Patent Document

FIELD OF THE INVENTION 
     The present invention relates to the fields of the life sciences, and more particularly dentistry and provides improved devices and methods to effect better interdental cleaning. More specifically, the present invention is directed to certain novel devices and methods for their use in interdental cleaning, including the ability to deliver pharmaceutical or other agents for topical or local administration to enhance cleaning and promote desired pharmacologic effects in the targeted interdental tissue. 
     BACKGROUND OF THE INVENTION 
     Deposits of bacteria upon the teeth (so-called dental plaque) are the cause of caries as well as teeth-loosening diseases (periodontitis). The deposits of bacteria are collected where they are best protected from the action of the chewing friction and the cleaning by the conventional tooth brush. It has also been established that the greatest loss of tooth attachment tissue takes place in the dental interspaces. As a rule, the most severe caries damage is present upon tooth faces adjacent to the dental interspaces. 
     In a vertical cross-sectional view the dental interspace takes the general shape of an isosceles triangle, the base of which is considerably shorter than the sides thereof. In a horizontal cross-sectional view the dental interspace is generally shaped as an hourglass on account of the round or oval cross-section of the teeth. Young persons with sound gums have their dental interspaces almost completely filled out by the gum papilla. These persons usually clean the tooth faces next to the interspace by means of a tooth thread or dental floss or a triangular pointed tooth pick which in this case has a sufficient cleaning effect. 
     On the other hand, if gum inflammation proceeds into teeth loosening, the mandible and other attachments of the tooth start deteriorating towards the tip of the tooth root. The gum papilla disappears and the dental interspace, triangular in the vertical cross-section, is laid bare. In these cases, a so-called interdental brush has been used hitherto as means for cleaning the dental interspaces. Such a brush resembles a bottle-brush, i.e. it is of even width and circular cross-section. The round core consists of metal threads twisted together and grasping the brush bristles projecting in all directions. It is self-evident that a round brush bristle or rounded toothpick is suboptimal for efficient cleaning of the triangular dental interspaces. 
     Prior art interdental cleaning devices include various known designs for tooth brushes, toothpicks, and water jet devices provided to clean the interdental spaces of debris that might lead to plaque formation and periodontal inflammation if left in place. In the known prior art, tooth brushes are generally provided with solid bristles, most commonly of nylon monofilament construction. Other solid polymers and natural fibers have also been used for bristles in prior art tooth brush design. Similarly, while toothpicks and similar interdental cleaners have been described with non-rounded cross-sectional structures, the prior art devices are disclosed and used only with solid structure designs of wood, plastics, and various other materials. 
     It would be useful, therefore, for an interdental cleaning device to be provided with a porous cleaning surface that may be adapted to better clean the interdental spaces. Such porous interdental cleaners may also be used to deliver pharmaceutical or other active agents to the interdental space to provide desired local therapy for conditions within the interdental spaces. 
     SUMMARY OF THE INVENTION 
     The present invention relates to certain interdental cleaning devices and methods for their manufacture and use to remove interdental debris, to alleviate and/or prevent gingival inflammation, and or to deliver desired pharmacological and therapeutic or other active agents to the gingival or tooth surfaces. The pharmacologic and therapeutic agents of the present invention include, but are not limited to, antibiotics, antiseptics, anesthetics, astringents, and whitening agents. 
     The present invention also includes various methods for the manufacture and use of interdental cleaning devices comprising a porous structural component that may be used to topically or locally deliver the pharmacologic and therapeutic agents according to the present invention to a desired target tissue within a mammalian body such as the interdental space to reduce or treat gingival infection, inflammation, or pain. 
     The present invention further includes various methods for the manufacture and use of interdental cleaning devices comprising a porous structural component that may be used to topically or locally apply negative pressure to remove debris from the interdental space. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is a side perspective view of an exemplary embodiment of an interdental cleaner of the present invention. 
         FIG. 1B  is a cross-sectional view of an exemplary embodiment of an interdental cleaner of the present invention through the points X-X′ on  FIG. 1A . 
         FIG. 1C  is a cross-sectional view of an exemplary embodiment of an interdental cleaner of the present invention through the points Y-Y′ on  FIG. 1A . 
         FIG. 2A  is a side perspective view of an exemplary embodiment of an interdental cleaner of the present invention. 
         FIG. 2B  is a cross-sectional view of an exemplary embodiment of an interdental cleaner of the present invention through the points X″-X′″ on  FIG. 2A . 
         FIG. 2C  is a cross-sectional view of an exemplary embodiment interdental cleaner of the present invention through the points Y″-Y′″ on  FIG. 2A . 
         FIGS. 3A-3D  show cross-sectional views of various exemplary embodiments of interdental cleaners of the present invention in which the base members are solid. 
         FIGS. 3E-3H  show cross-sectional views of various exemplary embodiments of interdental cleaners of the present invention in which the base members are provided with centrally continuous lumens. 
         FIG. 4A  is a side perspective view of an exemplary toothbrush embodiment of an interdental cleaner of the present invention. 
         FIG. 4B  is a cross-sectional view of an exemplary embodiment of a porous bristle of the exemplary toothbrush embodiment of an interdental cleaner of the present invention shown in  FIG. 4A . 
         FIG. 4C  is a cross-sectional view of an exemplary embodiment of a bristle of the exemplary toothbrush embodiment of an interdental cleaner of the present invention shown in  FIG. 4A  in which the bristle comprises a porous covering and a solid or tubular core. 
         FIG. 4D  is a side perspective view of an exemplary toothbrush embodiment of an interdental cleaner of the present invention in which the toothbrush body comprises a longitudinally continuous lumen. 
         FIG. 4E  is a cross-sectional view of an exemplary embodiment of an entirely porous bristle of the exemplary toothbrush embodiment of an interdental cleaner of the present invention shown in  FIG. 4D . 
         FIG. 4F  is a cross-sectional view of an exemplary embodiment of a bristle of the exemplary toothbrush embodiment of an interdental cleaner of the present invention shown in  FIG. 4D  in which the bristle comprises a porous covering and a solid or tubular core. 
         FIG. 4G  is a cross-sectional view of an exemplary embodiment of a bristle of the exemplary toothbrush embodiment of an interdental cleaner of the present invention shown in  FIG. 4D  in which the bristle comprises a porous covering for a tubular bristle core with a plurality of bristle ports. 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     The present invention may be understood more readily by reference to the following detailed description of the preferred embodiments of the invention and the examples included herein. However, before the preferred embodiments of the devices and methods according to the present invention are disclosed and described, it is to be understood that this invention is not limited to the exemplary embodiments described within this disclosure, and the numerous modifications and variations therein that will be apparent to those skilled in the art remain within the scope of the invention disclosed herein. It is also to be understood that the terminology used herein is for the purpose of describing specific embodiments only and is not intended to be limiting. 
     Unless otherwise noted, the terms used herein are to be understood according to conventional usage by those of ordinary skill in the relevant art. In addition to the definitions of terms provided below, it is to be understood that as used in the specification and in the claims, “a” or “an” can mean one or more, depending upon the context in which it is used. 
     In various embodiments of the present invention, an interdental cleaner comprises a handle and an interdental body, said handle configured to provide a desired ergonomic interface for a user, and said interdental body configured to allow optimal access to the anatomic inter-proximal area in and between the teeth and further comprising one or more porous interfaces. The porous interfaces are designed to provide a gentle but minimally abrasive contact surface for interdental mechanical cleaning, provide an absorbent cleaning surface at the interdental interface to allow removal of dental plaque, material alba, or bio film from the tooth surface or below the gingival margin, or any other material or debris therein, and further provide an absorbent interface that may be used to deliver desired pharmacologic or other active agents to the targeted interdental space. 
     Various other embodiments of the present invention permit the use of the delivery or application of positive or negative gas pressure through the interdental cleaner and the one or more porous interfaces to permit further displacement and/or removal of dental plaque, material alba, or bio film from the tooth surface or below the gingival margin, or any other material or debris within the interdental space or adjacent gum or tooth surfaces. 
     Referring now to  FIG. 1A , one exemplary embodiment interdental cleaner  100  of the present invention is shown, comprising a handle  101  and an interdental body  102 . The handle  101  may be constructed of any plastic or other polymer, or the handle  101  alternately may be fabricated from metals, metal alloys, wood, glasses, ceramics, or composites of any of the foregoing or other materials. In preferred embodiments of the present invention, the handle  101  is constructed of high durometer semi-rigid or rigid commercially available polymer or plastic resins, including but not limited to, polyethylene, polystyrene. PVC, HDPE, polypropylene, ABS/PVC alloys, and various elastomers, such as acetal, Santoprene, nylon and glass-filled ABS. In preferred embodiments of the present invention, the handle  101  may be fabricated by any extrusion, molding, injection molding, machining, or other manufacturing process. 
     In various embodiments according to the present invention, the cross-sectional shape of the handle  101  at the level of the points Y-Y′ from  FIG. 1A  as shown in  FIG. 1C  may be round. In various other embodiments according to the present invention, the cross-sectional shape of the handle  101  may be triangular, elliptical, rectangular, squared, polygonal, or any shape, with or without edges, to provide a desired ergonomic interface for a user. 
     In various embodiments according to the present invention, the interdental body  102  may be a continuous structural extension of the handle  101 , or the interdental body  102  may be a separate structural element that is cemented, bonded, secured, or otherwise attached to the handle  101 . 
     In those various embodiments according to the present invention in which the interdental body  102  may be a structural element separate from but attached to the handle  101 , the interdental body  102  may be constructed of any plastic or other polymer, co-polymer, or blend, or the interdental body  102  alternately may be fabricated from metals, metal alloys, wood, glasses, ceramics, or composites of any of the foregoing or other materials. In preferred embodiments of the present invention, the interdental body  102  is constructed of semi-rigid or rigid commercially available polymer or plastic resins, including but not limited to, polyethylene, polystyrene. PVC, HDPE, polypropylene, ABS/PVC alloys, and various elastomers, such as acetal, Santoprene, nylon and glass-filled ABS. 
     Preferred semi-rigid plastics or polymers in the various embodiments of the present invention include those plastics and polymers with a modulus of elasticity, either in flexure or in tension, between 700 and 7000 Kg per sq cm (10,000 and 100,000 psi) at 23° C. and 50% relative humidity. Preferred semi-rigid plastics or polymers in the various embodiments of the present invention include those plastics and polymers with durometer measurements in the range of about 30 to about 100 on the ASTM D2240 type A scale. 
     In various preferred embodiments of the present invention, the interdental body  102  is constructed of polymers or plastics of lower durometer than those of the associated handle  101 . In preferred embodiments of the present invention, the interdental body  102  may be fabricated by any extrusion, molding, injection molding, machining, or other manufacturing process. 
       FIG. 1A  shows the interdental body  102  to be a tapering element terminating in a tapered and angled manner for access to small spaces. In various preferred embodiments of the present invention, the interdental body  102  may be tapered, non-tapered, and may terminate in a blunted, rounded, tapered, non-tapered, angled, or non-angled manner. 
     Referring now to  FIG. 1B  which shows a cross-sectional view through the points X-X′ on  FIG. 1A , the interdental body  102  is shown to comprise a base member  103  and one or more porous interfaces  104 . In various embodiments according to the present invention, the base member  103  may be a structural element separate from but attached to the interdental body  102 , the base member  103  may be constructed of any plastic or other polymer, co-polymer, or blend, or the base member  103  alternately may be fabricated from metals, metal alloys, wood, glasses, papers, ceramics, or composites of any of the foregoing or other materials. In preferred embodiments of the present invention, the base member  103  is constructed of semi-rigid or rigid commercially available polymer or plastic resins, including but not limited to, polyethylene, polystyrene. PVC, HDPE, polypropylene, ABS/PVC alloys, and various elastomers, such as acetal, Santoprene, nylon and glass-filled ABS. 
     In various embodiments according to the present invention, the cross-sectional shape of the base member  103  as shown in  FIG. 1B  may be a triangular form with rounded edges. In various other embodiments according to the present invention, the cross-sectional shape of the base member  103  may be triangular, elliptical, rectangular, squared, polygonal, or any shape, with or without edges. As shown in  FIG. 1B , the interdental body  102  has a shape analogous to the anatomic configuration of the inter-proximal area in and between the teeth. In various preferred embodiments of the present invention, the interdental body  102  and base member  103  are optimally shaped and provided to be extended under orthodontic appliances and fixed bridge work on teeth and dental implants. 
     In various embodiments according to the present invention, the base member  103  as shown in  FIG. 1B  may be covered in whole or in part by one or more porous interfaces  104 . The porous interfaces  104  in various embodiments according to the present invention may be constructed of any commercially available polymer or plastic resins, including but not limited to, Ultra High Molecular Weight Polyethylene (UHMWPE), High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE), Very Low Density Polyethylene (VLDPE), Polypropylene (PP), Ethylene Vinyl Acetate (EVA), Polystyrene (PS), Epoxy Glass, and Phenol Glass, or co-polymers, co-extrusions, or blends thereof. In certain preferred embodiments of the present invention, the porous interfaces  104  may comprise microfiber woven or non-woven materials. In various preferred embodiments of the present invention, the porous interfaces  104  may further comprise hypoallergenic materials. In various preferred embodiments of the present invention, the porous interfaces  104  may further comprise hydrophobic materials; in other various preferred embodiments of the present invention, the porous interfaces  104  may further comprise hydrophilic materials. 
     Furthermore, the porous interfaces  104  in various embodiments according to the present invention may be constructed as single layer materials or as multi-layer structures. The porous interfaces  104  in various embodiments according to the present invention may further be provided as woven, non-woven, molded, extruded, sponge-like, or solid materials with a porous surface quality. Further still, the porous interfaces  104  in various embodiments according to the present invention may further be constructed of conventional or microfiber materials that are not limited in material fiber and include synthetic fibers such as olefin including polyethylene and polypropylene, polyester, polyamide, and like materials, reclaimed fibers such as rayon, dacron, nylon, teflon, and the like, and natural fibers such as cotton and like materials, for example. In addition, those materials are not limited in manufacturing method and include nonwoven materials manufactured by publicly known processing methods such as a spun lace method, a spun bond method, a thermal bond method, a melt-blown method, a needle punch method and like methods. In addition, woven or mesh materials may be employed, using molded meshes, or woven meshes or fabrics using conventional weaving, spinning, or electrospinning techniques. 
     In various embodiments according to the present invention, the one or more porous interfaces  104  may be attached to the base member  103  in whole or in part by welding, melding, thermal shrinkage, lamination, or by use of various conventional glues, adhesives, or other cements. Alternately, in certain embodiments according to the present invention, the one or more porous interfaces  104  may be dually extruded with the base member  103  during manufacture. 
     The advantages and purposes of the porous interfaces  104  in various embodiments according to the present invention may include, but are not limited to, providing a gentle but minimally abrasive contact surface for interdental mechanical cleaning, providing an absorbent cleaning surface at the interdental interface to allow removal of dental plaque, material alba, or bio film on the tooth surface or below the gingival margin, or any other material or other debris therein, and further providing an absorbent interface that may be used to deliver desired pharmacologic or other active agents including, but not limited to, antibiotics, antiseptics, anesthetics, and astringents, to the targeted interdental space. For example, an interdental cleaner  100  according to the present invention may be used as an inter-proximal delivery system for whitening rinses and gels, as well as antimicrobial and fluoride oral rinses to the teeth and surrounding gingival tissues. In various embodiments of the present invention, such desired pharmacologic or other active agents may be applied to the porous interfaces  104  at the time of delivery, or the interdental cleaner  100  may be manufactured and provided with such desired pharmacologic or other active agents in a ready for use manner. 
     Referring now to  FIG. 2A , one exemplary embodiment interdental cleaner  200  of the present invention is shown, comprising a handle  201  and an interdental body  202 . As shown in  FIG. 2A , the handle  201  and interdental body  202  further comprise a longitudinally continuous lumen  207 . In various embodiments of the present invention, the longitudinally continuous lumen  207  may terminate in a blind end within the interdental body  202 , or alternately may extend fully therethrough. Not shown in  FIG. 2A , the longitudinally continuous lumen  207  may further be provided with a connector or port at or near its origin in the handle  201  to allow its connection to external injection and/or negative pressure sources. The handle  201  may be constructed of any plastic or other polymer, or the handle  201  alternately may be fabricated from metals, metal alloys, wood, glasses, ceramics, or composites of any of the foregoing or other materials. In preferred embodiments of the present invention, the handle  201  is constructed of high durometer semi-rigid or rigid commercially available polymer or plastic resins, including but not limited to, polyethylene, polystyrene. PVC, HDPE, polypropylene, ABS/PVC alloys, and various elastomers, such as acetal, Santoprene, nylon and glass-filled ABS. In preferred embodiments of the present invention, the handle  201  and longitudinally continuous lumen  207  may be fabricated by any extrusion, molding, injection molding, machining, or other manufacturing process. 
     In various embodiments according to the present invention, the cross-sectional shape of the handle  201  at the level of the points Y″-Y′″ from  FIG. 2A  as shown in  FIG. 2C  may be round. As shown in  FIG. 2C , the longitudinally continuous lumen  207  is located in an off-center position to allow its continuous location in the tapered interdental body  202  as shown in the exemplary embodiment of  FIG. 2A . In various other embodiments according to the present invention, the cross-sectional shape of the handle  201  may be triangular, elliptical, rectangular, squared, polygonal, or any shape, with or without edges, to provide a desired ergonomic interface for a user. 
     In various embodiments according to the present invention, the interdental body  202  may be a continuous structural extension of the handle  201 , or the interdental body  202  may be a separate structural element that is cemented, bonded, secured, or otherwise attached to the handle  201 . 
     In those various embodiments according to the present invention in which the interdental body  202  may be a structural element separate from but attached to the handle  201 , the interdental body  202  may be constructed of any plastic or other polymer, co-polymer, or blend, or the interdental body  202  alternately may be fabricated from metals, metal alloys, wood, glasses, ceramics, or composites of any of the foregoing or other materials. In preferred embodiments of the present invention, the interdental body  202  is constructed of semi-rigid or rigid commercially available polymer or plastic resins, including but not limited to, polyethylene, polystyrene. PVC, HDPE, polypropylene, ABS/PVC alloys, and various elastomers, such as acetal, Santoprene, nylon and glass-filled ABS. 
     Preferred semi-rigid plastics or polymers in the various embodiments of the present invention include those plastics and polymers with a modulus of elasticity, either in flexure or in tension, between 700 and 7000 Kg per sq cm (10,000 and 100,000 psi) at 23° C. and 50% relative humidity. Preferred semi-rigid plastics or polymers in the various embodiments of the present invention include those plastics and polymers with durometer measurements in the range of about 30 to about 100 on the ASTM D2240 type A scale. 
     In various preferred embodiments of the present invention, the interdental body  202  is constructed of polymers or plastics of lower durometer than those of the associated handle  201 . In preferred embodiments of the present invention, the interdental body  202  and longitudinally continuous lumen  207  may be fabricated by any extrusion, molding, injection molding, machining, or other manufacturing process. 
       FIG. 2A  shows the interdental body  202  to be a tapering element terminating in a tapered and angled manner for access to small spaces. In various preferred embodiments of the present invention, the interdental body  202  may be tapered, non-tapered, and may terminate in a blunted, rounded, tapered, non-tapered, angled, or non-angled manner. 
     Referring now to  FIG. 2B  which shows a cross-sectional view through the points X″-X′″ on  FIG. 2A , the interdental body  202  is shown to comprise a base member  203  and one or more porous interfaces  204 . In addition,  FIG. 2B  shows the longitudinally continuous lumen  207  and the presence of one or more interconnecting ports  206  that connect the longitudinally continuous lumen  207  with the one or more porous interfaces  204 . In various embodiments according to the present invention, the base member  203  may be a structural element separate from but attached to the interdental body  202 , the base member  203  may be constructed of any plastic or other polymer, co-polymer, or blend, or the base member  203  alternately may be fabricated from metals, metal alloys, wood, glasses, papers, ceramics, or composites of any of the foregoing or other materials. In preferred embodiments of the present invention, the base member  203  is constructed of semi-rigid or rigid commercially available polymer or plastic resins, including but not limited to, polyethylene, polystyrene. PVC, HDPE, polypropylene, ABS/PVC alloys, and various elastomers, such as acetal, Santoprene, nylon and glass-filled ABS. 
     In various embodiments according to the present invention, the cross-sectional shape of the base member  203  as shown in  FIG. 2B  may be a triangular form with rounded edges. In various other embodiments according to the present invention, the cross-sectional shape of the base member  203  may be triangular, elliptical, rectangular, squared, polygonal, or any shape, with or without edges. As shown in  FIG. 2B , the interdental body  202  has a shape analogous to the anatomic configuration of the inter-proximal area in and between the teeth. In various preferred embodiments of the present invention, the interdental body  202  and base member  203  are optimally shaped and provided to be extended under orthodontic appliances and fixed bridge work on teeth and dental implants. 
     In various embodiments according to the present invention, the base member  203  as shown in  FIG. 2B  may be covered in whole or in part by one or more porous interfaces  204 . The porous interfaces  204  in various embodiments according to the present invention may be constructed of any commercially available polymer or plastic resins, including but not limited to, Ultra High Molecular Weight Polyethylene (UHMWPE), High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE), Very Low Density Polyethylene (VLDPE), Polypropylene (PP), Ethylene Vinyl Acetate (EVA), Polystyrene (PS), Epoxy Glass, and Phenol Glass, or co-polymers, co-extrusions, or blends thereof. In certain preferred embodiments of the present invention, the porous interfaces  204  may comprise microfiber woven or non-woven materials. In various preferred embodiments of the present invention, the porous interfaces  204  may further comprise hypoallergenic materials. In various preferred embodiments of the present invention, the porous interfaces  204  may further comprise hydrophobic materials; in other various preferred embodiments of the present invention, the porous interfaces  204  may further comprise hydrophilic materials. 
     Furthermore, the porous interfaces  204  in various embodiments according to the present invention may be constructed as single layer materials or as multi-layer structures. The porous interfaces  204  in various embodiments according to the present invention may further be provided as woven, non-woven, molded, extruded, sponge-like, or solid materials with a porous surface quality. Further still, the porous interfaces  204  in various embodiments according to the present invention may further be constructed of conventional or microfiber materials that are not limited in material fiber and include synthetic fibers such as olefin including polyethylene and polypropylene, polyester, polyamide, and like materials, reclaimed fibers such as rayon, dacron, nylon, teflon, and the like, and natural fibers such as cotton and like materials, for example. In addition, those materials are not limited in manufacturing method and include nonwoven materials manufactured by publicly known processing methods such as a spun lace method, a spun bond method, a thermal bond method, a melt-blown method, a needle punch method and like methods. In addition, woven or mesh materials may be employed, using molded meshes, or woven meshes or fabrics using conventional weaving, spinning, or electrospinning techniques. 
     In various embodiments according to the present invention, the one or more porous interfaces  204  may be attached to the base member  203  in whole or in part by welding, melding, thermal shrinkage, lamination, or by use of various conventional glues, adhesives, or other cements. Alternately, in certain embodiments according to the present invention, the one or more porous interfaces  204  may be dually extruded with the base member  203  during manufacture. 
     The advantages and purposes of the porous interfaces  204  in various embodiments according to the present invention as shown in  FIG. 2A-C  may include, but are not limited to, providing a gentle but minimally abrasive contact surface for interdental mechanical cleaning, providing an absorbent cleaning surface at the interdental interface to allow removal of dental plaque, material alba, or bio film on the tooth surface or below the gingival margin, or any other material or other debris therein, and providing an absorbent interface that may be used to deliver desired pharmacologic or other active agents to the targeted interdental space, and providing a means through the longitudinally continuous lumen  207  of either instilling such desired pharmacologic or other active agents and/or a means of applying negative or positive pressure to the porous interfaces  204  to further aid in cleaning those spaces of debris or plaque. 
     For example, the longitudinally continuous lumen  207  of an interdental cleaner  200  according to the present invention may be used as an inter-proximal delivery system for whitening rinses and gels, as well as antimicrobial and fluoride oral rinses to the teeth and surrounding gingival tissues. In various embodiments of the present invention, the longitudinally continuous lumen  207  may be connected to an external source in order that such desired pharmacologic or other active agents including, but not limited to, antibiotics, antiseptics, anesthetics, and astringents, may be delivered to the porous interfaces  204  through the one or more interconnecting ports  206  at the time of delivery, or the interdental cleaner  200  may be manufactured and provided with an internal supply source [not shown in  FIGS. 2A-C ] of such desired pharmacologic or other active agents that may be dispensed though the interdental lumen  205 , which is an extension of the longitudinally continuous lumen  207  in a ready for use manner. The interdental lumen  205  refers to that more distal portion of the longitudinally continuous lumen  207  within the interdental body  202  that contains the branching one or more interconnecting ports  206 . 
     As a further example, the longitudinally continuous lumen  207  of an interdental cleaner  200  according to the present invention may be used as a means of delivering positive or negative gas pressure from an external source [not shown in  FIGS. 2A-2C ] to the porous interfaces  204 , thus allowing to displace and/or attract and retain plaque and debris from the interdental spaces for enhanced cleaning effects. 
       FIGS. 3A-3H  shows a variety of alternate cross-sectional views that correspond to those of  FIGS. 1B and 2B  in various alternative embodiments of interdental bodies of the present invention. The alternate embodiments shown in  FIGS. 3A-3H  differ primarily in their cross-sectional shapes, and address alternate considerations in providing an optimal cleaning shape and surface for interdental cleaners according to the present invention. 
       FIGS. 3A and 3E  each show a generally blunted triangular cross-sectional shaped interdental body  300  comprising a base member  301  and one or more porous interfaces  302 . In addition,  FIG. 3E  shows a longitudinally continuous lumen  303  and the presence of one or more interconnecting ports  304  that connect the longitudinally continuous lumen  303  with the one or more porous interfaces  302 . In various embodiments according to the present invention, the base member  301  may be a structural element separate from but attached to the interdental body  300 . The base member  301  may be constructed of any plastic or other polymer, co-polymer, or blend, or the base member  301  alternately may be fabricated from metals, metal alloys, wood, glasses, papers, ceramics, or composites of any of the foregoing or other materials. In preferred embodiments of the present invention, the base member  301  is constructed of semi-rigid or rigid commercially available polymer or plastic resins, including but not limited to, polyethylene, polystyrene. PVC, HDPE, polypropylene, ABS/PVC alloys, and various elastomers, such as acetal, Santoprene, nylon and glass-filled ABS. 
     In  FIGS. 3A and 3E , the one or more porous interfaces  302  are located within a recessed trough in the base member  301 , such that there is no ridge or lip formed at the surface junctions of the one or more porous interfaces  302  and the base member  301  at the points A′″. This is designed to minimize local tissue trauma and better fit the interdental spaces. The features and functions of the interdental body  300  of  FIGS. 3A and 3E  are otherwise identical to the corresponding structures of  FIGS. 1A-1C  and  FIGS. 2A-2C . 
     In  FIGS. 3B and 3F , a more wedge-shaped cross-sectional shape is provided, in which the one or more porous interfaces  302  is shown as a continuous covering overlapping the edge of the base member  301  at the point B′″. In addition,  FIG. 3F  shows a longitudinally continuous lumen  303  and the presence of one or more interconnecting ports  304  that connect the longitudinally continuous lumen  303  with the one or more porous interfaces  302 . The features and functions of the interdental body  300  of  FIGS. 3B and 3F  are otherwise identical to the corresponding structures of  FIGS. 1A-1C  and  FIGS. 2A-2C . 
     In  FIGS. 3C and 3G , a more elliptical-shaped cross-sectional shape is provided, in which the one or more porous interfaces  302  is shown as a continuous covering overlapping the edges of the base member  301  at the points C′″. In addition,  FIG. 3G  shows a longitudinally continuous lumen  303  and the presence of one or more interconnecting ports  304  that connect the longitudinally continuous lumen  303  with the one or more porous interfaces  302 . The features and functions of the interdental body  300  of  FIGS. 3C and 3G  are otherwise identical to the corresponding structures of  FIGS. 1A-1C  and  FIGS. 2A-2C . 
     In  FIGS. 3D and 3H , a more band-shaped cross-sectional shape is provided, in which the one or more porous interfaces  302  is shown as a continuous covering overlapping the edges of the base member  301  at the points D′″. In addition,  FIG. 3H  shows a longitudinally continuous lumen  303  and the presence of one or more interconnecting ports  304  that connect the longitudinally continuous lumen  303  with the one or more porous interfaces  302 . The features and functions of the interdental body  300  of  FIGS. 3D and 3H  are otherwise identical to the corresponding structures of  FIGS. 1A-1C  and  FIGS. 2A-C . 
     In various embodiments according to the present invention, the base member  301  as shown in  FIGS. 3A-3H  may be covered in whole or in part by one or more porous interfaces  302 . The porous interfaces  302  in various embodiments according to the present invention may be constructed of any commercially available polymer or plastic resins, including but not limited to, Ultra High Molecular Weight Polyethylene (UHMWPE), High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE), Very Low Density Polyethylene (VLDPE), Polypropylene (PP), Ethylene Vinyl Acetate (EVA), Polystyrene (PS), Epoxy Glass, and Phenol Glass, or co-polymers, co-extrusions, or blends thereof. In certain preferred embodiments of the present invention, the porous interfaces  302  may comprise microfiber woven or non-woven materials. In various preferred embodiments of the present invention, the porous interfaces  302  may further comprise hypoallergenic materials. In various preferred embodiments of the present invention, the porous interfaces  302  may further comprise hypoallergenic materials. In various preferred embodiments of the present invention, the porous interfaces  302  may further comprise hydrophobic materials; in other various preferred embodiments of the present invention, the porous interfaces  302  may further comprise hydrophilic materials. 
     Furthermore, the porous interfaces  302  in various embodiments according to the present invention may be constructed as single layer materials or as multi-layer structures. The porous interfaces  302  in various embodiments according to the present invention may further be provided as woven, non-woven, molded, extruded, sponge-like, or solid materials with a porous surface quality. Further still, the porous interfaces  302  in various embodiments according to the present invention may further be constructed of conventional or microfiber materials that are not limited in material fiber and include synthetic fibers such as olefin including polyethylene and polypropylene, polyester, polyamide, and like materials, reclaimed fibers such as rayon, dacron, nylon, teflon, and the like, and natural fibers such as cotton and like materials, for example. In addition, those materials are not limited in manufacturing method and include nonwoven materials manufactured by publicly known processing methods such as a spun lace method, a spun bond method, a thermal bond method, a melt-blown method, a needle punch method and like methods. In addition, woven or mesh materials may be employed, using molded meshes, or woven meshes or fabrics using conventional weaving, spinning, or electrospinning techniques. 
     In various embodiments according to the present invention, the one or more porous interfaces  302  may be attached to the base member  301  in whole or in part by welding, melding, thermal shrinkage, lamination, or by use of various conventional glues, adhesives, or other cements. Alternately, in certain embodiments according to the present invention, the one or more porous interfaces  302  may be dually extruded with the base member  301  during manufacture. 
     The advantages and purposes of the porous interfaces  302  in various embodiments according to the present invention as shown in  FIGS. 3A-3H  may include, but are not limited to, providing a gentle but minimally abrasive contact surface for interdental mechanical cleaning, providing an absorbent cleaning surface at the interdental interface to allow removal of dental plaque, material alba, or bio film on the tooth surface or below the gingival margin, or any other material or other debris therein, and providing an absorbent interface that may be used to deliver desired pharmacologic or other active agents to the targeted interdental space, and providing a means through the longitudinally continuous lumen  303  (in  FIGS. 3E ,  3 F,  3 G, and  3 H) of either instilling such desired pharmacologic or other active agents and/or a means of applying negative or positive pressure to the porous interfaces  302  to further aid in cleaning those spaces of debris or plaque. 
       FIG. 4A  is a lateral view of a toothbrush embodiment of the present invention, showing a toothbrush  400  comprising a body  401  with imbedded or attached porous bristles  402 . The toothbrush body  401  is shown only in its distal tip in  FIG. 4A , and may be constructed of any known material including but not limited to, any plastic or other polymer, metals, metal alloys, wood, glasses, ceramics, or composites of any of the foregoing or other materials. In preferred embodiments of the present invention, the toothbrush body  401  is constructed of high durometer semi-rigid or rigid commercially available polymer or plastic resins, including but not limited to, polyethylene, polystyrene. PVC, HDPE, polypropylene, ABS/PVC alloys, and various elastomers, such as acetal, Santoprene, nylon and glass-filled ABS. In preferred embodiments of the present invention, the toothbrush body  401  may be fabricated by any extrusion, molding, injection molding, machining, or other manufacturing process. 
     The porous bristles  402  of the toothbrush  400  may be imbedded in or otherwise attached to the toothbrush body  401  using conventional manufacturing processes. In various embodiments according to the present invention, the porous bristles  402  may comprise entirely porous structures as shown in  FIG. 4B , or the porous component may be provided as a porous bristle covering  403  for a solid or tubular bristle core  404  as shown in  FIG. 4C . 
     In various embodiments according to the present invention, the porous bristles  402  or porous bristle covering  403  in various embodiments according to the present invention may be constructed of any commercially available polymer or plastic resins, including but not limited to, Ultra High Molecular Weight Polyethylene (UHMWPE), High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE), Very Low Density Polyethylene (VLDPE), Polypropylene (PP), Ethylene Vinyl Acetate (EVA), Polystyrene (PS), Epoxy Glass, and Phenol Glass, or co-polymers, co-extrusions, or blends thereof. In certain preferred embodiments of the present invention, the porous bristles  402  or porous bristle covering  403  may comprise microfiber woven or non-woven materials. In various preferred embodiments of the present invention, the porous bristles  402  or porous bristle covering  403  may further comprise hypoallergenic materials. In various preferred embodiments of the present invention, the porous bristles  402  or porous bristle covering  403  may further comprise hypoallergenic materials. In various preferred embodiments of the present invention, the porous bristles  402  or porous bristle covering  403  may further comprise hydrophobic materials; in other various preferred embodiments of the present invention, the porous bristles  402  or porous bristle covering  403  may further comprise hydrophilic materials. 
     Furthermore, the porous bristles  402  or porous bristle covering  403  in various embodiments according to the present invention may be constructed as single layer materials or as multi-layer structures. The porous bristles  402  or porous bristle covering  403  in various embodiments according to the present invention may further be provided as woven, non-woven, molded, extruded, sponge-like, or solid materials with a porous surface quality. Further still, the porous bristles  402  or porous bristle covering  403  in various embodiments according to the present invention may further be constructed of conventional or microfiber materials that are not limited in material fiber and include synthetic fibers such as olefin including polyethylene and polypropylene, polyester, polyamide, and like materials, reclaimed fibers such as rayon, dacron, nylon, teflon, and the like, and natural fibers such as cotton and like materials, for example. In addition, those materials are not limited in manufacturing method and include nonwoven materials manufactured by publicly known processing methods such as a spun lace method, a spun bond method, a thermal bond method, a melt-blown method, a needle punch method and like methods. In addition, woven or mesh materials may be employed, using molded meshes, or woven meshes or fabrics using conventional weaving, spinning, or electrospinning techniques. 
     In those embodiments of the present invention in which a solid or tubular bristle core  404  is employed as shown in  FIG. 4C , the solid or tubular bristle core  404  may be constructed of any natural fiber or synthetic fibers comprising any commercially available polymer or plastic resins, including but not limited to, Ultra High Molecular Weight Polyethylene (UHMWPE), High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE), Very Low Density Polyethylene (VLDPE), Polypropylene (PP), Ethylene Vinyl Acetate (EVA), Polystyrene (PS), Epoxy Glass, and Phenol Glass, or co-polymers, co-extrusions, or blends thereof. Alternately still, the solid or tubular bristle core  404  may be constructed of any metals, metal alloys, fiberglass, or any composites of any aforementioned materials. 
     The advantages and purposes of the porous bristles  402  in various embodiments of a toothbrush  400  according to the present invention may include, but are not limited to, providing a gentle but minimally abrasive contact surface for interdental mechanical cleaning, providing an absorbent cleaning surface at the interdental interface to allow removal of dental plaque, material alba, or bio film on the tooth surface or below the gingival margin, or any other material or other debris therein, and further providing an absorbent interface that may be used to deliver desired pharmacologic or other active agents to the targeted interdental space. For example, a toothbrush  400  according to the present invention may be used as an inter-proximal delivery system for whitening rinses and gels, as well as antimicrobial and fluoride oral rinses to the teeth and surrounding gingival tissues. In various embodiments of the present invention, such desired pharmacologic or other active agents including, but not limited to, antibiotics, antiseptics, anesthetics, and astringents, may be applied to the porous bristles  402  at the time of delivery, or the toothbrush  400  may be manufactured and provided with such desired pharmacologic or other active agents in a ready for use manner. 
       FIG. 4D  is a lateral view of a toothbrush embodiment of the present invention, showing a toothbrush  400 ′ comprising a body  401 ′ with imbedded or attached porous bristles  407 . As shown in  FIG. 4D , the body  401 ′ further comprises a longitudinally continuous lumen  405 . In various embodiments of the present invention, the longitudinally continuous lumen  405  may terminate in a blind end within the body  401 ′, and may have a branching plurality of bristle ports  406  in direct communication with the longitudinally continuous lumen  405 , such that liquids or gas pressure flowing within the longitudinally continuous lumen  405  would flow into the bristle ports  406 , where such liquids or pressures would be imparted to the associated porous bristles  407 . Not shown in  FIG. 4D , the longitudinally continuous lumen  405  may further be provided with a connector or port at or near its origin in the body  401  to allow its connection to external injection and/or negative pressure sources. 
     The toothbrush body  401 ′ is shown only in its distal tip in  FIG. 4D , and may be constructed of any known material including but not limited to, any plastic or other polymer, metals, metal alloys, wood, glasses, ceramics, or composites of any of the foregoing or other materials. In preferred embodiments of the present invention, the toothbrush body  401 ′ is constructed of high durometer semi-rigid or rigid commercially available polymer or plastic resins, including but not limited to, polyethylene, polystyrene. PVC, HDPE, polypropylene, ABS/PVC alloys, and various elastomers, such as acetal, Santoprene, nylon and glass-filled ABS. In preferred embodiments of the present invention, the toothbrush body  401 ′ and longitudinally continuous lumen  405  may be fabricated by any extrusion, molding, injection molding, machining, or other manufacturing process. 
     The porous bristles  407  of the toothbrush  400 ′ may be imbedded in or otherwise attached to the toothbrush body  401 ′ in direct communication with the bristle ports  406  using conventional manufacturing processes. In various embodiments according to the present invention, the porous bristles  407  may comprise entirely porous structures as shown in  FIG. 4E , or the porous component may be provided as a porous bristle covering  408  for a solid or tubular bristle core  411  as shown in  FIG. 4F , or the porous bristles  407  may comprise a porous bristle covering  409  for a tubular bristle core  412  with a plurality of bristle ports  413  as shown in  FIG. 4G . In embodiments with the latter construction, the bristle ports  413  may provide direct flow path from the lumen of the bristle ports  413  to the exterior surfaces of the porous bristles  407  or the bristle ports  413  may terminate within the interior structure of the porous bristles  407 . 
     In various embodiments according to the present invention, the porous bristles  408  or porous bristle covering  409  in various embodiments according to the present invention may be constructed of any commercially available polymer or plastic resins, including but not limited to, Ultra High Molecular Weight Polyethylene (UHMWPE), High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE), Very Low Density Polyethylene (VLDPE), Polypropylene (PP), Ethylene Vinyl Acetate (EVA), Polystyrene (PS), Epoxy Glass, and Phenol Glass, or co-polymers, co-extrusions, or blends thereof. In certain preferred embodiments of the present invention, the porous bristles  408  or porous bristle covering  409  may comprise microfiber woven or non-woven materials. In various preferred embodiments of the present invention, the porous bristles  408  or porous bristle covering  409  may further comprise hypoallergenic materials. In various preferred embodiments of the present invention, the porous bristles  408  or porous bristle covering  409  may further comprise hydrophobic materials; in other various preferred embodiments of the present invention, the porous bristles porous bristles  408  or porous bristle covering  409  may further comprise hydrophilic materials. 
     Furthermore, the porous bristles  408  or porous bristle covering  409  in various embodiments according to the present invention may be constructed as single layer materials or as multi-layer structures. The porous bristles  408  or porous bristle covering  409  in various embodiments according to the present invention may further be provided as woven, non-woven, molded, extruded, sponge-like, or solid materials with a porous surface quality. Further still, the porous bristles  408  or porous bristle covering  409  in various embodiments according to the present invention may further be constructed of conventional or microfiber materials that are not limited in material fiber and include synthetic fibers such as olefin including polyethylene and polypropylene, polyester, polyamide, and like materials, reclaimed fibers such as rayon, dacron, nylon, teflon, and the like, and natural fibers such as cotton and like materials, for example. In addition, those materials are not limited in manufacturing method and include nonwoven materials manufactured by publicly known processing methods such as a spun lace method, a spun bond method, a thermal bond method, a melt-blown method, a needle punch method and like methods. In addition, woven or mesh materials may be employed, using molded meshes, or woven meshes or fabrics using conventional weaving, spinning, or electrospinning techniques. 
     In those embodiments of the present invention in which a solid or tubular bristle core  411  is employed as shown in  FIG. 4C , the solid or tubular bristle core  411  may be constructed of any natural fiber or synthetic fibers comprising any commercially available polymer or plastic resins, including but not limited to, Ultra High Molecular Weight Polyethylene (UHMWPE), High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE), Very Low Density Polyethylene (VLDPE), Polypropylene (PP), Ethylene Vinyl Acetate (EVA), Polystyrene (PS), Epoxy Glass, and Phenol Glass, or co-polymers, co-extrusions, or blends thereof. Alternately still, the solid or tubular bristle core  411  may be constructed of any metals, metal alloys, fiberglass, or any composites of any aforementioned materials. 
     The advantages and purposes of the porous bristles  407  in various embodiments according to the present invention as shown in  FIGS. 4D-G  may include, but are not limited to, providing a gentle but minimally abrasive contact surface for interdental mechanical cleaning, providing an absorbent cleaning surface at the interdental interface to allow removal of dental plaque, material alba, or bio film on the tooth surface or below the gingival margin, or any other material or other debris therein, and providing an absorbent interface that may be used to deliver desired pharmacologic or other active agents to the targeted interdental space, and providing a means through the longitudinally continuous lumen  405  of either instilling such desired pharmacologic or other active agents and/or a means of applying negative or positive pressure to the porous bristles  407  to further aid in cleaning those spaces of debris or plaque. 
     In  FIGS. 4A-4G  herein, the porous bristles  407  are shown as rounded structures in exemplary embodiments of the present invention. The present invention, however, is not limited to any specific cross-sectional shape for the porous bristles  407 . In various other embodiments of the present invention, the porous bristles  407  may be rounded, elliptical, triangular, rectangular, square, polygonal, irregular, or any other geometric configuration in their cross-sectional shapes. 
     For example, the longitudinally continuous lumen  405  of a toothbrush  400  according to the present invention may be used as an inter-proximal delivery system for whitening rinses and gels, as well as antimicrobial and fluoride oral rinses to the teeth and surrounding gingival tissues. In various embodiments of the present invention, the longitudinally continuous lumen  405  may be connected to an external source in order that such desired pharmacologic or other active agents including, but not limited to, antibiotics, antiseptics, anesthetics, and astringents, may be delivered to the porous bristles  407  through the one or more bristle ports  406  at the time of delivery, or the toothbrush  400  may be manufactured and provided with an internal supply source [not shown in  FIGS. 4D-G ] of such desired pharmacologic or other active agents that may be dispensed though the longitudinally continuous lumen  405  in a ready for use manner. 
     As a further example, the longitudinally continuous lumen  405  of a toothbrush  400  according to the present invention may be used as a means of delivering positive or negative pressure from an external source [not shown in  FIGS. 4D-G ] to the porous bristles  407 , thus allowing to displace and/or attract and retain plaque and debris from the interdental spaces for enhanced cleaning effects. 
     The descriptions of the various exemplary embodiments of the present invention as presented herein are not to be construed in any way as imposing limitations upon the scope thereof. On the contrary, it is to be clearly understood that resort can be had to various other aspects, embodiments, modifications, and equivalents thereof which, after reading the description herein, can suggest themselves to one of ordinary skill in the art without departing from the spirit of the present invention or the scope of the appended claims. 
     Further, it is to be understood that this invention is not limited to specific materials, agents, or other compounds used and disclosed in the invention described herein, including in the following examples, as each of these can vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects or embodiments and is not intended to be limiting. Should the usage or terminology used in any reference that is incorporated by reference conflict with the usage or terminology used in this disclosure, the usage and terminology of this disclosure controls. 
     Although the foregoing examples of embodiments of the present invention have been described in some detail by way of illustration and example for purposes of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be practiced within the spirit and scope of the present invention. Therefore, the description and examples presented herein should not be construed to limit the scope of the present invention, the essential features of which are set forth in the appended claims.

Technology Category: 1