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
• • 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
• • 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
  • A61M2209/00—Ancillary equipment
  • A61M2209/08—Supports for equipment

Definitions

• the present invention generally relates to patient interface assemblies for use in a pressure support system that supplies a flow of gas to the airway of a patient, and, more particularly, to patient interface assemblies that are held securely to the head of a patient without the use of a conventional headgear assembly.
• NMV no n- invasive ventilation
• CPAP continuous positive airway pressure
• V variable airway pressure
• OSA obstructive sleep apnea
• COPD chronic obstructive pulmonary disease
• CHF congestive heart failure
• a patient interface device which is typically a nasal or nasal/oral mask (i.e., a full face mask), on the face of a patient to interface the ventilator or pressure support system 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.
• a patient interface device typically a nasal or nasal/oral mask (i.e., a full face mask)
• patient interface devices typically include a mask shell having a cushion attached to the shell that contacts, and seals against, the surface of the patient.
• the mask shell and cushion are held in place by a headgear that wraps tightly around the head of the patient.
• the mask and headgear form the patient interface assembly.
• a typical headgear includes flexible, adjustable straps that extend from the mask around the sides, back and top of a patient's head in order to secure the mask snugly to the patient's head.
• Such straps are used to aid in proper placement and to compress the mask and cushion to the patient's face in order to provide proper seal.
• Several issues commonly arise from the use of such straps for mask attachment the straps are uncomfortable on the patient's head, the straps slip on the patient's hair and cause sealing issues, the straps can be adjusted improperly and cause the mask to sit on the wrong location on the patient's face, the straps can cause undesired perspiration, and overtightening the straps can cause the mask to place too much pressure on sensitive facial skin.
• a patient interface assembly for use in a system delivering a flow of treatment gas from a pressure generating device to the airway of a patient.
• the patient interface assembly comprises: a pillow member structured to accommodate the patient's head thereon; a support member disposed above the pillow member; and a mask assembly coupled to the support member.
• the mask assembly includes a cushion structured to sealingly engage at least one of the nasal or oral orifices of the patient and the cushion is structured to be coupled to the pressure generating device for delivering the flow of treatment gas to the airway of the patient.
• the support member may be generally arcuate in shape.
• the support member may comprise a first end and an opposite second end and the first end and the opposite second end may be coupled to or near the pillow member.
• the support member may comprise a first portion extending from the first end and a second portion extending from the second end the first and second portions may be selectively coupled.
• the first and second portions may be selectively coupled by at least one of: a latch mechanism, a hook and loop fastener, or a snap.
• the support member may be generally rigid.
• the support member may comprise a first end and an opposite second end, only one of the first end and the opposite second end being coupled to or near the pillow member.
• the one of the first end and the opposite second end may be hingedly coupled to or near the pillow member.
• the cushion may be slidingly coupled to the support member.
• the patient interface assembly comprises: a pillow member structured to accommodate the patient's head thereon, the pillow member including a number of first coupling portions and a mask assembly.
• the mask assembly comprises: a cushion structured to sealingly engage at least one of the nasal or oral orifices of the patient, the cushion being adapted to receive the flow of treatment gas from a pressure generating device; and a number of strap members coupled to and extending from the cushion, each strap member of the number of strap members having at least one second coupling portion.
• Each of the second coupling portions are adapted to be selectively coupled to at least one of the first coupling portions.
• first coupling portions and the second coupling portions may be
• Each strap member may include an elastic portion disposed between the cushion and the second coupling portion.
• FIG. 1 is an isometric view of an example embodiment of a patient
• interface assembly according to the principles of the present invention shown (schematically) connected to a gas flow/pressure generating system to form a pressure support system;
• FIG. IB is a cross sectional view of the patient interface assembly of FIG.
• FIG. 2 is an isometric view of another example embodiment of a patient interface assembly according to the principles of the present invention shown
• FIG. 3 is an isometric view of yet another example embodiment of a patient interface assembly according to the principles of the present invention shown
• the word "unitary” means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a “unitary” component or body.
• the statement that two or more parts or components "engage” one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components.
• the term “number” shall mean one or an integer greater than one (i.e., a plurality).
• the phrase “pillow member” shall refer to any suitable member or assembly for supporting the head of a patient thereon.
• the phrase “generally rigid” shall refer to any suitable material that has a relative stiffness great enough to at least retain a desired predetermined shape.
• top, bottom, left, right, upper, lower, front, back, and derivatives thereof relate to the orientation of the elements shown in the drawings and are not intended to be limiting upon the claims unless expressly recited therein.
• FIGS. 1-3 illustrate example embodiments of systems 10, 10', 10" for administering a treatment gas to the airway of a patient without the use of a conventional headgear according to the principles of the present invention.
• system 10 includes a patient interface assembly, shown generally at 12, for communicating a flow of breathing gas between the patient's airway (via at least one of the patient's nasal or oral orifices) and a pressure/flow generating system 14 (shown schematically), such as a ventilator, CPAP device, or variable pressure device, e.g., a BiPAP ® device manufactured and distributed by Philips Respironics, Inc. of Pittsburgh, Pa., or an auto-titration pressure support system.
• a ventilator CPAP device
• variable pressure device e.g., a BiPAP ® device manufactured and distributed by Philips Respironics, Inc. of Pittsburgh, Pa., or an auto-titration pressure support system.
• a BiPAP ® device is a bi-level device in which the pressure provided to the patient varies with the patient's respiratory cycle, so that a higher pressure is delivered during inspiration than during expiration.
• An auto-titration pressure support system is a system in which the pressure varies with the condition of the patient, such as whether the patient is snoring or experiencing an apnea or hypopnea.
• pressure/flow generating system 14 is also referred to as a gas flow generating device, because gas flow results when a pressure gradient is generated.
• pressure/flow generating system 14 is any conventional system for delivering a flow of gas to an airway of a patient or for elevating a pressure of gas at an airway of the patient, including the pressure support systems summarized above and noninvasive ventilation systems.
• Communicating a flow of breathing gas between the patient's airway and pressure/flow generating system 14 includes delivering a flow of breathing gas to the patient from the pressure/flow generating device 14 and exhausting a flow of gas from the patient to ambient atmosphere.
• System 10 further includes a conduit 16 (shown schematically), which is also referred to as a patient circuit, having a first end portion (not numbered) operatively coupled to the gas flow generating device and a second end portion (not numbered) coupled to patient interface assembly 12 such that conduit 16 carries the flow of gas from pressure/flow generating device 14 during operation of the system to patient interface assembly 12.
• Conduit 16 corresponds to any structure suitable for communicating the flow of gas from pressure/flow generating device 14 to patient interface assembly 12.
• a typical conduit is a flexible tube.
• patient interface assembly 12 includes a pillow member 18 structured to accommodate the patient's head thereon.
• pillow member 18 comprises a cushiony pillow such as commonly used for supporting a human head during sleep, it is to be appreciated, however, that other suitable structures for supporting the head of a patient, whether in a lying or seated position, may be employed without varying from the scope of the present invention.
• Patient interface assembly 12 further includes a support member 20 having a mask assembly 22 coupled thereto.
• Support member is positioned such that mask assembly 22 is disposed generally above pillow member 18.
• mask assembly 22 may be fixedly coupled or slidingly coupled to support member 20.
• support member 20 is formed in a generally arcuate shape from a generally rigid material and includes a first end 20a and an opposite second end 20b.
• first and second ends 20a, 20b may be coupled directly or indirectly to pillow member 18.
• first and second ends 20a, 20b may also be suitably coupled to another fixed member near pillow member 18 as long as support member 20 is provided above pillow member 18 substantially as shown in FIG. 1.
• mask assembly 22 includes a shell
• cushion 24 is structured to sealingly engage at least one of the nasal and/or oral orifices of the patient. Although shown in the illustrated embodiment as being an oral/nasal cushion which encompasses both the nasal and oral orifices of the patient, it is to be appreciated that cushion 24 may encompass either the nasal or oral orifices alone, or encompass both separately, without varying from the scope of the present invention.
• cushion 24 is coupled to conduit 16, via shell portion 23, in a manner such that the flow of gas is communicated to the interior of cushion 24 through a passage (not numbered) in shell portion 23 for subsequent delivery to the patient. Conversely, gas exhaled from the patient is communicated from cushion 24 into conduit 16 via the passage in shell portion 23, where an exhaust port (not numbered) is located.
• shell portion 23 is formed from a generally rigid material, such as polycarbonate. It is to be understood that the present invention contemplates that one or more of the size, shape, or composition of shell portion 23 may be varied without varying from the scope of the present invention.
• cushion 24 is
• cushion 24 is coupled to conduit 16 via shell portion 23, it is to be appreciated, however, that cushion 24 may also be directly coupled to conduit 16 without varying from the scope of the present invention.
• support member 20 may be formed by two portions selectively coupled together.
• support member 20 includes a first portion 25 extending from first end 20a and a second portion 26 extending from second end 20b.
• First and second portions 25, 26 are selectively coupled via a clip mechanism, however, other means such as hook and loop structures, snaps, or other suitable mechanisms may be employed without varying from the scope of the present invention.
• support member 20 may also be provided with one or more adjustment mechanisms (not numbered) which provide for one or more of the length and/or relative height of support member 20 to be adjusted in order to provide for initial fitment of patient interface assembly 12 to the head of a patient.
• patient interface assembly 12 provides a patient experience that overcomes many of the drawbacks of known interfaces previously discussed.
• FIG. 2 shows another example embodiment of a system 10' for use in administering a treatment gas to the airway of a patient without the use of a conventional headgear according to the principles of the present invention.
• system 10' includes a patient interface assembly, shown generally at 12', for communicating a flow of breathing gas between a patient's airway (via at least one of the patient's nasal or oral orifices) and a pressure/flow generating system 14 (shown schematically), to which patient interface assembly 12' is coupled via a conduit 16.
• Patient interface assembly 12' similar to patient interface assembly 12, includes a pillow member 18 structured to accommodate the patient's head thereon. Unlike support member 20 of system 10 which was coupled at or near pillow member 18 at both ends, patient interface assembly 12' includes a support member 20' that is only coupled at or about pillow member 18 by a first end 20a', and thus includes an opposite second end 20b' which is freely disposed generally above a portion of pillow member 18. More particularly, support member 20' is hingedly coupled to a fixed point at or about pillow member 18 such that support member 20' (and thus opposite second end 20b') may pivot about an axis 28 in order to allow a patient's head to be generally disposed thereunder, such as shown in the illustrated embodiment of FIG. 2.
• a lock mechanism (not shown), is provided at or about axis 28 which inhibits movement of support member 20' about axis 28, and thus may be used to effectively lock support member 20' in a lowered position over the head of a patient.
• support member 20' is
• first end 20a' may be varied without varying from the scope of the present invention.
• support member 20' includes a cushion 24' coupled to an underside (not numbered) thereof which is coupled to conduit member 16 for communicating a flow of breathing gas between a patient's airway (via at least one of the patient's nasal or oral orifices) and pressure/flow generating system 14.
• Cushion 24' like cushion 24 previously described, is structured to sealingly engage at least one of the nasal and/or oral orifices of the patient.
• cushion 24' may encompass either the nasal or oral orifices alone, or encompass both separately, without varying from the scope of the present invention.
• cushion 24' is coupled directly to conduit 16, such that the flow of gas from pressure/flow generating system 14 is communicated to the interior of cushion 24' for subsequent delivery to the patient. Conversely, gas exhaled from the patient is communicated from cushion 24' into conduit 16, where an exhaust port (not numbered) is located.
• support member 20' may include a passage (not shown) formed therein which serves as an intermediary connection between conduit 16 and cushion 24'.
• support member 20' is rotated upward allowing a patient's head to be rested on pillow member 18.
• support member 20' is rotated downward until cushion 24' engages the appropriate portion of the patient's face such that cushion 24' sealingly surrounds the appropriate one or both of the patient's nasal and/or oral orifices.
• support member 20' is locked in place via the lock mechanism.
• an adjustment mechanism may be provided which allows for the relative of height of first end 20a' to be adjusted relative to the patient's head.
• patient interface assembly 12' provides a patient experience that overcomes many of the drawbacks of known patient interfaces.
• FIG. 3 shows yet another example of a system 10" for use in administering a treatment gas to the airway of a patient without the use of a conventional headgear according to the principles of the present invention.
• system 10 includes a patient interface assembly, shown generally at 12", for communicating a flow of breathing gas between a patient's airway (via at least one of the patient's nasal or oral orifices) and a pressure/flow generating system 14 (shown schematically), to which patient interface assembly 12" is coupled via a conduit 16.
• patient interface assembly 12" includes a pillow member 18" structured to accommodate the patient's head thereon. However, unlike pillow members 18 previously discussed, pillow member 18" includes a number of first coupling portions 32, the function of which is discussed in detail below. [41] Continuing to refer to FIG. 3, patient interface assembly 12" further includes a mask assembly 22" including a mask shell 23" and a cushion 24" structured to sealingly engage at least one of the nasal or oral orifices of the patient. Cushion 24" may be of conventional shape such as used in known applications and may be of an oral, nasal, or oral/nasal, design depending on the particular application.
• Cushion 24" is coupled to conduit 16 and thus adapted to receive a flow of treatment gas from pressure generating device 14.
• Mask assembly 22" further includes a number of strap members 34 coupled to and extending from one of mask shell 23" or cushion 24".
• Each strap member 34 includes at least one second coupling portion 36 adapted to be selectively coupled to at least one of first coupling portions 32 of pillow member 18".
• Each of first coupling portions 32 and second coupling portions 36 may be selectively coupled via a magnetic force provided by a magnetic material, and a corresponding material provided in each of portions 32 and 36.
• suitable mechanisms which provide for selective coupling may be employed without varying from the scope of the present invention. Examples of such mechanisms include, without limitation, snaps and hook and loop fasteners.
• each of strap members 34 are then coupled to pillow member 18" via coupling of corresponding first and second coupling portions 32 and 36.
• one or more of strap members 34 may be provided with an elastic portion 38 or other adjustment mechanism which allows for selective sizing of strap members 34.
• each of first coupling portions are preferably spaced a distance D such that when mask assembly 22" is disposed on a patient's face each of strap members 34 are generally disposed a distance from the sides of the patient's head, and thus not a nuisance to the patient.
• embodiments of the present invention provide patient interface assemblies that readily deliver a flow of treatment gas to the airway of a patient without having to utilize a tight fitting convention headgear assembly. Instead, embodiments of the present invention provide generally open, less restrictive mechanisms for suitably securing a mask to the head of a patient which provide for greater patient comfort than conventional interface assemblies.
• any reference signs placed between parentheses shall not be construed as limiting the claim.
• the word “comprising” or “including” does not exclude the presence of elements or steps other than those listed in a claim.
• several of these means may be embodied by one and the same item of hardware.
• the word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements.
• any device claim enumerating several means several of these means may be embodied by one and the same item of hardware.
• the mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.

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• Health & Medical Sciences (AREA)
• Emergency Medicine (AREA)
• Pulmonology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
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• General Health & Medical Sciences (AREA)
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• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
• Orthopedics, Nursing, And Contraception (AREA)

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• 2013
  • 2013-07-16 WO PCT/IB2013/055841 patent/WO2014020473A2/fr not_active Ceased

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