The present embodiments relate generally to head restraints and masks and more specifically to closure or tightening systems that may be used to tighten a restraint or mask against a user's head.
Head restraints and/or masks are commonly positioned and secured about a user's head. Conventional head restraints and/or masks often employ Velcro® straps and/or buckles in securing the mask or restraint to the head. The Velcro® straps and/or buckles often require the user to grasp the strap or the restraint/mask body to couple the strap and/or buckle and secure the restrain/mask to the head. In some instances, the user is required to use both hands to secure the mask/restraint to the head. Further, in some instances the strap and/or buckle may be positioned behind the user's head and thus, the user may not be able to view the buckle and/or coupling point of the strap. Accordingly, properly fitting a mask and/or restraint to the head may be difficult and/or challenging for users.
The present invention generally provides systems for closing and tightening a mask or head restraint about a user's head or face. According to one aspect, a system for securing a mask about a user's face includes a mask that is configured to fit about the user's face, a padded member that is postionable on the back of the user's head, and at least one strap that extends from the padded member toward the mask. The system also includes a closure system that is coupled with the mask and with the strap. The closure system includes a tension member, a guide that routes the tension member about the mask and/or the strap, and a tensioning device that is operable to tension the tension member and thereby pull the strap and padded member toward the mask to secure and/or tighten the mask about the user's face.
In some embodiments, the strap is positioned on a first side of the user's head and the system includes an additional strap or straps that are positioned on an opposite side of the user's head. In some embodiments, the tensioning device may be or include a rotatable knob and/or the tension member may include lace. In some embodiments, the tensioning device is positioned on the mask or on the padded member.
According to another aspect, a method for securing a mask about a user's face includes providing a mask having: a mask member, a padded member, at least one strap that extends from the padded member toward the mask, and a closure system that is coupled with the mask and with the strap. The closure system includes: a tension member, a guide that routes the tension member about the mask and/or the strap, and a tensioning device that is operable to tension the tension member. The method also includes positioning the mask member about the user's face, positioning the padded member on the back of the user's head, and operating the tensioning device to tension the tension member and thereby pull the strap and padded member toward the mask to secure and/or tighten the mask about the user's face.
In some embodiments, the strap is positioned on a first side of the user's head and the mask includes another strap that is positioned on an opposite side of the user's head. In some embodiments, the tensioning device includes a rotatable knob and/or the tension member includes lace. In some embodiments, the tensioning device is positioned on the mask and/or on the padded member.
The present invention is described in conjunction with the appended figures:
In the appended figures, similar components and/or features may have the same numerical reference label. Further, various components of the same type may be distinguished by following the reference label by a letter that distinguishes among the similar components and/or features. If only the first numerical reference label is used in the specification, the description is applicable to any one of the similar components and/or features having the same first numerical reference label irrespective of the letter suffix.
The embodiments described herein provide closure or tensioning devices for head restraints/masks and methods for using such closure/tensioning devices. For convenience in describing the embodiments, the devices will be generally refered to as closure devices. It should be realized, however, that closure of the head restraints/masks is not required and that in many embodiments, the devices will be used merely to tension lace and/or tighten the head restraints/masks. Also, the term head restraint/mask as used herein is meant to include any article that is fit about or coupled with a head, or any manner of holding or restraining the head from movement. For example, the term head restraint/mask may include various helmets, strap devices (e.g., for a table or bed), facial or head masks, and the like. For convenience in describing the embodiments herein, the disclosure will generally refer to head masks, although it should be realized that the closure devices may be used for essentially any other head restraints.
The embodiments described herein may find particular usefulness in head restraints for medical applications. For example, the devices described herein may be used for restraining an individual's head on an operating table or stretcher. Another specific use for the devices is in fitting medical masks to the individual's head. The masks may includes: sleep apnea masks, oxygen masks, gas masks, and the like. As described in greater detail below, the closure devices may aid in easily fitting such masks to the user's head and in comfortably holding the masks tightly to the head.
The closure devices described herein provide a variety or unique benefits or advantages when compared with conventional head restraints/masks. For example, the closure devices increase the life of the head restraints straps by reducing wear on the straps and/or providing alternative closure methods. For example, conventional head restraint straps that employ Velcro® and elastic, or similar closure mechanisms, may quickly wear out. As the user continually opens and closes the Velcro® straps, dirt, fibers, debris, and even the user's hair may entangle with the Velcro® components and negatively affect future closure and/or hold of the straps. The closure devices described herein do not suffer from such issues and may remove the need for using Velcro® type straps entirely.
The closure devices described herein also provide a dynamic fit for the head masks. For example, using the closure devices described herein, the entire mask may be closed about the user's head simultaneously rather than requiring the closure of individual straps. Further, as the user and/or mask moves, the closure device is able to adjust and compensate for such movement, thereby maintaining the fit and/or tightness of the mask about the user's head. This allows the mask, helmet, or head restraint to move without compromising the fit of the system. The closure devices also simplify adjustment by allowing the user to control multiple straps with a single user interface (e.g., a reel assembly as described below). This may reduce the number of straps and/or adjustment mechanisms needed for the mask since a single closure device can simultaneously pull on, or otherwise tighten, multiple areas that need adjustment. The closure devices also provide improved fit, which helps ensure that the mask is in full contact with the head/face. The result may be fewer gaps between the mask and the user's head/face. When oxygen or other gas is being delivered to the user via the mask, the result may be less leakage of the gas and/or increased delivery of the gas to the user.
The closure devices also provide micro-adjustability of the mask's fit about the head/face. Conventional systems that employ Velcro® or other straps do not provide such micro-adjustability. Rather, with conventional systems, the user typically grips the strap and performs a one-time gross or macro adjustment of the mask. This process may be performed multiple times as the user attempts to adjust (i.e., increase or decrease) the tightness and/or fit of the mask for comfort and/or other reasons. The result is that the fit of conventional masks may be somewhat, but not fully comfortable. The user may stop adjusting the mask when a tolerable, but not necessarily comfortable, fit is achieved. Further, as the user's situation changes (e.g., due to activity, swelling, and the like), the user may wish to adjust the fit of the mask, which necessitates the user uncoupling and recoupling the Velcro® or other straps as described above.
In contrast, the closure devices described herein, allow the user to easily micro-adjust the fit of the masks without requiring the user to uncouple the masks straps. In some embodiments, the micro-adjustment of the mask may be in millimeter, or smaller/larger, increments. The micro-adjustment may act dynamically throughout the system, or in other words, micro-adjustment of one side of the mask may be equally realized on an opposite side of the mask. Accordingly, the user may perform a one-time macro or gross adjustment of the masks and then make any micro-adjustments with the closure device. The micro-adjustability may allow the user to achieve comfort levels with the mask that are far greater than those achievable with conventional mask systems. Further, the user is not required to uncouple and recouple the masks straps to adjust the fit of the mask as conditions change throughout the day due to activity level, swelling, and the like. In many embodiments, the micro-adjustment of the mask may be performed with one hand.
The closure devices also allow one or more components of the mask to be quickly and easily replaced. For example, the mask's components may generally fall into one of two categories: soft good and hard goods. Hard goods typically includes any rigid or firm material, or any components attached thereto, such as the body of the mask, valves, oxygen or gas ports/inlets, cushioning pads, and the like. Soft goods typically includes flexible or soft materials, or any components attached thereto, such as fabrics that wrap around the head, straps, elastic body portions, buckles, and the like. The closure devices described herein may allow one or more of these components (i.e., hard or soft goods) to be easily and quickly replaced. For example, in some embodiments, the closure device may be coupled or attached with the soft good component (e.g., entire head adjustment fit system) to allow the soft good component to be detached from the hard good component (e.g., entire mask system) so that the soft good component can be replaced without requiring replacement of the hard good component. Similarly, in other embodiments, the closure device may be coupled or attached with the hard good component (e.g., mask) to allow the hard good component to be replaced without requiring replacement of the soft good component. Such embodiments may greatly reduce the cost in replacing or altering the mask.
In some embodiments, the closure device may employ unique attachment mechanisms, such as the male and female coupling components described in U.S. patent application Ser. No. 14/071,435, filed Nov. 4, 2013, and titled “Coupling Members for Closure Devices and Methods,” the entire disclosure of which is incorporated by reference herein. The use of such attachment mechanisms may simplify gross or macro adjustment of the mask by allowing the user to easily use one hand to attach and detach the mask about the head/face. In reel assembly based closure devices, the attachment mechanisms may also allow the user to use or take up some of the reel assembly's excess lace when donning and doffing the mask. As such, the user may easily don and doff the mask without excessively operating the reel assembly (i.e., excessively winding the reel assembly's knob).
In addition to, or as an alternative to, the use of the unique attachment mechanisms, the closure devices may use releasable guides that allow a reel assembly's lace to be easily coupled and uncoupled from the guides. As used herein, the term “guides” generally refers to any member that is capable of directing and guiding lace along a lace path. Such guides may be made of either relatively hard and rigid material, such as plastic, metal, and the like, or may be made of relatively soft materials, such as webbing, fabric, and the like. In some embodiments, the guide may be made of both types of material. Such guides are typically made of a low friction material so as to avoid abrading or damaging the lace.
The releasable guides may have an open back or rear surface around which the lace is positioned. The open rear surface may form a channel within which the lace is positioned when coupled with the guide. The open configuration allows the lace to be easily and quickly uncoupled from the guide by removing the lace from the channel. The releasable guides may be used as coupling or attachment points for the mask to allow the mask to be easily donned and doffed. In some embodiments, the releasable guides may be mounted on the hard good (e.g., mask) and lace that is coupled with the soft good may be positioned around the guides to couple the hard and soft good components. In other embodiments, the configuration of the releasable guides and lace may be reversed. These configurations allow the lace to be detached from the guide and mask, such as for periodic replacement (e.g., every 3 months) and the like.
As described in greater detail below, the positioning of the closure device about the mask may be adjusted based on the desired closure or fit, or based on access. For example, in one embodiment the closure device may be positioned on or near the front of the mask. In this position, the closure device may be easily accessed by the user and/or may be more comfortable for the user when sleeping. In another embodiment, the closure device may be positioned on or near the rear surface of the system opposite the mask. In this position, the closure device may be easily accessible to a physician or technician who may be fitting the product. This positioning of the closure device may be preferred in head restraint embodiments. The bilateral location of the closure device (i.e., positioning on the front of the mask or the rear surface opposite the mask) allows the laces to wrap around both sides of the head and equalize tension on each side of the head.
The masks/head restraints may have various installation options in addition to the other aspects described herein. For example, the masks/head restraints may include molded-in detachable female receivers that are configured for coupling with a corresponding male component, such as those described in the '435 application incorporated herein. The masks/head restraints may also include a coupling port or “bayonet” that is configured for releasable attachment with a housing of a reel assembly. In some embodiments, the bayonet may be formed into a body of the mask itself In some embodiments, the soft good components may include welded guides and/or tubing that function as guides for the lace. The welded guides/tubing may allow the lace to be easily coupled with the soft good components. Additional methods of forming lace guides are described in U.S. patent application Ser. No. 14/479,173, filed Sep. 5, 2014, and titled “Guides and Components for Closure Systems and Methods Therefore”, the entire disclosure of which is incorporated by reference herein.
Having described the closure devices and head restraints/masks generally, additional aspects and features of the devices will be more evident in the description of the several embodiments provided herein below.
Referring now to
Body portion 102 also includes a head cushion 134 that presses against the user's forehead. The restraint member 106 includes a main body portion and a plurality of arm portions 109 that extend towards the body portion 102 and/or head cushion 134. The arm portions 109 and restraint member 106 may be coupled with the head cushion 134 and/or body portion 102 via one or more buckles 110. The restraint member 106 is configured to pull the mask 100 tightly against the user's face to prevent gaps from developing between the user's face and the pads 132. To pull the mask 100 tightly against the user's face, mask 100 includes a reel assembly 104 that is operationally coupled with lace 108 that is in turn coupled with restraint member 106 and arm portions 109. As shown in
In other embodiments, the arm portions 109 may include lace guides 107 that direct and guide the lace 108 along a lace path as described herein. The lace guides 107 may include a channel or lumen within which the lace 108 is positioned. The lace guides 107 may be coupled with the arm portions 109 (or with body portion 102 or had restrained 134) via buckles 110. In such embodiments, the tubing 120 may be positioned along body portion 102 and/or head cushion 134. Such a configuration allows the reel assembly 104 to simultaneously tension an upper arm portion 109 and a lower arm portion 109 of restraint member 106. For example, the lace 108 may extend from reel assembly 104 to a first lace guide 107 positioned on an upper arm portion 109. The lace 108 may then be guided along the body portion 102 via tubing 120 and to a second lace guide 107 positioned on a lower arm portion 109. The lace 108 may then be directed across a bottom portion of body 102 and to lace guides (not shown) positioned on opposite side of mask 100. The lace may then return to reel assembly 104 and/or terminate on the mask 100. The reel assembly 104 may be operated to tension lace 108 and thereby tightening the mask 100 about the user's face.
Reel assembly 104, along with the other reel assemblies described herein, typically includes a knob that may be grasped and rotated by a user to wind lace 108 about a spool that is positioned within a housing of reel assembly 104, or to unwind lace 108 therefrom. As the lace 108 is wound about the spool, the lace 108 is tensioned, which pulls the mask 100 against the user's had and/or face. In some embodiments, the lace 108 may pull on straps or other components of body 102 and/or head cushion 134 to enable tightening of the mask 100. Exemplary emodiments of reel assemblies are described in the following U.S. Patent Applications, the entire disclosures of which are incorporated by reference herein: U.S. patent applications Ser. No. 13/343,658, filed Jan. 4, 2012, entitled “Reel Based Closure System,” U.S. patent applications Ser. No. 13/273,060, filed Oct. 13, 2011, entitled “Reel-Based Lacing System,” and U.S. patent applications Ser. No. 13/098,276, filed Apr. 29, 2011, entitled “Reel Based Lacing System.”
An advantage of mask 100 compared with conventional masks is that the single reel assembly 104 may be used to tighten the body 102 and head cushion 134 about the user's head and face. Further, the fit or tightness of the mask 100 is roughly uniform due to the use of lace 108, which is used to tighten both the upper and lower portions of the mask 100 (i.e., the head cushion 134 and body 102). Uniform fit and/or tightness is provided because the tension within the lace 108 is roughly uniform. Another advantage of mask 100 is that a user may adjust the tightness and/or fit of the mask via reel assembly 104 without opening or uncoupling straps of the mask, which is often required with conventional masks. Rather, the user may easily don the mask 100 via the use of buckles 110 and then make all subsequent adjustments via reel assembly 104. Reel assembly 104 additionally allows micro-adjustments (i.e., in mm increments) of the fit or tightness of the mask to be made.
In exemplary embodiments, one or more of the buckles 110 may include a male coupling component (see buckle 425 of
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In some embodiments, the removable portion 404 may be generally U-shaped and proximal ends of the removable portion 404 may be coupled with the mask 400. For example, an upper portion of the removable portion 404 may be coupled with an upper portion 405 of mask 400 while a lower portion of removable portion 404 is coupled with a lower portion 406 of mask 400. The upper and lower portions of removable portion 404 may also include straps that are attached to lace 408, which is in turn coupled with the reel assembly of mask 400. In some embodiments one or more buckles 407 may be used to couple the upper and lower portions of removable portion 404 with the upper and lower portions, 405 and 406 respectively, of mask 400. The buckles 407 may be conventional buckles or, in exemplary embodiments, may include male and female coupling components as described in the '435 patent application incorporated herein.
In some embodiments, the reel assembly 409 is positioned on the removable portion 404. For example, the left-hand image of
Referring now to
The lace guides 413 are releasable guides that have an open back or rear surface around or about which the lace 415 may be positioned. The open rear surface of the lace guides 413 forms a channel within which the lace 415 is positioned to couple the respective guides 413 and respective straps with the mask 410. For example, a loop formed in the lace 415 may be pulled over a lace guide 413 and positioned within the channel of the lace guide's rear surface. The lace 415 may then be tensioned via reel assembly 416 to secure the lace 415 within the channel of the lace guide 413 as shown in the right-hand image of
In some embodiments, only a single side of the mask 410 may include the lace guides 413. In such embodiments, an opposite side of the mask 410 may be permanently attached or coupled with the first strap 412 and the second strap 414. In such embodiments, a side of the mask 410 that includes the lace guides 413 may be used for donning and doffing of the mask 410. In other embodiments, both sides of the mask 410 may include the lace guides 413 so that the mask 410 may be fully removed from the first strap 412 and the second strap 414. Fully removing of the mask 410 from the first strap 412 and the second strap 414 may allow the mask 410 and/or first strap 412 and second strap 414 to be removed and replaced without requiring replacement of the entire mask assembly.
When coupled with the female coupling component 426, the male coupling component 425 is not removable or uncouplable from the female coupling component 426 while the lace 428 remains under tension. As such, accidental opening of the mask 420 is prevented. Further, when coupled together, the male coupling component 425 and the female coupling component 426 have a flat profile that may match the shape and/or curvature of mask 420. As illustrated, an upper portion of the mask 420 may be permanently coupled with restraint member 422 via lace 428. This configuration allows the reel assembly 424 to be positioned on mask 420.
In some embodiments, only a single side of the mask 430 includes the male coupling components 433. In such embodiments, an opposite side of the mask 430 may be permanently attached or coupled with the restraint member 432. In such embodiments, the side of the mask 430 that includes the male coupling components 433 may be used for donning and doffing of the mask 430. In other embodiments, both sides of the mask 430 include the male coupling components 433 so that the mask 430 is fully removable from the restraint member 432. In some embodiments, one or more components of the closure device (e.g., the male coupling components 433, reel assembly 424, and the like) may be attached to a common backing, such as a rigid, semi-rigid, or soft panel. The user may grasp the panel and couple the male coupling component(s) 433 with the female coupling component(s) 435 of the mask and/or operate the reel assembly 424. The use of panels may aid in donning and doffing of the mask and/or tensioning of the mask. Exemplary embodiments of panels that may be used with the mask are described in U.S. Provisional application Ser. No. 14/173,685, filed Feb. 5, 2014, and titled “Closure Devices for Medical Devices and Methods”, the entire disclosure of which is incorporated by reference herein.
A proximal end of the arm portions 445 is coupled with lace 447, which is routed through a lumen or channel of restraint member 442. The lace 447 allows the upper and lower arm portions, 445a and 445b, to move or shift dynamically relative to restraint member 442 as described herein. A distal end of the upper arm portions 445a is coupled with second lace 449, which is in turn coupled with reel assembly 446. Reel assembly 446 is positioned roughly centrally between opposing upper arm portions 445a of restraint member 442. Reel assembly 446 is operable to tension the second lace 449, which in turn tensions upper arm portions 445a. Tensioning of the upper arm portions 445a tensions the lower arm portions 445b via lace 447.
Reel assembly 446 is configured for coupling with an attachment site 441 of the upper portion of mask 440. In some embodiments, the reel assembly 446 is attached with a strap 448 which is positionable around the attachment site 441 of mask 440. The strap 448 may include Velcro® components that allow the strap 448 to be attached around attachment site 441. In other embodiments, other attachment mechanisms may be used to attach strap 448 or reel assembly 446 with attachment site 441. For example various mechanical fasteners, such as snaps, clamps, cams, locks, pins, and the like may be used to attach strap 448 or reel assembly 446 with attachment site 401. The embodiment of
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The left-hand image of
To couple the conventional masks 600 with the restraint member 608, the restraint member includes a front panel 610 and a rear panel 614. The front and rear panels, 610 and 614, arc attached or coupled together via lace 616 that is insertable through tubing 622 and/or one or more guides 624 attached to the front and rear panels, 610 and 614. In some embodiments, male and female coupling components, such as those described in the '435 patent application incorporated herein, may be used to couple the front and rear panels, 610 and 614.
The rear panel 614 is configured for positioning about the rear surface of the user's head. The front panel 610 may include a slot or opening 612 through which the inlet port 602 of the conventional mask 600 is positioned. The front panel 610 is configured for positioning over the conventional mask 600. In some embodiments, both the front panel 610 and the rear panel 614 are made of relatively soft and compliant fabrics or other materials that allow the front and rear panels, 610 and 614, to conform to the rear surface of the user's head and to the conventional masks 600 respectively. With the rear panel 614 positioned about the user's head, the reel assembly 620 may be operated to wind the lace 616 about the reel assembly's spool and thereby move the front panel 610 toward the rear panel 614 and into contact with conventional mask 600. The reel assembly 620 may be operated until the front panel 610 fully contacts the conventional mask 600 and/or until a desired fit or tightness of the mask 600 about the user's face is achieved.
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The perpendicular force applied to the user's head via the pads 904 may be adjusted or varied by adjusting the height of the pad 904 relative to the restraint member 902. For example, in some embodiments, the pad 904a may be roughly equivalent in size, or slightly larger, than the restraint member 902. In such embodiments, the perpendicular force applied to the user's head may be relatively weak. In other embodiments, the pad 904b may be relatively large compared with the restraint member 902. In such embodiments, the perpendicular force applied to the user's head may be relatively strong. In varying the size of the pad 904, an outer surface of the pad may be offset a distance X from an outer surface of the restraint member 902. A larger distance X would result in a stronger perpendicular force being applied to the user's head, while a smaller distance X would result in a weaker perpendicular force being applied to the user's head.
Referring now to
The distal end 1014 of strap 1000 also includes a reel assembly 1006 that is operationally coupled with lace 1008 as described herein. The lace 1008 in turn is coupled with a distal end of strap body 1004. Tensioning of the lace 1008 draws or pulls the distal end of strap body 1004 toward reel assembly 1006 and thereby tensions or tightness strap body 1004. An inner surface of strap body 1004 may include a pad 1010 or other cushioning member that is pressed or pulled tightly against the user's head. In operation, strap body 1004 is positioned over the user's head and the male and female coupling components 1012 are coupled together with the strap body 1004 positioned over the user's head. The reel assembly 1006 may then be operated to tension the lace 1008 and thereby tension or tighten strap body 1004 about the user's head. The pad or cushion member 1010 provides comfort to the user's head as strap body 1004 is pulled tightly about the user's head. It should be realized that in other embodiments strap 1000 may be used to restrain other parts of the body, such as the hands, feet, torso, and the like.
In some embodiments, the reel assembly 1006 may have “incremental release” capabilities that allow the lace tension to be incrementally released or decreased by operation of the reel assembly 1006. For example, the reel assembly 1006 may be counter-rotated, or rotated in a loosening direction, to incrementally release or decrease the lace tension. Such incremental release technology allows a physician to release tension on the head for patient comfort and/or other purposes.
Referring now to
This Application claims the benefit of U.S. Provisional Application No. 61/911,777, filed on Dec. 4, 2013, and titled “Closure Methods and Devices for Head Restraints and Masks,” the entire disclosure of which is incorporated by reference herein for all purposes.
Number | Date | Country | |
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61911777 | Dec 2013 | US |