于对原始信号进行处理并转化为最终的图像信号；所述图像显示模块主要用于显示图像信号并负责图像的后处理以及测量工作；所述执行机构由光纤旋转连接器、电机以及电动平移台组成，主要用于驱动OCT微探头机械螺旋扫描以获得OCT图像；所述OCT微探头主要用于进入人体内部脏器以传输扫频激光并采集从生物组织中背向散射的光学信号；所述球囊导管用于扩张人体内部脏器管道，消除皱褶并将OCT微探头稳定于球囊中心；所述充放气设备主要用于扩张球囊导管。
实施例4
一种OCT内窥扫描成像系统，与实施例3相似，所不同的是所述的OCT微探头如图8和图9a和9b所示：弹簧管2中套有单模光纤1，此弹簧管2能提 供足够的扭力，使一定长度的探头在旋转时保持远近两端同步，弹簧管2在有效保护脆弱的光纤的同时，降低了探头旋转时的阻力；玻璃棒3一端与自聚焦透镜4零度角面胶合，另一端与单模光纤1倾斜胶合，可以通过改变玻璃棒3和单模光纤1两个端面的胶合距离来改变OCT探头的工作距离以达到预期所要求的工作距离，进而提高OCT探头的数值孔径和横向分辨率；反射镜5为柱面反射镜并封装于开槽不锈钢管6内，反射镜5的反射面朝向开槽不锈钢管6的开槽口，可以降低光源通过圆柱形内管的散光对成像的影响。
如图8和图9a和9b，一种OCT内窥扫描成像系统的OCT微探头，包括单模光纤1，弹簧管2，玻璃棒3，自聚焦透镜4，反射镜5、开槽不锈钢管6以及支撑不锈钢管7，这些光学元件端面用光学胶水胶合。具体而言，将反射镜5装入开槽不锈钢管6中，然后放在工装上点A/B胶，再在显微镜下点UV胶，将玻璃棒3和自聚焦透镜4组装；将单模光纤1穿入弹簧管2中，再将组装好的玻璃棒3和自聚焦透镜4、单模光纤1和弹簧管2使用点UV胶组装，最后将组装后的弹簧管总成装进开槽不锈钢管6中，边缘空隙处使用A/B胶填满。
单模光纤1外部套有不锈钢弹簧管2(覆有PTFE膜)，在有效保护脆弱的光纤的同时，降低了探头旋转时的阻力，使微探头扫描起来更平稳顺畅。支撑不锈钢管7的主要作用是在OCT探头进行扫描时起支撑作用，使整个探头旋转扫描时更加平稳，开槽不锈钢管6的槽口可以使光束通过此槽口照射到被测样品上。
增透膜可以降低光线在光学面之间的反射及增加透光性能，从而降低由于光学面的反射光对信号光的影响，因此，本实施例中，通过改变自聚焦透镜的长度，可改变OCT探头的工作距离，实现在指定工作距离的条件下获得最佳横向分辨率，自聚焦透镜4与空气接触的面镀有增透膜，另外，自聚焦透镜与空气接触的面可加工成4°-8°斜面，此设计可进一步降低光线通过此面所形成的干扰信号，图9a与图9b的区别在于：自聚焦透镜4有无做出射面倾斜角度设计，图9b做了出射面倾斜4°-8°设计，这一设计使此面反射回去的无用光信号降到最低，提高了OCT探头的成像质量。同时玻璃棒3一端与自聚焦透镜4零度角面胶合，提高了微探头的灵敏度和分辨率。玻璃棒3的另一端与单模光纤1的胶合面有一定倾斜角度，在本实施例中，此处胶合面的倾斜角度可为8°，胶合面的倾斜有效降低了反射光对信号光的干扰，玻璃棒3的设计使用， 增大OCT探头的数值孔径，从而提高横向分辨率，并且，可以通过改变此两个端面的胶合距离来改变OCT探头的工作距离以达到预期所要求的工作距离。由于45°角安装反射镜5，使得入射光线和反射光线垂直从而造成光线干扰，本实施例中微探头前端安装40°角反射镜5，反射镜5封装于开槽不锈钢管6内且反射面朝向开槽不锈钢管6的开槽口，同时为了降低光源通过圆柱形内管的散光对成像的影响，本实施例中此处的反射镜是根据圆柱形内管的内外径以及内管材料的折射率而设计柱面反射镜，所述反射镜可以将前向的光线变为侧向，且所述反射镜为柱面反射镜，可以改变OCT探头外的保护套管对聚集光束造成的散光影响。
实施例5
一种OCT内窥扫描成像系统，与实施例3或4相似，所不同的是所述充放气设备是自动充放气设备，如图10所示，所述自动充放气设备包括：电源部分、控制和显示部分和气泵及其控制系统部分，所述气泵及其控制系统部分包括：气泵、充气电磁阀、放气电磁阀、节流阀、压力传感器、防爆压力传感器、机械压力开关。
本申请的压力传感器为多个，其中至少一压力传感器与球囊相连，至少一压力传感器设置在节流阀与充气电磁阀、放气电磁阀之间，所述压力传感器的作用是在充放气过程中对管路气压和球囊气压实时进行监测。其中压力传感器是由103、105两个压力传感器组成，其配合本申请中的多个电磁阀组件共同构成充放气过程的压力检测系统，具体结构为：气泵101与压力传感器103之间设有充气电磁阀102和放气电磁阀107，压力传感器103、105被节流阀104隔开的，压力传感器105与球囊相连。通过这种结构设置，可以达到如下三点功效：
(1)设置103、105两个压力传感器，经节流阀104进行分隔后，压力传感器105直接与球囊相连，获取的数据更为准确，而对于压力传感器103，其一来可以监测管路气压与105气压进行校对，再者在进行充放气过程中，在充气电磁阀102和放气电磁阀107打开后，节流阀104打开前，可以对气泵的充放气压强起到预警监测的作用，如压强有问题可以通过自动控制及时关闭电磁阀，防止过强的充放气压对球囊甚至病人的体腔造成不必要的损害，极大加强了系统的安全性。
(2)压力传感器103、104均是通过电磁阀与气泵和外界相连，通过电磁阀隔离了气泵及外界气压对其压力监测的干扰。
(3)对球囊以及官路气压进行双重监测，即使单个传感器故障系统仍能正常工作，增强系统稳定性。
本申请的压力监测系统还包括一与球囊相连的防爆压力传感器，该防爆压力传感器的作用是在充放气过程中实时对气压进行监测，其监测数据与压力传感器是独立的，当监测数据超过预设的气压值上限会启用泄压保护机制，若监测数据长时间不变，其会阻止气泵继续加压。本申请的压力监测系统分为压力传感器和防爆压力传感器，其通过设置多个传感器的方式实现了对气压的多重监测，增强了系统的稳定性；另外，不同的传感器设置在不同的位置相互之间还可以进行校对验证，传感器之间还有电磁阀进行隔离避免了充放气设备、泄压设备对压力测量的干扰，提高压力测量的准确性；最后，多个压力传感器配合电磁阀行程压力监测系统在自动控制功能的支持下，能防止过强的充放气压对球囊甚至病人的体腔造成不必要的损害，增强了系统的安全性。
如图11所示，所述自动充放气设备的使用过程包括：
1)充气过程：首先用户设定球囊10气压、充气时间等参数，发出充气命令，控制系统读取压力传感器103、105的数据，如果小于用户设定的气压，则启动气泵101，打开充气电磁阀102、节流阀104，充气过程中实时读取压力传感器103、105的反馈值，直到充到设定的气压值，关闭气泵101，关闭节流阀104、充气电磁阀102；
2)放气过程：首先用户设定球囊10气压、放气时间等参数，控制系统读取压力传感器105的数据，如果大于用户设定的气压，则启动气泵101，打开放气电磁阀107、节流阀104，放气过程中实时读取压力传感器105的反馈值，直到吸到设定的气压值，关闭气101泵，关闭节流阀104、放气电磁阀107。
充放气过程中，系统实时对防爆压力传感器106的反馈值进行监控，如果超过用户气压上限设定值，则立即进行软件程序保护，关闭气泵101，并报警；机械压力开关108为硬件保护，如超过设定值，则开关打开，泄压进行保护。
泄压保护机制是通过自动控制功能引导整个充放气设备系统实现的，其通过防爆压力传感器来监测触发，通过三种途径实施：其一，软件保护，即当防爆压力传感器监测到压力超限，会关闭气泵充气功能，同时关闭充气电磁阀， 如有必要，还会打开节流阀及放气电磁阀由气泵主动抽气泄压，该过程中压力传感器会配合进行压力监测，当压力正常后，会关闭电磁阀和气泵结束软件保护泄压，以防过度泄压导致危险；其二，硬件保护，在防爆压力开关监测到压力超限后，机械开关会自动打开进行泄压保护；其三，泄压阀保护，当设备不能正常运转时还可以通过打开泄压阀上的开关进行手动泄压。本申请结合防爆压力传感器对系统的过压风险提供了软件保护、硬件保护及泄压阀保护三重保护途径，实现了加强系统的安全性、稳定性，提升泄压系统准确度的功效。
此外，本申请的自动充放气设备还具备以下优势：
1、可以由用户随时在控制与显示模块上设置需要的压力值及充气时间等参数，并将相关参数实时上传至数据系统，系统会即时根据新的参数对系统进行监控、操作，能够操作过程中的各种突发状况进行及时应变，加强系统安全性。同时，精确的气压控制使得球囊充气后形状一致性较高，使得对扫描对象多次获取图像数据相关度更高，更容易进行对比。
2、因为气泵长时间工作气压没有变化或变化较小极有可能是球囊破裂或者漏气，如果保持气泵继续充气或者抽气可能会对病人的体腔造成伤害，因此若压力系统监测到气泵长时间充气或放气时气压一直没有变化或变化较小，则会自动启动保护机制，关闭气泵，加强系统安全性。
3、本申请能够通过自动控制的方式实现快速开闭电磁阀，减小充放气对监测系统的干扰，增加监测系统准确度。
4、本申请充气与抽气是两个不同的通道，可以快速的在充放气两个过程之间切换，尤其是在泄压保护过程中，快速的抽气能够够好的防止过度充气对球囊和病人体腔的损害，加强系统安全性。
5、本申请采用自动充放气气泵，其充气压力范围较大，根据本申请所采用的体腔环境，压力范围一般控制在1～5个大气压。而手动供压所能提供的气压压力范围远小于本申请的压力范围。
实施例6
如图12所示，一种在OCT内窥扫描成像系统中使用的光学时钟模块，其包括干涉模块、探测器模块和光学时钟转化电路模块，所述光学时钟转化电路模块包括宽频90度移相器、过零比较器以及异或门、或门组成的电路以及光学时钟信号输出模块。其中，干涉模块采用全光纤式马赫-曾德尔干涉仪(MZI) 结构，主要由两个光纤耦合器构成，其中第二个耦合器为对称式2×2光纤耦合器，首先在第一光纤耦合器处分成两路光，该两路光分别经过两段固定光程差的第一光纤和第二光纤，在第二光纤耦合器处发生干涉。探测器模块由高速平衡光电探测器组成，主要用于将从干涉模块输出的干涉光学信号转换成电学信号。经探测器模块转换后的MZI电学信号一部分传输到宽频90度移相器，另一部分传输到过零比较器，传输到宽频90度移相器的电学信号发生的90度的相位移动，过零比较器主要用于对发生相位移动和未发生相位移动的信号进行过零比较以转换为数字信号。异或门主要用于将两个数字时钟信号进行合并，以获得在一个自由光谱区(FSR)中产生两个时钟信号，这样在不增加FSR前提下增加了OCT最大成像深度，减少了有光学信号产生的抖动(jitter)。由于扫频激光器在两个相邻扫描之间总是存在一些空闲时间，光学时钟信号还需要通过一个或门在空白处填入一些假的时钟信号以保证高速模数采集卡可以正常工作，或门实现了将真实光学时钟信号与假的时钟信号合并的功能。光学时钟信号输出模块主要用于将合并后的真实光学时钟信号与假的时钟信号输送到数据采集模块。
如图13所示，91为经宽频90度移相器后发生90度相位移动的MZI电学信号，92为未发生相位移动的MZI电学信号，93为发生相位移动的MZI信号91进行过零比较后的数字信号，94为未发生相位移动的MZI信号92进行过零比较后的数字信号，因MZI信号的零点在频域上均匀分布,因此过零比较后产生的数字信号的上升沿或下降沿也在频域上均匀分布，96为频域上分布均匀的数字信号93和94经异或门合并之后的信号，95为假的时钟信号，95和96共同组成经或门合并之后的光学时钟信号。
如图14所示，一种OCT内窥扫描成像系统，与实施例3-5相似，所不同的是包括扫频激光模块、光学时钟模块、数据采集模块、数据处理模块、图像显示模块、执行机构、OCT微探头与球囊导管以及充放气设备，其中：所述的光学时钟模块如图12所示，包括干涉模块、探测器模块和光学时钟转化电路模块，所述光学时钟转化电路模块包括宽频90度移相器、过零比较器以及异或门、或门组成的电路以及外部时钟信号输出模块，从MZI产生的光学干涉信号由一个平衡光电探测器转换为电学信号后，经过一个由宽频90度移相器、过零比较器以及异或门组成的电路而转换为在频域上均匀、在时域上变频率的光学时钟 信号，或门将真实光学时钟信号与假的时钟信号合并以高速模数采集卡的正常工作。
所述扫频激光模块包括有高速扫频激光器、光纤隔离器与光纤耦合器，将从扫频激光器输出的光学信号与后续光路隔离，防止后续光路返回的光学信号干扰激光器正常工作，并将一小部分扫频激光输出分出至光学时钟模块，大部分激光继续输出；所述光学时钟模块包括干涉模块、探测器模块和光学时钟转化电路模块，主要用于获得在频域上均匀、在时域上变频率的光学时钟信号；所述数据采集模块可采用高速模数采集卡，主要以光学时钟模块输出的光学时钟信号为基准采集原始图像信号，并提供给数据处理模块进行处理；所述数据处理模块是具有数字信号处理能力的芯片(如CPU，GPGPU、DSP、FPGA等)，主要用于对原始信号进行处理并转化为最终的图像信号；所述图像显示模块主要用于显示图像信号并负责图像的后处理以及测量工作；所述执行机构由光纤旋转连接器、电机以及电动平移台组成，主要用于驱动OCT微探头机械螺旋扫描以获得OCT图像；所述OCT微探头主要用于进入人体内部脏器以传输扫频激光并采集从生物组织中背向散射的光学信号；所述球囊导管用于扩张人体内部脏器管道，消除皱褶并将OCT微探头稳定于球囊中心；所述充放气设备主要用于扩张球囊导管。
实施例7
一种OCT内窥扫描成像系统，与实施例3-6相似，所不同的是利用通用图像处理器处理OCT信号的方案如图15所示，包括依次相连的(1)数据采集；(2)数据传输；(3)数据处理和(4)传递至图像显示库这几个步骤，其中在数据传输时由于总线传输速度相对较慢，在传输数据的同时，通用图像处理器将上一次传输至设备内存中的OCT原始数据进行并行处理，其并行传输与处理过程如图16所示；数据处理的过程分为三步：一维数字重采样、一维快速傅立叶变换(FFT)以及计算幅值并归一化，其中，一维数字重采样步骤中通过两次线性纹理查找实现快速一次一维三次插值以提高重采样的精度。
如图15所示，一种利用通用图像处理器处理OCT信号的方案包括依次相连的(1)数据采集；(2)数据传输；(3)数据处理和(4)传递至图像显示库这几个步骤。
其中，(1)数据采集，本发明通过外部采集设备获取FD-OCT原始数据；
(2)数据传输，在数据采集步骤获得的FD-OCT原始数据被放置在计算机系统或嵌入式系统内存中，这些数据在系统内存中以帧为单位存放，当满足一定条件后(如数据积累够一帧或多帧)，这些数据可以通过数据总线(如PCI Express)传输至通用图像处理器(GPGPU)的设备内存中；由于总线传输速度相对较慢，在传输数据的同时，通用图像处理器将上一次传输至设备内存中的OCT原始数据进行并行处理。
例如：如附图16所示，当第n帧的原始数据被传输至通用图像处理器设备内存的同时，第n-1帧的原始数据同时在通用图像处理器中被进行数字信号处理，并在数据传输和处理结束后进行帧同步，即不管是数据传输还是数据处理完成的一方将等待后完成的一方结束后再进行下一帧的操作，通过这种并行信号传输/处理模型可以有效的提高通用图像处理器的数据处理速度。
(3)数据处理，如图15所示，在通用图像处理器中进行的数字信号处理分为三步：一维数字重采样、一维快速傅立叶变换(FFT)以及计算幅值并归一化。其中数字重采样可以通过图像处理器(GPU)内置的纹理查找功能实现，图像处理器内置的纹理查找功能对插值可以自动实现二维线性插值，而且图像处理器的纹理查找模块对插值具有特殊的硬件优化，相对于一般的通用图像处理器插值速度更快，特别是针对OCT信号处理中的非等距插值；通过精确设置一个维度上的查找点，可以通过图像处理器内置的纹理查找功能实现一维线型插值。在此基础上，通过两次线性纹理查找实现快速一次一维三次插值，从而以提高重采样的精度，由于纹理查找模块对非等距插值进行了特殊优化，这种方法比直接的三次插值在通用图像处理器上实现起来计算量更小、计算效率更高；FFT可以通过常见的商用基于图像处理器的数值计算库(如nVidia的cuFFT库或OpenCL FFT库)实现；计算幅度并归一化则可以通过自己编写图像处理器程序实现，例如可以使用nVidia提供的CUDA库来编写相应的核函数(kernel function)实现对二维数据的快速遍历以实现幅值与归一化计算。
(4)传递至图像显示库，处理好的数据放置于图像显示库的内存中，图像显示库可以直接调用，无需再通过总线传输，极大的提高了传输效率，节省了总线资源，具有高效的并行信号处理能力，实现实时数字信号处理，可移植性高，由于与流行的图像显示库可以无缝结合，也提高了软件显示的灵活性(例如：还可以通过通用图像处理器对图像进行后处理)，可实现较低的硬件与软件 开发成本。
实施例8
如图17所示，一种用于人体食管进行OCT成像扫描的微探头，将微探头从球囊近端手柄导丝腔插入直至球囊内管9中，将球囊手柄通气接口13连接到自动充气泵(图中未示出)，将球囊10内充气到额定气压，以便于将食道扩展开，所述球囊10及内管9都是光学透明材料制成，具有极好的透光性能。球囊10的作用是扩展食道以减小食道折皱及将OCT微探头固定在其工作距离范围之内。球囊10扩展的半径大约在8-10mm之间，这也是食道完全展开后的半径，因此，一个相对较大的工作距离(大约在8-10mm)是OCT微探头所必须具有的特性。在工作距离较大时OCT微探头需要选择较长的自聚焦透镜，其不易于弯折，在体腔内使用时会造成诸多不便，而且过度弯折时会导致透镜碎裂，存在安全隐患。因此通过设置玻璃棒改变自聚焦透镜的工作距离，使其成为多节结构，能够保证微探头具有更好的过弯性，使得整个微探头在工作距离较大时仍可以进入狭窄的通道。
本实施例中特别设计了玻璃棒3，前述中已经提及改变玻璃棒3与单模光纤1的胶合距离可以改变微探头的工作距离，此例微探头用于人体食道，工作距离大约在8-10mm，通过计算和测试玻璃棒3和单模光纤1两面的胶合距离应小于0.3mm。玻璃棒3的设计应用不仅使OCT微探头能工作在较长的工作距离范围内，还能改变微探头的数值孔径和横向分辨率，从而使得改变玻璃棒与单模光纤的胶合距离加大工作距离的同时能够增大数值孔径并提高微探头的横向分辨率。
数值孔径与光学元件的通光孔径关系如下：
Figure PCTCN2016081352-appb-000001
其中，D为光学元件的通光孔径，W.D为工作距离，N.A为数值孔径，当工作距离W.D.一定时，数值孔径与光学元件的通光孔径(D)成正比，由于自聚焦透镜本身加工工艺的缺陷，通光孔径只能达到其直径的80％左右，但是由于单模光纤较细，在实际应用中通过单模光纤直接连接自聚焦透镜所能实际使用的通光孔径仅有自聚集透镜自身直径10％不到，为了增大自聚焦透镜实际使用的通光孔径，本申请加入了该玻璃棒，由于光在玻璃棒中会进行扩散传输， 使玻璃棒对光线起到了扩束作用，增大了光纤通过自聚焦透镜时实际使用的通光孔径。
分辨率和数值孔径的关系如下：
Figure PCTCN2016081352-appb-000002
其中，λ为入射光波长是定值，横向分辨率△X正比于数值孔径(N.A)，即数值孔径越大，横向分辨率越高(数值越小)。
综上可知，玻璃棒3的使用不仅增加了微探头的工作距离，并且增大了微探头的数值孔径，而数值孔径的增加也导致横向分辨率的提高，同时这一设计，也极大的减短了自聚焦透镜的长度，保证了微探头的过弯性，这样整个微探头仍然可以通过内镜钳道与球囊导管一起直接进入人体食道。这一有效设计，使探头的横向分辨率约为10-30微米，工作距离能达到8-10毫米，工作距离和微探头的横向分辨率的关系如图18。整个微探头的直径小于1.5毫米，如采用直径1.0毫米自聚焦透镜，整个微探头的直径小于1.3毫米；如采用直径0.7毫米自聚焦透镜，整个微探头的直径小于1.0毫米；如采用直径0.5毫米自聚焦透镜，整个微探头的直径小于0.7毫米。本申请使得该OCT微探头能够应用于狭窄空间，且具有较大的工作距离，较大的数值孔径和较高的分辨率。
图19为通过OCT球囊导管内窥镜获得的一段健康动物食管图像，图像尺寸为1200横向扫描数×4096纵向扫描，扫描速率为0.2cm/3s，标尺为1mm。图20为图19健康动物食管图像的局部放大图，可辨别的图层包括，81：鳞状上皮层(SE)、82：固有层(LP)、83：肌粘膜(MM)、84：粘膜下层(SM)和85：固有基层(MP)。图21为通过OCT内窥扫描成像系统进行管腔表面及深度扫描，然后将扫描数据进行软件重建产生的健康动物食管3D图像。
上所述仅是本申请的优选实施方式，使本领域技术人员能够理解或实现本申请的发明。对于这些实施例的多种修改及组合对于本领域的技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本申请的精神或范围的情况下，在其他实施例中实现。因此，本申请将不会被限制在本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。

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  1. 一种应用于OCT内窥扫描成像的球囊导管，其特征在于，所述球囊导管包括：
    手柄，所述手柄的一个接口为主机接口，另一接口为通气接口；
    双腔管，所述双腔管可以允许OCT光学探头通过；
    球囊，所述球囊的前端封堵且球囊上有刻度；
    内管，所述内管长度根据所述球囊的长度定长，且其长度短于所述球囊，所述球囊与所述软头焊接时，将所述球囊下推一定距离，使其与内管平齐并固定后焊接，所述内管专门为OCT探头设计，内管内径为1.4mm，内管外径为1.65mm，所述内管与所述球囊的同心度在额定使用大气压下偏离不超过500微米；
    软头，所述软头为实心结构，其中，
    所述双腔管一端与所述手柄连接，另一端与所述内管及所述球囊的一端连接，所述球囊与所述内管的另一端与所述软头连接。
  2. 根据权利要求1所述的应用于OCT内窥扫描成像的球囊导管，其特征在于，所述额定使用大气压为3-5个大气压。
  3. 根据权利要求2所述的应用于OCT内窥扫描成像的球囊导管，其特征在于，所述额定使用大气压为3个大气压，所述内管与所述球囊的同心度在3个大气压下偏离不超过500微米。
  4. 根据权利要求1所述的应用于OCT内窥扫描成像的球囊导管，其特征在于，还包括膜套，所述膜套位于球囊与双腔管接合处。
  5. 根据权利要求1所述的应用于OCT内窥扫描成像的球囊导管，其特征在于：所述球囊导管采用0.055in OCT光学探头，不需要导丝支撑及导引。
  6. 根据权利要求1所述的应用于OCT内窥扫描成像的球囊导管，其特征在于：所述双腔管上印有刻度。
  7. 根据权利要求1所述的应用于OCT内窥扫描成像的球囊导管，其特征在于：所述双腔管通过UV粘胶与所述手柄相连接，其他各部件均采用焊接工艺连接。
  8. 根据权利要求1所述的应用于OCT内窥扫描成像的球囊导管，其特征 在于：所述手柄材料为聚碳酸酯，所述双腔管和软头材料为嵌段聚醚酰胺，所述球囊和内管材料为尼龙及其改性聚合物。
  9. 一种应用于OCT内窥扫描成像的球囊导管的使用方法，步骤包括：将带有OCT微探头的球囊导管插入钳道，并将球囊推送至所需扫描的位置；再将手柄一个接口与OCT设备相连，另一个接口与充气设备相连，进行充气，充气结束后进行图像扫描，扫描结束后吸气，最后在吸气结束后将球囊导管撤回。
  10. 一种OCT内窥扫描成像系统，其特征在于：所述OCT系统包括扫频激光模块、干涉模块、探测器模块、数据采集模块、数据处理模块、图像显示模块、执行机构、OCT微探头、充放气设备、以及权利要求1至7所述球囊导管。
  11. 根据权利要求8所述的OCT内窥扫描成像系统，其特征在于，所述执行机构驱动OCT微探头进行旋转扫描，可产生3D图像。
  12. 根据权利要求8所述的OCT内窥扫描成像系统，其特征在于，所述充放气设备为自动充放气设备，所述自动充放气设备包括：控制和显示模块、气泵、充气电磁阀、放气电磁阀、压力传感器、防爆压力传感器、机械压力开关。
  13. 根据权利要求8所述OCT内窥扫描成像系统，其特征在于：OCT内窥扫描成像系统中处理OCT信号的方法包括：a.数据采集；b.数据传输；c.数据处理；d.传递至图像显示库；其特征在于，在传输数据的同时，通过通用图像处理器将上一次传输至设备内存中的OCT原始数据进行并行处理，并将处理好的数据放置于图像显示库的内存中。
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