WO2023040232A1 - Tube à lumières multiples ayant une dureté changeant progressivement, procédé de fabrication, appareil de fabrication et endoscope - Google Patents

Tube à lumières multiples ayant une dureté changeant progressivement, procédé de fabrication, appareil de fabrication et endoscope Download PDF

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Publication number
WO2023040232A1
WO2023040232A1 PCT/CN2022/082717 CN2022082717W WO2023040232A1 WO 2023040232 A1 WO2023040232 A1 WO 2023040232A1 CN 2022082717 W CN2022082717 W CN 2022082717W WO 2023040232 A1 WO2023040232 A1 WO 2023040232A1
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WO
WIPO (PCT)
Prior art keywords
hardness
extruder
lumen tube
hopper
feeding
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2022/082717
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English (en)
Chinese (zh)
Inventor
白晓淞
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Innermedical Co Ltd
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Innermedical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Innermedical Co Ltd filed Critical Innermedical Co Ltd
Publication of WO2023040232A1 publication Critical patent/WO2023040232A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61B1/005—Flexible 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
    • A61B1/00064—Constructional details of the endoscope body
    • 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
    • A61B1/00131—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
    • A61B1/012—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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/285—Feeding the extrusion material to the extruder

Definitions

  • the invention relates to the technical field of medical instruments, in particular to a multi-lumen tube with gradually changing hardness, a manufacturing method, a manufacturing device and an endoscope.
  • Endoscope is a commonly used medical instrument, which enters the human body through the natural orifice of the human body or through a small incision made through surgery.
  • the adjustable curved outer sheath of the endoscope is introduced into the pre-examined organ, and changes in relevant parts can be directly observed.
  • the existing multi-lumen tubes in the outer sheath of adjustable curved endoscopes are usually assembled by multi-unit welding or gluing for the hard section, transition section and flexible tube section, which is difficult to assemble and requires a variety of special tools to assemble , the manufacturing cost is high, the yield rate of the finished product is low, and it is easy to break and deform during the use of the final product, and the control angle is not accurate enough.
  • the steering guide wire is also easily loosened due to misalignment with other unit sections, resulting in distortion of the steering angle.
  • the invention provides a method for manufacturing a multi-lumen tube with gradual hardness, comprising the following steps:
  • Step 1 Add the high-hardness polymer material into the duct extruder, and control the time of adding the high-hardness polymer material into the duct extruder, and extrude the high-hardness polymer material through the duct extruder to thereby Form a hard segment that meets the length requirement;
  • Step 2 When the quality of the polymer material added to the conduit extruder remains unchanged, reduce the weight of the high-hardness polymer material added to the conduit extruder to zero, and gradually increase from zero to add low hardness to the conduit extruder High polymer materials, control the time of adding high hardness polymer materials and low hardness polymer materials to the duct extruder, and extrude a transition section that meets the length requirements through the duct extruder;
  • Step 3 Stop adding high-hardness polymer materials to the duct extruder, add low-hardness polymer materials to the duct extruder, control the time for adding low-hardness polymer materials to the duct extruder, and pass Conduit extruders extrude low-hardness polymer materials to form flexible segments that meet length requirements.
  • a multi-lumen tube is manufactured by a manufacturing device, and polymer materials of the same type with high hardness and low hardness are respectively added into the first hopper and the second hopper, and the manufacture of the multi-lumen tube includes the following steps:
  • Step 1 Make the high-hardness polymer material in the first hopper flow into the duct extruder, and control the time for the first hopper to flow the high-hardness polymer material into the duct extruder through the feeding timing device , Extrude high-hardness polymer materials through a conduit extruder to form a hard segment that meets the length requirements;
  • Said step 2 under the condition that the quality of the polymer material added to the duct extruder remains unchanged, the weight of the polymer material added from the first feeding hopper to the duct extruder is reduced to zero through the first feeding metering device, and the weight of the polymer material added to the duct extruder is reduced to zero through the second
  • the feeding metering device gradually increases from zero, and the second feeding hopper adds low-hardness polymer materials to the duct extruder, and the first and second feeding hoppers are controlled by the feeding timing device to flow high-hardness polymer materials into the duct extruder When the material and low-hardness polymer material are used, the transition section that meets the length requirements is extruded through the conduit extruder;
  • Said step 3 close the first hopper, the second hopper works according to the amount, and control the time for the second hopper to flow the low-hardness polymer material into the duct extruder through the feeding timing device, and pass the duct extruder
  • the polymer material with low hardness is extruded to form a flexible segment that meets the length requirement.
  • the present invention also provides a device for making multi-lumen tubes with gradually changing hardness, including a first feeding hopper, a second feeding hopper, a first feeding metering device, a second feeding metering device, a feeding timing device, and a conduit extruder.
  • the first feeding hopper communicates with the first feeding metering device
  • the second feeding hopper communicates with the second feeding metering device
  • one end of the feeding timing device is respectively connected with the first feeding metering device and the The second feeding metering device is connected, and the other end of the feeding timing device is connected with the conduit extruder
  • the first feeding hopper is used for carrying high-hardness polymer materials
  • the second feeding hopper is used for carrying low hardness polymer material
  • the first feeding metering device is used to control the weight of the high hardness polymer material flowing from the first hopper into the conduit extruder
  • the second feeding metering device is used to control The weight of the low-hardness polymer material flowing into the duct extruder from the second hopper
  • the feeding timing device is used to control the flow of the first hopper and/or the second hopper into the duct extruder Time for the polymer material
  • the catheter extruder is used to extrude the multi-lumen tube at one time.
  • the multi-lumen tube of the present invention includes a hard section, a transition section and a flexible section, and the multi-lumen tube is integrally formed.
  • a steering guide wire channel is provided in the multi-lumen tube, and the steering guide wire is located in the steering guide wire channel.
  • the multiple steering wire channels are evenly distributed in the multi-lumen tube.
  • the number of steering wires is the same as the number of steering wire channels, and each steering wire is installed on the corresponding inside the steering wire channel.
  • the multi-lumen tube is provided with a working channel, an imaging channel, a water injection and gas injection channel, and an optical fiber channel.
  • the present invention also provides an endoscope comprising a multi-lumen tube, including a probe, a handle, a connection unit, a steering control device, a working port, an imaging port, a water injection or an air injection port, the handle is provided with a connection unit, the One end of the multi-lumen tube is connected to the connection unit, the working port communicates with the working channel, the imaging port communicates with the imaging channel, the water injection or gas injection port communicates with the water injection or gas injection channel, the The probe is located in the imaging channel, the steering control device is installed on the handle, one end of the steering guide wire is connected to the front end of the flexible section, and the other end of the steering guide wire is connected to the steering control device.
  • the beneficial effect of the present invention is that: the multi-lumen tube of the present invention is extruded at one time, and various parts with different hardness are produced on a multi-lumen tube, which is cheap and simplifies the traditional process of welding, injecting or gluing.
  • the hard catheter is made of endoscopic adjustable curved outer sheath multi-lumen tube. The process is simple and easy to mass produce; Molding makes the multi-lumen tube more integral and improves the safety and service life of the multi-lumen tube.
  • Fig. 1 is the schematic diagram of making device structure
  • Figure 2 is a schematic diagram of the multi-lumen tube structure
  • Fig. 3 is a schematic diagram of the structure of the endoscope
  • Figure 4 is a sectional view of the multi-lumen tube.
  • the invention discloses a method for manufacturing a multi-lumen tube 20 with gradually changing hardness, which includes the following steps:
  • Step 1 Add the high-hardness polymer material into the duct extruder 5, and control the time of adding the high-hardness polymer material into the duct extruder 5, and pass the high-hardness polymer material through the duct extruder 5 Extruding to form a hard segment 6 meeting the length requirement;
  • Step 2 When the quality of the polymer material added to the conduit extruder 5 remains the same, reduce the weight of the high-hardness polymer material added to the conduit extruder 5 to zero, and gradually increase from zero to the conduit extruder 5 Adding low-hardness polymer materials, controlling the time for adding high-hardness polymer materials and low-hardness polymer materials to the conduit extruder 5, and extruding the transition section 7 that meets the length requirements through the conduit extruder 5;
  • Step 3 Stop adding the high-hardness polymer material to the duct extruder 5, add the low-hardness polymer material to the duct extruder 5, and control the addition of the low-hardness polymer material to the duct extruder 5 time, extrude the low-hardness polymer material through the conduit extruder 5 to form a flexible segment 8 that meets the length requirement.
  • the present invention manufactures the multi-lumen tube 20 through a manufacturing device, and adds similar high-hardness and low-hardness polymer materials into the first hopper 1 and the second hopper 2 respectively, and the multi-lumen tube 20 Production includes the following steps:
  • Step 1 Make the high-hardness polymer material in the first hopper 1 flow into the duct extruder 5, and control the first hopper 1 to flow into the duct extruder 5 through the feeding timing device 4.
  • the high-hardness polymer material is extruded through the conduit extruder 5 to form a hard segment 6 that meets the length requirement;
  • Said step 2 under the condition that the quality of the polymer material added to the duct extruder 5 is constant, the weight of the polymer material added from the first feeding hopper 1 to the duct extruder 5 is reduced to zero by the first feeding metering device 31 , gradually increase the second feeding hopper 2 from zero to add the low-hardness polymer material to the duct extruder 5 through the second feeding metering device 32, and control the first feeding hopper 1 and the second feeding hopper 2 to the duct through the feeding timing device 4 When the high-hardness polymer material and the low-hardness polymer material flow into the extruder 5, the transition section 7 that meets the length requirement is extruded through the conduit extruder 5;
  • step 3 the first hopper 1 is closed, the second hopper 2 works according to the amount, and the second hopper 2 is controlled to flow into the duct extruder (5) by the feeding timing device 4. time, extrude the low-hardness polymer material through the conduit extruder 5 to form a flexible segment 8 that meets the length requirement.
  • the present invention also discloses a manufacturing device for a multi-cavity tube 20, comprising a first feeding hopper 1, a second feeding hopper 2, a first feeding metering device 31, a second feeding metering device 32, a feeding timer Device 4, duct extruder 5, the first feeding hopper 1 communicates with the first feeding metering device 31, the second feeding hopper 2 communicates with the second feeding metering device 32, and the feeding One end of the timing device 4 is communicated with the first feeding metering device 31 and the second feeding metering device 32 respectively, and the other end of the charging timing device 4 is connected with the conduit extruder 5; the first feeding hopper 1
  • the second feeding hopper 2 is used for carrying high-hardness polymer materials; the first feeding metering device 31 is used to control the extrusion of the first feeding hopper 1 to the conduit.
  • the charging timing device 4 is used to control the time when the first hopper 1 and/or the second hopper 2 flow into the polymer material in the conduit extruder 5; the conduit extruder 5 is used to 20 extrusion molding at one time.
  • the multi-lumen tube 20 of the present invention includes a hard section 6 , a transition section 7 and a flexible section 8 , and the multi-lumen tube 20 is integrally formed.
  • the hard segment 6 , the transition segment 7 and the flexible segment 8 are realized by using the first feeding metering device 31 and the second feeding metering device 32 , by controlling the addition of polymer materials of the same type and different hardness.
  • the total amount of the hard section 6, the transition section 7 and the flexible section 8 is kept constant through metering, and the first feeding hopper 1 and the second feeding hopper 2 add different weights to the conduit extruder 5 to control the degree of hardness change.
  • Control the length of the hard section 6, the transition section 7 and the flexible section 8 by controlling the time when the first hopper 1 and/or the second hopper 2 flow into the polymer material in the conduit extruder 5 by the feeding timing device 4, to reach the product Require.
  • High hardness and low hardness polymer materials can choose different hardness grades such as polyurethane, polyamide (PEBAX), etc., according to the use requirements of the multi-lumen tube.
  • the multi-lumen tube 20 is provided with a steering guide wire channel 9 , and the steering guide wire is located in the steering guide wire channel 9 .
  • the number of steering guide wires is the same as the number of steering guide wire channels 9, and each steering guide wire is installed on a corresponding steering wire. In the guide wire channel 9.
  • the multi-lumen tube 20 is provided with a working channel 10 , an imaging channel 11 , a water injection and gas injection channel 12 , and an optical fiber channel 13 .
  • the present invention also discloses an endoscope comprising a multi-lumen tube 20, including a probe 21, a handle 17, a connection unit 19, a steering control device 15, a working port 14, an imaging port 16, a water injection or an injection port Gas port 18,
  • the handle 17 is provided with a connection unit 19
  • one end of the multi-lumen tube 20 is connected to the connection unit 19
  • the working port 14 is in communication with the working channel 10
  • the imaging port 16 is in communication with the imaging channel 11
  • the water injection or gas injection port 18 communicates with the water injection or gas injection channel 12
  • the probe 21 is located in the imaging channel 11
  • the steering control device 15 is installed on the handle 17,
  • One end of the steering guide wire is connected to the front end of the flexible section 8 , and the other end of the steering guide wire is connected to the steering control device 15 .
  • the multi-lumen tube of the present invention is formed by one-time extrusion, and various parts of different hardness are produced on a multi-lumen tube, which is cheap and simplifies the traditional process of welding, injecting or gluing catheters with different hardness to make endoscopes
  • the method of multi-lumen tube with adjustable curved outer sheath has simple process and is easy to mass produce; the steering guide wire can be evenly distributed in each guide wire channel of the tube wall, and the steering is precise. The safety and service life of the multi-lumen tube are improved.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Optics & Photonics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Manufacturing & Machinery (AREA)
  • Extrusion Moulding Of Plastics Or The Like (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un tube à lumières multiples ayant une dureté changeant progressivement, un procédé de fabrication, un appareil de fabrication et un endoscope. Le tube à lumières multiples comprend un segment dur, un segment de transition et un segment souple, et le tube à lumières multiples est formé d'un seul tenant. Les effets bénéfiques de la présente invention sont les suivants : le tube à lumières multiples de la présente invention est formé au moyen d'un seul tour d'extrusion, chaque partie ayant une dureté différente est fabriquée sur un tube à lumières multiples, la présente invention est peu coûteuse, les moyens de fabrication d'un tube à lumières multiples de gaine externe pliable d'endoscope par l'intermédiaire d'un procédé de soudage classique, une liaison par injection, ou des cathéters adhésifs de duretés différentes, sont simplifiés, les procédés sont simples, et la présente invention est facilement produite par lots; des fils de guidage de modification de direction peuvent être répartis de manière uniforme dans divers canaux de fil de guidage d'une paroi de tube, la modification de direction est précise, en raison du fait que le tube à lumières multiples est formé d'un seul tenant, le tube à lumières multiples présente une unité supérieure, et la sécurité et la durée de vie du tube à lumières multiples sont améliorées.
PCT/CN2022/082717 2021-09-17 2022-03-24 Tube à lumières multiples ayant une dureté changeant progressivement, procédé de fabrication, appareil de fabrication et endoscope Ceased WO2023040232A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202111093089.7A CN113876283A (zh) 2021-09-17 2021-09-17 一种渐变硬度的多腔管、制作方法、制作装置及内窥镜
CN202111093089.7 2021-09-17

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WO2023040232A1 true WO2023040232A1 (fr) 2023-03-23

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PCT/CN2022/082717 Ceased WO2023040232A1 (fr) 2021-09-17 2022-03-24 Tube à lumières multiples ayant une dureté changeant progressivement, procédé de fabrication, appareil de fabrication et endoscope

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WO (1) WO2023040232A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113876283A (zh) * 2021-09-17 2022-01-04 深圳英美达医疗技术有限公司 一种渐变硬度的多腔管、制作方法、制作装置及内窥镜

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995028982A1 (fr) * 1994-04-20 1995-11-02 Wang James C Tubes et procede pour leur fabrication
US20040116901A1 (en) * 2002-12-04 2004-06-17 Appling William M. Variable characteristic venous access catheter
CN105120776A (zh) * 2014-03-20 2015-12-02 波士顿科学有限公司 血栓切除术导管
CN108618739A (zh) * 2017-03-28 2018-10-09 深圳英美达医疗技术有限公司 一种转向装置、制作方法及内窥镜
CN112590159A (zh) * 2021-03-02 2021-04-02 岱川医疗(深圳)有限责任公司 加工插入管外皮层的挤出装置及加工方法、内窥镜插入管
CN113876283A (zh) * 2021-09-17 2022-01-04 深圳英美达医疗技术有限公司 一种渐变硬度的多腔管、制作方法、制作装置及内窥镜

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995028982A1 (fr) * 1994-04-20 1995-11-02 Wang James C Tubes et procede pour leur fabrication
US20040116901A1 (en) * 2002-12-04 2004-06-17 Appling William M. Variable characteristic venous access catheter
CN105120776A (zh) * 2014-03-20 2015-12-02 波士顿科学有限公司 血栓切除术导管
CN108618739A (zh) * 2017-03-28 2018-10-09 深圳英美达医疗技术有限公司 一种转向装置、制作方法及内窥镜
CN112590159A (zh) * 2021-03-02 2021-04-02 岱川医疗(深圳)有限责任公司 加工插入管外皮层的挤出装置及加工方法、内窥镜插入管
CN113876283A (zh) * 2021-09-17 2022-01-04 深圳英美达医疗技术有限公司 一种渐变硬度的多腔管、制作方法、制作装置及内窥镜

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