WO1998030146A1

WO1998030146A1 - Device for mechanically palpating and determining the course of the tympanic wall of a middle ear along a line

Info

Publication number: WO1998030146A1
Application number: PCT/DE1998/000074
Authority: WO
Inventors: Eberhard Stennert; Martin Walger; Axel Mickenhagen
Original assignee: Eberhard Stennert; Martin Walger; Axel Mickenhagen
Priority date: 1997-01-13
Filing date: 1998-01-10
Publication date: 1998-07-16
Also published as: DE19800563A1; AU5981598A; EP0951234A1

Abstract

The invention relates to a device for mechanically palpating and determining the course of the tympanic wall of a middle ear along a line (81), preferably an O-shaped line (81), around the oval window. Said device comprises a plurality of thin, oblong sensor pins (80) arranged parallel to each other along a line (81), a housing (82) which consists of an outer area (84) that grasps the sensor pins (80) on the outside, an inner area (86) situated within the line (81) formed by the sensor pins (80), and a clamping device, which in its clamping position fixes the sensor pins (80) and which in its release position allows for the sensor pins (80) to be moved in a longitudinal direction.

Description

Description: Device for mechanical scanning and detection of the

Course of the tympanic wall of a middle ear along a line

The invention relates most to a device for mechanical Abta ^¬ and detecting the course of the eardrum wall of a middle ear along a line, preferably an O-shaped line to the oval window.

Various diseases or malformations can mean that a middle ear prosthesis must be used. It serves the care of patients with chronic otitis ^media , chronic bone dilation, cholesteatomas or middle ear malformations.

There are various prior art for such middle ear prostheses, for example DE 4 407 847 AI or EP 460 354 B1. In particular, the invention is directed to a middle ear prosthesis as described in the application "middle ear prosthesis" by the same applicant with the same filing date as the present application . This middle ear prosthesis consists of a usually two-part, but possibly also multi-part housing, which can be hermetically sealed. Movements of the eardrum are transmitted directly into the inner ear via two connected ossicles. For this purpose, the first ossicle part is passed through an opening in the stapes footplate and directly stimulates the inner ear.

The housing has a coupling part, which is attached to the tympanic wall of the ear around the oval window, it has a free end area that is as closely as possible modeled on the course of the individual relief of the medial tympanic wall of a wearer of the middle ear prosthesis. In this way, a good fit to the timpani wall is achieved. Furthermore, the coupling part has a holding device for the provisional fixation of the first ossicle part. This usually becomes later when the middle ear is composed, severed.

Furthermore, the housing has a transmission part on which an artificial eardrum is provided and which carries a second ossicle part which extends from the center of the eardrum into the interior of the transmission part.

To the individual relief of the eardrum wall capture a carrier and being able to give the free end portion of the coupling part to ge ^¬ desired course accordingly, one can think of several ways of detection. A high-resolution spiral computer tomogram can thus be carried out in order to maintain the course and to be able to process the free end region of the coupling part directly or via an intermediate stage. One can also think of an optical measurement. However, all of these processes are complex and they are also time-consuming.

This is where the invention begins. It has set itself the task of specifying and developing a device of the type mentioned at the outset, which on the one hand has a lower cost price and causes lower costs than the measurement methods mentioned and on the other hand enables direct measurement.

This object is achieved by a device for mechanical Abta ^¬ sten and detecting the course of the eardrum wall of a middle ear along a line, preferably an O-shaped line to the oval window,

- with a plurality of thin, elongated tactile pins which are never located along the Li ^¬,

- having a housing, on the one hand has an outer region, the tactile pins ^¬ externally surrounds and has an inner guide region on which the probe pins are guided and on the other hand has a lying within the line of styli inner region and

- is ^¬ arranged with a clamping device, which is within the line of styli, which cooperates with the inner region containing a scheibenförmi ^¬ ges, rubber-elastic element, which rests with its outer edge to the tactile pins and the screw clamping means, in particular a clamping ^¬ through which the rubber-elastic element can be compressed more or less, so that it expands more or less towards the outside and towards the styli and more or less against it presses and clamps the guide area.

With this device, the course of the line on which the coupling part later also touches the medial tympanic wall can be precisely grasped and tapped during the operation. For this purpose, the device is inserted into the ear. The clamping device is released so far that the styli can move freely to a certain extent in their longitudinal direction. The tactile pins can be pressed to the security or against the Pau ^¬ kenwand, for example, with a finger. The course of the front blunt tips of the styli then reflects the three-dimensional course of the line around the oval window. This course can be held by tightening the clamping device. The profile of the coupling part can now be incorporated via a processing machine, which can be considerably simpler than the processing machines to be used for the other methods. As Bearbeitungsmaschi ^¬ ne particular a copy router comes into consideration here.

Due to the mechanical scanning, a measuring result, he is aiming ^¬ relatively quickly, this can be further used directly. The advantage be ^¬ is that exactly, the measurement is performed along that line on which later also has the coupling part with the eardrum wall contact. The scanning by the pins, and particularly the formation of the Spit ^¬ zen of the tactile pins is such that the later contact of the free end region of the coupling part is as similar as possible.

The individual probe pins are guided in a typically circular under ^¬ rupted slot which is limited by the guide portion of the housing to the outside, inside it is limited by the outer edge of the rubber-elastic member and, in addition, in order to together ^¬ menbau and in practical use to facilitate the cohesion of the device, are formed by sections of the interior. Whose outer edge is pressed to the outside by squeezing the rubber-elastic element, this means that the tactile pins between the guide region and the elastic rubber element clamped ^¬ the. If the clamping device is released again, the feeler ^pins can be pushed back and forth in their longitudinal direction or can be released so far that they can move in their longitudinal direction by themselves under the influence of gravity. In a particularly preferred development, the housing and Klemmvor ^¬ direction provided with a central, continuous opening through which forms an optical observation instrument, similar to an endoscope is being ^¬ can be inserted. In particular monitoring intruments are eligible, as are known already in the ENT area, for example, actively illuminated observation devices with rigid, dün ^¬ nem tube, for example by the company Richards optics with the order no. 23- 0853rd It is particularly preferred, these optics with the actual Vorrich ^¬ tung to connect, in particular by clamping to be connected, so that the entire device as a part can be inserted into the ear. Thanks to the optics, the actual measuring device can be positioned precisely and checked during the measuring process.

The clamping device is preferably a clamping screw through the clamping screw Verdre ^¬ hen relative to the housing is set, the rubber elastic member more or less under axial pressure. In the preferred ^embodiment with observation ^device , the clamping screw is provided with an axial passage.

In a preferred embodiment, the styli are round. This has the advantage that they can be guided in drill holes in the housing. The ^¬ se holes are made sufficiently wide that the tactile pins on the one hand precisely guided in its longitudinal direction, but on the other hand, ^¬ but can move freely under the influence of gravity. The actual determination of the styli remains the elastomeric ele ^¬ ment reserved.

In another embodiment, the tactile pins are non-round, in particular ha ^¬ they ben planar side surfaces to which they are directly in contact. In this manner, in a preferred embodiment, the tactile pins sel ^¬ over a circular form when they have a cross section corresponding to a Kreisringsek ^¬ gate or similar. This configuration simplifies the herstel ^¬ lung of the housing. The lateral guidance of the styli is no longer as good as in the case of an individual hole for each stylus.

Further advantages and features of the invention result from the others Claims and the following description of a non-restrictive embodiment which is explained in more detail below with reference to the drawings. In this show:

FIG. 1: a top view of a device according to the invention for mechanical scanning and detection of the course of the tympanic wall of a middle ear along a circular line, without styli,

FIG. 2: a sectional representation of the device according to FIG. 1, now with styli and

FIG. 3: a side view of a middle ear prosthesis, in particular as

Cross-section, with associated artificial Eustachian tube.

In the exemplary embodiment of the device according to the invention shown, a total of 36 styli 80 which are round in cross section are arranged on a line 81 formed as a circle with a diameter of 9 mm. A bore 83 is provided in a housing 82 for each individual stylus. This bore is designed so that the styli 80 are guided in it, but can be moved easily. In the embodiment shown the housing is formed in two parts, it has a cross-sectionally U-shaped Ba ^¬ sisteil and a lid. Both in the base part and in the cover, the bores 83 are made for the styli. In this way, there is a longer guide path for the styli 80.

As can be seen from FIGS. 1 and 2, the housing engages with a substantially cylindrical outer area 84 around the stylus pins 80. They rest on the inner wall of this outer area 84. In addition, the housing has an inner area 86. In this, a thread is provided for an M4 hexagon socket screw. Between its head and the base part of the inner portion 86 of the housing 82 is a silicone ^¬ ring 89, the elastic in the shown embodiment as a disc-shaped rubber ^¬ element is used. The head of the screw 88 presses this silicone ring 89 via an interposed disc. If the screw 88 is tightened more or less, the silicone ring 89 is pressed outward, it presses against the inward-looking partial areas of the individual stylus pins 80 and presses them outward , against the inner wall of the outside area. In this way, the styli 80 are more or less fixed.

2, the silicone ring 89 is practically not in contact with the stylus 80, so the screw 88 is not tightened. In this state, the styli 80 can move as the bores 83 in the housing 82 allow. If the screw 88 is now tightened, there is a clamping, the currently existing individual position of each individual stylus 80 is recorded.

The following occurs in practical use: The erfindungsge ^¬ Permitted device is inserted into a middle ear. The free ends of the stylus pins 80 form a circular line around the stapes footplate 38 (FIG. 4) in accordance with the later position of a middle ear prosthesis. Either by gravitation alone or by light pressure, for example with the fingers, all styli 80 are brought into contact with the tympanic wall. This position of the individual styli 80 is now fixed by tightening the screw 88. The course of the free ends of the styli 80 now reflects the course of the circular line around the stapes footplate 38. In accordance with this course, a coupling part 28 of a middle ear prosthesis can be milled or otherwise machined.

As can be seen from FIGS. 1 and 2, a handle 91 is attached to the outer area 84. It is so angled and designed such that the ge ^¬ entire device may be a hand held comfortably outside the ear, on the other hand, the handle 91 does not interfere. The design of the hand ^¬ handle ansich arbitrary.

A through hole 93 is provided in the screw 88. The tube 97 of an observation lens is pushed through it. In this way, the positioning of the device according to the invention for the stapes footplate 38 can be monitored precisely.

As Figure 2 shows, the tactile pins, 80 at its outboard end has a substantially T-shaped form, so a projection 95. It prevents the individual feeler pins 80 freely housing by its respective bore in the Ge ^¬ 82 can fall down. In another embodiment not shown the handle 91 is omitted in the region of the housing 82 and / or the screw 88 is a Klemmvor ^¬ direction provided for the tube 97 of the observation device, it can work similarly to the clamping device with silicone ring 89 for the tactile pins.

How inventive device is used for better understanding and context in which it is beneficial, is described below a middle ear prosthesis, for the same day and for the ^¬ same applicant filed a patent application has been filed with the term "middle ear prosthesis." The content of this patent application is part of the disclosure content of the present patent application.

The middle ear prosthesis has an artificial eardrum 20, the surfaces in wesentli ^¬ has an oval blank. In terms of area, it is larger than the area of a normal human eardrum, for example 1.5 times as large. It is cut from a material that is biologically suitable for use as a prosthesis.

The eardrum 20 is tightly connected to a two-part housing, specifically it is connected to a transmission part 22. This is essentially tubular. It has an essentially cylindrical region, which is shown at the bottom in FIG. 3, and a region which widens from it and runs essentially on a conical ^surface . The diameter of the cylindrical area is about 6 mm, the widening area has corresponding dimensions of about 11 mm. As Figure 3 shows, is the tympanic membrane 20 in a plane, they ver ^¬ runs at an angle 37 ° to a longitudinal axis 23 of the transfer member 22. Due to the inclined position of the eardrum 20, the eardrum 20 has a relation to the normal ear larger area.

On the inside of the eardrum 20, preferably in the surface means ^¬ point, a second ossicle part 24 is permanently attached. In the specific exemplary embodiment, a commercially available ossicle replacement from Ri ^¬ chards GmbH is used. He has close to the eardrum 20 a Kugelge ^¬ steering, below that is a hollow shaft for receiving a first to be discussed Ossikelteils. The second ossicle part 24 runs below the ball joint centrally to the central axis of the transmission partly 22.

Furthermore, the housing includes a coupling part 28. Overall, it is somewhat smaller than the transmission part 22 and, together with it, is designed such that both parts can be connected to one another simply, tightly and permanently, in particular by plugging in the longitudinal direction and gluing. The coupling part 28 is essentially cylindrical, its diameter is also about 6 mm. It has a free end region 30 which has a course which is modeled as closely as possible to the respective individual relief of the tympanic wall of a wearer of the middle ear prosthesis. As already explained above, there are several methods for determining or scanning the course of the individual relief of the timpani wall. For this purpose, reference is also made "of a middle ear mechanical device for scanning and detecting the profile of the eardrum wall" of the same applicant and the same filing date of the patent application, the disclosure of this application is the subject of the present application open ^¬ barung made.

The free end region 30 is accordingly designed such that it lies precisely against the timpani wall 32, as can be seen from FIG. 3. In this way, a hermetically sealed closure is possible at this point; low-viscosity fastening and sealing material can be used in order to realize the connection between the free end region 30 and the tympanic wall 32.

In the coupling part 28 a holding device 34 is provided for the first ossicle part ^¬ 26th The latter is designed as a thin gold wire which extends through a very small, artificially created opening 36 in a stapes footplate 38 and thus projects with its lower, free end region into the inner ear 40. In the illustrated exporting approximately ^¬ example, the holding means 34 is a substantially diagonally running ver ^¬ wire on which the first ossicle part 26 is fixed is fixed respectively. During implantation, the middle ear prosthesis is the Halteeinrich ^¬ tung cut 34, so that is connected to the second ossicle part 24 ver ^¬ Thematic first ossicle part 26 freely reciprocated by it and can reciprocate.

In the embodiment of the middle ear prosthesis shown here, the connection of the two ossicular parts 24, 26 and also for the penetration NEN of the holding device 34 requires access to the interior. ^Other constructions without such access are possible. For this access, a window 42 is provided in the transmission part 22, which can be closed by a cover plate 44.

As FIG. 3 shows, the cover plate 44 has a connection 52. It is provided for a hose 54. The hose 54 leads to an inner part 56 of a pressure compensation device. This inner part 56 is designed as a can-shaped housing, it has two chambers, namely an outer chamber 58 and an inner chamber 60. Both are hermetically separated from one another by a very flexible membrane 52. In another embodiment, they are separated from one another by a fine filter 63, which is also tight against bacteria and microbes but is air-permeable. Hollow fiber filters are particularly suitable as fine filters 63, see FIG. 3.

Via a further hose 64, the outer chamber 58 is connected to an outer part ^¬ 66th It is anchored in a bone 76 and partially accessible from the outside, see skin 78. A construction is used here that is similar to so-called bone-conducting hearing aids. The Au ^¬ ßenteil 66 has a recess 68 into which a filter is inserted 70th The ^¬ ses is preferably replaceable. The filter 70 prevents water, coarse dirt, etc. from getting into the hose 64. The barrier against germs and the like is reached by the membrane 62 or the fine filter taking its place.

Claims

Description: Device for mechanically scanning and recording the course of the tympanic wall of a middle ear along a line

1. Device for mechanically scanning and detecting the course of the tympanic wall of a middle ear along a line (81), preferably a ^¬ he O-shaped line (81), around the oval window,

- are provided with a plurality of thin, elongated probe pins (80) paral lel to one another and ^¬ arranged along the line (81),

- having a housing (82), on the one hand has an outer region (84) surrounds the feeler pins (80) on the outside and at the other one located in ^¬ nerhalb the line (81) of the feeler pins (80) Interior (86) and

- With a clamping device that fixes the stylus (80) in its clamped position and allows movement of the stylus (80) in its longitudinal position in its release position.

2. Device according to claim 1, characterized in that the housing ^¬ se has a guide area in which the styli (80) are guided in their longitudinal direction.

3. Device according to claim 1, characterized in that the ^feeler pins (80) have at one end a projection (97), which is in particular designed as a thickening, development, and which prevents the guide ^pins from moving downward can slip out of the management area.

4. The device according to claim 1, characterized in that the ^tactile pins (80) are identical to one another.

5. The device according to claim 1, characterized in that the clamping ^¬ device and the inner portion (86) having a central, through hole (93) through which inserted an optical observation device, especially a device similar to an endoscope (tube 97), through can be.

6. Device according to claim 4, characterized is that the Obs ^¬ caution device releasably connected to the clamping device and / or the inner portion (86) of the housing (82).

7. The device according to claim 1, characterized in that the ^feeler pins (80) are arranged one behind the other on the line (81).

8. The device according to claim 1, characterized in that the ^feeler pins (80) have a round or non-circular cross section.

9. The device according to claim 1, characterized in that the ^feeler pins (80) have a bluntly designed free front end region.

10. The device according to claim 1, characterized in that the clamping ^¬ device contains a disc-shaped, rubber-elastic element which rests with its outer edge on the stylus (80) and that the clamping device further comprises a clamping means, in particular a clamping ^¬ screw, which is assigned to the rubber-elastic element and compresses it more or less, so that it extends more or less outwards towards the feeler pins (80) and presses them more or less against a guide area and clamps them.