Patent Application
20130104882
Not applicable.
The present invention relates generally to medical devices, and particularly to medical devices composed of at least two overlapping or overlaid components, including those medical devices having at least one component centrally registered, or island-placed, with at least one other component. The present invention further relates generally to methods of manufacturing, or converting, elongated sheets or rolls of thin flexible materials such as papers, thermoplastic films, foils, medical grade tapes, synthetic fabrics and the like into medical devices or components thereof.
The present invention relates more specifically to apparatus for and methods of dilating external tissue, and to methods of manufacturing tissue dilator devices for use in humans and equine athletes. As disclosed and taught in the preferred embodiments, the tissue dilator devices and methods of manufacturing tissue dilators or components thereof are particularly suitable for, and are directed primarily to, external nasal dilators used in supporting, stabilizing and dilating outer wall tissues of the nasal airway passages of the human nose. The United States Food and Drug Administration classifies the external nasal dilator as a Class I Medical Device.
A segment of the human population has some malformation of the nasal passages that interferes with breathing, including deviated septa or inflammation due to infection or allergic reactions. Part of the interior nasal passage wall may draw in during inhalation to substantially block the flow of air. Blockage of the nasal passages as a result of malformation, or nasal congestion symptoms of the common cold or seasonal allergies are particularly uncomfortable at night, and can lead to sleep disturbances, irregularities and general discomfort.
In use the external nasal dilator is flexed across the bridge of the nose, extending over and engaging the nasal passage outer wall tissues on each side of the bridge, and held thereto by adhesive. A resilient member (synonymously referred to in the art as a spring, spring member, resilient band, resilient member band, or spring band) extends along the length of the device, embedded within or affixed thereto. When flexed across the bridge of the nose, the resilient member, having resiliency or resilient properties, exerts spring biasing forces extending from the middle of the dilator to its opposite end regions, which urges the nasal outer wall tissues outward, providing dilation and/or stabilization thereto. Stabilized or dilated tissue decreases airflow resistance within the nasal passages, allowing for a corresponding increase in nasal airflow. Increased nasal airflow may have a beneficial effect on nasal congestion, nasal snoring and obstructive sleep apnea.
A portion of the external nasal dilator art is suitable for mass production and commercialization in the consumer market, including devices disclosed in U.S. Pat. Nos. D379513, 6,453,901, D429332, D430295, D432652, D434146, D437641 and U.S. patent application Ser. Nos. 12/024,763, 12/106,289, 12/402,214, 12/964,746 and 29/380,763, the entire disclosures of which are incorporated by reference herein. Nasal dilators that have heretofore been widely available to consumers through a retail product category referred to generically as nasal strips include devices disclosed in U.S. Pat. Nos. D379513, 5,533,503, 5,546,929, RE35408, and 7,114,495.
The preferred thermoplastic material from which external nasal dilator resilient members are fabricated carries a significantly greater cost per unit of measure than other materials typically found in nasal dilator construction. Accordingly, simple resilient member structures, such as one or two rectangular resilient bands having a single thickness prevail in dilator devices that have been successfully commercialized. These resilient members are easily mass produced, extending the entire length of the dilator device so as to be severed at the dilator device ends in a continuous die-cutting process.
A single rectangular resilient member bisected lengthwise into two or three narrower, closely parallel members, each having the same thickness, length and width, is disclosed in the art. A single resilient member having divergent end portions, or multiple resilient member structures where one or more individual members have divergent end portions, are more recent in the art. In each case, the multiple resilient members are positioned adjacent each other and slightly spaced apart, as seen, for example, in U.S. Pat. No. 6,453,901 and U.S. patent application Ser. Nos. 12/024,763 and 12/106,289.
A dynamic relationship exists between dilator design and its efficacy, including resiliency, comfort and useful duration (i.e., the amount of time the device will remain effectively adhered to the skin). To be effective for a majority of users, a nasal dilator must generate from about 15 grams to about 35 grams of resiliency, or spring biasing force. Less than 15 grams may not provide enough stabilization or dilation, while greater than 35 grams would be uncomfortable for most users. The amount of spring biasing force is determined by the type of resilient member material used, its peripheral configuration, its overall width and length, and its thickness.
Nasal dilator resiliency creates primarily peel forces at the device end regions together with some tensile forces that work to disengage the device from the skin. External nasal dilators having design attributes that transform or redirect at least some disengaging peel and tensile forces into shear forces are disclosed in U.S. Pat. Nos. 5,533,503, 6,453,901 (FIGS. 10-11), and in U.S. patent application Ser. Nos. 12/106,289, 12/964,746 and 29/380,763. Shear forces are more easily withstood by adhesives typically used to engage nasal dilators to the skin surface of the nose. Other external nasal dilators, such as those disclosed in U.S. Pat. Nos. 6,543,901, 5,546,929 and RE35408 and U.S. patent application Ser. No. 12/402,214, overcome disengaging peel forces using an island-placed resilient member centrally registered within the device's peripheral edges. Skin-engaging material extends continuously outward beyond the peripheral edges of the resilient member, particularly from the opposite ends thereof, to overcome disengaging peel and tensile forces thereat. Island-placed resilient member structures are traditionally more costly to fabricate and have been less common in mass-produced dilator devices.
U.S. Pat. No. 6,375,667 (Ruch) discloses a nasal dilator having first and second resilient bands secured to first and second end regions of a flexible strip, plus a third resilient band interconnecting the first and second bands. The ends of the third resilient band overlap the inward ends of the first and second resilient bands, respectively, such that the three bands extend in a longitudinal line successively from end to end. U.S. Pat. No. 6,470,883 (Beaudry) discloses a nasal dilator having two stacked rectangular spring laminates (22, 24) that form a leaf spring (20). The upper laminate has a shorter length, but appears to have the same width and thickness as the lower laminate.
There is a continuing need in the art to address nasal dilator disengaging or delaminating peel forces, the dynamic relationship between adhesive engagement and spring biasing forces, and to economically manufacture on a mass scale nasal strip devices having complex resilient member structures of improved efficacy, durational longevity, and comfort. Furthermore, the nasal strip consumer product category has heretofore been dominated by a single brand, creating a pent up demand for innovation, competition, variety and complexity in nasal strip products.
Dilator devices of the present invention comprise a functional element, an engagement element, and a directional element in a laminate of vertically stacked layers formed as a unitary, single body truss. The truss comprises first and second end regions adapted to engage outer wall tissues of first and second nasal passages, respectively, and an intermediate region adapted to traverse a portion of a nose located between the first and second nasal passages. The truss is capable of resilient deformation; when flexed and released it returns to a substantially planar or pre-flexed state. In use the dilator stabilizes nasal outer wall tissues to prevent tissues thereof from drawing inward during breathing, and may further expand, or dilate, the nasal outer walls. The truss is configured to be comfortable on the skin surfaces engaged and to be easily removed with little or no stress thereto.
Embodiments of the present invention are directed to nasal dilators adapted for use on the human nose. With appropriate adjustments to size, resiliency, and engagement means, the dilator devices depicted herein may be adapted for use on equine athletes.
Dilator layers are formed in whole or part from elongated material webs combined with elongated material strands. Dilator layers are preferably secured to one another by an adhesive substance disposed on at least portions of at least one flat surface side of at least one layer. The resulting laminate of vertically stacked layers forms a unitary, or single body, truss. Each layer includes one or more members. A member may further include one or more components, as described herein. Each of the engagement, functional, and directional elements is defined by at least a portion of at least one layer of the dilator.
The functional element comprises a resilient member structure having resilient properties that generate spring biasing force or resiliency. (The terms spring biasing, spring biasing force, spring force, resiliency, spring constant, etc. as used herein are generally synonymous.) The engagement element affixes, adheres, or engages the dilator to the nasal outer wall tissues. The engagement element, by itself, does not provide nasal dilation, although depending on the material used and its specific construction, could provide tissue stabilization. A simple oblong resilient member configuration, as typically found in dilator devices, generally will not by itself remain adhered to the nasal outer wall tissues for a suitable length of time. Accordingly, dilator devices of the present invention preferably include an engagement element in the form of at least one dedicated dilator layer that defines at least a substantial portion of the body of the truss and its peripheral outline. Alternatively, resilient member structures of the present invention may form the truss in its entirety.
The directional element modifies, directs, affects or alters spring biasing properties generated by the functional element of the dilator so as to enhance device efficacy, engagement, useful duration, comfort or ease of use. The directional element includes one or more design features that: spread spring biasing forces to a greater lateral extent of the dilator; increase or decrease localized spring biasing forces; mitigate or transform delaminating peel and tensile forces, at least in part, from primarily peel forces to primarily shear forces; direct spring biasing forces to discrete contact points on each side of the bridge of the nose; create lessening of or gradiently reduce spring biasing forces at the device end regions.
Nasal dilator devices of the present invention include a resilient member structure comprising at least two resilient members, and often three or more resilient members, arranged in an overlapping or overlaid spatial relationship relative to each other. Where one resilient member overlays another, an overlap surface area may include the entirety of a flat surface of one member. Where resilient members overlap, an overlap surface area typically extends across the overlapping resilient members' mid-sections, corresponding to at least a portion of the intermediate region of the truss. Overlaid resilient members are typically parallel to each other. Overlapping resilient members may also be parallel to each other, or their long edges may intersect or cross at an oblique angle. Overlaid resilient members may have progressively less length or width: a lateral stepped reduction in width (and thus thickness) extending perpendicular from the longitudinal centerline of the truss, or a longitudinal stepped reduction in length (and thus thickness) extending parallel to the longitudinal centerline of the truss, or a combination of both.
Resilient member structures of the present invention also includes at least one non-overlap surface area, having a thickness, and at least one overlap surface area, having a thickness greater than any non-overlap surface area. Non-overlap surface areas are generally a first thickness. (An exception, for example, is if two overlapping resilient members are each a different thickness, and cross in the form of an X so as to form four non-overlap areas, two non-overlap areas will have a greater thickness and two non-overlap areas will have a lesser thickness.) Otherwise, one resilient member overlapping or overlaid onto another creates at least one overlap surface area having a second thickness equal to the combined thickness of the two members. A third overlapping/overlaid member creates at least one overlap area having a third thickness, and so on. The relationship between overlap and non-overlap surface areas is dynamic, determined by length, width, peripheral configuration, and the spatial relationship between the resilient members.
Resilient member structures of the present invention are configured to: create areas of greater and lesser thickness and thus corresponding resiliency; generate greater spring biasing forces along at least one overlap surface area compared to one or more non-overlap surface areas; gradiently reduce spring biasing forces across the width and/or along the length of the truss; form spring finger components of lesser thickness extending to discrete engagement contact points having lesser spring biasing force thereat; and create the effect of an additional island-placed resilient member without having to fabricate and position one. Embodiments of the present invention illustrate complementary overlapping and overlaid resilient member structures having similar dimensions and resilient properties; the former including at least one resilient member overlapping another, the latter including at least one resilient member overlaid and centrally registered with, or island-placed onto, another.
Individual resilient members of the present invention may be configured to any viable peripheral shape, size or thickness, and are configured to be fabricated in a continuous process. The continuous process forms resilient members end to end, spaced apart, or nested along common die cut lines so as to form complex structures with the same efficiency and economy as traditional or more simply constructed resilient members or structures. Continuous slits form elongated strands from one or more webs of resilient material; select strands are separated from the web and combined, or overlaid, with each other, then combined with at least one additional web and/or material strand to form a fabrication laminate from which finished dilator devices are die cut. The process may also form individual resilient members spaced apart and divided into strips that may be combined so as to island-place, or centrally register, the spaced apart members to each other. The process may also be applicable to those medical devices where overlapping or island-placed components are required.
The individual resilient members within a resilient member structure may be vertically separated by one or more of an intermediate material layer interposed therebetween so as to separate one or more resilient members into two or more resilient layers. The intermediate layer may comprise an adhesive substance or a flexible material, or both. The intermediate layer may further contribute to the engagement element of the dilator, particularly where the resilient member structure forms the body of the truss in its entirety, or intermediate layer may define at least a portion of the truss peripheral outline.
The present invention builds upon the prior art and discloses new, useful, and non-obvious resilient member structures comprising overlapped and overlaid resilient members, including methods of economically and efficiently mass producing said structures and incorporating them into dilator devices.
It is the principal objective of the present invention to provide novel nasal dilator devices having complex overlapping, overlaid and island-placed resilient member structures. A further objective of the present invention is to provide novel methods of fabricating said structures, and converting elongated flexible material webs into finished medical devices or components thereof, including means for centrally registering parts or components to each other.
The present invention is not limited to the illustrated or described embodiments as these are intended to assist the reader in understanding the subject matter of the invention. The preferred embodiments are examples of forms of the invention comprehended by that which is taught, enabled, described, illustrated and claimed herein. All structures and methods that embody similar functionality are intended to be covered hereby. The manufacturing methods depicted, taught, enabled and disclosed herein, while particularly suitable for dilator devices, may be applicable to other medical devices. The nasal dilators depicted, taught, enabled and disclosed herein represent families of new, useful and non-obvious devices having a variety of alternative embodiments. Dilator elements, layers, members, components, materials, or regions may be of differing size, area, thickness, length, width or shape than that illustrated or described while still remaining within the purview and scope of the present invention. The preferred embodiments include, without limitation, the following numbered discrete forms of the invention, as more fully described herein.
Some embodiments of the present invention are arranged in groups so as to illustrate similarly configured resilient member structures or to illustrate manufacturing steps. Each group introduces a new or subsequent feature, design element, manufacturing technique, or variation thereof. Accordingly, later embodiments may refer to, or cross reference, previous embodiments. It will be apparent to one of ordinary skill in the art that device or component configuration, techniques, methods, processes, etc., may be applied, interchanged or combined from one embodiment or group thereof to another. Elongated material webs are generally shown in the drawings as only wide enough to illustrate the subject at hand. In practice, said widths may be greater, and in some cases lesser. The longitudinal extents of material webs, where shown, are fragmentary.
For descriptive clarity, certain terms are used consistently in the specification and claims: Vertical refers to a direction parallel to thickness, such as the thickness of a finished device, a material web, material layers, or a material laminate. Horizontal refers to length or longitudinal extent, such as that of a finished device, or a direction parallel thereto. Lateral refers to width, such as that of a finished device or a material web, and to a direction parallel to the cross direction (XD) of a material web. Longitudinal refers to length, such as that of a finished device, or the length or machine direction (MD) of a material web, or a direction perpendicular to width or lateral extent. A longitudinal centerline is consistent with the long axis of a finished device or material web, bisecting its width midway between the long edges. A lateral centerline bisects the long edges of a finished device or material web midway along its length, and is perpendicular to the longitudinal centerline. An object or objects referred to as adjacent or consecutive another generally means laterally, consistent with the width of a finished device or a material web. Objects referred to as successive are generally oriented lengthwise, end to end, parallel to the machine direction (MD) of a material web. The terms upper and lower may be used, particularly in plan views, to refer to object orientation on a drawing sheet.
Broken lines and dashed lines are used in the drawings to aid in describing relationships or circumstances with regard to objects:
In the drawings accompanying this disclosure, like objects are generally referred to with common reference numerals or characters, except where variations of otherwise like objects must be distinguished from one another. Where there is a plurality of like objects in a single drawing figure corresponding to the same reference numeral or character, only a portion of said like objects may be identified. After initial description in the text, some reference characters may be placed in a subsequent drawing(s) in anticipation of a need to call repeated attention to the referenced object. In describing manufacturing methods, Machine Direction is indicated in the drawings by the letters ‘MD’ adjacent a directional arrow: a single arrowhead indicates preferred direction; a double arrowhead indicates flow may be in either direction. Drawings are not rendered to scale, and where shown, the thickness of objects is generally exaggerated for illustrative clarity.
a is a perspective view showing a human nose, depicted in broken lines, with the attachment thereon of a first form of nasal dilator in accordance with the present invention.
b is an exploded perspective view of the nasal dilator of
c is a perspective view of the nasal dilator of
a shows two perspective views of resilient member structures seen in
b shows two sectional views comprising two and three resilient members, respectively, on an enlarged scale, taken along the lines 2-2 in
c is a sectional view of the resilient member structure of
a is an exploded perspective view of a second form of nasal dilator in accordance with the present invention.
b is a fragmentary plan view on an enlarged scale of the end region of the second form of nasal dilator in accordance with the present invention.
c is a plan view of the nasal dilator of
a and 6d are plan views illustrating initial steps of a first form of manufacturing method in accordance with the present invention by which to fabricate individual resilient members comprising resilient member structures substantially as illustrated in
b, 6c and 6e perspective views illustrating subsequent steps of the first manufacturing method.
a is a plan view of a third form of nasal dilator in accordance with the present invention.
b is a plan view of the individual resilient members comprising the resilient member structure of the nasal dilator of
c is an exploded perspective view of the nasal dilator of
d is a perspective view highlighting the resilient member structure shown in
a is a plan view of a fourth form of nasal dilator in accordance with the present invention.
b is an exploded perspective view of the nasal dilator of
c is a side elevation showing the attachment of the nasal dilator of
a and 10b are exploded perspective views illustrating an alternative configuration of the fourth form of nasal dilator.
c is a plan view of the nasal dilators shown in
a-11c are plan views highlighting the resilient member structures of the nasal dilators shown in
a and 12b are plan views of a third form of manufacturing method in accordance with the present invention by which to fabricate resilient member structures substantially as illustrated in
a-13c are exploded perspective views highlighting the resilient member structures of a fifth form of nasal dilator in accordance with the present invention.
a is a plan view illustrating the initial steps of a fourth form of manufacturing method in accordance with the present invention by which to fabricate member structures substantially as seen in
b-14d are exploded perspective views illustrating subsequent steps of the third manufacturing method.
a and 15b are plan views of a sixth form of nasal dilator in accordance with the present invention.
a and 17b are plan views of a eighth form of nasal dilator in accordance with the present invention.
c is a plan view highlighting the individual resilient members comprising the resilient member structure illustrated in
d is a side elevation showing the attachment of the nasal dilator of
a and 19b are plan views of a fifth form of manufacturing method in accordance with the present invention by which to fabricate individual resilient members comprising resilient member structures particularly illustrated in
c is an exploded perspective view of the fifth manufacturing method.
a, 21a, and 22a are plan views of three variations of a tenth form of nasal dilator in accordance with the present invention.
b, 21b and 22b are plan views of the individual resilient members comprising the resilient member structures illustrated in
c, 21c, and 22c are plan views highlighting the resilient member structures of the dilators illustrated in
d, 21d and 22d are exploded perspective views highlighting the resilient member structures of the nasal dilators illustrated in
a, 24a, and 25a are plan views of three variations of an eleventh form of nasal dilator in accordance with the present invention.
b, 24b, and 25b are plan views highlighting the resilient member structures of the nasal dilators illustrated in
c, 24c and 25c are perspective views highlighting the resilient member structures of the nasal dilators illustrated in
a, 26b, 26c and 26d are exploded perspective views of a twelfth form of nasal dilator in accordance with the present invention, highlighting the resilient member structures thereof.
a and 27b are exploded perspective views of a thirteenth form of nasal dilator in accordance with the present invention, highlighting the resilient member structures thereof.
a, and 29a are plan views of two variations of a fourteenth form of nasal dilator in accordance with the present invention.
b and 29b are plan views highlighting the resilient member structures of the nasal dilators illustrated in
c and 29c are perspective views highlighting the resilient member structures of the nasal dilators illustrated in
a is a plan view of a fifteenth form of nasal dilator in accordance with the present invention.
b is an exploded perspective view highlighting the resilient member structure of the nasal dilator of
a is a plan view of a variation of the nasal dilator of
b is a perspective view highlighting the resilient member structure of the nasal dilator of
c is a side elevation showing the attachment of the nasal dilator of
a and 32b are perspective views highlighting the resilient member structure of a variation of the nasal dilator of
a is a plan view of a sixteenth form of nasal dilator in accordance with the present invention.
b is an exploded perspective view highlighting the resilient member structure of the nasal dilator of
a is a plan view of a variation of the nasal dilator of
b is a perspective view highlighting the resilient member structure of the nasal dilator of
An embodiment of a nasal dilator, 10, in accordance with the present invention is illustrated in
As seen more clearly in
A protective layer of release paper, 15, removably covers exposed adhesive from any other layer preliminary to using the dilator. The shape and dimensions of release paper 15 may correspond to the periphery of dilator 10 or may exceed the periphery of one or more dilators 10. Release paper 15 may be bisected into two parts, which may overlap or abut, so as to facilitate removal from the dilator prior to use.
The base and cover layers of dilator 10 may be fabricated concurrently so as to have the same peripheral shape. Alternatively, the base and resilient layers may be fabricated concurrently to the same peripheral shape or the base layer may have a greater surface than the resilient layer(s) but lesser than the cover layer. The base and cover layers may be interchanged, the base and/or cover layers may be eliminated in whole or in part, or the cover layer may be interposed between the resilient layer and the skin surfaces engaged by the dilator. The cover layer may be divided into two parts, one each substantially defining each end region of the dilator.
Where the base layer has a significantly lesser surface area than the cover layer, adhesive on the skin-engaging side of the base layer may be optionally eliminated in whole or part. With or without adhesive, the base layer may also serve as a compressible buffer between the device and the skin, as has been historically common in medical devices that remain in contact with the skin for any length of time.
Dilators of the present invention generally include dedicated functional and engagement elements: the resilient member structure providing the former and the base layer and/or cover layer, and optionally the intermediate layer, providing the latter. Alternatively, resilient member structures of the present invention are configured, or otherwise may be configured, to form the truss in its entirety. Specifically, structures having a directional element that significantly reduces and/or laterally spreads spring biasing forces across the lateral extent of the truss, particularly at the end regions thereof, and resilient member structures comprising multiple engagement contact points are generally suitable or adaptable for use without the addition of a separate, dedicated engagement element. Of necessity, however, these structures preferably include an adhesive substance disposed on at least a portion of the tissue-engaging surface(s) thereof.
Dilator layers may be secured to each other by any suitable means such as stitching or fastening, heat or pressure bonding, ultrasonic welding, or the like, but are preferably laminated by an adhesive substance disposed on at least one flat surface side of at least one layer. This may be in addition to or in lieu of intermediate layer 16, which may comprise an adhesive substance, a carrier material, or a carrier material with an adhesive substance disposed on one or both flat surface sides whereby to bond two dilator layers together.
The preferred material for the dilator base and cover layers is from a group of widely available flexible nonwoven synthetic fabrics that are breathable and comfortable on the skin. Any suitable fabric or thermoplastic film, or various clear films, including high Moisture Vapor Transmission Rate (MVTR) polyurethane film, are suitable. A pressure sensitive adhesive, preferably biocompatible with external human tissue, may be disposed on at least one flat surface side of the material. A protective, removable, release liner covers the adhesive. The preferred materials are typically available in rolls wound in the machine direction (MD), or warp, of the material, which is perpendicular to the cross direction (XD), or fill, thereof.
The preferred material for the dilator resilient members is a widely available biaxially oriented polyester resin (PET), a thermoplastic film having suitable spring biasing properties across both its warp and fill. The material may have a pressure sensitive adhesive disposed on one or both flat surfaces covered by a removable protective release liner. PET may be laminated to the preferred base layer material, from the adhesive side of the former to the non-adhesive side of the latter, so that at least one resilient member and the base layer of dilator 10 may be die cut concurrently.
The functional element of dilator 10 is configured to provide spring biasing force within a suitable, or functional, range as described hereinbefore. The functional element of the present invention comprises a plurality of resilient members positioned, at least in part, in an overlapping or overlaid relationship in one or more resilient layers. Spring biasing force and its directional application is determined by the dimensional configuration of each resilient member and the combined resilient members, or resilient member structure, including overlap and non-overlap surface areas. A resilient member may have an adhesive substance disposed on at least a portion of at least one of two opposite flat surface sides for engaging or laminating it to other layers, members or components of dilator 10, or for adhering directly to the nasal outer wall tissues.
c illustrates that the layers of dilator 10 form a unitary, or single body, truss, 30, having a length, or longitudinal extent, c, indicated by broken lines and a bracket. Truss 30 has contiguous regions indicated generally by broken lines and brackets, including a first end region, 32, a second end region, 34, and an intermediate region, 36, which joins first end region 32 to second end region 34.
The truss end regions provide the primary surface area engagement to the nasal outer wall tissues on each side of the bridge of the nose. The width of intermediate region 36 is preferably narrower than the width of end regions 32 and 34. Portions of any layer may define a region of the truss or a portion thereof. The layers, members or components of dilator 10 may extend from one region to another. In the preferred embodiments end regions 32 and 34 are shown as identical in peripheral configuration and in size and shape. That is, they are the mirror images of each other. However, it will be apparent to one of ordinary skill in the art that they may be configured asymmetric or non-identical in size, shape or scale.
b shows overlaid resilient members 22a and 22b forming an overlap surface area, 20, as well as non-overlap surface areas, 19, as indicated by broken lines and brackets. Resilient member 22c in turn overlays resilient member 22b, which creates another overlap surface area. (Note: whether resilient members overlay or overlap, the area of resulting combined thickness is always referred to by the term “overlap area” or “overlap surface area”.) The resilient layer structure thus has at least one non-overlap surface area having a first thickness; overlaid resilient member 22b creates at least one overlap surface area of a second thickness, and overlaid resilient member 22c creates at least one overlap surface area of a third thickness. Directional arrows illustrate a stepped reduction from greater to lesser thickness of the resilient member structure, and thus a corresponding stepped reduction in resiliency thereof, extending laterally from longitudinal centerline a and vertical centerline v to respective outer long edges of resilient member 22a. The number of steps corresponds to the number of overlaid resilient members.
The thickness of respective overlap surface areas 20 shown in
c shows that resilient members may be vertically separated by intermediate layer 16 interposed therebetween, dividing the resilient member structure into two or more resilient layers. Intermediate layer 16 preferably comprises a very thin, inexpensive flexible material, such as a synthetic fabric or thermoplastic film, having an adhesive substance disposed on at least one flat surface side. Alternatively, intermediate layer 16 may comprises an unsupported transfer adhesive. Depending on the material type, intermediate layer 16 may be used as a matter of structural integrity, manufacturing efficiency or expediency (see
As noted, the overlaid resilient member structure shown in
The spring biasing of a single resilient member in a dilator device is generally no greater than that determined by the width and thickness at the resilient member mid-section. (Absent material separations, such as relief cuts, openings, notches, etc., formed in the resilient member, greater width and/or thickness at its mid-section generally means greater spring biasing force, and narrower width and/or lesser thickness at the resilient members ends generally lessens that spring biasing force.) The wider end portions of resilient member 22a thus do not necessarily increase spring biasing force, but do spread the resilient member spring constant across a greater lateral extent at the ends. Overlaid by resilient members 22b and 22c, however, the resiliency of the resilient member structure, as a whole, is increased. That increase occurs primarily along longitudinal centerline a, with the greatest spring biasing force generated at where the long edges of the overlaid resilient members are parallel to each other.
That increased resiliency is manipulated, or directed, at least in part, at end regions 32 and 34 of the truss; spread laterally by the increased width of resilient member 22a, and simultaneously decreased, at least in part, by the tapered portions of resilient member 22b. It will be apparent to one of ordinary skill in the art that the dimensions of the tapered portions of resilient members 22b and 22a are dynamic, and may be adjusted or configured relative to each other, along with the overall dimensions of all resilient members, in order to achieve a desired spring biasing constant and/or direction of spring biasing properties.
As seen in
End region elements may help the dilator conform to the contours of nasal outer wall tissues, and as a directional element, may direct spring biasing properties by changing the angle of focused spring biasing forces, at least in part, thus shifting or transforming at least some of these forces from primarily peel and tensile forces into primarily shear forces. The change in angle further redistributes or imparts said transformed forces to tissue engaging surface areas of the end regions, such as tab extensions 35, extending beyond the material separation. Spring biasing forces are thus imparted to the lateral width and longitudinal extent of end regions 32 and 34, as opposed to a greater delaminating tendency from peel forces being imparted to a lesser extent. Shear forces are more easily withstood by the tissue engaging adhesives disposed on the engagement element of dilator 10 than are peel forces.
c indicates the width, or lateral extent, d, of dilator 10 by broken lines and a bracket. Lateral centerline, b, is also indicated by a broken line, and generally aligned to the bridge of the nose. Dilator 10 is symmetric on each side of lateral centerline b, each horizontal half of dilator 10 being identical, one side being the mirror image of the other. Dilator 10 is also laterally symmetric on each side of its longitudinal centerline a. However, dilator 10 may be laterally asymmetric; end edge 33 and its associated elements may be angled inward from one long edge of the dilator to the opposite long edge, for example, making the upper long half of the dilator shorter than the lower long half so as to better correspond to the somewhat triangular shape of the nose.
a further illustrates that portions of the long edges of resilient material strands 26a and 26b correspond to the long edges of a plurality of resilient members 22a and 22b, respectively, interconnected end to end by waste pieces, 27′. Since strands 26 consist of a plurality of interconnected resilient members, then each continuous slit 25 forms, as well as defines, at least a portion of one long edge of the interconnected resilient members adjacent to each side of the slit, the long edges of adjacent interconnected resilient members thus being on common lines.
By virtue that resilient material strands 26a and 26b alternate laterally, side by side, their longitudinal centerlines are spaced equidistant, as indicated by broken lines and brackets. The strands are thus pre-registered to each other so that when separated into respective groups, as seen in
In
e illustrates combined overlaid resilient material strands 26a, 26b and 26c laminated with at least one additional material web corresponding to at least one additional layer of dilator 10 so as to form a fabrication laminate, 40. Laminate 40 may include at least one of a base layer material web or cover layer material web and a protective release liner. Prescribed die cut lines, 52, corresponding to the peripheral outline of finished dilator devices, extend vertically through fabrication laminate 40 to form finished dilators. In the process, die cut lines 52 sever strands 26 at the opposite end edges of each finished dilator device to form overlaid resilient member structure 22.
Spring fingers components 22′ are defined, at least in part, by material separations in the form of a slit, 21, extending inward from the end edges of resilient member 22a. Spring fingers 22′ could alternatively be separated by a slot or elongated opening, which would then define lateral spacing, or distance, between the spring finger inside long edges. Spring fingers 22′ may be of any length or width so as to influence or direct resilient properties independently to each long half of the resilient member. However, they are preferably substantially uniform. Depending upon the length of slits 21, resilient member 22a may have greater axial, torsional flexibility along its length, particularly near its ends. Greater flexibility generally allows dilator 10 to more closely conform to surface irregularities of the nasal outer wall tissues.
Resilient member 22b is preferably longitudinally aligned to at least one spring finger 22′, its width preferably no greater than the width of the spring finger overlaid, so as to add its thickness thereto and increase resiliency along thereat.
d also shows the engagement element, e, of dilator 10 represented by dashed lines in the form of the dilator periphery. Engagement element e may comprise any layer, or portion thereof, or any combination of layers that make up the engagement element, as described hereinbefore. The dilator engagement element is occasionally referenced in this manner in some embodiments of the present invention to particularly illustrate features and construction of the dilator functional element in the form of resilient member structure 22 and the constituent resilient members thereof. The reference symbol e may alternatively indicate that the dilator engagement element may be optional; the resilient member structure thus forming the truss substantially in its entirety, as described hereinbefore.
By virtue that resilient material strands 26a and 26b alternate side by side, their longitudinal centerlines are spaced equidistant. When separated into respective groups, one group may be overlaid squarely onto the other without having to align individual strands. The aligned overlaid strands may be combined with at least one additional material web corresponding to at least one additional layer of dilator 10 so as to form a fabrication laminate from which finished dilator devices are die cut.
The width of the resilient members, the angle at which they cross, or the angle at which said end portions diverge, is dynamic, and may be configured to direct resilient properties in a predetermined manner. Furthermore, the size and peripheral dimensions of overlap surface area 20 are influenced by the respective widths of the resilient members (a narrower width forms a lesser overlap surface area; a greater width forms a greater portion), by the angle at which the resilient members cross (a greater crossing angle forms a lesser overlap surface area; a narrower angle forms a greater portion), or by the degree of angle at which opposite ends of the resilient member diverge from the mid-section. It will be apparent to one of ordinary skill in the art that resilient members of a different shape or width would change the shape or size of overlap surface area 20 accordingly.
The longitudinal extent and peripheral shape of overlap surface areas 20 as seen in
As seen in
a illustrates that resilient members 22a and 22b may overlap without crossing. The resilient members are identical, but flipped laterally from each other. Instead of crossing, the resilient members overlap along their mid-sections, with the two divergent end portions of each resilient member being on the same side of longitudinal centerline a. Overlap surface area 20 has parallel long edges and the shape of a hexagon or six-sided polygon. By comparison, the end portions of the resilient members in
In overlapping resilient member structures, one resilient member may have greater resiliency than the other, such as by greater thickness or width. As seen in
Resilient member structures like those illustrated
Elongated resilient material strands 26a and 26b are slit from respective resilient material webs 24 and 24′, which are aligned to at least one additional material web corresponding to fabrication laminate 40. All webs are shown fragmentary.
The lengths of resilient material webs 24 and 24′ and the at least one additional material web corresponding to laminate 40 are preferably very similar. Webs 24 and 24′ must be shifted slightly to re-align with laminate 40 as each group of 1 from x number of resilient material strands 26 and 26a are peeled away. Once the desired resilient layer strands 26 and 26a are overlapped and incorporated into laminate 40, prescribed die cut lines 52, corresponding to the peripheral outline of finished dilator devices, extend vertically through fabrication laminate 40 to form finished dilators. In the process, die cut lines 52 sever strands 26 at the opposite end edges of each dilator device to form overlapping resilient member structure 22. Laminate 40 may include at least one of a base layer material web or a cover layer material web, and a removable protective release liner, as described hereinbefore.
a applies particularly to the resilient member structure seen in
Each resilient member 22a seen in
As previously discussed with regard to
a illustrates enclosed die cut lines 25′ extending through resilient material web 24 to, but not through, its protective release liner, kiss cutting a plurality of spaced apart resilient members 22b. Resilient material web 24 preferably has a layer of adhesive on at least one flat surface side covered by the liner. The resilient material extending around and between the kiss cut resilient members is removed and layered onto a separate protective release liner, 41, as indicated by broken lines, leaving resilient members 22b releasably secured on the original release liner of material web 24. Dashed lines illustrate where the original liner will be slit into a plurality of elongated strips 28a, each strip comprising a plurality of resilient members 22b. Layering the separated resilient material matrix on liner 41 effectively forms a second resilient material web, labeled 24′ for clarity.
As a practical matter, resilient material web 24′ is the same as resilient material web 24, albeit including a plurality of openings corresponding to the previously kiss cut resilient members 22b. Dashed lines in resilient material web 24′ represent where continuous slits 25 will form adjacent rows of elongated resilient material strands 26a, as more particularly illustrated in
b illustrates elongated resilient material strands 26a kiss cut and removed from release liner 41, of resilient material web 24′, as indicated by broken lines. The removed strands 26 are shown slightly spaced apart to indicate that while they were die cut in part along common lines, and thus abut, they are not attached to each other. The removed resilient material strands 26a leave behind a plurality of spaced apart additional resilient members 22c and 22d releasably secured on protective liner 41. Outside waste strand 27 is formed along each long edge thereof, in which some resilient members 22b were previously kiss cut. (Resilient members 22d could conceivably be formed around those openings as well.) Dashed lines in release liner 41 illustrate where the release liner will be slit into elongated strips 28b and 28c, each strip comprising a plurality of resilient members 22c or 22d, respectively, as more particularly illustrated in
a-14c show resilient material strand 26a comprising a plurality of successive interconnected resilient members 22a. Resilient member 22b is formed in resilient material web 24 immediately adjacent the mid-section of each interconnected resilient member 22a. As a result, the spaced apart resilient members 22b and the portions of strands 26a corresponding to finished resilient members 22a are effectively pre-registered to each other longitudinally, center to center. The process also renders resilient members 22c and 22d spaced longitudinally equidistant, and thus pre-registered to each other.
Turning now to
Similarly,
The overlaid resilient members are combined with at least one additional material web to form laminate 40 from which finished dilators are die cut, as represented by dashed lines. Die cut lines 52 extend outboard the periphery of the overlaid resilient members, but preferably sever, or ‘round off’ the pointed ends of resilient members 22d in the process. The overlaid resilient members are otherwise substantially island-placed within the peripheral edges of each finished dilator device.
Dilator 10 also features a distinct lateral separation between upper and lower discrete contact points, and also between the truss width along lateral centerline b and the lateral separation between upper and lower tab extensions 35. A narrower intermediate region means less potentially irritating adhesive engagement surface area across the bridge of the nose, the skin thereat less likely to be irritated upon removal of the device. (For some people the skin across the bridge of the nose is more sensitive to removal of adhesively attached medical devices. Minimizing device surface area or adhesive contact thereat can thus make a device more comfortable.)
The lateral separation between tab extensions, or the lateral extent d, of dilator 10, spreads spring biasing forces to a greater surface area of the nasal outer wall tissues. The extent of lateral separation between upper and lower contact points, roughly center-to-center, is about 2.7 times greater than the width of overlap surface area 20; the lateral extent d of dilator 10 is about six times greater than the width of overlap surface area 20, and about 3.7 times greater than the width of intermediate region 36 at its narrowest point, at lateral centerline b. At the same time, the length, or longitudinal extent, of overlap surface area 20 is substantial, relative to the overall length of the truss, being equal to about 60% thereof.
Resilient member 22a of
Resilient member 22a of
As discussed previously, the intermediate region of dilator 10 is narrower than the lateral separation of resilient member terminal ends 23. In
a further illustrates that the long edges of resilient material strand 26a correspond to the long edges of a plurality of successive interconnected resilient members 22a; dashed lines represent terminal ends 23 thereof. Strand 26a, and thus resilient members 22a and 22b, are configured so that their long edges nest along common die cut lines formed by continuous slits 25 and enclosed die cut lines 25′. Broken lines at the top of
b illustrates resilient material strands 26a separated from the protective liner of resilient material web 24, leaving a plurality of spaced apart resilient members 22b thereon. Dashed lines illustrate where the release liner will be slit into a plurality of elongated strips 28a, each strip comprising a plurality of resilient members 22b, as more clearly seen in
Overlaid resilient material strands 26a and elongated strips 28a may be combined with at least one additional material web corresponding to at least one additional layer of the dilator to form a fabrication laminate as described hereinbefore. Die cut lines extend vertically through the fabrication laminate, forming finished dilator devices and severing strands 26a in the process.
Resilient members 22b and 22c may have the same or similar shape as each other. Their rectangular mid-sections may abut, may be adjacent, spaced apart, or overlap. The divergent end portions of each resilient member are on the same long side of resilient member 22a, and thus the resilient members overlap but do not cross. The resilient members may optionally overlap and cross, as described hereinbefore, particularly with regard to
Overlap surface areas 20 are more particularly illustrated in
By virtue of the resilient member structures' divergent end portions, there is a distinct lateral separation between discrete contact points defined by upper and lower resilient member terminal ends 23. Overlap surface areas 20 are from about two to five times narrower than the lateral separation of the outermost contact points, and from about three to six times narrower than the lateral extent of each dilator end region. The length of overlap surface areas 20 range from about 50% to about 64% of the total length of the truss.
Resilient members 22a and 22b may be configured to overlap and cross, or alternatively, to overlap without crossing, as described hereinbefore. In either case, overlap surface area 20 extends at least along intermediate region 36, the resilient members having wider mid-sections that taper to narrower ends defined by terminal ends 23. Accordingly, the non-overlap surface areas comprise comparatively shorter spring finger components extending horizontally outward from the common center defined by overlap surface area 20.
As seen in
The peripheral outlines of resilient members 22a seen in
Resilient member 22b, having substantially the shape and position of overlap surface areas 20 as seen in
a and 27b illustrate further alternative resilient member structures to those shown in
As illustrated and described, the dilator devices of resilient member structures of
The spring finger components may have a constant or tapered width, they may be parallel to each other or diverge, or they may be uniform or asymmetric. The common center extends horizontally along at least a portion of the intermediate region of the truss, overlaid by resilient member 22b thereat. Terminal ends 23 of resilient member 22b may extend longitudinally to, past, or alternatively, short of, terminal ends 23 of spring finger components 22′. Similarly, terminal ends 23 of either resilient member 22a or 22b may extend to the lateral end edges of the truss, or alternatively, extend short thereof. The width of resilient member 22b at its mid-section preferably corresponds to the lateral spacing between upper and lower spring finger components.
The stepped reduction in resilient member structure thickness creates a corresponding stepped reduction in resiliency, a designed directional element of dilator 10, whereby to decrease spring biasing peel forces at the end regions of the truss, particularly in view of the resilient member structure's engineered spring constant as compared to that of a single member resilient structure (or two closely parallel resilient members). Individual resilient members preferably have the same thickness. However, to add a further dynamic element, some or all resilient members may be of greater or lesser thickness.
To generate a suitable range of spring biasing force, a single resilient member (or two adjacent, parallel, resilient members) have a length, a width, and a constant thickness along said length. To generate the same, similar, or greater range of spring biasing force, the plurality of stacked resilient members comprising the leaf spring structure may have the same or similar width as the single or two parallel members, but only a proportional fraction of thickness. Determining said proportional fraction of thickness should take into account the corresponding increase in resiliency for each stepped reduction in length, any compounding effect created by virtue of there being a plurality of stacked or overlaid members, and the maximum spring constant that may be generated given the reduction thereof at each end region.
a and 31c also illustrates that resilient member structure 22 may optionally include a plurality of small interior material separations in the form of openings, 13′, positioned so as to selectively reduce resiliency. Openings may extend vertically through all layers of the dilator so as to make the device more breathable by allowing moisture vapor to pass vertically through the openings, away from the skin.
The stepped reduction in thickness preferably extends along the respective end regions of the truss, as indicated approximately by broken lines in
The end portions of the individual resilient members illustrated in
This spatial arrangement of resilient members means that their respective mid-sections are not precisely overlaid, and the width of the resilient member structure thereat is not perfectly uniform. However, the cumulative resiliency of the stacked resilient member mid-sections is primarily imparted to the offset end portions and spread laterally across the end regions of the truss. To a lesser extent, the cumulative resiliency generated at lateral centerline b is spread along the gradually increasing width of resilient member structure 22 extending horizontally outward from lateral centerline b to the opposite end edges of the truss as indicated by directional arrows.
As illustrated and described in examples of the preferred embodiments, the present invention provides medical devices for dilating external tissue, including a wide range of nasal dilator devices having complex resilient member structures, including methods of fabricating the constituent members of said structures and corresponding finished nasal dilator devices.
