U.S. patent application number 10/887021 was filed with the patent office on 2005-02-03 for apparatus and method for altering generator functions in an ultrasonic surgical system.
Invention is credited to Donofrio, William T., Kemerling, Robert Alan, Wiener, Eitan T..
Application Number | 20050027311 10/887021 |
Document ID | / |
Family ID | 26934888 |
Filed Date | 2005-02-03 |
United States Patent
Application |
20050027311 |
Kind Code |
A1 |
Wiener, Eitan T. ; et
al. |
February 3, 2005 |
Apparatus and method for altering generator functions in an
ultrasonic surgical system
Abstract
The present invention provides a system for implementing
surgical procedures which includes an ultrasonic surgical hand
piece having an end-effector, a console having a digital signal
processor (DSP) for controlling the hand piece, an electrical
connection connecting the hand piece and the console, and a memory,
such as an EEPROM (Electrically Erasable Programmable Read Only
Memory), disposed in the electrical connection. The console sends a
drive current to drive the hand piece which imparts ultrasonic
longitudinal movement to the blade. The console reads the memory
and authenticates the hand piece for use with the console if
particular or proprietary data are present in the memory. Moreover,
to prevent errors in operating the hand piece, the memory can store
certain diagnostic information which the console can utilize in
determining whether the operation of the hand piece should be
handicapped or disabled. Furthermore, the memory can be used to
reprogram the console, if needed.
Inventors: |
Wiener, Eitan T.;
(Cincinnati, OH) ; Donofrio, William T.;
(Cincinnati, OH) ; Kemerling, Robert Alan;
(Cincinnati, OH) |
Correspondence
Address: |
PHILIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
26934888 |
Appl. No.: |
10/887021 |
Filed: |
July 8, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10887021 |
Jul 8, 2004 |
|
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09954795 |
Sep 17, 2001 |
|
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60242171 |
Oct 20, 2000 |
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Current U.S.
Class: |
606/169 |
Current CPC
Class: |
A61B 2017/00123
20130101; A61B 2017/00482 20130101; A61B 2017/320071 20170801; A61B
17/320068 20130101; A61B 2018/00988 20130101; A61B 2017/320069
20170801; A61B 2090/0805 20160201; A61B 2017/320089 20170801; A61B
2090/0803 20160201 |
Class at
Publication: |
606/169 |
International
Class: |
A61B 017/32 |
Claims
We claim:
1. A system for implementing surgical procedures comprising: an
ultrasonic surgical hand piece having an end-effector; a console
having a digital signal processor (DSP) for controlling the hand
piece; an electrical connection connecting the hand piece and the
console, wherein the console sends a drive current to drive the
hand piece which imparts ultrasonic longitudinal movement to the
end-effector; and a memory disposed in the electrical connection,
wherein the console reads information stored in the memory to
authenticate the hand piece for use with the console.
2. The system of claim 1 wherein the information stored in the
memory includes a cyclical redundancy check (CRC) code, and the
information stored in the memory is in the form of a data
implemented in firmware.
3. The system of claim 1 wherein the information is an encrypted
code, and the hand piece is authenticated for use with the console
by decoding a corresponding encryption algorithm in the console and
providing for a corresponding data pattern.
4. The system of claim 1 wherein: the memory stores a handicap
limit and a disable limit; the console instructs the hand piece to
operate in a handicap mode if the system exceeds the handicap
limit, and the console disables the hand piece if the system
exceeds the disable limit.
5. The system of claim 4 wherein handicap and disable limits relate
to temperature and the handicap mode is appropriate for temperature
conditions.
6. The system of claim 4 wherein the handicap limit and the disable
limit relate to the number of defective blades found in a time
period of operating the hand piece, and the handicap mode is
appropriate for the number of defective blade conditions.
7. The system of claim 4 wherein the handicap limit and the disable
limit relate to the time the hand piece has been active, and the
handicap mode is appropriate for the time conditions.
8. The system of claim 4 wherein the handicap limit and the disable
limit relate to the number of activations for the hand piece within
a time period, and the handicap mode is appropriate for the number
of activation conditions.
9. The system of claim 4 wherein the handicap mode involves one of
operations below a certain speed or vibrational frequency,
operating below a certain vibrational displacement, and in a
limited mode such as coagulation or cutting.
10. The system of claim 1 wherein the memory includes a reprogram
code, wherein said DSP reads the reprogram code stored in the
memory and alters at least one function of said console based on
said reprogram code.
11. The system of claim 10 further comprising storage and upgrade
code, whereon said DSP stores the storage and upgrade code which is
read with its operating program.
12. The system of claim 11 wherein the reprogram code and the
upgrade code are read from a non-volatile memory of a non-hand
piece device plugged into the electrical connection.
13. The system of claim 12 wherein said function of said console is
a diagnostic hierarchy.
14. The system of claim 12 wherein said function of said console is
a duty-cycle.
15. The system of claim 12 wherein said function of said console
redefines power level settings.
16. The system of claim 12 wherein said function of said console
redefines the console function assigned to a switch.
17. The system of claim 1 wherein the information stored in the
memory correlates energy level information and corresponding output
displacement, wherein the console reads the energy level
information and drives the hand piece according to the
corresponding output displacement.
18. The system of claim 1 wherein the information stored in the
memory includes a start sweep point and a stop sweep point
delimiting a frequency range, and wherein a frequency sweep is
effected under control of the DSP in the frequency range loaded on
the nominal resonate frequency, the start and stop sweep points for
detecting a resonant frequency for operating the hand piece.
19. The system of claim 1 wherein the information stored in the
memory includes a nominal resonant frequency, a bias amount and a
margin amount from which a frequency range is calculated, and
wherein a frequency sweep is effected under control of the DSP in
the frequency range based on the nominal resonate frequency, bias
current and margin current for detecting a resonant frequency for
operating the hand piece.
20. The system of claim 1 wherein the memory consists of at least
one of an Electrically Erasable Programmable Read Only Memory
(EEPROM), Read Only Memory (ROM), Erasable Programmable Read Only
Memory (EPROM), Random Access Memory (RAM), Programmable Array
Logic (PAL), Programmable Logic Array (PLA), analog serial storage
device, sound storage integrated circuit, a memory device in
conjunction with a numeric manipulation device including a
microprocessor for the purpose of encryption, and volatile memory
which is powered by a device consisting of a cell, battery and
capacitor.
21. The system of claim 1 wherein the memory is in a location
consisting of one of the electrical connection, the housing of the
hand piece, and an in-line location in a cable connecting the
electrical connection with the console and the hand piece.
22. A method for implementing surgical procedures in a system
including an ultrasonic surgical hand piece, a console having a
microprocessor for controlling the hand piece, an electrical
connection connecting the hand piece and the console, and a memory
disposed in the electrical connection, the method comprising the
steps of: reading information stored in the memory; determining
whether particular data is present in the memory; authenticating
use of the hand piece with the console if the particular data is
present; and sending a drive current to drive the hand piece to
impart ultrasonic movement to the blade.
23. The method of claim 22 wherein the data is stored in memory in
encrypted form further comprising the steps of: decoding the
encrypted data with an encryption algorithm in the console;
providing a corresponding-data pattern; and authenticating the hand
piece on the basis of the data pattern.
24. The method of claim 22 further comprising the steps of:
instructing the hand piece to operate in a handicap mode if
temperature of the hand piece exceeds a handicap limit; and
disabling the hand piece if the temperature of the hand piece
exceeds a disable limit.
25. The method of claim 22 further comprising the steps of:
instructing the hand piece to operate in a handicap mode if number
of defective blades found in a time period of operating the hand
piece exceeds a handicap limit; and disabling the hand piece if the
number of defective blades found in the time period exceeds a
disable limit.
26. The method of claim 22 further comprising the steps of:
instructing the hand piece to operate in a handicap mode if time
the hand piece has been active exceeds a handicap limit; and
disabling the hand piece if the number of defective blades found in
the time the hand piece has been active exceeds a disable
limit.
27. The method of claim 22 further comprising the steps of:
instructing the hand piece to operate in a handicap mode if number
of activations for the hand piece within a time period exceeds a
handicap limit; and disabling the hand piece if the number of
activations for the hand piece within the time period exceeds a
disable limit.
28. The method of claim 22 further comprising the step of
re-initializing the handicap limit and the disable limit based on
varied operational conditions of the hand piece.
29. The method of claim 22 further comprising the steps of:
determining whether a reprogram of the console is needed by reading
an upgrade code stored in the memory; and reading a reprogram code
stored in the memory and reprogramming the console using the
reprogram code, if it is determined that an upgrade of the console
is needed.
30. The method of claim 22 further comprising the steps of: reading
energy level information stored in the memory; and driving the hand
piece according to a corresponding output displacement; wherein the
energy level information stored in the memory is correlated with
corresponding output displacement for driving the hand piece.
31. The method of claim 22 further comprising the steps of: reading
a nominal resonant frequency, a start sweep point and a stop sweep
point delimiting a frequency range from the memory; effecting a
frequency sweep in the frequency range based on the reading; and
detecting a resonant frequency for operating the hand piece.
32. The method of claim 22 further comprising the steps of: reading
a nominal resonant frequency, a bias amount and a margin amount
from the memory; calculating a frequency range based on the nominal
resonant frequency, the bias amount and the margin amount;
effecting a frequency sweep in the frequency range; and detecting a
resonant frequency for operating the hand piece.
33. The method of claim 22 further comprising the steps of: keeping
track of a number of uses for the hand piece; and keeping track of
a number of remaining uses allowed for the hand piece.
34. The method of claim 22 further comprising the steps of:
providing an alert mode corresponding to the particular data;
alerting conditions meeting criteria for the alert mode.
Description
RELATED APPLICATIONS
[0001] The present application relates to, and claims priority of,
U.S. Provisional Patent Application Ser. No. 60/242,171 filed on
Oct. 20, 2000 and entitled EEPROM TO ENABLE/DISABLE GENERATOR
FUNCTIONS IN AN ULTRASONIC SURGICAL HAND PIECE, which is
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention generally relates to an apparatus
& method for altering generator functions in an ultrasonic
surgical system and, more particularly, to an ultrasonic system for
providing information to a generator from an ultrasonic surgical
instrument.
[0004] 2. Description of the Related Art
[0005] It is known that electric scalpels and lasers can be used as
a surgical instrument to perform the dual function of
simultaneously effecting the incision and hemostatis of soft tissue
by cauterizing tissues and blood vessels. However, such instruments
employ very high temperatures to achieve coagulation, causing
vaporization and fumes as well as splattering, which increases the
risk of spreading infectious diseases to operating room personnel.
Additionally, the use of such instruments often results in
relatively wide zones of thermal tissue damage.
[0006] Cutting and cauterizing of tissue by means of surgical
blades vibrated at high speeds by ultrasonic drive mechanisms is
also well known. One of the problems associated with such
ultrasonic cutting instruments is uncontrolled or undamped
vibrations and the heat as well as material fatigue resulting
therefrom. In an operating room environment attempts have been made
to control this heating problem by the inclusion of cooling systems
with heat exchangers to cool the blade. In one known system, for
example, the ultrasonic cutting and tissue fragmentation system
requires a cooling system augmented with a water circulating jacket
and means for irrigation and aspiration of the cutting site.
Another known system requires the delivery of cryogenic fluids to
the cutting blade.
[0007] It is known to limit the current delivered to the transducer
as a means for limiting the heat generated therein. However, this
could result in insufficient power to the blade at a time when it
is needed for the most effective treatment of the patient. U.S.
Pat. No. 5,026,387 to Thomas, which is assigned to the assignee of
the present application and is incorporated herein by reference,
discloses a system for controlling the heat in an ultrasonic
surgical cutting and hemostasis system without the use of a
coolant, by controlling the drive energy supplied to the blade. In
the system according to this patent an ultrasonic generator is
provided which produces an electrical signal of a particular
voltage, current and frequency, e.g. 55,500 cycles per second. The
generator is connected by a cable to a hand piece which contains
piezoceramic elements forming an ultrasonic transducer. In response
to a switch on the hand piece or a foot switch connected to the
generator by another cable, the generator signal is applied to the
transducer, which causes a longitudinal vibration of its elements.
A structure connects the transducer to a surgical blade, which is
thus vibrated at ultrasonic frequencies when the generator signal
is applied to the transducer. The structure is designed to resonate
at the selected frequency, thus amplifying the motion initiated by
the transducer.
[0008] The signal provided to the transducer is controlled so as to
provide power on demand to the transducer in response to the
continuous or periodic sensing of the loading condition (tissue
contact or withdrawal) of the blade. As a result, the device goes
from a low power, idle state to a selectable high power, cutting
state automatically depending on whether the scalpel is or is not
in contact with tissue. A third, high power coagulation mode is
manually selectable with automatic return to an idle power level
when the blade is not in contact with tissue. Since the ultrasonic
power is not continuously supplied to the blade, it generates less
ambient heat, but imparts sufficient energy to the tissue for
incisions and cauterization when necessary.
[0009] The control system in the Thomas patent is of the analog
type. A phase lock loop that includes a voltage controlled
oscillator, a frequency divider, a power switch, a match net and a
phase detector, stabilizes the frequency applied to the hand piece.
A microprocessor controls the amount of power by sampling the
frequency current and voltage applied to the hand piece, because
these parameters change with load on the blade.
[0010] The power versus load curve in a generator in a typical
ultrasonic surgical system, such as that described in the Thomas
patent has two segments. The first segment has a positive slope of
increasing power, as the load increases, which indicates constant
current delivery. The second segment has a negative slope of
decreasing power as the load increases, which indicates a constant
or saturated output voltage. The regulated current for the first
segment is fixed by the design of the electronic components and the
second segment voltage is limited by the maximum output voltage of
the design. This arrangement is inflexible since the power versus
load characteristics of the output of such a system can not be
optimized to various types of hand piece transducers and ultrasonic
blades. The performance of traditional analog ultrasonic power
systems for surgical instruments is affected by the component
tolerances and their variability in the generator electronics due
to changes in operating temperature. In particular, temperature
changes can cause wide variations in key system parameters such as
frequency lock range, drive signal level, and other system
performance measures.
[0011] In order to operate an ultrasonic surgical system in an
efficient manner, during startup the frequency of the signal
supplied to the hand piece transducer is swept over a range to
locate the resonance frequency. Once it is found, the generator
phase lock loop locks on to the resonance frequency, keeps
monitoring of the transducer current to voltage phase angle and
maintains the transducer resonating by driving it at the resonance
frequency. A key function of such systems is to maintain the
transducer resonating across load and temperature changes that vary
the resonance frequency. However, these traditional ultrasonic
drive systems have little to no flexibility with regards to
adaptive frequency control. Such flexibility is key to the system's
ability to discriminate undesired resonances. In particular, these
systems can only search for resonance in one direction, i.e., with
increasing or decreasing frequencies and their search pattern is
fixed. The system cannot hop over other resonance modes or make any
heuristic decisions such as what resonance/s to skip or lock onto
and ensure delivery of power only when appropriate frequency lock
is achieved.
[0012] The prior art ultrasonic generator systems also have little
flexibility with regard to amplitude control, which would allow the
system to employ adaptive control algorithms and decision making.
For example, these fixed systems lack the ability to make heuristic
decisions with regards to the output drive, e.g., current or
frequency, based on the load on the blade and/or the current to
voltage phase angle. It also limits the system's ability to set
optimal transducer drive signal levels for consistent efficient
performance, which would increase the useful life of the transducer
and ensure safe operating conditions for the blade. Further, the
lack of control over amplitude and frequency control reduces the
system's ability to perform diagnostic tests on the
transducer/blade system and to support troubleshooting in
general.
[0013] Some limited diagnostic tests performed in the past involve
sending a signal to the transducer to cause the blade to move and
the system to be brought into resonance or some other vibration
mode. The response of the blade is then determined by measuring the
electrical signal supplied to the transducer when the system is in
one of these modes. The ultrasonic system described in U.S.
application Ser. No. 60/693,621 and filed on Oct. 20, 2000 which is
incorporated herein by reference possesses the ability to sweep the
output drive frequency, monitor the frequency response of the
ultrasonic transducer and blade, extract parameters from this
response, and use these parameters for system diagnostics. This
frequency sweep and response measurement mode is achieved via a
digital core such that the output drive frequency can be stepped
with high resolution, accuracy, and repeatability not existent in
prior art ultrasonic systems.
[0014] However, the prior art systems do not provide for
authentication of the use of the hand piece with the console.
Furthermore, conducting diagnostic and performance tests in the
prior art systems is cumbersome. Reprogramming or upgrading of the
console in the prior art systems is also burdensome, since each
console needs to be independently tested and upgraded. In addition,
the prior art system do not allow operation of the console with
varied driving current and output displacement, depending on the
type and output ability of hand piece in operation with the
console. Therefore, there is a need in the art for an improved
system for implementing surgical procedures which overcomes these
and other disadvantages in the prior art.
SUMMARY OF THE INVENTION
[0015] The present invention provides a system for implementing
surgical procedures which includes an ultrasonic surgical hand
piece having an end-effector, a console having a digital signal
processor (DSP) for controlling the hand piece, an electrical
connection connecting the hand piece and the console, and a memory
device such as an EEPROM (Electrically Erasable Programmable Read
Only Memory) disposed in the electrical connection or the hand
piece. Data, in the form of a data string which identifies the hand
piece and generator performance characteristics, is stored in the
memory device. During initialization of the system, the console
sends an interrogation signal to the hand piece to obtain a readout
of the memory. As the console reads the memory, the hand piece is
authenticated for use with the console if the proper data is
present. The hand piece is not authenticated for use with the
console if the data is not present or is not correct. In a
particular embodiment of the invention, the data is an encrypted
code, where the hand piece is authenticated for use with the
console by decoding a corresponding encryption algorithm resident
in the console and providing a responding data pattern.
[0016] Moreover, to prevent errors in operating the hand piece, the
memory can store certain diagnostic information which the console
can utilize in determining whether the operation of the hand piece
should be handicapped or disabled. For instance, the memory can
store information such as limits on the time that the hand piece is
active, the number of activations within a time period, the number
of defective blades used, operating temperature, and other limits.
Those limits stored in the memory can be re-initialized accordingly
based on various operational conditions of the hand piece.
[0017] The memory can also be used to reprogram or upgrade the
console, if needed. For example, new hand pieces are issued
periodically as new system functionality is achieved. When such a
new hand piece is connected, the system perform diagnostic tests to
determine whether a reprogram or upgrade of the console is needed.
If it is determined that a reprogram or upgrade is needed, the
console reads the memory located in the electrical connection or
hand piece where a reprogram or upgrade code is stored. Using the
reprogram or upgrade code read from the memory, the console is
reprogrammed or upgraded accordingly. Therefore, the consoles in
the field can be upgraded automatically without having to return
them to the manufacturer or to send a service technician to the
console. In a particular embodiment, the memory is a non-volatile
memory can be plugged into the electrical connection or hand
piece.
[0018] The memory can also store energy level information and
corresponding output displacement for driving the particular hand
piece. By reading the energy level information, the console can
drive the hand piece according to the output displacement which is
best for that hand piece.
[0019] In addition, the memory can store frequency sweep
information including the nominal resonant frequency, and start and
stop sweep points for effecting a frequency sweep. Upon reading of
the frequency sweep information stored in the memory, the console
effects a frequency sweep in the indicated frequency range for
detecting a resonant frequency for operating the hand piece.
[0020] In accordance with the invention, a method is provided for
implementing procedures in a system including an ultrasonic
surgical hand piece having an end-effector, a console having a
digital signal processor (DSP) for controlling the hand piece, an
electrical connection connecting the hand piece and the console,
and a memory disposed in the electrical connection or hand piece.
The method according to the invention includes reading information
stored in the memory, determining whether particular or proprietary
data are present in the memory, authenticating use of the hand
piece with the console if the proprietary data are present, sending
a drive current to drive the hand piece, and imparting ultrasonic
movement to the end-effector of the hand piece according to
information in the memory. In a particular embodiment, the method
according to the invention also includes decoding an encryption
algorithm in the console, and providing a responding data pattern,
where the data is an encrypted code.
[0021] In a further embodiment, the method according to the
invention includes instructing the hand piece to operate in a
handicap mode if the temperature of the hand piece exceeds a
handicap limit, and disabling the hand piece if the temperature of
the hand piece exceeds a disable limit. The method according to the
invention can also include instructing the hand piece to operate in
a handicap mode if the number of defective blades found in a time
period of operating the hand piece exceeds a handicap limit, and
disabling the hand piece if the number of defective blades found in
the time period exceeds a disable limit. The method according to
the invention can further include instructing the hand piece to
operate in a handicap mode if the time the hand piece has been
active exceeds a handicap limit, and disabling the hand piece if
the number of defective blades found in the time the hand piece has
been active exceeds a disable limit. The method according to the
invention can include further steps of operating the hand piece in
a handicap mode if the number of activations for the hand piece,
and/or the number of activations within a time period, exceed a
handicap limit, and disabling the hand piece if the number of
activations for the hand piece within the time period exceeds a
disable limit. The handicap and disable limits stored in the memory
can be re-initialized based on varied operational conditions of the
hand piece.
[0022] In an additional embodiment, the method according to the
invention also includes determining whether a reprogramming or
upgrade of the console is needed, reading a reprogram or upgrade
code stored in the memory and reprogramming the console using the
reprogram or upgrade code, if it is determined that a reprogram or
upgrade of the console is needed.
[0023] Moreover, the method according to another embodiment of the
invention further includes reading energy level information stored
in the memory, and driving the hand piece according to a
corresponding output displacement, where the energy level
information stored in the memory is correlated with corresponding
output displacement for driving the particular hand piece. In yet
another embodiment, the method according to the invention also
includes reading a nominal resonant frequency, a start sweep point
and a stop sweep point delimiting a frequency range from the
memory, effecting a frequency sweep in the frequency range, and
detecting a resonant frequency for operating the hand piece.
Alternatively, the frequency range information stored in the memory
can be a nominal resonant frequency, a bias amount and a margin
amount, where the frequency range for the frequency sweep is
calculated based on the nominal resonant frequency, the bias amount
and the margin amount.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The foregoing and other advantages and features of the
invention will become more apparent from the detailed description
of the preferred embodiments of the invention given below with
reference to the accompanying drawings in which:
[0025] FIG. 1 is an illustration of a console for an ultrasonic
surgical cutting and hemostasis system, as well as a hand piece and
foot switch in which the method of the present invention is
implemented;
[0026] FIG. 2 is a schematic view of a cross section through the
ultrasonic scalpel hand piece of the system of FIG. 1;
[0027] FIGS. 3A and 3B are block diagrams illustrating the system
for the hand piece according to an embodiment of the present
invention;
[0028] FIG. 4 is a diagram illustrating the electrical connection
between the generator console and the ultrasonic surgical hand
piece according to the invention in further detail;
[0029] FIG. 5 is a flow diagram illustrating the operation of the
non-volatile memory according to the invention as proprietary
lockout for preventing inappropriate use of the ultrasonic surgical
hand piece;
[0030] FIG. 6 and FIG. 7 are flow diagrams illustrating the
operation of the non-volatile memory according to the invention for
error prevention when using the ultrasonic surgical hand piece;
[0031] FIG. 8 is a flow diagram illustrating the operation of the
non-volatile memory according to the invention for reprogramming or
upgrading the console using the hand piece;
[0032] FIG. 9 is a flow diagram illustrating the operation of the
ultrasonic surgical hand piece at a resonant frequency using
information stored in the memory according to the invention;
and
[0033] FIG. 10 is a diagram illustrating an alternative embodiment
of the operation of the hand piece at a resonant frequency using
information stored in the non-volatile memory according to the
invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0034] FIG. 1 is an illustration of a system for implementing
surgical procedures according to the invention. By means of a first
set of wires in cable 20, electrical energy, i.e., drive current,
is send from the console 10 to a hand piece 30 where it imparts
ultrasonic longitudinal movement to a surgical device, such as a
sharp end-effector 32. This blade can be used for generally
simultaneous dissection and cauterization of tissue. The generator
in console 10 drives the hand piece 30 such that the ultrasonically
tuned blade 32 mounted on the proximal end thereof vibrates and in
turn is used for cutting and coagulation in open or laparoscopic
surgical procedures. The hand piece 30 is a hand-held device that
includes an ultrasonic resonator or transducer that converts the
appropriate electrical signals supplied by the generator in console
10 into mechanical vibrations for vibrating the frequency-tuned
blade 32. The supply of ultrasonic current to the hand piece 30 may
be under the control of a switch 34 located on the hand piece 30,
which is connected to the generator in console 10 by a wire in
cable 26 via the electrical connection 19. The generator may also
be controlled by a foot switch 40, which is connected to the
console 10 by another cable 50. Thus, in use a surgeon may apply an
ultrasonic electrical signal to the hand piece 30, causing the
blade to vibrate longitudinally at an ultrasonic frequency, by
operating the switch 34 on the hand with his finger which is
activated by pressing button 18, or by operating the foot switch 40
with his foot.
[0035] In a specific embodiment according to the invention, the
button 18 is a set of twin rocker switches which are generally 180
degrees apart from each other. Each rocker switch in the button set
18 can signal to the generator console 10 for delivering power to
the transducer in the hand piece 30 at a minium or maximum power
levels. In addition, the foot switch 40 includes two paddles of the
press-and-hold activation type, where the paddle on the left serves
as the switch for activating power delivery at a minimum level, and
the paddle on the right serves as the switch for activating power
delivery at a maximum level.
[0036] The generator console 10 includes a liquid crystal display
device 12, which can be used for indicating the selected cutting
power level in various means such as percentage of maximum cutting
power or numerical power levels associated with cutting power. The
liquid crystal display device 12 can also be utilized to display
other parameters of the system. A power switch 11 and power "on"
indicator 13 are also provided on the console. Further, buttons and
switches 16 to 17 control various other functions of the system may
be located on the console front panel.
[0037] When power is applied to the ultrasonic hand piece by
operation of either switch 34 or 40, the assembly will cause the
surgical scalpel or blade to vibrate longitudinally at
approximately 55.5 kHz, and the amount of longitudinal movement
will vary proportionately with the amount of driving power
(current) applied, as adjustably selected by the user. When
relatively high cutting power is applied, the blade is designed to
move longitudinally in the range of about 40 to 100 microns at the
ultrasonic vibrational rate. Such ultrasonic vibration of the blade
will generate heat as the blade contacts tissue, i.e., the
acceleration of the blade through the tissue converts the
mechanical energy of the moving blade to thermal energy in a very
narrow and localized area. This localized heat creates a narrow
zone of coagulation, which will reduce or eliminate bleeding in
small vessels, such as those less than one millimeter in diameter.
The cutting efficiency of the blade, as well as the degree of
hemostasis, will vary with the level of driving power applied, the
cutting rate or force applied by the surgeon to the blade, the
nature of the tissue type, and the vascularity of the tissue.
[0038] As illustrated in more detail in FIG. 2, the ultrasonic hand
piece 30 houses a piezoelectric transducer 36 for converting
electrical energy to mechanical energy that results in longitudinal
vibrational motion of the ends of the transducer. The transducer 36
is in the form of a stack of ceramic piezoelectric elements having
a motion null point at the center of the stack. It is mounted
between two cylinders 31 and 33. In addition, a cylinder 35 is
attached to cylinder 33, which is mounted to the housing at another
motion null point 37. A horn 38 is also attached to the null point
on one side and to a coupler 39 on the other side. Blade 32 is
fixed to the coupler 39. As a result, the blade 32 will vibrate in
the longitudinal direction at an ultrasonic frequency rate with the
transducer 36. The ends of the transducer achieve maximum motion,
with the center of the stack constituting a motionless node, when
the transducer is driven at maximum current at the transducer's
resonant frequency.
[0039] The parts of the hand piece are designed such that the
combination will oscillate at generally the same resonant
frequency. In particular, the elements are tuned such that the
resulting length of each such element is one-half wavelength.
Longitudinal back and forth motion is amplified as the diameter
closer to the blade 32 of the acoustical mounting horn 38
decreases. Thus the horn 38 as well as the blade/coupler are shaped
and dimensioned so as to amplify blade motion and provide harmonic
vibration in resonance with the rest of the acoustic system, which
produces the maximum back and forth motion of the end of the
acoustical mounting horn 38 close to the blade 32, preferably from
20 to 25 microns.
[0040] The system which creates the ultrasonic electrical signal
for driving the transducer in the hand piece is illustrated in FIG.
3A and FIG. 3B. This drive system is flexible and can create a
drive signal at a desired frequency and power level setting. A DSP
60 or microprocessor in the system is used for monitoring the
appropriate power parameters and vibratory frequency as well as
causing the appropriate power level to be provided in either the
cutting or coagulation operating modes. The DSP 60 or
microprocessor also stores computer programs which are used to
perform diagnostic tests on components of the system, such as the
transducer/blade.
[0041] For example, under the control of a program stored in the
DSP or microprocessor 60, such as a phase correction algorithm, the
frequency during startup can be set to a particular value, e.g., 50
kHz. It can than be caused to sweep up at a particular rate until a
change in impedance, indicating the approach to resonance, is
detected. Then the sweep rate can be reduced so that the system
does not overshoot the resonance frequency, e.g., 55 kHz. The sweep
rate can be achieved by having the frequency change in increments,
e.g., 50 cycles. If a slower rate is desired, the program can
decrease the increment, e.g., to 25 cycles which both can be based
adaptively on the measured transducer impedance magnitude and
phase. Of course, a faster rate can be achieved by increasing the
size of the increment. Further, the rate of sweep can be changed by
changing the rate at which the frequency increment is updated.
[0042] If it is known that there is an undesired resonant mode ,
e.g., at say 51 kHz, the program can cause the frequency to sweep
down, e.g., from 60 kHz, to find resonance. Also, the system can
sweep up from 50 kHz and hop over 51 kHz where the undesired
resonance is located. In any event, the system has a great degree
of flexibility
[0043] In operation, the user sets a particular power level to be
used with the surgical instrument. This is done with power level
selection switch 16 on the front panel of the console. The switch
generates signals 150 that are applied to the DSP 60. The DSP 60
then displays the selected power level by sending a signal on line
152 (FIG. 3B) to the console front panel display 12.
[0044] To actually cause the surgical blade to vibrate, the user
activates the foot switch 40 or the hand piece switch 34. This
activation puts a signal on line 154 in FIG. 3A. This signal is
generally effective to cause power to be delivered from push-pull
amplifier 78 to the transducer 36. When the DSP or microprocessor
60 has achieved lock on the hand piece transducer resonance
frequency and power has been successfully applied to the hand piece
transducer, an audio drive signal is put on line 156. This causes
an audio indication in the system to sound, which communicates to
the user that power is being delivered to the hand piece and that
the scalpel is active and operational.
[0045] As described herein with respect to FIG. 2, FIG. 3A and FIG.
3B and in the related U.S. application Ser. No. 09/693,621 and
incorporated herein by reference, the parts of the hand piece 30 in
operational mode are designed, as a whole, to oscillate at
generally the same resonant frequency, where the elements of the
hand piece 30 are tuned so that the resulting length of each such
element is one-half wavelength or a multiple thereof.
Microprocessor or DSP 60, using a phase correction algorithm,
controls the frequency at which the parts of the hand piece 30
oscillate. Upon activation of the hand piece 30, the oscillating
frequency is set at a startup value or nominal resonant frequency
such as 50 kHz which is stored in memory. A sweep of a frequency
range between a start sweep point and a stop sweep point is
effected under the control of the DSP 60 until the detection of a
change in impedance which indicates the approach to the resonant
frequency. The change in impedance refers to the impedance of the
hand piece and its transducers, which may be modeled by a parallel
equivalent circuit for mathematically modeling the algorithm for
controlling the operation of the hand piece 30 as described in the
related U.S. application Ser. No. 09/693,621. The resonant
frequency is the frequency at a point during the frequency sweep
where the impedance of the equivalent circuit is at its minimum and
the anti-resonant frequency is the frequency where the impedance is
maximum. Phase margin is the difference between the resonant
frequency and an anti-resonant frequency. A correlation between the
phase margin and the output displacement of the hand piece 30
exists which can advantageously be used to control the displacement
so that the hand piece 30 operates at its optimal performance
level.
[0046] In order to obtain the impedance measurements and phase
measurements, the DSP 60 and the other circuit elements of FIG. 3A
and 3B are used. In particular, push-pull amplifier 78 delivers the
ultrasonic signal to a power transformer 86, which in turn delivers
the signal over a line 85 in cable 26 to the piezoelectric
transducers 36 in the hand piece. The current in line 85 and the
voltage on that line are detected by current sense circuit 88 and
voltage sense circuit 92. The current and voltage sense signals are
sent to average voltage circuit 122 and average current circuit
120, respectively, which take the average values of these signals.
The average voltage is converted by analog-to-digital converter
(ADC) 126 into a digital code that is input to DSP 60. Likewise,
the current average signal is converted by analog-to-digital
converter (ADC) 124 into a digital code that is input to DSP 60. In
the DSP the ratio of voltage to current is calculated on an ongoing
basis to give the present impedance values as the frequency is
changed. A significant change in impedance occurs as resonance is
approached.
[0047] The signals from current sense 88 and voltage sense 92 are
also applied to respective zero crossing detectors 100, 102. These
produce a pulse whenever the respective signals cross zero. The
pulse from detector 100 is applied to phase detection logic 104,
which can include a counter that is started by that signal. The
pulse from detector 102 is likewise applied to logic circuit 104
and can be used to stop the counter. As a result, the count which
is reached by the counter is a digital code on line 140, which
represents the difference in phase between the current and voltage.
The size of this phase difference is also an indication of how
close the system is operating to the resonant frequency. These
signals can be used as part of a phase lock loop that cause the
generator frequency to lock onto resonance, e.g., by comparing the
phase delta to a phase set point in the DSP in order to generate a
frequency signal to a direct digital synthesis (DDS) circuit 128
that drives the push-pull amplifier 78.
[0048] Further, the impedance and phase values can be used as
indicated above in a diagnosis phase of operation to detect if the
blade is loose. In such a case the DSP does not seek to establish
phase lock at resonance, but rather drives the hand piece at
particular frequencies and measures the impedance and phase to
determine if the blade is tight.
[0049] FIG. 4 is a diagram that illustrates the electrical
connection 19 between the console and the hand piece 30 in further
detail. According to a specific embodiment of the invention, the
electrical connection 19, which can be a serial or parallel
connection, is a male-female electrical connection set. It
includes, on one end leading to the hand piece 30 via the cable 26,
an electrical connector 19B with pins 401, 402, 403, 404, 405, 406
and 407, and on the other end a corresponding connector 19A leading
to the console 10 and having receptacles 401A, 402A, 403A, 404A,
405A, 406A and 407A. These receptacles respectively receive pins
401, 402, 403, 404, 405, 406 and 407 of connector 19B. For engaging
or disengaging the electrical connection 19, the connectors 19A and
19B only require simple act of connecting them by human hands, and
need no additional tooling to engage or disengage them. The
electrical connector 19B includes a memory 400 which is a
non-volatile memory device that retains its data for subsequent
usage even if power is removed therefrom, such as an electrically
erasable programmable read only memory or EEPROM. The memory 400 is
connected to pin 405 for transferring data to and from the console
10 at a direct current (DC) of generally 10 mA (milli-amperes).
[0050] With respect to the other pins, pin 401 is for delivering
the "transducer high" signal for operating the transducer 36 in the
hand piece 30 at a high power level, using an alternating current
(AC) of generally 1 A (ampere). Pin 402 is for delivering the
"transducer low" signal for operating the transducer 36 in the hand
piece 30 at a low power level, also using an alternating current
(AC) of generally 1 A. Pins 403 and 404 are for delivering
hand-activation signals (e.g., by pressing button 18) to the hand
piece 30, at an alternating current (AC) of generally 10 mA. Pin
406 is for delivering a general or common signal to the memory 400,
at a direct current (DC) of generally 10 mA. Pin 407 is for
delivering a signal which indicates the presence (or lack thereof)
of the hand piece 30, also at a direct current (DC) of generally 10
mA.
[0051] The memory 400 is advantageously provided in the electrical
connector 19B for reducing unneeded complexity in electrical
isolation configurations which contribute to increases in costs,
complications in cross-talk noise issues, and adversely affects the
ergonomic performance of the hand piece 30. By placing the memory
400 in the electrical connector 19B, with adequate electrical
isolation of the memory 400 circuitry, the human operator thereof,
and the patient is readily achieved. Also, the number of wires in
cable 26 can be reduced. However, if desired, the memory 400 can be
located in the hand piece 30, but this is not preferred.
[0052] FIG. 5 is a flow diagram that illustrates the operation of
the memory 400 as a proprietary lockout for preventing
inappropriate use of the hand piece 30. The memory 400 can be
utilized to prevent unauthorized, unintentional or inadvertent use
of the hand piece 30 with the console 10. Inappropriate usage
includes hazardous use, poor operational usage, or non-compatible
use with the console 10.
[0053] In step 501, the hand piece 30 is activated, e.g., by
pressing the button 18 on console 10for hand-activation-enable of
the hand piece 30. In step 503, console 10 then reads the memory
400 by accessing it via pin 405 in the electrical connection 19 at
its mated position. In step 505, it is determined whether
proprietary data (in the form of a data string) is present in the
memory 400. The proprietary data, input into the non-volatile
memory for all authorized hand pieces, are in digital or analog
form. The proprietary data can also be a musical, speech, or sound
effect in either digital or analog format. Having a proper
proprietary data string in the memory 400 means that the use of the
hand piece with console 10 is authorized or authenticated. The
proprietary data can be copyrighted to protect against unlawful or
unauthorized use of the hand piece. If the proprietary data are
present in the memory 400, the hand piece 30 is enabled or
activated by console 10 (step 507). If the proprietary data are not
present in the memory 400 or an improper data string is present,
the hand piece 30 is not enabled (step 509), and an error message
appears on the display device 12 at the console 10 indicating
unauthorized use.
[0054] In a specific embodiment according to the invention, when
the console 10 reads the data in the memory 400, a cyclical
redundancy check (CRC) is used to detect read errors and/or to
authenticate the hand piece. A CRC is a mathematical method that
permits errors in long runs of data to be detected with a very high
degree of accuracy. Before data is transmitted over a phone, for
example, the sender can compute a 32-bit CRC value from the data's
contents. If the receiver computes a different CRC value, then the
data was corrupted during transmission. Matching CRC values
confirms with near certainty that the data was transmitted
intact.
[0055] According to the CRC authentication technique, the entire
block of data is treated as a long binary number which is divided
by a conveniently small number and the remainder is used as the
check value that is tacked onto the end of the data block. Choosing
a prime number as the divisor provides excellent error detection.
The number representing the complete block (main data plus CRC
value) is always a multiple of the original divisor, so using the
same divisor always results in a new remainder of zero. This means
that the same division process can be used to check incoming data
as is used to generate the CRC value for outgoing data. At the
transmitter, the remainder is (usually) non-zero and is sent
immediately after the real data. At the receiver, the entire data
block is checked and if the remainder is zero, then the data
transmission is confirmed.
[0056] An 8-bit CRC generator can be implemented in hardware,
software or firmware in the memory 400. Firmware is the controller
software for a hardware device, which can be written or programmed
in a non-volatile memory (e.g., memory 400) such as an EEPROM or
flash ROM (read only memory). The firmware can be updated with a
flash program for detection and correction of bugs in the
controller software or to improve performance of the hardware
device. An exemplary EEPROM used in implementing the invention is
the 256-bit DS2430A 1 wire device organized as one page of 32 bytes
for random access with a 64-bit one-time programmable application
register, which is a part of the IBUTTON.TM. family of hardware
devices commercially available from DALLAS SEMICONDUCTOR.TM..
[0057] The following exemplary software code in "C" which is a
commonly used programming language in the art, illustrates how the
8-bit CRC is calculated when reading the data in the memory 400 for
authenticating use of the hand piece with console 10. Prior to the
calculation of the CRC of a block of data, the 8-bit CRC is first
initialized to zero. When console reads the 8 bytes of the data in
the memory 400, an 8-bit CRC is calculated for each of the 8 bytes
of the data. If the resultant 8-bit CRC is equal to zero, then the
use of the hand piece is with console 10 is authenticated, and the
hand piece is enabled. If the resultant 8-bit CRC is not equal to
zero, then the use of the hand piece with console 10 is not
authenticated, the hand piece not enabled, and an error message
appears on the display device 12 at console 10 indicating
unauthorized use.
1 /* ============================================= FUNCTION
mlan_CRC8 PASSED PARAMETERS `data` - data byte to calculate the 8
bit crc from `crc8` - the current CRC. RETURN the updated 8 bit
CRC. ============================================= /* static uchar
crc_table[ ] = { 0, 94, 188,226, 97, 63,221, 131, 194,156,126,
32,163,253, 31, 65 157,195, 33,127,252,162, 64, 30, 95, 1,227, 189,
62, 96,130,220, 190,224, 2, 92,223,129, 99, 61,124, 34, 192,158,
29, 67,161,255, 70, 24,250,164, 39,121,155,197,132,218
56,102,229,187, 89, 7, 219,133,103,57,186,228, 6, 88, 25, 71,
165,251,120, 38,196,154, 101, 59,217,135, 4, 90,184,230,167,249,
27, 69,198,152,122,36, 248,166, 68, 26,153,199, 37,123,
58,100,134,216, 91, 5,231,185 140,210, 48,110,237,179, 81, 15, 78,
16,242,172, 47,113,147,205, 17, 79,173,243,112, 46,204,146,211,
141,111, 49,178,236, 14, 80, 175,241, 19, 77,206,144,114, 44,109,
51,209,143, 12, 82,176,238, 50,108,142,208, 83, 13,239,177,240,174,
76, 18,145,207, 45,115, 202,148,118, 40,171,245, 23, 73, 8,
86,180,234,105, 55,213,139, 87, 9,235,181, 54,104,138,212,149,203,
41,119,244,170, 72, 22, 233,183, 85, 11,136,214, 52,106,
43,117,151,201, 74, 20,246,168, 116, 42,200,150, 21,
75,169,247,182,232, 10, 84,215,137,107,53 }; uchar mlan_CRC8(uchar
data, uchar crc8) { return crc_table[crc8 {circumflex over ( )}
data]; }
[0058] Another exemplary software code is listed below for
calculating a 16-bit CRC for the memory 400. Similarly, prior to
the calculation of the CRC of a block of data, the 16-bit CRC is
first initialized to zero. When console 10 reads the 16 bytes of
the data in the memory 400, a 16-bit CRC is calculated for each of
bytes 1 through 30 of the data, and the results are stored in bytes
31 and 32. After comparing the results, if the resultant CRC is
equal to zero, then the use of the hand piece with console 10 is
authenticated, and the hand piece is enabled. If the resultant CRC
is not equal to zero, then the use of the hand piece with console
10 is not authenticated, the hand piece is not enabled, and an
error message appears on the display device 12 at console 10
indicating unauthorized use.
2 /* ============================================= FUNCTION
mlan_CRC16 PASSED PARAMETERS `data` - current word to add into the
CRC `crc16` - the current value of the 16 bit CRC RETURN new value
of the 16 bit CRC =============================================/*
static int oddparity[16] = {0, 1, 1, 0, 1, 0, 0, 1, 1, 0, 0, 1, 0,
1, 1, 0}; uint mlan-CRC16(uint data, uint crc16) { data = (data
{circumflex over ( )} (crc16 & 0xff)) & 0xff;
crc16>>=8; if (oddparity[data & 0xf] {circumflex over (
)} oddparity[data >> 4]) crc16 {circumflex over ( )} =0xc001;
data <<=6; crc16 {circumflex over ( )}= data; data <<=
1; crc16 {circumflex over ( )}= data; return crc16; }
[0059] Furthermore, the data in the memory 400 can be an encrypted
code which, when decoded by a corresponding encryption algorithm
resident at console 10, provides a corresponding data pattern that
serves to authenticate proper usage of the hand piece with the
console. Encryption is achieved with algorithms that use a computer
"key" to encrypt and decrypt messages by turning text or other data
into an unrecognizable digital form and then by restoring it to its
original form. The longer the "key," the more computing is required
to crack the code. To decipher an encrypted message by brute force,
one would need to try every possible key. Computer keys are made of
"bits" of information of various length. For instance, an 8-bit key
has 256 (2 to the eighth power) possible values. A 56-bit key
creates 72 quadrillion possible combinations. If the key is 128
bits long, or the equivalent of a 16-character message on a
personal computer, a brute-force attack would be 4.7 sextillion
(4,700,000,000,000,000,000,000) times more difficult than cracking
a 56-bit key. With encryption, unauthorized use of the hand piece
with console 10 is generally prevented, with a rare possibility of
the encrypted code being deciphered for unauthenticated use.
[0060] A unique identification (ID) number is registered and stored
in the memory (e.g., memory 400) for every hand piece manufactured
which is compatible for use with console 10. In a specific
embodiment according to the invention, the memory 400 is the
DS2430A 1 wire EEPROM device, commercially available from DALLAS
SEMICONDUCTOR.TM., which stores a factory-lasered and tested 64-bit
ID number for each hand piece manufactured. The ID number can be a
model or model family number, in addition to being a unique serial
number ID for each individual hand piece. This allows the generator
console 10 to acknowlege its compatibility and useability
therewith, without requiring a list of serial numbers for that
model or model family. Foundry lock data in a hardware format and
protocol is stored in the memory 400 to ensure compatibility with
other products of generally the same communications protocol, e.g.,
the products of the MICROLAN.TM. protocol commercially available
from DALLAS SEMICONDUCTOR.TM. . This advantageously provides
scalability for providing a system with additional surgical devices
on a local area network (LAN) operating on generally the same
communications protocol.
[0061] FIG. 6 and FIG. 7 are flow diagrams that illustrate the
operation of the memory 400 according to the invention for error
prevention when using the hand piece 30 with console 10. To prevent
errors in operating the hand piece 30, the memory 400 can store
certain diagnostic information which console 10 can utilize in
determining whether the operation of the hand piece 30 should be
handicapped or disabled. For instance, the memory 400 can store
information such as limits on the time that the hand piece is
active, the number of activations within a time period, the number
of defective blades used, temperature, and any other performance
characteristics such as, for example, those listed in Table 1.
Those skilled in the art can appreciate that other error
prevention, diagnostic and performance characteristics can be
stored in memory 400. Exemplary performance characteristics that
can be stored in memory 400 (as shown in Table 1) include surgical
device type information and revision data (row 1 in Table 1),
current set point (row 2), transducer capacitance (row 3), cable
capacitance (row 4), phase margin for the hand piece equipped with
a test tip or end-effector (row 5), resonant frequency (row 6),
remaining operating procedures (row 7), lower bound or threshold on
operating frequency (row 8), upper bound or threshold on operating
frequency (row 9), maximum output power (row 10), power control
information and authorization (row 11), hand piece impedance (row
12), total on-time information at specific power levels (rows 13
and 14), hand piece enable/disable diagnostic information (row 15),
hand piece error codes (row 16), temperature range and change data
(rows 17, 18 and 19), current excess load limit (row 20), high
impedance fault limit (row 21), and cyclical redundancy check (CRC)
data (row 22).
[0062] Moreover, the memory 400 can store user-specific data such
as username, internal tracking number, calibration schedule, and
custom output performance. The user-specific data can be
manipulated or programmed through the generator console 10 or
initialized at the time the hand piece 30 is made at the
factory.
3TABLE 1 1 Bits 1-3. Device Type Bits 4-8: Revision 2 Current set
point I.sub.setpoint 3 Transducer Capacitance C.sub.o 4 Cable
Capacitance C.sub.c 5 Phase margin with test tip Pm.sub.0 6
Resonance frequency f.sub.ro 7 Allowed Procedures Remaining 8 Lower
bound on seek/lock frequency (offset from f.sub.ro) f.sub.lower
bound 9 Upper bound on seek/lock frequency (offset from f.sub.ro)
f.sub.upper bound 10 Maximum output power @ level 5 W.sub.max 11
Bit 1 Backside power curve control variable: Capped Power = 1;
Descending power = 0 Bit 2; Single cap at all levels = 1, Different
cap for each power level = 0 Bit 3: Hand piece Authorized
Activation Flag. Bits 4-8: Unused 12 Hand piece Impedance, Re
.vertline.Z.vertline. 13 Total On-Time @ level 5 14 Total on-Time @
level <5 15 Hand piece Diagnostics Enable/Disable Flags byte no.
1 Hand piece Diagnostics Enable/Disable Flags byte no. 2 16 Hand
piece error code 1 (newest) Hand piece error code 2 Hand piece
error code 3 Hand piece error code 4 Hand piece error code 5
(oldest) 17 .DELTA.C.sub.o Over Temp Entry 18 .DELTA.C.sub.o Over
Temp Exit 19 C.sub.oMax Rate of Change 20 Current Excessive Load
Limit 21 High Impedance with test tip fault limit 22 Data CRC
[0063] According to a specific embodiment of the invention, once
the hand piece 30 is activated for use, console 10 reads the memory
400 (step 601) for the diagnostic information. In step 603, console
10 determines whether the temperature of the hand piece 30 is over
the handicap limit stored in the memory 400. If so, console 10 then
instructs the hand piece 30 to operate in the handicap mode (step
605), e.g., operating below a certain speed or vibrational
frequency or in a limited mode such as coagulation or cutting in
order to avoid overheating, or in a non-limited mode with a
specific vibrational annunciation. If not, the flow control goes to
step 607, where console 10 determines whether the temperature of
the hand piece 30 is over the disable limit stored in the memory
400. If so, console 10 disables the hand piece 30 (step 609). If
not, the flow control goes to step 611, where console 10 determines
whether the number of defective blades found within a time period
of operating the hand piece 30 has exceeded the handicap limit
stored in the memory 400. If so, console 10 then instructs the hand
piece 30 to operate in the handicap mode (step 613), e.g.,
operating below a certain speed or vibrational frequency below the
nominal vibrational displacement, or in a limited mode such as
coagulation or cutting in order to decrease the incidences of
blades 32 becoming defective. The handicap mode in step 613 is not
necessarily the same as the handicap mode in step 605, depending on
the optimal mode for operating the hand piece 30 under the
circumstances with respect to steps 603 and 611.
[0064] If the number of defective blades found has not exceeded the
handicap limit, the flow control is directed to step 615, where
console 10 determines whether the number of defective blades found
within a time period has exceeded the disable limit stored in the
memory 400. If so, console 10 disables the hand piece 30 (step
609). If not, the control flow is directed, via step A, to step
617, where console 10 determines whether the time the hand piece 30
has been active has exceeded the handicap limit stored in memory
400. If so, console 10 instructs the hand piece 30 to operate in a
handicap mode, e.g., operating below a certain speed or vibrational
frequency, below the nominal vibrational displacement, or in a
limited mode such as coagulation or cutting. The handicap mode in
step 619 is not necessarily the same as the handicap mode in steps
605 or 613, depending on the optimal mode for operating the hand
piece 30 under the circumstances with respect to steps 603, 611 and
617.
[0065] If the time the hand piece 30 has been active has not
exceeded the handicap limit, the flow control is directed to step
621, where console 10 determines whether the time the hand piece
has been active has exceeded the disable limit stored in the memory
400. If so, the control flow is directed, via step B, to step 609
where console 10 disables the hand piece 30. If not, the control
flow goes to step 623, where console 10 determines whether the
number of activations for the hand piece 30 within a time period
has exceeded the handicap limit stored in memory 400. If so,
console 10 instructs the hand piece 30 to operate in a handicap
mode (step 625), e.g., operating below a certain speed or
vibrational frequency, below the nominal vibrational displacement,
or in a limited mode such as coagulation or cutting. The handicap
mode in step 625 is not necessarily the same as the handicap mode
in steps 605, 613 or 619, depending on the optimal mode for
operating the hand piece 30 under the circumstances with respect to
steps 603, 611, 617 and 623.
[0066] If the number of activations for the hand piece 30 within a
time period has not exceeded the handicap limit, the flow control
is directed to step 627, where console 10 determines whether the
number of activations for the hand piece 30 within a time period
has exceeded the disable limit stored in the memory 400. If so, the
control flow is directed, via step B, to step 609 where console 10
disables the hand piece 30. If not, the control flow is directed,
via step C, to step 601 from which the process steps according to
this particular embodiment of the invention may be repeated upon
subsequent users until the hand piece 30 is caused to be
disabled.
[0067] The disable limits and the handicap limits described herein
with respect to FIG. 6 and FIG. 7 may be of substantively different
criteria for console 10 to determine the operational mode of the
hand piece 30. The memory 400 may be re-initialized for different
disable or handicap limits for varied operational conditions of the
hand piece 30. Console 10 may likewise be re-initialized to operate
on varied criteria for controlling the operational mode of the hand
piece 30 based on the information stored in the memory 400.
[0068] In addition to the disable and handicap modes of operation,
an alarm or alert mode can further be provided when certain
criteria are met to alert and allow a human operator of the hand
piece to take appropriate action to remedy the alerted operating
condition.
[0069] FIG. 8 is a flow diagram that illustrates the operation of
the memory 400 according to the invention for reprogramming or
upgrading console 10 using the hand piece 30. In step 801, console
10 performs diagnostic tests on the functions of the console. It is
determined in step 803 whether any functions are deemed inadequate,
e.g., functions that need to be altered, disabled or added. For
example, the error prevention functions described herein with
respect to FIG. 6 and FIG. 7 may need to be added, or the handicap
limits and operational modes may need to be re-initialized. If it
is determined that certain functions are inadequate, the flow
control is directed to step 807. In step 807, console 10 reads the
memory 400 of the hand piece 30 where the reprogram code has been
stored in step 800. Using the reprogram code read from the memory
400, the functions of console 10 are reprogrammed.
[0070] If it is determined in step 803 that the functions of
console 10 are adequate or the memory has a newer version of the
program, then the console 10 has, the flow control directed to step
805. It is determined in step 805 whether an upgrade is needed for
console 10. If so, the flow control is directed to step 807. In
step 807, console 10 reads the memory 400 of the hand piece 30
where the reprogram or upgrade code has been stored in step 800.
Using the reprogram or upgrade code read from the memory 400, the
functions of console 10 are reprogrammed and upgraded. For example,
if console 10 is experiencing operational difficulties with a
specific generation or version of the hand piece, an upgrade from
the memory 400 instructs console 10 to allow its use with only
newer versions or generations of the hand piece. The memory 400 can
also store information including the manufacture date, design
revision, manufacturing code, lot code or other manufacture-related
information for a specific grouping of hand pieces according to
generation or version having operational difficulties or defects,
from which console 10 can be reprogrammed or upgraded to refuse
activation for use with such hand pieces.
[0071] In an alternative embodiment according to the invention, the
reprogram code can be stored in a non-volatile memory of a device
other than the hand piece 30 with the memory 400. The non-hand
piece device with the non-volatile memory can be plugged directly
into the electrical connection 19 for upgrading or reprogramming
console 10.
[0072] Moreover, the memory 400 can be utilized in adding an
odometer function to the generator console 10 by keeping track of
the number of uses performed for the hand piece 30 and/or the
number of allowable uses remaining.
[0073] In addition to storing reprogram or upgrade code, the memory
400 can also store performance criteria for operating the hand
piece 30 with console 10. For example, the memory 400 can store
energy level information such as a maximum energy level for driving
the particular hand piece 30, because, e.g., a relatively small
hand piece may not be able to be driven, in terms of energy levels,
as intensely as a relatively large hand piece for large-scale
surgical procedures. Information correlating the energy levels for
driving the hand piece 30 and the corresponding output displacement
can also be stored in the memory 400. The console 10 reads the
energy level information stored in the memory 400 and drives the
hand piece 30 according to the corresponding output displacement.
In addition to energy level information, driving signal
characteristics, such as types of amplitude modulation and
resonance frequency, can be stored in the memory 400. Using the
information stored in the memory 400, the console 10 and the hand
piece 30 can perform the error prevention described herein with
respect to FIG. 6 and FIG. 7, and the reprogramming or upgrade of
console 10 described herein with respect to FIG. 8.
[0074] As described herein with respect to FIG. 2 and FIG. 3 and in
the related U.S. application Ser. No. 09/693,621 incorporated
herein by reference, the parts of the hand piece 30 in the
operational mode are designed, as a whole, to oscillate at
generally the same resonant frequency, where the elements of the
hand piece 30 are tuned so that the resulting length of each such
element is one-half wavelength. Microprocessor or DSP 60, using a
phase correction algorithm, controls the frequency at which the
parts of the hand piece 30 oscillate. Upon activation of the hand
piece 30, the oscillating frequency is set at a startup value or
nominal resonant frequency such as 50 kHz which is stored in the
memory 400 of the hand piece 30. A sweep of a frequency range
between a start sweep point and a stop sweep point, whose values
are also stored in the memory 400, is effected under the control of
the DSP 60 until the detection of a change in impedance which
indicates the approach to the resonant frequency. Having obtained
the resonant frequency, the parts of the hand piece 30 are caused
to oscillate at that frequency.
[0075] FIG. 9 is a flow diagram that illustrates the operation of
the hand piece 30 according to the invention at a resonant
frequency using information stored in the memory 400. Once the hand
piece 30 is activated (step 901), console 10 reads the memory 400
of the hand piece 30 (step 903) and retrieves the information
needed for operating the hand piece 30 at the resonant frequency,
including the nominal resonant frequency, a frequency range
delimited by a start sweep point and a stop sweep point (step 905).
A frequency sweep in that frequency range is effected under the
control of the DSP 60 (step 907). Detection of the resonant
frequency is effected in step 909. If the resonant frequency has
not yet been detected, the control flow reverts back to step 907
where the frequency sweep is continued. Upon detection of the
resonant frequency, the control flow is directed to step 911 where
the parts of the hand piece 30 are caused to oscillate at that
resonant frequency.
[0076] FIG. 10 is a diagram that illustrates an alternative
embodiment of the operation of the hand piece 30 according to the
invention at a resonant frequency using information stored in the
memory 400. Instead of storing the start and stop sweep points of a
frequency range for the frequency sweep, the memory 400 stores the
nominal resonant frequency and a bias amount. The console 10
calculates the start and stop sweep points by subtracting and
adding the bias amount from the nominal resonant frequency,
respectively. A margin, which is a relatively small amount beyond
bias, is tacked on to the bias amount to respectively reach the
start and stop sweep points of the frequency range in which the
frequency sweep for seeking a resonant frequency is conducted. Once
the resonant frequency is found, the parts of the hand piece 30 are
caused to oscillate at that resonant frequency.
[0077] The memory 400 for an ultrasonic surgical hand piece 30
according to the invention is located in the electrical connector
which is disposed between the console 10 and the cable 26. The
memory device 400 can also be located in one or more locations,
including the electrical connector, within the housing of the hand
piece 30, or at an in-line location in the cable 26.
[0078] In addition to being an EEPROM, the memory 400 can be one or
a combination of a Read Only Memory (ROM), Erasable Programmable
Read Only Memory (EPROM), Random Access Memory (RAM) or any other
volatile memory which is powered by a cell, battery, or capacitor,
such as a super capacitor. The memory 400 can also be a
Programmable Array Logic (PAL), Programmable Logic Array (PLA),
analog serial storage device, sound storage integrated circuit or
similar device, or a memory device in conjunction with a numeric
manipulation device such as a microprocessor for the purpose of
encryption.
[0079] Although the invention has been particularly shown and
described in detail with reference to the preferred embodiments
thereof, the embodiments are not intended to be exhaustive or to
limit the invention to the precise forms disclosed herein. It will
be understood by those skilled in the art that many modifications
in form and detail may be made therein without departing from the
spirit and scope of the invention. Similarly, any process steps
described herein may be interchangeable with other steps to achieve
substantially the same result. All such modifications are intended
to be encompassed within the scope of the invention, which is
defined by the following claims and their equivalents.
* * * * *