Device for removal of calculi

Surgery – Instruments – Means for concretion removal

Reexamination Certificate

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C606S127000, C604S022000

Reexamination Certificate

active

06511485

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to a device for removal of calculi by using an intracorporeal lithotripter in accordance with the introductory clause of claim
1
.
BACKGROUND OF THE INVENTION
When removing calculi from body hollows it becomes necessary in general to crash first in situ those calculi which although still suitable for allowing a natural exit or drainage exceed a predetermined size. It therefore will be necessary to crash or fragment any overdimensioned calculi and to generate particles of a more or less minute size to thereby allow such minimised particles to being spontaneously removed from the body hollow. The minimisation is carried out by acting on the calculi with compressive and tensional forces which in the field of intracorporeal lithotripsy are exercised with the distal end of a metallic probe serving as a wave guide. Such forces result in a blasting-off of fragments from the surface of a calculus for effecting its crashing. However, when fragmenting calculi in this way there exists in general the problem of providing suitable energy transport or energy transfer specifically to those calculi which are to be minimised by avoiding at the same time any disturbing and rather dangerous side effects on the human tissue which therefore should not serve as a backing during such a fragmentation of calculi.
The European Patent EP 0 421 285 B1 discloses a device for removal of calculi by using an intracorporeal lithotripter. The device comprises a metallic probe or sonotrode which by means of an electrically controlled ultrasonic transducer generates longitudinal oscillations. When inserted into the operating passage of an endoscope as used for a fragmentation of calculi the distal end of the metallic probe or sonotrode when in contact with the calculi will crash the same by the transfer of those longitudinal oscillations. The ultrasonic transducer is composed of piezoceramic discs which are arranged within a surrounding casing between a reflector and a horn that are fastened to each other. For periodically oscillating the sonotrode the piezoceramic discs are controlled by a circuit arrangement which comprises a voltage-controlled oscillator the output signal of which is supplied to the piezoceramic discs via an output amplifier and an output transmitter. The circuit arrangement comprises a phase comparator for comparing the phases of the output voltage and of the output current of the output transmitter for generating a control voltage of the oscillator. With a device of this kind it will be possible to crash calculi into very fine fragments with a particle size which in general will not create any problems in sucking-off the calculi fragments through an axial hollow of the sonotrode and extending at its proximal end to an interconnected suction duct which is passed through the ultrasonic transducer. Any minimisation of calculi by means of an intracorporeal lithotripter operating with an ultrasonic transducer must be considered, however, as relatively time-consuming since for a careful handling of the lithotripter at the distal end of the tubular sonotrode it will only be allowable to use ultrasonic frequencies of about 20 to 25 kHz with amplitudes of about 50 &mgr;m for avoiding any damages of the human tissue. There will also be exist certain complications with calculi of a harder consistency which will not allow any spontaneous peeling with such frequencies and amplitudes at the tip of the sonotrode. The operational treatment will accordingly either last very long or will even be impossible.
The European Patent EP 0 317 507 B1 discloses a lithotripter comprising a metallic probe the proximal end of which is arranged for being hit periodically by a pneumatically driven impact member or projectile resulting in an impact energy which is transported along the metallic probe as far as to its distal end so that any calculus when contacted with the tip of the probe will be fragmented under the action of shock or pressure waves. Such shock or pressure wave lithotripters which with alternative designs may also be provided with an electric drive for the impact member or projectile are constructed in general as relatively simple units having nevertheless very high efficiencies with the fragmentation of calculi although it has to be conceded that the handling of such shock or pressure wave lithotripters is still somewhat time-consuming in the context of providing particles that may be spontaneously sucked-off.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a device for removal of calculi by using an intracorporeal lithotripter which will allow a more flexible fragmentation of calculi under consideration of the advantages and the disadvantages of the presently known methods when using lithotripters of the kind as above described.
In accordance with the present invention a device for removal of calculi by using an intracorporeal lithotripter of the kind as referred above is provided which is characterised by the features of the claims.
The present invention offers the possibility that by a combination of a metallic probe or sonotrode that is activated by an electrically controlled ultrasonic transducer on the one side and of an impact probe on the other side which is periodically hit by an impact member or projectile as both united in only a single device an alternative fragmentation of calculi may be exercised by simply switching-on either the electrical control of the ultrasonic transducer or the reversible drive for the projectile. Such an alternative possibility for the handling of the inventive device will certainly result in an optimum fragmentation of any kind of calculi whereby the change-over from either using the one or the other operational mode of the device will not necessitate any exchange of the one probe against the other probe and will also not necessitate any more time-consuming adaption of measures. Such change-over may instead take place instantaneously in any moment of a proceeding fragmentation of calculi. Since the composition of the calculi which are to be fragmented as well as the hardness and the actual size of the calculi is in most cases unknown before, this will therefore allow the surgeon to decide in situ which one of the two operational modes should be used for obtaining an optimum result of the fragmentation.
Other objects, features and advantages of the present invention will become apparent from reading the following description of a preferred embodiment of a device according to the present invention.


REFERENCES:
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patent: 5116343 (1992-05-01), Ams et al.
patent: 5160336 (1992-11-01), Favre
patent: 5741272 (1998-04-01), Kuhne
patent: 5868756 (1999-02-01), Henry et al.
patent: 5911699 (1999-06-01), Anis et al.
patent: 6077285 (2000-06-01), Boukhny
patent: 6214017 (2001-04-01), Stoddard et al.
patent: 6391042 (2002-05-01), Cimino
patent: 20 32 501 (1972-01-01), None
patent: 19609019 (1997-09-01), None
patent: 03 17 507 (1989-05-01), None
patent: 212 85 (1994-11-01), None
patent: 0421258 (1994-11-01), None
European Search Report dated Sep. 27, 2001.
EMS Medical GmbH and EMS SA, “Swiss Lithoclast® Master,” Edition May 2002.

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