CN211132535U - Flexible gasket, respiratory shell structure and respiratory interface - Google Patents

Abstract

The utility model relates to a flexible liner. The flexible gasket is detachably arranged on a housing of the respiratory interface device, the periphery of one end of the housing transversely extends inwards to form a sealing gasket, the sealing gasket surrounds to form an opening, and the flexible gasket is in a three-dimensional configuration and is matched with the three-dimensional contour of the sealing gasket to form a double-layer gasket structure. The flexible liner can enable the wearing effect of the shell structure for breathing to be good. The utility model also provides a breathing is with cover shell structure and breathing interface.

Description

Flexible gasket, respiratory shell structure and respiratory interface

Technical Field

The utility model relates to a flexible liner, breathe with cover shell structure and breathing interface.

Background

In the treatment of sleep disordered breathing such as obstructive sleep apnea, positive pressure ventilation therapy is generally used, in which positive pressure gas is delivered into the respiratory airways of a patient by a breathing apparatus. Such breathing apparatuses generally include Positive Airway Pressure devices, i.e., Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway Pressure (Bi-PAP), air delivery tubes, and face masks. The mask generally includes a fitting connected to the air delivery tube, an elbow, a shell, a flexible cover, a strap, and a brace. The joint, the bent pipe, the shell and the flexible housing are sequentially connected, the support is fixed on the shell, and two ends of the binding belt are buckled on the support. When the mask is used, the mask is fixed on the nose or mouth-nose area of a patient by the binding band, and the flexible cover casing is attached to the skin of the combining area to form air tightness under the action of the pressure difference between the inside and the outside of the binding band and the nose mask, so that positive pressure air is conveyed into the respiratory airway of the patient. In the use, comfort level, stability, the sealed effect of face guard and skin contact are three very important indexes, will directly influence patient and use experience and treatment effect.

The common flexible cover shell of the face mask or the nose mask contacting the skin is formed by molding a silica gel material, and the silica gel material is in direct contact with the skin and has the following problems: silica gel is hydrophobic oleophobic and the gas permeability is poor material, does not hardly have oil absorption fat, moisture absorption and sweat releasing's function, and when wearing face guard or nose cup for a long time, sweat, the grease that wearer's face skin metabolism came out can't effectively discharge, and the face skin of long-time contact face guard or nose cup will appear serious red seal, local skin ulcerate etc. easily under pressure load to make it wear the experience effect not good, influence treatment and patient's compliance of accepting the malleation treatment of ventilating.

SUMMERY OF THE UTILITY MODEL

Accordingly, there is a need for a flexible cushion, a respiratory shell structure, and a respiratory interface that are easy to wear.

A flexible gasket is detachably arranged on a shell of a respiratory interface device, the periphery of one end of the shell transversely extends inwards to form a sealing gasket, the sealing gasket surrounds to form an opening, and the flexible gasket is in a three-dimensional configuration and is matched with the three-dimensional contour of the sealing gasket to form a double-layer gasket structure.

In one embodiment, the material of the flexible pad is elastic fabric, or PU sponge, or a composite material of elastic fabric and PU film, or an adhesive layer, a PU sponge layer and elastic fabric which are stacked.

In one embodiment, the elastic fabric is a heat-settable elastic fabric comprising the following ingredients: nylon, lycra yarn, moisture absorbing fibers, and hot melt yarn.

In one embodiment, the elastic fabric is an elastic sandwich cloth, and the thickness of the flexible liner is 0.4-5 mm.

In one embodiment, the sealing gasket is formed with a bonding area thereon, the sealing gasket is a silicone gasket, and the flexible gasket is configured to at least partially cover the bonding area.

In one embodiment, the flexible liner has a skin contact area formed thereon in direct contact with the skin, the skin contact area at least partially overlapping the bonding area.

In one embodiment, the surface of the flexible pad is coated with an adhesive layer, the flexible pad is detachably attached to the bonding area through the adhesive layer, and the adhesive layer is a gel layer or a non-drying adhesive layer.

In one embodiment, the flexible gasket includes an annular main body and an annular peripheral edge formed on a peripheral edge of the annular main body, the annular peripheral edge of the flexible gasket is detachably connected to the casing and surrounds the sealing gasket, and the annular main body and the sealing gasket are separated from each other.

In one embodiment, a groove is formed on the casing, and an elastic member is arranged on the annular periphery of the flexible gasket and is detachably clamped in the groove.

In one embodiment, the flexible gasket further comprises a hard snap ring, the hard snap ring is arranged around the outer edge of the skin contact area in an outward protruding mode, a ring-shaped frame is arranged on the hard snap ring in a protruding mode, an annular groove is arranged on the housing in a concave mode, the annular groove is wrapped on the outer side of the combination area and is arranged at intervals with the combination area, the hard snap ring is sleeved and attached to the surface of the side wall of the housing, and the ring-shaped frame is detachably clamped in the annular groove to install the flexible gasket on the housing.

In one embodiment, the flexible cushion is thickened on opposite sides of the bridge of the nose.

A respiratory mask structure comprising a sealing liner integrally formed on a shell with a peripheral edge extending laterally inwardly to form the sealing liner, and a flexible liner as described above removably disposed on the shell and at least partially covering the sealing liner.

In one embodiment, the sealing pad is a silicone pad, the sealing pad has a bonding area formed thereon, the flexible pad at least partially covers the bonding area, and the flexible pad has a skin contact area formed thereon that is in direct contact with the skin.

In one embodiment, the flexible liner portion is fitted over and attached to the sealing liner.

In one embodiment, the bonding region has a nose bridge contacting region formed thereon, the flexible pad includes an attached portion and a detached portion connected to each other, the attached portion is detachably connected to the nose bridge contacting region, the detached portion is separated from the bonding region, and the skin contacting region is formed on the attached portion and the detached portion.

In one embodiment, the flexible cushion covers only the nose bridge contact region.

In one embodiment, a groove is formed on the casing, and an elastic member is arranged on the annular periphery of the flexible gasket and is detachably clamped in the groove.

A respiratory interface comprising a respiratory mask shell structure as described in any preceding claim.

In one embodiment, the respiratory interface is a face mask, a nasal mask, or an oral mask.

Because the flexible liner is spatial configuration and with the three-dimensional profile of sealing liner is identical to form double-deck liner structure, the flexible liner is located between housing and the skin of the person's face, and compressible deformation, dispersed load avoid local stress concentration (especially nose bridge portion) to obviously improve the travelling comfort of wearing, make the effect of wearing of breathing with the housing structure better.

In addition, the breathable mask is made of elastic fabric or PU sponge, the two materials are porous or reticular materials, and the breathable mask has good buffering characteristics and has the functions of moisture absorption, sweat releasing, skin friendliness and buffering, so that when the breathable mask shell structure is in contact with the skin, the flexible liner is in direct contact with the skin of a wearer, and the risks of red marks and skin damage can be reduced by utilizing the characteristics of hydrophilicity, oil absorption, moisture permeability and sweat releasing of the flexible liner.

Drawings

FIG. 1 is a schematic perspective view of a mask according to an embodiment.

Figure 2 is an exploded perspective view of the nasal mask of figure 1.

Figure 3 is a partially cut away perspective view of the nasal mask of figure 1.

Fig. 4 is a partially enlarged view of a portion a in fig. 3.

FIG. 5 is a perspective view of a flexible liner according to one embodiment.

Detailed Description

In order to facilitate understanding of the present invention, the present invention will be described more fully hereinafter with reference to the accompanying drawings. The preferred embodiments of the present invention are shown in the drawings. The invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "secured to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1-4, a nasal mask 100 includes an elbow assembly 11, a frame 12, a shell 13, a shell 102, and a flexible cushion 103. The bracket is fixed on the shell 13, and the elbow assembly 11 is arranged in the bracket 2 in a penetrating way and is fixedly connected on the shell 13. The cover 102 is connected to the side of the housing 13 facing away from the support 12, wherein the cover 102 and the housing 13 together form a cavity 30 for receiving the nose of the wearer, and the cover 102 is formed with an opening 101 at the side facing away from the housing 13. Wherein, a sealing gasket is formed on one side of the cover 102, the cover 102 is fixed on the housing 13, and the flexible gasket 103 is disposed on one side of the cover 102 away from the housing 13, i.e. on the sealing gasket. The sealing cushion and the flexible cushion 103 together form a respiratory shell structure 10.

For example, the sealing gasket is detachably connected to the flexible gasket 103, and in another embodiment, the sealing gasket is integrally formed on the housing 102, and the sealing gasket is fixedly connected to the flexible gasket 103. The cover 102 is made of silicone, and has a shore hardness of about 40 degrees. The enclosure 10 is provided with the sealing gasket around the edge of the opening 101, the sealing gasket extends laterally inwardly along the periphery of the enclosure 102, and is formed with a bonding area 1011, the bonding area 1011 extends from the periphery of the opening 101 to the maximum contour of the enclosure 102, and the bonding area 1011 will be in direct or indirect contact with the wearer's facial skin when worn.

For example, the flexible liner 20 is three-dimensional and has an opening in the middle to match the opening 101 in the housing 10, and the contour matches the three-dimensional contour and size of the bonding area 1011 on the sealing liner, which are stacked or compounded together to form the respiratory housing structure 10. For example, the flexible pad 20 is disposed on the cover 102 and at least partially covers the bonding region 1011 to form a skin contact region 201 on the flexible pad 20, the material of the flexible pad 20 is an elastic fabric (a knitted warp-knitted or weft-knitted elastic fabric, without fraying) or a PU (polyurethane) sponge (compression > 60%, stretch > 30%, stretch recovery > 95%, and high tear strength).

When the nose mask 100 is worn, the nose of the wearer is received in the cavity 30, and the skin contact area 201 of the flexible cushion 20 is in direct contact with the skin of the face of the wearer. Because the flexible liner 20 is in a three-dimensional structure and is made of elastic fabric or PU sponge, the two materials are materials with porous or reticular structures, have better buffer characteristics and have the functions of moisture absorption, sweat releasing, skin friendliness and buffering, when the respiratory shell structure 10 is in contact with the skin, the flexible liner 20 is in direct contact with the skin of a wearer, and by utilizing the characteristics of hydrophilicity, oil absorption, moisture permeability and sweat releasing of the flexible liner, the risks of red marks and skin damage can be reduced. And the flexible liner 20 is located between the shell 102 and the skin of the face of the wearer, and can compress and deform to disperse load and avoid local stress concentration (especially on the nose bridge part), so that the wearing comfort is obviously improved, and the wearing effect of the respiratory shell structure 10 is better.

For example, the combination region 1011 partially extends laterally to form a suspension structure to partially block the airflow direction in the cavity 30, and since the casing 102 has low compressibility in the thickness direction and poor cushioning effect of the material, and cannot effectively disperse the load applied to the skin of the face of the wearer, and the flexible pad 20 is attached to the suspension structure and extends in the direction perpendicular to the thickness direction of the casing 102, the flexible pad on the suspension structure can be utilized to improve the deformation degree of the flexible pad 20 on the combination region 1011 in the airflow direction in the casing 102, thereby improving the cushioning effect.

In order to enhance the cushioning effect of the flexible liner 20, the elastic fabric is a heat-settable elastic fabric comprising the following components: nylon, lycra yarn content, moisture absorbing fibers, and hot melt yarns. Specifically, the elastic fabric is an elastic sandwich cloth, and the thickness of the flexible pad 20 is 0.4-5 mm, preferably 0.4-0.2 mm. By providing the flexible pad 20 with the above-described components, the cushioning and moisture absorption effects can be improved.

For example, the housing 102 is a silicone housing, and the flexible gasket 20 is detachably attached to at least a portion of the bonding area 1011 of the sealing gasket. For example, the surface of the flexible pad 20 facing the cover 102 is coated with an adhesive layer, and the flexible pad 20 is detachably attached to the bonding area 1011 through the adhesive layer, which is a gel layer or a non-drying adhesive layer. By providing the flexible gasket 20 with a different composition than the shell 102, a double-layered composite sealing gasket structure is formed, thereby exerting the supporting function of the shell 102 and improving the contact flexibility of the respiratory shell structure 10 with the skin by the flexible gasket 20. By providing the adhesive layer, the flexible liner 20 is convenient to replace.

For example, in one embodiment, a nose bridge contact area 1013 is formed on the bonding area 1011, the flexible cushion 20 includes an attached portion 21 and a separated portion 23 that are connected to each other, a surface of the attached portion 21 facing the housing is coated with an adhesive layer, the attached portion 21 is attached to the nose bridge contact area 1013, the separated portion 23 is separated from the bonding area 1011, and the skin contact area 201 is formed on the attached portion 21 and the separated portion 23.

In another embodiment, the flexible sealing pad 20 comprises an attaching portion 21 and a separating portion 23 connected to each other, the attaching portion 21 is located at the edge of one side far from the opening, the separating portion 23 is separated from the bonding area 1011 by the attaching portion 21 contacting with the upper edge of the bonding area, and the skin contacting area 201 is formed on the attaching portion 21 and the separating portion 23.

For example, a frame (not shown) is disposed on the attachment portion 21, and the frame fixes the attachment portion 21 and the nose bridge contact region 1013 together. For example, in another embodiment, the frame removably connects the attachment portion 21 and the nose bridge contact region 1013 together. The separation portion 23 is provided, so that the flexible gasket 20 can be easily connected to and separated from the housing 102. For example, in another embodiment, the junction area 1011 has a nose bridge contacting area 1013 formed thereon, and the flexible cushion 20 only covers the nose bridge contacting area 1013, in which case, the material of the flexible cushion 20 is less, and the manufacturing of the respiratory mask structure 10 can be facilitated. When the breathing mask is worn, stress borne by the nose bridge is concentrated, and the structure can relieve and disperse the pressure stress of a contact area of the nose bridge, so that the wearing comfort level is improved.

For example, the present invention provides a nasal mask that includes the respiratory shell structure 10. For example, the respiratory shell structure 10 described above may also be used in a face mask, and the present invention also provides a face mask that includes the respiratory shell structure 10 described above. The manufacturing method of the mask comprises the following specific steps: forming the plane fabric into a prefabricated fabric part in a three-dimensional mode; spraying silica gel on the inner surface of the prefabricated fabric part to cover the gaps of the fabric yarns to form the airtight fabric silica gel composite liner; and placing the fabric silica gel composite gasket in an injection mold, and performing secondary injection molding to form a mask main body to obtain the integrated composite sealing gasket. The following process method can also be adopted: (1) manufacturing a three-dimensional flexible gasket made of polyurethane sponge through cavity foaming; (2) and placing the polyurethane flexible gasket in a liquid silica gel injection mold, and performing secondary molding to form a mask main body to obtain the integrated composite sealing gasket.

For example, the present invention provides a flexible cushion 20 for use on a face mask or a nose mask, the face mask or the nose mask including a shell 102, a bonding region 1011 is formed on one side of the shell 102, the flexible cushion 20 is configured to be disposed on the shell 102 and at least partially cover the bonding region 1011 to form a skin contact region 201 on the flexible cushion 20, the flexible cushion 20 has a three-dimensional configuration, and the material thereof is elastic fabric or PU sponge. For example, in one embodiment, the present invention further provides a method for manufacturing the flexible gasket 20, the method for manufacturing the flexible gasket 20 includes the following steps: coating liquid silica gel or gel on one side of the fabric; carrying out three-dimensional vulcanization molding on the fabric; and cutting the fabric according to a preset contour to manufacture the flexible liner. Through the arrangement of the manufacturing method, the flexible gasket 20 can be conveniently installed on the housing 102 or be conveniently detached from the housing 102.

Referring to fig. 5, the flexible gasket 103 of an embodiment includes a ring-shaped main body 1031 and a ring-shaped peripheral rim 1033 formed at a peripheral edge of the ring-shaped main body, the ring-shaped peripheral rim of the flexible gasket is detachably connected to the housing and surrounds the sealing gasket, and the ring-shaped main body and the sealing gasket are separated from each other. A groove is formed on the housing, and an elastic member 1035 is arranged on the annular periphery of the flexible gasket and is detachably clamped in the groove.

For example, the utility model provides a flexible gasket, flexible gasket is used for detachably setting up on the sealing liner of housing, flexible gasket be spatial configuration and with the three-dimensional profile of sealing liner is identical to form double-deck liner structure, its material is elastic fabric or PU sponge. In an embodiment, the combining area is concavely provided with a clamping groove, the flexible gasket is convexly provided with an inserting part, and the inserting part is detachably inserted into the clamping groove.

For example, the present invention provides a flexible liner. The flexible gasket is detachably arranged on a housing of the respiratory interface device, the periphery of one end of the housing transversely extends inwards to form a sealing gasket, the sealing gasket surrounds to form an opening, and the flexible gasket is in a three-dimensional configuration and is matched with the three-dimensional contour of the sealing gasket to form a double-layer gasket structure. The material of the flexible pad is elastic fabric, or PU sponge, or a composite material of the elastic fabric and the PU film, or a viscose layer, a PU sponge layer and the elastic fabric which are arranged in a laminated manner. The elastic fabric is a heat-settable elastic fabric and comprises the following components: nylon, lycra yarn, moisture absorbing fibers, and hot melt yarn. The elastic fabric is elastic sandwich cloth, and the thickness of the flexible liner is 0.4-5 mm. The sealing gasket is provided with a bonding area, the sealing gasket is a silica gel gasket, and the flexible gasket is used for at least partially covering the bonding area. The flexible liner has a skin contact area formed thereon in direct contact with the skin, the skin contact area at least partially overlapping the bonding area. The surface coating of flexible liner has the viscose layer, flexible liner passes through the viscose layer detachably attached in combine the region on, the viscose layer is gel layer or not dry glue layer.

For example, the flexible gasket includes an annular main body and an annular peripheral edge formed on a peripheral edge of the annular main body, the annular peripheral edge of the flexible gasket is detachably attached to the casing and surrounds the sealing gasket, and the annular main body and the sealing gasket are separated from each other. A groove is formed in the housing, an elastic piece is arranged on the annular periphery of the flexible liner, and the elastic piece is detachably clamped in the groove. The flexible liner further comprises a hard clamping ring, the hard clamping ring surrounds the outer edge of the skin contact area and is arranged in a protruding mode, a ring-shaped frame is arranged on the hard clamping ring in a protruding mode, an annular groove is arranged on the housing in a concave mode, the annular groove wraps the outer side of the combination area and is arranged at intervals of the combination area, the hard clamping ring is sleeved and attached to the surface of the side wall of the housing, and the ring-shaped frame is detachably clamped in the annular groove to enable the flexible liner to be installed on the housing. The opposite two sides of the flexible liner corresponding to the nose bridge are thickened.

For example, the present invention provides a respiratory shell structure comprising a sealing liner integrally formed on a shell, the sealing liner being formed by extending laterally inward a peripheral edge of the shell, the sealing liner surrounding an opening, and a flexible liner detachably disposed on the shell and at least partially covering the sealing liner. The sealing gasket is a silica gel gasket, a combination area is formed on the sealing gasket, the flexible gasket at least partially covers the combination area, and a skin contact area directly contacting with the skin is formed on the flexible gasket. The flexible liner portion is attached to and conforms to the gasket. The flexible cushion comprises an attaching part and a separating part which are connected with each other, the attaching part is detachably connected with the nose bridge contact area, the separating part is separated from the combining area, and the skin contact area is formed on the attaching part and the separating part. The flexible cushion covers only the nose bridge contact region.

For example, a groove is formed on the casing, and an elastic piece is arranged on the annular periphery of the flexible gasket and is detachably clamped in the groove. For example, the present invention also provides a respiratory interface comprising a respiratory shell structure as described in any of the above. In one embodiment, the respiratory interface is a face mask, a nasal mask, or an oral mask.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only represent some embodiments of the present invention, and the description thereof is more specific and detailed, but not to be construed as limiting the scope of the present invention. It should be noted that, for those skilled in the art, without departing from the spirit of the present invention, several variations and modifications can be made, which are within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the appended claims.

Claims (19)

1. A flexible gasket, wherein the flexible gasket is detachably disposed on a shell of a respiratory interface device, a peripheral edge of one end of the shell extends inwards in a transverse direction to form a sealing gasket, the sealing gasket surrounds to form an opening, and the flexible gasket is in a three-dimensional configuration and is matched with a three-dimensional contour of the sealing gasket to form a double-layer gasket structure.

2. The flexible pad of claim 1, wherein the material of the flexible pad is elastic fabric, or PU sponge, or a laminated adhesive layer, a PU sponge layer and elastic fabric.

3. The flexible liner of claim 2 wherein the elastic fabric is a heat-settable elastic fabric.

4. The flexible liner of claim 3 wherein the elastic fabric is an elastic sandwich and the flexible liner has a thickness of 0.4-5 mm.

5. The flexible liner of claim 1 wherein said sealing liner has a bonding area formed thereon, said sealing liner being a silicone liner, said flexible liner being adapted to at least partially cover said bonding area.

6. The flexible liner of claim 5 wherein said flexible liner has a skin contact area formed thereon in direct contact with the skin, said skin contact area at least partially overlapping said bonding area.

7. The flexible pad of claim 5, wherein the surface of the flexible pad is coated with a layer of adhesive by which the flexible pad is detachably attached to the bonding area, the layer of adhesive being a gel layer or a non-setting adhesive layer.

8. The flexible liner of claim 1, wherein the flexible liner includes an annular body and an annular peripheral edge formed on a peripheral edge of the annular body, the annular peripheral edge of the flexible liner being removably attached to the casing and surrounding the sealing liner, the annular body and the sealing liner being separable from one another.

9. The flexible liner according to claim 8, wherein the casing is formed with a groove, and the annular periphery of the flexible liner is provided with an elastic member detachably engaged in the groove.

10. The flexible liner according to claim 6, further comprising a rigid snap ring protruding outwardly around an outer edge of said skin contact area, said rigid snap ring having a ring-shaped frame protruding therefrom, said cover having an annular groove recessed therein, said annular groove surrounding an outer side of said bonding area and spaced from said bonding area, said rigid snap ring being fitted around and attached to a sidewall surface of said cover, said ring-shaped frame being removably snapped into said annular groove to mount said flexible liner to said cover.

11. The flexible cushion according to claim 1, wherein the flexible cushion is thickened on opposite sides of the flexible cushion corresponding to a nasal bridge region.

12. A respiratory mask structure comprising a sealing liner integrally formed with a shell, said shell having an end periphery extending laterally inward to form said sealing liner, said sealing liner surrounding an opening, and a flexible liner according to claim 1 removably attached to said shell and at least partially covering said sealing liner.

13. The respiratory mask shell structure of claim 12 wherein said sealing liner is a silicone liner having a bonding area formed thereon, said flexible liner at least partially covering said bonding area, said flexible liner having a skin contact area formed thereon in direct contact with the skin.

14. The respiratory mask shell structure of claim 13, wherein said flexible liner portion is conformed to and attached to said sealing liner.

15. The respiratory mask shell structure of claim 14, wherein said attachment region has a nose bridge contacting region formed thereon, said flexible cushion includes an attachment portion and a detachment portion that are connected to each other, said attachment portion is removably connected to said nose bridge contacting region, said detachment portion is separated from said attachment region, and said skin contacting region is formed on said attachment portion and said detachment portion.

16. The respiratory mask shell structure of claim 15, wherein the flexible backing covers only the nose bridge contact region.

17. The respiratory shell structure of claim 12, wherein the shell has a recess formed therein, and the annular periphery of the flexible liner has a resilient member removably engaged in the recess.

18. A respiratory interface comprising a respiratory shell structure according to any one of claims 12-17.

19. The respiratory interface of claim 18, wherein the respiratory interface is a face mask, a nasal mask, or an oral mask.

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