WO2006041936A2 - User interface having a pivotable coupling - Google Patents
User interface having a pivotable coupling Download PDFInfo
- Publication number
- WO2006041936A2 WO2006041936A2 PCT/US2005/035856 US2005035856W WO2006041936A2 WO 2006041936 A2 WO2006041936 A2 WO 2006041936A2 US 2005035856 W US2005035856 W US 2005035856W WO 2006041936 A2 WO2006041936 A2 WO 2006041936A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- shell
- coupling
- cushion
- patient interface
- recited
- Prior art date
Links
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. mouth-to-mouth respiration; 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. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
-
- 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. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
- A61M16/0638—Means for improving the adaptation of the mask to the patient with forehead support in the form of a pivot
-
- 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. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
- A61M16/0644—Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position
- A61M16/0655—Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position in the form of a linear or curvilinear slide
Definitions
- the present invention pertains to user interfaces, and, in particular, to self- conforming, compact user interfaces that have a pivot coupling with a port so that both the coupling and port rotate together.
- a variety of delivery systems are known that provide gas at positive pressure for consumption by a patient.
- the uses and applications of such systems vary.
- Some such systems have been developed for the treatment of sleep apnea and other sleep related disorders.
- PAP Positive airway pressure
- a typical PAP device comprises a flow generator (e.g., a blower) that delivers gas via a delivery conduit to a user interface, such as a mask. It is also known to deliver the PAP as a continuous positive airway pressure (CPAP), a variable airway pressure, such as a bi-level pressure that varies with the patient's respiratory cycle (Bi-PAP), or an auto-titrating pressure that varies with the monitored condition of the patient.
- CPAP continuous positive airway pressure
- Bi-PAP bi-level pressure that varies with the patient's respiratory cycle
- Pressure support therapies are also provided to treat other medical and respiratory disorders, such as Cheynes-Stokes respiration, congestive heart failure, and stroke.
- the user interface disclosed in this application has a rigid shell that supports a cushion and a fixed coupling with a coupling conduit.
- the coupling conduit extends generally upwardly from the shell along the bridge of the user's nose towards the user's forehead and includes a ball-and-socket joint to provide the coupling conduit with a limited range of motion. As the user moves their head, the ball-and socket joint will pivot so that the user interface will remain properly sealed to the face of the user.
- the coupling conduit is attached to a gas delivery conduit which, in turn, is connected to a ventilator to apply positive pressure.
- the shell is connected to the cushion by a retaining clip.
- the retaining clip fits into a channel formed on the shell.
- a corresponding retaining lip extends about the periphery of the cushion thereby defining the channel about the periphery of the cushion.
- the retaining clip engages the channel about the cushion.
- the retaining clip and the retaining lip on the cushion interlock in a c-shaped cross-section.
- a plurality of integral detents formed on the retaining clip fit through slots in the shell and hold the retaining clip in place.
- the shell includes an extension portion that extends upward from the mask towards the user's forehead.
- the extension portion is connected to a flexible horizontal strap that engages the sides and the rear rather than the front of the user's head so that the flexible horizontal strap is spaced from the user's forehead to reduce pressure in this region.
- the device disclosed in the ' 180 application is adequate for its intended purpose, it also has several drawbacks as well. Even though the ball-and-socket joint provides some range of motion, it is limited such that the coupling conduit must still be generally directed upward in the direction of the user's forehead. This device is ineffective at redirecting the coupling conduit in any other general direction. Since users often use these interfaces while they are asleep, it would be desirable to have a maximum degree of freedom so that the user can freely move their head, or even turn over in bed, without affecting the seal between the user interface and the user.
- Another drawback to this device is that it secures the patient interface with a flexible horizontal strap that contacts the sides of the user's head rather than the user's forehead.
- a flexible horizontal strap that contacts the sides of the user's head rather than the user's forehead.
- This device has yet another drawback.
- the cushion is secured to the mask with a retaining clip that engages the retaining lip of the shell in a c-shaped interlocking configuration.
- a tensile force is applied to the shell on one end and the cushion on the other, the cushion is likely to pull free of the retaining clip thus requiring reattachment.
- this device does not disclose a pressure port to monitor the internal pressure within the patient interface.
- the device described in U.S. Patent No. 6,467,483 discloses a patient interface that has a shell attached between a flexible cushion and a coupling conduit.
- the shell includes a shell body and a rigid support that supports a forehead pad. Together, the cushion and rigid support hold the user interface on the face of the user. The distance between the rigid support and the shell body may be adjusted to accommodate the unique facial characteristics of different users.
- the coupling conduit is a rotatable elbow that provides 360 degrees of rotation thereby allowing the gas delivery conduit to be directed in a multitude of directions from the patient interface rather than being limited to any one direction.
- the shell of this user interface has a port for the attachment of a variety of items when access to the interior of the user interface is desired such as a pressure port.
- the device described in the '483 patent has advanced the art, it can still be further improved upon. Because the coupling conduit is free to rotate 360 degrees, it may become tangled with the port that extends from a fixed location on the shell. If the user repeatedly spins the coupling conduit, each rotation may further tangle the coupling conduit with whatever is connected to the port.
- the forehead pad is supported by a rigid support. Even though the distance between the rigid support and the shell body may be adjusted, this may still not be comfortable for some users. Some users may have facial characteristics that are not precisely suited to the contours of this rigid extension. In this circumstance, the patient interface may not fit properly or may simply be uncomfortable.
- the coupling conduit is an elbow-type connector that extends a substantial distance away from the shell body.
- This coupling conduit may be more likely to become tangled with other items in the user's environment.
- many users of patient interface devices are self-conscious about wearing the device and would prefer a compact, low-profile user interface. Having a coupling conduit that extends a substantial distance away from the shell body is likely to be deemed undesirable by many users.
- a patient interface which is configured to deliver gas to a user.
- the patient interface includes a cushion, a shell and a coupling that are connected together.
- the cushion has a cavity
- the shell has an opening that is connected to the coupling, which in turn, is connected to a gas delivery conduit such that a breathing gas may be conveyed to the user through the cavity and the opening.
- the coupling is pivotable and has a port such that the port and the coupling rotate together.
- the user interface includes a retention ring that has detents which pass through slots in the cushion to prevent the cushion from being pulled free from the shell.
- the user interface includes a forehead support that has a hinge so that the forehead support may flex to conform to a particular user's forehead.
- FIG. 1 is a front perspective view of a user interface according to the principles of the present invention
- FIG. 2 is an exploded rear perspective view of the user interface
- FIG. 3 A is an exploded front perspective view of a shell, retaining ring, and cushion of the user interface
- FIG. 3B is a front perspective view of the assembled shell, retaining ring, and cushion of FIG. 3 A
- FIG. 4 is a cross-sectional view of the assembled shell along line 4 — 4 of
- FIG. 5 A is a front perspective view of a coupling
- FIG. 5B is a rear perspective view of the coupling
- FIG. 6 exploded perspective view of the forehead support of the user interface; and [24] FIG. 7 is a side elevational view of the user interface on a user's face.
- FIG. 1 schematically illustrates an exemplary embodiment of a user interface 30 according to the principles of the present invention.
- the user interface has a cushion 32 connected to a shell 34, which in turn, is connected to a coupling 36.
- the user interface is typically connected to a gas delivery conduit, not shown, to provide a breathing gas to the user.
- gas delivery conduit not shown
- shell 34 has an outer surface 38 and an inner surface 40. Extending about the inner surface is a skirt 42 which extends over a portion of the cushion to provide hoop strength to the shell.
- the shell also includes an extension 44 which has a plurality of catches 46, explained in further detail below.
- User interface 30 also includes a retaining ring 48 which interconnects cushion 32 with shell 34. Mechanically interconnecting the shell and the cushion can be performed with greater reliability in an industrial manufacturing environment than interconnecting the shell and cushion with an adhesive. As best appreciated with reference to FIG. 3A, shell 34 has slots 50 formed about an opening 52. Cushion 32 is configured to be attached to the shell and provide a flexible seal with the user. As shown in FIG 3 A, cushion 32 has a generally triangular shape. However, various other shapes may be used without departing from the spirit and scope of the invention.
- Cushion 32 has an outer wall 54 and an inner wall 56. Inner wall 56 defines a cavity 58 into which the user will place their nose when user interface 30 is in use.
- Cushion 32 has a lip 60 with slots 62. Extending from the lip is a flange 64 that defines an opening 65.
- Retaining ring 48 has detents 66 extending from ring body 68. Each detent 66 is defined by a projecting portion 70 and a hook portion 72. Detents 66 are configured to pass through slots 62. As seen in FIG. 3B, detents 66 engage a portion of outer surface 38 of shell 34 and capture cushion 32 between shell 34 and retaining ring 48 to secure cushion 32 in place.
- cushion 32 has a ledge 74 which extends about inner wall 56 of the cushion adjacent lip 60. Ring body 68 is captured between lip 60 and ledge 74.
- One unique feature of the present invention is the interconnection of cushion 32 with shell 34. Unlike prior art devices in which the cushion can be disconnected from the shell by applying a tensile force between the cushion and the shell, the present invention reduces the possibility that cushion 32 will become disconnected from shell 34 during use. This result is achieved by passing detents 66 through slots 62 in the cushion 32 and through slots 50 in shell 34 to anchor cushion 32 in place. In order to remove cushion 32, the user needs to disengage detents 66 thus preventing the possibility of inadvertent removal.
- a coupling 36 has a coupling body 76 and a coupling conduit 78 which interconnects coupling body 76 with the gas delivery conduit, not shown.
- the present invention provides a coupling that extends a minimum distance away from the user.
- coupling body 76 and coupling conduit 78 are coplanar.
- Coupling body 76 is preferably cylindrical with coupling conduit 78 extending radially outward from the coupling body.
- the coupling could have a variety of other shapes without departing from the present invention.
- Coupling body 76 has a bead 80 and a shoulder 82 extending around opening 84.
- bead 80 is passed through opening 52 on shell 34 such that shell 34 is captured between bead 80 and shoulder 82. This configuration allows for coupling body 76 to be rotated while remaining engaged with shell 34.
- Coupling 36 also has an exhaust port 88. Exhaust port 88 may include a one-way valve, not shown, such as a flapper valve or duck bill valve.
- coupling 36 also has a port 86.
- Port 86 may be used for any function in which it is desirable to access cavity 58 within cushion 32.
- One such use for port 86 is as a connection location for a pressure sensor, not shown, via a tube, not shown.
- a variety of other devices may be attached to port 86 of coupling body 76 without departing from the spirit and scope of this invention such as electrical wires or tubes used to monitor a variety of features.
- Port 86 can also be used as an access location for delivering items to the user other than the breathing gas. Since port 86 and coupling conduit 78 are both on coupling 36, the port and coupling conduit will rotate together thus preventing them from becoming tangled.
- the coupling body 76 may rotate a full 360 degrees so that the user can pivot the coupling to any angle that is the least intrusive. Patient interfaces are often used during sleep. Users of the present invention are free to switch sides or move their head while they are asleep without compromising the seal between the users' face and cushion 36 by simply rotating coupling 36 to a convenient location. When port 86 is not in use, the user may seal it with cap 90.
- bead 80 may be discontinuous about coupling body
- bead 80 may be interrupted by grooves 92. Grooves 92 reduce the hoop strength of coupling 36 in the region about bead 80 thus allowing bead 80 the ability to elastically flex inward as it is pressed into place in opening 52. Interconnecting the coupling with the shell is accomplished by pressing coupling body 76 on to outer surface 38 of shell 34. As the coupling body and shell are pressed together, the bead 80 will flex inward and then spring back once bead 80 is passed through opening 52 thus capturing bead 80 such that it provides a bearing surface with inner surface 40 of shell 34 in the region about opening 52.
- patient user interface 30 of the present invention also includes a forehead support 94.
- Forehead support 94 disperses the forces otherwise concentrated in the junction between the user and the cushion.
- the forehead support provides additional support to the device to prevent the user interface from being inadvertently repositioned and potentially undermine the seal between the cushion and the user.
- the user interface has an adjustable mount 96 and pads 98 supported by backing plates 100.
- Adjustable mount 96 has removable forehead latches 102.
- shell 34 also includes removable shell latches 104.
- Adjustable mount 96 has wings 106 connected by a central fastener portion 108.
- the fastener portion has a first set of ribs 110 and a second set of ribs 112 defining a passageway 114 therebetween.
- Fastener portion 108 also includes a pawl 116.
- Pawl 116 is defined by a torsion spring 118 connected to an elongate body 120 and a tooth 122. Tooth 122 is sized to engage catches 46 on extension 44 so that the distance between forehead support 94 and shell 34 may be adjusted to suit a particular user.
- the user presses the elongate body 120 to rotate torsion spring 118 until tooth 122 disengages a particular catch.
- the user may then slide the forehead support to an appropriate distance from shell 34 and release elongate body 120 such that tooth 122 reengages with a different catch.
- adjustable mount 96 also has hinges 124. As seen in FIG. 7, hinges 124 permit forehead support 94 to flex such that it may better conform to a particular user's head. In combination with the flexibility of extension 44, the flexibility of forehead support 94 provides two planes of flexibility both transversely across the user's forehead and longitudinally along the bridge of the user's nose.
- hinges 124 and pawl 116 are formed integrally with adjustable mount 96. However, hinges 124 and pawl 116 could be a separate discrete part without departing from the teachings of this invention.
- Pads 98 are attached to backing plates 100 with an adhesive. Backing plates 100 are, in turn, connected to adjustable mount 96 with legs 126 which engage apertures 128. Of course, any other contemporary method of attaching pads 98 to adjustable mount 96 may be used as well.
- the present invention may be assembled easily in a manufacturing environment. Preferably, this is achieved through use of multiple integral features that are incorporated into a common structure.
- the retaining ring is placed within cushion 32 with detents 66 extend out slots 62.
- shell 34 is pressed together with retaining ring 48 so that detents 66 pass through slots 50 and spring into engagement with outer surface 38 of shell 34.
- Coupling 36 is pressed into engagement with opening 52 of shell 34.
- Forehead support 94 is assembled by adhering pads 100 to backing plates 100.
- Backing plates 100 are coupled to adjustable mount 96 by engaging legs 126 with apertures 128.
- Extension 44 is feed between upper ribs 110 and lower ribs 112 until pawl 116 engages the appropriate catch 46.
- the headgear assembly 130 includes forehead straps 132 connected to forehead latches 102 and shell straps 134 connected to shell latches 104. To provide additional support forehead straps and shell straps are interconnected by web 136.
- any contemporary headgear assembly 130 may be used in accordance with the present invention.
- Latches 102 and 104 provide a unique mechanism for interconnecting headgear 130 and shell 34.
- latches 102 include buckles 138 having cantilevered arms 140.
- the cantilever arms are captured by sockets 142 formed on wings 106.
- the cantilevered arms may be disconnected from the sockets by squeezing the cantilever arms on each bucklel38 together so that the user may easily remove or adjust the forehead latches.
- latches 104 have a two-part construction with a buckle 144 releaseably attached to post 146.
- Buckle 144 has an opening 154 into which post 146 may be inserted.
- Buckle 144 also has a pair of integral pawls 148 adapted to engage an undercut 150 formed on post 146 to capture post 146 while still permitting post 146 to pivot relative to the shell.
- Post 146 includes a stop surface 152 to prevent over insertion of post 146 into buckle 144. Not only does this construction provide for adjustability, but it also permits the buckle to pivot relative to the shell to passively adjust to the particular facial characteristics of the user.
- coupling conduit is far more compact than prior art devices which use an elbow coupling. Since coupling 36 includes port 86, it reduces the potential for the gas delivery conduit to become tangled with items connected to port 86. Finally, extension 44 is formed from a flexible material and forehead support 94 includes hinges 124 so that the forehead support can flex. Together, these two features allow the user interface 30 to flex in two separate planes: one about the user's forehead and one about the user's nose. This flexibility of user interface 30 enhances the comfort of the device and permits use by multiple users with different facial characteristics.
- the present invention has been described as having a cushion that encapsulates the nasal region, it is to be understood that the present invention contemplates using other types of devices in conjunction with support body 36.
- larger cushions that encapsulate the nose and mouth can be attached to the support body.
- smaller cushions, or nasal prongs, that seal in or near the nares can be supported by the support body.
- any interface suitable for sealing against the user can be used in the mask assembly of the present invention.
- cushion 32 or pads 98 are not intended to be limited to a particular material for cushion 32 or pads 98.
- these components can be formed from a silicone, plastic, rubber, foam, gel, or any other material or combination of materials that provides a sufficiently comfortable interface with the user's skin.
- shell 34, coupling 36, retaining ring 48, and adjustable mount 96 can be formed from polypropylene, polyethylene or any other material which is sufficiently rigid to impart the necessary stability to patient interface 30 and sufficiently elastic so that the detents 66 and bead 80 will spring back into place.
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
BRPI0516256-4A BRPI0516256A (en) | 2004-10-08 | 2005-10-05 | user interface that has a pivot coupling |
EP05806420A EP1804925A2 (en) | 2004-10-08 | 2005-10-05 | User interface having a pivotable coupling |
AU2005294375A AU2005294375A1 (en) | 2004-10-08 | 2005-10-05 | User interface having a pivotable coupling |
JP2007535780A JP2008521451A (en) | 2004-10-08 | 2005-10-05 | User interface with pivotable connection |
CA002582601A CA2582601A1 (en) | 2004-10-08 | 2005-10-05 | User interface having a pivotable coupling |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US61726504P | 2004-10-08 | 2004-10-08 | |
US60/617,265 | 2004-10-08 | ||
US11/243,379 | 2005-10-04 | ||
US11/243,379 US7819119B2 (en) | 2004-10-08 | 2005-10-04 | User interface having a pivotable coupling |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2006041936A2 true WO2006041936A2 (en) | 2006-04-20 |
WO2006041936A3 WO2006041936A3 (en) | 2009-04-16 |
Family
ID=36144048
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2005/035856 WO2006041936A2 (en) | 2004-10-08 | 2005-10-05 | User interface having a pivotable coupling |
Country Status (7)
Country | Link |
---|---|
US (1) | US7819119B2 (en) |
EP (1) | EP1804925A2 (en) |
JP (1) | JP2008521451A (en) |
AU (1) | AU2005294375A1 (en) |
BR (1) | BRPI0516256A (en) |
CA (1) | CA2582601A1 (en) |
WO (1) | WO2006041936A2 (en) |
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2005
- 2005-10-04 US US11/243,379 patent/US7819119B2/en not_active Expired - Fee Related
- 2005-10-05 AU AU2005294375A patent/AU2005294375A1/en not_active Abandoned
- 2005-10-05 CA CA002582601A patent/CA2582601A1/en not_active Abandoned
- 2005-10-05 EP EP05806420A patent/EP1804925A2/en not_active Withdrawn
- 2005-10-05 JP JP2007535780A patent/JP2008521451A/en active Pending
- 2005-10-05 BR BRPI0516256-4A patent/BRPI0516256A/en not_active IP Right Cessation
- 2005-10-05 WO PCT/US2005/035856 patent/WO2006041936A2/en active Application Filing
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US20040094159A1 (en) * | 1996-07-26 | 2004-05-20 | Resmed Limited | Breathing mask and mask cushion therefor |
US6119693A (en) * | 1998-01-16 | 2000-09-19 | Resmed Limited | Forehead support for facial mask |
US20040216746A1 (en) * | 2003-02-28 | 2004-11-04 | Sunrise Medical Hhg Inc. | Adjustable nasal mask |
Also Published As
Publication number | Publication date |
---|---|
AU2005294375A1 (en) | 2006-04-20 |
EP1804925A2 (en) | 2007-07-11 |
US20060076019A1 (en) | 2006-04-13 |
US7819119B2 (en) | 2010-10-26 |
CA2582601A1 (en) | 2006-04-20 |
JP2008521451A (en) | 2008-06-26 |
WO2006041936A3 (en) | 2009-04-16 |
BRPI0516256A (en) | 2008-08-26 |
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