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WO2011071729A1 - Bouteilles d'alimentation entérale - Google Patents

Bouteilles d'alimentation entérale Download PDF

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Publication number
WO2011071729A1
WO2011071729A1 PCT/US2010/058540 US2010058540W WO2011071729A1 WO 2011071729 A1 WO2011071729 A1 WO 2011071729A1 US 2010058540 W US2010058540 W US 2010058540W WO 2011071729 A1 WO2011071729 A1 WO 2011071729A1
Authority
WO
WIPO (PCT)
Prior art keywords
rigid container
enteral
enteral feeding
container
bottle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2010/058540
Other languages
English (en)
Inventor
Thomas Anthony Dold
Thomas Lloyd Peterson
Thomas Guy Pilger
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nestec SA
Original Assignee
Nestec SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nestec SA filed Critical Nestec SA
Publication of WO2011071729A1 publication Critical patent/WO2011071729A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J9/00—Feeding-bottles in general
    • A61J9/001—Feeding-bottles in general with inner liners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0076—Feeding pumps

Definitions

  • the present disclosure generally relates to health and nutrition. More specifically, the present disclosure relates to bottles and methods useful in the storage and delivery of nutritional compositions and other fluids are described.
  • enteral bottles having feeding tubes that deposit food directly into the gastrointestinal tract at a point below the mouth are often used to sustain life while a patient is unable, or refuses, to take food orally.
  • Bottles, feeding tubes and other artificial delivery systems and routes can be used temporarily during the treatment of acute medical conditions.
  • such systems and routes can be used as part of a treatment regimen that lasts for the remainder of a patient's life. No matter the duration of use, these devices often provide the only means for feeding the patient.
  • Fluid nutritional compositions frequently referred to as "formula” are typically stored in feeding container to be administered to patients.
  • the use of conventional rigid formula containers has drawbacks, particularly in the clinical setting. For example, because the act of piercing the container with a spike involves the collection and handling of multiple components, an opportunity to introduce contamination into the nutritional composition is created.
  • air spaces left in the rigid bottle may provide space for bacteria to collect thereby contaminating the formula.
  • contaminated formula can lead to infection, including serious and difficult to treat nosocomial infections. Contaminated formula can also lead to microbial growth in the feeding tube, necessitating its flushing and/or replacement.
  • the present disclosure relates to enteral feeding bottles for providing nutritional compositions and other fluids and methods of using the enteral feeding bottles.
  • the present disclosure provides an enteral feeding bottle including a rigid container, a flexible container located within the rigid container, an adapter cap releasably attached to the rigid container, and an enteral administration set attached to the adaptor cap.
  • This design can enable an easy means to purge the enteral feeding bottle of air prior to use to prevent false air- in- line alarms.
  • the non-vented feature of the enteral feeding bottle allows the flexible container to collapse instead of needing to draw in air to replace lost fluid. This serves to prevent false air-in-line alarms in an ambulatory use when the flexible container could be turned in any orientation.
  • the enteral administration set includes a tubing.
  • the enteral administration set includes a tubing having at least one of a clamping device, a pump interface and a patient access tip.
  • the adapter cap provides a leak proof seal with the rigid container.
  • the adapter cap can be attached to the rigid container by a removable cap.
  • the flexible container is located entirely within the rigid container.
  • the flexible container can have a volume ranging from about 100 mL to about 275 mL.
  • the present disclosure provides an enteral feeding assembly including a first bottle and a second bottle.
  • the first bottle includes a first rigid container, a first flexible container located within the first rigid container, and a first adapter cap releasably attached to the first rigid container.
  • the second bottle includes a second rigid container, a second flexible container located within the second rigid container, and a second adapter cap releasably attached to the second
  • the enteral feeding assembly further includes an enteral administration set attached to the first adaptor cap and the second adaptor cap.
  • the present disclosure provides an enteral feeding system including a portable storage device, and an enteral feeding bottle located within the portable storage device.
  • the enteral feeding bottle including a rigid container, a flexible container located within the rigid container, an adapter cap releasably attached to the rigid container, and an enteral administration set attached to the adaptor cap.
  • the portable storage device can further include one or more carrying straps.
  • the enteral feeding system further includes a pump operatively associated with the enteral feeding bottle.
  • the pump can be located within the portable storage device.
  • the pump can be a peristaltic pump.
  • the present disclosure provides a nutritional feeding system including a rigid container, a flexible container located within the rigid container and including a nutritional composition, an adapter cap releasably attached to the rigid container by a removable cap, and an enteral administration set attached to the adaptor cap.
  • the present disclosure provides a method of supplying a nutritional composition to a patient for enteral delivery.
  • the method comprises filling an enteral feeding bottle with the nutritional composition, the bottle including a rigid container, a flexible container located within the rigid container, an adapter cap releasably attached to the rigid container, and an enteral administration set attached to the adaptor cap.
  • the method further comprises enterally administering to the patient the nutritional composition through an enteral administration set extending from the bottle.
  • the patient includes a mammal.
  • the mammal can include a human such as a child or adult.
  • the present disclosure provides a method of reducing the possibility of contamination of an enteral feeding formulation for delivery to a patient.
  • the method comprises filling an enteral feeding bottle with the enteral feeding formulation.
  • the bottle includes a rigid container, a flexible container located within the rigid container, an adapter cap releasably attached to the rigid
  • the method further comprises enterally administering to the patient the feeding formulation, wherein the flexible container collapses as the feeding formulation is being administered.
  • An advantage of the present disclosure is to provide an improved enteral feeding bottle.
  • Another advantage of the present disclosure is to provide a portable enteral feeding system.
  • Yet another advantage of the present disclosure is to provide an improved method of enteral nutrition administration that minimizes contamination.
  • Still another advantage of the present disclosure is to provide an improved method of enteral nutrition administration that minimizes the amount of air being administered to a patient.
  • FIG. 1 shows a perspective view of the enteral feeding bottle in an embodiment of the present disclosure.
  • FIG. 2 shows a Figure 1 shows a partial cross-section view II-II of the enteral feeding bottle of FIG. 1.
  • FIG. 3 shows a side view of the enteral feeding assembly in an embodiment of the present disclosure.
  • FIG. 4 shows a perspective view of the enteral feeding system in an embodiment of the present disclosure.
  • the present disclosure relates to enteral feeding bottles for providing nutritional compositions and other fluids.
  • the enteral feeding bottles include a flexible container that collapses as the nutritional compositions or
  • INCORPORATED BY REFERENCE (RULE 20.6) fluids are administered from the bottle to an individual or patient.
  • the bottles can prevent contaminants and air from entering the bottle during the administration.
  • the enteral feeding bottle can also be structurally suited to be portable and carried around by a user.
  • the term "nutritional composition” includes, but is not limited to, complete nutritional compositions, partial or incomplete nutritional compositions, and disease or condition specific nutritional compositions.
  • a complete nutritional composition i.e. those which contain all the essential macro and micro nutrients
  • Patients can receive 100% of their nutritional requirements from such complete nutritional composition.
  • a partial or incomplete nutritional composition does not contain all the essential macro and micro nutrients and cannot be used as a sole source of nutrition for the patient.
  • Partial or incomplete nutritional compositions can be used as a nutritional supplement.
  • a disease or condition specific nutritional composition is a composition that delivers nutrients or pharmaceuticals and can be a complete or partial nutritional composition.
  • a disease or condition specific nutritional composition is a composition that delivers nutrients or pharmaceuticals and can be a complete or partial nutritional composition.
  • Disease or condition specific nutritional compositions are those designed to aid with a given situation, such as Impact® sold by Nestle Nutrition to decrease post-operative infections, Diabetisource AC® sold by Nestle Nutrition for people with diabetes or hyperglycemia, and Novasource® Pulmonary sold by Nestle Nutrition for those patients with pulmonary disease or those requiring ventilator support.
  • the present disclosure provides an enteral feeding bottle 10 including a rigid container 20, a flexible container 22 located within rigid container 20, an adapter cap 30 releasably attached to rigid container 20, and an enteral administration set 12 attached to adaptor cap 30.
  • enteral administration set 12 can be removably or permanently attached to adapter cap 30.
  • a nutritional composition can be placed into and stored in flexible container 22 for subsequent administration.
  • flexible container means a container that is bendable/stretchable and does not resume its original form after pressure has been
  • the term "rigid container” means a container that is stiff or bending and does resume its original form after pressure has been applied to it.
  • Rigid container 20 can be constructed and arranged to be attached to or located within an ambulatory carry device like a backpack or fanny pack that would also hold an enteral pump.
  • Rigid container 20 can include one or more slits 24 so that the amount or content of the nutritional composition in flexible container 22 can be observed or determined.
  • Rigid container 20 can be made of any suitable rigid material such as polypropolene, polyethylene, etc.
  • Flexible container 22 can be constructed and arranged to partially or completely collapse at any desired negative (e.g. suction/vacuum) or positive pressure (e.g. compression) applied to flexible container 22.
  • the pressure can result from a nutritional composition/fluid being removed from flexible container 22 during the administration of flexible container's 22 contents to a patient. Accordingly, as the nutritional composition/fluid is removed, the vacuum pressure causes flexible container 22 to collapse so that no air enters the inside of flexible container 22.
  • the pressure can result from squeezing or compressing the exterior side of flexible container 22.
  • flexible container 22 is collapsible upon an applied pressure (positive or negative) ranging from about 15 mBar to about 80 mBar.
  • Flexible container 22 can be collapsible upon an applied pressure ranging from about 40 mBar to about 60 mBar.
  • flexible container 22 can be collapsible upon an applied pressure ranging from about 45 mBar to about 55 mBar.
  • Flexible container 22 can also be collapsible upon an applied pressure of about 50 mBar.
  • Flexible container 22 can be made from any suitable partially or completely flexible material such as monolayer or multi-layer films.
  • the monolayer or multi-layer films can be chosen for their cost and their recyclability.
  • the monolayer or multi-layer films can also be chose for their barrier properties.
  • Suitable materials for the monolayer or multi-layer films can be polyolefm such as, for example, polyethylene (“PE”), low density polyethylene (“LDPE”), high density polyethylene (“HDPE”), polypropylene (“PP”) or polyethylene terephthalate (“PET”).
  • PE polyethylene
  • LDPE low density polyethylene
  • HDPE high density polyethylene
  • PP polypropylene
  • PET polyethylene terephthalate
  • oxygen barrier materials such as, for example, ethylene vinyl alcohol (“EVOH”) and
  • the monolayer or multi-layer films can provide light barriers. They can provide partial or complete barriers to light/UV. For example, the films can be partially opaque. The films can allow the nutritional compositions in the bottle to be seen, but protect light labile and UV sensitive substances.
  • Adapter cap 30 can provide a leak proof seal with rigid container 20.
  • Adapter cap 30 can be attached to rigid container 20 by a removable cap 32.
  • Removable cap 32 can be made of any suitable material and can be re-usable. Criteria for the material that the adapter cap 30 is made from can include the following:
  • Flexible container 22 can be removed from rigid container 20 by opening removable cap 32, displacing adapter cap 30 and pulling flexible container 22 out from rigid container 20. In this manner, a new flexible container can be inserted into rigid container 20 and filled with a suitable nutritional composition. Adapter cap 30 and removable cap 32 can then be re-attached to rigid container 20.
  • Flexible container 22 can be constructed and arranged to fit partially or entirely within rigid container 20. Flexible container 22 can have any suitable volume. In an embodiment, flexible container 22 has a volume ranging from about 100 mL to about 275 mL.
  • enteral administration set 12 includes a tubing 40.
  • Tubing 40 can be any suitable length.
  • enteral administration set 12 can further include a clamping device 42, a pump interface 44 and a patient n
  • INCORPORATED BY REFERENCE (RULE 20.6) access tip 46 that are attached to or incorporated with tubing 40.
  • Clamping device 42, pump interface 44 and patient access tip 46 can be arranged in any suitable order along tubing 40.
  • Enteral administration set 12 provides a means and a route of travel for any nutritional composition or formula from enteral feeding bottle 10 to a user or patient.
  • Clamping device 42 can be used to attach a portion of enteral administration set 12 to a user.
  • Pump interface 44 can be constructed and arranged to interact with a suitable pump that cause the nutritional composition to be administered to the user,
  • Patient access tip 46 can be any suitable patient access termination, tip, or other suitable structure.
  • a person skilled in the art can select an appropriate patient access tip 46 based on various considerations, including the intended point of access in the patient's body, the nature of the formula, and other appropriate considerations.
  • suitable patient access tips include needles, luer connectors adapted to connect to previously placed needles and other access devices, structures capable of being connected to a previously placed access port in the patient, such as a nasal, neck or chest wall port that provides access to the stomach, jejunum and other suitable access ports, and other structures capable of delivering the formula from enteral feeding bottle 10 in an appropriate manner.
  • enteral administration set 12 and patient access tip 46 can be configured as a nasogastric tube, orogastric tube, or in any other suitable configuration.
  • First bottle 104 includes a first rigid container 110, a first flexible container 114 located within first rigid container 110, and a first adapter cap 120 releasably attached to first rigid container 110.
  • First adapter cap 120 can be attached to first rigid container 110 using a first removable cap 124.
  • Second bottle 106 includes a second rigid container 112, a second flexible container 116 located within second rigid container 112, and a second adapter cap 122 releasably attached to second rigid container 112. Second adapter cap 122 can be attached to second rigid container 112 by a second removable cap 126.
  • Enteral feeding assembly 100 can further include an enteral administration set 102 attached to first adaptor cap 120 and second adaptor cap 122. o
  • Enteral administration set can include a first tubing 140 and a second tubing 150 joined together at a Y-joint 152, which can have an extended tubing that includes a clamping device 142, a pump interface 144 and a patient access tip 146.
  • the enteral feeding bottles can be sized to hold any suitable volume such as, for example, from about 100 mL to 275 mL including 125 mL, 150 mL, 175 mL, 200 mL, 225 mL, 250 mL and the like.
  • the enteral feeding bottles can contain and be used to deliver nutritional products for tube and oral feeding, condiments, and enteral formula. By allowing the bottles to partially collapse during feeding, there is an increased safety as measured by fewer microbial contaminants in its content at 24 hour versus open feeding systems and rigid air vented bottles. This provides health and economic benefits in reducing the number of infections (e.g. needing fewer antibiotics) caused by a contaminated product and reduced days in a hospital.
  • the shape of the partially collapsible bottles can reduce the risk of being confused with an intravenous (“IV") bag.
  • IV intravenous
  • the bottles provide health and economic benefits, for example, by increasing safety. This can be done by decreasing incidences that result from contamination of the bottle. Such contamination can cause diarrhea and infections in the patient receiving the nutritional compositions in the bottles. Microbial overgrowth in the feeding tubes can be reduced, and feeding tube life can be extended. Less storage space may be needed using the bottles in embodiments of the present disclosure than typical enteral bottles.
  • an enteral feeding system 200 including a storage device 210, and an enteral feeding bottle 220 located within storage device 210.
  • Enteral feeding bottle 220 can include a rigid container 222, a flexible container (as previously described) located within rigid container 222, an adapter cap 230 releasably attached to rigid container 222, for example, by a removable cap 232.
  • enteral feeding system 200 further includes a pump 240 operatively associated with enteral feeding bottle 220, for example, by an enteral administration set 250 attached to the adaptor cap 230 and extending from pump 240.
  • Pump 240 can be located partially or wholly within portable storage device 210. Pump 240 can be a peristaltic pump.
  • Storage device 210 can be any suitable storage device that is portable.
  • storage device 210 can be a backpack, a fanny pack, a hand bag, a suit case, etc.
  • storage device 210 can include one or more straps 212 for ease of carrying.
  • Storage device 210 can further include one or more closing mechanisms 214 such as a zipper to prevent enteral feeding bottle 220 and/or pump 240 from in advertently falling out of storage device 210.
  • the present disclosure provides a method of supplying a nutritional composition to a patient for enteral delivery.
  • the method comprises filling an enteral feeding bottle with the nutritional composition, the bottle including a rigid container, a flexible container located within the rigid container, an adapter cap releasably attached to the rigid container, and an enteral administration set attached to the adaptor cap.
  • the method further comprises enterally administering to the patient the nutritional composition through an enteral administration set extending from the bottle. During the enteral administration, the patient can move freely to any desired location.
  • the patient includes a mammal.
  • the term "patient” refers to any mammal, but especially a human (e.g., child, adult). Mammals can also include but are not limited to rodents, aquatic mammals, domestic animals such as dogs and cats, and farm animals such as sheep, pigs, cows and horses. Wherein the term mammal is used, it is contemplated that it also applies to other animals, that are not mammals, that are capable of the effect exhibited or intended to be exhibited by the mammal.
  • the present disclosure provides a method of reducing the possibility of contamination of an enteral feeding formulation for delivery to a patient.
  • the method comprises filling an enteral feeding bottle with the enteral feeding formulation.
  • the bottle includes a rigid container, a flexible container located within the rigid container, an adapter cap releasably attached to the rigid container, and an enteral administration set attached to the adaptor cap.
  • the method further comprises enterally administering to the patient the feeding formulation, wherein the flexible container collapses as the feeding formulation is being administered. During the enteral administration, the patient can move freely to any desired location.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention porte sur des bouteilles d'alimentation entérale pour délivrer des compositions nutritionnelles et d'autres fluides et sur des procédés d'utilisation des bouteilles d'alimentation entérale. Dans un mode de réalisation général, la présente invention porte sur une bouteille d'alimentation entérale, qui comprend un récipient rigide, un récipient souple disposé à l'intérieur du récipient rigide, un capuchon adaptateur fixé de façon libérable au récipient rigide, et un ensemble d'administration entérale fixé au capuchon adaptateur. La bouteille d'alimentation entérale peut être disposée à l'intérieur d'un dispositif de stockage portable, de telle sorte qu'un utilisateur peut facilement porter et utiliser la bouteille d'alimentation entérale en tout emplacement approprié.
PCT/US2010/058540 2009-12-10 2010-12-01 Bouteilles d'alimentation entérale Ceased WO2011071729A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US28522609P 2009-12-10 2009-12-10
US61/285,226 2009-12-10

Publications (1)

Publication Number Publication Date
WO2011071729A1 true WO2011071729A1 (fr) 2011-06-16

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ID=43828185

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/058540 Ceased WO2011071729A1 (fr) 2009-12-10 2010-12-01 Bouteilles d'alimentation entérale

Country Status (1)

Country Link
WO (1) WO2011071729A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013000898A1 (fr) * 2011-06-27 2013-01-03 Sjursen Bjoernar Procédé, ensembles et dispositifs pour distribution de nutriments
US8956334B2 (en) 2012-07-11 2015-02-17 Douglas Hirt Enteral feed cup
NO20150142A1 (en) * 2015-01-30 2016-08-01 Pronova Biopharma Norge As Enteral feeding device

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004082560A1 (fr) * 2003-03-18 2004-09-30 Sherwood Services Ag Appareil d'alimentation enterale portable
US20090204097A1 (en) * 2008-02-08 2009-08-13 Knight Thomas F Enteral feeding safety reservoir and system

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004082560A1 (fr) * 2003-03-18 2004-09-30 Sherwood Services Ag Appareil d'alimentation enterale portable
US20090204097A1 (en) * 2008-02-08 2009-08-13 Knight Thomas F Enteral feeding safety reservoir and system

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013000898A1 (fr) * 2011-06-27 2013-01-03 Sjursen Bjoernar Procédé, ensembles et dispositifs pour distribution de nutriments
US8956334B2 (en) 2012-07-11 2015-02-17 Douglas Hirt Enteral feed cup
NO20150142A1 (en) * 2015-01-30 2016-08-01 Pronova Biopharma Norge As Enteral feeding device
EP3250174A1 (fr) * 2015-01-30 2017-12-06 Pronova BioPharma Norge AS Dispositif d'alimentation entérale

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