Vaginal douching and/or enteroclysm device

Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...

Reexamination Certificate

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Reexamination Certificate

active

06503220

ABSTRACT:

TECHNICAL FIELD
The present invention relates to a vaginal douching and/or enteroclysm device with an electric pump.
BACKGROUND ART
The administration of drugs for topical local-regional use represents a great period of therapeutical importance in diverse illnesses which affect various anatomical regions. It is enough to remember, amongst all of them, the use of eye-washes in multiple ocular illnesses or of mouth-washes in certain pathological oro-pharyngeal processes.
In the same manner, there are numerous vaginal and rectal pathological conditions which require a local therapy respectively by douching and clysis.
In the gynaecological field the use of vaginal washes has, moreover, not only a therapeutic aim, but there also exists the considerable diffusion of this finalised practice also simply for personal hygiene.
In the proctological field, beyond the frequent recourse as much by the general population as in hospital environments to clyster for evacuational purposes, there is to be considered the notable incidence and prevalence in the western world of chronic intestinal inflammatory pathologies both specific and aspecific prevailingly rectal and sigmoidal localising which require a local therapy with specific antiinflammatory drugs.
The traditional systems used as much for vaginal douching as for enteroclysm employ containers connected to cannulas which allow the exit of the washing fluid only by gravity or by means of manual pressure.
These systems so assembled do not allow to regulate the nature and duration of the flow, such that in the major part of cases the douching does not reach the desired effectiveness, given that, for a correct cleansing and/or disinfection of the mucous membranes, the volume of solution which makes contact with the targeted mucosa and the time of the contact itself are equally important. This is equally valid in the gynaecological field and in the colon-proctological field.
Moreover, the common systems adopted for enteroclysm, in fact, show the same cited disadvantages for vaginal douching with the aggravating circumstance that a possible non-correct orientation of the douching cannula, for example erroneously placed in direct contact with the rectal wall, brings about the inevitable result of a scarce effectiveness of the clyster itself, with the consequence of an increase of the number of days of therapy and/or of the daily administration of the drug.
U.S. Pat. No. 5,097,540 discloses a self-contained hand-held bidet comprising a pistol configuration housing which contains a pump, and which carries controls and support for a retractable conduit with a nozzle end for spraying a stream of fluid from a reservoir mounted at one end of the housing. The retractable conduit and nozzle end are configured such that during use of the self-contained hand-held bidet, a stream of fluid is directed to the desired area but sufficiently away from the conduit and nozzle end for preventing soiling or contaminating material from the lavaged area from coming into contact with any part of the self-contained hand-held bidet, which is thus for external use.
WO-A-86 00535 discloses an irrigation device for personal hygiene comprising a torch-like case containing a battery electrical source for supplying, through a manually-operated external contol member mounted on the case, an electric motor fitted in the case which drives an centrifugal pump which is also fitted in the case and into which lead an intake pipe for an irrigating liquid and a delivery pipe connected to a tube having a shaped end with delivery nozzles for the liquid for insertion into the intimate part to be irrigated.
FR-A-2 135 144 discloses a portable compact electric douche for being held directly in a user's hand and having a nozzle element for insertion to a desired length within the vagina. The douche includes a casing containing an electric motor, battery, and switch for pumping douching fluid to the nozzle element, from a reservoir, in the form of a disposable sealed plastic bag, connected to the douche by a hose.
GB-A-2 063 674 discloses a portable medical treatment device including an injection nozzle configured to enter an ear cavity or wound. The device includes a pistol-shaped housing containing a pump, an electric motor for driving the pump, and a switch for the motor, operated by a trigger carried by the housing. A tube connects the injection nozzle, carried by the housing, to the pump, which is also connected to a cleaning fluid reservoir by means of a flexible tube extending away from the housing.
It is a general object of the present invention to provide improvements in vaginal douching and/or enteroclysm devices.
DISCLOSURE OF THE INVENTION
In accordance with one preferred aspect of the present invention, there is provided a variable pressure and controlled electric pump for vaginal and/or rectal douching with natural and/or medicated liquids for local use, which allows to obtain, with respect to conventional methods, a more effective and controlled douching, favouring an improved hospital or domestic utilisation with the use of single-use endovaginal or rectal cannulas.
The vaginal douching and/or enteroclysm device of the invention in a preferred embodiment comprises an electric pump with a velocity switch lodged in a plastic material container, a liquid container, replaceable with ready medicated containers, a flexible tube for liquid passage, through the pump, from the container to the cannula, ergonomic grip holder with open and close command for the passage of liquid, and the vaginal and/or rectal cannula.
The present invention offers the following significant advantages with respect to the traditional systems:
a) increased convenience of use, for the possibility to adequately direct the flow of douching fluid due to the anatomicalness of the grip holder of the douching cannula and to the presence on the same of the on/off control, which allows the patient to focus his own attention exclusively on the correct positioning of the cannula rather than on the injection of the therapeutic solution which, in systems in use up to now, require the use of both hands in order to exert the correct pressure adapted to its exit; for the preventive regulation of the velocity of the douching flow in relation to the anatomical seat and to the pathology to treat; for the absolute management autonomy of the system on the part of the user;
b) greater therapeutical effectiveness, in that the constancy of the flow offers the possibility of an increased duration of the douching with an equal volume of solution administered, which translates in a more prolonged contact of the mucosa with the drug and, consequently, in an increased therapeutical effectiveness;
c) optimal cost/benefit ratio, in that the lesser cost of each single therapeutic cycle due to the improved utilisation of the drug permits the rapid recovery of the amount spent on the acquisition of the system:,
d) hygienic security, for the impossibility of reflow of the solution in the context of the washing system by the unidirectionality of the flow which saves the solution container from possible external contaminations. This is of particular importance in case of prolonged cyclic therapeutics for the convenience of carrying out a single loading of the reservoir, usable also in successive days. Moreover, the availability of single-use reservoirs obtains an easy utilisation also in hospital environments where the system may be employed on more patients with the simple substitution of the douching cannula and of the reservoir, with a consequent notable reduction of the technical times on the part of the nursing personnel.


REFERENCES:
patent: 3762411 (1973-10-01), Lloyd et al.
patent: 4622704 (1986-11-01), Chung
patent: 5081999 (1992-01-01), Hemstreet
patent: 5097540 (1992-03-01), Lovitt
patent: 5669394 (1997-09-01), Bergey et al.
patent: 5746721 (1998-05-01), Pasch et al.
patent: 5864895 (1999-02-01), Ota et al.
patent: 5941851 (1999-08-01), Coffey et al.
patent: 6059754 (2000-05-01), Pasch et al.
patent: 2135144 (1972-12-01), Non

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