EP2713930A1

EP2713930A1 - Personnel-safe in-body laser treatment system

Info

Publication number: EP2713930A1
Application number: EP12792594.9A
Authority: EP
Inventors: Wolfgang Neuberger
Original assignee: Biolitec Pharma Marketing Ltd
Current assignee: Biolitec Pharma Marketing Ltd
Priority date: 2011-05-28
Filing date: 2012-05-16
Publication date: 2014-04-09
Also published as: EP2713930A4; WO2012166361A1

Abstract

A safe, portable low power density, eye-safe, Class I system for in-body laser treatments is disclosed. One such device emits pulsed or continuous laser energy through an optical fiber from within a vessel. In a preferred embodiment, optical fiber and treatment part of body are enclosed within a protective case which protects patient and medical staff by preventing stray laser energy from being emitted beyond the protective case, in a preferred embodiment, a sensing system cuts off lasing energy when it detects backscattering from aiming beam corresponding to stray radiation when fiber is outside or nearly outside the body. In another embodiment, an introducer is temporarily glued to the entry point and acts as a switch when passed or when the fiber is close to it. Laser radiation is preferably emitted at a wavelength and power density such that accidental radiation of a person's eye causes virtually no damage. Described embodiments are applicable to medical conditions including but not limited to hysteroscopic gynecology, endoscopic urology, spinal surgery and otolaryngology.

Description

PERSONNEL-SAFE IN-BODY LASER TREATMENT SYSTEM

Inventors: Wolfgang Neuberger

Assignee: CeramOptec Industries Inc.

Background of the Invention

1. Domestic Priority under 35 USC 119(e)

This application claims the benefit and priority of U.S. Provisional Application Serial No. 61/491,179 filed May 28, 201 1, entitled "Personnel- Safe In-Body Laser Treatment System" by Wolfgang Neuberger, which is incorporated by reference herein.

2. Field of the invention

The present invention relates to minimally invasive treatments and in particular, to the treatment of vascular disorders by using local energy emitting devices and conveying means.

3. Prior Art Disclosure Statement

The blood vessels are the part of the circulatory system that transport blood throughout the body. There are three major types of blood vessels: the arteries, which carry the blood away from the heart, the capillaries, which enable the actual exchange of water and other substances between the blood and the tissues; and the veins, which carry blood from the capillaries back towards the heart.

The venous system comprises valves, whose main function is to achieve unidirectional blood flow back to the heart. Venous valves are usually bicuspid valves, with each cusp forming a blood reservoir, which force their free surfaces together under retrograde blood pressure. As a consequence, when properly operating, retrograde blood flow is prevented, allowing only antegrade flow to the heart. A valve becomes incompetent when their cusps are unable to seal properly under retrograde pressure gradient, so retrograde blood flow occurs. When retrograde blood flow occurs, pressure increases in the lower venous sections, dilating veins and usually leading to additional valvular failure.

Valvular failure, usually referred to as venous insufficiency, is a chronic disease that can lead to skin discoloration, varicose veins, pain, swelling and ulcerations. Varicose veins refer to blood vessels that have become enlarged and twisted and have progressively lost their wall elasticity. Due to the widening of the blood vessels, vein valves cannot be completely closed and veins lose their ability to carry blood back to the heart. This leads to an accumulation of blood inside the vessels, enlarging and twisting the veins even more.

i Furthermore, varicose veins usually have a blue or purple color and may protrude twisted above the surface of the skin, this being responsible for their characteristically unattractive appearance. They are commonly formed in the superficial veins of the legs, which are subject to high pressure when standing. Other types of varicose veins include venous lakes, reticular veins and telangiectasias.

There are a number of treatments available intending to cure these kinds of vascular pathologies. Some of them only consist in relief of symptoms but they do not treat varicose veins nor prevent them from forming. These include elevating the legs by lying down or using a footstool when sitting, elastic stockings and exercise.

Varicose veins are frequently treated by eliminating the insufficient veins. This forces the blood to flow through the remaining healthy veins. Various methods can be used to eliminate the problem of insufficient veins, including, sclerotherapy, surgery (vein stripping), electro-cautery, and laser treatments.

Laser treatments are usually preferred by those skilled in the art. Minimally invasive laser surgery has been improved due to new diode laser systems. In endovascular laser surgery, laser radiation applies thermal energy to the vein by means of an optical fiber, and while the fiber is withdrawn, the vein closes and, ideally, eventually disappears through resorption. In these and other cases, endovascular laser treatment provides an effective technique for eliminating or diminishing skin and vascular problems. A well known prior art describing endovascular laser ablation procedure includes the following steps: first, patient is usually anesthetized and placed in Trendelenburg position to partially drain blood from the legs. Second, a guide wire is inserted into the vein to be treated, with the help of an entry needle. Next, an introducer sheath is introduced over the guide wire and advanced to a treatment site. Then, the guide wire is removed leaving the introducer sheath in place. The optical fiber (coupled to a laser source) is inserted through the introducer sheath and positioned so that the emitting end at the distal tip of the fiber and the sheath are at the same point. Depending on type of fiber used, laser characteristics, and parameters applied, tumescent anesthesia may be used on the tissue surrounding the vein to be treated. Prior to lasing, the sheath is pulled back from the emitting end a distance sufficient to prevent the emitted laser energy from damaging the sheath. Then, the laser is fired to emit laser radiation into the blood and/or vein wall directly in front of the emitting face. Finally, while laser energy is emitted, optical fiber and introducer sheath are withdrawn together to treat and close a desired length of the vein. Laser energy is absorbed primarily by vein wall tissue in front of the distal tip. As a consequence, vein is thermally damaged, thus leading to fibrosis of the vein, which is resorbed after some time.

An example of an improved procedure rendering good results is described by US Patent Application Publication 2009/0240242 by Neuberger et al, which proposes a method and device for low power density endoluminal treatment of venous insufficiency using an optical fiber comprising an emitting end with a conical shaped tip for 360° radial emission.

Although treatment has rendered excellent results, there are a number of improvements desired by those skilled in the art to render such treatment safer without affecting effectiveness and if possible without considerably elevating cost of treatment. As laser energy is used, the possibility of accidental stray radiation reaching sensible parts of a patient or medical staff, particularly the eyes, can lead to serious injury of the affected person.

Currently used safety elements include laser goggles, a door interlock system, a footswitch or a tsandswitch and an emergency off button.

Protective laser goggles have an effective optical density around a wavelength that is specific for the laser wavelength being emitted, which reduces transmission of dangerous levels of radiation. Therefore, whoever wears protecti ve laser goggles designed for a specific wavelength range protects their eyes from laser radiation of that wavelength range. Door interlock systems can be connected to door of treatment room. Unit remains inoperative unless this interlock switch is closed. Therefore, if for example, someone without safety goggles on walks into the treatment room while laser is being emitted, then interlock system shuts off laser power. When a foot or hand switch is used, laser emits output radiation only as long as the user depresses the switch. Emergency off buttons are commonly large red easil accessible buttons that will instantly turn off power and shut down laser when pressed.

Mentioned safety elements still present limitations and may be insufficient under determined conditions. For example, in some places it is not uncommon that, even when strongly recommended by laser manufacturer, not everyone in the treatment room wears safety goggles, especially, medical staff who perform tasks not directly involved with treatment and who mistakenly feel they are safe from laser lesions. It is also not uncommon to see treatment rooms in which for different reasons, a door interlock system has not been installed and connected to room door.

Additionally, there is currently no disclosed safety mechanism that considers the possibility of fiber accidentally and inadvertently coming out of vessel while laser energy is being applied and therefore exposing everyone in the treatment room to danger of receiving stray radiation in sensible parts of the body. As previously mentioned, optical fiber is usually withdrawn as the insufficient vein is being irradiated, in order to cause obliteration along its length. This pullback movement can be carried out manually or by means of some automatic system. An example of the second case is described in U.S. Patent No. 7,524.316 B2 by Hennings et al., in which a motorized pullback system is described. In either case, the danger of fiber accidentally and inadvertently coming out of vessel while laser energy is being applied exists.

US patent 5,986,755 by Orni z et al. discloses a safety device for detecting elasticaliy scattered radiation comprising an excitation source of monochromatic radiation having a controllable output, a detector for detecting elasticaliy scattered radiation collected from a specimen illuminated by the excitation source, and a signal conditioning circuit that comprises a transducer and a comparator. An output transducer signal representative of the elasticaliy scattered radiation is compared with a predefined threshold signal. If the output transducer signal is less than the threshold signal, a control output signal coupled to the excitation source causes the output of the source to be reduced. The safety device is included with a Raman spectrometry apparatus. Thus device can be used to assess overtreatment of target tissue.

Laser systems classified as Class I by international standards are considered to be eye- safe and therefore do not require safety systems and controls previously mentioned.

For example, US Patent US 7758570B2 by Walmsley discloses a device for low level laser therapy to induce a non-heating photochemical reaction. Device proposed claims to be a Class I laser device by including a laser generating means for generating a laser beam, the laser generating means having an apparent source size and homogenizing means for modifying the apparent source size of the laser beam. Such system is limited to treatment of conditions like tendonitis and other soft tissue injuries, wound healing and pain relief, leaving out a wide range of existing laser medical applications including treatment of diseased leg veins. US Patent US7452356B2 by Groce et. al presents a dermatologic treatment apparatus which includes a housing configured for manipulation in a dermatologic treatment procedure, a light source, and an electrical circuit. The circuit energizes the light source to produce output light pulses. A light path includes an aperture through which eye-safe light pulses are propagated having properties sufficient for providing efficacious treatment. An optical diffuser is disposed along the light path to reduce the integrated radiance to an eye-safe level. Once again, mentioned device is limited in that it is applicable to a restricted small range of dermatologic treatments.

According to previously mentioned prior art, improvements are needed with respect to current vein treatments in order to enhance outcomes and render a safer procedure. Thus it would be beneficial to have a minimally invasive vascular treatment that improves on the state of the art, to enhance safety without affecting cost and efficiency of treatment over a broad range of applications. The present invention addresses these needs.

Objectives and Brief Summary of the Invention

It is an objective of the present invention to provide a device and method for improved in-body laser treatment of medical conditions.

It is another objective of the present invention to treat medical conditions accurately and safely, by using a localized, directed energy source and conveying means.

It is also an objective of the present invention to provide a device and method for safer, more reliable light medical treatments by preventing stray radiation from harming patients and medical staff.

Briefly stated, a safe, portable low power density, eye-safe, Class I system for in-body laser treatments is disclosed. One such device emits pulsed or continuous laser energy through an optical fiber from within a vessel part of the body. In a preferred embodiment, optica! fiber and treatment part of body are enclosed within a protective case which protects patient and medical staff by preventing stray laser energy from being emitted beyond the protective case. In a preferred embodiment, a sensing system cuts off lasing energy when it detects backscattering from aiming beam corresponding to stray radiation when fiber is outside or nearly outside the body. In another embodiment, an introducer is temporarily glued to the entry point and acts as a switch when passed or when the fiber is close to it. Laser radiation is preferably emitted at a wavelength and power density such that accidental radiation of a person's eye causes virtually no damage. Described embodiments are applicable to other medical conditions including but not limited to hysteroscopic gynecology, endoscopic urology, spinal surgery and otolaryngology.

The above and other objects, features and advantages of the present invention will become apparent from the following description read in conjunction with the accompanying drawings. Brief Description of Figures

FIG. 1 depicts a preferred embodiment of present invention describing main components the system disclosed.

FIG. 2 shows a diagram of an example of present invention applied for treatment of insufficient veins.

Figure 3 summarizes main steps involved in example of present invention applied for treatment of insufficient veins.

Figure 4 depicts a diagram of an example of present invention applied for treatment of benign prostate hyperplasia.

Detailed Description of Preferred Embodiments

The present invention addresses prior art disadvantages by assuring safe and economic, inside radiation treatment of body lumens by providing security measures to prevent the possibility of accidental stray radiation from reaching the patient or medical staff.

In a preferred embodiment, depicted in FIG. 1, device 100 is applied for laser treatment of in-body tissues. Optical fiber 102 comprising firing end 104 conveys energy from laser source 106. Optical probe 102 is inserted through entry port 108 with or without the help of an entry needle (not shown). Laser is fired to emit electromagnetic radiation into target tissue directly in front of emitting face 104. Before laser energy is emitted, area is enclosed within protective case 110 so that if fiber tip 104 is accidently and inadvertently set loose from entry port 108, protective case 110 prevents stray radiation from reaching people present at the time. Treatment reproducibility is enhanced with this procedure, and negative consequences of human errors are highly minimized.

In another preferred embodiment, a safety system is incorporated which senses an interaction between ablation energy and aiming beam. Sensing system measures back- scattering from aiming beam and senses a difference on signal when fiber is outside or inside the body and cuts off lasing energy when fiber is outside the body.

In another preferred embodiment, there is a sensor inside introducer sheath which detects the presence of optical fiber. Introducer is glued to the entry point and acts as a switch when fiber passes through it. Thus, radiation emission can be allowed or inhibited according to sensor signal. Variants may include but are not limited to, sensors of position, direction of movement, presence of radiation, or a combination of these. As a consequence of any or all of mentioned safety features, treatment reliability and safety are greatly enhanced.

Radiofrequency, microwave, thermal and other energy sources may also be used to reliably and control 1 ably perform the task and the method described, provided suitable enhancers and/or imaging means are used.

Present invention possesses a number of features that prevent injury to the unprotected eye, either by preventing occurrence of stray radiation or by applying radiation parameters such that power density of stray radiation is insufficient to cause harm. Therefore many treatments can benefit from present invention. Preferred embodiments of the present invention may be employed to treat different anatomical structures in areas of the body which may be affected by diverse pathologies. The following embodiments describe treatment of different medical conditions in which one or more aspects of present invention are useful to assure a safe and effective procedure.

Diseased vessels such as insufficient vessels are often treated by applying energy endoluminally to affected vessel walls or vessel valves. For instance, optical fiber is inserted through entry port and laser energy is fired to emit electromagnetic radiation into vessel wall directly in front of emitting face. Before laser energy is emitted, area is enclosed within protective case so that if fiber tip is accidently and inadvertently set loose from vessel, protective case prevents stray radiation from reaching people present at the time. Alternatively or additionally, safety system is incorporated which senses an interaction between ablation energy and aiming beam. Sensing system measures back-scattering from aiming beam and senses a difference of signal when fiber is outside or inside vessel and cuts off lasing energy when fiber is outside the vessel.

Procedures involving photodynamic therapy (PDT) can be performed safely with present invention. For PDT treatments the emitted laser radiation has a wavelength which is able to activate an exogenously administered photosensitizer or an endogenous photoactive substance. With present invention, before laser energy is emitted, area is enclosed within protective case so that if fiber tip is accidently or inadvertently aimed away from target, protective case prevents stray radiation from reaching people present at the time including damage to the patient^'s normal tissue at or around entry site.

Hysteroscopic gynecology includes using a hysteroscope to gain access to the uterus and associated areas, wherein energy is applied within uterus to treat rayomas, polyps, adhesions, and endometriosis. Safety system is incorporated which senses an interaction between application/treatment energy and aiming beam. Sensing system measures back- scattering from aiming beam and senses a difference of signal when fiber is outside or inside the uterus and cuts off lasing energy when fiber is outside the uterus.

Endoscopic urology is another field in which energy is applied internally to tissue to treat conditions such as benign prostatic hyperplasia (BPH) and therefore present invention contributes to assure safe treatment. At present, the preferred treatment of BPH by those skilled in the art is to insert a catheter through the urethra and to apply light energy to eliminate excess of prostate tissue. With present invention, before laser energy is emitted, area is enclosed within protective case so that if fiber tip is accidently or inadvertently set loose from urethra, protective case prevents stray radiation from reaching people present at the time including damage to the patient's normal tissue around or near catheter entrance/exit site. Alternatively or additionally, safety system is incorporated which senses an interaction between ablation energy and aiming beam. Sensing system measures back-scattering from aiming beam and senses a difference of signal when fiber is outside or inside the urethra and cuts off lasing energy when fiber is outside the urethra.

Percutaneous laser disc decompression (PLDD) is another minimally-invasive medical procedure that uses a laser beam to treat back and neck pains caused by a herniated disc. This is achieved by passing a laser probe into specific regions of a lumbar or cervical disc under X- ay control and directing energy at the degenerate tissues to eliminate unwanted, excess disc material, reduce inflammation in the disc and to reduce pressure upon nerves passing over the disc protrusion. With present invention, before laser energy is emitted, area is enclosed within protective case so that if fiber tip is accidently or inadvertently set loose from body, protective case prevents stray radiation from reaching patient, medical staff members or any other person present at the time.

Otorhinolaryngologists use laser systems for many conditions of the ear, nose and throat. Some examples are problems of the voice box, throat, mouth, nose and ear, nodules or polyps on the larynx, blood vessel defects in the upper airway and otosclerosis in the middle ear. With present invention, before laser energy is emitted, area is enclosed within protective case so that if fiber tip is accidently and inadvertently set loose and aimed outside of target body lumen, protective case prevents stray radiation from reaching patient, medical staff members or any other person present at the time.

The present invention is further illustrated by the following examples. Example 1

Figure 2 depicts device 200 applied for laser treatment of insufficient vessel XXX. Optical fiber 202 comprising firing end 204 conveys energy from laser source 206. Optical fiber 202 is inserted through entry port 208 with the help of an entry needle (not shown). Laser is fired to emit electromagnetic radiation into target tissue directly in front of emitting face 204. Before laser energy is emitted, area is enclosed within protective case 210 so that if fiber tip 204 is accidently and inadvertently set loose from entry port 208, protective case 210 prevents stray radiation from reaching people present at the time. Treatment reproducibility is enhanced with this procedure, and negative consequences of human errors are highly minimized.

Figure 3 depicts a preferred embodiment of present invention describing the main steps of the procedure disclosed in Fig. 2. Positioning is preferably done with the help of ultrasound imaging. First, a guide wire is inserted into the vein to be treated, with the help of an entry needle. Second, an introducer sheath is introduced over the guide wire and advanced to a treatment site. Then, the guide wire is removed, leaving the introducer sheath in place. Under echographic guidance or by direct vision of aiming beam through skin, the optical fiber (coupled to a laser source) is inserted through the introducer sheath and positioned so that the emitting end at the distal tip of the fiber and the sheath are at the same point. At this point, protective case is placed over leg such that entry point is completely covered by case. Prior to lasing, the sheath is pulled back from the emitting end a distance sufficient enough to prevent the emitted laser energy from damaging the sheath. Then, laser is fired to emit laser radiation into the blood and/or vein wall in the vicinity of emitting tip. Finally, while laser energy is emitted, optical fiber and introducer sheath are withdrawn together to treat and close a desired length of the vein. If, at any moment, laser energy is being emitted outside patient's leg due to, for example, optic fiber being accidentally disconnected from vessel while energy is being emitted, then this laser energy is absorbed within protective case. Laser energy is absorbed by the blood and/or vein wall tissue. As a consequence, vein is thermally damaged, thus leading to fibrosis of the vein, which is resorbed after some time.

When laser radiation is used to apply energy to the vessel, different wavelengths can be chosen. Laser wavelength is chosen, in the present case, according to the desired penetration depth in tissue. It has been found that a wavelength that is essentially absorbed within less than a millimeter fits best the actual dimensions of the vessel wall's thickness. In a preferred embodiment, wavelength of approximately 1470 ± 60nm is used. However, other wavelengths can be used including but not limited to 980 ± 30nm, 1050 ± 40nm 1950 + 50nm.

In another preferred embodiment, a 360-degree radial emission fiber such as the one disclosed in US Patent Application Publication 2009/0240242 by Neuberger et al mentioned in prior art, is used to carry out the procedure previously explained. Radial emission by this fiber is basically in a torus shape which is not only very efficient, but also minimizes power density applied in any given point in case of accidental stray radiation. In other preferred embodiments, optical fibers with different fiber tip configurations are employed. Variants include but are not limited to side emitting fibers, off-axis emitting fibers and direct emitting fibers.

The proper combination of wavelength and maximum radiation power applied, plus the fact that a 360-degree radial emission fiber is used, allows for a minimum power density of potentially stray radiation. For example, stray radiation of 15 W at a wavelength of 1470 nm or 2 W at a wavelength of 980 nm would be virtually harmless to the unprotected eye of someone present in the treatment office; i.e. greater than an arm's length (approximately 45 cm) from the emitting end of the active system. Additionally, when using a bare fiber with a numerical aperture of 0.48 NA, for example, a stray radiation of 7 W at a wavelength of 1470 nm or 1 W at a wavelength of 980 nm, or 1.5 W at a wavelength of 1050 nm would all be eye-safe treatment combinations for persons present in the treatment room.

As device has limited energy density values, low power allows for use of fibers with diameter as small as 220 & 360 μ. The use of less expensive, smaller diameter fibers reduces the cost of procedure.

Example 2

The preferred treatment of Benign Prostate Hyperplasia (BPH) by those skilled in the art is laser ablation of undesired tissue in which light is used to eliminate excess of prostate tissue either by ablation (vaporization), thermal coagulation or a combination of both these mechanisms. In a preferred embodiment for BPH procedures, depicted in Figure 4, an off- axis optic fiber 402, is used to convey laser radiation from laser source 406 to enlarged prostate tissue 412. In order to treat hyperplasic prostate 412, optic fiber 402 is directly inserted into urethra 414. Technique involves delivering high amounts of power, which means a potential dangerous situation if for example radiation is accidently emitted outside the urethra 414. A safety system 416 is incorporated which senses an interaction between ablation energy and aiming beam. Sensing system 416 measures back-scattering from aiming beam and senses a difference of signal when fiber tip 402 is outside or inside the urethra 414 and cuts off lasing energy from laser source 406 when fiber is outside the urethra 414. Having described preferred embodiments of the invention with reference to the accompanying drawings, it is to be understood that the invention is not limited to the precise embodiments, and that various changes and modifications may be effected therein by skilled in the art without departing from the scope or spirit of the invention as defined in the appended claims.

Claims

What is claimed is:

1. An eye-safe device for treatment of anatomical structures in a mammal with radiation- transmission means, having security means to prevent accidental/stray radiation from reaching patients or medical staff present.

2. An eye-safe device for treatment of vessels in a mammal wherein a treatment source delivers energy to inside walls of said vessel through an energy-transmission means coupled to an energy source and wherein accidental/stray radiation is limited within an area out of reach from people present in the procedure room.

3. The device for treatment of vessels according to claim 2, wherein treated anatomical portion is surrounded by a protective case whose interior absorbs stray radiation.

4. The device for treatment of vessels according to claim 2 further comprising means to detect stray radiation and means to diminish or suspend radiation when said stray radiation is detected.

5. The device for treatment of vessels according to claim 2 further comprising means to detect a disconnection of said energy-transmission means from said inside walls of said vessels and means to diminish or suspend radiation when said disconnection is detected.

6. The vessel treatment system according to claim 2, wherein said energy source is selected from the group of light sources, RF sources, MW sources and thermal sources.

7. The vessel treatment system according to claim 2, wherein said energy source is a light source and said energy transmission means is at least one optical fiber.

8. The vessel treatment system according to claim 2, wherein said distal end of said energy-transmission means is positioned in said vessel section to be treated, so as to be off axis and structured so as to output energy directly at said vessel's wall, such as a off-axis firing fiber including side firing fibers, a twister fibers, radial tip fibers, and direct firing fibers.

9. An eye-safe treatment of vessels in a mammal, wherein a treatment source delivers energy to inside walls of said vessel through an energy-transmission means coupled to said energy source including steps to prevent accidental stray radiation from reaching patients or medical staff present.

10. The treatment of vessels according to claim 9 comprising the steps of:

(a) introducing at a preselected entry site said coupled energy- transmission means into a vessel to be treated;

(b) advancing said coupled energy-transmission means to a treatment site within said vessel;

(c) placing a protective case over said entry site to minimize ability of treatment energy to exit freely from said entry site;

(d) emitting radiation into said vessel to be treated.

1 1. The treatment of vessels according to claim 10 wherein said protective case is placed over leg such that entry point of an optical fiber is completely covered by said case.

12. The treatment of vessels according to claim 10 further comprising the step of placing sensors inside introducer sheath that detect stray radiation.

13. The treatment of vessels according to claim 2 further comprising the step of ceasing radiation emission when said sensors detect said stray radiation.

14. The treatment of vessels according to claim 10 wherein said radiation is an eye-safe, low density laser radiation.

15. The treatment of vessels according to claim 14 wherein said eye-safe, low density laser radiation is selected from the group of:

radial emission of 1470 nm wavelength at a maximum power of 15 W,

radial emission of 980 nm wavelength at a maximum power of 2 W,

axial emission of 1470 nm wavelength at a maximum power of 7 W, axial emission of 980 nm wavelength at a maximum power of 1 W, and axial emission of 1050 nm wavelength at a maximum power of 1.5 W.

16. The eye-safe treatment device according to claim 1, wherein said security means allows for eye-safe medical procedures selected from the group consisting of photodynamic therapy treatments, hysteroscopic gynecology, endoscopic urology, percutaneous laser disc decompression and otorhinolaryngologic treatments.

17. A Class I medical laser device system for use in medical procedures selected from the group consisting of diseased leg vein treatments, hysteroscopic gynecology, endoscopic urology, percutaneous laser disc decompression, otorhinolaryngologic treatments and photodynamic therapy treatments.