MANDIBULAR POSITIONING DEVICE FOR CONTINUOUS POSITIVE AIRWAY PRESSURE THERAPY EQUIPMENT

Abstract

A mandibular positioning device for use with headgear for Continuous Positive Airway Pressure (“CPAP”) therapy face masks. The device can be integrated with existing headgear to maintain the position of a user's mandible during sleep while using CPAP therapy in order to prevent displacement of the user's face mask as a result of a posterior shift of the mandible. The device can include a pair of saddles for attaching the device to headgear, as well as a support strap which attaches to each saddle and which has a medial portion disposed underneath the user's chin when worn.

Claims

1. An apparatus for stabilizing a mandibular position during CPAP therapy, comprising: a) a first saddle and a second saddle, each comprising 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 comprising i) a first end having a fastener configured to engage said support strap fastener of said first saddle and ii) a second end having a fastener configured to engage said support strap fastener of said second saddle; wherein said first saddle is configured to receive a first lateral arm of a headgear device within an opening disposed between said proximal portion and said distal portion of said first saddle, wherein said second saddle is configured to receive a second lateral arm of said headgear device within an opening disposed between said proximal portion and said distal portion of said second saddle, wherein said first headgear fastener and said second headgear fastener of said first saddle are configured to retain said first lateral arm of said headgear device within said opening, and wherein said first headgear fastener and said second headgear fastener of said second saddle are configured to retain said second lateral arm of said headgear device within said opening.

2. The apparatus of claim 1, wherein a vertical width of said first saddle increases from an anterior end to a posterior end.

3. The apparatus of claim 1, wherein a width of said support strap increases from each of said first end and said second end toward a medial portion of said support strap.

4. The apparatus of claim 1, wherein said support strap further comprises a plurality of removable partitions at said first end for adjusting a length of said support strap.

5. A system for stabilizing a mandibular position during CPAP therapy, comprising a mandibular positioning apparatus and a headgear device having a first lateral arm and a second lateral arm, said apparatus comprising: a) a first saddle and a second saddle, each comprising 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 comprising i) a first end removably engaged with said first saddle and ii) a second end removably engaged with said second saddle; wherein said first lateral arm of said headgear device is retained within an opening between said proximal portion and said distal portion of said first saddle, and wherein said second lateral arm of said headgear device is retained within an opening between said proximal portion and said distal portion of said second saddle.

6. The system of claim 5, wherein said headgear device further comprises a third lateral arm and wherein a first portion of said support strap is disposed underneath said third lateral arm.

7. The system of claim 6, wherein said headgear device further comprises a fourth lateral arm and wherein a second portion of said support strap is disposed underneath said third lateral arm.

8. The system of claim 5, wherein said headgear device further comprises a top arm extending between said first lateral arm and said second lateral arm.

9. The system of claim 8, wherein, near said first saddle, a longitudinal axis of said top arm is aligned with a longitudinal axis of said support strap.

10. The system of claim 8, wherein an elongated edge of said support strap is about parallel to an elongated edge of said top arm of said headgear device.

11. The system of claim 8, wherein said support strap fastener of each saddle is aligned with said top arm of said headgear device.

12. A method for engaging a mandibular positioning apparatus to a headgear device, said device having a plurality of lateral arms and said apparatus comprising a first saddle, a second saddle, and a support strap, said method comprising 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 said lateral arms of said headgear device within said opening of said first saddle; c) positioning a second of said lateral arms of said headgear device within said opening of said second saddle; d) joining, along said top edge of each saddle, said proximal portion and said distal portion of each saddle; e) positioning a first portion of said support strap underneath a third of said lateral arms of said headgear device; f) positioning a second portion of said support strap underneath a fourth of said lateral arms of said headgear device; g) engaging a first end of said support strap to said first saddle; and h) engaging a second end of said support strap to said second saddle.

13. The method of claim 12, wherein, before the step of engaging said first end of said support strap to said first saddle, a length of said support strap is adjusted by removing at least one partition from an end of said support strap.

14. The method of claim 12, wherein said step of separating said proximal portion and said distal portion of each saddle comprises disengaging a first headgear fastener on each proximal portion from a second headgear fastener on each distal portion.

15. The method of claim 14, wherein said step of joining said proximal portion and said distal portion of each saddle comprises attaching said first headgear fastener to said second headgear fastener.

16. The method of claim 12, wherein said step of engaging said first end of said support strap to said first saddle comprises attaching a fastener on said first end to a first support strap fastener on said proximal portion of said first saddle.

17. The method of claim 16, wherein said headgear device further comprises a top arm extending between said first of said lateral arms and said second of said lateral arms and wherein said step of positioning said first of said lateral arms of said headgear device within said opening of said first saddle comprises aligning said first support strap fastener with said top arm.

18. The method of claim 12 wherein said step of engaging said second end of said support strap to said second saddle comprises attaching a fastener on said second end to a second support strap fastener on said proximal portion of said second saddle.

19. The method of claim 18, wherein said headgear device further comprises a top arm extending between said first of said lateral arms and said second of said lateral arms and wherein said step of engaging said first end of said support strap to said first saddle comprises aligning said support strap with said top arm.

20. The method of claim 19, wherein said step of engaging said first end of said support strap to said first saddle comprises aligning a longitudinal axis of said support strap with a longitudinal axis of said top arm.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG. 1 is a right perspective view diagram illustrating an exemplary headgear device attached to an exemplary face mask and an exemplary mandibular positioning device engaged thereto, each of which are being worn on a head of a user, in accordance with some embodiments of the present invention.

[0022] FIG. 2 is a left perspective view diagram illustrating the user, the face mask, the headgear device, and the mandibular positioning device of FIG. 1, in accordance with some embodiments of the present invention.

[0023] FIG. 3 is a side view diagram illustrating an exemplary first saddle of the mandibular positioning device illustrated in FIG. 1, in accordance with some embodiments of the present invention.

[0024] FIG. 4 is a side view diagram illustrating an exemplary second saddle of the mandibular positioning device illustrated in FIG. 1, in accordance with some embodiments of the present invention.

[0025] FIG. 5 is a side view diagram illustrating an exemplary mandibular positioning device engaged with an exemplary headgear device, each of which are being worn on a head (partially illustrated) of a user, in accordance with some embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0026] 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.

[0027] FIGS. 1 and 2 illustrate a user 3 wearing a face mask 5, which may be secured to the head of user 3 by a headgear device 7, and an exemplary mandibular positioning device 10 engaged with headgear device 7 at the sides of the head of user 3. According to some embodiments, a headgear device may have a plurality of straps which extend around a user's head and/or face. For example, as further illustrated in FIGS. 1 and 2, headgear device 7 may comprise upper lateral arms 8A and 8B, lower lateral arms 9A and 9B, and a top arm 6 extending between upper lateral arms 8A and 8B (another exemplary headgear device 70 is also illustrated in FIG. 5).

[0028] As further illustrated in FIGS. 1 and 2, and in accordance with some embodiments of the present invention, mandibular positioning device 10 may include a first saddle 20 (illustrated in FIG. 1), a second saddle 30 (illustrated in FIG. 2), and a support strap 40. In some embodiments, and as more clearly illustrated in FIGS. 3 and 4, a top edge 23 and 33 of first saddle 20 and second saddle 30, respectively, may be generally straight along the entire length thereof, whereas a bottom edge 24 and 34 of first saddle 20 and second saddle 30, respectively, may be straight along a first portion of the length thereof and curved in a downward direction (i.e., toward the neck of user 3, relative to the positions illustrated in FIGS. 1 and 2) along a second portion thereof. Thus, a vertical width of first saddle 20 and second saddle 30—that is, the distances between top edge 23 and bottom edge 24 and between top edge 33 and bottom edge 34, respectively—may increase from an anterior end 21 (right side of FIGS. 3) and 31 (left side of FIG. 4), respectively, to a posterior end 22 (left side of FIGS. 3) and 32 (right side of FIG. 4), respectively. Though, according to FIGS. 3 and 4, first saddle 20 and second saddle 30 are illustrated as mirror images of each other, it is to be appreciated that each saddle may differ in size and/or shape. Furthermore, and according to some embodiments, each saddle may be identical to the other such that they may be interchangeable. Additionally, it is to be appreciated that a saddle may be adapted to accommodate various headgear device designs. For example, the width of a saddle may increase in a posterior direction such that its top edge is upwardly curved and its bottom edge is downwardly curved (e.g., to accommodate headgear device straps which widen toward the back of a user's head). In another example, a saddle may comprise multiple openings (e.g., at an anterior and/or posterior end) which may accommodate headgear devices having more than one strap extending along the side of a user's head.

[0029] In some embodiments, and as further illustrated in FIGS. 3 and 4, first saddle 20 and second saddle 30 may each comprise a proximal portion 25 and 35, respectively (i.e., the portions closest to the head of user 3 in FIGS. 1 and 2), and a distal portion 26 and 36, respectively (i.e., the portions furthest from the head of user 3 in FIGS. 1 and 2), which may be joined together along the lengths of first saddle 20 and second saddle 30 near top edge 23 and 33, respectively, and bottom edge 24 and 34, respectively. According to some embodiments, and as illustrated in FIG. 3, proximal portion 25 (only the top of which is visible in FIG. 3) may be joined together with distal portion 26, near bottom edge 24, along a seam 29 (denoted by a dash-dotted line). Likewise, and as illustrated in FIG. 4, proximal portion 35 (only the top of which is visible in FIG. 4) may be joined together with distal portion 36, near bottom edge 34, along a seam 39 (denoted by a dash-dotted line). When proximal portion 25 and 35 is joined together with distal portion 26 and 36, respectively, an opening may be formed therebetween extending from anterior end 21 and 31 to posterior end 22 and 32, respectively. As illustrated in FIG. 1, for example, when mandibular positioning device 10 is engaged with headgear device 7, a portion of upper lateral arm 8A of headgear device 7 may be disposed within the opening of first saddle 20. Likewise, as illustrated in FIG. 2, for example, when mandibular positioning device 10 is engaged with headgear device 7, a portion of upper lateral arm 8B of headgear device 7 may be disposed within the opening of second saddle 30.

[0030] According to some embodiments, and as further illustrated, for example, in FIGS. 3 and 4, first saddle 20 and second saddle 30 may comprise headgear fasteners 27A and 27B and 37A and 37B, respectively, for attaching device 10 to headgear device 7. As more clearly illustrated in FIG. 3, for example, headgear fasteners 27A (denoted by a small dotted line depicting its position on the interior of first saddle 20) and 27B (denoted by a large dotted line depicting its position on the interior of first saddle 20) may be disposed on an interior of proximal portion 25 and on an interior of distal portion 26, respectively. Likewise, as more clearly illustrated in FIG. 4, for example, headgear fasteners 37A (denoted by a small dotted line depicting its position on the interior of second saddle 30) and 37B (denoted by a large dotted line depicting its position on the interior of second saddle 30) may be disposed on an interior of proximal portion 35 and on an interior of distal portion 36, respectively. In accordance with some embodiments, and as further illustrated in FIGS. 3 and 4, headgear fasteners 27A and 37A may be about the same length as, but narrower than, headgear fasteners 27B and 37B. This may allow the proximal portion and distal portion of each saddle to be attached at various positions. It is to be appreciated, however, that headgear fasteners 27A, 27B, 37A, and 37B may comprise various shapes and sizes which may be the same or different between two or more of the headgear fasteners.

[0031] 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.

[0032] As further illustrated in FIGS. 3 and 4, and in accordance some embodiments of the present invention, first saddle 20 and second saddle 30 may comprise a support strap fastener 28 and 38, respectively, for attaching support strap 40 thereto. Support strap fastener 28 may be disposed on an exterior of distal portion 26 to which a first end 41 of support strap 40 may be attached (illustrated, e.g., in FIG. 1). Likewise, second saddle 30 may have a support strap fastener 38 on an exterior of distal portion 36 to which a second end 42 of support strap 40 may be attached (illustrated, e.g., in FIG. 2). In some embodiments, and similar to headgear fasteners 27A, 27B, 37A, and 37B, support strap fastener 28 and 38 may comprise a male fastener configured to mate with a female fastener of support strap 40 (or vice versa). According to some aspects, and as further illustrated in FIGS. 3 and 4, support strap fastener 28 and 38 may be disposed near top edge 23 and 33 of first saddle 20 and second saddle 30 and toward anterior end 21 and 31 thereof, respectively.

[0033] Referring back, generally to FIGS. 1 and 2, according to some embodiments of the present invention, support strap 40 may be formed as a thin band generally comprising a “U” shape (when worn by user 3) which may support the lower jaw of user 3 and which may comprise a medial portion disposed underneath the chin of user 3. In some embodiments, the shape of a support strap may be configured according to the anatomical shape of a user's chin. For example, as further illustrated in FIGS. 1 and 2, the width of support strap 40 may increase from first end 41 and second end 42 towards the medial portion. It is to be appreciated, however, according to other embodiments, a support strap may have a fixed width along the entirety thereof, or may be narrower or wider near a medial portion (e.g., to accommodate different chin sizes). It is also to be appreciated that, when user 3 is wearing mandibular positioning device 10, support strap 40 may provide a force generally in an upward direction (i.e., toward the head of user 3), which may help stabilize the chin of user 3 in a vertical direction. Additionally, support strap 40 may be further stabilized in an anterior and posterior direction by the engagement of mandibular positioning device 10 with headgear device 7 (via first saddle 20 and second saddle 30), which provides a relatively stable point of attachment (as compared to, for example, engaging mandibular positioning device 10 around the top of the head of user 3).

[0034] As further illustrated in FIGS. 1 and 2, and according to some embodiments, support strap 40 may have a plurality of removable partitions 45A-D (illustrated in FIGS. 1) and 46A-D (illustrated in FIG. 2), separated by partition lines (denoted by broken lines), at first end 41 and second end 42, respectively, which may allow user 3 to adjust the length of support strap 40. For example, and without limitation, partition 45A may be separated from support strap 40 by cutting, tearing, or otherwise separating along the partition line between partition 45A and partition 45B, thereby shortening the overall length of support strap 40.

[0035] 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.

[0036] According to some implementations of the present invention, and with reference, generally to FIGS. 1-4, mandibular positioning device 10 may be attached to headgear device 7 by means of first saddle 20 and second saddle 30 (as illustrated, for example, in FIGS. 1 and 2). To engage first saddle 20 and second saddle 30 with headgear device 7, user 3 may first separate proximal portion 25 and 35 from distal portion 26 and 36, respectively, by disengaging headgear fastener 27A and 37A from headgear fastener 27B and 37B, respectively. By disengaging the headgear fasteners, the openings between proximal portion 25 and 35 and distal portion 26 and 36, respectively, may be exposed to receive portions of upper lateral arms 8A and 8B, respectively, of headgear device 7 which reside on the side of the head of user 3 when worn. Following, user 3 may position upper lateral arms 8A and 8B within the exposed openings of first saddle 20 and second saddle 30, respectively, with each saddle being oriented such that top edge 23 and 33 are closest to the head of user 3, relative to bottom edge 24 and 34. Once positioned, proximal portion 25 and 35 may be rejoined with distal portion 26 and 36, respectively, by engaging headgear fastener 27A and 37A with headgear fastener 27B and 37B, respectively, thus securing upper lateral arms 8A and 8B of headgear device 7 within the openings of first saddle 20 and second saddle 30.

[0037] 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.

[0038] 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.

[0039] 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 FIG. 5, a headgear device 70 may have a top arm 60 which extends around a head and which has a medial portion disposed posteriorly from a center C of the head. In this case, an end 141 of a support strap 140 may be attached to a saddle 120 at a more posterior position relative to an end of a support strap which may be engaged (via a saddle) to a headgear device having a top arm which extends across a center of a head.

[0040] In accordance with some implementations, and with further reference to FIGS. 1-4, the points of attachment of support strap 40 to first saddle 20 and second saddle 30 may be determined by the desired fit of user 3 and thus the attachment points may be relatively closer to, or further from, a top edge of each of first end 41 and second end 42. Optionally, and prior to the attachment of support strap 40, user 3 may remove one or more of partitions 45A-D and/or 46A-D near first end 41 and/or second end 42 (e.g., by cutting along a partition line) in order to shorten support strap 40 prior to attachment.

[0041] 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.