A medical mouth and nose mask for endotracheal intubation.
By employing a silicone plug, a flexible self-sealing interface, and a double-walled structure in the CPAP mask, the contradiction between the sealing performance and convenience of existing masks, as well as the issues of compatibility and reliability, has been resolved, achieving efficient device adaptation and safe insertion.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- DONGGUAN RONGRUI MEDICAL EQUIP CO LTD
- Filing Date
- 2025-07-10
- Publication Date
- 2026-07-03
Smart Images
Figure CN224441873U_ABST
Abstract
Description
Technical Field
[0001] This utility model belongs to the field of medical device technology, and specifically relates to a medical ventilation mouth and nose mask for use in inserting an endotracheal tube. Background Technology
[0002] CPAP (Continuous Positive Airway Pressure) masks deliver positive pressure air continuously to the patient's upper airway to keep the upper airway open and prevent upper airway collapse during sleep. They are the core device for treating sleep apnea / respiratory failure, and there is an urgent clinical need to connect auxiliary devices such as suction catheters while maintaining ventilation.
[0003] Existing face masks used for connecting assistive devices mostly employ rigid threaded interfaces and silicone puncture interfaces. Rigid threaded interfaces, such as the Fisher & Paykel FlexiFit 432, require manual screwing of the connector, a process that takes >30 seconds. Silicone puncture interfaces, such as the ResMed Mirage FX, result in irreversible hole diameter after puncture, leading to permanent air leakage. Existing technology also discloses a breathing mask with suction function, featuring a rigid three-way valve on the side wall, allowing switching between ventilation and suction modes by rotating the valve. However, this mask has the following drawbacks: ventilation must be interrupted when the valve is rotated, leading to a decrease in the patient's blood oxygen saturation (an average decrease of 8% in clinically measured SpO2); it also only supports single-diameter suction catheters with an outer diameter of 6mm, making it impossible to connect instruments such as gastric tubes; the mechanical valve has a risk of jamming, with a failure rate >7%.
[0004] Therefore, existing face masks have the following problems:
[0005] 1. The contradiction between sealing and convenience: Traditional CPAP masks require an external three-way valve or a removable cover for tube insertion, which requires interrupting ventilation during operation, leading to fluctuations in the patient's oxygenation;
[0006] 2. Poor compatibility: The rigid interface is only compatible with specific tube outer diameters and cannot meet the needs of multiple instruments such as suction tubes / gastric tubes;
[0007] 3. Poor structural reliability: The silicone cover is easily torn by repeated insertion and removal, and there is no insertion tube limit design, which poses a risk of excessive insertion. Utility Model Content
[0008] This invention provides a medical nasal mask for use in endotracheal intubation, which features good sealing, ease of use, good compatibility, and high structural reliability.
[0009] To achieve the above objectives, this utility model provides the following technical solution:
[0010] A medical ventilation mouth and nose mask for use in endotracheal tube insertion, the medical ventilation mouth and nose mask includes a mask body, a bent connector, a silicone plug and a rubber plug cap;
[0011] The main body of the mask is assembled and connected to one end of the elbow connector to cover the mouth and nose to form a sealed cavity.
[0012] The other end of the elbow is connected to a breathing tube that delivers positive pressure airflow; the elbow is provided with a silicone plug mounting hole that penetrates its wall thickness.
[0013] The silicone plug is press-fitted into the silicone plug mounting hole;
[0014] The silicone plug is provided with an elastic self-sealing interface, which enables elastic wrapping and sealing during insertion and self-closing after insertion and removal.
[0015] The rubber stopper cap is embedded in the silicone stopper and self-closes to prevent leakage when the tube is not inserted.
[0016] Furthermore, the silicone plug adopts a double-wall structure and includes an inner wall, an outer wall, and a plug core that are fixed together as one piece;
[0017] The inner wall is a tear-resistant layer with a Shore A hardness of 50-55;
[0018] The outer wall is a sealing layer with a Shore A hardness of 30-35;
[0019] The plug core is disposed at the inner bottom of the inner wall and has a pre-cut slit on its surface;
[0020] The elastic self-sealing interface is composed of a plug core with pre-cut slits.
[0021] Furthermore, the pre-cut slit is a cross-shaped cut; the depth of the cross-shaped cut is 70-90% of the thickness of the plug core.
[0022] Furthermore, the depth of the pre-cut slit is 80% of the thickness of the silicone plug.
[0023] Furthermore, the silicone plug is equipped with a composite limiting safety mechanism that limits the insertion depth of the instrument to ≤20mm.
[0024] Furthermore, the composite limiting safety mechanism consists of the plug core and a stepped rigid limiting ring disposed between the inner wall and the outer wall.
[0025] Furthermore, the inner wall and the outer wall are formed by double-layer co-extrusion, and the interfacial bonding force between the inner wall and the outer wall is >5MPa;
[0026] An anti-rotation groove is formed on the inner side of the stepped rigid limiting ring.
[0027] Furthermore, the diameter of the silicone plug mounting hole is 10mm;
[0028] The outer diameter of the plug core is 8mm.
[0029] Furthermore, the centerline of the silicone plug mounting hole forms a 30-45° angle with the airflow direction of the elbow joint;
[0030] A connecting strap connects the rubber stopper cap to the silicone stopper.
[0031] Compared with the prior art, the present invention has the following beneficial effects:
[0032] 1. A flexible self-sealing interface is provided within the silicone plug. This interface enables elastic sealing during insertion and self-closing after insertion and removal, thus providing an integrated self-sealing interface. The flexible self-sealing interface is achieved by a plug core with pre-cut slits. The pre-cut slits in the flexible silicone plug allow for rapid insertion / removal of the cannula, maintaining stable CPAP pressure throughout the operation with a leakage rate of <5%.
[0033] 2. The diameter of the silicone plug mounting hole is 10mm, and the outer diameter of the plug core is 8mm, which allows for dynamic adaptation to multiple sizes of instruments through the pre-cut slit. The elastic slit design supports stepless adaptation of instruments with an outer diameter of 4.0-8.0mm, such as suction catheters, gastric tubes, and monitoring probes.
[0034] 3. The silicone plug adopts a double-wall structure. The inner wall is a tear-resistant layer with a Shore A hardness of 50-55, and the outer wall is a sealing layer with a Shore A hardness of 30-35. It is equipped with a composite limiting safety mechanism that limits the insertion depth of the instrument to ≤20mm, thereby improving safety and durability. The composite limiting safety mechanism prevents the cannula from being inserted too deeply. The double-layer silicone reinforcement structure makes the insertion and extraction life >2000 times.
[0035] Therefore, the medical nasal mask of this invention has the characteristics of good sealing performance, convenient use, good compatibility and high structural reliability. Attached Figure Description
[0036] Figure 1 This is a schematic diagram of the overall structure of the medical ventilation mouth and nose mask of this utility model;
[0037] Figure 2 This is a schematic diagram of the exploded structure of the medical ventilation mouth and nose mask of this utility model;
[0038] Figure 3 A three-dimensional structural diagram of the assembly of the silicone stopper and the rubber stopper cap;
[0039] Figure 4 A cross-sectional view of the silicone stopper and rubber stopper cap during assembly;
[0040] Figure 5 This is a three-dimensional structural diagram of the rubber stopper cap being pulled out of the silicone stopper.
[0041] Among them, 1-mask body, 2-bent connector, 3-silicone plug, 4-plastic plug cap, 31-inner wall, 32-outer wall, 33-plug core, 34-cross-shaped cut, 35-stepped rigid limiting ring, 36-connecting strap. Detailed Implementation
[0042] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.
[0043] This utility model embodiment provides a medical ventilation mouth and nose mask for use in endotracheal intubation, such as Figure 1 and Figure 2 As shown, the medical nasal mask includes a mask body 1, a bent connector 2, a silicone plug 3, and a rubber plug cap 4; wherein:
[0044] One end of the elbow connector 2 is assembled and connected to the mask body 1, covering the mouth and nose through the elbow connector 2 and the mask body 1, thereby forming a sealed chamber between the elbow connector 2, the mask body 1, and the mouth and nose; the other end of the elbow connector 2 is connected to a breathing tube that delivers positive pressure airflow, thereby delivering positive pressure airflow into the mouth and nose; the elbow connector 2 is provided with a silicone plug 3 mounting hole that penetrates its wall thickness, such as... Figure 1 and Figure 2 As shown, a silicone plug 3 mounting hole is provided at the bend of the elbow 2 for installing the silicone plug 3; the silicone plug 3 is pressed into the silicone plug 3 mounting hole with an interference fit; the diameter of the silicone plug 3 mounting hole can be 10mm, so that a silicone plug 3 with an outer diameter of 10mm can be interference fitted on the elbow 2.
[0045] like Figure 3 and Figure 4 As shown, the silicone plug 3 has a flexible self-sealing interface, which enables elastic sealing during intubation and self-closure after insertion and removal. When no auxiliary device is needed, the rubber plug cover 4 is embedded in the silicone plug 3, allowing the silicone plug 3 to self-close and prevent leakage when no intubation is required. The aforementioned medical ventilation nasal mask has a flexible self-sealing interface in the silicone plug 3, which enables elastic sealing during intubation and self-closure after insertion and removal, thus providing an integrated self-sealing interface through the silicone plug 3.
[0046] The silicone plug 3 can adopt a double-wall structure, including an inner wall 31, an outer wall 32, and a plug core 33 fixedly connected as one piece; the inner wall 31 is a tear-resistant layer with a Shore A hardness of 50-55, thus providing sufficient structural strength; the outer wall 32 is a sealing layer with a Shore A hardness of 30-35, providing a sealing effect between the outer wall 32 and the mounting hole of the silicone plug 3 through a hardness lower than that of the inner wall 31; the inner wall 31 and the outer wall 32 are formed by double-layer co-extrusion, and the interfacial bonding force between the inner wall 31 and the outer wall 32 is >5MPa. Figure 5 As shown, the plug core 33 is located at the inner bottom of the inner wall 31 and has a pre-cut slit on its surface; the elastic self-sealing interface is formed by the plug core 33 with the pre-cut slit. The pre-cut slit can be a cross-shaped cut 34 or a star-shaped cut; the depth of the cross-shaped cut 34 is 70-90% of the thickness of the silicone plug 3, preferably 80-85% of the thickness of the silicone plug 3. The pre-cut slit is located on the surface of the plug core 33 and does not penetrate the plug core 33. The depth of the pre-cut slit can be 80% or 85% of the thickness of the plug core 33, and the thickness of the plug core 33 is the dimension along the axial direction of the silicone plug 3. The elastic silicone plug 3 with the pre-cut slit enables rapid insertion / removal of the cannula, maintains stable CPAP pressure throughout the operation, and has a leakage rate of <5%.
[0047] The silicone plug 3 is equipped with a composite limiting safety mechanism that limits the insertion depth of instruments to ≤20mm. This composite limiting safety mechanism consists of a plug core 33 and a stepped rigid limiting ring 35 positioned between the inner wall 31 and the outer wall 32. An anti-rotation groove is formed on the inner side of the stepped rigid limiting ring 35, allowing the plug cap 4 and the silicone plug 3 to be relatively fixed. The silicone plug 3 adopts a double-wall structure: the inner wall 31 is a tear-resistant layer with a Shore A hardness of 50-55, and the outer wall 32 is a sealing layer with a Shore A hardness of 30-35. The composite limiting safety mechanism, which limits the insertion depth of instruments to ≤20mm, enhances safety and durability. The plug core 33 and the stepped rigid limiting ring 35, constituting the composite limiting safety mechanism, prevent excessive insertion of instruments such as cannulas. The double-layer silicone reinforcement structure ensures an insertion / removal life of >2000 cycles.
[0048] When the diameter of the mounting hole of the silicone plug 3 is 10mm, the outer diameter of the plug core 33 can be 8mm. When the diameter of the mounting hole of the silicone plug 3 is 10mm and the outer diameter of the plug core 33 is 8mm, it allows for dynamic adaptation of multiple sizes of instruments through the pre-cut slit. The elastic aperture design formed by the pre-cut slit supports stepless adaptation of instruments with an outer diameter of 4.0-8.0mm, such as suction catheters, gastric tubes, and monitoring probes.
[0049] The assembly structure when the rubber stopper cap 4 is inserted into the silicone stopper 3 is as follows: Figure 4 As shown, the rubber stopper cap 4 is provided with a hollow plug body for inserting into the silicone stopper 3. When it is necessary to insert a tube to pull the rubber stopper cap 4 out of the silicone stopper 3, the structure is as follows: Figure 5As shown, in order to prevent the rubber stopper cap 4 from being lost, a connecting strap 36 is connected between the rubber stopper cap 4 and the silicone stopper 3. The connecting strap 36 can be made of silicone.
[0050] To prevent the positive pressure airflow delivered in the elbow joint 2 from directly impacting the pre-cut seam and thus reducing the risk of cut fatigue, the center line of the mounting hole of the silicone plug 3 forms an angle of 30-45° with the airflow direction of the elbow joint 2. Specifically, the angle can be 30°, 35°, 40°, 42°, or 45°.
[0051] The usage method of the above-mentioned medical nasal mask is as follows:
[0052] When not in use, the pre-cut seam closes under the elastic action of the silicone. When the airflow pressure inside the elbow 2 is >5cmH2O, the leakage rate is ≤2L / min (measured value).
[0053] When inserting a cannula into the silicone plug 3, an instrument with an outer diameter ≤ 8.0 mm (such as an endotracheal cannula) is vertically inserted into the pre-cut slit, and the slit expands elastically to wrap around the outer wall 32 of the cannula; after expansion, the gap between the inner wall 31 of the silicone plug 3 and the cannula is < 0.3 mm, which is better than the > 1 mm of the traditional design, and the air leakage rate increases by only 0.8 L / min.
[0054] Depth control: When the tip of the cannula contacts the plug 33, it is blocked, physically preventing excessive insertion, and the depth is controlled at 20±1mm.
[0055] When the tube is pulled out, the pre-cut seam elastically retracts and restores the initial sealing state within 1 second, without the need to manually close the auxiliary components.
[0056] Comparison of existing face masks with the medical nasal and oral mask of this invention:
[0057] 1. Risk of operational interruption: Existing technology requires rotating the valve to cut off the airflow, which takes 5-8 seconds; the medical ventilation nasal mask of this utility model has zero interruption operation, and the pre-cut slit elastic expansion maintains the airflow. The measured blood oxygen saturation SpO2 fluctuation is less than 2%, while that of the existing technology is greater than 8%.
[0058] 2. Multi-instrument compatibility: Existing technologies are only compatible with suction catheters with an outer diameter of 6.0±0.1mm. The medical ventilation mouth and nose mask of this utility model has dynamic stepless adaptation. After the insertion of instruments with a diameter of 4.0-8.0mm, the silicone deformation stress distribution is uniform (FEA simulation verification), and the air leakage rate difference is <0.5L / min.
[0059] 3. Long-term reliability: Existing mechanical valves have a 7% jamming rate after 200 cycles. Ultra-long life design: The medical ventilation nasal mask of this utility model adopts a double-layer silicone structure, which increases the tear resistance of the pre-cut seam by 300% (ASTM D624 test). After 2000 insertions and removals, the leakage rate is still <3L / min.
[0060] 4. Safety risk control: Existing masks do not have insertion depth control. The medical ventilation mouth and nose mask of this utility model has a dual anti-misinsertion function through the physical blocking of the plug core 33 and the stepped rigid limiting ring 35.
[0061] Obviously, those skilled in the art can make various modifications and variations to the embodiments of this utility model without departing from the spirit and scope of this utility model. Therefore, if these modifications and variations of this utility model fall within the scope of the claims of this utility model and their equivalents, this utility model also intends to include these modifications and variations.
Claims
1. A medical vent nose mask for use with a tracheal tube insertion, characterized in that, Includes the mask body, elbow connector, silicone plug, and rubber plug cap; The main body of the mask is assembled and connected to one end of the elbow connector to cover the mouth and nose to form a sealed cavity. The other end of the elbow is connected to a breathing tube that delivers positive pressure airflow; the elbow is provided with a silicone plug mounting hole that penetrates its wall thickness. The silicone plug is press-fitted into the silicone plug mounting hole; The silicone plug is provided with an elastic self-sealing interface, which enables elastic wrapping and sealing during insertion and self-closing after insertion and removal. The rubber stopper cap is embedded in the silicone stopper and self-closes to prevent leakage when the tube is not inserted.
2. The medical ventilation port nasal mask of claim 1, wherein, The silicone plug adopts a double-wall structure and includes an inner wall, an outer wall, and a plug core that are fixed together as one piece. The inner wall is a tear-resistant layer with a Shore A hardness of 50-55; The outer wall is a sealing layer with a Shore A hardness of 30-35; The plug core is disposed at the inner bottom of the inner wall and has a pre-cut slit on its surface; The elastic self-sealing interface is composed of a plug core with pre-cut slits.
3. The medical ventilation port nasal mask of claim 2, wherein, The pre-cut slit is a cross-shaped cut; the depth of the cross-shaped cut is 70-90% of the thickness of the plug core.
4. The medical ventilation port nasal mask of claim 3, wherein, The depth of the pre-cut slit is 80% of the thickness of the silicone plug.
5. The medical nasal mask with ventilation according to claim 2, characterized in that, The silicone plug is equipped with a composite limiting safety mechanism that limits the insertion depth of the instrument to ≤20mm.
6. The medical ventilation port nasal mask of claim 5, wherein, The composite limiting safety mechanism consists of the plug core and a stepped rigid limiting ring disposed between the inner wall and the outer wall.
7. The medical ventilation port nasal mask of claim 6, wherein, The inner wall and the outer wall are formed by double-layer co-extrusion, and the interfacial bonding force between the inner wall and the outer wall is >5MPa; An anti-rotation groove is formed on the inner side of the stepped rigid limiting ring.
8. The medical ventilation port nasal mask of claim 2, wherein, The diameter of the silicone plug mounting hole is 10mm; The outer diameter of the plug core is 8mm.
9. The medical ventilation mask according to any one of claims 1-8, wherein, The centerline of the silicone plug mounting hole forms a 30-45° angle with the airflow direction of the elbow.
10. The medical ventilation mask according to any one of claims 1-8, wherein, A connecting strap connects the rubber stopper cap and the silicone stopper.