Mask with port and method for using same

CROSS-REFERENCE TO RELATED APPLICATION

0001This application claims benefit of U.S. Provisional Patent Application No. 61/503,333 (Attorney Docket Number GBLS/0002L) filed on Jun. 30, 2011, and U.S. Provisional Patent Application No. 61/617,418 (Attorney Docket Number GBLS/0004L) filed on Mar. 29, 2012, which are both incorporated by reference in entirety.

BACKGROUND OF THE INVENTION

00021. Field of the Invention

0003Embodiments of the invention relate to a mask fabricated primarily from a breathable material and having an inlet port formed therethrough. The mask is suitable for may varied applications, such as filtered breathing, continuous positive airway pressure (CPAP) therapy, and respiratory resistance training, among others.

00042. Description of the Related Art

0005Masks are used in a variety of applications including, but not limited to, general filtration for breathing, CPAP therapy and resistance training. Breathable masks are generally worn over the nose and/or mouth and fail to allow a user to access a user's nose and/or mouth without removing the mask. Thus, there a need for an improved breathable mask.

0006One example of such a need is for the treatment of sleep apnea by CPAP therapy. A CPAP device includes a pump connected by a tube to a mask that is worn over the nose and/or mouth of the wearer while sleeping. The pump provides pressure through the mask at a pressure sufficient to prevent apneas.

0007Most masks are worn over the nose and/or mouth and are held in place by adjustable straps. The straps must be tight enough to prevent the mask from shifting during sleep. Failure of the mask to maintain a sufficient seal may prevent sufficient pressure from being delivered to the wearer in order to prevent the apneas. Additionally, loose straps may allow leakage that dries the eyes of the wearer or may create noise which disrupts restful sleep. Thus, there is a need for an improved mask for use with CPAP therapy.

0008Another application includes masks used in respiratory resistance training to focus on restricted breathing. Respiratory resistance training forces a person's body to work harder to produce the required amounts of energy with less available oxygen. The body is forced to work with reduced oxygen (anaerobically). This anaerobic struggle results in physiological adaptations geared towards enhancing the efficiency of the body's respiratory, cardiovascular and oxygen utilization systems.

0009Until recently, little development had been made in the area of respiratory resistance training. Other than traveling to high altitudes, respiratory resistance training has been hard to perform under normal environmental conditions. Thus, there is also a need for improvement in respiratory resistance training.

SUMMARY OF THE INVENTION

0010Embodiments of a face mask with a port configured to allow flow through the face mask at least in a direction towards a user, generally defined as an adhesive side or user side of the mask are provided, along with methods for using the same. In one embodiment, a face mask includes a breathable, flexible sheet having a first side and a second side, an adhesive disposed on a perimeter of the second side, the adhesive circumscribing a center region of the sheet and a port comprising a center region of the sheet. The port is configured to allow flow through the face mask at least in a direction towards a user without removal from the user.

0011In another embodiment, a face mask suitable for use in a CPAP system, a CPAP system and associated methods are provided. In one embodiment, a mask suitable for use with a CPAP system includes a breathable, flexible sheet having a first side and a second side, an adhesive disposed on a perimeter of the second side, the adhesive circumscribing a center region of the sheet and a hose fitting coupled to the center region of the sheet.

0012In another embodiment, a face mask suitable for use with a CPAP system includes a flexible sheet having a first side and a second side. An adhesive is disposed on a perimeter of the second side of the sheet, the adhesive circumscribing a center region of the sheet, the sheet having a fitting accepting aperture formed therethrough, the fitting accepting aperture having a diameter suitable to provide sufficient air for CPAP therapy.

0013In another embodiment, a CPAP system is provided that includes a CPAP machine, an air delivery hose and a face mask. The face mask is connectable to the CPAP machine by the hose, the mask formed from a flexible sheet having a first side and a second side, an adhesive disposed on the second side of the face mask, the adhesive circumscribing a center region of the sheet, the center region of the sheet containing a feature adapted for coupling the hose thereof. In some embodiments, the sheet may be breathable or porous.

0014In yet another embodiment, a method for CPAP therapy is provided that includes coupling a face mask to a CPAP machine, securing the face mask over the nose and mouth of a person, the mask secured using adhesives without the aid of straps and delivering CPAP therapy to the person through the face mask.

0015In still another embodiment, a method for providing a CPAP machine and providing a face mask connectable to the CPAP machine, the face mask comprising a flexible sheet having a first side and a second side, the second side of the sheet having an adhesive disposed on a perimeter, the adhesive circumscribing a center region of the sheet and an attachment feature formed in a center region of the sheet. In some embodiments, the sheet may be breathable.

0016A face mask suitable for use in resistance training and associated methods are also provided. In one embodiment, a face mask suitable for use in resistance training includes a breathable, flexible sheet having a first side and a second side, an adhesive disposed on a perimeter of the second side, an adhesive circumscribing a center region of the sheet and a port located in the center portion of the sheet. The port is configured to allow flow through the face mask at least in a direction towards the second side of the flexible sheet.

BRIEF DESCRIPTION OF THE DRAWINGS

0017So that the manner in which the above recited features of the present invention can be understood in detail, a more particular description of the invention, briefly summarized above, can be had by reference to embodiments, some of which are illustrated in the appended drawings. It is to be noted, however, that the appended drawings illustrate only typical embodiments of this invention and are therefore not to be considered limiting of its scope, for the invention can admit to other equally effective embodiments.

0018<figref idrefs="DRAWINGS">FIG. 1</figref> is a plan view of one embodiment of a face mask with port configured to allow flow through the face mask at least in a direction towards a user, generally defined as an adhesive side or user side of the mask;

0019<figref idrefs="DRAWINGS">FIG. 2</figref> is a sectional view of the face mask taken along section line <b>2</b>-<b>2</b> of <figref idrefs="DRAWINGS">FIG. 1</figref>;

0020<figref idrefs="DRAWINGS">FIG. 3</figref> is a simplified schematic of one embodiment of a CPAP system utilizing one embodiment of face mask having a port;

0021<figref idrefs="DRAWINGS">FIG. 4</figref> is a plan view of the face mask of <figref idrefs="DRAWINGS">FIG. 3</figref>;

0022<figref idrefs="DRAWINGS">FIG. 5</figref> is a sectional view of the face mask of <figref idrefs="DRAWINGS">FIG. 3</figref> taken along section line <b>5</b>-<b>5</b> of <figref idrefs="DRAWINGS">FIG. 4</figref>;

0023<figref idrefs="DRAWINGS">FIG. 6</figref> is sectional view of another embodiment of a face mask having a port;

0024<figref idrefs="DRAWINGS">FIG. 7</figref> is an exploded sectional view of another embodiment of a face mask;

0025<figref idrefs="DRAWINGS">FIG. 8</figref> is a side view of a person wearing one embodiment of a face mask of the present invention;

0026<figref idrefs="DRAWINGS">FIG. 9</figref> is a flow diagram of one embodiment of a method for providing CPAP therapy;

0027<figref idrefs="DRAWINGS">FIG. 10</figref> is another embodiment of a face mask suitable for use in a resistance training system;

0028<figref idrefs="DRAWINGS">FIG. 11</figref> is a sectional view of another embodiment of a face mask suitable for use in a resistance training system;

0029<figref idrefs="DRAWINGS">FIG. 12</figref> is a side view of a person wearing another embodiment of a face mask of the present invention; and

0030<figref idrefs="DRAWINGS">FIG. 13</figref> is a flow diagram of one embodiment of a method for providing resistance training using a face mask of the present invention.

0031To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures. It is contemplated that elements and features of one embodiment may be beneficially incorporated in other embodiments without further recitation.

0032It is to be noted, however, that the appended drawings illustrate only exemplary embodiments of this invention and are therefore not to be considered limiting of its scope, for the invention may admit to other equally effective embodiments.

DETAILED DESCRIPTION

0033<figref idrefs="DRAWINGS">FIG. 1</figref> depicts a rear elevation of one embodiment of a face mask <b>100</b> with a port <b>102</b>. The port <b>102</b> is generally configured to allow flow through the face mask at least in a direction towards a user, generally defined as an adhesive side or user side of the face mask. The face mask <b>100</b> is generally fabricated from primarily a flexible sheet <b>104</b> having a sufficient surface area to cover the mouth and nose of a user. The sheet <b>104</b> in its unused state may have a performed contour, or be flat and planer. The sheet <b>104</b> is strong and has sufficient flexibility to conform to the face of the user, thereby increasing comfort and minimizing air leaks. The sheet <b>104</b> may be fabricated from one or more layers of a melt blown material, spun bond material, wet laid glass material, cellulous material, carbon cloth or other suitable filtration media or air permeable material. It is also contemplated that the sheet <b>104</b> may comprise a plurality of breathable layers laminated together. The laminated layers comprising the sheet <b>104</b> may be quilted, spot welded or affixed in another manner which substantially prevents delamination. Examples of sheets <b>104</b> which may be adapted to benefit from the invention are described in U.S. Pat. No. 6,609,516, issued Aug. 26, 2003, which is incorporated by reference in its entirety. In one embodiment, the flexible sheet <b>104</b> may be breathable, such as being porous or a comprised of filtration media. The use of porous media for the sheet <b>104</b> allows for the continuous exchange of fresh air, proving comfort to the user while filtering out air on exhalation thereby reducing the spread of germs. In one embodiment, the sheet <b>104</b> has a filtration efficiency of at least 95% of 0.3 micron particles at 85 liters per minute flow rate. In another embodiment, the sheet <b>104</b> may have a MERV 4 rating or higher. In certain embodiments, the sheet <b>104</b> may not be porous.

0034As noted above, the port <b>102</b> is configured to allow flow through the face mask at least in a direction towards a user, generally defined as an adhesive side or user side of the face mask. The port <b>102</b> may be configured to couple with a conduit, such as a hose or tube, or be configured to be opened and closed. In one embodiment, the port <b>102</b> is configured to allow the entry of a fluid, for example, liquid or gas, to pass through the face mask <b>100</b> facing minimal resistance from the sheet <b>104</b> to a user and allow preferential passage of the fluid relative to the surrounding material of the sheet <b>104</b>. The port <b>102</b> may be a circular cut-out, slit or other hole through the sheet <b>104</b>. In some embodiments, the port <b>102</b> may be configured to be sealable, for example, by a valve or sealing member, which may be opened to allow flow through the face mask at least in a direction towards a user.

0035Referring to <figref idrefs="DRAWINGS">FIGS. 1 and 2</figref>, the flexible sheet <b>104</b> primarily comprising the face mask <b>100</b> includes a front side <b>105</b> and a back side <b>106</b>. The back side <b>106</b> generally is intended to face the user when the face mask <b>100</b> is worn. The flexible sheet <b>104</b> may have a rectangular plan form and be flat when not in use. Alternatively, the sheet <b>104</b> may have other plan forms. In one embodiment, a ring-shaped adhesive layer <b>108</b> is disposed on the back side <b>106</b> of the sheet <b>104</b> proximate an edge <b>110</b> of the sheet <b>104</b>, circumscribing a center region <b>112</b> of the sheet <b>104</b>. The adhesive layer <b>108</b> is utilized to secure the sheet <b>104</b> to the face of the user to achieve a uniform seal around the perimeter of face mask <b>100</b>. Suitable adhesives include pressure sensitive adhesives of the type suitable for adhesion to human skin, and releasable from human skin without injury, such as medical grade temporary adhesives. In one embodiment, the adhesive is a silicon adhesive which allows the face mask <b>100</b> to be reusable. The silicone adhesive advantageously allows the face mask <b>100</b> to be washed, stored in a manner where the mask may be folded to allow adhesive to adhesive contact, and reused. In another embodiment the adhesive is hydrogel adhesive suitable for adhesion to human skin and allows the user to sweat or come in contact with liquids and retain the effectiveness of the hydrogel adhesion. Any of the adhesives described above may be used on any of the masks described herein. However, other types of adhesives may be suitable as well.

0036In embodiments wherein the sheet <b>104</b> is breathable, the edge <b>110</b> may comprise a ring (not shown) of material circumscribing the center breathable region <b>112</b> to provide a surface of deposition of the adhesive layer <b>108</b>.

0037A release liner <b>114</b> (only shown in the enlarged portion of <figref idrefs="DRAWINGS">FIG. 2</figref>) may be disposed over the ring-shaped adhesive layer <b>108</b> when the face mask <b>100</b> is not in use. The release liner <b>114</b> may be removed from the sheet <b>104</b> to expose the adhesive layer <b>108</b> for securing the face mask <b>100</b> to the user.

0038The sheet <b>104</b> may include an adhesive-free narrow border <b>116</b> defined between the edge <b>110</b> and adhesive layer <b>108</b>. The adhesive-free border <b>116</b> provides a gripping surface to assist peeling of the release liner <b>114</b> from the adhesive layer <b>108</b>, as indicated by arrow <b>118</b>, and to assist removal of the face mask <b>100</b> from the user. The release liner <b>114</b> and the adhesive-free border may be incorporated in any of the embodiments of masks described herein.

0039In one embodiment the face mask <b>100</b> optionally includes a transparent eye guard <b>120</b>, shown in phantom in <figref idrefs="DRAWINGS">FIG. 1</figref>. The guard <b>106</b> may be made of transparent plastic or any other suitable transparent material for guarding a user's eyes from external factors, such as smoke or other eye irritant. In one embodiment, the guard <b>106</b> may be made of an anti-fog material. The adhesive layer <b>108</b> is utilized to secure the guard <b>120</b> to the face of the user to achieve a uniform seal around the perimeter of face mask <b>100</b>. The adhesive layer <b>108</b> and the edge <b>110</b> extend upwards from the flexible sheet <b>104</b> around the perimeter of the guard <b>120</b>. The guard <b>120</b> may be affixed to the mask by any suitable attachment means, for example, such as adhesives or sonic welding. The guard <b>120</b> may be incorporated in any of the embodiments of masks described herein.

0040In another embodiment, the face mask <b>100</b> optionally includes a stiffening member <b>122</b>, shown in phantom <figref idrefs="DRAWINGS">FIG. 1</figref>, coupled to the front side <b>105</b> to assist in removal of the face mask <b>100</b> from the user. In one embodiment, the stiffening member <b>122</b> may be affixed to the top edge <b>110</b> of the sheet <b>104</b>. The stiffening member <b>122</b> may be a printable material and/or be a reflective material to enhance safety of the user if using along roadways. The stiffening member <b>122</b> may be incorporated in any of the embodiments of masks described herein.

0041The face mask <b>100</b> may be utilized or adapted for utilization in resistance training, CPAP therapy, personal protection, medial use, security and police use, among others. The face mask <b>100</b> allows for fast and easy deployment, while being extremely portable and easily stowed or carried.

0042<figref idrefs="DRAWINGS">FIG. 3</figref> depicts one embodiment of a face mask <b>300</b> having port <b>102</b> is configured to accept a conduit, for example, a tube or a hose. The face mask <b>300</b> may be coupled by the conduit to a gas or liquid source, such as an oxygen supply, anesthetic supply or other gas supply. In the embodiment depicted in <figref idrefs="DRAWINGS">FIG. 3</figref>, the face mask <b>300</b> is schematically illustrated as part of a CPAP system <b>302</b>. The CPAP system <b>302</b> includes a CPAP machine <b>304</b> connected by a hose <b>306</b> to the face mask <b>300</b>, which may be strapless due to the use of the adhesive layer <b>108</b>. The CPAP machine <b>304</b> is operable to provide sufficient air pressure to a person wearing the face mask <b>300</b> sufficient to provide CPAP therapy to the person. It is contemplated that the CPAP machine <b>304</b> may be any commercially available CPAP machine or other suitable CPAP air source. Suitable CPAP machines are available from Phillips Respironics, among others. The face mask <b>300</b> is detachably connected to the hose <b>306</b>. In one embodiment, the face mask <b>300</b>, which may be permeable or impermeable to air, is configured to be affixed to the face of a person being treated for sleep apnea without the use of straps. Moreover, the lack of straps increases the comfort level of the wearer while minimizing the potential shifting and leakage of the face mask <b>300</b> due to movement of the strap.

0043The face mask <b>300</b> includes a sheet <b>104</b> constructed as described above. In one embodiment the sheet <b>104</b> may be a non-permeable flexible web of material. In another embodiment, the flexible sheet <b>104</b> is permeable and has sufficient resistance to air flow in order to provide the wearer with a continuous flow of air at a pressure sufficient to prevent apnea from occurring.

0044In one embodiment, the sheet <b>104</b> is permeable and muffles air passage during a users' exhalation, thereby providing a more restful sleep as compared to conventional masks. Additionally, the use of engineered breathable media for the sheet <b>104</b> allows for the correct pressure to be maintained within the face mask <b>300</b> for optimal breathing and treatment.

0045<figref idrefs="DRAWINGS">FIG. 4</figref> is a rear elevation of the face mask <b>300</b>, and <figref idrefs="DRAWINGS">FIG. 5</figref> is a cross-sectional view of the face mask <b>300</b> taken through section line <b>5</b>-<b>5</b> of <figref idrefs="DRAWINGS">FIG. 4</figref>. Referring to <figref idrefs="DRAWINGS">FIGS. 4 and 5</figref>, in one embodiment, the port <b>102</b> is a hose fitting attachment feature <b>400</b> formed in a center region <b>402</b> of the sheet <b>104</b>. The hose fitting attachment feature <b>400</b> may not necessarily be in the geometric center of the center region <b>402</b>.

0046A fitting <b>404</b> is generally interfaced with the fitting attachment feature <b>400</b> of the sheet <b>104</b>. The fitting <b>404</b> has a first end <b>406</b> which is configured to permit coupling of the fitting <b>404</b> to the hose <b>306</b>. A second end <b>408</b> of the fitting <b>404</b> is configured to facilitate attachment of the fitting <b>404</b> to the sheet <b>104</b> such that the second end <b>408</b> of the fitting <b>404</b> is disposed on a front side <b>410</b> of the sheet <b>104</b>. The first end <b>406</b> of the fitting <b>404</b> may be configured to mate with the hose <b>306</b> in a conventional manner, such as a press fit, thread, bayonet fitting, quarter turn or other suitable hose connection.

0047The second end <b>408</b> of the fitting <b>404</b> includes a flange <b>412</b>. The flange <b>412</b> facilitates affixing the fitting <b>404</b> to the flexible sheet <b>104</b>. In one embodiment, an adhesive <b>414</b> may be disposed between the flange <b>412</b> and the sheet <b>104</b> and the front side <b>410</b> of the sheet <b>104</b> as shown in <figref idrefs="DRAWINGS">FIG. 5</figref>. Alternatively, the flange <b>412</b> may be affixed to the front side <b>410</b> of the sheet <b>104</b> by sonic welding, stitching, clamping or other suitable method. It is also contemplated that the flange <b>412</b> may be coupled to a back side <b>416</b> of the sheet <b>104</b> via one of the methods described above as shown in <figref idrefs="DRAWINGS">FIG. 6</figref>.

0048Continuing to refer to <figref idrefs="DRAWINGS">FIG. 5</figref>, the fitting <b>404</b> is generally aligned with the feature <b>400</b> to facilitate the flow of air from the hose <b>306</b> through the fitting <b>404</b> to the user on the back side of the face mask <b>300</b>. The fitting <b>404</b> may be configured as a universal fitting or to include adapters such as to allow for different types of hose connections and use with different types of CPAP machines <b>304</b>. In one embodiment, the fitting <b>404</b> mates with hose <b>306</b> (or second fitting coupled to the end of the hole <b>306</b>) via a thread, quarter turn connection, bayonet connection, swag fitting or other suitable mating arrangement.

0049In the embodiment depicted in <figref idrefs="DRAWINGS">FIGS. 4-6</figref>, the fitting <b>404</b>, once attached to the sheet <b>104</b>, becomes an integral portion of the face mask <b>300</b>. Thus, a user may readily disconnect the fitting <b>404</b> of the face mask <b>300</b> from the hose <b>306</b> and attach a new mask to the hose <b>306</b> and CPAP machine <b>304</b> once the service life of the first mask has expired. Since the sheet <b>104</b> of the unused face mask <b>300</b> in one embodiment is flexible and flat, the face mask <b>300</b> may be packed flat or folded in flat poly bags or sleeves, thereby facilitating high density packing and convenient storage.

0050<figref idrefs="DRAWINGS">FIG. 7</figref> is an exploded sectional view of another embodiment of a mask <b>700</b> which may be utilized with the CPAP system <b>302</b> described above. The mask <b>700</b> includes a flexible sheet <b>104</b> constructed as described above. The mask <b>700</b> is substantially similar to the face mask <b>300</b> except that the fitting <b>702</b> is not permanently affixed to the sheet <b>104</b>. In this manner, only the sheet <b>104</b> of the mask <b>700</b> needs to be replaced at the end of the service life, wherein the fitting <b>702</b> removed from the old mask may be reused with replacement mask.

0051In the embodiment depicted in <figref idrefs="DRAWINGS">FIG. 7</figref>, the fitting <b>702</b> includes a first end <b>704</b> detachably couple-able to the hose <b>306</b> and a second end <b>706</b> configured to detachably affix to the first end of the fitting <b>702</b> in a manner which captures the sheet <b>104</b> to the fitting <b>702</b>. In the embodiment illustrated in <figref idrefs="DRAWINGS">FIG. 7</figref>, the second end <b>706</b> of the fitting <b>702</b> includes a male threaded tab <b>708</b> which engages a female threaded portion <b>710</b> formed in the second end <b>706</b>. When the tab <b>708</b> is threaded into the threaded portion <b>710</b>, flanges <b>712</b>, <b>714</b> of the tab <b>708</b> second end <b>706</b> are displaced toward each other, thereby capturing the sheet <b>104</b> therebetween. When a user wishes to replace the mask <b>700</b>, the tab <b>708</b> may be removed from the second end <b>706</b>, thereby releasing the sheet <b>104</b> and allowing the fitting <b>702</b> to be reassembled, capturing a new sheet therebetween.

0052<figref idrefs="DRAWINGS">FIG. 8</figref> depicts a side view of a user <b>800</b> wearing a face mask <b>802</b> of the present invention. The face mask <b>802</b> may be any of the masks described herein. The adhesive layer <b>108</b> on the back side of the face mask <b>802</b> allows the sheet <b>104</b> to flexibly conform to the user's face, thereby providing a substantially air-tight seal around the mouth and nose of the user. Since the face mask <b>802</b> does not include and/or need straps to hold the face mask <b>802</b> in place, the user's comfort level is increased while the probability of leakage due to straps falling at the mask is eliminated. A fitting <b>804</b> extending from the front side of the face mask <b>802</b> allows the hose <b>306</b> to be readily connected to the mask either before or after the hose is connected to the CPAP machine <b>304</b>. The fitting <b>804</b> may be configured as described above. Thus, CPAP therapy may be provided by the system <b>302</b> with greater comfort to the user and with less probability of leakage.

0053<figref idrefs="DRAWINGS">FIG. 9</figref> depicts a flow diagram of one embodiment of a method for providing CPAP therapy <b>900</b> using CPAP machine <b>304</b>, hose <b>306</b> and strapless face mask <b>802</b>. The method begins at step <b>902</b> by securing the strapless face mask <b>802</b> to a user <b>800</b> using an adhesive disposed on the back side of the face mask <b>802</b>. At step <b>904</b>, a CPAP therapy is provided by providing air from the CPAP machine <b>304</b> to the user <b>800</b> through a fitting formed in a center region of the face mask <b>802</b> which is surrounded by the adhesive.

0054The strapless face mask provides increased user comfort while minimizing potential leakage. Furthermore, the mask's flat form allows for easy packaging and storage. Additional benefits of the strapless mask include a substantially leak free seal which prevents pressure lost which causes conventional CPAP masks to stops working; comfortable fit without leakage and over tightening reduces skin irritation and pressure sores, improved hygiene due to single use and elimination of daily cleaning required by conventional CPAP masks. The strapless mask also allows a more natural sleeping position. Sleeping on your back is the worst position for sleep apnea. Sleeping on your side can put pressure on existing hard CPAP masks, which can break the seal and causing the mask to leak air. The flexibility of the strapless mask allows the user to sleep comfortably on their side. The strapless mask being substantially flat is easy to ship and store, with one size fits all—thereby eliminating need for custom, expensive fittings. The same strapless mask will accommodate both mouth and non-mouth breathers. The strapless mask is easy to get used to and reduces and/or eliminates claustrophobic feelings sometimes associated with conventional CPAP masks.

0055As discussed above, other embodiments of the mask include a port that is configured to be sealable, for example, by a valve or sealing member, so that the port may be selectively open and closed. The port, when in the open or unsealed state, is configured to allow flow through the face mask at least in a direction towards a user, generally defined as an adhesive side or user side of the face mask.

0056<figref idrefs="DRAWINGS">FIG. 10</figref> is a rear elevation of another embodiment of a face mask <b>1000</b>. The face mask <b>1000</b> is suitable for use in a resistance training system. The face mask <b>1000</b> is primarily fabricated from a flexible sheet <b>104</b> that is air permeable, and is configured to be affixed to the face of a person performing resistance training without the use of straps. The lack of straps increases the comfort level of the wearer while minimizing the potential shifting and leakage of the face mask <b>1000</b> during resistance training. In one embodiment, the face mask <b>1000</b> includes the flexible sheet <b>104</b> constructed as described above, and may be breathable, such as being porous. In one embodiment, the resistance level of the sheet <b>104</b> for inhalation has a range of between about 3.5 mm H₂O to about 10.5 mm H₂O based upon the National Institute for Occupational Safety and Health (NIOSH) test procedure RCT-APR-STP-0007, now TEB-APR-STP-0007.

0057The face mask <b>1000</b> may be provided as part of a kit comprising two or more different types of masks <b>1000</b>, each type of face mask <b>1000</b> having sheet <b>104</b> having a different flow resistance to allow the user to select an appropriate resistance mask for a particular training need and/or to include masks of varying resistance, such as low, medium and high resistance sheets, to facilitate training regimes which require different resistances at different training stages. In one embodiment, the mask types comprising the kit may be selected from mask types having a flow resistance based upon the NIOSH test procedure TEB-APR-STP-0007 in a range of between about 3.5 mm H₂O to about 5.5 mm H₂O for a first mask type, a range of between about 5.5 mm H₂O to about 6.5 mm H₂O for a second mask type, a range of between about 6.5 mm H₂O to about 7.5 mm H₂O for a third mask type, and a range of between about 7.5 mm H₂O to about 10.5 mm H₂O for a fourth mask type.

0058The sheet <b>104</b> muffles air passage during the users' exhalation, thereby providing resistance even during exhalation. Optionally, a flapper-type check valve (or other suitable valve, not shown) may be affixed to the sheet <b>104</b> to allow substantially unrestricted exhalation.

0059Referring to <figref idrefs="DRAWINGS">FIGS. 10 and 11</figref>, the port <b>102</b> is a sealable port <b>1002</b> formed in the center region <b>1004</b> of the sheet <b>104</b> in face mask <b>1000</b>. The port <b>1002</b>, in its open state, is configured to allow the flow of fluids through the mask to the user. In one embodiment the centerline of the port <b>1002</b> is located within around one inch of the centerline of the face mask <b>1000</b> so that it is aligned to where a user's mouth is located to facilitate use of the port <b>1002</b> to deliver water or other thirst quenching liquid to the user without removal of the face mask <b>1000</b> or partial peeling of the mask from the face of the user. In the embodiment depicted in <figref idrefs="DRAWINGS">FIG. 11</figref>, the port <b>1002</b> is in the form of an aperture formed through the center region <b>1004</b> of the sheet <b>104</b>. As described above, the port <b>1002</b> may be a circular cut-out, slit or other hole through the sheet <b>104</b> which allows preferential passage of air relative to the surrounding material of the sheet <b>104</b> comprising the center region <b>1004</b>. The port <b>1002</b> may be an elastomeric member that is bonded to the flexible sheet <b>104</b> which may be sealingly opened and closed.

0060In one embodiment, the port <b>1002</b> may be covered by a seal <b>1006</b> on a front side <b>1010</b> of the face mask <b>1000</b> (shown in phantom in <figref idrefs="DRAWINGS">FIG. 10</figref>). In one embodiment, the seal <b>1006</b> is in the form of a flap flexible material that operates to open and close access to the port <b>1002</b>. In one embodiment, the seal <b>1006</b> is securely attached to the flexible sheet <b>104</b> by an attachment <b>1008</b>, which may be a sonic weld or an adhesive strip. The seal <b>1006</b> has a temporary adhesive layer that removably secures the flap (e.g., seal <b>1006</b>) to the sheet <b>104</b>, such that the seal <b>1006</b> covers and substantially seals the port <b>1002</b>. The seal <b>1006</b> may also include an adhesive free tab <b>1012</b> positioned on the opposite side of the port <b>1002</b> from the attachment <b>1008</b> to assist in opening and closing the seal <b>1006</b>. The temporary adhesive layer may be of the same material as described for the adhesive layer <b>108</b>. The seal <b>1006</b> may be incorporated in any of the embodiments of masks described herein.

0061In another embodiment, the seal <b>1006</b> may be in the form of a valve <b>1014</b> interfaced with the port <b>1002</b> of the sheet <b>104</b>. The valve <b>1014</b> includes a valve body <b>1016</b> and a control knob <b>1018</b>. The valve body <b>1016</b> includes a flange <b>1020</b> and one or more valve apertures <b>1022</b> formed therethrough. The flange <b>1020</b> is sealingly coupled to the sheet <b>104</b>. The flange <b>1020</b> may be affixed to the sheet <b>104</b> by sonic welding, stitching, crimping or other suitable method. In one embodiment, an adhesive may secure the flange <b>1020</b> and the sheet <b>104</b>. The valve <b>1014</b> has an undercut <b>1024</b> which is configured to retain the knob <b>1018</b> while allowing the knob <b>1018</b> to be turned to control the flow of air through the valve <b>1014</b>, and hence, through the port <b>1002</b> of the face mask <b>1000</b>.

0062In one embodiment, the knob <b>1018</b> includes a knob flange <b>1026</b>, one or more knob apertures <b>1028</b>, and a knob base <b>1030</b>. The knob flange <b>1026</b> engages the undercut <b>1024</b> to retain the knob <b>1018</b> to the valve <b>1014</b>. The one or more knob apertures <b>1028</b> are located between the knob base <b>1030</b> and knob flange <b>1026</b>. The knob base <b>1030</b> includes a knob opening <b>1032</b> to allow liquids to be delivered to a user's mouth through the valve <b>1014</b> and port <b>1002</b>. As seen in <figref idrefs="DRAWINGS">FIG. 11</figref>, the knob opening <b>1032</b> may be selectively sealed by a cap <b>1034</b> at the knob base <b>1030</b>. In another embodiment, the cap <b>1034</b> is coupled to the knob <b>1018</b> by a living hinge (not shown). The cap <b>1034</b> may be incorporated in any of the embodiments of masks described herein.

0063In operation, the valve <b>1014</b> has at least three operational states. In one operational state, the knob <b>1018</b> may be turned to control the amount of alignment between the valve aperture <b>1022</b> of the body <b>1016</b> and the apertures <b>1028</b> of the knob <b>1018</b>, thus allowing the amount of air flowing through the valve <b>1014</b> and port <b>1002</b> to the user to be controlled, thereby controlling the ultimate flow resistance through the face mask <b>1000</b> (as shown in <figref idrefs="DRAWINGS">FIG. 11</figref>). When the knob <b>1018</b> is turned to prevent the valve apertures <b>1022</b> from aligning with the knob apertures <b>1028</b>, flow is substantially prevented through the valve <b>1014</b> and along the flow of air through the sheet <b>104</b> of the face mask <b>100</b>.

0064<figref idrefs="DRAWINGS">FIG. 12</figref> depicts a side view of a user <b>1200</b> wearing the face mask <b>1000</b> of the above embodiment, however the mask may be any of the masks described herein. The adhesive layer <b>108</b> on a back side <b>1036</b> (shown in <figref idrefs="DRAWINGS">FIGS. 10 and 11</figref>) of the face mask <b>1000</b> allows the sheet <b>104</b> to flexibly conform to the user's face, thereby providing a substantially air-tight seal around the mouth and nose of the user. Since the face mask <b>1000</b> does not include and/or need straps to hold the face mask <b>1000</b> in place, the user's comfort level is increased while the probability of leakage due to straps falling at the mask is eliminated. In one embodiment, the seal <b>1006</b> may be opened to allow a nipple <b>1202</b> of a water bottle <b>1204</b> or a straw to deliver liquid into the mouth of the user <b>1200</b>.

0065<figref idrefs="DRAWINGS">FIG. 13</figref> depicts a flow diagram of one embodiment of a method <b>1300</b> for providing resistance therapy using the strapless face mask <b>1000</b>. The method <b>1300</b> begins at step <b>1302</b> by securing the strapless mask to the user <b>1200</b> using an adhesive disposed on the back side of the mask. At step <b>1304</b>, resistive therapy is provided by wearing the mask during training activities such as bike exercise, running, jogging, sparring and the like.

0066Reducing the oxygen available using the different operational states duplicates the effects of training at high altitude. The big challenges with high altitude training are the expense, commitment and the exposure for someone who has not yet acclimatized. The mask provides benefits similar to high altitude training for resistive training in a more cost effective and safe manner.

0067While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention can be devised without departing from the basic scope thereof, and the scope thereof is determined by the claims that follow.