Hemostat coated dental floss and hemostat coated dental tape

Details Hemostat coated dental floss and hemostat coated dental tape Hemostat coated dental floss and hemostat coated dental tape

2000-12-29

2003-03-25

Wilson, John J. (Department: 3732)

Toilet

Toothpick

C132S329000

Reexamination Certificate

active

06536448

ABSTRACT:

FIELD OF THE INVENTION
The present invention pertains to the field of dental devices and more particularly, to dental floss and dental tape.
BACKGROUND OF THE INVENTION
Dental flosses have long been used to clean the spaces between the teeth and under the gum margin. One early example of a dental floss is described in U.S. Pat. No. 3,800,812. To increase the effectiveness of the floss, some flosses have included certain medicinal ingredients such as fluoride compounds to protect the tooth enamel from acid attack. Bactericides have also been used in connection with dental floss to inhibit periodontal disease.
When used properly, dental floss has been found to be effective in inhibiting tooth decay and gum disease and is recommended by dentists in the daily dental hygiene program. However, dental floss often causes the gums to bleed, which discourages its use by some people.
Attempts have been made to produce a superior dental floss that is convenient to use and is less prone to cause bleeding of the gums. One attempt to produce a dental floss that reduces gum bleeding is described in U.S. Pat No. 5,209,251. U.S. Pat. No. 5,209,251 describes a polytetrafluoroethylene dental floss having a low friction wax coating. Other dental flosses have been provided with a dentifrice component. For example, U.S. Pat. No. 3,830,246, U.S. Pat. No. 3,897,795, U.S. Pat. No. 4,215,478 and U.S. Pat. No. 3,771,536 describe dental flosses which are impregnated with a fluoride compound to aid in the delivery of the fluoride to the tooth surface between adjacent teeth. U.S. Pat. No. 4,033,365 describes a dental floss designed to retain flavorants over a long period of time through the use of non-wax polymeric coatings containing spray-dried flavor particles.
U.S. Pat. No. 3,943,949 describes a dental floss-like material in the form of a bundle of natural or synthetic fibers, such as nylon. The floss is coated with various waxes, including microcrystalline wax, to reduce the friction of the floss against the tooth surface. The wax coating is described as containing a spray-dried flavorant to be dispersed during use.
As exemplified by the above-noted patents, flossing is an extremely important adjunct to proper dental hygiene. Many of the dental flosses presently on the market have received limited consumer acceptance. The lack of consumer acceptance of any single dental floss in the market may be due at least in part to the propensity of dental floss to cause gingival bleeding. Dental floss is generally considered difficult and uncomfortable to use. Consumer dissatisfaction with dental flosses is frequently caused by the difficulty some consumers have in getting the floss into the tight spaces between teeth. The user must apply substantial downward force to pull the floss between the contact points of the teeth. The typical user will pull downward with sufficient force to allow the floss to pass between the teeth and snap against the gum surface, causing irritation and possible bleeding of the gum tissue. The difficulty in pulling the floss between the teeth is the result of the thickness of the floss compared to the spaces between the teeth. In order to reduce the risk of gum injury, many manufacturers have coated the floss with wax or other lubricant to reduce the friction coefficient and increase the ease with which it can be inserted between the teeth.
SUMMARY OF THE INVENTION
The present invention attempts to reduce the bleeding that occurs when consumers use such dental devices by providing dental devices that comprise a hemostatic agent. In certain embodiments, the dental device of the present invention is a dental floss or a dental tape comprising a hemostatic agent. In one desirable embodiment, the hemostatic agent is chitosan. Dental flosses and dental tapes of the present invention may be made from any of the materials that can be used to manufacture dental flosses or dental tapes, in particular commercially available polymers that are designed for such uses.
DETAILED DESCRIPTION OF THE INVENTION
Reference now will be made in detail to several embodiments of the invention, one or more examples of which are set forth below. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment may be used on another embodiment to yield a still further embodiment.
Thus, it is intended that the present invention covers such modifications and variations as come within the scope of the appended claims and their equivalents. Other objects, features and aspects of the present invention are disclosed in or are obvious from the following detailed description. It is to be understood by one of ordinary skill in the art that the present discussion is a description of exemplary embodiments only, and is not intended as limiting the broader aspects of the present invention.
In accordance with the present invention, it has been discovered that a dental device can be made that reduces bleeding by incorporating or otherwise including a hemostatic agent with the dental device. For example, a hemostatic agent may be impregnated in or coated onto a dental device. As used herein, hemostatic agents are substances or compounds that reduce or are capable of reducing bleeding and include, but are not limited to, such substances and compounds as oxidized cellulose, collagen, thrombin, fibrin and chitosan. One desirable hemostatic agent is chitosan. Desirable hemostatic agents includes chitosan, chitosan salts, derivative's of chitosan and mixtures thereof. Generally, chitosan is deacetylated chitin and is also known as &bgr;-1,4-poly-D25 glucosamine; poly-D-glucosamine; and poliglusam. Chitosan is a deacetylated product of chitin, an abundant natural glucosamine polysaccharide found in nature. In particular, chitin is found in the shells of crustaceans, such as crabs, lobsters and shrimp. Chitin is also found in the exoskeletons of marine zooplankton, in the wings of certain insects, such as butterflies and ladybugs, and in the cell walls of yeasts, mushrooms and other fungi.
On the structural level, chitosan is predominantly polyglucosamine, and is generally prepared by the alkaline hydrolysis of chitin. The degree of deacetylation normally ranges from about 70 to about 98 percent. The deacetylated amino groups are generally protonated at a pH of less than about 6, and therefore are responsible for positive charges, which make the chitosan polymer soluble in water. This characteristic also leads to high positive charge density in the chitosan compound. Chitosan generally dissolves in dilute solutions of organic acids such as formic, acetic, tartaric, and citric acids, and also in dilute mineral acids, except, for example, sulfuric acid. In general, the amount of acid required to dissolve chitosan is approximately stoichiometric with the amino groups. An excess of acid is acceptable, and in some cases, desirable.
The biocompatibility of chitosan administered orally and intravenously has been assessed in animals. In addition to being non-toxic, biocompatible and biodegradable, chitosan is also reported in the scientific literature to possess hemostatic, antimicrobial properties and other desirable biomedical properties. See for instance,
Rev. Macromol. Chem. Phys
., C40, 69-83 (2000),
Chitin and Chitosan
, Editors, G. Skjak-Braek, T. Anthonsen and P. Sanford, Elsevier, (1988); and
Chitin in Nature and Technology
, Editors, R. Muzzarelli, C. Jeuniaux and G. W. Gooday, Plenum Press, (1986).
It is desirable that the hemostatic agent is at least partially soluble in water in order to facilitate processing and coating of the hemostatic agent onto the dental device. Advantageously, increased water solubility of the hemostatic agent increases the ability of the hemostatic agent to dissolve on contact with saliva and reduce b

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