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
  • A61M16/0666—Nasal cannulas or tubing
• • 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
  • A61M16/0057—Pumps therefor
  • A61M16/0066—Blowers or centrifugal pumps
• • 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
  • A61M16/04—Tracheal tubes
• • 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
  • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
  • A61M16/0875—Connecting tubes
• • 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
  • A61M16/20—Valves specially adapted to medical respiratory devices
• • 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
  • A61M16/20—Valves specially adapted to medical respiratory devices
  • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves

Definitions

• the present invention pertains to an interface system for use in providing a flow of pressurized gas to a patient, and, in particular, to an interface system having a manually actuated valve structured to selectively impede the flow of pressurized gas to the patient.
• the invention also relates to a conduit having such a valve and to a method of providing a flow of pressurized gas to a patient using such a valve.
• Typical pressure support therapies are provided to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OS A), or congestive heart failure.
• a medical disorder such as sleep apnea syndrome, in particular, obstructive sleep apnea (OS A), or congestive heart failure.
• OS A obstructive sleep apnea
• a supply of pressurized gas is typically supplied to a patient through a patient interface, such as a nasal, oral, or combination nasal/oral mask. While wearing such an interface that is providing pressure, a patient commonly experiences difficulty speaking. Such difficulty generally occurs most dramatically in nasal masks, but is also a problem in full face mask applications, commonly used to treat obstructive sleep apnea. In such instances, as a person attempts to speak, they must fight the pressure and flow of the gas supply. This causes the patient's voice to become distorted, which is a major inconvenience to the user. If a person attempts to remove the mask as they speak, they risk changing or losing the seal as they re-apply the mask. Noise also generally increases in mask removal as the machine (typically CPAP) ramps up flow in an attempt to reach nominal pressure, without resistance. To stop the flow, and speak comfortably, the user must shut off the machine, which could be located an inconvenient distance away.
• CPAP typical CPAP
• the interface system comprises a patient interface structured to communicate a flow of gas to an airway of a patient.
• a conduit is coupled to the patient interface.
• the conduit is structured to communicate the flow of pressurized gas to the patient interface.
• a valve mechanism is disposed in or about the conduit.
• the valve mechanism is structured to selectively impede the flow of pressurized gas to the patient.
• the valve mechanism includes a manually manipulated element to enable a user actuate the valve mechanism so that the user can control the application of the flow of the gas to his or her airway. This is advantageous, for example, so that the user can substantially block the flow when he/she desires to speak, so that the user is not attempting to talk against a flow of gas.
• a conduit for use in providing a flow of pressurized gas to a patient comprises a housing having a first end and an opposite second end, the first end being structured to be coupled to a patient interface and the second end being structured to be coupled to a pressurized gas supply.
• the housing is structured to communicate the flow of pressurized gas therethrough.
• the conduit also comprises a valve mechanism coupled to the housing.
• the valve mechanism comprises a gate member selectively moveable between a first position in which the gate member is structured to generally not impede the flow of pressurized gas through the housing and a second position in which the gate member is structured to impede the flow of pressurized gas through the housing.
• the valve mechanism includes a manually manipulated element to enable a user actuate the valve mechanism so that the user can control the application of the flow of the gas to his or her airway.
• a method of providing a supply of pressurized gas to a patient comprising providing an interface system structured to engage a nasal and/or oral orifice of the patient, providing a flow of gas to the interface system, and providing a valve mechanism in the flow of gas.
• the valve mechanism including a manually manipulated element to enable a user actuate the valve mechanism so that the user can selectively impede the flow of pressurized gas to the patient when activated by the patient.
• FIG. 1 is a schematic diagram of a pressure support system according to the principles of the present invention
• FIG. 2 is a schematic side view of an example valve mechanism according to a non-limiting embodiment of the present invention.
• FIG. 3A is a schematic cross-sectional view of the example valve mechanism of FIG. 2;
• FIG. 3B is a schematic cross sectional end view of the example valve mechanism of FIG. 2 along B-B;
• FIGS. 4-6 are schematic views of an example valve mechanism according to another non-limiting embodiment of the present invention.
• FIGS. 7 and 8 are schematic views of further example valve mechanisms according to non-limiting embodiments of the present invention.
• FIG. 9 is a schematic exploded view of a further example valve mechanism according to a further non-limiting embodiment of the present invention.
• FIG. 10 is a schematic view of the example valve mechanism of FIG. 9 along C-C.
• fixed means that two components are coupled so as to move as one while maintaining a constant orientation relative to each other.
• 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 present invention addresses shortcomings of the prior art by placing a valve in, adjacent to, or in general proximity thereof, the patient interface system, in the pressurized gas flow channel.
• the purpose of the valve is to momentarily stop, or significantly restrict, the flow of pressurized gas to the patient and allow for talking. If a patient wants to speak, they can simply actuate the valve, and speak with ease, while staying in the same comfortable position as before.
• the valve Upon being released by the patient, the valve automatically returns to the unactivated state. This automatic return to the unactivated (open) state avoids the problem with the user forgetting to manually change the position of the valve.
• the valve has validity in home and hospital use, and
• FIG. 1 is a schematic diagram of pressure support system 10 according to one particular, non-limiting embodiment in which the present invention in its various embodiments may be implemented.
• pressure support system 10 includes a gas flow generator 12, such as a blower used in a conventional CPAP or bi- level pressure support device, which receives breathing gas, generally indicated by arrow C, from any suitable source, e.g., a pressurized tank of oxygen or air, the ambient atmosphere, or a combination thereof.
• Gas flow generator 12 generates a flow of breathing gas, such as air, oxygen, or a mixture thereof, for delivery to an airway of a patient 14 at relatively higher and lower pressures, i.e., generally equal to or above ambient atmospheric pressure.
• gas flow generator 12 is capable of providing a flow of breathing gas generally ranging in pressure from 3-30 cmH 2 0.
• the pressurized flow of breathing gas, generally indicated by arrow D, from gas flow generator 12 is delivered via a delivery conduit 16 to a patient interface 18.
• Patient interface 18 can be of any known construction, such as a nasal mask, nasal/oral mask, nasal cannula, total face mask, tracheal tube, endotracheal tube, or any other device that is typically worn by, or otherwise attached to, patient 14 to communicate the flow of breathing gas to the airway of patient 14.
• Delivery conduit 16 is also typically referred to as a patient circuit.
• an interface system is defined as the combination of a patient interface and at least a portion of conduit 16.
• exhaust vent 17 is provided in delivery conduit 16 for venting exhaled gasses from the system, as indicated by arrow E. It should be noted that exhaust vent 17 can be provided at other locations in addition to, or instead of, in delivery conduit 16, such as in patient interface 18. It should also be understood that exhaust vent 17 can have a wide variety of configurations depending on the desired manner in which gas is to be vented from pressure support system 10.
• pressure support system 10 further includes a talk valve 20 disposed along delivery conduit 16.
• a valve mechanism 20 is provided to allow a patient to selectively temporarily stop, or substantially stop, the pressurized flow of gas being delivered to the patient. This complete or partial cessation of the flow of gas to the airway of the patient allows the patient to speak without interference from the pressurized gas flow.
• valve mechanism 20 can be provided at other locations in addition to, or instead of, in delivery conduit 16, such as in patient interface 18 adjacent delivery conduit 16. However, it is generally desirable that valve mechanism 20 be located at a position that is readily and comfortably accessed by a patient.
• valve mechanism 20 may be constructed similar to a butterfly valve, such that a rotating plate or gate member 22 is disposed within delivery conduit 16.
• gate member 22 is of similar size and shape as the internal cross-section (not numbered) of conduit 16 such that when positioned as shown in solid line in FIGS. 3A and 3B, gas flow D is completely, or at least substantially, stopped.
• Gate member 22 is moveable among a first position (shown in dashed line in the cross-sectional view of FIG. 3 A) in which gate member 22 generally does not impede the flow D of gas within conduit 16, and a second position (shown in solid line in the cross-sectional view of FIG.
• gate member 22 has been rotated with respect to conduit 16 and thus impedes or substantially impedes the flow D of gas within conduit 16.
• movement of gate member 22 is selectable by a patient through actuation of a manually manipulated element, such as a rotatable switch mechanism 24 (FIG. 2).
• a manually manipulated element such as a rotatable switch mechanism 24 (FIG. 2).
• switch mechanisms include, but are not limited to, a knob or lever, that is generally disposed external to conduit 16 and coupled to gate member 22 by way of a rotatable shaft 25. It is to be appreciated that gate member 22 is thus rotatably coupled to conduit 16 by way of shaft 25, which, as shown in FIGS. 3 A and 3B, is preferably offset a distance x from the centerline of conduit 16.
• Such offset generally provides for gate member 22 to be biased in the first (open) position by the flow D of gas within conduit 16 when switch mechanism 24 is not being activated upon by a patient. It is further to be appreciated that a spring member (not shown) or other suitable mechanism may be provided to bias gate member 22 generally in the first (open) position such that the flow D of gas within conduit 16 is not interrupted unless switch mechanism 24 is being activated by a patient.
• FIGS. 4-6 show another example embodiment of a valve mechanism 20' that may be disposed adjacent delivery conduit 16.
• valve mechanism 20' employs a generally hemispherical gate member 22' that interacts with a reduced diameter portion 23' to stop or substantially stop gas flow D.
• FIG. 5 shows the valve mechanism 20' in a first (open) position wherein gate member 22' is spaced apart from reduced diameter portion 23', thus allowing gas flow D to pass therethrough.
• the pressure of flow D is generally sufficient to keep gate member 22' biased in such first position.
• a spring mechanism (not shown) may also be employed, either internal or external to conduit 16, to bias gate member 22' in the first (open) position.
• FIG. 6 shows the valve mechanism 20' displaced axially with respect to conduit 16 in a second (closed) position wherein gate member 22' is generally in contact with reduced diameter portion 23', thus obstructing, or substantially obstructing, gas flow D.
• Such displacement of gate member 22' from the first position (FIG. 5) to the second position (FIG. 6) may readily be accomplished by a patient pushing downward on switch mechanism 24', which is formed as a collar generally surrounding an outer portion of conduit 16.
• switch mechanism 24' which is formed as a collar generally surrounding an outer portion of conduit 16.
• an additional non- moveable fixed collar 25' may be rigidly coupled to, or integrally formed with, conduit 16 in order to provide a positive stop, and also to avoid possible damage to valve mechanism 20' due to over-actuation.
• FIGS. 7 and 8 show cross-sectional views of example embodiments of the present invention in which a valve, such as valve mechanism 20 previously discussed, has been placed in an elbow 19, 19' adjacent a patient interface 18.
• FIG. 8 shows such placement of valve mechanism 20 before an entrainment valve 30.
• FIGS. 9 and 10 show a further example embodiment of a valve mechanism 20" that may be disposed adjacent delivery conduit 16.
• Valve mechanism 20" employs a gate member 22" that extends generally inward from a switch mechanism
• Gate member 22" that is generally rotatable about a central axis A, as shown by arrow R.
• Gate member 22" interacts with a reduced diameter portion 23" to stop or substantially stop gas flow D.
• the pressure of flow D is generally sufficient to keep gate member 22" biased in an open (first) position.
• a spring mechansim (not shown) may also be employed, either internal or external to conduit 16, to bias gate member 22" in the first (open) position.
• valve mechanisms other than those examples described herein may be employed without varying from the scope of the present invention.
• the movement/position of the gating element can be controlled via an electronic motor rather than the mechanical structures shown in the figures and described above.
• the present invention contemplates diverting the flow from the patient circuit to the ambient atmosphere in addition to or in place of blocking the flow, either totally or partially.
• elbows described herein may instead of being formed as a separate piece, may be incorporated into, and thus formed as a part of, a patient interface system.
• valve mechanism may be formed within patient interface 18, rather than be provided in or along the gas delivery conduit.
• a manually actuated iris or shutter valve can be provided at the opening in the patient interface to which conduit 16 or elbow 19 is connected.
• the present invention provides a patient interface employing a mechanism that assists a patient desiring to speak while minimizing interference with the treatment.

Landscapes

• Health & Medical Sciences (AREA)
• Pulmonology (AREA)
• Emergency Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Otolaryngology (AREA)
• Respiratory Apparatuses And Protective Means (AREA)
• Safety Valves (AREA)

Priority Applications (7)

Applications Claiming Priority (2)

Publications (1)

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Family Applications (1)

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Cited By (3)

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Citations (2)

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• 2011
  • 2011-08-17 CN CN201180040128.5A patent/CN103068430B/zh not_active Expired - Fee Related
  • 2011-08-17 RU RU2013112000/14A patent/RU2013112000A/ru unknown
  • 2011-08-17 US US13/813,984 patent/US9364632B2/en not_active Expired - Fee Related
  • 2011-08-17 JP JP2013524505A patent/JP5993854B2/ja not_active Expired - Fee Related
  • 2011-08-17 WO PCT/IB2011/053627 patent/WO2012023107A1/en not_active Ceased
  • 2011-08-17 EP EP11761138.4A patent/EP2605818B1/en not_active Not-in-force
  • 2011-08-17 BR BR112013003546A patent/BR112013003546A2/pt not_active IP Right Cessation
  • 2011-08-17 AU AU2011292804A patent/AU2011292804B2/en not_active Ceased

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