Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-07-28
2002-01-08
Mendez, Manwel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06336912
ABSTRACT:
TECHNICAL FIELD
The present invention relates to an apparatus and method for modifying and feeding a liquid nutritional feeding composition, in particular to its modification by adding a beneficial agent to the liquid feeding composition, before feeding said liquid feeding composition.
BACKGROUND
It is known to enterally or intravenously feed liquid nutrition to patients who are not able to eat by themselves. Such liquid meals are normally provided in hangable containers such as bottles or plastic bags and are fed from the containers through a tube to the patient. A number of different liquid nutritional feeds are available for varying the nutritional intake of the patient. Nevertheless, there is a need to tailor the liquid meals to the patient's individual needs. This is known to be done by adding beneficial agents such as for example nutrients, probiotics and medicaments to the liquid nutritional feed. The adding of such beneficial agents should, for some applications, preferably take place just before the feeding starts as a premature mixing of the liquid nutritional feed and the beneficial agent may considerably decrease the quality and shelf-life of the liquid nutritional feed.
The liquid meals provided in hangable containers such as bottles or plastic bags are generally aseptically processed or terminally retorted before use. This increases the shelf life of the liquid meal. For providing an aseptic feed to the patient, the container is connected directly via a feeding tube or line to the patient. Any opening of the system for adding a beneficial agent increases the risk for bacterial growth or contamination.
A closed-line system for the modifying and feeding of patients is therefore desirable.
The prior art discloses closed-line systems wherein a liquid nutritional feeding composition is passed through a chamber comprising a beneficial agent before entering the patient feeding line. The beneficial agent is mixed or dissolved in the liquid nutritional feeding composition when it passes through the chamber.
In order to homogenise the feed to the patient in this type of feeding system and thus prevent an over concentration of the beneficial agent, it is necessary to control the release of the beneficial agent. Consequently, a beneficial agent in controlled release form is used, i.e. an agent the solubility of which is delayed or retarded. For example, supplying of the liquid nutritional feed releases the beneficial agent over a period of 2 to 24 hours. Furthermore, although the controlled release form allows the beneficial agent to be released over a period, in-homogeneity may be experienced in the start-up phase due to the protective coating on the beneficial agents.
SUMMARY OF THE INVENTION
It is an object of the invention to provide an improved system for modifying and feeding a homogeneous mixture of a liquid nutritional feed and a beneficial agent. In particular to provide a delivery apparatus useable with a beneficial agent in a non-controlled release form.
It is a further object of the invention to provide a closed-line system for modifying and feeding a mixture of a liquid nutritional feed composition and a beneficial agent by allowing the operations to take place without opening the system to bacteria or contamination.
Accordingly, in a first aspect, the invention concerns an apparatus for modifying and feeding a liquid nutritional feeding composition comprising,
a chamber for receiving a beneficial agent for modifying a liquid nutritional feeding composition, the chamber having an inlet connectable to a container containing the nutritional feeding composition and an outlet connectable to a feeding means, and
a pumping means associated with the chamber for pumping the nutritional feeding composition from the container into the chamber and back to the container for mixing the beneficial agent into the nutritional feeding composition.
Thus, the present invention provides an apparatus for modifying and feeding a liquid nutritional feeding composition which allows the addition of a beneficial agent to the liquid feed immediately before the feeding commences, which addition of the beneficial agent is done without an opening and reclosing of the system. The mixing of the beneficial agent and the liquid feeding is conducted by pumping means arranged to pump liquid feed from the container into the chamber and liquid and beneficial agent back into the container. After end mixing, the chamber is connected to feeding means for feeding of the mixture to the patient.
It has been found that a homogeneous modification and feeding can be obtained with the feeding system according to the invention. Furthermore, it has been found that the mixture of liquid feed and the beneficial agent is stable during 48 hours' feeding.
In a particularly advantageous embodiment of the invention the pumping means is adapted to vary the volume of the chamber being used for pumping of the nutritional feeding composition. Especially preferred is an embodiment of the invention wherein the chamber comprises at least one flexible wall capable of being squeezed and released for pumping of the nutritional feeding composition. For example, a wall of plastic material has flexibility which allows a deformation of the wall.
For the embodiment of the above-mentioned flexible wall type, in order to obtain an appropriate pumping effect and thus limit the number of pumping cycles necessary for the mixing of the beneficial agent with the liquid, the chamber should not be too full of the beneficial agent. Conveniently, at least 30% of the volume of the chamber is empty in the un-squeezed state. Preferably, the volume of beneficial agent constitutes from 5% to 70%, preferably from 30% to 50% of the volume of the chamber. The limits of the ratio filled and un-filled volume will depend on the solubility of the product.
The liquid nutritional feeding composition is of a conventional type. The liquid nutritional feeding composition may comprise from 0 to 25% protein, from 0 to 50% lipids, and from 0 to 60% carbohydrates. For example, it may comprise about 15% protein, about 35% lipids, and about 50% carbohydrates. The water content is preferably from 70 to 95% by weight.
The chamber may be delivered as a sealed unit comprising the beneficial agent. Alternatively, the chamber may be filled with the beneficial agent at the location where the treatment is to take place.
The connections between the container, the chamber, and the feeding means are preferably as follows: an inlet is provided with a hollow spike for piercing of a port of the container and creating a fluid path for the nutritional feeding composition. The feeding means comprises a hollow spike for piercing the outlet of the chamber and creating a fluid path for the nutritional feeding composition with the beneficial agent. The piercing of the outlet of the chamber is done after end mixing. The present system of connection allows for on-line feeding of an aseptic liquid nutritional feeding composition with a beneficial agent.
The flow from the container to and through the feeding tube means may be due to gravity alone, but preferably the flow from the container to and through the feeding tube means is assisted by a pump.
The beneficial agent is dispersible in the nutritional liquid feed. By dispersible is understood, soluble as well as agents that are suspendable so as to be mixed with the liquid feed and forwarded herewith.
The beneficial agent or agents is/are, for e.g., selected from the group consisting of nutrients, probiotics, medicaments and diagnostic tracer or a physiological combination thereof.
It is preferred that the beneficial agent(s) is/are dispersible in the nutritional feeding composition in less than 1 min, more preferably in less than 30 sec.
For beneficial agents that are stable in liquid conditions, the agents may be provided in liquid form. Even if the beneficial agent is stable in a certain liquid formulation, a mixture of the liquid nutritional feeding composition and the liquid beneficial agent may not be stable for a longer
Mendez Manwel
Nestec S.A.
Winston & Strawn
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