CN113713227B - Ultrasonic development air bag of tracheal catheter and preparation tool, preparation process and preparation method thereof - Google Patents

Ultrasonic development air bag of tracheal catheter and preparation tool, preparation process and preparation method thereof Download PDF

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Publication number
CN113713227B
CN113713227B CN202110912934.2A CN202110912934A CN113713227B CN 113713227 B CN113713227 B CN 113713227B CN 202110912934 A CN202110912934 A CN 202110912934A CN 113713227 B CN113713227 B CN 113713227B
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air bag
rubber sheet
silicone rubber
silica gel
coating
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CN113713227A (en
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陶坤明
孙玉明
计燕
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Third Affiliated Hospital Of Chinese People's Liberation Army Naval Medical University
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Third Affiliated Hospital Of Chinese People's Liberation Army Naval Medical University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C41/08Coating a former, core or other substrate by spraying or fluidisation, e.g. spraying powder
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C41/20Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. moulding inserts or for coating articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/34Component parts, details or accessories; Auxiliary operations
    • B29C41/52Measuring, controlling or regulating

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Pulmonology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention relates to an ultrasonic developing air bag of an endotracheal tube, which comprises a high-capacity low-pressure type positioning air bag used for being fixed on the endotracheal tube, wherein the wall thickness of the positioning air bag is uniform, the outline of the positioning air bag is long round, and a medical-grade room-temperature cured silicon rubber sheet is locally lined on the inner wall of the positioning air bag; the edges of the silicon rubber sheet are separated from the two long round end positions in the positioning air bag. The invention has the beneficial effects that the accuracy and timeliness of the active positioning of the tracheal catheter air bag can be ensured on the premise of not changing the advantages of the gaseous filling medium air bag.

Description

Ultrasonic development air bag of tracheal catheter and preparation tool, preparation process and preparation method thereof
Technical Field
The invention relates to an endotracheal tube matching technology, which is suitable for mechanical ventilation treatment of patients with general anesthesia and critical diseases.
Background
In patients receiving general anesthesia and criticality, a rapid and accurate determination of the position of the tracheal catheter cuff is a prerequisite for safe and effective mechanical ventilation. The prior art of ultrasonic cuff positioning generally adopts a method of injecting liquid in a cuff, and when liquid is injected into and extracted from a cuff connecting pipe, the problems of instant high pressure, larger injection force and the like are more easily generated compared with the injection air due to liquid resistance, so that the potential risk of causing the pressure rupture of the cuff exists, and the clinical application of the method is obviously influenced. Meanwhile, the traditional tracheal catheter cuff is ambiguous in positioning under ultrasound, so that real-time monitoring and drainage of secretion above the tracheal catheter cuff cannot be realized.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and solve the problem that the air bag of the conventional tracheal catheter cannot be positioned quickly and accurately.
In order to achieve the aim of the invention, the invention provides an ultrasonic developing air bag of an endotracheal tube, which comprises a high-capacity low-pressure type positioning air bag used for being fixed on the endotracheal tube, wherein the wall thickness of the positioning air bag is uniform, the outline of the positioning air bag is long round, and the inner wall of the positioning air bag is partially lined with a medical-grade room-temperature cured silicon rubber sheet; the edges of the silicon rubber sheet are separated from the two long round end positions in the positioning air bag.
The positioning balloon may be made of one of PVC, CPVC or TPU materials. The silicon rubber sheet is positioned between the two ends of the positioning air bag and does not cover the two ends of the positioning air bag. The center distance of the silicon rubber sheet can be set to be equal to the distance between two ends of the positioning air bag, the distance between the center of the silicon rubber sheet and the ends of the positioning air bag can be generally set to be 1.5cm, the silicon rubber layer is set to be cylindrical with the radius of 8-10mm, and the layer thickness is 2-2.5mm. The silicon rubber material generally needs to achieve the following technical performance indexes: the surface drying time is 25 ℃ and less than or equal to 25min, and the stable use temperature ranges from minus 60 ℃ to 200 ℃, so that the curing agent is suitable for the internal environment of human bodies.
Preferably, the tensile strength of the cured silicone rubber sheet is more than or equal to 0.3MPa, the elongation at break is more than or equal to 100%, and the shearing strength is more than or equal to 0.3MPa; hardness is 8-18Shore A.
Preferably, marks are printed on the edges of the corresponding inner silicone rubber sheets outside the positioning air bags.
Preferably, the silicone rubber sheet is coated on the inner wall of the positioning air bag by adopting a positive pressure irrigation curing process.
The positive pressure irrigation curing process is to coat the silicon rubber sheet based on the finished air bag.
The material that inside silicone rubber piece adopted has realized that convenient and simple silicone rubber is attached, does not change comparatively ripe blow molding or extrusion molding gasbag manufacturing process among the prior art, can directly reform transform conventional location gasbag. Through the spaced arrangement of the silicon rubber sheet and the long round end, the region of the silicon rubber sheet can be imaged stably under ultrasound, and the influence of curvature transformation on the imaging of the silicon rubber sheet at the position of the long round end is reduced.
The physical index control of the cured silicone rubber sheet ensures that the cured silicone rubber sheet is sensitive to ultrasonic imaging and does not influence the expansion and contraction of the air bag.
By printing the marks, the position of the silicone rubber sheet can be visually identified from the outside during processing, assembling and using, and the printing side (i.e. the silicone rubber sheet) is ensured to be positioned on the smaller radius side of the tracheal catheter bending during assembling and using, thereby being convenient for processing, assembling and using.
The silicone rubber sheet coating process in the ultrasonic developing air bag is also provided, the ultrasonic developing air bag is adopted, and the silicone rubber sheet coating process comprises the following steps: maintaining the positioning balloon in an inflated state; the manufacturing flow is sequentially air bag internal atmosphere adjustment before spraying, air bag internal injection spraying, silicone rubber sheet curing atmosphere adjustment and silicone rubber sheet drying atmosphere adjustment.
Through the control to the coating environment for the silicon rubber piece after the solidification shaping can firmly attach at flexible gasbag inner wall, and the solid of shaping accords with the ultrasonic development requirement.
Preferably, the silicone rubber sheet is coated by any one of the following A, B, C methods:
the method A comprises the steps that the coating stock solution is room temperature vulcanized silicone rubber, and 500mPa.s of viscosity and 1 mass fraction are added into the coating stock solution: 1, hydrogen-containing silicone oil; adding 5 per mill of defoaming agent polyoxyethylene polyoxypropylene pentaerythritol ether into the coating stock solution, and adopting a precise peristaltic pump for spraying when the coating stock solution is sprayed;
atmosphere adjustment in the air bag before spraying: before injection spraying, the air pressure in the air bag is maintained at 3.2-3.6kpa, the temperature is 40-60 ℃ and the humidity is 50-70%;
and (3) injecting and spraying in an air bag: starting injection spraying, and maintaining the injection flow rate at 1.0-1.5ml/min, wherein the residual silica gel in the injection head is flushed by sterile water, and the flushing flow rate is 10-20ml/min;
and (3) adjusting the curing atmosphere of the silicon rubber sheet: maintaining air pressure in the air bag at 3.0-3.7kpa after the silica gel injection is completed, and keeping the temperature at 40-60 ℃ and the humidity at 30-60% until the silica gel layer is solidified;
and (3) adjusting the drying atmosphere of the silicon rubber sheet: after the silica gel layer is solidified, the air pressure in the air bag is maintained at 3.5-3.7kpa, the temperature is 40-50 ℃, and the humidity is adjusted to 2% -5% until the excessive moisture of the silica gel layer is removed.
The room temperature vulcanized silicone rubber in the method A can be 107 rubber or 705 rubber, etc.
The method A ensures that the silicon rubber sheet can be matched with repeated contraction and expansion of the air bag in the use process by adding the proper hydrogen-containing silicone oil, thereby ensuring the adhesive force between the silicon rubber and the inner wall of the air bag. The precise peristaltic pump spraying is matched with the defoaming agent, so that the bubble generation rate of the silica gel coating can be reduced, a relatively uniform silicone rubber sheet is formed, and the self-development effect under ultrasound is ensured.
B, preparing a reagent of a first component and a reagent of a second component; wherein the component A comprises alpha, omega-dihydroxyl polydimethylsiloxane, quartz powder, vinyl polysiloxane, MQ silicon resin, methyl hydrogen silicone oil, zinc oxide and carbon black, and the mass ratio of the components A to B is 75:5:7:4:4:2:3; the component B comprises alpha, omega-dihydroxyl polydimethylsiloxane, quartz powder, vinyl polysiloxane, MQ silicone resin and hydroxyl silicone oil, wherein the mass ratio of the components is 75:5:10:4:6; uniformly mixing the reagent A and the reagent B respectively, and keeping a vacuum environment during stirring; 1:1, uniformly mixing a reagent A and a reagent B, and adding 0.6mg/mg of a platinum catalyst to form a stable coating stock solution;
atmosphere adjustment in the air bag before spraying: before injection spraying, the air pressure in the air bag is maintained at 3.5kpa, the temperature is 40 ℃, and the humidity is 65% -70%;
and (3) injecting and spraying in an air bag: starting injection spraying, maintaining the injection flow rate at 1.0ml/min, and flushing the residual silica gel in the injection head by a sterile water flushing pipe with the flow rate of 10ml/min;
and (3) adjusting the curing atmosphere of the silicon rubber sheet: maintaining air pressure in the air bag at 3.7kpa after the silica gel injection is completed, wherein the temperature is 50 ℃ and the humidity is 65%, and curing the silica gel layer;
and (3) adjusting the drying atmosphere of the silicon rubber sheet: after the silica gel layer is solidified, the air pressure in the air bag is maintained at 3.7kpa, the temperature is 50 ℃, and the humidity is adjusted to 5 percent until the excessive moisture of the silica gel layer is removed.
The uniform coating stock solution prepared by the reagent A and the reagent B matched with the catalyst can form a uniform foaming silica gel layer after coating, so that the original foaming flaw can be reversely utilized to enhance the development effect under ultrasound.
C, mixing room temperature vulcanized silicone rubber with nano calcium carbonate powder according to a proportion of 3:1, kneading, namely vacuumizing and dehydrating at 135-140 ℃ and kneading for 3.5 hours; adding tetraethoxysilane and a silane coupling agent KBM-13 into the kneaded component, wherein the mass of the tetraethoxysilane is 3% of the mass of the kneaded component, the mass of the silane coupling agent KBM-13 is 10% of the mass of the kneaded component, and the mixed component is uniformly stirred together with 0.4mg/mg of a platinum catalyst, and then the mixture is subjected to reduced pressure and air discharge for storage to form a coating stock solution;
atmosphere adjustment in the air bag before spraying: before injection spraying, the air pressure in the air bag is maintained to be 3.2kpa, the temperature is 50 ℃ and the humidity is 60%;
and (3) injecting and spraying in an air bag: starting injection spraying, and maintaining the injection flow rate at 1.2ml/min, wherein the residual silica gel in the injection head is flushed by sterile water, and the flushing flow rate is 15ml/min;
and (3) adjusting the curing atmosphere of the silicon rubber sheet: after the silica gel injection is finished, the air pressure in the air bag is maintained to be 3.0kpa, the temperature is 60 ℃, the humidity is 30%, and the silica gel layer is cured;
and (3) adjusting the drying atmosphere of the silicon rubber sheet: after the silica gel layer is solidified, the air pressure in the air bag is maintained at 3.6kpa, the temperature is 40 ℃, and the humidity is adjusted to 5 percent until the excessive moisture of the silica gel layer is removed.
The kneading apparatus used in the method C may preferably be a Z-type kneader. The prepared coating stock solution can be extruded into a PE sealing cylinder for sealing and preservation.
The silicon rubber sheet of the method C realizes the enhancement and development effect under the ultrasonic through the filler nano calcium carbonate, and simultaneously plays the roles of enhancing the anti-pulling and mechanical strength of the silica gel.
Preferably, when the method C is adopted, one or more of nano silicon dioxide, organic montmorillonite, graphene, nano zinc oxide, nano titanium dioxide, silicon carbide, aluminum oxide and nano silver wires are mixed in the nano calcium carbonate powder.
The above mixture can further improve the performance of the silica gel after molding.
Preferably, the silicone rubber sheet is trimmed at the end of the manufacturing process, and the temperature of the trimming blade is as follows: 120-200 ℃.
The silicone rubber sheet coating fixture for the ultrasonic development air bag of the tracheal catheter comprises a fixture tube similar to the outer diameter of the target tracheal catheter, a right-angle injection head used for penetrating the fixture tube and an inflation head used for penetrating the fixture tube;
the side wall of the tooling tube is provided with a hole for the outlet end of the right-angle injection head to pass through, the hole is matched with the projection size of the position of the silicon rubber sheet to be coated, and the outer wall of the tooling tube is sleeved with a ring rib for encircling the gap between the positions of the two long round ends of the pressing closed air bag and the outer wall of the tooling tube;
the inlet end of the right-angle injection head is communicated with a pump for conveying the coating stock solution of the silicon rubber sheet;
the inlet end of the air charging head is communicated with an air source; and an air pressure measurer and a pressure relief valve are also arranged between the air charging head and the air source.
The gasbag sheath that this place indicates is outside the endotracheal tube, and its two long round end positions are equipped with the mouth that is used for passing the endotracheal tube, and this mouth department can additionally set up towards the outer ring cover of gasbag, the ring cover is used for wrapping up at the endotracheal tube, and the ring muscle of this moment can wind outside the ring cover in order to pressfitting gasbag to frock pipe surface.
Preferably, a spraying printing arm for printing on the surface of the air bag is further arranged, and the spraying printing arm is positioned outside the tool pipe and directs the output end to the hole.
The spraying printing arm can spray ink or paint other marks on the outer surface of the air bag.
The silicone rubber sheet coating method for developing the air bag under the ultrasonic of the tracheal catheter is characterized by comprising the following steps of:
a, penetrating a sleeve-type air bag out of the tooling pipe, and moving the air bag along the tooling pipe so that a position to be sprayed on the inner wall of the air bag corresponds to the hole;
b, pressing and sealing openings at two ends of the air bag to the outer wall of the tool pipe by using the annular ribs;
c, enabling the inflation head to maintain output in the tool pipe and match with the air pressure measurer and the pressure release valve so as to maintain the atmosphere in the system to meet the curing requirement of the silicon rubber sheet;
d, after the air bag is inflated and expanded, adjusting the outlet end of the right-angle injection head to be aligned with the position to be sprayed;
e, pumping injection coating stock solution, and maintaining atmosphere for a specified time after injection is completed until the silica gel layer is solidified;
f, removing the ring rib and removing the coated air bag from the construction tube.
In order to facilitate finding the position to be sprayed, marks can be printed on the outer surface of the air bag in advance. In the process of spraying the coating stock solution, a form of fixed right-angle injection head or a form of track coating can be adopted.
The invention has the beneficial effects that the accuracy and timeliness of the active positioning of the tracheal catheter air bag can be ensured on the premise of not changing the advantages of the gaseous filling medium air bag.
Drawings
FIG. 1 is a schematic view of an ultrasound contrast balloon of an endotracheal tube of the present invention;
FIG. 2 is a schematic view of a silicone rubber sheet coating tool for developing an air bag under ultrasound of an endotracheal tube according to the present invention;
FIG. 3 is a schematic view of a silicone rubber sheet coating tool for developing an air bag under ultrasound of an endotracheal tube according to the present invention in use;
FIG. 4 is a schematic representation of a conventional balloon developed under ultrasound in an in vitro water box test;
FIG. 5 is a schematic view of an ultrasound imaging balloon of an endotracheal tube of the present invention in an in vitro water box test;
FIG. 6 is a schematic view of a conventional balloon developed under ultrasound in a human experiment;
FIG. 7 is a schematic view of an ultrasound imaging balloon of an endotracheal tube of the present invention in an ultrasound imaging in a human experiment;
wherein:
1-endotracheal tube 2-location gasbag 21-silicon rubber piece
3-construction tube 4-right angle type injection head 41-pump machine
5-inflation head 51-air source 52-air pressure measurer and pressure relief valve
6-hole 7-ring rib 8-spraying printing arm
Detailed Description
The invention is further described below with reference to the drawings and specific examples.
According to the ultrasonic development balloon of the tracheal catheter shown in fig. 1, the ultrasonic development balloon comprises a high-capacity low-pressure type positioning balloon 2 which is used for being fixed on the tracheal catheter 1, wherein the wall thickness of the positioning balloon 2 is uniform, the outer contour of the positioning balloon is in a long circle shape, and a medical-grade room-temperature cured silicon rubber sheet 21 is locally lined on the inner wall of the positioning balloon 2; the edge of the silicon rubber sheet 21 is spaced from the two long round end positions in the positioning air bag 2. The positioning balloon 2 is externally provided with a marking (not shown in the figures, but understood by those skilled in the art) corresponding to the edge of the inner silicone rubber sheet.
The positioning air bag 2 is made of one of PVC, CPVC or TPU materials; the silicon rubber sheet 21 is made of medical and sanitary room-temperature curing silicon rubber, and the coating thickness of the silicon rubber sheet 21 is 2-3mm. The silicon rubber sheet 21 is fixed at the midpoint of the long axis of the inner wall of the positioning air bag 2. The tracheal catheter 1 is made of polyurethane material. The positioning air bag 2 adopts a conventional high-capacity low-pressure air bag. The length of the connecting part of the positioning air bag 2 and the tracheal catheter 1 is 4mm, and the cuff fixing part is bonded on the tracheal catheter 1 through cyclohexanone in a hot melt mode. The radius of the silicone rubber sheet 21 is set to 3-5mm.
The tensile strength of the cured silicone rubber sheet 21 is more than or equal to 0.3MPa, the elongation at break is more than or equal to 100%, and the shearing strength is more than or equal to 0.3MPa; hardness is 8-18Shore A. The silicone rubber sheet 21 is coated on the inner wall of the positioning airbag 2 by a positive pressure casting curing process.
The structure is prepared by adopting a silicon rubber sheet coating process in an ultrasonic developing air bag, and the silicon rubber sheet coating process comprises the following steps: the positioning balloon 2 is kept in an inflated state. The silicone rubber sheet can be coated and the whole airbag can be manufactured by A, B, C three manufacturing implementation methods, and specific examples are shown as follows:
the method A comprises the steps that the coating stock solution is room temperature vulcanized silicone rubber, and 500mPa.s of viscosity and 1 mass fraction are added into the coating stock solution: 1, hydrogen-containing silicone oil; adding 5 per mill of defoaming agent polyoxyethylene polyoxypropylene pentaerythritol ether into the coating stock solution, and adopting a precise peristaltic pump for spraying when the coating stock solution is sprayed;
atmosphere adjustment in the air bag before spraying: before injection spraying, the air pressure in the air bag is maintained at 3.2-3.6kpa, the temperature is 40-60 ℃ and the humidity is 50-70%;
and (3) injecting and spraying in an air bag: after the air bag is inflated and expanded, the right-angle injection head is extended out, and the right-angle injection head is aligned with the center point of the control ring of the silicon rubber sheet to start injection. The right-angle injection head is used for injecting the coating stock solution through a precise peristaltic pump in a program-controlled manner. Maintaining the injection flow rate at 1.0-1.5ml/min for 15-25s, and flushing the residual silica gel in the injection head with sterile water at 10-20ml/min for 4-5s to form a semi-ellipsoidal silicone rubber layer with 15mm long diameter, 8mm short diameter and 3mm thickness in the silicone rubber sheet control ring by the injected coating stock solution;
and (3) adjusting the curing atmosphere of the silicon rubber sheet: maintaining air pressure in the air bag at 3.0-3.7kpa after the silica gel injection is completed, and keeping the temperature at 40-60 ℃ and the humidity at 30-60% for 12 hours until the silica gel layer is solidified;
and (3) adjusting the drying atmosphere of the silicon rubber sheet: after the silica gel layer is solidified, the air pressure in the air bag is maintained at 3.5-3.7kpa, the temperature is 40-50 ℃, the humidity is adjusted to 2% -5%, and the time is continued for 2 hours until the excessive moisture of the silica gel layer is removed;
pruning: and after the silicone rubber sheet is solidified and dried, the processing air bag is taken out, the air bag is turned over, and an electric heating R-shaped blade (120-200 ℃) is adopted on a hot processing operation table to trim along a control ring of the prefabricated silicone rubber sheet, so that the length diameter of the silicone rubber sheet is 15mm, the short diameter is 8mm and the thickness is 3mm. In experimental verification, after 8ml of air is injected into the positioning air bag 2 prepared by the method A, compared with a conventional air bag, the air pressure difference has no statistical significance (26.2mmHg Vs 26.3mmHg,n =6, and P is more than 0.05), which indicates that the pressure compliance of the air bag is not obviously changed by the process of the method A.
B, preparing a reagent of a first component and a reagent of a second component; wherein the component A comprises alpha, omega-dihydroxyl polydimethylsiloxane, quartz powder, vinyl polysiloxane, MQ silicon resin, methyl hydrogen silicone oil, zinc oxide and carbon black, and the mass ratio of the components A to B is 75:5:7:4:4:2:3; the component B comprises alpha, omega-dihydroxyl polydimethylsiloxane, quartz powder, vinyl polysiloxane, MQ silicon resin and hydroxyl silicone oil, wherein the mass ratio of the components is 75:5:10:4:6, and solid fillers such as quartz powder, zinc oxide, carbon black and the like are put into an oven and dried for 3 hours at 100 ℃ before being configured. The method comprises the steps of carrying out a first treatment on the surface of the Uniformly mixing the reagent A and the reagent B respectively, and keeping a vacuum environment during stirring; 1:1, uniformly mixing a reagent A and a reagent B, and adding 0.6mg/mg of a platinum catalyst to form a stable coating stock solution;
atmosphere adjustment in the air bag before spraying: before injection spraying, the air pressure in the air bag is maintained to be 3.2kpa, the temperature is 50 ℃ and the humidity is 60%;
and (3) injecting and spraying in an air bag: after the air bag is inflated and expanded, the right-angle injection head is extended out, and the right-angle injection head is aligned with the center point of the control ring of the silicon rubber sheet to start injection. The right-angle injection head is used for injecting the coating stock solution through a precise peristaltic pump in a program-controlled manner. Maintaining the injection flow rate at 1.2ml/min for 20s, and flushing the residual silica gel in the injection head by a sterile water flushing pipe at 15ml/min for 4s, so that the injected coating stock solution forms a semi-ellipsoidal silicone rubber layer with a long diameter of 15mm, a short diameter of 8mm and a thickness of 3mm in a silicone rubber sheet control ring;
and (3) adjusting the curing atmosphere of the silicon rubber sheet: maintaining air pressure in the air bag at 3.0kpa after the silica gel injection is completed, and keeping the temperature at 60 ℃ and the humidity at 30% for 12 hours until the silica gel layer is solidified;
and (3) adjusting the drying atmosphere of the silicon rubber sheet: after the silica gel layer is solidified, the air pressure in the air bag is maintained at 3.6kpa, the temperature is 40 ℃, the humidity is adjusted to 5%, and the time is continued for 2 hours until the excessive moisture of the silica gel layer is removed;
pruning: and after the silicone rubber sheet is solidified and dried, the processing air bag is taken out, the air bag is turned over, and an electric heating R-shaped blade (120 ℃) is adopted to trim along a control ring of the prefabricated silicone rubber sheet on a hot processing operation table, so that the long diameter of the silicone rubber sheet is 15mm, the short diameter of the silicone rubber sheet is 8mm, and the thickness of the silicone rubber sheet is 3mm.
C, mixing room temperature vulcanized silicone rubber with nano calcium carbonate powder according to a proportion of 3:1, and carrying out vacuum dehydration at 135 ℃ for 3.5 hours; adding ethyl orthosilicate and a silane coupling agent KBM-13 into the kneaded component, wherein the mass of the ethyl orthosilicate is 3 percent of the mass of the kneaded component, the mass of the silane coupling agent KBM-13 is 10 percent of the mass of the kneaded component, and the mixed component is uniformly stirred together with 0.4mg/mg of a platinum catalyst, and then is subjected to reduced pressure and air discharge for storage to form a coating stock solution. The nano calcium carbonate powder is also mixed with one or more of nano silicon dioxide, organic montmorillonite, graphene, nano zinc oxide, nano titanium dioxide, silicon carbide, aluminum oxide and nano silver wires;
atmosphere adjustment in the air bag before spraying: before injection spraying, the air pressure in the air bag is maintained to be 3.6kpa, the temperature is 60 ℃ and the humidity is 50%;
and (3) injecting and spraying in an air bag: after the air bag is inflated and expanded, the right-angle injection head is extended out, and the right-angle injection head is aligned with the center point of the control ring of the silicon rubber sheet to start injection. The right-angle injection head is used for injecting the coating stock solution through a precise peristaltic pump in a program-controlled manner. Maintaining the injection flow rate at 1.5ml/min for 15s, and flushing the residual silica gel in the injection head by a sterile water flushing pipe with the flow rate of 20ml/min and the flushing time of 4s, so that the injected coating stock solution forms a semi-ellipsoidal silicone rubber layer with the length of 15mm, the short diameter of 8mm and the thickness of 3mm in a silicone rubber sheet control ring;
and (3) adjusting the curing atmosphere of the silicon rubber sheet: maintaining air pressure in the air bag at 3.5kpa after the silica gel injection is completed, wherein the temperature is 40 ℃ and the humidity is 50%, and continuing for 12 hours until the silica gel layer is solidified;
and (3) adjusting the drying atmosphere of the silicon rubber sheet: after the silica gel layer is solidified, the air pressure in the air bag is maintained at 3.5kpa, the temperature is 50 ℃, the humidity is adjusted to be 2%, and the time lasts for 2 hours until the excessive moisture of the silica gel layer is removed;
pruning: and after the silicone rubber sheet is solidified and dried, the processing air bag is taken out, the air bag is turned over, and an electric heating R-shaped blade (150 ℃) is adopted on a hot processing operation table to trim along a control ring of the prefabricated silicone rubber sheet, so that the long diameter of the silicone rubber sheet is 15mm, the short diameter of the silicone rubber sheet is 8mm, and the thickness of the silicone rubber sheet is 3mm.
Among the three methods: the method A ensures that the silicon rubber sheet 21 can be matched with repeated contraction and expansion of the air bag in the use process by adding proper hydrogen-containing silicone oil, thereby ensuring the adhesive force between the silicon rubber and the inner wall of the air bag. The precise peristaltic pump spraying is matched with the defoaming agent, so that the bubble generation rate of the silica gel coating can be reduced, a relatively uniform silicone rubber sheet is formed, and the self-development effect under ultrasound is ensured. The method B is characterized in that the uniform coating stock solution prepared by the reagent A and the reagent B matched with the catalyst can form a uniform foaming silica gel layer after coating, so that the original foaming flaw can be reversely utilized to enhance the development effect under the ultrasonic. The silicon rubber sheet of the method C realizes the enhancement and development effect under the ultrasonic through the filler nano calcium carbonate, and simultaneously plays the roles of enhancing the anti-pulling and mechanical strength of the silica gel.
According to the silicone rubber sheet coating fixture of an ultrasonic developing balloon of an endotracheal tube shown in fig. 2 to 3, the coating fixture comprises a fixture tube 3 similar to the outer diameter of a target endotracheal tube 1, a right-angle injection head 4 for penetrating the fixture tube 3, and an inflation head 5 for penetrating the fixture tube 3;
the side wall of the tooling tube 3 is provided with a hole 6 for the outlet end of the right-angle injection head 4 to pass through, the hole 6 is adapted to the projection size of the position of the silicon rubber sheet 21 to be coated, and the outer wall of the tooling tube 3 is sleeved with a ring rib 7 for encircling the gap between the two long round end positions of the press-fit closed air bag and the outer wall of the tooling tube 3;
the inlet end of the right-angle injection head 4 is communicated with a pump 41 for conveying the coating stock solution of the silicone rubber sheet;
the inlet end of the air charging head 5 is communicated with an air source 51; an air pressure measurer and a pressure release valve 52 are also arranged between the air charging head 5 and the air source 51.
The device is also provided with a spraying printing arm 8 for printing on the surface of the air bag, wherein the spraying printing arm 8 is positioned outside the tool pipe 3 and directs the output end to the hole 6.
The coating method comprises the following steps:
a, penetrating a positioning air bag 2 out of the tooling tube 3, and moving the air bag along the tooling tube 3 so that a position to be sprayed of the inner wall of the air bag corresponds to the hole 6;
b, pressing and sealing openings at two ends of the positioning air bag 2 to the outer wall of the tool pipe 3 by using the annular ribs 7;
c, enabling the inflation head 5 to maintain output in the tool pipe and match with the air pressure measurer and the pressure release valve 52 so as to maintain the atmosphere in the system to meet the curing requirement of the silicon rubber sheet;
d, after the air bag 2 to be positioned is inflated and expanded, the outlet end of the right-angle injection head 4 is adjusted to be aligned with the position to be sprayed;
e, pumping injection coating stock solution, and maintaining atmosphere for a specified time after injection is completed until the silica gel layer is solidified;
f removing the ring rib 7 and removing the coated positioning balloon 2 from the tooling tube 3.
Experiment one for verifying the development effect of the positioning balloon 2 of this embodiment under ultrasound: in the in-vitro water box test of the finished product prepared by the method A, a linear array ultrasonic probe (6-13 MHz) is arranged above the positioning air bag 2, and compared with a conventional air bag (see figure 4), the silicon rubber sheet 21 of the positioning air bag 2 of the embodiment can form a remarkable high-echo reflecting layer (indicated by a white arrow in figure 5) under ultrasonic waves, so that the display effect of the upper edge of the positioning air bag 2 is improved.
Development effect experiment two for verifying the positioning balloon 2 of this embodiment under ultrasound: after the sample (finished product prepared by the method A) of the embodiment is sterilized by low-temperature plasma (50+/-5 ℃ for 55 min), the sample is placed into a general anesthesia patient through an oral tracheal cannula, the head of the patient is rotated to the right side by 15-20 degrees, the midpoint of a linear array ultrasonic probe (6-13 MHz) is placed at the level of annular cartilage at the neck of the trachea, and the ultrasonic probe is aligned with the direction of the trachea.
In addition, experiments in patients receiving general anesthesia show that the in-plane technology is adopted to horizontally scan the cuff position at the annular cartilage of the neck of the patient by adopting a linear array ultrasonic probe (6-13 MHz), the operation time for displaying the position of the positioning air bag 2 covering the silicon rubber sheet 21 under the ultrasonic wave is 12.3+/-2.73 s, and the operation time for displaying the common cuff position under the ultrasonic wave is 17.8+/-4.62 s (p is less than 0.05, n=6), so that the identification time of the tracheal catheter cuff under the ultrasonic wave can be effectively shortened.
The working principle or use procedure of this embodiment is as follows:
tracheal tube examination and preparation prior to use: 5-10ml of air is injected to check the air tightness of the high-volume low-pressure type positioning air bag 2 and the air tube thereof and the integrity of the whole tracheal catheter 1. Then sucking out air to enable the positioning air bag 2 to keep low pressure, and wiping the positioning air bag 2 and the front end part of the tracheal catheter 1 with paraffin oil for standby;
tracheal catheter placement and development under ultrasound: the tracheal catheter 1 is placed into the trachea of a patient through a laryngoscope, 5-8ml of air is injected to enable the positioning air bag 2 to be inflated, and the pressure in the positioning air bag 2 is kept to be lower than 20mmHg in use. The active display method comprises the following steps: the position of the air bag 2 is positioned in the trachea by adopting a linear array ultrasonic probe (6-13 MHz) and horizontally scanning the annular cartilage of the neck of a patient by an in-plane technology, and the position covering the silicon rubber sheet 21 can be displayed under ultrasonic.
While the preferred embodiments of the present invention have been illustrated and described, the present invention is not limited to the embodiments described, and various equivalent modifications and substitutions can be made by one skilled in the art without departing from the spirit of the present invention, and these are intended to be included within the scope of the present invention as defined in the appended claims.

Claims (8)

1. The coating process of the silicone rubber sheet in the ultrasonic development balloon is characterized in that the ultrasonic development balloon is adopted, the ultrasonic development balloon comprises a high-capacity low-pressure type positioning balloon which is used for being fixed on an endotracheal tube, the wall thickness of the positioning balloon is uniform, the outline of the positioning balloon is long round, and a medical-grade room-temperature cured silicone rubber sheet is locally lined on the inner wall of the positioning balloon; the edges of the silicon rubber sheets are separated from the two long round end positions in the positioning air bag;
in the coating process of the silicon rubber sheet: maintaining the positioning balloon in an inflated state; the manufacturing process sequentially comprises the steps of adjusting the atmosphere in the air bag before spraying, injecting and spraying in the air bag, adjusting the curing atmosphere of the silicone rubber sheet and adjusting the drying atmosphere of the silicone rubber sheet;
the coating of the silicone rubber sheet is made by any one of the following A, B, C methods:
the method A comprises the steps that a coating stock solution is room temperature vulcanized silicone rubber, and the coating stock solution is further added with 500mPa.s of viscosity and 1 mass percent: 1, hydrogen-containing silicone oil; adding 5 per mill of defoaming agent polyoxyethylene polyoxypropylene pentaerythritol ether into the coating stock solution, and adopting a precise peristaltic pump for spraying when the coating stock solution is sprayed;
atmosphere adjustment in the air bag before spraying: before injection spraying, the air pressure in the air bag is maintained at 3.2-3.6kpa, the temperature is 40-60 ℃ and the humidity is 50-70%;
and (3) injecting and spraying in an air bag: starting injection spraying, and maintaining the injection flow rate at 1.0-1.5ml/min, wherein the residual silica gel in the injection head is flushed by sterile water, and the flushing flow rate is 10-20ml/min;
and (3) adjusting the curing atmosphere of the silicon rubber sheet: maintaining air pressure in the air bag at 3.0-3.7kpa after the silica gel injection is completed, and keeping the temperature at 40-60 ℃ and the humidity at 30-60% until the silica gel layer is solidified;
and (3) adjusting the drying atmosphere of the silicon rubber sheet: after the silica gel layer is solidified, the air pressure in the air bag is maintained at 3.5-3.7kpa, the temperature is 40-50 ℃, and the humidity is adjusted to 2-5% until the excessive moisture of the silica gel layer is removed; b, preparing a reagent of a first component and a reagent of a second component; wherein the component A comprises alpha, omega-dihydroxyl polydimethylsiloxane, quartz powder, vinyl polysiloxane, MQ silicon resin, methyl hydrogen silicone oil, zinc oxide and carbon black, and the mass ratio of the components A to B is 75:5:7:4:4:2:3; the component B comprises alpha, omega-dihydroxyl polydimethylsiloxane, quartz powder, vinyl polysiloxane, MQ silicone resin and hydroxyl silicone oil, wherein the mass ratio of the components is 75:5:10:4:6; uniformly mixing the reagent A and the reagent B respectively, and keeping a vacuum environment during stirring; 1:1, uniformly mixing a reagent A and a reagent B, and adding 0.6mg/mg of a platinum catalyst to form a stable coating stock solution;
atmosphere adjustment in the air bag before spraying: before injection spraying, the air pressure in the air bag is maintained at 3.5kpa, the temperature is 40 ℃, and the humidity is 65% -70%;
and (3) injecting and spraying in an air bag: starting injection spraying, maintaining the injection flow rate at 1.0ml/min, and flushing the residual silica gel in the injection head by a sterile water flushing pipe with the flow rate of 10ml/min;
and (3) adjusting the curing atmosphere of the silicon rubber sheet: maintaining air pressure in the air bag at 3.7kpa after the silica gel injection is completed, wherein the temperature is 50 ℃ and the humidity is 65%, and curing the silica gel layer;
and (3) adjusting the drying atmosphere of the silicon rubber sheet: after the silica gel layer is solidified, the air pressure in the air bag is maintained at 3.7kpa, the temperature is 50 ℃, and the humidity is adjusted to 5 percent until the excessive moisture of the silica gel layer is removed;
c, mixing room temperature vulcanized silicone rubber with nano calcium carbonate powder according to a proportion of 3:1, kneading, namely vacuumizing and dehydrating at 135-140 ℃ and kneading for 3.5 hours; adding tetraethoxysilane and a silane coupling agent KBM-13 into the kneaded component, wherein the mass of the tetraethoxysilane is 3% of the mass of the kneaded component, the mass of the silane coupling agent KBM-13 is 10% of the mass of the kneaded component, and the mixed component is uniformly stirred together with 0.4mg/mg of a platinum catalyst and then subjected to reduced pressure and air discharge for storage;
atmosphere adjustment in the air bag before spraying: before injection spraying, the air pressure in the air bag is maintained to be 3.2kpa, the temperature is 50 ℃ and the humidity is 60%;
and (3) injecting and spraying in an air bag: starting injection spraying, and maintaining the injection flow rate at 1.2ml/min, wherein the residual silica gel in the injection head is flushed by sterile water, and the flushing flow rate is 15ml/min;
and (3) adjusting the curing atmosphere of the silicon rubber sheet: after the silica gel injection is finished, the air pressure in the air bag is maintained to be 3.0kpa, the temperature is 60 ℃, the humidity is 30%, and the silica gel layer is cured;
and (3) adjusting the drying atmosphere of the silicon rubber sheet: after the silica gel layer is solidified, the air pressure in the air bag is maintained at 3.6kpa, the temperature is 40 ℃, and the humidity is adjusted to 5 percent until the excessive moisture of the silica gel layer is removed.
2. The process for coating a silicone rubber sheet in an ultrasonic developing balloon according to claim 1, wherein the cured tensile strength of the silicone rubber sheet is not less than 0.3MPa, the elongation at break is not less than 100%, and the shear strength is not less than 0.3MPa; hardness is 8-18Shore A.
3. The process for coating a silicone rubber sheet in an ultrasonic development balloon according to claim 1, wherein the outer and inner silicone rubber sheet edges of the positioning balloon are printed with marks.
4. The process for coating a silicone rubber sheet in an ultrasonic developing airbag according to claim 1, wherein when the method C is adopted, one or more of nano silicon dioxide, organic montmorillonite, graphene, nano zinc oxide, nano titanium dioxide, silicon carbide, aluminum oxide and nano silver wires are mixed in the nano calcium carbonate powder.
5. The process for coating a silicone rubber sheet in an ultrasonic developing balloon according to claim 1, wherein the silicone rubber sheet is trimmed at the end of the manufacturing process, and the trimming blade has a temperature of: 120-200 ℃.
6. The process for coating a silicone rubber sheet in an ultrasonic developing balloon according to claim 1, wherein a silicone rubber sheet coating tool of an ultrasonic developing balloon of an endotracheal tube is adopted, the silicone rubber sheet coating tool comprises a tooling tube similar to the outer diameter of a target endotracheal tube, a right-angle injection head for penetrating the tooling tube, and an inflation head for penetrating the tooling tube;
the side wall of the tooling tube is provided with a hole for the outlet end of the right-angle injection head to pass through, the hole is matched with the projection size of the position of the silicon rubber sheet to be coated, and the outer wall of the tooling tube is sleeved with a ring rib for encircling the gap between the positions of the two long round ends of the pressing closed air bag and the outer wall of the tooling tube;
the inlet end of the right-angle injection head is communicated with a pump for conveying the coating stock solution of the silicon rubber sheet;
the inlet end of the air charging head is communicated with an air source; and an air pressure measurer and a pressure relief valve are also arranged between the air charging head and the air source.
7. The process of claim 6, further comprising a spray printing arm for printing on the surface of the balloon, wherein the spray printing arm is located outside the tube of the tool and directs the output end to the hole.
8. The process for coating a silicone rubber sheet in an ultrasonic developing balloon according to claim 6, wherein the coating method using the silicone rubber sheet coating tool is as follows:
a, penetrating a sleeve-type air bag out of the tooling pipe, and moving the air bag along the tooling pipe so that a position to be sprayed on the inner wall of the air bag corresponds to the hole;
b, pressing and sealing openings at two ends of the air bag to the outer wall of the tool pipe by using the annular ribs;
c, enabling the inflation head to maintain output in the tool pipe and match with the air pressure measurer and the pressure release valve so as to maintain the atmosphere in the system to meet the curing requirement of the silicon rubber sheet;
d, after the air bag is inflated and expanded, adjusting the outlet end of the right-angle injection head to be aligned with the position to be sprayed;
e, pumping injection coating stock solution, and maintaining atmosphere for a specified time after injection is completed until the silica gel layer is solidified;
f, removing the ring rib and removing the coated air bag from the construction tube.
CN202110912934.2A 2021-08-10 2021-08-10 Ultrasonic development air bag of tracheal catheter and preparation tool, preparation process and preparation method thereof Active CN113713227B (en)

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