WO2023040232A1

WO2023040232A1 - Multi-lumen tube having gradually changing hardness, manufacturing method, manufacturing apparatus, and endoscope

Info

Publication number: WO2023040232A1
Application number: PCT/CN2022/082717
Authority: WO
Inventors: 白晓淞
Original assignee: 深圳英美达医疗技术有限公司
Priority date: 2021-09-17
Filing date: 2022-03-24
Publication date: 2023-03-23
Also published as: CN113876283A

Abstract

Provided are a multi-lumen tube having a gradually changing hardness, a manufacturing method, a manufacturing apparatus, and an endoscope. The multi-lumen tube comprises a hard segment, a transition segment, and a soft segment, and the multi-lumen tube is integrally formed. Beneficial effects of the present invention are: the multi-lumen tube of the present invention is formed by means of a single round of extrusion, each part having a different hardness is manufactured on one multi-lumen tube, the present invention is low-cost, a means of manufacturing an endoscope bendable outer sheath multi-lumen tube via a traditional process of welding, injection connecting, or adhering catheters of different hardnesses is simplified, a process is simple, and the present invention is readily batch-produced; direction altering guide wires can be evenly distributed in various guide wire channels of a tube wall, direction alteration is precise, due to the multi-lumen tube being integrally formed, the multi-lumen tube has greater unity, and the safety and service life of the multi-lumen tube are improved.

Description

Multi-lumen tube with gradual hardness, manufacturing method, manufacturing device and endoscope

technical field

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.

Background technique

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. When in use, 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. At the same time, the steering guide wire is also easily loosened due to misalignment with other unit sections, resulting in distortion of the steering angle.

Contents of the invention

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.

As a further improvement of the present invention, 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, and 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, and 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.

As a further improvement of the present invention, 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.

As a further improvement of the present invention, there are multiple steering wire channels, and 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.

As a further improvement of the present invention, 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.

Description of drawings

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.

Detailed ways

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.

As a preferred embodiment of the present invention, 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. When the polymer material is used, 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;

Said 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.

As shown in Figure 1, 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 weight of the high-hardness high-molecular material flowing into the machine 5; the second feeding metering device 32 is used to control the weight of the low-hardness high-molecular material that the second hopper 2 flows into the conduit extruder 5 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.

As shown in FIGS. 2 and 4 , 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 .

There are multiple steering guide wire channels 9, and the multiple steering guide wire channels 9 are evenly distributed in the multi-lumen tube 20. 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 .

As shown in Fig. 3, 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, and 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, the 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.

The above content is a further detailed description of the present invention in conjunction with specific preferred embodiments, and it cannot be assumed that the specific implementation of the present invention is limited to these descriptions. For those of ordinary skill in the technical field of the present invention, without departing from the concept of the present invention, some simple deduction or replacement can be made, which should be regarded as belonging to the protection scope of the present invention.

Claims

A method for manufacturing a multi-lumen tube (20) with gradual hardness, comprising 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 duct extruder (5) to High-hardness polymer material is extruded to form a hard segment (6) that meets the length requirement;

Step 2: Under the condition that the quality of the polymer material added to the conduit extruder (5) remains unchanged, 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 The extruder (5) adds the macromolecular material of low hardness, controls the time of adding the macromolecular material of high hardness and the macromolecular material of low hardness in the duct extruder (5), extrudes through the duct extruder (5) Out of the transition section (7) that meets the length requirement;

Step 3: Stop adding high-hardness polymer materials to the duct extruder (5), add low-hardness polymer materials to the duct extruder (5), and control the addition of low-hardness polymer materials to the duct extruder (5). When the hard polymer material is used, the low-hard polymer material is extruded through the conduit extruder (5) to form a flexible segment (8) that meets the length requirement.
The production method according to claim 1, characterized in that: the multi-cavity tube (20) is produced by the production device, and the same high hardness and low hardness are respectively added to the first hopper (1) and the second hopper (2). Polymer material, the making of multi-lumen tube (20) comprises the steps:

Said 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 squeeze into the duct through the feeding timing device (4) When the high-hardness polymer material flows into the machine (5), 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 in the conduit extruder (5) is constant, reduce the amount of the first feeding hopper (1) to the conduit extruder (5) by the first feeding metering device (31) Add the high polymer material weight to zero, gradually increase the second feed hopper (2) from zero by the second feed metering device (32) to add the low hardness high polymer material to the conduit extruder (5), and pass the feed timing device ( 4) Control the time when the first hopper (1) and the second hopper (2) flow into the duct extruder (5) into the high-hardness polymer material and the low-hardness polymer material, through the duct extruder ( 5) Extrude the transition section (7) that meets the length requirement;

Said step 3: the first hopper (1) is closed, the second hopper (2) works according to the amount, and the second hopper (2) is controlled by the feeding timing device (4) to the conduit extruder (5) When the polymer material with low hardness flows in, the polymer material with low hardness is extruded through the conduit extruder (5) to form a flexible segment (8) meeting the length requirement.
A manufacturing device for a multi-chamber tube (20) with gradual hardness, characterized in that it includes a first feeding hopper (1), a second feeding hopper (2), a first feeding metering device (31), a second feeding metering device (32), feeding timing device (4), duct extruder (5), the first feeding hopper (1) communicates with the first feeding metering device (31), the second feeding hopper (2) It is communicated with the second feeding metering device (32), and one end of the feeding timing device (4) is respectively connected with the first feeding metering device (31) and the second feeding metering device (32). The other end of the feeding timing device (4) is connected to the conduit extruder (5); the first feeding hopper (1) is used to carry high-hardness polymer materials, and the second feeding hopper (2) is used to for carrying low-hardness high-molecular materials; the first feeding metering device (31) is used to control the flow of high-hardness high-molecular materials from the first hopper (1) into the conduit extruder (5) Weight; the second feeding metering device (32) is used to control the weight of the low-hardness macromolecule material flowing into the duct extruder (5) from the second feeding hopper (2); the feeding timing device (4) It is used to control the time when the first hopper (1) and/or the second hopper (2) flows into the polymer material in the conduit extruder (5); the conduit extruder (5) is used for The multi-lumen tube (20) is extruded into shape at one time.
A multi-lumen tube (20) with gradual hardness, characterized in that the multi-lumen tube (20) includes a hard section (6), a transition section (7) and a flexible section (8), and the multi-lumen tube (20) is integrated forming.
The multi-lumen tube (20) according to claim 4, characterized in that: a steering guide wire channel (9) is arranged in the multi-lumen tube (20), and the steering guide wire is located in the steering guide wire channel (9).
The multi-lumen tube (20) according to claim 5, characterized in that: there are multiple steering guide wire channels (9), and the multiple steering guide wire channels (9) are evenly distributed in the multi-lumen tube (20) , the number of steering wires is the same as the number of steering wire channels (9), and each steering wire is installed in a corresponding steering wire channel (9).
The multi-lumen tube (20) according to claim 5 or 6, characterized in that: the multi-lumen tube (20) is provided with a working channel (10), an imaging channel (11), a water injection and an air injection channel (12) , Fiber Channel (13).
An endoscope comprising a multi-lumen tube (20) according to claim 7, characterized in that: comprising a probe (21), a handle (17), a connecting unit (19), a steering control device (15), a working port ( 14), imaging port (16), water injection or gas injection port (18), a connection unit (19) is set on the handle (17), and one end of the multi-lumen tube (20) is connected to the connection unit (19), the The working port (14) communicates with the working channel (10), the imaging port (16) communicates with the imaging channel (11), and the water injection or gas injection port (18) communicates with the water injection or gas injection The channel (12) is connected, the probe (21) is located in the imaging channel (11), the steering control device (15) is installed on the handle (17), and one end of the steering guide wire is connected to the flexible The front end of the section (8) is connected, and the other end of the steering guide wire is connected with the steering control device (15).