The present invention concerns a device for use with Continuous Positive Airway Pressure (“CPAP”) therapy equipment. More particularly, embodiments of the present invention concern a device which can be integrated with a face mask and used during CPAP therapy to maintain and stabilize the mandibular position of a user.
Obstructive Sleep Apnea (“OSA”) is a well-known cause of excessive daytime sleepiness and other diseases which lead to significant morbidity and mortality, including hypertension and depression. It is during the deep stages of sleep that total body muscle relaxation occurs, including posterior mandibular relaxation. This posterior relaxation of the mandible is often associated with relaxation of the tongue into the airway, which can cause an obstruction of airflow and reduced oxygen to the brain and body. This airway obstruction stimulates a cascade of physiologic responses that result in the brain transitioning to a lighter stage of sleep and, therefore, re-establishing muscle tone to obviate occlusion of the airway by the tongue. The brain's drive to return to the deep stage of sleep is paramount to good quality sleep and is the underlying reason of the constant, and often frequent, sleep stage shifts in OSA. Greater awareness of the relationship between OSA and chronic disease has accelerated diagnostic and therapeutic technologies.
The treatment of OSA has become more effective with the rapid improvements to Continuous Positive Airway Pressure (“CPAP”) machines and face mask technologies. CPAP therapy provides an “air splint” that channels positive airflow through a plastic tube which is connected to a face mask interface. The delivery of the constant air pressure prevents occlusion of the airway by the tongue. The mask is held in place on the head with headgear. Mask headgear conventionally consists of a set of upper straps that surround the head at the temple, a set of lower straps that surround the head below the ears, and a top strap over the top of the head and interconnecting the upper straps, each of which are conventionally made from narrow strips of non-woven fabric. A patient has the ability to apply tension to the straps to adjust the face mask interface into position over the nose and mouth for a stable, comfortable fit of the mask on the face.
The nightly use of this mode of therapy for the treatment of OSA typically improves sleep quality and overall health. However, there are many potential complications that could disrupt success with the nightly use of CPAP machines. Adherence to CPAP machines has been a focus of active investigation throughout the world. Although there are many components of this treatment modality, one aspect that has been given little attention to are the issues related to mandibular relaxation and its impact on optimal CPAP therapy.
When a patient uses a mask-headgear interface that covers the mouth and extends either around the nose (i.e., a full-face mask) or under the nose, air pressure enters both the nasal or oral passageways. It is during sleep that the mandible relaxes posteriorly and thus a leak of the constant air pressure around the periphery of the mask can occur. This leak decreases the required pressure to maintain the “air splint”. Air leaks are disruptive to sleep, often causing a full awakening. An air leak may cause a noisy vibration along the periphery of the mask and is often felt on the skin of the face. This disruption often results in the patient excessively tightening the mask onto the face to a point that becomes uncomfortable. The patient may then request an alternative mask interface, or may completely discontinue the use of CPAP therapy all together.
Conventional headgear applies a force to the front and back of the head, but, however, lacks any support for the chin. Therefore, one conventional approach to addressing mask leaks is the use of a chin strap. A conventional chin strap is a separate piece of equipment designed to be used with face masks which completely encircles the head from the vertex to the chin. However, conventional chin straps have achieved varied success due to issues with discomfort and/or inconvenience, as well as their design. For instance, while conventional chin straps provide an upward force on the chin to help keep the mandible in place, they are prone to sliding off at the chin or at the top of the head, as there are no forces toward the front or the back of the head to keep the chin strap in place. Other conventional chin straps may have arms which attach to headgear, but their conventional design is still susceptible to issues with stability and security. Additionally, some conventional chin straps have a top strap extending across the top of the head, but cannot be integrated with headgear and thus lack any functional connection.
Therefore, the need exists for a device having a chin strap which avoids the complete encircling of the head and is adjustable for customization by the patient. Furthermore, the need exists for a device having a chin strap which may be used in tandem with existing headgear of facemasks and thereby becoming an integrated part of the headgear. More particularly, there exists the need for a device which utilizes a top strap of conventional headgear such that the device and the top strap function as a unitary, continuous member. Such device may be compatible with most or all existing styles and brands of headgear and corresponding full-face masks, while also taking advantage of the securing properties inherent in the headgear.
The present invention generally comprises an apparatus, referred to generally hereafter as a mandibular positioning device, adapted for use with headgear for CPAP therapy face masks. In particular, a mandibular positioning device may be integrated with existing headgear to provide support to a user's chin and maintain the position of the user's mandible during sleep. While the user is asleep (and undergoing CPAP therapy), the device may prevent the user's mandible from shifting in a posterior direction (i.e., toward the back of the user's head), thus preventing displacement of the mask around the user's nose and/or mouth. It is to be appreciated, and in contrast with conventional devices, a mandibular positioning device is configured to be integrated with headgear, utilizing stabilizing properties inherent in the headgear and functioning as a unitary device rather than independent devices.
As used herein, the terms “anterior”, “posterior”, “proximal”, and “distal”, or other like terms, are provided to describe the position of a mandibular positioning device or headgear (referred to hereinafter as a “headgear device”), as well as components thereof, relative to a user's head, when a device is being worn by the user. These terms are intended to provide a frame of reference and are not intended to limit the scope of the present invention.
According to some embodiments of the present invention, a mandibular positioning device may include a first saddle, a second saddle, and a support strap, wherein the first saddle and the second saddle may each be configured to be attached to a portion of a headgear device for securing a face mask to a user's face. In some embodiments, a top edge of each saddle may be generally straight along the entire length of each saddle, whereas a bottom edge of each saddle may be straight along a first portion of the length of each saddle and curved in a downward direction (i.e., away from the top edge) along a second portion of the length of each saddle. Thus, a vertical width of each saddle (i.e., the distance between the top edge and the bottom edge) may increase from an anterior end to a posterior end, generally forming an “L” or “J” shape (depending on the frame of reference), with each saddle being a mirror image of the other.
In some embodiments, the first saddle and the second saddle may each comprise a proximal portion and a distal portion which may be joined together (removably or fixedly) along the length of the saddles, near the top edge and the bottom edge thereof, thereby forming an opening therebetween. When the device is attached to (or otherwise integrated with) a headgear device, a first lateral arm and a second lateral arm of the headgear device (i.e., the lateral arms which may be positioned near the temples of a user's head when worn) may be disposed within the opening of the first saddle and the opening of the second saddle, respectively.
According to some embodiments, the first saddle and the second saddle may each comprise one or more headgear fasteners on an interior of the proximal and distal portions, near the top edge thereof, for securing the mandibular positioning device to the headgear device. In some aspects, a headgear fastener may comprise a male fastener on the interior of the distal portion and a female fastener on the interior of the proximal portion (or vice versa), wherein the male and female fasteners may be joined together to attach the distal portion to the proximal portion.
In some embodiments of the present invention, the first saddle and the second saddle may each include one or more support strap fasteners for attaching the support strap thereto. More particularly, and in accordance with some embodiments, the first saddle may have a support strap fastener on an exterior of the distal portion to which a first end of the support strap may be attached. Likewise, the second saddle may have a support strap fastener on an exterior of the distal portion to which a second end of the support strap may be attached. In some embodiments, a support strap fastener may comprise a male (female) fastener configured to be attached to a female (male) fastener. According to some aspects, the support strap fastener may be disposed near the top edge of the first (second) saddle and toward an anterior end thereof.
According to some embodiments of the present invention, the support strap may be formed as a thin, flexible band generally comprising a “U” shape configured to support a user's lower jaw with a medial portion configured to be disposed underneath a user's chin when being worn by the user. In some embodiments, the support strap may have a plurality of removable partitions at each of the first end and the second end of the support strap for adjusting the length of the support strap. A first partition may be separated from an adjacent second partition by cutting, tearing, or otherwise separating along a partition line between the first and second partitions, thereby shortening the overall length of the support strap. When a user is wearing the mandibular positioning device, the support strap may be stabilized by a force applied by the support strap on the user's chin, generally in an upward direction, and by the engagement of each of the first saddle and the second saddle with the headgear device, which may stabilize the support strap in the anterior and posterior directions.
According to some embodiments, at each of the first end and the second end of the support strap, and, in some embodiments, on an interior portion thereof, may be one or more fasteners for engaging one or more strap fasteners of the first saddle and the second saddle, respectively. In some aspects, a fastener of the support strap may comprise a male (female) fastener configured to be attached to the female (male) fastener on the exterior of the distal portion of the saddles. In other embodiments, the support strap may be unitarily formed with each of the first and second saddles.
According to some implementations of the present invention, the mandibular positioning device may be attached to a headgear device by means of the first and second saddles. To attach the first and second saddles, a user may first separate, near the top edge thereof, the proximal and distal portions of each saddle (e.g., by disengaging the male (female) fasteners from the female (male) fasteners on the interior of the proximal and distal portions, respectively) to expose the openings between the proximal and distal portions. Following, the user may position a first and a second lateral arm of the headgear device which reside on each side of the user's head within the exposed openings of the first and second saddles, respectively. Once positioned, the proximal and distal portions may be rejoined along near the top edge of each saddle (e.g., by engaging the male (female) fasteners with the female (male) fasteners on the interior of the proximal and distal portions, respectively), thereby securing the headgear device within the openings of each saddle. The user may then insert one or both ends of the support strap underneath the first and/or second lateral arm of the headgear device, with the support strap toward the front of the user's lower jaw. Optionally, the user may first attached the support strap to a saddle before inserting an end of the support strap underneath a lateral arm of the headgear device. Following, the user may attach the first and second ends of the support strap to the first and second saddles, respectively (e.g., by engaging the male (female) fasteners of the support strap with the female (male) fasteners on the exterior of the first and second saddles), where the points of attachment of the support strap to the first and second saddles may be determined by the user's desired fit. Optionally, and prior to the attachment of the support strap, the user may remove one or more partitions from the first and/or second end of the support strap to shorten the support strap prior to attachment.
According to some embodiments of the present invention, an apparatus for stabilizing a mandibular position during CPAP therapy may comprise a) a first saddle and a second saddle, each of which may comprise i) a proximal portion having a first headgear fastener and ii) a distal portion having a second headgear fastener and a support strap fastener, and b) a support strap which may comprise i) a first end having a fastener which may be configured to engage the support strap fastener of the first saddle and ii) a second end having a fastener which may be configured to engage the support strap fastener of the second saddle, wherein the first saddle may be configured to receive a first lateral arm of a headgear device within an opening disposed between the proximal portion and the distal portion of the first saddle, wherein the second saddle may be configured to receive a second lateral arm of the headgear device within an opening disposed between the proximal portion and the distal portion of the second saddle, wherein the first headgear fastener and the second headgear fastener of the first saddle may be configured to retain the first lateral arm of the headgear device within the opening, and wherein the first headgear fastener and the second headgear fastener of the second saddle may be configured to retain the second lateral arm of the headgear device within the opening. In some embodiments, a vertical width of the first saddle may increase from an anterior end to a posterior end. In some embodiments, a width of the support strap may increase from each of the first end and the second end toward a medial portion of the support strap. In some embodiments, the support strap may further comprise a plurality of removable partitions at the first end for adjusting a length of the support strap.
According to some embodiments of the present invention, a system for stabilizing a mandibular position during CPAP therapy may comprise a mandibular positioning apparatus and a headgear device having a first lateral arm and a second lateral arm, wherein the apparatus may comprise a) a first saddle and a second saddle, each of which may comprise i) a proximal portion, ii) a distal portion, iii) a pair of headgear fasteners, and iv) a support strap fastener, and b) a support strap which may comprise i) a first end removably engaged with the first saddle and ii) a second end removably engaged with the second saddle, wherein the first lateral arm of the headgear device may be retained within an opening between the proximal portion and the distal portion of the first saddle, and wherein the second lateral arm of the headgear device may be retained within an opening between the proximal portion and the distal portion of the second saddle. In some embodiments, the headgear device may further comprise a third lateral arm and a first portion of the support strap may be disposed underneath the third lateral arm. In some embodiments, the headgear device may further comprise a fourth lateral arm and a second portion of the support strap may be disposed underneath the third lateral arm. In some embodiments, the headgear device may further comprise a top arm extending between the first lateral arm and the second lateral arm. In some embodiments, near the first saddle, a longitudinal axis of the top arm may be aligned with a longitudinal axis of the support strap. In some embodiments, an elongated edge of the support strap may be about parallel to an elongated edge of the top arm of the headgear device. In some embodiments, the support strap fastener of each saddle may be aligned with the top arm of the headgear device.
According to some implementations of the present invention, a method for engaging a mandibular positioning apparatus, which may have a first saddle, a second saddle, and a support strap, to a headgear device, which may have a plurality of lateral arms, may comprise the steps of a) separating, along a top edge of each saddle, a proximal portion and a distal portion of each saddle to expose an opening therebetween, b) positioning a first of the lateral arms of the headgear device within the opening of the first saddle, c) positioning a second of the lateral arms of the headgear device within the opening of the second saddle, d) joining, along the top edge of each saddle, the proximal portion and the distal portion of each saddle, e) positioning a first portion of the support strap underneath a third of the lateral arms of the headgear device, f) positioning a second portion of the support strap underneath a fourth of the lateral arms of the headgear device, g) engaging a first end of the support strap to the first saddle, and h) engaging a second end of the support strap to the second saddle. In some implementations, before the step of engaging the first end of the support strap to the first saddle, a length of the support strap may be adjusted by removing at least one partition from an end of the support strap. In some implementations, the step of separating the proximal portion and the distal portion of each saddle may comprise disengaging a first headgear fastener on each proximal portion from a second headgear fastener on each distal portion. In some implementations, the step of joining the proximal portion and the distal portion of each saddle may comprise attaching the first headgear fastener to the second headgear fastener. In some implementations, the step of engaging the first end of the support strap to the first saddle may comprise attaching a fastener on the first end to a first support strap fastener on the proximal portion of the first saddle. In some implementations, the headgear device may further comprise a top arm extending between the first of the lateral arms and the second of the lateral arms and the step of positioning the first of the lateral arms of the headgear device within the opening of the first saddle may comprise aligning the first support strap fastener with the top arm. In some implementations, the step of engaging the second end of the support strap to the second saddle may comprise attaching a fastener on the second end to a second support strap fastener on the proximal portion of the second saddle. In some implementations, the headgear device may further comprise a top arm extending between the first of the lateral arms and the second of the lateral arms and the step of engaging the first end of the support strap to the first saddle may comprise aligning the support strap with the top arm. In some implementations, the step of engaging the first end of the support strap to the first saddle may comprise aligning a longitudinal axis of the support strap with a longitudinal axis of the top arm.
The invention, in its various aspects, will be explained in greater detail below. While the invention will be described in conjunction with several exemplary embodiments, the exemplary embodiments themselves do not limit the scope of the invention. Similarly, the exemplary illustrations in the accompanying drawings, where like elements have like numerals, do not limit the scope of the exemplary embodiments and/or invention, including any length, angles, or other measurements provided. Rather the invention, as defined by the claims, may cover alternatives, modifications, and/or equivalents of the exemplary embodiments.
As further illustrated in
In some embodiments, and as further illustrated in
According to some embodiments, and as further illustrated, for example, in
In some embodiments, headgear fasteners 27A and 37A may comprise a male fastener and headgear fasteners 27B and 37B may comprise a female fastener (or vice versa), which can be joined together to attach proximal portion 25 and 35 to medial portion 26 and 36, respectively. For example, and without limitation, headgear fasteners 27A, 27B, 37A, and 37B may comprise “hook-and-loop” type fasteners in which headgear fasteners 27A and 37A may each comprise a plurality of hooks configured to mate with a plurality of loops of headgear fasteners 27B and 37B, respectively. It is to be appreciated, however, that other types of fasteners may be used, such as, and without limitation, snap type fasteners, zipper type fasteners, or button type fasteners.
As further illustrated in
Referring back, generally to
As further illustrated in
According to some embodiments of the present invention, near each of first end 41 and second end 42 of support strap 40, and along a portion of an interior of support strap 40 (not illustrated), may be one or more fasteners (not illustrated) for engaging support strap fastener 28 and 38 of first saddle 20 and second saddle 30, respectively. As described above, fasteners near first end 41 and second end 42 may comprise a male (female) fastener configured to mate with a female (male) support strap fastener 28 and 38, respectively. It is to be appreciated, however, that according to other embodiments, a support strap may be unitarily formed with each of the first and second saddles, or may be fixedly attached thereto.
According to some implementations of the present invention, and with reference, generally to
In preferred implementations, first saddle 20 and second saddle 30 may be positioned such that support strap fasteners 28 and 38, respectively, are aligned with top arm 6 of headgear 7 extending between upper lateral arms 8A and 8B. According to some implementations, prior to engaging first saddle 20 and second saddle 30 with headgear device 7, a user may first wear headgear device 7 with face mask 5 and adjust headgear device 7 until it is secure on the head of user 3. In some aspects, user 3 may run air through face mask 5 (e.g., by turning on a CPAP machine connected therewith) to determine if any air can escape around face mask 5 and, if needed, user 3 may further adjust headgear device 7. Once secure, user 3 may remove headgear device 7 and face mask 5 and then proceed to engage first saddle 20 and second saddle 30 with headgear device 7.
According to some implementations, following the engagement of first saddle 20 and second saddle 30 with headgear device 7, user 3 may place headgear device 7 (now equipped with first saddle 20 and second saddle 30) and face mask 5 back around the head and face of user 3. Next, user 3 may insert first end 41 and second end 42 underneath lower lateral arm 9A and lower lateral arm 9B, respectively, positioning the medial portion of support strap 40 toward a front portion of the lower jaw of user 3 and bringing first end 41 to first saddle 20 and second end 42 to second saddle 30 such that portions of support strap 40 are disposed between the lower jaw of user 3 and each of lower lateral arms 9A and 9B of headgear device 7 (optionally, a user may instead attach the support strap to one of the saddles before inserting an end underneath a lower lateral arm). Following, user 3 may attach first end 41 and second end 42 of support strap 40 to first saddle 20 and second saddle 30, respectively, by engaging the fastener near first end 41 with support strap fastener 28 of first saddle 20 and by engaging the fastener near second end 42 with support strap fastener 38 of second saddle 30. In some implementations, user 3 may pull up on each of first end 41 and second end 42 and/or open their mouth (i.e., to lower the chin) to create tension in support strap 40 prior to attachment to first saddle 20 and second saddle 30.
In preferred implementations, support strap 40 may be positioned such that it is generally aligned with top arm 6, with the elongated edges of support strap 40 (i.e. the edges extending along the sides and lower jaw of the head of user 3) and the elongated edges of top arm 6 (i.e., the edges extending across the top of the head of user 3) being about parallel near first saddle 20 and second saddle 30. For example, when viewed from a side of a user's head and near a saddle, a central longitudinal axis of a top strap may be generally aligned with a central longitudinal axis of a support strap. Therefore, depending on a type of headgear device, the ends of a support strap may positioned relatively closer to a back, center, or front of a user's head. For example, and as illustrated in
In accordance with some implementations, and with further reference to
It is to be understood that variations, modifications, and permutations of embodiments of the present invention may be made without departing from the scope thereof. It is also to be understood that the present invention is not limited by the specific embodiments, descriptions, or illustrations or combinations of either components or steps disclosed herein. Thus, although reference has been made to the accompanying figures, it is to be appreciated that these figures are exemplary and are not meant to limit the scope of the invention. In particular, it is to be appreciated that a mandibular positioning device may be integrated with, or may otherwise be adapted to be used with, a variety of headgear devices and should not be limited to the examples provided herein.
The present application claims priority to, and the benefit of, U.S. Provisional Patent Application No. 63/338,303, filed May 4, 2022, which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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63338303 | May 2022 | US |