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Claims  |
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What is claimed:
1. An ultrasonic surgical apparatus comprising:
a surgical handpiece,
an ultrasonic tissue fragmenting tool adapted for ultrasonically
fragmenting tissue at a surgical site of a patient,
said tool being supported by said handpiece,
said tool having an ultrasonically-vibratable tool tip,
a supplying means for supplying ultrasonic vibrations to said tool tip,
a switching means for automatically and repeatedly switching the amplitude
of the ultrasonic vibrations of said tool, during a tissue fragmenting
procedure at the surgical site, back and forth between a working high
amplitude and a standby low amplitude which is a lower amplitude than said
high amplitude,
an aspirating means connected to said handpiece for aspirating, from the
surgical site, fluid and tissue fragmented by said
ultrasonically-vibrating tool tip, and
an irrigating means connected to said handpiece for supplying an irrigating
solution to the area of the surgical site for suspending the tissue
particles fragmented by said tool tip.
2. The apparatus of claim 1 wherein said switching means switches the
delivered vibration amplitude between said high and low amplitudes at a
switching repetition rate which is sufficiently rapid whereby the operator
of the apparatus does not distractedly sense said low amplitude.
3. The apparatus of claim 2 wherein said repetition rate is at least 30 Hz.
4. The apparatus of claim 1 wherein said low amplitude allows the tissue at
the surgical site to cool off during the tissue fragmenting procedure.
5. The apparatus of claim 1 wherein said ultrasonic vibrations comprise an
ultrasonic carrier wave of about 23 KHz.
6. The apparatus of claim 5 wherein said switching means provides a
periodically-applied pulse modulating wave which modulates said ultrasonic
carrier wave.
7. The apparatus of claim 1 wherein said switching means includes a
feed-back loop, said high amplitude remains at a constant level during the
tissue fragmenting procedure, and said switching means limits the amount
of energy allowed by said feed-back loop.
8. The apparatus of claim 1 wherein said switching means includes a feed
back means for measuring temperatures at the surgical site or surrounding
area to ensure that the energy transmitted by said tool to the patient
does not exceed allowable limits.
9. The apparatus of claim 1 wherein said switching means interrupts said
high amplitude so that the energy levels delivered do not harm to the
patient.
10. The apparatus of claim 1 wherein said supplying means comprises an
ultrasonic generator.
11. The apparatus of claim 1 further comprising a controlling means for
controlling the operation of said supplying means.
12. The apparatus of claim 11 wherein said switching means is operatively
connected to and cooperates with said controlling means.
13. The apparatus of claim 1 further comprising a manual switch means
having "on" and "off" positions for operatively connecting said supplying
means to said tool.
14. The apparatus of claim 13 wherein said switching means switches between
said low and high amplitudes when said manual switch means is in said "on"
position.
15. The apparatus of claim 14 wherein said low amplitude is a zero
amplitude.
16. The apparatus of claim 1 wherein said tool has a distal tool tip, said
tool is hollow and defines a fluid passageway which communicates with said
distal tool tip, and said aspirating means includes an applying means for
applying suction to said tool to aspirate material adjacent said tool tip
through said fluid passageway and away from the surgical site.
17. The apparatus of claim 1 wherein said switching means causes a duty
cycle which is between about 15% and less than 100%.
18. The apparatus of claim 1 wherein said supplying means comprises a
closed loop generator feed-back system.
19. The apparatus of claim 18 wherein said supplying means includes a high
amplitude adjust potentiometer means which provides a reference signal for
said closed loop generator feed-back system for setting said high
amplitude.
20. The apparatus of claim 19 wherein said supplying means further includes
a low amplitude adjust potentiometer means which provides a reference
signal for said closed loop generator feed-back system for setting said
low amplitude.
21. The apparatus of claim 19 wherein said switching means includes a timer
circuit which switches with a predetermined sequence between said high and
low amplitudes.
22. The apparatus of claim 1 wherein said low amplitude is zero, whereby
said ultrasonic vibrations at a predetermined frequency are provided
between an "on" state and an "off" state.
23. The apparatus of claim I further comprising an adjusting means for
adjusting said high amplitude.
24. The apparatus of claim 1 wherein said switching means includes a low
amplitude adjusting means for adjusting said low amplitude.
25. The apparatus of claim 24 wherein said low amplitude adjusting means
includes a potentiometer means for adjustably setting said low amplitude.
26. The apparatus of claim 24 wherein said low amplitude adjusting means
includes a circuit means for adjustably setting said low amplitudes.
27. The apparatus of claim 1 wherein said switching means includes an
oscillator means for providing a predetermined modulating frequency to
said tool.
28. The apparatus of claim 27 wherein said oscillator means provides a
modulating frequency at about 30 Hz or greater.
29. The apparatus of claim 1 wherein said tool is pulsed by said switching
means between said high amplitude and said low amplitude at a frequency of
about 5 Hz or more.
30. The apparatus of claim 1 wherein said switching means includes a duty
cycle control means for providing a variable preselected duty cycle for
said high and said low amplitude vibrations.
31. The apparatus of claim 1 wherein said switching means includes a duty
cycle control means for providing a variable preselected duty cycle for
said high and said low amplitude vibrations, said duty cycle control means
being responsive to a remotely sensed parameter.
32. The apparatus of claim 31 wherein said remotely-sensed parameter is
temperature.
33. The apparatus of claim 32 wherein said duty cycle is decreased in
response to increasing temperature.
34. The apparatus of claim 32 wherein said duty cycle is decreased when
said remotely-sensed temperature rises to a predetermined value.
35. The apparatus of claim 32 wherein said duty cycle is increased when
said remotely-sensed temperature is below a predetermined value to
increase the temperature at the surgical site.
36. The apparatus of claim 31 wherein said remotely-sensed parameter is the
rate said tool is fragmenting tissue at the surgical site.
37. The apparatus of claim 31 wherein said remotely-sensed parameter is the
vapor generation at the surgical site.
38. The apparatus of claim 1 wherein said tool provides surgical removal of
at least a part of the tissue to which it is applied, and wherein said
switching means causes a change of the stroke amplitude of said tool at a
repetition rate and a duty cycle so that the fragmenting procedure is not
interrupted while said tool is fragmenting and aspirating the tissue.
39. The apparatus of claim 1 further comprising a temperature sensing means
for sensing the temperature of tissue adjacent to the tissue to which said
tool is being applied while applied thereto, and said switching means is
responsive to said temperature sensing means to vary the amplitude of the
stroke of said tool with a duty cycle that is a function of the adjacent
tissue temperature.
40. The apparatus for claim 39 wherein said duty cycle is an inverse cycle
function of said temperature.
41. The apparatus of claim 1 wherein said switching means includes a
varying means for sequentially varying the repetition rate with which said
amplitude is automatically varied between said high amplitude and said low
amplitude according to a predetermined sequence.
42. The apparatus of claim 1 wherein said switching means controls the
total time cycle of the interruption of said ultrasonic vibrations by the
application of vibrations of said low amplitudes to less than 1,000 ms.
43. The apparatus of claim 1 wherein said switching means includes a
modulating means for modulating an ultrasonic carrier signal at a
frequency on the order of 30 Hz or more.
44. The apparatus of claim 43 further comprising a sensing means for
sensing a parameter, to produce a parameter-based control signal
representative thereof, said switching means being responsive to said
parameter-based control signal to vary the duty cycle of the modulated
ultrasonic signal.
45. The apparatus of claim 44 wherein said duty cycle lies within a range
of about 50% to about 100%.
46. The apparatus of claim 1 wherein said supplying means comprises a
general loop feed-back control system including a generator, and said
switching means switches the amplitude setting of said generator, when
said supplying means is in an "on" cycle thereof, between said high and
low amplitudes.
47. The apparatus of claim 46 wherein said low amplitude is a zero
amplitude.
48. An ultrasonic surgical apparatus for removing tumorous tissue from a
patient with minimal resulting damage to the healthy tissue adjacent to
the tumorous tissue comprising:
an ultrasonic tissue fragmenting tool,
a pulsing means for pulsing said tool with ultrasonic vibrations during the
ultrasonic tumorous tissue fragmenting procedures at a rapid pulse rate
between a working high amplitude for a first period of time and a standby
low amplitude which is lower than said high amplitude for a second period
of time,
a cycle time defined by said first period of time plus said second period
of time,
a duty cycle defined by said first period of time divided by said cycle
time,
a sensing means for sensing the temperature of the adjacent healthy tissue
while the tumorous tissue is being fragmented during a fragmenting
procedure, and
an adjusting means for automatically varying, as a function of the
temperature sensed by said sensing means, said duty cycle.
49. The apparatus of claim 48 wherein said low amplitude is one mil or
less.
50. The apparatus of claim 48 wherein said duty cycle is variable by said
adjusting means from about 10% to nearly 100%.
51. The apparatus of claim 48 wherein said duty cycle is an inverse cycle
function of the temperature sensed by said sensing means.
52. A method for the controlled fragmenting of unwanted tissue at a
surgical site with reduced resulting heat damage comprising:
during an ultrasonic tissue fragmenting procedure at the surgical site
using a vibratable tool of an ultrasonic fragmenting device, automatically
and periodically interrupting at a rapid rate the amplitude of the
ultrasonic vibrations delivered to the tool between a working high
amplitude and a standby low amplitude which is a lower amplitude than said
high amplitude.
53. The method of claim 62 wherein said periodically interrupting is
characterized in that the duty cycle thereof is between about 15% and less
than 100%.
54. The method of claim 62 wherein said low amplitude is a zero amplitude.
55. The method of claim 62 further comprising sequentially varying the
repetition rate with which the stroke amplitude of said tool is varied
between said high and low amplitudes according to a predetermined
sequence.
56. An ultrasonic surgical apparatus comprising:
an ultrasonic tissue fragmenting tool adapted for ultrasonically
fragmenting tissue at a surgical site of patient,
a supplying means for supplying ultrasonic vibrations to said tool,
a switching means for switching the amplitude of the ultrasonic vibrations
of said tool, during a tissue fragmenting procedure at the surgical site,
back and forth between a working high amplitude and a standby low
amplitude which is a lower amplitude than said high amplitude, and
said supplying means further includes a low amplitude adjust potentiometer
means which provides a reference signal for said closed loop generator
feed-back system for setting said low amplitude.
57. An ultrasonic surgical apparatus comprising:
an ultrasonic tissue fragmenting tool adapted for ultrasonically
fragmenting tissue at a surgical site of patient,
a supplying means for supplying ultrasonic vibrations to said tool,
a switching means for switching the amplitude of the ultrasonic vibrations
of said tool, during a tissue fragmenting procedure at the surgical site,
back and forth between a working high amplitude and a standby low
amplitude which is a lower amplitude than said high amplitude,
said switching means including a duty cycle control means for providing a
variable preselected duty cycle for said high and said low amplitude
vibrations,
said duty cycle control means being responsive to a remotely sensed
parameter, and
said remotely-sensed parameter being temperature.
58. An ultrasonic surgical apparatus comprising:
an ultrasonic tissue fragmenting tool adapted for ultrasonically
fragmenting tissue at a surgical site of a patient,
a supplying means for supplying ultrasonic vibrations to said tool,
a switching means for switching the amplitude of the ultrasonic vibrations
of said tool, during a tissue fragmenting procedure at the surgical site,
back and forth between a working high amplitude and a standby low
amplitude which is a lower amplitude than said high amplitude,
said switching means including a duty cycle control means for providing a
variable preselected duty cycle for said high and said low amplitude
vibrations,
said duty cycle control means being responsive to a remotely-sensed
parameter, and
said remotely-sensed parameter being vapor generation at the surgical site.
59. An ultrasonic surgical apparatus comprising:
an ultrasonic tissue fragmenting tool adapted for ultrasonically
fragmenting tissue at a surgical site of a patient,
a supplying means for supplying ultrasonic vibrations to said tool,
a switching means for switching the amplitude of the ultrasonic vibrations
of said tool, during a tissue fragmenting procedure at the surgical site,
back and forth between a working high amplitude and a standby low
amplitude which is a lower amplitude than said high amplitude,
a temperature sensing means for sensing the temperature of tissue adjacent
to the tissue to which said tool is being applied while applied thereto,
and
said switching means being responsive to said temperature sensing means to
vary the amplitude of the stroke of said tool with a duty cycle that is a
function of the adjacent tissue temperature.
60. An ultrasonic surgical apparatus comprising:
an ultrasonic tissue fragmenting tool,
a pulsing means for pulsing said tool with ultrasonic vibrations at a rapid
pulse rate during an ultrasonic tissue fragmenting procedure between a
working high amplitude for a first period of time and a standby low
amplitude which is lower than said high amplitude for a second period of
time,
a cycle time defined by said first period of time plus said second period
of time,
duty cycle defined by said first period of time divided by said cycle time,
a controlling means for controll | | |
