Patent ID: 12214133

DETAILED DESCRIPTION

In the following detailed description, reference will be made to the accompanying drawing(s), in which identical functional elements are designated with like numerals. The aforementioned accompanying drawings show, by way of illustration, and not by way of limitation, specific aspects, and implementations consistent with principles of this disclosure. These implementations are described in sufficient detail to enable those skilled in the art to practice the disclosure and it is to be understood that other implementations may be utilized and that structural changes and/or substitutions of various elements may be made without departing from the scope and spirit of this disclosure. The following detailed description is, therefore, not to be construed in a limited sense.

Turning toFIG.1, there is illustrated a patient10wearing a positive pressure mask12in accordance with the present disclosure.

The positive pressure mask12may include a mask body14which is receivable over the patient's mouth and nose, so as to cover the mouth and nostrils. The mask body14may be formed from a flexible material, such as silicone, biocompatible thermoplastic polyurethane, or any gel-like materials such that it may be capable of conforming to the contours of the patient's face at or adjacent to a patient-contact perimeter16thereof. However, the mask body14may be contoured and dimensioned so as to fit around a predetermined dimension and shape of a patient's face. In such a case, a more rigid mask body14material may be used.

To cover the user's respiratory access, that is, the nostrils and mouth, the mask body14may be configured to overlie the nostrils and the cheeks. The patient-contact perimeter16therefore may form the points of contact with the patient10, as best illustrated inFIG.2.

The mask body14, when positioned over the patient's face, may form a ventilation chamber which may be pressurized to urge air or oxygen from a gas inlet18of the positive pressure mask12into the patient's lungs.

To ensure that the ventilation chamber is sealed to the atmosphere, and in order to inhibit release of aerosols and therefore potential contagions for a medical practitioner, the positive pressure mask12advantageously may include an adhesive seal20, best seen inFIGS.3and5, positioned at the patient-contact perimeter16to secure the mask body14to the patient's face. The adhesive seal20may prevent or reduce gas leakage from the ventilation chamber.

The mask body14may include two separate body portions. Firstly, there may be a main body portion22which forms the bulk of the ventilation chamber, and which may be formed from a rigid or flexible material.

The main body portion22may have a small projecting profile beyond the patient's mouth and/or nose, in order to minimize wasted volume in the ventilation chamber which could otherwise lead to carbon dioxide rebreathing for the patient. In an embodiment, the main body portion22is formed from, or includes at least in part, a light-transmissible material, such as a transparent plastic material. In another embodiment, the light-transmissible material is fully see-through, allowing the medical practitioner to visually inspect the patient through the positive pressure mask12without needing to remove the positive pressure mask12. In yet another embodiment, the main body portion22may include a lightweight, flexible body made from silicone elastomer or other similar material.

Secondly, the mask body14may include a ridged body portion24. This ridged body portion24may include a distal flange46to support the adhesive seal20. The mask body14may furthermore be positioned at or adjacent to the patient-contact perimeter16to permit deformation of the mask body14during movement of the patient10. This ridged body portion24may include a soft or flexible concertinaed portion26, which allows for compressive or bellows-like motion similar to that of an accordion.

This structure may be best seen in the inset portions ofFIGS.1and2. The flexible concertinaed portion26may include at least one concertina ridge26′, preferably at least two said concertina ridges26′, and even at least three concertina ridges26′. This may achieve deformable flexibility at or adjacent to the patient-contact perimeter16. The positive pressure mask12having such a flexible concertinaed portion26may be able to accommodate movements of the patient's head within the flexion of the concertina ridges26′, despite the lag or tension experienced by the mask body14from the gas inlet18.

To further limit the pull on the mask body14at the gas inlet18, the gas inlet18may include a movable connector, such as an elbow swivel assembly28. This may permit rotation around the mask body14which may counteract the deformation of the flexible concertinaed portion26without increasing the forces thereon. The right-angled or near-right-angled elbow joint of the elbow swivel assembly28may be particularly appropriate for a prone patient10. The elbow swivel assembly28may be provided so as to be integrally formed with the mask body14, or may be a removable or releasably engageable component of the positive pressure mask12, thereby allowing for a more modular construction to be achieved. A releasable connector30is illustrated inFIG.2in the form of a quick-release snap-fit connector. However, alternative connectors may be provided, such as detent fit or screw-threaded engagement, and alternative connection mechanisms will be apparent to the skilled person.

To improve the positioning of the positive pressure mask12on the patient10, as well to limit the propensity for de-adhesion of the adhesive seal20over time, a strap32for engaging with the patient's head may be provided. The strap32may be adjustable.

An upper strap32′ may be provided, which may engage from an upper portion of the mask body14, which connects to the upper portion of the patient's head, typically above the ears. A bifurcated head strap32may be provided to secure to both the upper and lower occipital areas of the patient's head. A lower strap32″ may also be provided, which may engage from a lower portion of the mask body14below the level of the ears, and around an upper portion of the patient's neck.

The strap32may be composed of silicone. In another embodiment, the strap32may be made of synthetic neoprene or nylon or elastane fabric. In yet another embodiment, the strap32may include hook-and-loop fasteners, such as VELCRO™, to secure the mask in place. Alternatively, latch, buckle, or tied fasteners may be used.

An adjustable connector34may be provided so that the strap32can be used with patients of different sizes. Here, a hook-and-loop type fastener may be provided, but alternative latch, buckle, or tied fasteners may readily be implemented by the person skilled in the art.

The upper strap32′ and lower strap32″ may be connected to the mask body14via connectors on the front of the mask body14, preferably on the main body portion22so as to avoid interfering with the flexible concertinaed portion26.

FIG.3shows the inside of the positive pressure mask12. In a pre-use condition, the adhesive seal20may be protected by a cover member36to prevent drying out of the adhesive. This cover member36may be releasably engageable with the adhesive seal20, for example, by the use of a release tab38at or adjacent to the patient-contact perimeter16. This may allow the adhesive seal20to only become activated when required. Alternative release mechanisms may be considered instead of a tab, such as a perforation, or overhang of the material of the cover member36or protruded engageable loop.

The gas inlet18may be positioned so as to be at or adjacent to a mouth position of the patient10, so as to reduce the dead space in the ventilation chamber.

To improve the comfort of the positive pressure mask12for the patient10, a cushioned portion may be provided. The cushioned portion may comprise gel, such as in an embodiment with a silica gel cushion40. In another embodiment, the cushioned portion may comprise a silicone elastomer. In yet another embodiment, the cushioned portion may comprise memory foam.

In an embodiment, the cushioned portion is adjacent to the adhesive seal20. In yet another embodiment, the cushioned portion further comprises the adhesive seal20such that the cushioned portion may be directly adhered to the patient10. Given that the adhesive seal20may be positioned on the patient10for a long period of time, the cushioned portion will improve comfort for the patient10.

In an embodiment of the mask body14there is uniform flexion around the flexible concertinaed portion26, since this will permit movement in all directions. In another embodiment, the flexible concertinaed portion26further comprises a distal flange46to position and secure the modular, interchangeable adhesive seal20. In said embodiment the distal flange46has the same range of motion as the flexible concertinaed portion26.

The flexible concertinaed portion26may be continuous around the mask body14to permit said uniform flexion. A uniform distance between the flexible concertinaed portion26and the patient-contact perimeter16and/or adhesive seal20at least a majority of the mask body14may also assist in this regard. InFIG.3, there may be a minor change in the distance between the patient-contact perimeter16and the flexible concertinaed portion26at the bridge of the nose, but this will not have a significant effect on the flexible capabilities of the positive pressure mask12since there will be minimal movement at the nose.

FIG.4shows a positive pressure ventilation apparatus, referenced globally at50, utilizing the positive pressure mask12as previously described.

The positive pressure mask12may be connected to a positive-pressure source52, such as a peristaltic pump used as a ventilator, which may enable pressurized gas flow along a gas flow path between the pump and the positive pressure mask12. The gas flow path may be formed by the provision of a connector conduit54extending from the positive-pressure source52and the positive pressure mask12, and any appropriate type of gas-tight connector may be used here which is suitable for medical-grade use. In an embodiment, the gas-tight connector may further comprise a single limb circuit, such that the exhalation is accommodated via a gas circuit exhalation port with an attached gas exhalation filter. In another embodiment, the gas-tight connector further comprises a double limb circuit, such that the exhalation filter56is attached directly between the elbow swivel assembly28connector and the gas circuit.

An exhalation filter56may advantageously be positioned on a gas flow path, which may filter out contagions from the patient's exhaled breath. The exhalation filter56may be positioned as close to the positive pressure mask12as is feasible, and is illustrated inFIG.4as being directly subsequent to the elbow swivel assembly28. It will be apparent that the exhalation filter56could be provided further along the gas flow path, for example, closer to the positive-pressure source52, or could indeed be integrally formed with the positive pressure mask12.

The positive pressure ventilation apparatus50may provide a complete system for non-invasively ventilating a patient10in need of ventilatory care. The positive pressure ventilation apparatus50may be provided as a kit of parts, or may be provided as a complete set of components.

To use the positive pressure ventilation apparatus50, the apparatus may be assembled, that is, the positive pressure mask12may be provided, and the positive-pressure source52coupled to the positive pressure mask12, preferably with the exhalation filter56positioned on a gas flow path interconnecting the positive-pressure source52and positive pressure mask12. In another embodiment, the exhalation filter56is incorporated directly into the body of the positive pressure mask12.

The positive pressure mask12may then be engaged over the patient's face and adhered to the patient10via the adhesive seal20at or adjacent to the patient-contact perimeter16. In an embodiment, the adhesive seal20comprises one or more layers of form-carried adhesive material. The adhesive seal20may be coupled to the mask body14via a distal flange46on the flexible concertinaed portion26. The adhesive seal20at the patient-contact perimeter16may prevent gas leakage during flexion of the flexible concertinaed portion26. The positive-pressure source52may then be activated to ventilate the patient10.

While the positive pressure mask12is herein described as having an adhesive seal20in combination with a flexible concertinaed portion26, it will be apparent to the skilled person that an adhesive seal20could be provided with existing positive pressure masks, or indeed with other types of respiratory masks, to achieve improved sealing and therefore reduced cross-infection possibilities. A respiratory mask, and in particular, a positive pressure mask12, having an adhesive seal20at or adjacent to a patient-contact perimeter16of the mask body14, may therefore be considered to be within the scope of the present invention. This arrangement may be particularly effective in combination with a cushioned portion at or adjacent to the adhesive seal20, the adhesive seal20may be coupled to the distal flange46of the flexible concertinaed portion26of the mask body14, the adhesive seal20may further comprise multiple layers of form-carried adhesive material, and the adhesive seal20may be furthermore modular and interchangeable.

Similarly, a positive pressure mask12having a flexible concertinaed portion26at or adjacent to the patient-contact perimeter16, could be provided in the absence of an adhesive seal20. In particular, the head straps of the positive pressure mask12could be provided to create a sufficient seal without the need for adhesive on the patient's face. This may be particularly effective if the patient-contact perimeter16is formed from a deformable or flexible material so as to tightly contour to the patient's face when the positive pressure mask12is applied.

While a flexible concertinaed portion26is described, it will be apparent that the ridged structure may be akin to a bellows, and could be described as such. Furthermore, while a concertina shape is disclosed, alternative constructions may be considered. For example, the mask body14could comprise the main body portion22, formed of a comparatively rigid or hard material, while the flexible portion at/or adjacent to the patient-contact perimeter16may be provided as a softer or more flexible material, without necessarily needing to provide the concertina structure proposed above. Silicone, biocompatible thermoplastic polyurethane, and gel-like materials may also be used at/or adjacent to the patient-contact perimeter16.

As noted previously, any of the advantageous features of the present invention could be applied to respiratory masks other than positive pressure masks, and such mask arrangements are not excluded from the scope of the present invention.

A flexible transparent or translucent material may be preferred for the mask body14. In another embodiment, the mask body14may comprise silicone or biocompatible thermoplastic polyurethane. However, it will be apparent that other materials could be used without any corresponding deterioration in the gas-tightness, without compromising the function of the positive pressure mask12.

It is therefore possible to provide positive pressure equipment for ventilating a patient in a non-invasive manner while significantly reducing the risk of transmission of contagions to, in particular, medical practitioners. The positive-pressure mask may use an adhesive seal20to improve the sealing capabilities of the mask to the patient's face, while the flexible concertinaed portion26of the mask may allow for limited movement of the mask, particularly under the weight of the connectors to the positive-pressure source52, without creating gas leakage. This may provide improved patient ventilation capabilities without the need for an invasive solution.

As shown inFIG.5, the distal flange46of the flexible concertinaed portion26may be used to couple the adhesive seal20to the patient-contact perimeter16of the mask body14, the adhesive seal20may further comprise one or more layers of form-carried adhesive material. In an embodiment, the adhesive seal20is attached to the distal flange46via acrylate adhesive or other synthetic rubber adhesive.

In an embodiment, the adhesive seal20comprises one or more layers of form-carried adhesive material. In said embodiment, each layer of form-carried adhesive material comprises a form carrier4, with one or more sides of the form carrier4having adhesive material. The form carrier4may be made from woven cloth, non-woven polyesters, or polymeric film. In an embodiment, the adhesive layer comprises soft silicone gel adhesive3at the patient-contact perimeter16to adhere the form carrier4to the facial skin. In another embodiment, both sides of the form carrier4have adhesive material.

The adhesive seal20may further comprise one or more cover members36to protect the form-carried adhesive material2in pre-use condition. The cover member1may further comprise multiple release tabs, perforations, or other means for removing the cover member1from the adhesive layer. The cover member1may comprise paper material, woven cloth, non-woven polyesters, or polymeric film

In an embodiment of the adhesive seal20, at least two form-carried adhesive materials are arranged in a layered formation. When the first form-carried adhesive material is no longer performing as desired, and the user wants to gain access to the second form-carried adhesive material, the user may remove the first form-carried adhesive material to reveal the second form-carried adhesive material. A cover member36may separate the first form-carried adhesive material from the second form-carried adhesive material2.

In a preferred embodiment, the adhesive seal20is modular and interchangeable. In the pre-use condition of said embodiment, a first cover member1will couple with the side of the form-carried adhesive material2that will be joined to the distal flange46of the flexible concertinaed portion26, and a second cover member36will couple with the side of the first form-carried adhesive material2that will adhere to the patient10.

When the last available form-carried adhesive material2is no longer performing as desired, the user may remove said form-carried adhesive material from the distal flange46of the flexible concertinaed portion26and may replace it with another adhesive seal20by removing the first cover member of the adhesive seal20and adhering the form-carried adhesive material to the distal flange46of the flexible concertinaed portion26.

In another embodiment, the adhesive seal20may be attached to the cushioned portion of the mask body14.

In yet another embodiment, the cushioned portion comprises adhesive material at the patient-contact perimeter16such that the mask cushion may be adhered directly to the patient10. In an embodiment, the adhesive material comprises soft silicone gel adhesive3at the patient-contact perimeter16.

The words ‘comprises/comprising’ and the words ‘having/including’ when used herein with reference to the present invention are used to specify the presence of stated features, integers, steps or components, but do not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.

The embodiments described above are provided by way of examples only, and various other modifications will be apparent to persons skilled in the field without departing from the scope of the invention as defined herein.