Disposable respiratory mask with adhesive skin interface

Information

  • Patent Grant
  • 6341606
  • Patent Number
    6,341,606
  • Date Filed
    Wednesday, May 19, 1999
    25 years ago
  • Date Issued
    Tuesday, January 29, 2002
    22 years ago
Abstract
A disposable respiratory mask is provided according to the invention. The disposable respiratory mask includes a bag having a first opening and a second opening and may have an optional vent hole, adhesive strips around a perimeter of the first opening, the adhesive strips being capable of attaching the mask to a face region around a nose, an interface tube having an optional vent hole, the proximal end of the interface tube capable of being inserted into the second opening of the bag, the distal end of the interface tube capable of connecting to a gas supply hose, and a retainer ring capable of being positioned over the bag and the interface tube to hold the bag on an outer surface of the interface tube when the interface tube is inserted into the second opening of the bag, wherein a gas is supplied to the mask through the gas supply hose, with the bag being inflated by the gas and the bag is therefore positioned away from a wearer's face.
Description




BACKGROUND OF THE INVENTION




1. Field of the Invention




The present invention relates generally to the field of respiratory masks.




2. Description of the Background Art




A respiratory mask is a device used to deliver a gas or gases to a patient. In its simplest form, the respiratory mask includes a face piece, an attaching means, and a gas supply hose. The respiratory mask may be used to deliver any variety of gases, including air or oxygen, and a variety of medicines or treatments.




The face piece is fitted over a nose portion of the face of the patient, and may optionally also fit over the mouth of the patient. Preferably, the fit around the edges of the face piece with the skin of the patient is substantially airtight, not allowing the supplied gas to escape. A strap or other attaching means is fitted over the head of the patient. The function of the attaching means is to hold the face piece against the face of the patient in order to deliver the gas to the patient, and also to ensure that the face piece forms a seal with the face of the patient. Constant pressure gas is therefore delivered, with the mask also including a vent hole whereby a constant pressure is maintained in the mask. This is referred to as a continuous positive airway pressure (CPAP) mask. The vent hole allows clearance of expired CO


2


.




However, the respiratory mask of the related art has several drawbacks. First, related art respiratory masks have typically been constructed of a relatively inflexible material, such as rubber or plastic, and are therefore heavy to wear. The weight of a respiratory mask may become a major factor of wearer discomfort if the mask must be worn repetitively or for long periods of time. The weight of the mask may also affect the ease in which the mask may be positioned or retained in position. Wearing a related art respiratory mask may result in sag or slippage over time, even if the mask is not excessively heavy.




A second drawback is that the related art respiratory mask is relatively inflexible, and the seal between the face piece and a face of a patient is therefore problematic, as a patient's face may rapidly move, contract, expand, or shift as the patient's face moves under muscular control. Gaps between the mask and face may therefore appear and disappear. The application of a dosage of a gas or medicine may be affected as a result.




A third drawback of related art respiratory masks is that inflexible face pieces do not accommodate a variety of sizes of patients.




A fourth drawback is that related art devices are not disposable, and may require disinfection in order to avoid contamination between uses.




There remains a need in the art for an improved respiratory mask.




SUMMARY OF THE INVENTION




A disposable respiratory mask is provided according to the invention. The disposable respiratory mask includes a bag having a first opening and a second opening and may have an optional vent hole, adhesive strips around a perimeter of the first opening, the adhesive strips being capable of attaching the mask to a face region around a nose, an interface tube having an optional vent hole, the proximal end of the interface tube capable of being inserted into the second opening of the bag, the distal end of the interface tube capable of connecting to a gas supply hose, and a retainer ring capable of being positioned over the bag and the interface tube to hold the bag on an outer surface of the interface tube when the interface tube is inserted into the second opening of the bag, wherein a gas is supplied to the mask through the gas supply hose, with the bag being inflated by the gas and the bag is therefore positioned away from a wearer's face.




The above and other features and advantages of the present invention will be further understood from the following description of the preferred embodiment thereof, taken in conjunction with the accompanying drawings.











BRIEF DESCRIPTION OF THE DRAWINGS





FIG. 1

shows a respiratory mask of a first embodiment of the present invention;





FIG. 2

shows a placement of the respiratory mask;





FIG. 3

shows a respiratory mask of a second embodiment;





FIG. 4

shows a detail of a skin-to-mask interface;





FIG. 5

shows a detail of a plurality of adhesive strips for reuse of the respiratory mask; and





FIG. 6

shows a detail of a mating between the interface hose and a bag of the respiratory mask.











DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS





FIG. 1

shows a respiratory mask


100


of a first embodiment of the present invention. The respiratory mask includes a bag


103


with an optional vent hole


117


, adhesive strips


106


, a retainer ring


111


, an interface tube


114


having an proximal end


122


, a distal end


123


and an optional vent hole


116


, and a swivel


119


.




The adhesive strips


106


attach the bag


103


to a wearer's face, and more specifically the adhesive strips


106


removably attach the bag


103


to the wearer's face. In the preferred embodiment, the adhesive strips


106


are formed of a double-sided tape having adhesive on opposite surfaces thereof, but alternatively may be of an adhesive-impregnated foam. In yet another alternate embodiment, the adhesive strips may be a layer of adhesive deposited on the material of the bag.




The bag


103


is formed of a thin, flexible material that is substantially impervious to air or other gases. In the preferred embodiment, the bag


103


is formed of an elastomer. It is contemplated that the bag


103


may alternatively be formed of any other suitable material. The bag


103


is of a size so that a first end (the end corresponding to the adhesive strips


106


) fits easily and comfortably over the nose area of a wearer. However, the bag must not be too big so as to extend excessively across the wearer's face. The bag


103


also includes a second end which is discussed below.




The interface tube


114


connects the bag


103


to an air supply. The interface tube


114


is generally tapered in size, with an proximal end


122


flaring to the greatest size. The second end of the bag


103


fits over the proximal end


122


of the interface tube


114


, and the bag


103


is thereupon held in place by the retainer ring


111


.




The retainer ring


111


is rolled or otherwise moved over the top of the second end of the bag


103


, and traps the bag


103


onto the proximal end


122


of the interface tube


114


. The bag


103


is thereby retained on the interface tube


114


by the retainer ring


111


due to the taper of the interface tube


114


. In the preferred embodiment, the retainer ring


111


may be an elastic material such as a soft rubber ring, but alternatively may be formed of other materials and may be rigid and inflexible. If an elastic retainer ring


111


is employed, the retainer ring


111


may be positioned at a spot on the interface tube


114


where the inner diameter of the retainer ring


111


is less than the outer diameter of the interface tube


114


, thereby stretching the retainer ring


111


and so applying a constrictive force to the bag


103


and the interface tube


114


. As an additional feature, the interface tube


114


may have a circumferential groove or depression located near the upper end to provide a seat for the retainer ring


111


.




The vent hole


116


and/or


117


may be included, for flushing expired CO


2


from the respiratory mask


100


. The vent hole


116


is shown on the side of the interface tube


114


, but it should be understood that the vent hole


116


may be positioned anywhere on the interface tube


114


. In addition, the diameters of the vent holes


116


and/or


117


may be changed to accommodate a desired level of CO


2


clearance.




At the distal end


123


of the interface tube


114


is the swivel connector


119


. The swivel connector


119


allows the interface tube


114


to be rotatably attached to a gas supply hose


120


. The swivel connector


119


therefore allows the wearer to comfortably position the interface tube


114


to accommodate various positions, such as laying supine, laying on either side, sitting or erect.





FIG. 2

shows a placement of the respiratory mask


100


and shows how the adhesive strips


106


are positioned around the nose and nostrils of the wearer. It should be noted that the ends of the adhesive strips


106


may overlap as shown, or may butt against each other in some manner. The adhesive strips


106


therefore accommodate faces of different sizes while retaining a substantially airtight seal (airtight defined as a barrier to any type of gas).





FIG. 3

shows a second embodiment


300


of the respiratory mask of the present invention. The respiratory mask


300


includes, in addition to the components recited with respect to

FIG. 2

, a strap ring


324


and a strap


326


.




The strap ring


324


is a ring that freely moves on the interface tube


114


, but cannot escape from the proximal end


122


of the interface tube


114


due to the taper. The strap ring


324


is also held on the interface tube


114


by the retainer ring


111


.




The strap


326


has ends attached to the strap ring


324


, and the strap


326


may be placed around the head of the wearer. In the preferred embodiment, the strap


326


is made of an elastic material, with the tension of the strap


326


serving to hold the respiratory mask


300


in a desired position on the face of the wearer. The force produced by the strap


326


is resisted in part by the inflation of the bag


103


. The strap


326


may optionally include an adjusting means (not shown) wherein the length of the strap


326


may be adjusted to accommodate wearers of different sizes.




In a variation from the first embodiment


100


, the second embodiment


300


may optionally include a bag


103


of a semi-rigid plastic material, wherein the interface tube


114


is held away from the wearer's face partially by the inflation of the bag


103


and partially by a stiffness of the material of the bag


103


.





FIG. 4

shows a detail of the attachment of the bag


103


to the skin


400


of a wearer. Here the bag


103


is formed of two plies of material, labeled


103


A and


103


B in the figure. Ply


103


A includes an adhesive strip


106


A, while ply


103


B includes an adhesive strip


106


B. At the skin-to-mask interface, the two plies


103


A and


103


B are separated and the adhesive strips


106


A and


106


B are brought into contact with the skin


400


. Preferably the two plies


103


A and


103


B are bonded together, in a region outside of the adhesive strips


106


A and


106


B. This equalizes the shear forces to the skin and minimizes the chance of the adhesive detaching prematurely.





FIG. 5

shows a detail of an embodiment of the adhesive strips


106


wherein the adhesive strips


106


include a plurality of such strips disposed atop one another. Shown are five such strips


106


A-


106


E, although it should be understood that any number of strips may be employed. All of the strips are adhesive in nature, with the purpose of multiple strips being that after an adhesive strip


106


, such as strip


106


A, has been used, it may be peeled off and discarded. Therefore, a respiratory mask employing multiple adhesive strips


106


as shown, may be used multiple times without losing effectiveness. When the last strip has been reached, such as strip


106


E in this example, the disposable respirator mask has been expended and may be discarded.





FIG. 6

shows a detail of the proximal end


122


of the interface tube


114


. The figure shows the taper of the interface tube


114


at the proximal end


122


, whereby the bag


103


is more readily retained on the interface tube


114


. The taper also serves to limit the movement of the retainer ring


111


and the strap ring


324


(see FIG.


3


).




While the invention has been described in detail above, the invention is not intended to be limited to the specific embodiments as described. It is evident that those skilled in the art may now make numerous uses and modifications of and departures from the specific embodiments described herein without departing from the inventive concepts.



Claims
  • 1. A disposable respiratory mask, comprising:a bag having a first opening and a second opening; adhesive strips around a perimeter of said first opening, said adhesive strips being capable of attaching said mask to a face region around a nose; an interface tube having proximal and distal ends, said proximal end of said interface tube adapted for insertion into said second opening of said bag, said distal end of said interface tube adapted for connection to a gas supply hose; and a retainer ring capable of being positioned over said bag and said interface tube to hold said bag on an outer surface of said interface tube when said interface tube is inserted into said second opening of said bag; wherein, when a gas is supplied to said mask through a gas supply hose, said bag is inflated by said gas and said bag thereby extends away from a wearer's face.
  • 2. The mask of claim 1 wherein said bag further includes a vent hole.
  • 3. The mask of claim 1 wherein said interface tube further includes a vent hole.
  • 4. The mask of claim 1, wherein said bag is disposable while said interface tube is reusable.
  • 5. The mask of claim 1, wherein said bag is an elastomer.
  • 6. The mask of claim 1, wherein said bag is a semi-rigid plastic.
  • 7. The mask of claim 1, wherein said mask further includes a swivel connector at said distal end of said interface tube, said swivel connector capable of rotatably connecting said interface tube to said gas supply hose.
  • 8. The mask of claim 1, wherein said adhesive strips further include a plurality of layers of said adhesive strips, wherein said mask can be reused by peeling off a layer of said plurality of layers of said adhesive strips.
  • 9. A disposable respiratory mask, comprising:a bag having a first opening and a second opening; adhesive strips around a perimeter of said first opening, said adhesive strips being capable of attaching said mask to a face region around a nose; an interface tube having proximal and distal ends, said proximal end of said interface tube adapted for insertion into said second opening of said bag, said distal end of said interface tube adapted for connection to a gas supply hose; and a retainer ring capable of being positioned over said bag and said interface tube to hold said bag on an outer surface of said interface tube when said interface tube is inserted into said second opening of said bag; wherein, when a gas is supplied to said mask through a gas supply hose, said bag is inflated by said gas and said bag thereby extends away from a wearer's face; a strap ring positioned adjacent said proximal end of said interface tube, wherein said strap ring has an inner diameter less than an outer diameter of said proximal end of said interface hose because of a taper in the interface hose; and a strap having ends attached to said strap ring and sized to fit around a wearer's head. wherein said strap ring and said strap function to hold said mask onto said wearer's head.
  • 10. The mask of claim 9, wherein said strap ring is cardboard.
  • 11. The mask of claim 9, wherein said strap is elastic.
  • 12. A disposable respiratory mask, comprising:a bag having a first opening and a second opening; adhesive strips around a perimeter of said first opening, said adhesive strips being capable of attaching said mask to a face region around a nose; an interface tube having proximal and distal ends, said proximal end of said interface tube adapted for insertion into said second opening of said bag, said distal end of said interface tube adapted for connection to a gas supply hose; and a retainer ring capable of being positioned over said bag and said interface tube to hold said bag on an outer surface of said interface tube when said interface tube is inserted into said second opening of said bag; wherein, when a gas is supplied to said mask through a gas supply hose, said bag is inflated by said gas and said bag thereby extends away from a wearer's face; wherein said interface tube has a taper, increasing in size at said proximal end.
  • 13. A disposable respiratory mask, comprising:a bag having a first opening and a second opening; adhesive strips around a perimeter of said first opening, said adhesive strips being capable of attaching said mask to a face region around a nose; an interface tube having proximal and distal ends, said proximal end of said interface tube adapted for insertion into said second opening of said bag, said distal end of said interface tube adapted for connection to a gas supply hose; and a retainer ring capable of being positioned over said bag and said interface tube to hold said bag on an outer surface of said interface tube when said interface tube is inserted into said second opening of said bag; wherein, when a gas is supplied to said mask through a gas supply hose, said bag is inflated by said gas and said bag thereby extends away from a wearer's face; wherein a material of said bag is formed of two plies, with an edge of an outer ply pulled outward relative to an interior of the mask and having an adhesive strip placed adjacent an edge of said outer ply, and with an edge of an inner ply pulled inward relative to the interior of the mask and having an adhesive strip placed adjacent an edge of said inner ply, wherein each said ply is capable of adhesively contacting a face region around a nose.
  • 14. A disposable respiratory mask, comprising:a bag having a first opening and a second opening; adhesive strips around a perimeter of said first opening, said adhesive strips being capable of attaching said mask to a face region around a nose; an interface tube having proximal and distal ends, said proximal end of said interface tube adapted for insertion into said second opening of said bag, said distal end of said interface tube adapted for connection to a gas supply hose; and a retainer ring capable of being positioned over said bag and said interface tube to hold said bag on an outer surface of said interface tube when said interface tube is inserted into said second opening of said bag; wherein, when a gas is supplied to said mask through a gas supply hose, said bag is inflated by said gas and said bag thereby extends away from a wearer's face; wherein said retainer ring has an inner diameter less than an outer diameter of said proximal end of said interface hose.
  • 15. A method of using a bag with first and second openings as a respiratory mask, said method comprising the steps ofattaching the mask to the face of a user using adhesive strips around a perimeter of the first opening; inserting a proximal end of an interface tube into the second opening; moving a retainer ring to a position over the bag and the interface tube to hold the bag on an outer surface of the interface tube; and connecting a distal end of the interface tube with a gas supply hose.
  • 16. The method of claim 15, further comprising the step of flushing expired gases from the mask via a vent hole formed in the interface tube.
  • 17. The method of claim 15, wherein said step of connecting the interface tube with a gas supply hose is performed using a swivel connector.
  • 18. The method of claim 15, wherein said step of attaching the mask to the face of user include attaching ends of a strap to a strap ring on the interface tube and placing the strap around the head of the user.
  • 19. The method of claim 15, further comprising the steps of disposing of the mask and reusing the interface tube.
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