|
Description  |
|
|
BACKGROUND OF THE INVENTION
The present invention relates to a system for providing laser radiation for
medical or surgical applications.
A number of surgical techniques employing laser radiation have been
developed, such as cutting or cauterizing tissues. Various laser beam
manipulator devices having been employed as surgical scalpels as
illustrated, for example, in U.S. Pat. No. 3,865,113 to Sharon et al.
Photo-coagulating devices employing a laser have been employed to effect
coagulation in a portion of a patient's eye. See, for example, U.S. Pat.
No. 3,487,835 to Koester et al. Laser optical devices, known in the art,
may also include provisions for operation under a microscope to perform
microsurgery. See, for example, U.S. Pat. No. 4,091,814 to Togo. These
various techniques have created a need for medical laser systems having
varied power levels and peripheral attachments, so that a single laser may
be used in performing these various techniques.
It is necessary to precisely control the amount of laser radiation
delivered to biological tissues in photo-surgical procedures. The
appropriate amount of radiation is known to vary with the technique
employed. Systems have been developed to control the intensity and
duration of the laser radiation energy applied to the treated tissues. See
U.S. Pat. No. 4,215,694 to Isakov et al and U.S. Pat. No. 4,122,853 to
Smith. Systems such as the Smith system rely on exposure control devices
such as shutters and laser power level control circuits.
The difficulty of controlling the amount of laser radiation delivered to
tissues is aggravated when various peripheral devices, having varying
optical properties and power requirements are used in the same system.
Moreover, the optical properties and power requirements of a single tool
may gradually change due to wear, debris build-up, etc.
Accordingly, it is an object of the present invention to provide surgical
laser system and technique for identifying and calibrating various
interchangeable peripheral surgical devices before use.
It is another object of the present invention to provide surgical laser
systems and techniques, having interlocks to inhibit the use of
uncalibrated surgical devices.
It is another object of the present invention to provide a control system
for a surgical laser for producing appropriately selected laser radiation
dosages from various surgical devices, the radiation being derived from a
single laser radiation source.
It is another object of the present invention to provide a surgical laser
system having a power beam and aiming beam controlled by a calibrated
attenuation system and derived from a single laser radiation source.
It is another object of the present invention to provide displays of
calculated system energy output levels based on readings obtained from an
interlocked calibration system.
These and other objects and features will be apparent from this written
description and appended drawings.
SUMMARY OF THE INVENTION
The present invention relates to novel methods and systems for controlling
a medical laser device to provide calibrated radiation output levels and
interlock the system against uncalibrated or accidental use.
A laser apparatus, constructed according to the teachings of the present
invention, includes a laser and a plurality of peripheral medical output
devices adapted to be coupled to the laser to receive laser radiation from
the laser. These devices may include laser scalpel, opthalmic photo
cautery devices, microsurgical systems, etc. In preferred embodiments of
the present invention, such peripheral devices are equipped with
identifying signature devices, such as signature resistors, for
identifying the device and distinguishing it from other types of devices
or others of the same type of device.
The apparatus may also include a radiation sensor, such as the combination
of an integrating sphere and semi-conductor photo-detector, for sensing a
radiation output of a surgical device selectively coupled to the radiation
sensor. This coupling may be effected by inserting a radiation output
portion of the peripheral surgical device into the radiation sensor.
The apparatus may include a control circuit for identifying the surgical
device currently coupled to the laser, by means of the surgical device
signature means. The control circuit may also enable the apparatus to
produce a low power radiation output from the surgical device when the
surgical device is coupled to the radiation sensor, thereby permitting a
calibration reading to be taken for this particular surgical device. The
control circuit may also disable the apparatus from producing a radiation
output for surgical use until the radiation output of the surgical device
has been sensed by the radiation sensor. Thus the control circuit provides
an interlock to prevent the use of an uncalibrated surgical device to
avoid the possibility that an incorrect amount of laser radiation would be
delivered to biological tissues on which surgery is to be performed.
Preferred embodiments of the present apparatus may include a radiation
sensor for sensing the radiation output from the laser at a location in
the system ahead of the location where laser radiation is coupled to the
peripheral surgical device. In this case, the control circuitry may
determine and store a value representative of the ratio of the sensed
radiation output from the laser to the sensed radiation output of the
surgical device when coupled to such radiation output. This ratio may be
used as a calibration value for estimating the actual power output of the
surgical device when the surgical device is being used to perform surgical
procedures.
Provision may be made for manually or electrically entering a power output
set-point which represents the power output desired from a particular
surgical device to be used. The control circuit of the apparatus may
calculate a laser output power level from the power output set-point and
from the value representative of the output ratio. A signal related in
value to this calculated power level may be used to control the laser.
In embodiments of the present invention, the control circuit may store and
recall information concerning the output power ratio. In particular, the
information may be recalled responsive to a recoupling of a particular
peripheral surgical device to the laser. In such a case, the recalled
value may be displayed by the apparatus.
In embodiments of the present invention, the apparatus may include beam
directing and attenuating systems for producing a main laser power beam
and a lower power aiming beam, and for selectively coupling one of these
beams to the surgical device. A two state control switch may be provided,
for triggering emission of laser radiation from the peripheral device. In
a first state, the emission of the lower power aiming beam is triggered,
while in the second state the main beam is triggered. The switch may be
interlocked so that the switch is placed in the first state for a
predetermined period of time before it may be placed in the second state.
The present invention also embraces methods for effecting the calibration
of a surgical laser apparatus which includes a laser adapted to be coupled
to various peripheral surgical devices. The method may comprise
identifying a peripheral surgical device coupled to the laser by sensing
an identifying signature of the surgical device. The apparatus may then be
enabled for calibration to produce a radiation output from the surgical
device when the surgical device is coupled to a power sensor. The
radiation output of the surgical device is then measured with the power
sensor, while the radiation output of the laser itself is being measured.
Control circuitry of the apparatus may then determine and store a ratio of
the aforementioned sensed radiation outputs, the ratio being a calibration
value for the particular surgical device being calibrated. When these
steps have been performed, the apparatus may be enabled for surgical use
to produce a radiation output from the surgical device when the surgical
device is removed from the power sensor. Interlock mechanisms may be
provided to require that these procedures be repeated to calibrate each of
a plurality of peripheral surgical devices to be used. The interlock
systems also inhibits the use of uncalibrated peripheral devices, and
improperly connected peripheral devices, as well as use of the system with
no peripheral device connected.
The system may detect the recoupling to the laser of a surgical device
which was previously calibrated. When this occurs, the apparatus may
recall the stored calibration value from the surgical device. A desired
power output set-point may be entered for the tool and the apparatus may
calculate a laser power output level from the calibration value and from
the power output set-point for the surgical device. The apparatus may then
be enabled to produce radiation for surgical use at the calibrated power
output level.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a pictorial view of a medical laser system console and examples
of peripheral surgical peripheral devices used therewith.
FIG. 2 is a schematic diagram of an embodiment of the optical and
electrical elements employed in the laser system of the present invention.
FIG. 3 is a detail of FIG. 2 showing the construction of connector portions
of a peripheral surgical device and a cable emanating from the system
console.
FIG. 4 is a schematic illustration of modes of operation of the control
circuitry of a laser system embodiment of the present invention.
DETAILED DESCRIPTION
Referring first to FIG. 1, a medical laser system is illustrated including
a laser console 10 and several exemplary peripheral surgical devices 12,
14 and 16. The peripheral surgical devices are adapted to be selectively
coupled to the console 10 by means of a optical fiber cable 18.
The console 10 may include an optical system consisting of a laser,
directing and attenuating devices, and control electronics. These
constituents of the system are described in greater detail in connection
with FIG. 2. The console may also include a video display 20 by which the
operation of the system is monitored, and a switch panel 22 by which the
system may be manually controlled, for example, by entering of power
output set points suitable for the particular surgical technique and
peripheral device in use.
A calibration pod 21 may be stored in the console 10 under a lid 23. When a
peripheral device is to be calibrated, the lid 23 may be lifted and the
pod 21 removed thereby placing the system in a calibration mode. The
device may then be optically coupled to the pod, and a calibration mode
switch 25 actuated to initiate a low power laser pulse employed in the
calibration process. This process will be described in greater detail
below.
The exemplary peripheral surgical devices shown in FIG. 1 include a
combination microscope and laser beam directing system 12 for performing
microsurgery. This device may include a joy stick manipulator 24 for
directing the laser beam onto tissues observed through the microscope eye
pieces 26. Another exemplary peripheral surgical device shown is the laser
endoscope 14, which includes an eye piece 28 and optical system 30 for
viewing the surgical operation performed through a catheter portion 31 of
the device. The third exemplary periphery surgical device 16 is a laser
scalpel having a shank portion 32 for manual manipulation and an output
tip 34 through which laser light may be directed to tissues for the
purpose of cutting the tissues. It should be understood that the examples
of peripheral surgical devices shown in FIG. 1 are not exhaustive. Such
devices may also include dermal handpieces, microsurgical scalpels,
microsurgical handpieces, intraoccular probes, rhinal probes, microcautery
probes, macrocautery probes, endoscopic probes, laser microscopic devices,
and other laser powered medical devices known in the prior art. They may
also include cautery probes and scalpels having tip portions heated by
laser radiation, wherein the laser light does not impinge on the tissues.
Such devices are described in the patent application of Perkins and
Hertzmann, ser. no. G-485480 filed Apr. 15, 1983.
FIG. 2 is a schematic diagram of an embodiment of the optical and
electrical elements employed in the surgical laser system of the present
invention. The portion of the apparatus which may be enclosed within the
console 10 of FIG. 1 is surrounded by the dotted line 50. The apparatus
may include a laser 52, a beam directing and attenuating optical system 54
and control circuitry 56. Laser radiation may be coupled to a peripheral
surgical device 58 by means of a optical fiber cable 60.
In operation the control circuit may be employed to identify the peripheral
surgical device by means of a device signature, enable the apparatus to
produce a radiation output from the surgical device when the surgical
device is coupled to the radiation sensor 21 for calibration, and disable
the apparatus from producing a radiation output for surgical use until the
radiation output of the surgical device has been calibrated.
The details of the constructions of the apparatus of FIG. 2 will now be
described in detail.
The laser 52 may, advantageously, be a frequency doubled YAG laser. Such a
laser is capable of providing relatively high power levels at a frequency
or wavelength such that readily available, flexible optical fiber cables
may be used to couple the laser radiation to the peripheral surgical
device. Such a system may employ a Nd:YAG (Neodymium-doped yttrium
aluminum garnet) laser rod 64 located between an end mirror 66 and a laser
output mirror 68. The rod may be pumped by a single laser pump lamp 70. A
KTP (KTiOPO.sub.4) frequency doubling crystal 72 may be employed at the
required power levels to achieve frequency doubling. As shown, the KTP
crystal 72 is located between an end mirror 74 and the laser output mirror
68. An acoustoptical O switch 76 may be provided to selectively quench the
laser action to control the laser output. In operation the laser may be
capable of producing up to 20 watts of laser radiation at a wave-length of
about 532 nanometers. These output parameters make the system highly
flexible and adaptable to use with a variety of peripheral medical
devices.
An output laser beam 78 from the laser 52 may be coupled to a beam
directing and attenuating means, or optical system 54. The beam directing
and attenuating optical system 54 may include an input beam splitter and
folding mirror 80 and a selectively positionable beam splitter 82
controlled by a solenoid 84. The selectively positionable beam splitter 82
provides for the selective production of a main power beam (indicated by
the solid arrows 86), or a lower power aiming beam (indicated by the
dotted arrows 87). Conventional rotating polarized attenuators 88 and 90
may be placed in the path of the main power beam and the aiming beam,
respectively. The power of the laser radiation in the aiming beam may be
reduced by lossy aiming beam reflectors 92 and 94. The main power beam or
the aiming beam may be directed on a shutter 96 by means of beam splitter
and folding mirror 98. When the shutter 96 is open, the power beam or
aiming beam may be coupled to the optical fiber cable 60.
In operation, before the laser beam from the laser 52 enters the optical
fiber cable 60, a small portion of the beam may be sampled by a beam
splitter 81 and measured by a power detector 100, which is employed to
measure the average output power of the laser 52. When the beam splitter
82 is moved out of the path of the laser beam, the laser beam passes to
the main beam attenuator 88, which consists of two polarizing plates.
Because the output beam of the laser is polarized, a rotation of the plane
of incidence of the polarizing plates will attenuate the beam to a
selective degree determined by the degree of rotation of the attenuator. A
small motor (not shown) may be used to rotate the attenuator to produce
any desired degree of attenuation. The two polarizing attenuating plates
are used so that the lateral offset of the beam due to one plate is
compensated by second plate. Consequently, as the attenuator is rotated,
the output beam remains on axis.
Following the main beam attenuator, the main beam impinges on the beam
splitter 98. A portion of the beam is directed to the second power
detector 102. Ths detector monitors the power of the laser beam just
before it enters the optical fiber cable 60.
The electromechanical shutter 96 is employed to block the beam on command,
and is located between the beam splitter 98 and the optical fiber cable
60.
A parallel, lower power, aiming beam may be selectively derived from the
output beam of the laser 52 and attenuated in a fashion similar to the
main power beam just described. To produce the aiming beam the beam
splitter 82 may be positioned by the solenoid 84 in the location shown in
FIG. 2 to direct the laser beam toward the lossy reflector 92. From the
lossy reflector 92 the aiming beam may be directed into the aiming beam
attenuation 90, which operates in a fashion similar to the main power beam
attenuator 88, previously described. The aiming beam may then be reflected
off of lossy reflector 94 into the beam splitter 98. As in the main power
beam, an average output power level of the aiming beam may be detected by
the power detector 102.
The calibration pod or sensor 21 such as those known in the prior art, may
be provided to calibrate the peripheral surgical devices which are
selectively attached to the system. In the preferred embodiment shown in
FIG. 2, the calibration sensor 21 consists of an integrating sphere 104
having an aperture 106 through which the peripheral surgical device may be
inserted or its output beam directed, and a light sensitive electronic
device such as a light sensitive silicon diode 108 located in a wall of
the sphere. The inside surface of the sphere may be a diffusing surface as
sand-blasted metal, anodized aluminum or magnesium sulfate. At any point
on the surface of the sphere, the amount of illumination is essentially
constant and insensitive to the exact positioning of the peripheral
surgical device 58 with respect to the sensor. Sensor 21 is also referred
to herein 25 sensor means.
Advantageously, the calibration sensor 21 may be removable from the console
10 and this removal detected by a proximity detector 112 which causes the
system to enter its calibration mode.
As discussed above, many different peripheral surgical tools may be
employed with this system. Such tools may be selectively coupled to the
optical fiber cable 60. FIG. 3 is a detail of FIG. 2 showing the
construction of connector portions of a peripheral surgical device and a
cable emanating from the system console. The detail also illustrates the
construction and function of signature resistors which may be employed in
a preferred embodiment of the present invention to identify a particular
peripheral surgical devices in use.
In the preferred embodiment of the present invention, signature resistors
150 may be located in a portion of peripheral surgical device 58 and
provided with electrical contacts 152 by which the signature resistors are
selectively connected to the control circuitry 56. The peripheral surgical
device 58 may be coupled to the optical fiber cable and to a control
circuitry cable 154 by means of a releasable coupling such the threaded
coupling sleeves 156 and 158 shown in FIG. 3. When a shank portion of the
peripheral surgical device 58 is inserted in the coupling the optical
fiber cable 60 is optically coupled to the surgical device 58 and the
signature resistors 150 are coupled to the control circuitry. The
resistances of the signature resistors may be detected by the control
circuitry, and the peripheral surgical device identified on the basis of
these detected resistance. In alternative embodiments an end of the
optical fiber cable from the laser may be coupled to an end of an optical
fiber cable leading to the surgical device by a conventional optical
coupler which focuses light from one optical fiber cable end to the other.
With continued reference to FIG. 2 the operation of the control circuitry
will now be described. The control circuitry 56 may include a general
purpose digital computer or special purpose microcomputer, as well as,
appropriate conventional analog-to-digital and digital-to-analog
converters. The control circuitry 56 receives information concerning the
operation of the system from the data inputs grouped at location 200, and
from a foot switch 204, the calibration mode switch 25 and switch panel
22. Control signal outputs from the control circuitry are grouped at
location 202.
In operation a peripheral surgical device 58 may be selected for
calibration and surgical use. The surgical device 58 may be coupled to the
optical fiber cable 60 and electrical cable 154. The signature resistors
in the peripheral surgical device 58 may then be interrogated to determine
the identity of that particular surgical device.
The control circuitry will block the production of a laser beam by the
laser optical system until the peripheral device is calibrated. The system
may be switched to a calibration mode by removing the calibration sensor
21 from the console. A signal from the proximity detector 112 may be
employed to trigger the control circuitry to enter a calibration mode.
The peripheral surgical device 58 may then be inserted into the sensor 21.
The calibration mode switch 25 may be pressed to activate the control
circuitry. At this point, a low power laser radiation pulse is produced by
the system and coupled into the peripheral surgical device 58. The
radiation output of the device 58 is detected by the sensor 21 and a
signal representative of the power of the output beam of the peripheral
surgical device 58 is communicated to the control circuitry via amplifier
113. At about the same time, power detectors 100 and 102 may produce
signals representative in value of the power levels measured from the
beams provided to those power detectors by the beam splitters 81 and 98.
The control electronics 56 may then calculate a value representative of
the ratio between the output power levels sensed by the power detectors
100 and/or 102, and the actual output power of the peripheral surgical
device 58 as measured by the calibration sensor 21. Detector 100 and/or
detector 102 is also referred to herein as detector means. This value may
be stored for further use in an electronic memory.
When this process has been performed, the system may be enabled for
surgical use with the particular peripheral device 58 which has been
calibrated. Should another peripheral surgical device be coupled to the
system the calibration procedure must be repeated, unless that new
peripheral surgical device had been previously calibrated within a
predetermined period of time, programmed into the control circuitry. By
use of this system one or more peripheral surgical devices may be
calibrated prior to the performance of a surgical operation. Once
calibrated, the various devices may be interchanged during the operation
without recalibration.
When the peripheral surgical device is used in the surgical operations,
controls such as the foot switch 204 and the switch panel 22 may be
employed to control the operation of the laser system. The switch panel 22
may be used to manually select desired output power levels from the
peripheral surgical device 58. Of course, during a surgical operation, the
real power output of the peripheral surgical device 58 cannot be
conveniently measured, since such a measurement would interfere with the
operation. Instead, an approximation of the actual power output level of
the peripheral surgical device 58 may be calculated from the stored ratio
of power outputs produced in the calibration mode and from power levels
continuously detected by the power detectors 100 and 102. A feedback
circuitry may be provided as indicated by arrow 208 to control the
operation of the laser, to thereby adjust the output beam 78 so that the
desired set point power output level is achieved. The foot-switch 204 may
be employed to control the timing and/or pulse duration of the laser beam
used in the surgical operation.
A video display 20 may be connected to the control circuitry to provide a
display of various operating parameters of the system such as tool
identity, calculated device power output level, aiming beam power output
level, calibration status of the peripheral device, etc.
FIG. 4 is a schematic illustration of modes of operation of the control
circuitry of the laser system embodiment described in connection with the
first three figures. In the Figure, the arrows show transitions or control
flow between modes, indicated generally as circles. The operations
indicated in FIG. 4 may preferably be performed in a general purpose
digital computer with appropriate software.
The initial system mode, the system-off mode 300, represents the state of
the system when no electrical power is being applied to the apparatus. The
system may be placed in the laser-off mode 302 by unlocking a key lock
system. In the laser-off mode, the control electronics are activated, and
the system instructs the user to press an "on" button on the control
panel. By so doing, the system may be placed in the on-power up mode 304,
in which the laser is brought up to power. Once the laser has reached a
predetermined power level, the system may pass into the calibrate mode
306, in which the system recalls the identity of any peripheral device
which is presently calibrated and displays this information on the display
screen. A peripheral device will remain in a calibrated state and
calibration data retained in the electronic circuitry memory for a
predetermined period following system shut-down, for example, eight hours.
If the system determines that one or more peripheral devices are presently
calibrated, the system may pass to the standby mode 308. Removal of the
calibration pod will cause the system to return to the calibration mode
306. This is also true for modes 308 through 314, now to be discussed.
In the standby mode 308, desired power and pulse timing data for the main
power and/or aiming beams can be entered and modified. This data is
displayed on the display screen. Power values may be displayed which are
calculated from the calibration ratio and a laser output power sensed
internally in the system as discussed above. To go into the ready mode
310, a ready button may be pressed which activates the foot switch or
other laser pulse initiating triggers.
In a preferred embodiment, the foot switch is provided with the capability
of actuating two state or mode changes: light pressure on the foot switch
places the system in the aim mode 312, in which an aiming beam is produced
by the system; and greater pressure on the foot switch places the system
in a full power mode 314 in which a power beam is produced. The system is
designed so that it must be placed in the aim mode for a predetermined
short interval before going to the full power mode. This arrangement
inhibits the accidental triggering of the full power beam, for example, by
dropping the foot switch or accidentally stepping on the foot switch.
The standby simmer mode 316 represents a lower power mode to which the
system gravitates if the system has been in the standby or ready mode, but
has not been used for more than a predetermined time interval.
The system may pass to a fault 2 mode 318 from a number of the other modes
as shown. In response to the detection of a type 2 fault such as an
interruption in electrical or optical connections to the peripheral
device. In the fault 2 mode, the production of a laser pulse is inhibited.
In such a case, if a calibrated peripheral device is then connected to the
system, the system will return to the standby mode 308. If an uncalibrated
peripheral device is connected to the system at this point, the system
will pass to the calibration mode 306.
More serious problems such as a failure of the control circuitry or a
cabinet interlock malfunction may cause the system to enter the fault 1
mode 320. As shown in FIG. 4, the system may pass from the fault 1 to the
laser off mode 302. Correction of the type 1 fault must be effected before
the system can be again be operated in the on-power up mode.
The principles, preferred embodiments and modes of operation of the present
invention have been described in the foregoing specification. The
invention which is intended to be protected herein, however, is not to be
construed as limited to the particular forms disclosed, since these are to
be regarded as illustrative rather than restrictive. Variations and
changes may ne made by those skilled in the art without departing from the
spirit of the invention.
* * * * *
|
|
|
|
|
Description  |
|