CN113198080A

CN113198080A - Anti-condensation respirator pipeline and respirator

Info

Publication number: CN113198080A
Application number: CN202110376205.XA
Authority: CN
Inventors: 刘哲; 吴超民; 粟锦平; 袁再鑫; 周磊; 郑其昌
Original assignee: Hunan Ventmed Medical Technology Co Ltd
Current assignee: Hunan Ventmed Medical Technology Co Ltd
Priority date: 2021-04-08
Filing date: 2021-04-08
Publication date: 2021-08-03
Anticipated expiration: 2041-04-08
Also published as: CN113198080B

Abstract

The invention discloses an anti-condensation respirator pipeline and a respirator, and relates to the technical field of respirators. The invention discloses an anti-freezing respirator pipeline which is made of hydrophilic silica gel material, and the preparation method of the hydrophilic silica gel material comprises the following steps: activating and modifying the medical silicon rubber by sodium dodecyl benzene sulfonate; adopting pyromellitic dianhydride and polyether polyol to carry out acylation treatment on the soybean protein; then the activated medical silicon rubber, the acylated soybean protein solution and the composite antibacterial material are reacted under the action of a catalyst to prepare the hydrophilic respirator, and the hydrophilic respirator pipeline is applied to a respirator. The anti-condensation respirator pipeline disclosed by the invention is mainly used for a respirator, has excellent hydrophilicity and biocompatibility, can resist condensation water, protein adhesion and cell adhesion, has extremely low cytotoxicity, has good mechanical property, flexibility and thermal stability, is safe and non-toxic, and can be recycled.

Description

Anti-condensation respirator pipeline and respirator

Technical Field

The invention belongs to the technical field of respirators, and particularly relates to an anti-condensation respirator pipeline and a respirator.

Background

In modern clinical medicine, a ventilator has been widely used in respiratory failure due to various reasons, anesthesia and breathing management during major surgery, respiratory support therapy and emergency resuscitation as an effective means for manually replacing the function of spontaneous ventilation, and has a very important position in the modern medical field. When a patient uses the respirator, inspiration and expiration both pass through the respirator pipeline, a certain amount of water vapor is contained in the gas exhaled by the patient, and the water vapor in the exhaled gas can form condensed water when encountering the respirator pipeline with the temperature lower than the body temperature of the patient. The condensate flows along the ventilator tube (particularly the section of tube adjacent the endotracheal tube) into the patient's lungs. The condensed water flows into the lung, and the stimulation of foreign matters can cause the patient to choke, easily hurt the lung and the respiratory mucosa, and the severe cough aggravates the pain of the patient. When the condensed water flows through the pipeline of the respirator and the tracheal cannula, bacteria on the inner wall of the pipeline are easy to carry and enter the lung to form bacterial planting, so that the lung of a patient is infected.

At present, heating wires are mainly placed in an air supply pipeline to reduce the generation of condensed water, or a water collecting cup is placed in a breathing loop to promote the drainage of the condensed water and the like to reduce the medical risk brought by the condensed water. The temperature is difficult to accurately regulate and control when the heating guide wire is placed, and the replacement operation is troublesome; the condensed water in the water collecting cup is an important place for bacterial reproduction, and the bacterial reproduction in the breathing machine tube is easy to increase, so that the lung infection of a patient is caused. At present, the physical structure of the base material is changed or the base material is modified at home and abroad to improve the self heat preservation and heat insulation performance of the pipe, or a super-hydrophilic anti-fog coating is coated on the surface of the material to inhibit the condensation of water vapor on the surface, so that the formation of condensed water of a breathing pipeline is completely eradicated. Chinese invention patent CN109180985A discloses a method for preparing SiO with micron-class hollow mesopores₂Microsphere and PDMS (polydimethylsiloxane) blended crosslinking modified anticoagulant silica material for medical use, which adopts novel micron-sized reaction type hollow mesoporous SiO₂The microspheres are used as a cross-linking agent and are blended with Polydimethylsiloxane (PDMS) to obtain the porous microsphere doped silicon rubber base material. Mesoporous hollow SiO₂The microspheres not only can play a role in heat preservation and heat insulation, but also can load a small-molecule bacteriostatic agent therein, and the mesoporous shell layer of the microspheres enables the bacteriostatic agent to be slowly released in the base material to play a role in pipeline bacteriostasis. And coating SiO on the surface of the silicon rubber₂The nanoparticles improve the hydrophilicity of the base material and suppress the formation of water droplets on the surface. But the hydrophilicity of the anticoagulant silica gel material is improved relative to the hydrophilicity of PDMS, while the time for using the respirator by a general patient needs to be maintained for at least 6-8h, the invention is accompanied by a small amount of condensed water when the respirator is used for more than 2h, the pipeline of the respirator still generates a large amount of condensed water with the time extension, and the hydrophilicity is general; researches show that the particle size and the dosage of the mesoporous silica nanoparticles influence the biocompatibility, so that the biocompatibility of the mesoporous silica nanoparticles is general, and the material can generate biological side reactions in a human body after a long time in the human body and shows cytotoxicity.

Disclosure of Invention

The invention aims to provide an anti-condensation respirator pipeline which is mainly used for respirators, has excellent hydrophilicity and biocompatibility, can resist condensation water, protein adhesion and cell adhesion, has extremely low cytotoxicity, has good mechanical property, flexibility and thermal stability, is safe and nontoxic and can be recycled.

In order to solve the technical problem, the invention provides an anti-freezing respirator pipeline which is prepared from a hydrophilic silica gel material, wherein the hydrophilic silica gel material is prepared from the following raw materials in parts by weight: 100 parts of medical silicon rubber, 0.5-0.9 part of sodium dodecyl benzene sulfonate, 8.5-13.5 parts of acylated soybean protein and 0.36-0.45 part of dibutyltin diacetate.

The preparation method of the hydrophilic silica gel material specifically comprises the following steps:

(1) activating medical silicon rubber: adding the medical silicon rubber into anhydrous methanol, then adding sodium dodecyl benzene sulfonate, magnetically stirring for 60-90min at 45 ℃, after the reaction is finished, cleaning the medical silicon rubber with the anhydrous ethanol, and drying for 1-2h under vacuum at 80 ℃ to obtain the activated medical silicon rubber.

(2) Acylated soy protein: adding a 10 wt% soybean protein aqueous solution into a 2mol/L NaOH solution, adjusting the pH value to 10-11, then adding pyromellitic dianhydride, stirring at 60 ℃ for 3-4h, then adding acetic acid to adjust the pH value to 6-7, adding polyether polyol, stirring at normal temperature for 1-2h, washing with deionized water, and drying to obtain the acylated soybean protein. The mass ratio of the soybean protein to the pyromellitic dianhydride to the polyether polyol is 1: (0.1-0.3): (0.32-0.54).

(3) Adding activated medical silicon rubber into a mixed solution of an acylated soy protein solution and isopropanol, uniformly stirring, then adding dibutyltin diacetate, stirring for 4-6h at 40-60 ℃, filtering, washing with deionized water, and drying for 2h at 100 ℃ to prepare the required hydrophilic silica gel material.

Further, the mass fraction of the acylated soybean protein in the acylated soybean protein solution in the step (3) is 65-75%.

Further, the polyether polyol is one of polyoxypropylene glycol, polytetrahydrofuran glycol or polyethylene glycol.

Further, in the step (1), the mass ratio of the medical silicon rubber to the methanol is 1: (3-5).

Further, in the step (3), the mass ratio of the acylated soybean protein solution to isopropanol is 1: (1.5-3.2) preparing a mixed solution.

The anti-freezing respirator pipeline prepared from the hydrophilic silica gel material can be applied to a respirator.

The invention achieves the following beneficial effects:

1. the invention adopts the sodium dodecyl benzene sulfonate to activate the medical silicon rubber, so that the activated medical silicon rubber can be subjected to hydrophilic surface modification by the acylated soybean protein, thereby ensuring that the silicon rubber material has excellent hydrophilicity and ensuring that the breathing machine pipeline can resist condensed water. The acylated soybean protein is prepared by adopting pyromellitic dianhydride to carry out acylation modification on the soybean protein and reacting with polyether polyol, carboxyl groups are introduced through the acylation modification, ether bonds and hydroxyl groups containing oxygen groups are introduced through the reaction with the polyether polyol, the internal charge density and the hydrophilic capacity of the acylated soybean protein are greatly improved, and the binding force with medical silicon rubber is improved; under the catalytic action of dibutyltin diacetate, the acylated soy protein molecular chain and the activated medical silicon rubber are subjected to graft reaction, so that the hydrophilicity of the obtained silica gel material is greatly improved, and the breathing machine pipeline is not easy to generate condensed water.

2. The soybean protein used in the invention is vegetable protein, and is grafted to the surface of the medical silicon rubber through acylation modification, so that the biocompatibility of the invention is increased, the protein adhesion resistance and cell adhesion resistance of the silica gel material are improved, and the modified silica gel material has a cytotoxicity grade of 0 and can directly act on the human body in vivo and in vitro. The soybean protein belongs to an environment-friendly material, is biodegradable, and can be used in medical silicon rubber to improve the biodegradability of the medical silicon rubber, reduce environmental pollutants, save energy and protect environment.

3. The raw materials of the invention are easy to obtain, the operation is simple, the grafting modification can be completed without special test equipment, the requirements on the dosage of various reaction reagents are not high, the special precision is not required, the acylation modification degree of the soybean protein only needs to reach more than 50 percent, the grafting efficiency of the medical silicon rubber reaches more than 45 percent, and the invention can have excellent hydrophilicity and biocompatibility.

4. The medical silicon rubber is activated and reacts with the acylated soybean protein under the action of the catalyst, so that the compatibility between the medical silicon rubber and the acylated soybean protein is increased, the toughness of the silica gel material is improved, the silica gel material is softer, the excellent mechanical property and thermal stability of the silica gel material are ensured, the silica gel material can resist repeated washing, disinfection and drying treatment of a disinfection center, can be recycled, is safe and nontoxic, reduces the medical cost and saves resources.

5. The anti-freezing respirator pipeline prepared from the hydrophilic silica gel material through the steps of extrusion, processing and forming and the like can be applied to a respirator, so that the breeding of bacteria in the using process of the respirator can be reduced, and the infection probability of a user can be reduced.

Detailed Description

The technical solutions in the embodiments of the present invention are clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

The silicon rubber material used by the invention is Dow Corning silicon rubber RBB-2030-80.

The following describes an anticoagulation breathing machine tube and a breathing machine according to the present invention with reference to specific embodiments.

Example 1: anti-condensation water breathing machine pipeline and hydrophilic silica gel material thereof

An anti-freezing respirator pipeline is prepared from a hydrophilic silica gel material, and the preparation method of the hydrophilic silica gel material specifically comprises the following steps:

(1) activating medical silicon rubber: adding 1kg of medical silicon rubber into 3kg of anhydrous methanol, then adding 5g of sodium dodecyl benzene sulfonate, magnetically stirring for 60-90min at 45 ℃, cleaning the medical silicon rubber by using anhydrous ethanol after the reaction is finished, and drying for 1-2h under vacuum at 80 ℃ to obtain the activated medical silicon rubber.

(2) Acylated soy protein: adding 1kg of soybean protein aqueous solution with the concentration of 10 wt% into 2mol/L NaOH solution, adjusting the pH value to 10-11, then adding 10g of pyromellitic dianhydride, stirring at 60 ℃ for 3-4h, then adding acetic acid to adjust the pH value to 6-7, adding 32g of polyoxypropylene glycol, stirring at normal temperature for 1-2h, washing with deionized water, and drying to obtain the acylated soybean protein.

(3) Adding activated medical silicon rubber into a mixed solution of 180g of acylated soy protein solution and 576g of isopropanol, uniformly stirring, then adding 4.5g of dibutyltin diacetate, stirring for 4-6h at 40-60 ℃, filtering, washing with deionized water, and drying for 2h at 100 ℃ to obtain the required hydrophilic silica gel material.

The hydrophilic silica gel material prepared in this embodiment 1 is added into a twin-screw extruder to be melted, plasticized, extruded and granulated, and then is added into an injection molding machine to be injection molded, so as to obtain the anti-freezing breathing machine pipeline of the required model, and breathing machine pipelines of different models can be selected according to the requirements of breathing machines. The preparation method and application of the ventilator tube in other embodiments of the present invention are the same as those in embodiment 1, and the following embodiments will not be described again.

Example 2: anti-condensation water breathing machine pipeline and hydrophilic silica gel material thereof

(1) activating medical silicon rubber: adding 1kg of medical silicon rubber into 5kg of anhydrous methanol, then adding 9g of sodium dodecyl benzene sulfonate, magnetically stirring for 60-90min at 45 ℃, cleaning the medical silicon rubber by using anhydrous ethanol after the reaction is finished, and drying for 1-2h under vacuum at 80 ℃ to obtain the activated medical silicon rubber.

(2) Acylated soy protein: adding 1kg of soybean protein aqueous solution with the concentration of 10 wt% into 2mol/L NaOH solution, adjusting the pH value to 10-11, then adding 30g of pyromellitic dianhydride, stirring at 60 ℃ for 3-4h, then adding acetic acid to adjust the pH value to 6-7, adding 54g of polytetrahydrofuran diol, stirring at normal temperature for 1-2h, washing with deionized water, and drying to obtain the acylated soybean protein.

(3) Adding activated medical silicon rubber into a mixed solution of 131g of acylated soy protein solution and 197g of isopropanol, uniformly stirring, then adding 3.6g of dibutyltin diacetate, stirring for 4-6h at 40-60 ℃, filtering, washing with deionized water, and drying for 2h at 100 ℃ to obtain the required hydrophilic silica gel material.

The anti-freezing respirator pipeline made of the hydrophilic silica gel material can be used in a respirator.

Example 3: anti-condensation water breathing machine pipeline and hydrophilic silica gel material thereof

(1) activating medical silicon rubber: adding 1kg of medical silicon rubber into 3.2kg of anhydrous methanol, then adding 7g of sodium dodecyl benzene sulfonate, magnetically stirring for 60-90min at 45 ℃, cleaning the medical silicon rubber by using anhydrous ethanol after the reaction is finished, and drying for 1-2h under vacuum at 80 ℃ to obtain the activated medical silicon rubber.

(2) Acylated soy protein: adding 1kg of soybean protein aqueous solution with the concentration of 10 wt% into 2mol/L NaOH solution, adjusting the pH value to 10-11, then adding 25g of pyromellitic dianhydride, stirring at 60 ℃ for 3-4h, then adding acetic acid to adjust the pH value to 6-7, adding 46g of polyethylene glycol, stirring at normal temperature for 1-2h, washing with deionized water, and drying to obtain the acylated soybean protein.

(3) Adding activated medical silicon rubber into a mixed solution of 131g of acylated soy protein solution and 290g of isopropanol, uniformly stirring, then adding 4.2g of dibutyltin diacetate, stirring for 4-6h at 40-60 ℃, filtering, washing with deionized water, and drying for 2h at 100 ℃ to obtain the required hydrophilic silica gel material.

Example 4: anti-condensation water breathing machine pipeline and hydrophilic silica gel material thereof

(1) activating medical silicon rubber: adding 1kg of medical silicon rubber into 4kg of anhydrous methanol, then adding 8.3g of sodium dodecyl benzene sulfonate, magnetically stirring for 60-90min at 45 ℃, cleaning the medical silicon rubber by using the anhydrous ethanol after the reaction is finished, and drying for 1-2h under vacuum at 80 ℃ to obtain the activated medical silicon rubber.

(2) Acylated soy protein: adding 1kg of soybean protein aqueous solution with the concentration of 10 wt% into 2mol/L NaOH solution, adjusting the pH value to 10-11, then adding 18g of pyromellitic dianhydride, stirring at 60 ℃ for 3-4h, adding acetic acid to adjust the pH value to 6-7, adding 42g of polyoxypropylene glycol, stirring at normal temperature for 1-2h, washing with deionized water, and drying to obtain the acylated soybean protein.

(3) Adding activated medical silicon rubber into a mixed solution of 170g of acylated soy protein solution and 425g of isopropanol, uniformly stirring, then adding 3.9g of dibutyltin diacetate, stirring for 4-6h at 40-60 ℃, filtering, washing with deionized water, and drying for 2h at 100 ℃ to obtain the required hydrophilic silica gel material.

Comparative example 1

The raw material components and the preparation method of the silica gel material in this comparative example were the same as those in example 4, except that the acylated soybean protein was not added (i.e., the acylated soybean protein solution having a concentration of 10 wt% was not added) in this comparative example 1, and the other components and the preparation method were not changed.

Comparative example 2

The raw material components and the preparation method of the silica gel material in the comparative example are the same as those in the example 4, except that the activated medical silica gel in the comparative example 2 is not activated and modified by adding sodium dodecyl benzene sulfonate, and other components and the preparation method are not changed.

The mechanical properties of the hydrophilic silicone rubber material and the medical silicone rubber prepared according to the above examples 1 to 4 were measured, and the test results are shown in table 1 below.

TABLE 1 test result table of mechanical properties of silica gel materials

The experimental results show that the medical silicon rubber still has good strength and toughness after being modified by the activated and acylated soybean protein, the hardness of the medical silicon rubber is reduced, and the hydrophilic silicon rubber material has better flexibility and is more beneficial to being contacted with a human body.

The silica gel materials prepared in examples 1 to 4 and comparative examples 1 to 3 were tested for hydrophilicity and cytotoxicity, and the test methods were as follows.

Hydrophilicity test (dynamic contact angle test):

after the silica gel materials of the examples and comparative examples of the present invention were sufficiently vacuum-dried at room temperature, the advancing angle and the receding angle of the dynamic contact angle thereof were measured respectively by using a DCAT21 Dataphysics type dynamic contact angle tester.

Cytotoxicity test:

the cytotoxicity of the silica gel material was tested by the leaching solution method. According to the requirements of GB/T16886.5-2003, the silica gel material is 6cm²Per mL of surface area to prepare the leach liquor. According to the area requirements, the silica gel materials with the same surface area are placed into the culture solution, and placed in a 37 ℃ incubator containing 5% CO2 and 100% humidity for 24 hours at constant temperature to obtain the leaching liquor.

The MTT method (tetrazolium salt colorimetric method) is adopted in the experiment to test the cytotoxicity of the silica gel material. The prepared 1 × 104/mL cell suspension was inoculated into a 96-well cell culture plate, and a blank control, a positive control and two sample groups were set, each group having 6 wells, and 100 μ L of cell suspension was added to each well. Culturing at constant temperature in 37 deg.C incubator containing 5% CO2 and humidity 100% for 24 hr, discarding original culture solution, adding fresh cell culture solution into blank control group, adding 5g/L phenol solution into positive control group, adding two leaching solutions into two sample groups, adding 100 μ L per well, culturing in constant temperature incubator for 72 hr, adding 20 μ L MTT solution with concentration of 5g/L per well, culturing for 4 hr, discarding the liquid in the well, adding 150 μ L dimethyl sulfoxide (DMSO), reacting, developing, measuring absorbance at 570nm and 630nm, and calculating relative proliferation degree according to the following formula

In the above formula, A: positive or sample set absorbance; a. the₀: the absorbance of the blank control group was measured, and the cytotoxicity grade of the silica gel material was determined as shown in Table 2.

TABLE 2 cytotoxic response grading

Rank of	Relative increment (%)
		0	≥100
1	80-99
		2	50-79
3	30-49
		4	0-29

The silica gel materials obtained in the above examples 1 to 4 and comparative examples 1 to 2 were tested according to the above test methods, and the test results are shown in the following Table 3.

TABLE 3 hydrophilic property test results of silica gel materials

As can be seen from the test results in Table 3, the present invention has excellent hydrophilicity, and the cytotoxicity can reach 0 grade. After the acylated soybean protein is added, the hydrophilicity of the invention is greatly improved, and the biocompatibility of the invention is increased, so that the protein adhesion resistance and cell adhesion resistance of the silica gel material are improved, and the cytotoxicity grade of the silica gel material is 0 grade; the medical silicon rubber is activated and modified, so that the compatibility of each raw material component in the medical silicon rubber is improved, and the hydrophilicity of the medical silicon rubber is improved to a certain extent.

And (3) a condensed water resistance test:

1) two sections of the silicone rubber tube (example 4) made of the hydrophilic silicone material of example 4, which are 45cm in total, are taken as an inhalation pipeline and are connected by a Y-shaped connecting tube, a water collecting cup A1 is arranged below the Y-shaped tube, and a water collecting cup B1 is arranged in the exhalation pipeline in the same way and is sequentially connected with a breathing machine, a humidification tank and an artificial simulated lung.

2) Two sections of silicone rubber tubes (control group) made of medical silica gel materials used by the invention are taken as an inspiration pipeline, the two sections are connected by a Y-shaped connecting tube, a water collecting cup A2 is arranged below the Y-shaped tube, and a water collecting cup B2 is arranged in the expiration pipeline by the same method and is sequentially connected with a breathing machine, a humidification tank and an artificial simulated lung.

3) And (5) mechanically ventilating for 24h, counting the water amount in the water collecting cup, and detecting results are shown in the following table 4.

Table 4 example 4 and results of anticoagulation water-based test of medical silicone rubber

As can be seen from the test results in Table 4, the anti-freezing effect of the invention used in the breathing machine pipeline is good, the water vapor condensation in the pipeline can be prevented within 6-8h, and when the breathing machine pipeline is applied to the breathing machine, the water vapor condensation on the breathing machine can be reduced when a patient uses the breathing machine, the breeding of bacteria can be reduced, and the harm to the health of the human body can be reduced.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention.

Claims

1. The utility model provides an anti-water condensation breathing machine pipeline which characterized in that, breathing machine pipeline is made by hydrophilic silica gel material, hydrophilic silica gel material is made by the raw materials of following parts by weight: 100 parts of medical silicon rubber, 0.5-0.9 part of sodium dodecyl benzene sulfonate, 8.5-13.5 parts of acylated soybean protein and 0.36-0.45 part of dibutyltin diacetate;

(1) activating medical silicon rubber: adding medical silicon rubber into anhydrous methanol, then adding sodium dodecyl benzene sulfonate, magnetically stirring for 60-90min at 45 ℃, after the reaction is finished, cleaning the medical silicon rubber with the anhydrous ethanol, and drying in vacuum for 1-2h at 80 ℃ to obtain activated medical silicon rubber;

(2) acylated soy protein: adding a 10 wt% soybean protein aqueous solution into a 2mol/L NaOH solution, adjusting the pH value to 10-11, then adding pyromellitic dianhydride, stirring at 60 ℃ for 3-4h, then adding acetic acid to adjust the pH value to 6-7, adding polyether polyol, stirring at normal temperature for 1-2h, washing with deionized water, and drying to obtain acylated soybean protein; the mass ratio of the soybean protein to the pyromellitic dianhydride to the polyether polyol is 1: (0.1-0.3): (0.32-0.54);

2. The anti-coagulated ventilator conduit according to claim 1, wherein the mass fraction of said acylated soy protein in said acylated soy protein solution of step (3) is 65-75%.

3. The anti-coagulated ventilator conduit according to claim 1, wherein the polyether polyol is one of polyoxypropylene glycol, polytetrahydrofuran glycol, or polyethylene glycol.

4. The anti-freezing respirator tube according to claim 1, wherein in step (1), the mass ratio of the medical silicone rubber to the methanol is 1: (3-5).

5. The anti-freezing ventilator tube as claimed in claim 1, wherein in said step (3), said acylated soy protein solution and isopropanol are mixed in a mass ratio of 1: (1.5-3.2) preparing a mixed solution.

6. A ventilator having attached thereto an anti-condensation ventilator circuit according to any one of claims 1 to 5.