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US20110072553A1 - Headgear Assembly - Google Patents

Headgear Assembly Download PDF

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Publication number
US20110072553A1
US20110072553A1 US11/849,675 US84967507A US2011072553A1 US 20110072553 A1 US20110072553 A1 US 20110072553A1 US 84967507 A US84967507 A US 84967507A US 2011072553 A1 US2011072553 A1 US 2011072553A1
Authority
US
United States
Prior art keywords
headgear assembly
radius
curvature
headgear
coupling
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US11/849,675
Other languages
English (en)
Inventor
Peter Chi Fai Ho
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Respironics Inc
Original Assignee
RIC Investments LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by RIC Investments LLC filed Critical RIC Investments LLC
Priority to US11/849,675 priority Critical patent/US20110072553A1/en
Priority to EP07841840A priority patent/EP2066192A4/fr
Priority to JP2009527525A priority patent/JP5384345B2/ja
Priority to PCT/US2007/077573 priority patent/WO2008030831A2/fr
Assigned to RIC INVESTMENTS, LLC. reassignment RIC INVESTMENTS, LLC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HO, PETER CHI FAI
Publication of US20110072553A1 publication Critical patent/US20110072553A1/en
Abandoned legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0683—Holding devices therefor

Definitions

  • the present invention generally relates to a headgear adapted to support an object on the head of a user, and, more particularly, to a headgear having curved beams that enable the headgear to assume a spherical configuration when donned by a user.
  • non-invasive ventilation and pressure support therapies involve the placement of a patient interface device, which is typically a nasal mask that covers the nose, a nasal/oral mask that covers the nose and mouth, or full face mask that covers the patient face, on the face of a patient.
  • the patient interface device interfaces the ventilator or pressure support device with the airway of the patient, so that a flow of breathing gas can be delivered from the pressure/flow generating device to the airway of the patient.
  • non-invasive ventilation involves providing ventilatory gas to the airway of a patient without intubating the patient or surgically inserting a tracheal tube in their esophagus.
  • Pressure support therapies involve providing a pressure, such as a continuous positive airway pressure (CPAP) or variable airway pressure, which varies with the patient's respiratory cycle (bi-level pressure support) or with the condition of the patient (auto-titrating pressure support), to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OSA), or congestive heart failure.
  • CPAP continuous positive airway pressure
  • variable airway pressure which varies with the patient's respiratory cycle
  • auto-titrating pressure support to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OSA), or congestive heart failure.
  • OSA obstructive sleep apnea
  • the headgear taught by the '986 patent includes a cap-like headpiece adapted to fit the crown and back of a patient's head.
  • Lower straps provide a two-point connection with a gas delivery mask. Straps depending from the headpiece are connected to and moveable relative to the lower straps. Additionally, a pair of upper straps can be used to provide a four-point connection with the gas delivery mask if needed.
  • Another such headgear also manufactured by Respironics, Inc. includes five straps extending in a star-like manner from a rear joining piece, which is positionable along the rear portion of a patient's head. The three uppermost straps are adapted to fit on the patient's head.
  • a center top strap extends from the joining piece across the top of the patient's head to the patient's forehead.
  • Upper side straps, which are provided on either side of the top strap, extend from the joining piece along the sides of a patient's head above the ears to attach to the top strap at the patient's forehead.
  • the top strap includes a pair of elongated openings through which the upper side straps are threaded.
  • the headgear assembly includes a first beam and a second beam, both of which are adapted to wrap around a back of a user's neck or a back of a user's head.
  • the first beam is generally planer and is adapted to be disposed in a first plane when the headgear assembly is stretched flat. When in this position, the first beam has a first radius of curvature defined in the first plane.
  • the second beam is also generally planer and is adapted to be disposed in the first plane when the headgear assemblies is oriented in a flat position.
  • the second beam has a second radius of curvature defined in the first plane in a same direction as the first radius of curvature.
  • a first member couples the first beam with the second beam.
  • FIG. 1 is a plan view of a portion of a first embodiment headgear assembly according to the principles of the present invention
  • FIG. 2 is a perspective view of the headgear portion shown in FIG. 1 ;
  • FIG. 3 is a plan view a headgear assembly that includes the portion shown in FIG. 1 ;
  • FIG. 4 is a plan view of the headgear assembly of FIG. 3 showing the operation of the coupling members and including reinforcing members;
  • FIG. 5 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 the headgear portion shown in FIG. 5 ;
  • FIG. 7 is a plan view of a portion of an alternative configuration for the second embodiment of the headgear assembly
  • FIG. 8 is a perspective view of a coupling member and associated components
  • FIG. 9 is a plan view of a third embodiment of a headgear assembly according to the principles of the present invention.
  • FIG. 10 is a plan view of a fourth embodiment of a headgear assembly according to the principles of the present invention.
  • FIG. 11 is a plan view of a fifth embodiment of a headgear assembly according to the principles of the present invention.
  • FIG. 12 is a plan view of a sixth embodiment of a headgear assembly according to the principles of the present invention.
  • FIG. 13 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 showing the headgear assembly of FIG. 13 being worn by a user.
  • FIG. 15 is a view showing a headgear assembly according to the principles of the present invention with an optional cross-bar.
  • FIGS. 1-4 illustrate an exemplary first embodiment of a headgear assembly 30 and portions thereof according to the principles of the present invention.
  • Headgear assembly 30 includes a first beam 32 and a second beam 34 , both of which are adapted to wrap around a back of a user's neck or a back of a user's head.
  • first beam 32 is closer to the top of the head than the second beam, which is closer the neck.
  • the first beam is also considered the “top” beam and the second beam is considered the “bottom” beam relative to their respective orientation on the user.
  • First beam 32 and second beam 34 are generally planer, i.e., are relative thin, and are flexible or semi rigid. As such, when the headgear assembly is stretched flat, they are disposed in a first plane. In other words, when the headgear assembly is lying flat, such as on a flat surface, the first beam and the second beam also lie flat on that surface.
  • First beam 32 is curved along its length such that it has a first radius of curvature R 1 defined in the first plane.
  • Second beam 34 is also curved with respect to its lengthwise axis such that it has a second radius of curvature R 2 that is also defined in the first plane.
  • the first radius of curvature R 1 and the second radius of curvature R 2 are in the same direction.
  • the first radius of curvature R 1 ranges from 25-42 inches
  • the second radius of curvature R 2 ranges from 5-18 inches.
  • the present invention also contemplates that the first radius of curvature and the second radius of curvature need not can be the same, assuming that the center of the radius of curvatures are different, or they can different.
  • First beam 32 and second beam 34 can also be described in terms of their respective degrees 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 for that beam.
  • first beam 32 the degree of spread is indicated by angle ⁇ in FIG. 3 .
  • the degree of spread for second beam 34 is indicated by angle ⁇ .
  • the angle of spread for each beam ranges from 8° to 55°. It can be appreciated that the angle of spread will be dictated by where the ends of the first beam and second beams are defined. Thus, smaller and greater angles are possible depending on where one considered the ends of the first beam and second to be.
  • a first member 36 couples the first beam with the second beam.
  • a second member 38 couples the first beam with the second beam. While two members 36 and 38 are shown in the illustrated embodiments coupling the first and second beams, it is to be understood that one member is sufficient to join these beams. Conversely, more than two such member can be provided.
  • First member 36 , second member 38 , and any other such members can have any one of a variety of shapes, sizes, and configurations.
  • First beam 32 , second beam 34 , first member 36 , and second member 38 in this first exemplary embodiment are formed so that the overall structure is rigid or semi-rigid. For present purposes, “semi-rigid” means that these structures retain their shape when no load is applied on them, but flex to some degree to allow them to conform to the patient to reduce pressure points when a load is applied.
  • first beam 32 , second beam 34 , first member 36 , and second member 38 are formed as a unitary structure. More specifically, the present invention contemplates that the entire structure defined by first beam 32 , second beam 34 , first member 36 , and second member 38 is formed from a fabric or cloth material, such as UBL (unbreakable loop backing), perforated neoprene (breathable rubber), a foam lamination with at least one side formed from UBL, or a Lycra laminated with a foam.
  • a pad or cushion may be provided at one more locations, or over the entire structure, to provide a soft surface that contacts the user. Examples of suitable materials for such a pad or pads includes, foam, cloth, silicon, rubber, or any combination thereof.
  • the present invention contemplates providing reinforcements 40 at various locations on the headgear assembly.
  • reinforcements 40 are associated with first member 36 and second member 38 to assist in maintaining the spacing between first beam 32 and second beam 34 .
  • Reinforcements 40 can be provide using any conventional technique.
  • a rigid or semi-rigid support or batten can be provided in the fabric or material forming the portion of the headgear.
  • Reinforcing portions of the headgear assembly can also be accomplished by laminating or providing a stiffening agent, such as through screen printing process, on the portion of the headgear assembly where reinforcement is desired.
  • first beam 32 and second beam 34 bend or wrap around the head/neck of the user. Because the first and second beams have a radius of curvature R 1 and R 2 , as described above, the structure defined by the first and second beams has a generally spherical shape, enabling the beams to conform more closely to the anatomy of the human head/neck. The allows the headgear assembly to fit the user in a firm, stable fashion that is also comfortable over a wide range of patient populations.
  • Coupling members 42 a and 42 b are attached to each end 44 a and 44 b of first beam 32 .
  • coupling members 46 a and 46 b are attached to each end 48 a and 48 b of second beam 34 .
  • These coupling member are used to attach a patient interface device to the headgear assembly.
  • the coupling member extend from the ends of the first and second beams such that the coupling member on one side of the headgear assembly, e.g., coupling member 42 a and 46 a , are generally parallel to one another.
  • coupling members 42 a , 42 b , 46 , and 46 b are cloth or fabric so that they are flexible and lightweight and are attached to the ends of the first and second beams in any conventional manner.
  • the coupling member can be stitched, sewn, or sonic/heat welded onto the ends of the first and second beams.
  • the present invention contemplates that coupling members 42 a , 42 b , 46 , and 46 b can have a variety of sizes, shapes, and configurations
  • the present invention also contemplates that the attachment of the coupling members to the first and second beams can be fixed or adjustable, and can be selectively detachable.
  • coupling members 42 a , 42 b , 46 , and 46 b can be rotatably attached to first and second beams 32 and 32 , the patient interface device, or both.
  • the coupling members can be connected to the first and second beams, the interface device, or both via a snap or other detachable connectors so that the coupling member can be detached and reattached from the first and second beams or the interface device at the user's convenience.
  • the present invention contemplates threading a free end 50 of the coupling member through a slot or orifice provide in the patient interface or in a patient interface connector.
  • the free end of the coupling member is then attached to the rest of the coupling member, as shown, for example, by arrow A in FIG. 4 .
  • Any conventional technique can be used to attached the free end of the coupling member to itself.
  • a hook and loop fastening method such as VELCRO®
  • the free end of the coupling member includes one part of the hoop and loop fastener, and the other part of the hook and loop fastener is provided at one or more locations along the length of the coupling member.
  • one or more of the coupling members, or portions thereof are made from a stretchable fastening material, such as VELSTRETCH®, which is a spandex elastic band or strap.
  • headgear assembly 60 includes first and second beams 62 and 64 , respectively, and first and second coupling members 66 and 68 .
  • first beam 62 includes end portions 70 a and 70 b separated by an elastic portion 72 .
  • End portions 70 a , 70 b , second beam 62 , and first and second coupling members 66 and 68 are defined as a unitary structure that is semi-rigid, non-stretchy.
  • a pad 74 may be provided over the semi-rigid material to maximize patient comfort. Pad 74 can be provided over a majority of the structure, as shown, or it can be provided only at selected locations.
  • the elastic portion of the first beam allows the top beam to adjust to fit the user in comfort.
  • Any suitable elastic may be used for this portion of the headgear assembly.
  • the present invention contemplates that the size, shape, elasticity, configuration, number, and locations of the elastic portions can be changed from that shown.
  • elastic portions can be provided in second beam 64 , first member 66 , second member 68 , the coupling members, the junctions of any of these components, or any combination thereof.
  • coupling member 80 is a strap attached for an end portion of the first or second beam. The strap is threaded through a slot 82 provided in a patient interface connector 84 .
  • patient interface connector 84 is a ball-and-socket connector that attaches to a coupling provided on the patient interface device.
  • a similar patient interface connector and patient interface device using such as connector is described in U.S. Pat. No. 7,066,179, the contents of which are incorporated herein by reference.
  • a free end 86 is coupled to a clip 88 , and coupling member 80 is also threaded through the clip. Moving clip 88 along the length of coupling member 80 changes the effective length of the coupling member, allowing the user to tighten or loosen the patient interface device on the user. To facilitate moving the clip a grip 90 is connected to one end of the clip.
  • FIGS. 9-12 Various configurations for headgear assemblies 100 , 110 , 120 , and 170 are shown in FIGS. 9-12 , respectively. These alternative arrangements are provided to illustrate and emphasize that the headgear assembly of the present invention can have a variety of different configurations.
  • 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 angle of spread, and a second beam 104 , 114 , 124 , and 174 having a second radius of curvature and a second angle of spread.
  • FIG. 11 clearly illustrates that the first and second curvature need not be the same.
  • the first radius of curvature R 1 is less than the second radius of curvature R 2 .
  • the first member and second member that couple the first beam to the second beam includes a reinforcing element or region 130 .
  • These headgear assemblies shown in FIGS. 9-12 also include coupling members 140 a , 140 b attached to the first beam and coupling members 142 a , 142 b coupled to the second beam.
  • the coupling members on each side of the headgear assembly in FIGS. 9-11 extend away from the first and second beams at a non-zero angle ⁇ .
  • Angle ⁇ is measured from the center of the coupling member.
  • angle ⁇ between coupling members 140 a and 140 b is less than zero ( ⁇ ). That is, the coupling members diverge toward one another, rather than extend away from one another.
  • angle ⁇ has a range of ⁇ 10° to 20°.
  • radius of curvature R 1 for first beam 172 and radius of curvature R 2 for second beam 174 originate from the same center centers.
  • FIGS. 13 and 14 illustrate a sixth embodiment of a headgear assembly 150 according to the principles of the present invention.
  • 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.
  • Coupling members 162 a , 162 b are attached to end portions 160 a , 160 b of first beam 152
  • coupling members 166 , 166 b are attached to end portions 164 a , 164 b of second beam 154 .
  • coupling members 162 a , 162 b are rotatably attached to end portions 160 a , 160 b so that the coupling member can be moved, i.e., rotated, as indicated by arrows B to suit different types of patient interface devices.
  • FIG. 14 also illustrates a first patient interface device 170 that is situated relatively low in the face of the user, and a second patient interface device 180 (shown in dashed lines) that is situation higher on the face. Giving the upper coupling members the ability to rotate allows the same headgear assembly to be used on a variety of different types of patient interface devices.
  • lower coupling members 166 a and 166 b are not rotatably coupled to the second beam. It is to be understood, however, that the present invention also contemplates rotatably attaching coupling members 166 a and 166 b to end portions 164 a , 164 b of second beam 154 .
  • Patient interface device 170 , 180 couples a gas delivery conduit 190 , typically referred to as a patient circuit, to an airway of the patient.
  • Patient circuit 190 is typically a flexible tube that is coupled to the patient interface device.
  • patient interface device suitable for use with the headgear assembly of the present invention can be any conventional patient interface device, including a nasal mask, oral mask, nasal/oral mask, full face mask, nasal cannula, chin mounted mask, or any other device that interfaces with an airway of a patient.
  • patient circuit 190 communicates a flow of gas from a gas flow generating device 195 , such as a conventional pressure support system or ventilator, so that gas is delivered from the gas flow generator to the airway of the patient.
  • Gas flow generating device 195 can be any conventional device that accomplishes this function, such as a CPAP device, bi-level device, auto-titrating device, or any other pressure support system or ventilator using any conventional mode of therapy delivery.
  • patient circuit 190 is illustrated in FIG. 14 as being a single limb circuit, the present invention contemplates that the patient circuit can include multiple limbs and can include other elements, such as filters, exhaust ports, flow control valve, pressure relief valves, humidifiers, and sensors.
  • FIG. 15 illustrates yet another embodiment of a headgear assembly 180 according to the principles of the present invention.
  • the headgear assembly includes a cross strap 186 that spans the top of the user's head when the headgear assembly is donned by the user.
  • One end 188 a of cross strap 186 is attached to a first portion of first beam 182
  • another end 188 b of the cross straps is attached to a second portion of the first beam.
  • Cross strap 186 is a flexible or semi-rigid member that is capable of flexing or molding to the shape of the top of the user's head.
  • the cross strap can be attached to the first beam in any conventional manner; in either a fixed (permanent) or separable manner.
  • end 188 a can be permanently bonded to the first beam by being sewn, stitched, or welded.
  • End 188 b engages the second portion of first beam either directly, e.g., using a hook-and-loop engagement of the first beam to the cross strap, or indirectly, e.g., by looping the cross strap through an eyelet 190 provided on the first beam.
  • the free end of the cross strap can be looped over the eyelet and attached back to the cross strap, as indicated by arrow C.
  • This addition of cross strap 186 adds stability for lower mounting masks, such chin mount or small oral-nasal applications.
  • the present invention contemplates that the headgear assembly of the present invention can be used to attach other medical devices to the patient, such as a spirometer or other monitor, to the patient.
  • the headgear assembly can also be used to attach non-medical devices to the head of the user, such as gas masks, cosmetic objects, electronic devices, or apparel. No attempt is made in this disclosure to list the different types of objects that can serves as interface devices that can be held on the head of the patient by the headgear assembly of the present invention.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Helmets And Other Head Coverings (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
US11/849,675 2006-09-07 2007-09-04 Headgear Assembly Abandoned US20110072553A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US11/849,675 US20110072553A1 (en) 2006-09-07 2007-09-04 Headgear Assembly
EP07841840A EP2066192A4 (fr) 2006-09-07 2007-09-05 Dispositif de harnais
JP2009527525A JP5384345B2 (ja) 2006-09-07 2007-09-05 ヘッドギアアセンブリ
PCT/US2007/077573 WO2008030831A2 (fr) 2006-09-07 2007-09-05 Dispositif de harnais

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US84274106P 2006-09-07 2006-09-07
US11/849,675 US20110072553A1 (en) 2006-09-07 2007-09-04 Headgear Assembly

Publications (1)

Publication Number Publication Date
US20110072553A1 true US20110072553A1 (en) 2011-03-31

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Family Applications (1)

Application Number Title Priority Date Filing Date
US11/849,675 Abandoned US20110072553A1 (en) 2006-09-07 2007-09-04 Headgear Assembly

Country Status (4)

Country Link
US (1) US20110072553A1 (fr)
EP (1) EP2066192A4 (fr)
JP (1) JP5384345B2 (fr)
WO (1) WO2008030831A2 (fr)

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JP5384345B2 (ja) 2014-01-08
WO2008030831A2 (fr) 2008-03-13
EP2066192A4 (fr) 2009-08-26
WO2008030831A3 (fr) 2008-06-26
JP2010509942A (ja) 2010-04-02
WO2008030831A9 (fr) 2008-04-24
EP2066192A2 (fr) 2009-06-10

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