WO2008122386A1

WO2008122386A1 - Vibration instrument for placing a connecting element

Info

Publication number: WO2008122386A1
Application number: PCT/EP2008/002595
Authority: WO
Inventors: Walter Mössle; Micha Mayer
Original assignee: Kaltenbach & Voigt Gmbh
Priority date: 2007-04-04
Filing date: 2008-04-01
Publication date: 2008-10-16
Also published as: DE102007016323A1

Abstract

The invention relates to a vibration instrument for placing a connecting element in a porous basic material. At least part of the connecting element is made of a material that can at least partly be brought into a liquid state by supplying mechanical energy. The vibration instrument comprises means for generating mechanical energy, e.g. in the form of ultrasound, which can be transmitted to the connecting element such that the connecting element is at least partly brought into a liquid state by means of said energy. In the liquid state, part of the connecting element can penetrate into the porous basic material such that a stable connection is created. According to the invention, the vibration instrument is designed to discharge power discharged in the form of mechanical energy in a continuously modifiable manner. For example, the time curve of the discharged power (20) can gently rise at the beginning of a connecting process, which can be achieved especially by means of a continuously modifiable amplitude (22) of the discharged vibrational energy.

Description

Vibrating instrument for setting a connecting element

The invention relates to a vibrating instrument for setting a connecting element in a porous base material, wherein the connecting element consists at least partially of a material which can be at least partially brought into a liquid state by supplying mechanical energy. The vibrating instrument in this case has means for generating mechanical energy, which can be transmitted to the connecting element, so that thereby the connecting element is at least partially brought into a liquid state. Furthermore, the invention relates to a method for setting a corresponding connecting element in a porous base material. The method has the following step: transmission of mechanical energy to the connecting element such that thereby the connecting element is at least partially brought into a liquid state.

From WO 02/069817 Al a device and a method for connecting tissue parts is known. In the method, an implant is used, which is positively connected to a porous tissue part. The implant consists at least partially of a material that can be liquefied by mechanical energy. To produce the connection, a device with a vibration unit is used with which mechanical vibrations, for example in the ultrasonic range, can be transmitted to the implant. Simultaneously with the transmission of the mechanical energy, the implant is pressed against the porous tissue part. In this way, the implant is at least partially liquified and penetrates into the pores of the tissue. Subsequently, the supply of mechanical energy is stopped and the material solidifies again. The compound thus obtained is characterized in particular by very good stability.

In Fig. 3, the front portion of a vibrating instrument can be seen, which is suitable for carrying out such a method. The vibrating instrument is formed in handpiece shape and can generate vibrations in the ultrasonic range. One recognizes the front region of a grip part 2 and a sonotrode 4 with which the ultrasonic vibrations can be transmitted to a connecting element in the form of a pin-shaped implant 6. The implant has a "head 8, which serves as a connection region to the sonotrode 4.

In making such a connection with such an instrument, however, the head 8 of the implant 6 may begin to soften faster than desired. This can mean that the implant can be pressed less strongly against the base material and the material feed into the porous base material is accordingly not achieved to the desired extent.

Furthermore, there is a risk that in the connection region, the connecting element 6 bonded to the sonotrode 4. It is known in this context to make the implant so that it is in the connection region to the sonotrode of a material that is not liquefiable. In this case, the implant thus consists of at least two different materials. However, this is associated with increased effort in the manufacture of the implant. In addition, there are cases where it is desirable for the implant to be made of a biodegradable material. Also in this case, it is generally advantageous if the implant consists of only one material.

The invention is based on the object to improve a corresponding vibration instrument and a corresponding method. In particular, the reliability is to be increased, with which a connection of certain stability can be achieved.

This object is achieved according to the invention with the objects mentioned in the independent claims. Particular embodiments are specified in the dependent claims.

According to the invention is provided in vibrating instrument for setting a connecting element in a porous base material, wherein the connecting element consists at least partially of a material which are brought by supplying mechanical energy at least partially in a liquid state can. The vibration instrument in this case has means for generating mechanical energy, which can be transmitted to the connecting element, so that thereby the connecting element is at least partially brought into a liquid state. The vibrating instrument is designed to deliver a continuously variable output in the form of mechanical energy power.

The connecting element may be a pin-shaped connecting element, which preferably has at one end a thickened head area, which is provided as a connecting area to the vibration instrument. In this sense, such a connecting element is hereinafter also referred to as "pin" with "head.

The fact that the power can be output continuously variable with the vibration instrument, the energy input to the connecting element can be controlled so that the risk of premature melting of the connecting element in the connection region to the vibration instrument - as for example at the head of a pin - can be reduced. Furthermore, this is advantageous with respect to the development of the heat that arises during the bonding process in the porous base material. This heat can be reduced by the constantly variable power output, because the amount of energy introduced, not for the liquefaction of the

Connecting element contributes and is only converted into heat, can be reduced in this way.

It is particularly advantageously provided that the power can be output continuously variable starting from zero. In this way, at the beginning of setting of the connecting element, ie in the starting phase of the connecting process, a "soft" start can be achieved with which a premature melting in the connecting region can be prevented in a particularly effective manner.

Advantageously, it is provided that the continuous change of the output power can be effected by a continuous change in the amplitude and / or the frequency of vibrations of the vibration instrument. It can thus be provided, for example, that at a constant frequency, the amplitude can be changed continuously. It can also be provided that at a constant amplitude the frequency can be changed constantly. It can also be provided that both the frequency and the amplitude can be changed continuously.

Advantageously, it is provided that the output power can be changed continuously starting from zero to a predetermined value. The predetermined value may be selected depending on the shape and size, as well as the material of the connecting element.

Advantageously, the vibration instrument is designed to generate mechanical energy in the form of vibration energy, preferably in the form of ultrasound. It can be provided that the vibration instrument comprises a sonotrode with which the vibration energy can be transmitted to the connecting element.

Advantageously, the vibration instrument is designed in handpiece shape. It may be provided that the vibration instrument has a handle portion with a front and a rear end portion, and a supply hose, which is connected for example at the rear end portion with the handle portion and are arranged in the supply lines for media, which are required for operation of the vibration instrument , Optionally, the sonotrode can be arranged at the front end region of the handle part.

Advantageously, the connecting element is at least partially, preferably completely made of a thermoplastic material.

The connecting element may be a connecting element for surgical use.

Advantageously, it is provided that the vibration instrument has a self-test function, in particular the function of the vibration instrument with respect to functionality and possible electrical short circuits can be tested, each optionally with reference to a handpiece, a sonotrode and a supply hose of the vibration instrument. It can be provided that the self-test function automatically when switching the vibration instrument is executed and preferably can also be called manually.

Furthermore, it is advantageously provided that the vibration instrument has a memory function for storing a value of a delivered power, in particular a power that has been delivered during a connection process. This can serve, for example, in the surgical field of a functional check after completion of an operation. Advantageously, the vibration instrument further comprises a transmitting unit for the wireless transmission of a stored value of a delivered power.

Advantageously, the vibration instrument has means for storing a plurality of predefined values for a power to be delivered. In this way it becomes possible, for example, depending on the shape, the size and the material of a connecting element, to set a useful for the intended connection value in a user-friendly manner in advance.

Further advantageously, the vibration instrument has means for illuminating an environment of a region of the vibration instrument which is provided for contacting with the connection element, for example optionally an environment of a front end region of a sonotrode of the vibration instrument. In this way, the area of the intended connection can be illuminated.

Further advantageously, the vibration instrument has means for dispensing a cooling medium for cooling the connecting element or its surroundings.

Advantageously, the vibration instrument further comprises means for manually changing the output power. For example, it may be provided that the amplitude and / or the frequency of vibrations during a connection process is manually continuously variable. For example, if appropriate, an operating element can be provided on a grip part of the vibration instrument for this purpose.

Advantageously, the vibration instrument further comprises a sound transducer and a sonotrode, wherein the sonotrode is adapted to one of the sound transducer receive transmitted mechanical energy to the connecting element. The sonotrode can be designed as a hollow body. This allows a particularly good vibration characteristics. The transmission of the mechanical energy or the vibration energy to the front end region of the sonotrode or to the "distal" end of the sonotrode can be realized in this way with particularly good efficiency.

The sonotrode advantageously has a holder for the connecting element at its distal end region. The holder may for example comprise a pin-shaped projection which can engage in a correspondingly congruent opening in the connecting element, for example in the head of a pin.

Further advantageously, the sonotrode is overall elongate and has a contacting region for contacting with the connecting element, which is formed asymmetrically to the main axis of the sonotrode. In this way, for example, in the case of surgical applications, the handling of the vibrating instrument can be facilitated, especially in the case of difficult to access preparation areas.

According to a second aspect of the invention, a method is provided for placing a connecting element in a porous base material, wherein the connecting element consists at least partially of a material which can be at least partially brought into a liquid state by supplying mechanical energy. The method has the following step: transmission of mechanical energy to the connecting element such that thereby the connecting element is at least partially brought into a liquid state. In this step, a power given off in the form of mechanical energy is emitted continuously changed.

Advantageously, in the said step, the power delivered in the form of mechanical energy is emitted continuously from zero starting from zero.

Advantageously, in the said step, the continuous change of the output power by a continuous change in the amplitude and / or the frequency of Vibrations of the vibration instrument causes.

Advantageously, the power is continuously changed from zero to a predetermined value at said step.

Advantageously, the mechanical energy is generated in the form of vibration energy, preferably in the form of ultrasound.

The invention is explained in more detail below with reference to an embodiment and with reference to the drawings. Show it:

1 shows a diagram in which the time profile of the power, the amplitude and the energy in a connection process according to the invention is shown by way of example,

2 a sonotrode of a vibration instrument according to the invention,

Fig. 3 is an illustration of the front portion of a

Vibration instrument with attached pin, and

Fig. 4 shows the instrument shown in Fig. 3 in making a connection of the pin with a porous base.

FIGS. 3 and 4 depict the front region of a vibration instrument. As already briefly described above, the front region of a grip part 2 can be seen, a sonotrode 4 and a connecting element in the form of a pin 6 with a head part or short head 8. The pin 6 has an elongated overall shape. The head 8 is arranged on an end region of the pin 6 and represents a thickening of the pin 6. In the states depicted in FIGS. 3 and 4, there is no external difference to a known vibration instrument. The vibrating instrument serves to set the pin 6 in a porous base material. In this case, a connection between the pin 6 and the porous base material is produced. The setting of the pin 6 represents in this sense a connection process.

FIG. 4 shows a state in which the pin 6 is partially inserted into such a porous base material 10 - here by way of example in the form of a block-like structure. As in the example shown, it may be provided that a hole is provided in the base material 10 into which the connecting element or the pin 6 can at least partially be used in the un-liquefied state.

As further illustrated by way of example in FIG. 4, it can be provided that the connecting element 6 serves as connecting means between a plate 12 or the like and the porous base material 10.

In the surgical field, for example, as a porous base material human or animal tissue, so for example spongiosa of a bone may be provided.

The connecting element or the pin 6 is at least partially made of a material that can be brought at least partially by supplying mechanical energy in a liquid state. In the example shown, the pin 6 is made entirely of such a material. The material may be a thermoplastic.

The vibrating instrument has means for generating mechanical energy which can be transmitted to the pin 6, thereby at least partially bringing the pin 6 into a liquid state. In the example shown, the vibration instrument is designed to generate vibrations in the form of vibrations in the ultrasonic range in a manner known per se.

As also known per se, the sonotrode 4 serves to transmit the generated vibrations to the pin 6. For this purpose, it may be provided, for example, that at the front end - using medical parlance, ie at the distal end - the sonotrode has a holder with a small pin-shaped projection 14 is arranged, which can engage in a corresponding opening in the head portion 8 of the pin 6. In the illustration shown in Fig. 3, the pin 6 is made of a transparent material, so that this approach 14 can be seen in a translucent manner.

According to the invention, the vibrating instrument is designed to emit continuously variable power delivered in the form of mechanical energy. 1 shows, by way of example, a chronological progression for the variables power, amplitude and energy, as it can occur during a setting of the pin 6 according to the invention, in short "connection process." In the example shown, over a period of approximately seven Seconds (7200 ms) of energy delivered by the vibrating instrument, the abscissa represents the time t and the ordinate the values of power 20, amplitude 22 and power 24.

The curve 20 thus reflects the time course of the power output by the vibration instrument. It can be seen that, for example, within the first second, the value of the output power changes continuously and in particular does not change abruptly. The same applies to the course of the amplitude 22.

It is particularly advantageous if, at the beginning of the connection process, the power delivered by the vibration instrument does not jump abruptly from zero to a specific value, but steadily increases from zero in the sense of a "soft start".

It can be provided that, with the frequency kept constant, the amplitude is increased starting from zero. In the further course, it can be provided that the output power is continuously variable by changing the amplitude and / or the frequency of the oscillations. In particular, it may be provided that the amplitude of the vibration vibration during the connection process can be controlled manually.

Furthermore, it can be provided that different power levels for the vibration instrument can be set beforehand for different, in particular different sized, pins by a user Implementation of an application can be set. This setting can be provided manually or programmable and storable.

Thus, it can be provided, in particular, that a specific power value can be set in advance and "fine dosing" is manually possible, for example, the vibration instrument can be designed in handpiece form and have a corresponding operating element on the handle part of the handpiece.

FIG. 2 shows an exemplary embodiment of an overall elongated sonotrode 4 'with a main axis 36, a proximal end region 30 and a distal end region 32. The proximal end portion 30 is provided for connection to a front end portion of a handpiece 2.

At the distal end region 32, the sonotrode 4 'has a contacting region 34 for contacting with a pin 6 (not shown in this figure), this contacting region 34 being designed asymmetrically with respect to the main axis 36. The contacting region 34 comprises a comparatively short cylindrical formation on the main body of the sonotrode 4 ', on which in turn a small pin-shaped projection 14' is arranged, which is provided for engagement in a hole in the head of the corresponding pin 6.

The contacting region 34 has a contact surface 38, which is provided for abutment of the head 8 of the pin 6. The contact surface 38 in this case has a surface normal, which encloses an acute angle W with the direction of the longitudinal axis 36 pointing forwards or distally. The contact surface 38 extends to the front end face 40 of the sonotrode 4 '.

The illustrated angled shape of the sonotrode 4 'is particularly well when the environment of the intended junction is difficult to access. This may for example be the case in the surgical work environment.

The sonotrode 4 'is formed as a hollow body. This allows a particularly good vibration characteristics, ie the transmission of vibration energy to distal end portion 32 and the contacting region 34 is particularly low loss possible.

According to the exemplary embodiment shown here, the vibration instrument also has a self-test function with which the function of the entire instrument can be tested. If appropriate, such a function can be provided in particular for the components hand piece, sonotrode and connecting tube of the vibration instrument. In particular, a test for possible electrical short circuits can be provided.

It can be provided that the self-test function starts automatically when switching on the instrument and can also be started manually with the instrument turned on.

Furthermore, the instrument can have a memory function with which values of a power delivered during a connection process can be stored. This serves to check the function after production of one or more compounds. In the surgical environment, this can serve as a functional check after the end of an operation. Furthermore, the instrument may have means for radio transmission of the stored values.

Furthermore, it can be provided that the instrument has fixed power levels, which are provided for connections of different sized pins. It can be provided that these power levels can be set by a user programmable and storable.

Furthermore, the instrument can have a lighting unit for illuminating the distal end region of the sonotrode. The lighting unit can be arranged for example in or on the handpiece.

Furthermore, it can be provided that the instrument comprises means for supplying a cooling medium. In this case, an integrated controller for the supply of the cooling medium can be provided. Furthermore, the following can be provided:

• Temperature monitoring of the electronics

• integrated power switching at constant amplitude

• Monitoring of all functions by a controller or y controller • Galvanic isolation of a patient circuit directly in one

Output transformer (transformer)

• Power amplifier design as miniaturized half bridge

• Separate setting of upper and lower frequencies (e.g., 30kHz and 28.5kHz). • Specification of the amplitude by the controller

• Software updates through "on board" interface.

LIST OF REFERENCE NUMBERS

2 handle part

4, 4 'sonotrode

6 connecting element; Pin 8 Head of the connecting element

10 porous base material

12 plate

14, 14 'approach

20 temporal course of the output power 22 temporal course of the amplitude

24 temporal course of the energy delivered

30 proximal end of sonotrode 4 '

32 distal end of sonotrode 4 '

34 contacting area of the sonotrode 4 '36 main axis of the sonotrode 4'

38 contact surface of the sonotrode 4 '

40 front end surface of the sonotrode 4 '

Claims

claims

A vibratory instrument for setting a connecting element (6) in a porous base material (10), wherein the connecting element (6) consists at least partially of a material which can be at least partially brought into a liquid state by supplying mechanical energy, wherein the vibration instrument means for generating mechanical energy, which can be transmitted to the connecting element (6), so that thereby the connecting element (6) at least partially into a liquid

State is brought, characterized in that the vibration instrument is designed to be in the form of mechanical

Energy delivered power constantly changeable.

2. Vibration instrument according to claim 1, wherein the power starting from zero can be output continuously variable.

3. Vibration instrument according to claim 1 or 2, wherein the continuous change of the output power can be effected by a continuous change in the amplitude and / or the frequency of vibrations of the vibration instrument.

4. Vibration instrument according to one of the preceding claims, wherein the power can be varied continuously from zero to a predetermined value.

5. Vibration instrument according to one of the preceding claims, designed to generate mechanical energy in the form of vibration energy, preferably in the form of ultrasound.

6. vibration instrument according to any one of the preceding claims, wherein the instrument is formed in handpiece shape.

7. Vibration instrument according to one of the preceding claims, wherein the connecting element (6) at least partially made of thermoplastic

Plastic exists.

8. Vibration instrument according to one of the preceding claims, wherein the connecting element (6) is a connecting element for surgical use.

9. Vibration instrument according to one of the preceding claims, wherein the vibration instrument has a self-test function in which the function of the vibration instrument in functionality and possible electrical short circuits can be tested, each optionally with respect to a handpiece (2), a sonotrode (4) and to a supply hose of the vibration instrument.

10. Vibration instrument according to claim 10, wherein the self-test function automatically when turning on the

Vibrationsinstruments is performed and preferably can also be called manually.

11. Vibration instrument according to one of the preceding claims, with a memory function for storing a value of a dispensed

Power.

12. A vibration instrument according to claim 11, comprising a transmitting unit for wireless transmission of a value of a stored power.

13. Vibration instrument according to one of the preceding claims, comprising means for storing a plurality of predetermined values for a performance to be delivered.

14. Vibration instrument according to one of the preceding claims, further comprising means for illuminating an environment of a portion of the vibrating instrument, which is provided for contacting with the connecting element, for example, optionally an environment of the front end portion (32) of the sonotrode (4 ^' ) of the vibrating instrument.

15. Vibration instrument according to one of the preceding claims, further comprising means for discharging a cooling medium for cooling the

Connecting element (6) or its surroundings.

A vibratory instrument according to any one of the preceding claims, further comprising means for manually varying the output power.

17. Vibration instrument according to one of the preceding claims, further comprising a sound transducer and a sonotrode (4), wherein the sonotrode (4) is adapted to transmit a received from the transducer mechanical energy to the connecting element (6).

18. Vibration instrument according to claim 17, wherein the sonotrode (4) is designed as a hollow body.

19. Vibration instrument according to claim 17 or 18, wherein the sonotrode (4 ') at its distal end portion (32) has a holder, for example with a pin-shaped projection (14) for the connecting element (6).

20. Vibration instrument according to one of claims 17 to 19, wherein the sonotrode (4 ') as a whole is elongate and has a contacting region (34) for contacting with the connecting element (6), which is asymmetrical to the main axis (36) of the sonotrode (4'). is trained.

21. A method of placing a fastener into a porous base (10), said fastener (6) being at least partially made of a material that can be at least partially fluidized by the application of mechanical energy, the method comprising the step of:

(A) transmission of mechanical energy to the connecting element (6) such that thereby the connecting element (6) at least partially into a liquid

State is brought, characterized in that in step (a) a given in the form of mechanical energy power is emitted continuously changed.

22. The method of claim 21, wherein in step (a) the in the form of mechanical energy

Power is emitted from zero continuously changing.

23. A method according to claim 21 or 22, wherein at step (a) the continuous variation of the power delivered by a continuous change of the amplitude and / or the frequency of

Vibrations of the vibration instrument is effected.

A method according to any one of claims 21 to 23, wherein at step (a) the power is continuously varied from zero to a predetermined value.

25. The method according to any one of claims 21 to 24, wherein the mechanical energy is generated in the form of vibration energy, preferably in the form of ultrasound.