EP2570107A1 - Ensemble de tube gastrique auto-applicable - Google Patents

Ensemble de tube gastrique auto-applicable Download PDF

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Publication number
EP2570107A1
EP2570107A1 EP11181443A EP11181443A EP2570107A1 EP 2570107 A1 EP2570107 A1 EP 2570107A1 EP 11181443 A EP11181443 A EP 11181443A EP 11181443 A EP11181443 A EP 11181443A EP 2570107 A1 EP2570107 A1 EP 2570107A1
Authority
EP
European Patent Office
Prior art keywords
tube
patient
assembly
fluid
lump element
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.)
Withdrawn
Application number
EP11181443A
Other languages
German (de)
English (en)
Inventor
Stefan Enders
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.)
Ludwig Maximilians Universitaet Muenchen LMU
Original Assignee
Ludwig Maximilians Universitaet Muenchen LMU
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 Ludwig Maximilians Universitaet Muenchen LMU filed Critical Ludwig Maximilians Universitaet Muenchen LMU
Priority to EP11181443A priority Critical patent/EP2570107A1/fr
Priority to PCT/EP2012/003844 priority patent/WO2013037494A1/fr
Publication of EP2570107A1 publication Critical patent/EP2570107A1/fr
Withdrawn legal-status Critical Current

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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
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0003—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth
    • 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
    • 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
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/60—General characteristics or adaptations biodegradable

Definitions

  • the invention relates to a gastric tube assembly for introducing a fluid into a patient's stomach.
  • Gastric tubes are commonly used for introducing fluids into the stomach or the small intestine of a patient who is unconscious or otherwise not able to swallow fluids, e.g. due to dysphagia or in case of enteral nutrition.
  • the commonly used gastric tubes are usually inserted by force through the nasal passageways and may abrade tissue in the nostril and nasopharynx and/or may cause discomfort to the patient.
  • US 5,391,158 A suggests to use a weight attached to a guide string, both made of digestible material. The weight is inserted through a nostril and is then swallowed by the patient.
  • the free end of the guide string is inserted through an aperture of a naso-gastric tube which is then inserted into the nostril.
  • the naso-gastric tube still needs to be pushed forward on the guide string, whereby injuries and perforations may occur. Further, insertion of the tube usually requires the help of medical staff.
  • a gastric tube without the help of medical staff.
  • the patient in preparation of a colonoscopy, the patient is usually required to drink large quantities of fluid containing polyethylene glycol and electrolytes.
  • drinking the fluid causes substantial discomfort, such that some may refrain from taking prophylactic colonoscopy examinations at all. It is thus desirable to introduce the fluid into the patient's stomach, bypassing his taste buds and viscosity sensation. This may, e.g. be done via a gastric tube.
  • the patient would need to see the physician a day before the colonoscopy in order to insert the tube and to apply the liquid.
  • the present invention provides a gastric tube assembly comprising a tube with first and second ends and a lump element attached to the second end of the tube, wherein the tube and/or the lump element comprise dissolvable material, said lump element being configured to be swallowed by a patient, thereby feeding said tube through the patient's oesophagus.
  • the assembly of the present invention allows easy application of the tube at home by the patient him- or herself.
  • the patient may put the lump element into his mouth and swallow it.
  • the tube is dragged along.
  • the tube extends through the oesophagus, with the second end being positioned in the stomach and the first end being positioned outside the mouth and accessible for introducing a fluid.
  • the first end of the tube may then be used to insert the fluid through the tube into the stomach.
  • the tube is dissolvable and when the desired fluid quantity has been introduced, the patient may swallow the rest of the tube, which is further facilitated by the physiological peristaltic movement of the oesophagus. The tube may then be dissolved within the patient's body, e.g. within the stomach and/or the intestines.
  • the tube/assembly may be retracted from the patient via his/her mouth.
  • the tube and the lump element are comprised of dissolvable materials. With both, the tube and the lump element being dissolvable, they may be completely dissolved within the patient's body. Hence, no undissolved parts of the assembly need to go through the intestines, thereby avoiding any complications.
  • the term "dissolvable” refers to the conditions in the human body, e.g. in the stomach and/or the intestines. It may, but does not necessarily imply that the tube and/or the lump element are digestible, i.e. that material is received into the patient's blood by a digestion process. It rather implies that the material of the tube and/or the lump element is configured to dissolve when being subjected to the environment within the stomach or the intestines of the patient, e.g. by comprising food material.
  • the tube and/or the lump element substantially consist of dissolvable material. Hence, the risk of complications due to undissolved remainders passing through the patient's gastrointestinal tract is reduced.
  • the tube may be comprised of a flexible and tear-proof material.
  • the first end of the tube may be open such that it may be connected to an adapter or a syringe.
  • the second end of the tube may be open and/or the tube may comprise one or more holes in the vicinity of the second end.
  • the holes may, in particular, be positioned in different directions, such that fluid leaving the tube is directed towards different regions of the stomach.
  • the tube may have a circular cross section. This is advantageous as trauma is avoided when the tube moves down the oesophagus.
  • the lump element may comprise a pill-shaped element.
  • the lump element may comprise a pill, a lozenge, a capsula or a tablet, in particular a dragée.
  • the lump element may e.g. comprise a molded compound and/or may be coated, e.g. with a sugar coating.
  • the lump element may be flavoured in order to make the application of the tube assembly more comfortable for the patient.
  • the lump element is soft or comprises a soft sheath to avoid injuries and to further facilitate swallowing.
  • the lump element is configured to dissolve faster than the tube when inserted into the patient's stomach. Even if, after insertion, the lump element happens to block an opening at the second end of the tube such that fluid is kept form leaving the tube, the blocking may be removed by waiting until the lump element has substantially dissolved. In some embodiments, the lump element is configured to substantially dissolve in less than about 60 min, in particular, in less than about 30 min and, preferably, in less than about 15 min when inserted into the patient's stomach.
  • the tube comprises a sheet material, in particular gelatine, preferably leaf gelatine.
  • sheet material allows to easily form a tube.
  • gelatine is easy to process, tear-proof and dissolvable.
  • the tube and/or the lump element may additionally or alternatively comprise a compliant and/or food material.
  • the tube and the lump element are comprised of a same or of different materials.
  • the lump element is attached to the second end of the tube by lodging it into an opening of the tube.
  • the lump element is attached to the second end of the tube by a suture.
  • the suture may be comprised of a dissolvable material.
  • the lump element may be attached to the second end of the tube by a chemical process or by gluing.
  • the suture or glue, respectively, is preferably of compliant material, e.g. of food material.
  • the lump element has a larger diameter than the tube. It is hence ensured that the tube follows the lump element when it is moved down the oesophagus by the peristaltic movement.
  • the lump element is weighted, e.g. by comprising a liquid-filled cavity.
  • the liquid may, in particular, comprise water.
  • the assembly further comprises a connection element attached to the first end of the tube to allow a fluid-tight connection between said tube and a reservoir containing a fluid to be administered through said gastric tube assembly or between said tube and an intermediate part to be arranged in fluid communication between said tube and said reservoir.
  • the connection element comprises threads, in particular, external or internal threads.
  • the connection element may, in particular, comprise an adapter, preferably for a three-way stop-cock and/or a Luer Lock adapter. This facilitates introduction of a fluid into the tube.
  • the reservoir may, in particular, comprise means for pressurized application of a fluid, like e.g. a syringe.
  • the tube has an outer diameter of between 2 mm and 8 mm, in particular, of between 2.5 mm and 7 mm and, preferably, of between 3 mm and 6 mm. With such a diameter, the tube easily passes through the patient's oesophagus.
  • the tube has a length of between 45 cm and 100 cm, in particular, of between 50 cm and 80 cm and, preferably of between 55 cm and 70 cm. With this length, the tube extends between the patient's stomach and a position outside the patient's mouth, such that, when inserted, the first end of the tube is easily accessible to introduce a fluid into the tube. When the gastric tube assembly is applied, a first portion of the tube's length remains outside the patient's mouth to facilitate introduction of the fluid, while a second portion of the tube's length extends from the patient's oral cavity to the stomach.
  • the tube before application, is folded, rolled or reeled up along at least a part of its length. In some embodiments, the tube is folded, rolled or reeled up only along the second portion of the tube's length.
  • the tube may be folded, rolled or reeled up at least partially around the lump element. This facilitates packaging and transport of the tube assembly. Further, if the tube is folded e.g. in a concertina like or fanfold fashion, this would ensure that the tube unfolds as it follows the lump element.
  • the tube would not be pulled along its entire length down through the oral cavity and the oesophagus but would rather unfold and the unfolded part would be approximately stationary with respect to at least parts of the inner wall of the oral cavity and the oesophagus. This would reduce a foreign body sensation and a possible gag reflex during introduction of the tube.
  • the lump element has a maximum dimension of about 2 cm, in particular, of about 1.5 cm and, preferably, of about 1 cm.
  • the maximum dimension may be, e.g. a length or a diameter.
  • the lump element has an oval shape.
  • the maximum dimension may be the lump element's length. With such a dimension, the patient may easily swallow the lump element. Yet, this size is still large enough such that the lump element can be efficiently propelled by the oesophagus' peristaltic movement, thereby generating a sufficient dragging force to pull the tube downwards towards the stomach.
  • the present invention provides a kit comprising a gastric tube assembly of the aforementioned kind and a reservoir with a fluid for uptake by a patient.
  • the kit may be conveniently handed over to the patient for applying the kit at home by him- or herself.
  • the kit further comprises an intermediate part to be arranged in fluid communication between the tube of the gastric tube assembly and the reservoir. This facilitates assembling the kit at home.
  • the fluid is for uptake by a patient in preparation for a colonoscopy, wherein said fluid preferably contains electrolytes and/or polyethylene glycol.
  • the present invention provides a method for applying a gastric tube assembly of the aforementioned kind.
  • the method comprises giving the patient the lump element to swallow and, subsequently, introducing a fluid via the first end of the tube, especially after the second end of the tube has reached the patient's stomach.
  • the method may further comprise the step of retracting the tube from the patient's body via the patient's mouth, especially after the fluid has been introduced by the tube.
  • the method step of introducing a fluid may further comprise introducing the fluid over a time of between 5 min and 45 min, in particular, of between 8 min and 30 min and, preferably, of between 10 min and 20 min.
  • the step of introducing the fluid may comprise introducing the fluid at a rate of between 0.5 ml/s and 5 ml/s, in particular, of between 1 ml/s and 4 ml/s and, preferably, of between 2 ml/s and 3 ml/s.
  • the rate may, in particular, be substantially constant over time.
  • the step of introducing the fluid comprises introducing between 0.3 1 and 3 1, in particular, between 1 1 and 2.5 1 and, preferably, between 1.5 and 2.2. 1 of said fluid.
  • the Figure shows an embodiment of a gastric tube assembly according to the invention.
  • the assembly comprises an oro-gastric tube 10 with a first open end 11 and a second open end 12.
  • the assembly further comprises a lump element 13 attached to the second end 12 of the tube 10.
  • the tube 10 has a length of about 60 cm and a diameter of about 4 mm.
  • the cross section of the tube 10 is circular.
  • the walls of the tube 10 are comprised of a thin sheet of food material.
  • the lump element 13 is comprised of a pill-shaped tablet which may be flavoured.
  • the lump element 13 may have a peppermint flavour.
  • the length of the lump element is about 1 cm.
  • the lump element 13 may be a Mentos® dragée.
  • the patient 20 takes the lump element 13 into his mouth 21 and swallows it.
  • the lump element 13 then moves down the patient's oesophagus 22. This movement is facilitated by the natural peristaltic movement of the oesophagus 22. Since the lump element 13 is attached to the second end 12 of the tube 10, it pulls the tube 10 down the oesophagus 22.
  • the tube extends between the patient's stomach 23 and a position outside the patient's mouth 21, as shown in the Figure.
  • a first portion of the tube 10 extends outside the patient's mouth 21, the first portion having a length of about 40 cm.
  • a second portion of the tube 10 extends between the patient's mouth 21 and his or her stomach 23.
  • the second portion has a length of about 50 cm, of which about 40 cm extend between the patient's front teeth and his or her cardia, and another 10 cm extend from the cardia into the stomach.
  • the first end 11 of the tube is outside the patient's mouth 21, while the second end 12 of the tube is within the stomach 23 of the patient 20.
  • the tube assembly may now be used to introduce fluid into the stomach 23.
  • an adapter (not shown) may be attached to the first end 11 of the tube 10.
  • the adapter may be connected to a syringe containing the fluid.
  • the fluid By actuating the syringe, the fluid is pressed through the tube 10 into the patient's stomach 23. After having introduced the fluid into the stomach 23, which may take as little as a few minutes, the syringe and the adapter may be removed from the first end 11 of the tube 10.
  • the tube 10 is comprised of a dissolvable material.
  • the patient 20 may easily swallow the tube 10 as a whole after introduction of the fluid, which is assisted by the peristaltic movement of the patient's oesophagus 22.
  • the tube 10 will then be dissolved in the patient's body, e.g. in his stomach or intestines.
  • only the lump element 13 is comprised of a dissolvable material.
  • the tube 10 may easily be retracted from the patient 20 via the patient's mouth 21 after introduction of the fluid. In this case, the first end 11 of the tube 10 may be pulled away from the patient's mouth 21, while the remainder of the tube 10 follows. As the lump element 13 has dissolved, it does not block passage on the tube's way back through the oesophagus 22, thus avoiding any complications.

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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)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Medicinal Preparation (AREA)
EP11181443A 2011-09-15 2011-09-15 Ensemble de tube gastrique auto-applicable Withdrawn EP2570107A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP11181443A EP2570107A1 (fr) 2011-09-15 2011-09-15 Ensemble de tube gastrique auto-applicable
PCT/EP2012/003844 WO2013037494A1 (fr) 2011-09-15 2012-09-13 Ensemble tube gastrique auto-applicable

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP11181443A EP2570107A1 (fr) 2011-09-15 2011-09-15 Ensemble de tube gastrique auto-applicable

Publications (1)

Publication Number Publication Date
EP2570107A1 true EP2570107A1 (fr) 2013-03-20

Family

ID=46851394

Family Applications (1)

Application Number Title Priority Date Filing Date
EP11181443A Withdrawn EP2570107A1 (fr) 2011-09-15 2011-09-15 Ensemble de tube gastrique auto-applicable

Country Status (2)

Country Link
EP (1) EP2570107A1 (fr)
WO (1) WO2013037494A1 (fr)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3683890A (en) * 1970-10-02 1972-08-15 Charles B Beal Carrier system for delivery of an end of an elongated member to the upper gastrointestinal tract
US4279251A (en) * 1978-06-07 1981-07-21 Willy Rusch Gmbh & Co. Kg Tube for enteral treatment
US4306563A (en) * 1979-11-28 1981-12-22 Firma Pfrimmer & Co. Pharmazeutische Werke Erlangen Gmbh Catheter for introduction into body cavities
US4613323A (en) * 1984-11-19 1986-09-23 University Of Kentucky Research Foundation Multiple function intubation apparatus and method
US4692152A (en) * 1984-03-16 1987-09-08 Fresnius Ag Medical tube
US5391158A (en) 1994-02-24 1995-02-21 Peters; Michael J. Nasogastric tube
US20080269686A1 (en) * 2007-04-30 2008-10-30 Cook Critical Care Incorporated Device with removable projections
WO2011117853A1 (fr) * 2010-03-22 2011-09-29 Art Healthcare Ltd. Tube naso/orogastrique ayant un ou plusieurs éléments de blocage de reflux, éléments de blocage de reflux, et procédé d'utilisation des éléments de blocage de reflux

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3683890A (en) * 1970-10-02 1972-08-15 Charles B Beal Carrier system for delivery of an end of an elongated member to the upper gastrointestinal tract
US4279251A (en) * 1978-06-07 1981-07-21 Willy Rusch Gmbh & Co. Kg Tube for enteral treatment
US4306563A (en) * 1979-11-28 1981-12-22 Firma Pfrimmer & Co. Pharmazeutische Werke Erlangen Gmbh Catheter for introduction into body cavities
US4692152A (en) * 1984-03-16 1987-09-08 Fresnius Ag Medical tube
US4613323A (en) * 1984-11-19 1986-09-23 University Of Kentucky Research Foundation Multiple function intubation apparatus and method
US5391158A (en) 1994-02-24 1995-02-21 Peters; Michael J. Nasogastric tube
US20080269686A1 (en) * 2007-04-30 2008-10-30 Cook Critical Care Incorporated Device with removable projections
WO2011117853A1 (fr) * 2010-03-22 2011-09-29 Art Healthcare Ltd. Tube naso/orogastrique ayant un ou plusieurs éléments de blocage de reflux, éléments de blocage de reflux, et procédé d'utilisation des éléments de blocage de reflux

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Publication number Publication date
WO2013037494A1 (fr) 2013-03-21

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