CA2128090A1 - Ultrasonic surgical apparatus - Google Patents
Ultrasonic surgical apparatusInfo
- Publication number
- CA2128090A1 CA2128090A1 CA002128090A CA2128090A CA2128090A1 CA 2128090 A1 CA2128090 A1 CA 2128090A1 CA 002128090 A CA002128090 A CA 002128090A CA 2128090 A CA2128090 A CA 2128090A CA 2128090 A1 CA2128090 A1 CA 2128090A1
- Authority
- CA
- Canada
- Prior art keywords
- signal
- transducer
- amplitude
- feedback
- control loop
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B06—GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS IN GENERAL
- B06B—METHODS OR APPARATUS FOR GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS OF INFRASONIC, SONIC, OR ULTRASONIC FREQUENCY, e.g. FOR PERFORMING MECHANICAL WORK IN GENERAL
- B06B1/00—Methods or apparatus for generating mechanical vibrations of infrasonic, sonic, or ultrasonic frequency
- B06B1/02—Methods or apparatus for generating mechanical vibrations of infrasonic, sonic, or ultrasonic frequency making use of electrical energy
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B06—GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS IN GENERAL
- B06B—METHODS OR APPARATUS FOR GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS OF INFRASONIC, SONIC, OR ULTRASONIC FREQUENCY, e.g. FOR PERFORMING MECHANICAL WORK IN GENERAL
- B06B1/00—Methods or apparatus for generating mechanical vibrations of infrasonic, sonic, or ultrasonic frequency
- B06B1/02—Methods or apparatus for generating mechanical vibrations of infrasonic, sonic, or ultrasonic frequency making use of electrical energy
- B06B1/0207—Driving circuits
- B06B1/0223—Driving circuits for generating signals continuous in time
- B06B1/0238—Driving circuits for generating signals continuous in time of a single frequency, e.g. a sine-wave
- B06B1/0246—Driving circuits for generating signals continuous in time of a single frequency, e.g. a sine-wave with a feedback signal
- B06B1/0261—Driving circuits for generating signals continuous in time of a single frequency, e.g. a sine-wave with a feedback signal taken from a transducer or electrode connected to the driving transducer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/1206—Generators therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B2017/32007—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with suction or vacuum means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2217/00—General characteristics of surgical instruments
- A61B2217/002—Auxiliary appliance
- A61B2217/007—Auxiliary appliance with irrigation system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M3/00—Medical syringes, e.g. enemata; Irrigators
- A61M3/02—Enemata; Irrigators
- A61M3/0279—Cannula; Nozzles; Tips; their connection means
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B06—GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS IN GENERAL
- B06B—METHODS OR APPARATUS FOR GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS OF INFRASONIC, SONIC, OR ULTRASONIC FREQUENCY, e.g. FOR PERFORMING MECHANICAL WORK IN GENERAL
- B06B2201/00—Indexing scheme associated with B06B1/0207 for details covered by B06B1/0207 but not provided for in any of its subgroups
- B06B2201/20—Application to multi-element transducer
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B06—GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS IN GENERAL
- B06B—METHODS OR APPARATUS FOR GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS OF INFRASONIC, SONIC, OR ULTRASONIC FREQUENCY, e.g. FOR PERFORMING MECHANICAL WORK IN GENERAL
- B06B2201/00—Indexing scheme associated with B06B1/0207 for details covered by B06B1/0207 but not provided for in any of its subgroups
- B06B2201/50—Application to a particular transducer type
- B06B2201/55—Piezoelectric transducer
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B06—GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS IN GENERAL
- B06B—METHODS OR APPARATUS FOR GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS OF INFRASONIC, SONIC, OR ULTRASONIC FREQUENCY, e.g. FOR PERFORMING MECHANICAL WORK IN GENERAL
- B06B2201/00—Indexing scheme associated with B06B1/0207 for details covered by B06B1/0207 but not provided for in any of its subgroups
- B06B2201/70—Specific application
- B06B2201/76—Medical, dental
Abstract
An electrical apparatus for driving an ultrasonic piezoelectric crystal transducer in a surgical handpiece for the fragmentation and aspiration of tissue, which apparatus includes an electronic control loop (12) in combination with a voltage source amplifier (2) having an output which is connected to the piezoelectric crystal transducer (3) with a tuning inductor (4) in parallel. A
control system for monitoring the control loop (12) and a component for controlling tissue selectivity are also disclosed.
control system for monitoring the control loop (12) and a component for controlling tissue selectivity are also disclosed.
Description
WO 93/1S850 ~ PCl /US92/0~322 -1- Z~:l309 YLTRASONIC SUP~Glt~AL APPARATUS
Backqround ot the Invention The present invention relates to an electrical apparatus ior driving an ultrasonic transducer in a surgical handpiece for ths fragmentation and aspiration of ~issue at an oper~tion site on a patient, and to eleotronic control loops in the electrical circuitry o~
10 the apparatus. In particular, the invention relates to an apparatus ~or driving an ultrasonic suryical device while maintaining the vibration frequency at mechanical resonance utilizing a feedback control. The invention is also concerned ~!vith means for controlling amplitude and with a digital inter~ace for monitoring performance and restoring normal operation when the system parameters exceed analog control loopboundaries. The invention also provides means for controlling the tissue selectivity ol the apparatus.
The use of ultrasonically vibrating surgical devices for fragmenting and rem~ving unv~anted tissu~ by aspira~ion with precision and safety has led to the development of valuabie surgical procedures. Initially, the technique o~ surgical aspiration was applied to the tragmentation and removal of cataract tissue as disclosed, for example, in U.S.
Patent No. 3,589,363. Later, similar ~echniques were applied with significant success ; ~ ~ to neurosurgery and other surgery speci~ties where the application of ultrasonic energy through a handheld device for selectivity removing tissue on a layer-by-layer basis ~ith precise control was found to be fea~ible.
Certain devices known in the art characteristically prsduGe continuous vibrations having a substantially constant arnpiitude at a frequency of about twenty to about thirty KHz up to about forty to about fifty KHz. lJ.S. Pa~ents No. 4,û83,~57, 4,223,676 and 4,425,115 disclose a device suitable for the removal of soft tiss~e which is particularly adapted for removing highly compliant elastio tissue mixed with blood. Such a deYice is ~dapted to be corltinuously op~rated when the surgeon wishes to fragment and remov4 tissue, and generally is operated by a foot switch.
- A known instrument forthe ul~rasonic fragmentation of tissue at an operation site and aspiration of the tissue particles and tluid away from the site is the CUSA model System 200 Ultrasonic Aspirator manufactured and sold by Valleylab, Inc. of Stamford.
3S Connecticut; see also U.S. Patent No. 4,827,911. When the longitudinally vibraling tip in such an aspirator is brought into centact with tissue it gently, selectively and precisely fragments and removes the tissue. Advantages o~ this unique surgica!
WO 93/15850 ~Cl';/Us92~09322 .. , ;~ . `.
~ ~809 -2-,...... . .
.' instrument include little damage to healthy tissue in a tumor removal procedure, blood vessels can be skeletonized, healing of tissue is promoted, no charring or tearing oi margins of surrounding tissue, only minimal pulling of healthy tissue is experienced, and ~xcellent tactile feedback for selectlvely controlled tissue fragmentation and S removal is provided.
In many surgical procedures where ultrasonic ~ragmentation instruments are employed additional instrurnents are required for tissue cutting and hemostasis at the operation site. For example, hemostasis is n~ded in desicc.ation techniques ~or deep coagulation to dry out large volumes of tissue and also in tulguration techniques for 10 spray coagulation to dry out the surface of tissues.
The apparatus disclosed in U.S. Patents No. 4,931,047 and 5,015,227 provides hemostasis in combination with an ultrasonically vibrating surgical fragmentation , instrument and aspirator. The apparatus effectively provides both a coagulation , . .
.j capability and an enhanced ability to tragment and aspirate tissue in a m~nner which ~!: 15 reducestraumato surrounding tissue.
~1 U.S. Patent No. 4,750,488 and its two continuation Patents 4,750,902 and - 4,922,902 disclose a method and apparatus which utilQe a combination of ultrasonic tragmentation, aspiration and cauterization.
` In an apparatus which 1ragments tissue by the ultrasonic vibration of a tool tip, it is desirable, for optimum efficiency and energy utilization, that the transducer which provides the ultrasonic vibration should operate at resonant ~requency. When th~~ transducer is a piezoelectric crystal the trequency at which it vibrates will corresponb 3 ~ to the *equency of the electrical driving signal which causes the vibration. The i ~ operation is most efficient when the tr~nsducer vibrates at i~s resonant frequency 25 How~wr, changes in operational parameters, such as, changes in temperature, therma!
expansion and load impedance, resuH in deviations in the resonant frequency Accordingly, controlled changes in the *equency of the driving signa~ are required to track the resonant *equency.
The circuit disclosed in U,S Patent No. 4,750,488 includes a ~requency contro 30 loop which depends upon a ~eedback signal obtained by adding two signais that ar~
proportionai to the voltage and current input to the piezoelectric transducer.
. WO 93/15850 " PCr/US92/09322 ,:
Z~Z8090 3- . .
, . . ...
U.S. Patent No. 4,965,532 discloses a circuit for driving an ultrasonic transducer including a frequency control means utilizing a feedback control dependent upon tirst and second phase detection signals.
It h~s now been found that an efficient trequency control is obtained with the aid of a unique control loop which includes a feedback piezoelectric crystal mechanically coupled to the piezoelectric transducer.
!
The use of a feedback crystal in a tuned circuit which provides a filtered signal ~'~ to control a driving signal in an ultrasonic system is disclosed in U.S Patent No.
. 4,012,647. The system disclosed in this patent is not a surgical apparatus and the combination of ultrasonic vibrator, amplifier and tuning inductance with feedback from the feedback crystal to the mput of the ampkfier, constitutes an oscillator. In contrast thereto, the novel circuit of the present invention incorporates a voltage controlled oscillator ~VC0) as part of a control loop. The faedback signal from a feedback crystal is input to the control loop~which then drives the amplifier. The advantage of this novel 15 - circuit is that X tracks mechanical resonance without electrical interaction.
A problem which frec~uently~ arises during the operation of an ultrasonic surgicai , .
appuatus which includes a feedback control loop is the propensity of the control loop to lock into an unwanted adjAcent frequency rather than 1he desired resonant frequency.
The occurrene2 ot this problem depends upon the frequency spectrum of the system and the control loop characteristics. If the control loop is underdamped the large transient overshoots upon sta t-up or rapidly chulging loads move the driving frequency toward the adjacent frequencies. The propensity of the control loop to lock ,:
into an ~mwanted adjacent frequency increases with the magnitude of control loop 25 ~ overshoot and the proximi~y of said adjacent frequencies.
Due to per~ormance requirements and manufacturing variances, it is difficult to prodL~ce a pure analog control system which is not prone to said irregularities. Also, a dffliculty in the manufacture of ultrasonic vibr~tor~ is the variation in resonant frequency due to vuiaUons in materials and manufacturing processes. Such variations 30 in resonant frequency result in a greater magnitude ot error signal in the operation o~
the control loop. The probability of irregularities increases in direct proportion to the magnitude of the error signal.
WO 93~15850 . Pcr/~ls92/o9322 ,~
.. ; .
s .. ,~ 4-Z~x809o It has now been found that such irregularities may be avoided by the use o~ a microprocessor-based system interactively coupled to an analog control loop, which system provides a digitai intertace tor monitoring pertormance and restoring normal oper~tion when the system parameters exceed analog control loop boundaries.
. 5 Summarv of the Invention In accordance with the present invention there is provided an electrical apparatus for driving an ultrasonic piezoelectric crystal transducer in a surgical handpiece for the *agmentation and aspiration ot tissue, which apparatus comprises 1: a voltag2 controiled oscillator in series with an amplitier and a tirst electronic control J. 10 loop connected from a f~edback piezoelectric crystal through a phase comparator and a loop filter to the voltage controlled oscillator, which te~dback crystal is mechanically coupled to said transducer and provides a teadback signai which is a tunction of the actuai trequency of vibration of the transducer and which phase comparator compares I, the phase of the f~edback signal and ot the driving signai and provides a control signal 15 which m~ntains the driving signai at the resonant frequency of the transducer, wherein s~id ~nplffier is a voltage source arnpiffler having an output which is connected to the : piezoelectric crystal transducer with a tuning inductor in parallel.
Prefersbly the :~handpiece incorporates a piezoelactric crystal transducer operatively connected to a tool having a distai tip, which transducer, u~or.~ activation 20 by an el~ctrical driving signal provided by the apparatus according to the invention, uttr~sonically ~Jibrates said tool tip so that the tip is capable of tragmenting tissue at a surgicai operation site, and aspiration means for r~msving ~ragmented tissue from said site.
:~ ; Th~ piezoel~ric cryst~ transducer is connected in par~ilel to a tuning inductor 25 to hnn a network having a resonant ~requency corresponding to the operationalfrequency of the transducer and optimking the coupling of the voltag~ sour~e ampiifier to a r~al load. A piezoel~ctric crystal is a voltage con~rolled davice and, consequently, the advant~ge of a voltage source amplffler in parallel with a tuning inductor is that it provides a more direct control of the piezoelectric driven vib~a~r. Also, in a preferred 30 embodiment, a low value resistor is connected in series on the output of the voltage source amplffler tor added stability. This preferred embodiment is a substantialimprovement over the conventional use ot a series tuning inductor, since the response is instant because there is no inductive phase lag.
WO 93/15850 PCr/US92/09322 -5- z~ ~3090 .~ .
The invention also provides an apparatus as described above which includes a second control loop comprising means for sensing the amplitude of vibration of the , transducer ancl providing an amplitude signal, means for comparing the amplitude signal with a command signal adjustable by an operator and means for maintaining the 6 vibration at a desired operationaJ arnpHtude under varying loads by adjusting the driving sfgnal as required to bring the amplitude level into conformity with ~he command signal level.
Preterably, the second control loop includes a converter which converts the RMS
AC feedback signal to DC.
10The invention further pro~,rides a control systern for monitoring one or more electronic control loops to detect and respond to error conditions occurring during I
operations controlled by said loop or loops, which system comprises a microprocessor coupled to an analog-to-digital converter and a multiplexer, wherein the output from each control loop is input to the multiplexer, the output from the multiplexer is converted to digital forrn in the converter to provide an input digita! signal which is ~.~
processed in the microprocessor to respond with an appropriate algo~hm to correct - the error condition.
The above described control system is particularly adapted for moniioring a :
frequency control loop such as the above~escribed first control loop included in an apparatus according to the invent(on, or for monitoring an amplitude gain control loop such as the second control loop included in an apparatus according to the invention.
3 or, in the most preferred embodiment, for monitoring both first and second control loops. This preferred embodiment is more particularly described hereina~ter with3i reference to Figure 1 of the accomp~ying drawings.
.. . .
? 2~ The invention still further provides an apparatus as described above which includes n eans for achieving tissue ~electn~ r in ~l ultrasonic surgical aspirator comprising a limiter connected to the output o~the amplitude gain control loop whereby i the maximum error signal output by the loop may be ad~usted and limited by an operator.
The surgical handpiece to be used in combination with the apparatus of the 1, invention is preferably a handpiece as described and claimed in commonly assigned '? patent application Serial No. , the disclosure of which is incorporated hereby by reference.
?
~; .
80~ - -6-Thus, a preferred handpiece comprises a piezoelectric crystal transducer which is operatively connected to a tool having a distal tip, which transducer, upon activation by an electrical driving signal, ultrasonically vibrates the tool tip so that the tip is capable of fragmenting tissue at a surgical site, a teedback piezoelectric crystal S mechanically coupled to the transducer, and aspiration means for removing fragmented tissue *om the surgical site. Pr~bly, the transducer ~nd feedback crystal are mounted within an electrically insulated housing and switching means for selecting and actuding the various operations are mounted on the housing so that the handpiecemay be hand-operated.
Brief DescriDtion of the Drawinas The inventlon will ~ be more particularly described with reference to the accompanying drawings, in which:
; Figure 1 is~ a schematlc representation of control loops according to one embodiment~of the~invention;
15 ~ Figure 1A is a portion of a~ mod~led circuit between points A-A on Figure 1;
Fîgure 2 is an algorilfim illustrating the ~teps tor monitoring performance and .
restoring normal operation when the system parameters exce~d analog control loopboundaries;
Figurè 3 is an ~Igorithm which illustrates the steps for checking phase lock loop error and making necessary adjustments to bring sald error to zero;
Flgure 4 is a side elevation, partly in section, ot a preferred handpiece used with the apparatus of the invention;
Figure 5 Is a front view~ section through lme ~5 of Figure 4;
Figure 6 is a~ rear view through line 6-6 of Figure 4; and - Figure 7 is~a top view of the handpiece.
Detailed DescriDtion of the Inv~ntion - ~ The appa~us illus~hd in Figure 1 of the drawings comprises a voltage controlled osa!lator~ /C0) 1 which drives, mrough a power arnplitier 2, a driving piezoelectric crystal 3 with a sinusoidatly oscillsting voltage. This voltage is imparted 30 to the drive crystai at the output ot a voltage source power arnplifier 2, with a paralle!
inductor 4 and optionally with an impedance matching transformer T (Figure 1 A). Also .
for stability, a low value resistor R is connected to the output of the amptifier (Figure 1A). The frequency of the oscillation at the output of the VC0 is determined by the WO 93/15850 " PCI /US92/V9322 Z~2~30~0 voltage imparted to the inpu~ of the VCO. The midpoint of the oscillator's frequency range should be set at the point where it is anticipated that the system will normally be running and the range of the ~requency should cover the range over which the system will vary in normai use.
S The piezoelectric drive crystal 3 responds to the sînusoidally oscillating voltage applied to it by the VCO by vibr~ting at the same frequency and causing the entire ultrasonic vibrator assembly to vibrate at such frequency.
The feedback crystal 5, being in the ultrasonic assembly, vibrates with it. Whenstress is applied to a piezoelectric crystal, the crystal responds by developing a proportional vottage. This voltage is an indication of how the assembly is vibrating.
The amount of deflection of the vibrating assembly is indicated by the level of voltage across the feedback crystal. If the vibrating assembly is vibrating at a given sinusoidal frequency, the voltage signal from the feedback crystai will be a sine wave of such frequency. The resonant frequency of oscillation of the vibrating assembly is the ~requency at WhiCh the minimum amount of power is required to drive it. This requency is indicated by a 90 degree phase displacement between the sine wave ofthe driving signal and the sine wave of the feedback signal.
The two signals, drive 6 and feedback 79 are imparted to the inputs of a phase comparator 8. The output 9 of the phase comparator gives the cosine of the phaseangle between the drive and ~edback sine wave signals.
It the resonant freguency is the same as the center 1requency of the VCO, the VCO will drive the drive crystal at its resonant frequency. The phase angle fed back to the phase comparator between drive ~nd fe~dback will be 90 degrees giving O (zero) vOns to the VCO, through a loop filter 10 and ~n unplffler 11 which is described26 hereinafter; and the VCO will continue to drive the vibrating assembly at its resonant frequency.
If the resonance suddenly changes, due to loading, the phase angle between the two waYes wili no longer be 90 degrees. The output o~ the phase comparator will be the cosine of something other than 90 degrees, which will no longer be zero. When 30 this is te~ by the VCO (the ou~put of the pha~e comparator is fed ~o the VCO through a gain amplffler 11), the VCO will shffl its o~put ~requency in proportion to the gain o~
the amplffler multiplied by the signal from the phase comparator and in a sense so as to bring the phase angle between the drive and teedback signals back to 90 degrees.
WO 93/15850 Pcrtl~lS~2/09322 Z~;2 8090 -8-As the phase angle moves back ~oward 90 degrees the cosine of the phase angle moves back toward zéro. The system will be in equilibrium when the phase angle is as close to 90 degrees as possible with a voltage level applied to the VC0 sufficient to maintain oscillation at a frequency different from its center frequency to correspond to 6 the new resonant frequency. The more gain in the amplffler, the less will be the error.
Further complication exists due to the fact th~t the vibrating mechanical systemhas an inertia which impedes the r~t~ at which its vibration frequenc~l or arnplitude may be changed. A sudden load on the tip ot the vibrator can change its resonance. The phase comparator 8 will respond by applying a correcting voltage through the amplifier 1 û 1 1 to the VC0. It the gain of the amplffler is excessive, the VC0 will attempt to change the driving frequency mu~h taster than the vibrating mechanicai assembly can respond By the time the vibrating mechanicai assembly reaches the proper frequency defining resonance, the VC0 will have overshot it by some amount. The loop then anempts to correct in the opposite direc~ion ~nd once ~gain overshoots, and so on. If the system 15 is stable, the overshoot decreases on each cycle and eventually s0ttles. If the system is unstable, the ove7shoot does not decrease on each cycle but either stays constant and oscillates or else increases on each cycle until the system locks into an adjacent frequency or i~ darnaged.
The loop consisiing of ~he phase comparator 8, its output 9, the gain amplifier 20 11 and the VC0 1 comprises a phase locked loop (PLL) d~fined schematically by dæhed iines 12.
A second control loop 13 is provided for controlling amplitude. ~his is the automatic gain control loop ~AGC). The operator sets the amplitude of oscillation required ~r the vibrating tip at the comm~nd input 14. The sine wave 7 returning from 25 the teedback crystal is converted to a D.C. Ievel ~s a hmction of its amplitude by the RMS-to-DC converter 15. This siç~nal 16 is then fed to a summing node 17, the output 18 of which is the error sign~l betNeen the teedback and the command input 14, which error signal is fed to an error amplffler 19. The error amplifier 19 transmits a signal at its output in proportion to the ddfwence between the two inputs to the summing node 30 17. A signal 20 contrsls the amplitude of the drive signal which is the output of the power amplifier 2 which drives the driving piezoelectric crystal 3. The system is in equilibrium when the least amount of drfference exists between the two inputs. 14 and 16, but enough difference exists to achieve a level at 20 to drive the crystal and WO 93~15850 " PCl/US92/09322 2 3J. A ~ ~3 at 9 Qt feedback a signal ~rom the feedback crystal to achieve this minimal difference between 14 and 16. Error decreases with gain, but safe gain margins must be maintained to avoid instability.
One ~ature of ultrasonic ~spirators is the selectivity with which specific types5 of tissue may be fragmented and aspirated with little or no effect on adlacent tissue of other sp~cific types, In some surgical procedures this is a desirable effect, while in others it is desirable to have a less selective *agmentation capability.
It has been found that a greater or lesser tissue selectivity may be achieved byvarying, through a limiter 21, the maxinium amplitude of the driving signal applied by 10 the AGC
A multiplexer 22 has as it~ inputs an error signal 23 from the automatic gain control loop (AGC), 13, and an error signal 24 from the PLL. The output from themultiplexer is fed to an analog-to~ig tal converter 25, the output of which is transmmed to a microprocessor (liP) 26 An output signal 27 from the microprocessor is 15 transmitted to a center frequency adjusting unit 28, the output of which is fed to the VCO 1 A second output signaJ 29 from tl;e microprocessor is transmitted to a switching unit 30 ~or switching the command input be~ween either zero or a low ref~rence point 31 and an operator ~nplitude set poin~ 32.
The system in normal operation is given by the algorithm in Figure 2 The AGC
20 lop error signal 20 is polled and the level is checked 33 A dfflerence 34 greater than a predetermined value (>A) indicates a stall condition A stall condition is such that the amplitude of vibration is substantially lower than the commanded input 14 so indicating excessive loading, control loop lockup on an adjacent unwanted trequency, or some other error condition. If a stall condition is not indicated the polliny 33, 34 will continue 25 and the PLL is allowed to operate normally. If a stall condition is indicated, the PLL
error is checked 35. An abnormally high PLL error 36 (a B) indkates a lockup on an unwanted adjacent ~requency.
lf the PLL error is not greater 37 than the predetermined value (>B), and the stall condition is ir~dicated, the following algorithm is executed: A timer 38 in the 30 microprocessor system 26 is set for a maximum altowable period of time tor correction.
The interaction of the microprocessor system in this portion o~ the algorithm is an indication 39 to the operator by means of an appropriate audible, visual, tactile or other cornmunication means, that excessive pressure is being applied to the ultrasonic WO g3/1~;850 PCr/US92/0932' .
. . . , ~L~,8~90 - -1 o-surgical handpiece. The microprocessor will continue to poll 40, 41 for relie~ of th~
pressure and for an indication of excessive time by means of the timer 42, 43. Upon relie~ ot the stall condition, the microprocessor clears the tirner 44 and then clears means for operstor cornmunication 44 and retums to polling 33, 3~. If the statl is not 5 cleared and the check timer 42 indicates that the time limit has been exceeded 43 the system will shut down 45 disallowing further operation and an error condition will be signaled tothe operator by the communication means 45. A condition where both loop errors 34, 36 are simultaneously in excess of the predeterrnined values is an indication that the system has locked into an unwanted adjacent resonance. One way o~
10 correcting this condition is te relieve all pressure from the ultrasonic surgicai device 46.
set the timer 47, and switch the commanded input for the AGC loop to zero 31.
Vibration is stopped by applying zero volts 31 through switch 30 to the command input 14 ot the AGC loop. Ample time 48 is allowed for the ultrasonic generator to dissipate all stored energy 48. The command input is restored through 15 sw~tch 30 to the oporator set level 32. Ample time is allowed for the ultrasonic generator to achieve steady state vibration amplitude level 49. The error levels are rechecked 50, 51, 52, 53 along with the tirner 54O If error candition persists 51, the timer is checked 54. The algorithm will repeat continuously until either the error conditions are relieved or the timer value is exceeded 55. If the error conditions 50, 51, 20 ~52. 53 ar~ relieved prior to the timer value 55 being exc~dedl the timer is cleared 56.
and the ~Igorithm 57 (sèe Figure 3) adjusts the PLL center ~requency. The PLL error correcting algsrithm is executed, the communication means and timer are cleared 56 and the ultrasonic generator is rotumed to norrnal operaffon. I~ the timer value is exceeded 55, thc ultrasonic gener~tor is disabled 58 and an error message is 25 communicated to the operator by means of the above d~scribed communic~tion means 58.
The operation schematically represented by 57 in Figure 2 may b defined by the algorithm illustrated in Figure 3. The start of the algorithm is a polling 59, 60 to determine whether vibra~ion has been activated 61 or not 62. At the start of vibration.
30 the difference between the operator adjusted commanded input tor stroke level and the actual stroke l~vel is deterrnined by the level of the AGC loop error signal 63. I~ the signal is not zero 64, a loaded vibration condition is indicated causing the algorithm to go to normal operation 65. I~ the signal is zero 66, the PLL error signal is checked 67 2~;~8~t90 , ~, to determine it zero error exists 67. If zero error exists 68, the algorithm goes to normal operation 69. If the error is not zero 70, a determination ot the direction of the error is made 71, 72 and an increment of adjustment is imparted to the VC0 in the appropriate direction, oither higher 73 or lower 74. A loop settling ffme Is allowed 75 ~timeout) and 5 the error is once again chocked 67. Th;s is repeatod until the error is zeroed 68 after which the system is returnod to normal operaffon 69.
The handpiece illustrated in Figures 47 of the accompanying drawings comprises a housing 110, which is preferably made ot an electrically insulating plastic materlal. The housing accommodates a piezoelectric crystal transducer comprising a 10 stack of toroidal piezoehctric crystals 111. Each crystal is mechanically coupled to each ~djacent crysW and~each crystal is energized with altemating electrical energy by opposite polarity electrodes on either side of each crystal. Common polarity electrodes 106 are formed as~ a slngle part so as to reduce the number of wires within the handpiece. At the rear of the transducer is a feedback piezoelectric crystal 112 which 15 is mechanical!y coupled ~to~ tho driving crystds of the transducer and is commonly ground~d ~nth the drMng crystals. The teedback r rysbl also has a projecting electrode conneated to an electric~l iine (not shown) for conveying the feedback signal to an r~l cont~ct at tho rear o`f the housing and thence, through a connector, to a . ~ ~
1~ control ârcuit. The entire~piezoelectric assembly, including the driving and feedback ~ crystds, is electrically~msulated from the tront driver 107 and the rear driver 132 by insulating cerarnic oloments ~108 and an insulating sleeve tO9. The driving crystals f~edback cryst~l and assoaated ~electrodes are electrically insulated on both the inside and outslde with a poiymeric co~ng to prevent dielectric breakdown across the , ~ aystals~and across the insulating ceramic elements 108.
The transducer aJso~ has a propcting de rode 133 connected to an electrical line ~not shown) for conveying high trequency electrical energy 1O the front driver 107 for the purpose of tissue dissection or desiccation.
The ~ront end of the transducer terrninates in a ~oroidal flange 113 which is mounted in a rubber mount 114 bearing against the inner wall of the housing and a steel washer 115. The rear end of the transducer is attached through a vibrationisolation joint to a contact plate 1 16 which is hermetically bonded into the housing 1 10.
, ~ Electrical lines from the piezoelectric driving crystals and feedback crystal terrninate in electrical contacts 117 (Figure 6) at the rear end of the housing. The WO 93/1S850 PCr/US92/09322 ....
z~Z~09 -12-electrical contacts operativaly engaged with complementary sockets in a connector 118 when the connector is connected to the housing. The electrical lines are connected to a generator and control circuit through a csble 120 anached to the rear end of the conn~ctor. The connector O-rings 133 Isolate inigation liquid, aspiration liquid and any 5 liquid ~xternal to the handpiece *om eac,h other as well as from the electrical contacts.
The connector 118 when connected to the handpiece simultaneously engages the ultr~sonic power and feedback lines, the ele~trosurgery active w~re, the aspiration tube and the irngation tube. This the handpiece rnay be sterilized independent of anycabling.
Att~ched to the front end ot the transducer is a hollow tool 121 having a distaltip which is capable of fragmentin~tissue wt en the tool is uttrasonically vibrated by the transducer. The proximal end of the tool is threaded and a hexagonal periphery 122 adjacent the proximal end enables the tool to be threadably engaged to a cooperating thread in a fr~nt plate attachect to a flange 113 at the front end of the transducer. A
wAsher 12~ around the front piate besrs against a rubber mount 114 so that the combination of mourlt plates ~nd washers forms a liquid-tight seal about the front end o~ the transducer. This seal is essenUal to prevent any irri~ation liquid from entering the part of the housing which contains the transducer and the electrical components associated therewith.
-Irrigation liquid, usually saline solution, is conveyed to the tool tip through a channel 125 formedrbetween the inner wall of a flue 126 and the outer wall of the tool 121. The irrigation liquid reaches the channel 125 trom a conduit 127 passing along ;~ ~ the lower part of the housing, which conduit is supptied from an external reservoir through a tube ~not shown) termina~in~ in the connector 118.
The tool 121 is hollow to allow tragrnerlted tissue to be aspirated from the operaffon site. Aspiration is normally conducted by suction through the hollow tool and through a tube 128 ~Figure 5 ~nd Fi~ure 6) passing axi~ly through the housing and out through the connector.
Since the irrigation liquid, which may be conductive may have the electrical pstential of the high frequency energy applied to the front driverl sufficient insulation distance is required tor operator safety at the dQtachable connection points. Thus, a flue 126 is designed to shroud the housing 110 for a regulatory required insulation WO 93/~S850 ~ PCI/US92/09322 tracking distance. Ukewise, the connector 118 also may shroud the housing 110 toachieve the required insulation tracking distance.
In the embodiment illustrated in the drawings the handpiece is hand operated and a s~ntch module 129 is mounted on the housing. The illustrated module contains S two switches which are olectrically connected to a circuit board within the housing for operating the handpiece. It is to be understood that a handpidce used in the apparatus of the invention may have more than two hand sw~tches or may be operated by a toot suntch.
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Backqround ot the Invention The present invention relates to an electrical apparatus ior driving an ultrasonic transducer in a surgical handpiece for ths fragmentation and aspiration of ~issue at an oper~tion site on a patient, and to eleotronic control loops in the electrical circuitry o~
10 the apparatus. In particular, the invention relates to an apparatus ~or driving an ultrasonic suryical device while maintaining the vibration frequency at mechanical resonance utilizing a feedback control. The invention is also concerned ~!vith means for controlling amplitude and with a digital inter~ace for monitoring performance and restoring normal operation when the system parameters exceed analog control loopboundaries. The invention also provides means for controlling the tissue selectivity ol the apparatus.
The use of ultrasonically vibrating surgical devices for fragmenting and rem~ving unv~anted tissu~ by aspira~ion with precision and safety has led to the development of valuabie surgical procedures. Initially, the technique o~ surgical aspiration was applied to the tragmentation and removal of cataract tissue as disclosed, for example, in U.S.
Patent No. 3,589,363. Later, similar ~echniques were applied with significant success ; ~ ~ to neurosurgery and other surgery speci~ties where the application of ultrasonic energy through a handheld device for selectivity removing tissue on a layer-by-layer basis ~ith precise control was found to be fea~ible.
Certain devices known in the art characteristically prsduGe continuous vibrations having a substantially constant arnpiitude at a frequency of about twenty to about thirty KHz up to about forty to about fifty KHz. lJ.S. Pa~ents No. 4,û83,~57, 4,223,676 and 4,425,115 disclose a device suitable for the removal of soft tiss~e which is particularly adapted for removing highly compliant elastio tissue mixed with blood. Such a deYice is ~dapted to be corltinuously op~rated when the surgeon wishes to fragment and remov4 tissue, and generally is operated by a foot switch.
- A known instrument forthe ul~rasonic fragmentation of tissue at an operation site and aspiration of the tissue particles and tluid away from the site is the CUSA model System 200 Ultrasonic Aspirator manufactured and sold by Valleylab, Inc. of Stamford.
3S Connecticut; see also U.S. Patent No. 4,827,911. When the longitudinally vibraling tip in such an aspirator is brought into centact with tissue it gently, selectively and precisely fragments and removes the tissue. Advantages o~ this unique surgica!
WO 93/15850 ~Cl';/Us92~09322 .. , ;~ . `.
~ ~809 -2-,...... . .
.' instrument include little damage to healthy tissue in a tumor removal procedure, blood vessels can be skeletonized, healing of tissue is promoted, no charring or tearing oi margins of surrounding tissue, only minimal pulling of healthy tissue is experienced, and ~xcellent tactile feedback for selectlvely controlled tissue fragmentation and S removal is provided.
In many surgical procedures where ultrasonic ~ragmentation instruments are employed additional instrurnents are required for tissue cutting and hemostasis at the operation site. For example, hemostasis is n~ded in desicc.ation techniques ~or deep coagulation to dry out large volumes of tissue and also in tulguration techniques for 10 spray coagulation to dry out the surface of tissues.
The apparatus disclosed in U.S. Patents No. 4,931,047 and 5,015,227 provides hemostasis in combination with an ultrasonically vibrating surgical fragmentation , instrument and aspirator. The apparatus effectively provides both a coagulation , . .
.j capability and an enhanced ability to tragment and aspirate tissue in a m~nner which ~!: 15 reducestraumato surrounding tissue.
~1 U.S. Patent No. 4,750,488 and its two continuation Patents 4,750,902 and - 4,922,902 disclose a method and apparatus which utilQe a combination of ultrasonic tragmentation, aspiration and cauterization.
` In an apparatus which 1ragments tissue by the ultrasonic vibration of a tool tip, it is desirable, for optimum efficiency and energy utilization, that the transducer which provides the ultrasonic vibration should operate at resonant ~requency. When th~~ transducer is a piezoelectric crystal the trequency at which it vibrates will corresponb 3 ~ to the *equency of the electrical driving signal which causes the vibration. The i ~ operation is most efficient when the tr~nsducer vibrates at i~s resonant frequency 25 How~wr, changes in operational parameters, such as, changes in temperature, therma!
expansion and load impedance, resuH in deviations in the resonant frequency Accordingly, controlled changes in the *equency of the driving signa~ are required to track the resonant *equency.
The circuit disclosed in U,S Patent No. 4,750,488 includes a ~requency contro 30 loop which depends upon a ~eedback signal obtained by adding two signais that ar~
proportionai to the voltage and current input to the piezoelectric transducer.
. WO 93/15850 " PCr/US92/09322 ,:
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U.S. Patent No. 4,965,532 discloses a circuit for driving an ultrasonic transducer including a frequency control means utilizing a feedback control dependent upon tirst and second phase detection signals.
It h~s now been found that an efficient trequency control is obtained with the aid of a unique control loop which includes a feedback piezoelectric crystal mechanically coupled to the piezoelectric transducer.
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The use of a feedback crystal in a tuned circuit which provides a filtered signal ~'~ to control a driving signal in an ultrasonic system is disclosed in U.S Patent No.
. 4,012,647. The system disclosed in this patent is not a surgical apparatus and the combination of ultrasonic vibrator, amplifier and tuning inductance with feedback from the feedback crystal to the mput of the ampkfier, constitutes an oscillator. In contrast thereto, the novel circuit of the present invention incorporates a voltage controlled oscillator ~VC0) as part of a control loop. The faedback signal from a feedback crystal is input to the control loop~which then drives the amplifier. The advantage of this novel 15 - circuit is that X tracks mechanical resonance without electrical interaction.
A problem which frec~uently~ arises during the operation of an ultrasonic surgicai , .
appuatus which includes a feedback control loop is the propensity of the control loop to lock into an unwanted adjAcent frequency rather than 1he desired resonant frequency.
The occurrene2 ot this problem depends upon the frequency spectrum of the system and the control loop characteristics. If the control loop is underdamped the large transient overshoots upon sta t-up or rapidly chulging loads move the driving frequency toward the adjacent frequencies. The propensity of the control loop to lock ,:
into an ~mwanted adjacent frequency increases with the magnitude of control loop 25 ~ overshoot and the proximi~y of said adjacent frequencies.
Due to per~ormance requirements and manufacturing variances, it is difficult to prodL~ce a pure analog control system which is not prone to said irregularities. Also, a dffliculty in the manufacture of ultrasonic vibr~tor~ is the variation in resonant frequency due to vuiaUons in materials and manufacturing processes. Such variations 30 in resonant frequency result in a greater magnitude ot error signal in the operation o~
the control loop. The probability of irregularities increases in direct proportion to the magnitude of the error signal.
WO 93~15850 . Pcr/~ls92/o9322 ,~
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s .. ,~ 4-Z~x809o It has now been found that such irregularities may be avoided by the use o~ a microprocessor-based system interactively coupled to an analog control loop, which system provides a digitai intertace tor monitoring pertormance and restoring normal oper~tion when the system parameters exceed analog control loop boundaries.
. 5 Summarv of the Invention In accordance with the present invention there is provided an electrical apparatus for driving an ultrasonic piezoelectric crystal transducer in a surgical handpiece for the *agmentation and aspiration ot tissue, which apparatus comprises 1: a voltag2 controiled oscillator in series with an amplitier and a tirst electronic control J. 10 loop connected from a f~edback piezoelectric crystal through a phase comparator and a loop filter to the voltage controlled oscillator, which te~dback crystal is mechanically coupled to said transducer and provides a teadback signai which is a tunction of the actuai trequency of vibration of the transducer and which phase comparator compares I, the phase of the f~edback signal and ot the driving signai and provides a control signal 15 which m~ntains the driving signai at the resonant frequency of the transducer, wherein s~id ~nplffier is a voltage source arnpiffler having an output which is connected to the : piezoelectric crystal transducer with a tuning inductor in parallel.
Prefersbly the :~handpiece incorporates a piezoelactric crystal transducer operatively connected to a tool having a distai tip, which transducer, u~or.~ activation 20 by an el~ctrical driving signal provided by the apparatus according to the invention, uttr~sonically ~Jibrates said tool tip so that the tip is capable of tragmenting tissue at a surgicai operation site, and aspiration means for r~msving ~ragmented tissue from said site.
:~ ; Th~ piezoel~ric cryst~ transducer is connected in par~ilel to a tuning inductor 25 to hnn a network having a resonant ~requency corresponding to the operationalfrequency of the transducer and optimking the coupling of the voltag~ sour~e ampiifier to a r~al load. A piezoel~ctric crystal is a voltage con~rolled davice and, consequently, the advant~ge of a voltage source amplffler in parallel with a tuning inductor is that it provides a more direct control of the piezoelectric driven vib~a~r. Also, in a preferred 30 embodiment, a low value resistor is connected in series on the output of the voltage source amplffler tor added stability. This preferred embodiment is a substantialimprovement over the conventional use ot a series tuning inductor, since the response is instant because there is no inductive phase lag.
WO 93/15850 PCr/US92/09322 -5- z~ ~3090 .~ .
The invention also provides an apparatus as described above which includes a second control loop comprising means for sensing the amplitude of vibration of the , transducer ancl providing an amplitude signal, means for comparing the amplitude signal with a command signal adjustable by an operator and means for maintaining the 6 vibration at a desired operationaJ arnpHtude under varying loads by adjusting the driving sfgnal as required to bring the amplitude level into conformity with ~he command signal level.
Preterably, the second control loop includes a converter which converts the RMS
AC feedback signal to DC.
10The invention further pro~,rides a control systern for monitoring one or more electronic control loops to detect and respond to error conditions occurring during I
operations controlled by said loop or loops, which system comprises a microprocessor coupled to an analog-to-digital converter and a multiplexer, wherein the output from each control loop is input to the multiplexer, the output from the multiplexer is converted to digital forrn in the converter to provide an input digita! signal which is ~.~
processed in the microprocessor to respond with an appropriate algo~hm to correct - the error condition.
The above described control system is particularly adapted for moniioring a :
frequency control loop such as the above~escribed first control loop included in an apparatus according to the invent(on, or for monitoring an amplitude gain control loop such as the second control loop included in an apparatus according to the invention.
3 or, in the most preferred embodiment, for monitoring both first and second control loops. This preferred embodiment is more particularly described hereina~ter with3i reference to Figure 1 of the accomp~ying drawings.
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? 2~ The invention still further provides an apparatus as described above which includes n eans for achieving tissue ~electn~ r in ~l ultrasonic surgical aspirator comprising a limiter connected to the output o~the amplitude gain control loop whereby i the maximum error signal output by the loop may be ad~usted and limited by an operator.
The surgical handpiece to be used in combination with the apparatus of the 1, invention is preferably a handpiece as described and claimed in commonly assigned '? patent application Serial No. , the disclosure of which is incorporated hereby by reference.
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80~ - -6-Thus, a preferred handpiece comprises a piezoelectric crystal transducer which is operatively connected to a tool having a distal tip, which transducer, upon activation by an electrical driving signal, ultrasonically vibrates the tool tip so that the tip is capable of fragmenting tissue at a surgical site, a teedback piezoelectric crystal S mechanically coupled to the transducer, and aspiration means for removing fragmented tissue *om the surgical site. Pr~bly, the transducer ~nd feedback crystal are mounted within an electrically insulated housing and switching means for selecting and actuding the various operations are mounted on the housing so that the handpiecemay be hand-operated.
Brief DescriDtion of the Drawinas The inventlon will ~ be more particularly described with reference to the accompanying drawings, in which:
; Figure 1 is~ a schematlc representation of control loops according to one embodiment~of the~invention;
15 ~ Figure 1A is a portion of a~ mod~led circuit between points A-A on Figure 1;
Fîgure 2 is an algorilfim illustrating the ~teps tor monitoring performance and .
restoring normal operation when the system parameters exce~d analog control loopboundaries;
Figurè 3 is an ~Igorithm which illustrates the steps for checking phase lock loop error and making necessary adjustments to bring sald error to zero;
Flgure 4 is a side elevation, partly in section, ot a preferred handpiece used with the apparatus of the invention;
Figure 5 Is a front view~ section through lme ~5 of Figure 4;
Figure 6 is a~ rear view through line 6-6 of Figure 4; and - Figure 7 is~a top view of the handpiece.
Detailed DescriDtion of the Inv~ntion - ~ The appa~us illus~hd in Figure 1 of the drawings comprises a voltage controlled osa!lator~ /C0) 1 which drives, mrough a power arnplitier 2, a driving piezoelectric crystal 3 with a sinusoidatly oscillsting voltage. This voltage is imparted 30 to the drive crystai at the output ot a voltage source power arnplifier 2, with a paralle!
inductor 4 and optionally with an impedance matching transformer T (Figure 1 A). Also .
for stability, a low value resistor R is connected to the output of the amptifier (Figure 1A). The frequency of the oscillation at the output of the VC0 is determined by the WO 93/15850 " PCI /US92/V9322 Z~2~30~0 voltage imparted to the inpu~ of the VCO. The midpoint of the oscillator's frequency range should be set at the point where it is anticipated that the system will normally be running and the range of the ~requency should cover the range over which the system will vary in normai use.
S The piezoelectric drive crystal 3 responds to the sînusoidally oscillating voltage applied to it by the VCO by vibr~ting at the same frequency and causing the entire ultrasonic vibrator assembly to vibrate at such frequency.
The feedback crystal 5, being in the ultrasonic assembly, vibrates with it. Whenstress is applied to a piezoelectric crystal, the crystal responds by developing a proportional vottage. This voltage is an indication of how the assembly is vibrating.
The amount of deflection of the vibrating assembly is indicated by the level of voltage across the feedback crystal. If the vibrating assembly is vibrating at a given sinusoidal frequency, the voltage signal from the feedback crystai will be a sine wave of such frequency. The resonant frequency of oscillation of the vibrating assembly is the ~requency at WhiCh the minimum amount of power is required to drive it. This requency is indicated by a 90 degree phase displacement between the sine wave ofthe driving signal and the sine wave of the feedback signal.
The two signals, drive 6 and feedback 79 are imparted to the inputs of a phase comparator 8. The output 9 of the phase comparator gives the cosine of the phaseangle between the drive and ~edback sine wave signals.
It the resonant freguency is the same as the center 1requency of the VCO, the VCO will drive the drive crystal at its resonant frequency. The phase angle fed back to the phase comparator between drive ~nd fe~dback will be 90 degrees giving O (zero) vOns to the VCO, through a loop filter 10 and ~n unplffler 11 which is described26 hereinafter; and the VCO will continue to drive the vibrating assembly at its resonant frequency.
If the resonance suddenly changes, due to loading, the phase angle between the two waYes wili no longer be 90 degrees. The output o~ the phase comparator will be the cosine of something other than 90 degrees, which will no longer be zero. When 30 this is te~ by the VCO (the ou~put of the pha~e comparator is fed ~o the VCO through a gain amplffler 11), the VCO will shffl its o~put ~requency in proportion to the gain o~
the amplffler multiplied by the signal from the phase comparator and in a sense so as to bring the phase angle between the drive and teedback signals back to 90 degrees.
WO 93/15850 Pcrtl~lS~2/09322 Z~;2 8090 -8-As the phase angle moves back ~oward 90 degrees the cosine of the phase angle moves back toward zéro. The system will be in equilibrium when the phase angle is as close to 90 degrees as possible with a voltage level applied to the VC0 sufficient to maintain oscillation at a frequency different from its center frequency to correspond to 6 the new resonant frequency. The more gain in the amplffler, the less will be the error.
Further complication exists due to the fact th~t the vibrating mechanical systemhas an inertia which impedes the r~t~ at which its vibration frequenc~l or arnplitude may be changed. A sudden load on the tip ot the vibrator can change its resonance. The phase comparator 8 will respond by applying a correcting voltage through the amplifier 1 û 1 1 to the VC0. It the gain of the amplffler is excessive, the VC0 will attempt to change the driving frequency mu~h taster than the vibrating mechanicai assembly can respond By the time the vibrating mechanicai assembly reaches the proper frequency defining resonance, the VC0 will have overshot it by some amount. The loop then anempts to correct in the opposite direc~ion ~nd once ~gain overshoots, and so on. If the system 15 is stable, the overshoot decreases on each cycle and eventually s0ttles. If the system is unstable, the ove7shoot does not decrease on each cycle but either stays constant and oscillates or else increases on each cycle until the system locks into an adjacent frequency or i~ darnaged.
The loop consisiing of ~he phase comparator 8, its output 9, the gain amplifier 20 11 and the VC0 1 comprises a phase locked loop (PLL) d~fined schematically by dæhed iines 12.
A second control loop 13 is provided for controlling amplitude. ~his is the automatic gain control loop ~AGC). The operator sets the amplitude of oscillation required ~r the vibrating tip at the comm~nd input 14. The sine wave 7 returning from 25 the teedback crystal is converted to a D.C. Ievel ~s a hmction of its amplitude by the RMS-to-DC converter 15. This siç~nal 16 is then fed to a summing node 17, the output 18 of which is the error sign~l betNeen the teedback and the command input 14, which error signal is fed to an error amplffler 19. The error amplifier 19 transmits a signal at its output in proportion to the ddfwence between the two inputs to the summing node 30 17. A signal 20 contrsls the amplitude of the drive signal which is the output of the power amplifier 2 which drives the driving piezoelectric crystal 3. The system is in equilibrium when the least amount of drfference exists between the two inputs. 14 and 16, but enough difference exists to achieve a level at 20 to drive the crystal and WO 93~15850 " PCl/US92/09322 2 3J. A ~ ~3 at 9 Qt feedback a signal ~rom the feedback crystal to achieve this minimal difference between 14 and 16. Error decreases with gain, but safe gain margins must be maintained to avoid instability.
One ~ature of ultrasonic ~spirators is the selectivity with which specific types5 of tissue may be fragmented and aspirated with little or no effect on adlacent tissue of other sp~cific types, In some surgical procedures this is a desirable effect, while in others it is desirable to have a less selective *agmentation capability.
It has been found that a greater or lesser tissue selectivity may be achieved byvarying, through a limiter 21, the maxinium amplitude of the driving signal applied by 10 the AGC
A multiplexer 22 has as it~ inputs an error signal 23 from the automatic gain control loop (AGC), 13, and an error signal 24 from the PLL. The output from themultiplexer is fed to an analog-to~ig tal converter 25, the output of which is transmmed to a microprocessor (liP) 26 An output signal 27 from the microprocessor is 15 transmitted to a center frequency adjusting unit 28, the output of which is fed to the VCO 1 A second output signaJ 29 from tl;e microprocessor is transmitted to a switching unit 30 ~or switching the command input be~ween either zero or a low ref~rence point 31 and an operator ~nplitude set poin~ 32.
The system in normal operation is given by the algorithm in Figure 2 The AGC
20 lop error signal 20 is polled and the level is checked 33 A dfflerence 34 greater than a predetermined value (>A) indicates a stall condition A stall condition is such that the amplitude of vibration is substantially lower than the commanded input 14 so indicating excessive loading, control loop lockup on an adjacent unwanted trequency, or some other error condition. If a stall condition is not indicated the polliny 33, 34 will continue 25 and the PLL is allowed to operate normally. If a stall condition is indicated, the PLL
error is checked 35. An abnormally high PLL error 36 (a B) indkates a lockup on an unwanted adjacent ~requency.
lf the PLL error is not greater 37 than the predetermined value (>B), and the stall condition is ir~dicated, the following algorithm is executed: A timer 38 in the 30 microprocessor system 26 is set for a maximum altowable period of time tor correction.
The interaction of the microprocessor system in this portion o~ the algorithm is an indication 39 to the operator by means of an appropriate audible, visual, tactile or other cornmunication means, that excessive pressure is being applied to the ultrasonic WO g3/1~;850 PCr/US92/0932' .
. . . , ~L~,8~90 - -1 o-surgical handpiece. The microprocessor will continue to poll 40, 41 for relie~ of th~
pressure and for an indication of excessive time by means of the timer 42, 43. Upon relie~ ot the stall condition, the microprocessor clears the tirner 44 and then clears means for operstor cornmunication 44 and retums to polling 33, 3~. If the statl is not 5 cleared and the check timer 42 indicates that the time limit has been exceeded 43 the system will shut down 45 disallowing further operation and an error condition will be signaled tothe operator by the communication means 45. A condition where both loop errors 34, 36 are simultaneously in excess of the predeterrnined values is an indication that the system has locked into an unwanted adjacent resonance. One way o~
10 correcting this condition is te relieve all pressure from the ultrasonic surgicai device 46.
set the timer 47, and switch the commanded input for the AGC loop to zero 31.
Vibration is stopped by applying zero volts 31 through switch 30 to the command input 14 ot the AGC loop. Ample time 48 is allowed for the ultrasonic generator to dissipate all stored energy 48. The command input is restored through 15 sw~tch 30 to the oporator set level 32. Ample time is allowed for the ultrasonic generator to achieve steady state vibration amplitude level 49. The error levels are rechecked 50, 51, 52, 53 along with the tirner 54O If error candition persists 51, the timer is checked 54. The algorithm will repeat continuously until either the error conditions are relieved or the timer value is exceeded 55. If the error conditions 50, 51, 20 ~52. 53 ar~ relieved prior to the timer value 55 being exc~dedl the timer is cleared 56.
and the ~Igorithm 57 (sèe Figure 3) adjusts the PLL center ~requency. The PLL error correcting algsrithm is executed, the communication means and timer are cleared 56 and the ultrasonic generator is rotumed to norrnal operaffon. I~ the timer value is exceeded 55, thc ultrasonic gener~tor is disabled 58 and an error message is 25 communicated to the operator by means of the above d~scribed communic~tion means 58.
The operation schematically represented by 57 in Figure 2 may b defined by the algorithm illustrated in Figure 3. The start of the algorithm is a polling 59, 60 to determine whether vibra~ion has been activated 61 or not 62. At the start of vibration.
30 the difference between the operator adjusted commanded input tor stroke level and the actual stroke l~vel is deterrnined by the level of the AGC loop error signal 63. I~ the signal is not zero 64, a loaded vibration condition is indicated causing the algorithm to go to normal operation 65. I~ the signal is zero 66, the PLL error signal is checked 67 2~;~8~t90 , ~, to determine it zero error exists 67. If zero error exists 68, the algorithm goes to normal operation 69. If the error is not zero 70, a determination ot the direction of the error is made 71, 72 and an increment of adjustment is imparted to the VC0 in the appropriate direction, oither higher 73 or lower 74. A loop settling ffme Is allowed 75 ~timeout) and 5 the error is once again chocked 67. Th;s is repeatod until the error is zeroed 68 after which the system is returnod to normal operaffon 69.
The handpiece illustrated in Figures 47 of the accompanying drawings comprises a housing 110, which is preferably made ot an electrically insulating plastic materlal. The housing accommodates a piezoelectric crystal transducer comprising a 10 stack of toroidal piezoehctric crystals 111. Each crystal is mechanically coupled to each ~djacent crysW and~each crystal is energized with altemating electrical energy by opposite polarity electrodes on either side of each crystal. Common polarity electrodes 106 are formed as~ a slngle part so as to reduce the number of wires within the handpiece. At the rear of the transducer is a feedback piezoelectric crystal 112 which 15 is mechanical!y coupled ~to~ tho driving crystds of the transducer and is commonly ground~d ~nth the drMng crystals. The teedback r rysbl also has a projecting electrode conneated to an electric~l iine (not shown) for conveying the feedback signal to an r~l cont~ct at tho rear o`f the housing and thence, through a connector, to a . ~ ~
1~ control ârcuit. The entire~piezoelectric assembly, including the driving and feedback ~ crystds, is electrically~msulated from the tront driver 107 and the rear driver 132 by insulating cerarnic oloments ~108 and an insulating sleeve tO9. The driving crystals f~edback cryst~l and assoaated ~electrodes are electrically insulated on both the inside and outslde with a poiymeric co~ng to prevent dielectric breakdown across the , ~ aystals~and across the insulating ceramic elements 108.
The transducer aJso~ has a propcting de rode 133 connected to an electrical line ~not shown) for conveying high trequency electrical energy 1O the front driver 107 for the purpose of tissue dissection or desiccation.
The ~ront end of the transducer terrninates in a ~oroidal flange 113 which is mounted in a rubber mount 114 bearing against the inner wall of the housing and a steel washer 115. The rear end of the transducer is attached through a vibrationisolation joint to a contact plate 1 16 which is hermetically bonded into the housing 1 10.
, ~ Electrical lines from the piezoelectric driving crystals and feedback crystal terrninate in electrical contacts 117 (Figure 6) at the rear end of the housing. The WO 93/1S850 PCr/US92/09322 ....
z~Z~09 -12-electrical contacts operativaly engaged with complementary sockets in a connector 118 when the connector is connected to the housing. The electrical lines are connected to a generator and control circuit through a csble 120 anached to the rear end of the conn~ctor. The connector O-rings 133 Isolate inigation liquid, aspiration liquid and any 5 liquid ~xternal to the handpiece *om eac,h other as well as from the electrical contacts.
The connector 118 when connected to the handpiece simultaneously engages the ultr~sonic power and feedback lines, the ele~trosurgery active w~re, the aspiration tube and the irngation tube. This the handpiece rnay be sterilized independent of anycabling.
Att~ched to the front end ot the transducer is a hollow tool 121 having a distaltip which is capable of fragmentin~tissue wt en the tool is uttrasonically vibrated by the transducer. The proximal end of the tool is threaded and a hexagonal periphery 122 adjacent the proximal end enables the tool to be threadably engaged to a cooperating thread in a fr~nt plate attachect to a flange 113 at the front end of the transducer. A
wAsher 12~ around the front piate besrs against a rubber mount 114 so that the combination of mourlt plates ~nd washers forms a liquid-tight seal about the front end o~ the transducer. This seal is essenUal to prevent any irri~ation liquid from entering the part of the housing which contains the transducer and the electrical components associated therewith.
-Irrigation liquid, usually saline solution, is conveyed to the tool tip through a channel 125 formedrbetween the inner wall of a flue 126 and the outer wall of the tool 121. The irrigation liquid reaches the channel 125 trom a conduit 127 passing along ;~ ~ the lower part of the housing, which conduit is supptied from an external reservoir through a tube ~not shown) termina~in~ in the connector 118.
The tool 121 is hollow to allow tragrnerlted tissue to be aspirated from the operaffon site. Aspiration is normally conducted by suction through the hollow tool and through a tube 128 ~Figure 5 ~nd Fi~ure 6) passing axi~ly through the housing and out through the connector.
Since the irrigation liquid, which may be conductive may have the electrical pstential of the high frequency energy applied to the front driverl sufficient insulation distance is required tor operator safety at the dQtachable connection points. Thus, a flue 126 is designed to shroud the housing 110 for a regulatory required insulation WO 93/~S850 ~ PCI/US92/09322 tracking distance. Ukewise, the connector 118 also may shroud the housing 110 toachieve the required insulation tracking distance.
In the embodiment illustrated in the drawings the handpiece is hand operated and a s~ntch module 129 is mounted on the housing. The illustrated module contains S two switches which are olectrically connected to a circuit board within the housing for operating the handpiece. It is to be understood that a handpidce used in the apparatus of the invention may have more than two hand sw~tches or may be operated by a toot suntch.
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Claims (11)
1. An electrical apparatus for driving an ultrasonic piezoelectric crystal transducer in a surgical handpiece for the fragmentation and aspiration of tissue, which apparatus comprises a voltage controlled oscillator in series with an amplifier and a first electronic control loop connected from a feedback piezoelectric crystal through a phase comparator and a loop filter to the voltage controlled oscillator, which feedback crystal is mechanically coupled to said transducer and provides a feedback signal which is a function of the actual frequency of vibration of the transducer and which phase comparator compares the phase of the feedback signal and of the driving signal and provides a control signal which maintains the driving signal at the resonant frequency of the transducer, wherein said amplifier is a voltage source amplifier having an output which is connected to the piezoelectric crystal transducer with a tuning inductor in parallel.
2. An apparatus according to claim 1, in which the piezoelectric crystal transducer is operatively connected to a tool having a distal tip, which transducer, upon activation by a driving signal, ultrasonically vibrate the tool tip so that the tip is capable of fragmenting tissue at a surgical operation site.
3. An apparatus according to claim 2, in which the handpiece includes aspiration means for removing fragmented tissue from said surgical site.
4. An apparatus according to claim 1, in which a low value resistor is connected in series on the output of the voltage source amplifier for added stability.
5. An apparatus according to claim 1 which includes a second control loop comprising means for sensing the amplitude of vibration of the transducer and providing an amplitude signal, means for comparing the amplitude signal with a command signal adjustable by an operator and means for maintaining the vibration at a desired operational amplitude under varying loads by adjusting the driving signal as required to bring the amplitude level to conformity with the command signal level.
6. An apparatus according to claim 5, in which the second control loop includes a converter which converts the RMS AC feedback signal to DC.
7. An apparatus according to claim 5, in which a limiter is connected to the output of the second control loop whereby the maximum error signal output of the loop may be adjusted and limited by an operator to achieve tissue selectivity.
8. A control system for monitoring one or more electronic control loops to detect and respond to error conditions occurring during operations controlled by said loop or loops, which system comprises a microprocessor coupled to an analog-to-digital converter and a multiplexer, wherein the output from each control loop is input to the multiplexer, the output from the multiplexer is converted to digital form in the converter to provided an input digital signal which is processed in the microprocessor to respond with an appropriate algorithm to correct the error condition.
9. A control system according to claim 8, in which the electronic control loop being monitored is a frequency control loop incorporated in an apparatus for driving an ultrasonic piezoelectric crystal transducer in a surgical handpiece for the fragmentation and aspiration of tissue, which apparatus comprises a voltage controlled oscillator in series with an amplifier and said frequency control loop connected from a feedback piezoelectric crystal through a phase comparator and a loop filter to the voltage controlled oscillator, which feedback crystal is mechanically coupled to said transducer and provides a feedback signal which is a function of the actual frequency of vibration of the transducer and which phase comparator compares the phase of the feedback signal and of the driving signal and provides a control signal which maintains the driving signal at the resonant frequency of the transducer, wherein said amplifier is a voltage source amplifier having an output which is connected to the piezoelectric crystal transducer with a turning inductor in parallel.
10. A control system according to claim 8, in which the electronic control loop being monitored is an amplitude gain control loop comprising means for sensing the amplitude of vibration of an ultrasonic piezoelectric crystal transducer and providing an amplitude signal, means for comparing the amplitude signal with a command signal adjustable by an operator and means for maintaining the vibration at a desired operational amplitude under varying loads by adjusting the driving signal as required to bring the amplitude level into conformity with the command signal level.
11. A combination apparatus and control system for driving, monitoring and controlling an ultrasonic piezoelectric crystal transducer in a surgical handpiece for the fragmentation and aspiration of tissue, comprising a voltage controlled oscillator in series with an amplifier and a first electronic control loop connected from a feedback piezoelectric crystal through a phase comparator and a loop filter to the voltage controlled oscillator, which feedback crystal is mechanically coupled to said transducer and provides a feedback signal which is a function of the actual frequency of vibration of the transducer and which phase comparator compares the phase of the feedback signal and of the driving signal and provides a control signal which maintains the driving signal at the resonant frequency of the transducer, wherein said amplifier is a voltage source amplifier having an output which is connected to the piezoelectric crystal transducer with a tuning inductor in parallel; a second control loop comprising means for sensing the amplitude of vibration of the transducer and providing an amplitude signal, means for comparing the amplitude signal with a command signal adjustable by an operator and means for maintaining the vibration at a desired operational amplitude under varying loads by adjusting the driving signal as required to bring the amplitude level into conformity with the command signal level; and a control system for monitoring said first and second control loops to detect and respond to error conditions occurring during operations controlled by said loops, which system comprises a microprocessor coupled to an analog-to-digital converter and a multiplexer, wherein the output from each control loop is input to the multiplexer, the output from the multiplexer is converted to digital form in the converter to provide an input digital signal which is processed in the microprocessor to respond with an appropriate algorithm to correct the error condition.
Applications Claiming Priority (2)
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US83253492A | 1992-02-07 | 1992-02-07 | |
US832,534 | 1992-02-07 |
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CA2128090A1 true CA2128090A1 (en) | 1993-08-19 |
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Family Applications (1)
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CA002128090A Abandoned CA2128090A1 (en) | 1992-02-07 | 1992-11-06 | Ultrasonic surgical apparatus |
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US (1) | US6083191A (en) |
EP (2) | EP0625077B1 (en) |
JP (2) | JP2506563B2 (en) |
KR (1) | KR950700131A (en) |
AT (1) | ATE155054T1 (en) |
AU (3) | AU663543B2 (en) |
CA (1) | CA2128090A1 (en) |
DE (2) | DE69220814T2 (en) |
ES (1) | ES2104953T3 (en) |
FI (1) | FI943649A (en) |
NO (1) | NO942924L (en) |
TW (1) | TW233255B (en) |
WO (1) | WO1993015850A1 (en) |
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-
1992
- 1992-11-06 AT AT92924159T patent/ATE155054T1/en not_active IP Right Cessation
- 1992-11-06 KR KR1019940702701A patent/KR950700131A/en not_active Application Discontinuation
- 1992-11-06 CA CA002128090A patent/CA2128090A1/en not_active Abandoned
- 1992-11-06 DE DE69220814T patent/DE69220814T2/en not_active Expired - Lifetime
- 1992-11-06 DE DE9290173U patent/DE9290173U1/en not_active Expired - Lifetime
- 1992-11-06 EP EP92924159A patent/EP0625077B1/en not_active Expired - Lifetime
- 1992-11-06 JP JP5514027A patent/JP2506563B2/en not_active Expired - Fee Related
- 1992-11-06 EP EP96100475A patent/EP0711611A3/en not_active Withdrawn
- 1992-11-06 WO PCT/US1992/009322 patent/WO1993015850A1/en active IP Right Grant
- 1992-11-06 ES ES92924159T patent/ES2104953T3/en not_active Expired - Lifetime
- 1992-11-06 AU AU30576/92A patent/AU663543B2/en not_active Ceased
- 1992-11-09 TW TW081108938A patent/TW233255B/zh active
-
1993
- 1993-08-09 US US08/116,261 patent/US6083191A/en not_active Expired - Lifetime
-
1994
- 1994-08-05 FI FI943649A patent/FI943649A/en not_active Application Discontinuation
- 1994-08-05 NO NO942924A patent/NO942924L/en unknown
-
1995
- 1995-08-11 AU AU28497/95A patent/AU2849795A/en not_active Abandoned
- 1995-09-07 JP JP7230459A patent/JPH08103452A/en active Pending
-
1998
- 1998-02-24 AU AU56281/98A patent/AU5628198A/en not_active Abandoned
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WO1993015850A1 (en) | 1993-08-19 |
AU5628198A (en) | 1998-05-14 |
US6083191A (en) | 2000-07-04 |
EP0711611A2 (en) | 1996-05-15 |
KR950700131A (en) | 1995-01-16 |
FI943649A0 (en) | 1994-08-05 |
AU2849795A (en) | 1995-11-30 |
TW233255B (en) | 1994-11-01 |
JPH08103452A (en) | 1996-04-23 |
EP0625077B1 (en) | 1997-07-09 |
DE9290173U1 (en) | 1994-10-27 |
AU3057692A (en) | 1993-09-03 |
DE69220814D1 (en) | 1997-08-14 |
ES2104953T3 (en) | 1997-10-16 |
FI943649A (en) | 1994-08-05 |
ATE155054T1 (en) | 1997-07-15 |
AU663543B2 (en) | 1995-10-12 |
DE69220814T2 (en) | 1998-02-05 |
JP2506563B2 (en) | 1996-06-12 |
NO942924L (en) | 1994-10-05 |
JPH07500273A (en) | 1995-01-12 |
NO942924D0 (en) | 1994-08-05 |
EP0711611A3 (en) | 1996-11-13 |
EP0625077A1 (en) | 1994-11-23 |
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Legal Events
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EEER | Examination request | ||
FZDE | Discontinued |