WO2022174549A1

WO2022174549A1 - Medical laryngeal mask

Info

Publication number: WO2022174549A1
Application number: PCT/CN2021/105707
Authority: WO
Inventors: 邓枫
Original assignee: 浙江简成医疗科技有限公司
Priority date: 2021-02-20
Filing date: 2021-07-12
Publication date: 2022-08-25
Also published as: AU2021107544A4; CN217472518U

Abstract

A medical laryngeal mask, the surface of which is provided with a transparent insulation lubricating coating used for resisting the invasion of a corrosive gas. The medical laryngeal mask comprises a cuff (1), a connecting member (2), and a main airway tube (3); the connecting member (2) is disposed in the cuff (1); the front end of the main airway tube (3) penetrates into the cuff (1) and communicates with the connecting member (2); the rear end of the cuff (1) is connected to the outer surface of the main airway tube (3); and the cuff (1), the connecting member (2), and the main airway tube (3) are integrally formed by means of injection molding. The medical laryngeal mask can reduce the occurrence of postoperative complications for patients, saves costs, and has wide applicability.

Description

medical laryngeal mask

technical field

The invention belongs to the technical field of medical devices, in particular to a medical laryngeal mask.

Background technique

The laryngeal mask is used in general anesthesia surgery to establish a safe airway.

The laryngeal mask is made of polymer materials such as PVC or silicone. Under some special conditions, specific gas molecules can penetrate the material, such as nitrous oxide (N ₂ O), which can penetrate the silicone material, making the laryngeal mask sac increased pressure.

In the production process of the inflatable laryngeal mask, it is necessary to produce the cuff, the connecting piece, the main pipe and other components separately, and then glue the cuff and the connecting piece together first, and then use the glue to bond the main pipe, the cuff and the connecting piece on the At the same time, hit the glue in the same position several times during the bonding process. The laryngeal mask is composed of multiple parts, the production process has many processes, the bonding process is complex, and there are many control points.

However, the existing laryngeal masks have the following problems:

1. The inflation volume of the laryngeal mask and the pressure control in the sac are one of the focuses of clinical anesthesiologists. When nitrous oxide N ₂ O (laughing gas) is used as an anesthetic gas, the mass quickly enters the laryngeal mask sac, causing the pressure in the sac to rise sharply for a short time, which greatly exceeds the perfusion pressure of the mucous membrane of the throat, which may cause Ischemic damage to the oropharyngeal mucosa increases the incidence of postoperative pharyngeal complications.

2. The existing inflatable laryngeal mask is mainly composed of a cuff, a connector, a main pipe, an inflation system (if any), and a corresponding breathing tube connection joint. Among them, the cuff, connector, main pipe and other components need to be processed separately, and then combined together by bonding. The laryngeal mask has many processing steps, and there are many key points and key points for processing process control. For example, during the bonding process, it is necessary to check the appearance of the bonding surface and test the bonding strength for many times, resulting in an increase in production control elements and production costs.

3. The existing non-inflatable laryngeal mask is mainly composed of a cuff, a connecting piece, a main pipe, and a connecting joint of the breathing circuit. The type of laryngeal mask cannot be inflated during use, and the structure of the human larynx is different (the size of the larynx is large or small), resulting in poor adaptability of the non-inflatable laryngeal mask. It is necessary to continuously try different sizes of laryngeal masks to achieve sealing of the larynx airway after insertion into the human body, so that clinical users need to have higher operational requirements and clinical experience.

Therefore, it is very necessary to design a medical laryngeal mask that can reduce the occurrence of postoperative complications, save costs and have wide applicability.

For example, a non-inflatable laryngeal mask with a liquid absorption function described in the Chinese invention patent with the application number of CN201420604718.7 includes a joint, a soft gel mask bag, and an inflatable cavity is formed between the soft gel mask bag and the mask body, The cover body is provided with a number of suction holes, and the ventilation tube is provided with a ventilation channel, a feeding and drainage channel and a suction channel. The ventilation channel is communicated with the inflation cavity, and the feeding and drainage channel runs through the ventilation tube and the cover body and is connected with the feeding hole arranged at the front end of the cover body. The suction hole is communicated with the suction channel, and the joint is provided with an inflation port, a feeding port and a suction port, the inflation port is communicated with the ventilation channel, the feeding port is communicated with the feeding and drainage channel, and the suction port is communicated with the suction channel. Although the structure is simple, the design is reasonable, and the sealing performance is good, the mucus and blood clots in the throat can be discharged in time, the ventilation holes are not easily blocked, and the damage to the patient is small, but the disadvantage is that the overall structure is assembled by multiple parts, which leads to processing There are many steps, and there are many key points and key points of processing technology control, which increases the cost of production, and has a single applicability. It is necessary to continuously try different sizes of laryngeal masks to achieve sealing of the throat airway after insertion into the human body.

SUMMARY OF THE INVENTION

The present invention is to overcome the problems in the prior art that the existing medical laryngeal mask has high production cost, poor applicability and easy postoperative complications for patients, and provides a medical device that can reduce postoperative complications and save costs. And widely applicable medical laryngeal mask.

In order to achieve the above-mentioned purpose of the invention, the present invention adopts the following technical solutions:

A medical laryngeal mask, the surface of the medical laryngeal mask is provided with a transparent insulating lubricating coating for resisting corrosive gas parts; the medical laryngeal mask includes a cuff, a connecting piece and a main airway tube; the connecting piece is arranged on the cover In the bag, the front end of the main airway catheter penetrates into the cuff and communicates with the connecting piece, and the rear end of the cuff is connected with the outer surface of the main airway catheter; the cuff, the connecting piece and the main airway catheter One piece is formed by injection molding.

Preferably, the surface of the medical laryngeal mask is provided with a transparent insulating lubricating coating for resisting corrosive gas.

Preferably, the surface of the medical laryngeal mask is provided with a transparent insulating lubricating coating for resisting penetrating gas.

Preferably, the material used for the transparent insulating lubricating coating includes parylene.

Preferably, the curvature of the main airway catheter is 145° to 175°.

Preferably, the cuff is provided with a non-slip corrugated structure for preventing the laryngeal mask from retreating.

Preferably, the main airway catheter is made of silica gel or PVC material with a hardness of 55° to 80°.

Preferably, a shielding sheet is provided on the connecting piece, and an opening for ventilation is provided on the shielding sheet.

Preferably, the surface of the medical laryngeal mask includes edges, slits and inner surfaces.

Compared with the prior art, the present invention has the following beneficial effects: (1) the present invention adds a special blocking coating on the surface of the laryngeal mask to isolate the gas from penetrating the mask, so that the pressure in the mask is increased, and the postoperative complications of the patient are reduced. (2) In the present invention, the cuff, the connector and the main airway catheter are formed into one body by injection molding, and the whole structure can be completed by subsequent bonding, which saves the production cost of the laryngeal mask, improves the production efficiency, and avoids the Air leakage occurs at the sticking site; (3) the invention has wide applicability and can be completely fitted to the throat of a patient, overcoming the problem of poor clinical applicability of the non-inflatable laryngeal mask.

Description of drawings

Fig. 1 is a kind of structural representation of the present invention;

Fig. 2 is a kind of top view of the present invention;

Figure 3 is a bottom view of the present invention.

In the figure: the cuff 1, the connector 2, the main airway conduit 3, the anti-skid corrugated structure 4, the shielding sheet 5, the opening 6, and the tracheal outlet 7.

Detailed ways

In order to describe the embodiments of the present invention more clearly, the following will describe specific embodiments of the present invention with reference to the accompanying drawings. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can also be obtained from these drawings without creative efforts, and obtain other implementations.

Example 1:

As shown in Figures 1 and 2, the surface of the medical laryngeal mask is provided with a transparent insulating and lubricating coating for resisting corrosive gas; the medical laryngeal mask includes a cuff 1, a connecting piece 2 and a main Airway catheter 3; the connecting piece is arranged in the cuff, the front end of the main airway conduit penetrates into the cuff and communicates with the connecting piece, and the rear end of the cuff is connected with the outer surface of the main airway conduit; The cuff, the connector and the main airway tube are integrally formed by injection molding.

Among them, the transparent insulating lubricating coating is a special blocking coating, which is used to isolate the gas from penetrating the cuff, so that the pressure in the laryngeal cuff is increased, and the occurrence of postoperative complications of the patient is reduced. The cuff, the connector and the main airway catheter are separately processed and formed by three parts, bonded and assembled together, and the three parts are combined together for one molding, and then the overall structure can be completed by one bonding, which saves the laryngeal mask. The production cost is reduced, the production efficiency is improved, and the occurrence of air leakage at the pasting part is avoided.

Further, the material used for the transparent insulating lubricating coating includes parylene.

Parylene material has the following advantages:

It has good hydrophobicity (self-lubrication), does not adhere to human body fluids clinically, and reduces the infection caused by the adhesion of body fluids into splashes, jets, etc.;

Comply with ISO-10993 biological test requirements, tests include cytotoxicity, sensitization, intradermal irritation, acute systemic toxicity, implantation and hemolysis tests.

Parylene can be applied to surfaces of various shapes, and can play a good role in isolation and protection in harsh environments such as salt spray, mold, humidity, and corrosiveness.

Additionally, the parylene material can withstand routine sterilization.

The protective polymer material parylene is selected, and the active molecules of parylene are completely attached to the surface of the laryngeal mask through a unique vacuum vapor deposition process to form a transparent insulating lubricating coating with no pinholes and uniform thickness. Provide a complete high-quality protective coating for the laryngeal mask to resist acid and alkali, salt spray, mold and various corrosive gases or penetrating gases. At the same time, parylene is not a liquid, so it will not aggregate during the coating process; and the parylene coating is not a conventional solvent-based coating, there is no evaporation of the solvent after use, and no pinholes will be formed on the surface of the laryngeal mask. Form leaks.

Wherein, the surface of the laryngeal mask includes edges, cracks and an inner surface, and the inner surface includes the inner surface of the laryngeal mask bag; the transparent insulating lubricating coating covers the surface of the laryngeal mask.

The coating of parylene is based on the principle of vapor deposition. The dimer of parylene is heated in a vacuum state and changes from solid to gas, and then changes from gas to solid on the surface of the workpiece. The whole process is deposited. All are completed in a closed space, avoiding the independent liquid process in the middle, thereby avoiding damage to operators and the environment.

Further, the curvature of the main airway tube is 145° to 175°. The main airway tube adopts a large arc design, so that the channel in the main airway tube is straighter than the existing laryngeal mask, so that the fiberoptic bronchoscope can pass through the tube smoothly and will not be stuck in the middle.

Further, as shown in FIG. 3 , the cuff is provided with a non-slip corrugated structure 4 for preventing the laryngeal mask from retreating. The anti-skid corrugated structure 4 can increase the resistance of retreat, prevent the laryngeal mask from being extruded outward to cause displacement, and reduce damage and force when it is in frontal contact with the mucous membrane.

Further, the main airway catheter 3 is made of silica gel or PVC material with a hardness of 55° to 80°. The main airway tube 3 is more flexible with low stiffness materials.

Further, as shown in FIG. 3 , the connecting member 2 is provided with a shielding piece 5 , and the shielding piece 5 is provided with an opening 6 for ventilation. In order to prevent the epiglottis cartilage from covering the air hole in the connector, the design can block the epiglottis outside the air hole of the connector. When the epiglottis slides off the shielding piece 5 to block the airway, the opening 6 on the shielding piece 5 can play the role of ventilation.

In addition, the front end of the cuff is provided with a trachea outlet 7. The trachea outlet 7 is an obliquely arranged structure, which can reduce the thickness of the front end of the cuff, reduce the resistance of placing the laryngeal mask, and prevent the laryngeal mask from being folded when it is placed. Excessive compression of the cricoarytenoid joint.

In the present invention, a special blocking coating is added on the surface of the laryngeal mask to isolate the gas from penetrating the cuff, so that the pressure in the laryngeal mask is increased, and the occurrence of postoperative complications of the patient is reduced; the cuff, the connector and the main airway in the present invention The catheter is formed into a whole by injection molding, and the whole structure can be completed by one subsequent bonding, which saves the production cost of the laryngeal mask, improves the production efficiency, and avoids the occurrence of air leakage at the bonding part; the invention has wide applicability and can be completely fitted In the larynx of the patient, the problem of poor clinical applicability of the non-inflatable laryngeal mask is overcome.

The above is only a detailed description of the preferred embodiments and principles of the present invention. For those of ordinary skill in the art, according to the ideas provided by the present invention, there will be changes in the specific implementation, and these changes should also be It is regarded as the protection scope of the present invention.

Claims

A medical laryngeal mask, characterized in that the medical laryngeal mask comprises a cuff, a connecting piece and a main airway conduit; the connecting piece is arranged in the cuff, and the front end of the main airway conduit penetrates the cover The inside of the bag is communicated with the connecting piece, and the rear end of the cuff is connected with the outer surface of the main airway catheter; the surface of the medical laryngeal mask is provided with a lubricating coating for resisting corrosive gas parts; the The cuff, the connector and the main airway tube are formed into one body by injection molding.
The medical laryngeal mask according to claim 1, wherein the lubricating coating is a transparent insulating lubricating coating.
The medical laryngeal mask according to claim 2, wherein the material used for the transparent insulating lubricating coating comprises parylene.
The medical laryngeal mask according to claim 2, wherein the main airway tube has a curvature of 145° to 175°.
The medical laryngeal mask according to claim 2, wherein the mask bag is provided with a non-slip corrugated structure for preventing the laryngeal mask from retreating.
The medical laryngeal mask according to claim 2, wherein the main airway catheter is made of silica gel or PVC material with a hardness of 55° to 80°.
The medical laryngeal mask according to any one of claims 1-6, wherein a shielding sheet is provided on the connecting piece, and an opening for ventilation is provided on the shielding sheet.
The medical laryngeal mask according to any one of claims 1-6, wherein the surface of the medical laryngeal mask comprises edges, cracks and inner surfaces.
The medical laryngeal mask according to claim 2, characterized in that, the surface of the medical laryngeal mask is provided with a transparent insulating lubricating coating for resisting corrosive gas.
The medical laryngeal mask according to claim 2, wherein the surface of the medical laryngeal mask is provided with a transparent insulating and lubricating coating for resisting penetrating gas.
A medical laryngeal mask, characterized in that the medical laryngeal mask comprises a cuff, a connecting piece and a main airway conduit; the connecting piece is arranged in the cuff, and the front end of the main airway conduit penetrates the cover The inside of the bag is communicated with the connecting piece, and the rear end of the cuff is connected with the outer surface of the main airway catheter; the surface of the medical laryngeal mask is provided with a lubricating coating for resisting corrosive gas parts; the The cuff, the connector and the main airway tube are injection-molded at one time.