ЭНЦИКЛОПЕДИЯ ФОТОННОЙ МЕДИЦИНЫ И ФОТОННОГО КЛИМАТА

Low-intensity laser therapy apparatuses

The problems that we solved in the previous century.

Presently, manufacturers produce dozens of laser therapy apparatuses (LTAs) authorised and allowed by the Russian Ministry of Health for full-scale production. These apparatuses can be stationary and portable, universal and highly specialised, they can use various types and combinations of lasers. Such a diversity of LTAs is due to a wide variety of medico-technical tasks. While creating LTAs, one must take into account conditions under which laser therapy will be carried out. During the years of laser therapy development scientists have specified the main requirements for modern equipment. These requirements have been generalised in recent years [Titov M. N., Moskvin S. V., 1993; Titov M. N. et al., 1993; Romashkov A. P. et al., 1994] and are presented in this chapter.

The material of this chapter was compiled to cover the following aspects. First, the clinical practitioner, who influences the human being with physical methods, should be able to clearly understand the features and capabilities of used equipment. Second, it is essential to show the prospects for developing modern equipment, so that clinicians could effectively master new treatment procedures in the future. Third, this chapter may be useful for technical personnel since it touches upon the equipment maintenance and repair. Finally, it presents the principles and trends of designing the equipment, which may help the LTA manufacturers to properly map out their technical and industrial strategies.

It is known that the first investigations of laser influence on biological objects were performed with helium-neon (He-Ne) lasers. These lasers had been successfully used in various LTAs for many years. Although many of them find use today, helium-neon lasers are frequently replaced by semiconductor lasers. This happens because they virtually have no advantage over semiconductor lasers in therapeutic applications. The process of replacement was initiated in 1995 and it was actively stimulated both by developing 0.63-mm laser diodes and by postulating the identical irradiation efficiency of laser diodes to that of helium-neon lasers [Tuner J., Hode L., 1996]. Apart from that, semiconductor lasers offered a number of advantages over gas lasers in engineering principles, dimensions, design and serviceability. All these facts allowed semiconductor lasers to be widely applied [Kozlov V. I., Morskov V. F., 1995].

Helium-neon lasers as well as some other laser types will not be described since the literature review has shown that laser therapy very frequently employs laser diodes of various spectral ranges and it seldom relies on other laser types, such as an ultraviolet nitrogen (N2) laser (l = 0.337 mm) applied in dermatology · and in the treatment of burns [Gerasimova L. I. et al., 1996], a blue helium-cadmium (He-Cd) laser (l = 0.441 mm) applied in the treatment of various pathologies [Kryuk A. S. et al., 1986] and an infrared carbon dioxide (CO2) laser (l = 10.6 mm) [Galetty G., 1994; Ussia G., 1994].

The equipment developed by the «Technika» Firm (Moscow) will serve an example of practical realisation of modern LTA construction principles considered in this chapter. This firm was selected because it has priority in the medical instrument-making industry and its catalogue comprises virtually all the examples of technical equipment and of supplied accessories.

The process of LTA making has seen four stages. Initially, helium-neon and some other lasers were used in various investigations and laser therapy did not find broad use until the 1970s. The second stage was marked by the creation of special-purpose equipment when the manufacturers began to produce specialised apparatuses for laser therapy. These apparatuses incorporated not only a laser and a power supply unit but also some other necessary appliances such as timers, modulators, fibre-optic attachments, etc. These provided the physician with new tools that could improve treatment procedures. The third stage started in 1985 when the «Voskhod» Production Association on A. R. Evstigneev’s initiative developed the «Uzor» biophysical apparatus. It was the first LTA based on a pulsed GaAlAs semiconductor laser. The following year, this device went into quantity production. Although apparatus technical characteristics left much to be desired from the viewpoint of the modern instrument-making industry [Evstigneev A. R. et al., 1988; Poltoratskii V. V., et al., 1988], it had a great success among practical clinicians. This was largely due to novel treatment capabilities provided by the pulsed infrared semiconductor laser, which started to compete eagerly with the traditional helium-neon laser. The apparatus had relatively small dimensions and low weight, which was also of special importance. This allowed low-intensity laser therapy to be actively developed. It began to gain popularity and finally received such a great interest that there was a real boom in the development and production of LTAs. Many apparatuses began to copy each other and use semiconductor lasers of the same type. This all was quite natural and typical of market economy. However, the number of LTA manufacturers and modifications considerably diminished soon. This happened because of a decrease in profits, a raise in medical and state standards and some other objective reasons. Nevertheless, the interest in laser therapy did not fade away. On the contrary, it exhibited a rise. The researchers made many important advances, whose results are of significance today. With the level of laser medicine rapidly growing, the requirements to modern LTAs became sufficiently stringent. This was the fourth stage in the development of laser therapy devices. At this stage, laser therapy devices were separated into a novel medico-technical trend. It became necessary to create a unified task-oriented developing and industrial policy aimed at providing a close collaboration of researchers, clinical practitioners of various specialities and manufacturers.

Below, we will consider basic principles that guide modern designers in their creating LTAs.

Universality is among fundamental principles laid in a modern «instrument» designed for the clinician or researcher. This principle seeks to effectively satisfy numerous, sometimes discrepant, but valid physicians’ requirements to the equipment. This quality is important because of a number of reasons. First, one must bear in mind that laser therapeutic equipment can be used in various conditions: in hospitals, in polyclinics, in ambulance cars, in various climatic regions, etc. Second, a wide application range specifies requirements, which frequently cannot be satisfied in a single device. Third, one should combine universality with simple operation, small dimensions and weight. These problems can be overcome by using a block principle of building LTAs [Titov M. N., Moskvin S. V., 1993; Titov M. N. et al., 1993; Moskvin S. V. et al., 1994]. Equipment developed according to this principle can be schematically divided into three groups: basic blocks, radiating heads and attachments (Fig. 8.1).

The basic block is the main part of any LTA set. In fact, it includes a power supply unit and a control module. Its principal function is to set radiation modes and to control radiation parameters such as frequency, radiating power, session time, etc. Most models enable the control of several radiation parameters. However, the values of average and pulsed power are the most important parameters.

Basic blocks have different functional capabilities. They can be classified according to the way of setting their operating modes into two types: blocks with fixed parameters (Fig. 8.2) and blocks with arbitrarily set parameters (Fig. 8.3). Basic blocks can be equipped with all the developed radiating heads, which in their turn can be furnished with corresponding attachments.

The literature and recommended practices usually specify approximately 20 laser-beam modulated frequencies, whose application has been proved by clinical tests. For example, acupuncture therapy makes use of frequencies below 100 Hz and sometimes of frequencies above 1,500 Hz when it is necessary to influence some specific zones [Kozlov V. I., et al., 1993]. «Fixed-frequency» LTAs are most useful while treating a large number of patients according to approved and familiar treatment procedures. The front panel of such basic blocks has several buttons with frequency values shown above them. After pushing a button, the device automatically sets a corresponding frequency. In this case, a light indication of switching-on is necessary to ensure the correctness of mode selection. Session time is set automatically by using a timer. This fixed-parameter operating principle was realised in «Mustang» LTA models 016, 017 and 022 and it was found to be completely warranted. Instead of buttons, one might have used another types of switches as diverse as feather-touch switches, multi-wafer switches, self-locking switches, etc. However, none of these switches is reliable or user-friendly.

The limited number of fixed parameters provided by the first-type apparatuses impose limitations on their capabilities. These limitations have been removed, to a certain extent, in the second-type basic blocks which enable the physician to change parameters over a wide range. The application of processors and of other electronic devices can virtually meet any user’s requirements. Selected values are indicated on digital displays of various types (such as light-emitting diode displays, liquid-crystal displays, etc.).

Apparatuses of any type must be equipped with a radiation power meter (a photometer), either built-in or remote. Such a photometer has to be made in accordance with State Standard ¹ 24469-80: Measuring Instruments for Laser Radiation Parameters. General Technical Requirements.

«Mustang» LTAs were the first to be designed and constructed in compliance with the universality principle. Its electrical schematic diagrams as well as its soft hardware (for models 022-026) are given in Appendix 1.

 

«Mustang» LTA performance specification (Basic block)

Number of channels in simultaneous action ……..

2 (Model 016 has one channel)

Radiation power indication ………………………

Available

Radiation wavelength …………………………….

Depends on the interchangeable radiating head’s type

Timer ……………………………………………..

Automatic mode

Radiation power adjustment ……………………..

0 to maximum value

Mass ……………………………………………..

1.9 kg

Dimensions ……………………………………….

210´180´90 mm

Electrical safety class …………………………….

II, BF type (Grounding is not required)

Power requirements…….…………………………

220 ± 22 V, 50 ± 0.5 Hz

Maximal power consumption …………………….

14 W

Operating mode stabilisation time ……………..

4 s

Category temperature range ……………………...

+10 to +35°C

Transportation and storage temperature range …...

-50 to +50°C

Average non-failure time …………………………

5,000 hours

 

The front panel of basic blocks has a POWER switch, a START button, a photodetector window, a potentiometer to adjust radiation power, displays and control buttons to set laser pulse repetition frequencies and exposure time (Figs. 8.2 and 8.3). The apparatus is additionally equipped with a plug-in light indication and audible and light indications of session’s start and end. The rear panel of the block has sockets to connect a power cord and radiating heads. In addition, BIO models have a socket for heart-rate and respiration sensors (Fig. 8.4).

 

Features of «Mustang» LTA models

Model 017 (Model 016 is a one-channel variant) has:

- a set of fixed frequencies: 80; 150; 300; 600; 1,500; and 3,000 Hz;

- a timer operating in the automatic mode: 4; 8; 16; 32; 64; 128; 254 s;

- a bar-graph indicator to show the power of pulsed radiation emitted by infrared radiating heads (the measurement range of 2 to 11 W).

Model 022 has improved characteristics as compared with Model 017:

- an extended range of fixed frequencies: 1; 4; 10; 20; 80; 150; 1,500; 3,000 Hz;

- a timer operating in the automatic mode: 0.5; 1; 4; 8 min;

- a digital display to show the power of pulsed radiation emitted by infrared heads (the measurement range of 2 to 99 W);

Model 024 has:

- fixed frequencies for «fast selection»: 1; 20; 80; 600; 3,000 Hz. These values can be varied easily by pushing either the button «­« to increase the frequency or the button «¯« to decrease the frequency (the adjustment range of 0.5 to 3,000 Hz);

- fixed values of exposure time for «fast selection»: 0.5 and 4 min. These values can be varied by pushing either the button «­« to increase the time or the button «¯« to decrease the time (the adjustment range of 1 s to 90 min);

- laser radiation dose control over the range of 0.001 to 9999 mJ.

As soon as the audible signal ends, the radiating head begins to emit radiation and the time indicator starts displaying the time. When the session time is unrestricted, the time indicator shows the time passed from the session start (i.e. counting up). When the session time is predetermined, the time indicator shows the residuary time (i.e. counting down). The parameters are selected from fixed initial values by pushing a corresponding button. The necessary frequency or session time can be specified additionally. Model 024 allows the on-line visual control of all the parameters (such as radiation power, pulse repetition rate, session time and radiation dose). This control enables one to avoid errors in mode selection. Varying the parameters over a wide range enables clinicians and researchers to improve treatment and to select more efficient radiation parameter combinations [Ilich-Stoyanovich O., et al., 1996, 1997].

Model 026 is most complicated but most universal. It is known that each physician has a preferable set of 8 to 12 frequencies, which he or she frequently uses in practice. Therefore, model 024 allows setting any frequency and any session time. This, however, takes a little more time and requires more attention as compared with fixed-parameter models, in which one can «push a button and everything is all right!». Model 026 has partially eliminated these drawbacks because it can memorise 20 fixed frequencies in the range of 0.5 to 3,000 Hz and 10 fixed time values in the range of 1 s to 90 min. These parameters can then be extracted with a single button by scrolling the data. Model 024 as well as model 026 enables the on-line visual control of all the parameters (such as radiation power, pulse repetition frequency, session time and radiating dose). Furthermore, it has an additional laser-beam modulating mode with the frequency of 10 Hz. Model-026 enables the external modulation of radiation. This feature was realised in the «Mustang-026M» LTA recently developed by the «Technika» Firm. Besides a biosynchronised mode, «Mustang-026M» makes it possible to realise the external modulation from a CD player, which plays a specific music recording. If the patient likes the played melody (such as a musical composition or nature’s sounds), it can produce an auspicious effect on the patient and favour the treatment. The cumulative psychosomatic effect of such therapy greatly differs from that of conventional low-intensity laser procedures with modulation techniques since this kind of laser therapy activates the limbic-reticular system of the brain and renews forgotten associative series besides an external influence (such as modulated laser radiation). This all has an effect on various bodily systems. The external ergoinformational influence and internal psychoemotional informational-biochemical forms are synthesised into qualitatively new psychosomatic therapeutic effects. In view of these features, «Mustang-026M» seems to be useful for psychotherapists, acupuncturists, psycholinguists, paediatricians and therapists. It is also noteworthy that the wider the physician’s cultural and professional scope, the more efficient this novel LTA [Kozlov V. I., Builin V. A., 1998].

A single basic block can be connected to one, two or more radiating heads. However, two-channel apparatuses are prevailing. As a rule, the modern physician makes use of several types of radiating heads to maximally realise laser therapy capabilities. It seems therefore very convenient to employ various types of switchers, distributors, splitters, etc. instead of plug-and-socket connection. In this case, it becomes unnecessary to replace mechanically laser heads before every procedure. The physician can switch on a required head by pushing a button. This enables a simultaneous use of several radiating heads in any combination: for example, red and infrared lasers. Moreover, the physician may independently adjust the radiation power of each of the channels.

The compatibility of radiating heads and of attachments allows the physician to constitute his or her optimal set of equipment depending on the medical task. It also enables the organisation of multifunctional highly effective physiotherapeutic rooms. This is a salient advantage of the block principle of building LTA’s. Figure 8.5 demonstrates the outward appearance of an R-4 splitter specially designed for «Mustang» LTAs. This splitter allows the physician to use up to four radiating heads. The splitter’s rear side has cutoff points for a power cord and the basic block. The latter is connected through a special flex enclosed in an R-4 set.

Operation simplicityis a necessary requirement for any equipment, beginning with a household appliance and ending with an aeroplane. It is quite evident that this requirement should also be applied to medical equipment. Hence, the following question has to be answered: what are the criteria for assessing the operation simplicity? If a long-term service interruption does not make the physician refer to the operating manual, then this apparatus can be considered as simple in operation. The time of parameter adjustment and the number of mistakes can serve as additional criteria for assessing operation simplicity. LTA operation simplicity has a close relation to ergonomic improvement, i.e. to the minimisation of physical efforts and of discomfort while working with the equipment. In any case, the apparatus should enable the physician to focus his or her attention on the patient and to provide high-quality treatment. Moreover, handling with the equipment should not distract the physician from the patient.

Operation simplicity and ergonomic improvement enable the physician not only to receive more patients but also to treat them with a higher efficiency. The latter is due to the fact that the clinician has more time to think over the treatment tactics and strategy. Moreover, it becomes feasible to work effectively during cataclysms such as epidemic, war, natural disasters, etc. E. E. Kalinina et al. (1997) demonstrated that these capabilities of «Mustang» LTAs made it possible to successfully apply this apparatus in the prophylaxis of influenza virus’s epidemics.

Produced equipment compliance with Russian standards is determined by the Conformance Certificate granted by the State Standard authorities after carrying a series of technical tests to confirm the equipment’s compliance with State Standards ¹ R 50444-92, R 50267.0-92, 23511-79, with Sanitary Code and Regulations 5804 and with Working Documentation50-707-91. According to State Standard ¹ 15.013-94, the Russian Ministry of Health issues a document (an extract from the Session Protocol of the Physiotherapeutic Commission of the Novel Technique Committee at the Russian Ministry of Health) that regulates the LTA construction and marketing: Authorisation for Quantity Production and Clinical Application. In order to manufacture and sell medical equipment (including LTAs), a firm has to obtain a Licence for Production and Marketing Medical Equipment and Medical-purpose Goods.

Since LTAs are regarded as medical electrical hardware contacting with the patient, they have to comply with the safety requirements specified in State Standard ¹ R 50267.0-92. LTAs can be classified according to this State Standard into several groups as follows.

1)Depending on the type of electrical shock protection:

a)Electrical equipment operating off an external power source:

- Class I equipment (in which electrical shock protection is ensured not only by main insulation but also by additional safety measures realised with special means intended for connecting the equipment with the protective ground wire of fixed wiring so that accessible metal parts could not be alive in the case of the main insulation’s disruption);

- Class II equipment (in which electrical shock protection is ensured not only by main insulation but also by additional safety measures realised with double insulation and strengthened insulation but without special means intended for protective grounding; or in which electrical shock protection is ensured by the hardware’s design);

a)Equipment operating off an internal power source.

1)Depending on the degree of electrical shock protection:

- Type B equipment provides a certain degree of electrical shock protection, in particular, for permissible leakage current;

- Type BF equipment provides a certain degree of electrical shock protection, particular, for permissible leakage current with an F-type working part;

- Type CF equipment provides the highest degree of electrical shock protection.

An insulated F-type working part should be separated from other hardware’s parts so that a single insulation disruption would not allow the leakage current through the patient to exceed a permissible limit when the voltage applied between the working part and the ground is by 10 per cent higher than the maximal nominal supply-line voltage.

It is important that the user could easily ground equipment. In practice, Class II equipment is more preferable since it does not require additional grounding and it operates off the mains. Type BF equipment is sufficiently safety because it has a threefold electrical shock protection.

A laser hazards class for an LTA can be determined from State Standard ¹ R 50723-94: Laser safety. General safety requirements for developing and exploiting laser equipment.

Class 1. Laser equipment which is safety in anticipated operating conditions.

Class 2. Laser equipment which generates visible radiation in the range of 400 to 700 nm. Eye protection is provided by natural reactions including the wink reflex.

Class 3A. Laser equipment which is safety for observation with the unprotected eye. Eye protection against laser equipment emitting in the range of 400 to 700 nm is provided by natural reactions including the wink reflex. Hazard for the unprotected eye at other wavelengths should not be higher than that for Class 1.

It can be dangerous to observe directly a laser beam emitted from Class 3 laser equipment by using optical instruments such as a binocular, a telescope, or a microscope.

Class 3B. The direct observation of such laser-generated beams is always dangerous. However, visible scattered radiation is usually safety.

Note that the safety observation conditions of diffuse (non-specular) reflection for Class 3B lasers in the visible range are as follows: the viewing distance between the eye and a screen should not be less than 13 cm; the viewing time should not be more than 10 s.

Class 4. Laser equipment whose diffuse radiation is hazardous. This equipment may cause both skin injuries and fire hazard. It is necessary to exercise an extreme caution while using this equipment.

The class of laser hazards is determined during development and it must be specified in technical requirements, in-line documentation, repair documentation, engineering data and advertisements.

When laser devices are delivered on the domestic market, they are accepted in accordance with Articles 7.1-7.3 of Sanitary Code and Regulations 5804-91. The conditions of work are then classified according to the operational environment of laser equipment into laser hazards in accordance with maximal permissible levels specified in Sanitary Code and Regulations 5804-91.

If the basic characteristics of laser equipment (such as power, laser radiation energy, wavelength, beam diameter, pulse duration, etc.) are modified either during its production or during its exploitation, the organisation that made such a modification has to re-classify the laser equipment and to make changes both in the technical documentation and in the requirements for laser hazards.

Each laser equipment has to bear a warning sign (signs) indicating its laser hazards and its class according to State Standard ¹ 12.4.026-76. Moreover, laser equipment capable of producing additional hazards has to bear corresponding danger signs in compliance with State Standard ¹ 12.4.026-76.

The LTA reliability has to comply with State Standard ¹ 50-707-91, which should be verified by a certification test. State Standard ¹ 15150-69 determines the equipment’s climatic construction, transportation, storage and maintenance. Complied with State Standard ¹ 23511-79 medical devices may be used at dwelling houses or be connected to the electric mains (this is specified in the Apparatus’s Conformance Certificate).

Checking laser radiation parameters is extremely important to justify the applied methods and to administer proper doses. This can assure effective and high-quality treatment as well as the patient and physician’s safety. The following parameters are usually of special importance.

  1. Wavelength. This parameter depends on the laser type and is specified by the manufacturer. Additional indication is not needed.
  2. Pulse repetition frequency or modulation frequency. This parameter can be set with the aid of one of the above-mentioned switches from the front panel of a basic block. The accurate values of the frequency can be either indicated on a digital display as concrete figures or they can be precisely set by using discrete self-locking switches. It should be stressed that in the latter case each discrete mark must bear the information on the real value and dimensionality of parameters, for example, 80, 150, 300, etc. Hz. It is forbidden to use arbitrary units, such as 1, 2, 3, etc., with their explanation given either in the operating manual or data sheet, because it is inconvenient and, what is more, it considerably increases the probability of making errors while setting the influence parameters.
  3. Session time (timer). In addition to the frequency indication, it is necessary provide an audible indication of session’s start and end.
  4. Radiation power. It is also essential to check power radiation because low-intensity laser radiation is known to produce a dose-dependent effect. Radiation power can greatly vary with many factors such as changes in ambient temperature, variations in supply voltage and laser resource depletion. Checking power radiation enables a more accurate dose control. If a decrease in visible radiation power can be noticed visually, such a decrease in infrared radiation power cannot be perceived. Therefore, the control of radiation and the question of safety for infrared lasers are of special importance.

Power regulators make it possible to treat various diseases by selecting different values of radiating power. Laser therapy apparatuses should therefore be tested and calibrated not only during their production but also during their application [Romashkov A. P. et al., 1997].

Very frequently, simple methods turn out to be inapplicable to laser radiation measurements because their accuracy is greatly affected by inhomogeneous and variable spectral characteristics of widely used silicon photodiodes (Fig. 8 a). Since FD-24K photodiodes have the largest photosensitive surface (10 mm in diameter), they found broad application for these purposes. Despite the spectral measurement range of 0.47 to 1.12 mm, their spectral sensitivity maxima can vary from 0.75 to 0.85 mm. This means that their sensitivity can vary by several tens of per cent in the measurement range [Aksyonenko M. D., Baranochnikov M. L., 1987]. Apart from that, these photodiodes exhibit great variations in surface zonal sensitivity, even if they were taken from the same lot [Martynyuk A. S., Sachkov A. V., 1988], which additionally increases measurement errors. Germanium photodiodes are employed to measure laser radiation power in the range of 1.2 to 1.3 mm (Fig. 8.6).

Photometers allow the reliable and reproducible measurements of semiconductor laser radiation power. However, their designing is hindered by significant and specific difficulties resulted from the spatial and spectral heterogeneity of the luminous flux (such as a great divergence, non-uniformity, wavelength-temperature dependence, etc.) [Moskvin S. V. et al., 1988]. In order to provide the required accuracy, one must apply specific and sufficiently expensive techniques such as integrating spheres, correcting filters and telocentric systems for providing a required solid angle. In this case, the measurement accuracy amounts to 6-8 per cent [Moskvin S. V. et al., 1986, 1989]. Relatively simple and inexpensive measurement methods introduce errors of 25-30 and 40-45 per cent, respectively, for the average and pulsed laser radiation power. These errors are quite admissible for LTA measuring instruments (photometers).

A. P. Romashkov (1995) pointed out two additional high-priority questions, namely LTA unification and photometer’s measurement assurance. The proposed LTA unification is feasible due to equitype lasers and attachments (magnetic and optical). The provision for unified plug-and-socket connections between laser heads and attachments for different LTAs enables one not only to extend the consumers» choice but also to simplify the metrological calibration of photometers. This calibration consists of several steps: the primary calibration of measuring instruments (i.e. photometers) by the manufacturer and their periodic calibration by regional verification officers at worksites (at a hospital, polyclinic, etc.). The reference gages of regional verification officers are regularly checked by the State Standard Authorities, which ensures a so-called metrological vertical.

Dataware should be provided in order to fully realise LTA capabilities. First of all, it includes technical documentation such as a registration certificate, an operating instruction, an overhaul manual, a setup instruction and a manufacturer’s warranty. These documents have to be draw up in accordance with State Standard ¹ R 50444-92: Medical devices, apparatuses and equipment. General technical requirements. The dataware should also comprise methodical recommendations in which medical aspects of using LTAs should be given. The official status and significance of these recommendations depend on the instance that approved them, whereas the content’s quality largely depends on the body of authors.

An attractive feature of LTAs is that their operation can be easily mastered. However, during the treatment much depends on the physician, who must be able to adequately realise equipment capabilities. The manufacturer’s task is to provide the physician with a maximal access to information. This can be realised by holding various conferences, workshops and advanced training courses; by publishing and disseminating the literature about the latest achievements in laser medicine; etc. In other words, it is necessary to create informational space for practical clinicians. In its turn, their recommendations will help the manufacturer to modernise laser equipment.

L. Yu. Bzhilianskaya (1996) made a report on conversion in Russia at the International Sientific and Technical Symposium held in Princeton (U.S.A.). She reported about the «Technika» Firm developing and manufacturing LTAs based on conversion military-purpose lasers.

The LTA development can be divided into several basic steps. First, engineers and physicians should design an LTA complying with medico-technical requirements. After that, the designed and constructed LTA has to pass all the stages of technical and clinical tests so that the Russian Ministry of Health could grant an Authorisation for Full-scale Production. Thereafter, the State Standard Authorities certificate both the batch production and the full-scale production. Moreover, marketing the LTA should be accompanied by the multilevel education and re-qualification of physicians who will use the developed LTA.

Servicingis provided by the manufacturer either through the network of production dealers or through local service agencies with which the manufacturer signed corresponding treaties. It is known that any reliable equipment can get out of order with time. It is therefore of special importance to ensure such servicing that could prevent a treatment process from interruptions. In other words, the repair service should be able either to repair the broken apparatus within one day or to replace it with a serviceable one for the repair time. Repair service is also responsible for the calibration of photometers.

Radiating heads are connected to the basic block either directly or through a splitter. They are composed of one or several semiconductor lasers (or more rarely of light-emitting diodes (LED)) and of an electronic control circuit. The control circuit is employed to set laser pumping current and to adapt radiating heads to the block’s unified power supply. However, the electronic circuit can sometimes perform other functions.

It should be pointed out that it was laser diodes that enabled the designers to create remote radiating heads and to fully realise the block principle of building modern low-intensity laser therapy equipment.

Radiating heads can be classified either according to the employed laser parameters (such as a wavelength, radiation power, and radiation type: pulsed or cw) or according to the used attachments.

The first-type attachments enable the direct coupling of laser radiation into the light channel without using special optical systems by means of a simple threaded joint or a split terminal («stiff» instrument). The outward appearance of radiating heads that use such attachments (type LO) is shown in Figure 8.7, whereas their engineering data are listed in Table 8.1.

 

Table 8.1. Performance specification of LO-type radiating heads.

Radiating Head

Optical Range

Wavelength, mm

Operating Mode

Radiation Power

(not less than)

Array-based Heads

ML01K

IR

0.89

pulsed

50 W (10 LD)

Laser Heads

LO1

IR

0.89

pulsed

5 W

LO2

IR

0.89

pulsed

9 W

LO3

IR

0.89

pulsed

15 W

LO4

IR

0.89

pulsed

20 W

LO5

IR

0.89

pulsed

40 W

LO6

IR

0.89

pulsed

60 W

LO7

IR

0.89

pulsed

80 W

LOK1

Red

0.67

pulsed

3 W

LOK2

Red

0.67

pulsed

5 W

KLO1

Red

0.67

cw

5 mW

KLO2

Red

0.67

cw

24 mW

KLO3

Red

0.63

cw

10 mW

KLO4

Red

0.63

cw

20 mW

KLO5

IR

0.83

cw

30 mW

KLO6

(Miklan)

IR

0.83

cw

200 mW

LED-based Heads

MSO2

IR

0.96

pulsed

7´10 mW*

MSO3

Red

0.67

pulsed

7´2 mW*

MSO4

Yellow

0.59

pulsed

7´2 mW*

MSO5

Green

0.57

pulsed

7´2 mW*

MSO6

Blue

0.47

pulsed

7´3 mW*

      

* as measured at the frequency of 3,000 Hz.

 

The second-type attachments are connected to the main light-guiding fibre. Laser radiation is coupled into the opposite end-face of the fibre by means of a special optical system. Although this method is more expensive, it enables a high-efficient coupling of cw laser radiation into a flexible fibre-optic instrument. The outward appearance of heads that make use of such attachments (type MLO) is presented in Figure 8.8, whereas their engineering data are listed in Table 8.2. All these heads can operate either in a continuous or beam-modulation mode.

 

Table 8.2. Performance specification of MLO-type radiating heads.

Radiating Head

Optical Range

Wavelength, mm

Radiation Power

(not less than), mW

MLO2B

IR

0.83

20

MLO2V

IR

0.83

30

MLO3A

IR

1.3

1.5

MLO3B

IR

1.3

5

MLO5

Red

0.67

15

MLO6

Red

0.63

4.5

MLO7

IR

0.78

10

MLO8

IR

0.96

20

 

MLO2-MLO8 radiating heads have an elaborate design. The laser itself is built in an optical module (a micro-focusing assembly). This module enables the coupling of radiation into the main light-guiding fibre connected through a plug-and-socket. The designing and constructing of such an assembly is a labour-consuming task largely due to the spatial features of semiconductor-based laser radiation [Andrianov A. P., Bebchuk L. G., 1988]. However, this design enables a low-loss coupling of laser radiation into the fibre. Moreover, it allows using a flexible light-guiding instrument.

The buttons of setting continuous and beam-modulation modes are placed on the control panel of radiating heads. One must bear in mind, however, that beam modulation reduces the average power by a factor of 2. All the MLO2-MLO8 radiating heads are equipped with a photosensitive module. It consists of a photosensitive window, a digital display to show the average radiation power and control buttons to switch between internal and external measuring modes. The external mode is used to measure the output power of the main light-guiding fibre or of attachments. The internal mode is necessary to provide the on-line control of relative variations in laser radiation power (Fig. 8.8). This mode measures a signal coming from a feedback photodiode, which is essential for cw laser diodes.

Array radiating elements are a special class of radiating heads and self-contained apparatuses. They use only special magnetic attachments (MM50 and MM100). Clinical practitioners most frequently employ array radiating heads and self-contained apparatuses composed of 10 pulsed infrared lasers [McKibbin L., Downie R., 1991; Builin V. A., 1996]. Arrays of a larger size and of another wavelengths found few applications [Evstigneev A. R. et al., 1987]. For example, proposed by Fuchtenbusch A. (1998) was a cosmetological array composed of 10 or 14 lasers and a laser comb made up of 14 laser diodes emitting at the wavelength of 785 nm.

An ML01K array radiating head compatible with «Mustang» LTAs (Fig. 8.9) consists of 10 pulsed infrared laser diodes arranged in two rows. This allows a uniform illumination of an area of 30 cm2.

Equipment weight and overall dimensions are not always of great importance. It is much more important to provide a high-quality treatment, which is largely governed by universality, operation simplicity and by the feasibility of varying and checking radiation parameters. Weight and overall dimensions become of special value when the equipment is frequently moved, for example, when physicians work on board a train, ship and aeroplane, at mobile ambulance stations, in isolated groups (duty personnel, searching and rescue teams, expeditions, etc.) and in a field environment. The same goes for country physicians and private medical practitioners. These indices also become important when patients carry out physiotherapeutic procedures by themselves under physician’s intermittent monitoring or when out-of-the-way and hard-to-transport chronic patients need treating. In these cases, the treatment can be safe from interruptions during days off and red-letter days.

In situations like these, portable devices operating off a supply line through an adapter or off a battery present advantages in their minimal dimensions and low weight. Sometimes, it is more preferable and convenient to use accumulators as a power source. However, one must remember that the running time of the best accumulators is shorter than that of batteries. Moreover, it is sometimes impossible to periodically (or even daily) recharge accumulators.

It is worth noting, however, that in the first case the device’s minimal dimensions and low weight result in the loss of its universality, which imposes limitations on LTA capabilities, whereas in the second case the device’s simplicity is even necessary to avoid the danger of incorrect application by the patient. Apart from that, portable device capabilities can frequently satisfy medical practitioners» demands. A remote radiating head is convenient for acupuncturists while influencing acupuncture points. In this case, their activities are not hampered by electrical cords and they should not distract to the START button.

The LTA application in hospitals can engender the question of apparatus’s weight and dimensions. For example, it is convenient to place a compact device on a bed-side table near the patient’s couch, without rearranging the room for cumbersome equipment. There might also be situations in which it is necessary to temporarily shift the device, for example, during certification, redecoration and some other procedures. Lyudvichek I. A. et al. (1997) reported that the «Muravey» device, classified as a compact apparatus, was highly efficient, user-friendly and cheaper as compared with its analogues. This device was found to be highly suitable while treating in-patients.

However, it is essential to optimise, not to minimise the stationary equipment dimensions. This optimisation has to be aimed at the ergonomic and safety improvement of equipment performance so that the physician could fully realise laser therapy capabilities. Personal computers, for instance, can serve as a good example of solving this problem. It is known that modern technologies allow the notebook to realise powerful desk-top personal computer capabilities. Nevertheless, although it is easy to travel with the notebook, its ergonomic features can cause operating discomfort. In spite of different capabilities of desk-top computer systems, they all have virtually identical sizes. The size of computers is usually estimated with respect to the table. Hence, the size of stationary LTAs can be estimated with respect to the bed-side table. Placing LTAs on bed-side tables is encouraged by using compact single or matrix semiconductor lasers of various wavelengths [Moskvin S. V. et al., 1996(2)].

The «Muravey» LTA was created according to theoretical concepts and experimental clinical results presented by V. A. Builin (1996) in his monograph. This apparatus is greatly different from its previous analogues (Fig. 8.10). Figure 8.11 shows the «Muravey-T» LTA - a modification of the «Muravey» LTA - with an improved control panel.

 

 

 

 

«Muravey» LTA performance specification

Operating mode (radiation mode) …………………………...

pulsed

Laser radiation wavelength (at a temperature of 25 ± 5°C) …

0.89 ± 0.03 mm

Pulse repetition frequency …………………………………...

80 ± 5 Hz

Pulse duration ………………………………………………..

170 ± 50 ns

Maximal pulsed radiation power …………………………….

50 to 80 W

Built-in power meter for pulsed radiation …………………..

0 to 80 W

Maximal pulsed irradiance over the output window surface ..

4 to 9 W cm-2

Irradiated surface area

contact influence ……………………………………….…

at a 2 cm distance from the output window ………………

combined with a magnetic attachment ……………………

 

10 cm2

18 cm2

10 cm2

Modulation frequency ……………………………………….

2.4 ± 0.1 Hz

Modulated pulse period-to-pulse duration ratio …………….

2 ± 0.4 Hz

Power requirements:

220 V AC, 50 Hz ……..……………………….……………

Battery …………..………….………………………………

 

9 V (AC power adapter)

Battery 1604A

Battery operation time, not less than ………..………………

50 hours

Category temperature range …………………………………

+10 to +35°C

Mass (without a power supply unit) …………………………

130 g

Dimensions ………………………………………………….

150´65´35 mm

 

At customer’s request, power supply can be realised from the vehicle-borne electrical net (12 V) or from the electrical mains (110 V). This device is universal due to its portability, self-contained power supply and automatic laser radiation frequency modes. It can be used by physicians of various specialities, both in medical institutions and outside them.

The «Muravey» LTA’s radiating part is compatible to the ML01K construction. One can therefore use «Muravey» LTAs with 50 mTl (MM50) and 100 mTl (MM100) constant magnets. The design and field pattern of these magnets (Fig. 8.12) simplify magnetolaser therapy because it becomes unnecessary to select the polarity of magnets. The magnets are always placed in the same way: the white fluoroplastic overlay attached to the magnets should be turned to the «Muravey» working window.

The apparatus’s operating modes are optimal in terms of biophysics and physiology, which was earlier substantiated by Builin V. A., 1996. Figure 8.13 shows the radiation field pattern produced by a laser array. It is evident that the radiation field pattern created on the glass surface of the apparatus’s working window is identical to that produced on the patient’s skin when the influence is contact. In this case, the spot area (S) is approximately 0.13 cm2. Hence, when the pulse power is Pp = 6 W and pulse duration is tp = 170 ns, the average radiation power (Pa) in each field (frequency f = 80 Hz) reaches

Pa = Pp f tp = 6´80´ 1.7´10-7 = 8.16´10-5 (W),

and the power density amounts to

Pa / S = 8.16´10-5 / 0.13 = 6.28´10-4 (W cm-2).

In other words, the dose administered during a 2 min irradiation of a single zone on the patient’s skin by using 10 lasers of the «Muravey» LTA array (or by using the MLO1K radiating head with a corresponding frequency) is as follows

D = T×Pa / S = 120´ 6.28´10-4» 0.075 J cm-2

When the radiation is modulated by a frequency of 2.4 Hz, the dose is reduced by a factor of 2, i.e. it is 0.04 J cm-2. In this case, the total irradiated area is 1.3 cm-2 (10 space-separated spots).

Each laser radiating element produces a light spot of an area of approximately 0.8 cm2 at a distance of 1.5 cm from the working window. All the lasers administer a dose of 1.2´10-2 J cm- 2 (12 mJ cm-2). At a distance of 3.5 cm, a single laser produces a spot of an area of 2.9 cm-2 (the total irradiated area is approximately 30 cm2), whereas the total dose amounts to 3.4´10- 3 J cm- 2 (34 mJ cm-2). Laser-beam modulation (the pulse period - to - pulse duration ratio Q = 2) reduces these values by a factor of 2. These figures may be regarded as ideal because radiation intensity distribution has intricate patterns at a distance of more than 1 cm from the device’s working window. Similar calculations can be made for tables given in Chapter 7.

A self-contained portable LTA employs a single radiating element with various attachments (magnetic or optical) [Moskvin S. V. et al., 1996(1), 1996(3)]. These LTAs are indispensable in dealing with intra-cavitary instruments (such as otolaryngologic, stomatologic, etc.). They also yielded good results in acupunctural applications. For example, «Motylyok-Reflex» LTAs were specially designed and constructed for laser acupuncture (Fig. 8.14). The working set of these LTAs includes a corresponding attachment (A3). The specific application of «Motylyok-Reflex» LTAs is realised by using lasers emitting at the wavelengths of 0.63 and 1.3 mm, which are known to be most effective for acupuncture [Kozlov V. I. et al., 1993].

 

«Motylyok» LTA performance specification

Radiation wavelength …………………………………….

0.87 to 0.91 mm

Radiation regime ……………..…..……………………...

Pulsed

Pulse duration …………………………………………….

100 ± 30 ns

Pulse repetition frequency ………………………………..

80 ± 5 Hz

Pulsed radiation power (not less than):

«Motylyok-7» …………………………………………….

«Motylyok-12» …………………………………………..

«Motylyok-20» ………………………………………….

 

7 W

12 W

20 W

Beam divergence within a cone with angle at vertex …….

20 ´ 40 degree

Mass ……………………………………………………

180 g

Dimensions ……………………………………………….

140 ´Æ30 mm

Power source ……………………………………………..

Battery AA (1.5 V)

Continuous operation time without battery replacement (not less than) ……………………………………………

 

70 hours*

* This time is given for alkaline batteries (such as Energizer, GP ALKACELL, etc.)

«Motylyok-Reflex» LTA performance specification

Radiation wavelength:

«Motylyok-R1, R2» …………………………………...…

«Motylyok-RK1, RK2» ………………………………..

 

1.3 ± 0.03 mm

0.63 to 0.64 mm

Average radiation power (not less than):

«Motylyok-R1», at the output of a radiating element……

at the output of an acupuncture attachment …………

«Motylyok-R2» at the output of a radiating element…….

at the output of an acupuncture attachment …………

«Motylyok-RK1», at the output of a radiating element…..

at the output of an acupuncture attachment …………

«Motylyok-RK2», at the output of a radiating element…..

at the output of an acupuncture attachment …………

 

1.2 mW

0.6 mW

5 mW

2.5 mW

5 mW

2.5 mW

10 mW

5 mW

Radiation regime …………………………………………

Continuous, modulated

Modulating frequency ……………………………………

2.4 ± 0.1 Hz

Modulated pulse period-to-pulse duration ratio ………….

2 ± 0.4 Hz

Mass ……………………………………………………..

180 g

Dimensions ……………………………………………….

140 ´Æ 30 mm

Beam divergence within a cone with angle at vertex …….

10 ´ 30 degree

Power source ……………………………………………..

3.6 V accumulator

Continuous operation time without accumulator recharging (not less than):

«Motylyok-R1, R2, RK1» ………………………………..

«Motylyok-RK2» ………………………………………...

 

 

2 hours

1 hour

 

Apart from that, it was important to create optical attachments for intra-cavitary laser therapy. The problem of effective laser radiation delivery sprang up with the first surgical applications of lasers [Goldman J. et al., 1964; Kapany N. S., 1965]. Historically, low-intensity helium-neon lasers (l = 0.6328 mm) were the first to be applied in laser therapy. Since radiation at this wavelength does not penetrate biological tissues sufficiently deeply, it was necessary to employ a light-guiding instrument to influence internal organs. The creation of pulsed infrared semiconductor lasers and of laser arrays made it possible to abandon attachments in favour of a non-invasive radiation influence on the projection of an affected organ [Rapoport S. I., Rasulov M. I., 1997].

Applying polymeric optical fibres significantly simplified laser haemotherapy procedures. There have not been reports on complications related to the application of polymeric fibres. Utilising disposable sterile optical fibres secures the patient from being infected during the treatment. The attenuation coefficient of optical radiation in the optical fibres amounts to 200 dB km-1 [Sadov A. Yu. et al., 1989].

The intra-cavitary instrument development and its reduction to practice constitute one of the stages of laser therapy evolution [Rechitskii V. I., 1991]. In creating these instruments, it was essential to provide the following:

- convenient delivery of low-intensity laser radiation to an arbitrarily shaped cavity;

- instrument fixation;

- uniform irradiation of the cavity surface (either of the entire cavity or of a pathological focus alone);

- high laser radiation transmittance;

- convenient, quick, reliable and cold sterilisation.

In order to cope with this task, the engineers had to work in collaboration with clinicians belonging to different disciplines (such as gastroenterologists, urologists, proctologists, stomatologists, obstetricians, gynaecologists and otolaryngologists). It was important to discuss the constructive features of light-guiding attachments and of their radiation patterns.

Laser therapy instruments should have the following indicatrix patterns: a cone, wide-angle cone, side-directed cone, sphere and cylinder. Required scattering patterns depend on the medical task. They can be constructed either by putting fibre’s end-faces into a definite shape, or by inserting a metal reflector into the hollow of protective coating at the distant end, or by adding light-scattering agents (such as a zinc oxide, barium sulphate, etc.) to obtain a cylinder type indicatrix [Lozhenko A. S., Zharov V. P., 1989]. The intra-cavitary instruments can be schematically divided into two types:

Type I includes rigid light-guiding instruments composed of three basic parts: a plug connector, rod and working part (an optical scattering element). The light guide transmits radiation from the optical connector to the scatterer allowing the instrument to be positioned precisely in the cavity and to irradiate the pathological focus.

Type II comprises flexible light-guiding instruments. A quartz polymeric optical fibre is placed along a polyvinyl chlorid (PVC) catheter. A scattering element is hermetically sealed at the catheter’s distant end. Various radiation patterns are constructed by using special manufacturing methods.

Attachments can also be classified according to the types of radiating heads employed. For example, MM50 and MM100 (magnetic) attachments can be used only with MLO1K radiating heads or with «Muravey» LTAs because they are compatible with array radiating elements.

The «Technika» Firm produces a wide variety of intra-cavitary attachments, which can be effectively used in all medical fields. The MLO2-MLO8 series of laser heads have been specially designed and constructed for using with optical intra-cavitary attachments (Table 13.2). For example, these laser heads enable one to realise the intravenous laser irradiation of blood (ILIB) in a wide range of wavelengths.

Besides the scattering indicatrix, an attachment has another important parameter: the radiation-coupling coefficient. It can be defined as a ratio of the radiation power at the attachment output to the radiation power at the attachment input. This coefficient depends not only on the attachment type and constructive features but also on the laser type. Usually, it ranges from 0.4 to 0.8.

The P-1 proctologic attachment (Fig. 8.15 a) produces a radiation spot at an angle of 120° relative to its axis and with a diameter ranging from 5 to 10 mm. This enables one to obtain a local power density distribution. The P-1 attachment is employed in urology for prostate’s transrectal irradiation.

The P-2 proctologic attachment (Fig. 8.15 b) allows the radiation to be uniformly distributed over a cylinder with the dimensions of Æ 9 mm ´ 25 mm. This attachment can be of use either in urology for prostate’s transrectal irradiation or in proctology for rectum irradiation. Although the power density of this attachment is much lower than that of P-1 due to a larger scattering surface, this attachment is universal.

The P-3 proctologic attachment (Fig. 8.15 c) allows the radiation to be uniformly distributed over a Æ 9 mm ´ 25 mm cylinder. It can be applied in proctology to irradiate the rectum (scissures of the rectum, hemorrhoid and similar maladies).

The G-1 and G-2 gynaecologic attachments (Figs. 8.16 a and 8.16 b) can find use in gynaecology for the intravaginal irradiation of both cervix of the uterus and the adnexa. These contact attachments allow the radiation to be scattered over a surface of 15 to 20 mm in diameter. The G-3 gynaecologic attachment (Fig. 8.16 c) is of intravaginal use. It can be applied in treating some inflammatory diseases.

The U-1 urologic attachment (Fig. 8.17) was designed for transurethral irradiation of the prostate gland and of the urethra. It is made of flexible material. Its length is 30 cm and it has a 20 mm long cylinder-shaped area at its end.

Otolaryngologic and stomatologic attachments (Figs. 8.18 a and 8.18 b, respectively) are sold as a set consisting of a split terminal and of three attachments.

Optical attachments have to be manufactured in accordance with State Standard ¹ R 50444-92 and State Standard ¹ 15150-69. They should be made of special plexiglas and their transmission coefficient may range from 0.4 to 0.65.

The problem of handling light-guiding fibres and optical attachments is of great importance because they require especially gentle handling so as to avoid the danger of mechanical damage (such as scratches, excessive bends, fractures, etc.). Scratches and micro-cracks result in the reduced transparency of optical fibres and of attachments so that output power can decrease several times causing the need of replacing [Samosyuk I. Z. et al., 1997]. Apart from that, it is virtually impossible to ensure sterility before the second application after working because a majority of instrumentation admits of chemical cold sterilisation only. One should also bear in mind that an average service life period of attachments is 2 years.

Pre-sterilisation cleaning and sterilisation are performed in accordance with Regional Standard 42-21-2-85. Manual pre-sterilisation cleaning should be performed as listed in Table 8.3.

Sterilisation is made by a 1% Dezoxon-1 solution (relative to a peracetic acid concentration) according to Technical Requirements 6-02-09-06-78 at a temperature of not less than 18°C with total immersion into the solution for not less than 45 min. Thereafter, sterilised instrumentation may be rinsed with sterile water. Dezoxon-1 solution may be used during one day. The keeping time of sterilised instrumentation placed inside a sterile reservoir (a sterile box) lined with a sterile sheet is 3 days.

The disinfection of light-guiding fibres, attachments and of the functional surfaces of radiating heads intended for external non-contact laser therapy is carried out according to Regional Standard 42-21-2-85 by a chemical method using a double wipe with paper tissue made of unbleached calico and saturated either with an 0.1% Dezoxon-1 solution in accordance with Technical Requirements 6-02-09-06-78 or with an 0.1% chloramine solution at a temperature of not less than 18°C. One must make sure that there remain no filaments on the surface after the wipe.

Magnetic attachments can produce different values of magnetic flux density. They were designed to carry out magnetolaser therapy and to increase treatment efficiency. The magnets of 25, 50 and of 75 mTl are frequently used in medical applications. The «Technika» Firm specially developed an optimal set of KM-2 attachments for magnetolaser therapy. They can be used either with LO radiating heads or «Motylyok» LTAs. Magnets currently employed are made of special rare-earth metal alloys. They have such a construction that their magnetic field is maximally elongated in the direction of influence. A single metal box (used to shield against the magnetic field) contains two magnetic holders and two annular magnets (Fig. 8.19) with different values of magnetic flux density: 25 and 50 mTl and 50 and 75 mTl, respectively. This enables an easy handling with the magnets and a simultaneous use of one magnet with two heads. High spatial distribution characteristics of these attachments in magnetic flux density (Fig. 8.20) were achieved by using Nd2Fe12B-based alloys: materials with the highest magnetic energy.

These attachments have different functions, purposes and applications. Some of them are employed to achieve a maximal therapeutic effect, whereas the others are designed to simplify and secure the treatment.

Besides intracavitary and magnetic attachments, there exist optical attachments for LO-type heads and «Motylyok» LTAs. These attachments are intended for external applications and can be classified as follows.

-Mirror attachments ZN25 (with a diameter of 25 mm), ZN30 (with a diameter of 30 mm), ZN35 (with a diameter of 35 mm) and ZN50 (with a diameter of 50 mm) are intended for the contact-reflection type influence (Fig. 8.21). They are used to increase the depth and the intensity of therapeutic influence, to protect the physician from reflected radiation, to ensure procedure hygiene and to simplify the assessment of received dose (the effective area of influence is taken to be equal to 1 cm2).

-Acupuncture attachmentsA-2 and A-3 were developed to focus laser radiation on acupuncture points (Fig. 8.22).

-Magnetic acupuncture attachmentsMA-1 were engineered for magnetolaser acupuncture therapy.

The bio-synchronisation of laser radiation time parameters with patient’s endogenous biorhythms is one of the most interesting and promising trends in the equipment and treatment methodology development. Here, we shall consider only technical approaches to the realisation of a single biosynchronisation technique.

The researchers made endless attempts trying to apply feedback to the patient for achieving a reliable and stable therapeutic effect. T. A. Ventslavskaya et al. (1990) reported that the preliminary exposure of non-linear white mice with experimental arrhythmia to helium-neon laser radiation with the laser-beam modulated frequency equal to the heart rate was capable of preventing ventricular fibrillation and animals» death. These results provide evidence for expediency of modulating low-intensity laser radiation by the heart rate. V. M. Grimblatov et al. (1990) advanced an automatic selection of the administered dose by using a feedback system based on the computer processing of cardiac signals. P. N. Boitsev et al. (1994) developed an automated system in which the biological feedback assessed the state of sensory (informational) functional systems. N. I. Syuch et al. (1996) evaluated the efficiency of magnetolaser therapy in patients with chronic non-specific lung disease by counting lymphocyte percentage in periphery blood, which served as a criterion for correcting the administered dose.

The timed influence on biological systems made it possible to extend considerably the range of intensities, not affecting the harmony of internal biorhythms. In order to avoid the detuning effect of low-intensity laser radiation at all levels, one should time laser radiation with all endogenous biorhythm periods. However, because of fundamental difficulties, the realisation of this mode is limited to an a priori determination of not less that 3 frequencies of internal rhythms for every patient, which was realised in the «Mustang-BIO» apparatus (Russia). The application of semiconductor lasers ensures small dimensions and operating convenience [Grimblatov V. M., 1996].

It is worth noting that the current stage of low-intensity laser therapy development is characterised by a growing number of reports on chronobiology and chronomedicine. The technical implementation of a particular biological feedback depends on the operating principle, the number of processed parameters, the method of detecting biological parameters, the complexity of signal processing and on the mode of functioning (power modulation, phase changes, frequency shifts, etc.). Every particular realisation therefore requires unique custom-made equipment.

Below, we will consider an example of the technical implementation of a typical biological feedback based on the blood flow parameters: heart and respiration rates, when they were modulated by a frequency of approximately 10 Hz. This frequency corresponds to many physiological processes in human beings [Zaguskin S. L. et al., 1993; Titov M. N. et al., 1994, Moskvin S. V. et al., 1995]. «Mustang-BIO» LTAs should be pointed out as specific biocontrolled models based on a unique and efficient operating mode (Patent 2117506). Figure 8.23 shows the biocontrol principle based on this pattern. Laser radiation power is modulated by three signals. The sliding carrier frequency in the range of 7 to 14 Hz is set with the aid of an internal generator. In this case, radiation power (Fig. 8.23 a) is reduced to 1/3 (Fig. 8.23 b). Attaching a pulse sensor enables the radiation to be modulated by the heart rate (Fig. 8.23 c), whereas a respiration sensor allows the radiation to be modulated by the respiration rate (Fig. 8.23 d). As result of this, radiation power is minimal during expiration and diastole phases and it reaches its maximum during inspiration and systole phases (which are the most favourable moments for the influence) (Fig. 8.23 e).

Pulse and respiration sensors are connected to sockets on the apparatus’s back panel. The heart-rate measurement principle is based on a photodiode-LED system as follows. Because the blood engorgement of a patient’s finger varies synchronously with his or her heart rate, this variation decreases the LED radiation intensity passing through the patient’s finger, which is then detected by the photodiode. Having been processed the signal thereafter comes to a laser power modulator circuit. Figure 8.24 shows a heart-rate sensor in action (when it is put on the finger).

The respiration sensor is positioned near the patient’s nostrils. It consists of two temperature-sensitive resistors placed in a plastic casing. Their resistance changes proportionally with the temperature of the ambient air during respiration. Figure 8.25 shows a respiration sensor in action (when it is put on the patient’s ears and positioned in front of the nose).

Modulated radiation should strictly match pulse-waves propagating through various pathological regions. We therefore carried out special investigations to determine the accurate values of pulse-wave time delays relative to the right-hand finger. The measurements were made in several people of both sexes and of various age groups. The minimal time delays were observed both in children (because of short pulse-wave propagation paths) and in aged people, in whom the pulse-wave velocity increased as a result of reduced vessel elasticity [Karo K. et al., 1981]. The maximal time delay between a signal from the finger, which was carefully matched in phase with radiation modulation, and a signal from the most distant region, i.e. from the toe, amounted to 60 ms (Fig. 8.26). This value showed good agreement with the experimental results reported by G. S. Malindzak (1971). He found that the average pulse-wave velocity in arteries was equal to 15 m s-1. At a distance of 1 m, which is an approximate distance between the finger and the toe in our experiments, this velocity will bring about the same time delay. These results make it possible to ensure the matching of maximal intensity of laser radiation with systolic phases. Moreover, they justify the technique in question as a biological feedback.

The specialisation of some apparatuses specifies requirements completely different from those imposed by universality, which is not always very important. To a certain extent, this was demonstrated earlier on the example of self-contained apparatuses. The universality of intravenous laser irradiation of blood (ILIB) as a treatment method and the necessity for providing sterile conditions during the treatment require the development of highly specialised equipment.

The first communications on the efficiency of using ILIB in treating patients affected by angina pectoris and acute myocardial infarction were published in the early 1980s [Kapustina G. M., 1990; Kipshidze N. N. et al., 1993]. This technique found application in many other medical fields·. It became necessary to develop its hardware implementation. An ALOK apparatus based on a helium-neon laser with a wavelength l = 0.633 nm and an output power of 2.5 mW have been successfully employed for this purpose for a long time. However, helium-neon lasers are expensive, unreliable (due to the natural degradation of performance), supplied with a high voltage (several kilovolts), cumbersome and heavy. In addition, they have a long setup time and have to be constantly on as a result of this. This all imposed limitations on a broad ILIB application in clinical practice. Semiconductor lasers are widely used in medicine, because they are free of these drawbacks.

It was also revealed that blood had a strong absorption band with a maximum in the region of 633 to 642 nm, which was ascribed to the luminescence of protoporphyrin type IX. These results made it possible to come to a conclusion that heme was the primary absorber in this region. Orange-red radiation was assumed to induce the photoexcitation of d-electrons of reduced Fe ions in the heme of cytochrome a3 and the capture of d-electrons by NAD (nicotinamide adenine dinucleotide) and FAD (flavin adenine dinucleotide) dehydrogenases with the subsequent utilisation of the absorbed energy through respiratory paths. In this case, the effect of optical radiation on biological objects results in the adenosine 5’-triphosphate (ATP) photosynthesis [Zakharov S. D. et al., 1989; Chudnovskii V. M. et al., 1989]. The emission spectrum of laser diodes has a virtually ideal fit into this spectral region with allowance for the industrial and temperature spread.

Presently, there are batch-produced, inexpensive and reliable radiating elements based on semiconductor lasers. Their optical characteristics are identical to those of helium-neon lasers (l = 0.63 mm) and they can be effectively applied in medical practice [Marsagishvili L. et al., 1997]. It was evident that inconvenient helium-neon lasers would be replaced by more efficient semiconductor lasers. With this end in view, the researchers have performed experimental and clinical investigations since 1995 to show that semiconductor lasers produce the same therapeutic effect [Kapustina G. M. et al., 1995; Kapustina G. M. et al., 1996]. Apart from that, the designers actively developed an apparatus that could completely satisfy the physician’s requirements. Semiconductor lasers applied in cardiology were demonstrated to produce an identical effect to that of helium-neon lasers, which was reported at scientific conferences and in publications. The results obtained thus showed a promising application of 0.63-mm semiconductor lasers.

The «Technika» Firm developed «Mulat» LTAs (Fig. 8.27), which successfully passed technical and clinical trials. The small dimensions, low weight and non-grounding operation of these LTAs make it possible to apply them in treating both in-patients at wards and hard-to-transport patients at their homes. The feasibility of using these LTAs in ambulance cars for ILIB procedures makes fundamental changes in the provision of urgent medical care. Medical experts believe that «Mulat» LTAs will soon replace the existing helium-neon lasers in ILIB applications.

 

«Mulat» LTA performance specification

Number of channels in simultaneous action ……....

1

Radiation power indication ………………………..

Available

Radiation wavelength ……………………………..

0.63 mm

Average radiation power ………………………….

4.5 mW

Timer ……………………………………….……..

Automatic mode; 5 to 40 min

Radiation power adjustment …………………….

0 to maximal value

Mass ……………………………………………….

2.3 kg

Dimensions ……………………………………….

210 ´ 180 ´ 90 mm

Electrical safety class …………………………….

II, BF type (Grounding is not required)

Power requirements ………………………………

220 ± 22 V, 50 ± 5 Hz

Maximal power consumption …………………….

14 W

Operating mode stabilisation time ……………….

4 s

Climatic design ……………………………………

UKhL 4.2 according to State Standard ¹ 15150-69

Category temperature range ……………………….

+ 10 to +35°C

Transportation and storage temperature range ……

- 50 to + 50°C

Average non-failure time ………………………….

5,000 hours

 

The front panel of the «Mulat» LTA basic blocks includes a POWER switch, a START button, a lasing emitter, a potentiometer to adjust radiation power, a photodetector window, buttons to set exposure time and displays to show the parameters of laser radiation (Fig. 8.27). These LTAs also provide a plug-in light indication and audible and light indications of session’s start and end. The supplied accessories include a specific main light-guiding fibre and sterile disposable fibres with needles (Fig. 8.28).

Recommendations on equipping laser therapy rooms [Skobelkin O. K. et al., 1995]. The organisation and functioning of laser service in Russia has shown that it is extremely promising to create laser therapy departments within large general hospitals. In this case, laser therapy departments can offer centralised treatment to virtually all the patients of the hospital. The staff of these departments is appointed by the head physician of the hospital and it depends on the volume and complexity of laser therapeutic procedures. For example, an average laser therapy department for 60 beds should employ: a head of the department, 2 therapeutists, 6 hospital nurses, 3 orderlies and 1 engineer. Such a department should be equipped with 2 magnetolaser devices, 2 helium-neon lasers with the output power of more than 20 mW (or 2 semiconductor lasers with similar parameters), 4 «Mustang» type LTAs and 2 ILIB apparatuses. Sometimes, it is effective to simultaneously apply red and infrared therapies [Korochkin I. M., Babushkina G. V., 1995]. In this connection, the department should also possess an infrared radiating head.

 

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  84. Titov M. N., Moskvin S. V., Priezzhev A. V. Optimization of the parameters of biostimulator «Mustang» in respect to the light scattering properties of the tissues. Paper № U-2086-22, presented at the SPIE Symposium on Biomedical Optics (Europe’93), Budapest, Hungary, 1993.
  85. Titov M. N., Moskvin S. V., Priezzhev A. V., Zaguskin S. L. Role of biological rhythms in the formation of cell and tissue response on laser irradiation. Paper№ 2323/529, presented at the SPIE Symposium on Biomedical Optics (Europe’94), Lille, France, 1994.
  86. Tuner J., Hode L. Laser therapy in dentistry and medicine. Stockholm, Sweden: Prima Books, 1996, 236 p.
  87. Ussia G. Beneficial effects of CO2. LLLT in the Postoperative Period after Aesthetic Surgery. The Laser Barcelona International Congress, 1994, p. 37.
  88. Zaguskin S. L., Moskvin S. V., Titov M. N. Biocontrolled «Mustang» - a new direction in laser medicine. Laser-Inform, Issue 28, pp. 2-3, 1993.
 

· The application of lasers in dermatology is more thoroughly considered in the corresponding chapter of this monograph.

· The application of this technique in other medical fields is more thoroughly considered in Chapter: Low-intensity Laser-Radiation Therapeutic Methods.

 
 
 
 
 
 
 
 
 
 
 
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