AU617688B2 - Device for treatment of gum disease - Google Patents

Description

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617688 COMMONWEALTH OF AUSTRALIA Patents Act 1952 C O M P L E T E S P E. C I.F I-CIA T I O N

(ORIGINAL)

i 'It 0 Application Number Lodg'ed Complete Specification Lodged Accepted Published Priority September 16, 1987 Related Art Name of Applicant COLGATE-PALMOLIVE COMPANY, a Delaware corporation Address of Applicant 300 Park Avenue, New York, New York 10022, United States of America Actual Inventor/s Jordan Barth and Stanley E.

S

V

Piechota, Jr.

Address for Service F.B. RICE CO., Patent Attorneys, 28A Montague Street, Balmain N.S.W. 2041 Complete Specification for the invention tntitled: DEVICE FOR TREATMENT OF GUM DISEASE The following statement is a full description of this invention including the best method of performing it known to us:ii 99$4#* 4 44 4, 4 t~* 4 9 49*4 49 4 9, 44 .9 4 4 49 $4 44 44 4 o 44 9 44 4 4 4, 44.4 4 *4 9 FIELDr OF THE

INVENTION

Devices for the treatment of sub-gingival gum disease.

BACKGROUND

A maJor cause Of sub-9ingival gum disease, I.e..

periodonlCal disease (PD) are bacterial toxins released by plaque in the sub-.gingival area

(SCA).

IL Is 4 )C,12ivec1 that the toxins damage bone structure which Ia I~LC u-L iiir- holds each tooth. Untreated, such bone "anchors" are damaged to thp extent that they can no longer properly hold the teeth to which they were originally attached.

The economic cost of PD is very high. Attempts to alleviate even moderately advanced conditions require extremely expensive treatment and, often, oral surgery.

Moreover, when one or more teeth become disengaged from their anchors and are removed, artificial teeth must be inserted at high cost and with considerable discomfort and continuing Sexpense to the patient.

Notwithstanding the very substantial cost of PD, which is a I 0o significant factor in the rapidly escalating cost of health care, no really efficacious solution to the problem has been found, although a solution has long been sought.

Moreover, in addition to the economic cost, patients suffer severe pain, have difficulty in eating food and endure psychological discomfort from PD.

Although the etiology of PD is not completely understood, existing practice is, of course, aimed at attempting to prevent the onset of the disease by the maintenance of an oral environment free of food debris, desquamated or shed tissue and bacteria. Brushing the teeth with toothpaste using a toothbrush helps to keep the oral cavity clean, but, unfortunately, it is relatively ineffective in removing debris and bacteria-laden plaque from between the teeth.

More significantly, it has little effect in removing the bacterial toxins in the ,sub-gingival pockets (SGPs).

2 Thus, plaque tends to build up in the SGPs and produces toxins which, in turn, cause gum disease, which starts as gingivitis, an inflammation which is the precursor to periodontitis.

Medicaments are available which kill the bacteria in plaque and aid in reducing gingivitis and periodontis. However, it is difficult for the consumer to apply these materials to the SGPs in a home environment.

i In recognition of this problem, one manufacturer has 09 "0 devised an appliance sold under the Trademark "Water Pik" 000: that uses pressurized water which is emitted through a small hand held nozzle against the gums for the purpose of attempting to remove food debris. However, this device is S not suitable or convenient for delivering medicaments to the 0 o. SGPs.

Moreover, certain medications which are proven to kill S toxins, chlorhexidene, can have significant drawbacks if applied as liquids in the oral cavity via mouthwashes or even as dental creams, including tooth staining and a very unpleasant taste. Even if such significant disadvantages did not exist, mouthwashes and dental creams have little effect, at most, in delivering anti-toxin medications below the gum line into the SGPs.

Given the serious health care issue involved, numerous attempts to solve the problem have been made by those expert in the art. One prominent example is the device disclosed in U.S. Patent 4,617,918, -emm e. asq nj;kd; and other 3 appliances are disclosed in the patents referred to there'in.

While such prior art devices are generally effective for delivering liquids into the SGA, they do not deliver viscous or gelled medicaments thereto. This can be critical since liquids are, relatively speaking, quickly washed from the SGA, so that their "residence time" (RT) is short.

Consequently, although they may kill toxins in the SGPs during their RT, since that RT is short, a portion of the toxins remain and continue to produce the bacteria which destroys the anchors.

it i i, Moreover, prior art devices are relatively large and expensive and are cumbersome to use at home.

Presented with the serious health care problem, the inadequacy of existing treatment modes and the need for an inexpensive device which is easy to use at home and which is S, also capable of delivering efficacious amounts of medications to the SGPs for a long RT, the present invention provides a solution to such health care, technical and economic problems by means of a device which is less complicated than those of 2 the prior art while, at the same time, considerably more effective.

Thus, an important object of this invention is to provide a device for delivering long RT medications to the SGA and the SGPs, preferably in the form of viscous or gelled medicaments which will not quickly flow therefrom.

Another important object of the invention is to provide a device that is inexpensive and easy to use in the home. This S 4 is a significant factor, since it is believed that the more complicated and expensive the device, the less likely it is that the patient will, in fact, use the same in accordance with the regimen prescribed by the dentist.

Another important object of the invention is to provide a device which attaches to current and future tubes and other squeezable containers for medications, so that the patient can conveniently and inexpensively attach the same to such tubes and, without further difficulty, commence the beneficial use thereof.

Accordingly the present invention lprovides a device for treatment of gum disease comprising; a squeeze container; a first element having an internal channel and a o15 means for connecting the first element to a squeeze o container of medicament, wherein said first element has O segments angled relative to each other, configured to allow easy access to the oral cavity; and a flexible applicator attached to said first element having a channel therein communicating with the channel of the first element and terminating in a tip adapted to fit into the sub-gingival areas of the oral cavity and having an orifice communicating with the channel of the applicator.

The device preferably has a removable applicator tip, so that the same can be sterilized or, if desired, the patient can simply purchase the same in quantity and discard tips after use in the manner of disposable syringe needles.

Other objects and advantages of this invention will be apparent from the following description and the drawing.

THE DRAWING The drawing is a vertical sectional view of one preferred embodiment of the device of this invention attached to a tube containing medicament for periodontal disease.

DETAILED DESCRIPTION As illustrated in the drawing, the device of this invention is designed to be attached to a medicament tube, so that the two together can be hand-held for easy and convenient use in the home by a person having gum disease.

As will be be explained in more detail, the device is unique because it is capable of delivering high RT gels and other viscous medications directly into the SGPs and because of the theology of such medications, they remain in the SGPs '10 for long periods and are not quickly washed therefrom, as are o" liquid anti-toxin agents.

As shown in the drawing, a preferred embodiment of the invention is angled so that it is easily Inserted into the oral cavity with an applicator tip at its end positioned for insertion below the gum line and into the SGPs.

n Turning now to the drawing, there is shown a Container 9, which is of the squeeze type, and preferably is a tube (as shown) which may be of any suitable material, such as metal, plastic and laminates. The upper end of the tube 9 2i terminates in a neck 10 having external threads 10a. When purchased, the tube 9 is closed by a threaded cap (not shown) which threads onto threads 10a. The cap is removed when the I device of this invention is ready to be attached to the tube.

Thus, as illustrated, the cap has been removed, and the applicator device of this invention, generally enumerated as 12, has been attached thereto.

6 More specifically, device 12 has a lower portion 13 which may of any suitable material, plastic, and which has Internal threads 14 which screw onto the threads 10a of the tube neck 10. The tube neck 10, of course, has an I internal channel 10b extending into the tube itself and an upper opening 10c, so that the contents of the tube can be squeezed out. The lower segment 13, in turn, has an internal channel 15 which communicates with the opening 10c in tube neck 10, so that the contents of the tube, which preferably (10 are viscous or gel medicaments 11, are extruded from the opening in the neck 10 and into the channel 15 of segment 13.

Lower segment 13 is integrally connected to a middle segment 16 of the device, and the latter is at an angle to t I segment 13. In turn, segment 16 is connected to an upper segment 17 which is angled from segment 16. Segments 13, 16 |and 17 may, if desired, be an integral element, but, in either case, they all have inter-communicating channels which fI communicate with channel 15. Accordingly, medicament 11 |i squeezed from tube 9 flows through the opening 10b in neck I 20 and thence through the inter-connecting channel 15 of segments 13, 16 and 17.

Upper segment 17 terminates in an opening 19, which may be in the form of a tubular collar 19a. A flexible applicator tip, which may be rubber, for example, and which is generally designated as 20, is attached to segment 17. As shown, tip 20 is frictionally fit into opening 19 of the 7 Ii n t 9 0r 4 I a 4* 4I s*gment 17,- but other modes of attachment may be employed, such as screw threads.

Tip 20 has an inte;rnal channel 21 which communicates with channel 15 and which terminates in a small orifice 22 at the pointed end 23 of the tip.

Thus, the medication 11 is delivered through orifice 22 via channel 15 when the tube 9 is squeezed. Since the orifice 22 is very small and pointed and flexible, it will be understood that the tip 20 can be inserted into the desired ,0 SOPs and SCAs very easily, and that this is assisted by the angled configuration of the applicator 12, In use, the applicator tip 20 is inserted into a SGP or SGA and the tube 9 is squeezed by hand pressure, thereby extruding high RT medicament into the SGP. To facilitate compression of the tube, which, as can be observed is hand-held, there is shown an optional handle 23 which the patient can press against the tube 11.

It will be understood that the above process is repeated for each SGP on the lingual and buccal sides of each tooth, including the gingival margin.

Treatment time and frequency of use will depend upon several factors, including the severity of the gum disease and the specific type of medication employed. For viscous and gelled medicaments used to treat disease of moderate severity, a typical treatment time per SGP will be about 1-3 minutes, repeated once or twice a day for a period of about 8 4 1-4 weeks. Although, as indicated, this device is especially suited for delivering non-liquid solutions, it may also br,, used to deliver liquid siolutions, saline solutions, to the ScPs, in which case the treatment times will be longer.

As indicated, the applicator tip 20 is easily detachable from the applicator body 12, so that it may be sterilized or otherwise cleaned. In addition, it is contemplated that such tips may be sold as a "disposable", the same may o be discarded after each use, as in the case of disposable o syringes.

o o 0 04 From the beginning, it will be appreciated that the devlce of this Invention has many advantages over those of the prior art. For example, it is far less complicated, so that it will be relatively less espensive. Also, it is small enough to be operated by one hand and at home, thereby increasing the liklihood that the user actually employs the same as instructed. Moreover, the special configuration Is designed so that the device can be easily inserted into the oral cavity, and the flexible applicator tip makes it possible to deliver the medication precisely into the infected area6.

In addition t.O the, foregoing advantages over the prior art, as described hereinabove, the device has the unique car-ability of delivering high RT gels and viscous medicaments into the SOPs and elsewhere under the gum line, The gelled and viscous medicaments which can be 9t v. ed b t hIs dev Ic.e Inay c s Ist 11f ui t-abl)e ztntib..ceril agents, oxygenating ,gents, antibiotics, anti-Inflammatory agents, ::-odium bicarbonate and other matera.ils effective for treating gum disease.

Typical antibacterial agents which are used in medlicaments for PD include: N 1-4 (ch Ior oben zyl) 4-d ichl or obtenzyl) biguanide p-chi orophenyl hi g',ialnide 'I-chlorobenz hydryl biguanide 4-chlorobenz hydrylqoanylurea 1, G-dl-p-chilorophenylblguanihexane 1-(lauryldlmethylammoniurn)-8-(p-chlQro benzyldlmethylarnmonium) octane dichloride 5,6-dlchloro-2-3uanldlnobenziidazole 5-amlno--X,3-bis(2-ethylhexyl)-5mothylhe~ahydropyr iridine and their non-toxic acid addition salts.

The device can also be u~sed to treat sub-gingival. caries and remove sub-gingival calculus with gelled medicaments, such as flouride, calum chelating and anti-nuculeating.

lndgredients and other suitable materials. The us-e of local, anesthetics such as benzocalne may also be used, to relleve tenderness of inflamed areas and associated pain.

Ir) rheoloqIcal terms, the medicament should have a

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4 q 4 44 4 4 4 44 4. 4, 44 44 I 44 44 44 suitable yield point for maximum effectiveness. That im, if the yield point is: too low, the medicament will not have ]ong PT and thus will not be as effectively retained within the SPs and elsewhere within the gingival margin. On the other hand, if the yield point is too high, then the medicament will be difficult to dispense through the relatively small opening 22 of applicator tip 23, although it is well within the scope of this invention to provide varying 4 sizes for opening 22 to accorniodate the need to dispense high 10 yield point medicaments.

4 g In addition, low thixotropy is a desirable characteristic of the medicament. The medicament undergoes extensive shear as it Is forced through the small orifice 22 of tip 23 and, therefore, rapid re-development of the solid 4 Sstructure of the medicament will improve the retention of the product within the SGPs and the SGAs.

There are, of course, occasions when it may be desirable to apply medicaments that have relatively low yield points and even those having a rheology as low as water or other liquids. While, as indicated, the primary and significant purpose of this device is to deliver gelled and viscous medicaments with high RTs, it is a further advantage that it also may just as conveniently be used to dispense-low yield point material, water and other liquids as well, In this regard, the device has a dual functionality of being capable of delivering prior art liquids to the SOPs arid SGA -11- 1 1 and also the new and unique capability of being effective to dispense hitherto non-deliverable gelled and viscous medicaments, all in a relatively uncomplicated, inexpensive hand held device suitable for home use.

It will be clear to those skilled in the art that the device illustrated in the drawing is a preferred embodiment of the invention, and that variations of the basic concept of the invention are possible without departing from the scope S' of the claims. For example, it is part of this invention to 1 0o,' provide a protective cap (not shown) for the applicator tip to protect the same while not in use and to maintain it in 4& 4 I I a sanitary condition, The specific means for attaching such protective cap may vary, but Is well within the knowledge of those skilled in the art.

Finally, it is also possible that the medicam.eni; tube will be sold already attached to the present device, in which case the p-otectlve cap will be desirable to prevent leakage of the medicament during shipment.

4' From the foregoing, it will be understood that, in addition to the device of this invention, there is disclosed a method of treating qum disease which comprises: the steps jof selecting a viscous or gelled medicament, supplying the same to an applicator 4navlng a tip of a size and flexibility 'A to be inserted under the gum line and into the SGPs and having an orifice capable of permitting the medicament to pass therethrough, inserting the tip into the SGPs and then causing the medicament to be passed into the SGPs through the orifice.

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Claims (12)

1. A device for treatment of gum disease comprising: a squeeze container; a first element having an internal channel and means for connecting the first element to a squeeze container of medicament, wherei, said first element has segments angled relative to each other, configured to allow easy access to the oral cavity; and a flexible applicator attached to said first element having a channel therein communicating with the channel of the first element and terminating in a tip adapted to fit into the sub-gingival areas of the oral cavity and having an orifice communicating with the channel of the applicator. 15

2. The device of claim 1 wherein the applicator is tr detachable from the first element.

3. The device of claim 1 wherein the applicator has a protective cap over its tip.

4. -he device of claim 1 wherein the first element is an integral structure.

The device of claim 1 wherein the first element has internal threads and the container has an outlet with external threads which match those of the first element, whereby the first element can be threaded onto the outlet by means of said matching threads.

6. The device of any of claims 1-6 wherein the container is a tube.

7. The device of any of claims 1-6 wherein the container has within it gelled and/or viscous medicament for treatment of gum disease.

8. The device of any of claims 1-6 wherein the container has within it medication for the tzeatment of gum disease which medication has a residence time after application into sub-gingival areas and pocket substantially greater than the residence time of a liquid. 13 in~ 2. 41

9. The device of any of claims 1-6 where the first element has means for compressing the container to squeeze the contents therefrom.

The device of claim 1 wherein the tip is of a size to be inserted into sub-gingival pockets.

11. A hand-held device for the treatment of gum disease comprising a squeezable container having medication for treatment of gum disease therein, said container having an outlet, and applicator means attached to said outlet, said applicator means having an internal channel communicating with said outlet, said applicator means terminating in a flexible tip adapted to fit into the sub-gingival areas of the oral cavity, said applicator means having segments angled relative to each other, configured to allow easy access to the oral cavity, said tip having an orifice communicating with the channel of the applicator, whereby pressure on the container forces said medication from the tube and into the channel of the applicator means and thence from the tip orifice.

12. A method for treating gum disease by killing bacterial toxins in sub-gingival pockets (SGPs) comprising the steps of: selecting a viscous or gelled medicament having a residence time greater than liquid medicaments, supplying the medicament to an applicator having segments angled relative to each other, configured to allow easy access to the oral cavity and having a flexible tip adapted for insertion into the SGPs, said tip having an orifice which will allow the medicament to pass therefrom inserting the tip into a SGP, and then causing the SJ 30 medicament to pass through the orifice into the SGP, DATED this 12th day of September 1991 COLGATE-PALMOLIVE COMPANY Patent Attorneys for the Applicant: F.B. RICE CO. 14 _i