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WO2024141284A1 - Cathéter auriculaire amélioré pour appliquer un médicament - Google Patents

Cathéter auriculaire amélioré pour appliquer un médicament Download PDF

Info

Publication number
WO2024141284A1
WO2024141284A1 PCT/EP2023/085952 EP2023085952W WO2024141284A1 WO 2024141284 A1 WO2024141284 A1 WO 2024141284A1 EP 2023085952 W EP2023085952 W EP 2023085952W WO 2024141284 A1 WO2024141284 A1 WO 2024141284A1
Authority
WO
WIPO (PCT)
Prior art keywords
lumen
pressure
ear
catheter
compartment
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/EP2023/085952
Other languages
German (de)
English (en)
Inventor
Holger SUDHOFF
Maximilian SUDHOFF
Aleksandar OBRADOVIC
Milisav Obradovic
Dirk Dittmann
Daniel Baumgartner
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.)
Auriventis GmbH
Original Assignee
Auriventis 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 Auriventis GmbH filed Critical Auriventis GmbH
Priority to AU2023418202A priority Critical patent/AU2023418202A1/en
Priority to CN202380089863.8A priority patent/CN120500313A/zh
Priority to IL321838A priority patent/IL321838A/en
Priority to EP23836351.9A priority patent/EP4642407A1/fr
Publication of WO2024141284A1 publication Critical patent/WO2024141284A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F11/00—Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0039—Multi-lumen catheters with stationary elements characterized by lumina being arranged coaxially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/004—Multi-lumen catheters with stationary elements characterized by lumina being arranged circumferentially

Definitions

  • the invention relates to an ear catheter for transnasal or transmeatal introduction into the Eustachian tube, which allows a medication to be made available in the middle ear area even over a longer period of time without it flowing away via the Eustachian tube.
  • Treatment of the middle and inner ear can also be done via the middle ear area.
  • An ear catheter inserted through the nose is often used for treatment, also to introduce medication.
  • the administration of medication into the Eustachian tube or middle ear, especially in liquid form is often not sustainable, as the medication usually runs off into the nasopharynx shortly after administration.
  • DE 10 2018 102 937 A1 describes an ear catheter that can be inserted into the Eustachian tube via the nasopharynx and includes an expandable balloon to seal it off from the nasopharynx.
  • An injection channel is guided through the balloon so that a medication can be administered into the Eustachian tube distal to the balloon, and the balloon prevents the medication from flowing back into the nasopharynx.
  • the medication is administered non-invasively using the well-known ear catheter via the nasopharynx and the auditory tube (the Eustachian tube).
  • DE 10 2021 105 036 A1 also describes an ear catheter that can be inserted into the Eustachian tube via the nasopharynx.
  • this application proposes an expandable coated nitinol basket or a balloon.
  • the known ear catheters can still be improved in essential details, especially when using an expandable balloon as a sealing element. With such a design, it is essential to provide a convincing valve arrangement that reliably prevents the development of undesirable excess pressure in the ear as soon as medication is applied and that also prevents the inadvertent outflow of medication from the ear.
  • the ear catheter according to the invention for insertion into the Eustachian tube comprises a catheter tube with at least three lumens, namely a first lumen as an application lumen for applying a medication (this can alternatively also be used as a guidewire lumen, provided it ends open distally), a second lumen as an inflation lumen for inflating a distally provided inflatable balloon and a third lumen as a pressure relief lumen for pressure relief in the middle ear area.
  • the inflatable balloon is designed to seal the middle ear distally on the ear catheter so that the medication administered through the application lumen cannot flow out through the nasopharynx.
  • the balloon should not be subjected to high pressure, as this can lead to injuries or pressure points in the sensitive middle ear.
  • low-pressure balloons low-pressure cuffs
  • a pressure limiter is provided, which preferably limits the pressure to below a slight overpressure.
  • the pressure limiter is provided in particular in the form of an umbrella valve.
  • the frame construction also serves as a handling aid and allows safe handling of the ear catheter.
  • an overpressure limiter 13 - preferably in the form of a first umbrella valve - is provided between the proximally arranged one-way valve 12 and the distally arranged balloon and is fluid-permeable to the inflation lumen.
  • an overpressure limiter 13 - preferably in the form of a first umbrella valve - is provided between the proximally arranged one-way valve 12 and the distally arranged balloon and is fluid-permeable to the inflation lumen.
  • the compartment B forms a fluid-connected unit together with the pressure relief lumen of the catheter tube and is connected to the sealing element or the second umbrella valve, wherein a second recess 14a is provided in the frame element 4 for the sealing element or the second umbrella valve.
  • Compartment A together with the inflation lumen of the catheter tube, forms a fluid-connected unit which is connected to the pressure limiter or the first umbrella valve via a first connection 8a, with a first recess 13a being provided in the frame element 3 for the pressure limiter or the first umbrella valve. If the pressure in the inflation lumen or in the combination of inflation lumen and compartment A rises above a certain pressure, the first umbrella valve opens.
  • the inflation pressure is preferably limited to a slight overpressure by the first umbrella valve.
  • the compartment B forms together with the pressure relief lumen of the catheter tube a fluid-connected unit which is connected to the sealing element or the second umbrella valve via a second connection 15, wherein a second recess 14a is provided in the frame element 4 for the sealing element or the second umbrella valve. If the pressure in the pressure relief lumen or in the combination of pressure relief lumen and compartment B rises above a certain pressure, the second umbrella valve opens. Preferably, the opening pressure of the second umbrella valve is set to practically 0 bar and the second umbrella valve functions as a sealing element.
  • Second umbrella valve (sealing element; 14a: second recess)
  • a First compartment (inflation lumen)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Physics & Mathematics (AREA)
  • Acoustics & Sound (AREA)
  • Otolaryngology (AREA)
  • Psychology (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un cathéter auriculaire destiné à être introduit dans la trompe d'eustache, comprenant un tube de cathéter (2) ayant au moins trois lumières, à savoir une première lumière en tant que lumière d'application (2a) pour appliquer un médicament, une deuxième lumière en tant que lumière de gonflage (2b) pour gonfler un ballonnet (17), et une troisième lumière en tant que lumière de détente en pression (2c) pour relâcher la pression dans la région auriculaire centrale. Afin d'empêcher un écoulement de médicament hors de la lumière d'application (2a) et afin d'empêcher un écoulement de fluide de gonflage hors de la lumière de gonflage (2b), une valve unidirectionnelle respective (11, 12) est prévue, et un limiteur de pression (13) est prévu afin de limiter la pression du ballonnet.
PCT/EP2023/085952 2022-12-30 2023-12-14 Cathéter auriculaire amélioré pour appliquer un médicament Ceased WO2024141284A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU2023418202A AU2023418202A1 (en) 2022-12-30 2023-12-14 Improved ear catheter for applying medication
CN202380089863.8A CN120500313A (zh) 2022-12-30 2023-12-14 用于药物给药的改进的耳导管
IL321838A IL321838A (en) 2022-12-30 2023-12-14 Improved ear catheter for applying medication
EP23836351.9A EP4642407A1 (fr) 2022-12-30 2023-12-14 Cathéter auriculaire amélioré pour appliquer un médicament

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102022135028.2A DE102022135028A1 (de) 2022-12-30 2022-12-30 Verbesserter Ohrkatheter zur Medikamentenapplikation
DE102022135028.2 2022-12-30

Publications (1)

Publication Number Publication Date
WO2024141284A1 true WO2024141284A1 (fr) 2024-07-04

Family

ID=89474844

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2023/085952 Ceased WO2024141284A1 (fr) 2022-12-30 2023-12-14 Cathéter auriculaire amélioré pour appliquer un médicament

Country Status (6)

Country Link
EP (1) EP4642407A1 (fr)
CN (1) CN120500313A (fr)
AU (1) AU2023418202A1 (fr)
DE (1) DE102022135028A1 (fr)
IL (1) IL321838A (fr)
WO (1) WO2024141284A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE202023106064U1 (de) * 2023-10-19 2025-02-10 Jörg Schwarzbich Ohrkathetervorrichtung

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009157884A2 (fr) * 2008-06-27 2009-12-30 Erturk Genc Dispositif d'application locale de médicament (ldad)
WO2018050165A1 (fr) * 2016-09-16 2018-03-22 David Spiggle Cathéter servant à administrer un fluide dans l'oreille moyenne
DE102018102937A1 (de) 2018-02-09 2019-08-14 Holger Sudhoff Ohrkatheter
WO2022112402A2 (fr) * 2020-11-27 2022-06-02 Auriventis Gmbh Cathéter auriculaire et élément d'aide à l'insertion pour cathéter

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009157884A2 (fr) * 2008-06-27 2009-12-30 Erturk Genc Dispositif d'application locale de médicament (ldad)
WO2018050165A1 (fr) * 2016-09-16 2018-03-22 David Spiggle Cathéter servant à administrer un fluide dans l'oreille moyenne
DE102018102937A1 (de) 2018-02-09 2019-08-14 Holger Sudhoff Ohrkatheter
WO2022112402A2 (fr) * 2020-11-27 2022-06-02 Auriventis Gmbh Cathéter auriculaire et élément d'aide à l'insertion pour cathéter
DE102021105036A1 (de) 2020-11-27 2022-06-02 Auriventis Gmbh Ohrkatheter und Einführhilfe für Katheter

Also Published As

Publication number Publication date
DE102022135028A1 (de) 2024-07-11
EP4642407A1 (fr) 2025-11-05
AU2023418202A1 (en) 2025-07-10
CN120500313A (zh) 2025-08-15
IL321838A (en) 2025-08-01

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