Nasal dilator

WO 96/01093 PCT/US95/08293

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-1NASAL DILATOR

BACKGROUND OF THE INVENTION

The present invention relates to devices for separating bodily tissues and, more particularly, to devices for separating outer wall tissues 5 from inner structure tissues to dilate nasal passages of a human nose.

Humans are often subject to interior obstructing of their nasal passages which makes breathing more difficult. Examples of such obstructing are a deviated septum typically resulting from injury to the nose, swelling of interior nose tissues due to allergic reactions, and the nasal 10 symptoms present in those suffering with the common cold. The lower portion of a nostril, immediately interior the entrance to the nostril, is known as a vestibule. The vestibule tapers inwardly to a narrowed neck-like area called the nasal valve. Nasal passages, posterior to the nasal valve, widen again. Nasal obstructions commonly occur at the nasal valve to the 15 point that the nasal valve may be substantially blocked. Commonly, the lateral wall (i.e., the outer wall tissues partially about the nasal passage) at the nasal valve is loose with the result that the outer wall tissues draw in during the inhalation portion of the breathing process to substantially or completely block passage of air through the nasal passage particularly if such 20 obstruction is present

Blockage of the nasal passage is obviously an irritation and a possible detriment to persons who experience it. In particular, sustained mouth breathing over a long period of time may cause lung irritation due to the inhalation of foreign particles that would otherwise be filtered if the 25 breath had passed through the nose. Blockage of the nasal passage is particularly uncomfortable at night, since it is uncomfortable for many people that have a problem to breathe through their mouth while asleep. Nasal blockages can lead to sleep disturbances, sleep irregularities, or snoring or a combination thereof. In addition, a person with such a

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-2condition may wake often because that person is not easily inhaling sufficient quantities of oxygen.

Where the cause of the obstruction in the nasal passage is due to structural problems such as a deviated septum or an unusually small valve opening, and where the effect on breathing is relatively serious, a common resort is to surgically attempt to correct the malformation of the nasal passages. However, surgety is expensive and may not ultimately correct the problem. Where the cause is allergies or the common cold, another alternative often used is a medicated spray to reduce the associated swelling of tissues along the nasal passages. This treatment too often was insufficient to alleviate the problem, and there are possible detrimental effects on the tissues themselves with long-term use.

Because of these shortcomings experienced using these methods, mechanical aids termed nasal dilators have been used in attempts to open nasal passages. Such dilators have been both of the internal variety which in effect push out the sides of the nasal passages to open them, and of the external variety effectively pulling on some of those sides. The internai types, which require insertion in the nasal passages, may irritate them and result in an itching feeling. Because of the large variety of geometries encountered in human nasal passages, these nasal dilators often must be specifically designed for each particular user. External nasal dilators have either been securely adhered to the user’s nose (requiring some aid to remove) but adjustable with respect to the force of the pull on the outer wall tissues, or have been removably adhered to the user’s nose but unadjustable single body items which provide a force pulling on wall tissues determined by the single body structure. The former are difficult to remove and difficult to adjust to provide a proper force which yields sufficient expansion of the wall tissues without the mechanical arrangement for doing so becoming disengaged, knocked askew during ordinary use, or the like.

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Single body external nasal dilltors have had designs developed therefor which provide a satisfactory outwardly pulling force on tissues being dilated without discomfort, and which can also be relatively easily put in place for use as a dilator while yet being relatively easily removed. This latter feature has been accomplished in dilators using spring containing bodies with pressure sensitive adhesives, and the peel force which is generated by motion of the skin under and adjacent to such dilators adhered thereto with such adhesives has been prevented from causing the dilators to separate from the skin through a suitable geometry at the ends thereof. One possibility is to use spring members in the dilator body which are of shorter length than the length of the body in which they are contained so that centering the position of such spring members in that body leaves each of the spring member ends spaced apart from the corresponding body ends. This possibility was shown in earlier filed copending U.S. Patent Application by B.C. Johnson entitled Nasal Dilator having Serial No. 08/183,916 and filed on January 19,1994&gt; which issued as U.S. Patent No. 5,533,499.

In effect, the portions of the body ends past the spring members ends serve as body extensions that resist the peel forces occurring at the ends of these spring members. Unfortunately, the need to individually position spring members during the manufacturing process is expensive and subject to errors.

“* Alternatively, the central end portions of the dilator body at the opposite ends thereof past the spring member ends can be cut out during manufacture so that the end edges reach back to the ends of the short spring members or, more practically, the springs, rather than being short and positioned, can extend for the length of the dilator body before being cut into units with the central end portions being cut out along with the cutting into units. This will leave body side extensions without any spring member portions therein, and these side extensions will extend past the ends of the

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PCT/ÜS93/08293 spring members after such cutting as described in earlier filed copending U.S. Patent AppÉcatkm by WJ. Doubek, D.E. Cohen and B.C. Johnson entitled Nasal Dilator* having Serial No. 08/070354 and filed on April 20, 1993 which, issued as U.S. Patent No. 5,533,503. However, the adhering extensions used in the geometry of the dilator ends described there to prevent that dilator from peeling away from the skin restrict the possible end shapes which might otherwise be used and, because such extensions do extend past the spring members in the dilator body, they unavoidably result in some waste of material in the manufacturing process. This situation can 10 be eased by eliminating any central end portions being cut out and, instead, just providing relief cuts between the spring members and the side extensions portions. Such an arrangement, however, will result in a small amount of peeling of the central end portions not cut out as they were in the previous version. The resulting peeled away central end portions will be 15 subject to catching onto objects brought into contact with, or near to, the wearer’s nose, collecting dirt, becoming unsightly, causing itching, etc.

In addition, the skin under those extensions accumulates some moisture therein due to the reduced evaporation therefrom resulting from the presence of the extensions over that skin which weakens the structure 20 thereof at such locations. At dilator removal, the forces between the dilator extensions and the skin change from being primarily peel forces to being primarily sheer forces which are much greater in magnitude due to the nature of the pressure sensitive adhesive used on the extensions, and so there is a potential for damaging the weakened skin upon the introduction 25 of the greater magnitude of sheer forces during removal of those extensions b from the skin.

I On the other hand, the omission of the extensions or any relief cuts between the spring force member and the adjacent side portions of the dilator leads to the spring members reaching the extreme end edges of the f

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-5dilator. The substantially constant spring force along the dilator from end edge to end edge provided by the resilient members therein leads to the occurrence of peel forces due to the motion of the skin beneath the dilator during ordinary use that are sufficient in a significant number of dilator uses 5 to cause the ends of the dilator to begin to disengage from the skin of the user therebeneath. Thus, there is a desire for a single body dilator structure that reduces waste in manufacture, allows design freedom for the ends of dilators, and reduces the risk of skin damage during separation of the dilator from the user’s skin.

SUMMARY OF THE INVENTION

The present invention provides a dilator which in use tends to force wall tissues in the human body, on which it is engaged under force, away from one another. The dilator comprises a truss having a pair of spaced-apart end surfaces which provides a restoring force tending to 15 separate those surfaces if they are forced toward one another. The end surfaces have engagement means adhered thereto which can engage exposed surfaces of such outer wall tissues sufficiently to remain engaged against such restoring force. This restoring force is provided in part by at least a first resilient band of a selected thickness extending between end edges of the 20 opposite ends of the truss, adjacent the end surfaces, where this band has a plurality of notches therein exceeding at least a third of that thickness which are directed across the band. These notches can be in two groups near the opposite end edges of the resilient band in the truss with the deepest notches closest to the ends and the others getting successively less deep in 25 sequence toward the middle of the truss. A second resilient band can also be provided in the truss spaced apart from the first resilient band to also extend between the end edges thereof, and which also has notches provided therein.

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-6BRIEE DESCRIPTION OF THE DRAWINGS

Figure 1 shows a pictorial view of a portion of a human face including the nose, and of a dilator embodying the present invention engaged with that nose;

Figure 2A shows an exploded pictorial view of components of the present invention shown in Figure 1;

Figure 2B shows a fragmentary view of a portion of Figure 2A;

Figure 3 shows a pictorial view of the same portion of the human face shown in Figure 1 absent any dilator;

Figure 4 shows a cross section view taken from the view of Figure 3 with the nose shown being in a state of relatively little flow of air through the nasal passages;

Figure 5 shows a cross section view similar to that of Figure 4 with an appreciable air flow through the nasal passages; and

Figure 6 shows a cross section view taken from Figure 1 with an appreciable air flow through the nasal passages.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A dilator, 10, embodying the present invention is shown in Figure 1. Dilator 10 is shown being used as a nasal dilator on a subject in being engaged with a nose, 12, seen as part of a portion of a human face, 14.

The elements used in the construction of dilator 10 can be seen in the exploded pictorial view of that dilator shown in Figure 2. As seen there, dilator 10 comprises a unitary, or single body, truss member, 16, having a strip of base material, 18, with a first end region, 20, and a second end region, 22, joined to first end region 20 by an intermediate segment, 24. The width of intermediate segment 24 is less than the width of first and second end regions 20 and 22 for the comfort of the user because of

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-7covering less of the user’s skin. Base material 18 is preferably formed of a polyester fabric that allows the skin on user nose 12 to exchange gases with the atmosphere relatively easily to maximize comfort and minimize irritation during use. A suitable, nonwoven, spun-laced, 100 percent polyester fabric 5 from which to form base material 18 is available from E.I. DuPont Nemours &amp; Co. under the trade name SONTARA*. SONTARA* fabric typically has a breaking strength property in a ratio of approximately 2:1 as determined by the machine direction (MD) or warp, relative to the cross direction (XD) or fill, of the fabric. In addition, SONTARA* fabric typically has an 10 elongation percentage ratio of approximately 3:1 as determined by the resulting elongations for equal forces in the cross and machine directions of the fabric. The machine direction of the fabric is parallel to the longitudinal extent of base material 18.

Truss 16 further includes resilient means, 26, secured to a first 15 side, 28, of base material 18. Resilient means 26 includes a first resilient band, 30a, and a second resilient band, 30b. First resilient band 30a has a first end, 41a, and a second end, 42a. Second resilient band 30b has a first end, 41b, and a second end, 42b. First and second resilient bands 30a and 30b are each formed of a polymer material. For example, an industrial 20 grade, biaxially oriented polyester such as MYLAR* Type A offered by E.I.

DuPont Nemours &amp; Co. which is cut to approximately 0.080 in. to 0.135 in. in width from 0.010 in. thick stock has been found suitable. Using a polymer material which is relatively thin as just described for each of first and second resilient bands 30a and 30b enhances the axial, torsional flexibility of each 25 of these bands about the longitudinal extent of each depending on the width of the bands actually used.

A sequence of three notches, 43a, 43b, and 43c, is shown in each of first and second resilient bands 30a and 30b. Notches 43a, nearest the extreme ends of each of first and second resilient bands 30a and 30b, is

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-8the deepest notch and, for example, in a resilient band with a 2.60 in. length and a 0.135 in. width, this notch would be typically 0.15 in. inward from the resilient band end nearest thereto with a depth of 80% to 100% of the thickness of that resilient band, typically 90% to 100% of the thickness. The next notches inward in this example, notches designated 43b, would be each located 0.10 to 0.20 in. closer to the middle with a depth of 60% to 90% of the resilient band thickness, typically 70%. Finally, the last notch shown in each sequence and closest to the middle of the resilient band, notches designated 43c, would typically be another 0.10 to 0.20 in. closer to the middle but with a depth of only 40% to 70% of the resilient band thickness, typically around 40%.

Further notches could be included in sequence extending closer to the middle of the corresponding resilient bands, and different depths for each of the notches could be used. The effect of introducing these notches ever less deep in the sequence thereof toward the middle is to monotonically decrease, or taper off, the effective spring constant along the two half-lengths of each of the resilient bands starting from the middle thereof. The deepest notches reduce effective spring constant the most so that locating them at the ends of the bands is quite effective in reducing the peel forces at the ends of the resilient bands resulting from the bands spring force and the motion of the skin therebeneath. The other notches of lesser depth as one proceeds to go to the center of the band reduced the spring constant less at each location thus giving an increasing effective spring constant along the directions from the ends of the resilient bands toward the center. As a result, the desired pull on the outer wall tissues of the user’s nose can be set by the type of material, length, thickness and width to provide the desired pull on those tissues while being reduced sufficiently to, as will be described, avoid undue peel forces occurring between the pressure

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-9sensitive adhesive beneath the ends of these bands and the skin to which it is attached.

First and second resilient bands 30a and 30b are secured by first and second flexible strips of interface adhesive material, 31a and 31b, to a first side, 28, of base material of strip 18. First interface adhesive material strip 31a has a first end, 33a, and a second end, 34a. Second interface adhesive material strip 31b has a first end, 33b, and a second end, 34b. First and second strips of interface adhesive material 31a and 31b are of the same shape and size in the plan view thereof as are first and second resilient bands 30a and 30b, respectively, in a plan view thereof.

First resilient band 30a is secured by adhesive material strip 31a to base material strip 18 adjacent a first edge, 32, of intermediate segment 24 thereof. Second resilient band 30b is parallel to, and spaced apart from, first resilient band 30a, and is secured by adhesive material strip 31b to base material strip 18 adjacent a second edge, 36, of intermediate segment 24 thereof. First and second resilient bands 30a and 30b are oriented, as stated above, generally parallel to one another and substantially parallel to the longitudinal extent of base material strip 18. Each of interface adhesive material strips 31a and 31b is preferably an acrylic, pressure sensitive bio-compatible transfer tape adhesive material such as that designated 3M 1509 offered by, and available from, Minnesota, Mining &amp; Manufacturing Company, Inc., or an acrylic, pressure sensitive biocompatible transfer adhesive material such as that designated 1368B offered by, and available from, the Betham Corporation.

Truss 16 further includes a flexible strip of top material, 38, having a first end region, 39, a second end region, 40, and an intermediate segment, 47, with the same size and shape in plan view as base material strip 18 has in plan view. A bottom surface 35, of top material strip 38 includes a layer of an adhesive substance, 48, that extends over the first and second

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-10end regions 39 and 40 and over an intermediate segment 47 thereof. Adhesive substance 48 is a porous, acrylic, pressure sensitive bio-compatible adhesive. Top material strip 38 covers first and second resilient bands 30a and 30b and first side 28 of base material strip 18, and is secured thereto by adhesive substance layer 48.

Top material strip 38 aids in preventing first and second resilient bands 30a and 30b from separating from base material strip 18 and interface adhesive material strips 31a and 31b in those situations where truss 16 is flexed by movement of that skin thereunder on which it is being used. In addition, top material strip 38 limits to some degree base material strip 18 by together providing a stiffer material in the major plane thereof to provide a geometrically more stable combination which permits installing and removing dilator 10 more easily. Top material strip 38 is preferably a porous, nonwoven material with adhesive substance 48 provided thereon such as that designated 3M 1533 offered by, and available from, Minnesota, Mining &amp; Manufacturing, Inc.

Further in connection with base material strip 18 in Figure 2, a second side, 44, thereof has a layer of an adhesive substance, 46, extending over it including over first and second end regions 20 and 22 and over intermediate segment 24 on that side thereof. Adhesive substance 46 is a porous, acrylic, pressure sensitive bio-compatible adhesive. Adhesive 46 is used to engage dilator 10 with the skin of the outer wall tissue on which that dilator is to be used, the outer wall of nose 12 in Figure 1. A fabric suitable for forming base material strip 18 can be obtained with adhesive substance 46 provided thereon such as the material 3M 1776 offered by, and available from, Minnesota, Mining &amp; Manufacturing, Inc.

Adhesive substance 46 is covered before use by a pair of release liners including a first release liner, 49, and a second release liner, 50. These release liners cover adhesive substance 46 on first end region

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-11portion 20 and second end region portion 22 of base material strip 18 with an extended portion, 51, of first release liner 49 and an extended portion, 52, of second release liner 50 covering the adhesive substance 46 portion on intermediate segment 24 of base material 18. First and second release liners 49 and 50 are readily removable from adhesive substance 46.

As can be seen in Figures 3 and 4, a human nose 12 includes a first nasal passage, 54, a second nasal passage, 56, and a portion of nose 12 generally referred to as a bridge, 58, of that nose, extending between but outside of first and second nasal passages 54 and 56. The state of the nasal passages in Figure 4 is that occurring in the portion of the breathing cycle in which there is little airflow occurring therethrough, and are the nasal passages of a person that is neither sick with an ailment which has symptoms involving the nasal passages nor has had nasal passage injury. Thus, nasal passages 54 and 56 are relatively open and can easily pass airflows.

During the peak of an inhalation in the breathing process, the slight decrease in pressure inside the nose leads to a slight drawing in of the outer walls of the nose. If, however, there has been an injury to the nasal passages leading to some obstructing thereof, or there is a swelling of the tissues lining those passages because of an allergic reaction or sickness, the tissues forming outer walls, 60 and 62, on the exterior sides of first and second nasal passages 54 and 56, respectively, inhalations can lead to even greater decreases in air pressure as air velocity through the narrowed passages increases as the breather attempts to get a full breath. Outer wall tissues 60 and 62 then tend to be more strongly drawn in to the nasal passages as can be seen in Figure 5, even to the point in some circumstances of the passages collapsing to near closure. The portion of the outer wall tissues 60 and 62 so drawn in during inhalation is that located between the end of the nasal passage bone and the skull shown in a dashed line in Figures 1 and 3, and the entrance to nasal passages 54 and 56. Such

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-12drawings in of the outer wall tissues 60 and 62, as a result, cause further nasal blockage. The severity of this nasal blockage condition depends on how narrow the nasal valve is in the person involved. Nasal dilator 10 is provided as a remedy for this nasal blockage problem.

In use, nasal dilator 10 is engaged with the skin on outer wall tissues 60 and 62 of nose 12 by adhesive substance 46 after the removal of first and second release liners 49 and 50 therefrom. Figures 1 and 6 show nasal dilator 10 placed on the exterior skin of nose 12 such that intermediate segment 24 traverses bridge 58 of nose 12 with first and second end regions 20 and 22 held in contact with outer wall tissues 60 and 62 of first and second nasal passages 54 and 56, respectively, by adhesive substance 46. Adhesive substance 46 located at first and second end regions 20 and 22 of dilator 10, and at intermediate segment 24, releasably engages unitary, or single body, truss member 16 to outer wall tissues 60 and 62 and bridge 58 of nose 12.

The resiliency of first and second resilient bands 30a and 30b, the tendency of these bands to return to their normally planar state once having the ends thereof forced toward one another, provides an outward pull on outer wall tissues 60 and 62 when nasal dilator 10 is properly positioned on nose 12. This outward pull counters the drawing in force on outer wall tissues 60 and 62 during inhalation, and so acts to stabilize the position of those wall tissues 60 and 62 during such inhalations. The flexibility of base material 18, interface adhesive materials 31a and 31b, and top material 38, along with the resiliency of first and second resilient bands 30a and 30b together with the flexibility they exhibit due to having a relatively slight thickness, all allow nasal dilator 10 to closely conform about the curves of nose 12 of each individual wearer to increase the comfort of that person during use. The relatively slight thickness of resilient bands 30a and 30b also enhances the axial torsional flexibility of truss member 16 about the

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-13longitudinal extent thereof which further increases wearer comfort and aids in maintaining adhesion of adhesive substance 46 to the wearer’s nose.

Further, the spun-laced fabric structure of the fabric strip serving as base material strip 18 permits limited, primarily plastic but somewhat elastic, deformation within the thickness of base material 18. This deformation property spreads out through that strip delaminating forces such as may be caused by (1) the inherent tendency of resilient bands 30a and 30b to return to their normally planar state, (2) surface configuration differences between those resilient bands and nose 12 of a wearer, and (3) displacement of unitary, or single body, truss member 16 relative to outer wall tissues 60 and 62 as a result of shear, tensile, cleavage or peel forces imparted at or to those outer wall tissues and truss member 16 due to wearer skin movement (e.g. nose gestures) or contact with an exterior object such as a pillow. Such delaminating forces tend to cause nasal dilator 10 to be inadvertently detached from nose 12 of a wearer. In spreading out these delaminating forces, base material strip 18 acts as a mechanical buffer to prevent transfers of focused forces to adhesive substance 46, and so to the skin of nose 12 of the wearer. Providing the transfer of focused delaminating forces substantially eliminates itching sensations caused by the separation of adhesive substance 46 from portions of the skin under dilator 10 that a wearer 14 may experience if such delaminating forces were focused at the skin of nose 12.

The range of dilating force provided by dilator 10, that is, the outward pull provided to outer wall tissues 60 and 62 by the resiliency of truss member 16 due to resilient bands 30a and 30b therein has been found to have a suitable range of from 5 to 50 grams or more. Under 10 grams of such dilating force is usually insufficient to help most wearers with any significant degree of nasal blockage during inhalations; However, if the nasal blockage is mild enough, a positive effect may be noticed by the

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-14wearer with as little as 5 grams of dilating force provided by dilator 10. A dilating force in excess of 40 grams is often somewhat obtrusive and uncomfortable for many wearers, though not all, wearers of such a dilator.

As a result, nasal dilator 10 is fabricated to provided typically from 20 to 30 grams of dilating spring force on outer walls 60 and 62 of nasal passages 54 and 56, at least at locations inwardly from notches 43a, 43b and 43c along resilient bands 30a and 30b. Each of these resilient bands provides a portion of this total. The dilating spring force at these notches out to the ends of dilator 10 are progressively reduced as described above to thereby reduce the peel forces experienced at the ends of dilator 10. Since the two resilient bands 30a and 30b used in unitary, or single body, truss member 16 are generally of equal proportions with generally similarly located and sized notches 43a, 43b and 43c provided therein, each of bands 30a and 30b provide approximately one-half of the total dilating spring force occurring at each location along the length of dilator 10.

As can be best seen in Figures 1 and 6, unitary truss member 16, comprising base material strip 18, interface adhesive material strips 31a and 31b, top material 38, and first and second resilient bands 30a and 30b, include a first scalloped edge, 70a, at one end, and a second scalloped edge, 70b, at the opposite end of that member. First scalloped end edge 70a is formed by first end region 20 of base material strip 18 and first end region 39 of top material 38, and by first ends 41a and 41b of resilient bands 30a and 30b, and first ends 33a and 33b of adhesive strips 31a and 31b. Second scalloped end edge 70b is formed by second end region 22 of base material strip 18 and second end region 40 of top material 38, and by second ends 42a and 42b of first and second resilient bands 30a and 30b, and by second ends 34a and 34b of adhesive strips 31a and 31b. Because of the similarity

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-15of first and second scalloped end edges 70a and 70b, only one need be described to understand both which will be first scalloped end edge 70a.

First scalloped end edge 70a includes two protrusions, 72a and 74a, separated by a setback portion, 76a. The protrusion extent of 5 protrusion 72a and 74a are set by the cutting die used in forming a dilator 10 from a continuous strip of combined materials matching the materials in a truss member 16, the protruding portions being chosen in dilator 10 to be formed by first ends 41a and 41b of resilient bands 30a and 30b, respectively, in the corresponding first ends 33a and 33b of adhesive material strips 31a 10 and 31b. Since protrusions of the resilient bands are outermost, the die cutting a truss member 16 from a continuous strip need not waste any resilient band material. The protrusions containing resilient bands from one truss member 16 will match those from the next truss member 16 so that essentially no material need be cut out between them and lost in the 15 fabrication process. Due to the setbacks from the protrusions contained in the resilient bands, on either side of each, that is including setback, 76a, and the material on the outer sides of the resilient bands, there will be some loss of this material at each cutting between adjacent truss member portions. However, the loss of these materials is significantly reduced in addition to 20 the near elimination of any loss of resilient band material. Therefore, the resulting economies in the manufacturing process in using continuous resilient bands extending to the ends of the dilator are significant.

Thus, dilators can be fabricated without undue waste in a continuous fabrication operation. However, these dilators of the shown 25 design do not result in inadvertent peeling at the ends thereof during use, that is, delamination of the end region from the skin of a wearer’s nose, because of facial gestures, forces from external objects like pillows during sleep, and the like. This is because the spring constant is much reduced toward each of the opposite ends of the dilator by the notches 43a, 43b and

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-1643c provided toward the ends of the resilient bands 30a and 30b provided in that dilator. Hence, a dilator is provided in an efficient fabrication process which permits tailoring the spring constant along the lengths thereof to desired values at various locations along that length.

Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.