Description:Form 2
THE PATENTS ACT, 1970
(39 OF 1970)
And
THE PATENTS RULES 2003
COMPLETE SPECIFICATION
(See section 10: Rule 13)
1. Title of the Invention
Orifice Controlled Nipple Shield Closure System
2. Applicant (s)
(a) Name: Prabhu R
(b) Nationality: Indian
(c) Address:
4/368-A, Gandhi Street,
Srichakra nagar
Annamedu Iyer Bungalow
Madurai
Tamilnadu -625104
3. Preamble to the Description
The following specification particularly describes the invention and the manner in which it is to be performed.

Field of the Invention
This utility model is related to technical field of medical instruments, especially a kind of pediatric nursing medicine feed device.
Background of the Invention
An optimal pediatric formulation should meet the following requirements: low frequency of dosing, an appropriate dosage form for various pediatric age groups, convenient and reliable administration, convenient dose administration devices, minimal impact on lifestyle and daily routines, use of non-toxic and well tolerated excipients, taste masking, and cost-efficient manufacturing. In summary, introducing child-friendly, age-appropriate, formulations and devices is part of an innovative approach to enhance drug acceptability and to improve drug adherence and clinical outcomes.
Medication errors occur frequently in paediatric outpatient clinics, commonly at the medication administration stage. Incidences of medication errors among children and young people can be prevented or reduced. Studies have indicated that improved communication between different healthcare professionals and parents could lead to a reduction of medication harm for a child. Furthermore, convenient medical dose administrative devices and improving dosage instructions on the medication labels provided to parents and caregivers could lead to a decrease in medication errors.
As demonstrated above, medication errors among children and young adults are mainly due to administration errors. Errors due to inaccurate dosing by parents or caregivers account for 50% of all medication errors in children. Different standardised measurement tools exist in the market such as droppers, dosing cups, oral syringes and dosing spoons. Those tools are available to support parents in measuring the child’s dose.
It is imperative that formulations can be administered accurately to ensure the correct dose is provided. Furthermore, acceptability and ease of use of a device with which the product will be administered both from the patient and carer's perspectives is required to facilitate dosing and patient compliance. When developing paediatric formulations, it is therefore important to consider the requirement for a delivery device at an early stage in the development process. The device must be technically capable of delivering the required dose in a “user friendly” way. The need for and type of delivery device will depend upon the formulation, age of patient and route of administration (Jennifer Walsh et al., International Journal of Pharmaceutics, Volume 415, Issues 1–2, 30 August 2011, Pages 221-231).
The interaction of pharmaceutical formulations and their administration device regarding incompatibilities or dosing accuracy are common issues that have to be considered not only in paediatric product development. The viscosity of a drug solution and the design of the corresponding dropper or the dispersing properties of an inhalation powder formulation and the inhalation device used are examples of critical interactions that influence the performance and quality of a pharmaceutical product. These issues are also addressed in regulatory guidance as for instance the reflection paper “Formulations of Choice for the Paediatric Population” by the European Medicine Agency. Frequency and duration of dosing may also have an impact on device requirements (Jennifer Walsh et al., International Journal of Pharmaceutics, Volume 415, Issues 1–2, 30 August 2011, Pages 221-231).
The interaction of pharmaceutical formulations and their administration device regarding incompatibilities or dosing accuracy are common issues that have to be considered not only in paediatric product development.
The availability and technological sophistication of pediatric devices lag behind their adult counterparts by as much as 10 years. Many unique hurdles impact pediatric device development in clinical, technical, regulatory, and financial domains.
Children are physiologically, neurodevelopmentally, and epidemiologically distinct from adults. Their disease processes, even when nominally the same as those in adults, often present differently, and may be diagnosed and treated differently. Medical device developers must consider the progressive growth of pediatric patients, which may impact the size, function, and design of a device. Physiologically, multiple organ systems, such as the cardiovascular, respiratory, and renal systems change from childhood to adulthood, with significant implications for medical devices (Juan Espinoza et al., Pediatrics, Volume 149, number 5, May 2022: e2021053390).
Developmentally, devices that require active participation from the patient may not be appropriate in younger children. For example, dry powder inhalers are difficult for young children to use in the management of asthma. Activities of daily living are also specific to the age of the patient. The types of play and physical activities in certain groups have often caused unexpected problems (Juan Espinoza et al., Pediatrics, Volume 149, number 5, May 2022: e2021053390).
The smaller size of children can pose engineering challenges. Some technologies cannot be miniaturized or are less effective when made smaller. In some cases, miniaturization requires that a completely different technology be used. Further, devices that can expand with the child’s growth can be difficult to engineer (Juan Espinoza et al., Pediatrics, Volume 149, number 5, May 2022: e2021053390).
Several of the regulatory pathways discussed above can be used by paediatric devices, but none were designed specifically for paediatrics. It is difficult to conduct trials on small numbers of patients from heterogeneous populations spread across many institutions. Further, study blinding is difficult to ensure.
Medical device expertise may be lacking in the local IRB, which may delay approvals. Patients can be difficult to recruit if parents are hesitant, and ethical challenges surround how and when device research should be conducted in critically ill children. All of these issues can serve as barriers for generating the data needed for a regulatory application. For Class III products, pivotal trials, which are generally intended to be the primary source of clinical data to demonstrate a “reasonable assurance of safety and effectiveness,” can be particularly difficult for paediatric devices. For Class II devices seeking regulatory clearance, identifying an appropriate predicate may be difficult, if no similar devices have yet been approved for use in children. After approval, postmarket surveillance can also be challenging with pediatric populations. The overall complexity of medical device regulation has increased over the past several decades, and the associated regulatory uncertainty and increased time to clearance or approval creates additional financial pressures that small pediatric medical device developers may be less able to tolerate ((Juan Espinoza et al., Pediatrics, Volume 149, number 5, May 2022: e2021053390).
Several strategies have been suggested to support pediatric medical device development, including most recently in a report from a group of subject matter experts and industry stakeholders that focused on regulatory changes. These include measures to increase funding opportunities, reform certain regulatory disincentives, develop a supportive ecosystem, create novel incentives, and advocate for legislative changes. A number of organizations and stakeholders are actively engaged in these strategies to advance pediatric medical device innovation.
Thus, a need exists for improved methods and devices for delivering drugs, and in particular, to infants and children weighing less than 15 kg.
Summary of the Invention
The present invention provides for a new and unique technique, device or feature that enables a direct fluid flow measurement to be obtained through an orifice plate that can be temporarily employed in any system with a means of pressure dependent flow regulation and requiring constant flow.
The object of the present invention is to provide a container with a double compartment which be lower and upper compartment and in-between having an orifice plate which is rotatable and where it holds a dip tube placed in it.
The object of the present invention is to provide a container with a double compartment which be lower and upper compartment, when pressure applied in lower compartment, the dip tube which pulls up liquid dosage form content from lower to upper compartment.
The object of the present invention is to provide a container with a double compartment which be lower and upper compartment, wherein the upper compartment has the graduations as 1ml, 2ml, etc are drawn on outer side. The graduations help to show the amount of pressurized liquid in upper part.
The object of the present invention is to provide a container with a double compartment which be lower and upper compartment and in-between having a rotatable manually adjustable orifice plate adjustable by rotation. The orifice plate helps to prevent backward flow of liquid and remove excess amount of liquid in upper part, in case high. Once action is done, the orifice plate be closed by rotating a plate to 180?. Once the prescribed amount of medication filled in upper compartment, the dip tube goes inside the lower compartment for preventing the contamination by rotating the upper part to 180° and for projection in upper part, it again rotated to anticlockwise direction at 180°.
The object of the present invention is to provide a container with a nipple shield closure system. Nipple shield orifice is made as per appropriate age group children. Nipple shield closure helps children for easy administration of liquid dose as per prescribed amount.

BRIEF DESCRIPTION OF THE DRAWINGS
Other objects, features and advantages of the present invention will become apparent from the detailed description of the invention which follows, when considered in light of the accompanying drawings in which:
FIG. 1 shows a perspective view of the liquid dispensing and administering system
FIG. 2 shows a top view of the rotatable orifice plate
FIG. 3 shows a perspective view of upper compartment and Nipple shield closure system
FIG. 4 shows cross-sectional view of container

Description of the Invention
Far close to the past two decades, researchers concern with the development of oral dosage forms and administrative devices for the paediatric and bed ridden patients’ needs. It all because of immature organs development in paediatrics. The critical factors are safety, efficacy, and quality of finished products. Modification of existing devices still under the research for administration of novel drug delivery system.
Novel drug design involves helps in maintaining the dose accuracy and flexibility in drugs. Some approaches like, the container with a double compartment which be lower and upper compartment and in-between having an orifice plate with knob and which it holds a dip tube placed in it.
In the drawings, FIG. 1 shows a series of components which can be used to form a liquid dispensing apparatus for delivering liquid from a single bottle, or which can be used for other purposes as well.
FIG. 1 is a perspective view of an exemplifying embodiment of a liquid-dispensing container 10 that has a first configuration in which the container can dispense liquid through a dip tube 5. Therefore, the container 10 can be used and may allow liquid to be easily and conveniently stored, transported and consumed. The lower compartment 4 dispense the liquid through dip tube to the upper compartment 2. The rotatable orifice plate 3 is placed between the upper compartment 2 and lower compartment 4. The container is closed with a nipple shield closure system 1. The Nipple shield orifice is made as per appropriate age group children and helps children for easy administration of liquid dose as per prescribed amount.
FIG. 2 illustrates an exploded view of the rotatable orifice plate 3 of FIG. 1 from a first perspective. As used herein, the term “dispense” may include allowing fluid to be removed or released from a container under the influence of external force(s) and/or action(s), e.g., suction through a straw or squeezing of the container.
When pressure applied in lower compartment, the dip tube which pulls up liquid dosage form content from lower to upper compartment.
The graduations as 1ml, 2ml, etc are drawn on outer side of upper compartment 2. The graduations help to show the amount of pressurized liquid in upper part.
The orifice plate 2 helps to prevent backward flow of liquid and remove excess amount of liquid in upper part, in case high. Once action is done, the orifice plate be closed by rotating a plate to 180°. Once the prescribed amount of medication filled in upper compartment, the dip tube goes inside the lower compartment by rotating the upper part to 180° and for projection in upper part, it again rotated to anticlockwise direction at 180°.
The container is closed with a nipple shield system 1. Nipple shield orifice is made as per appropriate age group children. Nipple shield closure helps children for easy administration of liquid dose as per prescribed amount.
When baby sucked the medications, the air flow from the baby mouth which causes the oxidation of medications. This should be overcome by the internal vent system. It helps reducing negative pressure and air bubbles.
The internal vent system prevents the air flow which interacts with the medications. The mechanism be airflow which goes to the bottom of the container and doesn’t get react with it and gives a continuous flow of medicament to a baby.
The dip tube which projects out in upper compartment may have a chance of oxidation of medicines in lower compartment by the air flow. This is to be prevented by rotatable upper compartment.
Once the prescribed amount of medication filled in upper compartment, the dip tube goes inside the lower compartment by rotating the upper part to 180° and for projection in upper part, it again rotated to 180°.
Fig 3 shows a perspective view of upper compartment 2 and Nipple shield closure system 1.
Fig 4 shows cross sectional view of container.
The vessel can be made of metal, glass, plastic, ceramic, or other materials, or combinations thereof. In some embodiments, the vessel may be at least partially constructed of a readily deformable and/or squeezable material, such as certain plastics or other materials or combinations thereof. For example, the vessel may be constructed from a material that allows the vessel to be squeezed and then resiliently return to at least generally the same shape and configuration as it had prior to the squeezing. The vessel may have an opening sufficiently large to allow the container to be easily filled, cleaned, and/or washed. One of ordinary skill in the art will appreciate, after reviewing this disclosure, that the vessel could have shapes, sizes, configurations and/or arrangements different than that of the illustrated vessel 10, depending, for example, upon the intended use of the container.
, Claims:1. A fluid dispensing container comprising: a. upper compartment b. lower compartment c. rotatable orifice place placed located in-between the two compartments and d. nipple shield closure system, wherein the rotatable orifice plate holds a dip tube placed in it; wherein the pressure applied in lower compartment, the dip tube which pulls up liquid dosage form content from lower to upper compartment.
2. The fluid dispensing container as claimed in claim 1, wherein the upper compartment has the measuring graduations on the outer side.
3. The fluid dispensing container as claimed in claim 1, wherein the outer side graduations help to show the amount of pressurized liquid in upper part.
4. The fluid dispensing container as claimed in claim 1, wherein the orifice plate helps to prevent backward flow of liquid and remove excess amount of liquid in upper part, in case high.
5. The fluid dispensing container as claimed in claim 1, wherein the orifice plate be closed by rotating a plate to 180? once prescribed amount of medication filled in upper compartment.
6. The fluid dispensing container as claimed in claim 1, wherein the dip tube goes inside the lower compartment for preventing the contamination by rotating the upper part to 180° and for projection in upper part, it again rotated to anticlockwise direction at 180°.
7. The fluid dispensing container as claimed in claim 1, wherein the lower compartment means being formed of a transparent material.