1. Field of the Invention
The invention relates to forehead pads. These pads can be used with a respiratory mask for Non-invasive Positive Pressure Ventilation (NPPV) treatment of Sleep Disordered Breathing (SDB).
2. Background of the Invention
Nasal masks are commonly used in the treatment of respiratory conditions and sleep disorders by delivering a flow of breathable gas to a user to either assist the user in respiration or to provide a therapeutic form of gas to the user to prevent sleep disorders such as obstructive sleep apnea (OSA). These nasal masks typically receive a gas through a supply line, which delivers the gas into a chamber formed by walls of the mask.
The mask is generally semi-rigid and has a face portion that is in communication with the nose and/or mouth of a user. The mask is normally secured to the user's head by straps. The straps are adjusted to pull the mask against the face with sufficient force to achieve a gas-tight seal between the mask and the user's face. Gas is thus delivered to the mask through the aperture to the user's nasal passages and/or mouth.
One of the problems that arises with the use of the mask is that in order for the straps to be tight, the mask is compressed against the user's face and may push unduly hard on the user's nose. Additionally the mask may move around on the user's face. Therefore, masks often contain a forehead support that creates addition contact points between the mask and the user's head. The forehead support minimizes the movement of the mask as well as minimizes uncomfortable pressure points of the mask by preventing the mask from pushing too strongly against the user's nose and/or facial region.
Forehead supports typically have attached thereto a soft comfortable patient-contacting forehead pad. Forehead pads are generally constructed from soft materials, such as silicone, in contrast to the forehead support, which is generally rigid. One form of prior art forehead pad is disclosed in U.S. Pat. No. 6,119,693, the contents of which are hereby incorporated by reference in their entirety.
A problem with existing forehead pads is the mechanism by which the pad is connected to forehead support. The pad must be secured in such a way so as to be easy to insert and remove, but not be unintentionally dislodged. Furthermore, regardless of the relative proximity between the forehead support/pad and the mask frame, there should be no sharp edges against which the user's face can make contact, leading to further discomfort.
One form of known forehead pad is used on the AIR PILOT mask, manufactured by MPV, Truma, Germany, shown in
A further problem with existing forehead pads is that they can lead to uneven pressure on the user's forehead, leading to discomfort and marks on the face. For example, one form of known forehead pad includes a patient contacting surface and a pair of reinforcing struts, as shown in
Another problem with a known form of forehead support is the mechanism for engaging the forehead pad with the forehead support. The forehead support includes a pair of rigid L-shaped catches c adapted to slidably engage with a recess in the forehead pad, as shown in
Therefore, there exists a need in the art for a forehead pad that overcomes the problems listed above.
One aspect of the invention is directed towards a mask assembly having a forehead support and a forehead pad that provide more comfort to a user.
Another aspect of the invention is directed towards a forehead pad that distributes contact pressure around the user's forehead.
Another aspect of the invention is directed towards a forehead pad that permits a wide range of motion.
Another aspect of the invention is directed towards a forehead pad that lessens or avoids contact between the user and the edges of the forehead pad.
Another aspect of the invention is directed towards a forehead pad that achieves an even pressure distribution with no localized regions of high forces.
Another aspect of the invention is directed towards providing a forehead pad that is easy to insert in a forehead support and is flexible enough to accommodate a range of different forehead sizes and shapes.
Another aspect of the invention is directed towards a forehead pad that tapers smoothly from the support post to the base region, causing lines of force to be smoothly and evenly carried from the support post to the base region, resulting in an even distribution of the pressure across a user's forehead.
Another aspect of the invention is directed towards a forehead pad for a forehead support of a respiratory mask that comprises a plate region connected to a support post, the support post including a forehead support engaging mechanism.
Another aspect of the invention is directed towards a forehead pad that it is relatively easy to engage with a forehead support but relatively more difficult to disengage.
Another aspect of the invention is directed towards a forehead pad that lessens or avoids contact between the user and the edges of the forehead support.
Another aspect of the invention is directed towards a forehead pad that includes a base portion to contact a user's forehead, a support post comprising a necked down region connected to the base portion, and a head adapted to connect the support post to a forehead support of a respiratory mask.
Another aspect of the invention is directed towards a forehead pad assembly that includes at least two pads, each pad comprising a base portion to contact a user's forehead, a support post comprising a necked down region connected to the base portion, and a head adapted to connect the support post to a forehead support of a respiratory mask. The assembly further comprises at least one connector to connect adjacent base portions.
Other aspects, features and advantages of this invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawings, which are a part of this disclosure and which illustrate, by way of example, principles of preferred embodiments.
The forehead support 102 is advantageously connected to the frame portion 101 of the mask assembly 100, e.g., by a pivot device 105, which can be adjusted to allow the forehead support 102 to the accommodate the configuration of a user's face. The forehead support 102 is preferably made from a thermoplastic material. One embodiment of a forehead support is shown in greater detail in
The forehead support 102 can be configured to be essentially straight or it can be curved. The essential straight embodiment is shown in
The forehead support 102 can be provided with one or more openings. These openings can be adapted to serve numerous purposes including points of connection to the mask frame, points of connection to any another support surface, points of connection 201 for straps to secure the mask to the user, and apertures 202 for a forehead pad.
In a preferred embodiment of the forehead support 102, the apertures 202 are designed to receive a head of the forehead pad 300. The apertures 202 can be disposed about the forehead support 102 in a manner to allow a user to adjust the position of the forehead pad 300. The apertures 202 are also designed to allow a user to attach the forehead pad 300 securely to the forehead support 102. In a preferred embodiment, the apertures 202 designed to allow a user to attach the forehead pad 300 securely and reversibly to the forehead support 102.
The forehead pad 300 in accordance with a first embodiment of the invention is shown in greater detail in
The base portion 305, support post 301, and head 302 can be separate pieces, designed to fit with each other. In one embodiment, the base portion 305 and the support post 301 can be constructed as one piece. In another embodiment, the support post 301 and the head 302 can be constructed as one piece. In yet another embodiment, the base portion 305 and the head 302 can be constructed without a support post 301. Finally, in a preferred embodiment, the base portion 305, the support post 301, and the head 302 are molded integrally into one piece.
The embodiment shown in
In a preferred embodiment, the necked down region 303 is at least as long as the length of the aperture 202 (
Typically, this insertion can be carried out by a user by applying axial pressure to the base portion 305 of the pad 300. While the support post 301 is flexible, it can withstand the forces needed for assembly. Using the forehead pad embodiment described in
The removal of the pad occurs by applying a pulling force it in a direction opposite to the axial force applied for insertion. Once again, the head 302 and the lip 304a distort as the lip 304a disengages with the first surface 215 of the forehead support 102 adjacent to the aperture 202. Lip 304a disengages with the second surface 205 of the forehead support 102. Both the head 302 and the lip 304a regain their original shape after disengagement from the forehead support 200.
The pressure can be applied by a user's fingers and the successful insertion of the pad 300 is indicated not only by the emergence of the head 302 through the first surface 215 of the aperture 202 but typically also by a clicking sound. The combination of sight, sound, and ease of insertion is useful for aged or otherwise infirm users with limited manual and/or digital dexterity. The sound produced has the added benefit of providing the user of knowledge that the pad 300 has been successfully inserted in the dark. This feature can be of importance due to the fact that the masks are used at night. Both the forehead support 102 and the forehead pad 300 are configured such that the pad 300 can be placed in different positions on the support 102 so as to achieve different positions of contact on the user's forehead.
A wide variety of methods well known to a person skilled in the art for the manufacture of the base portion, support post, and head. A preferred method of manufacture is by injection molding.
The support post 301 can project from the base portion 305 at an angle α, defined between a tangent t to the outer surface of the base portion 305 at a point of contact between the support post 301 and the base portion 305. This angle α can be about 90°, i.e., the support post 301 extends essentially straight out from the base portion 305.
The support post 401 can be constructed in a manner so as to make it more flexible. For example, the support post 401 includes cut away portions 405. These cut away portions help the support post to be able to be bent or flexed, varying the angle β in use. In this way, a support post 401 of larger diameter may be used while still retaining a degree of flexibility as shown in
The base portion 408 can be of any shape, preferably in a pad-like configuration. In one embodiment, a contact region 407 of the base portion 408 is shaped so that the transmission of contact forces to the surface of the forehead of the user takes place under physiologically compatible pressures, as shown in
The contact region 407 can optionally include a raised surface pattern 510 as shown in
The base portion 408 and support post 401 of the pad 400 can also include a hollowed out region 608 extending a pre-determined distance 601 into the base portion 408 and/or the support post 401 as shown in the cross-sectional view in
Increasing the diameter of the support post 401 makes the forehead pad 400 easier to insert into the forehead support 102. Furthermore, a larger diameter reduces the likelihood of localized pressure points. However, as the support post 401 is made thicker, it becomes less flexible. Hence the preferred embodiment of the invention balances ease of insertion with flexibility.
In another embodiment, the hollowed out region 608 extends through the base portion 408, the support post 401, and the head 402 resulting in a through-bore 509 (shown in
The support post 401 has a diameter that is in its broadest aspect between about 0.1 cm and about 3.0 cm. More specifically the diameter of the support post of the embodiment of
The support post 401 has a length that is in its broadest aspect between about 0.1 cm and about 2.5 cm. More specifically the length is between about 0.5 cm and about 1.25 cm, and most preferably the length is about 1 cm. Dimensions for one form of forehead pad are shown in
The support post 401 can be straight or it can taper. An example of a straight support post is shown in the embodiment in
As would be understood by one skilled in the art, a wide variety of materials can be used to manufacture the forehead pad in accordance with the present invention. Features of any material used should include biocompatibility, flexibility and comfort. Some examples of such materials include rubber and flexible plastics. In a preferred embodiment, the pad is constructed from cured Liquid Silicone Rubber (Part#2666031, Silastic 94-595-HC) manufactured by Dow Corning, alternatively a silicone with a hardness of approximately 35-45 Shore A may be used. These examples are merely intended to be illustrative and are not limiting in any manner.
In accordance with a preferred embodiment of the present invention, at least two base pads can be joined in a forehead pad assembly 700. In this embodiment, two versions of which are shown in
As mentioned earlier, the hollowed out region 608 can extend a pre-determined distance into the base portion 708 and/or the support post 701. This distance can be adjusted to increase flexibility of the forehead pad assembly 700. For example, the hollowed out region 608 extends a longer distance into the support post 701 in the embodiment shown in
The hollowed out region 608 can also have a variety of shapes including conical, pyramidal, cylindrical, or combinations thereof. It is within the scope of this invention that the hollowed out region 608 have additional sub-structures within it including ridges, bumps, or holes.
In a preferred embodiment, the two base portions 708 of a forehead pad assembly 700 are adapted in order to be situated above left and right eyebrows of the user. As shown in
The cut away portions 705 define an undercut 720 between the cut away portions 705 and the base portion 708. The undercut 720 can be a variety of shapes including curved, square, conical, triangular, or any combinations thereof. The undercut 720 depth e can also be varied. The depth e can range between about 0.25 mm to about 1.25 mm, preferably between about 0.5 mm and about 1 mm, and most preferably about 0.75 mm. The term “about” is meant to indicate that the widths and lengths are not absolute and can be deviated by one skilled in the art.
The number, shape, and size, width w, and length l of the cut away portions 705 can be varied to serve a variety of purposes including ease of insertion, ease of removal, flexibility of motion when unassembled with the forehead support, flexibility of motion when assembled with the forehead support, minimization of contact between the user and the edges of the base portion 708, minimization of contact between the user and the edges of the forehead support 102, and angles between the forehead pad assembly 700 and the forehead support 102. The width w can range between about 0.25 mm to about 1.25 mm, preferably between about 0.5 mm and about 1 mm, and most preferably about 0.75 mm. The length l can range between about 0.05 mm to about 1.5 mm, preferably between about 0.25 mm and about 1 mm. Once again, the term “about” is meant to indicate that the widths and lengths are not absolute and can be deviated by one skilled in the art.
The cut away portions 705 can have regions of similar or different widths w and similar or different lengths l. Comparison of the embodiment of the forehead pad assembly 700 shown in
The undercut 720 in
One advantage of reducing the width w and/or increasing the depth e is to vary the angle δ between the forehead pad assembly 700 and the forehead support 102, which in turn allows for greater range of motion and user comfort. The angle δ is the angle between a horizontal line h and a line passing through the center of the base portion 708 and the support post 701.
Presentation of the base portion 708 of the forehead pad assembly 700 at an angle which is generally parallel to the users forehead provides improved comfort to the user, reducing the likelihood of pressure sores which may result from an uneven presentation. In some forms of long masks, for example a full face mask, the forehead support 102 may be positioned in use higher up the forehead of the user than in a nasal mask.
In the embodiment of forehead support shown in
To remove the pad 900 from the forehead support 940 the pad 900 is pulled in an opposite direction to arrow 914. Once again, the head 902 and/or the lip 904 distort as they pass through the aperture 930 enable the pad 900 to disengage from the forehead support 940.
A cross section of another embodiment of a forehead pad 1000 engaged with a rigid forehead support 1040 is shown in
In another embodiment of the invention, the support post 1010 includes a generally cylindrical end region adapted to engage with a key-shaped slot of a forehead support. To attach the stalk to the forehead support, a small-diameter portion of the end region is slid through a generally rectangular region of smaller diameter, causing it to distort, before being received within a generally cylindrical region having a diameter slightly larger than that of the stalk, as in
In one form, the base portion 408 of the forehead pad is generally plate- or disc-shaped. In a preferred form, it presents a concave surface to a forehead of a patient in use. Possible shapes of the base portion include rectangular and oval shapes.
The shape of the support post 401 and base portion 408 are designed to cause lines of force 490 to be smoothly and evenly carried from the support post 401 to the base portion 408, as shown in
An alternative embodiment of a forehead pad according to the present invention is shown in
In a preferred embodiment, the pad includes a pair of dimples adapted to engage with corresponding protrusions on the arm of the forehead support. Engagement between the dimples and respective protrusions provides feedback to the user that the pad has been correctly rotationally aligned. Furthermore, the engagement between dimples and protrusions reduces unintentional rotational movement of the pads. Alternative locking mechanisms, such as those with keys or moveable slider blocks, fall within the scope of the invention.
In alternative embodiments, shown in
While this application has described a few embodiments of forehead pads and forehead supports, it is well understood by one skilled in the art that various forehead pads, forehead supports, and masks can be used interchangeably. A type of forehead pad is not limited to a particular forehead support or to a specific mask.
In an alternative embodiment, the support post of the forehead pad can be used in combination with an extruded pad such as used on the MIRAGE mask (U.S. Pat. No. 6,119,693). Another embodiment has a forehead pad devoid of a convex surface, instead including a support post used in combination with a concave surface. Another embodiment includes a pad with varying cross-sectional thicknesses, e.g., it could be thinner at edges for greater flexibility when rolling, than at the center.
It can thus be appreciated that the aspects of the present invention have been fully and effectively accomplished. The foregoing specific embodiments have been provided to illustrate structural and functional principles of the present invention, and are not intended to be limiting. To the contrary, the present invention is intended to encompass all modifications, alterations and substitutions within the spirit and scope of the present invention.
The present application is a continuation of U.S. application Ser. No. 10/655,595, filed Sep. 5, 2003, now U.S. Pat. No. 7,216,647, which claims the benefit of U.S. Provisional Application Ser. No. 60/424,696 filed Nov. 8, 2002 and U.S. Provisional Application Ser. No. 60/467,572 filed May 5, 2003, and which is a Continuation-In-Part of U.S. Non-Provisional application Ser. No. 10/235,846 filed Sep. 6, 2002, now U.S. Pat. No. 6,823,869, which in turn claims priority to U.S. Provisional Patent Application Ser. No. 60/317,486 filed Sep. 7, 2001 and U.S. Provisional Patent Application Ser. No. 60/342,854 filed Dec. 28, 2001. Each of the above applications is hereby incorporated herein by reference in its entirety.
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Child | 11705451 | US |
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Child | 10655595 | US |