Tracheal tube and manufacturing process

Abstract

The application discloses a tracheostomy cannula and a preparation process, the tracheostomy cannula comprises an outer sleeve and an inner tube nested in the outer sleeve, a spiral metal wire is embedded in the wall of the outer sleeve, the spiral metal wire extends spirally along the length direction of the outer sleeve, and the outer sleeve and the inner tube are both made of bio-based elastic polyester; the bio-based elastic polyester is prepared by copolymerization of diacid and diol, the diacid is furan dimethyl acid, the diol is composed of cyclohexane dimethyl alcohol and polytetrahydrofuran, and the mass of the polytetrahydrofuran accounts for 20-70% of the total mass of the diacid and the diol. The application provides a tracheostomy cannula and a preparation process, which can reduce the wall of the outer sleeve without reducing the bending strength, so that the inner tube can be installed in the outer sleeve, and the process of cleaning accumulated sputum is simple and convenient.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, specifically to a tracheostomy cannula and its manufacturing process. Background Technology

[0002] Existing tracheostomy cannulas can be categorized into metallic and non-metallic materials. Metallic tracheostomy cannulas have several drawbacks: 1) High thermal conductivity of metal, making the cold metal irritate the airway; 2) The rigid metal walls cannot adapt to airway curvature, potentially causing airway compression and long-term tracheal mucosal ulceration and stenosis; 3) Sputum and mucous membranes easily accumulate on the metal walls, necessitating the insertion of an inner metal tube within the outer cannulas, requiring frequent removal and cleaning. Due to these drawbacks, the use of metallic tracheostomy cannulas has gradually decreased with the development of medical polymer materials.

[0003] Non-metallic tracheostomy cannulas are mostly made of silicone or medical-grade plastic. Existing conventional silicone cannulas have poor biocompatibility, with the potential for the release of trace amounts of toxic chemicals, posing a high risk of airway irritation. Furthermore, the tube body of commonly used silicone tracheostomy cannulas lacks flexibility, easily compressing the tracheal mucosa and making them unsuitable for long-term placement. Additionally, to maintain unobstructed ventilation, existing silicone tracheostomy cannulas require a certain wall thickness to ensure sufficient bending strength and maintain the cross-sectional area of ​​the inner wall. However, a thicker wall limits the inner diameter, thus limiting the use of a single outer tube in current non-metallic tracheostomy cannulas to a single inner tube. Consequently, existing non-metallic tracheostomy cannulas commonly suffer from difficulty in cleaning the accumulated sputum on the inner wall during daily use. Summary of the Invention

[0004] The present invention aims to at least partially solve one of the technical problems in the related art: to provide a tracheostomy sleeve and its manufacturing process, which can reduce the wall of the outer sleeve without reducing the bending strength, thereby enabling the installation of an inner tube inside the outer sleeve, making the process of cleaning sputum simple and convenient.

[0005] Therefore, one object of the present invention is to provide an air-cutting sleeve, which includes an outer sleeve and an inner sleeve nested inside the outer sleeve, wherein a spiral metal wire is embedded in the wall of the outer sleeve, the spiral metal wire extends spirally along the length direction of the outer sleeve, and both the outer sleeve and the inner sleeve are made of bio-based elastic polyester. The bio-based elastic polyester is obtained by copolymerizing a diacid and a diol, wherein the diacid is furan dicarboxylic acid and the diol is composed of cyclohexanediethanol and polytetrahydrofuran, and the mass of polytetrahydrofuran accounts for 20%-70% of the total mass of the diacid and the diol.

[0006] According to one example of the invention, the molar ratio of the diol and the diacid is 1 to 2, and the polytetrahydrofuran accounts for 40% to 90% of the total mass of the diol.

[0007] According to one example of the present invention, the rear end of the outer tube is provided with a base, the base having a central hole communicating with the outer tube, and connecting pieces being provided on both sides of the base along the width direction, the connecting pieces having rope holes for passing through a medical strap.

[0008] According to one embodiment of the invention, the thickness of the abutment is 2-8 mm. The smaller abutment thickness results in a flatter portion of the tracheostomy tube protruding from the tracheostomy opening after it is fitted onto the patient's throat, reducing interference with the patient's daily life and work. Furthermore, different abutment thicknesses can be selected for tracheostomy tubes for adults and children, allowing for the use of abutments with even smaller thicknesses for pediatric tracheostomy tubes.

[0009] According to one embodiment of the present invention, the base is provided with a device connector detachably connected to the base, and the device connector has a central channel communicating with the inner lumen of the inner tube. When the patient needs to connect to an external device, the device connector can be temporarily installed on the base to connect to the external device, such as connecting the device connector to the oxygen supply tube of an oxygen supply machine.

[0010] According to one example of the invention, the device connector is threadedly connected to the base.

[0011] According to one example of the invention, the rear end of the inner tube has a radially outwardly convex pipe fitting, and the device fitting and the base together form an annular cavity for accommodating the pipe fitting.

[0012] According to one embodiment of the present invention, a positioning balloon is provided on the outer side wall of the front end of the outer sleeve, and an air supply hose is provided outside the outer sleeve, one end of the air supply hose having a valve, and the other end communicating with the balloon through an airflow pipe in the wall of the outer sleeve.

[0013] According to one embodiment of the present invention, an indicator airbag is provided at the end of the air supply hose opposite to the outer sleeve, and the air supply hose and the valve are respectively connected to both ends of the indicator airbag. The indicator airbag allows medical personnel to determine whether the air pressure of the indicator airbag is sufficient by pressing the inflated indicator airbag with their fingers when installing the outer sleeve. This, in turn, determines whether the air pressure of the positioning balloon connected to the indicator airbag is sufficient, avoiding the problem of positioning failure due to insufficient air pressure in the positioning balloon.

[0014] According to one embodiment of the present invention, the indicating airbag is partially or entirely made of transparent material. A secondary indicator is provided within the airbag. The secondary indicator includes a cylindrical body, one end of which is sealed, and the other end has an opening. A piston is disposed within the cylindrical body, slidingly engaging with the cylindrical body. The outer wall of the piston is divided axially into several color-changing areas. A transparent observation window is provided on the side wall of the cylindrical body, corresponding to the outer wall of the piston. Since the pressure of the indicating airbag can only be judged by the touch and experience of medical personnel when pressing it with a finger, inaccurate judgments are prone to occur. Therefore, by adding a secondary indicator within the airbag, the secondary indicator can display the air pressure value within the airbag through the piston's position within the cylindrical body. Finally, by observing the different color-changing areas of the piston corresponding to the observation window, medical personnel can intuitively determine whether the air pressure within the airbag is within the acceptable range based on the color seen on the observation window.

[0015] Therefore, another object of the present invention is to provide a manufacturing process for an air-cutting sleeve, comprising the following steps: S1. Dimethyl furanate was synthesized from furanate and methanol, and the purity of the dimethyl furanate was verified by nuclear magnetic resonance technology. S2. Dimethyl furanate is copolymerized with a diol to form a bio-based elastic polyester, wherein the diol is composed of cyclohexanediethanol and polytetrahydrofuran, and the polytetrahydrofuran accounts for 40% to 90% of the total mass of the diol, and the molar ratio of the diol to dimethyl furanate is 1 to 2. S3. The obtained bio-based elastic polyester is used as raw material to make the outer tube and inner tube as described in claim 1.

[0016] The above technical solution has the following advantages or beneficial effects: First, during the fabrication and molding process of the outer and inner tubes using bio-based elastic polyester, extremely fine spiral metal wires are simultaneously embedded. Due to the spiral extension structure of the spiral metal wires, the outer tube has better bending strength. Therefore, when inserted into the patient's tracheostomy, it can resist external force on the outer tube, allowing it to maintain its original cross-sectional shape and preventing deformation from external force. Second, because the built-in spiral metal wires allow the overall wall thickness of the outer tube to be much smaller than that of existing silicone outer tubes, the inner tube can be placed inside the outer tube of this application. In addition, the total wall thickness of the outer tube is roughly the same as or slightly smaller than that of the existing silicone tracheostomy tube. Therefore, if there is sputum buildup on the inner tube wall, the inner tube can simply be removed and cleaned externally, reducing the difficulty of care. Finally, the outer and inner tubes are made of a new type of bio-based elastic polyester, which has the following advantages: 1) It possesses superior mechanical properties, high rigidity, resistance to compression deformation, and strong chemical stability; 2) It has better biocompatibility, as the material itself contains no phthalates or other additives, and there will be no chemical migration that irritates the airway mucosa; 3) The inner wall is less prone to sputum buildup and crust formation, making care simpler.

[0017] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0018] Figure 1 This is an isometric view of the gas cutting sleeve of the present invention.

[0019] Figure 2 This is a front view of the gas cutting sleeve of the present invention.

[0020] Figure 3 for Figure 2 A cross-sectional view along the "AA" direction.

[0021] Figure 4 This is a top view of the gas cutting sleeve of the present invention.

[0022] Figure 5 This is a side view of the gas cutting sleeve of the present invention.

[0023] Figure 6 for Figure 5 A cross-sectional view along the "BB" direction.

[0024] Figure 7 for Figure 5 A cross-sectional view along the "CC" direction.

[0025] Figure 8 for Figure 6 A magnified view of a portion of the "D" region.

[0026] Figure 9 This is a mechanical property test diagram of the test strip of bio-based elastic polyester in this invention.

[0027] Figure 10 This is a schematic diagram of the internal structure of the sterile cannula inserted inside the outer cannula in this invention.

[0028] The components are as follows: 1. Outer tube; 1.1. Airflow duct; 2. Inner tube; 3. Spiral metal wire; 4. Base; 4.1. Central hole; 4.2. Connecting piece; 4.3. Rope hole; 5. Medical strap; 6. Equipment connector; 6.1. Central channel; 7. Pipe connector; 8. Annular cavity; 9. Positioning balloon; 10. Air supply hose; 11. Valve nozzle; 11.1. Valve body; 11.2. Valve core; 11.3. Valve plate; 11.4. Partition; 11.5. Abutment joint; 11.6. Spring; 12. Indicating balloon; 13. Secondary indicator; 13.1. Cylinder; 13.2. Piston; 13.2.1. Color display area; 13.3. Observation window; 14. Sterile cannula core; 14.1. Handheld end; 14.2. Plug. Detailed Implementation

[0029] Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention.

[0030] The gas cutting sleeve and its manufacturing process according to embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0031] Bending strength refers to the bending strength of the outer tube 1 when an external force compresses the outer tube 1 radially inward, thereby reducing the cross-sectional area inside the outer tube 1.

[0032] 2,5-Furfurandicarboxylic acid, abbreviated as FDCA.

[0033] Dimethyl 2,5-furandicarboxylate, abbreviated as DMFD.

[0034] Nuclear magnetic resonance (NMR) is an existing molecular structure characterization technique used to verify molecular chemical structures and confirm the purity of raw materials.

[0035] Polytetrahydrofuran diol with a molecular weight of 1000, abbreviated as PTMG1000.

[0036] 1,4-Cyclohexanediethanol, abbreviated as CHDM.

[0037] The unit mol% refers to the mole percentage.

[0038] The units Pa and MPa are pressure units, respectively, Pascal and Megapascal.

[0039] First aspect The present invention provides an air cutting sleeve, as shown in the figure, which includes an outer sleeve 1 and an inner sleeve 2.

[0040] The outer tube 1 is designed with an arc-shaped structure to fit the respiratory tract after a tracheostomy. The outer tube 1 is made of bio-based elastic polyester particles through existing injection molding, extrusion, blow molding and other equipment. During the preparation of the outer tube 1, a spiral metal wire 3 is embedded in the tube wall. The spiral metal wire 3 is placed inside the outer tube 1 during the preparation of the outer tube 1 and then extends in a spiral shape along the length of the outer tube 3 itself, so that the spiral metal wire 3 and the outer tube 1 are an integral structure.

[0041] Optionally, the diameter of the spiral metal wire 3 is 0.01mm to 0.15mm, and the wall thickness of the outer tube 1 is 0.25mm to 0.8mm. For example, the wall thickness of the outer tube 1 is 0.25mm, 0.3mm, 0.35mm, 0.4mm, 0.45mm, 0.5mm, 0.55mm, 0.6mm, 0.65mm, 0.7mm, 0.75mm, or 0.8mm.

[0042] Optionally, the spiral metal wire 3 is a stainless steel wire in the form of a spiral.

[0043] The inner tube 2 is shaped to match the inner cavity of the outer tube 1, so that the inner tube 2 can be inserted into the outer tube 1 through the rear end of the outer tube 1, and the outer wall of the inner tube 2 fits against the inner wall of the outer tube 1.

[0044] In conjunction with the first aspect, both the outer tube 1 and the inner tube 2 are made of bio-based elastic polyester, which is obtained by copolymerizing a diacid and a diol, i.e., the diacid and the diol are formed through a polycondensation reaction. Specifically, the diacid is 100% furanylcarboxylic acid, and the diol is composed of cyclohexanediethanol and polytetrahydrofuran, wherein the polytetrahydrofuran is a di-polyether polyol with a molecular weight of 1000, and the mass of the polytetrahydrofuran accounts for 20-70% of the total polymer mass.

[0045] Preferably, the molar ratio of the diol to the diacid is 1 to 2, and the polytetrahydrofuran accounts for 40% to 90% of the total mass of the diol.

[0046] In conjunction with the first aspect, the bio-based elastic polyester is mixed with silver ions during the preparation process, which gives the outer tube 1 and inner tube 2 made of the bio-based elastic polyester antibacterial properties.

[0047] Optionally, the wall thickness of the inner tube 2 is 0.15mm to 0.8mm. For example, the wall thickness of the inner tube 2 is 0.15mm, 0.2mm, 0.25mm, 0.3mm, 0.35mm, 0.4mm, 0.45mm, 0.5mm, 0.55mm, 0.6mm, 0.65mm, 0.7mm, 0.75mm, or 0.8mm.

[0048] In conjunction with the first aspect, a hydrophilic anti-adhesion coating is applied to the inner wall of the inner tube 2. This hydrophilic anti-adhesion coating is a polyvinyl alcohol / polyethylene glycol composite hydrophilic coating, used to improve the hydrophilicity and smoothness of the inner wall surface, reducing the adhesion and retention of sputum, mucus, and secretions on the inner wall of the tube, thereby reducing the risk of crust formation and tube blockage. This coating should meet the biocompatibility requirements of medical polymer materials, have no significant irritation to the tracheal mucosa, and remain stable during suctioning, humidification, and inner tube replacement.

[0049] In conjunction with the first aspect, the front end of the outer tube 1 is designed to extend into the patient's airway. A positioning balloon 9 is provided on the outer wall of the outer tube 1 near the front end. Correspondingly, the rear end of the outer tube 1 is an end exposed outside the patient's body. A base 4 is provided on the rear end of the outer tube 1. The base 4 extends outward along the horizontal plane where the rear end of the outer tube is located, so that the outer contour of the base 4 is located outside the outer wall of the outer tube 1. The middle position of the base 4 has a central hole 4.1 communicating with the outer tube 1. Connecting pieces 4.2 are provided on both sides of the base 4 along the horizontal width direction. The connecting pieces 4.2 have lanyard holes 4.3 for passing through a medical strap 5.

[0050] Optionally, the medical bandage 5 is made of flexible medical cotton cloth or gauze. Specifically, the medical bandage 5 is made of flexible medical pure cotton fabric. The function of the medical bandage 5 is to allow the two ends of the medical bandage 5 to pass through the loop holes 4.3 on both sides of the base 4, and the middle part of the medical bandage 5 to wrap around the patient's neck, thereby securing the outer tube 1 and preventing the outer tube 1 from accidentally slipping out. This pure cotton medical bandage 5 is soft and breathable, effectively reducing pressure damage to the neck skin.

[0051] Based on the preferred dimensions of the abutment 4 in the above embodiments, the thickness of the abutment 4 is 2-8 mm. Optionally, the thickness of the abutment 4 is 3 mm, 4 mm, or 5 mm. The thickness of the abutment 4 can be divided into adult and children's versions as needed, with the children's version further divided into versions for young children and teenagers, thus allowing the abutment 4 to be available in different thicknesses according to different styles. After the patient wears the tracheostomy cannula, the small thickness of the abutment 4 makes it fit the patient's laryngeal incision more closely, reducing the protrusion and ultimately minimizing interference with the patient's daily life and work.

[0052] In conjunction with the first aspect, the tracheostomy cannula also includes a device connector 6 for connecting to external medical equipment. One end of the device connector 6 is configured to be adapted to the tubing on the external medical equipment, and the other end is detachably connected to the base 4. The device connector 6 has a central channel 6.1 that runs axially through both the upper and lower ends of the device connector 6. When the device connector 6 is connected to the base 4, the central channel 6.1 on the device connector 6 communicates with the inner lumen of the inner tube 2. The external medical equipment in this embodiment includes, but is not limited to, an oxygen concentrator. The oxygen supply tube of the oxygen concentrator is connected to the device connector 6 after docking to provide oxygen to the patient.

[0053] Optionally, such as Figure 3 and Figure 6 As shown, the upper end face of the base 4 is recessed to form an installation groove, the inner wall of the installation groove has an internal thread, the lower end of the equipment connector 6 has a boss, the outer wall of the boss has an external thread, and the equipment connector 6 is threadedly connected to the base 4.

[0054] Optionally, the device connector 6 is snap-fitted to the base 4. For example, a Luer connector is used to connect the device connector 6 to the base 4.

[0055] Based on the preferred embodiment of the inner tube 2 described above, such as Figure 3 and Figure 6 As shown, the rear end of the inner tube 2 has a radially outwardly protruding pipe joint 7, and the equipment joint 6 and the base 4 together form an annular cavity 8 for accommodating the pipe joint 7. In the installation process of this embodiment, the front end of the inner tube 2 is first inserted into the outer tube 1 through the central hole 4.1 of the base 4 until the pipe joint 7 abuts against the base 4. Then, the equipment joint 6 is placed on the pipe joint 7 of the inner tube 2 from top to bottom, and the pipe joint 7 is connected and fixed to the base 4, thereby forming an annular cavity 8 with the pipe joint 7 and the base 4. At this time, the pipe joint 7 is axially limited within the annular cavity 8.

[0056] In the above embodiments, after the device connector 6 on the base 4 is used and disassembled, in order to keep the inner tube 2 inside the outer tube 1, one preferred example is that the pipe connector 7 of the inner tube 2 is tightly fitted with the inner wall of the central hole 4.1 on the base 4. Another preferred example is that the tracheostomy sleeve includes a common connector (not shown in the figure), which has the same threaded connection structure as the device connector 6 and a groove structure for forming an annular cavity 8, so that the common connector can be threadedly connected to the base 4 and form an annular cavity 8 with the base 4, thus axially limiting the pipe connector 7 within the annular cavity 8. The common connector has an air hole communicating with the central hole 4.1 of the base 4. The axial dimension of this common connector is small, therefore, it causes little interference to the patient's daily life and work during daily wear.

[0057] Based on the preferred embodiment described above, where the outer tube 1 is provided with a positioning balloon 9, the outer tube 1 is provided with an air supply hose 10. One end of the air supply hose 10 has an air valve 11, and the other end is connected to the balloon via an airflow passage 1.1 in the wall of the outer tube 1. The air valve 11 has an inflation / deflation function and can automatically close after inflation / deflation is completed. Figure 8 The valve 11 includes a valve housing 11.1 and a rod-shaped valve core 11.2 inside the valve housing. A valve plate 11.3 is fixed at the middle position of the valve core 11.2. An annular partition 11.4 is provided at the middle position of the valve housing 11.1. The partition 11.4 has an air hole at its center for the valve core 11.2 to pass through. The left end of the valve core 11.2 is located to the left of the partition 11.4, and an abutment 11.5 is provided on the left end of the valve core 11.2. The right end of the valve core 11.2 passes through the air hole and extends to the right side of the partition 11.4. The valve plate 11.3 is located on the right side of the partition 11.4 and is fixed to the valve core 11.2. A spring 11.6 is provided inside the valve housing 11.1 at the right side of the valve plate 11.3. The two ends of the spring 11.6 abut against the right end of the valve housing 11.1 and the valve plate 11.3, respectively, to drive the valve plate 11.3 to press against the partition 11.4 and seal the air hole. When an external air pump is inserted from the left end of the valve housing 11.1, the air pump pushes the abutment 11.5 and drives the valve core 11.2 to the right, opening the air hole. When the air pump is withdrawn, the spring 11.6 drives the valve core 11.2 back to the valve plate 11.3 to seal the air hole. The air pump includes, but is not limited to, a syringe.

[0058] Preferably, such as Figure 8 As shown, the end of the air supply hose 10 away from the outer sleeve 1 is provided with an indicator airbag 12, and the air supply hose 10 and the valve 11 are respectively connected to the two ends of the indicator airbag 12.

[0059] Furthermore, the indicator airbag 12 is made of transparent material, and a secondary indicator 13 is provided inside the indicator airbag 12. The secondary indicator 13 is suspended inside the indicator airbag 12. The secondary indicator 13 includes a cylinder 13.1, one end of which is sealed and the other end has an opening. A piston 13.2 is provided inside the cylinder 13.1, and the piston 13.2 slides in conjunction with the cylinder 13.1. The outer side wall of the piston 13.2 is divided into several color-displaying areas 13.2.1 of different colors along the axial direction. The side wall of the cylinder 13.1 has a transparent observation window 13.3, which corresponds to the outer side wall of the piston 13.2. In this embodiment, since the indicator airbag 12 is transparent, medical staff can pinch the secondary indicator 13 through the indicator airbag 12 to more intuitively judge the air pressure. Through the transparent indicator airbag 12, they can observe the color of the color display area 13.2.1 corresponding to the current piston position through the transparent observation window 13.3 on the cylinder 13.1. Thus, the air pressure in the indicator airbag 12 can be judged, that is, the range of air pressure can be intuitively judged by the color of the color display area 13.2.1.

[0060] Alternatively, the indicator airbag 12 may contain a secondary indicator 13, which includes a cylinder 13.1. The outer wall of the cylinder 13.1 is fixed to the indicator airbag 12, and the area of ​​the indicator airbag 12 at the connection between the cylinder 13.1 and the indicator airbag 12 is made of transparent material. One end of the cylinder 13.1 is sealed, and the other end has an opening. A piston 13.2 is provided inside the cylinder 13.1, and the piston 13.2 is slidably engaged with the cylinder 13.1. The outer wall of the piston 13.2 is divided into several color-displaying areas 13.2.1 of different colors along the axial direction. The side wall of the cylinder 13.1 has a transparent observation window 13.3, which corresponds to the outer wall of the piston 13.2. In this embodiment, since the connection between the indicator airbag 12 and the cylinder 13.1 is transparent, medical personnel can observe the color of the color display area 13.2.1 corresponding to the current piston position through the transparent observation window 13.3 on the cylinder 13.1 through the transparent position of the indicator airbag 12. Thus, the current air pressure in the indicator airbag 12 can be determined, that is, the range of air pressure can be intuitively judged by the color of the color display area 13.2.1.

[0061] Preferably, the observation window 13.3 is an annular structure on the side wall of the cylinder 13.1. The observation window 13.3 can be made of transparent glass or resin material and embedded in the cylinder 13.1. Alternatively, the cylinder 13.1 itself can be made of transparent glass or resin material, and a light-shielding coating can be applied to the area of ​​the outer side wall of the cylinder 13.1 outside the observation window 13.3, thereby allowing light to pass through the location of the observation window 13.3. The color-developing areas 13.2.1 on the piston 13.2 are multiple color-developing areas 13.2.1 of different colors formed after the outer side wall of the piston 13.2 is coated with color. Alternatively, during the manufacturing process of the piston 13.2 itself, multiple segments of pistons of different colors are spliced ​​together axially to form a whole piston 13.2, thereby the piston 13.2 has color-developing areas 13.2.1 of different colors along the axial direction. The colors of each color-developing area 13.2.1 on the piston 13.2 include, but are not limited to, red, blue, green, yellow, white, and black.

[0062] In conjunction with the first aspect, such as Figure 10 As shown, the tracheostomy cannula of this application also includes a sterile insert 14, which is made of rigid polypropylene. The rear end of the sterile insert 14 has a handheld end 14.1, and the front end of the sterile insert 14 has a bullet-shaped plug 14.2. When the sterile insert 14 is inserted into the outer cannula 1, it can seal the opening at the front end of the outer cannula 1, and the bullet-shaped part of the plug 14.2 is exposed outside the opening at the front end of the outer cannula 1, thereby facilitating the insertion of the outer cannula 1 into the patient's tracheostomy and smooth guidance into the airway. After the outer cannula 1 is successfully inserted, the sterile insert 14 is withdrawn, and then the inner cannula 2 is reinserted. The insert is a conventional accessory of existing metal tracheostomy cannulas. The sterile insert 14 of this application has the same structure as the insert of existing tracheostomy cannulas, only the material is changed. Therefore, the structure and usage of the sterile insert 14 will not be described in detail.

[0063] Second aspect This application provides a manufacturing process for the gas cutting sleeve described in the first aspect above, comprising the following steps: S1. Dimethyl furanate was synthesized from furanate and methanol, and the purity of the dimethyl furanate was verified by nuclear magnetic resonance technology. S2. Dimethyl furanate is copolymerized with a diol to form a bio-based elastic polyester, wherein the diol is composed of cyclohexanediethanol and polytetrahydrofuran, and the polytetrahydrofuran accounts for 40% to 90% of the total mass of the diol, and the molar ratio of the diol to dimethyl furanate is 1 to 2. S3. Using the obtained bio-based elastic polyester as raw material, the above-mentioned outer tube 1 and inner tube 2 are made by plastic molding process.

[0064] The bio-based elastic polyester obtained by copolymerization in step S2 is mostly in granular form. This granular bio-based elastic polyester is used as a raw material in the subsequent plastic molding process, and then the outer tube 1 and inner tube 2 are made through step S3.

[0065] The plastic molding process in this embodiment refers to the process of preparing products from plastic granules through injection molding, extrusion, blow molding, etc. In this process, the plastic granules are heated and melted to form products of the required shape. These products include, but are not limited to, the outer tube 1 and the inner tube 2 mentioned above.

[0066] In conjunction with the second aspect, during the preparation process of step S3 above, a spiral metal wire 3 with a wire diameter between 0.01 and 0.15 mm can be pre-fabricated in an existing plastic molding die. The spiral metal wire 3 and bio-based elastic polyester particles are then processed using existing injection molding, extrusion, blow molding, and other existing plastic molding equipment to form the outer tube 1 and inner tube 2 mentioned in the first aspect above. The process of embedding the spiral metal wire 3 and then performing plastic molding in this application is an existing process, commonly known as insert injection molding or encapsulation.

[0067] In conjunction with the second aspect, silver ions are incorporated into the above steps S1 and / or S2, so that the bio-based elastic polyester particles obtained after copolymerization contain silver ions. Finally, after the bio-based elastic polyester particles are made into an outer tube 1 and an inner tube 2, the outer tube 1 and the inner tube 2 can be made to have antibacterial properties.

[0068] Based on the preparation process described in the second aspect above, specific embodiments of this application are as follows: Pretreatment of dicarboxylic acid feedstock: DMFD was synthesized from FDCA and methanol. The molecular structure of DMFD was verified by nuclear magnetic resonance. After confirming that the purity of DMFD was up to standard, it was put into use.

[0069] Example 1 Diol and DMFD were weighed according to a molar ratio of 1.05, with PTMG1000 accounting for 30% of the total mass of the diol and CHDM accounting for 70%. All raw materials were added to the reactor, along with 0.15 mol% tetrabutyl titanate (the molar amount of DMFD). The reactor was evacuated to 0.1 kPa and purged with nitrogen three times. Then, under nitrogen protection, the temperature was raised to 180°C for transesterification / esterification reaction for 2 hours. The temperature was then slowly raised to 240°C for another 2 hours. After the transesterification / esterification reaction was completed, the temperature was raised to 260°C, and polycondensation was carried out under vacuum at 10 Pa for 5 hours. After the reaction was completed, nitrogen was introduced to restore atmospheric pressure, and the desired bio-based elastic polyester was obtained. In this example, the bio-based elastic polyester prepared contained 30% PTMG1000 in the diol, abbreviated as PCF-PTMG30.

[0070] Example 2 Diol and DMFD were weighed according to a molar ratio of 1.02, with PTMG1000 accounting for 34% of the total mass of the diol and CHDM accounting for 66%. All raw materials were added to the reactor, along with 0.12 mol% tetrabutyl titanate (the molar amount of DMFD). The reactor was evacuated to 0.1 kPa and purged with nitrogen three times. Then, under nitrogen protection, the temperature was raised to 180°C for transesterification / esterification reaction for 2.1 h. Subsequently, the temperature was slowly raised to 235°C for another 2 h. After the transesterification / esterification reaction was completed, the temperature was raised to 255°C, and polycondensation was carried out under vacuum at 15 Pa for 4.8 h. After the reaction was completed, nitrogen was introduced to restore atmospheric pressure, and the desired bio-based elastic polyester was obtained. In this example, the bio-based elastic polyester prepared contained 34% PTMG1000 in the diol, abbreviated as PCF-PTMG34.

[0071] Example 3 Diol and DMFD were weighed according to a molar ratio of 1.10, with PTMG1000 accounting for 38% of the total mass of the diol and CHDM accounting for 62%. All raw materials were added to the reactor, along with 0.10 mol% tetrabutyl titanate (the molar amount of DMFD). The reactor was evacuated to 0.1 kPa and purged with nitrogen three times. Then, under nitrogen protection, the temperature was raised to 180°C for transesterification / esterification reaction for 2.2 h. Subsequently, the temperature was slowly raised to 230°C for another 1.8 h. After the transesterification / esterification reaction was completed, the temperature was raised to 250°C, and polycondensation was carried out under vacuum at 20 Pa for 4.5 h. After the reaction was completed, nitrogen was introduced to restore atmospheric pressure, and the desired bio-based elastic polyester was obtained. In this example, the bio-based elastic polyester prepared contained 38% PTMG1000 in the diol, abbreviated as PCF-PTMG38.

[0072] Example 4 Diol and DMFD were weighed according to a molar ratio of 1.12, with PTMG1000 accounting for 42% of the total mass of the diol and CHDM accounting for 58%. All raw materials were added to the reactor, along with 0.08 mol% tetrabutyl titanate (the molar amount of DMFD). The reactor was evacuated to 0.1 kPa and purged with nitrogen three times. Then, under nitrogen protection, the temperature was raised to 180°C for transesterification / esterification reaction for 2.3 h. Subsequently, the temperature was slowly raised to 225°C for another 1.6 h. After the transesterification / esterification reaction was completed, the temperature was raised to 245°C, and polycondensation was carried out under vacuum at 15 Pa for 4.0 h. After the reaction was completed, nitrogen was introduced to restore atmospheric pressure, and the desired bio-based elastic polyester was obtained. In this example, the bio-based elastic polyester prepared contained 42% PTMG1000 in the diol, abbreviated as PCF-PTMG42.

[0073] Example 5 Diol and DMFD were weighed according to a molar ratio of 1.14, with PTMG1000 accounting for 46% of the total mass of the diol and CHDM accounting for 54%. All raw materials were added to the reactor, along with 0.06 mol% tetrabutyl titanate (the molar amount of DMFD). The reactor was evacuated to 0.1 kPa and purged with nitrogen three times. Then, under nitrogen protection, the temperature was raised to 180°C for transesterification / esterification reaction for 2.4 h. Subsequently, the temperature was slowly raised to 220°C for another 1.5 h. After the transesterification / esterification reaction was completed, the temperature was raised to 240°C, and polycondensation was carried out under vacuum at 10 Pa for 3.8 h. After the reaction was completed, nitrogen was introduced to restore atmospheric pressure, and the desired bio-based elastic polyester was obtained. In this example, the bio-based elastic polyester prepared contained 46% PTMG1000 in the diol, abbreviated as PCF-PTMG46.

[0074] Example 6 Diol and DMFD were weighed according to a molar ratio of 1.08, with PTMG1000 accounting for 50% of the total mass of the diol and CHDM accounting for 50%. All raw materials were added to the reactor, along with 0.03 mol% tetrabutyl titanate (the molar amount of DMFD). The reactor was evacuated to 0.1 kPa and purged with nitrogen three times. Then, under nitrogen protection, the temperature was raised to 180°C for transesterification / esterification reaction for 2.5 h. Subsequently, the temperature was slowly raised to 215°C for another 1.6 h. After the transesterification / esterification reaction was completed, the temperature was raised to 240°C, and polycondensation was carried out under vacuum at 10 Pa for 3.5 h. After the reaction was completed, nitrogen was introduced to restore atmospheric pressure, and the desired bio-based elastic polyester was obtained. In this example, the bio-based elastic polyester prepared contained 50% PTMG1000 in the diol, abbreviated as PCF-PTMG50.

[0075] like Figure 9 As shown, the bio-based elastic polyester obtained by copolymerization in Example 1 was used to prepare test strips for mechanical property testing. The test results are shown in Table 1 below: Material tensile modulus Tensile strength Yield strength Elongation at break Bio-based elastic polyester 1882 MPa 60Mpa 60Mpa 336.6% It should be noted that in the description of this invention, the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0076] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0077] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0078] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0079] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0080] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

[0081] For those skilled in the art, various changes and modifications will undoubtedly be apparent after reading the above description. Therefore, the appended claims should be construed as covering all changes and modifications that encompass the true intent and scope of the invention. Any and all equivalent scope and content within the scope of the claims should be considered to remain within the intent and scope of the invention.

Claims

1. A gas cutting sleeve, comprising an outer sleeve and an inner sleeve nested within the outer sleeve, characterized in that: The outer tube has a spiral metal wire embedded in its wall, which extends in a spiral shape along the length of the outer tube. Both the outer tube and the inner tube are made of bio-based elastic polyester. The bio-based elastic polyester is obtained by copolymerizing a diacid and a diol, wherein the diacid is furan dicarboxylic acid and the diol is composed of cyclohexanediethanol and polytetrahydrofuran, and the mass of polytetrahydrofuran accounts for 20%-70% of the total mass of the diacid and the diol.

2. The gas cutting sleeve according to claim 1, characterized in that: The molar ratio of the diol to the diacid is 1 to 2, and the polytetrahydrofuran accounts for 40% to 90% of the total mass of the diol.

3. The gas cutting sleeve according to claim 1 or 2, characterized in that: The outer tube has a base at its rear end, with a central hole communicating with the outer tube. Connecting pieces are provided on both sides of the base along the width direction, and the connecting pieces have rope holes for medical straps to pass through.

4. The gas cutting sleeve according to claim 3, characterized in that: The thickness of the base is 2~8mm.

5. The gas cutting sleeve according to claim 2, characterized in that: The base is provided with a device connector that can be detachably connected to the base, and the device connector has a central channel that communicates with the inner cavity of the inner tube.

6. The gas cutting sleeve according to claim 5, characterized in that: The rear end of the inner tube has a radially outward-protruding pipe joint, and the equipment joint and the base form an annular cavity for accommodating the pipe joint.

7. The gas cutting sleeve according to claim 1, characterized in that: A positioning balloon is provided on the outer wall of the front end of the outer tube, and an air supply hose is provided outside the outer tube. One end of the air supply hose has an air valve, and the other end is connected to the balloon through an airflow pipe in the outer tube wall.

8. The gas cutting sleeve according to claim 7, characterized in that: An indicator airbag is provided at the end of the air supply hose away from the outer sleeve, and the air supply hose and the valve are respectively connected to the two ends of the indicator airbag.

9. The gas cutting sleeve according to claim 8, characterized in that: The indicator airbag is partially or entirely made of transparent material. The indicator airbag contains a secondary indicator, which includes a cylinder. One end of the cylinder is sealed, and the other end has an opening. A piston is provided inside the cylinder, and the piston slides in conjunction with the cylinder. The outer wall of the piston is divided into several color-changing areas of different colors along the axial direction. The side wall of the cylinder has a transparent observation window, which corresponds to the outer wall of the piston.

10. A manufacturing process for an air-cutting sleeve, characterized in that, Includes the following steps: S1. Dimethyl furanate was synthesized from furanate and methanol, and the purity of the dimethyl furanate was verified by nuclear magnetic resonance technology. S2. Dimethyl furanate is copolymerized with a diol to form a bio-based elastic polyester, wherein the diol is composed of cyclohexanediethanol and polytetrahydrofuran, and the polytetrahydrofuran accounts for 40% to 90% of the total mass of the diol, and the molar ratio of the diol to dimethyl furanate is 1 to 2. S3. The obtained bio-based elastic polyester is used as raw material to make the outer tube and inner tube as described in claim 1.

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