EP3784201B1 - Transnasale schlauchvorrichtung zum zugang zu einer körperhöhle eines patienten - Google Patents

Transnasale schlauchvorrichtung zum zugang zu einer körperhöhle eines patienten

Info

Publication number
EP3784201B1
EP3784201B1 EP19716862.8A EP19716862A EP3784201B1 EP 3784201 B1 EP3784201 B1 EP 3784201B1 EP 19716862 A EP19716862 A EP 19716862A EP 3784201 B1 EP3784201 B1 EP 3784201B1
Authority
EP
European Patent Office
Prior art keywords
tube
inflatable chamber
transnasal
esophagus
patient
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.)
Active
Application number
EP19716862.8A
Other languages
English (en)
French (fr)
Other versions
EP3784201A1 (de
Inventor
Barbara AMON
Virginie Cuadrado
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.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
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 Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of EP3784201A1 publication Critical patent/EP3784201A1/de
Application granted granted Critical
Publication of EP3784201B1 publication Critical patent/EP3784201B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • 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
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0046—Expandable retainers inside body lumens of the enteral tract, e.g. fixing by radially contacting a lumen wall
    • A61J15/0049—Inflatable Balloons

Definitions

  • the inflation device with its inflatable chamber may in particular be arranged in the proximity of the distal end of the tube by which a desired body cavity is accessed. Once the body cavity is accessed the inflatable chamber may be inflated to assume the second, inflated state such that the transnasal tube device is retained within the accessed body cavity and/or, for example, a reflux of liquid is prevented by the inflatable chamber blocking a fluid path for example through the esophagus.
  • the inflatable chamber In the second, inflated state the inflatable chamber is filled for example with air, wherein a rather low pressure may be sufficient for filling the inflatable chamber.
  • the volume of the inflatable chamber In the first, deflated state the volume of the inflatable chamber is reduced with respect to the volume of the inflatable chamber in the second, inflated state, hence allowing to pass the tube of the transnasal tube device in particular through the esophagus during placement of the transnasal tube device in the patient's body for accessing a body cavity of interest.
  • the tube of the transnasal tube device may in particular be a multi-lumen tube.
  • the tube may comprise a first lumen for administering a medical solution, such as a nutritional feeding solution, a medication or biotics, into a body cavity accessed by the transnasal tube device.
  • feeding equipment may for example be connected to the port of the tube at the first, proximal end of the tube, allowing feeding a medical solution to be delivered to the patient into the tube.
  • a second lumen in contrast, may be in fluid connection with the inflatable chamber of the inflation device, such that via the second lumen the inflatable chamber may be transferred from its first, deflated state to its second, inflated state and vice versa.
  • air may be guided to inflate the inflatable chamber to assume the second, inflated state.
  • the inflatable chamber preferably comprises a predefined shape formed by a suitable molding technique of a material having an increased hardness, a filling of the inflatable chamber at rather low pressure using air or even a partial filling may be sufficient.
  • a suction device may be connected to the second lumen of the tube at the first, proximal end of the tube, the suction device for example being constituted as a syringe which may be used to suck a predefined amount of air from the inflatable chamber such that the inflation device assumes the first, deflated state.
  • the suction device for example being constituted as a syringe which may be used to suck a predefined amount of air from the inflatable chamber such that the inflation device assumes the first, deflated state.
  • the suction device for transferring the inflatable chamber, after passing the tube towards the body cavity to be accessed, to the second, inflated state the amount of air previously sucked from the inflatable chamber using the suction device may be refilled into the inflatable chamber, having the advantage that the filling state of the inflatable chamber in the second, inflated state is exactly known.
  • Such suction device for example formed by a syringe, is cost-effective and may easily and intuitively be operated manually by a user.
  • a second inflatable chamber in between the first, proximal end and the second, distal end may be placed on the tube, the second inflatable chamber having similar characteristics to the inflatable chamber on the second, distal end of the tube, being made in particular from a material having a Shore-hardness greater than 64, preferably greater than 70, the material for example comprising polyurethane.
  • the second inflatable chamber may also be in fluid connection with the second lumen of the tube such that the inflatable chamber at the second, distal end and the second inflatable chamber in between the first, proximal end and the second, distal end of the tube may be inflated together via the second lumen.
  • the object is also achieved by a method for manufacturing a transnasal tube device for access to a body cavity of a patient through the esophagus, comprising:
  • the method is characterized by forming the inflatable chamber by a membrane envelope made of a material having a Shore-hardness equal to or greater than 64.
  • a transnasal tube device 1 comprises a tube 10 to be guided through the nose 23 and the esophagus 22 of the patient 2 towards a body cavity such as the patient's stomach 20 or the patient intestinal tract 21, in particular the patient's jejunum.
  • a medical solution such as a nutritional feeding solution for the enteral feeding of the patient 2
  • a medication or biotics may be fed directly into the body cavity 20, 21 accessed by the transnasal tube device 1, a suitable feeding device for this being connectable to a port 11 at a first, proximal end 100 of the tube 10 for feeding the medical solution into the tube 10 towards a second, distal end 101 of the tube 10 placed within the body cavity 20, 21 to be accessed.
  • the amount of air previously withdrawn from the inflatable chamber 150 is refilled into the inflatable chamber 150 by delivering the air from the suction device 16 into the inflatable chamber 150 (for example by pressing on a piston of the syringe forming a suction device 16), such that the chamber 150 is filled by a known amount of air at a known pressure.
  • the second lumen 14 at a first end 140 is in fluid connection with the connector 12 for connection to the suction device 16.
  • the second lumen 14 opens into the inflatable chamber 150 such that air may be passed through the second lumen 14 to/from the inflatable chamber 150.
  • the shape of the inflation device 15 with its membrane envelope 151 may be adapted to anatomic needs of the patient 2 and to a specific application, for example for placement of the tube 10 within the stomach 20 of the patient 2.
  • the membrane envelope 151 may be shaped, in particular when placing the tube 10 to access the patient's stomach 20, to prevent a reflux from the stomach 20 into the esophagus 22, which is to be avoided in particular when feeding a medical solution via the tube 10 into the stomach 20.
  • the inflation device 15 in the second, inflated state may be formed to block the entrance of the esophagus 22 at the stomach 20 such that fluid may not enter from the stomach 20 into the esophagus 22.
  • Fig. 2 and Fig. 3 are functionally identical, besides the different shape of the inflation device 15, the membrane envelope 151 in the second, inflated state having a spherical shape in the embodiment of Fig. 2 and a cylindrical shape in the embodiment of Fig. 3 .
  • the inflatable chamber 150 primarily serves to prevent a reflux through the esophagus 22 when placing the tube 10 of the transnasal tube device 1 within the patient's stomach 20.
  • the inflatable chamber 150 may assume, in the second inflated state, a substantially cylindrical shape which may adapt to the specific anatomy of the esophagus 22 such that the esophagus 22 is blocked and a reflux through the esophagus 22 is prevented, hindering an aspiration and a potential infection of the patient's lungs.
  • the inflatable chamber 150 may be fully filled or only partially filled for inflating the inflatable chamber 150. In each case a rather low pressure may be sufficient to fill the inflatable chamber 150, wherein a partial filling of the inflatable chamber 150 way furthermore be helpful to adapt the inflatable chamber 150 to the specific anatomy of for example the esophagus 22.
  • one or multiple inflatable chambers 150 can be placed at different locations on the tube 10, in particular close to the distal end 101, close to the proximal end 100 or in between the distal end 101 and the proximal end 100.
  • multiple chambers 150 of equal or different shape and of equal or different function may be provided on the tube 10 on different axial locations.
  • the inflatable chamber 150 comprises different portions 152, 153, a first portion 152 having a substantially spherical shape, whereas a second portion 153 has a substantially cylindrical shape.
  • the tube 10 comprises an inflatable chamber 150 having only one portion having a substantially spherical shape.
  • the inflatable chamber 150 assumes, in the second inflated state, a substantially cylindrical shape.
  • transnasal tube device of the type described herein may be used for different applications, for example for feeding a nutritional solution for the enteral feeding of a patient, for feeding a medication or for feeding biotics.
  • the tube may be a single lumen tube or a multi-lumen tube.

Landscapes

  • 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)
  • Media Introduction/Drainage Providing Device (AREA)

Claims (9)

  1. Transnasale Schlauchvorrichtung (1) für den Zugang zum Magen (20) eines Patienten (2) durch die Speiseröhre (22), umfassend:
    - einen Schlauch (10), der ein erstes, proximales Ende (100) und ein zweites, distales Ende (101) aufweist,
    - einen Anschluss (11), der am ersten, proximalen Ende (100) des Schlauchs (10) angeordnet ist, um eine medizinische Lösung in den Schlauch (10) einzuführen, und
    - eine Aufblasvorrichtung (15), die an dem Schlauch (10) angeordnet ist, wobei die Aufblasvorrichtung (15) eine aufblasbare Kammer (150) umfasst, die dazu konfiguriert ist, in einem ersten, nicht aufgeblasenen Zustand ein erstes Volumen (V1) einzunehmen, um ein Hindurchführen des Schlauchs (10) durch die Speiseröhre (22) zum Magen (20) zu ermöglichen, zu dem die transnasale Schlauchvorrichtung (1) Zugang haben soll, und in einem zweiten, aufgeblasenen Zustand ein zweites Volumen (V2) einnehmen, das größer ist als das erste Volumen (V1), wobei die aufblasbare Kammer (150) in dem zweiten, aufgeblasenen Zustand gebildet ist, um den Schlauch im Magen (20) zurückzuhalten und einen Reflux zu verhindern,
    dadurch gekennzeichnet,
    dass die aufblasbare Kammer (150) durch eine Membranhülle (151) definiert ist, die aus einem Material hergestellt ist, das eine Shore-Härte A gleich oder größer als 64, vorzugsweise größer als 70, aufweist, wobei die Membranhülle (151) in dem zweiten, aufgeblasenen Zustand eine vordefinierte Form annimmt, die durch eine Formtechnik gebildet ist, und die aufblasbare Kammer (150) zwei Kammerabschnitte (152, 153) umfasst, wobei ein erster Abschnitt eine im Wesentlichen kugelförmige Form aufweist und ein zweiter Abschnitt (153) eine im Wesentlichen zylindrische Form aufweist.
  2. Transnasale Schlauchvorrichtung (1) nach Anspruch 1, dadurch gekennzeichnet, dass die Aufblasvorrichtung (15) in der Nähe des distalen Endes (101) des Schlauchs (10) angeordnet ist.
  3. Transnasale Schlauchvorrichtung (1) nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass die Membranhülle (151) im Wesentlichen nicht über den zweiten, aufgeblasenen Zustand der aufblasbaren Kammer (150) hinaus ausdehnbar ist.
  4. Transnasale Schlauchvorrichtung (1) nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass die Membranhülle (151) aus einem Material hergestellt ist, das Polyurethan umfasst.
  5. Transnasale Schlauchvorrichtung (1) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der Schlauch (10) ein erstes Lumen (13) zum Verabreichen einer medizinischen Lösung in eine Körperhöhle (20, 21), zu der die transnasale Schlauchvorrichtung (1) Zugang hat, und ein zweites Lumen (14) umfasst, das in Fluidverbindung mit der aufblasbaren Kammer (150) der Aufblasvorrichtung (15) steht.
  6. Transnasale Schlauchvorrichtung (1) nach Anspruch 5, dadurch gekennzeichnet, dass die aufblasbare Kammer (150) der Aufblasvorrichtung (15) durch Befüllen der aufblasbaren Kammer (150) mit Luft durch das zweite Lumen (14) aufblasbar ist.
  7. Transnasale Schlauchvorrichtung (1) nach Anspruch 5 oder 6, gekennzeichnet durch eine Saugvorrichtung (16), die mit dem zweiten Lumen (14) am ersten, proximalen Ende (100) des Schlauchs (10) verbindbar ist, um die aufblasbare Kammer (150) zwischen dem ersten, nicht aufgeblasenen Zustand und dem zweiten, aufgeblasenen Zustand zu überführen.
  8. Transnasale Schlauchvorrichtung (1) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die aufblasbare Kammer (150) in dem zweiten, aufgeblasenen Zustand gebildet ist, um einen Reflux durch die Speiseröhre (22) zu verhindern.
  9. Verfahren zum Fertigen einer transnasalen Schlauchvorrichtung (1) für den Zugang zu einer Körperhöhle (20, 21) eines Patienten (2) durch die Speiseröhre (22), umfassend:
    - Bereitstellen eines Schlauches (10), der ein erstes, proximales Ende (100) und ein zweites, distales Ende (101) aufweist,
    - Anordnen eines Anschlusses (11) am ersten, proximalen Ende (100) des Schlauchs (10), um eine medizinische Lösung in den Schlauch (10) einzuführen, und
    - Anordnen einer Aufblasvorrichtung (15) an dem Schlauch (10), wobei die Aufblasvorrichtung (15) eine aufblasbare Kammer (150) umfasst, die dazu konfiguriert ist, in einem ersten, nicht aufgeblasenen Zustand ein erstes Volumen (V1) einzunehmen, um ein Hindurchführen des Schlauchs (10) durch die Speiseröhre (22) zu einer Körperhöhle (20, 21) zu ermöglichen, zu der die transnasale Schlauchvorrichtung (1) Zugang haben soll, und in einem zweiten, aufgeblasenen Zustand ein zweites Volumen (V2) einzunehmen, das größer als das erste Volumen (V1) ist,
    gekennzeichnet durch
    das Bilden der aufblasbaren Kammer (150) durch eine Membranhülle (151), die aus einem Material hergestellt ist, das eine Shore-Härte gleich oder größer als 64, vorzugsweise größer als 70, aufweist, wobei die Membranhülle (151) in dem zweiten, aufgeblasenen Zustand eine vordefinierte Form annimmt, die durch eine Formtechnik gebildet ist, und die aufblasbare Kammer (150) zwei Kammerabschnitte (152, 153) umfasst, wobei ein erster Abschnitt eine im Wesentlichen kugelförmige Form aufweist und ein zweiter Abschnitt (153) eine im Wesentlichen zylindrische Form aufweist.
EP19716862.8A 2018-04-25 2019-04-04 Transnasale schlauchvorrichtung zum zugang zu einer körperhöhle eines patienten Active EP3784201B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP18169141 2018-04-25
PCT/EP2019/058496 WO2019206593A1 (en) 2018-04-25 2019-04-04 Transnasal tube device for access to a body cavity of a patient

Publications (2)

Publication Number Publication Date
EP3784201A1 EP3784201A1 (de) 2021-03-03
EP3784201B1 true EP3784201B1 (de) 2025-08-13

Family

ID=62063358

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19716862.8A Active EP3784201B1 (de) 2018-04-25 2019-04-04 Transnasale schlauchvorrichtung zum zugang zu einer körperhöhle eines patienten

Country Status (2)

Country Link
EP (1) EP3784201B1 (de)
WO (1) WO2019206593A1 (de)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4943275A (en) 1988-10-14 1990-07-24 Abiomed Limited Partnership Insertable balloon with curved support
WO1991000752A1 (en) 1989-06-28 1991-01-24 Zimmon David S Balloon tamponade devices and methods for their placement
EP0586717B1 (de) * 1992-08-13 2001-12-12 Terumo Kabushiki Kaisha Endotrachealtubus sowie Herstellungsmethode
AU3098400A (en) 1998-11-09 2000-05-29 Datascope Investment Corp. Intra-aortic balloon catheter having an ultra-thin stretch blow molded balloon membrane
WO2008121603A1 (en) * 2007-03-30 2008-10-09 Cook Critical Care Incorporated Self-advanceable feeding tube
US20150366760A1 (en) * 2014-05-30 2015-12-24 Ibrahim Elali Nasogastric tube anti aspiration device
WO2017132423A1 (en) * 2016-01-26 2017-08-03 Travis Nicholas Richard Insertable device to prevent aspiration of stomach contents during ventilation and intubation

Also Published As

Publication number Publication date
WO2019206593A1 (en) 2019-10-31
EP3784201A1 (de) 2021-03-03

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