This invention relates to a new field of devices which can be derived from lamination elements consisting of fabric materials bonded to layers of plastic which are resistant to tension, compression and bending forces. The lamination elements when properly applied by the user include a layer that integrates the outer surface of skin into the lamination element. The lamination element with its ability to resist these forces is used to strengthen or stabilize the skin in a way that reduces deformation and can strengthen or reinforce soft skin tissue to prevent deformation under some conditions.
One use of such a skin stabilizing lamination element is to prevent deformation of the soft tissue (as used in this application, typically referring to soft tissue, including the overlying skin) external to a nasal passage on the side of the nose. A lamination element can be applied on one side of the nose between the bridge of the nose and the cheek, which in turn causes the center of the lamination to hold the soft outer tissue of the nasal passage and prevent any deflection that restricts breathing through the respective nasal passage. A similar but opposite-shaped lamination element is required on the opposite side of the nose to stabilize the outer tissue of the second nasal passage.
Blockage of the nasal passages for reasons such as swelling due to allergies, colds, and physical deformities can lead to breathing difficulty and discomfort. The nasal passages have mucus membranes which condition the air in the nasal passages prior to its arrival in the lungs. If the nasal passages are constricted due to swelling or minor deformities, then the alternative is to breathe through the mouth. This means that the air bypasses the mucus membranes, losing the conditioning effects and causing irritation in the throat and lungs. At night, restrictions to breathing through the nasal passages can lead to snoring and/or sleep disturbances. In some cases, the restricted air supply can cause sleep problems brought on by a lack of oxygen.
For people with chronic blockages in the nasal passages, the alternative to correct the problem has been expensive surgery or medication. People with minor deformities and breathing problems brought on by swelling of the walls of the nasal passageways have been turning to various products fitted in or on the nose which claim to open the nasal passages.
The structure of the nose limits the options available for the design of nasal dilators. The nose terminates at the nostril, which has a slightly expanded volume immediately above it known as the vestibule. Above the vestibule, the nasal passage becomes restricted at a point called the nasal valve. At the nasal valve, the external wall of the nose consists of soft tissue known as the lateral wall, which will deform with air pressure changes induced within the nasal passage during the breathing cycles. Above the nasal valve, the nasal passage opens up to a cavity with turbinates over the top of the palate and turns downward to join the passage from the mouth to the throat.
The external structure of the nose consists of tissue and skin covering the nasal bones which are part of the skull. This gives the top of the nose a rigid structure at its base. Beyond the rigid nose bones, there is thin cartilage under the tissue which is attached to the septum, which in turn contributes to the outside shape of the nose. The septum forms the wall between the two nostrils and may, if it is crooked, contribute to breathing problems.
As an alternative to surgery, the structure of the nose and the prior art leave two alternatives for the design of nasal dilators. One alternative is the type of dilator that consists of a tube or structure which can be inserted into the nasal passage to hold it in the open position allowing the free passage of air. The disadvantage of this design is that the dilator structure covers up the mucus membranes which condition the air. Also dilators of this design are uncomfortable and can irritate the walls of the nasal passage.
The second alternative is a dilator design where each end that attaches to the external lateral wall of each of the nasal passages has a resilient member connecting the ends for generating an external pulling force on the lateral wall to thereby open the nasal passage. The advantage of this design over the first alternative is that the nasal passages are not disturbed by an internal insert. However, this second alternative permits only limited control over the resilient force on the lateral wall of each of the nasal passages, and the resilient members crossing over the bridge of the nose can cause discomfort.
The present invention differs from prior art systems in that it is a laminated skin stabilizer that locally stabilizes the lateral wall of the nasal passage. The lamination element adheres to the skin at the bridge of the nose at one end and to the skin adjacent to the cheekbone structure on the other end. It stabilizes the lateral wall tissue where it adheres to the soft skin external to the nasal passage. The ability of the lamination element to resist tension, compression and bending forces prevents deformation of the soft tissue of the lateral wall and promotes easier breathing.
In the prior art, there are items, such as bandages, tapes, and splints, which have some characteristics of a laminated skin stabilization system. Bandages and tapes have adhesives which stick to the skin; however, they cannot resist compression and bending loads. Splints, on the other hand, do not adhere to the skin, but have the rigid structure required to resist compression, tension, and bending loads. Splints are usually attached to the skin using tape which is independent of the splint structure itself.
The prior art that comes closest to the present invention are the nasal dilators disclosed in patents to Muchin, Johnson, and Deubek et al, which are all limited to placing resilient members over the bridge of the nose and which function very differently from the present invention.
The development of nasal dilators goes back to U.S. Pat. No. 701,538, which was filed Sep. 16, 1901, teaches a dilator that fits within the nasal passages, and functions like the above-described first alternative. Many of the devices that fit this alternative are not only used as nasal dilators, they also teach methods for filtering air or providing a platform for releasing medication which is entrained in the air passing through the device located in the nostril. U.S. Pat. No. 1,256,188 to Wilson, U.S. Pat. No. 2,055,855 to Weaver, U.S. Pat. No. 2,264,153 to Rowe, U.S. Pat. No. 2,277,390 to Crespo, U.S. Pat. No. 2,674,245 to Tanditter, U.S. Pat. No. 2,715,904 to Hill, U.S. Pat. No. 3,905,335 to Kapp, U.S. Pat. No. 3,935,859 to Doyle, U.S. Pat. No. 4,201,217 to Slater, U.S. Pat. No. 4,221,217 to Amezcua, U.S. Pat. No. 4,267,831 to Aguilar, U.S. Pat. No. 4,327,719 to Childers, U.S. Pat. No. 4,414,977 to Rezakhany, and U.S. Pat. No. 5,479,944 to Petruson are all examples of devices which either dilate, medicate or filter by inserting the device inside the nostril.
U.S. Pat. No. 5,479,944 to Petruson is of particular interest in the group, because it has tabs which insert in each nostril which are connected to a resilient member located between them which is deformed into a curved shape when the tabs are inserted in each nostril. The single resilient member curves around the end of the nose clearing the septum and provides a biasing force to the tabs forcing them against the outer wall of each nostril, thereby causing each nostril to be opened further. This design has disadvantages over the present invention, in that the tabs in contact with the sensitive surface on the inside of the nostril can cause discomfort to the user. The tabs cannot be located far up into the vestibule or even further up to the nasal valve, so that this type of nasal dilator is of limited effectiveness. Because of the location of the tabs in the nasal passages, the Petruson dilator will interfere with any attempt by the user to clear nasal congestion. Also the biasing force is fixed by the design and size of the connecting member and is not adjustable by the user.
The second alternative is the dilator design which attaches to the outside surface of the nasal lateral walls and has a resilient member for generating a pull force on the lateral walls of the nose. An example of this type of nasal dilator is U.S. Pat. No. 1,292,083 to Sawyer, which has two pads with metal loops that are attached to the outside of the nasal passages above the nostril on each side of the nose with an adhesive. A resilient member is attached to the pads and exerts a pulling force on them, thereby causing the nasal passage to be dilated. U.S. Pat. No. 1,950,839 to Chirila is similar to the Sawyer patent except that Chirila uses suction cups instead of adhesive pads. In both instances, the resilient member is a single metal spring and the resilient force is determined by the size and spring rate of the resilient member. These designs are difficult to fit and can cause injury to the user if the resilient member should come loose. This would be a significant problem for a user who is asleep and moves, causing the resilient member to become dislodged.
Patents which are part of the second alternative include U.S. Pat. No. 5,546,929 to Muchin and Spanish Patent 289,561 issued to Miguel Angel Aviles Iriarti. Generally speaking, they teach that a single resilient member, or spring, made from a flat piece of plastic extends over the bridge of the nose to the lateral wall and is covered by a pad with adhesive material that extends around the spring member. The spring is inset centrally in the pad, and the pad is located over the nose bridge and adheres to the outside of the nasal passages. This enables the respective ends of the spring to apply a pulling force on the outside of the soft tissue of the nose, thus dilating the nasal passages.
A similar dilator is disclosed in U.S. Pat. No. 5,476,091 to Johnson, except that in the case of the Johnson patent the single plastic resilient member is replaced by two parallel but not connected resilient members that provide the spring force to pull on the nasal valve external wall. The Johnson patent has a top and bottom pad to contain the resilient members which also have notches at each end to reduce delamination forces on the dilator. The dilator of the Johnson patent forms a truss which has a flexible strip material that defines the first and second end regions and an intermediate segment. The first and second resilient bands extend over the length of the truss and generate a force when the end regions are attached to the skin which lifts the underlying tissue upwardly and thereby dilates the nasal passages.
U.S. Pat. No. 5,533,499 to Johnson is a variation of the dilator shown in U.S. Pat. No. 5,476,091. It teaches that two parallel but not connected resilient members are mounted on a single base pad. Each of the end regions of the nasal dilator are adhesively fixed to the external walls of the nasal passages, while the interconnecting truss member passes over the bridge of the nose. The nasal strip configuration of the ""499 Johnson patent turned out to be difficult to fabricate and subject to delamination of the resilient members.
U.S. Pat. No. 5,533,503 to Deubek et al is a further development of the nasal dilator disclosed in the two Johnson patents discussed above. Deubek has two parallel but not connected resilient members that are mounted between top and bottom pads. This patent discloses a new pad configuration at each end of the dilator which is designed to improve the ease of manufacture and prevent delamination of the resilient members. The dilator of Deubek also has a truss with pads at each end and an intermediate section that bends over the bridge of the nose. The resilient members generate a force which pulls on the lateral wall, causing the nasal passage to open.
U.S. Pat. No. 5,553,605 to Muchin is related to U.S. Pat. No. 5,546,929 of the same inventor. The ""605 patent describes the same nasal dilator design shown in U.S. Pat. No. 5,546,929, except that the nasal dilator is transparent. It also has a single resilient member that crosses over the bridge of the nose and terminates in two pads that attach to the lateral wall on each side of the nose.
The Spanish patent, the two Muchin patents, the two Johnson patents, and the Deubek et al patent all have a single band that crosses the bridge of the nose which contains the resilient member. The Spanish patent and the Muchin patents use a single resilient member, while the Johnson and Deubek et al patents have two parallel but not interconnected resilient members contained in a single truss passing over the bridge of the nose. The spring rate in all these dilators is determined by the design of the resilient member and is set during the manufacture of the nasal dilator.
The present invention teaches about lamination elements resistant to tension, compression and bending forces which can be used as an improved nasal dilator. The lamination element of the present invention works in a manner that is opposite to the manner in which the nasal dilation systems of the Spanish, Muchin, Johnson, and Deubek et al patents work.
This invention relates to a new field of devices which can utilize lamination elements alone or in combination to stabilize skin, so it can resist deformation caused by external forces. The lamination elements are made up of fabric materials permanently bonded to a thin, resilient layer of plastic which resists tension, compression and bending forces. The lamination element is permanently bonded to a cushion layer located beneath the plastic layer. The lamination element also includes a layer that integrates the outer surface of skin into the lamination element when properly applied by the user. The lamination element uses its resistance to tension, compression and bending to stabilize the skin beneath the center of the lamination element from deflection due to forces acting on the tissue.
The lamination elements are small in size and made up of a top or fabric layer, a plastic layer, a cushion layer, and the skin layer. Each layer of the laminate is bonded to its adjacent layer with a permanent adhesive, with the exception of the bond between the cushion and the skin, which is a strong, but temporary bond. Each level or layer of the laminate can either have the same dimensions or be a different size than the adjacent level. This allows different levels to accomplish different functions, the plastic layer being the most important element of the laminate.
The plastic layer provides the structure that resists tension, compression and bending forces. The plastic layer can be from 0.005 inch to 0.030 inch thick and is typically up to 1.5 inches long. In a preferred embodiment, the width of the plastic layer is between about 0.125 inch to about 0.5 inch; depending on the application. The plastic layer may be solid, may have some porosity, or may have a hole pattern to provide for the ventilation of air and moisture from the skin through the lamination element. The opposite sides of the plastic layer are generally parallel; however, in some cases, the sides may not be parallel, and the plastic layer can have another, e.g. triangular, shape.
Between the plastic layer and the skin is a cushion layer which cushions the skin from the plastic layer. The cushion layer is made from woven polyester or equivalent and provides relief from the rigidity in the plastic layer.
The top of the lamination element is preferably made from woven, stretchable synthetic fabric or the like. The top layer is bonded to the plastic layer and is used to interconnect multiple lamination elements, depending on how they are being applied. The most common interconnection is to connect the lamination elements end-to-end. The stretchable top cover allows the user to adjust the distance between adjacent lamination elements to properly position them on the user""s nose.
In a preferred embodiment, the lamination element is used to stabilize the soft tissue forming the lateral wall of the nasal passage to perform the functions of a nasal dilator. In this application, the lamination element is applied so that one of its ends adheres to the skin which covers the cartilage on the side of the bridge of the nose. The other end of the lamination element is positioned on the skin at the cheekbone where the bone provides support for the skin. The center section of the lamination element is pushed against and adheres to the soft tissue of the nasal wall between bridge cartilage and the cheekbone. This resiliently deforms the plastic layer and generates a force that stabilizes the lateral nasal wall, thereby pulling it outwardly and opening the nasal passage. A second and opposite-shaped lamination element is installed on the adjacent lateral wall of the other nasal passage.
Users of the lamination element for stabilizing the lateral wall of the nasal passage will normally use one on each side of the nose. To aid the person in positioning the respective lamination elements, the external fabric layer is preferably extended to connect the two lamination elements end-to-end. This fabric layer is readily deformable, e.g. flexible, acts as a positioner, and can be stretched to assist in properly locating the two lamination elements which stabilize the nasal walls.
The specific elements of the design of the adjustable nasal dilator are shown in the attached drawings and description of the preferred embodiment.