CN110548204A

CN110548204A - Integrated inflation-free laryngeal mask and production method thereof

Info

Publication number: CN110548204A
Application number: CN201910966172.7A
Authority: CN
Inventors: 郭淑儿; 刘小敏; 赖远沛
Original assignee: Individual
Current assignee: Guangzhou Man Xiang Pharmaceutical Co ltd
Priority date: 2019-10-12
Filing date: 2019-10-12
Publication date: 2019-12-10

Abstract

the invention discloses an integrated inflation-free laryngeal mask and a production method thereof, and relates to the field of medical supplies. The scheme is provided for solving the problem that the integrated laryngeal mask is not friendly to human bodies in the prior art. Comprises a joint section, an extension section and a cuff which are sequentially connected and communicated in an integrated manner; the hardness of the joint section is greater than that of the extension section, and the hardness of the extension section is greater than that of the cuff; the cuff is provided with a plurality of suckers at the edge of the opening of the trachea connected with the trachea. The advantage lies in, the integral type structure of the different hardness of syllogic can adapt to the characteristic of the different positions of throat oral cavity simultaneously. The hardest joint section is used for easily inserting the externally connected tracheal cannula, and the occlusion of teeth can be prevented. The extending section is used as extending transition with a certain length and has certain flexibility, so that the relative positions of the joint section and the cuff at the two ends can be kept stable, and the human body can be comfortable enough. The cuff is the softest component, in combination with the suction cup arrangement, to prevent migration and provide adequate sealing while minimizing soft tissue compression.

Description

Integrated inflation-free laryngeal mask and production method thereof

Technical Field

The invention relates to the field of medical supplies, in particular to an integrated inflation-free laryngeal mask and a production method thereof.

Background

The laryngeal mask is a ventilation tool between a mask and an endotracheal tube and is divided into an inflatable type and a non-inflatable type. The two laryngeal masks achieve the effect of sealing with the airway opening through physical extrusion between tissues and high coincidence of the laryngeal mask and the laryngeal part of the pharynx. Most of the existing laryngeal mask is made of silica gel or PVC materials, and all parts are fixedly connected through glue adhesion through blow molding or injection molding.

The inflatable laryngeal mask has the defects that: 1. pressure is applied to the mucosa, and ischemic injury of the mucosa and damage of the hypoglossal nerve are easily caused. 2. The operation is time-consuming. 3. The implantation of the laryngeal mask is easy to displace. 4. When the inflation is insufficient, the sealing performance is poor, and the backflow and aspiration are easily caused.

Non-inflatable laryngeal masks (e.g. SLIPA laryngeal masks) have the disadvantages: such laryngeal masks utilize physical compression seals and are relatively rigid and may cause damage to the patient's laryngeal mucosa and hypoglossal nerve.

The structural defects are as follows: the split laryngeal mask is combined through glue, and connection is not firm. The glue has certain toxicity, influences the chemical property and the biological property of the product and has certain harm to the human body, and the whole body of the integrally formed laryngeal mask (such as the SLIPA laryngeal mask) only adopts one material. The hard material is selected, which can provide good sealing performance and can be easily inserted into an external tracheal cannula, but the pressure on human soft tissues is large, and nerves are easily crushed. The soft material is relatively friendly to human body, but has poor sealing effect and is not easy to be externally connected with an endotracheal tube.

Disclosure of Invention

In order to solve the problems in the prior art, the invention aims to provide an integrated inflation-free laryngeal mask and a production method thereof.

The invention relates to an integrated inflation-free laryngeal mask which comprises a joint section, an extension section and a cuff, wherein the joint section, the extension section and the cuff are sequentially and integrally connected; said connector segment having a greater hardness than said extension segment, said extension segment having a greater hardness than said cuff; the cuff is provided with a plurality of suckers at the edge of the opening of the trachea connected with the trachea.

Preferably, the material of the joint section is acrylate resin, and the Rockwell hardness is 40-90R scale; the extension section is made of acrylate rubber, and the shore A hardness is 40-70; the cuff is made of acrylate rubber, and the shore A hardness is 20-40.

preferably, the sucker comprises an air cavity sunken into the edge of the opening of the air pipe, and an air plug is arranged in the air cavity; one end of the air plug is connected with the bottom of the air cavity, and the other end of the air plug extends towards the opening direction of the air cavity; the air plug expands transversely at two sides and contacts the side wall of the air cavity in an airtight manner when being extruded.

Preferably, the air cavity is a cylindrical cavity with one open end, and the air plug is a sphere.

Preferably, at least one suction cup is provided with a notch in the side wall adjacent to the trachea opening.

Preferably, an expansion part for transitional extrusion deformation is arranged between the air cavity and the edge of the opening of the air pipe.

The production method of the integrated inflation-free laryngeal mask comprises the steps of injecting a first polymerization liquid into a forming position of a cuff in a mold, and polymerizing the first polymerization liquid into a gel prepolymer under the inert gas atmosphere; then injecting the second polymerization liquid into the forming position of the extension section in the mold, and polymerizing into a gel prepolymer under the inert gas atmosphere; injecting the third polymerization liquid into a forming position of a joint section in the mold, and carrying out pressure-maintaining polymerization forming under the atmosphere of inert gas; and finally curing and demolding.

Preferably, the first polymerization solution comprises an acrylate hard monomer A, an acrylate soft monomer B, an acrylate glycol ester cross-linking agent C and a peroxy radical initiator D, and the weight ratio of A is more than or equal to 5% and less than or equal to 15%, B is more than or equal to 79% and less than or equal to 92.8%, C is more than or equal to 2% and less than or equal to 5%, and D is more than or equal to 0.2% and less than or equal to 1%; the second polymerization solution comprises an acrylic hard monomer A, an acrylic soft monomer B, an acrylic glycol ester cross-linking agent C and a peroxy free radical initiator D, wherein the weight ratio of A to B is more than or equal to 20% and less than or equal to 40%, B is more than or equal to 55% and less than or equal to 75%, C is more than or equal to 2% and less than or equal to 5%, and D is more than or equal to 0.2% and less than or equal to 1%; the third polymerization solution comprises an acrylic hard monomer A, an acrylic soft monomer B, an acrylic glycol ester cross-linking agent C and a peroxy free radical initiator D, wherein the weight ratio of A to B is more than or equal to 91% and less than or equal to 97.8%, B is less than or equal to 3%, C is more than or equal to 2% and less than or equal to 5%, and D is more than or equal to 0.2% and less than or equal to 1%.

Preferably, the prepolymerization temperature is 40-70 ℃, the post-curing temperature is 100-150 ℃, and the post-curing time is 4-8 h.

Preferably, after curing and demolding, neutral organic solvent is used for extraction cleaning, and the cleaning is carried out for 6-16 h and 3-4 times each time.

The integrated inflation-free laryngeal mask and the production method thereof have the advantages that the three-section integrated structure with different hardness can be adapted to the characteristics of different parts of the throat and the oral cavity at the same time. The hardest joint section is used for easily inserting the externally connected tracheal cannula, and the occlusion of teeth can be prevented. The extending section is used as extending transition with a certain length and has certain flexibility, so that the relative positions of the joint section and the cuff at the two ends can be kept stable, and the human body can be comfortable enough. The cuff is the softest component, in combination with the suction cup arrangement, to prevent migration and provide adequate sealing while minimizing soft tissue compression. And the segments are connected by covalent bonds and intermolecular winding, so that the connection strength is high enough.

Drawings

FIG. 1 is a schematic structural view of an integrated non-inflatable laryngeal mask in accordance with the present invention;

FIG. 2 is a side view of FIG. 1;

FIG. 3 is a first isometric view of FIG. 1;

FIG. 4 is a second isometric view of FIG. 1;

fig. 5 is a partially enlarged schematic view of a portion a in fig. 4.

FIG. 6 is a first schematic diagram of the operation of the sucker;

FIG. 7 is a second schematic diagram of the working principle of the sucker;

Fig. 8 is a third schematic diagram of the working principle of the sucker.

Description of the drawings: 10-joint section, 11-esophageal joint jack, 12-tracheal joint jack; 20-an extension; 30-cuff, 31-trachea opening, 32-esophagus opening, 33-suction cup, 34-air cavity, 35-air plug, 36-expansion part and 37-notch.

Detailed Description

as shown in figures 1-5, the integrated non-inflatable laryngeal mask comprises a connector section 10, an extension section 20 and a cuff 30 which are sequentially and integrally connected and penetrated. One end of the joint section 10, which is far away from the extension section 20, is provided with an esophageal joint jack 11 and a tracheal joint jack 12, the esophageal joint jack 11 is used for externally connecting an esophageal joint in the oral cavity, and the tracheal joint jack 12 is used for externally connecting a tracheal joint in the oral cavity. The end of the cuff 30 away from the extension 20 is provided with an esophageal opening 32, and the middle of the cuff 30 is provided with a tracheal opening 31. The esophageal opening 32 is used for connecting a gastric tube in the throat, and the tracheal opening 31 is used for connecting the trachea in the throat. Two pipelines extending in the same direction are arranged in the extending section 20, and the esophageal joint jack 11 is communicated with the esophageal opening 32, and the trachea joint jack 12 is communicated with the trachea opening 31. The connection relationship between the sections is actually intermolecular bond crosslinking connection. With a process that is not fully reactive, subsequent crosslinks between the curing monomers form.

The joint section 10 is made of acrylate hard resin and can prevent teeth from biting and connect air. The Rockwell hardness is 74-89R scale, the glass transition temperature Tg is more than 60 ℃, and the polymer is prepared from a third polymer solution. The third polymerization solution comprises an acrylic hard monomer A, an acrylic soft monomer B, an acrylic glycol ester cross-linking agent C and a peroxy free radical initiator D, wherein the weight ratio of A to B is more than or equal to 91% and less than or equal to 97.8%, B is less than or equal to 3%, C is more than or equal to 2% and less than or equal to 5%, and D is more than or equal to 0.2% and less than or equal to 1%.

The specific implementation values of the joint segment 10 and the test hardness of the corresponding finished product are shown in the following table:

A(％)	B(％)	C(％)	D(％)	Hardness (Rockwell)
					94.8	3	2	0.2	74
94.4	3	2	0.6	74
					94	3	2	1	75
96.3	1.5	2	0.2	82
					95.9	1.5	2	0.6	82
95.5	1.5	2	1	82
					97.8	0	2	0.2	86
97.4	0	2	0.6	86
					97	0	2	1	86
93.3	3	3.5	0.2	76
					92.9	3	3.5	0.6	76
92.5	3	3.5	1	76
					94.8	1.5	3.5	0.2	84
94.4	1.5	3.5	0.6	84
					94	1.5	3.5	1	84
96.3	0	3.5	0.2	87
					95.9	0	3.5	0.6	87
95.5	0	3.5	1	87
					91.8	3	5	0.2	79
91.4	3	5	0.6	79
					91	3	5	1	79
93.3	1.5	5	0.2	85
					92.9	1.5	5	0.6	85
92.5	1.5	5	1	85
					94.8	0	5	0.2	89
94.4	0	5	0.6	89
					94	0	5	1	89

The extension section 20 is made of acrylic rubber with high hardness, can resist distortion and can ensure smooth airflow when the laryngeal mask is bent. The shore A hardness is 46-65, the glass transition temperature Tg is 25-35 ℃, and the polymer is prepared from a second polymer liquid. The second polymerization solution comprises an acrylic hard monomer A, an acrylic soft monomer B, an acrylic glycol ester cross-linking agent C and a peroxy free radical initiator D, wherein the weight ratio of A to B is more than or equal to 20% and less than or equal to 40%, B is more than or equal to 55% and less than or equal to 75%, C is more than or equal to 2% and less than or equal to 5%, and D is more than or equal to 0.2% and less than or equal to 1%.

The specific implementation values of the extension section 20 and the test hardness of the corresponding finished product are shown in the following table:

A(％)	B(％)	C(％)	D(％)	Hardness (shoreA)
					40	55	4.8	0.2	65
40	55	4.4	0.6	65
					40	55	4	1	65
40	56.3	3.5	0.2	65
					40	55.9	3.5	0.6	65
40	55.5	3.5	1	65
					40	57.8	2	0.2	64
40	57.4	2	0.6	64
					40	57	2	1	64
30	64.8	5	0.2	58
					30	64.4	5	0.6	58
30	64	5	1	58
					30	66.3	3.5	0.2	56
30	65.9	3.5	0.6	57
					30	65.5	3.5	1	57
30	67.8	2	0.2	55
					30	67.4	2	0.6	55
30	67	2	1	55
					20	74.8	5	0.2	46
20	74.4	5	0.6	46
					20	74	5	1	46
20	75	4.8	0.2	46
					20	75	4.4	0.6	46
20	75	4	1	46

The cuff 30 is made of soft acrylic rubber, so that the tissues can be prevented from being pressed and scratched. The shore A hardness is 27-39, the glass transition temperature Tg is less than 10 ℃, and the shore A is prepared from a first polymerization solution. The first polymerization solution comprises an acrylic hard monomer A, an acrylic soft monomer B, an acrylic glycol ester cross-linking agent C and a peroxy free radical initiator D, wherein the weight ratio of A to B is more than or equal to 5% and less than or equal to 15%, B is more than or equal to 79% and less than or equal to 92.8%, C is more than or equal to 2% and less than or equal to 5%, and D is more than or equal to 0.2% and less than or equal to 1%.

The specific implementation values of the cuff 30 and the corresponding test hardness of the finished product are shown in the following table:

A(％)	B(％)	C(％)	D(％)	Hardness (shoreA)
					5	92.8	2	0.2	27
5	92.4	2	0.6	27
					5	92	2	1	27
10	87.8	2	0.2	34
					10	87.4	2	0.6	34
10	87	2	1	34
					15	82.8	2	0.2	39
15	82.4	2	0.6	39
					15	82	2	1	39
5	91.3	3.5	0.2	27
					5	90.9	3.5	0.6	27
5	90.5	3.5	1	27
					10	86.3	3.5	0.2	34
10	85.9	3.5	0.6	34
					10	85.5	3.5	1	34
15	81.3	3.5	0.2	39
					15	80.9	3.5	0.6	39
15	80.5	3.5	1	39
					5	89.8	5	0.2	27
5	89.4	5	0.6	27
					5	89	5	1	27
10	84.8	5	0.2	34
					10	84.4	5	0.6	34
10	84	5	1	34
					15	79.8	5	0.2	39
15	79.4	5	0.6	39
					15	79	5	1	39

The acrylic hard monomer A is preferably methyl methacrylate, and may be ethyl methacrylate, butyl methacrylate, hexyl methacrylate, isopropyl methacrylate, isobutyl methacrylate, tert-butyl methacrylate, or the like. The acrylic acid ester soft monomer B is preferably ethyl acrylate, and may be butyl acrylate, hexyl acrylate, isopropyl acrylate, isobutyl acrylate, tert-butyl acrylate, etc. The acrylic glycol ester-based crosslinking agent C is preferably ethylene glycol dimethacrylate, and may be ethylene glycol diacrylate, butylene glycol dimethacrylate, butylene glycol diacrylate, hexanediol dimethacrylate, or the like. The peroxy radical initiator D is preferably dilauroyl peroxide, and may be bis (4-t-butylcyclohexyl) peroxydicarbonate, dicetyl peroxydicarbonate, ditetradecyl peroxydicarbonate, or the like.

The cuff 30 is provided with a plurality of sucking discs 33 at the edge of a trachea opening 31 connected with a trachea. The suction cups 33 can be arranged in a plurality of rows from inside to outside around the air tube opening 31, and each suction cup 33 respectively comprises an air cavity 34 sunken into the edge of the air tube opening 31. An air plug 35 is arranged in the air cavity 34, one end of the air plug 35 is connected with the bottom of the air cavity 34, and the other end of the air plug extends towards the opening direction of the air cavity 34. In a specific example, the air cavity 34 is a cylindrical cavity with one open end, and the air plug 35 is a sphere. The inner diameter range of the air cavity 34 is 1-4 mm, and preferably 2.74 mm; the depth of the air cavity 34 is preferably the same as the diameter of the corresponding air lock 35. The diameter range of the air plug 35 is 0.73-2.92 mm, and preferably 2.11 mm.

an expansion part 36 for transition extrusion deformation is arranged between the air cavity 34 and the edge of the air pipe opening 31, so that the connection part is more stable in the deformation process. Wherein the working principle of the suction cup 33 is shown in fig. 6-8. After insertion of cuff 30 into the human larynx, the edges of the tracheal opening 31 will contact the soft tissue as shown in figure 6. At this time, the cuff 30 is pressed toward the soft tissue, so that the air plug 35 and the air chamber 34 are squeezed and deformed, and the gas originally in the air chamber 34 is discharged. The air plug 35 is expanded transversely and then is in close contact with the side wall of the air cavity 34, so that the air cavity 34 is divided into two small cavities, one small cavity is closed by the air plug 35 and the bottom of the air cavity 34, and the other small cavity is closed by the air plug 35 and soft tissues, as shown in fig. 7. The cuff 30 will then reset under its own resilience by the released pressure and will move the air lock 35 away from the soft tissue. Because the small cavity closed by the air plug 35 and the bottom of the air cavity 34 is not supplemented by air, the negative pressure can be maintained on the air plug 35, and the air plug 35 is always sealed with the side wall of the air cavity 34. However, the small cavity enclosed by the soft tissue always creates a negative pressure on the soft tissue during reduction, which pulls the cuff 30 and soft tissue together, as shown in figure 8. The suction of the inside of the cuff 30 in a non-inflation mode is realized, the air tightness is not generated by extruding hard materials and soft tissues, and the cuff is greatly friendly to human bodies.

Preferably, at least one suction cup 33 has a notch 37 in the side wall adjacent to the tracheal opening 31. The number of suction cups 33 is very large, and can be as high as tens to hundreds, so discarding several suction cups 33 will not affect the seal of cuff 30 to the soft tissue. The notch 37 can ensure that the edge of the trachea opening 31 has good deformation space when the cuff 30 is pressed, the suction operation can be completed without great pressing force, and the comfort of the human body is further optimized.

The invention also provides a method for producing the integrated inflation-free laryngeal mask. First polymerization liquid is added into the forming position of the cuff 30 in the mould, and the first polymerization liquid is polymerized into gel-like acrylate prepolymer under the nitrogen atmosphere, and then the gel-like acrylate prepolymer is rapidly cooled and is polymerized under the nitrogen atmosphere under the pressure maintaining condition. Then, a second polymerization solution is added to the molding position of the extension section 20, and when the extension section 20 becomes a gel-like prepolymer, the prepolymer is rapidly cooled. Then, a third polymerization liquid is added to the forming position of the cuff 30, and the polymerization is carried out under the pressure maintaining condition in the nitrogen atmosphere. In order to achieve sufficient polymerization, the formed laryngeal mask needs to be fully cured again and then demoulded. Through subsequent full curing, the post-added polymer liquid is intertwined and cross-linked with the formed prepolymer with poor fluidity, so that different sections of the laryngeal mask are firmly connected. The segments are connected by covalent bonds and intermolecular winding, and the connection strength is high enough. And (3) extracting and cleaning the laryngeal mask by using ethanol or acetone after demoulding, wherein the cleaning is carried out for 6-16 h and 3-4 times each time so as to achieve the effect of cleaning residues.

Wherein the prepolymerization temperature is 40-70 ℃, the postcuring temperature is 100-150 ℃, and the postcuring time is 4-8 h. And the pressure is applied to 2atm-5atm during pressure maintaining.

After the integrated inflation-free laryngeal mask produced by the method is tested and determined for multiple times, the connection strength of each connection part is determined, and each connection part is kept under the axial tension of 15N and is not broken for 15 seconds. All monomers are essentially completely polymerized by the post-cure reaction. After thorough washing with neutral solvent, A, B had less than 5ppm of both monomers and less than 10ppm of solvent remained. Since the product is polymerized, the residual monomer content becomes an important link for medical safety. The process method provided by the invention can reduce monomer residues to the maximum extent and obtain good medical safety.

It will be apparent to those skilled in the art that various other changes and modifications may be made in the above-described embodiments and concepts and all such changes and modifications are intended to be within the scope of the appended claims.

Claims

1. An integrated inflation-free laryngeal mask comprises a joint section (10), an extension section (20) and a cuff (30) which are sequentially and integrally connected and communicated; characterized in that said connector segment (10) is harder than said extension segment (20), and said extension segment (20) is harder than said cuff (30); the cuff (30) is provided with a plurality of suckers (33) at the edge of a trachea opening (31) connected with a trachea.

2. The one-piece non-inflatable laryngeal mask according to claim 1, wherein the connector segment (10) is made of acrylate resin and has Rockwell hardness of 74-89R scale; the extension section (20) is made of acrylate rubber, and the shore A hardness is 46-65; the cuff (30) is made of acrylate rubber, and the shore A hardness is 27-39.

3. The integrated inflation-free laryngeal mask according to claim 1 or 2, wherein the suction cup (33) comprises an air cavity (34) recessed in the edge of the trachea opening (31), and an air plug (35) is arranged in the air cavity (34); one end of the air plug (35) is connected with the bottom of the air cavity (34), and the other end of the air plug extends towards the opening direction of the air cavity (34); the two sides of the air plug (35) transversely expand and are in airtight contact with the side wall of the air cavity (34) when being extruded.

4. The one-piece non-inflatable laryngeal mask according to claim 3, wherein the air cavity (34) is a cylindrical cavity with an open end, and the air plug (35) is a sphere.

5. The one-piece, non-inflatable laryngeal mask according to claim 3, characterised in that at least one suction cup (33) is provided with a notch (37) in the side wall near the trachea opening (31).

6. The one-piece non-inflatable laryngeal mask according to claim 3, characterised in that an expansion (36) for transitional squeeze deformation is provided between the air cavity (34) and the edge of the air tube opening (31).

7. The production method of the integrated inflation-free laryngeal mask is characterized in that first polymerization liquid is injected into a forming position of a cuff (30) in a mould and polymerized into gel prepolymer under the inert gas atmosphere; then injecting the second polymerization liquid into a forming position of the extension section (20) in the mold, and polymerizing into a gel-like prepolymer under an inert gas atmosphere; then injecting the third polymerization liquid into the forming position of the joint section (10) in the mold, and carrying out pressure-maintaining polymerization forming under the inert gas atmosphere; and finally curing and demolding.

8. The production method according to claim 7, wherein the first polymerization solution comprises an acrylate hard monomer A, an acrylate soft monomer B, an acrylate glycol ester cross-linking agent C and a peroxy radical initiator D, and the weight ratio of A is 5% to 15%, B is 79% to 92.8%, C is 2% to 5%, D is 0.2% to 1%; the second polymerization solution comprises an acrylic hard monomer A, an acrylic soft monomer B, an acrylic glycol ester cross-linking agent C and a peroxy free radical initiator D, wherein the weight ratio of A to B is more than or equal to 20% and less than or equal to 40%, B is more than or equal to 55% and less than or equal to 75%, C is more than or equal to 2% and less than or equal to 5%, and D is more than or equal to 0.2% and less than or equal to 1%; the third polymerization solution comprises an acrylic hard monomer A, an acrylic soft monomer B, an acrylic glycol ester cross-linking agent C and a peroxy free radical initiator D, wherein the weight ratio of A to B is more than or equal to 91% and less than or equal to 97.8%, B is less than or equal to 3%, C is more than or equal to 2% and less than or equal to 5%, and D is more than or equal to 0.2% and less than or equal to 1%.

9. The production process according to claim 7 or 8, wherein the prepolymerization temperature is 40 to 70 ℃, the postcure temperature is 100 to 150 ℃, and the postcure time is 4 to 8 hours.

10. the production method according to claim 7 or 8, characterized in that after curing and demolding, neutral organic solvent is used for extraction cleaning, and the cleaning is carried out for 6-16 h and 3-4 times each time.