MXPA97005137A - Alteration of nutritional product during food by tube ente - Google Patents

Abstract

An apparatus and method are described for modifying a liquid enteral nutrient product during its application from a supply (22) to a feeding tube (23) that delivers the modified liquid enteral nutrient product to the gastrointestinal tract (25, 26) of a patient. At least one benefit agent is provided that is not in a controlled release dosage form in a useful amount or dose (32) within a formulation chamber (27), to be recovered in a liquid enteral nutrient product that traverses the formulation chamber (27), while feeding the modified nutritional product to the gastrointestinal tract of a patient. The beneficial additives are selected from nutrients, medicaments, probiotics, or diagnostic agents, or diagnostic agents, or mixtures thereof, each in a dosage form that can be dispersed in the medium of the liquid enteral nutrient product. less than two hor

Description

ALTERATION OF NUTRITIVE PRODUCT DURING FOOD BY ENTERAL TUBE an? T? '? The invention relates to an apparatus and method for feeding liquid enteric nutritive products, and particularly to the modification of a liquid enteral nutrient product having a viscosity on the scale of 1 to about 300 centipoise (cps), by addition of ingredients, during feeding, to the gastrointestinal tract of a patient.

Background of the Invention Feeding a liquid enteral nutrient product from a collapsible container, such as a bottle or a plastic bag with an outlet at the bottom that connects with a drip chamber, and the latter with a flexible tubing, or lumen, which leads to a nasogastric tube or a feeding tube inserted through a gastronomy or jejunostomy, by gravity flow or auxiliary by a pump, is well known. The liquid enteral nutrient product can be processed aseptically or terminally distilled, and can be supplied in a pre-filled container, ready to be hung, or it can be placed in this container by an assistant. However, the selection of diets, particularly special diets, from the rather modest number of liquid enteral nutrient products typically available, is limited. As a practical matter, this narrows the physician's choices regarding diet modifications, temporary or long-term, that could significantly benefit the patient. In view of the now recognized importance of providing aseptic nutritional compositions, it can be seen that modified diets are not easily prepared without observing the strict requirements necessary to deliver an aseptic nutrient composition to the patient. Until now, the need to observe these requirements has militated against the preparation of small amounts of special diets designed for a specific patient. Moreover, a number of nutrients, as well as drugs, diagnostic agents, and other ingredients such as probiotics, which at any given time might be desirable to orally administer to a patient, are not stable during heat sterilization, or may not be mutually compatible with other desired ingredients over an extended period of time, such as days or even months until used, and therefore, are not easily susceptible to large-scale preparation and consequent storage as the product moves through trade.

Although it has been the practice for some time to use a container, such as a collapsible container, to apply a liquid enteral nutrient product through a drip chamber, and connect the flexible tubing to a feeding device, such as a feeding tube that extends to the gastrointestinal tract of a patient, as far as is known, there has been no attempt to use the drip chamber as a formulation chamber in this feeding system, and by adding ingredients such as medications or additional nutrients to a Enteral nutritive product that flows at the moment of administering the nutritive product to the gastrointestinal tract of a patient. The liquid enteral nutrition products currently on the market are described in the reference text "Nutrition In Critical Care," Gary P. Zaloga, ed., Mosby - Year Book Inc., St. Louis, MO, 1994, in Chapter 24, by the author Barbara Hopkins, Part III, "Feeding", pages 439-467. This reference indicates that complete nutrient compositions contain proteins, carbohydrates, fibers, fats, and vitamins and minerals in an aqueous medium.

SUMMARY OF THE INVENTION A first aspect of the invention relates to an apparatus for modifying a liquid enteral nutrient product by adding ingredients thereto during application from a supply thereof., such as a collapsible container, to a feeding tube that delivers the liquid enteral nutrient product to a patient's gastrointestinal tract. The apparatus comprises: a formulation chamber, usually in the form of a drip chamber, which can be connected to a supply container of a liquid enteral nutrient product, typically an aqueous composition, to receive the contents of the supply container from the the same, the formulation chamber having an inlet and outlet, a useful amount of at least one beneficial agent placed inside the formulation chamber, to make contact with, i.e., be moistened by, or submerged in, an enteral nutrient product liquid passing through the formulation chamber during enteral feeding, each beneficial agent in the formulation chamber being dispersible in the medium of the liquid enteral nutrient product employed, and being free of any coatings, or wraps or controlled release mechanisms, i.e., being in an uncontrolled release dosage form, and each agent being selected b enfico from the group consisting of nutrients, drugs, probiotics, and diagnostic agents, and a fluid communication element that connects the outlet of the formulation chamber with a tube to feed the modified enteral nutrient product, which contains the minus a beneficial agent thus added, to the gastrointestinal tract of a patient. Each at least one beneficial agent to be added in an uncontrolled release dosage form during feeding is preferably added in at least one physiologically effective or diagnostically detectable amount, and is selected from the group consisting of: nutrients; medicines; probiotics; and diagnostic agents; and chemically and physiologically compatible combinations thereof; and any of the above beneficial agents or combinations thereof together with at least one marker dye or combination of physiologically acceptable dyes compatible with the beneficial agent, the latter being in a sustained release dosage form, the dye or dyes being soluble in the medium of the liquid enteral nutrient product. The formulation chamber is usually a conventional drip chamber which here also serves as the formulation chamber. If desired, one or more additional formulation chambers, which are not necessarily drip chambers, may be employed in order to introduce a greater amount of a given beneficial agent or mixture thereof, or to add additional beneficial agents and / or marker dye when it is not readily available in combination, or are not compatible during storage together in the formulation chamber of a feeding set. Each additional formulation chamber will have placed therein: (1) a useful amount of at least one beneficial agent, each of which is not in a controlled release dosage form, or (2) at least one labeling dye in a sustained release dosage form, or (3) both at least one beneficial ingredient, each of which is not in a controlled release dosage form, and at least one label dye in a controlled release dosage form. Each additional formulation chamber can be connected in series as part of the fluid communication element. In each formulation chamber, the liquid enteral nutrient product flows over the content thereof. If desired, two supply vessels can be used in parallel with the inputs of the respective formulation chambers connected to the respective supply vessels, and with the respective outputs of the formulation chambers connected by fluid communication elements, such as Flexible tubing, to a "Y" connector. The parallel flows of modified liquid enteral nutrient product are united in a single stream in the "Y" connector, and are directed by additional fluid communication elements to the feeding tube of a patient. Each marker dye or marker dye mixture employed is introduced from a controlled release dosage form. Preferably, each controlled release dosage form unit is configured or stopped in such a manner as to prevent or prevent the dosage form unit from blocking product flow out of the drip chamber or formulation chamber. where it is placed. The combination of: (1) a formulation chamber, ordinarily in the form of a drip chamber, (2) a fluid communication element, and (3) an amount of at least one beneficial agent, as defined in present, in an uncontrolled release dosage form, and with or without a dye or marker dyes in a controlled release dosage form, with the amount of at least one beneficial agent together with, or without, marker dye disposed in The formulation chamber, or merely accompanying the formulation chamber, and supplied together, constitutes a useful case. The kit is used to direct a liquid enteral nutrient product from a supply container, such as a collapsible container, and modify the liquid enteral nutritional product by adding thereto an amount of one or more beneficial agents with or without a marker dye, as the nutritive product flows from the supply container, and feeding the modified nutritional product into a feeding tube leading to the gastrointestinal tract of a patient. If the at least one beneficial agent supplied as part of a case is not already placed in the formulation chamber, it is easily placed manually in the same, ordinarily before connecting the apparatus to the supply container that can be hung from where the liquid enteral nutrient product is going to be directed. In a further aspect of the invention, the invention relates to a method for preparing a special diet for a patient, which comprises modifying a liquid enteral nutrient product during its flow from a supply container containing this product, to a tube of feeding that leads to the patient's gastrointestinal tract. In a more specific manner, the method comprises the steps of: (a). To provide an apparatus comprising: a formulation chamber having an inlet and an outlet, wherein an amount of at least one beneficial agent disposed in the formulation chamber can be connected in fluid communication with the supply container of a liquid enteral nutrient product; , to be moistened by, or immersed in, a liquid enteral nutrient product that traverses it, selecting each beneficial agent from the group consisting of: nutrients; medicines; probiotics; and diagnostic agents; and a chemically and physiologically compatible combination of these beneficial agents; and any of the above agents or combinations of agents together with at least one compatible and physiologically acceptable marker dye in a controlled release dosage form, each label dye being dispersible in the medium of the liquid enteral nutrient product being modified; and each benefit agent being in a controlled release dosage form; and a fluid communication element capable of operatively connecting the outlet of the formulation chamber with a device, such as a feeding tube, for feeding a liquid enteral nutrient product to the patient's gastrointestinal tract; B. Provide a supply container that contains a liquid enteral nutrient product; C. Place the apparatus in a communicative series in the fluid flow between the supply container and the device for feeding, - and D. Flow the liquid enteral nutrient product through the apparatus, where the nutritional product becomes modified, and from there to the device to feed. In a modification of this method, which may be especially useful in tailoring a diet for a patient, the apparatus provided includes, in a communicative series, one or more additional formulation chambers, which are not necessarily drip chambers, but each having at least one amount of at least one beneficial agent, as defined herein, and the chambers are connected and placed to allow the flow of the liquid enteral nutrient product on each beneficial agent to contact it or even submerge it. dynamically, that is, immerse it in a constantly changing quantity of liquid, in order to introduce a greater amount of given beneficial agent or mixture of beneficial agents than would be easily supplied in only one formulation chamber, or to add beneficial agents additional that are not readily available in combination or that are not compatible with each other in the same container or carrier envelope during storage before use. If desired or necessary, a pump may be used to make flow or to aid the flow of the modified liquid enteral nutrient product to the feeding device or tube, for example, when it is not convenient to hang or otherwise locate the container of supply in an elevated position in relation to the patient, or when the nutritive product is rather viscous and flows slowly by gravity flow.

BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be better understood with reference to the accompanying drawings, in which: Figure 1 is a partially schematic representation of an apparatus for modifying a liquid enteral nutrient product, and feeding it by nasogastric tube in accordance with invention. Figure 2 is a partially schematic representation of an apparatus for modifying a liquid enteral nutrient product, and feeding it by tube by means of a gastronomy tube according to the invention. Figure 3 is a partially schematic representation of an apparatus for modifying a liquid enteral nutrient product, and feeding it by tube, with the aid of a pump, by means of a jejunostomy tube according to the invention. Figure 4 is an enlarged fragmentary view in front elevation of the lower portion of a hanging supply container of a liquid enteral nutrient product, such as the container shown in Figures 1 to 3, with the inlet tube bevelled from a chamber drip inserted through the closure, and depending on it, and with a beneficial agent in the form of loose particles inside a fibrous bag-shaped envelope, and disposed inside the drip chamber and immersed in the enteral nutrient product flowing liquid, the lower part of the drip chamber being partially separated into parts and in section, and the pipe portion of the fluid communication element leading, ie, primarily the pipe leading away from the drip chamber, truncated for purposes of illustration. Figure 5 is a perspective view of a formulation chamber, in the form of a drip chamber, which can be used according to the invention, with a beneficial agent tablet in an uncontrolled release dosage form, in the shape of a substantially rectangular solid with slightly rounded corners, disposed inside the drip chamber, the end of the bevelled entry tube of the drip chamber being the upper end which is pushed in the normal way through the container closure of supply to communicate with it and to receive the liquid enteral nutrient product from it. Figure 6 is a perspective view of the drip chamber of Figure 5 inverted to show more detail of the construction. Figure 7 is a perspective view of a suitable formulation chamber similar to that shown in Figure 5, but with a different form of connection for connecting to a supply container, the screw cap being here, in which it fits threachably a supply container, integrally formed with the closure or plug that fits on the inlet end of the body of the formulation chamber. Figure 8 is a perspective view of the formulation chamber shown in Figure 7, as seen in the opposite direction. Figure 9 is a side elevational view and partially broken away in parts and in section, of an easily soluble or disintegrable capsule type carrier containing beneficial agent in the form of particles, and not in a controlled release dosage form. Figure 10 is a perspective view, partially broken away in parts and in section, of a highly permeable fibrous package, preferably of the non-spun tea bag carrier type, suitable for insertion in a drip chamber, or in another chamber of formulation, and capable of containing a quantity of beneficial agent that is not in a controlled release dosage form, e.g., in the form of a tablet or in an easily soluble or disintegrable capsule. Figure 10A is a perspective view partially broken away in parts and in section, of a fibrous package similar to that seen in Figure 10, but the fibrous package containing a quantity of one or more beneficial agents in a loose particle form. Figure 11 is a view similar to Figure 4, but with the beneficial agent in the form of a tablet or capsule together with a marker dye in a controlled release dosage form confined and supported inside a shirt or mesh bag. Figure 12 is a view similar to Figure 4, but with some beneficial agent in an uncoated tablet form confined inside a foraminate or perforated liner or bag. Figure 13 is a view similar to Figure 4, but with the beneficial agent as uncoated tablets supported by a foraminous plate above the bottom orifice of the formulation chamber. Figure 13A is a cross-sectional view of a formulation chamber taken at the level just above a grid that has been placed in the formulation chamber of Figure 13 in place of the foraminous plate shown therein, for the support of tablets not coated with beneficial agent, and any label dye employed in a sustained release dosage form, placed in the formulation chamber. Figure 14 is a side elevational view of a feeding assembly which is useful as a case in accordance with the invention, the case including a drip chamber as the formulation chamber, with one or more beneficial agents in a compressed tablet but uncoated in the formulation chamber, and a fluid communication element connected to the outlet of the formulation chamber, the fluid communication element having a removable protective cover on the end connector which is adapted to be connected to a tube of conventional feeding, and the fluid communication element being shortened and shortened for illustration purposes. Figure 15 is a side elevational view of a feeding set or case, very similar to that shown in Figure 14, with the exception that the uncoated compressed tablet containing one or more beneficial agents has not been placed in the chamber drip, but accompanying the drip chamber and the connected fluid communication element. Figure 16 is a side elevational view of a feed assembly similar to that of Figure 14, but where two formulation chambers are connected in a row in the form of drip chambers. Figure 17 is a side elevational view of part of the apparatus for modifying a liquid enteral nutrient product during enteral feeding, wherein two formulation chambers are suspended from respective suspended supply vessels, each containing liquid enteral nutrient product, the outputs of the formulation chambers connected to pipe segments that are connected to a "Y" connection that joins the parallel flow from each formulation chamber in a single stream inside the communication element, truncated here. Figure 18 is a side elevation view partially broken away in sections and in section, of a suitable form of osmotic application device for sustained release of a dye marker or a dye mixture. Figure 19 is a view similar to Figure 18 of another osmotic application device suitable for sustained release of a dye marker or a dye mixture. Figure 19A is a view of the osmotic application device of Figure 19, which has a surface coating of a marker dye or a dye mixture.

Definitions Used in the Present The following terms and phrases are defined for the purposes of the description and the claims. "Enteral" nutritional product refers to liquid compositions commonly understood to be supplied to, and used in, the gastrointestinal tracts of patients. These enteric nutritive products have a viscosity in the range of one to about 300 cps, and more frequently in the range of about 5 to about 150 cps. "Enteral nutrient product medium" refers to the liquid portion of a liquid enteral nutrient product, primarily water, but often including minor amounts of one or more non-aqueous liquid substances, such as lipids, for example vegetable oil and marine oil. The term "gastrointestinal tract," as used herein, refers only to the stomach and small intestine. Feeding to the gastrointestinal tract is done by using a nasogastric tube that extends through a nasal passage and esophagus, and from there to the stomach, or by using a feeding tube that extends through the stomach. abdominal wall to the stomach or small intestine. A "physiologically significant" or "beneficial" agent is an ingredient that is, or is believed to be, nutritionally or pharmaceutically important to the patient, or is otherwise medically important as in the case of a probiotic or an agent of diagnosis such as an opaque agent. A "probiotic" is understood as a food supplement of live microbes that beneficially affects the human host by improving the microbial balance of the individual in the gastrointestinal tract, for example, Lactobacillus reuteri. A "beneficial agent or ingredient that can be dispersed in the medium of the liquid enteral nutrient product" is an agent or ingredient that is beneficially added in a physiological manner, or that is beneficially added in another useful way, as in the case of an agent of diagnosis, to the liquid nutritional product during enteral feeding. The beneficial agent (s) or ingredient (s), recovered by the liquid enteral nutrient product in the formulation chamber according to the invention, is not in a dosage form. controlled or sustained release, and should be able to be dispersed in the middle of the liquid enteral nutrient product that is being modified during feeding, in order to be taken along with the nutritive product to the patient's gastrointestinal tract. The term "dispersible" as used herein with respect to beneficial agents or ingredients, must be understood to apply to substances that are soluble, as well as those that can be suspended sufficiently to be easily recovered and carried by the liquid medium. as the liquid enteral nutrient product flows through the formulation chamber containing the one or more beneficial agents in an uncontrolled release dosage form plus any label dye employed. A "useful amount" of a beneficial agent that can be dispersed in the medium of the liquid enteral nutrient product is an amount that is "physiologically effective" and is demonstrably, or reasonably expected to be, physiologically effective with respect to a patient, that is, to produce a detectable beneficial effect on the patient, either on a short-term or long-term basis, when it is fed as part of a liquid enteral nutrient product, or is "diagnostically detectable", and can be detected in the diagnosis of a condition or disease. The phrase "at least one beneficial agent that can be dispersed in the middle of the liquid enteral nutrient product" refers to both the singular and the plural, as may be judged from the context, and includes combinations of ingredients, agents, or factors. The term "feed set" refers to the combination of a drip chamber, or other formulation chamber, charged with at least a useful amount of at least one beneficial agent as defined above, and not in a dosage form of controlled release, together with or without a marker dye in a controlled release form, and a fluid communication element that can be connected to a feeding tube for enteral feeding. The term "feed set" also applies to the combination of a formulation chamber and a fluid communication element when they are supplied together, usually in the same package, with a useful amount of at least one beneficial agent. The term also encompasses the feed assembly having at least one additional formulation chamber in fluid flow series or connectable in parallel with separate supply vessels, as a part of the fluid communication element. None of the formulation chambers of the above described sets contains or is accompanied by a beneficial agent, as defined above, in a controlled release dosage form. The term "a controlled release dosage form" refers to any of the well-known conventional controlled release dosage forms, such as a coated tablet, an osmotic application device, a coated capsule, microencapsulated microspheres, agglomerated coated particles, for example molecular sieve particles, or a bundle of permeable fine fibers, which contain and subsequently store and release a beneficial agent ingredient content into the medium of a liquid nutrient product at room temperature, in a delayed, or delayed manner or intermittent, comparing with the solubility characteristics normally exhibited by the beneficial agent in particles not coated in said medium, at about room temperature. Any dosage form that employs coating, encapsulation, microencapsulation, closure in an osmotically driven device, or capture in a molecular sieve type structure, or in a thin permeable hollow fiber, to slow or slow down, delay or delay a intermittently the solubilization of an immediately soluble beneficial agent, such that its dissolution or dispersion, as with an osmotically driven device, takes place over at least a period of 30 minutes, and preferably during at least a period of time of two hours, is exhibiting a controlled release behavior. With respect to a beneficial agent that is inherently not immediately soluble in the medium of a nutritional product, any of these dosage forms that retards or slows, delays or intermittently delays the solubilization of this beneficial agent by at least the 20 percent of the normal time for solubilization or dispersion in the medium of a liquid enteral nutrient product, of a given unit amount of the beneficial agent that is not coated or treated to obtain a controlled release, is considered, for the purpose of the description and of the claims, as a controlled release dosage form. On the other hand, the mere formation of a tablet of a beneficial agent, either not mixed with another material, or not mixed with a relatively insoluble binder-type excipient, for example, while resulting in a further surface area being exposed small to a liquid solvent, and a slower dissolution rate than that of a fine particle form, will not be considered as in a controlled release dosage form. Clearly, a beneficial agent in a form of particles that have not been coated with, or encased in, any other material, is not in a controlled release dosage form. Neither tablets or particles not coated with a beneficial agent, which are clearly not in a controlled release dosage form, will be considered transformed to a controlled release dosage form merely by being enclosed in a carrier, such as a type. of fibrous tea bag package, or a capsule that dissolves or disintegrates easily, such as a very thin gelatin capsule. The term "controlled release" is intended to encompass sustained release, as well as intermittent and delayed release. The beneficial agents used exclusively in accordance with the invention are not in a "controlled release dosage form" as defined above. The label dye or dye mixtures employed, however, are in a controlled release dosage form, which is understood to include delayed or intermittent release, as well as sustained release dosage forms. It should also be understood that the phrase "to make the liquid enteral nutrient product flow through the apparatus, where it becomes modified, and into the feeding tube", includes using gravity flow from a hanging vessel, as well as using a pump in addition to, or without, flow by gravity, to promote the flow of the modified enteral nutrient product to and through a feeding tube.

Detailed Description of the Invention Referring now to the drawings, in which like parts are referred by like reference numerals, the apparatus of the invention is shown in Figure 1 in the form of a feeding set, indicated generally by numeral 20, which connects the outlet 21 of the hanging supply container 22, with the nasogastric feeding tube 23 that extends through a nasal passage 24 of the patient, and down the esophagus 25 to the stomach 26. Here the assembly The feed consists of a formulation chamber 27, in the form of a drip chamber that also serves as a formulation or contact chamber, and a fluid communication element indicated generally by 28. "Fluid communication element" "is understood to include all fluid communication components used in series from the outlet of the formulation chamber 29 to the connection 30 and up to the feeding tube, such as the nasogastric feeding tube 23. The components include not only portions of flexible tubing 54, but also any drip chambers or other additional formulation chambers connected in series, as seen in Figures 3 and 16 for the flow in series, or in parallel but soon joined in a single stream as seen in Figure 17, for the flow of the liquid enteral nutrient product to the patient's feeding tube. The components may also include any special pipe portions necessary for the use of a pump, and connecting elements, respectively, among all other components, such as the connector elements 31 or adapters 30. It may be useful to use two row formulation chambers. , such as drip chambers 27 and 73, as seen in Figure 16, to introduce a higher concentration or amount of a given ingredient. The formulation chambers can be used in a row to also introduce different respective ingredients that are not supplied together within the same pre-filled or pre-filled formulation chamber. These may constitute a combination of little use, for example, or a combination that is not compatible in mixed storage or in close proximity within a previously filled formulation chamber. As indicated above, two formulation chambers are shown in sequential use in the feed assemblies of Figures 3 and 16. In the assembly shown as part of the apparatus of Figure 3, the second formulation chamber 76 is connected by from the end of the flexible tubing 54 that is distal to the supply container 22. This can be found useful for adding a special ingredient to an already formed feeding set. With the formulation chamber 76 near the end of the assembly that is distal from the supply container, more possibly will be placed approximately horizontal, and care must be taken to ensure good contact of the liquid enteral nutrient product that flows, with the content of beneficial agent. of this second formulation chamber. If desired, this second formulation chamber can be configured with a depression or bag, or a channel where the content of beneficial agent is placed and through which the nutritive product will flow. The double formulation chambers 74 can be used in parallel, depending on the double supply vessels, as indicated in Figure 17, and for similar reasons, such as row chambers, or it can be simpler where one wishes to administer one. charitable agent completely before starting to administer another. It is preferable to hang these supply containers, as shown, to avoid control problems, in order to obtain an adequate flow through both formulation chambers from a single supply container. The outputs of each formulation chamber shown in Figure 17, are connected to segments of flexible tubing 54 leading to a "Y" connection 75, where liquid enteral nutrient product streams are joined to be conducted as a single stream to a feed tube. Referring again to Figure 1, the formulation chamber 27 has placed therein a useful amount or dose 32 of one or more beneficial agents, none of which are in a controlled release dosage form, in addition to one or more marker dyes in a controlled release dosage form, if included. The useful amount or dose 32 constitutes at least a physiologically effective or diagnostically detectable amount of at least one beneficial agent that can be dispersed in the medium of the liquid enteral nutrient product 33 flowing from the supply container 22 to the formulation chamber 27, wherein the liquid enteral nutrient product 33, which is normally based on water, makes contact with the dose 32 of one or more beneficial agents and any marker dye inside the formulation chamber 27, causing its recovery into the liquid enteral nutrient product that flows. The flow of the liquid enteral nutrient product is conveniently activated or deactivated, or sometimes regulated by the use of a conventional adjustable compression fastener 34. Turning now to Figure 2, a hanging supply container 22 is shown which supplies the product liquid enteral nutrient 33 to a formulation chamber 27 from which the liquid enteral nutrient product flows through flexible tubing 54 of feeding assembly 20a to gastronomy feeding tube 23a. The gastronomy feeding tube shown in Figure 2 is merely an example of the wide variety of gastronomy feeding tubes that are commercially available, it being understood that the apparatus of the invention can be used with a variety of gastronomy or other tubes. ostomy tubes.

A feeding configuration for a jejunostomy very similar to that of the apparatus of Figure 1 is shown in Figure 3, with the exception that the feeding assembly 20b is adapted to be used with a pump 35 that provides a positive flow to a tube of feeding 23b leading to the small intestine 26a of the patient, while in a number of cases, flow by gravity is used. Also, a second formulation chamber 76 is used as part of the feed assembly 20b in order to add an additional or different beneficial agent and / or marker dye, each dispersible in the medium of the liquid enteral nutrient product 33 flowing from the hanging supply container 22 to the formulation chamber 27 of the feed assembly 20b, and thence through the remainder of the communication element 28b of the feed assembly 20b and the second formulation chamber 76, to the jejunostomy feeding tube 23b . If desired or necessary, as often as the case when fed by a feeding tube, such as a jejunostomy tube, a pump 35 may be used, such as a peristaltic pump with cam action, acting on the portion of flexible tubing 54 of the communication element 28b, or a positive displacement pump with a disposable fluid infusion pump chamber cartridge such as described in United States Patent Number 4,927,411, and connected in series in the communication element, for flowing or assisting the flow of the modified liquid enteral nutrient product to the feeding tube, for example, when it is not convenient to hang or otherwise locate the delivery container in an elevated position in relation to the patient, or when the nutritive product is rather viscous and flows slowly by gravity flow. The fluid communication element, such as element 28b, of the ordinarily used apparatus will include a portion of flexible tubing 54 connectable to, or usable with, a conventional pump. If the pump used, for example, is a peristaltic pump that requires the use of tubing with a specially configured portion, this tubing can be used to replace all or a part of the communication element that applies the modified liquid enteral nutrition product to the tube. of patient feeding. The end of the flexible tubing 54 that connects to the inlet end of the second formulation chamber 76 is preferably provided with a coupling element 30, such as that shown in the feeding assemblies of Figures 14-16 , while the inlet end of the formulation chamber 76 is preferably further configured to receive the coupling element 30, and the outlet of the formulation chamber 76 communicates with a short length of flexible tubing which likewise terminates in the same manner. in a coupling element 30, which is connected to the feed tube 23b. It can be seen that it is convenient to add the second formulation chamber 76, when the need arises, without having to disconnect the parts of the feeding assembly. Here, for example, the flexible tubing 54 would have to be disconnected from the formulation chamber 27 to add the formulation chamber 76 immediately adjacent thereto. The formulation chamber 76 can be hung vertically, like a conventional drip chamber, but will generally be positioned with the direction of flow of the liquid nutritive product therethrough approximately horizontally. Accordingly, the formulation chamber 76 should be provided with elements for guiding or channeling the flowing liquid enteral nutrient product, on the dosage of beneficial agent and any dosage forms of label dye therein. These elements can be a coaxial channel that is low, or a bulbous enlargement of the camera body, or even a lateral depression in the side wall of the lower side of the chamber, or a trap, or spillway, or any other element for retaining the dose 32 of one or more beneficial agents and any marker dye where there is an adequate flow or depth of liquid sufficient to provide good contact with the beneficial agents and the dye located in these guide elements or channel. In the amplified fragmentary view of Figure 4, a fibrous packet 79 is seen containing a dose of beneficial agent (not visible) immersed in the liquid enteral nutrient product 33 inside the formulation chamber 27. The dose in the fibrous package 79 of Figure 4 is not in a controlled release form, but in the form of loose particles or tablets. The dose of beneficial agent may be in the form of particles or tablets of a wide range of sizes or dimensions, but free of any coating or other controlled release mechanism other than the size of the particles or tablets, which inhibits disintegration and the solution, provided that the dose normally dissolves or disintegrates in the flow of the liquid enteral nutrient product in less than two hours, and in many cases in less than about 30 minutes. Preferably, the dosage form is, in quantity, a kind of unit, such as a tablet, or an agglomerate, or a capsule filled but dissolving or disintegrating easily, or a measured amount of loose particulate material. , for example, in a highly permeable carrier, such as a fibrous and porous teabag type envelope. Individual tablets, or other particles, or capsules, must have a geometric shape, for example, that of a rectangular solid or a pointed star shape, which prevents blocking or obstructing the flow of the liquid enteral nutrient product 33 outwardly. from the outlet orifice 40 of the formulation chamber 27, or another element, such as a mesh jacket, can be used to support a dose 32, or a plurality of doses 32, to prevent blocking. Where one or more marker dyes are employed in a controlled release dosage form together with the beneficial agent, it is important in the same manner to similarly avoid blocking the exit orifice 40 by the controlled release dosage form of the dye or dyes. markers . A capsule that easily disintegrates or dissolves for use in containing a quantity or dose of beneficial agent can be formed of, for example, a thin-walled, water-soluble gelatin material. The details of the construction of a conventional drip chamber are illustrated in Figures 5 and 6, which are highly amplified perspective views. The drip chamber 27 as shown, has two parts. The first part is a hollow, almost cylindrical chamber body 37, with an open upper entry end 38, and a lower exit end 39, which is thinned or narrowed to form a hole 40 that leads to a portion of a tube. output 29 integrally formed. The body 37 of the chamber should be formed of a transparent material, such as glass or transparent plastic, to allow visibility of the flow of the nutritive product. Typically, the drip chamber is formed of a transparent, somewhat flexible plastic that can be autoclaved, such as a polyvinyl chloride or a transparent polyolefin resin. The second part of the drip chamber 27 shown is in the nature of a plug 42 with a cylindrical body having an inward end portion 43 that fits comfortably at the upper end, ie inlet, 38, of the body 37 of the camera. Preferably, the end portion 43 of the plug body 37 that extends into the body of the chamber has a slightly reduced diameter. The edge 44 of this end portion 43, remote from the end face of the stopper, rises slightly, being of a slightly larger diameter, and serves as a stop when the body of the chamber and the stopper are assembled together. The body of the plug is provided with an integrally formed fluid communication passage 45, which may take the form of an axial bore in a solid plug body communicating with a portion 46 of the inlet tube, which projects outwardly in the axial direction from a flange-shaped flange 47 radially extending from the upper end 48 of the plug body. But preferably, in order to provide a plug body with more elasticity for easier insertion into the upper inlet end 38 of the body 37 of the chamber, the fluid communication passage 45 is a concentric tube axially located inside and around the body of the stopper. The concentric tube 45 is integrally formed with, or otherwise operatively connected to, the inlet tube portion 46. A short, integrally formed peripheral flange 50, extending longitudinally from the collar-shaped flange 47 may be provided. along one side of the plug body, if desired, to assist in holding the plug body when the drip chamber is assembled. The plug can be molded from a plastic such as a polyvinyl chloride resin, which may be pigmented, if desired, for visibility, as an aid in observing the proper seating. The distal or free end 49 of the inlet pipe portion 46 has a bevelled end sufficiently sharp to facilitate punching of the seal (not shown) in the closure of the neck of the conventional hanging supply vessel, such as the supply container 22. The collar-shaped flange 47 can serve as a stop to the insertion of the sharpened inlet tube portion 46 into the closure in the neck of the supply container 22.

Other modes of construction of the drip chamber can be employed, provided that a suitable connection is provided with the supply container, as well as a transparent tubular portion, wherein the flow velocity of the liquid enteral nutrient product can be observed. For example, see the formulation chamber 82 illustrated in Figures 7 and 8, wherein the plug end 83 of the formulation chamber is formed integrally with the closure 84 so that a conventional supply container is threadably connected thereto. The apparatus of the invention should not be considered limited to the inclusion of any of the drip chambers used herein by way of illustration, nor is the method limited to its use. The drip chamber shown in Figures 5 and 6 has one or more beneficial agents such as dose 32 in an uncoated tablet form disposed therein, ready for use. The one or more doses 32 will be pre-selected according to their content, to provide the nutrients and / or medicaments and / or other additional complementary beneficial agents selected by the assistant for the health care in charge, together with a marker dye, if desired As used herein, and in the claims, medicaments are understood as the substances used in therapy. More than one dose of beneficial agents can be placed in the formulation chamber, as desired, to provide a combination selected from nutrients or drugs or other beneficial agents tailored to the needs of the patient being fed. For example, one could add a nutrient such as glutamine, and one of the probiotics, as a supplement to a liquid enteral nutrition product, or either or both of these along with a drug to be added to a liquid enteral nutrient product. In general, the nutrients added to the formulation chamber according to the invention, will be those that are suitable for aggregation as a bolus feed, while other types of beneficial agents added in this way, such as drugs, will be those that are they need, or can be added, for a short period of time, such as approximately 30 minutes or less, and clearly in less than two hours. As indicated, dose 32 of beneficial agent will normally be in the form of one or more tablets, particles in one or more capsules, one or more particle agglomerates, or loose particles in one or more carriers, such as a porous fibrous carrier like a tea bag not spun. It is highly desirable to avoid causing the dose or doses in any physical form to block or greatly impede the flow of the enteral nutrient composition out of the orifice 40 of the outlet 29 of the formulation chamber, such as the formulation chamber 27. If a dose 32 takes the rigid solid form of a tablet or capsule or agglomerated particle, it is preferred that the rigid form have a geometric shape, for example, a polyhedron, such as a rectangular solid, or a narrow form, any of the which will not block a round passage. A dose 32 in the form of a tablet, in the form of a rectangular solid, is shown in the formulation chamber illustrated in Figures 5 and 6, as well as in Figures 7 and 8. It is also possible to eliminate the blockage of the output of the tablet. a formulation chamber, by confining the solid forms in a shirt or pouch supported inside a formulation chamber, for example, from its inlet tube. A dosage form of a beneficial agent tablet and a label dye in an osmotically driven controlled release dosage form confined in a mesh bag supported from the inlet tube 45 are shown in Figure 11. In Figure 12 show two doses 32 of beneficial agent in the form of a tablet confined together in a foraminous bag supported from the inlet tube 45. Figure 32 shows dose 32 of the beneficial agent in the form of a tablet supported on a perforated or foraminous plate 53. The plate 53 can be made of ceramic or a rigid plastic material or an inert metal such as stainless steel, and can be disposed transversely through the body of the chamber 37, just above the exit orifice 40. A grid, such as that shown in Figure 13A, can be used instead of a plate, such as a support inside. of the formulation chamber for doses 32 of beneficial agent. The grid can also be made of an inert material such as a ceramic or a rigid plastic material or inert metal. If the physical form of any of the doses 32 is simply loose particles, it is preferred to confine the particles in a dosage amount in a carrier, such as a porous or rapidly disintegrating capsule, or a tea-bag type wrap. In Figure 9, a capsule 70 is seen having telescopic cover sections formed of a material that is very porous or rapidly disintegrates, such as a reconstituted cellulosic material, that encloses a dosage amount of beneficial agent in particulates. In Figure 10 a fibrous and porous wrap 79, preferably unstained, can be seen, of the tea bag type enclosing a dosage amount 32 of a beneficial particulate agent or a mixture of beneficial agents in the form of tablets, while that a tea bag type carrier containing a dose of the particulate beneficial agent is illustrated in Figure 10A. The capsule carrier may be preferred for longer term storage purposes, while the tea bag type may be preferred due to the easy permeability to the medium of the liquid enteral nutrient product in the formulation chamber. The above means for confining, ie, supporting, the doses 32 within the formulation chamber 27, may also be used in any additional formulation chambers in the feed assembly employed. Where a marker dye is employed together with one or more doses of beneficial agent or agents according to the invention, the marker dye is not only useful as a marker for the shortest , while the beneficial agents that are not in a Controlled dosage form are being dispersed towards the liquid enteral nutrient product, but also for the remainder of the up to 24 hours or more during feeding of the amount of liquid enteral nutrient product normally provided in the conventional supply container, ie, up to approximately 3 liters. A marker dye, if it is a visible coloring dye under white light, that is, daylight or artificial light normally found in hospital establishments, provides a visual indicator that the nutrient product continues to flow through the drip chamber from the formulation chamber. A marker dye can also be an important aid for the detection of the liquid enteral nutrient product that has reflux from the stomach or from the small intestine of a patient for any of several reasons, and that can find its way to the lungs, asking that it be immediately give special care. A label dye or a dye mixture which is useful in accordance with the invention, when used in conjunction with a beneficial agent that is not in a controlled release dosage form, is a dye or fluorescent dye or a mixture of dyes. These dyes make it physiologically acceptable to the patient, and compatible with the beneficial agents that are being fed with it. The dye or dye mixture should also be capable of recovering at a detectable concentration in the liquid medium of the liquid enteral nutrient product as long as the product flows through a drip chamber or other formulation chamber having the controlled dosage form of the dye or mixture of dye placed in it. If the dye can be detected in the drip chamber, it can be expected that it can be detected, if it reaches in some way the oral cavity of a patient. The dye marker used can be a coloring dye that imparts color that is visible under white light, for example, normal daylight, or artificial light found in the hospital or clinic, or the marker dye may be a fluorescent dye that visibly fluoresces under ultraviolet light, or a mixture of dye dye and a fluorescent dye. A mixture of a dye dye and a fluorescent dye seems to be especially convenient, because the flow through the formulation chamber is easily perceived under normal lighting conditions with the dye present, while even a small amount of nutritive product outside of the dye is present. its place, for example, in the oral cavity or in the nasal passage, will be more easily detected with the help of ultraviolet light if it contains a fluorescent dye. This is due to the nature of the fluorescent dyes, which are especially visible under ultraviolet light, even when they are present in a very low concentration. The dye or dye mixture used must be physiologically acceptable. Normally food coloring dyes approved under the provisions of the Food, Drug, and Cosmetic Act of the United States are suitable. F.D dyes are preferred. & C. Blue # 1 and F.D. & C Blue # 2. The dye or dye mixture must be soluble in the medium of the liquid enteral nutrient product being fed, and must be compatible with the agent or beneficial agents that are being added during feeding. In general, approximately 0.1 milligrams (mg) of dye per milliliter of liquid enteral nutrient product is desired to give an easily visible coloration to the nutritional product. Where it is important to detect the poorly directed liquid enteral nutrient product, the marker dye used can be a fluorescent dye, such as F.D. & C Red # 3, which is highly visible in a very low concentration of ultraviolet light, and also imparts a visible coloration to liquid mineral nutrients under white light conditions. Other suitable fluorescent dyes are: quinine, F.D. & C. Red # 22, F.D. & C. # 28, Fluorescein, and D 282 UV Blue, available from DaGlo of Cincinnati, Ohio, and also identified as 16470-24-9 on the Chemical Abstracts System with a color index of 220 as a fluorescent brightener. As indicated above, if desired, a mixture of dye dye and fluorescent dye can be used. In general, the addition to the nutritional product in the formulation chamber of approximately 0.01 to 0.05 milligrams / milliliter of fluorescent dye is suitable for detectability under ultraviolet light. In order to provide a continuous supply of marker dye in the liquid enteral nutrient product that flows during feeding, the dye is used herein in a controlled release dosage form. An example of this dosage form illustrated in Figure 18 is of the osmotic pump type that operates in the manner of the osmotically driven application device described and claimed in U.S. Patent No. 5,318,558, the specification and The drawings are incorporated herein by reference with respect to the structure of the units in controlled release dosage form described therein, and the method for manufacturing them and their mode of operation, although here it is with different environments and contents and end uses. In pump-type osmotic dosage forms, the beneficial agent in liquid form, ie, either in the liquid state or in solution in a suitable solvent, is squeezed out from a cylindrical chamber or cavity 56 into the reservoir, through a small hole 57, by the action of a piston 58 driven by the pressure developed by the osmotic infusion of moisture through a semi-permeable membrane 59 which confines a hydroactive substance 60 behind the piston 58, urging the piston continuously towards the side of the tank wherein the ingredient 61 is forced out through the hole 57. The hole 57 is very small and preferably drilled with a laser beam. The cylindrical enclosure 56 is formed inside a non-permeable membrane or coating 62. The hydroactive substance can be a water soluble salt such as magnesium sulfate, magnesium chloride, potassium sulfate, sodium chloride, sorbitol, inositol, urea, or a saccharide such as glucose or fructose or dextran, or a hydrophilic polymer such as a poly (hydroxyalkyl methacrylate) with a molecular weight of 30,000 to 5,000,000, poly (vinyl pyrrolidone) with a molecular weight of 10,000 to 360,000, an anionic hydrogel or cationic, or polyvinyl alcohol that has low acetate residues. Another suitable controlled release dosage form illustrated in Figure 19 is another osmotically driven delivery system that functions in the manner of the osmotically operated delivery device described and claimed in U.S. Patent No. 5,324,280, the specification and drawings are incorporated herein by reference with respect to the structure of the units in sustained release dosage form described therein., and the method to manufacture them and their way of working, although here it is with different environments and contents and end uses. In this type of system, the beneficial agent 63 to be fed in the liquid state or in the form of a solution, is enclosed within a non-permeable coating 64 which is surrounded by a layer 65 of hydroactive material that is entirely confined within a membrane or semipermeable external coating 66. The osmotic pressure that develops in the hydroactive layer 65, on the infusion of moisture into it, compresses the core 67 that contains the beneficial agent, in the form of liquid 63, and forces this liquid out continuously through a very small passage 68 from the core 67 to the outside of the unit. Turning now to FIG. 19A, the unit in controlled release dosage form shown in FIGS. 18 or 19 can be coated with an easily soluble coating, such as the marker dye coating 69, preferably a dye label dye, for the purpose of achieving the initial rapid release of sufficient dye within seconds, to show the initial placement of the liquid enteral nutrient product that flows into the formulation chamber, until the dye is ejected out of the osmotically driven device orifice . To apply this coating, the marker dye is mixed with a small amount of one or more conventional easily dispersible tablet coating excipients, such as polyvinyl pyrrolidone having an average molecular weight on the scale of about 35,000 to 50,000, mannitol, stearate magnesium, and small amounts of zein or guar gum, in a solvent such as water or alcohol, and applied to the units in controlled release dosage form as a very light coating, of only tens or hundreds of 1 milligram of dye Normally needed per unit. In general, the amount of excipients in total in the coating is less than about 10 weight percent of the coating. 0, the dosage form unit can simply be moistened with an aqueous or alcoholic solution of the label dye, and dried. The label dye can also be used as a tablet, a capsule, as agglomerated particles, or as microspheres, each coated to provide a conventional sustained release type of controlled release dosage form. Normally, materials such as zein, shellac, polymers and methacrylate copolymers, and cellulose ethers and esters are used as coatings. The microspheres are microencapsulated with a range of coating layers or respective fraction thicknesses, and the fractions are mixed to obtain a series of delayed releases from the mixture when used. Any mode of manufacture of a sustained or controlled release dosage form can be employed in the manufacture of a controlled release dosage form of label dye which is usable in accordance with the invention, provided that the soluble, dispersible, or Disintegrables of the dosage form units are physiologically acceptable, and that the controlled release dosage form can store one or more marker dyes as defined above, and release them into a liquid enteral nutrient product in a visibly detectable amount, as can be seen under either or both of white light or ultraviolet light, for a period of time useful during enteral feeding. Preferably, the controlled release dosage form is an osmotically driven device, because typically there is more uniformity of rate of release over time and a rather long sustained release period of many hours can be obtained., while the other forms may be adequate in many cases and of lower cost. Among the nutrients that are most likely to be added to conventional enteral nutrition compositions according to this invention are nutrients, such as glutamine, vitamins, arginine, fermentable dietary fibers, non-fermentable dietary fibers, enzymes such as lipases, combinations of amino acids, oligosaccharides such as fructo-saccharides, short-chain fatty acids (of 3 to 4 carbon atoms), pyruvate precursors such as pyruvamide, or pyruvam-amino acids, such as pyruvic-glycine, pyruvic-alanine, pyruvyl-leucine, pyruvic-valine , piruvil-sarcosamine and its amides, esters, and salts, lipid structures, d-ciroinositol, lactoferrin, marine oils and acidulants such as ascorbic acid. An example of a structured lipid that provides excellent nutritional support is a glycerol base structure with at least one gamma-linolenic acid or dihomogamma-linolenic acid residue in combination with a medium-chain fatty acid residue (from 6 to 12 atoms) carbon) and an n-3 fatty acid residue of 18 to 22 carbon atoms selected from alpha-linolenic and stearodonic acid, eicosapentaenoic acid and docosahexaenoic acid. Medications that can be usefully administered in this manner include, for example, antihistamine drugs, anti-infective agents, such as antibiotics, antivirals, and anti-infectives of the urinary tract.; antineoplastic agents; autonomic drugs such as adrenergic and relaxing agents of the skeletal muscles; drugs for the formation and coagulation of blood, cardiovascular drugs; agents for the central nervous system; diagnostic agents; electrolytic, caloric, and water balance agents, - enzymes, - antitussive, expectorant, and mucolytic agents, - gastrointestinal drugs such as antacids, - gold compounds, - hormones, and synthetic substitutes; Smooth muscle relaxants - and unclassified therapeutic agents. Other examples are H2 blockers such as Tagamet, prokinetic drugs, bioactive peptides, drugs for the diabetic condition, agents for chemotherapy, or any medicine intended for oral administration that does not react adversely with the nutritional formulation that is being fed into the gastrointestinal tract. . Probiotics that can be usefully administered in this manner include, for example, Lactobacillus acidophilus GG, as described in U.S. Patent Number 4,839,281, Lactobacillus reuteri, Lactobacillus ani alis, and Lactobacillus salivarius, as described in Patent Number WO 93/02558. Probiotics are living organisms that aid in the digestion of food or that help control the population of harmful microorganisms in the intestines. A feeding set, such as the case 20 shown in Figure 14, is conveniently provided in a packaged form ready for use in the feeding of a liquid enteral nutrient product. The kit includes (1) a dose unit 32 of beneficial agent, for example, in the form of an uncoated tablet, or of tablets or particulate material in a tea-bag type package, (2) a chamber of formulation 27 in the form of a drip chamber, and (3) a liquid communication element 28 consisting mainly of a length of flexible tubing 54 connected at one end to the outlet 29 of the formulation chamber 27, and in the another end with a connection 30 for a coupling connection with a feeding tube. The dosage unit 32 of the beneficial agent has already been placed in the formulation chamber 27, and contains one or more beneficial agents as defined hereinabove, for the modification of a liquid enteral nutrient product during its feeding. The kit can also be provided with a plurality of dose units 32 of the same beneficial agent or of a different one within the formulation chamber 27 if a single dose unit 32 does not contain each type of beneficial agent desired for the modification of the nutritional product. . A marker dye in a controlled release dosage form can also be added to the formulation chamber, or if a marker dye is desired during feeding. A similar case 20a, as shown in Figure 15, includes a dose unit 32 of beneficial agent that has not been placed in the formulation chamber 27 before shipping the case, but may accompany the formulation chamber, ordinarily packed as a complete feeding set ready to be hung as soon as the dose unit 32 is placed in the formulation chamber. Any of the types of dose units 32 described herein, and containing one or more additional and different selected beneficial agents, may also be placed in the formulation chamber, if desired, before use. In a preferred embodiment of the apparatus and method of the invention, the apparatus illustrated in Figure 2 is provided and assembled with a formulation chamber, such as a drip chamber 27, which has placed on it five tablets of 4 grams of glutamine, free of any coating or other controlled release mechanism, such as dosage units 32 of beneficial agent. Drip chamber 27 is also provided with a controlled release dosage form similar to the osmotically driven device shown in Figure 19A containing approximately 375 milligrams of dye F.D. & C. Blue # 1, in a form of micronized fine particles. The controlled release dosage form is also externally coated with a thin layer of the same blue dye mixed with about 3 weight percent total of polyvinyl pyrrolidine having an average molecular weight on the scale of about 35,000 to 44,500. The fluid communication element, such as the communication element 28, is attached to the outlet 29 of the formulation chamber, and connected to a volume flow meter device. The drip chamber of the feeding box is connected to a hanging supply container of a liquid enteral nutrient product having a viscosity of about 40 cps, such as PULMOCARE, a product of the Ross Products Division of Abbott Laboratories, Columbus, Ohio, and a continuous flow of the nutritious product begins. The 4 gram tablets not coated with glutamine dissolve in the flow of the nutrient product for about six hours, thus supplementing the nutrient content thereof. The dye coating provides an immediate visible color inside the drip chamber within about 2 seconds, and the controlled release dosage form of the blue dye provides the dye at a visible concentration of at least 0.075 milligrams / milliliter, over a period of time. of more than 1,440 minutes during the flow of approximately 3,000 milliliters of the liquid enteral nutrient product. The above embodiment is repeated in a very similar manner, with the exception that a dose 32 consisting of 25 grams of fine particulate glutamine enclosed in a fibrous teabag type carrier is placed in the drip chamber 27, together with the blue marker dye in the osmotically driven device coated with blue dye. The same liquid enteral nutrient product is flowed in the same amount and at the same rate, with closely similar results, with the exception that the amount of 25 grams of glutamine in the tea bag type carrier dissolves in the flow of the nutritious product for approximately 4 hours, thus supplementing the nutrient content of the liquid enteral nutrient product.

Claims (6)

1. An apparatus for modifying a liquid enteral nutrient product during feeding thereof, which comprises .- a formulation chamber having an inlet and an outlet, and the inlet can be connected to a supply container of a liquid enteral nutrient product, for receiving its content, at least one dose unit of beneficial agent in at least one dosage amount, the dose unit being arranged inside the formulation chamber, to be moistened by, or submerged in, the liquid enteral nutrient product passing through it , each at least one beneficial agent being selected in the dosage unit from the group consisting of: nutrients; medications, - probiotics; and diagnostic agents; and chemically and physiologically compatible combinations thereof, - and any of the above beneficial agents and chemically and physiologically compatible combinations thereof in addition to at least one physiologically acceptable label dye in a controlled release dosage form; each dosage unit of beneficial agent and each marker dye in controlled release dosage form disposed in the formulation chamber, dispersible in the medium of the liquid enteral nutrient product, and each benefit agent being not inside the formulation chamber in a controlled release form, and being dispersible in the medium of the liquid enteral nutrient product in less than two hours; and a fluid communication element capable of operatively connecting the outlet of the formulation chamber with a tube for feeding, to the gastrointestinal tract of a patient, the modified liquid enteral nutrient product. 2. The apparatus of claim 1, wherein the formulation chamber is a drip chamber. 3. The apparatus of claim 1, wherein the formulation chamber contains a plurality of beneficial agents, each in an amount of dose unit. The apparatus of claim 1, wherein the formulation chamber contains as the beneficial additive, at least one nutrient selected from the group consisting of: glutamine, arginine, vitamins, fermentable dietary fibers, non-fermentable dietary fibers, enzymes , combinations of amino acids, oligosaccharides, short chain fatty acids (of 3 to 4 carbon atoms), pyruvate precursors and their amides, esters, and salts, structured lipids, d-ciroinositol, lactoferrin, marine oils, and acidulants. 5. The apparatus of claim 4, wherein the formulation chamber contains glutamine as the beneficial agent. The apparatus of claim 1, wherein the formulation chamber contains as the beneficial agent, at least one medicament selected from the group consisting of antacids, antibiotics, prokinetic drugs, bioactive peptides, drugs for the diabetic condition, agents of chemotherapy, or any other medication intended for oral administration that does not react adversely with the nutritional formulation that is being fed into the gastrointestinal tract. The apparatus of claim 6, wherein the formulation chamber contains, as the beneficial agent, a probiotic. 8. The apparatus of claim 1, wherein the beneficial agent is confined within a mesh bag, inside the formulation chamber. The apparatus of claim 1, wherein the beneficial agent is confined within a foraminous bag inside the formulation chamber. 10. The apparatus of claim 1, wherein the beneficial agent is confined within a porous fibrous envelope within the formulation chamber. 11. The apparatus of claim 10, wherein the fibrous sheath is spun. The apparatus of claim 1, wherein the fluid communication element includes a section of flexible tubing suitable for use with a pump. 13. The apparatus of claim 1, wherein the fluid communication element further includes, as a component thereof, at least one additional formulation chamber having at least one beneficial agent therein. The apparatus of claim 1, wherein the fluid communication element further includes, as a component thereof, at least one additional formulation chamber having therein a controlled release dosage form containing only, as the additive dispersible in the medium, a physiologically acceptable dye marker. 15. A method for modifying a liquid enteral nutrient product during the flow thereof from a supply container containing this product, to a feeding tube leading to the gastrointestinal tract of a patient which comprises the steps of: (a) ) providing an apparatus comprising: a formulation chamber having an inlet and an outlet, and the inlet being connectable to a container for supplying the liquid enteral nutrient product, to receive the contents therefrom, - at least one dose unit of at least one beneficial agent that is not in a controlled release dosage form, or at least one dose unit together with a controlled release dosage form containing at least one label dye, the at least one dosage unit being placed of beneficial agent with or without the dye or marker dyes in controlled release dosage form, as the only agent Holding of beneficial agent in solid form in the formulation chamber; and a fluid communication element capable of operatively connecting the outlet of the formulation chamber with a device for feeding the liquid enteral nutrient product to the gastrointestinal tract of a patient; (b) providing a supply container containing a liquid enteral nutrient product; (c) placing the apparatus in a communicative series in the fluid flow between the supply container and the device for feeding, - and flowing the liquid enteral nutrient product through the apparatus and into the device for feeding. 16. The method of claim 15, wherein the liquid enteral nutrient product has a viscosity on the scale of about 1 cps to about 300 cps. The method of claim 15, wherein the liquid enteral nutrient product has a viscosity on the scale of about 5 cps to about 150 cps. The method of claim 15, wherein the apparatus provided includes more than one formulation chamber, and at least one beneficial agent that is not in a controlled release dosage form, and in a dosage unit amount, and with or without a marker dye, it is placed in each formulation chamber as the sole content thereof. The method of claim 18, wherein the liquid enteral nutrient product has a viscosity on the scale of about 1 cps to about 300 cps. The method of claim 18, wherein the liquid enteral nutrient product has a viscosity on the scale of about 5 cps to about 150 cps. The method of claim 15, wherein the apparatus provided includes more than one formulation chamber in a serial flow relationship, and one of the formulation chambers contains at least one label dye in a controlled release dosage form. as the only content of the formulation chamber.

2. A method for modifying a liquid enteral nutrient product during its flow from a supply container containing this product, to a feeding tube leading to a patient's gastrointestinal tract, which comprises the steps of: (a) providing a apparatus comprising: a formulation chamber having an inlet and an outlet, and the inlet being connectable to a container for supplying the liquid enteral nutrient product, for receiving the contents therefrom, - and a fluid communication element capable of operatively connecting the outlet of the formulation chamber with a device for feeding the modified liquid enteral nutrient product to the gastrointestinal tract of a patient; (b) providing at least one dose unit of at least one beneficial agent that is not in a controlled release dosage form, or at least one dose unit together with a controlled release dosage form containing at least one dye marker, - (c) placing the at least one unit dose of beneficial agent with or without the dye or marker dyes in controlled release dosage form, in the formulation chamber as the sole content of beneficial agent in solid form in the same, - (d) provide a supply container containing a liquid enteral nutrient product, - (e) place the apparatus in a communicative series in the fluid flow between the supply container and the device for feeding, - and (d) ) to make the liquid enteral nutrient product flow through the device and into the feeding device. 2

3. A drip chamber having at least one physiologically useful or diagnostically detectable amount of at least one beneficial agent as a unit of dose disposed therein, not in a controlled release dosage form, for feeding an enteral nutrition product. liquid, selecting each beneficial agent from the group consisting of: nutrients, -medicines; probiotics; diagnostic agents; and chemically and physiologically compatible combinations thereof; each beneficial agent being within the formulation chamber dispersible in the medium of a liquid enteral nutrient product in less than about two hours, and the at least one beneficial agent in the form of a unit dose being the only content of the drip chamber . 2

4. The drip chamber of claim 23, which additionally contains at least one label dye in a controlled release dosage form. 2

5. A case for feeding a liquid enteral nutrient product to a patient's gastrointestinal tract, which comprises: a formulation chamber having an inlet and an outlet, and the inlet can be connected to a supply container for a liquid enteral nutrient product, - at least one beneficial agent in a unit dose form, the at least one beneficial agent inside the formulation chamber to be moistened by, or immersed in, the liquid enteral nutrient product passing through it, each at least one beneficial agent being selected from the group consisting of:; medicines; probiotics; and diagnostic agents; and chemically and physiologically compatible combinations thereof; and any of the above beneficial agents and chemically and physiologically compatible combinations thereof in addition to at least one physiologically acceptable dye marker in a controlled release dosage form, - each dosage unit of beneficial agent and each marker dye being in the form of controlled release dosage disposed in the formulation chamber, dispersible in the medium of the liquid enteral nutrient product, and each beneficial agent being not inside the formulation chamber in a controlled release form, and being dispersible in the medium of the product. liquid enteral nutrient in less than two hours, - and a fluid communication element capable of operatively connecting the outlet of the formulation chamber with a tube to feed, to the gastrointestinal tract of a patient, a modified liquid enteral nutrient product. 2

6. The kit of claim 25, wherein the at least one beneficial agent is not placed in the formulation chamber, but is packed together with it.