Oral hygiene irrigator syringe bulb

An oral irrigator syringe bulb having an elastic compressible bulb, which may be filled with irrigation fluid, and a rigid nozzle having a base portion which may be sealingly fitted to the bulb. The nozzle has a lumen along the longitudinal axis thereof, and the lumen has a fluid outlet at its upper part to which suitable irrigation means can be attached. The nozzle also has an elongate non-kinking flexible dip tube which reaches into the lumen, the free end of the dip tube being provided with a weight, whereby when the nozzle is fitted onto the bulb the free end of the dip tube extends into the bulb and is submerged in the irrigation fluid at any spatial position in which the bulb is held.

FIELD OF THE INVENTION 
The present invention relates to a oral irrigation fluid dispensing device, 
which may be equipped with suitable irrigation probe device, for the 
delivery of medically compatible fluids into the periodontal pocket or the 
gingival sulcus or the interdental space. 
BACKGROUND OF THE INVENTION 
Periodontal inflammation is one of the most common diseases of the adult 
population. Periodontal inflammation is induced by the dental plaque, a 
mixture of bacteria embedded in an adhesive matrix, present on the tooth 
surface particularly at the interdental spaces and near the gums. The 
initial pathological reaction to the plaque, called gingivitis, is 
expressed by the soft gum tissue as redness, bleeding, swelling, bad 
breath and sour taste. Later, over a period of several years, the gum 
disease progresses and causes destruction of the tooth supporting bone, 
leaving a pathologic space between the tooth root and the gum. This space 
is the periodontal pocket. The plaque extends into the pockets, from which 
it cannot be removed by conventional oral hygiene methods, such as 
brushing and flossing. This plaque induces further damage, increasing the 
pocket size in depth and width, with eventual tooth loss. In addition to 
the gingivitis, plaque present in the interdental space also causes 
interproximal tooth decay. 
Since the implication of plaque in the development of dental diseases, the 
majority of plaque control devices introduced over the past decades have 
been developed for supragingival plaque removal. Supragingival plaque can 
be effectively removed by brushing and flossing, but most brushing and 
flossing devices are restricted by physical restraints that limit their 
ability to extend far enough below the gingival margin. The configuration 
of tooth picks, pipe cleaners, interdental brushes and other interdental 
cleaning aids also limits the effect of these devices on subgingival 
plaque. Furthermore, antiplaque agents used as mouth rinses affect only 
supragingival plaque unless such agents are introduced below the gingival 
margin with an irrigating device. Oral irrigators allow practitioners and 
patients access to subgingival areas in order to disrupt the plaque that 
proliferates at these sites. 
Irrigation can be defined simply as "the flushing of a specific site or 
area with a stream of fluid delivered by an irrigator". In 1968, the first 
powered oral irrigation device, WaterPik.RTM. (Teledyne WaterPik), was 
accepted by the American Dental Association for its ability to remove food 
particles and debris from interdental areas and below the gum line. This 
device was widely recommended, particularly for orthodontic and 
prosthodontic patients. However, research was unable to establish a 
definitive relationship between the presence of debris and periodontal 
disease and found no evidence that irrigation with WaterPik.RTM. could 
significantly reduce plaque. Subsequent research utilizing antimicrobial 
solutions delivered by an oral irrigator equipped with a fine probe, has 
helped to establish oral irrigation as a useful procedure for plaque 
control, especially for "site specific" therapeutic approaches that 
require direct delivery of antimicrobial solutions into the affected 
sulcus or pocket, and has expanded the usefulness of the irrigator in 
preventative care, beyond its application as a mechanism to simply flush 
away debris. 
Researchers of general preventive techniques, dental hygiene educators as 
well as various practitioners, have maintained that oral irrigation is an 
effective adjunctive plaque control therapy throughout the course of 
periodontal treatment, from initial plaque removal instruction through 
maintenance. Furthermore, experts gathered at the April 1991 meeting of 
the International Association of Dental Research in Acapulco, Mexico, 
agreed that the use of antimicrobial solutions applied with oral 
irrigation systems exhibits high promise in the site specific treatment of 
periodontal conditions. 
Irrigators designed for home care by the patient consist of a power driven 
pump or flexible syringe bulb and a tip. The early irrigator tips, 
designed for supragingival removal of debris were too large to penetrate 
the interdental space and gingival sulcus of patients with undisrupted gum 
architecture or periodontal pockets. In addition, the motor driven pumps 
deliver a powerful stream that causes undesirable enforcement of debris 
and microorganisms into the dental tissues. Subgingival irrigation 
devices, introduced into the dental market over the past decade, are 
capable of delivering medicaments directly to the site of the periodontal 
infection. This form of therapy can effectively remove bacterial plaque in 
sites inaccessible to brushing, flossing and other mechanical 
manipulations [a variety of available irrigation devices can be found in 
Dental Products Report.RTM. Europe (also published in the U.S.A.); MEDEC 
Dental Communications, A Division of Medical Economics Publishing Company, 
Inc., October 1991]. 
However, one of the main drawbacks of oral hygiene techniques used for 
arrest or prevention of periodontal diseases, particularly irrigation, is 
patient compliance, since the patient should maintain routine, day-by-day 
treatment. A great deal of the noncompliance can be attributed to the 
non-handiness of most available oral irrigators. 
U.S. Pat. No. 5,127,831, corresponding to co-pending Israel Patent 
Application No. 98355, discloses a novel irrigation probe, particularly 
suitable for use by a patient. Conventional irrigation devices, like 
blunt, rigid metal needles, are also used for irrigation, by trained 
personnel [e.g. Soh, L. L., et al., J. Clin. Periodontol. 9: 66-74 (1982); 
J. G. L. Khoo and H. N. Newman, J. Periodont. Res. 18: 607-619 (1983)]. 
Another dental irrigation needle is disclosed in U.S. Pat. No. 4,993,941. 
Additionally, IMAX.RTM. Periotips.RTM. (SDI Group, Inc., IL U.S.A.) are 
used for in-office professional subgingival irrigation. 
All of the known prior art irrigation probes can be used with various 
pumping devices containing the irrigation fluid, which may be water or 
medically compatible solutions. These devices include different manual and 
automatic syringes, spray injectors and mechanically or electrically 
driven pump systems. The known pumping devices, particularly syringes, are 
mostly designed for in-office use by trained personnel. 
Another pumping device, stated to be suitable for use by a patient, is sold 
under the name Luer Syrette.RTM. (Perio Dental, Inc., Colorodo USA). This 
pumping device consists of a compressible bulb, which has a narrow 
opening, and a hollow shaft. One end of the shaft can be sealing fitted 
into the opening is the bulb, the other end has a luer lock for connecting 
the irrigation probe. This Luer Syrette.RTM. in only operable when held in 
an upright position. Thus, in order to irrigate lower jaw sites, or other 
sites which are difficult to reach, an elongate extension tube is used, 
connecting said luer lock with the irrigation probe, to enable the 
attending dentist or the patient to reach all subgingival pockets, while 
maintaining the Luer Syrette.RTM. in the upright position. To achieve the 
upright position, both hands of the user are engaged which is a drawback 
since one hand should preferably be free, to push aside the lip/s or 
cheek/s, to expose the target site. In addition, the structure of the Luer 
Syrette.RTM. is rather complex, since it requires the inclusion of an 
anti-suction valve, preventing suction of the irrigation fluid back into 
the bulb when pressure on the bulb is released. Moreover, the bulb opening 
is narrow and the bulb is filled with the irrigation fluid by suction from 
a larger container. Also washing of the bulb with water between uses is 
achieved by suction. Evidently, the fact that the bulb can only be 
operated when in an upright position is a major drawback, particularly 
when considering the anatomy of the mouth, and especially when used by the 
patient. 
The present invention intends to overcome the described drawbacks, 
essentially by providing an irrigation device which is equipped with a 
non-kinking weighted dip tube, which is submerged in the irrigation fluid 
irrespective of the spatial position in which the irrigator is held. 
Various fluid dispensing devices comprising a weighted dip tube assembly, 
some of them non-kinking tubes, which ensures that the free end of the dip 
tube is always submerged in the fluid to be dispensed are known. Such 
fluid dispensing devices are described, for example, in UK Patent 
Applications Nos. 902,114, 1,008,733, 2,136,057, 2,217,394 and 2,234,555, 
U.S. Pat. Nos. 2,978,152, 3,088,680, 3,211,349, 3,490,656 and 3,667,655, 
DE 36 36 409 and French Patent Applications Nos. 1,479,528, 1,565,071, 
2,101,505 and 2,437,246. However, none of the dispensers disclosed in 
these publications is intended for dental use, and in all of the disclosed 
dispensers, the container is rigid and the pressurized fluid is dispensed 
by aerosol means. Moreover, the prior art dispensers appear to be only 
suitable for one-time use and cannot be refilled. 
BRIEF DESCRIPTION OF THE INVENTION 
The present invention relates to an oral irrigator syringe bulb comprising 
an elastic compressible bulb, which may be filled with the irrigation 
fluid, having an opening, and a rigid nozzle having a base portion which 
may be sealingly fitted to said bulb opening, and a lumen along the 
longitudinal axis thereof, the lumen having a fluid outlet at the upper 
part thereof, to which suitable irrigation means can be attached, and an 
elongate non-kinking flexible dip tube accomodated therein, one end of 
said dip tube reaching into said lumen, the free end of said dip tube 
being provided with a weight, whereby when the nozzle is fitted onto the 
bulb the free end of said dip tube extends into the bulb and is submerged 
in the irrigation fluid at any spatial position in which the bulb is held.

DETAILED DESCRIPTION OF THE INVENTION 
The present invention relates to an oral irrigator syringe bulb comprising 
essentially two parts: (i) an elastic compressible bulb, which may be 
filled with the irrigation fluid, the bulb having an opening; and (ii) a 
nozzle having a base portion, which may be sealingly fitted to said bulb 
opening, and a lumen along the longitudinal axis thereof, having a fluid 
outlet at one end thereof, to which suitable irrigation means, such as 
probes, tips or needles, can be attached, and an elongate non-kinking 
flexible dip tube accomodated within said-nozzle, one end of said dip tube 
reaching into the said lumen, the free end of said dip tube being provided 
with a weight. Thus, when the nozzle is fitted onto the bulb, the free end 
of said dip tube extends into the bulb and, due to the weight attached 
thereto, is submerged in the irrigation fluid at any spatial position in 
which the bulb is held. Upon compression of the bulb, the irrigation fluid 
is urged into the lumen through said dip tube and from the lumen into the 
irrigation tip through said fluid outlet. 
The bulb may be essentially ball- or pear-shaped or essentially 
cylindrical. The bulb may be made from any suitable elastic material, for 
example, rubber, silicon rubber and soft polyvinylchloride, which are 
medically compatible materials, are preferred. The opening of the bulb may 
be provided with means for sealingly fitting the base portion of the 
nozzle thereto. These means may be threads, O-rings, bayonets or any other 
suitable means providing for sealed-fitting. 
The bulb opening can be large enough to enable filling the bulb with the 
irrigation fluid by simply pouring the irrigation fluid thereinto, 
optionally via a funnel, before fitting the nozzle thereon. The bulb can 
be washed, between uses, in the same manner, after removing the nozzle. 
This facilitates use considerably. 
The nozzle may be made from any suitable rigid material, preferably rigid 
medically compatible plastic material. The base portion of the nozzle, 
which is to be sealingly fitted to the bulb opening, may be provided with 
means for said sealed-fitting, which correspond to the sealing means 
provided on said opening, and which may be threads, O-rings, bayonets or 
any other suitable means providing for sealed-fitting. The nozzle may be 
manufactured in the form of a single, integral part, or it can be mounted 
from separate parts. 
The non-kinking dip-tube can be straight or spiral, and can be made from 
any suitable medically compatible material. Preferred materials are 
polyvinylchloride and other soft plastic materials, rubber, silicon rubber 
and latex. 
The irrigation means, namely tips, probes or needles, are attached to the 
irrigator via the fluid outlet, which is suitably designed or can 
optionally be equipped with means for attaching the irrigation means, such 
means being known in the art. 
The weight which is attached to the free end of the dip tube is made from a 
suitable material having high specific gravity, preferably metal. 
The present invention also relates to a method of treating or preventing 
periodontal disease or of improving oral hygiene, by using the irrigator 
according to the present invention, equipped with a suitable irrigation 
tip or probe, for irrigating interdental spaces and pathologic spaces 
formed between the soft gum tissue and the tooth root with water or a 
suitable medically compatible solution. For example antiseptic/antibiotic 
solutions can be used. 
A preferred embodiment of an oral irrigator according to the invention is 
illustrated in the appended Figures. As may be seen in FIGS. 1 and 2, the 
oral irrigator comprises a bulb (1), which has an opening (2). The second 
part of the oral irrigator is a nozzle (3). The nozzle has a base portion 
(4), which may be sealingly fitted to the bulb opening (2). In the 
illustrated embodiment, the sealed fitting is achieved by means of 
threads. The nozzle (3) is threaded onto the bulb at opening (2) by means 
of threads (5) and corresponding threads on the base portion (4) of the 
nozzle. The threads can be replaced by other sealing means known to the 
man skilled in the art, such as O-rings, bayonets and the like. The bulb 
opening and the base part of the nozzle can also be dimensioned as to 
achieve sealed-fitting by pressure only, pressing the base portion of the 
nozzle into the bulb opening, without the need for any particular sealing 
means. thereof, ending with a fluid outlet (7) at the upper end thereof. 
This fluid outlet is designed to be fitted with any suitable irrigation 
tips, probes or needles (8, 8', 8"). Alternatively the fluid outlet (7) 
may be equipped with means known in the art for attaching the irrigation 
means thereto. 
The nozzle (3) is further provided with an elongate, flexible non-kinking 
dip tube (9). The illustrated did tube is spiral, but it can also be 
non-spiral. One end of the dip tube (9) is accommodated within said lumen 
(6), the free end of said dip tube (10) is provided with a weight (11). As 
may be seen in FIGS. 3A to 3D, the weight (11) ensures that the free end 
(10) of the dip tube to which it is attached is submerged in irrigation 
fluid (12) at any spatial position in which the oral irrigator is held 
(upside-down--FIG. 3A; upright--FIG. 3B; inclined--FIG. 3C; 
horizontal--FIG. 3D). Upon compression of the bulb (1), the irrigation 
fluid (12) is urged via the dip tube, through the opening at said free end 
thereof (10), into the said lumen (6), and from there into the irrigation 
tip (8), through said fluid outlet (7). 
FIGS. 4A and 4B illustrate another embodiment of the present invention in 
which the syringe of FIG. 1 is equipped with one-way valves. In this 
embodiment, the nozzle may be equipped with a one-way valve, which may be 
located within the lumen of the nozzle, which permits exit of the 
irrigation fluid through the nozzle and the irrigation means into the oral 
cavity, but prevents back-flow of oral fluids, e.g. saliva, back into the 
bulb. In this embodiment, contamination of the bulb and of the irrigation 
fluid contained therein by contaminants such as oral bacteria or blood is 
prevented, improving hygiene. Alternatively, this one-way valve may be 
located in other portions of the oral irrigator, such as within the dip 
tube (9) or the irrigation means (8). In this embodiment, a second one-way 
valve may be provided, to permit suction of air into the bulb. This second 
one-way valve prevents the irrigation fluid from escaping therethrough and 
may be situated at any convenient location, for example, at any outside 
wall of the bulb, or on the rigid nozzle. 
As illustrated in FIGS. 4A and 4B, the nozzle (3) may be further equipped 
with a one-way valve (13), accommodated within the lumen (6). The one-way 
valve (13) allows for exit of the irrigation fluid (12) to the irrigation 
means (8), but prevents back-flow of any oral fluids into the bulb (1) and 
irrigation fluid (12). A second one-way valve (14 in FIG. 4A; 14 in FIG. 
4B) permits suction of air into the bulb. As is to be appreciated, 
elements similar to those in FIGS. 1-3 are identified by the same 
reference numerals, and accordingly a further description is omitted 
herein. 
While several embodiments have been described in detail, the invention is 
not limited thereto, and that many modifications and variations may be 
effected by one skilled in the art without departing from the spirit and 
scope of the invention as defined by the appended claims.