JP2010509942A - Headgear assembly - Google Patents

Abstract

  Headgear assemblies (30, 150, 180) for attaching an object to a user's head are first (32, 152, 182) and second adapted to wrap around the user's neck and / or the back of the head. (34, 154, 184) defined by the beam. The first and second beams are generally flat and are adapted to be placed in a first plane when flattened. The first beam has a first radius of curvature defined in the first plane, and the second beam has a second radius of curvature defined in the first plane in the same direction as the first radius of curvature. The first member couples the first beam to the second beam. When worn by the user, the headgear assembly typically exhibits a spherical shape that matches the back of the person's head.

Description

  The present invention relates generally to headgear adapted to support an object on a user's head, and more particularly to a curved beam that allows the headgear to exhibit a spherical structure when worn by the user. Related to headgear.

  In many situations, it is necessary to connect an object to the user's face. For example, non-invasive ventilation and pressure support therapy are commonly used on a patient's face, a nasal mask covering the nose, a nasal / oral mask covering the nose and mouth, or a full face mask covering the patient's face. Requires the placement of patient interface equipment. The patient interface device interfaces the patient's airway with a ventilator or pressure support device, and respiratory gas flow can be supplied from the pressure / flow generator to the patient's airway. In general, noninvasive ventilation requires supplying ventilating gas to the patient's airway without intubating the patient or surgically inserting an endotracheal tube into the patient's esophagus . Pressure support therapy is performed by patient respiratory cycles (biphasic pressure support) or patients to treat medical disorders such as sleep apnea syndrome (especially obstructive sleep apnea (OSA)) or congestive heart failure. It is necessary to supply pressures such as continuous positive airway pressure (CPAP) or variable airway pressure, which vary depending on the condition (automatic titration pressure support).

  Holding such a mask on the wearer's face by headgear comprising upper and lower straps, each having opposing ends that pass through opposing elements of the mask and connecting elements provided thereon, respectively. Are known. Since such masks are typically worn for extended periods of time, it is important that the headgear hold the mask in close enough contact with the patient's face so as not to cause discomfort.

  One such headgear is disclosed in US Pat. No. 5,517,986 (patent 986) (Applicant, patentee is Respironics, Inc., Pittsburgh, PA). The headgear taught by the 986 patent includes a cap-like headpiece adapted to fit the top and back of the patient's head. The lower strap provides a two point connection with the gas supply mask. A strap subordinate to the helmet is connected to the lower strap and is movable relative to the lower strap. Further, if necessary, a set of upper straps can be used to form a four point connection with the gas supply mask.

  Another headgear manufactured by Respironics, Inc. also includes five straps extending in a star shape from a back connection piece that can be positioned along the back portion of the patient's head. Three top straps are adapted to fit the patient's head. The central top strap extends from the connecting piece across the top of the patient's head to the patient's forehead. Upper straps provided on both sides of the top strap extend from the connecting part over the ear along the side of the patient's head and are attached to the top strap at the patient's forehead. The top strap includes a set of elongated openings, through which the upper strap is passed.

  Other conventional headgears include Deluxe Patient Interface Headgear and SimpleStrap (TM) Patient Interface Headgear, both manufactured and sold by Respironics (Pittsburgh, PA), the assignee of the present application. Both Deluxe Patient Interface Headgear and SimpleStrap Patient Interface Headgear include a straight (linear) top strap and a straight (linear) bottom strap that wraps around the user's head / neck. The top and bottom straps are parallel to each other.

  These and other conventional headgears provide convenient attachment of patient interface equipment to the user's head. However, they do not optimize the comfort of the headgear on the user's head / neck. They also do not maximize headgear stability to ensure that the patient interface device is securely attached to the user. Therefore, there is a need for a headgear that is easy to use and adjust, is comfortable, stably supports an object attached to the user, and does not stay much on the patient's hair.

  Accordingly, it is an object of the present invention to provide a headgear that overcomes the disadvantages of conventional headgear. This object is achieved according to one embodiment of the present invention by providing a headgear assembly for attaching an object to a user's head. The headgear assembly includes a first beam and a second beam, both of which are adapted to wrap around the back of the user's neck or the back of the user's head. The first beam is generally flat and is adapted to be placed in the first plane when the headgear assembly is flattened. When in this position, the first beam has a first radius of curvature defined in the first plane. The second beam is also generally flat and is adapted to be placed in the first plane when the headgear assembly is placed on a flat surface. The second beam has a second radius of curvature defined in the first plane in the same direction as the first radius of curvature. In addition, the first member connects the first beam to the second beam. By providing the first and second beams with such curvature, the headgear assembly generally exhibits a spherical shape, at least in a portion extending over the back of the user's head / neck. This provides a headgear that better takes the form of a human anatomy and provides a comfortable and stable device.

  These and other objects, features and characteristics of the present invention, as well as the function of the relevant elements of the method of operation, structure and combination of components, as well as the economy of manufacture, are described in the following description and attached with reference to the accompanying drawings. It will become more apparent in light of the appended claims. All drawings form part of the specification, wherein like reference numerals refer to corresponding parts throughout the several views. It should be expressly understood, however, that the drawings are for purposes of illustration and description only and are not intended to define the scope of the invention. As used in this specification and the claims, the singular noun includes the presence of a plurality of nouns unless the context clearly dictates otherwise.

1 is a plan view of a portion of a headgear assembly of a first embodiment according to the principles of the present invention; FIG. 2 is a perspective view of a part of the headgear shown in FIG. FIG. 2 is a plan view of a headgear assembly including the portion shown in FIG. FIG. 4 is a plan view of the headgear assembly of FIG. FIG. 6 is a plan view of a portion of a second embodiment of a headgear assembly according to the principles of the present invention. FIG. 6 is a perspective view of a part of the headgear shown in FIG. FIG. 9 is a plan view of a part of another structure for the second embodiment of the headgear assembly. The perspective view of a connection member and related components. FIG. 6 is a plan view of a third embodiment of a headgear assembly according to the principles of the present invention. FIG. 6 is a plan view of a fourth embodiment of a headgear assembly according to the principles of the present invention. FIG. 10 is a plan view of a fifth embodiment of a headgear assembly according to the principles of the present invention; FIG. 10 is a plan view of a sixth embodiment of a headgear assembly according to the principles of the present invention; FIG. 9 is a perspective view of a seventh embodiment of a headgear assembly according to the principles of the present invention. FIG. 14 is a side view of the headgear assembly of FIG. 13 being worn by a user. 1 shows a headgear assembly according to the principles of the present invention with an optional crossbar. FIG.

  1-4 illustrate a first exemplary embodiment of a headgear assembly 30 and portions thereof in accordance with the principles of the present invention. The headgear assembly 30 includes a first beam 32 and a second beam 34, both of which are adapted to wrap around the back of the user's neck or the back of the user's head. When the headgear is worn by the user, the first beam 32 is closer to the top of the head than the second beam, and the second beam is closer to the neck. Thus, in connection with their respective placement on the user, the first beam is considered the “top” beam and the second beam is considered the “bottom” beam.

  The first beam 32 and the second beam 34 are generally planar, i.e. relatively thin, and flexible or semi-rigid. In this way, when the headgear assemblies are spread flat, they are placed in the first plane. In other words, when the headgear assembly is laid flat, for example on a flat surface, the first beam and the second beam are also laid flat on that surface. The first beam 32 is curved along its length so that it has a first radius of curvature R1 defined in the first plane. The second beam 34 is also curved with respect to its longitudinal axis so that it also has a second radius of curvature R2 defined in the first plane. The first radius of curvature R1 and the second radius of curvature R2 are in the same direction. In an exemplary embodiment, the first radius of curvature R1 is in the range of 25-42 inches and the second radius of curvature R2 is in the range of 5-18 inches. In the present invention, it is envisaged that the first radius of curvature and the second radius of curvature need not be the same, and the centers of the radius of curvature may be different or different.

  The first beam 32 and the second beam 34 can also be described in terms of their respective extents of spread. The degree of spread is the angle from one end of the beam to the other, measured from the center of the radius of curvature of the beam. For the first beam 32, the extent of the spread is indicated by the angle θ in FIG. The degree of spread of the second beam 34 is indicated by the angle λ. The divergence angle can be the same for both beams (ie, θ = λ), or the beam divergence angle can be different. In the exemplary embodiment, the angle of spread of each beam ranges from 8 ° to 55 °. It will be appreciated that the angle of spread is affected by what defines the ends of the first and second beams. Thus, smaller and larger angles are possible depending on what is considered the end of the first and second beams.

  A first member 36 connects the first beam to the second beam. In addition, the second member 38 connects the first beam to the second beam. In the illustrated embodiment, two members 36 and 38 are shown connecting the first and second beams, but it is understood that one member is sufficient to connect these beams. It should be. Conversely, more than two such members can be provided. The first member 36, the second member 38, and any such other members can have any one of a variety of shapes, sizes and structures. The first beam 32, the second beam 34, the first member 36 and the second member 38 are formed in this first exemplary embodiment such that the entire structure is rigid or semi-rigid. For this purpose, “semi-rigid” means that these structures keep their shape when unloaded, but they conform to the patient to reduce the pressure point when loaded. Means some bending to make it possible.

  In an exemplary embodiment of the invention, the first beam 32, the second beam 34, the first member 36 and the second member 38 are formed as a unitary structure. More specifically, the overall structure defined by the first beam 32, the second beam 34, the first member 36 and the second member 38 is UBL (unbreakable loop lining), perforated neoprene (rubber that allows air to pass through). The present invention contemplates being formed from a textile or fabric material, such as a foam laminate having at least one side formed from UBL, or a lycra laminated with foam. Pads or cushions are provided at one or more locations or throughout the structure to provide a soft surface that contacts the user. Examples of suitable materials for such pads include foam, fabric, silicone, rubber or any combination thereof.

  As shown in FIG. 4, the present invention contemplates providing reinforcements 40 at various locations on the headgear assembly. In the illustrated embodiment, the stiffener 40 is coupled to the first member 36 and the second member 38 to assist in maintaining the spacing between the first beam 32 and the second beam 34. . The stiffener 40 can be provided using any conventional technique. For example, a rigid or semi-rigid support or batten can be provided with a fabric or material that forms part of the headgear. A pocket or other mechanism for selectively attaching the reinforcement member to the headgear is contemplated to allow the amount of reinforcement or stiffening to be changed or removed. Reinforcing a portion of the headgear assembly can also be accomplished by laminating or supplying a curing agent to the portion of the headgear assembly where a reinforcement is required, for example using a screen printing process.

  Perhaps best shown in FIG. 2, when the headgear assembly 30 is worn by the user, the first beam 32 and the second beam 34 bend, ie wrap around the user's head / neck. Since the first and second beams have radii of curvature R1 and R2 as described above, the structure defined by the first and second beams generally has a spherical shape, and the beam is of the human head / neck. Allows a closer fit to the anatomy. This allows the headgear assembly to fit the user securely and stably so as to be comfortable for a wide range of patients.

  Connection members 42a and 42b are attached to each end 44a and 44b of the first beam 32. Similarly, connecting members 46a and 46b are attached to respective ends 48a and 48b of the second beam 34. These connecting members are used to attach the patient interface device to the headgear assembly. In the illustrated embodiment, the connection members extend from the ends of the first and second beams such that the connection members on one side of the headgear assembly (eg, connection members 42a and 46a) are generally parallel to each other.

  In the exemplary embodiment, connecting members 42a, 42b, 46 and 46b are cloth or woven to be flexible and lightweight and are attached to the ends of the first and second beams in any conventional manner. For example, the connecting member can be stitched, stitched or sonic / heat welded to the ends of the first and second beams. The connecting members 42a, 42b, 46 and 46b can have various sizes, shapes and structures.

  The attachment of the connecting member to the first and second beams can be fixed or adjustable and can be selectively removable. For example, the connecting members 42a, 42b, 46 and 46b can be rotatably attached to the first and second beams 32 and 32, the patient interface device, or both. In addition, the connection member may be snapped or other removable connectors so that the connection member can be removed from the first and second beams or interface equipment and reattached for the convenience of the user. Can be connected to the first and second beams, the interface device, or both.

  In order to attach the illustrated connection member to a patient interface device, the present invention contemplates mounting the free end 50 of the connection member in a slot or orifice provided in the patient interface or patient interface connector. For example, as indicated by arrow A in FIG. 4, the free end of the connecting member is then attached to the remaining connecting member. Any conventional technique can be used to attach the free end of the connecting member to itself. For example, hook and loop coupling methods (eg VELCRO®) can be used. In that case, the free end of the connecting member includes one part of a hook and loop fastener, and the other part of the magic tape is provided at one or more locations along the length of the connecting member. . In a further exemplary embodiment, the one or more connecting members or parts thereof are made from a stretchable fastener material, such as VELSTRETCH®, which is a spandex elastic band or strap.

  5-7, a second embodiment of a headgear assembly 60 according to the principles of the present invention will now be described. As in the previous embodiment, the headgear assembly 60 includes first and second beams 62 and 64 and first and second connecting members 66 and 68, respectively. However, in the present embodiment, the first beam 62 includes end portions 70a and 70b separated by the elastic portion 72. The end portions 70a, 70b, the second beam 62, and the first and second connecting members 66 and 68 are defined as a single structure having no semi-rigid stretchability. Examples of materials suitable for forming this monolithic structure include spandex, lycra laminates, rubber bands including silicone strips, VELSTRETCH, or any combination thereof. As shown in FIG. 7, a pad 74 can be provided on the semi-rigid material to maximize patient comfort. The pad 74 can be provided on the majority of the structure as shown, or can be provided only at selected locations.

  The elastic portion of the first beam allows the top beam to adapt to comfortably fit the user. Any suitable elastic material can be used for this portion of the headgear assembly. The present invention contemplates that the size, shape, elasticity, structure, number and location of the elastic portion can be varied from what is shown. For example, the elastic portion can be provided at the second beam 64, the first member 66, the second member 68, the connecting member, the joint of any of these components, or any combination thereof.

  An example of a connection member 80 and associated components suitable for use with any of the headgear assembly embodiments is shown in FIG. In this embodiment, the connecting member 80 is a strap attached to the end of the first or second beam. The strap is attached to a slot 82 provided in the patient interface connector 84. In the illustrated embodiment, patient interface connector 84 is a ball and socket connector that attaches to a coupler provided in patient interface equipment. Similar patient interface connectors and patient interface devices using such connectors are described in US Pat. No. 7,066,179, the contents of which are incorporated herein by reference.

  In this embodiment, free end 86 is connected to clip 88 and connecting member 80 is also threaded through the clip. Moving clip 88 along the length of connecting member 80 changes the effective length of the connecting member, allowing the user to tighten or loosen the patient interface device on the user. A grip 90 is connected to one end of the clip to facilitate moving the clip.

  Various structures of the headgear assemblies 100, 110, 120 and 170 are shown in FIGS. 9-12, respectively. These other structures are provided to illustrate and emphasize that the headgear assembly of the present invention can have a variety of different structures. The headgear assembly in each of these embodiments includes a first beam 102, 112, 122 and 172 having a first radius of curvature and a first divergence angle, and a second beam having a second radius of curvature and a second divergence angle. Beams 104, 114, 124 and 174 are included. FIG. 11 clearly shows that the first and second curves need not be the same. In the present embodiment, the first radius of curvature R1 is less than the second radius of curvature R2. In each embodiment, the first member and the second member that connect the first beam to the second beam include a reinforcing element or region 130.

  These headgear assemblies shown in FIGS. 9-12 include connecting members 140a and 140b attached to the first beam and connecting members 142a and 142b connected to the second beam. The connecting members on each side of the headgear assembly of FIGS. 9-11 extend from the first and second beams to leave at a non-zero angle α. The angle α is measured from the center of the connecting member. However, in the embodiment illustrated in FIG. 12, the angle α between the connecting members 140a and 140b is less than zero (−α). That is, the connecting members do not extend away from each other, but spread out toward each other. The present invention contemplates that the angle α has a range from −10 ° to 20 °. In the embodiment of FIG. 12, the radius of curvature R1 of the first beam 172 and the radius of curvature R2 of the second beam 174 have the same center.

  FIGS. 13 and 14 illustrate a sixth embodiment of a headgear assembly 150 according to the principles of the present invention. As in the previous embodiment, headgear assembly 150 includes first and second beams 152 and 154, respectively, and first and second members 156 and 158 span the first and second beams. The connecting members 162a and 162b are attached to the end portions 160a and 160b of the first beam 152, and the connecting members 166 and 166b are attached to the end portions 164a and 164b of the second beam 154. In this embodiment, the connecting members 162a, 162b are end 160a so that the connecting members can be moved, i.e. turned, as shown by arrow B to suit different types of patient interface devices. , 160b can be rotatably mounted. FIG. 14 also shows a first patient interface device 170 in a relatively low position on the user's face and a second patient interface device 180 (shown in broken lines) in a high position on the face. By allowing the upper connecting member to rotate, the same headgear assembly can be used for a variety of different types of patient interface devices.

  13 and 14, the lower connection members 166a and 166b are not rotatably connected to the second beam. However, the present invention also contemplates that the connection members 166a and 166b are rotatably attached to the end portions 164a and 164b of the second beam 154.

  Patient interface devices 170, 180 connect a gas supply line 190 (commonly referred to as a patient circuit) to the patient's airway. Patient circuit 190 is typically a flexible tube that connects to patient interface equipment. Patient interface devices suitable for use with the headgear assembly of the present invention include nasal masks, oral masks, nasal / oral masks, full face masks, nasal cannulas, chin-mounted masks, or any other that interfaces with the patient's respiratory tract. It should be noted that any conventional patient interface device can be included, including: As shown schematically in FIG. 14, the patient circuit 190 is from a gas flow generator 195 (eg, a conventional pressure support system or ventilator) so that gas is supplied from the gas flow generator to the patient's airway. Feed gas flow.

  The gas flow generator 195 can be any conventional device that accomplishes this function (eg, CPAP device, biphasic device, automatic titrator, or any other pressure support system or ventilator using any conventional therapy delivery mode). Can be. Although the patient circuit 190 is shown in FIG. 14 as being a single limb circuit, the present invention can include multiple rims and other elements (eg, filters, exhaust ports, flow control valves, pressures). It is intended that relief valves, humidifiers and sensors) can be included.

  FIG. 15 illustrates yet another embodiment of a headgear assembly 180 according to the principles of the present invention. In this embodiment, the headgear assembly includes a cross strap 186 that spans the top of the user's head when the headgear assembly is worn by the user. One end 188a of the cross strap 186 is attached to the first portion of the first beam 182 and the other end 188b of the cross strap is attached to the second portion of the first beam. The cross strap 186 is a flexible or semi-rigid member that can be bent to fit the shape of the top of the user's head.

  The present invention contemplates that the cross strap can be attached to the first beam in a fixed (permanent) or separable manner in any conventional manner. For example, end 188a can be permanently coupled to the first beam by being stitched, sewn, or fused. End 188b can be directly, for example, by using hook and loop coupling of the first beam to the cross strap, or indirectly by tying the cross strap to the loop through a lace 190 provided in the first beam, Engage with the second part of the first beam. In that case, the free end of the cross strap can be wrapped around the string hole and reattached to the cross strap as indicated by arrow C. The addition of the cross strap 186 in this manner increases the stability of the mask worn below such as a chin-mounted application or a small nasal-oral application.

  It will be appreciated that the number, type, size, function and other characteristics of objects that can be used as a patient interface device suitable for use with the headgear assembly of the present invention is almost unlimited. For example, the headgear assembly of the present invention can be used to attach other medical devices (eg, spirometers or other monitors) to a patient. On the other hand, the headgear assembly can also be used to attach non-medical devices (eg, gas masks, facial objects, electrical devices or clothing) to the user's head. This document does not attempt to list different types of objects used as interface devices that can be held on the patient's head by the headgear assembly of the present invention.

  Although the present invention has been described in detail for purposes of illustration based on what is presently considered to be the most practical and preferred embodiment, such details are merely for purposes of the present invention and However, it is not intended to be limited to the disclosed embodiments, but rather to cover modifications and equivalent devices that are within the spirit and scope of the appended claims. For example, it is understood that, where possible, the present invention contemplates that one or more features of any embodiment of the present invention can be combined with features of any other embodiment.

Claims (18)

A headgear assembly for attaching an object to a user's head,
A first beam that wraps around the back of the user's neck or the back of the user's head and is flat and disposed in the first plane when flattened and having a first radius of curvature defined in the first plane;
A second curvature that wraps around the back of the user's neck or the back of the user's head, is flat, is placed in the first plane when flattened, and is defined in the first plane in the same orientation as the first radius of curvature A second beam having a radius, and a first member coupling the first beam to the second beam;
A headgear assembly.   The headgear assembly according to claim 1, wherein the first radius of curvature and the second radius of curvature are substantially the same, or the first radius of curvature is greater than the second radius of curvature.   The first beam has a first length and the second beam has a second length and the first length is substantially the same as the second length or the first length The headgear assembly of claim 1, wherein is longer than the second length.   The headgear assembly of claim 1, further comprising a second member that couples the first beam to the second beam.   The headgear assembly according to claim 1, wherein the first beam, the second beam, and the first member are defined as a unitary structure.   The headgear assembly of claim 1, further comprising a reinforcement member selectively coupled to the first beam, the second beam, the first member, or any combination thereof.   The headgear assembly according to claim 1, wherein at least a portion of the first beam, the second beam, and the first member is defined by a stretchable material or a semi-rigid material.   The headgear assembly according to claim 1, wherein the first member is disposed in the first plane when flattened. A first coupling member attached to the first end of the first beam, and a second coupling member attached to the first end of the second beam;
The first and second coupling members are linear, the first end of the first beam and the second end of the second beam are disposed on one side of the headgear assembly, and the first and second beams are disposed on the headgear. The headgear assembly according to claim 1, wherein the first and second coupling members are configured not to be parallel to each other when the assembly is flattened.   The centerline separates the first half of the headgear assembly from the second half of the headgear assembly, and the first beam, the second beam, or both are symmetric about the centerline. Headgear assembly.   The headgear assembly of claim 1, further comprising a coupling member attached to the ends of the first beam, the second beam, or both, wherein the coupling member is straight.   The headgear assembly of claim 11, further comprising an adjustment mechanism coupled to the coupling member for adjusting a length of the coupling member.   12. A headgear assembly according to claim 11, wherein the coupling member is rotatably attached to the ends of the first beam, the second beam or both.   The headgear assembly of claim 11, further comprising a patient interface connector operatively coupled to each coupling member.   15. The headgear assembly of claim 14, wherein the patient interface connector is movable along the length of the coupling member to which the patient interface connector is coupled.   The headgear assembly of claim 11, wherein at least a portion of at least one of the coupling members is defined by a stretchable material.   The headgear assembly according to claim 16, wherein the stretchable material is a fixing material having stretchability.   The headgear assembly according to claim 1, further comprising a cross strap straddling the two portions of the first beam.

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