MXPA97005134A - Apparatus for adding marker tint to product nutrit - Google Patents

Abstract

The present invention relates to an apparatus for feeding a liquid enteral nutrient product comprising: a formulation chamber having a formulation chamber having an inlet and an outlet and which is connected to a supply container of a liquid enteral nutrient product that has a viscosity in the range from about 5 to about 300 centipoise, to receive the product thereof, the formulation chamber further comprising at least one physiologically acceptable dye marker, the at least one label dye being contained within at least one sustained release reservoir placed within the formulation chamber so that it is in physical contact with the liquid enteral nutrient product in the formulation chamber, the at least one marker dye is soluble in the medium of the liquid enteral nutrient product, the minus a sustained release deposit contains marker dye that is a n element for providing and dosing marker dye towards the liquid nutritional product when the sustained release reservoir is physically contacted therewith during feeding thereof to a patient in a period of time from about 2 to about 24 hours; fluid communication element capable of operatively connecting the outlet of the formulation chamber with a device for feeding the liquid enteral nutrient product that is dye-labeled to the gastrointestinal tract of a patient

Description

APPARATUS FOR ADDING MARKER DYE TO NUTRITIVE PRODUCT Field of the Invention The invention relates to an apparatus 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 the addition of ingredients, during feeding, into a patient's gastrointestinal tract, to make it easier to visually detect the flow of the product.

Background of the Invention The feeding of a liquid enteral nutrient product from a 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 a jejunostomy, by gravity flow or auxiliary by a peristaltic pump, is well known. The liquid enteral nutrient product can be processed aseptically or terminally distilled, and can be supplied in a container previously: filled, ready to be hung, or it can be placed in this container by an assistant. However, sometimes problems arise because the flow of the liquid enteral nutrient product does not start due to a mechanical malfunction or a distraction from the health care assistant, and this is not noticed for a while. Sometimes the product is misdirected, for similar reasons. A still further problem arises, because the nutritive product can be refluxed from the stomach or from the patient's small intestine for any of several reasons of indigestion or overfeeding, and can find its way into the lungs. In that case, special care of the patient is needed, and the problem usually becomes more serious if it is not noticed immediately. In each of these instances, it would ordinarily be very useful if the presence of the liquid enteral nutrient product could be more easily detected in an out-of-place location outside the patient's stomach or intestines. One way to more easily detect the presence of a liquid enteral nutrient product would be to make it visible by dissolving a suitable physiologically acceptable label dye in the product. However, this can not be undertaken lightly outside specially equipped facilities, such as a manufacturing facility, because information on the compatibility of specific dyes, with different nutrients or specific medications that may be present, is usually lacking. in the liquid nutritive product, during the heat sterilization and / or the subsequent storage of the product, when mixed with the dye. If the marker dye is placed in solution before the sterilization of the product, there is the possibility of altering the composition of the product or the color of the dye. Moreover, the process of introducing a marker dye, such as a food grade dye, after sterilization, can cause a loss of sterility, even when using certified sterile dyes. Therefore, care must be taken to avoid contamination of the nutrient product where organisms could multiply rapidly during storage or transport. Drug application systems have been described and claimed in U.S. Patent Nos. 4,511,353; 5,318,558; and 5, 324, 280, wherein the drug component to be delivered is stored in a capsule from where it is expelled over time on the osmotic infusion of moisture into the capsule, with the drug being carried from the surface externally of the capsule by a suitable liquid in an intravenous delivery system, ie parenteral, or even by the device of U.S. Patent No. 5,318,558, for body fluids when implanting the capsule. In US Pat. No. 5,069,671 a formulation chamber is described, which may also be a drip chamber, wherein different forms of sustained release mechanisms are employed to release a drug or medicament, or other physiologically beneficial component. such as a nutrient, within the formulation chamber from which the drug or other component is carried by a suitable liquid to a parenteral application system. The teachings of U.S. Patent Nos. 4,511,353 and 5,069,671 relate to the intravenous application of parenteral compositions, and in the case of the latter patent, include the application by infusion through the intravenous, intraarterial, intraperitoneal, or subcutaneous. The osmotic dosage system of U.S. Patent No. 5,324,280 relates to the application of drug formulations over time to a biological environment, such as an implant of tissue or organ in a mammal, or a current. or tank for marine life. The osmotically driven device of U.S. Patent No. 5,318,558 is said to be used to apply drugs, medications, and nutrients in a range of environments ranging from veterinary medicine to drug administrations to human beings. , and recreational situations such as fish tanks. Again, in the case of administration to humans, the application seems to be by implantation within the tissue or an organ of the patient, followed by the action of the body fluids on the osmotic device. Although osmotic application devices and other sustained release dosage forms have been available for some time, as far as is known, there has been no attempt to use this application system to add a marker dye to a liquid enteral nutrient product, with a viscosity up to 300 cps, at the time of administration of the product to the gastrointestinal tract of a patient. The liquid inorganic nutrient 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, authored by Barbara Hopkins, Part III, "Feeding", page 439-467. This reference indicates that the complete nutrient compositions contain proteins, carbohydrates, fibers, fats, and vitamins and minerals in different proportions in an aqueous or aqueous / fatty medium. Nutrient compositions for special diets may omit, wholly or in part, one or more kinds of these components.

SUMMARY OF THE INVENTION A first aspect of the invention relates to an apparatus for modifying, by dye labeling, a liquid enteral nutrient product during application from a supply thereof, such as a collapsible container, to a feeding tube that delivers the nutritive product enteral to the gastrointestinal tract of a patient. The apparatus comprises: a formulation chamber which can be connected to a supply container for a liquid enteral nutrient product, the formulation chamber having an inlet and outlet, a physiologically acceptable dye marker which is soluble in the medium of the enteral nutrient product liquid, or a mixture of these dyes, the label dye or the mixture of label dyes contained within at least one sustained release reservoir positioned inside the formulation chamber, to be contacted with, or submerged in, the nutritional composition liquid enteral that traverses through it, the amount of marker dye or mixture of marker dyes being within the at least one sustained release reservoir inside the formulation chamber, sufficient to visibly mark a liquid enteral nutrient product that flows through the formulation chamber for a period of time út il; and a fluid communication element that connects the outlet of the formulation chamber with a tube for feeding the liquid enteral nutrient product containing the at least one label dye into the gastrointestinal tract of a patient. The sustained release reservoir used is preferably in the form of a coated capsule, an osmotic application device, a coated tablet, a microencapsulated microsphere, a particle agglomerate of a molecular sieve material, or a group of thin, hollow fibers , of permeable walls, or a coil of said fibers, and can store, ie, retain, and subsequently release a marker dye or a dye mixture upon contacting the liquid enteral nutrient product within a formulation chamber. Ordinarily, a drip chamber is used here as the formulation chamber. Preferably, the sustained release reservoir is configured or stopped in such a manner as to prevent a sustained release reservoir from blocking the flow of the liquid enteral nutrient product out of the drip chamber. Also, the at least one marker dye preferably is a blue dye or a dye that fluoresces under ultraviolet light, or a mixture of the two. The blue color is not exhibited by any known body fluid. The combination of the formulation chamber and the fluid communication element, accompanied by at least one sustained release reservoir, each containing at least one label dye that is soluble in the medium of the liquid enteral nutrient product, with the release reservoir being provided held in the formulation chamber, or merely accompanying the formulation chamber, constitutes a feeding box useful for feeding a liquid enteral nutrient product from a supply container to the gastrointestinal tract of a patient. In a further aspect of the invention, the invention relates to a method for preparing a dye-labeled liquid enteral nutrient product, which comprises modifying a liquid enteral nutrient product during its flow from a supply container containing this composition, to a feeding tube that leads to the patient's gastrointestinal tract. More specifically, the method comprises the steps of: A. Providing an apparatus comprising: (a) a formulation chamber having an inlet and an outlet, the inlet being connected in fluid communication with the product supply container liquid enteral nutrient, (b) a physiologically acceptable dye marker that is soluble in the medium of the liquid enteral nutrient product, or a mixture of these dyes, the marker dye or the mixture of marker dyes contained in at least one sustained release container, and each sustained release reservoir being placed inside the formulation chamber to be moistened by, or submerged in, the dye. , the liquid enteral nutrient composition passing through it, the amount of marker dye or mixture of marker dyes within the formulation chamber being sufficient to visibly mark the liquid enteral nutrient product flowing in the formulation chamber during a useful period of time; and (c) a fluid communication element capable of operatively connecting the outlet of the formulation chamber with the tube to feed the dye-labeled liquid enteral nutrient product into 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 supply tube; and D. Flowing the liquid enteral nutrient product through the apparatus, where the product becomes modified, and into the feeding tube. If desired or necessary, the communication element of the apparatus, which includes flexible tubing, may also include, in series, a pump to make flow or to promote the flow of the liquid enteral nutrient product labeled with dye into the feeding tube. . A peristaltic pump can be used by placing a portion of the flexible tubing in the clamps or guides of the pump to receive the cam action, and the pump is operated during feeding. 0, the pump may be of the positive displacement type, as described in U.S. Patent No. 4,927,411, which utilizes a disposable infusion pump chamber cartridge. Accordingly, the above method should be understood to include, in Step D, the use of a pump, in addition to, or in place of, the gravity flow, to promote the flow of the liquid enteral nutrient product labeled with dye to the feeding tube of a patient. If a quick mark is desired, especially with a visible dye under normal lighting conditions, a small amount of additional marker dye is placed that is not in a sustained release dosage form in the formulation chamber, either as a surface coating on the sustained release tank, or separately from it.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a partially schematic representation of an apparatus for dyeing a liquid enteral nutrient product, and feeding it by nasogastrically tube, the apparatus including a feeding set in which a nutritional product is marked with dye. according to the invention, while the nutritive product is conducted from a hanging container to a nasogastric feeding tube. Figure 2 is a partially schematic representation of an apparatus for marking with dye, in accordance with the invention, a liquid enteral nutrient product, and feeding it by tube by means of a gastronomy tube. Figure 3 is a partially schematic representation of an apparatus for marking with dye, according to the invention, a liquid enteral nutrient product, and feeding it by tube, with the aid of a pump, by means of a jejunostomy tube. 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 end of the inlet tube beveled from a drip chamber inserted through the closure of the container and the drip chamber, depending on it, and with a sustained release tank disposed inside the drip chamber and immersed in the liquid enteral nutrient product that flows, the part being bottom of the drip chamber and the sustained-release reservoir inside, partially separated in sections and in section, and conducting the fluid communication element, that is, here primarily the flexible tubing leading away from the drip chamber, truncated for purposes of illustration. Figure 5 is a perspective view of a drip chamber that can be used according to the invention, with a sustained release reservoir in the form of a substantially rectangular solid disposed inside the drip chamber, the end of the tube being of bevelled inlet of the drip chamber the upper end which is pushed in the normal way through the closure of the supply container to communicate with it and to receive the liquid enteral nutrient product therefrom. 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, partially broken away in parts and in section, of a sustained release reservoir in the form of a rectangular solid, of the osmotic pump type, used to supply a physiologically acceptable dye inside the drip chamber of according to the invention, the dye being in liquid form in the tank, and being soluble in the medium of the liquid enteral nutrient product. Figure 8 is a front elevational view, partially broken away in parts and in section, of a sustained release deposit in the form of a rectangular solid, of another type of osmotic device, used to supply at least one physiologically acceptable dye marker within the drip chamber according to the invention. Figure 8A is a view similar to Figure 8, of a sustained release reservoir of the same type, but with an outer coating of marker dye that is immediately and readily recovered in the medium of the liquid enteral nutrient product at the beginning of the flow start of it through the drip chamber. Figure 9 is a front elevational view, partially broken away in parts and in section, of an easily disintegrable or soluble capsule type carrier of a useful amount of sustained release reservoirs, of the microencapsulated particle type, of the molecular sieve type , or of the crushed permeable hollow fiber type, which contains at least one physiologically acceptable dye marker which is soluble in the medium of the liquid enteral nutrient product within the drip chamber according to the invention.

Figure 9A 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 placement in a drip chamber, or in another form formulation chamber, and capable of sustaining a sustained release reservoir, such as a tablet or osmotically driven device or capsule, or a useful amount of sustained release reservoirs in the form of microencapsulated particles, or a material of the sieve type molecular or permeable hollow fibers, each reservoir containing at least one physiologically acceptable dye marker which is soluble in the medium of the liquid enteral nutrient product within the drip chamber according to the invention. Figure 10 is a side elevational view of a case useful for dyeing a liquid enteral nutrient product during feeding, the case including a drip chamber connected to a tubing communication element for connecting the case to a feeding tube , and a sustained release reservoir containing a useful amount of a marker dye or a suitable dye mixture accompanies the drip chamber, ready to be emplaced therein. Figure 11 is a view similar to Figure 4, but with the sustained release reservoir of any of Figures 7 through 9A confined within a shirt or mesh bag. Figure 12 is a view similar to Figure 4, but with the sustained release reservoir of any of Figures 7 through 9A confined within a foraminous or perforated liner or bag. Figure 13 is a view similar to Figure 4, but with a plurality of the sustained release containers or carriers of Figures 7 to 9A, supported by a foraminous plate above the drip chamber outlet orifice. Figure 13A is a cross-sectional view of a formulation chamber taken at the level just above a grid that can be used in place of the foraminous plate in the drip chamber shown in Figure 13. Figure 14 is a side elevation of a case consisting of a feeding assembly according to the invention, including a drip chamber charged with a sustained release reservoir containing marker dye, and a fluid communication element for connecting the drip chamber with the tube of feed used to direct the liquid enteral nutrient product labeled with dye to the gastrointestinal tract of a patient, which includes a cap for the end connector. Figure 15 is a side elevational view of a feeding case in which a second formulation chamber has been connected by its input in fluid communication with the connector at the end of the flexible tubing which is normally connected to a connection that is connects to the patient feeding tube, the outlet tube of the second formulation chamber having a connection to connect to the feeding tube. Figure 16 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 a supply container, integrally formed with the inlet end of the formulation chamber. Figure 17 is a perspective view of the formulation chamber shown in Figure 16, inverted and viewed in the opposite direction.

Detailed Description of the Invention The following terms and phrases are defined for the purposes of the description and the claims. "Inorganic liquid food products" refers to compositions commonly understood to be delivered in a liquid medium to and used in the gastrointestinal tracts of patients. These nutritious products have a viscosity in the scale from 1 to approximately 300 centipoises (cps), and more frequently on the scale 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 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. The term "feed set" refers to the combination of a formulation chamber loaded with one or more sustained release tanks containing, in total, at least a sufficient amount of the dye marker or physiologically acceptable dye mixture for coloring under conditions of normal illumination or to make visible under ultraviolet light a substantial amount of liquid enteral nutrient product over time, and a fluid communication element that can be connected to a feeding tube for enteral feeding. The phrase "to visibly mark the liquid enteral nutrient product" means to visibly mark, to a sufficient degree under visible or ultraviolet light, in such a way that the presence of the dye in the nutritive product for the human eye is evident. Sometimes visible light is referred to as white light. The term "engagement element" generically denotes an element or system for storing and subsequently applying, within a formulation chamber, or a drip chamber, a marker physiologically acceptable dye which is soluble in the medium of the liquid enteral nutritional product transiting in the formulation chamber. Sustained release deposits are also understood as "speed control elements" or "controlled rate dosage forms" or "sustained release dosage forms". 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 assembly, indicated generally by the numeral 20, which connects the outlet 21 of the hanging supply container 22, with the nasogastric feeding tube 23 which extends through a nasal passage 24 of the patient, and down the esophagus 25 to the stomach 26. Here the feeding set consists of a drip chamber 27, which also serves as a formulation chamber, for the recovery of dye or marker dyes in the liquid enteral nutrient product 33 flowing from the supply container 22, and a fluid communication element indicated generally by the numeral 28. The fluid communication element consists largely of one or more pieces of flexible tubing 54, usually of a transperent plastic, such as polyvinyl chloride. If there is more than one piece of pipe, they are connected in series, or used to connect other components in series by means of the connecting elements 31. Each formulation chamber selected for use, as well as the deposit or the sustained-release tanks used therein during a given feed, the sustained release tank is configured and / or placed in relation to the chamber, so that the sustained release tank (s) makes contact (i.e. n) moistened by, or immersed in, the liquid enteral nutrient product that flows through the chamber. Preferably, the drip chamber is used as a formulation chamber, although a formulation chamber can be used or not in addition to a drip chamber, and a formulation chamber does not have to be, or does not have to serve as, a drip chamber when used in series with a drip chamber. A drip chamber is almost always used in such a way that the flow of liquid enteral nutrient product can be visibly monitored from the supply container, so that it can also be used as the formulation chamber. A "formulation chamber" is a hollow flow chamber traversed, in the form of a column in most cases, where one or more sustained release tanks are placed. Examples of a variety of formulation chamber designs suitable for use in addition to a drip chamber, or where a drip chamber is not needed, are shown in Figures 4 and 5 of the United States Patent. Number 5,069,671. Formulation chambers of other designs may be, or may be useful, such as that shown herein in Figure 15, for use in a horizontal position, and a formulation chamber with a connection other than the supply container illustrated in the Figures. 16 and 17. "Fluid communication element" is to be understood to include all fluid communication components commonly used in series from the outlet of the drip chamber 29 to the flexible tubing 54, to the connection 30, and up to the tube of feeding, such as the nasogastric feeding tube 23. The components include not only the flexible tubing 54 and any segments of the tubing, but also any portions of tubing and / or additional connectors specially adapted or configured, if necessary, for the use of a pump to aid the flow of the nutritive product to the patient, such as the pump 35 showed. schematically in Figure 3. Connector elements, or adapters 31, can be used between pipe pieces 54 connecting other components. The drip chamber 27 is charged with a sustained release reservoir 32 which contains at least a sufficient amount of a physiologically acceptable dye marker or a mixture of dye markers, to impart visibility, under appropriate lighting conditions, to a liquid enteral nutrient product 33 flowing from the supply container 22 to the drip chamber 27, wherein the nutrient product, which is normally based on water, makes contact with the sustained release tank 32, or a plurality thereof, by wetting or submerging it in the flow, causing the release or discharge towards the nutritive product of the dye or marker dyes stored in the tank. A "dye marker or dye mixture" that is useful in accordance with the invention is a dye or fluorescent dye or a mixture of dyes that is physiologically acceptable to the patient and can be recovered in a detectable concentration. in the liquid medium of the liquid enteral nutrient product as long as the product flows through a formulation chamber, such as a drip chamber, having at least one sustained release reservoir containing the dye or label dyes therein. The marker dye used can be a coloring dye that imparts color that is visible under white light, that is, under normal daylight, or artificial light found in the hospital or clinic, or the dye marker can be a fluorescent dye , such as FD dye &; C. Red # 3, which fluoresces visibly 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 drip chamber is easily perceived under normal lighting conditions with the dye present, while even a small amount of nourishing product outside 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, because they are especially visible under ultraviolet light, even when they are present in a very low concentration. It is essential that the dye or dye mixture be soluble in the liquid medium of the liquid enteral nutrient product. In general, food grade dyes can be used where a dye coloring is desired. A preferred dye is the dye F.D. & C. Blue # 2, while the dye F.D. & C. Blue # 1 for the brand with color of the liquid mineral nutrients. F.D. & C. refers here to the so-called "Food, Drug and Cosmetic Act" of the United States of America, and dyes approved for use in food in accordance with its provisions are identified in the above manner. The red dye F.D. & C. Red # 3 is a preferred fluorescent dye. A "useful amount" of a physiologically acceptable dye label or a mixture of these dyes is sufficient to visibly mark the human eye, either by color under white light, or by fluorescence under ultraviolet light, an enteral nutritive product liquid over time, for a period previously selected on the scale of approximately 1 minute to 30 hours or more, but in general from at least 2 hours to no more than 24 hours, in accordance with typical feeding practices that are usual in an infusion process. The process of "infusion" refers, in the present context, to the process of supplying a liquid enteral nutrient product containing a marker dye, over time, such as from at least one minute and up to 48 hours, in general no more 24 hours, but preferably at least as long as the liquid enteral nutrient product is being fed and is microbiologically safe, for example, when feeding from a given feeding set connected to a supply container containing a low nutrient product. acid. These feeds generally continue for at least two hours, and can continue for longer periods up to approximately 24 hours, but can be performed intermittently, rather than continuously. The sustained release reservoirs used in accordance with this invention contain only a label dye or a mixture of these dyes, apart from any excipients, such as mannitol, sorbitol, sodium or potassium alginate, sodium carboxymethyl cellulose, hydroxypropylmethyl cellulose, hydroxypropyl cellulose, potassium or sodium chloride, polyvinyl pyrrolidone, triethyl citrate, cellulose acetate, magnesium stearate or polyethylene oxide, which may be used in minor amounts of up to about 10 weight percent of the dye present, for moderate the solubility of the dye or dyes in the middle of the liquid enteral nutrient product. The term "sustained release deposit", for the purposes of the specification and claims, refers to a coated tablet, an osmotic delivery device, a coated capsule, microspheres that have been microencapsulated, agglomerated molecular sieve particles, or thin and hollow fibers of permeable walls that have been coiled or crushed and placed in a porous carrier, wherein the marker dye is stored prior to use in accordance with the present invention, and is released in a sustained manner during a feeding period when immersed in, or brought into contact in another manner, in a formulation chamber, , such as a drip chamber, with a flowing stream of a liquid enteral nutrient product. In the case of osmotic devices, which are the preferred sustained release reservoirs due to their more continuous and more predictable application of the dye to the liquid enteral nutrient product that is flowing for many hours at a moderately sustained rate, the sustained release reservoir is provided with an external coating or membrane that maintains its integrity during the application of the dye. The types of sustained-release deposits of osmotic application can be designed for different capacities or feeding times, so as not to lower the release rate to less than about 25 percent of the initial velocity, until the deposit is nearly exhausted. The other types of sustained-release deposits are usually less expensive, but tend to release the dye at a rate that varies even more over time, which can be overcome to some degree, for example, with microencapsulated microsphere deposit mixtures. containing particles in dye microspheres coated with a lag of coating thicknesses, from none to about six layers that dissolve or become permeable at successive intervals. Molecular sieve types have a curve, non-linear release for each grade or type of sieve. Mixtures of sieve grades can be used to flatten the curve. Provided that the marker dye is persistently released in a sufficient amount during a feeding period, to serve as a marker, these other non-osmotic types of sustained release deposits appear to be suitable. However, with a more variable or very changeable release rate of the marker dye, color depth or fluorescence can not be used to calibrate the degree of dilution of the nutrient product, if it is to be diluted with body fluids. Referring again to Figure 1, the flow of the nutritive product is conveniently activated or deactivated, or sometimes merely regulated, by the use of a conventional adjustable compression fastener 34 through which the flexible tubing 54 extends, although regulation tends to be difficult using only the fastener. Turning now to Figure 2, there is shown a hanging supply container 22 which supplies the liquid enteral nutrient product 33 to a drip chamber 27, which functions as a formulation chamber, from which the nutrient product flows to the feeding assembly. 20a, and up to the gastronomy feeding tube 23a. The gastronomy tube shown in Figure 2 is merely one example of the many varieties of gastronomy feeding tubes that are commercially available, and it should be understood that the present invention can be used in conjunction with any of these feeding tubes. gastronomy. A feeding configuration for a jejunostomy, very similar to the apparatus illustrated in Figure 1, is shown in Figure 3, with the exception that, after the soluble marker dye has been added to the nutrient product in the medium of the enteral nutrient product. liquid enteral 33 flowing from the hung supply container 22 to the drip chamber sustained release reservoir 27 which serves as a formulation chamber, the dye-labeled composition moves through the feed assembly 20b to the tube of jejunostomy 23b. The feeding assembly 20b is shown to be used with a pump 35, which provides a positive flow to the small intestine or jejunum 26a of the patient, for which gravity flow is used less frequently without help. In any feeding set where a series pump is used as here, the pump 35 can be a peristaltic pump with cam action acting on a section of the hose portion of the communication element, in some cases with a portion of pipe specially configured to fit the pump housing. The pump 35 may also be a positive displacement pump with a disposable fluid infusion pump chamber cartridge, such as that described in United States Patent Number 4,927,411. A pump may be used in any appropriate type of tube feeding procedure, for example, when it is not convenient to hang or otherwise locate the supply container in an elevated position relative to the patient, or when the nutritional product is more very viscous and flow slowly by gravity flow. In the amplified fragmentary view of Figure 4, a sustained release reservoir 32a is seen in the form of an osmotic pump device immersed in a liquid enteral nutrient product 33 inside the drip chamber 27, which functions as the formulation chamber . This type of sustained release reservoir, which has an outer membrane or wrapper that maintains its integrity, must have a solid geometric shape or other non-spherical shape that prevents or totally prevents blocking of the flow of the liquid enteral nutrient product 33 through the outlet of the drip chamber 27, or another element may be used to prevent this blocking. Suitable solid geometric shapes that can be used with a drip chamber, or other formulation chamber, which is round in section, include: a polyhedron, such as a rectangular solid, a tetrahedron or pentahedron. Sustained-release tanks can be designed with slightly rounded corners to prevent damage from occurring easily in handling, but pointed shapes, such as star shapes, are also useful. Details of the construction of an example of a conventional drip chamber that can be employed as a formulation chamber are illustrated in Figures 5 and 6, which are highly amplified perspective views taken in the respective opposite directions. This drip chamber, in this case, also serves as a formulation chamber and serves in that capacity in the illustrated apparatus. The chamber, drip 27 as shown, has two parts. The first part is a hollow body, almost cylindrical or slightly thinned chamber 37, of a capacity of more than about 5 milliliters (mi) and up to about 250 milliliters, but more generally of a capacity of about 10 milliliters to about 25 milliliters, with an open first end 38, and a second end 39 that narrows to form an outlet hole 40 that leads to an integrally formed outlet tube portion 29. When a drip chamber is in its normal operative position, it is erect or almost erect, with the first end 38 arranged higher than the second end 39. The body 37 of the chamber must be formed of a transparent material, such as plastic or glass, to allow visibility of the flow of the nutritional composition. 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 this first example drip chamber 27 is in the nature of a plug 42 with a cylindrical body having an inward end portion 43 that fits snugly in the first end 38 of the body 37 of the chamber . Preferably, the inboard end portion 43 of the plug body 42 has a slightly reduced diameter, whose proximal edge 44, that is, the edge towards the beveled end 49 of the inlet tube 46, serves as a stop when the two parts are assembled. The body of the plug is provided with an integrally formed fluid communication passage 45, which can take the form of an axial hole in a solid plug body communicating with the inlet tube portion 46, 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 end 38 of the body 37 of the chamber, the fluid communication passage 45 is a concentric tube axially located in and around the body of the plug, which in this case is mainly a hollow cylinder, except for a short solid portion. The concentric tube 45 is integrally formed with, or otherwise connected in fluid communication with, the inlet tube portion 46. A short, integrally formed peripheral flange 50, extending longitudinally from the shaped flange, can be provided. of collar 47 along one side of the plug body, if desired, to assist in holding the plug body when the drip chamber is assembled. The body of the plug can be molded from a plastic such as a polyvinyl chloride resin, and can be pigmented, if desired. The distal, ie free, end 49 of the inlet tube portion 46 has a bevelled end sufficiently sharp to facilitate piercing of the seal (not shown) in the closure of the conventional hanging supply vessel, such as the supply container. 22 The collar-shaped flange 47 serves as a stop to the insertion of the sharpened or bevelled entry tube portion 46 into the closure in any of the conventional connecting elements provided in the neck of the supply container 22. A second construction Example of a drip chamber that will function suitably as a formulation chamber in the apparatus used in the present invention, is shown in Figures 16 and 17. The drip chamber 82 illustrated in these views has a plug end 83 that is integrally formed with the closure 84 for one of the conventional styles of supply container (not shown) to which the drip chamber 82 is easily connected in a threadable manner and from which it hangs. 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 portion of transparent tubular chamber, where the drip or flow rate of the nutrient product can be observed. liquid enteral The apparatus of the invention is not to be considered limited to the inclusion of the drip chamber shown herein by way of illustration, nor is the method limited to the use thereof. For example, the formulation chamber 76 shown in Figure 15 is suitable for use in a horizontal position at the end of the flexible tubing 54 of a feed assembly that is distal to the supply container and approximately at the level of the bed of a patient. The health care worker may find it more convenient to connect this formulation chamber 76 at the end of the flexible tubing 54 that is distal to the supply container, rather than bringing the separate supply assembly adjacent to the drip chamber, particularly if there is a need or a desire to introduce a fluorescent marker dye into the nutritive product, by using a sustained release reservoir during feeding, in addition e? a coloring dye that is in a sustained release tank in the drip chamber 27. The formulation chamber shown has a provision for holding or supporting in this manner one or a plurality of sustained release tanks, such that the nutritive product Enteral fluid that is being fed will be guided over the sustained release reservoir (s). In this embodiment, the formulation chamber has a bulbous me section 77 where the sustained release reservoir 32 is placed, so that the flowing stream of nutritive product 33 will flow over it and recover the marker dye from the reservoir. The formulation chamber can also be configured or molded with a longitudinal groove along the side wall of the lower side of the chamber body, and the sustained release tank (s) is placed in this chamber. groove before starting feeding. In all embodiments of the present invention, the formulation chamber is a hollow flow through chamber, having an inlet and an outlet, and is suitable for receiving therein at least one sustained release reservoir at a position in the reservoir. that the depot or sustained release tanks will make contact with the liquid enteral nutrient product flowing through the formulation chamber, while the formulation chamber itself is supported or held in its intended normal orientation. The drip chambers shown in Figures 5, 6, 16, and 17, have a sustained release tank 32 disposed therein, ready for use. The sustained release reservoir contains at least one acceptable marker dye according to the objectives of the invention. More than one sustained release tank may be placed in the drip chamber if necessary to provide sufficient depth of color, or fluorescence, as the case may be., or to provide a longer period of dye mark. Accordingly, the deposits may be selected to have different release rates, or one of the deposits may provide a delayed start of release, to extend over a longer period of time. The sustained release reservoir will typically be in the form of a coated tablet, an osmotically driven device, a coated capsule, a microencapsulated microsphere, agglomerated molecular sieve particles, or hollow fiber pieces of permeable walls within a porous carrier or wrapper or as a fiber coil, containing a given amount of dye or an amount that provides a given period of time for a mark. To prevent the sustained release reservoir 32 from substantially blocking the flow of liquid enteral nutrient product through the outlet orifice 40 of the drip chamber 27 or another formulation chamber, it is preferred that the individual reservoirs or the carrier of a plurality of the same, and the exit 40, have mutually non-complementary forms, to facilitate the flow of the liquid between them. For example, the sustained release container can be configured substantially as a rectangular solid, or as a star-shaped solid, which will not block a cylindrical or thinned cylindrical chamber that forms a neck going down to a round hole to the passage of outlet 29. This is particularly pertinent if the sustained release container is one that maintains the integrity of the outer layer or coating thereof, or of the carrier therefor, while the ingredients leach outward or squeeze outward during the contact with the liquid enteral nutrient composition. If a different type of sustained release tank is used that does not maintain the integrity of its coating or wrapper or carrier, it is preferred to arrange the sustained release tank in some kind of confinement, such as the mesh bag 51 shown hanging from the end. inside of the inlet tube 45 inside the drip chamber in Figure 11. With this kind of sustained release tank, there is little need for special forms of the tanks, since the confinement element used can prevent the hole from being covered outlet 40 of the drip chamber. Also shown in Figure 11 are a plurality of sustained release reservoirs 32 that can be used for the purpose of providing additional dye to obtain a greater depth of the dye mark, if desired. As seen in Figure 12, 'a foraminous shirt-shaped bag, ie one with numerous holes in it, can be hung inside the drip chamber, and can be used to place and confine the Sustained release tank (s) in the drip chamber. 0, as seen in Figure 13, a plastic or ceramic or inert metal plate 53 that is foraminous or that is perforated, transversely through the lower part of the body 37 of the drip chamber, can be placed to support the (the) sustained release deposit (s). Figure 13 shows a very large number of sustained release deposits 32 used to obtain a long-term dye brand release of tablets or capsules that release each dye very slowly, or, depending on the release rates, to obtain a greater concentration of the marker dye in the nutritive product. In Figure 13A a cross section of the body 37 of the formulation chamber, taken just above a grid 41, of ceramic or plastic material, or of an inert metal such as stainless steel, which can be used in place of the foraminous plate 53 in the drip chamber 27 of Figure 13, to support one or more sustained release tanks. The sustained release reservoir illustrated in Figure 7 is of the osmotic pump type that functions in the manner of the osmotically driven delivery device described and claimed in US Pat. No. 5., 318,558, the specification and drawings of which are incorporated herein by reference with respect to the structure of the sustained release tanks described therein, and to the method for manufacturing them and their mode of release, although different means are employed here environments and contents and final uses. The pump type reservoir comprises: (a) a first body wall portion 59 defining an enclosed elongated cavity that is essentially cylindrical, with first and second ends, (b) a piston 58 that can slide longitudinally in the cavity while sliding the first wall portion of surrounding body 59, and (c) a hole 57 formed through a second body wall portion 62 at the second end of the cavity. The piston defines first and second zones inside the cavity. The first zone 60 is filled with a hydroactive substance, while the second zone 61 is filled with a marker dye in liquid form or in solution. The body wall portions 59 and 62 together provide a complete enclosure. The first body wall portion 58 surrounds the first zone and the first end of the cavity, and a portion of the second adjacent zone, and is formed of a membrane permeable to moisture. The second body wall portion 62 surrounds the second end of the cavity, and telescopically overlaps a portion of the first body wall portion 59, and is formed of a membrane that is not permeable to the medium of the liquid enteral nutrient product. It is through the second body wall portion 62 at the second end of the cavity, that a hole 57 is formed for the discharge of marker dye towards the flowing liquid enteral nutrient product. Each of the body wall portions is of a material that maintains its integrity for at least 24 hours in the presence of moisture. In pump-type tanks, the ingredient to be fed, such as the marker dye or the dye mixture herein, in a liquid or solution form, is squeezed out of the cylindrical enclosure or cavity 56 into the reservoir, through a very small orifice 57, by the action of a piston 58 driven by the pressure developed by the osmotic infusion of moisture, taken in the form of a liquid enteral nutrient product, through a semi-permeable membrane 59 bordering a hydroactive substance 60 behind the piston 58, urging the piston continuously towards the side of the reservoir wherein the dye or dye mixture 61 is forced out gradually through the orifice 57. The enclosure 56 is formed inside a non-permeable membrane or coating 62. The sustained release reservoir illustrated in Figure 8 is another osmotic dosing system with a sustained release reservoir operating at in the manner of the osmotically operated application device described and claimed in U.S. Patent No. 5,324,280, the specification and drawings of which are hereby incorporated by reference with respect to the structure of the sustained release reservoirs described therein, and the method to manufacture them and their way of liberation, although here we have different environments and content and end uses. This type of osmotic device comprises: (a) a capsule formed by an outer wall made, at least in part, by a semipermeable composition that maintains its integrity in the presence of an aqueous fluid, (b) a hydroactivated layer surrounded by the wall external, and comprising a hydroactivated inflatable composition or a hydroactivated composition occupying space at a controlled rate, (c) an inner capsule surrounded by the hydroactivated layer, and (d) a lumen communicating with the internal capsule, and extends to the outside of the outer capsule. The internal capsule contains at least one useful amount of water soluble marker dye in a liquid form or in solution. The wall of the internal capsule is substantially not permeable to the liquid enteral nutrient product that is being fed. In this type of system, the ingredient, such as the dye or mixture of dye 63 herein, to be fed in liquid or solution form, is enclosed within a non-permeable coating 64 which is surrounded by a layer 65 of hydroactive material that it is entirely confined within an outer membrane coating 66, which is semipermeable to the liquid medium of a liquid enteral nutrient product. The osmotic pressure that develops in the hydroactive layer 65 on the infusion of moisture into it from the liquid enteral nutrient product, compresses the core 67 that contains the dye or liquid dye mixture 63, and forces that liquid towards out continuously through a very small passage 68 from number 67 and to the outside of the reservoir. A sustained release deposit of the type shown in Figure 8 is shown in Figure 8A, but with an easily soluble outer coating 69 consisting of the label dye alone or mixed with one or more physiologically acceptable excipients to preferably lightly fix the dye outside of the sustained release tank. Individuals may be selected individually such as polyvinyl pyrrolidone having a weight average molecular weight in the range of about 35,000 to 50,000, mannitol, sorbitol, starch, or magnesium stearate, or in combination with zein or gum, of guar, in a total amount up to about 10 weight percent of the coating. The marker dye coating, to be useful, is one that rapidly dissolves in the medium of the liquid enteral nutrient product to provide a practically immediate dye mark, preferably within ten seconds, and more preferably within less than three seconds. If fast marking with dye is especially useful, particularly with a dye dye, this can be achieved in a rather simple way by selecting and using a feeding set where it has been placed in the drip chamber or in the another formulation chamber, a small amount of readily soluble and suitable dye that is not in a sustained release dosage form, but in a fibrous package such as package 79 shown in Figure 9A. This can be done instead of using a sustained release coating with dye for quick coloration. Some marker dye 78 may be placed, which is not in a sustained release dosage form, but, for example, in a loose particle form, in the fibrous pack 79, and both the pack and one of the release tanks sustained described above are placed adjacent to each other in the formulation chamber. Also, if desired, some non-sustained release dye dye may be placed in the fibrous pack, accompanied by a sustained release reservoir containing the same dye, to continue dye marking for up to 24 hours during feeding. In general, from about 1 to about 10 milligrams, and preferably about 5 milligrams, of a coloring dye, such as the dye F.D. &; C. Blue # 1 in a non-sustained release dosage form, provides sufficient almost instantaneous visible color when the flow of the liquid enteral nutrient product through the formulation chamber is initiated. The carrier 70 of the sustained release reservoir illustrated in Figure 9 is of the type wherein a number of microcapsules or sieve particles are provided within a shell 71 readily soluble in the medium or disintegrable in the medium of the enteral nutrient product. molecular agglomerates 72. If they are microcapsules, they are microspheres, each individually coated, each containing at least one physiologically acceptable dye marker which is soluble in the medium of the nutritive product, with a plurality of respective portions or fractions thereof each provided. with one or more soluble or permeable or disintegrable coatings in the middle of the nutritive product, in a range of coating thicknesses by which it is obtained; a sustained release effect. The envelope and the coatings must in essence be physiologically acceptable for nourishing food, either soluble in the liquid medium of the liquid enteral nutrient product, or merely disintegrable in a waste carried by the medium flow. If the particles are of a type of molecular sieve, or a mixture of two or more grades of molecular sieve, the particles should be impregnated with the marker dye or the dye mixture, to be used for the mark with color, and the particles should be agglomerate into granules or lumps of the desired size, which are used as such within the envelope 71 of Figure 9 or the fibrous bag of Figure 9A, or lightly coated with a soluble, disintegrable or permeable coating, to form a deposit of sustained release that can be used by itself in accordance with the invention. Sustained release deposits within a carrier wrapper, can also take the form shown in Figure 9A of a fibrous, preferably non-spun, bag 79, similar to a conventional tea bag, with a content of permeable, fine hollow fibers, crushed, instead of the loose particulate dye 78. These crushed hollow fibers can be formed of a permeable material, such as a reconstituted cellulose, or a cellulose ester, or cellulose ester, capable of recovering and storing a label dye or a a physiologically acceptable dye mixture, and subsequently releasing it on contact with a liquid enteral nutrient product that flows into a drip chamber or other contact chamber. The hollow fibers 78 of Figure 9A are carried within a highly permeable non-spun fibrous wrap 79 which is similar to a conventional tea bag. Any sustained release mode can be employed in the manufacture of a reservoir that can be used in accordance with the invention, provided that any soluble or disintegrable components of the coating, or a carrier wrap, are physiologically acceptable, and the sustained release reservoir is capable of storing a marker dye or suitable dye mixture, and of releasing it to the liquid enteral nutrient product at a useful rate over a useful period of time during enteral feeding. In a preferred embodiment of the apparatus of the invention, the reservoir or the small number of reservoirs in the formulation chamber, are each of the type illustrated in Figure 8A where each reservoir is externally coated with a soluble or rapidly disintegrable layer of, or containing approximately 5 milligrams in total of FD & C. Blue # 1. The dye coating on the reservoir provides a blue coloration of the enteral nutrient product that flows within 3 seconds, and the reservoir, or reservoirs collectively, provide the blue dye at a concentration in the liquid enteral nutrient product at a sustained concentration of at least 0.075 milligrams per milliliter (mg / ml) and not more than 0.125 milligrams / milliliter, and more preferably from about 0.10 milligrams / milliliter, within less than one minute and continuing to about 1,440 minutes, during the flow of from 0.7 milliliters to about 3,000 milliliters of the liquid nutritional product having a viscosity of about 15 centipoise. In another preferred embodiment of the apparatus of the invention, the reservoir or more sustained release reservoirs in the formulation chamber are each of the type illustrated in Figure 8, wherein each reservoir contains dye F.D.; C. Red # 3 as the marker dye, and the deposit or deposits collectively provide the fluorescent red dye in the liquid enteral nutrient product at a concentration of at least 0.01 milligrams / milliliter, and no more than approximately 0.05 milligrams / milliliter within less than about 10 seconds and continuing to about 1,200 minutes, during the flow of from about 1.5 milliliters to about 3,000 milliliters of the liquid enteral nutrient product having a viscosity of about 28 cps. In yet another preferred embodiment of the apparatus of the invention, which utilizes a feeding assembly connected to a hanging container of liquid enteral nutrient product, as shown in Figure 2, the reservoir or more sustained release reservoirs in the formulation chamber, are each of the type illustrated in Figure 8A, wherein each sustained release reservoir is externally coated with a soluble or rapidly disintegrable layer of, or containing FD & C. Blue # 2, and the deposit, or the reservoirs collectively contain a dye mixture F.D. & C. Blue # 2 and dye F.D. & C. Red # 3, and provide the blue dye in a concentration of at least 0.075 milligrams per milliliter (mg / ml) and not more than 0.125 milligrams / milliliter, and more preferably approximately 0.10 milligrams / milliliter, and the red fluorescent dye in a concentration of at least 0.01 milligrams / milliliter and not more than 0.02 milligrams / milliliter, the blue dye appearing at least a minimum concentration within 10 seconds, and the fluorescent red dye within 15 seconds, and continuing both until approximately 1,440 minutes , during the flow of from about 0.7 milliliters to about 3,000 milliliters of the liquid nutritional product having a viscosity of approximately 53 cps. The dye-labeled liquid enteral nutrient product, when examined under ultraviolet light, visibly fluoresces. In still another preferred embodiment of the apparatus and method of the invention, a feeding assembly as shown in Figure 2 is connected to a collapsible container, to receive the flow of a nutritive product therefrom. The container is filled with a liquid enteral nutrition product, such as PULMOCARER, a product of the Ross Products Division of Abbott Laboratories, Columbus, Ohio, which has a viscosity of about 40 cps. The drip chamber of the feeding set contains an osmotic device, such as that shown in Figure 8, which contains dye F.D. & C. Blue # 1, as the sustained release deposit in the formulation chamber. A continuous flow of the liquid enteral nutrient product is begun. The osmotically driven device provides the blue dye in the flow of the liquid enteral nutrient product in a variable concentration of at least 0.075 milligrams per milliliter (mg / ml) and not more than 0.125 milligrams / milliliter, but more predominantly about 0.10 milligrams / milliliter , the blue dye appearing in at least a minimum concentration within 10 seconds, and continuing until approximately 1,440 minutes, during the flow from about 0.7 milliliters to about 3,000 milliliters of the liquid enteral nutrient product. In still another embodiment of the apparatus and method of the invention, a power assembly as shown in Figure 1 is connected, but with a formulation chamber equipped with a foraminous plate such as that shown in Figure 13, to a collapsible container , to receive a continuous flow of a nutritious product from it. The collapsible container is filled with a liquid enteral nutrient product having a viscosity of approximately 12 cps., Such as OSMOLITER, a product of the Ross Products Division of Abbott Laboratories, Columbus, Ohio. The drip chamber of the feed set contains a gelatin capsule carrier for sustained release tanks, such as that shown in Figure 9. The sustained release deposits of dye F.D. &; C. microencapsulated, are contained in the thin-walled gelatin capsule carrier which is supported on the foraminous plate and immediately disintegrates in the medium of the liquid enteral nutrient product. The blue dye has been processed in a number of microspheres that have been divided into six portions. Five portions have been microencapsulated, having, respectively, from one to five layers of a zein coating applied to the microspheres of the respective portions, in order to slow down the solubilization of the dye, relatively, from portion to portion, in the medium of the liquid enteral nutrient product. The five microencapsulated portions have been mixed with the uncoated microspheres and used to fill the gelatin capsule. The gelatin capsule has additionally been coated with a fast dissolving layer of a mixture of about 8 milligrams of the blue dye and a minor amount of about three percent by weight, based on the weight of the dye, of polyvinyl pyrrolidone having a weight average molecular weight in the range of 35,000 to 44,500. The surface coating of the gelatin capsule provides the coloration of the liquid enteral nutrient product that flows, within 2 seconds, and the microencapsulated microspheres provide the blue dye in the flow of the liquid enteral nutrient product in a variable concentration of at least 0.065 milligrams per milliliter (mg / ml) and not more than 0.25 milligrams / milliliter, the blue dye appearing fast enough to maintain the blue coloration visible at least a minimum concentration, and continuing until approximately 1,320 minutes, during the flow from approximately 0.7 milliliters to approximately 2,400 milliliters of the liquid nutritional product. Where it is necessary or very important to provide a liquid enteral nutrient product labeled with dye at a rate that is closely uniform over time, such as from about 2 to about 30 hours or more, but more usually not more than 24 hours, they will prefer osmotic pump or osmotic dosing systems to have greater uniformity of operation and less decrease in dye release over time during a given feed. A feeding set, such as the case 20 shown in Figure 14, is conveniently provided in a packaged form ready for use in feeding a liquid enteral nutrient product with a sustained release reservoir 32 containing a physiologically acceptable marker dye and placed inside the drip chamber 27 that serves as a formulation chamber, and having the drip chamber connected to its outlet an adequate length of flexible tubing 54 that serves as the most part of the communication element that terminates in a coupling element conventional 30 having a cover 55, as seen in Figure 14, that is removable to connect the coupling element to the inlet of a feed tube. The kit will be selected to contain a sustained release reservoir containing a physiologically acceptable dye marker which is soluble in the medium of the liquid enteral nutrient product to be fed using the kit. The case may also be provided with a plurality of sustained release tanks to be used where a greater depth of dye mark is needed or desired, in case the flow of the nutritive product is expected to be very fast, or the dye is of a limited solubility in the product. A similar case 20a, as shown in Fig. 10, includes the sustained release tank 32, which has not been placed in the drip chamber 27, but may be provided with a protective wrapper (not shown), if desired, until it is used. For example, the plug 42 of the drip chamber can be made easily removable from the body 37 of the chamber, and can be made reinsertable to facilitate the placement of one or more sustained release tanks in the formulation / drip chamber. The dye mark of a liquid enteral nutrient product is widely useful, employing the apparatuses and methods of the invention, whether the enteral product is exclusively marked by itself, or that the product is marked while also being added thereto, inside a formulation chamber, such as a drip chamber, one or more beneficial agents such as nutrients, medicaments, probiotics, or diagnostic agents, in either or both of a controlled release dosage form or in a form of dosage of uncontrolled release, during enteral feeding. Controlled release includes sustained release, as well as delayed or intermittent release.

Claims (30)

1. CLAIMS 1. An apparatus for feeding a liquid enteral nutrient product, which comprises: a formulation chamber having an inlet and an outlet, and which can be connected to a supply container of a liquid enteral nutrient product; at least one physiologically acceptable dye marker, the at least one marker dye being contained within at least one sustained release reservoir placed inside the formulation chamber, to physically make contact with a liquid enteral nutrient composition passing through it, the at least one soluble marker dye in the liquid enteral nutritional product medium, the at least one sustained release reservoir containing marker dye being an element for providing and dosing the label dye towards a liquid enteral nutrient product when the sustained release reservoir he physically gets in contact with it during his feeding to a patient; 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 labeled with dye to the gastrointestinal tract of a patient.
2. 2. The apparatus of claim 1, wherein the marker dye is a visible dye under white light.
3. 3. The apparatus of claim 1, wherein the marker dye is a fluorescent dye. The apparatus of claim 1, wherein at least one sustained release reservoir in the formulation chamber is externally coated with an easily dispersible dye colorant. 5. The apparatus of claim 1, wherein the formulation chamber is a drip chamber. The apparatus of claim 1, wherein the formulation chamber contains a plurality of sustained release reservoirs containing at least one physiologically acceptable dye marker. The apparatus of claim 1, wherein the liquid enteral nutrient product is an aqueous composition, and each of the at least one sustained release reservoir containing marker dye is an application device for a water soluble ingredient that contains when minus a water soluble marker dye comprising: at least one internal mass transfer conductor; the at least one water soluble label dye being provided in the at least one internal mass transfer conductor, and the at least one internal mass transfer conductor being permeable to the passage of at least one water soluble label dye; and a membrane surrounding the at least one internal mass transfer conductor, whose membrane releases at least a useful amount of at least one water-soluble marker dye into the liquid enteral nutrient product employed when the liquid enteral nutrient product is passed over the membrane and enterally administered to a patient. The apparatus of claim 1, wherein each of the at least one sustained release reservoir containing a marker dye is an osmotically driven device that contains at least one physiologically acceptable dye marker that is soluble in the nutrient medium. liquid enteral, the device comprising: a body wall defining an enclosed elongated cavity, with first and second ends; a piston that can slide longitudinally in the cavity, while touching the wall of the body laterally thereof; the first and second piston defining zones within the cavity, the first zone being filled with a hydroactive substance, and the second zone being filled with the at least one physiologically acceptable dye marker in a liquid or solution form; the body wall having first and second portions, the first portion surrounding the first zone and the first end of the cavity, and a portion of the second adjacent one, and being of a membrane permeable to moisture, and surrounding the second portion of the body wall to at least the second end of the cavity, and overlapping the first portion, and being of a membrane that is not permeable to the nutritional product liquid enteral, with a hole formed therethrough at the second end of the cavity, each portion of the body wall being a material that maintains its integrity for at least 24 hours in the presence of moisture. The apparatus of claim 1, wherein the liquid enteral nutrient product is an aqueous composition, and each of the at least one sustained release reservoir containing marker dye is an osmotically en device, the device comprising: a capsule formed by an outer wall made, at least in part, of a semipermeable composition that maintains its integrity in the presence of an aqueous fluid, surrounding the outer wall to a hydroactivated layer comprising a hydroactivated, inflatable composition, or a hydroactivated composition that occupies space at a controlled rate, and an inner capsule surrounded by the hydroactivated layer and communicating with a lumen extending to the outside of the outer capsule, the inner capsule containing at least a useful amount of at least one water-soluble marker dye in one form of liquid formulation, and the inner capsule being substantially not permeable to The liquid enteral nutritious product. The apparatus of claim 1, wherein there is a plurality of sustained release reservoirs containing a label dye, and substantially each sustained release container comprises a microsphere particle containing at least one physiologically acceptable label dye, having the respective particles from nothing to approximately six microencapsulating coating thicknesses that gradually dissolve and release at least one physiologically acceptable dye marker from within the particles upon contact, over time, with the liquid enteral nutrient product. The apparatus of claim 1, wherein the at least one sustained release reservoir is a type of agglomerated molecular sieve impregnated with the at least one physiologically acceptable dye marker, releasing the agglomerated molecular sieve gradually the at least one physiologically-labeled dye acceptable put in contact over time with the liquid enteral nutrient product. The apparatus of claim 1, wherein the at least one physiologically acceptable dye marker is a blue dye or a mixture of a plurality of blue dyes. The apparatus of claim 12, wherein the at least one physiologically acceptable dye marker is F.D. &; C. Blue # 1 or F.D. & C. Blue # 2. The apparatus of claim 1, wherein the at least one sustained release tank is provided with an outer layer that substantially maintains its integrity for at least the shelf life while exposed to the nutritive product. liquid enteral, and the reservoir is in the form of a rectangular solid. 15. The apparatus of claim 1, wherein the at least one sustained release reservoir is confined within a mesh bag inside the formulation chamber. 16. The apparatus of claim 1, wherein the at least one sustained release reservoir is confined within a foraminous bag inside the formulation chamber. 17. The apparatus of claim 1, wherein the at least one sustained release reservoir is confined within a highly porous fibrous package. 18. The apparatus of claim 17, wherein the fibrous package contains additional marker dye that is not in a sustained release reservoir. 19. The apparatus of claim 17, wherein the fibrous bundle is of a non-spun construction. The apparatus of claim 1, wherein the formulation chamber contains a physiologically acceptable soluble marker dye that is not in a sustained release reservoir, in addition to at least one sustained release reservoir containing marker dye. The apparatus of claim 1, wherein the at least one sustained release tank is supported within the formulation chamber on a foraminous plate or grid. 22. An apparatus for feeding a liquid enteral nutrient product, which comprises: a formulation chamber having an inlet and an outlet, and which can be connected to a supply container for a liquid enteral nutrient product; at least one sustained release reservoir disposed within the formulation chamber for physically contacting the liquid enteral nutrient product passing through it, at least one sustained release reservoir present in the formulation chamber which is an osmotically driven device that contains at least one physiologically acceptable dye marker which is soluble in the medium of the liquid enteral nutrient product; 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 labeled with dye to the gastrointestinal tract of a patient. The apparatus of claim 22, wherein the osmotically driven device is in the form of a capsule formed by an outer wall made, at least in part, of a semipermeable composition that maintains its integrity in the presence of an aqueous fluid, surrounding the outer wall a hydroactivated layer comprising a hydroactivated, inflatable composition, or a hydroactivated composition occupying space at a controlled rate, and an inner capsule surrounded by the hydroactivated layer and communicating with a lumen extending to the exterior of the external capsule, the inner capsule containing at least one marker dye in the form of a liquid formulation, and the inner capsule wall being substantially not permeable to the liquid enteral nutrient product. 24. The apparatus of claim 23, wherein the marker dye is a visible dye in the liquid enteral nutrient product under white light. 25. The apparatus of claim 24, wherein the dye is dye F.D. & C. Blue # 1 or dye F.D. & C. Blue # 2. The apparatus of claim 23, wherein the marker dye is a fluorescent dye. 27. The apparatus of claim 23, wherein the marker dye is a mixture of a dye and a fluorescent dye. 28. A drip chamber having therein disposed a sustained release reservoir which contains as the sole water soluble ingredient, apart from moderating excipients, at least one useful amount of at least one water soluble marker dye that is physiologically acceptable. for enteral use. 29. A drip chamber as in claim 28, having at least one additional sustained release reservoir disposed therein, each containing as the only water-soluble ingredient, at least one useful amount of at least one soluble marker dye. in physiologically acceptable water. 30. 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 which can be connected to an enteral nutrient product supply container liquid, and the formulation chamber having therein an element for supporting at least one sustained release reservoir in a position to be moistened by, or submerged in, a liquid enteral nutrient product passing through it.; at least one sustained release reservoir containing at least one physiologically acceptable marker dye that is soluble in the medium of the liquid enteral nutrient product, the at least one physiologically acceptable label dye being present and being able to be released in a sustained manner at least one amount sufficient to impart a coloration, visible under daylight or ultraviolet light, to the liquid enteral nutrient product for a period of at least 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 liquid enteral nutrient product visibly containing the at least one physiologically acceptable dye marker.