Surgery – Respiratory method or device
Reexamination Certificate
1999-06-10
2002-11-12
Brown, Michael A. (Department: 3764)
Surgery
Respiratory method or device
C128S202250, C606S204450
Reexamination Certificate
active
06478023
ABSTRACT:
BACKGROUND OF THE INVENTION
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 u
Brown Michael A.
Hamilton Lalita
Townsend and Townsend / and Crew LLP
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