Title of Invention	" A PERCUTANEOUS SURGICAL INSTRUMENT FOR DE-BULKING CALCULI OR DRILLING BONE"
Abstract	A perculaneous surgical instrument for de-bulking calculi or drilling bone includes an actualor for generating vihrd- tion al ulicennic frequcities and a horn coupled to said aciuator for ampliying the actuator vibration. A fixed grobe is attached to said horn for engaging the calccculi and introducing the ullrasonic frequencies thereto, A floating probe is disposed conecntric to and over said fixed probe and slidable thereover, A free mass is disposed between the horn and the floating probe for oscillaling therebetwcen. in response.to actuator vibration, for causing low fiequency impact with the calcoli.

Title of Invention

" A PERCUTANEOUS SURGICAL INSTRUMENT FOR DE-BULKING CALCULI OR DRILLING BONE"

Abstract

A perculaneous surgical instrument for de-bulking calculi or drilling bone includes an actualor for generating vihrd- tion al ulicennic frequcities and a horn coupled to said aciuator for ampliying the actuator vibration. A fixed grobe is attached to said horn for engaging the calccculi and introducing the ullrasonic frequencies thereto, A floating probe is disposed conecntric to and over said fixed probe and slidable thereover, A free mass is disposed between the horn and the floating probe for oscillaling therebetwcen. in response.to actuator vibration, for causing low fiequency impact with the calcoli.

Full Text	The present invention is generally directed to a surgical instrument for disintegrating and de-bulking calculi or 5 drilling atone, or bone and is more particularly directed to percutaneous surgical instruments for use in urological lithotripsy. Many people develop calculi within their common bile; 10 urinary, renal, or urethral systems. Such calculi may block; ducts and/or cause great pain and therefore must be removed. Originally, open surgery has been performed wherein multiple incisions are made to approach and remove the 15 calculi. However, this treatment results in a relatively long recovery period and has long fallen into disfavor. Presently, such calculi are destroyed in situ after which the fragmented calculi can be naturally evacuated. Various 20 methods of de-bulking such calculi are known in the art. Instruments currently in use are typically ultrasonic fixed probe devices or pneumatic impacting probes that operate at fixed low frequencies. 25 Fixed ultrasonic probe devices that operate in the low 20-30 kHz range are best in disintegrating the small stones and pneumatic impact probes that deliver very high energy but at lower frequencies of 5-20 impacts per second. 1 WO 2O04/060141 PCT/US2003/039218 2928 Another technique uses extra- eorporeal shock waves for de-bulking calculi. In this instance, a patient is subjected to shock waves with the shock waves passing through a patient's skin which causes bruising and is not acceptable for 5 pregnant women and is slow requiring multiple procedures for large stones. However, there are calculi, which cannot be removed by this technique because of the location, volume or composition, or health of patient. 10 The present invention is directed to a dual probe instrument that combines the higher 20 kHz or more frequency and the high energy shock impacting of the low, for example, less than 1 kHs, frequencies. With the use of concentric probes, a lumen may be established therethrough allowing 15 suction to remove calculi, or stone, debris from a patient. SUMMARY OF THE INVENTION A percutaneous surgical instrument for de-bulking calculi 20 or drilling bone in accordance with the present invention generally includes an actuator for generating vibrations at ultrasonic frequencies along with a horn coupled, to the actuator for amplifying the actuator vibration. 25 A fixed probe is attached to the horn for engaging the calculi and introducing ultrasonic frequencies thereto. A floating probe is provided and disposed concentric to and over the fixed probe with the floating probe being 2 WO 2O04/060141 PCT/US2003/039218 2928 slidable over the fixed probe, A free mass is disposed between the horn and floating probe for oscillating therebetween in response to actuator vibration for causing low frequency impact with the floating probe and calculi. The 5 floating probe could also be on the inside and concentric to the fixed probe on the outside. A generator may be provided for driving the actuator at desired. frequencies, pulse cycles and duty cycles in order to 10 both change the ultrasonic frequency introduced by the fixed probe and the oscillations of the low frequency impacts. In addition, the fixed probe may include a lumen therethrough for aspiration of disintegrated calculi or bone 15 with the fix probe lumen in communication with a lumen through the horn. The floating probe may be shorter or longer than the fixed probe and when shorter extends beyond a distal length of 20 the fixed probe during oscillation of the floating probe. A collar may be provided and fixed to the floating probe at a proximal end thereof for receiving impacts from the free mass. In addition, a housing may be provided for containing 25 the actuator within the housing, including a distal end surrounding the fixed probe and the floating probe at a spaced apart distance from distal ends of the fixed probe and the f1oating probe. 3 WO 2O04/060141 PCT/US2003/039218 2928 A biasing spring element is preferably disposed between the collar and the housing distal end for urging the collar into the free mass, compression of the spring occurring during oscillation of the free mass. 5 The fixed probe and the floating probe may be detachable from the horn and further a plurality of fixed probes and floating probes may be utilised. The plurality of fixed and floating probe preferably include different cutting tips of 10 different, design and the generator driving frequency, pulse cycle and duty cycle is preferably selected to optimize the cutting/disintegration effectiveness of a, selected fixed and floating probe. Additionally, varying spring rates will affect the impact energy and cycle frequency. 15 BRIEF DESCRIPTION OF THE DRAWING The advantages end features of the present invention will be better understood by the following description when 20 considered in conjunction with the accompanying drawings, in which; Figure 1 is a cross sectional view of a percuteneous surgical instrument in accordance with the present invention 25 generally showing an actuator for generating vibrations at ultrasonic frequencies, a horn coupled to the actuator for amplifying the actuator vibration, a fixed probe attached to the horn for engaging calculi (not shown), a floating probe disposed concentric to and over the fixed probe, a free mass 4 WO 2O04/060141 PCT/US2003/039218 2928 disposed, between the horn and the floating probe for oscillating therebetween and a generator/control for driving the actuator at desired frequencies; 5 Figure 2 is an enlarged view of the distal end of the instrument shown in Figure 1 showing the floating probe in a rearward position exposing a tip of the fixed probe; Figure 3 is a cross sectional view similar to Figure 2 10 showing the floating probe in a forward position as moved by the free mass against a spring or spring like material with the tip of the floating probe past the tip of the fixed probe; and. 15 Figures 4a, b, c are enlarged cross sectional views of the tips of the fixed and floating probes showing various configurations for different cutting and disintegration procedures. 20 DETAILED DESCRIPTION With reference to Figures 1-4c there is shown a percutaneous surgical instrument 10 for de-bulking calculi or dilling/coring bone generally including an actuator 12 for 25 generating vibrations at ultrasonic frequencies which may be. formed from a plurality of piezoelectric crystals or magnetostrictive asssmbly 16 and a back plate 18, 5 WO 2O04/060141 PCT/US2003/039218 2928 Additionally, a transducer assembly 15 may be configured reduce the capacitive effect of piezo crystals in an insulated stack. This may have an interference affect on other sensitive electrical instruments being operated close by. 5 This is overcome with the placement of insulators 20 at each end and one in the center of the poled crystals is to create opposite polarity. A horn 22 is coupled to the actuator 12 through an 10 abutment 26 and a proximal end 28 of the horn 22. This arrangement provides for amplification of the actuator 12 vibration, A fixed probe is attached to a distal end 36 of the horn 15 22 through a fitting 38 for receiving ultrasonic frequencies and engaging a calculi, net shown, for introducing the ultrasonic frequencies thereto. As hereinabove noted, the fixed probe and actuator 20 operate generally in the 18 kMz frequencies or above for disintegrating small stones, or calculi. A floating probe 44 is disposed concentric to and over/under the fixed probe 32 and is slidable over the fixed 25 probe. A fixed and floating probe that may be coated with, a lubricating element such as Teflon or a hydrophilic coating. 6 WO 2O04/060141 PCT/US2003/039218 2928 A collar 48 is attached to a proximal end 52 of the floating probe 44 and provides a means far receiving impacts from a free mass 56 which is disposed between the born 22 and the floating probe 44 for oscillating therebetween in response 5 to actuator 12 vibration. This causes low frequency impact with the floating probe 32 which in turn transfers the impact forces to the calculi as a distal end 58 of the floating probe 44 is driven pass a distal end 60 of the fixed probe 32. 10 The induced movement of the free mass due to vibration of the actuator 12 causes forward movement of the free mass 56 against a bias provided by a spring 64, The spring 64 returns the free mass 56 to an original position abutting the distal end 36 of the horn 22, These oscillations are at very low 15 frequencies, for example, less than 1 kHz, Accotdingly, the floating probe 44 operating at these low frequencies efficiently breaks large stones into small pieces and the ultrasonically driven fixed probe 32 then is effective 20 for disintegracing the ruptured calculi into finer particles which then may be aspirated through a lumen through the fixed probe 32 and a lumen through 70 through the horn 22 which communicates with, a Suction port 74 intercOnnected with a vacuum source (not shown) , 25 It should be appreciated that the fixed probe 32 and the floating probe 44 shown represent a plurality of fixed and floating probes which may have a variety of tips 80, 82, 84 which may include saw of serrated teeth 88, external bevels 90 7 WO 2O04/060141 PCT/US2003/039218 2928 or internal bevels 92. Tip 85 is a floating tip that may have, the cutting edge finished as 88, 90, or 92. The tips 80, 82, 84 provide examples of various configurations suitable for cutting or drilling calculi, flesh, or bone of different 5 density and configuration. The fixed probe 32 and the floating pxobe 44 are preferably adapted for interchangement with the horn 22 either by press fit, as illustrated, or through any other 10 conventional coupling arrangement such as threading, silver solder, or welding. The fixed probe 32 and floating probe 44 may be made of various materials including grades of plastic. The outside 15 diameter of the floating probe may be 4mm and for use in lithotripsy, the outside floating probe 44 may be approximately 0-1 mm shorter than the fixed probe 32 and will extend past the fixed probe 32 longitudinally when excited as hereinabove noted. A generator/controller 96 is provided for driving the actuator 12 at desired frequencies. The generator provides for varying the pulse frequencies to fit the type and size of stone or other material to assure the most expedient and 25 efficient disintegration. In fact, the actuator 12 is driven at various frequencies, pulse cycles and duty cycles to maximize efficiency of the instrument 10. 8 WO 2O04/060141 PCT/US2003/039218 2928 The actuator 12 may be driven by the generator 96 at various frequencies, pulse cycle frequency and duty cycles to maximize the efficiency of each of the cutting tips 80, 82, 84, for example, 5 A housing 100 is provided for containing the actuator 12 and it includes a distal end 102 surrounding the fixed probe 22 and floating proba 44 from the distal ends 60, 58 of the fixed and floating probes 32 and 44 at a distance. An 10 interior surface 104 provides a means of support for the spring 64 which provides for the biasing element between the collar 48 and the housing distal end 102 as hereinabove noted. Although there has been hereinabove described a specific 15 dual probe in accordance with the present invention for the purpose of illustrating the manner in which the invention may be used to advantage, it should be appreciated that the invention is not limited thereto. that is, the present invention may suitably comprise, consist of, or consist 20 essentially of the recited elements. Further, the invention illustratively disclosed herein suitably may be practiced in the absence of any element which is not specifically dieclosed herein. Accordingly, any and all modifications, variations or equivalent arrangements which may occur to those skilled in 25 the art, should be considered to be within the scope of the present invention a a defined in the appended, claims, 9 WO 2O04/060141 PCT/US2003/039218 2928 WHAT IS CLAIMED IS: 1. A. percutaneous surgical instrument for de -bulking calculi or drilling bone, the instrument comprising; 5 an actuator for generating vibrations at ultrasonic frequencies; a horn coupled to said actuator for amplifying the actuator vibration; a fixed probe attached to said horn for engaging the 10 calculi and introducing the ultrasonic frequencies thereto; a floating probe disposed concentric to and over said fixed probe, said floating probe being slidable over said fixed probe; a free mass, disposed between said horn and said 15 floating probe for oscillating therebetween, in response to actuator vibration, for causing low frequency impact with the calculi. 2. The instrument according to claim 1 wherein said 20 fixed probe includes a lumen therethrough for aspiration of disintegrated calculi or bone. 3. The instrument according to claim 2 therein said horn includes a lumen therethrough in communication with the 25 fixed probe lumen. 4. The instrument according to claim 1 wherein said floating probe is longer than said fixed probe. 10 WO 2O04/060141 PCT/US2003/039218 2928 5. The instilment according to claim 1 wherein said floating probe is shorter than said fixed probe and extends beyond a distal end of said fixed probe during oscillation of said floating probe, 6. The instrument according to claim 1 further comprising a collar, fixed to said floating probe at a proximal end thereof, for receiving impacts from said free mass , 10 7. The instrument according to claim 1 further comprising a generator for driving said actuator at desired frequenciss, pulse cycles and duty cycles in order to both change the ultrasonic frequency introduced by said fixed probe 15 and the oscillations of the low frequency impacts. 6. The instrument according to claim 6 further comprising a housing for containing said actuator and having a distal end surrounding said fixed probe and said floating 20 probe at a spaced apart distance from distal ends of said fixed probe and said floating probe. 9. The instrument according to claim 8 further comprising a biasing element disposed between said collar and 25 the housing distal end. 10. The instrument according to claim 1 wherein said fixed probe and floating probe are detachable from said horn. 11 WO 2O04/060141 PCT/US2003/039218 2928 11. The instrument according to claim 10 further comprising a plurality of fixed probes and floating probes. 12. The instrument according to claim 10 wherein said 5 plurality of fixed and floating probes include cutting tips of different designs. 13. The instrument according to claim 1 further comprising a generator for driving said actuator at desired 10 frequencies, pulse cycles and duty cycles in order to both change the ultrasonic frequency introduced by said fixed probe and the oscillations of the low frequency impacts depending on a selected one of the plurality of fixed probe and a selected one of the plurality of floating probes. 15 14 . A percutaneous surgical instrument for de-bulking calculi or drilling bone, the instrument comprising: an actuator for generating vibrations at ultrasonic frequencies; 20 a horn coupled to said actuator for amplifying the actuator vibration; a fixed probe attached to said horn for engaging the calculi or bone and introducing the ultrasonic frequencies thereto, said fixed probe having a lumen Cherethrough for 25 aspiration of disintegrated calculi or bone; a floating probe disposed concentric to and over said fixed probe, said floating probe being slidable over said fixed probe; 12 WO 2O04/060141 PCT/US2003/039218 2928 a free mass, disposed between said horn and said floating probe for oscillating therebetween, in response to actuator vibration, for causing low frequency impact with the calculi or bone. 5 15, The instrument according to claim 14 wherein said horn includes a lumen therethrough in communication with the fixed probe lumen. 10 16. The instrument according to claim 14 wherein said floating probe is longer than said fixed probe. 17. The inacruaient according ta claim 14 wherein said floating probe is shorter than said fixed probe and extends 15 beyond a distal end of said fixed probe during oscillation of said floating probe. 18. The instrument according to claim 14 further comprising a collar, fixed to said floating probe at a 20 proximal end thereof for receiving impacts from said free mass . 19. The instrument according to claim 14 further comprising a generator for driving said actuator at desired 25 frequencies, probe cycles and duty cycles in order to both change the ultrasonic frequency introduced by said fixed probe and the oscillations of the low frequency impacts. 13 WO 2O04/060141 PCT/US2003/039218 2928 20. The instrument according to claim 19 further comprising a housing for containing said actuator and having a distal end surrounding said fixed probe and said floating probe at a spaced apart distance from distal end of said fixed 5 probe and said floating probe. 21. The instrument according to claim 20 further comprising a biasing element disposed between said collar and the housing distal end. 10 22. The instrument according to claim 14 wherein said fixed probe and floating probe are detachable from said horn. 23. The instrument according to claim 22 further 15 comprising a plurality of fixed probes and floating probes. 24. The instrument according to claim 23 further comprising a generator for driving said actuator at desired frequencies, pulse cycles and duty cycles in order to both. 20 change the ultrasonic frequency introduced by said fixed probe and the oscillations of the low frequency impacts depending on a selected one of the plurality of fixed probe and a selected one of the plurality of floating probes, 25 25. A method for percutaneous de-bulking calculi or drilling bone comprising the steps of: inserting concentric probes precutaneously to engage a calculi or bone; 14 WO 2O04/060141 PCT/US2003/039218 2928 driving an outer probe of said concentric probes at a lew frequency in order to break up the calculi or bone; driving an inner probe of said concentric probes at a high frequency for disintegrating broken calculi or bone; 5 and aspirating disintegrating calculi or bone thraugh a lumen through the inner probe. 26. A percutaneous surgical instrument for de-bulking 10 calculi or drilling bone, the instrument comprising; an actuator for generating vibrations at ultrasonic; frequencies; a horn coupled to said actuator for amplifying the actuator vibration; 15 a fixed probe attached to said horn for engaging the calculi and introducing the ultrasonic frequencies thereto; a floating probe disposed concentric to and within said fixed probe, said floating probe being slidable within said fixed probe; 20 a free mass, disposed between said horn and said floating probe fox oscillating therebetween, in response to actuacor vibration, for causing low frequency impact with the calculi. 25 27. The transducer stack according to claim 1 wherein the actuator is configured with unpoled insulators for reducing capacitive effect on the horn. 15 A perculaneous surgical instrument for de-bulking calculi or drilling bone includes an actualor for generating vihrd- tion al ulicennic frequcities and a horn coupled to said aciuator for ampliying the actuator vibration. A fixed grobe is attached to said horn for engaging the calccculi and introducing the ullrasonic frequencies thereto, A floating probe is disposed conecntric to and over said fixed probe and slidable thereover, A free mass is disposed between the horn and the floating probe for oscillaling therebetwcen. in response.to actuator vibration, for causing low fiequency impact with the calcoli.

Full Text

The present invention is generally directed to a surgical
instrument for disintegrating and de-bulking calculi or
5 drilling atone, or bone and is more particularly directed to
percutaneous surgical instruments for use in urological
lithotripsy.
Many people develop calculi within their common bile;
10 urinary, renal, or urethral systems. Such calculi may block;
ducts and/or cause great pain and therefore must be removed.
Originally, open surgery has been performed wherein
multiple incisions are made to approach and remove the
15 calculi. However, this treatment results in a relatively long
recovery period and has long fallen into disfavor.
Presently, such calculi are destroyed in situ after which
the fragmented calculi can be naturally evacuated. Various
20 methods of de-bulking such calculi are known in the art.
Instruments currently in use are typically ultrasonic fixed
probe devices or pneumatic impacting probes that operate at
fixed low frequencies.
25 Fixed ultrasonic probe devices that operate in the low
20-30 kHz range are best in disintegrating the small stones
and pneumatic impact probes that deliver very high energy but
at lower frequencies of 5-20 impacts per second.
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Another technique uses extra- eorporeal shock waves for
de-bulking calculi. In this instance, a patient is subjected
to shock waves with the shock waves passing through a
patient's skin which causes bruising and is not acceptable for
5 pregnant women and is slow requiring multiple procedures for
large stones. However, there are calculi, which cannot be
removed by this technique because of the location, volume or
composition, or health of patient.
10 The present invention is directed to a dual probe
instrument that combines the higher 20 kHz or more frequency
and the high energy shock impacting of the low, for example,
less than 1 kHs, frequencies. With the use of concentric
probes, a lumen may be established therethrough allowing
15 suction to remove calculi, or stone, debris from a patient.
SUMMARY OF THE INVENTION
A percutaneous surgical instrument for de-bulking calculi
20 or drilling bone in accordance with the present invention
generally includes an actuator for generating vibrations at
ultrasonic frequencies along with a horn coupled, to the
actuator for amplifying the actuator vibration.
25 A fixed probe is attached to the horn for engaging the
calculi and introducing ultrasonic frequencies thereto.
A floating probe is provided and disposed concentric to
and over the fixed probe with the floating probe being
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slidable over the fixed probe, A free mass is disposed
between the horn and floating probe for oscillating
therebetween in response to actuator vibration for causing low
frequency impact with the floating probe and calculi. The
5 floating probe could also be on the inside and concentric to
the fixed probe on the outside.
A generator may be provided for driving the actuator at
desired. frequencies, pulse cycles and duty cycles in order to
10 both change the ultrasonic frequency introduced by the fixed
probe and the oscillations of the low frequency impacts.
In addition, the fixed probe may include a lumen
therethrough for aspiration of disintegrated calculi or bone
15 with the fix probe lumen in communication with a lumen through
the horn.
The floating probe may be shorter or longer than the
fixed probe and when shorter extends beyond a distal length of
20 the fixed probe during oscillation of the floating probe.
A collar may be provided and fixed to the floating probe
at a proximal end thereof for receiving impacts from the free
mass. In addition, a housing may be provided for containing
25 the actuator within the housing, including a distal end
surrounding the fixed probe and the floating probe at a spaced
apart distance from distal ends of the fixed probe and the
f1oating probe.

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A biasing spring element is preferably disposed between
the collar and the housing distal end for urging the collar
into the free mass, compression of the spring occurring during
oscillation of the free mass.
5
The fixed probe and the floating probe may be detachable
from the horn and further a plurality of fixed probes and
floating probes may be utilised. The plurality of fixed and
floating probe preferably include different cutting tips of
10 different, design and the generator driving frequency, pulse
cycle and duty cycle is preferably selected to optimize the
cutting/disintegration effectiveness of a, selected fixed and
floating probe. Additionally, varying spring rates will
affect the impact energy and cycle frequency.
15
BRIEF DESCRIPTION OF THE DRAWING
The advantages end features of the present invention will
be better understood by the following description when
20 considered in conjunction with the accompanying drawings, in
which;
Figure 1 is a cross sectional view of a percuteneous
surgical instrument in accordance with the present invention
25 generally showing an actuator for generating vibrations at
ultrasonic frequencies, a horn coupled to the actuator for
amplifying the actuator vibration, a fixed probe attached to
the horn for engaging calculi (not shown), a floating probe
disposed concentric to and over the fixed probe, a free mass

4

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disposed, between the horn and the floating probe for
oscillating therebetween and a generator/control for driving
the actuator at desired frequencies;
5 Figure 2 is an enlarged view of the distal end of the
instrument shown in Figure 1 showing the floating probe in a
rearward position exposing a tip of the fixed probe;
Figure 3 is a cross sectional view similar to Figure 2
10 showing the floating probe in a forward position as moved by
the free mass against a spring or spring like material with
the tip of the floating probe past the tip of the fixed probe;
and.
15 Figures 4a, b, c are enlarged cross sectional views of
the tips of the fixed and floating probes showing various
configurations for different cutting and disintegration
procedures.
20 DETAILED DESCRIPTION
With reference to Figures 1-4c there is shown a
percutaneous surgical instrument 10 for de-bulking calculi or
dilling/coring bone generally including an actuator 12 for
25 generating vibrations at ultrasonic frequencies which may be.
formed from a plurality of piezoelectric crystals or
magnetostrictive asssmbly 16 and a back plate 18,

5

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Additionally, a transducer assembly 15 may be configured
reduce the capacitive effect of piezo crystals in an insulated
stack. This may have an interference affect on other
sensitive electrical instruments being operated close by.
5 This is overcome with the placement of insulators 20 at each
end and one in the center of the poled crystals is to create
opposite polarity.
A horn 22 is coupled to the actuator 12 through an
10 abutment 26 and a proximal end 28 of the horn 22. This
arrangement provides for amplification of the actuator 12
vibration,
A fixed probe is attached to a distal end 36 of the horn
15 22 through a fitting 38 for receiving ultrasonic frequencies
and engaging a calculi, net shown, for introducing the
ultrasonic frequencies thereto.
As hereinabove noted, the fixed probe and actuator
20 operate generally in the 18 kMz frequencies or above for
disintegrating small stones, or calculi.
A floating probe 44 is disposed concentric to and
over/under the fixed probe 32 and is slidable over the fixed
25 probe.
A fixed and floating probe that may be coated with, a
lubricating element such as Teflon or a hydrophilic coating.

6

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A collar 48 is attached to a proximal end 52 of the
floating probe 44 and provides a means far receiving impacts
from a free mass 56 which is disposed between the born 22 and
the floating probe 44 for oscillating therebetween in response
5 to actuator 12 vibration. This causes low frequency impact
with the floating probe 32 which in turn transfers the impact
forces to the calculi as a distal end 58 of the floating probe
44 is driven pass a distal end 60 of the fixed probe 32.
10 The induced movement of the free mass due to vibration of
the actuator 12 causes forward movement of the free mass 56
against a bias provided by a spring 64, The spring 64 returns
the free mass 56 to an original position abutting the distal
end 36 of the horn 22, These oscillations are at very low
15 frequencies, for example, less than 1 kHz,
Accotdingly, the floating probe 44 operating at these low
frequencies efficiently breaks large stones into small pieces
and the ultrasonically driven fixed probe 32 then is effective
20 for disintegracing the ruptured calculi into finer particles
which then may be aspirated through a lumen through the fixed
probe 32 and a lumen through 70 through the horn 22 which
communicates with, a Suction port 74 intercOnnected with a
vacuum source (not shown) ,
25
It should be appreciated that the fixed probe 32 and the
floating probe 44 shown represent a plurality of fixed and
floating probes which may have a variety of tips 80, 82, 84
which may include saw of serrated teeth 88, external bevels 90
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or internal bevels 92. Tip 85 is a floating tip that may have,
the cutting edge finished as 88, 90, or 92. The tips 80, 82,
84 provide examples of various configurations suitable for
cutting or drilling calculi, flesh, or bone of different
5 density and configuration.
The fixed probe 32 and the floating pxobe 44 are
preferably adapted for interchangement with the horn 22 either
by press fit, as illustrated, or through any other
10 conventional coupling arrangement such as threading, silver
solder, or welding.
The fixed probe 32 and floating probe 44 may be made of
various materials including grades of plastic. The outside
15 diameter of the floating probe may be 4mm and for use in
lithotripsy, the outside floating probe 44 may be
approximately 0-1 mm shorter than the fixed probe 32 and will
extend past the fixed probe 32 longitudinally when excited as
hereinabove noted.
A generator/controller 96 is provided for driving the
actuator 12 at desired frequencies. The generator provides
for varying the pulse frequencies to fit the type and size of
stone or other material to assure the most expedient and
25 efficient disintegration. In fact, the actuator 12 is driven
at various frequencies, pulse cycles and duty cycles to
maximize efficiency of the instrument 10.

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The actuator 12 may be driven by the generator 96 at
various frequencies, pulse cycle frequency and duty cycles to
maximize the efficiency of each of the cutting tips 80, 82,
84, for example,
5
A housing 100 is provided for containing the actuator 12
and it includes a distal end 102 surrounding the fixed probe
22 and floating proba 44 from the distal ends 60, 58 of the
fixed and floating probes 32 and 44 at a distance. An
10 interior surface 104 provides a means of support for the
spring 64 which provides for the biasing element between the
collar 48 and the housing distal end 102 as hereinabove noted.
Although there has been hereinabove described a specific
15 dual probe in accordance with the present invention for the
purpose of illustrating the manner in which the invention may
be used to advantage, it should be appreciated that the
invention is not limited thereto. that is, the present
invention may suitably comprise, consist of, or consist
20 essentially of the recited elements. Further, the invention
illustratively disclosed herein suitably may be practiced in
the absence of any element which is not specifically dieclosed
herein. Accordingly, any and all modifications, variations or
equivalent arrangements which may occur to those skilled in
25 the art, should be considered to be within the scope of the
present invention a a defined in the appended, claims,
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WHAT IS CLAIMED IS:
1. A. percutaneous surgical instrument for de -bulking
calculi or drilling bone, the instrument comprising;
5 an actuator for generating vibrations at ultrasonic
frequencies;
a horn coupled to said actuator for amplifying the
actuator vibration;
a fixed probe attached to said horn for engaging the
10 calculi and introducing the ultrasonic frequencies thereto;
a floating probe disposed concentric to and over
said fixed probe, said floating probe being slidable over said
fixed probe;
a free mass, disposed between said horn and said
15 floating probe for oscillating therebetween, in response to
actuator vibration, for causing low frequency impact with the
calculi.
2. The instrument according to claim 1 wherein said
20 fixed probe includes a lumen therethrough for aspiration of
disintegrated calculi or bone.
3. The instrument according to claim 2 therein said
horn includes a lumen therethrough in communication with the
25 fixed probe lumen.
4. The instrument according to claim 1 wherein said
floating probe is longer than said fixed probe.

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5. The instilment according to claim 1 wherein said
floating probe is shorter than said fixed probe and extends
beyond a distal end of said fixed probe during oscillation of
said floating probe,
6. The instrument according to claim 1 further
comprising a collar, fixed to said floating probe at a
proximal end thereof, for receiving impacts from said free
mass ,
10
7. The instrument according to claim 1 further
comprising a generator for driving said actuator at desired
frequenciss, pulse cycles and duty cycles in order to both
change the ultrasonic frequency introduced by said fixed probe
15 and the oscillations of the low frequency impacts.
6. The instrument according to claim 6 further
comprising a housing for containing said actuator and having a
distal end surrounding said fixed probe and said floating
20 probe at a spaced apart distance from distal ends of said
fixed probe and said floating probe.
9. The instrument according to claim 8 further
comprising a biasing element disposed between said collar and
25 the housing distal end.
10. The instrument according to claim 1 wherein said
fixed probe and floating probe are detachable from said horn.
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11. The instrument according to claim 10 further
comprising a plurality of fixed probes and floating probes.
12. The instrument according to claim 10 wherein said
5 plurality of fixed and floating probes include cutting tips of
different designs.
13. The instrument according to claim 1 further
comprising a generator for driving said actuator at desired
10 frequencies, pulse cycles and duty cycles in order to both
change the ultrasonic frequency introduced by said fixed probe
and the oscillations of the low frequency impacts depending on
a selected one of the plurality of fixed probe and a selected
one of the plurality of floating probes.
15
14 . A percutaneous surgical instrument for de-bulking
calculi or drilling bone, the instrument comprising:
an actuator for generating vibrations at ultrasonic
frequencies;
20 a horn coupled to said actuator for amplifying the
actuator vibration;
a fixed probe attached to said horn for engaging the
calculi or bone and introducing the ultrasonic frequencies
thereto, said fixed probe having a lumen Cherethrough for
25 aspiration of disintegrated calculi or bone;
a floating probe disposed concentric to and over
said fixed probe, said floating probe being slidable over said
fixed probe;
12

WO 2O04/060141 PCT/US2003/039218
2928
a free mass, disposed between said horn and said
floating probe for oscillating therebetween, in response to
actuator vibration, for causing low frequency impact with the
calculi or bone.
5
15, The instrument according to claim 14 wherein said
horn includes a lumen therethrough in communication with the
fixed probe lumen.
10 16. The instrument according to claim 14 wherein said
floating probe is longer than said fixed probe.
17. The inacruaient according ta claim 14 wherein said
floating probe is shorter than said fixed probe and extends
15 beyond a distal end of said fixed probe during oscillation of
said floating probe.
18. The instrument according to claim 14 further
comprising a collar, fixed to said floating probe at a
20 proximal end thereof for receiving impacts from said free
mass .
19. The instrument according to claim 14 further
comprising a generator for driving said actuator at desired
25 frequencies, probe cycles and duty cycles in order to both
change the ultrasonic frequency introduced by said fixed probe
and the oscillations of the low frequency impacts.
13

WO 2O04/060141 PCT/US2003/039218
2928
20. The instrument according to claim 19 further
comprising a housing for containing said actuator and having a
distal end surrounding said fixed probe and said floating
probe at a spaced apart distance from distal end of said fixed
5 probe and said floating probe.
21. The instrument according to claim 20 further
comprising a biasing element disposed between said collar and
the housing distal end.
10
22. The instrument according to claim 14 wherein said
fixed probe and floating probe are detachable from said horn.
23. The instrument according to claim 22 further
15 comprising a plurality of fixed probes and floating probes.
24. The instrument according to claim 23 further
comprising a generator for driving said actuator at desired
frequencies, pulse cycles and duty cycles in order to both.
20 change the ultrasonic frequency introduced by said fixed probe
and the oscillations of the low frequency impacts depending on
a selected one of the plurality of fixed probe and a selected
one of the plurality of floating probes,
25 25. A method for percutaneous de-bulking calculi or
drilling bone comprising the steps of:
inserting concentric probes precutaneously to engage
a calculi or bone;
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WO 2O04/060141 PCT/US2003/039218
2928
driving an outer probe of said concentric probes at
a lew frequency in order to break up the calculi or bone;
driving an inner probe of said concentric probes at
a high frequency for disintegrating broken calculi or bone;
5 and
aspirating disintegrating calculi or bone thraugh a
lumen through the inner probe.
26. A percutaneous surgical instrument for de-bulking
10 calculi or drilling bone, the instrument comprising;
an actuator for generating vibrations at ultrasonic;
frequencies;
a horn coupled to said actuator for amplifying the
actuator vibration;
15 a fixed probe attached to said horn for engaging the
calculi and introducing the ultrasonic frequencies thereto;
a floating probe disposed concentric to and within
said fixed probe, said floating probe being slidable within
said fixed probe;
20 a free mass, disposed between said horn and said
floating probe fox oscillating therebetween, in response to
actuacor vibration, for causing low frequency impact with the
calculi.
25 27. The transducer stack according to claim 1 wherein
the actuator is configured with unpoled insulators for
reducing capacitive effect on the horn.
15

A perculaneous surgical instrument for de-bulking calculi or drilling bone includes an actualor for generating vihrd-
tion al ulicennic frequcities and a horn coupled to said aciuator for ampliying the actuator vibration. A fixed grobe is attached
to said horn for engaging the calccculi and introducing the ullrasonic frequencies thereto, A floating probe is disposed conecntric to
and over said fixed probe and slidable thereover, A free mass is disposed between the horn and the floating probe for oscillaling
therebetwcen. in response.to actuator vibration, for causing low fiequency impact with the calcoli.

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Patent Number

217422

Indian Patent Application Number

01177/KOLNP/2005

PG Journal Number

13/2008

Publication Date

28-Mar-2008

Grant Date

26-Mar-2008

Date of Filing

20-Jun-2005

Name of Patentee

CYBERSONICS, INC.

Applicant Address

5368 KUHL ROAD, ERIE, PA 16510-4703 U.S.A

Inventors:

#	Inventor's Name	Inventor's Address
1	DU,SHU	4816 FOXBORO COURT, ERIE, PA 16510 U.S.A
2	PETERSON, THOMAS, M,	4249 NEPTUNE STREET, ERIE, PA 16510 U.S.A
3	SONG, TAO	4816 FOXBORO COURT, ERIE, PA 16510 U.S.A

PCT International Classification Number

A61B

PCT International Application Number

PCT/US2003/039218

PCT International Filing date

2003-12-09

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	10/334,486	2002-12-30	U.S.A.