RU2452524C2 - Inflatable face seal for respiratory mask and method for making such face seal - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine. An inflatable face seal comprises a ring air-tight hollow portion. The face seal in its cross-section section of the ring hollow portion comprises an adhesive joint which connects two overlapped boards glued together so that a surface of the first board facing inside from the two overlapped boards contact with a surface of the second board facing outside from said overlapped boards. The surface of the first board facing inside is pressed to surface of the second board facing outside due to initial stress in the inflatable face seal. There are disclosed a method for making the inflatable face seal with using a mould and extending a part of the section, and a workpiece for making the face seal.

EFFECT: cutting production costs.

9 cl, 9 dwg

Description

FIELD OF THE INVENTION

The present invention relates to an inflatable facial obturator for a respiratory mask, for example, such as an anesthetic mask or a respiratory facial mask.

State of the art

Such face masks are commonly used to provide medical care to patients. The inflatable front obturator comprises an annular hollow airtight part, and the cross section of the annular hollow part contains an adhesive joint that connects two overlapping sides.

A typical application of an inflatable front obturator according to the present invention is found in face masks, which consist of a relatively rigid casing and an inflatable annular front obturator attached to the periphery of the casing by means of an airtight connection. Such a mask is disclosed in European Patent 0602424. However, the face seal according to the present invention can also be used for face masks, which consist of a single molded element containing a semi-rigid shell, and an inflatable ring face seal according to the present invention.

Such inflatable annular face obturators are currently available in various designs, providing a different degree of anatomical compliance, ease of use, durability, as well as ease of cleaning and sterilization. In addition, it is desirable to provide a low production cost for such facial obturators.

However, currently available masks are difficult to manufacture. In particular, since in its final form the mask contains an annular hollow airtight part, it is impossible to form such a mask directly by injection or dipping into rubber. Therefore, the molding of masks is usually carried out in two stages, in which the masks are first cast using an annular inner core, through which the inner hollow part is formed. After the casting of the mask is completed, the mask is removed from the core through the gap provided in it, and this gap is formed along the circumference of the annular hollow portion. After the core is removed, the specified gap is closed and sealed to obtain an airtight adhesive connection.

Adhesive bonding is usually performed by placing glue between the two sides of the mask. However, since the curing time of the adhesive is usually about a day, a clamping device is required to compress the two sides together and to ensure the effectiveness of gluing. This technique requires a very large number of devices. For example, if the productivity in the manufacture of masks is 500 masks per day, then at least 500 devices are required for the curing operation. The acquisition of all these devices and the organization of work with them greatly increases production costs and complicates the production process.

In addition, as indicated in patent 0602424, two surfaces that are glued to each other are usually made in the form of two parallel sides, and the gluing is formed between two "facing inward" surfaces of these sides. By “facing inward” surfaces are meant surfaces that face the center of the cross section of a portion of the annular hollow portion of the obturator. Thus, when pressure is applied to the internal volume of the mask, for example, during machine washing or sterilization, the gluing is subjected to the action of “delaminating” forces that tend to tear off the glued surfaces from each other. “Stratifying” forces adversely affect gluing, since pressure is applied to a limited area of the inner edge of the gluing.

Disclosure of invention

Therefore, in one of its aspects, the present invention provides an inflatable annular face obturator design that makes it possible to produce low cost manufacturing obturators from a plurality of elastomeric materials suitable for single and multiple use articles.

In another aspect, the present invention provides an inflatable facial obturator of the aforementioned type, which is highly resistant to reuse, as well as cleaning and sterilization processes.

In the above aspects, the object of the invention is solved by an inflatable front obturator, in which the two sides are glued together so that the inwardly facing surface of the first side of the two overlapping sides is in contact with the outwardly facing surface of the second side of the two overlapping sides.

It should be noted that in the present description of the invention, it is understood that the phrase “inwardly facing surface” indicates a surface that is facing inward toward the hollow part, while the phrase “facing outward” indicates a surface that is facing outward from the hollow part .

In one embodiment, the internal stresses of the inflatable facial obturator may cause the inwardly facing surface of the first side to press against the outwardly facing surface of the second side. Thus, internal stresses hold the sides together, and no external devices are required during the curing of the adhesive joint. Such internal stresses may be generated during the execution of the adhesive joint. Such internal stresses can be generated, for example, by stretching a portion of the walls of an inflatable facial obturator and then holding the walls in a stretched state.

The cross section of the hollow part may be a closed segment, and the adhesive joint may be located on the periphery of the specified closed segment. This design provides simplicity of geometric shape and gives strong bonding. In a preferred embodiment of the invention, said two sides may be parallel to each other.

The second side can also be made protruding from the outer wall of the inflatable front obturator, and the first side can be made in the form of a hook connected with the inner wall of the inflatable front obturator. This gives a structure in which the first side can be “hooked” over the second side.

Further, the design of the sides can be performed so that the first side protrudes along the periphery of the cross section of the annular hollow part in the opposite direction with respect to the second side. In this case, an adhesive connection is provided in which, when applying pressure to the hollow part, shear forces are applied to the gluing of the two sides, and not the forces delaminating the glued parts of the sides.

A preferred method for manufacturing an inflatable facial obturator for a respiratory mask comprises the steps of casting an inflatable facial obturator in a mold that comprises an annular hollow portion and which has a first side and a second side in a cross section of one portion of the annular hollow portion, overlapping and spaced apart from each other in a radial direction, so that the first side is radially below the second side; a binder is applied to the outer surface of the second side and a portion of said cross-section, located between the first side and the second side, is pulled in order to lay the first side over the second side, so that the inner surface of the first side comes into contact with the outer surface of the second side and to the second side due to internal stresses in the cast part of the shutter caused by its stretching.

It should be noted that in the present description of the invention, the term "radially" should be understood as located in the direction of the radius. And it should also be noted that the term "radius" does not limit the invention to only circular shapes. The cross section of the annular hollow part can be of any shape. Such a segment has a center, and the term "radius" in this case is defined as a vector from the specified center to some point in the cross section. The radius over the cross section is not constant - it can have a variable length. It should also be noted that the cross section is open when the shutter is removed from the mold, and this segment is not completely covered by the section contour.

In a preferred manufacturing method, casting of an inflatable facial obturator is performed by injection molding in a closed mold. Due to the closed mold, the wall thickness of the cast part can be varied.

The intermediate product obtained in the manufacturing process of the inflatable front obturator for a respiratory mask contains an annular hollow part, while in the cross section the annular hollow part is an open semicircular segment containing the first side and the second side located on opposite edges of the indicated open semicircular segment. The second side may overlap the first side and be farther from the center of the open semicircular segment than the first side. In addition, the first side may protrude in the opposite direction with respect to the second side.

In one embodiment of the intermediate product, the first side and the second side may be substantially parallel to each other.

It should be noted that the phrase "open semicircular segment" in the context of this description should be understood as a part that does not have to have a circular shape, on the contrary, it can have any geometric shape. However, in general, this part covers a specific area. Moreover, this part is "open", which means that the walls of this part in some place form a gap.

It should be emphasized that the term "contains / containing" in this description is used to indicate the presence of defined features, aggregates, steps or components, but not to exclude the presence or addition of one or more other features, aggregates, steps, components or groups.

Brief Description of the Drawings

Embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. It should be emphasized that the presented options are used only as examples, and should not be used as options limiting the scope of the invention.

Figure 1 is a perspective projection of a first embodiment of an inflatable facial obturator according to the present invention, prior to the gluing operation.

Figure 2 in perspective view and in cross section depicts an inflatable front obturator of figure 1.

Figure 3 depicts a cross section along the line III-III of the inflatable facial obturator of figure 1.

Figure 4 depicts a cross section of figure 3 after the gluing operation.

Figure 5 depicts a cross section along the line V-V of the inflatable facial obturator of figure 1.

Fig.6 depicts a cross section of Fig.5 after the gluing operation.

Fig.7 depicts a cross section of one embodiment of a mold for injection molding an inflatable face seal obturator of Fig.1.

Fig. 8 is a cross-sectional view of a second embodiment of an inflatable facial obturator prior to the gluing operation.

Fig.9 depicts an inflatable front obturator of Fig.8 after the gluing operation.

The implementation of the invention

Figure 1-6 shows a preferred embodiment of a shutter in accordance with the present invention. Figure 1, 2, 3 and 5 shows the shape of a single cast billet or part 1 in the form as it comes out of the mold. This blank can be called an “intermediate product” 1, which appears in the manufacturing process of an inflatable facial obturator. Figures 4 and 6 show the shape of the part 1 'after gluing. This part can be called the "final product" 1 ', which appears at the end of the manufacturing process of the shutter.

The inflatable front obturator 1 comprises a fastening cone 2, which enables ring fastening to the circumference of the hard mask cover (not shown). The inflatable front obturator further comprises an outer wall 3, an inner wall 5, a first side 6 and a second side 7. The outer wall 3 extends outward and downward from the cone 2. The curved wall 4 is a continuation of the outer wall 3 and forms an anatomical shape, which in the process use adjacent to the patient's face (not shown). The inner wall 5 is connected to the curved wall 4 and is its continuation. The first board 6 is connected with the edge of the inner wall 5 and lowered a certain distance below the level where the cone 2 is mating with the outer wall 3. The second board 7 extends inward from the mounting cone 2, following parallel to the first board 6 and overlapping overlapping with it, while a small gap remains between them.

After the casting operation, a binder material, for example, adhesive 8, is applied to the upper facing outward surface 9 of the second bead 7. Then, the inner wall 5 is pulled outward and upward so that the first bead 6 can be laid on the second bead 7 and put on top of the binder, this, the inner surface 10 of the first flange will be slightly pressed against the binder material due to the elastic forces arising from such axial deformation. Therefore, the inflatable face seal can now be left to cure the glue without any clamping devices, as shown in FIGS. 4 and 6. Thus, the bonding material forms an adhesive joint 11 between the two sides. Therefore, as shown in FIGS. 4 and 6 , the final product 1 'comprises an annular airtight hollow portion 12'. Figures 4 and 6 also show that the cross section of one section of the annular airtight hollow part defines a closed segment 13 'and that the adhesive joint 11 is located on the periphery of this closed segment.

In addition to the simplicity of manufacture and freedom of choice from a wide range of materials, this design also has the additional advantage that, when the pressure inside the shutter increases, the adhesive joint is exposed only to shear forces. This guarantees a much higher gluing reliability than previously considered adhesive joints, which undergo delamination with increasing pressure inside the seal,

The inflatable front obturator 1 also comprises a boost tube 14, which is molded integrally with the front obturator. In addition, a locking plug 15 is attached to the outer wall of the strap 16. However, in some cases, the presence of a charge pipe is not necessary, for example, in disposable masks. The main purpose of the pressurization tube is to prevent an excessive pressure increase in the annular hollow part 12 'during the flushing / sterilization process due to the hole provided in the airtight hollow part 12'.

Figures 3-6 show that the first side 6 is made in the form of a hook, which, when the inflatable front obturator is assembled, is hooked to the second side 7. Thus, the function of the hook is to hold the sides together when the first side is stretched and circled around the second side . To achieve the same, these two sides can be formed in many different ways. For example, instead of molding two sides in the form of a hook and a protrusion, these two sides could be molded in the form of two curved surfaces corresponding to each other, which, when the inflatable front obturator is assembled, mesh with each other and prevent the relative displacement of the sides during the curing of the adhesive .

According to figure 3-6, it should also be noted that the sides are formed in such a way that they protrude in opposite directions. This refers to opposite directions around the circumference or periphery of the cross section of the annular hollow part. Thus, these two sides protrude towards each other, and overlap overlap each other. When in this case the said sides are glued together, the stresses in the walls of the annular hollow part 12 'arising from the pressure in the annular hollow part will create shear stresses in the gluing, and not the forces that tear the surfaces apart, as is the case in well-known technical solutions.

It should be noted that the embodiment of the obturator, illustrated by the considered figures, is intended for use in a mask consisting of two parts - an obturator and a rigid casing of the mask. However, the present invention can also be applied to masks that are molded in one piece, containing both the obturator and mask parts.

In addition, it should be noted that the presented embodiment comprises a fastening cone 2 made in one piece for connecting the inflatable front obturator 1 with a rigid mask casing. However, it is also possible to imagine the option when the mounting cone is a separate part, which is attached to the inflatable front obturator by gluing.

FIG. 7 shows an example of a mold 20 used for injection molding (casting) of an inflatable facial obturator 1 shown in FIGS. 1-6. The mold consists of three parts: the lower part 21, the upper part 22 and the inner ring core 23. The upper part 22 and the inner ring core 23 are vertically movable relative to the lower part 21. When the mold is closed, the inner ring core is suspended between top and bottom. Then the material of the front obturator is fed into the mold. After the material has hardened, the upper part 22 and the inner core 23 are moved up. The face shutter will remain worn on the inner core 23. After that, the face shutter can be removed from the inner core 23.

It should be noted that due to the design of the mold, which is closed, there is the possibility of changing the wall thickness of the molded part. This can be used, for example, to make the inner wall 5, the outer wall 3 and the curved wall 4 thinner, and the two sides 6 and 7 - thicker. This will increase the flexibility of the walls while maintaining the strength of the sides.

Figs. 8 and 9 show a second embodiment 30 of an inflatable facial obturator according to the present invention. The second embodiment 30 includes a fastening cone 31 for attaching to a hard mask cover (not shown), an inner wall 32, a curved wall 33, which, when using the shutter, is in contact with the patient’s face, the outer wall 34, the first side 35, which connects to the outer wall, being a continuation of the latter, and the second side 36, which connects to the inner wall and is its continuation. When two sides are required to be bonded, a binder, such as glue 37, is applied to the outward facing surface 38 of the second flange. Then, the first side 35 is pulled upward, stretching the walls of the shutter so that the first side 35 can be placed on top of the second side 36. As in the first embodiment 1 of the invention, due to the stretching of the walls and the application of the sides, stresses arise in the walls of the inflatable front obturator cause the inwardly facing surface 39 of the first side 35 to press against the outwardly facing surface 38 of the second side. The finished product 30 ', containing an annular airtight hollow part 40', with an adhesive connection 41 is shown in Fig.9. The annular airtight hollow portion 40 'also defines a closed segment 42'.

In this embodiment, the adhesive joint 41 is arranged on the outside of the mounting cone 31, in contrast to the first embodiment 1, where the adhesive joint is arranged on the inside of the mounting cone 2. However, it should be noted that the adhesive joint could be located anywhere on the periphery of the annular hollow volume.

It should also be noted that in the considered embodiments, a bonding material such as adhesive was used to bond the surfaces together. However, other attachment forms could also be used, such as solvent bonding.

It should also be mentioned that after assembly, the final product could be subjected to heat treatment in order to relieve internal stresses in the product. However, in the process of curing the binder material, holding the two flanges together would still be carried out due to internal stresses.

Claims (9)

1. An inflatable front obturator for a respiratory mask containing an annular airtight hollow part, the front obturator in cross section of the annular hollow part containing an adhesive joint that connects two overlapping sides, glued together so that the inwardly facing surface of the first side of the two overlapping the sides are in contact with the outwardly facing surface of the second side of the indicated overlapping sides, characterized in that the inwardly facing surface the first side is pressed against the outward facing surface of the second side due to internal stresses in the inflatable front obturator. 2. The obturator according to claim 1, characterized in that said cross-section is a closed segment, wherein the adhesive joint is located on the periphery of said closed segment. 3. The shutter according to claim 1 or 2, characterized in that the said two sides are parallel to each other. 4. The obturator according to claim 1 or 2, characterized in that the second side is made in the form of a side protruding from the outer wall of the inflatable front obturator, and the first side is made in the form of a hook connected to the inner wall of the inflatable front obturator. 5. The shutter according to claim 1 or 2, characterized in that the first side protrudes along the periphery of the cross section of the annular hollow part in the opposite direction with respect to the second side. 6. A method of manufacturing an inflatable facial obturator for a respiratory mask, comprising stages in which:
an inflatable front obturator is molded in a mold, which contains an annular hollow part and in which there is a first side and a second side in cross section of the annular hollow side, overlapping and spaced apart so that the first side is below the second side in the direction of the axis annular hollow part;
applying a binder to the outer surface of the second bead, and
stretch the part of the indicated section located between the first side and the second side for applying the first side over the second side so that the inner surface of the first side comes into contact with the outer surface of the second side, and so that the first side is pressed against the second side due to internal stresses in the cast parts of the shutter caused by stretching. 7. The method according to claim 6, characterized in that the casting of an inflatable front obturator is performed by the injection molding method in a closed mold. 8. A workpiece for the manufacture of an inflatable front obturator for a respiratory mask containing an annular hollow part, which in its cross section is an open semicircular segment containing the first side and the second side located on opposite edges of the specified open semicircular segment, the second side overlapping the first board and is further from the center of the open semicircular segment than the first side, with the first side protruding in the opposite direction with respect to the second mu board. 9. The workpiece according to claim 8, characterized in that the first side and the second side are located essentially parallel to each other.

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