U.S. patent application number 09/780854 was filed with the patent office on 2001-07-19 for method and apparatus for photon therapy.
Invention is credited to Campbell, Iain, Kahn, Fred, Van Zuylen, Jeffrey.
Application Number | 20010008973 09/780854 |
Document ID | / |
Family ID | 26310388 |
Filed Date | 2001-07-19 |
United States Patent
Application |
20010008973 |
Kind Code |
A1 |
Van Zuylen, Jeffrey ; et
al. |
July 19, 2001 |
Method and apparatus for photon therapy
Abstract
A photon therapy unit implement has a flexible head for
conforming to a body part to be treated. The head has a thermally
conductive backing to remove heat from the treatment area. The
operation of the head is monitored by a photon detector to provide
a feedback to the diode drive circuit to maintain the output at the
required level. Operation of the head is monitored by a
microprocessor which performs a diagnostic function and reports on
defects. The treatment protocol is generated by a main control unit
that formulates a treatment waveform from a set of treatment
protocols. The selection of protocols is performed through a
graphical user interface (GUI) which allows selection of treatment
areas and customization of treatment as well as maintaining patient
history and annotations.
Inventors: |
Van Zuylen, Jeffrey;
(Mississauga, CA) ; Kahn, Fred; (Toronto, CA)
; Campbell, Iain; (Owen Sound, CA) |
Correspondence
Address: |
Thomas F. Peterson
Ladas & Parry
Suite 1200
224 South Michigan Avenue
Chicago
IL
60604
US
|
Family ID: |
26310388 |
Appl. No.: |
09/780854 |
Filed: |
February 9, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09780854 |
Feb 9, 2001 |
|
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08892857 |
Jul 15, 1997 |
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6221095 |
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Current U.S.
Class: |
607/88 ;
607/89 |
Current CPC
Class: |
A61N 5/0619 20130101;
A61N 5/0616 20130101; A61N 2005/0652 20130101; A61B 2017/00477
20130101; A61N 2005/0644 20130101; A61N 5/067 20210801; A61N
2005/007 20130101; A61B 2017/00482 20130101; A61N 2005/0645
20130101; A61N 5/0622 20130101 |
Class at
Publication: |
607/88 ;
607/89 |
International
Class: |
A61N 001/18 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 13, 1996 |
GB |
9623627.8 |
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. A photon therapy unit having a photon emitter, a drive circuit
to drive said photo emitter, a photon detector to monitor emission
from said photo emitter and provide a feedback signal indicative
thereof and a control to modulate said drive circuit in response to
variations in said signal and maintain said emission at a
predetermined level.
2. A photon therapy unit according to claim 1 wherein said detector
is a photo detecting diode optically coupled to said photon emitter
device.
3. A photon therapy unit according to claim 1 wherein a control
signal indicative of a desired level of emission is supplied to
said control and said control compares said control signal to said
feedback signal to modulate said driver circuit.
4. A photon therapy unit according to claim 3 wherein a difference
between said control signal and said feedback signal greater than a
predetermined difference is detected by a diagnostic function.
5. A photon therapy unit accordingly to claim 4 wherein said
diagnostic function includes a microprocessor and an error signal
is generated by said microprocessor.
6. A photon therapy unit according to claim 1 wherein a plurality
of photon emitters are arranged in an array and said photon
detector monitors are one of said emitters in said array to provide
said feedback signal.
7. A photon therapy unit according to claim 6 wherein said emitters
are superluminous diodes.
8. A photon therapy unit according to claim 6 wherein a plurality
of arrays are provided each having a plurality of emitters and said
detector monitors an emitter of one of said arrays to provide said
feedback signal.
9. A photon therapy unit according to claim 8 wherein a power
sensing monitor monitors power delivered to said array and
indicates changes therein to said diagnostic function.
10. A photon therapy unit according to claim 1 wherein a control
signal indicative of a desired level of emission and representative
of a treatment protocol to be applied is supplied to said
control.
11. A photon therapy unit according to claim 10 wherein an
amplifier is provided to amplify said control signal and thereby
modulate said drive circuit.
12. A photon therapy unit according to claim 11 wherein said
amplifier is selectively operable to vary the gain applied to said
control signal.
13. A photon therapy unit having a treatment head including at
least one of a photon emitter, a drive circuit to drive said photon
emitting device, a control to modulate said drive circuit and a
switch responsive to placement of said head on a treatment location
with said emitter directed to said treatment location, said switch
inhibiting operation of said control drive circuit until said
emitter is placed on said treatment location.
14. A photon therapy unit according to claim 7 wherein said switch
is an optical sensor responsive to ambient light to determine
placement on said treatment location.
15. A photon therapy unit according to claim 13 wherein said switch
is a proximity sensor responsive to contact with said treatment
location.
16. A photon therapy unit having a photon emitter, a drive circuit
to drive said photon emitter, a control to modulate power supplied
to said photon emitter and a power sensing monitor to identify
changes in power supplied to said device and indicate such change
to said control.
17. A photon therapy unit according to claim 16 wherein said power
sensing monitor senses current supplied to said device.
18. A photon emitting device according to claim 17 wherein said
control includes a microprocessor and changes in said power supply
are communicated to said microprocessor.
19. A photon therapy unit having a photon emitter, 8 drive circuit
to drive said emitter, and a control to modulate said drive
circuit, said control including a microprocessor to monitor
operation of said device.
20. A photon therapy unit according to claim 19 wherein said
microprocessor receives signals from a switch responsive to
placement of said device on a treatment location and a power
sensing monitor to monitor operation of said device.
21. A photon therapy unit according to claim 20 wherein said switch
inhibits operation of said photon emitter prior to placement on a
treatment location.
22. A photon therapy unit according to claim 19 wherein a photon
detector is provided to monitor emission from said emitter and
provide a feedback signal to modulate said drive circuit and
maintain said emission at a predetermined level.
23. A photon therapy unit according to claim 22 wherein said
microprocessor compares said feedback signal and a control signal
representative of a treatment protocol and generates an indication
of a difference greater than a predetermined difference.
24. A photon therapy unit according to claim 23 wherein said
indication is provided to a remote location to display a
warning.
25. A photon therapy unit according to claim 19 wherein said
microprocessor includes identification of said unit for
communication to an external location.
26. A photon therapy unit according to claim 25 wherein said
identification includes operating parameters of said unit.
27. A photon therapy unit according to claim 26 wherein a control
signal is provided to said drive circuit representative of a
treatment protocol to be performed, and transfer of said control
signal is inhibited if said identification indicates incorrect
operating parameters.
28. A photon therapy unit according to claim 19 wherein said device
is an SLD and said control includes a gain control to amplify
control signals to said driver circuit, said microprocessor setting
said gain control in accordance with operating parameters of said
unit.
29. A treatment head for photon therapy, said head having an array
of photon emitters, a thermally insulating support for said
emitters to maintain said array and a thermally conductive backing
to secure said devices on said support, said backing thereby
conducting heat from said devices and away from a treatment
array.
30. A treatment head according to claim 29 wherein said support and
backing is flexible.
31. A treatment head according to claim 29 wherein said backing has
fins formed thereon to dissipate heat from said backing.
32. A treatment head according to claim 29 wherein a control
circuit is located at one end of said head adjacent said array.
33. A treatment head according to claim 32 wherein a retaining band
is secured to said head at opposite ends of said array.
34. A treatment head according to claim 33 wherein one end of said
retaining band is secured to said head adjacent to said array at
said one end to inhibit flexure of said control circuit upon
tightening of said retaining band.
35. A treatment head according to claim 32 wherein a control panel
is provided at said one end on an opposite side thereof to said
diodes.
36. A treatment head according to claim 35 wherein said diodes are
arranged in a plurality of discrete arrays arranged in seriatim and
flexibly connected to one another.
37. A treatment head according to claim 36 wherein said arrays are
connected by flexible tube extending between adjacent arrays, said
tube containing electrical connections for each of said arrays.
38. A treatment head according to claim 37 wherein said tube forms
a loop at an end opposite said one end for attachment of said
retaining band.
39. A treatment head according to claim 35 wherein said support is
flexible and said backing is molded from a thermally conductive
material.
40. A photon therapy unit comprising a treatment head having at
least one photon emitting device therein, and a drive circuit to
drive said device, a control unit to provide control signals to
said drive circuit to implement a treatment protocol and a user
interface to select a treatment protocol from a plurality
thereof.
41. A photon therapy unit according to claim 24 wherein said
interface is a graphical user interface to permit access to a
plurality of protocols stored on a database.
42. A photon therapy unit according to claim 41 wherein said GUI
permits selection of treatment protocols by identification of areas
to be treated.
43. A photon therapy unit according to claim 40 wherein said head
includes an identification to advise said control unit of the
characteristics of said head upon connection thereto.
44. A photon therapy unit according to claim 43 wherein said head
includes a microprocessor to monitor operation of said head and
communicate such operation to said control unit.
Description
[0001] This invention relates to a photon therapy system, commonly
referred to as a low intensity laser therapy system, wherein a
substantial number of treatment parameters may be relatively
accurately and consistently controlled.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] Photon therapy is used amongst others for the treatment of
muscular skeletal disorders and wound healing. Photon therapy
systems arm primarily administered by chiropractors,
physiotherapists, sports therapists, and medical doctors in a
clinical environment. Generally, photon therapy treatment is
effected by applying light energy or photons in the visible and/or
infrared regions to parts of the body. Strictly speaking, in photon
therapy the light energy generated does not produce any significant
heating effects but does invoke photochemical and photobiological
effects in the biological tissue.
[0004] 2. Description of the Prior Art
[0005] While numerous photon therapy systems are in existence
today, none provide a complete range of flexibility in choosing
treatment parameters. Having the ability to choose various
treatment parameters is essential for a commercial application. For
example, U.S. Pat. No. 5,358,503 to Bertwell et al. describes a
flexible pad in which an array of photodiodes are mounted. Power is
supplied to the pads and is controlled by a knob connected to a
rheostat. A current supplied to the pads is visually monitored by a
light bar display. One of the major disadvantages of this device is
the inability to guarantee consistent priorities for successive
treatments. Although the patent describes a mechanism for recording
treatments applied to specific body regions, there is no guarantee
that with this device the amount of current supplied to the pads as
set by the rheostat will always produce the same light intensity
from the diodes on successive treatments.
[0006] U.S. Pat. No. 5,259,380 to Mendes et al. discloses a light
therapy system in which the light is emitted in a narrow bandwidth.
A continuous voltage differential is utilized to energize the
diodes.
[0007] In U.S. Pat. No. 4,930,504, a device for biostimulation of
tissue is disclosed which comprises an array of substantially
monochromatic radiation sources of at least three different
wavelengths. The system has a control unit to which a single beam
probe or a cluster beam probe may be connected. The control unit
provides control of the beam radiation pulse frequency, duration,
period of treatment and measurement of the conductivity of the
tissue being treated. A means for measuring the optical power
emitted by the probes is described.
[0008] As mentioned briefly above, of the numerous photon therapy
systems in existence, none provide the ability to accurately vary
the pulse width, duty cycle, waveform, average power and peak power
as well as provide a "hands off" treatment of the practitioner.
Furthermore, the probes of the prior art do not provide internal
diagnostics.
SUMMARY OF THE INVENTION
[0009] This invention seeks to provide an apparatus for photon
therapy in which treatments may be completely, accurately and
consistently characterized.
[0010] Embodiments of the invention will now be described by way of
example only with reference to the detailed description below and
in connection with the following drawings, in which
[0011] FIG. 1 is a block diagram of the overall system
architecture;
[0012] FIGS. 2(a)-(c) show a top, side and bottom view respectively
of a flexible treatment head;
[0013] FIG. 3 shows a perspective view of the top of the flexible
treatment head;
[0014] FIG. 4 shows a perspective view of the bottom of the
flexible treatment head;
[0015] FIGS. 5(a)-(c) show multiple side views of the flexible
treatment head;
[0016] FIG. 6 shows a side view of the flexible treatment head
which includes an attachment strap;
[0017] FIGS. 7(a)-(h) show various views of a second embodiment of
head in which
[0018] FIG. 7(a) is a side view of the head,
[0019] FIG. 7(b) is a plan view of FIG. 7a,
[0020] FIG. 7(c) is a rear view of FIG. 7(a),
[0021] FIG. 7(d) is a front view of the head of FIG. 7(a),
[0022] FIG. 7(e) is a view in the direction of arrow e-e of FIG.
7(a),
[0023] FIG. 7(f) is an enlarged perspective view of a component
used in the head shown in FIG. 7(a),
[0024] FIG. 7(g) is a side view of the component of FIG. 7(f),
and
[0025] FIG. 7(h) is an end view of the component of FIG. 7(f);
[0026] FIG. 8 is a schematic block diagram of the electrical
control circuit for the flexible head;
[0027] FIG. 9 is a schematic block diagram of a controlled circuit
for the single diode treatment head;
[0028] FIG. 10 shows a cross-sectional view of the diode pod;
[0029] FIG. 11 shows the control signals between the main
controller and a treatment head;
[0030] FIGS. 12 and 13 are graphs showing the peak average
optimization for the diode current;
[0031] FIG. 14 is a block diagram of the main control
architecture;
[0032] FIG. 15 is a frontal view of the main control panel;
[0033] FIGS. 16(a) and 16(b) show the overall system flow chart for
the main controller;
[0034] FIGS. 17(a)-(c) are flowcharts showing the gain calculation
for the digital signal processor;
[0035] FIG. 18 is a flowchart showing the communication of messages
between the microprocessor of the main control unit and the
treatment heads;
[0036] FIG. 19 is a flowchart showing the flow of messages from the
treatment head to the microprocessor in the main control unit;
[0037] FIG. 20 is a flowchart showing the communication between the
control unit and a personal computer;
[0038] FIGS. 21(a),(b)-32 show a parameter input and control
screens making up the graphical user interface;
[0039] FIG. 33 is a plan view of a further embodiment of treatment
head;
[0040] FIG. 34 is a side view of the treatment head of FIG. 33;
[0041] FIG. 35 is a bottom view of the underside of the treatment
head of FIG. 33;
[0042] FIG. 36 is a sectional view on the line 36-36 of FIG.
33;
[0043] FIG. 37 is a schematic circuit diagram of the control
circuit incorporated into the head of FIG. 33;
[0044] FIG. 38 is a front elevation of a still further embodiment
of treatment head and associated communication interface; and
[0045] FIG. 39 is a side view of the head of FIG. 38.
BRIEF DESCRIPTION OF THE DRAWINGS
[0046] Referring to FIG. 1, the various components of a photon
therapy system are shown generally by numeral 100. The system is
composed of three main components, namely one or more treatment
heads 200, a main controller (MCU) 104 and a computer 105 for
running a graphical user interface program 106 and including a
display 116, keyboard 117 and mouse 118. The computer 105
communicates with the MCU 104 via an RS232 link 107, while the
treatment heads 200 are connected via a suitable cable to the main
controller 104. Communication between each of the components 105,
104 and 200 is achieved by using a specific protocol. Details of
these protocols will be discussed later. As an overview, the
treatment heads 200 generate and deliver light energy to the
anatomical area requiring treatment. The treatment heads 200 may
have specific key operating characteristics, including coherence,
spectral width, peak operating wavelength, maximum irradiance and
beam profile stored within dedicated microprocessors 815 in each
head 200. The system 100 is preferably capable of recognizing and
utilizing multiple treatment heads 200 with varying characteristics
by communicating with the dedicated microprocessors 815. The light
energy sources used in the treatment heads 200 may include
semiconductor laser diodes (LD) and superluminous diodes (SLD) also
known as light-emitting diodes (LED).
[0047] The main controller unit 104 is composed of two major
components, a microprocessor 108 and a digital signal processor
(DSP) 110. The microprocessor 108 is responsible for the overall
system operation while the DSP 110 is responsible for producing
complex treatment protocols and for performing complex calculations
under the direction of microprocessor 108. Treatment protocols are
a series of operating parameters which control the treatment heads
200 and include control of such diode parameters as frequency, duty
cycle, wave form, average power and peak power. MCU 104 is also
provided with a standalone user interface 102 when GUI 106 is not
available.
[0048] The graphical user interface (GUI) 106 is a software system
that resides in memory on the computer 105 and serves to control
the MCU 104 via information exchanged along the RS232 link 107. The
GUI includes a database of preset prescription protocols, patient
record-keeping, anatomical illustrations, detail specifications,
customized treatments and the like. Each of the system components
will now be discussed in detail below.
DESCRIPTION OF THE PREFERRED EMBODIMENTS OF TREATMENT HEAD
[0049] Several types of treatment heads are described in the
following description. FIGS. 2(a), 2(b), 2(c), 3, 4 and 5(a)-(c)
illustrate a flexible treatment head shown generally by numeral 200
primarily for treating large surface areas, while FIG. 7
illustrates a single source treatment head 700 generally referred
to as a laser treatment head, which may be used for the treatment
of numerous smaller regions or for stimulating acupuncture points.
FIGS. 33-35 show a further embodiment of treatment head intended
for personal use and FIG. 36 shows a head similar to FIGS. 33-35
with an enhanced interface.
[0050] In FIGS. 2(a)-(c), in which like numerals indicate similar
structures, a flexible head is shown generally by numeral 200. The
flexible head 200 includes a rectangular control pod 202 or housing
which contains the main circuitry for controlling and powering
diodes 210; and a plurality of diode carrying pockets 204 extending
from one end of the control pod and threaded on a flexible tubing
206. The flexible tubing 206 is arranged to form a loop 208 at the
end of the treatment head 200. The loop 208 serves as a means for
grasping and manipulating the flexible head 200 or for attaching a
flexible strap such as a Velcro strap 600 as shown in FIG. 6.
Preferably in this arrangement, the VELCRO attachment strap 600 is
attached at one end 602 to the underside of the pod 202 adjacent
the first of the pockets 204. The strap mechanism allows the
flexible head to be attached to a patient, thus providing for a
so-called "hands off" treatment of a patient by a practitioner
without flexing the pod 202. The control pod 202 includes the main
circuitry for controlling and powering the diodes.
[0051] The diodes 210 project from a bottom surface of the
treatment head 200 as more clearly seen in FIGS. 2(b) and FIG. 4.
Each pocket 204 as shown in the embodiment contains an array of
diode devices 210. In the preferred embodiment, the diode devices
are SLD devices. Each array of the SLDs is arranged in two linear
rows 290 and 292 of five diodes each. Adjacent linear rows of
diodes are staggered in order to achieve a closer packing density
as well as to provide an increased luminous output per unit area.
This arrangement also enables the pockets to be made relatively
narrow, which when arranged side by side on the flexible tubing,
allow a high degree of flexibility as shown in FIGS. 5(a), (b) and
(c), thus allowing the head to easily conform to various parts of
the body being treated in order to provide good coupling of light
energy to the treatment area.
[0052] In the embodiment shown, 10 diodes are used in each array,
which to some extent is dictated by supply voltage, forward voltage
drop of the diodes and its available driver circuitry. In this
embodiment, this provides a surface area of approximately 24 square
centimeters. However, a larger or lesser number of diodes may be
utilized, in order to realize a correspondingly larger or smaller
head. For example, in another embodiment, the flexible head may
contain 20 SLD's per pocket with a total of eight pockets resulting
in a surface area of approximately 65 square centimeters
[0053] Referring to FIG. 10, a cross-sectional view of a pocket 204
is shown. As may be seen, the SLDs 210 are mounted on one side of a
printed circuit board 1004 and arranged to project from one side of
the pocket 204 on the lower surface of the treatment head 200. Each
pocket includes a driver 1006 for controlling power to the diodes
210 of that array and in the preferred embodiment comprise a FET
and a resistor. One of the problems associated with treatment heads
in general is the generation of heat from the diode devices 210.
This is particularly problematic with a large number of devices.
Photon therapy by definition should not produce any substantial
increase in skin surface temperature. In order to minimize the
heating effect of the diodes 210 and the driver 1006, the bottom
surface 1001 of the pockets 1000 comprise a thermally insulating
plastics material, while the upper surface 1002 comprises an
aluminum heat sink 1009. Internally the diodes 210, driver 1006 and
PCB 1004 are thermally connected to the aluminum heat sink 1009 by
thermal epoxy 1007, providing heat transfer from the inside of the
pocket to the outside top surface of the pocket. The upper surface
of the aluminum heat sink is grooved to form cooling fins 1008.
Furthermore the surface of the aluminium is painted black in order
to increase its emisivity. Thus both radiation and convection are
optimized to reduce the temperature of the head surface 1001 which
is in contact with the patient. Power to the driver 1006 is
supplied by a conductor 1010 located within the tube 206. Power in
the conductor is controlled by the circuitry in the pod 202.
[0054] Referring back to FIGS. 2(a)-(c), a flexible control cable
288 extends from an opposite end of the pod 202 and connects the
treatment head 202 to the main control unit 104 via a suitable
connector. As may be seen in FIG. 11, in addition to ground and
power signals, an RS-232 Tx and Rx line and a control voltage line
818 is provided from the MCU 104 via the main control cable 288.
Power to the drive 1006 of each of the pockets is derived from the
circuitry in the pod 202 and is fed via the conductors in the
flexible cable 206 to each of the pockets 204.
[0055] Referring to FIG. 8, a schematic block diagram of the
control circuitry associated with the pod 202 is shown generally by
block 800. As shown, the diode devices 210 in each of the pockets
204 are connected in series. In the embodiment shown, this is a
sting of ten diodes 210, with the string of diodes in successive
pockets 204 being connected in parallel. A +12 Volt and -12 Volt
supply 806 and 808, respectively, is provided across each string of
diodes. A voltage drive signal 812 derived from the control signal
818 in cable 288 is applied to each of FET drivers 1006. The FET
drivers are in series with the string of diodes 210 in respective
pockets and serves to control the current through the diodes,-thus
controlling the diode luminosity, in response to the drive signal
812
[0056] As stated earlier, a plurality of pockets may be connected
together in parallel. In order to ensure that a predictable and
consistent luminous signal is provided by the treatment heads 200,
a feedback loop was implemented. This is achieved in principle by
monitoring the luminous output from one of the diodes in the
string. The assumption is that by constructing or ensuring that the
remaining strings of diodes in the other pockets behave in a
similar manner to the pocket used in the feedback loop, a more
consistent luminous output can be achieved.
[0057] As shown in FIG. 8, the feedback diode 814 is optically
coupled to a pin diode 820, which is responsive to the photon
energy generated by the diode 814. The output from the pin diode is
fed via an amplifier 822 to an analog to digital input 824 of a
microprocessor 815. The microprocessor 815 performs a comparison
with this input and with the input from the control signal which is
received on the analog to digital input 824. The output from the
pin diode 820 and the input from the control signal 818 are
compared in a summer 826 to provide the output control signal 812
for the device drivers 810. As may be seen then, the feedback loop
around the pin diode 820 and the summer 826 provides a real-time
loop with high bandwidth (1 MHz) and thus provides stable and
absolute luminous output power that is not dependent upon the type
of modulation or the underlying limitations of the diodes. The
benefits of this feedback are invaluable in that, for example, if a
treatment head is composed of a number of SLD devices--for example
60--but one of the 60 is used to provide feedback as a
representative sample, then based on the assumption that the
remaining 59 devices will behave in a similar fashion, the effects
due to diverse linearity, heating and aging effects are all but
eliminated. A further significance of monitoring the luminous
output directly in this type of feedback arrangement is that it
achieves a direct control of the luminous output rather than the
drive current. A pin diode is preferably used as a photo receptor
as it provides a linear response while being relatively
temperature-insensitive, extremely fast and accepts a wide range of
power and spectral intensities,
[0058] A further advantage of this feedback arrangement is that the
feedback loop integrity may be ensured by utilizing the
microprocessor 815 to constantly measure or compare the desired
output signal with the measured output signal. These signal lines
are indicated as numerals 824 and 822 respectively. Should the
signals be dissimilar, the software contained within the
microprocessor would inform the main control unit via the RS232
line.
[0059] The total current through the diodes 210 is monitored by a
current monitor indicated by block 828, which provides a signal on
an analogue-to-digital input line of the microprocessor 815. The
microprocessor utilized in this embodiment is a PIC 16C71 chip
which includes 4 analogue-to-digital input lines. Thus, by
monitoring the total current through the diodes 210, a failure of
one or more diodes will be noted by a change in total current and
once again the microprocessor will communicate this via the RS232
line to the main controller unit Also, as devices age, more current
will be required to maintain a desired intensity; thus a current
monitor may inform the user when the useful lifetime of a head has
been realized. Thus, the net effect of the feedback loop combined
with the built-in diagnostics in the microprocessor 815 ensures a
stable, absolute and reliable luminous output.
[0060] A photo diode 830 located within a pocket 802 is connected
via a current-to-voltage converter to an analogue-to-digital input
832 of the microprocessor in order to provide a signal indicative
of the ambient light The microprocessor 815 receives this ambient
light monitor signal 832, relays the information to the MCU over
communication lines 816, which determines whether a treatment
should be activated. If the head 200 is not attached to a physical
object, such as the body, the ambient light reading will be high,
indicating an unsafe operating condition. When attached, the
ambient light reading will be low and the treatment may proceed. In
addition, a user may alter the sensitivity of the ambient light
sensor via the GUI software program in order to accommodate various
lighting conditions. In addition to communication over control 816,
the microprocessor 815 provides a light enable/disable control
signal 833 to the summer 826 to ensure that the luminous output is
disabled for all situations other than when a treatment is active.
This is particularly useful in failsafeing the system and
preventing any low-level optical signals from being emitted when
the heads are idle. This feature is of particular relevance for
laser heads as they operate within the active lasing region and
thus low-level or off-power setting is not zero but a relatively
low intensity signal compared to the high-level.
[0061] Besides performing control functions within the head 200,
the microprocessor 815 stores an identification of the head 200 and
its operating characteristics that it may communication to the MCU
104 over lines 816.
[0062] SLD devices 210 are capable of producing high instantaneous
optical peak power pulses, often an order of magnitude greater than
its average optical power output. These high instantaneous peak
pulses may be produced if the pulses are of short duration and duty
cycle (typically 10 microseconds, 1% DC). To provide a suitable
form of control signal for SLDs 210, a fixed gain amplifier 840 is
provided between the control signal line 818 and the summer 826 and
is controlled from the microprocessor 815 via gain control line
838. Thus, when the gain amplifier 840 is activated, the signal to
the driver is amplified by a predetermined factor, amplifying the
light output by a corresponding factor as will be explained more
fully below.
[0063] Manual control of the head 200 is provided by a switch 220
and two indicator LED's 222 and 224 which as seen in FIG. 2(a) are
mounted on top of control pod 204. The switch 220 provides the
function of a start/stop button and is connected to an input port
of the microprocessor 815 as indicated in FIG. 8. As a safety
feature, the switch 220 must be "double-clicked", i.e. depressed
twice in rapid succession, which sends a signal to the
microprocessor 815 to enable the diode devices 210. Any single
click of the switch 220 thereafter will deactivate the diode
devices. The indicators 222 and 224 identify when the diodes are
enabled (green) and when the head is active (red). This is a
particularly important safety feature when the head is composed of
infrared diode devices.
[0064] As a further safety measure, a disposable polymer-based
membrane in the form of a preshaped sheath (not shown) will allow
the flexible treatment head to be encased therein. This is
particularly useful in open wound applications where there is risk
of infection. The optical properties of the disposable polymer
material is such as to allow for ready transmission of photon
energy. Upon completion of a treatment, the sheath may be disposed
of.
[0065] Single Point Treatment Head
[0066] Referring to FIGS. 7(a), (b), (c) ,(d) and (e), an
embodiment of a point source treatment head is shown generally by
numeral 700. In the embodiment shown, the treatment head utilizes a
laser diode 702 which is capable of producing a small point of high
irradiance. The head 700 includes an elongated, elliptical
cross-section body 704 for gripping the head 700 and a nose 706
extending at an angle to the main axis of the body. As may be seen
in FIG. 7(a), the laser diode 702 is mounted at the tip of the nose
706 and projects a beam at an angle to the axis of the body 704. A
hump 708 or protrusion is formed at the junction of nose 706 and
body 704. The hump 708 allows a practitioner to apply, for example,
thumb pressure to a point being treated while still having a firm
grip of the body. The elliptical cross-section of body 704 also
provides better grip of the body for the practitioner and the angle
of the laser diode facilitates manipulation of the device while
observing the area of treatment. The shape of the head 700 also
allows the head to be held more traditionally like a pen, being
squeezed between the forefinger and a thumb.
[0067] The nose 706 terminates in a tip 710 which is made as small
as possible to facilitate applications such as laser acupuncture.
An optical window 712 as more clearly seen in FIG. 7(d) and 7(e) is
positioned at the tip of the head, behind which the laser diode is
mounted. This arrangement provides protection for the laser diode
behind the optical window while preventing build-up of contaminants
and allowing the head to be easily cleaned, thermally and
electrically isolating the diode from the patient. In the
embodiment shown, heat produced by a laser diode during treatment
is conducted away from the patient by a heat sink contained
internally within the head (not shown). This combined with the
optical window maintains the surface of treatment relatively
cool.
[0068] As with the flexible head described earlier, safety features
have been incorporated in the point source head to prevent ocular
hazards, particularly with the use of laser diodes. Two indicator
light-emitting diodes 714 and 715 respectively are provided on
either side of the head 700. The position of the indicator diodes
714 and 715 provides a high degree of visibility from all angles.
The light-emitting diodes utilized in this embodiment are of the
bi-colour type and provide a green output when the head is enabled
and a red output when the head is active. To provide a start
control for the operation of the head, a proximity sensor device
716 is mounted on either side of the laser diode 702 and projects
to the surface of the tip 710. The proximity sensor 716 includes a
pair of contact electrodes 718, 720 which when placed in contact
with a suitable medium such as the skin provides a conduction path
between the electrodes 718, 720. Preferably the electrodes 718, 720
are integrally molded from a conductive epoxy with the balance of
the tip 710 molded from a non-conductive epoxy material. The
electrodes are then covered with a think protective layer, i.e.
paint, to reduce the effects of moisture. The electrodes 718, 720
are attached to conductors passing through the housing 703, a
driver circuit which is composed of an oscillator whose frequency
varies with the capacity of the electrode and then converts the
output frequency to DC signal of varying voltage. The up 915
monitors this voltage and when the head is in contact with the
skin, a voltage of predetermined value is obtained which allows the
head to be activated. Similarly, removal of the head from the skin
terminates operation of the head. Thus, the proximity sensor also
serves as a local start-stop switch, namely activating the head
when the head is enabled and in contact with the skin and stopped
when the head is enabled but removed from contact with the skin. An
automatic delay may be incorporated within the head control
circuitry to delay activation of the laser diode, in response to a
signal from the proximity sensor, in order to avoid unintentional
spurious luminous output. The proximity sensor provides an
advantage to a practitioner since it allows a sequence of points to
be illuminated for short durations without having to consciously or
physically having to keep activating the laser diode. The laser
diode used in the present embodiment has a power output that may
range from 10's milliwatts to several hundred milliwatts which is
calculated to produce an irradiance in the order of 1,000
milliwatts per square centimeter.
[0069] In FIG. 9, an electrical circuit diagram showing the major
functional blocks for control of the point source treatment head is
shown generally by block 900. As may be seen, the control circuitry
for the diode 702 is similar to that of the control circuitry for
the flexible head as shown in FIG. 8. However, an optical feedback
is provided by a PIN diode 904 which is incorporated with the
module containing laser diode 702. The remaining components will
not be discussed further as they are similar to that of the control
circuitry described with reference to FIG. 8 but for clarity are
identified by like reference numerals with 9 and the m.s.d. rather
than 8.
[0070] Main Controller Unit
[0071] The main controller 104 as shown in FIG. 1 is a
self-contained device used exclusively to control the treatment
heads and communicate with the graphical user interface. The
controller 104 has two key elements, microprocessor 108 and digital
signal processor 110. The controller unit 104 has a user interface
102 as illustrated in FIG. 15 or it may be controlled remotely via
the GUL. The main controller user interface 102 shown in FIG. 15
includes sockets 1502 and 1504, to which may be attached the
treatment head control cable. A set of push buttons 1506, 1508 and
1510 provide the functions of enabling treatment, pausing treatment
or ending treatment, respectively. A liquid crystal display 1512
provides display of various parameters associated with the
treatment. A data entry key pad along with an associated cursor
control key pad 1516 and 1518 respectively, as well as an optical
incremental encoder 1517 provides means for entering data and
accessing various treatment parameters. A mode selection switch
1520 provides a means of selecting various modes of operations such
as a preset mode and a manual mode. A key lock mechanism 1522 is
provided as a safety feature to prevent unauthorized use of the
system.
[0072] Referring to FIG. 14, a simplified block diagram of the main
controller architecture is illustrated generally by numeral 1400.
The microprocessor 108 shown in FIG. 14 acts as a central processor
for handling the intercommunication functions between the DSP 110,
treatment heads and the main controller user interface and RS232
interface via the GUI. A timer 1402 is settable by the
microprocessor 108 to control the time of treatment and a buzzer
1404 connects to the microprocessor and provides audible indication
of user significant events. The microprocessor 108 is associated
with random access memory (RAM) 1406 as well as user programmable
memory in the form of E.sup.2PROM (for storing preset treatment
parameters) 1408 and an EPROM for storing the operating program for
the microprocessor 108 and the DSP. Communications to the
microprocessor 104 are switched via multiplexer 1412 between the
generic treatment head ports 1502, 1504 and the RS232 interface 107
to the external computer. Protection circuitry 1414 disposed
between the ports 1502, 1504 and the microprocessor 108 is provided
to protect the treatment heads when they are plugged into or out of
the ports. The protection circuitry also serves to prevent spurious
luminous output during attachment or removal of the treatment heads
from the ports. Supplementary bicolor indicators are located beside
each port, 1528 and 1530 as shown in FIG. 15. The indicator
provides a green indication that a treatment head is attached and
functional and will provide a red indication when the treatment is
active.
[0073] As outlined earlier, the central microprocessor 108 is not
only responsible for ensuring communication between the various
components of the main controller unit but also includes
programming for timing treatment, providing a specific enable
sequence to the treatment heads via the ports 1502, 1504, staring,
pausing and stopping treatment, monitoring the ambient line sensor
and controlling the treatment heads, providing head diagnostics,
and controlling the treatment heads.
[0074] The DSP 110 is primarily used to synthesize various
modulation schemes for the creation of treatment protocols and thus
controlling the luminous output of the treatment heads. The DSP 110
allows the diodes 210 to be operated in continuous wave modulation
or pulse modes. In modulation mode, the DSP 110 is further capable
of generating any repetitive wave forms such as a square wave, sine
wave and triangular wave. The frequency of operation may range from
0.01 Hz to 100 kHz in modulation mode and in pulse mode, the pulse
width may be as small as one microsecond.
[0075] In the pulse and modulation modes, the DSP 110 may be used
to optimize the ratio of peak to average power for the diode
devices. As mentioned earlier, SLDs are capable of peak intensities
which may be an order of magnitude greater than their average
intensities. This, however, is only possible under certain
conditions. It must be noted, however, that other laser devices,
such as laser diodes, generally are incapable of producing peak
pulses and will be damaged by any transients or peaks above their
specified maximum average. Thus, as outlined earlier, the specific
operating capabilities of each treatment head 200, 700 are stored
in the dedicated microprocessor 815, 915 in the respective
treatment head control unit, and uploaded to the central
microprocessor 108 of main controller unit 104 when the treatment
head is attached to the control unit. This information may include
the type of head being used, either SLD or LD, the gain which may
be applied to the diodes and information relating to the range of
acceptable duty cycles and periods.
[0076] For most laser devices, such as LDs, the operating
parameters such as duty cycle and frequency are fixed.
[0077] In the case of an SLD, when operated in modulation or pulse
mode, and the period and duty cycle is small, the currents through
the diode may be much larger than average. Systems, currently
available using SLDs, normally operate at a fixed frequency and
duty cycle and thus the operating parameters are fixed. In the
preferred embodiment, the system is capable of operating over a
wide range of parameters and automatically optimizes the peak to
average intensity applied to the diodes 210 when an SLD head is
recognized.
[0078] FIGS. 12 and 13 illustrate the operating characteristics of
SLDs with a graph showing the maximum peak pulse current versus the
pulse width of the SLD identified as numeral 1300 and a graph
showing the maximum pulse current versus duty cycle identified as
numeral 1302. The graph of 1302 indicates that the duty cycle must
be low in order to achieve a high peak intensity. The maximum
current may be calculated by the following equation: 1 I m ax = ( 1
dutycycle .times. A ) + B
[0079] where A and B are provided from the manufacturer's data
sheets and are specific for each device. As well, the pulse width
must be small to achieve high peak intensity. The graph 1302 is
divided into three sections. As shown, for high pulse widths, the
maximum current allowable will equal the average while for various
short pulse widths, the diode current will reach the peal limit. In
the region between the two extremes is a transition region allowing
varying degrees of increases in peak current. By determining which
of the two values of current, ie. Imax or that deteruned by curve
1300, optimum operation of the SLDs may be obtained. The algorithm
illustrated in FIG. 17(a)-(c) shows the sequence of steps performed
by the DSP for performing the duty cycle limit calculation,
checking the pulse width to determine pulse width limit and setting
the peak current value to the highest possible of the two upper
limits. A flag is then set to indicate whether gain is required.
Should gain be required, the output is multiplied by a fixed gain
amplifier 840 accordingly. The product of the gain factor and
amplitude 818 equals the peak intensity. Based on the above
information, the average intensity may be calculated.
[0080] Before a treatment can start, the practitioner must select
the form of treatment and required operating parameters. This is
facilitated by the GUI 106.
[0081] Graphical User Interface
[0082] FIG. 21(a) shows the interaction between the graphical user
interface program 106, the display 116 and the main controller unit
104 via RS-232 interface 107. The GUI program also interacts with a
database 2100 which in the preferred embodiment resides on the
computer 105, and responds to events which include user input from
a keyboard 117 or a mouse 118. The GUI program 106 is composed of a
number of screen displays. The preferred embodiment contains a main
screen 2150 which provides access to four main groups of further
screen objects, each group of screens is associated with patient
information 2152, treatments 2154, device control 2156 and program
configuration 2158.
[0083] FIG. 21(b) depicts the main screen display 2150. This screen
provides a menu bar 2104 which is divided into user input areas.
The screen is further divided into a patient profile area 2152, a
prescription detail area 2154 and a treatment control area 2156.
Each of these areas includes a series of command buttons 2162 for
accessing the other screens associated with that group. For
example, by clicking on the NEW command button 2160, a new patient
screen is displayed by the GUI program in FIG. 22(a). The new
patient screen includes input areas for patient name, patient code
number and date of birth. An ACCEPT button allows the new patient
data to be saved in a database. Referring to FIG. 22(b), an
existing patient may also be selected from a scrolling list which
is provided by the select patient display. A display as shown in
FIG. 22(c) is accessed from a FACTORS button on the new patient
screen in FIG. 22(a) or from the main screen in FIG. 21(b) and is
used for setting various patient factors such as age, complexion
and build, each of which has some bearing on the treatment
protocols selected. In the embodiment, each of these patient
factors is divided into subcategories which are assigned a scale
factor. This scale factor is then used to increase or decrease the
total treatment time for that patient. Thus, standard treatment
protocols may be altered to account for an individual's physical
characteristics. This not only makes for a more effective treatment
but also reduces the amount of knowledge that a practitioner
requires in order to personalize treatments.
[0084] All patient related information is saved in database 2100.
All treatments administered to the particular patient are then
recorded in a patient history that is accessed from the main screen
of FIG. 21(b) through the "HISTORY" button. As shown in FIG. 23(a),
the Patient History screen includes the treatment protocol used,
dates of treatments and energy density applied and specific details
of the treatment protocol. The user also has the ability to enter
text-based details or comments at various stages of the treatment
process such as new patient entry, every treatment session and the
end of a course of treatments. This information may be viewed via
display screen as shown in FIG. 23(b). Both the patient history
display shown in FIG. 23(a) and the patient history display shown
in FIG. 23(b) include view and print command buttons which allow a
complete patient record to be viewed or printed to produce a hard
copy.
[0085] Referring to FIG. 24, a display for selecting a treatment
protocol is shown generally by numeral 2400. Prescribing a
treatment protocol involves the selection of a preset protocol.
Preset protocols contain all the information required to implement
a treatment. Protocols are stored in two groups. The first group is
supplied with the system and may not be altered by the user while
the second group may be created by the user using a customized
sub-routine. The treatment protocols are divided into three levels.
The levels are labeled A, B and C as shown in FIG. 24 and indicated
by numerals 2402, 2404 and 2406, respectively. For each item in
column A, a corresponding list of items will appear in column B.
Similarly, a selection of an item in column 13 will produce a
listing for that item in column C. Treatment names may be based
upon specific protocols or user-specified protocols, physical body
regions, disease entities, various dosage levels and such-like. The
details of each specific protocol may be accessed via a view
prescription command button 2168 on the main screen or a custom
treatment may be created via the customize button 2408. Once a
treatment has been selected, it may be prescribed to the patient
via the accept button 2400. All of the associated parameters are
stored in the database 2100. The treatment may then be sent to the
MCU and administered under treatment control via the enable button
2170 on the main screen.
[0086] FIGS. 25(a), 26 and 27 display screen objects for creating
prescription protocols and display corresponding head parameters
for the prescriptive protocols. The screen selected is determined
by which mode of operation is selected, ie. pulsed as in FIG.
25(a), modulation as in FIG. 26 or continuous as in FIG. 27. For
each prescription, the user may change how often the treatment is
repeated, the total number of treatments and the number of stages
in treatment. Each stage in a treatment is a set of specific
operating parameters. Thus numerous stages may be set up to
effectively administer multiple protocols in a single treatment.
This may also include changing treatment heads as well as
parameters of operation. The end of each stage may also include a
forced stop allowing the practitioner to examine the patient at
preset intervals. The final stage of a protocol may be repeated
which is ideal for extending treatments or for treating a sequence
of numerous points.
[0087] A specific head may also be selected from a listing of
available heads for each stage of a treatment The detailed
specifications for each head may be viewed as for example indicated
by the head parameter displays shown in FIG. 25(b). These
parameters are specific to each head and may not be altered. This
information, however, is crucial to the creation of a protocol.
[0088] The Create Prescription display as for example shown in FIG.
25(a) provides under its Stage Detail section the user with a
selection for the mode of operation of the particular treatment
head. The mode of operation includes continuous wave, modulation or
pulsed mode operation. By selecting a particular mode of operation,
the parameters of displayed operation will vary accordingly. The
system is also able to administer various repetitive wave forms in
modulation mode including sign, square and triangular waves as
indicated at 2602. A novel system feature is that the user controls
luminous power via percentage rather than absolute values. The
system also optimizes the ratio between peak and average power.
This optimization is based upon the type of treatment head used and
the characteristics of its diode, the selected frequency and duty
cycle as described earlier. All other parameters such as power
density, duration and energy density may be altered. Once a
treatment has been created it may be stored as a protocol as shown
in FIG. 28.
[0089] To assist the practitioner in his prescription, the GUI
program also includes screen objects for an anatomical tutor. As
indicated in FIG. 29, detailed diagrams of a part of the human
anatomy may be viewed and linked to specific protocols. These
diagrams may include specific views of anatomy, die specific
illustrations or specific information regarding treatment
application and probe placement. The display may be composed of
illustrations and/or text and may be layered as shown in the two
illustrations of FIG. 20 to provide successive detailed views of
the selected region.
[0090] In some circumstances, it may be desirable to operate
without the computer 105. In this case, the GUI 106 may be used to
download prescriptions to the MCU 104. FIG. 31 indicates screen
displays for initiating a download of groups of preset protocols to
the main controller 104 via the RS232 link 107, which is stored in
the E.sup.2PROM 1408. System operating conditions may be set via a
configuration screen as shown in FIG. 30. The download of protocols
to the MCU 104 allow the access of the protocols via the user
interface 102 for standalone operation.
[0091] In addition, the GUI software program includes help screens
for providing online assistance to a user in a conventional manner
as illustrated in FIG. 32.
[0092] The communication protocol between the MCU 104 and head 2009
or computer 105 is shown schematically in FIGS. 18 and 19 and 20
and 21 respectively. The protocols are conventional in nature
permitting two-way communication from the MCU 104 to head 200, 700
or computer 105. In this way, treatment protocols or data may be
retrieved from the computer 105 and stored in the E.sup.2PROM 1408
and information gathered from the dedicated microprocessors 815,
915 and instructions forwarded for treatment.
[0093] Having described the various components of system 100, the
overall operation will be described.
[0094] Referring now to FIGS. 16(a) and 16(b), system operation
treatment may be initiated in one of two ways, either by
downloading a protocol from the GUI software database to the
microprocessor 108 in the main controller unit 104, or having a
preset protocol stored in E.sup.2PROM 1408 selected via the data
entry controls 1516 on the interface 102. In either instance,
information regarding the desired treatment is displayed on the
liquid crystal display 1512 and/or the GUI and all actions entered
by the user directly via the control panel and/or via the GUI
program. Once the treatment is selected, the microprocessor checks
that the required treatment head as required by the selected
protocol is currently plugged into either one of the sockets 1502
or 1504. If the required treatment head is not plugged in as may be
detected from the dedicated microprocessor 108, the microprocessor
108 sends a message either to the GUI program via the RS232 link of
the computer or to the liquid crystal diode 1521 informing it that
the head is not available. The microprocessor then waits for the
requisite head to be plugged into the socket. The program may be
ended by the user. Once the correct treatment head is detected, the
microprocessor sets the timer 1402, then downloads a wave form
table, head parameters and wave form parameters to the DSP 110. A
command is then sent by the microprocessor to the DSP to begin
processing the protocol. The indicator lights 1528, 1530 adjacent
the socket 1502, 1504 on the main controller panel is switched from
green to red and the head indicator 222 is switched to green,
indicating that the head is enabled, i.e. ready to perform a
treatment protocol. At this time, the microprocessor 108 waits for
a double click of the push-button 220 on the treatment head. Once a
double click is detected, the microprocessor 108 checks for ambient
light to ensure that the head is securely fastened onto the
patient's body (as in the case of a flexible treatment head), or in
the case of the head 700, this is automatically perfomed by the
proximity sensor. The microprocessor 108 then tests the treatment
head to ensure that it is in good order.
[0095] As seen in FIG. 16(b), should an error signal be detected at
this stage, a message is sent to the PC or the liquid crystal
display to inform the user of the particular error. The processor
then returns to Point C on FIG. 16A. If no error message is
received at this stage, the treatment begins. The microprocessor
108 turns the treatment diodes on via control signal 818 derived
from the DSP 110, the head indicator light 224 on (red) to indicate
the head is active, and activates the gain mechanism of the
treatment head if the gain flag has been set. The main control
circuit in the head 200, 700 then monitors operation as described
above with reference to FIGS. 8 and 9 respectively. The LCD display
and or the GUI program is constantly updated with the elapsed time
of treatment. At this time, if a PAUSE command is received or the
treatment time has elapsed, the microprocessor freezes the timer,
turns the treatment diodes off, and turns off the indicator LED of
the optical head. If at this stage an END-OF-TREATMENT command has
not been received, the microprocessor returns to point C on FIG.
16A. If an end-of-treatment command is received, the microprocessor
freezes the timer, turns off all the indicators at the treatment
head, and turns the socket indicator light from red to green. The
sequence of operation is then completed. Further use of the bead
requires enablement of the treatment protocol and subsequent
activation of the head.
[0096] It may be seen then that once the treatment protocol has
been determined and the treatment enabled, further adjustment or
control of the optical characteristics of the treatment heads need
not be manually adjusted since the microprocessor within the
treatment heads with its associated feedback loop ensures that the
characteristics of the optical devices such as the SLDs and LDs
remain accurately calibrated.
[0097] The embodiment described above provides full flexibility of
treatment for a number of patients as may be required by a medical
practitioner. The principles of operation may also be utilized in
an environment suitable for personal use, for remote use by a
practitioner, as an outpatient treatment for treatment at a clinic
where a number of units may be programmed and used simultaneously.
The unit may be programmed with generic protocols by the
manufacturer for personal use or with specific protocols 2400 by
the practitioner for prescription use.
[0098] A unit intended as a personal unit is shown in FIGS. 33-39
in which like reference numerals will denote like components with a
suffix "a" added for clarity. The system 100a is self-contained
having functions of the main operating unit 104a integrated into
treatment head 200a. The unit is programmed via programmer module
270 from the GUI program 106 and RS 232 interface 107 through
communication port 272.
[0099] The head 200a includes diodes 210a mounted directly on a
flexible printed circuit board 250. The printed circuit board 250
is sandwiched between two layers of silicon 252, 254. The lower
layer 252 through which the diodes 210a project is thermally
insulative electrically nonconductive to inhibit heat transfer to
the skin of the patient. The upper layer 254 is thermally
conductive electrically non-conductive and has cooling fins 1008a
integrally formed in it. This arrangement has the same heat
transfer attributes as described previously.
[0100] The PCB 250 extends into control pod 202a and carries the
electrical components associated with the main control circuit
illustrated schematically in FIG. 37. Microprocessor 815a has an
E.sup.2PROM 1408a associated with it in which is stored a number of
different protocols received from programmer module 270. The
microprocessor 815a may access a selected one of the protocols and
output control signals to control line 818a to operate the SLDs
210a. A diagnostics function 262 is associated with the
microprocessor 815a to monitor operation of the head 200a and
communicate to the module 270 periodically.
[0101] Selection of a respective one of the protocols is provided
by buttons, 256, 258, 260 located on the upper layer 254. Each of
the buttons carries an indicia indicative of its treatment
protocol, such as its treatment level, ie. low, medium, high, or
the region to be treated, ie. elbow, knee, neck, the type of
ailment to be treated, ie, sprain, arthritis, tennis elbow, or a
generic treatment A,B,C. Selection of one of the buttons conditions
the microprocessor 815a to access the corresponding protocol.
[0102] Activation of the microprocessor 815a is controlled by
switch 220a in the upper layer 254 and indicator lights 222a, 224a
provide status indications to the user. A series of indicator EDs
269 surrounding the array 210a provide a visual indication of an
active probe.
[0103] A strap 600a is secured to the lower layer 242 adjacent the
initial array 210a and its opposite end is secured to a releasable
hook and loop fastener pad 264, available under the trademark
"Velcro", mounted on the upper surface 254. Power is supplied to
the pod 202a by an AC/DC adapter 266 through a pin and socket 265.
Downloading of protocols to E.sup.2PROM 1408a or other information
exchange is achieved via two additional contacts (not shown) or via
the connector 265.
[0104] An override system is incorporated into the head 200a. A
series of contacts 267 provides a similar method of sensing the
presence of the body as the proximity sensor 716 described earlier.
Multiple contacts 267 are spread along each side of the arrays of
the diodes 210a outboard of the indicators 269. Contacts may be
grouped in various patterns to create a pair of electrodes such as
718, 720. Also two or more sets may be created, each with its own
driver circuit. Thus, numerous contacts must be in contact with the
body in order for the probe to activate. The contacts will be made
from a metal to simulate the appearance of an LED. The contacts 267
identify contact with the skin by varying the impedance in an a.c.
circuit. The resultant frequency variations modulate a voltage
signal in driver circuit 274 which is provided to the
microprocessor 815a.
[0105] The flexible PCB 250 permits the head to accommodate curved
surfaces and allows the head 200a to flex along both longitudinal
and transverse axes for optimum engagement with the skin. To
inhibit undue flexure of the control pod 202a, stiffening panels
275, 276 are secured to the upper and lower layers 242, 254. These
may provide access to the electronic components or may be
integrally molded with the layers 242, 254. Conveniently, the panel
275 may incorporate the buttons 256, 258, 260 and switch 220 in a
membrane switch panel. The simplified operation and control of the
available protocols renders the unit suitable for home use without
the intervention of a qualified practitioner. The incorporation of
the override control, feedback loop and diagnostic monitoring by
the microprocessor provide the requisite level of safety for such
use.
[0106] The E.sup.2PROM 1408a retains protocol instructions that can
be accessed by the microprocessor 815a to reproduce the protocols.
Other information retained in the E.sup.2PROM may include
identification allowing the GUI 105 to record patient history 23a
as well as a measure of treatment compliance.
* * * * *