MXPA99004457A - Method and apparatus for photon therapy - Google Patents
Method and apparatus for photon therapyInfo
- Publication number
- MXPA99004457A MXPA99004457A MXPA/A/1999/004457A MX9904457A MXPA99004457A MX PA99004457 A MXPA99004457 A MX PA99004457A MX 9904457 A MX9904457 A MX 9904457A MX PA99004457 A MXPA99004457 A MX PA99004457A
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- photon
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- head
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- therapy unit
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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.
Description
METHOD AND APPARATUS FOR THERAPY WITH PHOTONS FIELD OF THE INVENTION
This invention relates to u? photon therapy system, commonly referred to as a low intensity laser therapy system, wherein a considerable number of treatment parameters can be controlled relatively precisely and consistently.
BACKGROUND OF THE INVENTION Photonic therapy is used, among others, for the treatment of "muscular skeletal disorders and wound healing." Photonic therapy systems are mainly administered by chiropractors, physiotherapists, sports therapists and medical doctors in a clinical setting. In general, the treatment of photon therapy is carried out by applying light energy or photons to the body parts in the visible and / or infrared regions, strictly speaking, in photon therapy, the light energy generated does not produce any significant thermal effect. it invokes photochemical and photobiological effects in the biological tissue.
DESCRIPTION OF THE PREVIOUS TECHNIQUE While many photon therapy systems exist today, none provide a full range of flexibility in the selection of treatment parameters. Having the ability to select several treatment parameters is essentially a commercial application. For example, U.S. Patent No. 5,358,503 to Bertwell et al. describes a flexible attenuator where an array of photodiodes is mounted. The power is supplied to the attenuators and controlled by a knob connected to a rheostat. A
, current supplied to the attenuators is monitored visually by a light bar display. One of the main disadvantages of this device is the inability to guarantee consistent priorities for successive treatments. Although the patent describes a mechanism for registering treatments applied to specific regions of the body there is no guarantee that with this device the current quality supplied to the attenuators in the manner adjusted by the resistor will always produce the same light intensity from the diodes, in successive treatments. U.S. Patent No. 5,259,380 to Mendes et al. exposes a light therapy system where light is emitted in a narrow bandwidth.
A continuous voltage differential is used to energize the diodes. In U.S. Patent No. 4,930,504, a tissue biostimulation device is disclosed which comprises an array of essentially monochromatic radiation sources of at least three different wavelengths. The system has a control unit to which a single beam probe or a beam cluster probe can be connected. The control unit provides control of the probe radiation pulse frequency, duration, treatment period and measurement of the conductivity of the tissue being treated. A means for measuring the optical power emitted by the probes is also described. As mentioned before, in summary, of the various photon therapy systems that exist, none provide the ability to accurately vary the pulse width, duty cycle, waveform, average power and peak power, nor do they provide the practitioner with the possibility of performing a "hands-free" treatment. In addition, probes of the prior art do not provide internal diagnostics.
SUMMARY OF THE INVENTION The invention seeks to provide an apparatus for photonic therapy wherein the treatments can be characterized completely, accurately and consistently. The embodiments of the invention will now be described by way of example only with reference to the detailed description that follows and in relation to the following drawings, wherein: Figure 1 is a block diagram of the overall architecture of the system; Figures 2 (a) - (c) show a top, side and bottom view, respectively, of a flexible treatment head; Figure 3 shows a perspective view of the upper part of the flexible treatment head; Figure 4 shows a perspective view "of the bottom of the flexible treatment head, Figures 5 (a) - (c) show multiple side views of the flexible treatment head, Figure 6 shows a side view of the flexible treatment head which includes a tie tape, Figures 7 (a) - (h) show various views of the second head mode where Figure 7 (a) is a side view of the head; plant of Figure 7a, Figure 7 (c) is a rear view of Figure 7 (a), Figure 7 (d) is a front view of the head of Figure 7 (a), Figure 7 (e), ) is a view in the direction of arrow ee of Figure 7 (a), Figure 7 (f) is an enlarged perspective view of a component used in the head shown in Figure 7 (a); (g) is a side view of the component of Figure 7 (f), and Figure 7 (h) is an end view of the component of Figure 7 (f); Figure 8 is a schematic block diagram of the electronic control circuit of the flexible head; Figure 9 is a schematic block diagram of a controlled circuit for the single-diode treatment head; «Figure 10 shows a cross-sectional view of the diode receptacle; Figure 11 shows the control signals between the main controller and a treatment head; Figures 12 and 13 are graphs showing the average peak optimization of the diode current; Figure 14 is a block diagram of the main control architecture;
Figure 15 is a front view of the main control panel; Figures 16 (a) and 16 (b) show the general system flow diagram for the main controller; Figures 17 (a) - (c) are flow diagrams showing the gain calculation of the digital signal processor; Figure 18 is a flowchart showing the communication of messages between the microprocessor of the main control unit and the treatment heads; Figure 19 is a flow chart showing the flow of the messages from the treatment head to the microprocessor in the main control unit; Figure 20 is a flow diagram showing the communication between the control unit and a personal computer; Figures 21 (a), (b) -32 show parameters and control entry screens that form the graphic user interface; Figure 33 is a plan view of an additional embodiment of the treatment head; Figure 34 is a side view of the treatment head of Figure 33;
Figure 35 is a bottom view of the bottom side of the treatment head of Figure 33; Figure 36 is a sectional view of the line 36-36 of Figure 33; Figure 37 is a schematic circuit diagram of the control circuit incorporated in the head of Figure 33; Figure 38 is a front elevation of yet another additional embodiment of the treatment head and the associated communication interface; and Figure 39 is a side view of the head of Figure 38.
BRIEF DESCRIPTION OF THE DRAWINGS With reference to Figure 1, the various components of a photonic therapy system are shown in general with the number 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, which includes a screen 116, a keyboard 117 and a mouse 118. The computer 105 communicates with the MCU 104 via an RS232 link 107, while the treatment heads 200 are connected by means of a suitable cable to the main controller 104. The communication between each of the components 105, 104 and 200 is achieved using a specific protocol. The details of these protocols will be discussed later. As a general overview, the treatment heads 200 generate and deliver light energy to the anatomical area that requires treatment. The treatment heads 200 can have specific key operation characteristics, including coherence, spectral width, peak operating wavelength, maximum irradiation and beam profile, stored within the dedicated microprocessors 815 in each head 200. The system 100 of Preference is able to recognize and use multiple treatment heads 200 with various characteristics, communicating with the dedicated microprocessors 815. The light energy sources used in the treatment heads 200 may include semiconductor laser diodes (LD) and known superluminous diodes (SLD) also as light-emitting diodes (LED). The main controller unit 104 is composed of two special components, a microprocessor 108 and a digital signal processor (DSP) 110. The microprocessor 108 responds for the overall operation of the system while the DSP 110 responds to produce complex treatment protocols and for perform complex calculations under the direction of the microprocessor 108. The treatment protocols are a series of operating parameters that control the treatment heads 200 and include the control of diode parameters such as: frequency, duty cycle, waveform, average power and peak power. The MCU 104 is also provided with a separate user interface 102 when the GUI 106 is not available. The graphical user interface (GUI) 106 is a software system that resides in the memory of the computer 105 and serves to control the MCU 104 through the information exchanged along the RS232 107 link. The GUI includes a database for the current description protocols, patient records, anatomical illustrations, details specifications, individualized treatments and the like. Each of the components of the system will be analyzed below in greater detail.
DESCRIPTION OF THE PREFERRED MODALITIES OF THE TREATMENT HEAD Several types of treatment heads are described in the following description. Figures 2 (a), 2 (b), 2 (c), 3, 4 and 5 (a) - (c) illustrate a flexible treatment head which is shown, in general, with the number 200, mainly for the treatment of large surfaces, while Figure 7 illustrates a head 700 from a single source, generally referred to as a laser treatment head, which can be used for the treatment of several small regions or for stimulating acupuncture points. Figures 33-35 show a further embodiment of the treatment head intended for personal use and Figure 36 shows a head similar to that of Figures 33-35 with an improved interface. In Figures 2 (a) - (c), where the same numbers are used to indicate similar structures, a flexible head with the number 200 is generally shown. The flexible head 200 includes a rectangular control housing or receptacle 202, which contains the main circuitry for controlling and energizing the diodes 210; and a plurality of diode carrier cavities 204 extending from one end of the control receptacle and threaded onto a flexible tube 206. The flexible tube 206 is positioned to form a curl 208 at the end of the treatment head 200. The curl 208 it serves as a means for holding and manipulating the flexible head 200 or for attaching a flexible tape, for example a Velero 600 tape, as shown in Figure 6. Preferably, in this arrangement, the VELCRO 600 binding tape is attached to an end 602 in the lower part of the receptacle 202 adjacent to the first of the cavities 204. The tape mechanism allows the flexible head to be attached to the patient, thus providing a treatment of the so-called "hands free" type, without the intervention of the practitioner and without flexing the receptacle 202. The control receptacle 202 includes the main circuitry for controlling and energizing the diodes. The diodes 210 project from the lower surface of the treatment head 200, as seen more clearly in Figures 2 (b) and Figure 4. Each cavity 204, as shown in the embodiment, contains an array of diode devices 210 In the preferred embodiment, the diode devices are SLD devices. Each arrangement of the SLDs is placed in two linear rows 290 and 292 of five diodes each. The adjacent linear rows of diodes are staggered in order to achieve a narrower packing density, as well as to provide a greater light output per unit area. This arrangement also allows the cavities to be elaborated in a relatively narrow manner, so that when placed side by side on the flexible tube they allow a high degree of flexibility as shown in Figures 5 (a), (b) and (c) , thus allowing the head to easily conform to various body parts being treated, in order to provide a good coupling of light energy towards the treatment area. In the mode shown, 10 diodes are used in each array, a number that is governed to some degree by the supply voltage, the direct voltage drop of the diodes and their available driving circuitry. In this mode, this provides a surface area of approximately 24 square centimeters. However, a larger or smaller number with diodes may be used in order to make a head correspondingly larger or smaller. For example, in another embodiment, the flexible head may consist of SLD per cavity with a total of eight cavities, resulting in a surface area of approximately 65 square centimeters. _ * Referring now to Figure 10, a sectional view of a cavity 204. As can be seen, the SLD 210 is mounted on one side of a printed circuit board 1004 and positioned to project from one side of the cavity. 204 on the lower surface of the treatment head 200. Each cavity includes an impeller 1006 for controlling energy to the diodes 210 of the array and in the preferred embodiment comprises an FET and a resistor. One of the problems associated with treatment heads in general, is the generation of heat from diode devices 210. This is particularly problematic with a large number of devices. Photonic therapy, by definition, should not produce any substantial increase in the surface temperature of the skin. In order to minimize the heating effect of the diodes 210 and the impeller 1006, the lower surface 1001 of the cavities 1000 comprises a thermally insulating plastic material, while the upper surface 1002 comprises an aluminum heatsink 1009. In a manner internal to the diodes 210, the impeller 1006 and the PCB 1004 are thermally connected to the heat sink 1009 of aluminum by thermal epoxy 1007, providing thermal transfer from the interior of the cavity to the exterior of the upper surface of the cavity. The upper surface of the aluminum heatsink is etched in order to form cooling fins 1008. In addition, the surface of the aluminum is painted black with an effect of increasing its emissivity. Therefore, both radiation and convection are optimized to reduce the temperature of the surface 1001 of the head, which is in contact with the patient. The power to the impeller 1006 is supplied by a conductor 1010 located inside the tube 206. The power in the conductor is controlled by the circuitry in the receptacle 202. Referring again to FIGS. 2 (a) - (c), a flexible control cable 288 extends from an opposite end of the receptacle 202 and connects the treatment head 202 with the main control unit 104 via a suitable connector. As can be seen in Figure 11, in addition to ground and energy signals, a Tx and Rx RS-232 line and a control voltage line 818 are provided from the MCU 104 via the main control cable 288. The power to the impeller 1006 of each of the cavities is derived from the circuitry in the receptacle 202 and fed through the conductors in the flexible cable 206 to each of the cavities 204. Referring to Figure 8, a schematic block diagram of the control circuitry associated with the receptacle 202 is generally shown by the block 800. As shown, the diode devices 210 in each of the cavities 204 are connected in series. In the embodiment shown, this is a string of ten diodes 210, the string of diodes in successive cavities 204 is connected in parallel. A supply of +12 volt and -12 volt 806 and 808, respectively, is provided through each diode array. A driving voltage signal 812 is derived from the control signal 818 on the cable 288 and applied to each FET impeller 1006. The FET impellers are in series with the diode string 210 in respective cavities and serve to control the current through of the diodes, thereby controlling the brightness of the diode, in response to the driving signal 812.
As mentioned before, a plurality of cavities can be connected together in parallel. In order to ensure that a predictable and consistent light signal is provided by the treatment heads 200, a feedback loop is implemented. This is achieved in principle by monitoring the light output from one of the diodes in the string. The assumption is that by constructing or ensuring that the remaining strings of the diodes in the other cavities behave in a similar way with the cavity used in the feedback loop, a more consistent light output can be achieved. As shown in Figure 8, the feedback diode 814 is optically coupled to a PIN diode 820, which responds to the photonic energy generated by the diode 814. The output coming from the PIN diode is fed by an amplifier 822 to an input analog / digital 824 of a microprocessor 815 the microprocessor 815 makes a comparison with this output and with the output that comes from the control signal that is received on the analog / digital input 824. The output coming from the PIN 820 diode and the input which comes from the control signal 818 are compared in an adder 826 to provide the output control signal 812 for the impellers 810 of the device. As can be seen later, the feedback loop around the PIN 820 diode and the adder 826 provides a real-time loop with a high bandwidth (1 MHz) and therefore provides stable and absolute light output power that does not depends on the type of modulation or the underlying limitations of the diodes. The benefits of this feedback are invaluable since, for example, if a treatment head is composed of several SLD devices - for example 60, but one of the devices 60 is used to provide feedback as a representative sample, then based on the Assuming that the remaining devices will behave in a similar way, the effects due to diverse linearity, warming and aging effects, all are limited. An additional importance of monitoring the light output directly in this type of feedback arrangement is that it achieves direct control of the light output and not of the drive current. A PIN diode is preferably used as a photoreceptor since it provides a linear response while being relatively insensitive to temperature, extremely fast and accepts a wide range of power intensities and spectral type. An additional advantage of this feedback arrangement is that the integrity of the feedback loop can be ensured by using the microprocessor 815 to constantly measure or compare the desired output signal with the measured output signal. These signal lines are indicated with the numbers 824 and 822, respectively. If the signals were different, the software contained within the microprocessor would inform the main control unit via the RS232 line. The total current through the diodes 210 is monitored by a current monitor indicated by block 828, which provides a signal on an analog / digital input line of the microprocessor 815. The microprocessor used in this mode is a PIC chip 16C71 which Includes 4 analog / digital input lines. Therefore, by monitoring the total current through the diodes 210, a fault of one or more diodes will be observed by a change in the total current and once again, the microprocessor will communicate this via the RS232 line to the main controller unit . Also, as the devices age, more current will be required to maintain a desired intensity, therefore, a current monitor can inform the user when the life time of a spindle has already elapsed. In this way, the net effect of the feedback loop combined with the integrated diagnosis in the microprocessor 815 ensures a stable light output, absolute and reliable. A photodiode 830 located within a cavity 802 is connected by a current-to-voltage converter with an analog / digital input 832 of the microprocessor, in order to provide a signal indicative of ambient light. The microprocessor 815 receives this ambient light monitor signal 832, it relays the information to the MCU on the communication lines 816, which determine whether a treatment should be activated. If the head 200 is not attached to a physical object, for example the body, the reading of ambient light will be high, indicating an unsafe operating condition. When attached, the reading of ambient light will be low and treatment can continue. In addition, a user can alter the sensitivity of the ambient light sensor through the software program of the GUI in order to adjust to various lighting conditions. In addition to communication over control 816, microprocessor 815 provides a light on / off control signal 833 to summer 826 to ensure that the light output is deactivated for all situations other than when the treatment is activated. This is particularly useful in the security mechanism of the system and to prevent any low-level optical signal from being emitted when the heads are inactive.
This characteristic is of particular relevance for laser heads since they operate within the active laser region and, therefore, the "low level" or "no power" setting does not correspond to zeros but corresponds to a relatively strong signal low compared to the "high level". In addition to performing control functions within the head 200, the microprocessor 815 stores an identification of the head 200 and its operating characteristics that can communicate to the MCU 104 on the lines 816. The SLD 210 devices are capable of producing high peak power optical pulses. , instantaneous, usually an order of magnitude higher than its average optical power output. These high and instantaneous peak pulses can occur if the pulses are short-lived and short-cycle (typically 10 microseconds, 1% of the duty cycle). To provide a suitable form for the control signal for the SLD 210, a fixed gain amplifier 840 is provided between the control signal 818 and the adder 826 and controlled from the microprocessor 815 via the gain control line 838. In this way, when the gain amplifier 840 is activated, the signal to the impeller is amplified by a predetermined factor, amplifying the light output by a corresponding factor, as explained in more detail below. The manual control of the head 200 is provided by a switch 220 and two LED indicators 222 and 224 which, as seen in Figure 2 (a) are mounted on the upper part of the control receptacle 204. The switch 220 provides the function of a start / stop button and it is connected to an input port of the microprocessor 815 as indicated in Figure 8. As a safety feature, the switch 220 must be "pressed twice" ie pressed twice in rapid succession; which sends a signal to the microprocessor 815 to capacitate the diode devices 210. Any simple pulsing of the subsequent switch 220 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. As an additional security measure, a polymer-based disposable membrane, in the form of a preformed sheath (not shown), will allow the flexible head to be inserted therein. This is particularly useful in open wound applications where there is a risk of infection. The optical properties of the disposable polymeric material are such that they allow the easy transmission of the photonic energy. To the terminal the treatment, the pod can be discarded.
Treatment Head For a Single Point With reference to Figures 7 (a), (b), (c), (d) and (e), a modality of a treatment head with a point source is generally shown, with the number 700. In the embodiment shown, the treatment head uses a laser diode 702 which is capable of producing a small point of high irradiation. The head 700 includes a body 704 of elongated cross-section, elongated, for holding the head 700 and a nose 706 extending at an angle with respect to the main axis of the body. As can be seen in Figure 7 (a), the laser diode 702 is mounted on the tip of the nose 706 and projects a beam at an angle of the axis of the body 704. A hump 708 or projection, is formed at the junction of the nose 706 and body 704. Hump 708 allows a practitioner to apply, for example, thumb pressure at a point being treated while still having a firm hold on the body. The elliptical cross section of the body 704 also provides a better grip of the body by the practitioner and the angle of the laser diode facilitates manipulation of the device while observing the treatment area. The shape of the head 700 also allows the head to be held more traditionally like a pen, on which pressure is exerted between the index finger and the thumb. The nose 706 ends in a tip 710 that is made with a size as small as possible to facilitate applications such as laser acupuncture. An optical window 712, as seen more clearly in Figures 7 (d) and 7 (e), is placed on the tip of the head, - behind which the laser diode is mounted. This arrangement provides protection of the laser diode behind the optical window while preventing the accumulation of contaminants and allows the head to be easily cleaned, thereby thermally and electrically isolating the patient's diode. In the embodiment shown, the heat produced by a laser diode during the treatment is led away from the patient by a heat sink thermally contained within the head (not shown). This feature in combination with the optical window retains the relatively cold treatment surface. As with the flexible head that has already been described, safety features have been incorporated in the point source head to avoid eye damage, particularly with the use of laser diodes. Two light emitting diode indicators 714 and 715, respectively, are provided on both sides 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 used in this mode are bicolour type and provide a green light when the head is enabled and a red output when the head is active. To provide a running control for the operation of the head, a proximity sensor device 716 is mounted on both sides of the laser diode 702 and projects towards 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, for example the skin, provide a conduction path between the electrodes 718, 720. Preferably, the electrodes 718, 720 are integrally molded from a conductive epoxy resin , and the rest of the tip 710 is molded from a non-conductive epoxy material. The electrodes are then covered with a thick protective layer, for example with paint, to reduce the effect of moisture. The electrodes 718, 720 are attached to the conductors by passing through the housing 703 a drive circuit that is composed of an oscillator whose frequency varies with the capacity of the electrode and then converts the output frequency into a variable voltage direct current signal. . The microprocessor 915 monitors this voltage and when the head is in contact with the skin, a predetermined voltage is obtained that allows the head to be activated. Similarly, removal of the head from the skin terminates head operation. Therefore, the proximity sensor also serves as a local start / stop switch, mainly by activating the head when it is enabled and in contact with the skin, and stopping it when it is enabled but is removed from contact with the skin. An automatic delay can be incorporated into the head control circuitry to delay the activation of the laser diode, in response to a signal from the proximity sensor, in order to avoid an unintentional light-emitting parasitic 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 keep the laser diode activated in a conscious or physical manner. The laser diode used in the present mode has a power output that can vary from 10 milliwatts to several hundred milliwatts, which are calculated to produce an irradiation in the order of 1,000 milliwatts per square centimeter. In Figure 9, an electrical circuit diagram showing the main functional blocks for control of the point source treatment head, generally shown by the block 900. As can be seen, the control circuitry of the diode 702 is similar to the control circuitry of the flexible head shown in Figure 8. However, an optimal feedback is provided by a diode PIN 904 which is incorporated with the module containing the laser diode 702. The remaining components will not be analyzed anymore since they are similar to those of the control circuitry described in relation to Figure 8, but to give clarity to the description they are identified with the same numbers and with 9 and msd, and not with 8.
Main Controller Unit The main controller 104 shown in Figure 1 is a self-contained device that is used exclusively to control the processing heads and communicate with the graphical user interface. The controller 104 has two key elements, the microprocessor 108 and a digital signal processor 110. The controller unit 104 has a user interface 102 as illustrated in Figure 15 or can be controlled remotely by the GUI. The user interface 102 of the main controller shown in Figure 15 includes plugs 1502 and 1504, to which the control cable of the treatment head can be attached. A set of push buttons 1506, 1508 and 1510 provide the functions of: activating the treatment, pausing the treatment or finishing the treatment, respectively. A liquid crystal display 1512 provides visual display of various parameters associated with the treatment. A data entry key together with a control key associated with the cursor 1516 and 1518, respectively, as well as an optical increment encoder 1517, provide a means to enter data and access various processing parameters. A mode selection switch 1520 provides a means for selecting various modes of operation, such as preset mode and manual mode. A key lock mechanism 1522 is provided as a security feature to prevent unauthorized use of the system. Referring to Figure 14, there is shown a simplified block diagram of the architecture of the main controller, indicated in general with the numeral 1400. The microprocessor 108 shown in Figure 14 acts as a central processor to handle the intercommunication functions between the DSP 110, the treatment heads and the user interface of the main controller and the RS232 interface via the GUI. A timer 1402 can be set by the microprocessor 108 to control the processing time and a buzzer 1404 is connected to the microprocessor and provides audible indication of significant events for the user. The microprocessor 108 is associated with a random access memory (RAM) 1406 as well as with a user programmable memory in the form of an E2PR0M
(to store the current treatment parameters)
1408 and an EPROM for storing the operation programs of the microprocessor 108 and the DSP. The communications to the microprocessor 104 are switched by the multiplexer 1412 between the ports of the generic processing head 1502, 1504 and the RS232 interface 107 to the external computer. The protection circuitry 1414 positioned 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 stray light output during the joining or removal of the treatment heads from the ports. The supplementary two-color indicators are placed on one side of each port, 1528 and 1530 as shown in Figure 15. The indicator provides a green indication that a treatment head is attached and functional, and provides a red indication when the treatment It is active. As already mentioned before, 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 the timing treatment, provides a specific activation sequence for the control heads. treatment through ports 1502, 1504, starts up, pauses or for treatment, monitors the environmental line sensor and controls the treatment heads, providing head diagnostics and controlling the treatment heads. The DSP 110 is mainly used to synthesize various modulation schemes for the creation of the treatment protocols and thus control the light output of the treatment heads. The DSP 110 allows the diodes 210 to operate in a continuous wave modulation or in pulse modes. In modulation mode, the DSP 110 is also capable of generating any repetitive waveform, for example a square wave, a sine wave and a triangular wave. The operating frequency can vary from 0.01 Hz to 100 kHz in the modulation mode and in the pulse mode, the pulse width can be as small as one microsecond. In pulse and modulation modes, the DSP 110 can be used to optimize the ratio of peak power to average power for diode devices. As already mentioned, the SLDs are capable of providing peak intensities that can be of the order of magnitude greater than their average intensities. However, this is possible under certain conditions only. However, it should be noted that other laser devices, for example laser diodes, are generally unable to produce peak pulses and will be damaged by any transient or peak power above their maximum specified average, therefore, as already mentioned, the specific operating capabilities of each treatment head 200, 700, are stored in the dedicated microprocessors 815, 915 in the respective treatment head control unit and loaded into the central microprocessor 108 of the main controller unit 104 when the head treatment is attached to the control unit. This information can include the type of head that is being used, either SLD or LD, the gain that can be applied to the diodes and the information - which is related to the interval of acceptable periods and duty cycles. For most laser devices, for example LD, the operating parameters such as the operating cycle and frequency are fixed. In the case of an SLD, when operating in modulation or pulse mode, and the operating cycle and period are small, the currents through the diode can be much larger on average. The systems, which are currently available and use SLD, normally operate at a fixed frequency and duty cycle and, therefore, the operating parameters are fixed. In the preferred embodiment, the system is capable of operating in a wide range of parameters and automatically optimizes the peak intensity at the average intensity applied to the diodes 210 when an SLD head is recognized. Figures 12 and 13 illustrate the operating characteristics of the SLD with a graph showing the maximum peak pulse current against the pulse width of the SLD identified with the number 1300 and a graph showing the maximum pulse current against the cycle of operation identified with the number 1302. The graph of 1302 indicates that the duty cycle should be low in order to achieve a high peak intensity. The maximum current can be calculated by the following equation:
Imax x A + B work cycle where A and B are provided from the manufacturer's data sheet and are specific to each device. Also, the pulse width must be small to achieve a high peak intensity. The graph 1302 is divided into three sections. As shown, for high pulse widths, the maximum current that can be allowed will be equal to the average, while for several short pulse widths, the diode current will reach the peak limit. In the region between the two extremes is a transition region that allows several degrees of increase in peak current. When determining the two values of current, it is to say Imax or the one determined by the curve 1300, the optimal operation of the SLD can be obtained. The algorithm illustrated in Figure 17 (a) - (c) shows the sequence of steps performed by the DSP to develop the calculation of the working or operating cycle limit, by checking the pulse width to determine the pulse width limit and adjust the peak current value to the highest possible limit of the upper limits. Subsequently, a flag is placed to indicate if profit is required. If gain is required, the output is multiplied by a fixed gain amplifier 840, consistently. The product of the gain factor and the amplitude 818 is equal to the peak intensity. Based on the above information, the average intensity is calculated. Before you can start a treatment, the practitioner must select the treatment form and the required operating parameters. This is facilitated by GUI 106.
Graphical User Interface Figure 21 (a) shows the interaction between the program 106 of the graphical user interface, the screen 116 and the main controller unit 104 via the 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 that include inputting user data from a keyboard 117 or a mouse 118. The program of the GUI 106 is composed of several screens or displays on the screen. The preferred embodiment contains a main display 2150 which provides access to four main groups of other objects on the screen, each display group is associated with patient information 2152, treatments 2154, control of device 2156 and configuration of program 2158. Figure 21 ( b) illustrates the main display gain factor and the amplitude 818 is equal to the peak intensity. Based on the above information, the average intensity is calculated. Before you can start a treatment, the practitioner must select the treatment form and the required operating parameters. This is facilitated by GUI 106.
Graphical User Interface Figure 21 (a) shows the interaction between the program 106 of the graphical user interface, the screen 116 and the main controller unit 104 via the 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 that include inputting user data from a keyboard 117 or a mouse 118. The program of the GUI 106 is composed of several screens or displays on the screen. The preferred embodiment contains a main display 2150 which provides access to four main groups of other objects on the screen, each display group is associated with patient information 2152, treatments 2154, control of device 2156 and configuration of program 2158. Figure 21 ( b) illustrates the main deployment divided into subcategories to which a scale factor is assigned. A scale factor is then used to increase or decrease the total treatment time for the patient. Therefore, standard treatment protocols can be altered to take into account the characteristics individual physics. Not only does this provide more effective treatment, it also reduces the amount of data a practitioner needs to know in order to personalize treatments. All information related to the patient is stored in the 2100 database. All the treatments administered to the particular patient are recorded in a patient record accessed from the main screen of Figure 21 (b) through the " HISTORY ". As shown in Figure 23 (a), the Patient history screen includes the treatment protocol used, the dates of the treatments and the energy densities applied as well as specific details of the treatment protocol. The user will also have the ability to enter comments or details based on text in different stages of the treatment process, for example in a new patient's admission, in all treatment sessions and at the end of a treatment course. This information can be observed on the screen as shown in Figure 23 (b). Both the patient history screen shown in Figure 23 (a) and the patient history screen shown in Figure 23 (b) include observation and printing control buttons that allow a complete record of a patient to be observed or printed. patient, to produce a printed copy. Referring to Figure 24, a screen for the selection of a treatment protocol is shown, indicated in general with the number 2400. The prescription of a treatment protocol involves the selection of a pre-established protocol. The established protocols contain all the information required to implement a treatment. The protocols are stored in two groups. The first group is supplied with the system and can not be altered by the user, while the second group can be created by the user using an individualized subroutine. The treatment protocols are divided into three levels. The levels are marked A, B and C as shown in Figure 24 and are indicated by the numbers 2402, 2404 and 2406_, respectively. For each point in column A, a corresponding list of points will appear in column B. Similarly, a selection of a point in column B will produce a listing of that point for column C. The names of the treatments may be based on specific protocols or protocols specified for a user, in physical regions of the body, in disease entities, in levels of various doses and the like. The details of each specific protocol can be accessed by means of a prescription control button 2168 on the main screen or an individualized treatment that can be created by means of the individualization button 2408. Once a treatment has been selected, it can be prescribed for the patient through the acceptance button 2400. The four associated parameters are then stored in the 2100 database. The processing can then be sent to the MCU and administered under treatment control by means of the 2170 training control on the main screen. Figures 25 (a), 26 and 27 are screen objects for creating prescription protocols and display the corresponding head parameters for the prescription protocols. The selected screens are determined by selecting the mode of operation, ie when pressed as in Figure 25 (a), with the modulation in Figure 26 or continuously in Figure 27. For each prescription, the user can change how often the treatment will be repeated, the total number of treatments and the number of stages in the treatment. Each stage of the treatment is set with specific operating parameters. These numerous steps can be established to effectively administer multiple protocols in a single treatment. This may also include changing treatment heads as well as operating parameters. The end of each stage can include a forced stop that allows the practitioner to examine the patient at predetermined intervals. The final stage of a protocol can be repeated, which is ideal for extending the treatments or for treating a sequence of several points. A specific head can also be selected from a list of heads available for each stage of a treatment. The detailed specifications of each head can be observed, for example, as indicated in the spindle parameter screens shown in Figure 25 (b). These parameters are specific to each head and can not be altered. However, this information is crucial for the creation of a protocol. The Create Prescription screen as shown for example in Figure 25 (a) provides the user, in the Stage Detail section, with a selection of the operating mode of the particular treatment head. The mode of operation includes continuous wave, modulation or pulse mode of operation. When selecting a particular operation mode, the operation parameters shown on the screen will vary accordingly. The system is also capable of managing several repetitive waveforms in the modulation mode including sign, square and triangular waves as indicated in 2602. A novel feature of the system is that the user controls the light output by the percentage and not by Absolute values. The system also optimizes the ratio between peak and average power. This optimization is based on the type of treatment head used and on the characteristics of its diode, the frequency and selected work cycle, as described above. The other parameters such as power density, duration and energy density may be altered. Once a treatment has been created it can be stored as a protocol as shown in Figure 28. To assist the practitioner in this prescription, the GUI program also includes on-screen objects for an anatomical tutor. As indicated in Figure 29, detailed diagrams of a part of the human anatomy can be observed and linked to specific protocols. These diagrams may include specific observations of the anatomy, specific illustrations of the disease or application of treatment regarding specific information and placement of the probe. The screen may be composed of illustrations and / or text and may be stratified as shown in the two illustrations of Figure 20, to provide successive detailed views of the selected region. In some circumstances, it may be desired to operate without the computer 105. In this case, the GUI 106 may be used to download the prescription data to the MCU 104. Figure 31 indicates the on-screen displays to initiate the download of a group of predefined protocols. to the main controller 104 via the link RS232 107 which is stored in the E2PR0M 1408. The conditions of the operating system can be adjusted by a configuration screen as shown in Figure 30. Downloading the protocols to the MCU 104 allows access of the protocols through the user interface 102 for independent operations. In addition, the software program for the GUI includes help screens for providing online help to a user in a conventional manner, as illustrated in Figure 32. The communication protocol between the MCU 104 and the head 2009 or the computer 105 is shows schematically in Figures 18 and 19 and 20 and 21 respectively. The protocols are conventional in nature allowing bidirectional communication from the MCU 104 to the head 200, 700 or the computer 105. In this way, the treatment data or protocols can be retrieved from the computer 105 and stored in the E2PR0M 1408 and the information can be gathered from the dedicated microprocessors 815, 915 and the instructions provided for the treatment. Having described the various components of the system 100, the operation in general will now be described. Referring to Figures 16 (a) and 16 (b), the operation treatment of the system can be initiated in one of two ways, either by downloading a protocol from the software database of the GUI to the microprocessor 108 in the unit main controller 104 or causing a preset protocol to be stored in E2PR0M 1408 and selected by data entry controls 1516 in interface 102. In any case, the information regarding the desired treatment is displayed on the screen on the liquid crystal display 1512 and / or the GUI and all the actions are entered by the user directly by the control panel and / or by the GUI program. Once the treatment is selected, the microprocessor verifies that the required treatment head corresponds to the selected protocol and is plugged into any of the sockets 1502 or 1504. If the required treatment head is not plugged in, as can be detected by the microprocessor dedicated 108, it 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 required head to be plugged into the socket. The program can be terminated by the user. Once the correct treatment head has been detected, the microprocessor sets the timer 1402, unloads a waveform box, spindle parameters and waveform parameters towards the DSP 110. An order is sent by the microprocessor to the DSP to start the processing of the protocol. The indicator lights 1528, 1530 adjacent the plugs 1502, 1504 of the main controller panel are switched from green to red and the head indicator 222 is switched to green, indicating that the head is enabled, ie ready to effect a treatment protocol . At this time, the microprocessor 108 waits by a double click of the push button 220 on the treatment head once the double click is detected, the microprocessor 108 checks the ambient light to ensure that the head is securely attached to the body of the patient (as in the case of a flexible treatment head) or in the case of a head 700, this is carried out automatically by the proximity sensor. The microprocessor 108 then tests the treatment head to make sure it is working well. As shown in Figure 16 (b), if an error signal is detected at this stage, a message is sent to the PC or liquid crystal display to inform the user of the particular error. The processor then returns to Point C of Figure 16A. If no error message is received at this stage, the treatment begins. The microprocessor 108 turns on the treatment diodes by the control signal 818 derived from the DSP 110, the indicator light of the head 224 (in red) indicates that the head is active, and activates the gain mechanisms of the treatment head if the Gain flag has been adjusted. The main control circuit 200, 700 then supervises the operation as described above, with reference to Figures 8 and 9, respectively. The LCD screen and / or the GUI program are constantly updated with the elapsed time of the treatment. At this time, if a PAUSE command is received or the treatment time has elapsed, the microprocessor stops the timer, turns off the treatment diodes and turns off the LED indicator of the optical head. In this step, an END-OF-TREATMENT command has not been received, then the microprocessor returns to Point C of Figure 16A. In case of receiving the order of end-of-treatment (end of treatment), the microprocessor stops the timer, turns off all the indicators in the treatment head and changes the light of the plug indicator from red to green. The operation sequence is then completed. The additional use of the head requires the enabling of the treatment protocol and the subsequent activation of the head. It can be observed that once the treatment protocol has been determined and the treatment has been enabled, it does not need to manually adjust the adjustment or control of the optical characteristics of the treatment, since the microprocessor inside the treatment heads with its feedback loop associate ensures that the characteristics of optical devices, as they are the SLD and the LD they remain calibrated of precise panera. The above described modality provides complete treatment flexibility for several patients, as required by a medical practitioner. The operating principles can also be used in a suitable environment for personal use, for remote use by a practitioner, for example an external patient treatment to be treated in a clinic where several units can be programmed and used simultaneously. The unit can be programmed with generic protocols by the manufacturer for personal use or with specific 2400 protocols by the practitioner for prescription use. A unit intended for a personal unit is shown in Figures 33-39 where the reference numbers are consistently used to denote similar components with the suffix "a" to give clarity. The system 100a is self-contained and has functions of the main operation unit 104a integrated into the treatment head 200a. The unit is programmed by the programmer module 270 from the GUI program 106 and the RS 232 interface 107 through the communication port 272. The head 200a includes the 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 a thermally insulating and electrically non-conductive layer to inhibit thermal transfer to the patient's skin. . The upper layer 254 is electrically non-conductive and thermally conductive and has cooling fins 1008a integrally formed thereto. This arrangement has the same thermal transfer attributes as described above. The PCB 250 extends into the control receptacle 202a and carries the electrical components and their associated with the main control circuit illustrated schematically in Figure 37. The microprocessor 815a has an E2PR0M 1408a associated with it, where several different protocols are stored. received from the programmer module 270. The microprocessor 815a can access a selected protocol and output control signals to the control line 818a to operate the SLDs 210a. A diagnostic function 262 is associated with the microprocessor 815a to monitor the operation of the head 200a and communicate it to the module 270 periodically. The selection of the respective protocol is provided by the buttons 256, 258, 260 located in the upper layer 254. Each of the buttons bears marks indicative of its treatment protocol, for example treatment level, that is: low, medium or high; or region to be treated, that is: elbow, knee, neck; type of condition to be treated, ie kink, arthritis, tennis elbow or a generic treatment A, B, C. The selection of the buttons conditions the microprocessor 815a to access the corresponding protocol. The activation of the microprocessor 815a is controlled by the switch 220a in the upper layer 254 and the indicator lights 222a, 224a provide status indications for the user to observe. A series of EDs indicators 269 surround array 210a to provide visual indication of an active probe. A 600a tape is secured to the lower layer
242 adjacent to the initial arrangement 210a and its opposite end secured to a releasable hook and a loop fastening pad 264, available under the trademark "Sailboat", which is mounted on the upper surface 254. Power is supplied to the receptacle 202a by an adapter AC / DC 266 through a plug and plug 265. Discharging the protocols to the E2PROM 1408a or any other type of information exchange is accomplished by two additional contacts (not shown) or via connector 265. A primary system is incorporated in the head 200a. A series of contacts 267 provides a simulated method to detect the presence of the body as well as the proximity sensor 716 that has already been described. Several contacts 267 are scattered along each side of the arrangement of the diodes 210a outside the indicators 269. The contacts can be grouped into several patterns to create a pair of electrodes, for example 718, 720. Two or more sets can also be created. , each with its own driving circuit. Therefore, several contacts may be in contact with the body in order for the probe to be activated. 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 alternating current circuit. The resulting frequency variations modulate a voltage signal in the driver circuit 274 that is provided to the microprocessor 815a. The flexible PCB 250 allows the head to conform to the curved surfaces and allows the head 200a to flex along both the longitudinal axis and the transverse axis for optimal engagement with the skin. To inhibit undue flexing of the control receptacle 202a, the stiffening panels 275, 276 are secured to the upper and lower layers 242, 254. These can provide access to the electronic components or can be integrally molded with the layers 242, 254. Conveniently, panel 275 may incorporate buttons 256, 258, 260 and switch 220 on a membrane switch panel. Simplified operation and control of the available protocols make the unit suitable for use in the home, without the intervention of a qualified practitioner. The incorporation of the predominant control, the feedback loop and the diagnostic monitoring by the microprocessor provide the required level of security for this type of use. The EPROM 1408a retains the protocol instructions that can be accessed by the 815a microprocessor to reproduce the protocols. Other information retained in the E2PROM may include the identification that allows the GUI 105 to record the patient's history 23a as well as a measure of its compliance with the treatment.
Claims (35)
- CLAIMS. 1. A photon therapy unit having a photon emitter, a control for modulating the driving circuit and thus establishing a predetermined level of emission from the photon emitter, a photon detector for monitoring the emission from the photon emitter and providing a feedback signal indicative of this to the driving circuit to maintain the emission at a predetermined level.
- 2. A photon therapy unit according to claim 1, wherein the detector is a photodetector diode optically coupled to the photon emitting device.
- A photon therapy unit according to claim 1, wherein the control signal indicative of a desired level of emission is supplied to the control and the control compares the control signal with the feedback signal to modulate the driving circuit.
- 4. A photon therapy unit according to claim 3, wherein the difference between the control signal and the feedback signal greater than a predetermined difference is detected by a diagnostic function.
- 5. A photonic therapy unit according to claim 4, wherein the diagnostic function includes a microprocessor and an error signal is generated by the microprocessor.
- 6. A photon therapy unit that includes a plurality of photon emitters placed in an array, a drive circuit to drive the array, and a photon detector monitor to monitor the emission from one of the array emitters to provide a signal from feedback to a control, the control modulates the drive circuit in response to the variation in the signal to maintain the emission at a predetermined level.
- 7. A photon therapy unit according to claim 6, wherein the emitters are superlight diodes.
- 8. A photon therapy unit according to claim 6, wherein the plurality of arrays are each provided with a plurality of emitters and the detector monitors are emitters of one of the arrays to provide the feedback signal.
- 9. A photon therapy unit according to claim 8, wherein the power sensor monitor monitors the power delivered to the array and indicates the power changes to the diagnostics function.
- 10. A photonic therapy unit according to claim 1, wherein a control signal indicative of a desired level of emission and representative of a control protocol to be applied is supplied to the control.
- 11. A photonic therapy unit according to claim 10, wherein the amplifier is provided for amplifying the control signal and modulating in this way the drive circuit.
- 12. A photon therapy unit according to claim 11, wherein the amplifier operates selectively to vary the gain applied to the control signal.
- 13. A photon therapy unit having a head and treatment including at least one photon emitter, a driving circuit for driving the photon-emitting device, a control for modulating the driving circuit and a switch that responds to the placement of the head over a treatment location, the switch inhibits the operation of the driver circuit until the emitter is placed over the treatment location and includes at least a pair of terminals at separate locations in the head and positioned relative to the emitter device. photons to contact the skin at the treatment location, to complete an electrical circuit during the placement of the head on the treatment location with the emitter directed towards the treatment location.
- A photon therapy unit according to claim 7, wherein the switch has a treatment head including at least one photon emitter, a driving circuit for driving the photon emitting device, a control to modulate the driving circuit and a switch that responds to the placement of the head on a treatment location, with the emitter directed towards the treatment location, the switch inhibits the operation of the driving circuit until the emitter is placed in the treatment location and including an optical sensor that responds to ambient light to determine placement on the treatment location
- 15. A photon therapy unit according to claim 13, wherein a photon emitting device is placed between each of the pair of terminals.
- 16. A photon therapy unit having a photon emitter, a driving circuit for driving the photon emitter, a control for modulating the power supplied to the photon emitter and a power detecting monitor for identifying power changes supplied to the emitter of photons and indicate this change to the control.
- 17. A photonic therapy unit according to claim 16, wherein the power detecting monitor detects the current supplied to the photon emitter.
- 18. A photon therapy unit according to claim 17, wherein the control includes a microprocessor and the changes in power delivered to the photon emitter are communicated to the microprocessor.
- 19. A photon therapy unit having a photon emitter, a driving circuit for driving the emitter and a control for modulating the driving circuit, the control includes a microprocessor to establish a treatment protocol having predetermined parameters, a signal of feedback indicative of at least one of the parameters and operably communicated with the microprocessor, the microprocessor compares the feedback signal with a predetermined allowable value and provides an indication of the feedback signal that is different from the allowable value.
- 20. A photon therapy unit according to claim 19, wherein the microprocessor receives signals from a switch that responds to the placement of the device on a treatment location and a monitor that detects the power to monitor the operation of the photon emitter. .
- 21. A photon therapy unit according to claim 20, wherein the switch inhibits the operation of the photon emitter prior to its placement in a treatment location.
- 22. A photon therapy unit according to claim 19, wherein a photon detector is provided to monitor the emission from the emitter and provide a feedback signal to the driver circuit to maintain the emission at a predetermined level.
- 23. A photon therapy unit according to claim 22, wherein the microprocessor compares the 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 the indication is provided to a remote location to display a warning on the screen.
- 25. A photonic therapy that has a photon emitter, a driving circuit to drive the photon emitter and a control to modulate the driving circuit, to establish the treatment protocol, the control includes a microprocessor to monitor the operation of the emitter. photons and provide an indication during the operation of the photon emitter outside a permissible value, and wherein the microprocessor includes the identification of the unit for communication to an external location.
- 26. A photon therapy unit according to claim 25, wherein the identification includes operating parameters of the unit.
- 27. A photon therapy unit according to claim 26, wherein the control signal is provided to the driving circuit representative of a treatment protocol to be performed and the transfer of the control signal is inhibited if the identification indicates operating parameters. wrong.
- 28. A photon therapy unit according to claim 19, wherein the device is an SLD and the control includes a gain control to amplify the control signals to the driving circuit, the microprocessor adjusts the gain control according to the parameters of operation of the unit.
- 29 A treatment head for photonic therapy, the head has an arrangement of photon emitters, a support for the emitters to maintain the arrangement and a technically conductive backrest to secure the devices on the support, the backrest thus conducts the heat of the devices and away from a treatment area.
- 30. A treatment head according to claim 29, wherein the support and the backrest are flexible.
- 31. A treatment head according to claim 29, wherein the backrest has fins formed therein to dissipate the heat that comes from the backrest.
- 32. A treatment head according to claim 29, wherein a control circuit is placed at one end of the head adjacent to the array.
- 33. A treatment head according to claim 32, wherein the retainer band is secured to the head at opposite ends of the array.
- 34. A treatment head according to claim 33, wherein one of the ends of the retainer band is secured to the head adjacent to the array, at that mentioned end, to inhibit bending of the control circuit during the fixation of the retainer band.
- 35. A treatment head according to claim 32, wherein a control panel is provided at said end, on an opposite side thereof, in the array. protocols to allow a user to select one of the treatment protocols from a plurality of them. 41. A photonic therapy unit according to claim 40, wherein the user interface is a graphical user interface to allow access to a plurality of protocols stored on a database. 42. A photonic therapy unit according to claim 41, wherein the graphical user interface allows the selection of treatment protocols by identifying the areas to be treated. 43. A photonic therapy unit according to claim 40, wherein the head includes an identification to alert the control unit to the characteristics of the head during connection thereto. 44. A photonic therapy unit according to claim 43, wherein the head includes a microprocessor to monitor the operation of the head and communicate that operation to the control unit.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB9623627.8 | 1996-11-13 | ||
| US08892857 | 1997-07-15 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MXPA99004457A true MXPA99004457A (en) | 2000-06-01 |
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