AU602123B2 - Optical therapeutic and surgical system - Google Patents

4- 662123 _NT

OFFICE

7764 6 Cllsafor of Public Monmys 4.

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AUSTRALIAN

ONB

1 9 MAY 1986 PATENT OFFICE.

7 6- 4r.

APPLICANT:

NUMBER:

MONARO RESEARCH LABORATORIES PTY LTD PH 00625.; PH 01124 and PH 01108 FILING DATE: 17 MAY 85 20 JUN 85; 19 JUN FORM 101 COMMONWEALTH OF AUSTRAL The Patents Act 1952 This docuiment contains the amendments made under Section 49 and is correct for printing COMPLETE SPECIF'ICATION FOR AN INVENTION ENTIT[LED: OPTICA,- THERAPEUTIC AND SUROICAL SYSTEM The following statement i8 a full. description of this invention, including the best method of performing it known to me: 1. 1 SDeclared at c~4 this 27 day of e c-7 198 6.

(Signature of Declarant) TO: THE COMMISSIONER OF PATENTS .1

ABSTRACT

This invention relates to a system for the therapeutic and surgical treatment of human and animal patients consisting of coherently pulsed arrays of optical fibre bundles used for delivering the laser beams onto the skin and organs of the patients and to observe the effects of such treatments for a variety of output beam configurations.

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AUSTRALIAN

ONB

S9 MAY 1986 PATENT OFFICE 02 FIELD OF THE INVENTION This invention relates to a system for therapeutic and surgical treatment of human and animal bodies over a wide range of wavelengths from the deep ultra-violet to the near infra-red regions of the electro-magnetic spectrum utilizing both coherent and incoherent light o to stimulate and observe said bodies said inventMiTRALIAN

ONB

consisting of a laser beam generator, lmser beam 1 MAY 1985 Soptical fibre bundle delivery system, laser beam PATENT OFFICE a 4W 10 focussing attachments, skin and internal body organ So optical viewing attachments, coherently packed optical fibre bundle viewing system, image processing modules, optical data storage and viewing modules and safety enclosures for the laser beam treatment of patients.

15 The invention has applications for the therapeutic treatment of a patient's skin and allows for detailed recorda of the treatment of microscopic areas of skin for full analysis. The invention is particularly useful in skin treatments on, or in the vicinity of, acupuncture points. The invention has application for scalp massage and stimulation and can be used to remove unwanted hair by directing a laser beam along said hair destroying its root. The invention can also be used to remove blemishes and other skin and body ailments. By increasing the laser beam powers beyond the levels normally used for therapeutic treatments, the invention r r 03 can be used for the treatment of skin and organ disorders both in and below the surface of said skin.

In the high power mode, the invention has applications in opthalmic surgery for the removal of secondary cataracts and for the treatment of eye disorders including eye tumours. The invention has application in therapeutic treatment including acupuncture where the needle is replaced by a focussed laser beam and the St itirradiation of acupuncture points is accomplished via 10 the spatial and intensity modulation of said laser beam I

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at different wavelengths. The invention has applications in all aspects of surgery where the j I *operations can be carried out within sterilised enclosures with full manipulation capabilities for ,i i& 15 light knife, light coagulator and therapeutic heads, either manually for critical incisions or automatically for less critical manipulations.

SUMMARY OF THE PRIOR ART Laser based therapeutic and surgical systems are well known in prior art as are optical fibre based endoscopes for viewing internal body organs. Prior art systems also utilize single optical fibres to deliver laser beam energies along the inside of human arteries to remove substances clogging up said arteries, said process being viewed via an optical fibre endoscope by injecting water to clear the blood away from the 04 constricted region of said artery during the operation.

Prior art systems exist for delivering laser beam energy for opthalmic treatments along optical fibres with the opthalmologists directing the procedure via a microscope. Prior art systems exist for delivering laser beam energy for surgical operations along optical fibre bundles but these have been limited due to the poor quality of the laser beam emerging from said 1,0 optical fibres and the severe limitations placed on the use of optical fibre bundles regarding the laser power levels that can be transmitted by these devices, particularly pulsed power where damage thresholds have t' •been experienced at the megawatts per pulse level.

15 Also, a severe limitation regarding the availability of laser beam power in regions of the electro-magnetic spectrum corresponding to the transmission characteristics of optical fibre bundles, the tendency being to use the much larger wavelength carbon dioxide laser beam outputs delivered along complex articulated arms in prior art surgical laser systems. Prior art laser and optical fibre beam delivery systems for the treatment of skin blemishes have on the one hand consisted of low power helium&-neon lasers to simulate acupuncture needles for the treatment of acupuncture points, and pain relief, argon d -1 U lasers for the removal of birthmarks and dye and metal vapour laseL for photo-radiation therapy. These prior art laser and optical fibre beam delivery systems have been used, therefore, for skin stimulation, removal of skin blemishes and the treatment of skin disorders in the form of tumours. Prior art systems for viewing the human body via the heat emitted by the skin have included thermographic units operating in the temperature range 2.6 microns to about 20 microns with 10 particular emphasis on the regions 2.6 to 5.6 microns S. and 8 to 14 microns. However, prior art thermographic views have surveyed the heat patterns of the body as a whole with particular emphasis on repetitive strain I injuries which are reputedly observable S\ 15 thermographically. The present invention differs from prior art laser, optical and thermographic medical Ssystems in that it provides means for the precise and controllable stimulation of microscopic areas of skin and means of observing and recording the results of said laser beam stimulation in real time from the deep ultraviolet to the far infra-red regions of the electromagnetic spectrums, that is from about 0.25 microns or 250 nanometers optical wavelength to 14 microns or 14,000 nanometers.

Specific tasks that can be accomplished with the present invention which are beyond the capabilities of _i -i 06 prior art laser systems include the recording of the heat pattern around a laser beam stimulated acupuncture point, the stimulation of acupuncture points with spatially and intensity modulated laser beams, the electror-optical scanning of microscopic regions of the human skin to locate skin blemishes and hair ends, the I t, precise delivery of laser beam energy to said located t blemishes and hair ends, and the recording of detailed t results of such laser beam treatments.

BACKGROUND OF THE INVENTION S The stimulation of selected regions of the human skin has been practised since ancient times in China and is known as acupuncture therapy involving the use of needles which are inserted into regions of the body S 15 known as acupuncture points. To increase the effect of the needle inserted into the acupuncture point, it is mechanically vibrated.

The known acupuncture points on the human body are difficult to locate, the prior art technique being to locate a change of skin resistance to an electrical current due to variations in moistur levels, the device being commonly referred to as a "point locator".

The other technique used by acupuncturists is one of trial and error relying on the best response from the patient. Although, acupuncture treatments are not practiced in the main avenues of medicine, even in

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China, a large number of acupuncturists practice their art throughout the world making the field one of the most financially rewarding in the therapeutic disciplines in the world today.

During the 1960's, it was realised that laser beams were the light equivalent of the mechanical needle, being able to illuminate very small areas of the skin's surfaces. Furthermore, as mechanical needles were vibrated to improve the therapeutic effect in acupuncture, so could the light beam be modulated to vary its intensity. The present invention introduces another type of light vibration, namely, spatial modulation whereby the laser beam focus is reduced and enlarged around the acupuncture point allowing for bot i 15 a new type of skin stimulation and the scanning of said skin to precisely locate areas of blemish.

One of the major problems with acupuncture therapy is the fact that nobody knows what an acupuncture point looks like if such an entity exists at all on the human skin. Although the present invention is not claimed to be an acupuncture point locator, it does provide the acupuncturist, for the first time, with a means to observe the human skin on a microscopic scale, locate any blemishes which show up optically or thermographically, that is in the range 250 nanometers to 14,000 nanometers, precisely irradiate a selected WWI, 08 microscopic skin area with laser light and then record the effect of said laser beam irradiation in detail.

The problem of unwanted hair the human skin is the basis of an industry akin to that associated with hair growth, except that the result of hair removal is beyond doubt, at least until a new root may form and the unwanted hair grows again. Prior art techniques of hair removal range from very crude forceps extraction to sophisticated chemical treatments. The present invention provides a new approach to the method of removing unwanted hair, namely, the location of said unwanted hair on the human skin and the directing of an v intense laser pulse along said located hair in the manner of an optical waveguide, said laser light pulse tit 15 being absorbed by the root of said hair destroying it in the process.

For the treatment of skin blemishes such as birthmarks or tumours, the invention, for the first time, provides structural details of said blemishes "OW 20 when using laser beams so that the "hit and miss" macroscopic approach of prior art is replaced by the microscopic precision of structural location, laser beam irradiation and the detailed recording of the results in a two and three dimensional format.

Surveying the surface of human skin on the microscopic scale optically has been carried out using microscopes.

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;ri I~C-LL~ Unfortunately, microscopes are unweildy instruments and cannot be made compact enough to be held in the therapist's hand whilst the skin is studied. The present invention allows the therapist a compact, portable hand piece which provides for the survey of the skin, the results of which are displayed on television monitors after image processing, the laser beam irradiation of selected sites and the detailed i observation and recording of the results. These tasks are achieved via dedicated optical and infra-red fibre bundles, and optical scanning techniques in the hand-held piece, connected to signal processing, display recording units and laser beam generators. Use is made of charge couple device cameras to fully h, 15 digitize the images, OBJECTS OF THE INVENTION It is an object of the invention to provide means of surveying microscopic sections of skin in both two and three dimension, format, illuminate the selected area with spatially and inteisity modulated laser light over a range of wavelengths, then observed the effects of such laser beam treatment over the spectral range from 250 nanometers to 14,000 nanometers across the electromagnetic spectrum using optical and thermographic imaging apparatus.

Another object of the invention is to display, thermographically recorded skin moisture patterns so that regions of high and low electrical resistance of said skin can be determined without the use of electrical current conducting electrodes having to be placed on the patient's body.

Another object of the invention is to provide means of optically scanning areas of the patient's skin to locate the cut ends of unwanted hairs so that the apparatus can then be used to direct a laser beam along said located hairs, under the surface of the patient's j skin down to the hair root, destroying said root in the process.

Yet another object of the invention is to provide Idetails of the structure of skin blemishes such as birth marks or tu-ulours so that laser beams of adequate power can be directed onto the appropriate part of said blemish so as to provide the best possible chance of destroying said blemish, the results of such destruction being recorded in microscopic detail both optically and thermographically.

It is an object of the invention to pr~ovide the therapist with a hand~held instrument which provides for the survey, treatment, display and recording of skin abnormalities on, remotely located instruments., Another object of the invention is to provide an optical fibre bundle composed of arrays of fibres of 44 11 different diameters so that the same scene can be viewed at different wavelengths in the range 250 to 14,000 nanometers.

Another object of the invention is to provide optical fibre bundle ends of different configuration so that unfocusped, convergent and divergent beams of light oan emerge from said ends.

Another object of the invention is to provide arrangements of fibre ends so that the profile of a skin blemish can be recorded in three dimensions.

Yet another object of the invention is to provide an opthalmic instrument for the removal of secondary cataracts and internal eye tumours using a hand-held instrument rather than the unwieldy slit lamps of prior art.

Another object of the invention io to provide means of treating skin or tissue layers internal to the patient's body.

Yet another object of the invention is to provide means of treating the patient without the release of intense laser light from the apparatus e"i~he4 by shielding the output end of the hand -held appavatus or by enclosing the patient's body within said apparatus.

BRIEF DESCRIPTION OF THE DRAWINGS A better understanding of the Invention may be obtairied from the following deseription taken ib 12 conjunction with the figures which are not meant to liii the scope of the invention in any way.

Figure 1 shows the layout of the invention with a common optical-infra red fibre bundle connecting the handheld probe to a series of optical and infra-red surveying, display and recording instruments and a laser beam generator.

L* Figure 2 shows the schematic layout of the optical S' and infra red fibres in the hand piece where the 10 optical survey and laser beam transmission occurs through one section whilst the infra-red recording is accomplished via the other section.

tFigure 3 shows a schematic of the hand piece of t the invention with the optical and infraired fibres all St" 15 mixed up together.

Figure 4 shows the layout of the hand piece when used for hair location and removal and for opthalmic surgery. The broad field of view is provided by the larger, outer optical fibre bundle and associated lens whilst the narrow field of view and laser beam delivery is accomplished vi4 the higher tesolution central optical fibre bundle and lens. The positioning of the lenses relative to said hairs or eye cataracts is achieved by sliding the optical assembly relative to the caSinG of the hand piece.

Figure 5 shows a schemat.c of the optical fibre 1 ,i arrangement of the hand piece when the fibres are arranged in concentric circles within tubular holders which can slide relative to each other.

Figure 6 shows a cross -section of the system shown in Figure 5 where each concentric rinc of optical fibres and its associated annular or circular lens can be positioned relative to each other so as to record a Sthree dimensional structure of a skin blemish.

Figure 7 shows a schematic of a patient undergoing S"s 10 laser therapeutic treatment in a totally enclosed environment utilizing the present invention in a form of a whole or part ring emitter which scans the said patient's body.

DETAILED DESCRIPTION OF THE DRAWINGS 15 In Figure 1, numeral 1 indicates a visible laser beam generator and numeral 2 indicates an infra-red rti laser beam generator whose output wavelength exceeds two microns metching the established thermographic recording bands of 2 to 6 microns and 8 to 14 microns respectively. Numerals 3 and 4 indicate the visible and infrared laser beam fibre delivery system respectiively with the infraured transmitting fibres being either crystalline or fluorine based glasses.

Numerals 5 and 6 indicate optical and infra-red wavelength beamasplitters respectively, inserted into .:bre bundles 3 and 4 respectively so as to reflect Ai 14 of the return signal from the maximum number of fibres possible for image analysis. Numerals 7 and 8 respectively indicate the transmission and reflection-recording paths of the optical and infra-red bundles of fibres. Numerals 9 and 10 indicate the point where the optical and infra-red fibre bundles are packed together into a single bundle which connects the laser generators and recording instruments to the hand-held piece. Numeral 11 indicates the output end of the composite fibre bundle whilst numeral 12 indicates the composite lens system needed to focus both the visible and infra-red light paths onto the surface of I the patient's skin indicated by numeral 13. Numeral 1 indicates the outer casing of the handheld piece.

Numeral 15 indicates an optically transparent fluid line through which fluid is pumped via the generator and indicated by numeral 16.

SNumeral 17 indicates the visible recording path from bundle 7. Numeral 18 indicates the recording camera of the visible image, numeral 19 the visible image display monitor whilst numeral 20 indicates the video recorder.

Numeral 21 indicates the infra'red, thermographic observation and recording path with the thermographic camera and image processing equipment indicated by numeral 22. Numeral 23 indicates a colour video monitor for observing the thermographic image whilst numeral 24 indicates a video recorder.

In Figure 2, numeral 25 indicates a central distribution of optical fibres whilst numeral 26 indicates a concentric distribution of infra-red optical fibres. Numeral 27 indicates the casing of the hand piece of the invention which protects fibre t bundles 25 and 26 and provides a convenient means for r "Il the therapist to manipulate the output and recording f 10 head of the invention. In Figure 3, numeral 28 indicates the output crossysecticn of a large diameter infraLred fibre whilst numeral 29 indicates the cross-section of the much smaller visible light conducting fibres. It should be noted that both the S 15 visible and infra-red fibres are mixed up.

In Figure 4, numeral 30 indicates a hair embedded in the patient's skin indicated by numeral 31. Numeral 32 indicates a precisely focussed laser beam, focussed by the lens indicated by numeral 33 onto the cut hair 30. Nuieral 34 indicates the optical fibre bundle through which the laser beam used to destroy the hair is propagated and the hair is viewed via a narrow field of view.

Numeral 35 indicates an annular lens through which, in conjunction with optical fibre bundle indicated by numeral 36, the surface of skin 31 is 16 viewed through a wide field of view so as to determine the presence of hairs 30 and said skin 31. Numeral 37 indicates the tube containing the optical fibre bundles 34 and 36 which can be moved relative to the outer hand piece casing indicated by numeral 38. This allows the lenses 33 and 35 to be accurately positioned .orelative to hair 30 utilizing the instrumentation shown ow~o 4r •u in Figure i, in this case those corresponding to the 0 4 visible portion of the electromagnetic spectrum.

oo 10 In Figure 5, numeral 37 indicates the casing rr holding the optical fibre bundles which can be positioned within the outer casing indicated by numeral 38 relative to the patient's skin surface indicated by rk 4 64numeral 31. Numeral 39 indicates a series of concentric, annular fibre bundles each contained within a tubular jacket indicated by numeral 40, said jackets being movable with respect to each other so that Soutput annular lenses 33 can be stepped relative to each other. In this way the output piece of the invention can be used to survey skin blemishes in three dimensions because the profile of said blemishes can be determined via image processing in the recording instrumentation of the invention shown in Figure 1. If the concentric tubes 40 are positioned relative to each other so that the stepped output lenses 33 form a convex surface then the probe can be used for divergent process being viewed via an optical fibre endoscope by injecting water to clear the blood away from the 17 beam illumination with the illuminating angles depend ant in the relative positions of lenses 33 along the said convex surface. The convex output distribution has particular application in the illumination of skin internal to the patient's body. In Figure 7, numeral 41 indicates the patient undergoing laser therapy within the enclosure indicated by numeral 42 when tt !positioned in the bench indicated by numeral 43.

t 1 Numeral 44 indicates the concentric bundles of o t, 10 optical fibres connected to the instrumentation of 4« Figure 1 and terminating in the ring distribution indicated by numeral 45 which surrounds the patient 41.

The output beam from ring array 45 is indicated by numeral 46 and its beam width distribution can be S" 15 changed simply by passing the laser beam in sequence through the res., ctive concentric optical fibre bundles 44.

Alternatively, the spatial scanniig of the patient can be achieved by utilizing a composite fibre bundle 44 of the type shown in Figure 3 with each set of fibres being of increasing diameter relative to each other so that the output beam diameter from aperture will be variable with the smallest fibres giving rise to the largest beam diameter 46 whilst the widest diameter fibres would prov(:e the smallest beam spread on beam 46. Numeral 47 indicates the to and fro motion 18of aperture 45 that can be achieved relative to the patient 41.

The invention has application for the therapeutic treatment of both human and animal patients. By increasing the laser beam powers transmitted through the optical fibre delivery system, the invention can also be used for surgical and opthalmic applications.

For example, if the hair 30 in Figure 4 is replaced by the human eye, then the configuration of the invention shown in Figure 4 becomes a powerful opthalmic surgical instrument which eliminates the need for microscopes since the handrheld piece can be placed directly over the eye and the target in the eye, be it secondary cataracts or tumours, can be observed via the instrumentation of Figure 1.

To recapitulate, broadly this invention provides a system for the therapeutic and surgical treatment of selected parts of human and animal bodies over a wide ran/e of wavelengths extending from the ultra-violet to the infra,-red regions of the electromagnetic spectrum comprising laser beam generators emitting laser beams ranging from the infra-red into the visible and through into the ultra-violet regions of the electromagnetic spectrum with at least one infra-red laser connected to a coherently packed optical fibre bundle beam delivery system operating in the infra-red region, at least one visible or ultra-violet laser connected to a coherently present invention which are beyond the capabilities of i

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19 packed optical fibre bundle beam delivery system operating in the visible or ultra-violet region, the output end of the said optical fibre bundles having laser beam focusing and viewing lenses, the rput end of the said optical fibre bundles having beam splitter means to which infra -red and visible or ultra-violet image processing modules are respectively connected, infra-red and visible or ultra-violet optical storage and viewing modules are respectively connected to the processing modules, allowing an operator of said system to place the output end of the said optical fibre bundle beam delivery system which can be hand-held, to direct said laser beams onto selected parts of the patient's body and then allow the viewing of the said selected parts using the viewing module whilst carrying out the treatment.