MXPA00008384A - Apparatus for altering composition of nutritional product during enteral tube feeding - Google Patents

Abstract

An apparatus for modifying a liquid enteral nutritional product. The apparatus includes a feeding set having an inlet and an outlet. The inlet is constructed forfluid connection to a supply container. The feeding set defines an interior space. The apparatus further includes a canister disposed in the interior space defined by the feeding set. The canister includes a wall portion that defines an aperture therethrough. The canister is constructed to receive one or more beneficial agents in an interior chamber defined therein. At least one beneficial agent is disposed in the interior chamber defined by the canister.

Description

APPARATUS TO ALTER THE COMPOSITION OF A PRODUCT OF NUTRITION DURING FOOD BY TUBE ENTERIC FIELD OF THE INVENTION The invention relates to an apparatus for delivering enteric, liquid nutrition products and, in particular, for modifying an enteric, liquid nutrition product, having a viscosity on the scale of 1 to about 300 centipoise (cps), adding ingredients during its supply to the gastrointestinal tract of a patient BACKGROUND OF THE INVENTION It is well known to provide an enteric nutrition product, liquid, from a suspended container, such as a bottle or a plastic bag, with a lower outlet connecting to a drip chamber, and this with a flexible tube or lumen, which leads to a nasogastpco tube or supply tube (feeding) inserted through a gastrostomy or jejunostomy, by gravity flow, or aided by a pump. The enteric, liquid nutrition product can be aseptically processed, or finish in retort, and can be supplied in a pre-filled container, ready to suspension, or may be placed in said container by whoever is in charge However, the selection of diets, particularly special diets, from the most modest number of enteric, liquid, typically available nutrition products is limited. This reduces, as practical issue, the selection of the doctor in charge, in terms of dietary modifications, temporarily or long-term, that could significantly benefit the patient In view of the importance, now recognized, of providing aseptic nutrition compositions, you can see that modified diets are not easily prepared without observing the strict requirements necessary to supply the patient with an aseptic nutrition composition. Until now, the need to adhere to said requirements has been opposed to the preparation of small amounts of special diets, designed for a patient. In addition, many nutrients as well as medications, diag- and other ingredients, such as probiotics, which at any given time may be convenient to be administered orally to a patient, are not stable during heat sterilization, or may not be mutually compatible with other desirable ingredients, over a prolonged period of time For example, days or even months, until they are used, and in such a way, they are not readily available for large-scale preparation and consequent storage when the product stops marketing. These drug delivery systems have been described and claimed in US patents 4,511,353, 5,318,558 and 5,324,280, in which the drug component to be delivered is stored in a capsule, from which it is ejected during the time by osmotic infusion of moisture into the capsule, the drug being expelled from the outer surface of the capsule by means of a suitable liquid in an intravenous, ie, parenteral, delivery system, or even, by the device of US Pat. No. 5,318,558, by the body fluids, when the capsule is implanted. US Patent 5,069,671 a formulation chamber is described, which may also be a drip chamber, in which various forms of sustained release mechanisms are employed, to release a drug or a 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 delivery system The teachings of U.S. Patents 4,511,353 and 5,069,671 are directed to the intravenous delivery of a parenteral composition and, in the case of this latter patent, include delivery by infusion through the intravenous, intraartepal, intrapeptoneal routes. or subcutaneous The osmotic dosage system of US Pat. No. 5,324,280 is related to the delivery of drug formulations over time, to a biological environment, such as a tissue or an implant. of organs in a mammal, or to a stream or tank for marine life It is said that the osmotically driven device of US Pat. No. 5,318,558 is usable to deliver drugs, drugs and nutrients in a variety of environments, ranging from veterinary medicine to the administration of drugs to humans, and hobby situations, such as fish tanks Again, in the case of administration to humans, the supply seems to be within an implant of tissue or organ While the osmotic delivery devices and other dosage forms Sustained or controlled release, either as forms or as deposits, have been known for some time, as far as is known, there have been no attempts to use such a delivery system to add one or more nutrients, or one or more medications, or a mixture of nutrients and medications, or a probiotic, or a diagnostic agent, or any of them mixed with a dye marker, to an enteric, liquid nutrition product, with a viscosity up to 300 cps, during the administration of the nutrition product to the gastrointestinal tract of a patient The enteric, liquid nutrition products, currently on the market, are described in the text Reference Nutrition In Critica! Care, Gary P Zaloga, ed, Mosby - Year Book Inc, St. Louis, MO, 1994, chapter 24, authored by 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 various proportions, in an aqueous or aqueous / fatty medium Nutrient compositions for special diets may omit one or more kinds of these components BRIEF DESCRIPTION OF THE INVENTION The apparatus of the present invention is constructed to modify an enteric, liquid nutrition product. The apparatus includes a supply set having an inlet and an outlet, the inlet being constructed for fluid connection with a supply container. The supply set defines an interior space The apparatus further includes a receptacle disposed in the interior space defined by the supply set. The receptacle comprises a wall defining an interior chamber, the wall defining at least one opening therethrough. The apparatus additionally includes at least a beneficial agent disposed in the inner chamber, defined by the wall of the receptacle 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 product of enteric nutrition, liquid, and supply by tube by nasogastric route, according to the invention Figure 2 is a partially schematic representation of an apparatus for modification of an enteric, liquid nutrition product and feed it by tube, through a tube for gastrostomy, according to the invention Figure 3 is a schematic representation of an apparatus for modification of an enteric nutrition product, liquid, and feeding it by tube, with the aid of a pump, through a jejunostomy tube, according to the Fig. 4 is a fragmentary view, enlarged, in front elevation of the lower portion of a hanging supply container, of an enteric, liquid nutrition product, such as the container shown in Figs. 1 to 3, with the entrance tube beveled from a drip chamber inserted through the lid and hanging from it, and with a beneficial agent in the form of a release dose controlled being disposed within the drip chamber and immersed in the flowing liquid enteral nutrition product, the lower part of the drip chamber being the controlled release dosage form therein, partially cut out and sectioned, and being truncated the tube portion of the fluid communication medium, ie, primarily the tube exiting the drip chamber, for illustrative purposes; Figure 5 is a perspective view of a drip chamber usable according to the invention, with a form of controlled release dose in the form of a substantially rectangular solid, with slightly rounded corners, disposed within the drip chamber, the bevelled inlet tube of the drip chamber being the upper end which is pushed in the normal way through the cover of the supply container for communicating with and receiving from it the enteric, liquid nutrition product Figure 6 is a perspective view of the drip chamber of Figure 5, inverted, to show the construction in more detail Figure 7 is a perspective view, partially cut away and in section, of a controlled release dosage form, in rectangular solid form, of the osmotic pump type, used to deliver a beneficial ingredient or mixture thereof, within the formulation chamber of According to the invention, FIG. 8 is a front elevational view, partially cut away and in section, of a delivery dose form. rolled, solid, almost rectangular shape, of another type of osmotic device, used to deliver a beneficial ingredient or mixture thereof, into the formulation chamber according to the invention. FIG. 8A is a view similar to FIG. 8, of FIG. a sustained release dosage form of the same type, but with an outer coating of marker dye, which is readily absorbed immediately in the medium of the enteric nutrition product, liquid, at the moment it begins to flow through the formulation chamber, and of use, where the dosage form contains a marker dye for sustained release Figure 9 is a front elevational view, partially cut away and in section, of a carrier of solid, almost rectangular and controlled release dosage forms, of the microencapsulated particle type or of the molecular sieve type, used to deliver a beneficial ingredient or a mixture thereof, into the drip chamber according to The invention Figure 9A is a perspective view, partially cut away and in section, of a highly permeable fibrous package, preferably of the non-woven tea bag type, suitable for being placed in a drip chamber or other formulation chamber, and capable of containing a sustained release dosage form, such as a coated tablet, or an osmotic delivery device, or a coated capsule, or a capsule that contains a quantity of controlled release dosage forms in the form of microencapsulated particles of molecular sieve type material or permeable hollow fibers, each of said articles or dosage form units contain at least one beneficial agent or a mixture of them, with a marker dye A beneficial agent can also be placed that is not in the form of a controlled release dose, either as a tablet or as an agglomerate or as loose particles, in a measured amount, in a porous carrier, such as one or more fibrous packages of the kind shown in the Figure 9A and used in a formulation chamber, in addition to one or more controlled release dosage form units, or separately if there is at least one of said controlled release dose forms placed in the same formulation chamber or in At least one formulation chamber used with the same media A small amount of marker dye that is not in the form of a controlled release dose may also be placed in the fibrous package for initial, rapid dye labeling Figure 10 is a side elevation view and partially truncated, a game or feeding equipment, which includes a beneficial people in the form of controlled release dosage, which is going to be placed in the formulation chamber by whoever is in care, the equipment being useful for modifying an enteral, liquid nutrition composition, during its delivery according to the invention Figure 11 is a view similar to Figure 4, but with the controlled release dosage forms of any of FIGS. 7 to 9A, confined within a mesh sleeve or bag. FIG. 12 is a view similar to FIG. 4, but with the controlled release dosage forms of FIG. any of Figures 7 to 9A, confined within a foraminous, perforated or fibrous sleeve or pouch Figure 13 is a view similar to Figure 4, but with a plurality of controlled release dosage forms of any of Figures 7 to 9A, supported by a plate foraminous above the lower orifice of the drip 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 drip chamber of Figure 13, instead of the foraminous plate shown for the support of a controlled release dosage form, located in the drip chamber. Figure 14 is a side elevational view, similar to Figure 13, showing a drip chamber that depends on a container of delivery, with an enteric, liquid nutrition product, flowing through the chamber, over a beneficial agent, in a controlled release dosage form, intermixed with the additional beneficial agent that is not in controlled dosage form, while the dosage forms are supported on a perforated plate, near the bottom of the formulation chamber. Figure 15 is a side elevation of a feeding set according to the invention. tion, including a drip chamber, loaded with a beneficial agent in the form of controlled release dosage, and a fluid communication means for connecting the drip chamber with the feeding tube used to direct the liquid enteral nutrition product, modified, to the gastrointestinal tract of a patient, including a removable protective cap for the end connector Figure 16 is a side elevational view of a feeding equipment in which the second formulation chamber has been fixed by its entrance, in communication of fluid, to the end of the tube flexible that is usually fixed to an attachment that connects to the patient's feeding tube, the outlet tube of the formulation chamber being an attachment to connect it to the feeding tube Figure 17 is a perspective view of a suitable formulation chamber , similar to that shown in figure 5, but with a different form of attachment for connecting it to a supply container, the cover here is screwed to a supply container and is formed integrally with the upper end of the formulation chamber. Figure 18 is a perspective view of the formulation chamber shown in Figure 17, as seen in the opposite direction. Figure 19 is a side elevation of a feed set in which two formulation chambers are connected in series, here In tandem Figure 20 is a side elevational view of part of the apparatus for modifying an enteric, liquid nutrition product during the enteric feeding, where two formulation chambers are suspended from respective hanging supply vessels, the outputs of the formulation chambers being connected to tube segments that connect to a "Y" attachment that joins the parallel flow of each of the formulation cameras in a single stream within the communication medium, shown here truncated Figure 21 is an elevational view of a chamber and a retainer constructed in accordance with an embodiment of the present invention; Figure 22 is a sectional view of a retainer constructed in accordance with an embodiment of the present invention; Figure 23 is a viewed in elevation from a receptacle constructed in accordance with an embodiment of the present invention, and Figure 24 is an elevational view of an alternative embodiment of a retainer constructed in accordance with the present invention DEFINITIONS USED HERE The following terms and phrases are defined for the purposes of the description and the claims. "Enteric" nutrition products refer to liquid compositions that are commonly understood to be supplied to, and used in the gastrointestinal tract of patients. Such products. of enteric nutrition have a viscosity in the approximate range of 1 to 300 cps and, very frequently, in the approximate range of 5 to 150 cps "Enteric nutrition product medium" refers to the liquid portion of an enteric nutrition product, liquid, mainly water, but often including minor or minor amounts of one or more non-aqueous liquid substances, as lipids, for example, vegetable oil and marine oil The term "gastrointestinal tract", as used herein, refers only to the stomach and the small intestine. The supply is made to the gastrointestinal tract by the use of a nasogastric tube that extends through a nasal passage and esophagus and from there to the stomach, or through the use of a supply or feeding tube that extends through the abdominal wall to the stomach or small intestine A "physiologically important" or "healthy" ingredient "beneficial" is an ingredient that is, or is believed to be, nutritionally or pharmaceutically important to the patient, or that is medically important in another way, such as in the case of a probiotic, or a diagnostic agent, such as an opaque agent It is understood that a "probiotic" is a live, microbial food supplement that beneficially affects the human host, improving the microbial balance of the individual in the tract Gastrointestinal, for example, Lactobacillus reuten A "beneficial agent or beneficial ingredient that is dispersible in the medium of the enteric, liquid nutrition product" is an agent or ingredient that is added in a physiologically beneficial manner, or otherwise added beneficially useful, as in the case of a diagnostic agent, to the liquid nutrition product during enteric delivery, and which is dispersible in the medium of the nutrition product. The beneficial agent or ingredient or the beneficial agents or ingredients, whether they are supplied or not, by, that is, from the units or devices of units in the form of controlled release doses, and used according to the invention, must be dispersible in the medium of the enteric, liquid nutrition product, which is being modified during delivery, in order to be transported with the nutrition product to the patient's gastrointestinal tract A "useful amount" of a beneficial ingredient that is dispersible in the medium of the liquid enteral nutrition product is an amount that is "physiologically effective" or detectable by diagnosis "with respect to a patient, that is, it produces, or is reasonably expected to produce, a beneficial effect detectable in the patient, either on a short-term or a long-term basis, when it is provided as part of an enteric, liquid nutrition product, or that is detectable in the diagnosis of a condition or disease In general, it will not be contained more than around 5 grams of beneficial agent in a single unit or device in controlled release dosage form, and a plurality or even a multiplicity of units, such as microencapsulated microspheres containing a beneficial agent, can be used to give a desired level of beneficial agent in the nutrition product being fed The phrase "at least one beneficial agent dispersible in the middle of the enteric, liquid nutrition product" is used to refer to the singular as well as the plural, as can be well judged from the context , and includes combinations of ingredients, agents or Factors The term "dispersible" when used herein with respect to the beneficial agent or ingredient or the beneficial agents or ingredients, should be understood as applied to substances that are soluble, as well as those that can be suspended sufficiently to be easily absorbed and transported with the liquid medium as the liquid enteral nutrition product flows through the formulation chamber containing the one or more dosage forms of controlled release. The term "feeding equipment" refers to the combination of a drip chamber or another formulation chamber, and fluid communication means leading to a supply tube for enteric delivery. The drip chamber or other formulation chamber is loaded with, or is accompanied by at least a useful amount of, at least a beneficial agent in the form of controlled release dosage, being the beneficial agent as defined above, with or without a marker dye, in combination, and with or without additional beneficial agent, not in the form of controlled release dosage, the term also comprises said feeding equipment having at least one additional drip chamber or one or more fluid flow or parallel flow formulation chambers as part of the fluid communication means, each feeder unit having at least one drip chamber or chamber formulation, loaded with at least one beneficial agent in the form of a release dose controlled, each beneficial agent being present in at least one useful amount, as defined above. When more than one formulation chamber is employed, the additional chamber or chambers may contain (1) one or more beneficial agents in the form of a release dose. controlled alone, with or without marker dye, in the form of controlled release doses, or (2) one or more beneficial agents in the form of controlled release doses, intermixed with one or more beneficial agents that are not in the form of a release dose controlled, and with or without marker dye in controlled release dosage form, or (3) one or more beneficial agents, none of which is in the form of controlled release dose, and with or without marker dye, in dosage form Controlled Release The "infusion" process is used to refer, in the present context, to the process of supplying a soluble beneficial ingredient, enteric, to the gastrointestinal tract of a patient, which extends for a time from at least one minute to about 30 hours, but more usual, at least about 2 hours to about 24 hours. The term "means of delivery" denotes generally a medium or system for storing and subsequently supplying or releasing a beneficial ingredient or agent or a mixture thereof, within a formulation chamber, such as a drip chamber, during, and as a consequence of, the flow through it of a nutrition product enteric, liquid, which uses a form of controlled-release dose of the beneficial ingredient or agent The term "a controlled-release dosage form" refers to any of the conventional, well known, controlled release forms, such as a coated tablet, an osmotic delivery device, a coated capsule , microencapsulated particles, such as microspheres, agglomerated particles, for example, particles in molecular sieve, or a thin, hollow fiber, with permeable walls, such as a bundle of shredded fibers or a spiral, each of these forms contains and stores, and subsequently liberates or disperses, in the case of osmotically driven devices, a useful content of a beneficial agent in the medium of an enteric nutrition product, liquid, at room temperature, in a slow or delayed or intermittent manner, compared to solubility characteristics normally exhibited by that beneficial agent when it is in the form of particles does not reveal Stresses or untreated, in such medium, at approximately room temperature Any dosage form employing coating, encapsulation, microencapsulation, wrapping in an osmotically driven device, or capture in a molecular sieve type structure, or in a thin hollow fiber , permeable, to retard or diminish, delay or intermittently delay the solubilization of a rapidly soluble beneficial agent, so that its dissolution or dispersion is effected as with an osmotically operated device, during the course of at least 30 minutes and, preferably, , at least two hours, contact with the enteric nutrition product, liquid, flowing, or delaying the release, that is, it is not started for at least 10 minutes after the initial contact in a formulation chamber, with the enteric nutrition product, liquid, exhibits controlled release behavior. As to a beneficial agent that is inherently soluble in a non-fast manner in the medium of an enteric, liquid nutrition product, any of said dosage forms that delay or decrease, delay or retard are considered. inherently the solubilization of said beneficial agent for at least 20% of the normal time for the solubilization or dispersion in the medium of an enteric, liquid nutrition product, of a given unit amount of the beneficial agent that is neither coated nor treated to obtain a controlled release, for the purposes of the present disclosure and the claims, which is a controlled release dosage form It is preferred that the controlled release dosage forms prolong the release of their contents for an appropriate time for the nutrient or drug or other agent On the other hand, the simple formation of tablets of a beneficial agent, either without mixing with another material or not mixed with a relatively insoluble agglutinating type excipient, for example, at the same time that it results in This is by exposing a smaller surface to a solvent liquid, and at a slower dissolving rate than that of a particulate form fine of the beneficial agent, is not considered to constitute the beneficial agent in a controlled release dosage form Clearly a beneficial agent in the form of particles that have not been coated with, nor enclosed in another material, is not a release dosage form Also, uncoated tablets or particles of a beneficial agent, which are clearly not in the form of a controlled release dose, are not to be considered transformed to a controlled release form when being enclosed in a carrier, such as a bag type. of fibrous tea, or in an easily dissolved or disintegrated capsule It is understood that the "controlled release dosage forms" useful in accordance with the invention include delayed or intermittent release, as well as sustained release dosage forms, some of which constitute "speed control means" or "dosage forms of controlled speed" It is preferred that the of controlled release doses prolong the release of their contents for an appropriate time for the nutrient or drug that is being delivered. The terms 'controlled release dose form units' or 'controlled release dosage form particles' should be understood as which refer to individual coated tablets or coated capsules, or devices such as osmotic delivery devices or microcapsule particles, or small bundles of small hollow fibers, or small, agglomerated accumulations of material of the molecular sieve type, Each of which is sustained supply layers or delayed or intermittent supply of the beneficial agent or marker dye, as defined above. It should also be understood that the phrase "flow of the enteric liquid nutrition product through the apparatus, where it remains modified, and inside the feeding tube ", means the inclusion of the flow that uses gravity, from a hanging vessel, as well as the use of a pump, in addition to, or without the flow by gravity, to promote the flow of the enteric nutrition product, liquid, modified, to and through the feeding tube DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawings, in which similar parts have similar reference numbers, the apparatus of the invention is shown in Figure 1 in the form of a supply equipment, indicated generally by the number 20, which connects the outlet 21 of the hanging supply container 22, to the nasogastric supply or delivery tube 23, which extends through a nasal passage 24 of the patient, and after the esophagus 25, to the stomach 26 The supply equipment consists here of a chamber 27 of formulation, in the form of a drip chamber, which also serves as a contact or formulation chamber, and fluid communication means, indicated generally by the number 28 It is understood that "fluid communication medium" includes all fluid communication components used in series from the outlet 29 of the drip chamber to the connection 30 to the supply tube, such as the nasogastric supply or delivery tube 23 The components include not only portions of the flexible tube 54 , but also any additional drip chamber or other formulation chamber, connected in series as seen in figures 16 and 19, for serial flow, or connected in parallel, but soon joined to a single current, as seen in FIG. figure 20, for the flow of the enteric, liquid nutrition product, to the patient feeding tube. The components can also include any special tube portions for the use of a pump, and the connecting elements, respectively, among all the other components, as the connecting elements 31 or the adapters 30 It may be useful to employ two tandem formulation chambers, such as the got cameras eo 27 and 73, as seen in figure 19, to introduce a higher concentration or a greater amount of a certain ingredient. The tandem formulation chambers can also be used to introduce different beneficial ingredients, which are not supplied together within the same unit or controlled-release dosage form particle The respective ingredients may constitute a combination of little use, for example, or may not be compatible with each other in storage, within a controlled release reservoir Two formulation chambers in use, sequentially in series, are shown in the supply equipment of Figure 16, where the second formulation chamber 76 is attached to the end of the flexible tube 54, which is distal from the supply container. This may be useful for adding a special beneficial ingredient to an already constituted supply equipment With the formulation chamber 76 at the end of the equipment that is distal from the supply container, it will most likely be positioned hopzontally, as illustrated, and is preferably made with a bulbous middle portion 77, or with a longitudinally extending low channel portion, where the beneficial agent 32 in the form of controlled release dosage will remain on the lower side of the formulation chamber and be wetted by the enteric nutrition product, fluid, which is flowing If the beneficial agent is not in controlled dosage form, it will probably remain, for example, in The lower side of the bulbous section 77 until it is dispersed. Double formulation chambers 74 can be used in parallel, as indicated in Figure 20, and for the same reason as the tandem chambers, or it can be simpler, when you want to feed a beneficial agent, on a bolus basis, and another on a sustained basis It is preferable to hang those cameras from respective supply vessels, as shown, to avoid control problems, in order to obtain adequate flow through both chambers of formulation, from a single container of supply, which would require the use, preferably, of a divider valve to distribute the inflow between the two parallel routes. The outlets of each formulation chamber shown in Figure 20 are connected to segments of flexible tubing 54 leading to an attachment 75 in "Y", in which the currents of the enteric, liquid nutrition product are brought together Referring again to Figure 1, the formulation chamber 27 has disposed in it a unit 32 of controlled release dosage form, which contains at least one The physiologically effective or detectable amount in the diagnosis of at least one beneficial ingredient which is dispersible in the medium of the enteric nutrition liquid product 33, which flows from the supply container 22 to the formulation chamber 27, where the product of enteric nutrition, liquid, which is normally based of water, makes contact with the unit 32 of controlled release dosage form, moistening it or immersing it within the formulation chamber 27, which causes the release or discharge into the nutrition composition of the dispersible beneficial ingredient or ingredients, furthermore of the marker dye, if included, stored in the reservoir The flow of the enteric, liquid nutrition product is conveniently initiated or cut, or sometimes regulated, by the use of a conventional, adjustable, compression clamp 34. Turning now to FIG. 2, a container is shown 22 supply, pendant, which provides nutrition product 33 enteric, liquid into a formulation chamber from which the enteric nutrition product, liquid, flows through the flexible tube 54 of the feeding or delivery equipment 20a, to the feeding tube 24a for gastrostomy The feeding tube for gastrostomy, shown in Figure 3 is simply exemplary of the wide variety of gastrostomy feeding tubes, which are commercially available, it being understood that the apparatus of the present invention is usable with a variety of gastrostomy feeding tubes. 3 there is shown a feeding or delivery device for a jejunostomy, very similar to the apparatus of Figure 1, except that the delivery equipment 20b is adapted to be used with a pump 35, which provides a positive flow to the feeding tube 23b , which leads to the patient's small intestine 26a, whereas in many cases gravity flow is used. A second formulation chamber 27a is also used, as part of the supply equipment 20b, in order to add an additional or different beneficial agent and / or a label dye, each of the which is dispersible in the medium of the enteric nutrition liquid product 33, which flows from the supply container 22 to the formulation chamber 27, and from there, through the rest of the communication means 28b and the formulation chamber 27a of supply equipment 20b, to feeding tube 23b for jejunostomy The additional benefit agent may be in the form of uncontrolled dosesIf desired, or if necessary, as is frequently the case when feeding through a feeding tube, such as a jejunostomy tube, a pump, such as a peristaltic cam pump, acting on the portion 54 of the flexible tube of the communication means 28, or a positive displacement pump, with a disposable liquid infusion chamber pumping chamber, such as that described in US Patent 4,927,411, and connected in series in the means of communication, for flowing or helping to flow the enteric, liquid, modified nutrition product into the feeding tube, for example, when it is not convenient to hang or otherwise locate the supply container in an elevated position with relationship to the patient, or when the nutrition product is rather viscous and flows slowly by gravity flow. The fluid communication means 28 of the apparatus used, incl. Ordinarily, a portion 54 of flexible tubing, connectable to or usable with a conventional pump, will be used. If the pump used, for example, is a peristaltic pump, which requires a flexible tube, in a special way, said tube can replace all or part of the tubing. of the communication medium supplying the modified nutrition product from the formulation chamber to the patient feeding tube The end of the flexible tube 54, connected to the entrance end of the second formulation chamber 27a, preferably it is provided with a coupling element 30, such as that shown in the supply equipment of figure 15, while the inlet end of the formulation chamber is adapted in addition to receive the coupling element, and the output of the formulation chamber communicates with a short section of flexible tube, which also ends in a coupling element 30, which is connected to the feeding tube 23b It can be seen that it is convenient to add the second formulation chamber 27a, when the need arises, without having to disconnect the parts of the supply equipment Here, for example, the flexible tube 54 would have to be disconnected from the drip chamber 27 and add the formulation chamber 27a directly in tandem at that end of the equipment The formulation chamber 27 has was loaded with a beneficial agent in controlled release dose form 32, while the second formulation chamber 27a has been provist a with the same or different beneficial agent, not in the form of controlled release dosage The use of beneficial agent that is not in the form of controlled release dose is also illustrated in Figure 14, where a plurality of dosage form units 32 controlled release, which contain one or more beneficial agents, are supported on the perforated plate 53, together with the beneficial agent that is not in the form of controlled release doses, as dispersible particles or tablets. formulation 27a, as a conventional drip chamber, but it is probably more convenient to place it with the direction of flow of the enteric nutrition product, liquid, through it, approximately horizontal Accordingly, the formulation chamber 27a should be provided with means for guiding or channeling the liquid nutrition product, so that it makes physical contact with the unit or dose controlled release dosage units present therein. Such means may be a longitudinal channel, which remains low in the body wall of a bulbous enlargement. of the body of the chamber, of the type illustrated in Figure 16, or even a simple lateral depression in the side wall of the lower side of the chamber, or a trap, or a gate or any other means for retaining the dosage form units , where there will be an adequate flow or a sufficient depth of liquid to produce good contact with the units or particles of the dosage form controlled ration, located in these guide means or channel As can be seen in figure 16, a second formulation chamber 76 is provided in a supply equipment, with a portion 77 of bulbous body in which the unit 32 is arranged in a way of controlled release dosage, so that the flow of the enteric, liquid nutrition product is permanently in contact with the unit 32 of controlled release dosage form, and picks up the beneficial agent from it In the enlarged fragmentary view of the figure 4, a 32a unit of controlled release dosage form is seen, which has the form of a capsule with osmotic device, immersed in an enteric, liquid nutrition composition 33, within the drip chamber 27 This kind of controlled release dosage form unit 32a, having an outer coating or membrane that is not it easily disintegrates, it must preferably have a geometric shape, for example, that of a rectangular solid, which prevents blocking of the flow of the enteric, liquid nutrition product 33, through a circular opening, such as that of channel 40. , which serves as an outlet for the lower part 39 of the drip chamber 27, or other means, such as a mesh sleeve, can be used to prevent said blocking The construction details of an example of a conventional drip chamber, suitable for use as a formulation chamber according to the invention, they are illustrated in figures 5 and 6, which are seen in greatly enlarged perspective. As shown, the drip chamber 27 ti The first part is a hollow cylindrical chamber body 37 with a first end 38 open, which is the upper end when the drip chamber is in its normal operative position, and a second end 39, opposite the first , which tapers or narrows downwards, to form a hole 40, which leads to an integral formed outlet tube portion 29. Preferably the chamber body 37 is formed of a clear material, such as plastic or glass, to allow visibility through it, the flow of the nutrition product Usually, the drip chamber is formed of a clear plastic, somewhat flexible, that can be treated in an autoclave, such as a clear pohvinyl chloride or a clear polyolefin resin. The second part of the drip chamber 27 shown, is of the type of a plug 42, with a cylindrical body having an inner end portion 43 that fits snugly under pressure into the inlet end 38 of the chamber body 37 It is preferred that the end portion 43 of the plug body, which extends into the chamber body, have a slight diameter The edge 44 of this end portion 43, remote from the end face of the cap, is slightly raised, being of a slightly larger diameter, and serves as a limiter when assembling the body of the chamber and its cap The cap is provided with a fluid communication passage 45, integrally formed, which can take the form of an axial hole in a solid plug body, communicating with a portion 46 of inlet tube, projecting h Axis out in axial direction from a flange-like flange 47, extending radially from the upper end 48 of the plug body. However, it is preferred to provide a plug body with more elasticity to facilitate insertion into the upper end 38 of the body. 37, and the fluid communication passage 45 is a concentric tube, axially located within, and approximately as long as, the body of the cap. The concentric tube 45 is integrally formed with, or otherwise operatively connected to, the portion 46 inlet tube A short, peripheral, integral, formed flange 50 extending longitudinally from the flange-like flange 47 may be provided along one side of the plug body, if desired, to assist in grasping the plug body when assembles the drip chamber The plug of a plastic, such as a polyvinyl chloride resin, can be molded, which can be pigmented, if desired, for visibility, as an aid to observe the proper seating in the camera body. distal 49 or free end of the inlet tube portion 46, has a beveled end, sharp enough to facilitate punching of the seal (not shown) in the closure 21 of the neck of a conventional hanging supply container, such as the container 22 The flange-like flange 47 serves as a limiter for insertion of the inlet pipe portion 46, pointed, inside the closure 21, in the neck of the supply container 22 Other modes of construction of the formulation chamber can be employed, provided that a suitable connection is provided to the supply container, as well as a tubular portion through which can be seen, so that the flow regime of the enteric, liquid nutrition product can be observed. For example, see the formulation chamber 82 illustrated in Figures 17 and 18, where the plug end 83 of the chamber of formulation is formed integral with the cover 84 so that it can be Threatably connecting a conventional supply container The apparatus of the invention is not considered to be limited to the inclusion of any of the drip chambers here used by way of illustration, nor is the method limited to its use The drip chamber shown in the figures 5 and 6 has a unit 32 of controlled release dosage form disposed therein, ready for use. The controlled release dosage form unit will be pre-selected in accordance with its contents, to provide the additional nutrients and / or the / the medicines and / or the probiotic and / or the diagnostic agents and / or the other beneficial ingredients, selected by the person in charge of the care, together with a marker dye, if desired. When used here and in the claims, it is understood that the drugs are substances used in therapy. The chamber or formulation chambers selected may contain more than one release depot. controlled, in order to provide a combination of nutrients or a combination such as nutrients and medications or other beneficial agents, tailored to the needs of the patient being fed The formulation chamber can also be one that is provided with the same or different agent or the same or different beneficial agents, both in the form of controlled and uncontrolled release doses, in order to provide, for example, a greater amount, as in the case of a nutrient. A controlled dosage form can be used of a beneficial agent to supply the beneficial agent during a shorter period of time, as would be desirable with a medicament The controlled release dosage form units, employed, will preferably be in the form of a coated tablet, an osmotic delivery device, a coated capsule, a microencapsulated microsphere, an agglomerated particle, for example, as particles of the molecular sieve type, or a bundle of permeable, hollow, thin fibers, or hollow permeable fibers, shredded, agglomerated or held in a fibrous package To prevent a dosage form unit or The particle blocks the flow of the liquid enteral nutrition composition through the exit orifice 40 of the drip chamber, if the dosage form unit is one that maintains the integrity of the outer layer or its coating, while the ingredients are leached. or are squeezed out during contact with the enteric, liquid nutrition product, it is preferred that the dosage form unit have a a geometric shape, for example, a rectangular solid or a star shape, any of which will not completely block a round passage If a different type of controlled release dosage form is used, it dissolves or disintegrates so that the If the intermediate form is not controllable, or if it leaves a skeletal structure or insoluble waste, it is preferred to confine the controlled release dosage form units in a mesh-like pouch, within the drip chamber or other formulation chamber, such as the 51 mesh cuff shown in the figure A plurality of controlled release dosage form units are shown in Figure 11, which can be employed to provide additional beneficial ingredients, which are dispersible in the medium of the enteric, liquid nutrition product, in order to obtain a nutrient composition tailored for the patient This can be especially useful when none of the controlled release dosage forms available have the exact combination of ingredients that are desirable or necessary for a patient, and the combination can be performed a la carte if controlled release dosage form units containing the various contents of desired ingredients are available As seen in Figure 12, a foraminous sleeve or foraminous bag may be used, that is, having numerous holes, for placing the reservoir or the controlled release tanks in the drip chamber or another formulation chamber Or, turning now to FIG. 13, a plastic or ceramic plate 53 may be placed. or corrosion-resistant metal, which is foraminous or perforated, within the body of the bottom of the drip chamber 37, or another formulation chamber, to support the controlled release dosage form units, in this case, a very large number, where the desired ingredient is needed in relatively large quantities. If desired, the foraminous plate 53 can be replaced by a grid or a screen 41, as shown in Figure 13A, and it is also preferably formed of a plastic or vitrified ceramic or of a corrosion-resistant metal, such as stainless steel. The above means for arranging, ie, for supporting, the controlled-release dosage form units within the drip can also be used in any additional formulation chambers, in the employed delivery equipment. The controlled release dosage form illustrated in Figure 7 is of the osmotic pump type, which operates in the manner of the delivery device, osmotically driven, which was described and claimed in US Pat. No. 5,318,558, the specification of which and the drawings of which are incorporated herein by reference, with respect to the structure of the controlled-release dosage form units, described therein, and as to the method to form them and their way of working, although here with different modalities and contents and end uses In controlled release dosage form units, pump type, or such delivery devices, the beneficial ingredient (s) in liquid form, ie, in liquid form or in solution in a solvent suitable, is / are expelled from a cylindrical shell or cavity 56 within the reservoir, through a small orifice 57, by the action of a piston 58 driven by the pressure developed by the osmotic infusion of moisture through of a semi-permeable membrane 59, which confines a hydroactive substance 60 behind the piston 58, permanently driving the piston towards the side of the reservoir where the ingredient / ingredients 61 is / are forced out through the orifice 57 The orifice 57 is very small and preferably is perforated by a laser beam. The cylindrical shell 56 is formed within an outer, non-permeable membrane or coating 62. The hydroactive substance 60 may be a water-soluble salt, such as magnesium sulfate, magnesium chloride, potassium sulfate. , sodium chloride, sorbitol, mositol, 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, or a pol? (v? n? lp? rrol? d? na) with a molecular weight of 10,000 to 360,000, an ammonium or cationic hydrogel or polyvinyl alcohol having little residual acetate. The controlled release deposit illus Figure 8 is another osmotic dosing system, with a sustained release dosage form operating in the manner of an osmotically operated delivery device, described and claimed in US Patent 5,324,280, the specification and drawings of which are incorporated herein. by this reference, in relation to the structure of the sustained release dosage form units described therein, and the method for forming them, as well as their way of functioning, even though here with different modalities and contents and end uses In this type of system, the The ingredients or beneficial ingredients that are to be fed in the liquid state or in the form of solution are / are enclosed within a non-permeable coating 64 that is surrounded by a layer 65 of hydroactive material, which is completely confined within a coating 66 of semipermeable, outer membrane The osmotic pressure that develops in the layer 65 hydroactive by infusing moisture into it, compresses the core 67 that contains the beneficial ingredient or ingredients in liquid form, and out that liquid to exit sustainably through a very small passage 68, from the core 67 to the exterior of the reservoir Returning now to FIG. 8A the controlled release dosage form unit shown in any of FIGS. 7 and 8, may be coated with an easily soluble coating, such as the coating 69, which may be a coating of the type marker or beneficial agent, for the purpose of obtaining rapid initial release of said dye or beneficial agent. In the case of a beneficial agent, such as a medicament, this may be convenient in order to quickly obtain a high level of content in the blood, after which a uniform, sustained release level may be necessary. The controlled release reservoir 70, illustrated in FIG. 9, is of the type in which it is provided, within a carrier envelope 71, that is very rapidly soluble or disintegrable in the medium of the carrier. enteric nutrition product, liquid, a number of microcapsules or particles 72 of the molecular sieve type If they are microcapsules, the particles 72 are microspheres, each of which is individually coated, and each contng the same beneficial ingredient or the same mixture thereof, with a plurality of different numerical portions or fractions, each provided with a coating that dissolves or disintegrates in, or that is penetrated by, the medium of the enteric, liquid nutrition product. The various numerical fractions, respectively, each have a coating of a thickness different, whereby they constitute a mixture of the microcapsules with a fraction that is not coated, the mixture exhibits a sustd release effect when exposed to an aqueous medium, such as the medium of an enteric nutrition product, liquid The envelope and the coatings must be essentially acceptable for nutrition feeding or disintegrable, that is, suspe If the particles 72 are of the molecular sieve type, or a mixture of two or more grades of molecular screening, the particles have been impregnated with one or more beneficial ingredients that are to be supplied during feeding, and the particles have been agglomerated to granules or lumps of desired size, which are unable, with or without the coating, to form a controlled release dosage form according to the invention, the coating being soluble or disintegrable, if applied, is to say that can be suspended in, or that is permeable to, the medium of the liquid enteric nutrition product to be modified. The molecular sieve type material has a porous structure with non-aligned pores, where the pore size is critically controlled in manufacturing, in order to create the property of contng molecules of different size characteristics, or of different molecular weights, selectively The content or storage properties impart the sustd release behavior The carrier for the controlled release dosage form units can also take the form shown in Figure 9, but contng a fibrous material in which the fibers are hollow and permeable and slowly release substances such as the beneficial ingredients added here to a nutrition product. A measured amount of those fibers can be used, in rolled or shredded form, in a holding means, such as a sleeve or bag, or agglomerated with a binder, or coated with a dispersible, disintegrable or permeable coating Said fibers, which can be formed primarily of an ether or cellulose ester, are capable of storing and subsequently retng a beneficial ingredient or a mixture of beneficial ingredients, when brought into contact with the enteric, liquid nutrition product, which flows into the drip chamber or other formulation chamber The type of fibrous and highly porous tea bag carrier 79 can also be used, shown in the figure 9A, for contng or supporting, within a formulation chamber, a quantity of microencapsulated microspheres, or an amount of material of the molecular sieve type or, for example, a quantity of hollow, fine, shredded permeable fibers, any of these forms ret or cont a quantity of doses of one or more beneficial agents. Such a bag-type envelope, or a plurality thereof, may also be used to place within any formulation chamber any combination of (1) one or more beneficial agents in the form of controlled release dosage, (2) one or more beneficial agents in the form of controlled doses, together with one or more beneficial agents that are not in controlled dosage form, where the beneficial agents that are not in the form of Controlled doses can be the same or different agents, than those that are present in a controlled dose form, and (3) a marker dye or a mixture of marker dyes, in combination with (1) or (2), and in a controlled release dosage form presentation, as well as in any of the external coatings of the units In a controlled release dose form Where more than one formulation chamber is used, the additional formulation chamber may have disposed therein, for example, a fibrous carrier bag, having only the uncontrolled beneficial agent, together with, or without the marker dye Any way of forming the coating, the shell or the binder of sustained or controlled release can be used, forming the controlled-release dosage form unit usable according to the invention, provided that the soluble, dispersible or disintegrable components of the dosage form units used are physiologically acceptable and the dosage unit form of release controlled is able to store one or more beneficial ingredients as defined above, until they are used, and to release them into an enteric, liquid nutrition product, at a useful rate or in a useful manner and / or over a period of useful time of at least half an hour and, preferably, more than at least two hours, during enteric delivery, or more, if necessary, for certain medications and nutrients Tablets and capsules and other dosage forms may generally be coated with well-known materials, which slow and retard the solubilization or suspension of the beneficial agent, the materials such as zein, Shellac, polymers and meta-plate copolymers and cellulose ethers and esters, which are frequently used for such purposes. These materials are described in US Patent 5,160,742, and are generally adaptable for the purposes of the present, although the coated articles described in that patent are used for different way When it is necessary or important enough to provide a beneficial ingredient or a mixture of ingredients, as defined herein, for example, one or more drugs, according to the invention and at a fairly uniform rate over time, with a variation preferably not greater than 25% above or below the average speed, over a period of two to about 24 hours or more, the osmotic pump or other osmotic delivery systems should be preferred. A wide variety of speeds can be achieved, provided that at least one effective amount is delivered, without reaching excess amounts. Among the beneficial agents that are very susceptible to being added to conventional, enteric nutrition compositions are, for example, nutrients, such as glutamine, arginine, fermentable dietary fiber, non-fermentable dietary fiber, enzymes, such as hpasas, combinations of amino acids, ohgosacpods, such as fructo-oligosaccharides, vitamins, short-chain fatty acids (3 to 4 carbon atoms) , pyruvate precursors in the form of pyruvamide, or pyruvaylamino acids, such as pivuplglicine, pyruvilalanine, pyruvyl-leucine, pyruvalavin, pyruvicsarcosamine and their ami das, its esters and its salts, structured lipids, d-ciromositol, lactoferpna, marine oils and acidulants, such as ascorbic acid An example of a structured liquid that provides excellent nutrition support, is a skeleton of g cerol with at least one gamma acid -hyolenic acid or a dihomogamma-linolenic acid residue, with a medium chain fatty acid residue (of 5 to 22 carbon atoms) and a n-3 fatty acid residue of 18 to 22 carbon atoms, selected from the alpha-hnolénico and stearodónico, eicosapentaenoico and docosahexaenoico acids Medications that can be administered in a useful manner, in this form, include, for example, antihistamine drugs, antineoplastic agents, such as antibiotics, antiviral and antineoplastic agents for the urinary tract, antineoplastic agents, autonomous drugs, such as adrenergic agents and muscle relaxants. skeletal, drugs for the formation and coagulation of blood, cardiovascular drugs, agents for the central nervous system, diagnostic agents, electrolyte, water and caloric 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 medication, bioactive peptides, medication for diabetic condition, chemotherapeutic agents or any medication intended for oral administration, which does not react adversely with the nutrition formulation being fed to the gastrointestinal tract. Probiotics that may be administered in a useful manner in this form include, for example, Lactobacillus acidophilus GG, which is described in U.S. Patent 4,839,281, Lactobacillus reuteri, Lactobacillus animalis and Lactobacillus salivaria, which is described in WO 93/02558. Probiotics are living organisms that aid in the digestion of food or that help control the population of harmful microorganisms in animals.

Intestines If desired, a marker dye or a mixture of pharmaceutically acceptable dye markers can be provided in the chamber or formulation chambers, in addition to the one or more beneficial ingredients described above, so that the flow can be made visible. of the liquid nutrition product, modified, as an aid to the person attending This can be done by placing in the formulation chamber one or more units of sustained release dosage form, containing both the dye or the mixture of dyes, and the beneficial ingredient (s), if such dosage form units are available. Alternatively, a controlled release dosage unit containing the dye or mixture of dyes and a unit can be placed together in the formulation chamber. in a separate controlled release dosage form containing the beneficial ingredient or ingredients As indicated above, in order to avoid In the rapid visibility of the flow of the modified nutrition product, as an aid to the person in charge of the city, it may be preferable to apply an eternal, readily soluble coating of the marker dye to a controlled release dosage unit, ordinarily one containing marker dye The marker dye is mixed with a small amount of one or more easily dispersible tablet coating excipients, such as polyvinylpyrrolidine, having an average molecular weight on the scale of about 35,000 to 50,000, Mannitol, magnesium stearate and zein or guar gum, when applying the dye to the dosage form unit, during manufacture In general, the amount of excipients in total is less than about 10 weight percent of the coating OR the Dosage unit unit can be simply immersed in a solution of the marker dye, and then dried A dye marker or a mixture of dyes, which is useful according to the invention, is a dye or a fluorescent dye, or a mixture of those dyes, which is physiologically acceptable to the patient, and compatible with the beneficial agents that are being supplied with it. The dye or mixture of dyes must also be capable of being absorbed at a detectable concentration in the liquid medium of the enteric nutrition product. liquid, while the product flows through the drip chamber or another formulation chamber that has placed therein at least one dosage unit form of liquid. Sustained release containing dye or marker dyes If the dye is detectable in the drip chamber, it can be expected to be detectable, usually, if something of it reaches the patient's oral cavity. The dye marker used can be a dye dye that imparts color that is visible under white light, for example, normal daylight or artificial light from a room in a hospital or clinic, or the marker dye can be a fluorescent dye, which fluoresces visibly under ultraviolet light , or a mixture of dye and fluorescent dye seems to be especially advantageous is a mixture of a dye and fluorescent dye, since the flow through the formulation chamber is easily perceived under normal lighting conditions with the dye present, while even a small amount of off-site nutrition product For example, in the oral cavity or in the nasal passage, it will be detected more easily with the help of ultraviolet light if it contains a fluorescent dye. This is because the nature of the fluorescent dyes are especially visible under ultraviolet light, even in the presence of of very low concentrations The dye or mixture of dyes used must be physiologically acceptable. Generally food coloring dyes, approved under the provisions of the Food, Drug and Cosmetic Act of the United States, are adequate. Dyes are preferred. FD & C Blue # 1 and FD &C Blue # 2 The dye or mixture of dyes used must be soluble in the medium of the liquid enteric nutrition product, which is supplied, and compatible with the beneficial ingredient or ingredients that are being added. During the supply In general it is convenient around 0 1 milligram of dye per milliliter of enteric nutrition product, liquid, to give an easily visible coloration to the nutrition product When it is important to be able to detect the enteric nutrition product, liquid, which takes a Inadequate direction, a fluorescent dye, such as red, can be used as the dye marker # 3 FD &C, which is highly visible at a very low concentration, under ultraviolet light, and also imparts a visible coloration to the liquid nutrition product, under white light conditions. Other suitable fluorescent dyes are quinine, red # 22 FD &C , fluorescein and UV blue D 282, obtainable from DaGlo, Cincinnati, Ohio, USA, and also identified as 16470-24-9 in 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 fluorescein dye can be used. In general, adding to the nutrition product present in the formulation chamber about 001 to 005 mg / ml of fluorescein dye is suitable for the possibility of detection under ultraviolet light A feeding apparatus, such as the equipment 20 shown in Figure 15, is conveniently provided in packaged form, ready to be used in the supply of a product of n enteric utrición, liquid The equipment includes a unit 32 of controlled release dosage form, a drip chamber 27 or another formulation chamber, and liquid communication means 28, consisting mainly of a length of flexible tube fixed at one end at the outlet of the drip chamber 27, and at the other end to an attachment 30 for coupling the attachment to a feeding tube. The attachment 30 is shown with a telescopic cover 55 for illustrative purposes. The lid is simply for protection of the attachment 30. , until the equipment is used The unit 32 of controlled release dosage form has already been placed in the drip chamber 27 and contains one or more beneficial ingredients, as defined above, for modification of a liquid enteral nutrition product during its feeding and, additionally, , a marker dye, if desired The equipment may also be provided with a plurality of units 32 of controlled release dosage form, within the drip chamber 27, if a single dosage form unit does not contain each type of ingredient beneficially desired for the modification of the nutrition product, or if it is desired to add a marker dye and is not present in the controlled release dosage form units, for the beneficial ingredients selected A similar equipment 20c, which is shown in Figure 10 , includes the unit 32 of controlled release dosage form, which has not been placed in the drip chamber 27 before packing the eq. It is also used to accompany the drip chamber as part of the equipment. Other equipment is prepared with different numbers and varieties of controlled release dosage form units, which contain various beneficial agents and various combinations of marker dye and beneficial agent, not in controlled release form, to accompany the feeding equipment In a preferred embodiment of the apparatus of the invention, of the type illustrated in Figure 2, a controlled release dosage form unit, of the type illustrated in Figure 8A, is placed in the formulation chamber The dosage form unit contains glutamine and blue dye # 1 FD &C, and is coated with a layer of the same blue dye, mixed with about 3 weight percent polyvinylpyrrohdine, which has an average molecular weight in the approximate range of 35,000 to 44,500 The equipment of feed is connected to a hanging supply container of an enteric, liquid nutrition product, having an approximate viscosity of 40 cps, such as PULMOCARE®, a product of The Ross Products Division of Abbott Laboratories, Columbus, Ohio, USA, and a sustained flow of the nutrition product is initiated. The dye coating provides immediate visible color within the drip chamber, within two seconds, and the controlled release dosage form unit provides a blue dye at a concentration of at least 0 075 mg / ml for a period of more than 1, 440 minutes, during the flow of about 3,999 ml of the liquid enteric nutrition product The dosage form unit also provides glutamine at a concentration of approximately 25 mg / ml during the flow of the enteric, liquid nutrition product, beginning after of about 1 ml of flow. As discussed above, the present invention can be embodied so that the delivery equipment 20 delivers one or more beneficial agents from one or more dosage unit 32, contained in one or more storage chambers. For example, in the embodiment of the present invention illustrated in Figure 3, the drip chambers 27 and 27a are each constructed in such a way that one or more units 32 can be placed therein. of dosage form of beneficial agent, thereby allowing the delivery equipment 20 to deliver a selected amount of a single beneficial agent, that is, when both drip chambers 27 and 27a contain dosage form units containing the same agent beneficial and, thereby, allow the feeding equipment 20 to supply more than one beneficial agent at the same time, that is, when the drip chambers 27 and 27a contain dosage form units containing more than one beneficial agent. 16 and 20 illustrate alternative embodiments of the present invention that are also capable of simultaneously delivering one or more beneficial agents from one or more dosage unit units. Figure 21 illustrates an alternative embodiment of the present invention constructed to simultaneously deliver one or more agents. beneficial to a patient In this embodiment of the present invention, the camera 100 is configured to receive the fork 102 therein Chamber 100 and retainer 102 can be constructed from a variety of materials known to be suitable for use in enteric feeding equipment Examples of those materials are discussed further back Chamber 100 can have a variety of configurations suitable for use in an in-line enteric fluid delivery equipment. As illustrated in Figure 21, the chamber 100 is in the form of a drip chamber of a suitable size to receive the retainer 102 therein.

As illustrated in Figure 21, the retainer 102 includes a first support member 104 and a plurality of second support members 106 that extend from the first support member 104 The retainer 102 may be of unitary construction, eg, a molded plastic , or may be constructed of a plurality of interconnected members by means of a variety of known methods. The first support member 104 is constructed to interconnect the second support members 106 and may have a variety of configurations. In the preferred embodiment of the present invention illustrated in FIG. Figure 22, the first support member 104 is of substantially semicircular cross section It will be appreciated that this configuration will prevent lateral movement of the dose form units 32 placed on the first support member 104, between the second support members 106. The first support member 104 can have a variety of other cross-sectional configurations, for example, circular and rectangular, without departing from the scope of the present invention, as defined in the appended claims. The dimensions of the first support member 104 and the second support members 106 may be varied, to receive A variety of sizes and shapes of dosage form units 32 It will also be appreciated that a variety of sizes and shapes of dosage form units 32 may be employed in a single retainer configuration 102, without varying the dimensions of the first member. carrier 104 and / or of the second support members 106, as long as the dosage form units are properly retained by the retainer 102 within the chamber 100, as described in more detail here. The second support members 106 preferably define one or more openings 107 through they, as illustrated in Figure 22, so that the liquid enteral nutrition product flowing through the chamber 100, passes through the openings 107. The openings 107 defined through the second supporting members 106 may vary in size, shape, spacing and number It will be appreciated that the flow characteristics through the second support members 106 may vary as one or more of these parameters of the openings 107 vary. Thus, it is possible to control the manner in which the units 32 of dosage form release the beneficial agents, by varying one or more of these parameters. For example, it is possible to delay the delivery of the beneficial agent from a dose unit 32 relative to other dose unit units 32, contained in the retainer 102, by adjusting the size, shape, number and / or spacing of the openings 107 defined through the second supporting members 106, adjacent to the dosage unit 32, in order to limit the volume of fluid remaining in contact with the unit 32 of dosage form, which is to be provided in a prolonged release form The size, shape, spacing and number of openings 107, in such a manner, are determined by the desired flow characteristics through the chamber 100 and the retainer 102 In the preferred embodiment of the present invention, the openings 107 direct the flow through the retainer 102, such that the fluid directly contacts each of the units 32 in the form of doses contained therein, thereby ensuring that the beneficial agent of each of the dosage form units 32 is released into the fluid. However, as discussed above, the flow characteristics through the retainer 102 may to be varied so as to delay the delivery of beneficial agent from one or more of the dose unit 32 units. The second support members 106 are preferably spaced a sufficient distance from each other, so that one or more of them can be retained therebetween. more dosage units 32 of the beneficial agent As illustrated in Figure 2, the second supporting members 106 extend substantially pe However, it will be appreciated that the angular orientation of the second supporting members 106, relative to the first supporting member 104, may vary without detrimentally affecting the effectiveness of the present invention. For example, the second supporting members 106. they may be oriented so as to form an upward angle when the retainer 102 is maintained so that the first support member 104 is substantially vertical and the first end 108 is located above the second end 110, thereby forcing the dose unit 32 toward the first support member 104 The second support member 106 and the first support member 104 have sizes such that the retainer 102 in the chamber 100 The outlet 112 of the chamber 100 is preferably constructed in such a way that it can be connected in fluid connection with an enteric fluid supply equipment, in line The first end portion 114 of the chamber 100 preferably is constructed to receive a closing device, such as the plug 42, illustrated in figure 6 and described in more detail later The closing device will preferably be constructed in such a way that it can be connected in fluid connection to a fluid supply equipment Enter in line or directly to a fluid source, thereby allowing the chamber 100 to be connected in a fluid connection n a fluid supply equipment, enteric nutrition product, in line The chamber 100 can be configured so that the closure device, for example, the plug 42, can be secured to it, thereby preventing inadvertent opening of the bottle. the chamber 100 during use In a preferred embodiment of the present invention the chamber 100 is configured to receive the closure device, for example, the plug 42, by means of a press fit which at the same time secures the closure device to the chamber 100 and minimizes the possibility of violation to the retainer 102 and the units 32 of form of doses retained there, after the retainer 102 has been placed in the chamber 100 When the retainer 102 is placed on a flat surface, such that the first support member 5 104 is horizontal and the second support members 106 extend towards up therefrom, the dosage form units 32 can be loaded into the retainer 102, by placing them in the first support member 104, between the second support members 106. This process can be carried out at any time before the delivery of the enteric nutrition product to the patient For example, the dose form units 32 containing the selected beneficial agents can be loaded into the retainer 102 and the chamber 100, by a manufacturer or supplier and subsequently distributed to the end users Alternatively, dosage units 32 can be charged in retainer 102 and chamber 100 in a pharmacy, prior to delivery to a patient. Additionally, dosage form units 32 can be loaded in retainer 102 and chamber. by a medical professional or by a patient, before connecting the camera 100, with fluid connection, with an enteric feeding system The number and type of dosage form units and the beneficial agents contained in them can be varied from one patient to another, thus allowing a significant variation in the number and type of beneficial agents provided to the patient with the enteric nutrition product Additionally some of the Dosage unit units 32 may be in the form of sustained release, while others are not in a sustained release form, which allows the selection of a phased delivery plan, of the beneficial agents contained in the retainer 102 Thus, it should be evident that this embodiment of the present invention provides a great opportunity to design and deliver a variety of beneficial agents to a patient with an enteric nutrition product, in accordance with the individual needs of the patient, as well as the needs of medical professionals attempting to treat the patient and / or diagnose the condition of the patient. The retainer 102 can be constructed in such a way that it does not swing when placed on a flat surface, in the manner discussed above. For example, when the first support member 104 is of semicircular cross section, as illustrated in Figure 22, a supe can be made substantially flat the surface of the first supporting member 104 or of the retainer 102, thereby preventing the retainer 102 from swinging during its loading Alternatively, the first supporting member 104 can be provided with limiters preventing the retainer 102 from swinging during its loading Who is skilled ordinary skilled in the art will appreciate that other methods are possible to prevent the balancing of the retainer 102. The camera can be constructed of a material that is substantially transparent, thus allowing a professional The physician will visually determine the contents of the chamber 100 while in use. Such visual determination will be facilitated if the various beneficial agents and dosage form units, present in the retainer 102, have distinguishable shapes, sizes and / or colors. chamber 100 of a translucent or opaque material, without departing from the scope of the present invention Although retainer 102 is illustrated in Figure 21 including four second support members 106, it will be appreciated that retainer 102 may be constructed to include one or more second supporting members 106, without departing from the scope of the present invention pointed out in the appended claims In the alternative embodiment illustrated in FIG. 24, the retainer 102 includes the lid 110 which is constructed to retain the shaped units 32 dose in the retainer 102 In the embodiment illustrated in figure 24, the lid 110 is fixed hinged However, it will be appreciated that the lid 110 may be a separate element from the first support member 104, without departing from the scope of the present invention. The lid 110 includes an exterior wall 112 that , in the illustrated embodiment, is constructed so that the outer wall 112 and the first supporting member 104 enclose a periphery of a dosage form unit 32, contained in the retainer 102, when the lid 110 is in its closed position with respect to to the retainer 102 In this mode, the lid 110 also has an open position relative to the retainer 102 in which the dosage form units 32 can be easily placed between the second supporting members 106. It will be appreciated that the lid 110 and the first supporting member 104 need not necessarily enclose completely the periphery of the dosage form unit 32 for retaining the dosage form units 32 in the retainer 102 For example, one or more apertures may be formed through the cap 110 Dichas openings can vary in size, shape, location and number, in order to create the desired flow characteristics through the retainer 102 and the chamber 100. Additionally, the lid 110 and the first support member 104 can be constructed so that one or more separations are present between them, when the lid 110 is in its closed position Again the flow characteristics through the retainer 102 and the chamber 100 may vary upon changing the size, shape, location and number of said separations In the embodiment illustrated in Fig. 24, the top 110 further includes supporting walls 114 Supporting walls 114 extend from outer wall 112 and are constructed to interact with second supporting members 106, in order to retain the dosage form units 32 and to allow flow through them. second members 5 supports 106 and the supporting walls 114 In the illustrated embodiment, the second supporting members 106 and the supporting walls 115 are substantially identical in construction and define semicircular openings therethrough When placed in contact with each other when loosely closing the lid 110 in the embodiment of the invention illustrated in the figure 24, the respective sets of second supporting members and the supporting walls 114 define lateral supporting members, capable of retaining a dosage unit 32 therein. A single circular opening is defined through each of the lateral supporting members thus formed, thus facilitating flow through the retainer 102 As discussed further back, the size, shape, number and position of the openings thus formed can vary, depending on the desired flow characteristics through the retainer 102. achieve the variation of these parameters by varying the size, shape, number and position of the openings defined through the second supporting members 106 and / or the supporting walls 114 A securing mechanism 116, of known construction, can be provided in order to prevent premature opening of the retainer 102, after it is The lid 110 has been closed. In the illustrated embodiment, the securing mechanism 116 includes a pair of pins 118 located in the outer wall 112 of the lid 110, and a pair of complementary holes 120, formed in the first support member 104. the pins 118 are constructed in such a way that the pins 118 are physically retained in the holes 120 when the lid 110 is moved to its closed position, thereby preventing unwanted opening of the retainer 102 in the embodiment of the present invention in which the lid 110 is mounted hingedly on the first supporting member 104, one or more pairs of bolts 118 and complementary holes 120, positioned as illustrated in Figure 24, will provide the desired securing effect if the lid 110 is a separate element, instead to be connected hinged to the first support member 104, additional pairs of complementary pins 118 and holes 120 can be placed in the lid 110 and the first support member 104, to provide the desired securing effect therebetween. It will be appreciated that the additional securing mechanisms 116 of known construction , can be used with the retainer 102 of the present invention. Figure 12 illustrates an embodiment of the present invention in which a foraminous sleeve or bag 52 is provided in the drip chamber 27. Figure 9A illustrates one embodiment of the present invention. in which a carrier envelope is provided 79, so that it can be placed in a drip chamber 27 The foraminous sleeve 52 and the carrier casing 79 can be constructed in such a way that one or more beneficial agents can be placed in them In this way, one can be placed or more beneficial agents in the foraminous cuff or in the envelope carrier, in order to alter the characteristics of a product of enteric nutrition, which is delivered through a fluid delivery system in which the forameno sleeve 52 and / or the carrier envelope 79 are present. It will be appreciated that the benefit agent thus provided may be in the form of a unit 32 of form. of dose, or it may be in the form of a powder, granule, gel or other form, depending on the characteristics of the beneficial agent and the manner in which the beneficial agent is to be delivered to the patient, for example, as a bolus or with a prolonged release delivery profile The amount of the beneficial agent can be varied by additional amounts of the beneficial agent present in the foraminous sleeve 52 and / or in the carrier wrap 79 Additionally the number of beneficial agents thus provided can vary, by placing more than one agent Thus, these embodiments of the present invention allow the system and method of the present invention to be tailored to the particular medical and diagnostic needs of the patient to whom it is going to be delivered. Supplying the Enteric Nutrition Product In the embodiment of the present invention illustrated in Figure 23, a receptacle is provided. The receptacle 200 includes a peripheral wall 202 defining one or more openings or windows 204 therethrough. An example of a type of receptacle suitable for use in the present invention is described in detail in U.S. Patent 4,093,105, to Russell et al. , which is incorporated here by means of this reference The receptacle 200 has dimensions that allow it to be placed in a drip chamber 27, a tube 54 or other selected portion of a delivery equipment, before administering an enteric nutrition product through the delivery equipment. The receptacle 200 is constructed in a manner that a beneficial agent may be contained within the interior space defined by the receptacle 200 The beneficial agent may be in a variety of forms, for example powder, granules, gel, etc., so long as the beneficial agent is dispersible in a nutrition product enteric through the interior of the receptacle 200 The receptacle 200 is also preferably constructed so that the enteric, liquid nutrition product can pass through openings 204 into the interior of the receptacle 200 and so that the product of liquid enteral nutrition, which has a beneficial agent dispersed in it, can leave the receptacle 200 through of the openings 204 Thus, when the receptacle 200 is placed in the drip chamber 27, the tube 54 or other portion of a supply equipment, so that the enteric nutrition product flowing through the supply equipment enters contact with the receptacle 200, the beneficial agent within the receptacle 200 will be dispersed in the enteric nutrition product and subsequently be delivered to the patient. In the embodiment illustrated in Figure 23, the receptacle 200 is substantially cylindrical in shape and has closed ends. , it will be appreciated that the receptacle 200 can having any of many known shapes and configurations The shape and configuration of the receptacle 200 will be limited based on the construction of the supply equipment with which the receptacle 200 is used. For example, if the receptacle 200 5 is intended to be placed inside. of a supply tube of the feeding equipment, the receptacle 200 preferably will have the cylindrical shape illustrated in figure 23, and will have a diameter no greater than the inner diameter of the tube in which it will be located in case the receptacle 200 is going to be placed in a For example, a camera, for example a drip chamber, the receptacle 200 can have a variety of configurations, as long as the receptacle 200 has dimensions that allows it to be placed in the chamber. In the embodiment illustrated in Figure 23, the openings 204 are formed through end wall portions 206 of the wall 202 However, it will be appreciated that the size, location, shape and number of the openings 204 may vary, in order to alter the flow characteristics of a enteric nutrition product through the openings 204 That is, the openings of various sizes, shapes and number, may be located in the end wall portions 206 and / or in the side wall portion 208, that is, in any position on the peripheral wall 202, according to the flow characteristics desired through the receptacle 200. The receptacle 200 is preferably constructed of so that it can be closed after having placed a beneficial agent thereon. For example, one or both end wall portions 206 can be separate elements of the side wall portion 208, so that the end wall portions 206 can be fixed to the wall. side wall portion 208 Alternatively, one or both end wall portions 206 may be hingedly attached to the side wall portion 208. A locking or securing mechanism, of known construction, may be provided in order to retain the end wall portions 206. in a closed position relative to the side wall portion 208. For example, the fixing mechanism may be in the form of a functional fit between the end wall portions 206 and the side wall portion 208. The fixing mechanism may also be in the form of complementary threads, formed in the end wall portions 206 and the side wall portion 208 who is ordinary expert and n matter will appreciate that other mechanisms can be used to fix two members, for example, mechanical structures and chemical and thermal bonding techniques, without departing from the spirit of the present invention In one embodiment the receptacle 200 is configured so that it can not be reopened after it has been closed, without damaging the receptacle 200, thus providing evidence that the contents of the receptacle 200 have been violated, that is, the beneficial agent contained in the receptacle 200 has been altered. In this embodiment, the receptacle 200 can be filled with a beneficial and closed agent fixing the end wall portions 206 to the side wall portion 208 After closing the receptacle 200 the beneficial agent contained therein will be substantially resistant to violations. Whoever is an ordinary expert will appreciate that other methods can be used to make The violation of the receptacle 200 is evident The receptacle 200 of the present invention eliminates the need to place the beneficial agent in a tablet or unit dose form prior to its placement in the additional supply equipment, the placement of the beneficial agent in the receptacle 200 it will minimize the possibility of touch contamination during handling of the beneficial agent. It will also be appreciated that the volume and type of beneficial agent or beneficial agents contained in the receptacle 200 may be adjusted to the needs of individual patients, varying the number of receptacles 200 placed in a supply equipment and varying the beneficial agents contained in the receptacles 200 The placement of a beneficial agent in the receptacle 200 can be performed next to the patient's bed, in a pharmacy or by the manufacturer who then distributes the receptacle 200 and the beneficial agent contained therein, to an end user The beneficial agent may also be placed in the receptacle 200 by the patient or by a medical professional, before placing the receptacle 200 in a delivery equipment. Although the present invention has been described herein in In the context of certain modalities, those of ordinary skill in the art will appreciate that vain modifications are possible, without departing from the scope of the invention set forth in the claims that follow

Claims (6)

1 - . 1 - An apparatus for modifying an enteric, liquid nutrition product, characterized in said apparatus because it comprises a supply equipment having an inlet and an outlet, the inlet is constructed to be connected with fluid connection to a supply container, defining the equipment for supplying an interior space, a receptacle disposed in the interior space defined by the supply equipment, the receptacle comprising a wall defining an interior chamber, the wall defining an opening therethrough, and at least one beneficial agent, arranged in the inner chamber defined by the wall of the receptacle

2 - An apparatus according to claim 1, further characterized in that the wall of the receptacle defines a plurality of openings therethrough

3 - An apparatus according to claim 1, characterized furthermore because the supply equipment comprises a chamber, and where the receptacle is arranged in chamber

4 - An apparatus according to claim 3, further characterized in that the chamber is a drip chamber

5 - A method for modifying an enteric, liquid nutrition product, during its flow from a supply container, characterized in that it comprises the Steps of providing an apparatus comprising a supply equipment having an inlet and an outlet, the inlet being connected in fluid communication with a supply container containing an enteric, liquid nutrition product, the supply equipment defining an interior space, and a receptacle comprising a wall defining an inner chamber, the wall defining an opening therethrough, the receptacle being constructed to be placed in the interior space defined by the supply equipment, at least one beneficial agent contained in the chamber interior defined by said wall of the receptacle, placing the receptacle in the interior space defined by the supply equipment, so that said at least one beneficial agent is wetted by, or submerged in, the enteric, liquid nutrition product, when the Enteric nutrition product, liquid, flows through the supply equipment, and flow the product of nu enteric trituration, liquid, from the supply container, through the supply equipment

6 - A method for modifying an enteric, liquid nutrition product, characterized in that it comprises the steps of providing an apparatus comprising a supply equipment having an input and an outlet, the supply equipment defining an interior space, and a receptacle comprising a portion of the wall defining an interior chamber, the wall portion defining an opening therethrough, the receptacle being constructed to be disposed in the interior space defined by the delivery equipment, and the interior chamber being constructed to receive one or more beneficial agents therein, providing at least one beneficial agent, placing the at least one beneficial agent in the inner chamber of the receptacle, placing the receptacle and the at least one beneficial agent in the interior space defined by the delivery equipment, and flowing an enteric nutrition product , liquid, through the supply equipment