Dilator for tissues of external wall of man's anatomic formations

The invention relates to devices for separating bodily tissues, more particularly, to devices for separating outer wall tissues from inner structure tissues to expand the nasal passages of the human nose.

People are often prone to internal obstruction of the nasal passages, making it difficult to breath. Examples of such obstructions are a deviated septum, most often occurs as a result of injury to the nose, nasal cavity tissue swelling due to allergic reactions, and associated symptoms of nasal cavity, existing in people suffering from the common cold. The lower part of the nostrils, located directly inwardly from the entrance to the nostril, is known as a vestibule. The vestibule tapers inwardly to a narrowed neck-like area called the nasal valve. Behind the nasal valve, nasal passages widen again. Obstruction of the nasal passages usually occur in the nasal valve to the point that the nasal valve may be substantially blocked. Typically, the side wall (i.e., the outer wall tissues partially surrounding the nasal passage) at the nasal valve is freely movable, whereby during inhalation during respiration external nasal wall tissue drawn inward, which leads to significant or complete block passage of air through the nasal pass, especially in the case of such obstruction.

Obviously, blocking irritates the nasal passages and may have a detrimental effect on humans, in which it occurs. In particular, the permanent mouth breathing over a long period of time may cause lung irritation due to the inhalation of foreign particles that would be filtered if the breath was carried out through the nose. Lock the nasal passages is particularly uncomfortable at night, since it is inconvenient for many people who are faced with the need to breathe through your mouth while you sleep. Locking nasal passages can lead to sleep disturbances, intermittent sleep, accompanied by snoring or a combination of these disorders. In addition, a person in such a condition may wake often because when breathing is difficult, he does not inhale enough oxygen.

In cases where an obstruction of the nasal passages caused by structural problems such as a deviated septum or an unusually small valve opening, and when the respiration interfering relatively serious, usually resort to a surgical attempt to correct malformation of the nasal passages. However, surgical treatment is expensive, and may not lead to the complete elimination of the problem. Where the cause is allergies or the common cold, another alternative often used is the application of the aerosolized medicament to reduce edema accompanying along the nasal passages. This treatment too often was insufficient to alleviate the condition, and it is long-term use is associated with possible harmful effects on the tissues themselves.

Because of these disadvantages observed with these methods when attempting disclosure nasal passages used mechanical devices called nasal dilator (dilator). Such dilators have been both domestic species that act by moving apart the sides of the nasal passages to open them, and the outdoor variety, effectively pulls any of those parties. The internal types, which require the administration to the nasal passages they may cause irritation and lead to itching. Because of the diversity of the observed geometry of the human nasal passages, these nasal dilators often need to be designed specifically for each user. External nasal dilators or tightly attached to the nose of the user (that removal requires the use of assistive devices), but to enable the selection of forces pulling the fabric of the outer wall, or attached to the bow by ensuring the possibility of their removal, but is a non-single body devices that provide pulling the tissue wall of the nose with the force determined by single body structure. The first of these is difficult to remove and difficult to find the necessary strength that will provide sufficient tensile fabric wall, without intended for this mechanical device that in normal use can be detached or dropped to the side, or the like.

Single body external nasal dilators include devices designed to provide action sufficient force pulls outward on the extensible fabric without discomfort, and which can also be relatively easily positioned for use as a dilator while at the same time comparatively easily removed. This latter feature was implemented in extenders with the help contain the spring housings with adhesive, pressure-sensitive adhesive, and the power of detachment, which operates under the influence of the motion of the skin under such glued to him expanders and adjacent areas of the skin, is opposed to the corresponding geometry of all expanders, which prevents peeling of the skin expanders. One possibility is to use spring members in the dilator body which are of a length which is shorter than the length of the body in which they are contained so that centering the position of such a spring in the body leaves each of the ends of the spring element separate from the respective ends of the housing. This possibility was shown in earlier filed copending U.S. BC Johnson, entitled "Nasal Dilator", having Serial N and 08/183916 filed January 19, 1994, which is incorporated herein by reference. As a result, ends of the body portion beyond the ends of the spring elements serve as an extension that counteract delamination forces acting on the ends of these spring members. Unfortunately, the need for individual location of the spring elements in the manufacturing process is expensive and subject to errors.

Alternatively, parts of the central end of the expander housing at opposite ends thereof beyond the spring element may be clipped during manufacture so that the end edges rather stretched back to the ends of the short spring members or, in fact the springs, not short and positioned and may extend the length of the dilator body before the incision to a part of the central elements of the end cut off along with dissection into elements. This will leave the side bolsters the body without any parts of the spring elements in them, and these side extensions will extend beyond the ends of the spring members after such cut-off as described in previously filed US patent application WJ Doubek, DE Cohen and BC Johnson, called "The Bow Expander ", having Serial N 08/070554, and filed on April 20, 1993 which is incorporated herein by reference. However tightly attached protrusions used in the geometry of the ends of the expander described in the aforementioned application for preventing detachment of the expander from the skin restrict the possible end form, which could be used in another way, so that such projections extend beyond the spring elements in the housing of the expander, they unavoidably result in some overspray during manufacture. This situation can be resolved by eliminating any central end portions cut off by, instead, between the spring members and the side extensions portions simply place diverting grooves, however, such a construction would reduce the peeling of the central end portions neotsechennyh that occurred in the previous embodiment. As a result, the central end of the peeled off will be subject to adhesion to objects in contact or adjacent to the user's nose, collecting dirt, getting unsightly, causing itching, etc.

In addition, the skin under those projections accumulates in these areas of some moisture, due to the reduction of evaporation from it due to the presence of protrusions on the skin which weakens the structure in such areas. When removing the dilator forces between the projections of the expander and the skin change from predominantly forces detachment to advantageously shearing forces which are much greater in magnitude due to the nature of the adhesive, pressure-sensitive adhesives used on the projections, and thus, there is the possibility of damaging the weakened skin upon exposure of large largest shear forces during removal of the protrusions from the skin.

On the other hand, excluding protrusions, 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 point of the expander.

Substantially constant spring force along the dilator from one to the other end edge provided located thereon elastic elements leads to exfoliate the forces due to the motion of the skin under dilator during ordinary use, which in a significant number of cases of extender is sufficient to cause the beginning of detachment ends of dilator user's skin under them. Thus, a need exists in the single body dilator structure that reduced material consumption in the manufacture of ensuring freedom in design of the ends of the expander and reduced risk of skin damage during separation of the expander from the skin of the user.

The present invention provides a dilator which in use causes the wall tissue in the human body, with which it comes into contact by a force away from one another. The dilator comprises a truss member having a pair of spaced end surfaces which provides a restoring force action tending to separate those surfaces if they are under the influence of forces directed towards each other. The end surfaces have attached thereto means for entering into contact, which can come in contact with exposed surfaces of such outer wall tissues with sufficient force to maintain the contact resistance in such a restoring force. This restoring force is partly provided by at least a first resilient plate of a selected thickness extending between end edges of the opposite ends of the truss member adjacent the end surfaces, where this plate has a plurality of grooves recessed on at least one third of the thickness, and directed transversely to the plate . These grooves may be divided in two groups near the opposite end edges of the elastic plate on a laminated member, with the deep grooves located closest to the edges, and other, becoming successively less deep in sequence toward the middle of the multilayer structure. The multilayer structure may also comprise a second elastic plate separated from the first elastic plate, and extending between its end edges, and which also bears the grooves.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a portion of a human face including the nose, and the dilator of the present invention mounted on it nose; FIG. 2A is a perspective view of parts of the image components of the present invention shown in FIG. 1; FIG. 2B shows a side view of a portion of FIG. 2A; FIG. 3 is a perspective view of the same portion of a person's face, which is shown in FIG. 1, without the expander; FIG. 4 shows a cross-sectional view taken from FIG projection. 3 with the nose shown in a state of relatively small air flow through the nasal passages; FIG. 5 shows a cross-sectional view similar to FIG. 4 with an appreciable air flow through the nasal passages; and FIG. 6 shows a cross-sectional view taken from FIG projection. 1 with an appreciable air flow through the nasal passages.

Description of a preferred embodiment of dilator 10, embodying the present invention is shown in FIG. 1. Dilator 10 is shown when used as a nasal dilator in contact with the nose 12, as the visible part of the human face 14.

The elements used in the construction of dilator 10 can be seen to take to pieces generally form the dilator shown in FIG. 2. As seen in Figure 2, the dilator 10 comprises a unitary or single layered member 16 having a strip of base material 18, a first end portion 20 and a second end portion 22 connected to the first end portion 20 of the intermediate segment 24. The width of intermediate segment 24 is less than the width of the first and second end portions 20 and 22, for the convenience of the user since a smaller portion covers the user's skin. The base material 18 is preferably made of a polyester fabric that allows the skin to the user's nose 12 is relatively easy to exchange gases with the atmosphere to provide maximum comfort and minimize irritation during use. Suitable not braided, stranded mesh material from 100 percent polyester fabric from which it is recommended to make the base material 18, can be purchased in the company "EI DuPont Nemours & Co" under the trade name SONTARA &. & SONTARA fabric, as determined for the machine direction (MD) of the fibers or the substrate relative to the transverse direction (TD) or filling fabric usually has a characteristic tensile strength in the ratio 2: 1. In addition, SONTARA & cloth typically has a percentage elongation ratio of about 3: 1 in the determination of the resulting elongation at application of the same force and in the cross machine direction of the fabric. The machine direction fabric parallel to the longitudinal extent of the base material 18.

The multilayer structure 16 further includes resilient means 26 secured to the first side 28 of the base material 18. The resilient means 26 includes a first resilient band 30a, and a second resilient band, 30b. The first elastic plate 30 has a first end 41a, and a second end 42a. Second resilient band 30b has a first end 41b, and a second end, 42b. Each of the first and second resilient bands 30a and 30b, made of a polymeric material. For example, as it has been found suitable biaxially oriented polyester technical grade, such as, MYLAR & Type A, offered by "EI DuPont Nemours & Co", which is cut into billets from a width of about 2 mm to 3.4 mm and a thickness of 0.025 mm. Using a polymer material which is relatively thin, as described for each of the first and second resilient bands 30a and 30b, enhances the pliability axial and torsional strain of each of these bands about the longitudinal extent of each depending on the actually used strips.

On each of the first and second resilient bands 30a and 30b are a series of three grooves 43a, 43b and 43c. Bevel 43a, closest to the edges of the ends of each of the first and second resilient bands 30a and 30b, is the deepest groove, and, for example, an elastic strip length of 6.6 mm and a width of 3.4 mm, the groove should usually be located 3 8 mm inward from the resilient band end nearest thereto with a depth of from 80% to 100% of the resilient band thickness, typically 90% to 100% of the thickness. Next grooves inward in this example, certain numeral 43b, each should be located at a distance of 2.5 to 5 mm closer to the middle with a depth of 60% to 90% of the resilient band thickness, typically 70%. Finally, the last furrow is shown in each row, closest to the middle of the resilient band that is designated numeral 43c, typically must be located a further 2.5-5 mm closer to the middle but with a depth component from a 40% to 70% of the thickness of the elastic plate, typically about 40%.

Additional grooves, which are located closer to the middle of the corresponding resilient bands, can be incorporated into a number of grooves, each groove can have different depths. Effect of the location of these grooves having a depth successively diminishing towards the middle, is the gradual reduction, or attenuation, the effective spring constant along the two half-lengths of each of the resilient bands starting from the middle of them. The deepest grooves most reduced effective spring constant, so that the location of the ends of the strips sufficiently effective in reducing the peel forces acting on the ends of the resilient bands resulting from the impact force of the springs and movement of the strips of skin beneath. Other grooves shallower toward the center of the plate, reduced spring rate in each segment, thus providing an increasing effective spring constant along the directions from the ends of the resilient bands toward the center. As a result, the desired pulling force exerted on the outer wall tissue of the nose user can set the type of material, length, thickness and width for applying the desired traction to said tissue, while its low enough to avoid the action of undesirable forces delamination occurring between the laminating pressure sensitive adhesive beneath the ends of these bands and the skin to which it is attached, as will be described below.

The first and second resilient bands 30a and 30b are fixed by the first and second flexible plates separating the adhesive 31a and 31b, to a first side of the base material 28 lining the separating pad 18. First adhesive material strip 31a has a first end 33a, and a second end 34a. The second adhesive separating pad 31b has a first end 33b, and a second end 34b. The first and second separating pad adhesive 31a and 31b are in their overall projection the same shape and size as well as in its overall projection have respective first and second resilient bands 30a and 30b.

The first elastic plate 30a is fixed overlay of adhesive 31a to the lining of the base material 18 adjacent the first end 32 of intermediate segment 24. The second resilient band 30b is parallel to and separated from the first resilient band 30a and the fixed plate 31b of adhesive material to the lining of the main Material 18 adjacent to the second edge 36 of intermediate segment 24. As discussed above, the first and second resilient bands 30a and 30b, generally parallel to each other and preferably parallel to the longitudinal extent of base material strip 18. Each of the separating adhesive pads 31a and 31b is preferably an acrylic, pressure-pressure sensitive, biocompatible, portable, tape adhesive material, such as material, designated mark ZM 1509 proposed and supplied by "Minnesota, Mining & Manufacturing Company, Inc." or acrylic, pressure-pressure sensitive, biocompatible, portable, tape, adhesive material, such as material, designated mark 1368B, offers and supplies corporation "Betham Corporation".

Multilayer structure 16 also includes a flexible pad surface material 38 having a first end portion 39, a second end portion 40 and an intermediate segment 47 having a total projection of the same size and shape as the base material 18 in the overall projection. Lower surface 35 of pad surface material 38 comprises a layer of adhesive 48 that extends beyond the edges of the first and second end portions 39 and 40 and its intermediate segment 47. The adhesive substance 48 is a porous, acrylic, pressure sensitive bio-compatible adhesive. Surface material strip 38 covers first and second resilient bands 30a and 30b and first side 28 of base material 18, and fixed thereto a layer of adhesive 48.

The surface pad material 38 helps to prevent separation of the first and second resilient bands 30a and 30b from the base material 18 and overlap the separating adhesive material 31a and 31b in those situations where the layered structure 16 is bent portion of the motion of the skin under it, on which it is applied. Furthermore, the surface of the material strip 38 limits to some degree base material strip 18, together providing a stiffer material in its main projection to create a geometrically more stable combination which facilitates application and removal of the expander 10. The material of the surface plates 38 is preferably a porous, woven not material placed on it with adhesive 48, for example, a material denoted mark ZM 1533 proposed and supplied by "Minnesota, Mining & Manufacturing Company, Inc.".

Furthermore, as shown in FIG. 2, with respect to base material strip 18, its second side 44 has adhesive layer 46 protruding beyond and outside the first and second end regions 20 and 22 and beyond the intermediate segment 24 on that side thereof. The adhesive 46 is a porous, acrylic, pressure sensitive bio-compatible adhesive. Adhesive 46 is used to grip dilator 10 with the skin tissue of the outer wall, which is expected to use extender, i.e. the outer wall of nose 12 in FIG. 1. The fabric suitable for the production of base material strip 18 can be obtained with adhesive 46, such as the material designated mark ZM 1776 offered by, and available from "Minnesota, Mining & Manufacturing Company, Inc.".

The adhesive 46 prior to use is covered by a pair of isolating spacers comprising a first peelable gasket 49 and second gasket 50. This disconnects the isolating pads coated adhesive 46 on the side of the first end portion 20 and second end region portion 22 of base material strip 18 with protruding portion 51, a first divisive napkin 49 and with the projecting portion 52 of the second divisive liner 50 covering the adhesive substance 46 portion on intermediate segment 24 of the base material 18. The first and second disconnecting gaskets 49 and 50 are easily removed from the adhesive 46. As seen from FIG. 3 and 4, the human nose 12 includes a first nasal passage 54, a second nasal passages 56 and a portion of nose 12, which is usually called the nasal bridge 58 located between but outside of first and second nasal passages 54 and 56. The condition of the nasal passages, FIG. 4 corresponds to that in the part of the respiratory cycle at which passes through it a small air flow, and are the nasal passages of the human image, which has no diseases involving the pathological process in the nasal passages, and had no injuries of the nasal passages. Thus, nasal passages 54 and 56 are relatively open and can easily pass the air flow.

At the height of the inspiratory breath, a slight decrease in pressure inside the nose leads to a slight retraction within the outer walls of the nose. However, if in the past was a trauma of the nose, leading to a certain obstruction of the nasal passages, or has swelling of the tissues lining those passages because of an allergic reaction or disease (or modified by) tissues forming outer walls 60 and 62 on the outer sides of the first and a second nasal passages 54 and 56, respectively, inhalation may lead to a further reduction in air pressure as air velocity through the narrowed passages increases as a person trying to make a complete inhalation and exhalation. Wherein the outer wall tissue 60 and 62 tend to have a stronger retraction in the nasal passages, as shown in FIG. 5, in some circumstances, to the extent that the passages are fallen down to near closure. Part of outer wall tissues 60 and 62, thus retracting during inhalation is that which is located between the end of the nasal passage bone and the skull shown in dotted lines in FIG. 1 and 3, and the entrance to nasal passages 54 and 56. Such retraction of the outer wall tissues 60 and 62 as a result cause additional blocking of the nasal passages. The severity of this nasal passages lockout condition depends on how narrow the nasal valve is in the entity. The nasal dilator 10 is proposed as a treatment for this problem blocking the nasal passages.

When using the nasal dilator 10 is fixed to the skin of the outer wall tissues 60 and 62 of nose 12 by adhesive substance 46 after the removal from it of the first and second isolating spacers 49 and 50. In FIG. 1 and 6 shows the placement of the nasal dilator 10 to the skin of the outer surface of the nose 12 such that intermediate segment 24 traverses the back 58 of the nose 12, the first and second end portions 20 and 22 are held in contact with outer wall tissues 60 and 62 of first and second nasal passages respectively 54 and 56, using adhesive 46. The adhesive 46 disposed on the first and second end regions 20 and 22 of dilator 10 and the intermediate segment 24 is fixed with the possibility of providing a single deletion, or single body, truss member 16 to the tissues outer walls 60 and 62 and the backrest 58 of nose 12.

The resiliency of the first and second resilient bands 30a and 30b, and the tendency of these bands to return to their normally planar state by the action of forces which compel their ends converge provides outward pulling outer wall tissues 60 and 62 when nasal dilator 10 is properly positioned on nose 12. This pulling outwards against the force of the retraction exerted on outer wall tissues 60 and 62 during inhalation, and so acts to stabilize the position of said tissues 60 and 62 during such inhalations. The flexibility of base material 18, separating adhesive material 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 the fact that they have a relatively small thickness, - together allow close fit the nasal dilator 10 to the curved surface of the nose 12 of each user to improve the convenience of the patient during use. The relatively small thickness of resilient bands 30a and 30b also enhances flexibility in the axial torsional forces laminate member 16 to its longitudinal extent, which further increases the convenience for the user and helps to maintain the adhesive 46 in a state glued to the nose of the user.

Furthermore, no filament woven mesh structure of the material 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 on this strip delaminating forces, such as those that may be caused by (1) the inherent tendency of resilient bands 30a and 30b to return to their normal planar state, (2) differences in surface configuration of these resilient bands and nose 12 by user, and (3) displacement of a single, or single body, truss member 16 relative to outer wall tissues 60 and 62 as a result of shear forces, strains, delamination or peeling force at the outer wall tissue and the multilayer structure 16 due to movement of the user's skin (e.g., facial movements nose) or contact with an external object, such as a pillow. Such delaminating forces tend to cause unwanted peeling nasal dilator 10 from nose 12 of the user. By distributing these delaminating forces, the material strip foundations 18 acts as a mechanical buffer to prevent transfer of focused forces to adhesive substance 46 and, consequently, on the skin of the nose 12 of the user. Preventing transmission of focused delaminating forces substantially eliminates itching sensations extent caused by separation of the adhesive 46 on the portions of the skin under dilator 10 that a user 14 may experience if such delaminating forces were focused at the skin of nose 12.

As stated, an acceptable range of the spreading force provided by dilator 10, that is pulling outward outer wall tissues 60 and 62, provides resiliency of truss member 16 due to it being in resilient bands 30a and 30b, is from 5 to 50 grams or more. Such expanding force of less than 10 grams, is usually sufficient to provide assistance during inspiration most users with any significant degree of locking of the nasal passages, however, if the blockade of the nasal passages is mild enough, a positive effect can be seen by the user even under the action of the expanding force of 5g provided expander . Extends the power of more than 40 grams is often somewhat obtrusive and uncomfortable for many, but not all, members of the expander.

As a result, nasal dilator 10 is generally manufactured so that on the outer walls 60 and 62 of nasal passages 54 and 56 are operated expanding spring force of 20 to 30 grams of at least a portion inwardly from the grooves 43a, 43b and 43c along resilient bands 30a and 30b. Each of these resilient bands provides a portion of the total force. Expandable spring force acting on the groove outwards towards the ends of dilator 10 are progressively reduced as described above, thereby reducing the peel forces acting on the ends of dilator 10. Since the two resilient bands 30a and 30b, are used in a single or single body, truss member 16 are generally equally spaced in proportion to them, as a rule, in a similar manner and having the same size of grooves 43a, 43b and 43c, each of the strips 30a and 30b, provides approximately half the total spreading force of a spring. Inaction on each section along the length of dilator 10.

As best seen in Figure 1 and 6, a single multilayer structure 16 comprising base material strip 18, the strip separating the adhesive 31a and 31b, top material 38, and first and second resilient bands 30a and 30b, include a first scalloped end edge 70a at one end and a second edge with a notch 70b at the opposite end of the element. 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 first ends 41a and 41b of resilient bands 30a and 30b, and first ends 33a and 33b of adhesive material strips 31a and 31b. A second edge with a notch 70b formed by second end region 22 of base material strip 18 and second end region 40 of top material 38, and second ends 42a and 42b of the first and second resilient bands 30a and 30b, and by second ends 34a and 34b of strips of adhesive 31a and 31b . In view of the similarity of first and second edges with a recess 70a and 70b, only one need be described to understand both, and they will be the first region to the recess 70a.

First scalloped end edge 70a includes two protrusions 72a and 74a, separated by a recessed portion 76a. The severity of the projections 72a and 74a mouth anavlivaetsya using a cutting die in the manufacture of dilator 10 from a continuous strip of combined materials corresponding materials in a multilayer element 16, the protruding portion of the expander 10, as a variant of the preferred choice, should be formed by first ends 41a and 41b of resilient bands 30a and 30b in the corresponding first ends 33a and 33b of adhesive material strips 31a and 31b, respectively. Since protrusions of the resilient bands extending furthest from the middle, there is the need for excess material consumption in the manufacture of resilient band truss member 16 from a continuous strip using a cutting die. The protrusions containing resilient bands from one truss member 16 will match those from the next truss member 16 so that the transition from one element to another, almost no need for cutting off the material and the loss in the manufacturing process. In view of the recesses between the projections located on both sides of the resilient bands, i.e., the inclusion of recesses 76a, and the material on the outer sides of the resilient bands to be associated with some loss of this material at each cutting off the cutting die adjacent truss member portions. Therefore, when using continuous resilient bands extending to the ends of the dilator to achieve considerable savings in the manufacturing process.

Thus, dilators can be fabricated in a continuous production process without unwanted flow of material. However, these dilators of this construction do not cause undesirable delamination ends thereof during use, that is, the end portions of a discharge of the user's nose from the skin due to facial movements face the forces acting on external objects like a pillow during sleep, and the like. This is due to the fact that the elasticity constant significantly decreases toward each of the opposite ends of the expander grooves 43a, 43b and 43c, deposited toward the ends of the resilient bands 30a and 30b, within the design of the expander. Therefore, it is proposed an effective method for manufacturing the expander, which allows adjustment of the elastic constant along the length thereof to desired values ​​at various locations along that length.

Although the present invention has been described with reference to preferred embodiments, those 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.