The inventors' official us application and/or PCT counterpart of us provisional application s.n.60/423,539 entitled "oral hygiene system, dosage package and method" filed on day 11/4 2002, as claimed under clause 119 and related treaties of the federal code 35.
Background
"halitosis" or "oral malodor" refers to a variety of oral conditions ranging from episodic halitosis ("coffee breath") to malodorous breath related to chronic periodontal disease. The current method of treating halitosis is to use a commercially available prescription-free liquid mouthwash (mouthrinse) to achieve temporary breath freshening.
There are two major and predominant types of mouthwashes: one is of the boric acid type, such as Listerene * (trade mark of the company vener) or its general equivalent; the other is of benzoic acid type, such as Scope * (trade mark pro & Gamble) or its general equivalent. Boric acid types include boric acid, thymol, eucalyptol, alcohol, and various colorants, flavorants, carriers, sweeteners, and preservatives. Boric acid, thymol and eucalyptol produce a "burning" sensation and an unpleasant taste. The benzoic acid type has become a strong competitor to the boric acid type of mouthwash because it produces only a slight, if not an imperceptible, burning sensation and tastes better.
However, popular mouthwashes focus primarily on aromas. In fact, popular mouthwashes have a short "rinse" time of only 10-30 seconds, and lose most of their efficacy after a few minutes. In addition, consumers are generally unaware or aware that popular mouthwashes are relatively acidic below ph 5.5. It is known that tooth enamel demineralization occurs below this pH, see Pontefract h. A clinical study, J.Clin periodontics, Vol.28, No. 4, 391-324 (4 months 2001). For example, popular mouthwashes have a pH of 4.3(Listerene *) and 5.4(Scope *). In addition, popular mouthwashes contain about 14-28% alcohol (Scope *: 14-16%; Listerene *: 26-28%), and therefore require a child-resistant cap to prevent children from alcoholism.
Halitosis-causing bacteria multiply on the tongue, between the teeth, in the longitudinal sulcus (periodontal space) between the roots of the teeth and the gums. Irrigation methods such as filament, resin toothbrush or water stream are used to clean between teeth, while tongue brushes are used to clean the tongue. However, this physical effect is only partially effective and residual bacterial plaque remains. Furthermore, such cleaning activities cannot be performed in public places or during sports, and one reality is that bad breath can occur during work, such as after break-time or after lunch. Listerene * "gel strips", breath freshening candies (Eclipse * of Wrigley), high intensity flavored candies (Binaca *), and "candy" -type tooth freshening strips (Tic-Tacs * by Smith-Kline Beecham, or Aqua-fresh freshening strips) are directed to this reality. However, they are not highly perfumed breath malodor masks, but are used to simply stimulate saliva, thereby rinsing the mouth. In addition they are not oriented where the most treatment is needed.
Thus, there is a real need in the art for a fully effective oral hygiene agent delivery system and method of treating oral conditions such as bad breath that is simple, inexpensive, highly portable, ready to use, aimed at the site where the agent is needed, provides long agent delivery times, and does not interfere with or limit activities of daily living. The present invention meets these needs.
Disclosure of Invention
The present invention is a novel oral hygiene product for the consumer market with the advantages that are significantly superior to the currently popular mouthwashes. The system and method of the present invention includes a disposable applicator roll that can be inserted between the teeth and the cheek with the tongue or fingers. It slowly delivers the drug solution directly to the critical target site, the tiny "sulcus" and the spaces between the teeth, both of which are the primary fouling sites for the bacteria responsible for bad breath. The medicated roll can be kept at the action position for more than 5-30 minutes, does not cause discomfort, and does not influence normal activities such as speaking or rotating and the like. Preferably, an alcohol-free antimicrobial solution is used, preferably having a pH of greater than 5.5, more preferably from 5.5 to 8.5.
The inventive medicated cotton rolls are a novel "platform" for delivering topical oral medications to treat various periodontal conditions, such as halitosis (bad breath), gingivitis, acute necrotizing ulcerative gingivitis (angg), and dry mouth. The cotton roll medicament delivery system can be used for accurately positioning, prolonging the physiotherapy time and enabling the medicament to be more effective. The medicated cotton rolls also act through the cheek muscles to produce a gum massaging effect, which opens the sulcus recess to introduce the medicament. This will produce saliva, a natural antimicrobial agent that is believed to be effective.
The system of the present invention is aimed at being less and more precise. That is, a small amount of antimicrobial is applied where needed, which is more effective than a full mouth rinse used only for a short period of seconds, which is virtually ineffective for long-term physical therapy. An important advantage of the system of the present invention is that the user is still mobile and talking while the medicament is being applied to the gingival area. The user may insert the roll on the way to a meeting, for example requiring 5 to 20 minutes of transit time, then board a bus, make a call along the way, and simply dispose of the used roll (in a resealable sachet) upon arrival, as he/she would do with chewing gum.
The oral antimicrobial and agent delivery system of the present invention is both a method and an apparatus for slowly releasing a treatment fluid (agent/antimicrobial) or gel into the oral cavity. In the main example, the device has a cotton roll with a diameter of 3/16 inches to 7/16 inches and a length of 1 inch to 2 inches, dipped or impregnated with a pharmaceutical composition, such as an antimicrobial solution, for the treatment of halitosis, gingivitis, angg (acute necrotizing ulcerative gingivitis), chronic periodontal disease, and other oral disorders. In various applications, the rolls may be impregnated with various medicaments and analgesics for delivery to the buccal mucosa and gums. Examples include: for the former, antibiotics are used to help physical therapy of oral infections and diabetes; for the latter, local anesthetics such as xylocaine, benzocaine or eugenol can be impregnated to treat the baby's deciduous teeth and toothache until the dentist is visited or oral surgery is performed.
The mouthwash rinses the tongue and lower jaw more than the upper jaw, with only a few seconds of contact. In most bad breath, the main source or stain is the maxillary sulcus, not the mandible. In contrast, the medicated roll of the present invention may be placed in the upper buccal vestibule from which the treatment solution is gradually released to directly reach the upper longitudinal sulcus and between the upper teeth, thereby rinsing the tongue and lower jaw downwardly. A typical cartridge may be left in the mouth for 10-20 minutes before the dose is exhausted.
It will be appreciated that conventional mouthwashes may be used as a treatment solution in the delivery platform of the present invention. Surprisingly, in actual testing, the benzoic acid based mouthwash delivered to the buccal vestibule using a stick did not develop a burning sensation. That is, the boric acid mouthwash can be delivered to the upper and lower buccal vestibules via the rolls for a period of time of 20 minutes or more without the usual burning sensation.
The preferred cartridge materials are natural fiber and cotton, sterilized prior to packaging. For rolls intended for adults, the rolls are "open-ended". I.e. they have a thin cotton covering or filament braid around their periphery, but not at their ends, because they are cut from a long roll. In addition, soluble fibers, such as oxidized fibers or some type of polymer that is readily biodegradable or enzymatically degradable, may also be used. Similarly, a plurality of small "pellets" wrapped in a porous coating after the "mechanical" (structural) redesign of the roll may be used. Even if such a roll is ingested, the polymer coating is degraded by gastrointestinal enzymes, but no enzymes are present in the saliva, so that the coating can disintegrate in the gastrointestinal tract and the pellets can easily pass through the intestine. In another design for children, shorter rolls may be used. The roll is impregnated with a local anesthetic liquid or anesthetic to anesthetize the gum area afflicted with dental caries during toothache. The child bites the roll or places it on the inflamed gum area. In this case, the rolls should be durable and the ends should be completely covered.
In the oral agent delivery system of the present invention, a plurality of treatment cartridges, each having a width of 1.75 inches to 2.25 inches and a length of 2 inches to 3 inches, are packaged in plasticized paper or foil pouches with resealable seals and a tear strip. Each packaging bag can contain 2-4 cotton rolls, and the dosage of the physiotherapy liquid medicine of each cotton roll can reach 1-3 ml. The agent delivery system of the present invention can be readily adapted for use with a variety of product types, such as, for example, 1) consumer-oriented impregnated rolls of agents targeted for the oral malodour (halitosis) treatment market; 2) consumer or prescription-specific medicated rolls targeted to the market for physical therapy of specific periodontal diseases and conditions, such as dry mouth; pre-and post-operative oral surgery physiotherapy; angg (acute necrotizing ulcerative gingivitis); and 3) consumer or prescription specified caries control rolls, targeted to the children and teenagers market. For the class 1 and 2 product types of drug delivery systems described above, the drug-impregnated rolls can also be used to carry various medications and over-the-counter medications, such as topical oral solutions containing antibiotics (for the treatment of a range of severe periodontal infections associated with type 2 diabetes); chlorhexidine; quinones; aloe vera extract or gel; a ferment; zinc compounds (for the treatment of colds and bad breath caused by watery nasal discharge); fluorine compounds such as tin fluoride (less than about 1.2 ppm) are used to inhibit plaque formation and the associated tooth decay and halitosis, and to treat xerostomia (dry mouth), thereby enhancing remineralization of tooth enamel; anti-inflammatory agents; analgesics, anti-caries agents, and the like. Other applications include to prevent or mitigate: anterior gingival plaque concentration and associated caries, gingival infection and gingivitis; periodontitis; periodontal diseases; aphtha, herpes (cold-like pain/fever blisters type 1). The permeability characteristics of the vestibular mucosa (buccal and gingival mucosa) are unique, and physical therapy gels and medical solutions can be tailored to take advantage of these unique characteristics.
The preferred form of the product system of the present invention is to package 4 cartridges in a resealable sachet of the size of each shirt pocket, 30-60 bags per case (1-2 month supply). The packaging bag is easy to manufacture at high speed according to the packaging requirements of food standards or cosmetic standards (aseptic). The pouch is a standard and commercially available bag (2 inches wide by 2-2.5 inches long with or without reinforcing tabs) that can be mass produced on a conventional resealable zipper-type pouch machine. The open sealed side and zipper-type reseal side of the pouch were lowered (i.e., plugged to the bottom of the opening) and 4 rolls were inserted into the opened pouch. Next, a selected aliquot of the medication or treatment solution or gel is dispensed to the rolls in the pouch and the bottom edge is heat sealed. The opening sealing edge at the top end is provided with a notch which can be conveniently torn by hand. The sealed bag has a unique appearance of 'top grade', and the size of the packaging box can ensure the use amount of the sealed bag for 1-2 months. Other packaging forms are: setting punctuation so as to facilitate sales counter salespeople to 'unpack' for retail; and holes are punched at the upper part so as to facilitate the 'hanging' sale.
During filling, the pouch is preferably evacuated of air by an inert gas (e.g., nitrogen) which is passed between a pair of spaced apart rolls to force excess nitrogen out of the pouch as the bottom is heat sealed. The rolls are highly absorbent and the amount of medicament is selected and controlled to ensure that there is no excess liquid or gel in the pouch, so that the bottom surface of the pouch remains dry for sealing.
The consumer tears the top seal open the zipper seal, removes one or more rolls, places them on his/her tongue, and pushes them into the buccal vestibule. The user can make a call, continue dressing, talk, walk, sleep and even eat while holding the cotton rolls. The time can be as long as 30 minutes to more than 1 hour without discomfort. The cheeks muscles flatten the rolls to form a comfortable oval shape, and in most cases, the outsiders do not perceive that the user's mouth contains rolls.
One particularly useful embodiment of the drug delivery system of the present invention is: a more neutral liquid medicine with a pH value of about 5.5 to 8.5 is adopted to remove the corrosion effect of the mouthwash with a low pH value. When saliva enters the mouth, which has been acidified by soda, sweet and popular rinses, the calcium and phosphate in the saliva create an acidified condition, resulting in the formation of calculus (tartar). This will accelerate calcification of existing plaque bacteria. In liquids with higher pH, stone formation can be limited. In addition, the massaging action of the rolls accelerates the flow of saliva, thereby helping to flush soda water and plaque acids.
Detailed Description
The following detailed description refers to examples, but does not limit the scope or principles of the present invention's method and apparatus, dose pack and packaging system for treating oral conditions. One skilled in the art will appreciate the present invention and be able to use the physiotherapy method of the present invention without undue experimentation to treat a variety of conditions and to design various equivalents and other packaging systems for use with the dosage package of the present invention using other conventional packaging methods and modes.
Fig. 1 shows a pocket-sized portable enclosure 10 of the present invention comprising a water-tight enclosure containing 2 to 4 disposable rolls 26a-26d of antimicrobial solution or gel in a compartment 24. The pouch has a strip 12 which is torn to reveal a resealable bead 20. In tearing open the edge strip, a starting notch 14 and an apertured or other type of opening line 16 may be used. The opening line may also be a line of weakness and tear, or a foil line, string or other type of opening pull. The resealable bead portion may be of any suitable sealing form, such as a built-in snap bead and groove arrangement of the Zip-Lock * type, a resealable press-type adhesive tape, or the like.
The package is preferably a plastic, metallized plastic or laminated paper package comprising an outer layer of paper having an inner layer of plastic. Any suitable material that is impermeable to water and alcohol may be used, but the outer surface of the pouch material should be printable to carry the product name and instructions for use. In a simple form, the envelope 10 may be made of 4 mil printable polyethylene material, but may also be made of two or more layers of impervious and air-tight packaging plastic, metalized plastic, or plastic-coated or laminated paper. Typical film thicknesses are 1-5 mils.
Those skilled in the packaging arts can select the pouch material to suit the desired properties. For example, shelf life; a sanitary state; transparency; mechanical strength; inner printing (printing on one layer of the transparent laminate); sealability; permeability, and the like. Suitable reinforcing films may be of nylon or PET material, or of a polyolefin (such as PE, polyethylene or PP, polypropylene) film reinforced with PET, or of PET/vinylidene chloride/LDPE or HDPE film (PET is a polyethylene terephthalate and Mylar * is a commercially available metallized PET film, produced by dupont and well suited as packaging material). When the rolls 26 are loaded into the pouch 10, the pouch is opened at the bottom and inverted upwards, the rolls are inserted and the dosage solution is introduced, and the bottom is sealed along line 22.
The size of the pouch of the present invention is about 2 inches by 2.5 inches and the rolls 26a-26d are each about 1.5 inches long and have a diameter of 3/4 inches to 3/8 inches. The web material should be of medical quality and cleanliness, be sterile, have good rapid moisture absorption, and be able to hold the selected liquid or gel. A plurality of pouches are placed in a single box, for example, each box containing 10-30 pouches or pouches, the box being of the size: about 2 * inches to 2.vz inches in width, about the same height as the pod and about 4.vz inches to 7 inches in length (about the size of a tea box). Other packaging configurations are apparent. Packaging configurations are fully feasible, such as size, shape, or antihistamine or throat pack of the case. In addition, the packaging bag can be placed in a plastic bag with hanging holes or a marking card container with hanging holes. The pouches can be connected to each other in a string, separated from each other by lines of perforations, and folded into a fan shape.
Fig. 2 shows two embodiments of a lap 26 that can be used in the present invention. The roll 28 shown in fig. 2A is encased in an outer cotton, paper or polyester/rayon fabric or non-woven layer 30. Further, the outer layer may be any microporous plastic layer. Fig. 2B illustrates a presently preferred embodiment in which a roll having a diameter of 5/16 inches is contained or contained within a thin cotton thread or plastic filament braid 32, the cotton fibers of the roll having a length of 1.5 inches. This preferred embodiment is referred to as a "knitted roll" and uses nylon and acetate knitted filaments. Both embodiments of the rolls are commercially available from dental pharmaceutical companies.
While it is presently preferred to use cotton in its pure natural form, any suitable fiber-or roll-form polymer that is capable of absorbing and releasably impregnating a medical fluid or gel may be used. For example, cotton and certain polymers may be chemically treated to contain hydrogen-bonded or covalently-bonded radicals that have an antibacterial or anti-corrosive effect. Due to the presence of the outer layer 30 or the braided filaments 32, the roll will retain its overall shape until and during use, until it is disposed of. After use, the rolls can be removed from the mouth, but the roll lint or threads do not remain in the mouth and become trapped, entangled, and packed between or on other parts of the teeth.
As shown in fig. 2, the end of the roll 26 is cut transversely into a section 34 with the core exposed. However, the outer layer 30 or the braided layer 32 may also be folded or gathered and sealed at the ends to completely encase the absorbent core. One solution to reduce cost is to omit the outer layer, although pure cylindrical (or other prismatic shape) rolls without a cover layer can be used, but this is not preferred because the roll mass and the threads tend to fall off. The gel-like chemical helps maintain the integrity of the roll, but in practice, it is preferred to use an outer layer 30 or a braided layer 32 as shown in FIG. 2B.
Fig. 3 is an isometric view of a pouch 10 used in the present invention. After tearing and removal of edge strip 12 along line 16, reseal 20 is accessible and after opening it, four impregnated or saturated rolls of braided medicated tissue 26a-26d are accessible. If only two rolls are required, then two are removed and inserted into the opening and the seal 20 is snapped into the channel to reseal the pouch. The packaging bag may then be placed back into a purse or pocket, such as a pocket of a shirt or coat, for the next use. The used rolls can be resealed in the pouch and then thrown away into a trash receptacle.
Figure 4 shows the placement of the cartridges 26a-26d of the present invention. Rolls 26a and 26b are placed in the upper buccal vestibules 40a and 40b adjacent the upper molars 44 and impregnated rolls 26c and 26d are placed in the lower vestibules 42a and 42b, respectively, adjacent the lower molars 46. By gently squeezing the cheeks, the treatment solution or gel is released from the roll and the solution flushes the adjacent gums, sulcus and teeth, which is precisely where it is most needed. In addition, lateral pressure on the cheek forces the flow of the liquid between the teeth. Sufficient medical fluid is released to enter the mouth 50 where it washes the mouth and tongue 48. The massaging action of the buccinator muscles opens the longitudinal channels 52 and allows the liquid medicine to enter therein.
For the liquid medicine or gel, two kinds of gargle liquids of benzoic acid (Scope * type) and boric acid (Listerene * type) can be used. Suitable roll-on medicaments in liquid, gel or dry form may include one or more of the following active ingredients: thymol; eucalyptol; aloe vera; methyl salicylate; menthol; alcohol (ethanol); benzoic acid; sodium benzoate; boric acid; citric acid; calcium lactate; cetylpyridinium chloride; tetrasodium pyrophosphate; ammonium benzenedimethane chloride; domiphen bromide; sodium benzoate; eugenol; eucalyptus essential oil; clove oil; dichlorophenoxy chlorophenol; chlorhexidine and chlorhexidine gluconate; sodium hypochlorite; sodium stannate; hydrogen peroxide; a carbamide peroxide; garlic formulations (e.g., Garlique *); (ii) an antibiotic; zinc-containing compounds and complexes, such as zinc gluconate or zinc chloride; chlorine dioxide; fluoride ion-providing compounds such as sodium fluoride; enzymes and enzyme compounds; copper gluconate and other suitable antimicrobial agents; and oral and throat care compounds and formulations. Examples of effective enzyme-based antimicrobial systems may include one or more of lysozyme, lactoferrin, glucose oxidase, lactoperoxidase, and the like. Analgesic compounds are also useful in pharmaceutical compositions, including: aspirin; methyl salicylate; acetylaminobenzene; sodium naproxen, and the like; local anesthetics such as xylocaine, benzocaine, eugenol, and the like. Likewise, various natural herbs, essential oils or extracts having antimicrobial or other physical or therapeutic properties may be used as the active ingredient in appropriate amounts, such as: aloe, resveratrol, naphthoquinone, juglone, 7-methyljuglone, pindus indica, etc. The active ingredients may be present in any form: carrier, gel and dry agent. The effective weight, volume or mole percent of the active ingredient is well established and can be determined by those skilled in the art.
Further, suitable carriers, colorants, fragrances, and vehicles are, for example, but not limited to: water; deionized water; poloxamer 407 (poloxamer); polysorbate 20 and 80; tween 20; potassium sorbate; disodium hydrogen phosphate; sodium benzoate; sodium chlorate; sodium citrate; sodium lauryl sulfate; polyethylene ditolun 40; hydrogenated castor oil; a silicone emulsion; citric acid; calcium disodium poor dentate; menthol; cocoamidopropyl betaine; sodium saccharin; isomalt; mannitol; lactitol; acesulfame potassium; magnesium stearate; sorbitol; xylitol; glycerol; a saccharide; saccharin; propylene glycol; a carboxymethyl cellulose; hydroxyethyl cellulose; calcium lactate; aloe vera; natural flavors such as peppermint, peppermint oil, cinnamon, and clove; hydrogenated starch hydrolysate; thickeners, such as xanthan gum and the like, can be used as special, pleasant or improved flavoring and texturizing agents and can also be used to enhance mouthfeel (organoleptic) characteristics and color. In addition, the packaging or/and the rolls or solutions/gels used may be color coded to distinguish different ingredient mixtures, intensity levels and types or frequency of use.
Figure 5 shows a typical consumer packet, a box 54 containing 10-50 packets, typically 10 packets, and typically 20-30 packets. The box may be wrapped with a clear plastic or adhesive film. More than 2 boxes may be packed together at the time of sale or inventory.
Fig. 6 shows the flow of an exemplary packaging system and process for filling rolls into pouches, and also shows the process of filling pouches into consumer distribution boxes. The packaging station 60 includes a roll hopper into which sterile dry rolls of cotton are placed. The hopper may resemble a cigarette packer. When the rolls are placed, their axes generally coincide with the sides of the hopper, and they are "discharged" into the dispensing station by the bottom ramp. The hopper may include a timed rotary incremental metering wheel with a gripper thereon for aligning and bringing adjacent groups of 4 rolls. A slight upward flow of air can be used to separate the individual rolls or groups of 4 rolls. Alternatively, a vacuum conveyor, such as a Coanda induction vacuum hoist, may be used to pick individual rolls from a conveyor belt or other conveyor, or groups of 2-4 rolls at a time, and deliver them to the dispensing station 62.
The dispensing station 62 is equipped with tools for bringing the 4 rolls into position so that they are inserted into an open enclosing bag (see filling station/step 66 below). For example, the tool may "bunch" four rolls with their axes parallel to form a diamond or circular cross-section to reduce the size (cross-section) for "packing" into a pouch. In addition, since the rolls are slightly compressible, they can be side-by-side 4 and then squeezed together for insertion into the pouches. Those skilled in the packaging and materials processing arts can readily provide suitably shaped hoppers and pushing devices.
At the same time, the preformed and preprinted pouches are continuously fed on reels at the pouch roll station 64. The pouch is provided with a "zipper" and a pre-formed tear-open seal (as shown in figures 1 and 3) is provided on the upper portion of the zipper. In this example, each pouch is 2 inches wide and about 2 and 3/8 inches long, with about 1/2 inches of spare length for the zipper (20 in FIG. 1) and with portions for the upper seal (12, 14, 16 in FIG. 1). In addition, a section of about 1/8 inches was provided for the bottom seal, which was performed in the packaging station 70. The bottom of the pouch (22 in fig. 1) is open (not sealed) and the pouch is inverted in the filling station 66. The bag material is preferably a reinforced plastic film having an outer printed surface which is resistant to ingress of oxygen and carbon dioxide gases, as well as to egress of water vapor, alcohol and nitrogen. The continuous stream of pouches dispensed by the packaging station 64 is delivered from a reel on a post-tensioning spool to a pouch filling station 66.
At the filling station 66, the end of the stream of pouches is held by a moving finger or opposing compression roller or traction drive to allow the pouches to pass through the filling station. In this station, the bottom of the envelope is opened by one or more mechanical devices, pneumatic devices (air or nitrogen gas flow), or by vacuum cups or vacuum suction devices. After opening, the roll dispenser of the dispensing station 62 inserts groups of 4 rolls into the open end of the pouch and holds the rolls by a pusher arm as the tool is withdrawn. The push strip also holds the pouches open to facilitate dispensing of the liquid medication to the rolls in the pouches in the next step, at the dispensing station 68.
A specific amount of a liquid medication for treating bad breath, such as 6-10 milliliters of an antimicrobial agent, is dispensed to the rolls in each pouch using an automatically adjustable dispenser in the dispensing station 68. The dosage is generally as follows: for all rolls, 4-12 ml were dispensed simultaneously, and for the exposed end of each roll, 0.75-3 ml were dispensed toward the center of the shaft. The metered dose of liquid medicine is rapidly absorbed by the roll and retained therein by capillary action. A small amount of nitrogen is introduced into the open pouch to vent air and create an inert atmosphere within the pouch.
The filled pouches are fed to a sealing station 70 where they are fed or lowered between rolls or onto a tractor drive which compresses the pouch edges, thereby forcing out excess nitrogen and gathering the 1/4 inch upper bottom edges of the pouch edges together for sealing. The compression edge is positioned near the roller part to ensure that the liquid medicine does not enter the sealing area. Stations 68 and 70 may be combined into one station. After the pouches are sealed in the sealing station 70, the pouches are cut from the continuous web stream by a sharp cutter positioned above the top seal, and the filled and sealed pouches are then transferred to a storage station 72.
At the deposit station 72, the transferred pouches are grouped in sizes appropriate for the consumer package (54 in FIG. 5) and transferred to a box filling station 74 where they are loaded into the box, which is then closed and sealed or wrapped with clear plastic or film. At the packing station 76, the boxes are stacked together and loaded into shipping boxes. The box packing stations 74-76 may be combined into one station, or 72 and 74 may be combined into one station, and packing may be performed automatically or manually in the packing station 76.
In another packaging method, the cotton rolls may be impregnated or saturated with the selected treatment solution prior to being placed in the pouches.
Industrial applicability
Mouthwashes have a worldwide market, ranging in age from 15 to over 80 years. In the united states, this market has annual sales in excess of billions of dollars and is growing at 3-4% per year. In contrast to commercially available mouthwashes, the rolls of the present invention provide a directed antimicrobial agent directly to the site of greatest need for an extended period of time. The drug delivery system of the present invention has real potential to significantly improve periodontal health, and is particularly suitable for children and adults with long-term halitosis, gingivitis, angg (acute necrotizing ulcerative gingivitis), and similar periodontal diseases. Various proprietary oral hygiene solutions can be used; of particular utility are oral hygiene solutions having an enamel-free pH, low or no alcohol, and better antimicrobial efficacy.
Good oral hygiene practices such as normal brushing and scrubbing should not be abolished. However, the rolls of the present invention are effective in the presence of signs of halitosis.
Other advantages of the invention are:
where desired, more targeted and focused application;
long drug effect time and better effect;
portable, light, not easy to damage, not spattered, disposable outer package;
the user is fully active in physiotherapy;
it is particularly effective in the case where the user cannot brush and scrub during travel, long meetings, or the like, or in other cases, and in the case where bad breath is caused by food/drink;
by squeezing the cheeks, the liquid or gel can enter the mouth and tongue, thus allowing a more gentle and prolonged physical therapy without burning sensation;
larger doses of the drug may be used, which in conventional techniques may be uncomfortable or may cause burning on the tongue;
the liquid medicine can be selected according to the desired physiotherapy: halitosis medicinal liquid, antimicrobial agent, and medicinal liquid for throat part for common cold and throat swelling and pain;
the pouches are easy to manufacture and fill, and can be printed, manufactured, filled, and packaged as boxes or pouches for distribution using current packaging techniques.
It will therefore be appreciated by those skilled in the art that the present invention provides a particularly effective consumer product in a variety of forms. Indeed, any commercially available mouthwash, mouth rinse, and oral hygiene solution may be used as the agent for the roll-form agent delivery system of the present invention, including but not limited to: listene * and Store Brand Equivalents; scope * and Store Brand Equivalents; act * (Johnson & Johnson); plax * (fevery); breath Remedy * (DenTek, USA); biotene * antibacterial enzyme system (Laclede corporation); PreventionTM periodontal and orthodontic mouth rinses; advanced Breath Care * (Arm & Hammer); cepacol *; targon *; peridex *; colgate Phosflur *; colgate peroxide *; florigard * (Colgate); therabreath *; oragel periodic *; BreathRx (Discus Dental); peridex *; periodgard *, and the like.
The recommended unit dose for popular mouthwashes is 20 ml, so 1 liter can provide 50 servings and 1.5 liter can provide 75 servings. In contrast, the unit dose of the cartridge system of the present invention requires only 0.75-3 ml, 4-12 ml portions, which is 40-80% lower than popular mouthwashes, with the same or better results.
It will be appreciated by those skilled in the art that various modifications may be made within the scope of the invention without departing from the spirit thereof and without undue experimentation. For example, the physiotherapeutic agent need not be completely soaked in the cartridge, but only soaked (less than the soaking amount), and the agent may be in a dry state, in which case saliva in the mouth may produce a wetting and dissolving effect over a period of time, thereby better controlling or delaying the release of the agent. The invention is defined by the scope of the claims, not to be restricted by the prior art, but to include all equivalents thereof available now and in the future.