Respirator attachment component with molded thermoset elastomeric seal

European).

EP 2 185 244

CONNECTION ELEMENT OF THE RESPIRATOR WITH FORMED, THERMOUTHERMAL ELASTOMER SEALING

Field of the invention

The present disclosure relates to a ventilator attachment member and a respirator mask including such a ventilator attachment member.

State of the art

The ventilator provides respiratory protection against airborne substances through filtration processes and / or allowing access to clean air in other ways. One of the features of these devices is the seal that is created between the user and other functional components of the ventilator, and the seal that is formed between the functional parts and the respirator's structural parts.

One of the design conditions in these ventilators is the tight attachment of the inhalation air supply, the exhalation element and / or the voice diaphragm to the respirator's structural components. This hermetic seal often requires the use of a separate gasket and / or mechanical seal that increases the complexity and cost of the respirator design.

US 6,298,849 discloses a respirator mask comprising a body member made of a thin, rigid plastic material and having an inner surface conforming to a user's face, the body member including an inner surface and at least one opening for receiving a filter cartridge, a first overmolded element, formed of an elastic, rubber-like material and overmoulded on the inner surface of the body member to form an inner surface to be sealed and sealingly adhered to the user's face, a second overmoulded member formed of an elastic, rubber-like material and overmolded in at least one aperture for receiving the filter cartridge with the other. the element being injected,comprising at least one flange member protruding inwardly around the cartridge opening and flexing from the first position to seal the cartridge element to the second position in order to

To allow the cartridge element to pass and then return to the first position to lock the cartridge element into the cartridge opening.

US 2005/109343 discloses a face piece insert that includes a fluid transfer element connected in a non-integrated manner to a support portion, which pad can be manufactured by (a) providing at least one portion of the support pad of the face portion; (b) providing at least one element for communicating fluids separated from the supporting part of the face-actinus; and (c) attaching at least one fluid communication member to at least one supporting portion.

WO 2007/009182 discloses a breathing mask for delivering a breathing gas to a patient, wherein the respirator comprises a first element, a sealing washer formed of an elastic material and a second element, a frame formed of a material that is stiffer than a flexible material in which the first one the element is formed on the second element in the overmoulding process.

Summary

The present disclosure relates to a respirator connection member according to claim 1. This disclosure further relates to a respirator mask according to claim 2, which comprises a ventilator attachment member.

Brief description of drawings

The invention may be better understood with reference to the following detailed description of various embodiments of the invention in connection with the attached drawings, in which:

FIG. 1 is a perspective view of an illustrative respirator with a full face mask;

FIG. 2 is an exploded perspective view of an illustrative respirator with a full face mask;

FIG. 3 is a perspective view of a respirator connection member;

FIG. 4 is a perspective sectional view of the ventilator attachment member shown in FIG. 3;

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FIG. 5 is a perspective view of a ventilator attachment member;

FIG. 6 is a perspective sectional view of the ventilator attachment member shown in FIG. 5;

FIG. 7 is a perspective view of a ventilator attachment member; and

FIG. 8 is a perspective sectional view of the ventilator attachment member shown in FIG. 7.

Figures may not be in proportion. The same numbers used in the figures refer to the same elements. Nevertheless, it should be understood that the use of a number relating to an element in a given figure is not intended to limit an element in another figure labeled with the same number.

Detailed description of the invention

In the following description of the invention reference is made to the accompanying drawings, which form a part thereof and on which several specific embodiments are illustrated by way of illustration. It is to be understood that other embodiments are contemplated and may be practiced without departing from the scope of the present invention. The following detailed description should not therefore be taken in a restrictive sense.

All scientific and technical terms used in the present description have the meaning commonly used in the art, unless otherwise stated. The definitions provided herein are intended to facilitate the understanding of some of the terms frequently used herein and are not intended to limit the scope of the present disclosure.

Unless otherwise indicated, all numbers expressing the sizes of the elements, quantities and physical properties used in the description and claims are to be understood as being modified in all instances by the term "about". Accordingly, unless otherwise indicated, the numerical parameters set forth in the description above and in the appended claims are approximations that may vary depending upon the desired properties sought to be obtained by those skilled in the art using the information disclosed herein.

The recitation of numerical ranges through endpoints is intended to cover all numbers falling within such a range (e.g., from 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4 and 5).

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As used throughout this specification and in the appended claims, the singular forms in the English language "a", "an" and "the" include plural forms unless the content clearly dictates otherwise. As used herein and in the appended claims, the term "or" is generally used in the sense including "and / or" unless the content clearly dictates otherwise.

The term "respirator" means an individual respiratory protective device that is worn by a person to filter air before air enters the person's respiratory system. This term covers respirators with full-face masks, respirators with half-masks, air hoods with air supply, respirators that purify the air with forced air flow, and self-contained breathing apparatus.

The term "respirator with a full face mask" means a respirator that is worn over the nose, mouth and eyes of a person.

The present disclosure relates to a ventilator connection member, in particular a ventilator attachment member with a molded thermoset elastomer seal. This disclosure further relates to a ventilator that includes a ventilator attachment member with a molded thermoset elastomer seal. This molded, thermoset elastomeric seal is chemically bonded to at least one or two surfaces of the connection member. In many embodiments, the silicone sealing member penetrates through the body of the ventilator attachment member. These ventilator connection elements are characterized by a strong bond between the silicone sealing element and the rigid polymer connection element. The present invention is not limited in this way,

The sprayed, thermoset elastomer seal of the respirator connection member is a sealing element that is connected in an integral manner to the body of the connection member. It has been found that such a construction increases the durability of the seal and prevents the entry of impurities between the body of the connecting element and the thermoset elastomeric seal. This integral design also reduces the number of assembly elements and size diversity

EP 2 185 244 parts. The materials of the thermosetting elastomeric sealant described in this specification do not require the priming of the connection element to be bonded in order to allow the thermosetting elastomer seal to chemically connect to the body of the connection element.

FIG. 1 is a perspective view of an illustrative respirator with a full face mask 10. FIG. 2 is an exploded perspective view of an illustrative respirator with a full face mask 10. This respiratory mask 10 includes a rigid polymer body 11, a face shield 11 or a viewfinder 11 attached to a plurality of ventilator attachment members, including, e.g., one or more inspiratory valves 18 with an optional dust or chemical filter cartridge (not shown) connected to one or more inspiratory valves 18, one or more inspiratory valves 16, one or more speech membranes 14 and / or one or more headbands or strips 34 configured so as to fix the ventilator 10 to the user's head.

The ventilator 10 includes a conforming element in contact with the face 9, which is suitably shaped to allow comfortable support of the respirator body or face shield 11 on the nose and mouth of the person. The illustrated respirator 10 includes two buccal openings 12 and two nasal openings 13. FIG. 1 shows two buccal openings 12, one of the buccal holes does not include a ventilator attachment member, and one buccal opening includes an inspiratory valve 18. FIG. 2 shows an inspiratory valve 18 in the buccal cavity 12.

The ventilator attachment elements 14, 16 and 18 are placed inside or attached to the openings 12 and 13 by any useful method, such as, for example, a bayonet fastening system. The bayonet fastening system is configured to connect the two parts to each other, which two parts comprise elements other than predominantly threads so that the two parts are joined by inserting one part at least partially into the other part and rotating one part relative to the other part so that the two parts parts could be combined without making many turns.

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FIG. 1 and FIG. 2, although presenting a respiratory mask 10 with one or two buccal inspiratory valves 18, a nasal exhalation valve 16 and a nasal voice membrane 14, any useful configuration of respiratory protection is possible. For example, the respiratory mask 10 may include a single inspiratory valve attached to a filtering cartridge of particulate contaminants or chemicals or a clean air supply element and one or two exhaust valves or one or more speech membranes as needed.

FIG. 3 is a perspective view of an illustrative inspiration valve 18, and FIG. 4 is a perspective view in section of an illustrative inspiration valve 18 shown in FIG. 3. The inspiratory valve 18 includes a rigid polymer body portion 20 of the respirator connection member with a first surface 21 and a second surface.

22. The silicone sealing member 23 is chemically bonded to the first surface 21 and the second surface 22.

The silicone sealing member 23 can be formed by overmolding a thermosetting silicone material onto the rigid polymeric thermosetable body portion 20 of the ventilator attachment member. The thermosetting silicone material bonds chemically (i.e., as a result of bonding or covalent bonding) directly to the first surface 21 and the second surface 22 of the rigid polymeric thermoset body portion 20 of the ventilator attachment member.

The terms "chemical bond" or "chemically related" refer to the physical processes responsible for the attractive interactions between atoms and molecules, and include covalent and ionic bonds as well as hydrogen and van der Walls bonds and may often depend on the available functional groups on the rigid surface, the polymer body part of the respirator connection member and their reactivity with a thermoset silicone material. In many embodiments, the thermosetting silicone material is selected such that pretreatment of the rigid polymeric thermoplastic body portion of the ventilator attachment member is not necessary. In other words, the thermosetting silicone material automatically adheres to the rigid polymeric thermoplastic body part of the connection element

EP 2 185 244 respirator. The thermosetting silicone material is often heated to cure the thermosetting silicone material during the overmolding process to a temperature sufficient to cure the thermosetting silicone material, but lower than the glass transition temperature of the rigid polymeric thermoplastic body portion of the respirator connection member.

As shown in the examples below, the degree of chemical bonding can be determined by the method of measuring the average tensile force. In many embodiments, the average bursting force is 25 N or higher, 50 N or higher, 100 N or higher, 150 N or higher, 200 N or higher, or 300 N or more.

The rigid, polymeric, thermoplastic body portion 20 of the respirator connection member may be formed of any useful thermoplastic material. In many embodiments, the rigid polymeric thermoplastic body portion 20 of the respirator connection member is formed of a polyamide (e.g., nylon), polycarbonate, polybutylene terephthalate, poly (phenyl oxide), polythalamide or mixtures thereof.

Any useful thermoset, liquid silicone rubber or material may be used to form the silicone sealing member 23. Liquid silicone rubber is a high purity silicone with a hardened platinum, with a small permanent deformation after compression, high stability and resistance to extremely high and low temperatures. Because of the thermoset nature, liquid silicone injection molding often requires a special treatment such as intense spreading while keeping the material cool before it is allowed to enter the heated seat and vulcanized.

Silicone rubber belongs to the group of thermosetting elastomers that have a backbone in the form of alternating silicon and oxygen atoms as well as methyl or vinyl side groups. Silicone rubbers retain their mechanical properties over a wide temperature range, and the presence of methyl groups in silicone rubbers makes these materials hydrophobic.

The illustrative thermosetting silicone material includes self-adhesive liquid silicone rubbers available under the trade name: ELASTOSIL LR 3070 from the Wacker-Silicones offer based in Munich, Germany; KE2095 or KE2009 series (such as, for example, KE2095-60, KE2095-50, KE2095-40) or X-34-1547A / B, X-34-1625A / B, X-34-1625A / B,

EP 2 185 244 all from the offer of Shin-Etsu Chemical Co., LTD. from Japan. These self-adhesive liquid silicone rubbers do not require pre-treatment of certain thermoplastic surfaces to ensure chemical bonding of liquid silicone rubbers to the thermoplastic surface.

In the embodiment shown, the first surface 21 and the second surface 22 are opposed main surfaces. One or more openings 24 extend through the entire thickness of the respirator connection element body, defined between the opposing first surface 21 and the second surface 22. During manufacture of the ventilator attachment member by overmolding, the liquid silicone (which forms the silicone sealing member 23) flows through one or more openings. 24 and forms a mechanical lock between the silicone sealing member 23 and the rigid body portion 20 of the respirator connection member.

The membrane 25 may be attached to the body portion 20 of the ventilator attachment member. This diaphragm 25 is deflected relative to the body portion 20 of the ventilator attachment member to allow unidirectional air flow through the body portion 20 of the ventilator attachment member.

The body portion 20 of the connection member may also include a bayonet fastening element. The bayonet fastening element 26 assists in fixing the body portion 20 of the respirator attachment member to the buccal opening 12 of the respiratory protection mask 10. The bayonet fastening element 26 connects to a complementary element inside or next to the buccal opening 12 of the respiratory mask 10. This fastening system The bayonet device mounts the shown inspiratory valve 18 to the buccal opening 12 of the respiratory protection mask 10.

After folding, the silicone sealing member 23 of the illustrated inspiratory valve 18 is positioned between the first surface 21 and the adjacent surface of the buccal opening 12 to form a hermetic seal on the surface of the sealing element and the adjoining surface of the buccal opening. The term "hermetic seal" refers to a connection that substantially prevents penetration

Of unfiltered or ambient air into the interior of the composite face part for respiratory protection 11 on the interface surface.

Hermeticism is measured in a tightness test. The test device consists of a sealed chamber with three connections. The chamber volume is approximately 750 cm³. The ventilator attachment piece attaches to one of the connections using a bayonet mount. A vacuum gauge enabling the measurement of the pressure difference between the interior of the chamber and the ambient air (at a level of at least 24.5 hPa (25 cm water column)) is connected to the second connection on the instrument. The vacuum generating device is connected to the third connection via a shut-off valve. In order to carry out the test, the shut-off valve opens and the negative pressure device is turned on to empty the chamber to a pressure level of 24.5 hPa (25 cm water column) below the atmospheric pressure (indicated by the vacuum gauge). The shut-off valve then closes and the vacuum-generating device turns off. The vacuum level inside the chamber is monitored for 60 seconds. The ingress of air into the inside causes the pressure inside the chamber to increase, thus reducing the level of underpressure. In the case of the current disclosure, the pressure difference between the chamber and the ambient air is greater than 14.7 hPa (15 cm water column) after 60 seconds. More preferably, the pressure difference is maintained above 23.5 hPa (24 cm water column) after 60 seconds. A silicone sealing element 23 of the illustrated inspiration valve 18 is also positioned between the second surface 22 and the attached filter air supply element (not shown). The filter element that supplies the filtered air can be a dust filter cartridge or a clean air supply element. The filtered air supply element can be attached to the shown inspiration valve 18 by means of the bayonet fastener 27 on the body portion 20 of the ventilator attachment member. This bayonet fastening element 27 connects to a complementary element on the filter air supply element. Accordingly, the silicone sealing element 23 of the illustrated inspiration valve 18 forms a hermetic seal on the surface of the sealing element and the interface of the supply element of the filtered air.

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FIG. 5 is a perspective view of an exhalation valve 16 without showing the membrane 35 (shown in FIGURE 2). FIG. 6 is a perspective sectional view of the exhalation valve 16 shown in FIG. 5. The exhalation valve 16 includes a rigid polymer body portion 30 of the respirator connection member with first surface 31 and second surface 32. The silicone sealing member 33 is chemically bonded to the first surface 31.

The silicone sealing member 33 can be formed by overmolding the thermosetting silicone material onto a rigid polymeric thermosetable body portion 30 of the ventilator attachment member. The thermosetting silicone material bonds chemically (i.e., as a result of bonding or covalent bonding) directly to the first surface 31 of the rigid polymeric thermoset body portion 30 of the ventilator attachment member. The terms "chemical bond" or "chemically bound" are described above.

The rigid, polymeric, thermoplastic housing portion 30 of the ventilator attachment member may be formed of any useful thermoplastic material as described above. Any useful thermoset, liquid silicone rubber or material as described above may be used to form the silicone sealing member 33.

In the embodiment shown, the first surface 31 and the second surface 32 are opposite major surfaces. In some embodiments, one or more openings (not shown) extend through the entire thickness of the respirator connection element body defined between the opposite first surface 31 and the second surface 32. During manufacture of the ventilator attachment member by overmolding, the liquid silicone (which forms the silicone sealing member) flows through one or more openings and forms a mechanical lock between the silicone sealing member and the rigid body portion of the respirator connection member.

The membrane 35 may be attached to the body portion 30 of the ventilator attachment member (see FIG. 2). This diaphragm 35 is deflected in relation to the body portion 30 of the connecting element

A ventilator to allow unidirectional air flow through the body portion 30 of the ventilator attachment member.

The body portion 30 of the connection member may also include a bayonet fastening element 36. The bayonet fastening element 36 assists in fixing the body portion 30 of the respirator attachment member to the nostril 13 of the respiratory mask 10. The bayonet fastening element 31 connects to a complementary element inside or next to the nostril 13 of the respiratory mask 10. This fastening system The bayonet device mounts the exhalation valve 16 shown to the nostril 13 of the respiratory protection mask 10.

After folding, the silicone sealing member 33 of the illustrated exhaust valve 16 is positioned between the first surface 31 and the adjacent surface of the nascent opening 13 to form a hermetic seal on the surface of the sealing element and the abutment surface of the nasal cavity. The term "hermetic seal" is described above.

FIG. 7 is a perspective view of an illustrative speech membrane 14, and FIG. 8 is a perspective view in cross-sectional view of the speech membrane 14 shown in FIG. 7. The voice diaphragm 14 includes a rigid polymer body portion 40 of the ventilator attachment member with first surface 41 and second surface 42. The silicone sealing member 43 is chemically associated to first surface 41. Membrane 45 is attached to the rigid polymer body portion 40 of the respirator connection member. . Membrane 45 helps in transmitting sound from ventilator user 10 to another person.

The silicone sealing member 43 may be formed by overmolding the thermosetting silicone material onto a rigid polymeric thermosetable body portion 40 of the ventilator attachment member. The thermosetting silicone material chemically bonds (i.e., as a result of bonding or covalent bonding) directly to the first surface 41 of the rigid polymeric thermoset body portion 40 of the ventilator attachment member. The terms "chemical bond" or "chemically bound" are described above.

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The rigid, polymeric, thermoplastic body portion 40 of the respirator connection member may be formed of any useful thermoplastic material as described above. Any useful thermoset, liquid silicone rubber or material as described above may be used to form the silicone sealing member 43.

In the illustrated embodiment, the first surface 41 and the second surface 42 are opposite major surfaces. In some embodiments, one or more openings (not shown) extend through the entire thickness of the respirator attachment member body defined between the opposite first surface 41 and the second surface 42. During manufacture of the ventilator attachment member by liquid injection, the liquid silicone (which forms the silicone sealing member) flows through one or more openings and forms a mechanical lock between the silicone sealing member and the rigid body portion of the respirator connection member.

The body portion 40 of the connection member may also include a bayonet fastening element 46. The bayonet fitting element 46 assists in fixing the body portion 40 of the respirator attachment member to the nostril 13 of the respiratory mask 10. The bayonet fastening element 46 connects to a complementary element inside or next to the nostril 13 of the respiratory protection mask 10. This mounting system The bayonet fastens the shown voice diaphragm 14 to the nostril 13 of the respiratory mask 10.

After folding, the silicone sealing member 43 of the shown voice diaphragm 14 is positioned between the first surface 41 and the adjacent surface of the nasal opening 13 to form a hermetic seal on the surface of the sealing element and the contact surface of the nasal cavity. The term "hermetic seal" is described above.

Examples

A number of attempts have been made to determine the preferred combinations of silicone rubbers and thermoplastic materials. Particular attention was paid to the bond strength between the silicone rubber

And a thermoplastic material that affects the durability of the hermetic seal.

To enable the binding force to be measured, a replacement test strip was prepared. The test strip was prepared by forming a rigid, flat piece of substrate 51 mm long, 25 mm wide and 2 mm thick from thermoplastic material. The substrate was then closed in a second mold, so that one end of the substrate protruded into the nest of the second mold at 6 mm. The second mold cavity is 27 mm wide and 49 mm long. The mold depth is 2 mm, increasing to 4 mm in the immediate vicinity of the protruding end of the substrate, so that after injecting the silicone into the mold cavity, it forms a 1 mm thick layer on all sides of the protruding end of the substrate. The resulting test strip is thus 94 mm long, with a rigid, thermoplastic piece of substrate at one end and a silicone rubber at the other end.

The bond strength between base material and silicone is measured by clamping the two ends of the test strip in the jaws of a mechanical testing machine, such as the MTS Model 858 Material Test System (by MTS Systems Corporation based in Eden Prairie, Minnesota), stretching it until the strip ruptures. test, and recording the force at which the tearing occurs. Examples of burst strength are shown in Table 1. Examples 1 to 4 show that through the appropriate combination of materials, bond strengths greater than 300 N can be achieved. In Comparative Examples C1 and C2 the silicone did not bind to the thermoplastic material.

<td>Example</td><td>Silicon</td><td>Subsoil thermoplastic</td><td>Average tear force (N)</td>

<td>one</td><td>Shin-Etsu KE 2095-60</td><td>RTP Nylon 6/6</td><td>136</td>

<td>2</td><td>Wacker 3070-60</td><td>RTP Nylon 6/6</td><td>303</td>

<td>3</td><td>Dow LC-70-2004</td><td>Zytel PA</td><td>174</td>

<td>four</td><td>Wacker 3070-60</td><td>Zytel PA</td><td>166</td>

<td>C1</td><td>Dow LC-70-2004</td><td>RTP Nylon 6/6</td><td>No binding</td>

<td>C2</td><td>Shin-Etsu KE 2095-60</td><td>Zytel PA</td><td>No binding</td>

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Silicone Dow LC-70-2004 is manufactured by Dow Corning Corporation based in Midland, Michigan; RTP Nylon 6/6 is a polyamide manufactured by RTP Company based in Winona, Minnesota; Zytel PA is a polyamide produced by EI

du Pont de Nemours, based in Wilmington, Delaware.

In connection with the above, the embodiments of the connection ELEMENT ELEMENT OF THE RESPIRATOR WITH FORMED, THERMO-INDIVIDUAL ELASTOMER SEAL are disclosed. One skilled in the art will appreciate that the present invention may be practiced according to embodiments other than those disclosed. The disclosed embodiments are for illustrative purposes, not limiting, and the present invention is limited only by the following claims.

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