GB2209680A - Device for treatment of gum disease - Google Patents

Description

1 2209680 "DEVICE FOR TREATMENT OF GUM DISEASE" The present invention

relates to devices f or the treatment of sub-gingival gum disease.

A major cause of sub-gingival gum disease, i.e. periodontal disease is bacterial toxins released by plaque in the sub-gingival area.

It is believed that the toxins damage the bone structure which holds each tooth. Untreated, such bone "anchors" are damaged to the extent that they can no longer properly hold the teeth to which they were originally attached.

The economic cost of periodontal disease is very is 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 20 considerable discomfort and continuing expense to the patient.

Notwithstanding the very substantial cost of periodontal disease, which is a significant factor in the rapidly excalating 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 difficult in eating food and endure psychological discomfort from periodon- tal disease.

Although the etiology of periodontal disease is not completely understood, existing practice is, of course, aimed at attempting to prevent the onset of the 2 disease by the maintenance of an oral environment f ree 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 toxin generating bacteria in the subgingival pockets.

Thus. plaque tends to build up in the sub-gingival pockets harbouring bacteria which produce toxins which. in turni, cause gum disease. which starts as gingivitis, an inf lammation which is the precursor to periodontitis.

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

In recognition of this problem, one manufacturer has devised an appliance sold under the Trademark "Water Pik" 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 not suitable or convenient for delivering medicaments to the subgingival pockets.

Moreover, certain medications which are proven to kill the bacteria which produce the toxins,, e.g. 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 11 3 disadvantages did not exist, mouthwashes and dental creams have little effect, at most, in delivering antibacterial medications below the gum line into the subgingival pockets.

Given the serious health care issue involved, numerous attempts to solve the problem have been made by those skilled in the art. One prominent example is the device disclosed in U.S. Patent 4,617,918, commonly assigned, and other appliances are disclosed in the patents referred to therein.

While such prior art devices are generally effective for delivering liquids into the sub-gingival area, they do not deliver viscous or gelled medicaments thereto. This can be critical since liquids are, relatively speaking, quickly washed from the sub- gingival area, so that their "residence time" is short. Consequently, although they may kill bacteria in the sub-gingival pockets during their residence time, since that residence time is short, a portion of the bacteria remain and continue to produce the toxins whic h destroys the anchors.

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 also capable of 'delivering efficacious amounts of medications to the sub-gingival pockets for a long residence time, 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 the prior art while, at the same time, considerably more effective.

4 This invention aims to provide a device for delivering long residence time medications to the subgingival area and the sub-gingival pockets, preferably in the form of viscous or gelled medicaments which will not quickly flow therefrom.

The invention also aims to provide a device that is inexpensive and easy to use in the home. This 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 f act, use the same in accordance with the regimen prescribed by the dentist.

The invention also aims 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.

The invention also aims to provide a device which 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.

The invention may be put into.practice in various ways and one specific embodiment will be described to illustrate the invention with reference to the accompanying drawing which: is a vertical sectional view of one preferred embodiment of the device of this invention attached to a tube containing medicament for periodontal disease. 30 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 -1 gum disease.

As will be explained in more detail, the device is unique because it is capable of delivering high residence time gels and other viscous medications directly into the sub-gingival pockets and because of the rheology of such medications, they remain in the sub-gingival pockets for long periods and are not quicklywashed therefrom, as are liquid antibacterial agents.

As shown in the drawing, a preferred embodiment of the invention is angled so that,t is easily inserted into the oral cavity with an applicator tip at its end positioned for insertion below the gum line and into the sub-gingival pockets.

Turning now to the drawing, there is shown a container, 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 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 1 Oa. The cap is removed when the 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.

More specifically, the device 12 has a lower segment 13 which may be of any suitable material, e.g. plastic, and which has internal threads 14 which screw onto the threads 1 Oa of the tube neck 10. The tube neck 10, of course, has an internal channel 10b extending into the tube itself and an upper opening 1 Oc, so that the contents of the tube can be squeezed 6 out. The lower segment 13, in turn, has an internal channel 15 which communicates with the opening 10c in the tube neck 10, so that the contents of the tube, which preferably are viscous or gel medicaments 11, can be extruded f rom the opening in the neck 10 and into the channel 15 of the segment 13.

The lower segment 13 is integrally connected to a middle segment 16 of the device, and the latter is positioned at an angle to segment 13. In turn, the segment 16 is connected to an upper segment 17 which is positioned at an angle to the segment 16. The segments 13, 16 and 17 may, if desired, be an integral elongated body or element, but, in any case, they all have intercommunicating channels which constitute the channel 15. Accordingly, the medicament 11 squeezed from the tube 9 flows through the opening 10b in the neck 10 and thence through the i nter- connecting channel 15 of the segments 13, 16 and 17.

The 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. the tip 20 is a frictional fit into the opening 19 of the segment 17, but other modes of attachment may be employed, such as screw threads. The tip 20 has an internal channel 21 which communicates with the channel 15 and which terminates in a small orifice 22 at the pointed end 23 of the tip. 30 Thus, the medication 11 is delivered through the orifice 22 via the 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 7 tip 20 can be inserted into the desired sub-gingival pockets and sub-gingival areas 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 sub-gingival pocket or a sub-gingival area and the tube 9 is squeezed by hand pressure, thereby extruding the high residence time medicament into the sub-gingival pocket or area. To facilitate compression of the tube, which, as can be observed is hand-held, there is shown an optional handle 24 which the patient can press against the tube 11.

It will be understood that the above process is repeated for each subgingival pocket 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 sub-gingival pocket will be about 1-3 minutes, repeated once or twice a day for a.. period of about 1-4 weeks. Although, as indicated, this device is especially suited for delivering non-liquid solutions, it may also be used to deliver liquid solutions, e.g. saline solutions, to the sub-gingival pockets, 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", i.e. the same may be discarded after each use, 8 as in the case of disposable syringes.

From the beginning, it will be appreciated that the device 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 expensive. Also, it is small enough to be operated by one hand and at home, thereby increasing the likelihood that the usertactually 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 areas.

In addition to the foregoing advantages over the prior art, as described hereinabove, the device has the unique capability of delivering high residence time gels and viscous medicaments into the sub-gingival pockets and elsewhere under the gum line.

The gelled and viscous medicaments which can be delivered by this device may consist of suitable antibacterial agents, oxygenating agents, antibiotics, anti- inflammatory agents, sodium bicarbonate and other materials effective for treating gum disease.

Typical antibacterial agents which are used in medicaments for periodontal disease include:

Nl-4(chlorobenzyl)-N5-(2,4-dichlorobenzyl) biguanide P-Chlorophenyl biguanide 4-chlorobenzhydryl biguanide 4- chlorobenzhydrylguanylurea N-3-lauroxypropyl-N5-p-chlorobenzylbiguanide lr6-di-p-chlorophenylbiguanihexane 1-(lauryldimethylammonium)-8-(p-chloro i 9 benzyldimethylammonium)octane dichloride 5,-6-dichloro-2-guanidinobenzimidazole Nl-p-chlorophenyl-NS-laurylbiguanide 5-amino-li3-bis(2-ethylhexyl)-5-methylhexa- hydropyrimidine and their non-toxic acid addition salts.

The device can also be used to treat sub-gingival caries and remove sub-gingival calculus with gelled medicaments, such as fluoride, calcium chelating and anti-nucleating ingredients and other suitable materials. The use of local anesthetics such as benzocaine may also be used to relieve tenderness of inflamed areas and associated pain.

In rhological terms, the medicament should have a suitable yield point for maximum effectiveness. That is, if the yield point is too low, the medicament will not have a long residence time and thus will not be as effectively retained within the sub-gingival pockets 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 the applicator tip 23, although it is well within the scope of this invention to provide varying sizes for the opening 22 to accommodate the need to dispense high yield point medicaments.

In addition, thixotropy is a desirable characteristic of the medicament. The medicament undergoes extensive shear as it is forced through the small orifice 22 of the tip 23 and, therefore, rapid redevelopment of the solid structure of the medicament will improve the retention of the product within the sub-gingival pockets and the sub-gingival areas.

Z, 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 residence times, it is a further advantage that it also may just as conveniently be used to dispense low yield point materialg, 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 sub-gingival pockets and areas and also the new and unique capability of being effective to dispense hitherto non-deliverable gelled and viscous medica- ments, 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 of the claims. For example, it is part of this invention to provide a protective cap (not shown) for the applicator tip 20 to protect the same while not in use and to maintain it in 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 medicament tube will be sold already attached to the present device, in which case the protective cap will be desirable to prevent leakage of the medicament during shipment.

From the foregoing, it will be understood that, in 1 1 addition to the device of this invention, there is disclosed a method of treating gum disease which comprises: the steps of selecting a viscous or gelled medicament, supplying the same to an applicator having a tip of a size and flexibility to be inserted under the gum line and into the sub- gingival pockets and having an orifice capable of permitting the medicament to pass therethrough, inserting the tip into the subgingival pockets and then causing the medicament to be passed into the sub-gingival pockets through the orifice.

12

Claims (17)

1. A device for the treatment of gum disease 5 comprising:

   (a) a body having an internal channel and means for connecting the body to a squeeze container adapted to contain medicament. with the internal channel of the body in communication with the interior of the said 10 container; and (b) an applicator attached to the said body and having a channel therein communicating with the channel of the body and terminating in a tipped end having an opening communicating with the channel of the 15 applicator.
2. 2. A device as claimed in Claim 1 in which the applicator is flexible.
3. 3. A device as claimed in Claim 1 or Claim 2 in which the applicator is detachable from the body.
4. 4. A device as claimed in.Claim 1, 2 or 3 in which the applicator has a protective cap over its tip.
5. 5. A device as claimed in Claim 1 y 2, 3 or 4 in which the body has angled segments conf igured to be easily inserted into the oral cavity.
6. 6. A device as claimed in any one of Claims 1 to 5 in which the body is an integral structure.
7. 7. A device as claimed in any one of Claims 1 to -R 13 7 6 in which the body has internal threads and the container has an outlet with external threads which match those of the body, whereby the body can be threaded onto the outlet of the container by means of the said matching threads.
8. 8. A device as claimed in any one of the preceding claims in which the container is a tube.
9. 9. A device as claimed in any one of Claims 1 to 8 in which the body has means for compressing the container to squeeze the contents therefrom.
10. 10. A device as claimed in any one of Claims 1 to 8 in which the body affords means against which the container can be pressed to squeeze the contents therefrom.
11. 11. A device as claimed in any one of Claims 1 to 10 in which the tipped end is of a size to enable it 1 tobe inserted into sub-gingival pockets.

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12. 12. A device as claimed in Claim 1 substantially as specifically described herein with reference to the 25 accompanying drawings.
13. 13. A device as claimed in any one of Claims 1 to 12 in combination with a container which has within it gelled and/or viscous medicament for treatment of gum 30 disease.
14. 14. A device as claimed in Claim 13 in which the medicament has a residence time, after application into 14 sub-gingival areas or pockets, which is subsantially greater than the residence time of a liquid.
15. 15. A device as claimed in Claim 14 substantially as specifically described herein w ith reference to the accompanying drawing.
16. 16. A hand-held device for the treatment of gum disease comprising a squeezable container containing medication for treatment of gum disease, the said container having an outlet, and applicator means attached to the said outlet, the said applicator means having an internal channel communicating with the said outlet, and the said applicator means terminating in a is tip configured to fit into the sub-gingival areas of the oral cavity, the said tip having an orifice communicating with the channel of the applicator, whereby pressure on the container forces the said medication from the container and into the channel of the applicator means and thence from the tip orifice..
17. 17. A method for treating gum disease by killing toxin generating bacteria in sub-gingival pockets 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 a tip of a size capable of being inserted into the sub-gingival pockets, the said tip having an orifice which will allow the medicament to pass there- from, inserting the tip into a sub-gingival. pocket, and then causing the medicament to pass through the orifice into the sub-gingival pocket.

    Published 1988 at. The Patent Office. State House. 6671 High Holborn. London, WC1R 4TP. Further copies may be obtained from The Patent Mce. Sales Branch, St Mary Cray. Orpitigton, Kent BR5 3RD. Printed by Multiplex techniques ltd, St Mary Cray. Kent. Con. 1187- :i 4