EP2701629A1

EP2701629A1 - Medical tool and method for producing a medical tool

Info

Publication number: EP2701629A1
Application number: EP12758998.4A
Authority: EP
Inventors: Dieter Frauenfeld; René DRAHEIM
Original assignee: Geuder AG
Current assignee: Geuder AG
Priority date: 2011-07-13
Filing date: 2012-07-11
Publication date: 2014-03-05
Also published as: US9474646B2; US20140128879A1; DE102011107676A1; WO2013007255A1

Abstract

The invention relates to a medical tool, in particular a hollow needle for an ophthalmological surgical instrument for the in-vivo fragmentation of organic lenses using ultrasound, comprising a functional part (1) and a connecting part (2). The connecting part (2) has handling means (3) and is used to removably connect to a handle. The invention is characterized in that the condition of the handling means (3) changes when connecting/releasing the tool to/from the handle and/or when reprocessing the tool, for example when sterilizing the tool. For example, the color or transparency of the handling means (3) changes. The handling means (3) can further become visibly damaged while connecting or releasing the instrument. The aim of the invention is to ensure only one-time use. The invention further relates to a method for producing a corresponding medical tool.

Description

MEDICAL TOOL AND METHOD FOR

MANUFACTURE OF A MEDICAL TOOL

The invention relates to a medical tool, in particular a hollow needle for an ophthalmological instrument for in vivo disintegration of organic lenses by means of ultrasound, with a functional part and a connecting part, wherein the connecting part has handling means and serves for releasable connection to a handle. Furthermore, the invention relates to a method for producing a corresponding medical tool.

Medical tools of the type in question have been known for years from practice. In concrete terms, such a medical tool can be, for example, an ultrasound-actuated hollow needle for an ophthalmological surgical instrument. By way of example, reference is made here to DE 10 2008 023 967 A1.

Ultrasonic operated hollow needles are used in cataract surgery in ophthalmic surgery to destroy the lens. The free end of the hollow needle - the functional part - is placed in a high-frequency axial movement and brought directly to the cataract. From the functional part ultrasonic waves are emitted to emulsify the tissue. Separated lens debris are aspirated through the hollow needle with a liquid supplied to the eye. The medical tool must be connected via a connector with a handle before the operation. If the medical hand-held device is an ultrasonically operated eye-surgical hollow needle, then it is connected to a handle which stimulates the functional part to vibrate and aspirate lens debris. Furthermore, it is known from the prior art that the connection part of the tool has handling means. To connect the tool in the simplest possible way with the handle, it can be taken to the handling means. The handling means are formed integrally with the attachment part. In order for the patient to recover as quickly as possible after an operation, an attempt is made to perform the procedure with minimal trauma. For example, reference should be made here to the hollow needles used in eye surgery, which are designed to be extremely small. The trend in development is towards ever smaller geometries and lumens of the tools or hollow needles. However, the problem here is that the reprocessing or sterilization of tools once used can not be reliably performed due to the small geometries and lumens. Thus, there is a realistic risk of cross-contamination for the patient if the tool has already been used and subsequently not properly sterilized. Diseases such as hepatitis or HIV can be transmitted in this way.

Another problem is that due to the small geometries of the tools material fatigue occur, which can even lead to breakage of the tool in extreme cases. Especially with tools - such. As ophthalmic surgical needles - which are set in vibration, safe multiple use is therefore not possible. The risk of injury to the patient is too high for a multiple use of prepared tools.

The present invention is therefore based on the object, a medical tool of the type mentioned in such a way and further develop that with simple handling ensures a safe for the patient always functioning and the risk of cross-contamination is minimized. In addition, a method for producing such a medical tool is to be specified.

According to the invention the above object is solved by the features of claim 1. Thereafter, the medical tool in question is characterized in that changes the nature of the handling means when connecting / disconnecting the tool with / from the handle and / or when reprocessing the tool. With regard to the method according to the invention, the aforementioned object is solved by the features of patent claim 12. Thereafter, the method according to the invention is characterized in that the handling means are applied by injection molding or by a three-dimensional printing process on the already manufactured connection part.

In accordance with the invention, it has been recognized that the underlying object can be achieved in a surprisingly simple manner by a clever design of the handling means. For this purpose, the handling means are designed such that changes the nature of the handling means when connecting or disconnecting the tool with or from the handle or when reprocessing the tool. It should be noted at this point that the term constitution is to be understood in the broadest sense. In this case, any property of the holding means is included, which can be perceived by the user of the medical tool. By this structural design of the handling means an undesirable multiple use of the tool is prevented in a surprisingly simple manner. The change in the nature of the holding means can be triggered, for example, by connecting or disconnecting the tool with or from the handle. This automatically indicates whether the tool has already been used. Furthermore, the change in the holding means can be triggered by a - whatever - reprocessing of the tool. The operator is always indicated by the nature of the handling means, whether the tool can be used for medical intervention. The risk of infection and injury emanating from the medical tool is reduced by the embodiment according to the invention to a minimum.

In terms of design, it is of particular advantage if the handling means at least partially enclose the connecting part radially. In a further advantageous manner, the handling means completely surround the connection part, so that the handling means are always visible independently of the radial orientation of the tool. The surgeon always has an ideal view of the handling means and their nature. A change in the condition is easy to recognize for the surgeon. With regard to a secure connection between the handling means and the connection part, it is conceivable for the connection part to have a recess and the handling means to have a projection corresponding to the recess. The recess on the connecting part can be designed, for example, in the form of a groove which extends in the longitudinal direction of the tool. The survey of the handling means is then formed correspondingly elongated and extends in the recess of the connecting part. By this constructive measure, the handling means are non-rotatably arranged on the connection part. Furthermore, it is conceivable that the handling means have a recess and the connecting part have a corresponding with the recess elevation. It is also possible to provide a plurality of recesses or elevations on the connection part and on the handling means, which have any desired geometries. In order to secure the handling means in the longitudinal direction of the tool, the recess may be designed, for example, as a groove extending radially around the connecting part.

Advantageously, the handling means are designed such that changes their visual quality in a preparation or sterilization of the tool. In this case, any type of reprocessing or sterilization is conceivable, such as steam sterilization, hot air sterilization, chemical sterilization, radiation sterilization, plasma sterilization etc. For this purpose, the handling means may be made of a material that recognizes, for example, its color and / or its transparency in a reprocessing changes. Any change in the optical properties of the handling means which can be recognized by the surgeon is conceivable here. Even during operation operation can thus be easily determined whether the tool is used for the first time. It is also conceivable that the handling means are coated with a material which has corresponding properties - for example lacquered -.

Furthermore, the handling means may be designed to be damaged during reprocessing or sterilization of the tool. Any type of reprocessing or sterilization is conceivable, such as steam sterilization, hot air sterilization, chemical sterilization, Radiation sterilization, plasma sterilization, etc. For example, the handling means may be made of a material that melts when heated. This makes it easy for the surgeon to see if the tool has already been used and reprocessed or sterilized. It is also conceivable that the handling means are coated, for example painted, with a material which has corresponding properties. The use of remanufactured tools and the associated risks for the patient is thus prevented. To easily attach the tool on the handle, the handling means can serve as a point of attack for a clamping tool. The handling means can for this purpose have a polygonal cross-section, for example the shape of a hexagon nut. Furthermore, the surface of the handling means may have any contour or recesses, so that the clamping tool can engage the handling means.

In a further advantageous manner, the handling means can be designed such that they are recognizably damaged upon connection to or release from the handle by the clamping tool.

To simplify the handling of the tool, it is of particular advantage if the handling means have a coding that identifies the tool. The coding can be realized, for example, by a specific shape or geometry or a specific color of the handling means. Different geometries or different lumens of the tool can be characterized in this way with little design effort. Since these are often small tools, the handling of the tool is significantly simplified by the coding of the handling means.

In a particularly advantageous manner, the handling means as an attenuator influence the vibration behavior of the tool. For example, if the tool is an ophthalmic surgical instrument that uses Ultrasound is applied, the vibration behavior can be selectively influenced by the handling means.

With regard to the method according to the invention, the same statements apply as to the medical tool according to the invention. In addition to the above statements, it should be mentioned that it is advantageous if the handling means are applied by injection molding or by a three-dimensional printing process to the already produced connection part. The tool can thus be produced, for example, initially by machining or deformation, and then the handling means are applied to the connection part. The handling means are manufactured in the manner according to the invention by injection molding or by "growth" of material onto the connection part, thereby producing a firm connection between the handling means and the connection part, so that the handling means does not readily, especially not without visible destruction let loose the connection part.

There are now various possibilities for designing and developing the teaching of the present invention in an advantageous manner. For this purpose, on the one hand to the claims subordinate to claim 1 and on the other hand to refer to the following explanation of a preferred embodiment of the invention with reference to the drawings. In conjunction with the explanation of the preferred embodiment of the invention with reference to the drawing, generally preferred embodiments and developments of the teaching are explained. In the drawing show

1 is a schematic representation of an embodiment of a tool according to the invention in a partially sectioned side view,

2 shows a schematic representation of the tool according to the invention from FIG. 1 in a side view, the handling means being detached from the connecting part and FIG Fig. 3 is a schematic representation of the tool according to the invention from Fig. 1 in a perspective view, wherein the handling means are released from the connection part.

Fig. 1 shows a schematic representation of an embodiment of a tool according to the invention. The tool is designed here as a hollow needle for an ophthalmological instrument for the in vivo-Zertmmerung organic lenses by means of ultrasound. The hollow needle has a functional part 1, which is introduced into the eye and placed in a high-frequency axial movement in order to smash the lens tissue. Furthermore, a connection part 2 is provided with which the hollow needle can be releasably connected to a handle. At the connection part 2, the handling means 3 are provided. The handling means 3 are applied by injection molding to the connection part 2. The handling means change their nature when connecting the tool with or releasing the tool from the handle or when reprocessing the tool. In order to fix the handling means 3 in the longitudinal direction of the hollow needle, the attachment part 2 has a first recess 4 into which a first elevation 5 of the handling means 3 engages.

In Fig. 2, the tool according to the invention of Fig. 1 is shown in a side view. For better clarification of the construction, the handling means 3 are shown detached from the connection part 2. From Fig. 2 it can be clearly seen that the connection part 2 has a second recess 6 in the form of a groove. The second recess 6 extends in the longitudinal direction via the connection part 2. The handling means 3 have a corresponding to the second recess 6 survey. As a result, the handling means 3 are also secured in the radial direction against slipping. On the surface of the handling means 3 recesses 7 are provided, which serve as a point of attack for a clamping tool. The hollow needle can be firmly screwed onto the handle with the aid of the clamping tool, the handling means 3 being secured against radial slippage by the second recess 6 and the corresponding elevation of the handling means 3. Fig. 3 shows the tool according to the invention from Fig. 1 in a perspective view, wherein the handling means 3 are shown detached from the connector part 2. 3 makes it clear that the handling means 3 completely surround the connection part 2 radially. The handling means 3 are applied to the connection part 2 in an injection-molding process and serve as a point of application for a clamping tool 3.

In the following, the handling of the tool will be explained using the example of the hollow needle according to the invention shown in FIG. 1 to FIG. 3. The operator selects the desired hollow needle, wherein the handling means 3 are of particular importance, since they encode the hollow needle by their color or shape. The surgeon can thus recognize the "correct" hollow needle on the handling means 3. The handling means 3 has a further significance The surgeon can see, with a glance at the handling means 3, whether the tool has already been connected to a handle or already If the nature of the handling means 3 does not show any changes, the hollow needle is screwed tightly to the handle with its attachment 2. For this purpose, a clamping tool is used which acts on the depressions 7 of the handling means 3. The surgeon thus has the option It is easy to determine if the cannula has already been used, minimizing the risk of infection and injury to the patient.

With regard to further advantageous embodiments of the device according to the invention, reference is made to avoid repetition to the general part of the description and to the appended claims.

Finally, it should be expressly pointed out that the above-described embodiments of the device according to the invention are merely for the purpose of discussing the claimed teaching, but do not restrict it to the exemplary embodiments. LIST OF REFERENCE NUMBERS

1 functional part

2 connection part

3 handling means

4 first recess

5 first survey

6 second recess

7 deepening

Claims

1. A medical tool, in particular hollow needle for an ophthalmological instrument for the in vivo destruction of organic lenses by means of ultrasound, with a functional part (1) and a connecting part (2), wherein the connecting part (2) has handling means (3) and the releasably connecting with a handle,

That is, the nature of the manipulating means (3) changes when the tool is connected / disconnected with / from the handle and / or when the tool is reprocessed.

2. Medical tool according to claim 1, characterized in that the handling means (3) at least partially surround the connection part (2) radially.

3. Medical tool according to claim 1 or 2, characterized in that the connecting part (2) or the handling means (3) has a recess (4, 6) and the handling means (3) or the connecting part (2) with the recess ( 4, 6) corresponding elevation (5), so that the handling means (3) are inhibited against slipping on the connecting part (2).

4. Medical tool according to one of claims 1 to 3, character- ized in that the handling means (3) are made of a material, for example of a plastic or resin, which in a reprocessing or sterilization of the tool its optical nature, preferably the color or transparency, changed.

5. Medical tool according to one of claims 1 to 3, characterized in that the handling means (3) are coated with a material, such as a plastic or resin, which in a reprocessing or sterilization of the tool its optical condition, preferably the color or Transparency, changed.

6. Medical tool according to one of claims 1 to 5, characterized in that the handling means (3) are made of a material, for example of a plastic or resin, which is damaged in a reprocessing or sterilization of the tool, for example, melts.

7. Medical tool according to one of claims 1 to 5, characterized in that the handling means (3) are coated with a material, such as a plastic or resin, which is recognizable damaged during a reprocessing or sterilization of the tool, for example, melts ,

8. Medical tool according to one of claims 1 to 7, characterized in that the handling means (3), for example, by a polygonal cross-section of the handling means (3), are designed as a point of attack for a clamping tool.

9. Medical tool according to claim 8, characterized in that the clamping tool the handling means (3) when connecting / disconnecting the tool with / from the handle damage recognizable.

10. Medical tool according to one of claims 1 to 9, characterized in that the handling means (3) have a tool identifying the coding, for example, a specific color or geometry, have.

1 1. A medical tool according to one of claims 1 to 10, characterized in that the handling means (3) take as an attenuator influence on the vibration behavior of the tool.

12. A method for producing a medical tool, in particular hollow needle for an ophthalmological instrument for in vivo fragmentation of organic lenses by means of ultrasound, with a functional part (1) and a connecting part (2), wherein the connecting part (2) has handling means (3) and is used for releasable connection to a handle and wherein the nature of the handling means (3) when connecting / disconnecting the tool with / from the handle and / or reprocessing of the tool changes, in particular for the production of a medical tool according to one of the claims until 11,

dadu rch geken nzeich net, that the handling means (3) by injection molding or by a three-dimensional printing process on the already manufactured connection part (2) are applied.