Patent Application
20150165150
A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.
Respiratory masks and more particularly, non-invasive ventilation masks having a port for receiving an implement such as a nasogastric tube for use by a patient.
Various respiratory masks are used for delivering gases to the nose and mouth of a patient. One type of respiratory masks are non-invasive ventilation (“NIV”) masks which generally comprise a rigid cone or shield for covering a portion of the patient's face and a cushion about the cone or shield which is compliant and conformable to the contours of a patient's face to form a substantially gas-tight seal with the patient's face. As used herein, “substantially gas-tight seal” means a seal of sufficient integrity that a gas can be supplied to a patient at a desired pressure without the seal diminishing the therapeutic effect of the supply of gas. It may be desirable at times to provide additional therapies to a patient using an NIV mask. For example, it may be desirable to provide nutrition to the patient by a nasogastric (“NG”) tube which is received in the nares of the patient during NIV therapy. It is known to provide a port in the cone or shield of the mask to receive an NG tube which can then be inserted into the nares of the patient. However, such ports do not provide a substantially gas-tight seal about the periphery of the NG tube and thus allow for the loss of pressurized gas from around the periphery of the NG tube which can affect the therapeutic delivery of the pressured gas to the patient. Also, such ports are typically provided at a location requiring a sharp bend in the NG tube after it is received in the port of the mask in order to insert the NG tube into the nares of the patient. This can be both difficult to manipulate during insertion of the NG tube into the nares of the patient and uncomfortable for the patient after insertion.
The present invention is directed toward overcoming one or more of the problems discussed above.
Disclosed is a respiratory mask for delivery of pressurized gas to a patient. The respiratory mask has a rigid shield and an elastic cushion surrounding the shield, the cushion being configured to conform to facial contours of a patient. A port is provided in the cushion, the port being configured to receive an implement inserted into the port and to provide a substantially gas-tight seal about the periphery of an implement received in the port. Embodiments include the port being located in an area of the cushion that allows for a relatively direct route to the nares of the patient to allow insertion of the NG tube into the patient's nares. Embodiments may include the port being a slit in the cushion, the port having an “s” shape configured to form an orifice which substantially seals the cushion about the periphery of the implement. Embodiments may also include the port being slightly smaller than the outer circumference of the implement to allow the cushion material to stretch and form a tight seal with the periphery of the implement. Embodiments may also include a thin film over the port to seal the port prior to the insertion of an implement. In one embodiment, the film may be disposed over a port defined by a slit. In other embodiments the port may just be a hole in the cushion with the film providing the substantially gas-tight seal before insertion of an implement therein.
Another aspect of the invention is a method of providing access of an implement to a nose or mouth of a patient receiving non-invasive ventilation via a respiratory mask. The method includes providing a respiratory mask with a rigid shield and an elastic cushion surrounding the shield, the cushion being configured to conform to facial contours of a patient. An implement having a select outer diameter is provided. A slit is provided in the cushion of the mask, the slit being configured to substantially prevent the passage of gas through a gas-tight seal about the periphery of the slit. The implement is axially inserted into the slit.
Various modifications and additions can be made to the embodiments discussed without departing from the scope of the invention. For example, while the embodiments described above refer to particular features, the scope of this invention also included embodiments having different combination of features and embodiments that do not include all of the above described features.
A further understanding of the nature and advantages of particular embodiments may be realized by reference to the remaining portions of the specification and the drawings, in which like reference numerals are used to refer to similar components. In some instances, a sub-label is associated with a reference numeral to denote one of multiple similar components. When reference is made to a reference numeral without specification to an existing sub-label, it is intended to refer to all such multiple similar components.
While various aspects and features of certain embodiments have been summarized above, the following detailed description illustrates a few embodiments in further detail to enable one of skill in the art to practice such embodiments. The described examples are provided for illustrative purposes and are not intended to limit the scope of the invention.
In the following description, for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the described embodiments. It will be apparent to one skilled in the art, however, that other embodiments of the present invention may be practiced without some of these specific details. Several embodiments are described and claimed herein, and while various features are ascribed to different embodiments, it should be appreciated that the features described with respect to one embodiment may be incorporated with other embodiments as well. By the same token, however, no single feature or features of any described or claimed embodiment should be considered essential to every embodiment of the invention, as other embodiments of the invention may omit such features.
Unless otherwise indicated, all numbers used herein to express quantities, dimensions, and so forth used should be understood as being modified in all instances by the term “about.” In this application, the use of the singular includes the plural unless specifically stated otherwise, and use of the terms “and” and “or” means “and/or” unless otherwise indicated. Moreover, the use of the term “including,” as well as other forms, such as “includes” and “included,” should be considered non-exclusive. Also, terms such as “element” or “component” encompass both elements and components comprising one unit and elements and components that comprise more than one unit, unless specifically stated otherwise.
Embodiments of the respiratory mask 10 with a port in the form of a self-sealing slit 16 may include a thin plastic film that completely seals the slit 16 before insertion of an implement 18 therein. Upon insertion of an implement 18 into the slit 16, the film is torn to allow passage of the implement 18 therethrough. Another embodiment of the port could be a hole that is sealed by a thin plastic film until the film is pierced by insertion of an implement.
Embodiments include the elastic cushion 14 being made of a silicon having a durometer in the rage of 40-80 shore A. Embodiments of the elastic cushion have a thickness that allows an implement to be readily inserted therein while having sufficient integrity to maintain the substantially gas-tight seal. Silicon with a thickness in the range of 0.01-0.1 inches is believed to be acceptable.
The respiratory mask 10 could be an NIV mask intended to deliver gas at pressures ranging from 0-50 cm of H2O. In embodiments where the port 16 is a slit, in its un-deformed state and with an implement 18 received therein the slit is configured to maintain a substantially gas-tight seal over such a range of pressures. Embodiments may include the slit 16 having a length that is no more than an outer diameter than the implement 18.
This application claims priority from U.S. Provisional Patent Application Ser. No. 61/916,639, filed Dec. 16, 2013, entitled “Respiratory Mask With Self-Sealing Implement Port,” which is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61916639 | Dec 2013 | US |
