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WO2025045449A1 - Dispositif de cathéter auriculaire - Google Patents

Dispositif de cathéter auriculaire Download PDF

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Publication number
WO2025045449A1
WO2025045449A1 PCT/EP2024/070415 EP2024070415W WO2025045449A1 WO 2025045449 A1 WO2025045449 A1 WO 2025045449A1 EP 2024070415 W EP2024070415 W EP 2024070415W WO 2025045449 A1 WO2025045449 A1 WO 2025045449A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
ear
catheter device
plug
valve
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.)
Pending
Application number
PCT/EP2024/070415
Other languages
German (de)
English (en)
Inventor
Jörg Schwarzbich
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.)
Individual
Original Assignee
Individual
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
Priority claimed from DE202023104948.6U external-priority patent/DE202023104948U1/de
Priority claimed from DE202023105616.4U external-priority patent/DE202023105616U1/de
Priority claimed from DE202023106064.1U external-priority patent/DE202023106064U1/de
Priority claimed from DE202023107388.3U external-priority patent/DE202023107388U1/de
Application filed by Individual filed Critical Individual
Publication of WO2025045449A1 publication Critical patent/WO2025045449A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • 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
    • A61F11/20—Ear surgery
    • A61F11/202—Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
    • 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
    • A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels

Definitions

  • the invention relates to an ear catheter device for introducing a substance into the middle ear of a patient, comprising a catheter, a tubular insertion aid for inserting the catheter from the nose through the Eustachian tube into the middle ear, a closure element surrounding the catheter at the distal end for closing the Eustachian tube, and a backflow preventer associated with the catheter.
  • Ear catheter devices of this type are used to administer a medication into the patient's inner ear and then hold it in the inner ear for a longer period of time so that it can take effect.
  • the insertion aid is withdrawn after the medication has been administered, while the catheter remains in the ear.
  • the non-return valve and the closure element prevent the medication from flowing out of the middle ear through the catheter or through the annular gap between the catheter and the Eustachian tube.
  • DE 10 2021 105 036 A1 describes an ear catheter device of the type mentioned above, in which the backflow preventer is a one-way valve arranged in a relatively bulky connection housing at the proximal end of the catheter.
  • the catheter In addition to an injection lumen used to administer the medication, the catheter also has a pressure relief lumen through which the middle ear can be ventilated during administration of the medication. This pressure relief lumen can also be shut off by means of a one-way valve arranged in the connection housing.
  • the introducer Since the connector housing represents an obstacle when withdrawing the introducer, the introducer has a longitudinal seam along which it can be cut open so that it can be separated from the catheter.
  • the closure element is formed by an expandable umbrella which, in the collapsed state, can be inserted together with the catheter through the insertion aid and is then expanded with an expansion device.
  • a similar ear catheter device is known from DE 10 2018 102 937 Al, in which the closure element is an inflatable balloon. An additional lumen is then required in the catheter to inflate this balloon.
  • the object of the invention is to provide an ear catheter device which is easier to manufacture and easier to handle.
  • the closure element is a plug made of elastomeric material which is supported on the distal end of the insertion aid and firmly connected to the catheter.
  • the unit consisting of plug and catheter is inserted into the Eustachian tube with the insertion aid and pushed forward until the plug is inserted under slight tension in the narrow spot between the cartilaginous part and the bony part of the Eustachian tube and is held in position there with force.
  • the annular gap between the catheter and the Eustachian tube is then closed by the plug.
  • the medication supplied via the catheter is released into the middle ear through the non-return valve.
  • the non-return valve then prevents the fluid from flowing back through the injection lumen of the catheter.
  • the insertion aid can be withdrawn while the plug and catheter remain in the ear.
  • a pulling force is exerted on the catheter, which overcomes the frictional connection between the plug and the Eustachian tube so that the plug can be withdrawn.
  • the outer diameter of the catheter is smaller than the inner diameter of the insertion aid, so that an annular gap is formed between these components, which can be used as a pressure relief lumen.
  • a backflow of the medication liquid through this pressure relief lumen can be prevented by forming a valve at the mouth of this lumen into the inner ear, which only opens when a certain excess pressure in the middle ear is reached. Since the plug, which forms the closure element is made of elastomeric material, this valve can easily be formed in one piece with the plug.
  • the insertion aid forms an actuating element at the distal end, by means of which the valve is opened when the plug reaches its final position in the Eustachian tube.
  • the valve is automatically closed again by the withdrawal movement.
  • the backflow preventer can be integrated into the catheter at any point and can optionally be formed in one piece with the catheter.
  • the non-return valve is integrated into the stopper.
  • a backflow of the liquid through the injection lumen of the catheter is prevented at the opening of the catheter into the inner ear.
  • the non-return valve can be formed in one piece with the stopper and, for example, have the shape of a duckbill valve.
  • a centering piece can be provided at the proximal end of the insertion aid and the catheter, which facilitates the insertion of an injection needle into the injection lumen of the catheter.
  • the medication liquid can then be easily supplied using an injection needle, so that no bulky connection housing is required.
  • Fig. 1 is a half-section through a distal end of an ear catheter device according to an embodiment of the invention
  • Fig. 2 is a front view of the distal end of the ear catheter device
  • Fig. 3 is a partially cutaway complete view of the ear catheter device
  • Fig. 4 is a half-section through a distal end of an ear catheter device according to another embodiment
  • Fig. 5 is a section through a proximal end of the ear catheter device of Fig. 4;
  • FIG. 6 and 7 partial sections through an ear catheter device according to a further embodiment in two different positions;
  • Fig. 8 and 9 representations analogous to Figs. 6 and 7 for a modified embodiment;
  • Fig. 10 is a section through the proximal end of the ear catheter device according to Figures 6 and 7 or 8 and 9;
  • Fig. H is a section through the distal end of an ear catheter device according to another embodiment.
  • Fig. 1 shows a distal end of a tubular insertion aid 10 which accommodates a catheter 12 and is used to insert the catheter from the nose into the Eustachian tube of a patient in order to administer a liquid, e.g. a medication, into the patient's middle ear.
  • a stopper 14 made of elastomeric material which is firmly connected to the end of the catheter 12 and serves to mechanically fix the catheter in the narrow area between the cartilaginous part and the bony part of the Eustachian tube.
  • the stopper has a sequence of circumferential ribs 16 and grooves 18 on its peripheral surface (in this example there is only one groove).
  • the ribs 16 have a slightly larger outer diameter than the insertion aid 10 and are dimensioned such that they rest against the inner surface of the Eustachian tube under slight pressure and/or bending stress and offer a certain resistance to a mechanical retraction force acting on the catheter 12.
  • the catheter 12 has the configuration of a simple tube with a single (central) lumen, which shall be referred to here as the injection lumen 20.
  • This injection lumen 20 continues into a lumen 22 of the plug 14, which extends into a rounded end section 24 of this plug and is closed at the end by a non-return valve 26 in the form of a duckbill valve.
  • the non-return valve 26 is formed by a gap, which extends from the apex of the end section 24 to the tapered end of the lumen 22, dividing the end section 24 into two valve lips which lie against one another under tension and thus close the lumen 22.
  • the two valve lips can be spread apart when liquid is supplied through the injection lumen 20 into the lumen 22 and the pressure gradient between the lumen 22 and the interior of the middle ear exceeds a certain threshold value. In this way, the liquid supplied through the lumen 22 can be released into the middle ear via the duckbill valve. Since the plug 14 with its circumferential ribs 16 seals the inner surface of the Eustachian tube, the plug also forms a closure element that prevents the administered liquid from flowing back outside the insertion aid 10.
  • the outer diameter of the catheter 12 is smaller than the inner diameter of the insertion aid 10, so that an annular gap is formed between the catheter and the insertion aid, which serves as a pressure relief lumen 28.
  • a ventilation opening 30 is formed that runs parallel to the lumen 22 and is closed off by a valve 32 at the proximal end adjacent to the pressure relief lumen 28.
  • the valve 32 is formed by a sealing sleeve made in one piece with the plug 14. If liquid is released into the middle ear via the non-return valve 26 and the pressure of the air displaced thereby exceeds a certain value, the sealing sleeve can give way elastically so that the displaced air can flow out via the pressure relief lumen 28.
  • the stiffness of the sealing cuff is adjusted so that the pressure in the middle ear cannot rise to a level that would be harmful or uncomfortable for the patient.
  • the valve 32 closes and thus prevents the fluid from flowing out again via the pressure relief lumen 28.
  • the stopper 14 is in the narrow part of the Eustachian tube, the supplied medication fluid is therefore held in the middle ear so that the medication dissolved or suspended in the fluid can take effect.
  • the opening pressure of the non-return valve 26 is set so that the duckbill valve remains closed as long as the pressure fluctuations in the nose/throat area caused by swallowing movements do not exceed the normal level. This prevents the fluid held in the middle ear from gradually being displaced by incoming air.
  • Fig. 2 the plug 14 is shown in a front view.
  • Fig. 3 is a complete view of the ear catheter device with the insertion aid 10 and the plug 14 at the distal end.
  • the insertion aid 10 is a relatively rigid tube which is bent at the distal end so that the plug 14 can be easily inserted into the Eustachian tube from the patient's nose/pharynx.
  • a proximal end section of the insertion aid 10 is shown in section in Fig. 3, so that the proximal end of the catheter 12 and the injection volume 20 can be seen.
  • the proximal end of the catheter 12 rests on a narrowed end section 34 of the insertion aid 10, which then merges integrally into a centering aid 36 in a handle 38.
  • the centering aid 36 has an opening at the end opposite the insertion aid 10 for receiving the Luer cone of an injection syringe (not shown) and then narrows conically to form a needle channel 40 that is aligned with the injection lumen 20 of the catheter 12. While the user holds the handle 38 in his hand, he can thus insert an injection needle into the needle channel 40 and then into the end section of the injection volume 20 in order to apply the liquid.
  • FIGs 4 and 5 show an ear catheter device according to a modified embodiment. The details of the device are designated by the same reference numerals as the corresponding details in Figures 1 to 3, but increased by 100 in each case.
  • the ear catheter device has an insertion aid 110 that accommodates a catheter 112.
  • a plug 114 is supported on the distal end of the insertion aid 110 and in this example is manufactured in one piece with the catheter 112, for example in a 3D printing process.
  • the plug 114 does have an end section 124 that is reduced in diameter and rounded at the end, but in this embodiment it does not form a backflow preventer, so that the lumen 120 of the catheter 112 opens freely into the middle ear.
  • the multiple ventilation channels 130 reduce the risk of the ventilation path becoming blocked by mucus.
  • FIG. 5 A proximal end of the ear catheter device according to this embodiment is shown in Fig. 5.
  • the insertion aid 110 merges in one piece into a centering aid 136 in a handle 138.
  • the catheter 112 is narrowed at a point near the proximal end to a gap that forms a backflow preventer 126.
  • the walls of the catheter are deformed at this point so that they can elastically yield when there is sufficient pressure in the injection lumen and allow the medication liquid to enter the distal part of the catheter.
  • an injection needle with which the medication is administered can also be inserted into the catheter so far that it mechanically opens the backflow preventer 126 during the injection.
  • Fig. 6 only the part of the plug 214 that forms the closure element is shown.
  • the plug is formed in one piece with the catheter 212, which together with the insertion aid 210 delimits the pressure relief lumen 228.
  • the plug again has two diametrically opposed ventilation openings 230, which in the state shown in Fig. 6 are connected to the pressure relief lumen 228.
  • two valves 232 are formed, which serve to block access from the ventilation openings 230 to the pressure relief lumen 228.
  • the valves 232 are held in an open position by a respective actuating member 240 that protrudes from the distal end of the insertion aid 210.
  • the actuating elements 240 protrude into the ventilation openings 230 without blocking the opening of the pressure relief lumen 228.
  • any excess pressure that may arise in the middle ear can be relieved via the pressure relief lumen 228.
  • Fig. 7 shows the state in which, after the administration of the medication, the insertion aid 210 has been retracted a little so that the actuating elements 240 have emerged from the ventilation openings 230.
  • the valves 232 which are designed as flap valves, then rest against the
  • the actuating members 240 are attached to the peripheral surface of the catheter 212 so that they block the proximal ends of the ventilation openings 230 and thus prevent the medication from escaping from the middle ear.
  • the actuating members 240 each have an insertion bevel so that they spread the flaps of the valves 232 apart when the Insertion aid 210 is advanced in the direction of the plug 214. In this way, the valves 232 are automatically opened when the plug 214 is introduced into the Eustachian tube with the aid of the insertion aid 210 and reaches its end position in which it offers greater resistance to the advance movement while the insertion aid 210 is advanced further until it reaches the stop positions according to Fig.
  • the front end of the catheter 212 or the end portion of the plug 214 is not shown in Figures 6 and 7.
  • This end can optionally form a duckbill valve, as in Figure 1, or form a lumen that continues to the distal end, as in Figure 4.
  • the non-return valve can be integrated into the catheter in a similar way to Figure 5.
  • Figures 8 and 9 are representations analogous to Figures 6 and 7 and show the plug 314 of an ear catheter device according to another embodiment, which differs from the embodiment according to Figures 6 and 7 only in the design of the valve 332. While the valve 232 in Figures 6 and 7 is a flap valve which is integrally connected to the plug 214 at its distal end, the valve 332 in Figures 8 and 9 is a flap valve which is integrally connected to the plug 314 at its proximal end. The mode of operation is the same as in Figures 6 and 7.
  • the distal end section can also form a duckbill valve or create an open connection between the middle ear and the injection lumen.
  • the non-return valve can be integrated into the catheter 312 in a similar way to Fig. 5.
  • Such a non-return valve 326 on the proximal end of the insertion aid 310 is shown in Fig. 10.
  • the insertion aid 310 and the handle 338 are shown in Fig. 10 in a state in which the distal end of the insertion aid 310 has not yet quite reached the stop position on the plug. Accordingly, in Fig. 10 the proximal end of the catheter 312 is still a certain distance from the handle 338.
  • An end section of the insertion aid 310 adjoining the handle 338 is made of transparent material and forms a window 342 so that the user can check the position of the catheter 312 in the insertion aid to ensure that the insertion aid is fully advanced into the stop position according to Fig. 6 or 8 and that the valves 232 and 332 are accordingly open before he begins to administer the medication.
  • a distal end of an ear catheter device according to another embodiment is shown, with an introducer 410 and a catheter 412 which is formed in one piece with the plug 414.
  • the injection lumen 420 extends continuously through the plug 414.
  • the pressure relief lumen 428 is connected directly - without a valve - to the ventilation opening 430.
  • the device shown in Fig. 11 is intended for applications in which the medication is administered in the form of a highly viscous liquid or a gelatinous mass.
  • the cross-section of the vent opening 430 is dimensioned such that the highly viscous or gelatinous mass penetrates into the vent opening at most a short distance and then forms a plug that prevents the outflow of the medication through the pressure relief lumen 428.
  • the injection of the medication can be carried out in the same way as in Fig. 5. During the injection, the displaced air can flow out unhindered through the vent opening 430 and the pressure relief lumen 428 until the medication has filled the cavity in the inner ear and closed the vent opening 430.
  • the cross-section of the injection lumen 420 is not larger than the cross-section of the ventilation opening 430, the viscous mass will not penetrate into the injection lumen, so that a non-return valve is not required.
  • the injection lumen only has this small cross-section at its opening at the distal end. Further proximally, the cross-section is larger so that the flow resistance during the injection does not become too great.

Landscapes

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

Abstract

L'invention se rapporte à un dispositif de cathéter auriculaire pour introduire une substance dans l'oreille moyenne d'un patient, comprenant un cathéter (12), un dispositif d'aide à l'insertion tubulaire (10) pour insérer le cathéter (12) à partir du nez à travers la trompe d'Eustache dans l'oreille moyenne, et un élément d'étanchéité (14) entourant le cathéter au niveau de l'extrémité distale, pour sceller la trompe d'Eustache, caractérisé en ce que l'élément d'étanchéité est un bouchon (14) qui est supporté sur l'extrémité distale du dispositif d'aide à l'insertion (10) et relié de manière fixe au cathéter (12) et qui est constitué d'un matériau élastomère.
PCT/EP2024/070415 2023-08-30 2024-07-18 Dispositif de cathéter auriculaire Pending WO2025045449A1 (fr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
DE202023104948.6 2023-08-30
DE202023104948.6U DE202023104948U1 (de) 2023-08-30 2023-08-30 Ohrkathetervorrichtung
DE202023105616.4U DE202023105616U1 (de) 2023-09-26 2023-09-26 Ohrkathetervorrichtung
DE202023105616.4 2023-09-26
DE202023106064.1U DE202023106064U1 (de) 2023-10-19 2023-10-19 Ohrkathetervorrichtung
DE202023106064.1 2023-10-19
DE202023107388.3 2023-12-14
DE202023107388.3U DE202023107388U1 (de) 2023-12-14 2023-12-14 Ohrkathetervorrichtung

Publications (1)

Publication Number Publication Date
WO2025045449A1 true WO2025045449A1 (fr) 2025-03-06

Family

ID=91967143

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2024/070415 Pending WO2025045449A1 (fr) 2023-08-30 2024-07-18 Dispositif de cathéter auriculaire

Country Status (1)

Country Link
WO (1) WO2025045449A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Also Published As

Publication number Publication date
TW202523262A (zh) 2025-06-16

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