| JP2008036367 | PACIFIER |
| WO/1992/011836 | LOW BIRTH WEIGHT INFANT PACIFIER |
| US5127903A | 1992-07-07 | |||
| US2612165A | 1952-09-30 | |||
| US5013321A | 1991-05-07 |
| 1. | MEDICAL DEVICE FOR DRUG CONTROLLED RELEASE IN THE MOUTH, characterised for being basically composed by a tubular deposit (3), a retention piston or embolus (4), a unidirectional valve (7) (that could be a sphere or a membrane valve) avoiding the reflux and a exit pore, all located inside the rubber teat (5). MEDICAL DEVICE FOR DRUG CONTROLLED RELEASE IN THE MOUTH, according to claim 1 , characterised for allowing the release of a small amount of drug solution which is accompanied by the advance of the retention piston towards the exit pore at the extremity of the rubber teat in which this advance of the retention piston corresponds to the volume of the administrated solution and is a result of an equilibrium between the internal pressure of the tubular deposit and the external pressure of the mouth. MEDICAL DEVICE FOR DRUG CONTROLLED RELEASE IN THE MOUTH, according to claims 1 and 2, characterised by being supported to take advantage of the babies suction reflex for the slow and prolonged release of drug solutions, generating, in the adequate dosage for each age, an increase of direct mouth drug absorption, avoiding the adverse effects that could result of the systemic absorption of the drug. MEDICAL DEVICE FOR DRUG CONTROLLED RELEASE IN THE MOUTH, according to claim 3, characterised by the exit of the solution being slowed by an increase of its own viscosity (gel) and also by the existent friction between the retention piston seals (4.2.2.2) and the walls of tubular deposit, being this friction an opposite force of the movement of the retention piston when it slides along the tubular deposit in direction of the exit pore, during the emptying process generated by the suction reflex.. MEDICAL DEVICE FOR DRUG CONTROLLED RELEASE IN THE MOUTH, according to claims 1 to 4, characterised by the system being user friendly in its usage and by guaranteeing with precision the dosage administered needing to that effect outside the tubular deposit (3) in the rubber teat, a scale level which allow the adjustment of the volume of the solution/gel to the posology indicated for each situation. |
MEDICAL DEVICE FOR DRUG CONTROLLED RELEASE IN THE
MOUTH "
This invention concerns a metered dose device for the controlled release of drug solutions in the mouth and is located in the rubber teat.
The administration of the drug can be adjustable to the required posology.
In the case of fluoride salts it is generally accepted that the efficiency of this element in the dental caries prophylaxis.
The dental caries prophylaxis has its beginning during pregnancy and is prolonged until the adolescence, period in which the new dentition is terminated.
Apart from the importance of this ion in the odontogenesis, the fluoride salts have an important role in the increase of bone density.
According bibliography, fluoride is deposited predominantly in the bones and teeth. Fluoride can be incorporated in the teeth by a systemic way or by a direct contact in mouth rinses ( Martindale - The Extra Pharmacopoeia - 31 st ed. p. 1752) .
The aim of this device is to lower the amount of systemic fluoride that is absorbed by the teeth, and increase the amount of fluoride that can be
incorporated in the teeth by direct exposure and by local mucosa absorption.
This device took as a starting point the existence of the innate suction reflex in new-borns which led to the generalised usage of rubber nipples, accounting as well for the fact that is already a current practice the oral administration of fluoride salts in the dental caries prophylaxis.
The central idea consists on the possibility of incorporating in the rubber teat a metered dose device for a slow release of fluoride solutions in the mouth.
The objective is the reduction of the systemic fraction of fluoride administered and an increase in the time of the teeth's exposure to fluoride, thereby intensifying its direct absorption and its absorption by buccal mucosa.
The continuos use of this device with fluoride salts may render the enamel of teeth more resistant to acid, promote remineralization, or reduce microbial acid production.
This is a friendly use device and offers an high accuracy in the drug administration in the fulfilment of indicated posology for each age.
This device is composed by a tubular deposit (3) made from the same material of the rubber teat (silicon in preference) longitudinally located inside the rubber teat.
Inside this tubular deposit (3) there is a retention piston (4) with a similar function to the syringe embolus adjusting the liquid volume against the pore (6) located at the rubber teat extremity.
At the opposite side, in the rubber teat, there is a opening (2) with a cover that has a breathing pore through which the feeding of de tubular deposit is
carried out with the help of the capillary tube (8) of the supplier flask (1).
The capillary tube of the supplier flask fits in the small coupler notch (4.1.1) of the mobile shaft (4.1), connected with the retention piston.
As the capillary tube rotates clockwise overlaps in the outside the window of the mobile disc (4.1.5.1) to the existing window in the rigid disc (4.2.2.1) and internally, inside the mobile shaft of the retention piston (4.1) overlaps the hub cap of the mobile shaft (4.1.3) with the hub cap of the fixed shaft ( 4.2.1), allowing the feeding of the tubular deposit with the drug solution.
The air that was inside this space is released through the windows (4.1.5.1 and 4.2.2.1) of moving disc (4.1.5) and fixed disc (4.2.2) of the retention piston (4) which are now coincident.
After achieving the prescribed amount of solution, we must eliminate the air from the tubular deposit, placing the retention piston against the solution level.
Then the capillary tube of the supplier flask is turned around in the opposite sense closing thereby the internal (4.1.3 and 4.2.1) and external valve (4.1.5.1 and 4.2.2.1) of the retention piston (4) and the capillary tube (8) of the supplier flask can be withdrawn and the cover (2) is closed.
These steps are carried out with the rubber nipple in the vertical position with the pore looking down.
The rubber nipple is now ready to be used and it may have any other position.
During its utilisation, the suction by the child generates a pressure gradient between the tubular deposit and the mouth forcing the drug solution to leave
the tubular deposit through the minuscule pore which exists in the extremity of the rubber teat.
The exit of the drug solution out of the tubular deposit is accompanied by a slow descent of the retention piston (4) towards the pore (allowed by the air entrance through the breathing pore (2)of the cover, at the opposite side) such that it compensates the negative pressure formed inside of the tubular deposit when the suction stops, avoiding the admission of saliva, which would result in an undesirable contamination of the deposit through the buccal microbes.
In order to do that it becomes necessary to balance the friction of the retention piston along the tubular wall with the negative pressure resulting from the suction in a way to maintain a slow and unidirectional flow in the system.
The unidirectional flow may be achieved trough a check valve (ball or membrane valve) ( (7) - Fig. 2) before the pore (6) of the rubber teat according to the shown drawings.
This Utility Model is next illustrated in a non limitative mode with drawings in a way of preferred conception of the metered dose device where:
Fig 1 - Shows in a longitudinal plan the metered dose device located inside the rubber nipple.
- (1) - Supplier flask.
- (2) - Inlet cover of the tubular deposit with the breathing pore.
- (3) - Tubular deposit in core of the rubber teat.
- (4) - Retention piston.
- (5) - Rubber teat.
- (6) - End pore of the rubber teat.
- (7) - Unidirectional valve (check valve).
- (8) - Capillary tube of supplier flask ( it fits in the mobile shaft ).
Fig 2 - Shows in a longitudinal plan a detail and the location of the unidirectional valve.
- (3) - Tubular deposit.
- (5) - Rubber teat.
- (6) - End pore of the rubber teat.
- (7) - Unidirectional valve (ball valve in this case).
Fig 3 - Shows a detail of the retention piston
- (4) - Retention piston. - (4.1 ) - Mobile shaft.
- (4.1.1) - Small coupler notch (barrel cam) where the capillary tube of the supplier flask fits in the mobile shaft.
- (4.1.2) - Stabilising disc of the mobile shaft (to maintain the mobile shaft parallel to the tubular wall).
- (4.1.3) - Hub cap of the mobile shaft.
- (4.1.4) - Circular cam that fits the mobile shaft to the fixed shaft.
- (4.1.5) - Mobile disc.
- (4.1.5.1)- Triangular window of the mobile disc.
- (4.1.5.2)- Support sealers between the mobile and the fixed disc.
- (4.2) - Fixed shaft.
- (4.2.1) - Hub cap of the fixed shaft.
- (4.2.2) - Fixed disc.
- (4.2.2.1) - Triangular window of the fixed disc.
- (4.2.2.2) - Fixing seal of fixed disc to the internal wall of tubular deposit.
- (8) - Extremity of the capillary tube of the supplier flask with the fixation holes.
Fig 4 - Shows a cross cut of the retention piston at level of the mobile disc.
- (4.1.5) - Mobile disc.
- (4.2.2.1) - Triangular window of the fixed disc ( in an inferior level).
- (4.2.1) - Hub cap of the fixed shaft ( in an inferior level ).
- (4.1.3) - Hub cap of the mobile shaft ( in an superior level ).
- (4.1.5.1) - Triangular window of the mobile disc ( in an superior level ).
Fig 5 - Shows a lateral perspective of the coupling system of the mobile shaft with the fixed shaft.
- (4.1) - Mobile shaft.
- (4.1.3) - Hub cap of the mobile shaft.
- (4.1.4) - Circular cam that fits the mobile shaft to the fixed shaft.
- (4.1.5) - Mobile disc.
- (4.2) - Fixed shaft.
- (4.2.1) - Hub cap of the fixed shaft. - (4.2.2) - Fixed disc.
- (4.2.3) - Circular cam that fits the fixed shaft to the mobile shaft.
The stabilising disc was skipped in fig. 5, in order not to surcharge the picture drawing.
The mechanisms that slow the exit of the drug solution/gel lie in the pore dimension, in the viscosity of the drug solution/gel and in the friction between the tubular wall and the fixed disc of the retention piston, more specifically between the fixing seal of fixed disc (4.2.2.2) and the internal wall of tubular deposit (3).
This force counteracts the movement of retention piston (4) when it slides along the tubular deposit towards the ending pore (6) during the emptying process which is caused by suction.
When the drug solution/gel runs out, the retention piston is directly aspirate by the suction force and stays against the unidirectional valve (7) blocking it transforming this device in a normal rubber nipple.
The solutions to be used in this device should have no flavour such that the child does not realise when the solution runs out of the rubber nipple.
Next Patent: SUSTAINED RELEASE OXYCODONE FORMULATIONS WITH NO FED/FAST EFFECT