CN112842522A - Intravascular optical coherence tomography laser ablation catheter - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
- A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
- A61B18/245—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter for removing obstructions in blood vessels or calculi
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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
- A61B5/0059—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
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- A—HUMAN NECESSITIES
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- 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
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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
- A61B5/0059—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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
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- A—HUMAN NECESSITIES
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
- A61B2018/2205—Characteristics of fibres
- A61B2018/2211—Plurality of fibres
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
- A61B2218/002—Irrigation
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Abstract
The invention provides an intravascular optical coherence tomography laser ablation catheter which is used for imaging and real-time ablation treatment of intravascular lesions by adopting full-optical-fiber array arrangement and double-hollow design. The catheter comprises a tube head end, a tube wall part, a tube cavity part and a tube tail end. The circular aperture of the centermost portion of the catheter is a guide wire aperture, allowing the catheter to flexibly pass over a guide wire. The circular pore diameter at the center of the catheter is designed into a circular pore diameter as a normal saline injection pore diameter, so that the injection of the normal saline or the introduction of other miniature temperature measuring equipment is allowed. A plurality of optical fibers used for optical coherence tomography imaging and laser ablation are sequentially arranged in an adjacent concentric circular array in the catheter. The inner and outer walls of the catheter are provided with a micro spring and a flexible material to control the bending angle of the catheter for imaging and treatment. The catheter design can improve the imaging speed in the blood vessel and better combine the imaging in the blood vessel and the treatment in the blood vessel.
Description
(I) technical field
The invention relates to the field of medical instruments, in particular to an intravascular optical coherence tomography laser ablation catheter.
(II) background of the invention
Cardiovascular disease is the first cause of death worldwide, with more people dying from cardiovascular disease annually than others. The world health organization data shows that about 1790 million people die of cardiovascular disease in 2016 worldwide, accounting for 31% of the total number of deaths worldwide. Since 2017, cardiovascular disease death is the first general death cause of urban and rural residents in China. The occurrence of cardiovascular diseases is strongly linked to the hampered transport of blood in blood vessels. A significant portion of the obstruction to blood transport is due to the formation of atherosclerotic plaques, which rupture, triggering a thrombus and thereby occluding the blood vessel. Thus, ablation of plaque in the vessel is needed for revascularization and ultimately cure cardiovascular disease.
Clinical methods for the image examination of vascular diseases are ultrasound, computed tomography, angiography and magnetic resonance imaging. These inspection methods have certain limitations. The anatomical structure and the shape of the blood vessel can be imaged, and the position, the size and the specific pathological change information in the blood vessel cannot be acquired. These limitations are remedied by the advent of new techniques for intravascular ultrasound imaging and intravascular optical tomography. However, intravascular ultrasound imaging is susceptible to blood flow noise interference, and the resolution of intravascular imaging is poor. The intravascular optical tomography has higher resolution, can evaluate intravascular plaques, and has the functions of predicting complications after vascular interventional operation, stent intima coverage degree and the like.
At present, most of the treatments for the plaque and the thrombus in the blood vessel are to carry out imaging and treatment by leading a catheter into the blood vessel of a human body under the guidance of an angiography technology and X-ray. Because plaque thrombus is accumulated to block a blood vessel, the saccule needs to enter a blood vessel to enlarge an official cavity for clinical treatment so as to place a blood vessel stent, and the purpose of dredging blood flow is further achieved. However, plaque thrombi still exist in the blood vessel, and the thrombi are not completely eliminated. In addition, these techniques have certain clinical complications. The laser ablation technology can eliminate thrombus and plaque, and the most fundamental treatment purpose is achieved. However, in order to avoid laser damage to the blood vessel wall and accurately act on the thrombus plaque, the intravascular imaging technology and the intravascular ablation technology need to be combined to accurately treat intravascular diseases. There is currently no catheter or similar product that combines intravascular imaging and laser ablation.
Disclosure of the invention
It is a primary object of the present invention to overcome the disadvantages and drawbacks of the prior art and to provide an intravascular optical coherence tomography laser ablation catheter. The invention integrally combines optical coherence tomography imaging and laser ablation in a blood vessel, and carries out real-time imaging and real-time ablation treatment on thrombus plaques in the blood vessel.
The intravascular optical coherence tomography laser ablation catheter adopts full-fiber array arrangement and double-hollow design. The concrete design of the catheter is divided into four parts: the tube head end, the tube wall part, the tube cavity part and the tube tail end. The most central part of the catheter tube head end is designed into a circular aperture, so that the catheter can flexibly pass through a guide wire to reach a specific position of a lesion. The periphery of the circular aperture at the center of the head end of the catheter is provided with an annular pore, so that the physiological saline can be injected. The injection of physiological saline can eliminate the interference of blood and reduce the damage of blood vessel walls, and is more helpful for imaging and treatment. The periphery of the pipe head of the catheter is sequentially arranged in an adjacent concentric circle array by a plurality of optical fibers used for optical coherence tomography and laser ablation. The wall of the catheter is internally provided with a flexible material and a micro spring which are used for controlling the bending angle of the catheter for imaging and treatment. The guide wire aperture and the normal saline injection aperture are reserved in the catheter lumen. A plurality of optical fibers are disposed in the lumen of the catheter. The tail end of the catheter is designed with a physiological saline introducing port. The intravascular optical coherence tomography imaging optical fiber is connected to the imaging device, and the laser ablation optical fiber is connected to the multi-wavelength power-adjustable laser.
The intravascular optical coherence tomography laser ablation catheter reaches a lesion part under the guidance of the guide wire. Blood in the imaging area is pushed away by the injection of the physiological saline, and the interference to light is reduced. The laser light source is transmitted to the intravascular patch tissue by the intravascular optical coherence tomography optical fiber, and the reflected or scattered light source is reflected back to the intravascular optical coherence tomography optical fiber. And processing the reflected or scattered light source information in the imaging equipment to obtain a real-time intravascular image. The catheter is adjusted in angle and different wavelengths are selected according to the intravascular image to treat the intravascular lesion. Finally, the intravascular imaging and the laser ablation are synchronously performed, and the intravascular interventional therapy time is shortened.
The invention has the advantages that:
in a first aspect: the intravascular optical coherence tomography laser ablation catheter adopts all-fiber array arrangement, reduces the size of the catheter, enables intravascular imaging and laser ablation treatment to be carried out synchronously, and shortens intravascular interventional treatment time;
in a second aspect: the physiological saline injection aperture is arranged in the catheter, so that the physiological saline can be injected at any time, the imaging is further facilitated, and meanwhile, the vascular wall is also facilitated to be protected during laser ablation;
in a third aspect: the optical coherence tomography optical fibers in the catheter are sequentially arranged in an array of adjacent concentric circles, so that more intravascular tissue information is collected, the imaging time is shortened, and a multi-azimuth and multi-angle cross-section image in the blood vessel can be obtained;
in a fourth aspect: the multi-wavelength frequency-adjustable laser connected with the laser ablation optical fiber in the catheter can select different laser energy to carry out laser ablation according to the position and the tissue property of the plaque;
in a fifth aspect: the micro spring and the flexible material are arranged inside and outside the wall of the catheter, so that the bending angle of the catheter for imaging and treatment is controlled, and the catheter can act on pathological tissues more flexibly.
(IV) description of the drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is a schematic view of an intravascular optical coherence tomography laser ablation catheter tip;
FIG. 2 is an interior view of a lumen portion of an intravascular optical coherence tomography laser ablation catheter;
fig. 3 is a schematic diagram of the working structure of the intravascular optical coherence tomography laser ablation catheter.
Icon:
100: optical coherence tomography laser ablation catheter, 110: catheter tip, 111: guide wire aperture, 112: saline injection aperture, 113: optical coherence tomography fiber, 114: laser ablation optical fiber, 120: catheter lumen portion, 130: conduit tube wall, 131: micro spring, 132: flexible material, 140: catheter tail, 200: imaging system, 210: imaging light source, 220: isolator, 230: coupler, 240: detector, 250: imaging apparatus, 300: brine injection system, 400: laser device
(V) detailed description of the preferred embodiments
To make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings, and it is apparent that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The first embodiment is as follows:
the central aperture (111) of the catheter tip is used for passing through a guide wire to reach a lesion site, and the aperture size can be 0.3-0.4 mm. The outer aperture (112) of the central bore of the head end of the conduit tube can be an injection port for physiological saline, and the size of the gap can be 0.1-0.2 mm. The injection time and the injection speed of the physiological saline are controlled, so that the possibility of damage to the blood vessel wall in thermal relaxation generated by laser can be effectively reduced. Finally, the diameter of the whole catheter can be controlled within 1.5-2.0mm, and the catheter can smoothly pass through the vascular cavity of the aorta in the blood vessel to carry out imaging and laser ablation.
The second embodiment is as follows:
the physiological saline injection port (112) according to the first embodiment may be an inlet of a micro temperature measuring device. The miniature temperature measuring equipment can be a thermocouple and a miniature temperature sensor, and can detect the change of the temperature in the blood vessel in the laser ablation process.
The third concrete implementation mode:
the intravascular optical coherence imaging fiber (113) used in the catheter may be a graded index fiber and the laser ablated fiber (114) may be a multi-wavelength fiber. The flexibility of imaging and therapy within the vessel can be maintained by using a plurality of small optical fibers. The optical fiber must perform total reflection in the core and the cladding, and the core diameter of the small optical fiber can be controlled between 40 and 100 microns considering that the core-to-core ratio of the optical fiber is 1:1.05 or 1: 1.10. In order to ensure the flexibility and flexibility of the catheter, the total number of the optical fiber arrangement in the whole catheter can not exceed 250, and the number of the optical fibers can be controlled to be 100 and 200 according to the size of the catheter.
The fourth concrete implementation mode:
in accordance with a third embodiment, the optical fibers in the catheter are concentrically arranged around the lumen, using epoxy as the filler material to provide efficient and reliable energy transfer. The tip of the laser ablated fiber (114) is polished at an angle and the outer edge of the fiber is assured to be rounded for atraumatic placement into the catheter. The polished angle of the laser ablated fiber tip cannot exceed 24 ° or it will fail due to internal reflection.
The fifth concrete implementation mode:
at the trailing end (140) of the catheter, an optical coherence tomography (113) and laser ablation (114) fiber are inserted into the laser system (400) and broadband laser light source (210), respectively. In the plug, the optical fibers are arranged in a bundle, and laser energy can be better transmitted into the optical fibers. The designed length of the whole catheter can be 110-150 cm, and the catheter is used for vascular interventional therapy of coronary arteries and limb vessels.
The sixth specific implementation mode:
the number of optical fibers is tailored to the specific clinical situation based on the specific embodiment three, to be tailored to a close-packed catheter, an optimal-spacing catheter, and a high-density catheter. Close-packed catheters continue to produce larger ablation areas, high-density catheters with high energy density and minimal optical dead space, and optimally spaced catheters have advantages between close-packed and high-density catheters.
The seventh embodiment:
the flexibility of the far end of the catheter is increased by wrapping a flexible material (132) with the length of 1-3cm outside a tube wall (130) of the far end of the catheter and a micro spring (131) inside the tube wall. Intravascular imaging and therapy are performed by bending different angles through a curved vessel. The flexible material can be silica gel, plastic and carbon material of carbon nano tube. The catheter may be externally wrapped with a mylar material.
The specific implementation mode is eight:
intravascular tissue is illuminated by transmitting a broadband laser light source (210) into an optical fiber (113) for intravascular optical coherence imaging, and reflected or scattered light is received by the fiber and directed to a detector (240) for imaging in a computer imaging system (250). The optical fiber can be a graded index optical fiber, and the light source of the intravascular optical coherence tomography is 1300 nm and 1700 nm.
The specific implementation method nine:
according to the eighth embodiment, the broadband laser light source (210) images the tissue in the blood vessel along the optical fiber through the isolator (220), the reflected light is received by the optical fiber and then transmitted to the detector (240) through the coupler (230), and then the imaging is performed in the computer imaging system (250).
The detailed implementation mode is ten:
intravascular thrombus plaque is affected by transmitting laser light through a multi-wavelength power tunable laser (400) into a laser ablated optical fiber (114). Lasers of different wavelengths and different powers are selected for ablation depending on the composition, location of plaque tissue and the extent of the lesion. During this procedure, flushing of the vessel during treatment is performed using a saline flush technique (300).
Claims (6)
1. An intravascular optical coherence tomography laser ablation catheter comprising four parts: a tube head end, a tube wall portion, a tube cavity portion and a tube tail end; the most central part of the catheter tube head end is designed into a circular aperture, so that the catheter is allowed to flexibly pass through a guide wire to reach a specific position of a lesion; an annular pore is designed at the periphery of the circular pore diameter at the center of the tube head end of the catheter and is used as the injection pore diameter of the physiological saline; the periphery of the head end of the catheter tube is sequentially arranged in an adjacent concentric circle array by a plurality of optical fibers used for optical coherence tomography imaging and laser ablation; the inner and outer walls of the catheter wall part are provided with a micro spring and a flexible material for controlling the bending angle of the catheter for imaging and treatment; the guide wire aperture and the physiological saline injection aperture are reserved in the catheter lumen part; the catheter tail end connects the optical fiber of the intravascular optical coherence tomography to the imaging equipment, and the optical fiber of the laser ablation is connected to the laser with adjustable multi-wavelength power, which is characterized in that: the full optical fiber array arrangement and double hollow design in the catheter can carry out real-time imaging and ablation treatment on thrombus plaques in blood vessels.
2. The all-fiber array arrangement in the catheter as claimed in claim 1, wherein the plurality of optical fibers used for optical coherence tomography and laser ablation are sequentially arranged in a concentric circle array, so as to collect more intravascular tissue information, shorten imaging time, obtain multi-directional and multi-angle cross-sectional images of the inside of the blood vessel, and the plurality of laser ablation optical fibers can accurately and rapidly act on the intravascular lesion tissue.
3. The dual hollow design of claim 1, wherein the most central portion of the catheter tip is designed as a circular aperture to allow the catheter to flexibly pass through a guide wire to a specific location of a lesion; the circular pore is designed at the periphery of the circular pore diameter at the center of the tube head end of the catheter and is used as a physiological saline injection pore diameter, so that the physiological saline is allowed to be injected.
4. The catheter tube wall of claim 1 having a micro spring and flexible material inside and outside the wall, wherein the micro spring and flexible material is 1-3cm in length, and the flexible material is silicon, plastic or carbon material of carbon nanotubes for controlling the bending angle of the catheter for imaging and therapy.
5. The optical fiber for optical coherence tomography and laser ablation as claimed in claim 2, wherein the intravascular optical coherence imaging fiber is graded index fiber, the laser ablation fiber is multi-wavelength fiber, the diameter of the fiber core is 40-100 μm, the number of the optical fibers is 100 and 200, and the number of the optical fibers can be adjusted by specific clinical conditions to customize a close-packed catheter, an optimal-spacing catheter and a high-density catheter.
6. The saline infusion aperture of claim 3, saline excluding blood interference for imaging while also helping to protect the vessel wall during laser ablation; the physiological saline injection aperture is a micro temperature measuring device, and the micro temperature measuring device is a thermocouple and a micro temperature sensor.
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| CN202110107483.5A CN112842522A (en) | 2021-01-27 | 2021-01-27 | Intravascular optical coherence tomography laser ablation catheter |
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| CN202110107483.5A CN112842522A (en) | 2021-01-27 | 2021-01-27 | Intravascular optical coherence tomography laser ablation catheter |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113616318A (en) * | 2021-09-06 | 2021-11-09 | 上海康德莱医疗器械股份有限公司 | Renal sympathetic nerve ablation system and method |
| CN114469333A (en) * | 2021-07-05 | 2022-05-13 | 深圳市中科微光医疗器械技术有限公司 | Ablation catheter, laser ablation system and intravascular laser plaque ablation method |
| CN114469334A (en) * | 2021-07-05 | 2022-05-13 | 深圳市中科微光医疗器械技术有限公司 | Laser output device, method, terminal and storage medium |
| CN114948197A (en) * | 2022-06-24 | 2022-08-30 | 武汉镭健科技有限责任公司 | Optical fiber catheter system for treating vascular diseases |
| CN116138875A (en) * | 2023-03-02 | 2023-05-23 | 哈尔滨工业大学（威海） | Interventional intravascular three-mode imaging, ablation and auxiliary temperature measurement integrated catheter |
| CN116172695A (en) * | 2023-03-02 | 2023-05-30 | 哈尔滨工业大学（威海） | Interventional intravascular multimode imaging and ablation integrated catheter |
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| CN114469333B (en) * | 2021-07-05 | 2024-02-20 | 深圳市中科融光医疗科技有限公司 | Ablation catheter, laser ablation system and intravascular laser plaque ablation method |
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| CN114948197A (en) * | 2022-06-24 | 2022-08-30 | 武汉镭健科技有限责任公司 | Optical fiber catheter system for treating vascular diseases |
| CN116138875A (en) * | 2023-03-02 | 2023-05-23 | 哈尔滨工业大学（威海） | Interventional intravascular three-mode imaging, ablation and auxiliary temperature measurement integrated catheter |
| CN116172695A (en) * | 2023-03-02 | 2023-05-30 | 哈尔滨工业大学（威海） | Interventional intravascular multimode imaging and ablation integrated catheter |
| CN116138875B (en) * | 2023-03-02 | 2023-09-26 | 哈尔滨工业大学（威海） | Interventional intravascular three-mode imaging, ablation and auxiliary temperature measurement integrated catheter |
| CN116172695B (en) * | 2023-03-02 | 2024-03-01 | 哈尔滨工业大学（威海） | Interventional intravascular multimode imaging and ablation integrated catheter |
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Application publication date: 20210528 |