Surgery – Respiratory method or device
Reexamination Certificate
1999-07-19
2002-09-24
Lewis, Aaron J. (Department: 3761)
Surgery
Respiratory method or device
C128S848000, C606S191000, C606S196000, C606S199000, C606S201000, C606S204450
Reexamination Certificate
active
06453901
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to devices for dilating human tissue, and more specifically to a novel nasal dilator construction of improved performance.
Nasal dilators are well known, and are generally of the internal or external variety. Internal nasal dilators are placed inside the interior of the nose and act to urge the nostril wall tissues outward, to enhance breathing. This type of nasal dilator is both uncomfortable and obtrusive. Their very presence inside the nose increases resistance to airflow, thereby at least in part defeating the intended purpose of increasing airflow within the nasal passageways.
External nasal dilators typically use a flat, semi-rigid spring member flexed across and extending on each side of the bridge of the nose adjacent the nasal valve. That portion of an external nasal dilator which extends across the bridge of the nose is generally the intermediate segment, and those portions which engage the nasal outer wall tissues adjacent the first and second nasal passageways on each side of the bridge are generally the first and second end regions, which are thus interconnected by the intermediate segment. The inherent force of the flexed spring member, held to the skin of the nose by the adhesive, lifts the outer wall tissues of the nostrils and dilates the nasal passageways, reducing the resistance to airflow and correspondingly increasing airflow through the nasal passageways during breathing. The spring members of current well known external nasal dilators are about 4.6 to 6.1 cm (1.80″ to 2.40″) long, approximately 0.5 cm (0.20″) wide, and are typically 0.010″ thick, so as to allow the dilator to exert a spring return dilating force of about 25 grams. This amount of spring return is considered ideal for general use. Departing significantly from the aforementioned dimensions would render the spring return force outside the desired limits of between 15 and 35 grams. Less than 15 grams of spring return force may not be enough dilation for many users, while a spring return force of greater than 35 grams may be uncomfortable for many users. The preferred spring member material as defined in the art is a biaxially oriented polyester resin. This material is widely available in standard thicknesses of 0.005″, 0.007″, and 0.010″.
External dilators are, of necessity, releasably secured to the skin of the nose by use of pressure sensitive adhesives. However, external nasal dilators also have an inherent problem of maintaining adhesion to the skin for extended periods, primarily at the end regions of the device, due to the constant return force of the spring member acting on the releasable adhesive. Use of stronger adhesives that would maintain adhesion to the skin under all conditions, is undesirable because such adhesives are likely to damage the skin upon removal of the dilator.
U.S. Pat. No. 1,292,083 discloses an external nasal dilator which employs two discreet adhesive pads connected one each to opposite ends of a spring member. The adhesive pads engage the outer wall tissues of the first and second nasal passages, effectively dilating them. Each terminal end of the spring member is attached centrally to each pad, which evenly distributes the delaminating force of the spring member in a radius extending around the terminal end. While this arrangement is effective in maintaining adhesion of the device end regions to the nose, it cannot be mass produced on an economical basis.
Spanish Utility Model No. 289,561 and U.S. Pat. No. 5,546,929 each discloses a nasal dilator which uses a spring member centrally located on an adhesive pad. The adhesive pad extends around the spring member on all sides, extending well past each terminal end thereof. This arrangement adequately maintains adhesion of the device end regions to the nose, but the requirement of centrally located spring member renders these devices difficult to mass produce.
U.S. Pat. No. 5,533,503 discloses a nasal dilator which uses two narrow resilient bands, each approximately 0.80″ to 0.135″ wide and 0.010″ thick. The two bands combined provide a spring return force of approximately 26 grams. This dilator is produced in a continuous manufacturing process from a continuous laminate of several materials. To accomplish the continuous process, adhesive material for engaging the nose which would otherwise extend immediately beyond the terminal ends of the spring members is omitted in lieu of a complicated end region structure which requires extensions separated from protrusions by back cuts (or other discontinuity of material), said protrusions in turn separated by a valley. The back cuts redirect the delamination forces exerted by the spring members from primarily peel forces into primarily sheer forces. All of these elements must be present, and must work in concert, in order to maintain adequate adhesion of the end regions to the sides of the nose. This complex structure also requires the two parallel resilient bands to be in very close proximity to each other. As a result of the aforementioned requirements, this device is difficult to accurately mass produce.
U.S. Pat. No. 5,611,333 discloses a nasal dilator which employs various relief cuts, notches or other removal of material from within the perimeter of the spring member, primarily at the end regions of the spring member, in order to reduce the spring return force sufficiently so as to maintain adhesion of the device to the skin of the nose. The removal of material during manufacturing renders the device problematic for mass production on an economic basis.
Nasal dilators provided heretofore address only that area of the nasal passageways in the immediate vicinity of the nasal valve, while ignoring the vestibule area located immediately beyond the nostril openings and extending to the nasal valve.
U.S. Pat. No. 5,669,377 discloses a device which pulls upward on the tip of the nose and purportedly affects the vestibule area to aid nasal breathing. However, users may not readily accept, even in the privacy of their homes, wearing such a device which distorts the shape of the nose. Additionally, this device has no dilating effect on the nasal passage areas located above the vestibule.
External nasal dilators are meant to be centered horizontally across the bridge of the nose, so that the dilating force is evenly distributed across the first and second nasal passages. Nasal dilators provided heretofore lack a means for aiding the end user in precise alignment of the dilator with the bridge of the nose.
The Clear Passage nasal strip distributed by Schering Plough and marketed under the Afrin brand label is asymmetric. Its length is curved arcuately, and it has a wide protrusion of material along the apex of the curve. To aid end users in applying the dilator, the marketing and labelling of this device illustrates that the protrusion of material is meant to be placed up, so that the curved length of the device extends the end regions downward over the first and second nasal passages. However, this construction does little to aid the user in precise alignment of the dilator with the bridge of the nose.
Spanish Utility Model 289,561 FIGS. 1d and 2d also illustrate a protrusion of material extending upward from the device center. However, the protrusion also extends horizontally at least partway on each side of the bridge of the nose, and thus does not aid the user in precise horizontal alignment of the dilator to the nose.
Most medical devices which are adhered to or otherwise engage the skin, including those devices noted above, provide in their structure a layer of soft, absorbant material interposed between all or part of the device and the skin, for the purpose of making the device comfortable to use and wear. In some cases the material may include features which allow it to aid in device function, or aid in interfacing the device with the skin. However, use of a material layer for the purpose of user comfort has long been commonplace throughout medical device art.
Lewis Aaron J.
Olson & Olson
Pital Mital
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