WO2021175087A1 - 一种多功能导管 - Google Patents

一种多功能导管 Download PDF

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Publication number
WO2021175087A1
WO2021175087A1 PCT/CN2021/075482 CN2021075482W WO2021175087A1 WO 2021175087 A1 WO2021175087 A1 WO 2021175087A1 CN 2021075482 W CN2021075482 W CN 2021075482W WO 2021175087 A1 WO2021175087 A1 WO 2021175087A1
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WO
WIPO (PCT)
Prior art keywords
catheter
cavity
lens
distal
tube
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PCT/CN2021/075482
Other languages
English (en)
French (fr)
Inventor
高端贵
王继伟
李晓春
刘峰亮
顾威
管明勋
Original Assignee
南微医学科技股份有限公司
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Application filed by 南微医学科技股份有限公司 filed Critical 南微医学科技股份有限公司
Priority to EP21765339.3A priority Critical patent/EP4094671A4/en
Priority to JP2022551704A priority patent/JP7450055B2/ja
Publication of WO2021175087A1 publication Critical patent/WO2021175087A1/zh
Priority to US17/823,072 priority patent/US20220409854A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
    • 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
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00091—Nozzles
    • 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
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00096—Optical elements
    • 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
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/0011—Manufacturing of endoscope parts
    • 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
    • A61B1/005—Flexible endoscopes
    • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
    • A61B1/0052—Constructional details of control elements, e.g. handles
    • 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
    • A61B1/005—Flexible endoscopes
    • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
    • A61B1/0055—Constructional details of insertion parts, e.g. vertebral elements
    • 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
    • A61B1/005—Flexible endoscopes
    • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
    • A61B1/0057—Constructional details of force transmission elements, e.g. control wires
    • 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
    • A61B1/012—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 characterised by internal passages or accessories therefor
    • A61B1/015—Control of fluid supply or evacuation
    • 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
    • A61B1/012—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 characterised by internal passages or accessories therefor
    • A61B1/018—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 characterised by internal passages or accessories therefor for receiving instruments
    • 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
    • A61B1/05—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 characterised by the image sensor, e.g. camera, being in the distal end portion
    • 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
    • A61B1/313—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 for introducing through surgical openings, e.g. laparoscopes
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • 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
    • A61B1/273—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 for the upper alimentary canal, e.g. oesophagoscopes, gastroscopes
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M2025/0042—Microcatheters, cannula or the like having outside diameters around 1 mm or less

Definitions

  • This application relates to the technical field of medical devices, and in particular to a multifunctional catheter.
  • slender instruments are usually used to pass through the patient’s internal cavity to reach the lesion for diagnosis and treatment. Since minimally invasive surgery requires high accuracy and judgment, its visualization is particularly important. Therefore, minimally invasive surgery requires Use slender endoscopic equipment or catheters to assist the operation. In addition to the cavities for liquid (gas) entry and exit, data transmission, lighting, and direction deflection, the slender catheter also needs to provide working cavities for the entry and exit of medical equipment, making it difficult to achieve a small outer diameter. Generally, its diameter exceeds Above 5mm, it is impossible to directly perform visual diagnosis and treatment operations for narrow cavities such as bile ducts or pancreatic ducts.
  • a duodenal endoscope when inspecting small tracts such as the biliary tract or pancreatic duct, a duodenal endoscope can be inserted through the digestive tract to the vicinity of the duodenal papilla, and then the guide can be inserted through the working cavity of the endoscope. Then, the guide wire is used to guide the insertion of various slender diagnosis and treatment instruments, and X-rays are used to determine the internal conditions of these channels and adjust the position of the guide wire and the instrument.
  • the duodenal endoscope cannot enter the biliary tract, and only stays outside the duodenal papilla. This surgical method is less intuitive, especially when entering the branches of the biliary tract. Due to the complex biliary environment, the operation is more difficult .
  • the choledochoscope After the choledochoscope reaches the duodenal papilla through the working channel of the conventional duodenal endoscope, it continues to enter the biliary tract, which is equivalent to the sub-scope of the endoscope, and its outer diameter allows it to pass through the duodenal endoscope
  • the working channel of the mirror is equipped with working channel, liquid (gas) in and out, data transmission, illumination and direction deflection.
  • the inner diameter of the working channel of the choledochoscope itself is 1.2mm, and only devices with an outer diameter of 1.1mm or less can be passed through, while the outer diameter of the existing ERCP diagnosis and treatment instruments is generally 1.8-2.5mm, which is greater than 1.1mm, making this diagnosis and treatment The instrument cannot pass the above-mentioned choledochoscope with the inner diameter of the working channel of 1.2mm.
  • the present application provides a multifunctional catheter to solve the problem that the existing endoscope is not suitable for the biliary surgery environment.
  • the present application provides a multifunctional catheter, comprising: a catheter body with a multi-lumen tube structure and a distal tube, the distal tube is connected to the distal end of the catheter body; wherein the catheter body and the distal tube are provided with Working cavity; the distal end of the distal tube is provided with a through hole communicating with the working cavity; the catheter body and the distal tube are also provided with a lens cavity, the distal end of the distal tube A through hole communicating with the lens cavity is provided on it;
  • the lens cavity is a lumen structure extending along the catheter body and the distal tube; the inner wall of the lens cavity is provided with a plurality of accommodating grooves to accommodate the light in the lens assembly through the plurality of accommodating grooves.
  • Sense chip
  • the plurality of accommodating grooves are distributed symmetrically with the center axis of the lens cavity as the center.
  • the accommodating groove is a right-angled V-shaped groove; four accommodating grooves are provided in the lens cavity to form a rectangular space capable of accommodating the light sensor chip in the lens assembly.
  • the rectangular space formed by the four accommodating grooves is coaxial with the lens cavity.
  • the distal tube includes a soft end and a functional end; the soft end is located at the proximal end of the distal tube, and the functional end is located at the distal end of the distal tube.
  • the end surface of the through hole connecting the functional end to the working cavity is an inclined surface.
  • the diameter of the working lumen is greater than or equal to 48% of the outer diameter of the soft end, and the diameter of the working lumen is greater than or equal to 45% of the outer diameter of the catheter body.
  • a plurality of operation cavities are further provided in the catheter main body and the soft end; a plurality of connection holes that communicate with the operation cavities are provided on the functional end;
  • Each of the operating channels is provided with a steering wire, and the distal end of the steering wire is fixed in the connecting hole of the operating channel, so as to draw the functional end through a plurality of the steering wires to orient the distal tube bending.
  • the catheter body includes a reinforcement layer that covers the outer wall of the catheter body and the soft end; the reinforcement layer is a woven mesh tube structure, including a metal woven mesh located on the inner layer and an outer layer Plastic matrix tube.
  • the multifunctional catheter further includes a handle connected to the proximal end of the catheter main body, and a plurality of coaxial rotating parts are provided on the handle;
  • the rotating member is connected to the proximal end of the steering wire to draw the steering wire through the rotating member to control the directional bending of the distal tube.
  • the handle is further provided with a working cavity entrance, the working cavity entrance is a 6% standard Luer connector, and the working cavity entrance is connected to the working cavity.
  • two steering wires are connected to each of the rotating members, and the winding directions of the two steering wires on the rotating shaft of the rotating member are opposite, so as to generate a pulling force that controls the directional bending of the distal end tube.
  • the functional end is a cylindrical structure with an outer diameter equal to that of the soft end, and the hardness of the functional end is greater than the hardness of the soft end.
  • the outer diameter of the catheter body is less than or equal to 3.7 mm; the diameter of the working lumen is greater than or equal to 1.8 mm.
  • the present application provides a multifunctional catheter, which includes a catheter main body with a multi-lumen tube structure and a distal tube.
  • the main body of the catheter and the distal tube are provided with a working channel and a lens channel, and the distal end surface of the distal tube is also provided with a through hole communicating with the lens channel;
  • the catheter main body and the lumen structure extending from the soft end;
  • the inner wall of the lens cavity is provided with a plurality of receiving grooves to accommodate the light sensing chip in the lens assembly through the plurality of receiving grooves.
  • the catheter provided in the present application can form a space for accommodating a light sensor chip through a plurality of accommodating slots in the lens cavity, so that the lens assembly can be accommodated without increasing the diameter of the lens cavity, and the overall diameter of the catheter can be reduced to adapt to the The digestive tract is a more complex biliary environment.
  • Figure 1 is a schematic diagram of the structure of a multifunctional catheter of this application.
  • Figure 2 is a schematic cross-sectional structure diagram of the catheter main body of the application.
  • Figure 3 is a schematic cross-sectional structure diagram of the soft end of the application.
  • Figure 4 is a schematic diagram of the three-dimensional structure of the handle of the application.
  • FIG. 5 is a schematic diagram of a cross-sectional structure of a functional end of this application.
  • Figure 6 is a schematic diagram of the three-dimensional structure of the functional end of the application.
  • FIG. 7 is a schematic diagram of a cross-sectional structure of another functional end of this application.
  • the end of the catheter placed in the human body is called the distal end, and this end is mainly used to perform surgical actions on the tissue; the end outside the body is called the proximal end, and this end is mainly used Operate by the operator of the operation.
  • the distal end of each component refers to the end close to the inside of the body, and the proximal end of each component refers to the end close to the outside of the body.
  • a multifunctional catheter provided by the present application includes a catheter main body 1 and a distal tube 2.
  • the catheter body 1 and the distal tube 2 are both multi-lumen tube structures.
  • the distal tube 2 is connected to the distal end of the catheter main body 1 as an extension of the distal end of the catheter main body 1.
  • the length of the catheter body 1 should be sufficient to meet the lesion location extending from the patient's body to the internal lumen of the patient, and the length of the distal tube 2 should be able to meet the stroke requirement for the maximum steering angle of the distal end of the catheter.
  • the catheter body 1 and the distal tube 2 are provided with a working cavity 3; the distal end of the distal tube 2 is provided with a through hole communicating with the working cavity 3; the catheter body 1 and the distal end
  • the tube 2 is also provided with a lens cavity 6, and the distal end surface of the distal tube 2 is provided with a through hole communicating with the lens cavity 6.
  • the distal tube 2 includes a soft end 21 at the proximal end and a functional end 22 at the distal end.
  • the functional end 22 can be used to install various endoscope detection components, such as a camera, a light source, etc., and also to connect a steering wire that drives the steering of the distal end tube 2.
  • the soft end 21 is used to connect the catheter main body 1 and the functional end 22.
  • the hardness of the soft end 21 is less than the hardness of the catheter body 1, so that the soft end 21 is more easily deformed relative to the catheter body 1, so that it can be smoothly entered under the guidance of the guide wire.
  • the resistance of the catheter by the cavity tissue wall can also be reduced, so as to prevent the catheter from scratching the internal tissue of the patient.
  • the fact that the hardness of the soft end 21 in this application is less than the hardness of the catheter body 1 means that the soft end 21 is more likely to be deformed relative to the catheter body 1 and is not simply the difference in hardness of the material itself. Therefore, in practical applications, the hardness of the soft end 21 is less than the hardness of the catheter body 1 can be realized by different materials, or can be realized by an easily deformable structure.
  • the catheter body 1 can be made of hard materials, such as: polytetrafluoroethylene (PTFE), polyamide (PA), polyether block amide (Pebax) and other plastic materials; soft
  • the end 21 can be made of soft materials, such as polytetrafluoroethylene (PTFE), polyamide (PA), silicone rubber, polyurethane (PU), and polyether block amide (Pebax) with lower hardened and tempered hardness.
  • the soft end 21 can be configured as an easily deformable corrugated structure, a thin tube structure, a multi-cavity structure, and the like.
  • the catheter body 1 and the soft end 21 are provided with a working cavity 3; the functional end 22 is provided with a through hole communicating with the working cavity 3 .
  • the working channel 3 can be used in practical applications to insert auxiliary instruments for further diagnosis and treatment, such as biopsy forceps and laser lithotripsy instruments, etc., and it can also be used to transport drugs, etc. through the working channel 3, as well as to flush the cavity and to The liquid is transported to the body.
  • the diameter of the working channel 3 is greater than or equal to 48% of the outer diameter of the soft end 21, and the diameter of the working channel 3 is greater than or equal to 45% of the outer diameter of the catheter body 1.
  • the outer diameter of the catheter main body 1 and the soft end 21 cannot be very large, so the diameter of the working cavity 3 cannot be set too large.
  • the outer diameter of the catheter body 1 is less than or equal to 3.7 mm, that is, the diameter design of the working lumen 3 should refer to this parameter limit.
  • the end surface of the through hole connecting the functional end 22 to the working cavity 3 is an inclined surface, which can reduce the resistance of the catheter when it travels in the digestive tract and facilitate reaching the patient's position.
  • the inclination angle of the inclined surface may be 45°.
  • the end face of the through hole communicating with the working cavity 3 can also be formed by splicing multiple surfaces with different inclination angles.
  • the end face of the functional end 22 transitions from the position of the lens cavity 6 to the working cavity. 3 It can be composed of two inclined surfaces, so that the shape of the end surface changes gradually from flat to sharp, which is convenient for entering the digestive tract.
  • the catheter body 1 and the soft end 21 are also provided with a lens cavity 6, and the functional end 22 is also provided with a communication point.
  • the end face of the through hole on the functional end 22 can be provided with a lens assembly to collect images of the environment in the digestive tract.
  • the inside of the lens cavity 6 can be used to set up wire components such as the data line of the lens assembly to capture the image collected by the lens assembly. The data is transferred to the display device for display.
  • the lens assembly generally includes a lens and a photosensitive chip.
  • the images in the digestive tract reach the photosensitive chip through the refraction of the lens to generate image signals.
  • the volume of the lens assembly is limited by the shape of the photosensitive chip, that is, the photosensitive chip cannot be too small to avoid the low resolution of the captured image.
  • the lens in the lens assembly can have various shapes, but the photosensitive chip can only be made into a rectangular structure. During the assembly process, the photosensitive chip of the rectangular structure needs to satisfy that the inner diameter of the lens cavity 6 is greater than the diagonal length of the photosensitive chip, which results in a larger accommodating space required for the lens assembly.
  • the diagonal length is 1.697mm, so a lens cavity 6 with an inner diameter of 1.7mm or more is required to accommodate the photosensitive chip, and for a rectangular photosensitive chip, it needs a lens
  • the inner diameter of the cavity 6 is larger.
  • the lens cavity 6 will occupy the entire space of the catheter, so that when the entire outer diameter of the catheter is restricted, the available space of the working cavity 3 is compressed, so that the inner diameter of the working cavity 3 is also restricted. At lower values.
  • the lens cavity 6 is a circular lumen structure extending along the catheter body 1 and the soft end 21.
  • the inner wall of the lens cavity 6 is provided with a plurality of accommodating grooves 61 for accommodating the light sensor chip in the lens assembly through the plurality of accommodating grooves 61.
  • the multiple accommodating grooves 61 can form a rectangular space for accommodating the photosensitive chip, so as to adapt to the shape of the photosensitive chip and reduce the diameter of the circular lumen of the lens cavity 6.
  • the receiving groove 61 is a right-angled V-shaped groove.
  • the lens cavity 6 is provided with four accommodating grooves 61 to form a rectangular space capable of accommodating the light sensor chip in the lens assembly.
  • the four accommodating grooves 61 are right-angled V-shaped grooves, forming a rectangular accommodating space of 1.12 ⁇ 1.12mm, which can accommodate a light sensor chip of up to 1.12 ⁇ 1.12mm.
  • the diameter of the circular lumen of the lens cavity 6 is 1.36mm or less. If the above-mentioned accommodating groove 61 is not used, a circular lumen with a diameter of 1.7 mm or more is required to accommodate the light sensor chip of 1.12 ⁇ 1.12 mm. It can be seen that the multiple receiving grooves 61 in the lens cavity 6 form a space for accommodating the light sensor chip, and the lens assembly can be installed without increasing the diameter of the lens cavity 6, thereby reducing the overall diameter of the catheter.
  • the diameter of the lens cavity 6 can be smaller, the space occupied by the lens cavity 6 for the entire catheter is reduced. Therefore, under the premise of a limited outer diameter of the catheter, a larger working cavity 3 can be obtained.
  • the outer diameter of the catheter body is less than or equal to 3.7 mm, the diameter of the working lumen can be greater than or equal to 1.8 mm, so as to facilitate the passage of conventional ERCP diagnosis and treatment equipment.
  • the rectangular structure formed by the four accommodating grooves 61 compared with the traditional cylindrical lumen structure, is also convenient to fix the lens assembly, that is, the photosensitive chip is restricted by the rectangular edge to prevent the lens assembly from being in the lens during operation.
  • the internal rotation of the cavity 6 is convenient to maintain the stability of the image during the operation.
  • the rectangular space formed by the four accommodating grooves 61 is coaxial with the lens cavity 6, which can be realized on the basis of accommodating the light sensor chip of the lens assembly, and the center position of the light sensor chip It is limited to the center position of the lens cavity 6 to facilitate installation and fixation.
  • the rectangular space formed by the accommodating groove 61 is coaxial with the lens cavity 6, which also facilitates the establishment of a connection between the photosensitive chip and the optical fiber data in the lens assembly, thereby reducing redundant wiring and circuit board layout, and saving lens cavity The space within Road 6.
  • the plurality of accommodating grooves 61 are centered on the central axis of the lens cavity 6 and are distributed symmetrically; The distance between the pockets 61 is greater than or equal to the diagonal length of the light sensor chip.
  • the lens cavity 6 includes four accommodating grooves 61, which are located in the upper left corner, upper right corner, lower left corner and lower right corner of the lens cavity 6 respectively.
  • the central axis is centered and distributed symmetrically.
  • the distance between the two accommodating grooves 61 at the upper left corner and the lower right corner of the lens cavity 6 should be greater than or equal to the diagonal length of the light-sensing chip
  • the distance between the two accommodating grooves 61 located at the upper right corner and the lower left corner of the lens cavity 6 is also greater than or equal to the diagonal length of the light sensor chip, so that the light sensor chip can be accommodated and the distance between the light sensor chip The side is limited to prevent it from rotating.
  • the lens assembly includes a light-sensing chip and a data line.
  • the light-sensing chip can acquire images of the cavity in real time, and transmit it to the display device at the proximal end of the catheter through the data line, so as to check the progress of the catheter in the cavity. As well as the actual operation of the operation of the surgical instrument to demonstrate.
  • the guide wire in the endoscope can be guided to control the distal end of the catheter to realize the steering action, but when the distal end of the catheter runs into the bile duct that the endoscope cannot reach, the steering wire 5 is required to
  • the distal end of the catheter is controlled to steer, that is, in some of the embodiments provided in this application, the catheter body 1 and the soft end 21 are also provided with a plurality of operating cavities 4; the functional end 22 is provided with a communication with the operating A plurality of connecting holes of the cavity 4; each of the operating channels 4 is provided with a steering wire 5, and the distal end of the steering wire 5 is fixed in the connecting hole of the operating cavity 4 to pass through a plurality of The control wire 5 pulls the functional end 22 to make the distal tube 2 directional bend.
  • one end of the manipulation wire 5 is connected to the functional end 22, and the other end extends from the distal end of the catheter to the proximal end. Therefore, the manipulation wire 5 can be pulled to the functional end 22 by pulling the manipulation wire 5 at the proximal end of the catheter. Movement tends to form a serpentine bend on the distal tube 2.
  • the functional end 22 in order to meet the requirements for fixing the distal end of the manipulation wire 5, can be set to a metal or plastic structure, and the functional end 22 is connected to the manipulation wire 5 by welding or insert injection molding, so that the distal end of the manipulation wire 5 It is fixedly connected to the functional end 22 to control the steering of the distal end tube 2 by adjusting the length of the control wire 5.
  • the diameter of the control wire 5 should be less than 0.35 mm, and strong and wear-resistant metal wires or plastic fibers can be used.
  • the catheter body 1 in the present application has the same arrangement of the channels on the soft end 21 and the functional end 22, for example, the catheter body 1 There is a working channel 3, four operating channels 4 and a lens channel 6. It can meet the deflection function in four different directions, not only the process is simple, but also a lot of space is saved. And it can realize the functions of steering, working cavity, liquid injection and optical vision at the same time, and its outer diameter is reduced to 3.7mm or less, which can meet the use of most ERCP devices, that is, meet the requirements of visualized diagnosis and treatment of bile duct and pancreatic duct.
  • the catheter body 1 includes a reinforcing layer 11 that covers the outer walls of the catheter body 1, the soft end 21 and the functional end 22.
  • the reinforcing layer 11 can enhance the rigidity of the entire catheter and facilitate the delivery of the catheter to the patient’s internal lumen; Therefore, when the catheter main body 1 and the distal tube 2 do not use the same material or an integrated structure, they can still be connected as a whole, thereby avoiding the deformation of the cavity and the catheter caused by the use of a connector.
  • the reinforcing layer 11 is a woven mesh tube structure, including a metal woven mesh on the inner layer and a plastic matrix tube on the outer layer.
  • the pipe wall thickness of the reinforcing layer 11 must be at least 0.1 mm on one side to maintain sufficient connection strength. Therefore, when the outer diameter of the catheter body 1 is less than or equal to 3.7 mm, the internal physical diameter should be less than 3.5 mm.
  • the effective limit wall thickness of the catheter body 1 and soft end 21 (such as PEBAX, silica gel, etc.) can be achieved is 0.1mm, so the internal diameter space for multi-cavity design is 3.3 mm or less, and the diameter of the working channel can be designed to be 1.8 mm or more, that is, the diameter of the working channel 3 is greater than or equal to 1.8 mm.
  • the multifunctional catheter further includes a handle 7 connected to the proximal end of the catheter body 1, and a plurality of coaxial rotating members 71 are provided on the handle 7
  • the rotating member 71 is connected to the proximal end of the steering wire 5 to pull the steering wire 5 through the rotating member 71 to control the directional bending of the distal tube 2.
  • each of the rotating members 71 is connected with two of the operating wires 5, and the winding directions of the two operating wires 5 on the rotating shaft of the rotating member 71 are opposite, so as to control the directional bending of the distal tube 2 pull.
  • the handle 7 is further provided with a working cavity inlet 72, the working cavity inlet 72 is a 6% standard Luer connector, and the working cavity inlet 72 is connected to the working cavity 3.
  • the proximal end of the catheter body 1 includes a handle 7.
  • the handle 7 includes a pair of coaxial rotating members 71, that is, rotating wheels. Each rotating wheel is connected to two control wires 5 on both sides of its rotating shaft.
  • the doctor holds the handle 7 with one hand or hangs the handle 7 on other endoscopes (such as duodenal (Mirror) near the working cavity.
  • the rotating shafts of the two coaxial rotating wheels in the handle 7 are respectively driven to rotate.
  • the two connected to it are operated symmetrically
  • the wire 5 will move relative to the operating lumen 4 in the catheter body 1 and the distal tube 2, and respectively generate a pulling and pushing force in opposite directions, so that the functional end 22 connected to it is inclined and compressed.
  • the soft end 21 in the end tube 2 makes the distal end tube 2 bend in a predetermined direction.
  • the distal tube 2 will bend in another direction.
  • the other rotating wheel rotates clockwise and counterclockwise, it will also drive the distal tube 2 to bend in other directions.
  • the doctor controls the direction in which the distal tube 2 enters into the patient's body and the cavity of the matched endoscope and the direction of observation by rotating the rotating member 71 on the rotating handle 7, and at the same time pushes the catheter body 1
  • the proximal handle 7 can control the depth of the distal tube 2 into and out of the cavity.
  • the proximal end of the handle 7 has a working channel entrance 72 with a 6% standard Luer connector.
  • the working channel entrance 72 is connected to the working channel 3, and the doctor can insert auxiliary instruments through the working channel entrance 72 for further diagnosis and treatment.
  • biopsy forceps and laser lithotripsy instruments can also inject liquid through the working cavity entrance 72 to flush the cavity and wash out the liquid in the cavity to the body.
  • the functional end 22 is a cylindrical structure with an outer diameter equal to the soft end 21, and the hardness of the functional end 22 is greater than the hardness of the soft end 21.
  • the functional end 22 can be made of hard plastic or stainless steel into a cylindrical structure, and the cylindrical structure is provided with through holes corresponding to the multi-cavities of the soft end 21.
  • the functional end 22 can be pre-opened with a plurality of holes for installation through hard materials, such as a camera hole, a hole for fixing the steering wire 5, and a medicine hole or a liquid injection hole connected to the liquid injection cavity 8.
  • the hardness of the functional end 22 is greater than the hardness of the soft end 21, which facilitates the fixing of various installation components, and makes the overall working process more stable.
  • the selection of the functional end 22 with higher hardness also facilitates processing into holes and improves the process accuracy.
  • the multifunctional catheter provided in the above embodiment includes a catheter main body 1 and a distal tube 2 with a multi-lumen tube structure.
  • the distal tube 2 includes a soft end 21 at the proximal end and a functional end 22 at the distal end; the hardness of the soft end 21 is less than that of the catheter body 1; the catheter body 1 and the soft end 21 are provided with working Lumen; the functional end 22 is provided with a through hole connecting the working lumen 3; the diameter of the working lumen 3 is greater than or equal to 51% of the outer diameter of the soft end 21, and the diameter of the working lumen 3 is greater than or equal to the outer diameter of the catheter body 1 49%.
  • the catheter provided in the present application can cooperate with the working lumen 3 through the soft end 21 of the distal tube 2 to realize the steering function so that the distal end of the catheter can adapt to the more complicated biliary environment relative to the digestive tract.
  • the lens cavity 6 is a circular lumen structure extending along the catheter body 1 and the soft end 31; the inner wall of the lens cavity 6 is provided with a plurality of accommodating grooves 61 to pass through the plurality of The accommodating groove 61 accommodates the light sensor chip in the lens assembly.
  • the catheter provided in the present application can form a space for accommodating a light sensor chip through a plurality of accommodating grooves 61 in the lens cavity 6, so that the lens assembly can be accommodated without increasing the diameter of the lens cavity 6, and the overall diameter of the catheter can be reduced.
  • the multifunctional catheter provided by the present application has a working channel that can pass through a 1.8mm conventional device, which is convenient for doctors to use, saves manufacturing costs, and reduces the price of devices used in conjunction with it to further reduce the burden on patients.

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Abstract

一种多功能导管，包括多腔管结构的导管主体（1）和远端管（2）。其中，远端管（2）包括位于近端的软质端（21），和位于远端的功能端（22）；导管主体（1）和软质端（21）内设有工作腔道（3）和镜头腔道（6），功能端（22）上还设有连通镜头腔道（6）的通孔；镜头腔道（6）为沿导管主体（1）和软质端（21）延伸的圆形管腔结构；镜头腔道（6）的内壁上设有多个置容槽（61），以通过多个置容槽（61）容纳镜头组件中的光感芯片。该导管可以通过镜头腔道（6）中的多个置容槽（61）形成容纳光感芯片的空间，可在不增加镜头腔道（6）直径的前提下安装镜头组件，从而减小导管整体直径，以适应相对于消化道更复杂的胆道环境。

Description

一种多功能导管
本申请要求在2020年3月4日提交中国专利局、申请号为202010143001.7、发明名称为“一种多功能导管”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，尤其涉及一种多功能导管。
背景技术
在微创手术中，通常采用细长器械穿过患者体内腔道，到达病灶部位进行诊疗，由于微创手术需要较高的精确性和可判断性，其可视化尤为重要，因此，微创手术需要借助细长的内窥设备或导管辅助操作。细长的导管除需要包含液体(气体)进出、数据传输、照明以及方向偏转等腔道外，还需要提供诊疗器械进出的工作腔道，使得其外径很难做到较小，一般其直径超过5mm以上，这对于胆管或者胰管等狭窄腔道，是无法直接进行可视化诊疗操作。
通常，在检查胆道或者胰管等较小腔道时，可先采用十二指肠内窥镜通过消化道插入到十二指肠乳头附近，然后通过该内窥镜的工作腔道置入导丝，再通过导丝来引导插入各种细长诊疗器械，并不断借助X射线来判定这些腔道内部的情况以及调整导丝和器械所在的位置。十二指肠内窥镜无法进入胆道，只停留在十二指肠乳头外，这种手术方式的直观性较差，尤其是在进入胆道分支时，由于复杂的胆道环境，使得操作难度较大。
胆道镜通过常规的十二指肠内窥镜的工作腔道到达十二指肠乳头后，再继续进入胆道，相当于内窥镜的子镜，其外径允许其通过十二指肠内窥镜工作腔道，同时具备工作腔道、液体(气体)进出、数据传输、照明以及方向偏转等腔道。胆道镜自身的工作腔道的内径为1.2mm，只能通过外径为1.1mm以下的器械，而现有的ERCP诊疗器械的外径普遍在1.8-2.5mm，大于1.1mm，使得这种诊疗器械无法通过上述工作腔道内径为1.2mm的胆道镜。
发明内容
本申请提供了一种多功能导管，以解决的现有内窥镜不适用于胆道手术环境的问题。
本申请提供一种多功能导管，包括：多腔管结构的导管主体和远端管，所述远端管连接在所述导管主体的远端；其中，所述导管主体和远端管内设有工作腔道；所述远端管的远端端面上设有连通所述工作腔道的通孔；所述导管主体和远端管内还设有镜头腔道，所述远端管的远端端面上设有连通所述镜头腔道的通孔；
所述镜头腔道为沿导管主体和远端管延伸的管腔结构；所述镜头腔道的内壁上设有多个置容槽，以通过多个所述置容槽容纳镜头组件中的光感芯片。
可选的，多个所述置容槽以所述镜头腔道的中轴线为中心，呈中心对称分布。
可选的，所述置容槽为直角V形槽；所述镜头腔道内设有四个置容槽，以形成能够容纳镜头组件中的光感芯片的矩形空间。
可选的，四个所述置容槽所形成的矩形空间与所述镜头腔道同轴。
可选的，所述远端管包括软质端和功能端；所述软质端位于所述远端管的近端，所述功能端位于所述远端管的远端。
可选的，所述功能端连通所述工作腔道的通孔端面为倾斜面。
可选的，所述工作腔道直径大于或等于所述软质端外径的48％，所述工作腔道直径大于或等于所述导管主体外径的45％。
可选的，所述导管主体和软质端内还设有多个操作腔道；所述功能端上设有连通所述操作腔道的多个连接孔；
每个所述操作腔道中设有操纵丝，所述操纵丝的远端固定在所述操作腔道的连接孔内，以通过多个所述操纵丝牵引所述功能端，使远端管定向弯曲。
可选的，所述导管主体包括加强层，所述加强层包覆在所述导管主体和软质端的外壁；所述加强层为编织网管结构，包括位于内层的金属编织网和位于外层的塑料基质管。
可选的，所述多功能导管还包括连接在所述导管主体近端的手柄，所述手柄上设有同轴的多个转动件；
所述转动件连接操纵丝的近端，以通过所述转动件牵引所述操纵丝，控制远端管定向弯曲。
可选的，所述手柄上还设有工作腔道入口，所述工作腔道入口为6％标准鲁尔接头，所述工作腔道入口连通工作腔道。
可选的，每个所述转动件上连接有两个所述操纵丝，两个所述操纵丝在所述转动件转轴上的缠绕方向相反，以产生控制远端管定向弯曲的拉力。
可选的，所述功能端为外径与所述软质端相等的圆柱形结构，所述功能端的硬度大于所述软质端的硬度。
可选的，所述导管主体的外径小于或等于3.7mm；所述工作腔道的直径大于或等于1.8mm。
由以上技术方案可知，本申请提供一种多功能导管，包括多腔管结构的导管主体和远端管。其中，所述导管主体和远端管内设有工作腔道和镜头腔道，所述远端管的远端端面上还设有连通所述镜头腔道的通孔；所述镜头腔道为沿导管主体和软质端延伸的管腔结构；所述镜头腔道的内壁上设有多个置容槽，以通过多个所述置容槽容纳镜头组件中的光感芯片。本申请提供的导管可以通过镜头腔道中的多个置容槽形成容纳光感芯片的空间，从而在不增加镜头腔道直径的前提下能够容纳镜头组件，减小导管整体直径，以适应相对于消化道更复杂的胆道环境。
附图说明
图1为本申请一种多功能导管的结构示意图；
图2为本申请导管主体的截面结构示意图；
图3为本申请软质端的剖面结构示意图；
图4为本申请手柄的立体结构示意图；
图5为本申请一种功能端剖面结构示意图；
图6为本申请功能端的立体结构示意图；
图7为本申请另一种功能端横剖面结构示意图。
具体实施方式
下面将详细地对实施例进行说明，其示例表示在附图中。下面的描述涉及附图时，除 非另有表示，不同附图中的相同数字表示相同或相似的要素。以下实施例中描述的实施方式并不代表与本申请相一致的所有实施方式。仅是与权利要求书中所详述的、本申请的一些方面相一致的系统和方法的示例。
本申请提供的技术方案中，为了便于描述，将整个导管置入人体内的一端称为远端，这一端主要用于对组织实施手术动作；位于体外的一端称为近端，这一端主要用于手术实施者进行操作。本申请除另有说明外，各部件所称的远端都是靠近体内一侧的一端，各部件所称的近端都是指靠近体外一侧的一端。
参见图1，为本申请一种多功能导管的结构示意图。由图1、图2可知，本申请提供的一种多功能导管，包括：导管主体1和远端管2。导管主体1和远端管2均为多腔管结构。远端管2连接在所述导管主体1的远端，作为导管主体1远端的延伸。实际应用中，导管主体1的长度应足以满足从患者的体外一直延伸到患者的体内腔道的病灶位置，远端管2的长度要能够满足使导管的远端最大转向角度下的行程要求。
所述导管主体1和远端管2内设有工作腔道3；所述远端管2的远端端面上设有连通所述工作腔道3的通孔；所述导管主体1和远端管2内还设有镜头腔道6，所述远端管2的远端端面上设有连通所述镜头腔道6的通孔。
在一些实施例中，所述远端管2包括位于近端的软质端21，和位于远端的功能端22。其中，功能端22上可以用来安装各种内窥镜探测部件，例如摄像头、光源等，还用来连接驱动远端管2转向的操纵丝。软质端21用于连接导管主体1和功能端22。本实施例中，所述软质端21的硬度小于所述导管主体1的硬度，使软质端21相对于导管主体1更容易产生变形，以便能够顺利地在导丝的指引下，进入到患者的体内腔道中，还能够减轻导管受到腔道组织壁的阻力，避免导管划伤患者的体内组织。
需要说明的是，本申请所述软质端21的硬度小于所述导管主体1的硬度是指软质端21相对于导管主体1更容易产生变形，而并非单纯材质本身的硬度差异。因此，在实际应用中，所述软质端21的硬度小于所述导管主体1的硬度可以通过不同材质实现，也可以通过易变形的结构实现。当通过不同材质实现硬度差异时，导管主体1可以采用硬质材料制成，如：聚四氟乙烯(PTFE)、聚酰胺(PA)和聚醚嵌段酰胺(Pebax)等塑料材质；软质端21可以采用软质材料制成，如调质硬度较低的聚四氟乙烯(PTFE)、聚酰胺(PA)、硅橡胶、聚氨酯(PU)和聚醚嵌段酰胺(Pebax)。当通过易变形结构实现硬度差异时，可以通过将软质端21设置为容易变形的波纹结构，薄管结构，多腔体结构等。
本申请提供的技术方案中，如图3所示，所述导管主体1和软质端21内设有工作腔道3；所述功能端22上设有连通所述工作腔道3的通孔。工作腔道3可以在实际应用中用来插入辅助器械进行进一步诊疗，例如活检钳和激光碎石器械等，也可以通过工作腔道3来输送药剂等，以及对腔道进行冲洗并将腔道内的液体输送至体外。为了便于辅助器械的操作，所述工作腔道3直径大于或等于所述软质端21外径的48％，所述工作腔道3直径大于或等于所述导管主体1外径的45％。
实际应用中，工作腔道3的直径越大，用于手术操作的空间也越大，因此越有利于实施手术操作。但由于受人体体内腔道的限制，导管主体1和软质端21的外径不可能很大，因此工作腔道3的直径也不可能设置的很大。以胆管和胰管为例，受胆管和胰管腔道内径的影响，所述导管主体1的外径小于或等于3.7mm，即工作腔道3的直径设计要参考这一 参数限制。
在一些实施例中，所述功能端22连通所述工作腔道3的通孔端面为倾斜面，倾斜面可以减少导管在消化道中行进时的阻力，便于到达病患位置。示例地，如图5、图6所示，倾斜面的倾斜角度可以为45°。显然，连通所述工作腔道3的通孔端面还可以由多个不同倾斜角度的面拼接构成，如图7所示，在功能端22的端面，从镜头腔道6位置过渡到工作腔道3可以由两个斜面构成，以使端面形状从平缓逐渐趋于锐利，便于进入消化道。
本申请提供的技术方案中，如图2、图5、图6所示，所述导管主体1和软质端21内还设有镜头腔道6，所述功能端22上还设有连通所述镜头腔道6的通孔。功能端22上的通孔端面处可设有镜头组件，以便对消化道内的环境进行图像采集，镜头腔道6内部可以用于设置镜头组件的数据线等线材部件，以将镜头组件采集的图像数据传递至显示设备进行显示。
镜头组件一般包括镜片和感光芯片。消化道内影像通过镜片的折射作用，到达感光芯片上，以产生图像信号。镜头组件的体积会受限于感光芯片形状限制，即感光芯片不能太小，以避免采集的图像分辨率过低。并且镜头组件中的镜片可以为多种形状，但感光芯片只能做成矩形结构。在装配过程中，矩形结构的感光芯片需要满足镜头腔道6的内径大于感光芯片的对角线长度，导致镜头组件需要的容纳空间较大。
例如，对于1.12×1.12mm的正方形感光芯片，其对角线长度为1.697mm，因此需要内径在1.7mm以上的镜头腔道6才能够容纳该感光芯片，并且对于长方形的感光芯片，其需要镜头腔道6的内径更大。而当镜头腔道6的内径较大时，镜头腔道6将占用导管整体的空间，使得在导管整体外径被限制时，压缩工作腔道3可用空间，使工作腔道3的内径也限制在较低的数值。
为此，本申请中，镜头腔道6为沿导管主体1和软质端21延伸的圆形管腔结构。镜头腔道6的内壁上设有多个置容槽61，以通过多个所述置容槽61容纳镜头组件中的光感芯片。实际应用时，多个置容槽61可以形成容纳感光芯片的矩形空间，从而适应感光芯片形状，减小镜头腔道6圆形管腔的直径。
为了形成矩形结构，所述置容槽61为直角V形槽。所述镜头腔道6内设有四个置容槽61，以形成能够容纳镜头组件中的光感芯片的矩形空间。例如，4个置容槽61为直角V形槽，形成1.12×1.12mm的矩形容纳空间，可以容纳最大1.12×1.12mm的光感芯片，此时，镜头腔道6的圆形管腔直径为1.36mm或更小。而如果不采用上述置容槽61，则需要直径为1.7mm以上的圆形管腔才能容纳1.12×1.12mm的光感芯片。可见，通过镜头腔道6中的多个置容槽61形成容纳光感芯片的空间，可在不增加镜头腔道6直径的前提下安装镜头组件，从而减小导管整体直径。
由于镜头腔道6的直径可以更小，使得镜头腔道6对导管整体所占用的空间减小，因此在导管有限的外径前提下，可以获得较大的工作腔道3。例如，在导管主体的外径小于或等于3.7mm的前提下，所述工作腔道的直径可达到大于或等于1.8mm，以便于通过常规的ERCP诊疗器械。
另外，通过四个置容槽61所形成的矩形结构，相对于传统的圆柱形管腔结构，还便于对镜头组件进行固定，即通过矩形边限制感光芯片，防止在操作过程中镜头组件在镜头腔道6内旋转，便于维持手术过程中影像画面的稳定。
在一些实施例中，四个所述置容槽61所形成的矩形空间与所述镜头腔道6同轴，可以实现在容纳镜头组件光感芯片的基础上，能够将光感芯片的中心位置限制在镜头腔道6的中心位置，便于进行安装固定。同时，置容槽61所形成的矩形空间与镜头腔道6同轴，还便于镜头组件中感光芯片与光纤数据先之间建立连接关系，从而减少多余走线和电路板排布，节省镜头腔道6内的空间。
在一些实施例中，多个所述置容槽61以所述镜头腔道6的中轴线为中心，呈中心对称分布；多个所述置容槽61中，具有对角关系的两个置容槽61之间的距离大于或等于所述光感芯片的对角线长度。
例如，在图2示出的导管横截屏形状中，镜头腔道6包括4个置容槽61，分别位于镜头腔道6左上角、右上角、左下角和右下角，以镜头腔道6的中轴线为中心呈中心对称分布。并且，为了容纳光感芯片，在4个置容槽61中，位于镜头腔道6左上角和右下角的两个置容槽61之间的距离应大于或等于光感芯片的对角线长度，同理位于镜头腔道6右上角和左下角的两个置容槽61之间的距离也大于或等于光感芯片的对角线长度，从而能够容纳光感芯片，并对光感芯片的侧边进行限位，防止其转动。
本实施例中，镜头组件包括光感芯片和数据线，其中光感芯片可以实时获取腔道影像，并通过数据线传输至导管近端的显示设备中，以便对导管于腔道内的行进情况，以及实际手术操作中的手术器械动作情况进行展示。
本申请中，可以通过内窥镜中的导丝进行引导，以控制导管远端实现转向动作，但在导管远端运行到内窥镜所不能到达的胆管中时，则需要通过操纵丝5来控制导管远端进行转向，即本申请提供的部分实施例中，所述导管主体1和软质端21内还设有多个操作腔道4；所述功能端22上设有连通所述操作腔道4的多个连接孔；每个所述操作腔道4中设有操纵丝5，所述操纵丝5的远端固定在所述操作腔道4的连接孔内，以通过多个所述操纵丝5牵引所述功能端22，使远端管2定向弯曲。
实际应用中，操纵丝5的一端连接功能端22，另一端从导管的远端一直延伸到近端，因此可以通过在导管的近端拉动操纵丝5，来使操纵丝5牵引功能端22产生运动倾向，在远端管2上形成蛇骨弯曲。显然，能够满足手术操作的操纵丝5的数量要至少有两条，而为了实现更灵活的转向操作，还可以适当增加操纵丝5及操作腔道4的数量。
本实施例中为了满足操纵丝5的远端固定要求，可以将功能端22设置为金属或塑料结构，其与操纵丝5之间采用焊接或者嵌件注塑连接，以使操纵丝5的远端固定连接在功能端22上，实现通过调节操纵丝5的长度，控制远端管2实施转向。所述操纵丝5的直径要在0.35mm以下，可以选用坚固耐磨的金属丝或者塑料纤维。
由以上技术方案可知，如图5所示，为了实现连贯的腔体，本申请中的导管主体1与软质端21、功能端22上的腔道布置方式是一致的，例如，导管主体1上设有一个工作腔道3、四个操作腔道4和一个镜头腔道6。即可以满足四个不同方向的偏转功能，不仅工艺简单，而且节省大量空间。并且能够同时实现转向、工作腔道、注吸液体和光学视觉等功能，其外径缩小至3.7mm以下，可以满足绝大部分ERCP器械的使用，即满足胆管和胰管的可视化诊疗要求。
在本申请的部分实施例中，所述导管主体1包括加强层11，所述加强层11包覆在所述导管主体1、软质端21以及功能端22的外壁上。所述加强层11一方面可以增强整体导 管的刚度，便于将导管向患者的体内腔道进行输送；另一方面，还可以通过加强层11将导管主体1、软质端21以及功能端22进行连通，从而使导管主体1与远端管2不采用相同材料或一体式结构时，依然能够连接为一个整体，从而避免使用连接件造成腔道及导管的变形。
在一些实施例中，所述加强层11为编织网管结构，包括位于内层的金属编织网和位于外层的塑料基质管。加强层11的管壁厚度单边至少要在0.1mm以上才能保持足够的连接强度，因此，在所述导管主体1的外径小于或等于3.7mm时，其内部的实体直径要小于3.5mm。以目前挤出技术及材料特性，导管主体1及软质端21(如采用PEBAX，硅胶等材料)能做到的有效极限壁厚为0.1mm，所以内部用于多腔设计的直径空间为3.3mm以下，进而用作工作腔道的直径可以设计为1.8mm以上，即所述工作腔道3的直径大于或等于1.8mm。
在本申请的部分实施例中，如图4所示，所述多功能导管还包括连接在所述导管主体1近端的手柄7，所述手柄7上设有同轴的多个转动件71；所述转动件71连接操纵丝5的近端，以通过所述转动件71牵引所述操纵丝5，控制远端管2定向弯曲。其中，每个所述转动件71上连接有两个所述操纵丝5，两个所述操纵丝5在所述转动件71转轴上的缠绕方向相反，以产生控制远端管2定向弯曲的拉力。在一些实施例中，所述手柄7上还设有工作腔道入口72，所述工作腔道入口72为6％标准鲁尔接头，所述工作腔道入口72连通工作腔道3。
本实施例中，所述导管主体1的近端包含手柄7，手柄7中包含一对同轴转动件71即转动轮，每个转动轮在其转动轴的两侧分别连接两根操纵丝5，当所述多功能导管单独使用或配合十二指肠镜使用到达目标腔道后，医生单手握住手柄7或者将手柄7悬挂在配合其使用的其他内窥镜(如十二指肠镜)工作腔道附近。
通过扭动手柄7上的同轴转动件71，分别带动手柄7中的同轴两个转动轮的转轴发生转动，当其中一个转动轮发生顺时针转动时，与其相连接的两根对称的操纵丝5将在导管主体1和远端管2中的操作腔道4中发生相对移动，并分别产生一拉一推相反方向的作用力，使得与其相连接的功能端22产生倾斜，并压缩远端管2中的软质端21，使得远端管2向预定方向弯曲。当转动轮发生逆时针转动时，远端管2将向另一个方向弯曲。同理，当另外一个转动轮发生顺时针和逆时针转动时，也将带动远端管2发生其他方向进行弯曲。
在本实施例中，医生通过转动转动手柄7上的转动件71，控制远端管2在患者体内及配合的内窥镜的腔道中进入的方向，以及观察的方向，同时通过推送导管主体1近端的手柄7可以控制远端管2进出腔道的深度。另外，手柄7近端有一个结构为6％标准鲁尔接头的工作腔道入口72，工作腔道入口72与工作腔道3相连接，医生可以通过工作腔道入口72插入辅助器械进行进一步诊疗，如活检钳和激光碎石器械，也可以通过工作腔道入口72来注射液体对腔道进行冲洗并将腔道内的液体洗出至体外。
在本申请的提供的部分实施例中，所述功能端22为外径与所述软质端21相等的圆柱形结构，所述功能端22的硬度大于所述软质端21的硬度。实际应用中，功能端22可以采用硬质塑料或者不锈钢材料制成圆柱形结构，并且在圆柱形结构上开设有与软质端21多腔道相对应的通孔。功能端22上可以通过硬质材料预先开设多个用于安装的孔，如相机孔，固定操纵丝5的孔，以及连通注液腔道8的药剂孔或注液孔等。因此，功能端22 的硬度大于软质端21的硬度可以便于对各种安装部件进行固定，使整体工作过程更加稳定。另外，选用较高硬度的功能端22，还便于进行加工成孔，提高工艺精度。
由以上技术方案可知，上述实施例中提供的多功能导管，包括多腔管结构的导管主体1和远端管2。其中，远端管2包括位于近端的软质端21，和位于远端的功能端22；软质端21的硬度小于导管主体1的硬度；导管主体1和软质端21内设有工作腔道；功能端22上设有连通工作腔道3的通孔；工作腔道3直径大于或等于软质端21外径的51％，工作腔道3直径大于或等于导管主体1外径的49％。本申请提供的导管可以通过远端管2的软质端21配合工作腔道3，实现转向功能使导管的远端可以适应相对于消化道更复杂的胆道环境。
同时，所述镜头腔道6为沿导管主体1和软质端31延伸的圆形管腔结构；所述镜头腔道6的内壁上设有多个置容槽61，以通过多个所述置容槽61容纳镜头组件中的光感芯片。本申请提供的导管可以通过镜头腔道6中的多个置容槽61形成容纳光感芯片的空间，从而在不增加镜头腔道6直径的前提下能够容纳镜头组件，减小导管整体直径，以适应相对于消化道更复杂的胆道环境。
另外，本申请提供的多功能导管，其工作腔道能够通过1.8mm的常规器械，方便医生使用，而且节约制造成本，降低配合使用的器械价格进一步降低患者的负担。
本申请提供的实施例之间的相似部分相互参见即可，以上提供的具体实施方式只是本申请总的构思下的几个示例，并不构成本申请保护范围的限定。对于本领域的技术人员而言，在不付出创造性劳动的前提下依据本申请方案所扩展出的任何其他实施方式都属于本申请的保护范围。

Claims (10)

  1. 一种多功能导管，其特征在于，包括：
    导管主体(1)，为多腔管结构；
    远端管(2)，为多腔管结构，连接在所述导管主体(1)的远端；
    其中，所述导管主体(1)和远端管(2)内设有工作腔道(3)；所述远端管(2)的远端端面上设有连通所述工作腔道(3)的通孔；所述导管主体(1)和远端管(2)内还设有镜头腔道(6)，所述远端管(2)的远端端面上设有连通所述镜头腔道(6)的通孔；
    所述镜头腔道(6)为沿导管主体(1)和远端管(2)延伸的管腔结构；所述镜头腔道(6)的内壁上设有多个置容槽(61)，以通过多个所述置容槽(61)容纳镜头组件中的光感芯片。
  2. 根据权利要求1所述的多功能导管，其特征在于，所述置容槽(61)为直角V形槽；所述镜头腔道(6)内设有四个置容槽(61)，以形成能够容纳镜头组件中的光感芯片的矩形空间。
  3. 根据权利要求2所述的多功能导管，其特征在于，四个所述置容槽(61)所形成的矩形空间与所述镜头腔道(6)同轴。
  4. 根据权利要求1所述的多功能导管，其特征在于，多个所述置容槽(61)以所述镜头腔道(6)的中轴线为中心，呈中心对称分布；多个所述置容槽(61)中，具有对角关系的两个置容槽(61)之间的距离大于或等于所述光感芯片的对角线长度。
  5. 根据权利要求1所述的多功能导管，其特征在于，所述远端管(2)包括软质端(21)和功能端(22)；所述软质端(21)位于所述远端管(2)的近端，所述功能端(22)位于所述远端管(2)的远端。
  6. 根据权利要求5所述的多功能导管，其特征在于，所述功能端(22)连通所述工作腔道(3)的通孔端面为倾斜面。
  7. 根据权利要求5所述的多功能导管，其特征在于，所述工作腔道(3)直径大于或等于所述软质端(21)外径的48％，所述工作腔道(3)直径大于或等于所述导管主体(1)外径的45％。
  8. 根据权利要求5所述的多功能导管，其特征在于，导管主体(1)和软质端(21)内还设有多个操作腔道(4)；所述功能端(22)上设有连通所述操作腔道(4)的多个连接孔；
    每个所述操作腔道(4)中设有操纵丝(5)，所述操纵丝(5)的远端固定在所述操作腔道(4)的连接孔内，以通过多个所述操纵丝(5)牵引所述功能端(22)，使 远端管(2)定向弯曲。
  9. 根据权利要求5所述的多功能导管，其特征在于，导管主体(1)包括加强层(11)，所述加强层(11)包覆在所述导管主体(1)和软质端(21)的外壁；所述加强层(11)为编织网管结构，包括位于内层的金属编织网和位于外层的塑料基质管。
  10. 根据权利要求5所述的多功能导管，其特征在于，所述功能端(22)为外径与所述软质端(21)相等的圆柱形结构，所述功能端(22)的硬度大于所述软质端(21)的硬度。
PCT/CN2021/075482 2020-03-04 2021-02-05 一种多功能导管 WO2021175087A1 (zh)

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