DE102010028705B4 - Eardrum implant (tympanostomy tube) - Google Patents

Abstract

An eardrum implant for ventilating the middle ear of a patient, from a tube insertable into the eardrum between the middle ear and the outer ear, having an end-side flange and a through-opening, the tube (1) between the end-side flange (2) and the opposite end (FIG. 3) of the through-opening (4) is provided with a plurality of further, outer, contiguous screw flights (7), flanges (5), characterized in that the tube (1) is conical, that the end-side flange (2) in the outer edge region ( 9) with indentations (10) and the other, outer flanges (5) in the outer edge region (8) with indentations (11) are provided, wherein the recesses (10, 11) relative to the axis (6) of the tube (1) respectively are arranged diametrically opposite one another and that between the outer surface (13) of the tube (1) and the surfaces of the other, outer flanges (5) are designed as depot acting cavities (14) for receiving pharmaceuticals.

Description

The invention relates to an eardrum implant (tympanic tube) for ventilating the middle ear of a patient from a usable in the eardrum between the middle ear and the outer tube tube with at least one end-side flange and with a through hole.

Such an eardrum implant is by means of a surgical incision (paracentesis) for ventilation of the middle ear (middle ear drainage) u. a. inserted into the eardrum in the middle ear effusion and when the eustachian tube is blocked.

An eardrum implant of the generic type is made U.S. Patent 4,650,488 previously known. This comprises a shaft-like tube with an axial passage opening and with an end, inner and with an outer flange. In the axial passage opening, a porous membrane is used in the region of the outer flange, which prevents the ingress of liquids, especially water, into the interior of the tube, but should not impede an exchange of air to prevent pressure build-up in the middle ear. The material of the eardrum implant is biodegradable.

Out DE 85 18 118 U1 Another eardrum implant is previously known as a prosthetic device for ventilation or drainage on the one hand and as a paracentesis tube on the other hand for the treatment of middle ear effusions. This implant is made of Teflon or other biocompatible material and has in the through hole a ceramic ball as a closing device, which closes the passage opening upon exposure to liquid at the outer end, but allows a gas flow freely in both directions through the through hole to pressure differences between balance the middle ear cavity and the external auditory canal.

The US patent US Pat. No. 5,775,336 describes a tympanic membrane implant with a tube insertable into the tympanic membrane, which has an end flange, a passage opening and a helically encircling further structure. The latter is intended to be screwed into an opening in the eardrum of a patient.

A disadvantage of the known eardrum implants is that they are expensive to manufacture, do not allow secure fixation in the eardrum and regularly have to be removed surgically or cause difficulties in insertion and / or removal.

The invention has for its object to provide a tympanic membrane implant that is easy to manufacture, allows for secure fixing in the eardrum and does not need to be removed surgically or is easier to handle when using and / or removal.

To achieve this object, the invention provides an eardrum implant for ventilation of the middle ear of a patient, from an insertable into the eardrum between the middle ear and the outer ear tube with an end flange and with a through hole, before, wherein the tube between the end flange and this opposite end of the through hole is provided with a plurality of other outer flanges, which are formed as a continuous thread, wherein the eardrum implant is characterized in that the tube is conical, that the end-side flange in the outer edge region with indentations and the other, outer flanges in the outer edge region (also) are provided with recesses, wherein the recesses are arranged relative to the axis of the tube in each case diametrically opposite one another and that between the outer surface of the tube and the surface n the other outer flanges are designed as depot acting cavities for receiving pharmaceuticals. The other outer flanges allow for easy implant fabrication, easy insertion into the eardrum and easy removal from the tympanic membrane without the need for further surgery. Due to the special structural design of the eardrum implant or its geometric configuration, the quality of treatment is improved and high patient safety achieved by the special, atraumatic geometry absorption while increasing functionality.

The formation of the other outer flanges as a continuous screw thread allows screwing the implant into the eardrum and unscrewing the implant from the eardrum, without the need for expensive operations. The thread has a thread pitch of 1 to 20%, preferably 10%.

The cavities (cavities) formed between the outer surface of the tube and the surfaces of the other, outer flanges serve as receptacles for medicaments. These are z. B. broad spectrum antibiotics or proliferation stimulants.

The indentations of the end flange and the other, outer flanges in outer edge region are arranged diametrically opposite relative to the axis of the tube. The recesses serve to attach an auxiliary instrument when inserting the eardrum implant in the eardrum of a patient.

In a further embodiment, the helically arranged further outer flanges have sealing lips on the outer flanks which are provided with a drug-mixed hydrogel for insertion of proliferation-promoting medicaments.

Finally, the tube with the end-side and the further outer flanges is formed from resorbable micro-injection-processed biomaterial, in particular starch acetate / polyethylene glycol 85/15 w / w, starch acetate / polyethylene glycol / polyethylene carbonate 60/30/10 w / w or starch acetate / polyethylene glycol / Polypropylenecarbonate 60/10/30 w / w.

The invention is explained in more detail below with reference to several embodiments of eardrum implants (tympanostomy tubes). It shows:

1 a perspective view of an embodiment without indentations,

2 a perspective view of an embodiment with indentations in the outer edge region of the end-side flange,

3 a perspective view of the embodiment of the invention and

4 a sectional view through the eardrum of a patient with inserted, cut represented eardrum implant.

In the 1 an embodiment of an eardrum implant (tympanic tube) shown in a perspective view consists of a tube 1 , an end flange 2 and between the end flange 2 and the opposite end 3 the passage opening 4 through the tube 1 several other outer flanges 5 , The tube 1 is cylindrical in cross section and in the direction of its axis 6 from the end flange 2 to the end 3 slightly conical. The other outer flanges 5 are as a contiguous thread 7 formed, the thread pitch of 1 to 20%, preferably 10%, is. The outer edge area 8th the other outer, helical flanges 5 lies according to the conicity of the tube 1 on a conical surface.

In the embodiment according to 2 is the end flange 2 in its outer edge area 9 with indentations 10 provided to enable the attachment of an auxiliary instrument when inserting the eardrum implant into the eardrum of a patient.

In the embodiment according to the invention 3 are also the outer edge areas 8th the other outer, helical flanges 5 with indentations 11 Mistake.

All indentations 10 . 11 are relative to the axis 6 of the tube 1 arranged diametrically opposite.

The 4 Shows the eardrum implant in the eardrum 12 a patient is surgically inserted, wherein the end-side flange 2 on the outside of the eardrum 12 , d h. on the side of the external auditory canal, rests, the surgically inserted tube 1 the eardrum 12 penetrates into the middle ear cavity and the other outer flanges 5 partly on the inside or in the middle ear cavity on the eardrum 12 issue. The conical shape of the tube 1 and the border areas 8th the other outer flanges 5 are in 4 shown.

Between the outer surface 13 of the tube 1 and the surfaces of the other outer flanges 5 are cavities acting as depot 14 (Cavities) are formed, in which pharmaceuticals can be included, in particular broadband antibiotics or proliferation stimulants.

The required diameter of the eardrum flanges and the length of the tube 1 may be prior to surgical insertion into the eardrum 12 a patient at the distal or proximal end are shortened in situ. The eardrum implant is located on the eardrum 12 autoadhesive with resorption times in the range of 2 to 6 months.

The entire eardrum implant from the tube 1 and the flanges are integrally formed from resorbable biomaterials. These are in particular starch acetate and misery thereof, such. Starch concentrate / polyethylene glycol 85/15 w / w, starch acetate / polyethylene glycol / polyethylene carbonate 60/30/10 w / w or starch acetate / polyethylene glycol / polypropylene carbonate 60/10/30 w / w, which are preferably processed by microsyringe injection molding.

LIST OF REFERENCE NUMBERS

1

tube

2

end-side flange

3

The End

4

Through opening

5

further outer flanges

6

axis

7

screw thread

8th

Edge region of the other outer flanges

9

Edge area of the end flange

10

Indentation (s) in the end flange

11

Indentation (s) of the other outer flanges

12

eardrum

13

outer surface of the tube

14

cavity

Claims (9)

An eardrum implant for ventilating the middle ear of a patient, from a tube insertable into the eardrum between the middle ear and the outer ear, having an end-side flange and having a passage opening, wherein the tube ( 1 ) between the end flange ( 2 ) and the opposite end ( 3 ) of the passage opening ( 4 ) with several other, outer than contiguous screw thread ( 7 ) formed flanges ( 5 ), characterized in that the tube ( 1 ) is conical in that the end flange ( 2 ) in the outer edge region ( 9 ) with indentations ( 10 ) and the other outer flanges ( 5 ) in the outer edge region ( 8th ) with indentations ( 11 ), the indentations ( 10 . 11 ) relative to the axis ( 6 ) of the tube ( 1 ) are each arranged diametrically opposite one another and that between the outer surface ( 13 ) of the tube ( 1 ) and the surfaces of the other outer flanges ( 5 ) acting as depot cavities ( 14 ) are designed for receiving pharmaceuticals. An eardrum implant according to claim 1, characterized in that the screw thread ( 7 ) has a thread pitch of 1 to 20%. An eardrum implant according to claim 1 or 2, characterized in that the screw thread ( 7 ) has a thread pitch of 10%. An eardrum implant according to any one of claims 1 to 3, characterized in that the helically arranged further outer flanges ( 5 ) are provided on the outer edges with sealing lips. An eardrum implant according to any one of claims 1 to 4, characterized in that the tube ( 1 ) with the end and the further outer flanges ( 2 . 5 ) is formed from resorbable biomaterial. An eardrum implant according to claim 5, characterized in that the resorbable biomaterial is starch acetate / polyethylene glycol 85/15 w / w. An eardrum implant according to claim 5, characterized in that the resorbable biomaterial is starch acetate / polyethylene glycol / polyethylene carbonate 60/30/10 w / w. An eardrum implant according to claim 5, characterized in that the resorbable biomaterial is starch acetate / polyethylene glycol / polypropylene carbonate 60/10/30 w / w. An eardrum implant according to any one of claims 5 to 8, characterized in that the resorbable biomaterial is processed in microsystem injection molding.

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