WO2005117740A2

WO2005117740A2 - Digital wipes and method of handling

Info

Publication number: WO2005117740A2
Application number: PCT/US2005/018518
Authority: WO
Inventors: Ray A. M. D. Wagner
Original assignee: Dr Products, Llc
Priority date: 2004-05-26
Filing date: 2005-05-25
Publication date: 2005-12-15
Also published as: IL179591A0; WO2005117740A3; ZA200610649B; EP1768512A2; US20050262655A1

Abstract

A new and useful digital wipe structure, and method for handling the wipe structure, are provided that is particularly useful in forming and handling a an oral wipe to clean teeth and gums, especially a young child’s teeth and gums. A digital wipe structure comprises a piece of material impregnated with an oral therapeutic solution and configured to be wrapped completely about a user’s index finger to provide a sleeve about the user’s index finger. The wipe structure is further configured so that when wrapped about a user’s index finger an outer portion of the sleeve is oriented so that pressure from the user’s thumb will hold stabilize the sleeve and maintain the sleeve on the user’s index finger, preferably against the middle or distal phalanx. The digital wipe structure can form an oral wipe that can be efficiently produced and easily handled by a user to produce a wipe that is impregnated with an oral therapeutic solution and can be formed into a sleeve that can be effectively stabilized on a user’s finger (preferably against the middle or distal phalanx), and effectively used to clean a person’s teeth and gums. Moreover, a preferred wipe can be folded into a pattern that enables the wipe to be effectively packaged, and effectively unfolded and formed into a sleeve that can be stabilized on a user’s finger, despite the fact that the wipe is impregnated with an oral therapeutic solution.

Description

Title: Digital Wipes and Method of Handling

Inventor: Ray A. Wagner, M.D.

Related Application/Claim of Priority

This application is related to and claims priority from Provisional Application Serial Number 60/574,515, filed May 26, 2004, and entitled Digital Wipes and Method of Handling, which provisional application is incorporated by reference herein.

Background

[0001] The present invention relates to a new and useful digital wipe structure, to a method of handling a wipe structure, and particularly to an oral wipe that can be simply produced and effectively handled to clean the teeth, gums, tongue, and oral mucosa. In addition, the present invention provides an oral digital wiping process, that provides a new and useful technique for accurately delivering an oral therapeutic material to the oral cavity.

[0002] In applicant's experience as a pediatrician, there has been a need to provide a simple and effective way of cleaning the teeth, gums, tongue, and oral mucosa, especially in young children. However, applicant has also learned of a number of issues that have to be confronted in the design of an oral wipe for such purposes. For example, US Patent 6,721,987 describes a number of issues that have to be addressed in the design of an oral cleaning device for removing films and residues (e.g. plaque) from a person's teeth. . The patent describes the inconvenience often associated with carrying a toothbrush, and finding an appropriate facility in which to use the toothbrush. Moreover, the patent describes issues involved in designing a dental wipe as an alternative to a toothbrush, e.g. designing a dental wipe that can be effectively maintained on a user's finger without slippage, as well as the need to efficiently manufacture the dental wipe. Applicant further notes that such issues are particularly applicable to an oral wipe that is impregnated (effectively saturated) with a mouth rinse solution, and intended to be used to clean the oral cavity, and in the process to physically remove retained food particles as well as biofilms such as dental plaque while simultaneously applying therapeutic substances such as antimicrobial agents, as well as other therapeutic substances, to the teeth, gums, tongue, and oral mucosa..

[0003] In addition, in applicant's experience, existing methods for delivering an oral therapeutic material to the oral cavity for preventing and treating various oral disease conditions including dental caries, dental discoloration, gum disease, teething pain, oral pain, and oral thrush can also be significantly improved upon, through a delivery system that utilizes a digital oral wipe to more precisely deliver the therapeutic material to the mouth. In this application, reference to an "oral therapeutic material" means a material that is applied to any or all of a person's teeth, gums, tongue and oral mucosa (e.g. the soft tissue inside the person's cheek). The oral therapeutical material would include any or all of (i) a mouth wash, preferably with a non cariogenic or anti cariogenic material, (ii) an antimicrobial material, e.g. an antifungicide, or an antibiotic material, and (iii) an anesthetic material. Reference to an "oral therapeutic solution" means a solution that includes an oral therapeutic material.

Summary of the Invention

[0004] The present invention provides a new and useful digital wipe structure, and method for handling the wipe structure, that can be used to form an oral wipe that is efficient to produce and effective to clean the oral cavity, including the removal of dental plaque and biofilms from the teeth, gums, tongue, and oral mucosa.

[0005] In addition, the present invention provides a digital wiping process, particularly for the oral cavity, that provides a new and useful process for delivering an oral therapeutic material to the teeth, gums, tongue, and oral mucosa .

[0006] A digital wipe structure according to the present invention, when formed as an oral wipe, comprises a piece of material impregnated with an oral therapeutic solution, and configured to be wrapped completely about a user's index finger to provide a sleeve about the user's index finger. The digital wipe structure is further configured so that when wrapped about a user's index finger an outer portion of the sleeve is oriented so that pressure from the user's thumb will hold and stabilize the sleeve and maintain the sleeve on the user's index finger. The digital wipe structure is then in a condition to accurately and effectively apply wiping pressure and an oral therapeutic material to a localized area, particularly an area where accurate wiping pressure and/or application of an oral therapeutic material is desirable or necessary.

[0007] An oral wipe according to the present invention can be efficiently produced, and effectively handled by a user to form a piece of material that is impregnated with an oral therapeutic solution into a sleeve that can be effectively stabilized on a user's finger, and effectively used to clean and apply the oral therapeutic material to a person's oral cavity.

[0008] Moreover, a preferred oral wipe can be folded into a pattern that enables the wipe to be efficiently packaged, and effectively unfolded and formed into a sleeve that can be stabilized on a user's finger, despite the fact that the oral wipe is impregnated with an oral therapeutic solution.

[0009] In addition, the present invention provides a new and useful way of delivering an oral therapeutic material that includes an antimicrobial material (e.g. nystatin) to the oral mucosal surface of a patient, particularly a patient that is affected by oral thrush.

[0010] Other features of the present invention will become further apparent from the following detailed description and the accompanying drawings and exhibits.

Brief Description of the Drawings and Exhibits

[0011] Figure 1 is a schematic three dimensional view of an oral wipe, constructed according to the principles of the present invention;

[0012] Figure 2 is a top view of the oral wipe of Figure 1; [0013] Figure 3 is a side view of the oral wipe of Figure 1;

[0014] Figure 4 is a schematic view of oral wipe according to the present invention, in a folded condition, and disposed in a packet;

[0015] Figure 5 is a schematic top view of an oral wipe according to the present invention, and showing the lines upon which the dental wipe is folded, according to the principles of the present invention;

[0016] Figure 6 is a schematic illustration, showing the manner in which an oral wipe, according to the present invention, can be unfolded: and

[0017] Figures 7-11 are schematic illustrations, showing the manner in which the wipe is wrapped about a user's index finger, according to the principles of the present invention.

[0018] Exhibits A-H are color illustrations of a digital wipe and a method of handling the digital wipe, according to the principles of the present invention (in those Exhibits, some numbering, along the lines of the figures, is provided).

Detailed Description

[0019] As discussed above, the present invention relates to a new and useful digital wipe structure that is particularly useful as an oral wipe, and to a method for handling the wipe, that is efficient to produce and effective to use to clean and apply therapeutic materials to the teeth, gums, tongue, and oral mucosa. The principles of the invention are described herein in connection with a preferred form of an oral wipe, but it will be clear to those in the art how those principles can be used in the configuration and handling of various types of digital wipe structures.

[0020] An oral wipe 100, configured according to the present invention, is illustrated in the Figures 1-11 and Exhibits A-H. The oral wipe 100 comprises a flat piece of material 102 that is configured in accordance with the principles of the present invention and which is impregnated with an oral therapeutic solution. The piece of material 102 can be made from woven or non-woven absorbent material, and is preferably of a cellulosic or synthetic material similar to the type of material that is typically used to form paper towels or synthetic fiber towels. Also, the piece of material can be textured on the side of the material that is intended to rub against the teeth and gums of a child. It has been common for some time to make textured material by texturing a sheet of material so that the material is textured on both sides, but for the purposes of the present invention, it is preferred, but not required, that if the piece of material is textured, it only needs to be textured on the side that is intended to be rubbed against a person's teeth, gums, tongue, and oral mucosa in order to facilitate biofilm removal.

[0021] The piece of material 102 is configured to be wrapped completely about a user's index finger to provide a sleeve 113 about the user's index finger, and is further configured so that when wrapped about a user's index finger an outer portion of the sleeve is oriented so that pressure from the user's thumb stabilizes the sleeve 113 and maintains the sleeve on the user's index finger (preferably against the middle phalanx or distal phalanx of the index finger). Figure 9 (and Exhibit F) show the sheet of material wound into a sleeve about a user's index finger, and stabilized by the user's thumb (against the middle phalanx of the index finger).

[0022] Moreover, the piece of material 102 is preferably configured so that when the sleeve 113 is wrapped about the user's index finger, the sleeve extends at least from the distal tip of the user's finger to a location that is past the middle inter phalangeal joint of the user's index finger (typically the middle inter phalangeal joint is between the proximal and middle phalanges of the finger). Figure 9 (Exhibit F) show the sleeve being wrapped about a user's index finger, with the sleeve extending past the middle inter phalangeal joint of the user's finger (the approximate location of the middle inter phalangeal joint is shown by the dashed line 117).

[0023] As seen from Figures 1-3, 5 and Exhibits B, C, the piece of material 102 preferably has a parallelogram shape. The piece of material 102 has a pair of parallel sides, 104, 106, and another pair of parallel sides 108, 110. Adjacent sides 104, 108 form an acute angle end portion 112, and adjacent sides 106, 110 form another acute angle end portion 114. Each of the acute angle end portions 112, 114 defines an acute angle that is preferably between 40 and 70 degrees.

[0024] In addition, each of the parallel sides 104, 106 preferably has a length of at least 4 inches, and is preferably about 5 inches. Also, the height 115 of the piece of material (see Figure 2,) is at least 2.5 inches, and is preferably at least 2.75 inches. Still further, each of the parallel sides 108, 110 has a length of about 3.5-4 inches. A piece of material that has a parallelogram configuration, with parallel sides 104, 106, acute angle end portions 112, 114 and a height 115 with the foregoing dimensions, can be effectively formed into a sleeve in the manner described herein.

[0025] The parallelogram configuration of the piece of material 102 is particularly useful in facilitating wrapping the piece of material into a sleeve about a user's finger. One of the acute angle end portions 112, 114 can be used as a lead point to initiate wrapping of the piece of material about a user's index finger (see Figures 7-8, Exhibit E, where wrapping is initiated about the finger at the upper end of the illustration) and the other acute angle portion will form a trailing point that overlies the remainder of the sleeve and which can be engaged by a user's thumb to stabilize the sleeve on the user's index finger, preferably against the middle phalanx (see Figure 9, Exhibit F).

[0026] Additionally, the piece of material 102 is large enough that when it is wrapped into a sleeve about a user's index finger, the sleeve can have a distal end 116 that extends past the distal tip of the user's finger (see Figure 9, Exhibit F), where the approximate distal tip of the user's finger is shown by dashed line 119) and can be bent back over the sleeve and captured between the user's thumb and the sleeve, to stabilize the sleeve and maintain the sleeve on the user's finger, preferably against the middle or distal phalanx (see Figures 10, 11, Exhibits G, H). When wrapped and stabilized in this manner, the wipe provides additional surface area that can be rubbed against a person's teeth or gums (or any other part of an oral cavity). [0027] Moreover, while a parallelogram configuration with acute angles is preferred (because it can also produce the leading and trailing ends that are useful in folding and packaging the wipe, as described below), it will be clear to those in the art that the wrapping process described above can also be practiced with a rectangular wipe (with 90 degree rather than acute angles), so long as the dimensions of the rectangular wipe are sufficient to enable the wipe to provide a sleeve with an overlapped portion (Figure 9. Exhibit F), and a distal end portion that extends beyond the end of the user's finger (Figure 9, Exhibit F), and can be folded back and stabilized by the user's thumb, in the manner described above (Figures 10-11, Exhibits G, H).

[0028] As described above, the piece of material is impregnated (and preferably saturated) with an oral therapeutic solution. Preferably, the oral therapeutic solution includes a non-cariogenic or an anti-cariogenic agent such as xylitol or fluoride. An example of one formulation for the oral therapeutic solution is shown in the following table:

[0029] In addition, the oral therapeutic solution can be formulated to contain antimicrobial agents such as nystatin USP (an antifungal agent) as a therapy for oral yeast infections (which are often found in children), or various antibiotics (e.g. , penicillin, tetracycline) or antiseptics (chlorhexadiene) for local application to oral infections. Anti-inflamatory agents such as corticosteroids (e.g. hydrocortisone) can be added to treat certain inflammatory conditions such as mouth sores or apthous ulcers. Also, flavoring agents can be used, and when the dental wipe is specially designed for adult use, cleansing surfactants, dental whitening agents, re- calcifying agents, and/or certain types of mouth freshening agents (e.g. ethanol, menthol)) can be included in the mouth rinse solution. Anesthetic agents (e.g. benzocaine, lidocaine) could also be incorporated into the wipe solution to treat painful oral lesions or to treat teething pain in children. The sheet of material can be impregnated with the oral therapeutic solution either before it is folded or after it is folded, in the manner described herein.

[0030] The piece of material 102, which has the unfolded parallelogram configuration described above, can be folded into a predetermined folded configuration (see Figures 4-6 and Exhibits A-D). It is desirable to fold the piece of material into the configuration shown in Figure 4, when the oral wipe is to be distributed in individual packets (a packet 120 is outlined schematically in dashed lines in Figure 4 and Exhibit A). Figure 5 (and Exhibit B) show in dashed lines the pattern from which the piece of material can be folded into the configuration of Figure 4. Specifically, the piece of material can be initially folded along fold lines 122 that are parallel to the height 115 of the piece of material and where the initial fold incorporates one of the acute angle end portions 112, 114. The folding continues in an accordion fashion along the parallel fold lines 122 and thereafter the piece of material is folded along a center fold 140 that leaves the other of the angle end portions 112, 114 on the outside of the folded piece of material (see Figure 4 and Exhibit A). Figure 6 and Exhibit C show the piece of material prior to the fold along center fold line 140, and Figure 6 and Exhibit D show a folded sheet of material partially unfolded to show the accordion nature of the folds about fold lines 122.

[0031] The parallelogram shape of the piece of material is particularly useful when the piece of material is in the folded configuration of Figure 4 (and Exhibit A). In that folded configuration, at least one of the acute angle end portions 112, 114 overlies the remainder of the folded piece of material and provides a convenient gripping portion to enable the piece of material to be conveniently unfolded. This feature is particularly useful with a piece of material that is impregnated with oral therapeutic solution, since the wet material might otherwise be difficult to grip when the material is being unfolded. Moreover, the parallelogram shaped piece of material is also useful in facilitating the material impregnated with the oral therapeutic solution being wrapped about a user's index finger to form a sleeve on the user's index finger, and in providing a convenient trailing point that can be engaged by a user's thumb to stabilize the sleeve on the user's index finger (see e.g. Figures 7-11 and Exhibits E-H). As explained in US Patent 6,721,987, maintaining a dental wipe on a user's finger while resisting slippage of the dental wipe is a significant issue, and the present invention addresses that issue with an oral wipe structure that is simple and efficient to produce and effective to handle to accurately wipe and apply oral therapeutic solution to a localized area of a person's mouth.

[0032] Thus, as seen from the foregoing description, the present invention provides a wipe structure, and method of handling the wipe structure, that is particularly useful in forming an oral wipe that is impregnated with an oral therapeutic rinse solution and which is wrapped into a sleeve about a user's index finger and stabilized by the user's thumb. In view of the foregoing description, it is believed that various modifications and adaptations of the present invention will be apparent to those in the art. For example, while it is preferred to wrap the sleeve about a user's index finger, the sleeve can also be wrapped about the user's index and middle fingers, and stabilized by the user's thumb in the manner described above. Also, while the disclosed parallelogram shaped piece of material is preferred, in light of the foregoing description, it is expected that other configurations of a piece of material that can be used to form a digital dental wipe that can be impregnated with an oral therapeutic solution, folded and unfolded, and wrapped into a sleeve on a user's index finger, and stabilized on the user's finger, will be apparent to those in the art. For example, other configurations for a sheet of material that can form lead and trailing points that enable the structure to be effectively folded and unfolded, wrapped about an index finger and stabilized with a user's thumb will be apparent to those in the art.

[0033] In addition the principles of the present invention, as described above, while particularly useful as an oral wipe, may also be useful in forming, packaging and handling other types of digital wipe structures, where such wipe structures are intended to be impregnated with oral therapeutic solution, formed into a sleeve on a user's index finger and stabilized against slippage on the user's finger, so that they can be accurately and effectively apply wiping pressure and deliver an oral therapeutic solution to a localized area, particularly an area where accurate wiping pressure and/or oral therapeutic solution is desirable or necessary. For example, the principles of the present invention may be useful in the production and handling of digital wipe structures for cleansing and debridement of skin wounds, for the careful application of a substance to the face or other irregular body surface (e.g. earlobe, nostril or eyelid), or the local application of the wipe to a mechanical device in which other areas of the mechanical device need to not be disturbed or touched by the wipe. Thus, various applications of the principles of the present invention will be apparent to those in the art.

[0034] Furthermore, the inventor-pediatrician is particularly interested in facilitating the prevention and treatment of oral disease conditions in infancy through the use of the digital oral wipe. It is proposed that the digital oral wipe may be especially useful in addressing three of the most common oral conditions of early childhood: early childhood caries, oral candidiasis, and teething syndrome. The Centers for Disease Control have reported that dental caries is the most common infectious disease of children, affecting as many as forty percent of children by five years of age. Early childhood caries (cavities) are caused by various mouth bacteria, most importantly Streptococcus mutans (MS). This bacterium begins to colonize the mouth as soon as the baby teeth erupt, typically at age six months. MS has adapted to the local ecology of the tooth enamel surface through its ability to form complex biofilms referred to as dental plaque, which adhere and propagate on all tooth surfaces. The plaque biofϊlm secretes organic acids that demineralize (decalcify) the tooth enamel resulting in erosions and pits on the teeth, which in turn allows progressive sequestration of the plaque colony deeper into the tooth structure. This disease process begins in infancy, but may be interrupted in a timely way through the application of proper oral hygiene practices to remove plaque from the baby teeth. Currently parents are restricted to using infant toothbrushes and finger cots which are not always convenient to use, or a wet washcloth or gauze pad which is not always hygienic, to clean the primary dentition (baby teeth). In addition, most dental professionals do not recommend the use of fluoride containing products in children less than two years of age due to the risk of fluorosis (staining) of the teeth. Recent advances in dental science have suggested that xylitol, a natural sugar alcohol found in many fruits and vegetables, may inhibit the propagation of MS plaque colonies. Xylitol, instead of fluoride, can readily be incorporated into a mouthrinse solution, which can be used to saturate the oral wipe. The digital oral wipe can be particularly effective to physically remove dental plaque from the anterior primary dentition, which consists of the flat, spade-like incisors. The xylitol solution diffuses into the plaque biofilm where it may be active as an inhibitor of MS energy pathways (i.e. may inhibit simple sugar fermentation with production of organic acid by-products). Thus the oral wipe may be conveniently used in infancy as an initial application of an oral hygiene practice that may help prevent the long term establishment of MS plaque forming colonies in the mouth of the child.

[0036] The present invention also provides a new and useful way of delivering an oral therapeutic solution that includes an antimicrobial material (e.g. nystatin) to the mucosal surface (e.g. the gums) of a patient, particularly a child that is affected by oral thrush.

[0037] Oral thrush, referred to as oropharyngeal candidiasis in the medical literature, in otherwise healthy infants is an extremely common disease, estimated to occur in 15% of one-month-old infants. This mouth infection is caused by Candida species (mainly Candida albicans) which are classified as yeast fungi. The yeast microbe can be transmitted to the infant during birth via the mother's birth canal, or after birth via maternal candidal skin colonization at the breast, or through maternal saliva where Candida species are normal colonizers. By 6 months of age most healthy infants become less susceptible to oral thrush. By this age, Candida species become a normal component of the orointestinal flora in many humans, but no longer cause disease except in patients with diabetes mellitus, or in situations where immunodeficiency occurs, such as HIV infection or patients receiving chemotherapy.

[0038] The oropharyngeal infection by Candida albicans typically presents as whitish patches or pseudomembranes adhering to the oral mucosa inside the cheeks, and on the gum surfaces and the tongue. With some effort, these tenaciously adherent membranes can be physically scrapped off to reveal a reddened erosive base. Analysis of the candidal pseudomembranes reveals they consist largely of sloughed mucosal cells, white blood cells, fungal elements including spores and hyphae, as well as keratin and food debris. As the oral infection progresses, these inflammatory psuedomembranes may become confluent, covering larger and larger surfaces of the oral mucosa. The infant with oral thrush may experience mouth discomfort and pain, with poor feeding and loss of appetite. The infection is self limited in healthy infants, and will often resolve spontaneously within two weeks, but in some cases may persist for up to two months. Most medical authorities agree that oral thrush in infancy should be treated, especially if the infant is irritable and not feeding well. Oropharyngeal candidiasis in immunocompromised patients should always be treated due to the potential of the infection to spread to the esophagus, and even into the bloodstream.

[0039] Treatment of oral thrush includes antifungal drugs classified as polyenes (nystatin, amphotericin B) or imidazoles (miconazole, clotrimazole, fluconazole, ketoconazole, itraconazole). The polyene, nystatin, given orally is not absorbed by the gastrointestinal tract, thus its mode of action is through direct contact with the candidal pseudomembranes in the mouth. The drug is typically delivered to the mouth as liquid nystatin suspension in a concentration of 100,000 units per milliliter. The suspension is squirted into the baby's mouth with a medicine dropper. The usual dosage is two dropperfuls (2 ml. or 200,000 units) four times per day for ten to fourteen days. One dropperful is applied to each inner cheek or buccal surface of the baby's mouth with each dose. Because nystatin does not adhere to the oral mucosa, the time that the drug is actively in contact with the infected surface can be highly variable. In most cases, the nystatin is quickly swallowed by the infant, resulting in suboptimal contact time. In contrast, older children and adults can actively retain and swish the nystatin throughout the mouth, insuring a longer contact time. The candidal psuedomembrane itself may serve as a protective cap or barrier to the penetration and diffusion of the drug through the pseudomembrane matrix, preventing the drug from reaching the active fungal elements at the surface of the oral mucosa. Clinical cure rates using this nystatin dosing regimen are variously reported as 50-85% following a ten day course of treatment. Relapses requiring re-treatment occur in 20-30% of cases.

[0040] Due to its relatively high cost as compared to nystatin, the imidazole, fluconazole is primarily indicated for patients failing to respond to nystatin, or for more severe cases of oropharyngeal candidiasis. Unlike nystatin, fluconazole is absorbed via the intestinal tract, and thus its mode of action is not dependent on direct contact with the yeast biofilm. Nystatin suspension continues to be the drug of choice for oral thrush in infancy because of its low cost (~$ 15.00 per treatment) and extremely low incidence of side effects coupled with a long history of safe usage in early infancy. By using an oral wipe according to the present invention, the non- absorbable polyene antifungal, nystatin, in which drug efficacy is dependent upon direct contact with the infected mucosal surface, can be delivered to the infection site more efficaciously by direct physical application of the antifungal agent to the oral mucosal membranes. Thus, the wipe becomes a unique drug delivery system for an antimicrobial material such as nystatin. By saturating a disposable oral applicator such as a wipe, swab, or sponge with sufficient antifungal solution and applying the solution directly to the candidal pseudomembranes, it is expected that the overall efficacy of therapy will improve. Moreover, in applying an antimicrobial material such as nystatin, while the oral wipe described in this application is preferred, it is believed that this aspect of the present invention can also be practiced with disposable oral wipes of the types that exist in the art, by saturating such wipes with a solution that includes nystatin, and using the wipes to apply pressure to and to wipe against a mucosal surface such as an infant patient's gums. For example, an oral wipe can be saturated with two to three milliliters of nystatin suspension, and upon digital application to the mouth, using pressure and wiping action, will release one to two milliliters of the antifungal drug (100,000- 200,000 units of nystatin) into the mouth. Furthermore, by using an oral wipe as preferred above, and wrapping the nystatin saturated wipe around the index finger of the person applying the wipe to the infant's mouth, the wipe can be physically manipulated over the mucosal surfaces covered by the candidal pseudomembranes. By applying continuous back and forth digital pressure to the infected membranes, a debridement action will result, whereby the pseudomembranes are at least partially disrupted, providing increased exposure of the pseudomembrane surfaces to the antifungal drug, as well as providing open conduits for the drug to be delivered through the pseudomembrane barrier to the inflamed oral mucosal surface. Debridement has long been an advisable therapeutic maneuver in the management of damaged or infected epithelial surfaces. Examples include the scrubbing of skin surfaces superficially infected by bacterial pathogens (impetigo) or the sponge cleansing of skin abrasions and burns prior to the application of topical anti-infectives. By using a nystatin saturated oral wipe of the type described above (or other antimicrobial saturated oral applicator), the processes of oral lesion debridement and simultaneous application of an anti-infective are combined into one efficient and effective process.

[0042] Accordingly, the present invention provides a new and useful oral wipe structure and method, and also a new and useful way of applying an antibacterial material (e.g. nystatin) to the mucosal surface of a patient, particularly an infant patient. With the foregoing disclosure in mind, it is believed that various ways to configure and handle a dental wipe, and also to apply an antimicrobial material (e.g. nystatin) to a patient's mucosal surface, particularly an infant's mucosal surface, will become apparent to those in the art.

[0043] Finally, it is intended that the digital oral wipe may also be saturated with an oral therapeutic solution that includes a topical anesthetic such as benzocaine to provide to infants and young children a method for relieving pain associated with teething. Current methods of delivering topical anesthetic generally rely on squeezing a gel or paste with the anesthetic onto a finger or directly onto an aral lesion, and then using a bare finger to apply the anesthetic. An oral wipe according to the invention that is saturated with an oral therapeutic solution containing topical anesthetic, a more hygienic option for parents to apply the pain relieving substance to the infant's teeth and gums.

Claims

[0044] 1. An oral wipe comprising a piece of material impregnated with an oral therapeutic solution, the piece of material configured to be wrapped completely about a user's index finger to provide a sleeve about the user's index finger, and further configured so that when wrapped about a user's index finger an outer portion of the sleeve is oriented so that pressure from the user's thumb will stabilize the sleeve and maintain the sleeve on the user's index finger.

[0045] 2. An oral wipe as defined in claim 1 , wherein the piece of material is configured so that when the sleeve is wrapped about the user's index finger, the sleeve extends at least from the tip of the user's finger to a location that is past the middle inter phalangeal joint of the user's index finger.

[0046] 3. An oral wipe as defined in claim 2, wherein the piece of material is further configured so that a distal end of the sleeve extends past the distal tip of the user's finger and can be bent back over the sleeve and captured between the user's thumb and the sleeve, to stabilize the distal end on the sleeve and maintain the sleeve on the user's finger.

[0047] 4 An oral wipe as defined in claim 1 , wherein the piece of material has a parallelogram shape.

[0048] 5. An oral wipe as defined in claim 4, wherein the parallelogram shaped piece of material has (i) parallel sides, each of which has a length of at least 4 inches, (ii) a height of at least 2.5 inches, and adjacent surfaces that form acute angle portions of 40 to 70 degrees.

[0049] 6. An oral wipe as defined in claim 5, wherein the piece of material is absorbent and the oral therapeutic solution includes anti cariogenic agent and or anti microbial agent. [0050] 7. An oral wipe as defined in claim 3, wherein the piece of material is absorbent and the oral therapeutic solution includes anti cariogenic agent and/or anti microbial agent.

[0051] 8. An oral wipe as defined in claim 1, wherein the oral therapeutic solution includes anti-cariogenic agent and/or anti microbial agent.

[0052] 9. An oral wipe as defined in claim 1, wherein the sheet of material includes a pair of acute angle end portions provide an acute angle lead point for initiating wrapping about a user's index finger and an acute angle trailing point that overlies the remainder of the sleeve an which can be engaged by a user's thumb to stabilize the sleeve on the user's index finger.

[0053] 10. A method of handling an oral wipe, comprising the steps of; a. providing an oral wipe structure comprising a piece of material in a predetermined folded condition, the piece of material having a predetermined unfolded configuration and being impregnated with oral therapeutic solution, b. unfolding the piece of material to its predetermined unfolded configuration, and c. wrapping the piece of material about a user's index finger to form a sleeve about the user's index finger, and applying pressure to the sleeve by the user's thumb to stabilize the sleeve on the user's finger.

[0054] 11. A method as defined in claim 10, wherein the step of wrapping the piece of material about a user's index finger comprises using a portion of the piece of material as a lead point to initiate wrapping of the piece of material about a user's index finger and wrapping the piece of material in a pattern that produces a trailing point that overlies the remainder of the sleeve and which can be engaged by a user's thumb to stabilize the sleeve on the user's index finger.

[0055] 12. A method as defined in calim 11, wherein a distal portion of the sleeve extends past the distal tipe of the user's index finger, and the method includes bending the distal portion of the sleeve back over the sleeve and capturing the bent back distal portion between the user's thumb and the sleeve, to stabilize the distal end of the sleeve and maintain the sleeve on the user's finger.

[0056] 13. A method as defined in claim 12, wherein the unfolded configuration of the piece of material comprises a parallelogram.

[0057] 14. A wipe comprising a piece of material impregnated with a solution that is intended to be used as part of a wiping process, the piece of material configured to be wrapped completely about a user's index finger to provide a sleeve about the user's index finger, and further configured so that when wrapped about a user's index finger an outer portion of the sleeve is oriented so that pressure from the user's thumb will stabilize the sleeve and maintain the sleeve on the user's index finger.

[0058] 15. A wipe as defined in claim 14, wherein the piece of material is configured so that when the sleeve is wrapped about the user's index finger, the sleeve extends at least from the tip of the user's finger to a location that is past the middle inter phalangeal joint of the user's index finger.

[0059] 16. A wipe as defined in claim 15, wherein the piece of material is further configured so that a distal end of the sleeve extends past the distal tip of the user's finger and can be bent back over the sleeve and captured between the user's thumb and the sleeve, to stabilize the sleeve and maintain the sleeve on the user's finger.

[0060] 17. A wipe as defined in claim 16, wherein the piece of material is configured such that the distal end of the sleeve can be bent back over and stabilized against the middle or distal phalanx of the user's finger.

[0061] 18 A wipe as defined in claim 16, wherein the piece of material has a parallelogram shape.

[0062] 19. A wipe as defined in claim 18, wherein the parallelogram shaped piece of material has adjacent surfaces that form a pair of acute angle end portions, each acute angle end portion defining an acute angle. [0063] 20 A wipe as defined in claim 19, wherein the parallelogram shaped piece of material has (i) parallel sides, each of which has a length of at least 4 inches, (ii) a height of at least 2.5 inches, and adjacent surfaces that form acute angle portions of 40 to 70 degrees.

[0064] 21 A wipe as defined in claim 20 wherein the piece of material is folded into a predetermined folded configuration in which at least one of the acute angle end portions overlying the remainder of the folded piece of material and provides a convenient gripping portion to enable the piece of material to be conveniently unfolded.

[0065] 22. A method of handling a wipe, comprising the steps of; a. providing a wipe comprising a piece of material in a predetermined folded condition, the piece of material having a predetermined unfolded configuration and being impregnated with a solution, b. unfolding the piece of material to its predetermined unfolded configuration, and c. wrapping the piece of material about a user's index finger to form a sleeve about the user's index finger, and applying pressure to the sleeve by the user's thumb to stabilize the sleeve on the middle phalanx of the user's finger.

[0066] 23. A method as defined in claim 22, wherein the piece of material includes a pair of acute angle portions, and wherein the step of wrapping the piece of material about a user's index finger comprises using one of the acute angle portions as a lead point to initiate wrapping of the piece of material about a user's index finger and applying the other acute angle portion as a trailing point that overlies the remainder of the sleeve and which can be engaged by a user's thumb to stabilize the sleeve on the middle phalanx of the user's index finger.

[0067] 24. A method as defined in claim 23, wherein a distal portion of the sleeve extends past the distal tip of the user's index finger, and the method includes bending the distal portion of the sleeve back over the sleeve and capturing the bent back distal portion between the user's thumb and the sleeve, to stabilize the distal end of the sleeve and maintain the sleeve on the user's finger.

[0068] 25. A method as defined in claim 24, wherein the unfolded configuration of the piece of material comprises a parallelogram.

[0069] 26. A method of applying an anti-cariogenic, anti-microbial, anti- inflamatory, re-calcifying, dental whitening, mouth freshening, or topical anesthetic material to a patient's mouth, comprising providing an oral wipe that is impregnated with an oral therapeutic solution, and applying pressure and wiping the wipe against the teeth, and against any or all of the gums, tongue, or mucosal surfaces of a patient's mouth.

[0070] 27. A method as defined in claim 26 wherein the therapeutic solution includes an anti-cariogenic substance such as xylitol that may be applied to the teeth for the potential prevention of early childhood caries.

[0071] 28. A method as defined in claim 26, wherein the oral therapeutic solution includes an antimicrobial material that includes nystatin for the treatment of oral candidiasis

[0072] 29. A method as defined in claim 26, wherein the therapeutic solution includes a topical anesthetic, including benzocaine, which may be applied to the teeth and gums for the treatment of teething pain.