Medical device and system including such device

Abstract

The present invention relates to a medical instrument with a free distal end intended to penetrate tissue and a proximal end connectable to a light source, characterized in that the instrument comprises a tubular support in which at least one light guide is mounted for a substantially frontal emission of light by the light guide via a first optical outlet, the instrument comprises at least one optical deflection means for light forming a second optical outlet for deflected emission of light, the instrument comprising at least one machining operation on the distal part of the instrument, and at least one reflective and / or concave polishing configured for light convergence and a reflective and / or convex polishing configured for light divergence, the polishing operation being performed on the light guide and / or on the support.

Description

[Technical field]

[0001] The present invention relates generally to the field of light therapy instruments, and in particular to an intravenous laser that can be used to treat varicose veins. This technology can be applied in industrial environments, especially in food, dentistry and veterinary medicine. In addition, the present invention is not limited to intravenous treatment, but can relate to various types of surgical procedures, such as conization, or any other procedure that requires a tool that allows both cleaning and / or destruction and photocoagulation. Similarly, the present invention provides a novel solution for lasers, and in particular CO2 lasers, but is not limited to lasers, and covers various types of light at various wavelengths. [Background technology]

[0002] Surgical procedures requiring cleaning and / or destruction are often costly and time-consuming, especially since they generally require anesthesia. Moreover, they produce scars, especially due to the fact that tissues are not always easy to coagulate. In this context, it is interesting to propose tools that facilitate cleaning and / or destruction and improve the possibilities of photocoagulation.

[0003] More recent techniques for vascular sclerosing, in particular the treatment of varicose veins, such as the technique disclosed in US Patent Application Publication No. 2003 / 0078569, are less invasive for the patient, but nevertheless require catheter introduction preparation, operator dressing, sterile draping, extensive disinfection, and complex handling in the operating room. They also use long and expensive optical fibers. In addition, the technique requires the injection of anesthesia products that may have undesirable effects, e.g. allergies. This is the case for traditional sclerosing in medical procedures, which use chemical sclerosing agents.

[0004] US Patent Application Publication No. 2005 / 0131400 details a device for transmitting a laser in an optical fiber, the end of which passes through a catheter for insertion into a blood vessel. The laser beam scattered at the end of the optical fiber in the vein serves to treat varicose veins by acting on the endothelial cells of the vein wall and the entire vein wall, the effect being thermomechanical. However, such a device does not optimize light diffusion during peripheral treatment of the wall of the blood vessel.

[0005] WO 2007 / 104836 A1 teaches a tubular support such as a needle, in which there is a light guide such as an optical fiber, and discloses the use of side windows in the support, or various configurations of the distal end of the instrument for light scattering. However, this type of instrument can be improved, especially with regard to light deflection, by converging or diverging, depending on the type of target application.

[0006] The aim of the present invention is to propose simpler techniques as well as equipment, instruments and systems that are less costly, easier to handle and / or improve the possibilities for cleaning, tissue destruction and photocoagulation. Summary of the Invention

[0007] The object of the present invention is therefore to propose a medical instrument and a system comprising such an instrument, which makes it possible to overcome at least some of the drawbacks of the prior art by proposing simpler techniques, as well as instruments, devices and systems that are cheaper and easier to handle and / or improve the possibilities of cleaning, tissue destruction and photocoagulation.One of the advantages is therefore the reduction of the costs of procedures outside the operating room, allowing the operation to be repeated, if necessary, at lower costs.

[0008] This object is achieved by a medical instrument comprising a free distal end intended to penetrate tissue or organs and / or blood vessels and a proximal end connectable to a light source, characterized in that the instrument comprises a tubular support in which at least one light guide is mounted, the support comprising an inclined distal end with at least one orifice forming a first optical outlet for a substantially frontal emission of light by the guide via the first optical outlet, the instrument comprising at least one optical deflection means for light forming a second optical outlet for a deflected emission of light, the instrument comprising at least one machining operation on the distal part of the instrument, and comprising at least one reflective and / or concave polishing configured for convergence of light and a reflective and / or convex polishing configured for divergence of light, the polishing operation being performed on the light guide and / or on the support.

[0009] In another feature, the light guide comprises an optical fiber.

[0010] According to another feature, the optical fiber is hollow and is associated with a CO2 laser source.

[0011] According to another feature, the light guide comprises a reflective coating on an inner wall of the tubular support.

[0012] According to another feature, the beveled distal end of the support is sagittally sharpened to a sharpening angle that imparts cutting and penetrating properties.

[0013] According to another feature, at least one distal portion is curved according to a radius of curvature to facilitate manipulation of the instrument from outside the tissue or organ.

[0014] According to another feature, the optical deflection means comprises at least one lateral orifice in the wall of the support near the distal end, the lateral orifice comprising at least one chamfer within the thickness of the wall of the support to provide an optical deflection angle that either flares outward to form a diverging deflection means or flares inward to form a converging deflection means.

[0015] According to another feature, the light deflection means are divergent deflection means comprising a convex grinding performed on a light guiding ball placed on the surface of the light guide.

[0016] According to another feature, the distal end of the light guide, e.g. a cross-sectioned or beveled bare-end optical fiber or a hollow fiber, is positioned back from the beveled distal end of the support, so that a reflective polished inner surface within the beveled distal end of the support acts as a reflective tool forming an optical deflection means.

[0017] According to another feature, the inclined distal end of the support comprises a second inclined portion having a circumferential abrasive region on a surface of the inclined portion at an inclination angle and obtained by a second abrasion of a portion of the abrasive region.

[0018] According to another feature, a second polishing is performed on a lateral portion of the polished area to provide a lateral optical deflection angle.

[0019] According to another feature, the second polish is on the entire circumference of the polished area to provide a distal optical deflection angle.

[0020] According to another feature, a second polish is performed on a central and apex portion of the polished area to provide a apex optical deflection angle.

[0021] According to another feature, a second polishing is performed at a height determined to also obtain a polished area of ​​the distal end of the light guide, resulting in two optical deflection angles and a modified active surface of the light guide.

[0022] According to another feature, the inclined distal end of the support comprises a circumferential polished area on the surface of the inclined portion at the inclination angle and at least one hemispherical or triangular depression forming at least one optical deflection means either at the side or at the center and apex.

[0023] According to another feature, the distal end of the light guide is housed within the support and is recessed from the distal end of the support by a distance of at least 1-10 mm.

[0024] According to another feature, the instrument comprises two light guides, preferentially two optical fibers, one of the guides carrying a diverging optical deflection means, for example a convex polish, and the other of the guides carrying a converging optical deflection means, for example a concave polish.

[0025] According to another feature, the light guide comprises both divergent and convergent optical deflection means.

[0026] According to another feature, the support comprises both divergent and convergent optical deflection means.

[0027] According to another feature, the instrument comprises means for rotating and / or advancing the light guide and / or the support, in particular relative to each other.

[0028] According to another feature, the instrument includes at least one marking for verifying correct positioning of the instrument.

[0029] According to another feature, at least one colored filter is disposed in the light path.

[0030] According to another feature, the support is made of a biologically neutral material, preferably chosen from stainless steel or aluminium.

[0031] According to another feature, the support has a distal coating of a material with enhanced thermal conductivity.

[0032] According to another feature, the light guide is an optical fiber reflecting wavelengths between 200 nm and 5 μm.

[0033] According to another feature, the light guide is a coating on the inner surface of the support forming an inner reflecting tube reflecting wavelengths between 200 nm and 11 μm, preferably between 5 μm and 11 μm.

[0034] According to another feature, the light guide is a doped optical fiber having an outer diameter of 50 to 1000 μm, preferably 50 to 150 μm, preferably 75 to 125 μm.

[0035] According to another feature, the support has a length of 10-120 mm, the outer diameter of the guide is 100-4000 μm, preferably 50-1000 μm, the outer diameter of the needle is 200-5000 μm, preferably 450 μm-1000 μm, and the distal end of the support is inclined at an inclination angle of 10-20°.

[0036] According to another feature, it comprises an electronic accounting device together with the light vector and the light source to calibrate the power of the beam at the needle outlet.

[0037] According to another characteristic, the guide aperture, preferably the aperture number of the fiber, is between 15° and 40°, preferably between 20° and 35° and more preferentially between 23° and 32°.

[0038] According to another feature, the instrument comprises two channels, either a dual channel in the support or a channel in the support associated with another channel of another instrument, and the assembly is coupled to a thermocouple measurement device for measuring the temperature at the distal end of the support.

[0039] According to another feature, the instrument further comprises an alarm system when the measured temperature value exceeds a predefined threshold.

[0040] According to another feature, the instrument further includes a thermal reagent configured to react when the instrument reaches a predetermined temperature to visualize overheating.

[0041] According to another feature, the light guide comprises a plurality of different optical fibers and has different optical deflection means from one fiber to another, and the instrument is coupled to a multiplexer at the light source for performing optical diagnostics by differential collection of signals from the different fibers.

[0042] Another object of the present invention is to provide a food control process that is easy and inexpensive to implement.

[0043] This object is achieved by a process for detecting toxic products in food control using a medical device according to the present application, by detecting chromophores. [Brief description of the drawings]

[0044] Further features, details and advantages of the invention will become apparent from the following description, taken in conjunction with the accompanying drawings. [Figure 1] 1 shows a schematic diagram of a system according to a particular embodiment of the invention in use. [Diagram 2] 1 shows a schematic side view of a connection means of a system according to some embodiments. [Diagram 3] FIG. 3 is a vertical cross-sectional view of the connection means shown in FIG. 2. [Figure 4] 1 is a schematic side view of a connection means and a tubular support according to some embodiments. [Diagram 5] 13A-13C are schematic diagrams of a distal tapered portion of a tubular support, according to some embodiments. [Figure 6] 13 is a schematic perspective view of a distal end of a support according to some embodiments comprising a second lateral distal slope portion. FIG. [Figure 7] 7 is a schematic perspective view of the distal end of the support shown in FIG. 6, further illustrating a light guide and its digital aperture according to some embodiments. [Figure 8] FIG. 13 is a schematic perspective view of a tubular support and light guide of an instrument according to some embodiments comprising a second circumferential distal tapered portion. [Figure 9]FIG. 2 is a schematic perspective view of a light guide formed by a hollow tube for carrying an instrument support and a CO2 laser according to a particular embodiment. [Figure 10] 1A-1C are schematic side views of a support having a distal curvature, according to some embodiments. [Figure 11] 1 shows a schematic perspective detail of a distal end of a support in various embodiments with at least one lateral distal window with an abrasion. [Figure 12] 1 shows a schematic perspective detail of a distal end of a support in various embodiments with at least one lateral distal window with an abrasion. [Figure 13] 1 shows a schematic perspective detail of a distal end of a support in various embodiments with at least one lateral distal window with an abrasion. [Figure 14] FIG. 13 is a schematic perspective view of a tubular support and light guide of an instrument according to some embodiments comprising a second central and apical distal slope. [Figure 15] 13 is a schematic front view of a distal end of an instrument according to some embodiments comprising a second central and apical distal bevel that extends beyond the light guide, thus forming a polish of the distal end of the light guide. FIG. [Figure 16] FIG. 16 is a schematic front view of the distal end of the device as shown in FIG. 15, showing two different heights of the central and apical distal second sloped portions extending beyond the light guide, the active surface of the light guide being modified by distal grinding thereof. [Figure 17] FIG. 17 is a schematic perspective view of the distal end of the device as shown in FIG. 16, illustrating the angle of the distal ramp on the light guide and tubular support, and the deformation of the active surface of the light guide. [Figure 18] 1A-1C are schematic perspective views of a tubular support and light guide of an instrument according to some embodiments including at least one lateral, hemispherical, and / or triangular distal indentation. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] This application relates to a surgical instrument for light therapy, in particular laser therapy. Numerous combinations of the embodiments detailed in this application can be envisaged without departing from the scope of the invention. Those skilled in the art will choose one or the other according to economic, ergonomic, dimensional or other constraints that must be followed according to regulations. In addition, it will be understood from reading this application that various technical features are described in functional terms and that a single device may combine the functional features of various embodiments.

[0046] Light therapy, especially laser therapy, is well known in the medical field. It should be noted that the effects of this therapy can be both thermal and mechanical. Thermal effects occur when laser radiation is absorbed by the obstacle (tissue). These then induce tissue reactions linked to changes in body temperature and duration of heating. Depending on the temperature increase in the tissue, different types of reactions can occur. Hyperthermia corresponds to a moderate increase in tissue temperature of about a few degrees. Thus, a tissue temperature of about 41°C for a few tens of minutes can lead to cell death. Coagulation corresponds to irreversible necrosis without immediate tissue destruction. In this action, the temperature of the tissue can reach temperatures of 50°C to 100°C in about one second. This temperature then causes drying, whitening and shrinkage of the tissue through denaturation of proteins and collagen. The tissue is then removed (cleaned) and heals. Volatilization or vaporization corresponds to the loss of substances. Herein, tissue temperatures above 100°C are mentioned. Under these conditions, cellular components evaporate in a relatively short time. A zone of coagulation necrosis can be seen at the edge of the volatilized zone, since the temperature transition between the volatilized and healthy zones occurs gradually. Mechanical effects are induced by the creation of plasma, explosive vaporization, or cavitation. These effects are mainly linked to the expansion of shock waves (created from thermal effects) that will generate destructive effects. Indeed, when material is released from the substrate by irradiation, the substrate will bounce. This bouncing effect is linked to the conservation of energy and to the fact that light energy is converted into kinetic energy. The present application proposes to exploit these effects in order to optimize treatment options.

[0047] According to a first object of the present invention, such an instrument comprises a light guide, e.g. an optical fiber, and a rigid tubular support that houses the guide, e.g. a needle that forms a protective guide sheath around the light guide. The terms "tubular support" and "needle" are therefore used in this application in a non-limiting and interchangeable manner. Similarly, the terms "light guide", "light vector", "vector", "optical fiber" or "fiber" are used in this application in a non-limiting and interchangeable manner.

[0048] Such an optical needle is connected by a light vector contained therein to a variable wavelength, for example filtered laser or white light source, and carries the light from the light source to the distal end. The connection to the light source (4) can be achieved via a standard connector (SMA or other), which can be resterilized (especially chemically) for use in a sterile operating environment. Thus, in contrast to previous uses where flexibility of the optical fiber was preferred, on the contrary a certain stiffness provided by the support is preferred, for example to be able to traverse (catheterize) a vein or even an artery over a long distance from the inlet of the fiber to the area to be treated. Of course, this stiffness is not absolute, but rather should be compared with the flexibility of the optical fiber, especially as used in intravenous lasers. This stiffness can be fine-tuned according to the use. For example, in the case of an angled needle, the needle can be sufficiently stiff to make it possible, for example, to penetrate the skin of the patient and cut tissue, such as a tumor lesion, or to cleanse tissue, such as an ulcer.

[0049] Advantageously, the instrument may comprise means of connection to a light source, in particular a laser light source. The laser light source may have a wavelength between 200 and 4000 nm, which is suitable for intravascular use. Other wavelengths are possible depending on the application. In particular, embodiments are provided in which a hollow fiber with internal reflection (or a reflective coating) is used in the hollow needle, in particular for CO2 lasers (10.6 μm wavelength, which makes it impossible to use solid optical fibers).

[0050] In some embodiments, the laser light source may advantageously have a wavelength between 800 and 1000 nm, and even more advantageously, the wavelength is 980 nm due to its preferential absorption by oxygenated hemoglobin and water.

[0051] The instrument comprises means for a substantially frontal light emission and means for light deflection, in particular for lateral light emission or deflection not parallel to the frontal emission axis (corresponding to the generatrix of the cylinder formed by the needle and / or fiber). Lateral diffusion can be done through one or more lateral windows and / or by lateral bevels on the distal end of the instrument and / or by polishing (or circumferential or apical bevels or flats) on either the support or the guide, or both. Depending on the intended use, the windows can be distributed laterally or longitudinally along the light guide and / or the support. In some embodiments, the type of polish used is called "glossy" polishing. In other embodiments, the type of polish used is "matt" polishing. This type of polishing is more costly but allows the light to be directed in the desired direction.

[0052] Generally speaking, the invention comprises a medical instrument (1) with a free operable distal end intended to penetrate a tissue or organ (6) and / or a blood vessel (V) and a proximal end connectable to a light source (10), the instrument comprising a tubular support (3) in which at least one light guide (2) is mounted. This support (3) comprises a bevelled distal end (31) with at least one orifice forming a first optical outlet for a substantially frontal emission of light by the guide (2) via said first optical outlet. This bevelled distal end is arranged to facilitate needle penetration, as known in the prior art. The angle (A) of this distal bevel can vary according to the size of the needle, in particular the diameter or length, as for example shown in FIG. 5. The bevel angle of the needle is between 10 and 40°, preferably between 20° and 30°, more preferably 25°. The smaller the angle, the less painful the penetration of the skin. This angle therefore conditions the painful nature of the puncture. It also provides that the shape of the photon field, i.e. the optical and active surface, which depends on the numerical aperture of the light guide (2), here the fiber, is increased when the tilt angle is smaller. The tilt angle optically influences the shape of the photon field and therefore the biological effect.

[0053] According to various embodiments of the invention, the instrument comprises at least one optical deflection means (210, 310, 312, 313, 314, 315) of light forming a second optical outlet for the deflected emission of light. This deflection means, which can take various forms according to various embodiments, comprises at least one machining and / or polishing operation on the distal part of the instrument. The polishing operation can be reflective for a linear deflection of light and / or concave for light convergence and / or convex for light divergence. Advantageously, this polishing operation is performed on the light guide (2) and / or on the support (3). In the case of a reflective polishing inducing a right deflection of light, depending on the position of this reflective polishing relative to the guide (2) and / or the support (3), this deflection can either expand the active zone, thus generating a divergence of light, or focus a part of the active zone, thus generating a convergence of light. It is understood that in order to obtain several measures of light deflection, several different polishing operations can be performed at different positions on the distal part of the instrument, which allows the effects generated by each to be combined in one and the same tool, thus minimizing the cost and invasiveness of the medical device. Indeed, light convergence, for example by concave polishing, facilitates the cleaning, especially cutting, even destruction of tissue. Conversely, light divergence, for example by convex polishing, facilitates photocoagulation and / or photodiagnosis and / or photodynamic therapy. For example, a suitable reflective polishing on the inner wall of the beveled end of the light guide allows a part of the light to be focused on the bevel where this reflective polishing is not provided, thus generating a convergence that allows the cleaning, cutting or destruction of tissue. On the other hand, depending on the numerical aperture of the light guide and the angle of the distal bevel, it is possible to allow light divergence through reflective polishing, for example when the guide is retracted into a support provided with such polishing at its distal end. Similarly, polishing to form a second bevel or a flat or a chamfer on the edge of the exit orifice allows the light to diverge, thereby facilitating photocoagulation. Therefore, the present application envisages various configurations combining convergent light deflection means and divergent deflection means on the light guide and / or support in order to obtain a single tool that combines the therapeutic effects of convergent and divergent light.It is also worth noting that the various embodiments offer greater reliability and robustness thanks to the protection offered by the support and the stability given by the machining operation of the tool. Thus, rather than using a convex polishing obtained by a ball placed at the distal end (by a technique known as "ball fiber"), which is costly and complicated to implement, it is possible to machine the support and / or guide to obtain a light divergence at a lower cost, controlling the degree of diffusion based on the angle (C, G, D, F) of the bevel, flat or chamfer and its polishing, as detailed below. Thus, instead of using a single bevel or distal polishing as in the prior art, the various embodiments advantageously use a second polishing (or bevel) of either the support or the fiber, or both. Other embodiments advantageously use a second polishing of the coating inside the support. It is understood that the term "substantially frontal emission" means a light emission at the distal end that is frontal to the optical outlet, but that due to the presence of the distal bevel, this emission is not completely frontal and the light is emitted in a direction that is not parallel to the generatrix of the cylinder formed by the support and / or the light guide.

[0054] Generally speaking, the instrument may comprise an optical fiber as light guide (2), for example a fiber of the type commonly used in medical applications, for example a fiber made of silica, in particular straight silica. This fiber may be mounted in a tubular support (3), such as a needle. "Needle" is understood to mean a tubular structure or support having sufficient rigidity to allow precise manipulation of the light guide. In addition, in particular for intravenous treatment, this needle must have sufficient rigidity to puncture the skin, such as a puncture needle. The instrument is understood to have a first end, called distal in the present application, intended to penetrate the tissue, and another end intended to be connected to a light source, in particular a laser. Between these two ends, the tubular support forms a cylinder and defines a generatrix of the cylinder, which may be straight but may also be curved, as for example shown in FIG. 10. The radius of curvature (E) of the instrument may vary depending on the application (in particular depending on the depth at which it is desired to work in the tissue), since it allows the instrument to be manipulated from outside the tissue or organ. Thus, the term "distal" refers to the free end of the instrument that penetrates the tissue, organ (6) or blood vessel (V), and the term "tip" refers to the apex, i.e. the furthest point or zone on this distal end. Meanwhile, the instrument has another end, called the proximal end (as it is closest to the user), which can be connected to a light source to illuminate the light guide of the instrument. This proximal end can also be connected to other devices according to various embodiments detailed in this application.

[0055] In some embodiments, the diffusion orifices and light guides of the support, in particular the light deflection means, are located close to the distal portion (31) of the instrument of the tubular support, either at their tips and / or at least one lateral window allowing lateral or circumferential treatment when the instrument is rotated.

[0056] The term "near" is understood to mean that the diffusing orifice is closer to the tip of the component than to its base, and preferably closer to the apical end of the component than to its middle, e.g. at the apical end of the component. Thus, an orifice at the apical end of the support (and guide) allows linear treatment, whereas an orifice forming a lateral window allows circumferential treatment to be performed by rotating the tool.

[0057] In some embodiments, the end of the support (3) is a concave or convex semicircle, for example in the shape of a "cutting spatula", allowing for tissue cleaning or dissection (e.g. cervical conization, ulcer irrigation, tissue dissection). This increases the dissection effect, especially when the polishing of the optical surface is concave with a converging effect on the optical field, thus concentrating the optical energy or energy density. This increases the precision of the dissection.

[0058] light deflection means In addition to the beveled distal end (31) of the support (3), the instrument comprises at least one light deflection means by at least one second bevel, flat or polishing. This polishing at the needle tip can be convex or concave to diffuse or focus the output beam, the purpose of which is to increase the light diffuse field for tissue destruction (e.g. ulcer irrigation) (in the case of a convex polishing) or to focus the light diffuse field for tissue sectioning (e.g. conization) (in the case of a concave polishing).

[0059] In some embodiments, the light deflection means comprises at least one side orifice (312) in the wall of the support near the distal end (31), the side orifice (312) comprises at least one chamfer (3121) in the thickness of the wall of the support (3) to provide an optical deflection angle (F) that either flares outward to form a divergent deflection means or flares inward to form a convergent deflection means. Figures 11, 12 and 13 show illustrative and non-limiting examples of such side orifices, which can be of various shapes and numbers. The chamfer allows the light to be diffused in a different way than the distal bevel of the instrument. For example, at a divergent angle as shown in these figures, the side orifice promotes photocoagulation. Thus, the result is a tool that cuts at its apex and coagulates at its distal part, at a lower cost. In some embodiments, the window of the support (3) (for needles or cutting tools) can be circular, elliptical, square or rectangular, depending on the application, as shown, for example, in a non-limiting manner, in Figures 11, 12 and 13. This number varies depending on the application, especially thermal and thermo-mechanical effects in intravenous vascular applications. There is a chamfer angle (F) that can vary depending on the machining of the device and conditions the shape of the photon field and therefore the biological effect. It can be added, for example, in a judiciously determined position behind or to the side of the bevel to add a coagulation effect and to surround the section above the bevel. The chamfer angle through the wall of the needle body is generally between 30 and 90°, preferably between 50 and 70°, preferentially 60°.

[0060] Various embodiments of the present invention aim to provide an instrument having a first optical outlet that is approximately parallel to the generatrix of the cylinder formed by the support (3) and / or the guide (2) and a second deflected optical outlet that is not approximately parallel to the generatrix of the cylinder formed by the support (3) and / or the guide (2). The result is thus at least two different anglings of the optical surface (or active surface) for the same instrument, which is particularly cost-effective to manufacture and easy to use.

[0061] In some embodiments, the light deflection means is a divergent deflection means comprising convex grinding performed on a light guiding ball placed on the surface of the light guide (3) (by a technique known as "ball fiber").

[0062] In some embodiments, the distal end of the light guide, e.g. a cross-sectioned or beveled bare optical fiber or hollow fiber, is positioned back from the beveled distal end (31) of the support (3), so that a reflective polished inner surface (315) in the beveled distal end (31) of the support (3) acts as a reflecting tool forming an optical deflection means. This advantageously allows for lower cost embodiments than when polishing is performed. In other embodiments, a reflecting device or coating is provided at the end of the needle, on the inner part of the bevel that is not covered by the fiber. There are two solutions to convey light over the beveled distal part that extends beyond the fiber (whether hollow as in Figures 9 and 18 for example, or otherwise). The first one is to leave the metal surface uncoated to reflect light, since the inner surface of the beveled end is already metallic and polished (typically made of biologically neutral stainless steel, as required for CE marking). This reduces the manufacturing costs of such products. The second is to advantageously limit the polishing of the end of the bevel to sharpening this zone. This offers good value for money. In some of these embodiments, the distal end of the light guide (2) is housed inside the support (3) and is set back from the distal end (31) of the support by a certain distance, preferentially a gap of at least 1 to 10 mm. This distance may vary from instrument to instrument or may be variable on the same given instrument, due to the translational movement of the fiber inside the needle. This change in distance changes the photon field at the distal end of the instrument and therefore advantageously makes it possible to select the physical effect (irrigation, photocoagulation, etc.) obtained by the instrument. It should also be noted that, as an alternative to hollow fibers, a reflective covering or coating may be used inside the needle. This coating may stop at a certain distance from the distal end of the support (3) to obtain the same effect as in the case of hollow or solid fibers. In fact, in some embodiments, the light guide (2) is not an optical fiber independent of the needle, but a covering or coating inside the needle (3). The coating may be attached to the needle over the entire coated surface.Alternatively, the guide and the support remain independent. It may be made, for example, of silica, offering the same light-guiding qualities as an optical fiber made of the same material, but made of a different material, for example capable of carrying longer or shorter wavelengths. It further benefits from the protection given by the sheath formed by the support or needle (3), especially in terms of strength and protection from impacts. Furthermore, the precision of the instrument is improved when the covering is integral with the needle. In some embodiments, the light guide is an optical fiber reflecting wavelengths between 200 nm and 5 μm. Furthermore, in some embodiments, the light guide is a coating on the inner surface of the hollow fiber or support forming an internal reflecting tube reflecting wavelengths between 200 nm and 11 μm, preferably between 5 μm and 11 μm. It is also noted that these hollow fiber or coating embodiments can be combined with various means of deviation of the present application, be it side windows, or side, circumferential or apex grinding, or other indentations, as detailed below.

[0063] In some embodiments, the beveled distal end (31) of the support (3) has a circumferential polished area (310) on the surface of the bevel at an angle of inclination (A) and comprises a second bevel obtained by a second polishing (313) of a portion of the polished area (310). This second polishing thus forms an optical deflection means for the deflected emission of light by the instrument. In some of these embodiments, the second polishing (313) is performed on a lateral portion of the polished area (310) to provide a lateral optical deflection angle (C). The lateral polishing angle of the bevel (C) determines the penetration due to the carving and cutting nature of the needle edge. Moreover, it conditions the overflow of the photon field and therefore its shape and therefore also the biological effect. Preferably, the lateral polishing angle of the bevel (C) is between 10 and 40°, preferably between 20° and 30°, more preferably 25°. Illustrative and non-limiting examples of such grinding or side bevels are shown in Figures 6, 7, 11 and 12. It is noted that if this second grinding is associated with a side orifice, the side orifice is aligned with respect to the second grinding, for example to obtain photocoagulation through the side orifice at the cross-section point obtained by the side grinding. Generally speaking, the side orifice is approximately aligned along the generatrix of the cylinder formed by the support to provide their effect to the distal bevel or extension of the deflection means located further towards the apex than this side orifice. Thus, when the instrument comprises two side orifices, they are approximately aligned with the generatrix. Moreover, in some of these embodiments, the second grinding (313) is the entire circumference of the grinding area (310) and provides the distal optical deflection angle (D). The angle of distal deflection (D) conditions the photon field with its lower overflow, and therefore the biological effect of the cutting is enhanced by the quality of the machining of the device edge, which also adjusts the mechanical cutting ability of the tool. An illustrative and non-limiting example of such polishing is shown in FIG. 8. However, in some of these embodiments, a second polishing (313) is performed on the center and apex portion of the polished area (310) to provide the apex optical deflection angle (G). An illustrative and non-limiting example of such polishing or apex bevel (or flattening) is shown in FIG. 14, FIG. 15, FIG. 16, and FIG. 17.These embodiments allow, for example, photocoagulation to be achieved by a second apex polishing at the edge of the section obtained by the distal bevel of the support. Moreover, when the second tip polishing (313) is performed on both the support and the fiber, advantageously a modified active surface (212) is obtained, which provides a multiple effect of the instrument on the tissue, organ (6) or vessel (V). Indeed, in some of these embodiments with apex polishing, as shown, for example, in Figures 16 and 17, the second polishing (313) is performed at a height (H1, H2) determined to also obtain a polished area (210) at the distal end of the light guide (2), resulting in two optical deflection angles (G) and a modified active surface (212) of the light guide (2). Finally, in some embodiments, the beveled distal end (31) of the support (3) comprises a circumferential polished region (310) on the surface of the bevel at an angle of inclination (A), and the optical deflection means comprises at least one hemispherical or triangular depression (314) forming at least one optical deflection means, either on the side or in the center and at the apex. Illustrative and non-limiting examples of such depressions are shown in FIG. 18.

[0064] Support / needle Generally, the support (3) is made of a biologically neutral material, preferably chosen from stainless steel or aluminum. A biologically neutral material is chosen that has a variable thermal conductivity and is preferably resistant to high temperatures in order to limit undesirable effects such as burning at the puncture site. The result is therefore a biologically neutral instrument. Furthermore, due to the use of deflection means, the invention allows the use of power such that, unlike certain devices of the prior art, the fiber is never damaged and thus does not introduce carcinogens into the tissue. In fact, it is important to guarantee the biological neutrality of the instrument at temperatures well above 150° C., above which, in the prior art, not only destruction of the fiber core but also burning of its sheath (e.g. polyimide or Tefzel) is observed, often generating toxic combustion products (e.g. polycyclic aromatic hydrocarbons, recognized by the WHO as carcinogens). In addition, due to the manufacturing technique, it is often still necessary to add a drop of glue to the needle tip, but this glue is biologically neutral.

[0065] In some embodiments, for better penetration and cutting effect of the needle, as shown for example in Figures 6, 7, 11, 12 and 13, it is possible to sharpen the distal end of the instrument sagittally, the arrow angle (B) can be varied, for example as shown in Figure 6. The arrow angle (B) conditions the penetration of the skin, i.e. the higher it is, the less painful the puncture. Preferably, the arrow angle of the needle (B) is 10 to 40, preferably 20° to 30°, even more preferably 25°. In other embodiments, the distal end is not sharpened like an arrow, but remains circular or rather elliptical in shape, since it is beveled for better tissue penetration. These embodiments also allow the medical instrument to be used as a cleaning or dissection tool. Thus, a particular embodiment relates to an instrument in which the beveled distal end (31) of the support (3) is sharpened sagittally to a sharpening angle (B) that confers cutting and penetration properties.

[0066] In some embodiments, the support, e.g. the needle, is curved. This advantageously limits the stress at the tip of the needle and facilitates the vascular puncture procedure. For example, as shown in a non-limiting manner in FIG. 10, the support (3), here the needle, is curved. The use of curved needles is entirely feasible from a technical point of view, in order to optimize the catheter insertion through the blood vessel and its angle, in order to be able to reach anatomical structures during surgery or medical procedures in the operating room, especially for venology. The radial angle (E) can be modified to suit the particular application. It is generally between 10 and 40°, preferably between 20 and 35°, ideally between 22 and 32° for medical procedures.

[0067] The length of the needle, the diameter of the needle and the angle of its bevel may vary depending on the application. Thus, they will be larger and longer for conization and tissue (ulcer) irrigation. Preferably, the needle may have an outer diameter ranging from 200 to 5000 μm, preferably from 450 μm to 1000 μm, especially for the treatment of varicose veins. The light guide may have an outer diameter of 100 to 4000 μm (4 mm), preferably from 50 to 1000 μm. Furthermore, the distal end (31) of the support (3) is preferably beveled with an inclination angle (A) of 10 to 20°. Meanwhile, the inner diameter of the support (3) may be equal to or larger than the outer diameter of the fiber (2) to accommodate any fiber sheath and / or to form a channel around the fiber, especially for injecting substances and / or for controlling blood reflux. The instrument may further comprise a channel, the reflux of blood in the channel proving the correct intravascular position of the needle. Channels can also be provided for injecting an anesthetic, or for fitting thermocouples or optical tools for spectrophotometry, or for injecting products for studying tissue fluorescence. Moreover, in some embodiments, the needle comprises a dual channel. The second channel may include a secondary fiber carrying another light, not only for optical diagnostics, in particular in spectroscopy, but also for thermocouple measurements at the distal end of the instrument. Thus, in some embodiments, the instrument comprises two channels, either a dual channel in the support (3) or a channel in the support (3) associated with another channel of another instrument, and the assembly is coupled to a thermocouple measuring device for measuring the temperature at the distal end (31) of the support (3). In some of these embodiments, the instrument is connected to or further comprises an alarm system when the measured temperature value exceeds a predefined threshold. On the other hand, in some of these embodiments, the instrument further comprises a thermal reagent configured to react when the instrument reaches a predefined temperature, in order to visualize overheating. In some embodiments, the support has a distal coating of a material with increased thermal conductivity to facilitate obtaining the desired treatment temperature, in particular to amplify the thermal effect in the tissue by maintaining the proximal portion of the needle in a material of lower thermal conductivity, or even insulating material, to protect the skin.

[0068] In some embodiments, the support (3) has a length of 10-120 mm and is preferably spatula-shaped. Needles are generally shorter and smaller in diameter, especially for vascular procedures in the absence of anesthesia or for laser lipolysis.

[0069] In some embodiments, the instrument is connected to or equipped with an electronic accounting device, together with the light vector and light source, to calibrate the power of the beam at the needle outlet. This type of technology is well known and, by varying the effect obtained by light deflection means and / or by possible movements of the fiber (2) in the support (3), allows the output power to be checked, which is particularly advantageous in the context of the present invention.

[0070] In some embodiments, the support is made of a biologically neutral material with variable thermal conductivity and is resistant to high temperatures to limit undesirable effects or to amplify thermal effects such as burning at the puncture site, the material being preferably selected from stainless steel or aluminum.

[0071] Light Guide / Fiber The optical fibers used may be of common type, for example made of silica, and in particular of the type used for interventional fiberoptic testing, intravenous lasers, surgery, etc. The light guides may be made of materials other than silica, depending on the wavelength of the light, in particular the laser light.

[0072] The cost of the device according to the invention, when manufactured on a large scale, can be five or ten times lower than devices currently used to treat varicose veins with laser light, and when performed in a medical procedure or treatment room, avoids the high costs of an operating room and allows for repeat treatments if initial results are unsatisfactory.

[0073] In some embodiments, the numerical aperture of the fiber is between 15° and 40°, preferably between 20° and 35°, ideally between 23° and 32°, for vascular applications. This can be increased by introducing several fibers into the same channel to modify the shape of the photon field. Thus, in some embodiments, the instrument comprises two light guides, preferentially two optical fibers, one of the guides carrying divergent optical deflection means, for example a convex polish, and the other carrying convergent optical deflection means, for example a concave polish. In some embodiments, the same light guide (2) comprises divergent and convergent optical deflection means. In some embodiments, the light guide (2) comprises several different optical fibers, as for example in a confocal microscope, with different optical deflection means from one fiber to another, and the instrument is coupled to a multiplexer at the light source to perform optical diagnostics, for example in photofluorescence, by differential collection of signals from the different fibers. Advantageously, the surface of the optical field determines the isolating or destructive effect on tissue, especially when the fiber aperture is between 10° and 30°, preferably between 15° and 25°, or conversely, when widened for photodiagnosis and tissue fluorescence revealing abnormal proteins in oncology, especially when the aperture is between 20° and 40°, preferably between 25° and 35°.

[0074] In fact, the angle of the bevel determines the surface area of ​​an ellipse that corresponds to the concept of an "optical surface". The numerical aperture determines the "active surface" (212) within this optical surface. The angle of the bevel of the needle determines the size of this active surface (212), which is increased, resulting in an "optical amplification". Illustrative and non-limiting examples of such numerical apertures and active surfaces (212) are shown in Figures 7, 16 and 17. In Figure 7, it can be seen that the active surface depends on the distal bevel, and in Figure 17, an additional deflection means (313) deforms the active surface by widening it by polishing both the support (3) and the fiber (2), thus achieving a double effect at the distal end of the instrument. Due to the different angles of the two polishes providing different optical field modifications, the first polished surface (310) at the beveled distal end of the support allows the first effect and the second polish (313) at the apical end allows the second effect.

[0075] Numerical aperture is understood to mean the sine of the maximum input angle of light into a light guide, for example a fiber, such that the light can be guided without losses measured relative to the fiber axis.

[0076] In some embodiments, the light guide is an optical fiber reflecting wavelengths between 200 nm and 5 μm. This allows to broaden clinical applications by targeting new chromophores. Fiber types can be chosen with a wavelength window wider than infrared (250 nm, UV silica), such as 3 or 4 μm (chalcogenides) for the needle and its light vector. This allows to broaden clinical applications by targeting new chromophores or fluorophores. Preferably, the fiber is made of silica.

[0077] Therefore, the composition of the optical fiber is selected based on the wavelength to be used. The table below summarizes the different compositions of guides according to wavelength.

[0078] [Table 1]

[0079] In some embodiments, the support is hollow and does not contain a fiber, in which case the light guide consists of a coating on the inside surface of the support that forms an internal reflecting tube such as those used in CO2 laser handpieces.

[0080] Thus, advantageously, the tube allows longer wavelengths, e.g., 10600 nm (10.6 μm), to be reflected when a CO2 laser is used rather than a conventional laser source. This wavelength is not very penetrating (20 μm depth) and is therefore widely used for tissue cleaning, e.g., in dermatological or neurosurgery. Furthermore, this wavelength is not accessible to any other type of fiber, and therefore some embodiments of the present application allow the use of such lasers via a coating inside a hollow fiber or needle.

[0081] In some embodiments, the CO2 laser can be delivered by a hollow fiber that must stop just before the bevel. Indeed, grinding the bevel is likely to result in the creation of powder residues that may make the secondary light transmission incompatible. Figure 9 shows an illustrative and non-limiting example of such a hollow fiber, where the light deflection means are not shown separately from the distal bevel, but it is of course possible to provide a deflection means such as one of the deflection means described in the present application, as shown for example in Figure 18, but it is noted that any other embodiment featuring a deflection means is also possible. In the field of CO2 lasers, tissue cleaning plays a very important role in the operating room, regardless of the specialty involved (neurosurgery, ophthalmology, dermatology, vascular surgery, tumor surgery, gynecological surgery, etc.). A fully usable hollow fiber (2) can be incorporated upstream of the bevel of the needle, whose precisely polished (metal) end is quite sufficient to transmit and even focus this light to optimize its cutting and destructive effect on the tissue involved.

[0082] In some embodiments, at least one colored filter is placed in the light path. For example, the instrument comprises at least one filter and / or coloring, allowing the use of filtered and / or colored white light, which is less expensive than a laser source. Thus, for example, at least a portion of the light guide (2) is filtered and / or colored. This advantageously allows filtering white light as a non-laser source (e.g., PDT, tissue ablation, etc.), which represents a source of savings since lasers are more expensive than filtered white light sources (e.g., flash lamps), and facilitates the use of certain processes, such as those of dynamic phototherapy.

[0083] In some embodiments, the light guide comprises a doped optical fiber, preferentially with an outer diameter of 50 to 1000 μm, preferably 50 to 150 μm, preferably 75 to 125 μm. Advantageously, the doped fiber allows working with small diameter fibers, with a diameter of the order of 100 μm, for cosmetic applications, in particular for photocoagulation of blood vessels and lipolysis, for example in the face. Preferably, the fiber is doped with erbium, holmium, thulium or praseodymium.

[0084] connector As already mentioned above, the instrument is preferably connected to the light source (10) by a connector (4), making it possible to change the instrument between, for example, two patients or two applications. This connector is known in the art and can be of the SMA type, as shown in Figures 2, 3, 4 and 10, but can be replaced by a locking clip connector, avoiding the use of threaded ferrules that can lead to incorrect positioning or damage of the instrument's components. Therefore, the present application uses the terms "connector" or "mating" or "connection" interchangeably, with or without the term SMA, but without being limiting. In some embodiments, the needle and the vector are connected inside a hollow metal guide, the male connector of the needle mating into the female connector of the light vector, preferably with a spring-loaded ball to keep the connector in the correct position for the optical guide.

[0085] FIG. 2 is a non-limiting example of some embodiments, in which the mating or connecting means (4) comprises a support and an SMA connector with a threaded ferrule. A mounting ring secures and strengthens the connection. A connecting tube (41) can be crimped into the connecting means (4), and a reinforcing support (42) can be provided to further strengthen the connection. The support (3) is inserted into the connecting tube (before or after the connection). In some embodiments, for example as shown in a non-limiting manner in FIG. 4, the support (3) is a needle crimped into a crimping tube (41) with one or more crimp points (411). In these embodiments, the crimping is essential to ensure the rigidity of the needle and to avoid any mechanical twisting or angulation that could alter the fibers in the body of the needle (3). It is integrated around the latter in the crimping body part of the connecting means (4). Advantageously, the crimping also provides a mass reserve to contain the excess heat generated by the needle in the tissue. Its composition, especially its density, affects parameters such as thermal conductivity, heat transfer, thermal inertia and thermal resistance. It is a buffer for excess heat that is a safety feature when using this device in vivo.

[0086] In some embodiments, the base of the support is crimped onto the connection clip. This improves strength and prevents fiber breakage at the needle tip, which can be a source of breakage and therefore accidents. The clip is upstream of the crimp and can be metallic to increase strength. In some embodiments, the base of the needle and connector features a bevel marker for the needle after it is screwed in to maximum tightening, or a clip with a face to ensure that the bevel is correctly positioned. Some operations require the device to be rotated, especially in the vascular area.

[0087] In some embodiments, the light guide has a diameter smaller than the diameter of the support at the connection between the support and the light guide. Advantageously, this prevents overheating between the SMA connector of the needle and the light vector, a safety factor.

[0088] In some embodiments, a thermal reagent is contained within the sheath of the light vector and the SMA clip or connector. This reagent can be non-metallic and single-use. Advantageously, this allows abnormal heating to be visualized on the device.

[0089] In some embodiments, the instrument comprises means for rotating and / or advancing the light guide (2) and / or the support (3), in particular relative to one another, In some embodiments, the instrument comprises at least one marking for verifying correct positioning of the instrument.

[0090] The present invention also relates to improving the ergonomics and use of medical instruments. Although presented separately and forming part of separate embodiments from the above-mentioned embodiments, it will be readily understood by those skilled in the art that the features described below can also be combined with those described in the remainder of the specification.

[0091] Thus, in some embodiments, the support (3), e.g., an optical needle, can be connected to a tunable laser source by a light guide (light vector) connected to either side of the laser and support by a connecting clip, instead of a standard connector (SMA or other). This saves time and improves ergonomics by making it easier to hold. In addition, screwing an SMA connector can sometimes destroy the threads of the light guide (light vector) and the support itself, e.g., the needle itself. In addition, the connecting clips can be color-coded for each device depending on the application, making it even easier to use.

[0092] In some embodiments, the connection between the needle and the light vector is colored, preferably the same color as the clip, depending on the application, making it even easier to identify each type of device according to its intended application.

[0093] Purpose Laser light treatment processes can advantageously be used with the device or system according to the invention. They can be used in particular for vascular applications, in particular for the treatment of varicose veins. Laser treatment can be used for sclerotherapy. It can also be used for arterial occlusion replacement chemoembolization and for fibrocalcium arterial debulking in preparation for angioplasty. The same applies to ulcer irrigation, tumor dissection or laser lipolysis.

[0094] For example, after local anesthesia, the instrument according to the invention is used to puncture the varicose veins to be treated, through the skin, in the same way as a puncture. The injection can be performed under visual or ultrasound control. The instrument itself can be used to inject the anesthetic through a dedicated channel, thus avoiding the need for additional injections and syringes. The same channel can possibly be provided to check the blood flow. It is therefore possible to ensure that the instrument is correctly positioned in the vasculature. Perivascular or peritumoral intumescent anesthesia can be used. Identification can be performed under ultrasound. When applied to tumor pathology, photochemicals can also be injected to enhance the thermal or phototherapeutic effect.

[0095] Once the instrument is in place, the laser shot is fired. It is advantageous to rotate the end of the light guide to ensure circumferential injury of the wall of the varicose vein being treated. As a result, the varicose vein becomes sclerosed and is no longer irrigated. Intravenous laser treatment produces photocoagulation of blood accompanied by tissue retraction due to contraction of collagen, which is of greater proportion in varicose veins.

[0096] The instrument can then be removed and decarbed, if necessary, with a sterile compress. The instrument is then ready to treat another varicose vein. Direct puncture without a guide needle is also possible.

[0097] In some embodiments, the instrument comprises an electronic accounting device (chip) together with the light guide and light source to calibrate the beam at the output of the support (needle exit). This allows to know exactly the power loss at the tip of the needle by comparing with the data from the light source. In addition, it can be coupled to a device that allows spectrophotometry or optical cell biopsy.

[0098] In some embodiments, the instrument is equipped with a thermocouple device at the distal end of the support to measure the temperature at this point, prevent burns, and provide in vivo temperature measurement via the already patented dual channel and alarm system in case of critical temperatures that allows to study in vivo and in vitro thermodynamic models with external thermography coupling for each application. Both of these can be used to design thermodynamic simulations. In addition, this allows to detect chromophores for screening toxic products in food control as soon as they have a specific absorption spectrum, thus avoiding slow and costly biological analysis and significantly increasing screening in the food chain.

[0099] The invention therefore enables the detection of toxic products in food control by chromophore detection using a medical device according to the invention.

[0100] Temperature studies using thermocouples based on the graph to be studied make it possible, for example, to evaluate the percentage of fat and protein in minced meat in the food chain or to study tumors in situ in human or veterinary pathology.

[0101] In some embodiments, the use of a "multiplexer" type device allows the recovery of emission and frequency shift at specific wavelengths, in particular immunofluorescence, for example by injection of fluorescent substances through a needle channel, or even the use of chromophores. Some embodiments therefore relate to the use of the instrument to detect chromophores. In addition, this type of tool allows spectrophotometric analysis, in particular infrared analysis, for example to study tissues in vivo. This means that the tool can be used in medical research as well as in the veterinary and food sectors to search for specific substances in spectrophotometric analysis. For fluorescence, it may be useful for calibration to use an end with a tip that allows this fluorescence to be examined.

[0102] Wavelength division multiplexing or WDM requires fewer channels to be employed for the needle and therefore remains a lower cost or "coarse WDM". It uses a dichroic filter placed in the fiber itself. It splits the photon field in two and allows bidirectional transmission to observe absorption shifts in spectrophotometry (e.g. immunofluorescence) for optical diagnosis of tumors and reveal abnormal proteins.

[0103] To take advantage of optical imaging equivalent to “phased array” in ultrasound, one might consider increasing the number of fibers in the needle, even at gauges of just 2 mm, and then refer to “high density WDM” or “ultra high density WDM.”

[0104] The present invention is therefore applicable to optical diagnostics when using a multiplexer for the light source, because in these multi-fiber systems, by modifying the optical field using the configurations of this application, specific images can be obtained with varying levels of specificity and sensitivity, especially in immunofluorescence. Light is injected and its return is examined, but if a dual channel needle is used (with an injection channel for immunofluorescent molecules), it is possible to distinguish cell types (e.g. astrocytoma vs. glioma) by recovering the frequency shift, for example. Thus, various dual channel (or two channels in two instruments) embodiments use one channel to inject immunofluorescent molecules and the other channel for light, using the principles described in this application.

[0105] Spectrophotometry (with an upstream multiplexer) can also be used to detect specific molecules (with specific absorption spectra), in which case two channels or an injection channel are not required.

[0106] Applications include utilizing gradients or index jumps, especially to carry several different wavelengths. There are essentially two types of optical fibers that utilize the principle of total internal reflection: index-hopping fibers and graded-index fibers. In index-hopping fibers, the index drops abruptly from a value in the core to a lower value in the cladding. In graded-index fibers, this index change is much more gradual. A third type of optical fiber guides light using the band gap principle of photonic crystals rather than total internal reflection. Such fibers are called photonic crystal fibers or microstructured fibers. These fibers usually have a very high index contrast between the different materials (usually silica and air). Under these conditions, the physical properties of the guide are significantly different from those of index-hopping and graded-index fibers. The invention may therefore encompass the use of these various types of fibers. On the other hand, the invention may also be applied to single-mode and / or multimode fibers. Finally, the invention may also use dichroic filters.

[0107] In some embodiments, the wavelength of the light is between 200 and 5000 nm. For example, for arterial or venous unblocking, the wavelength may be about 308 to 310 nm.

[0108] As mentioned above, the numerical aperture of the fiber determines the active surface of the device that can be utilized for these various applications, such as optical imaging, so-called optical biopsy, medical applications in the thermal field, and destructive applications, especially in ophthalmology, arterial unblocking (stenosis or occlusion), and venous unblocking in case of stenosis or occlusion. It can be used, for example, to prepare blood vessels for stenting, either arterial or venous. Vascular unblocking utilizes wavelengths in the ultraviolet range, for industrial marking or industrial cutting of materials. Since the mission time is much shorter, the peak power is very high, which means that the thermal effects at the biological level become non-thermal effects, thermomechanical effects and tissue destruction that are therefore safe for medical applications. On the other hand, as mentioned above, the light source can be white light filtered by the fiber itself, for example to determine the correct wavelength for photodynamic therapy and photodiagnosis (PDT = Photo Dynamic Therapy), which uses long emission times, generally more than 1 second.

[0109] As mentioned above, in some embodiments, as shown, for example, in a non-limiting manner, in FIG. 8, the optical needle is not sagittally ground, but has no lateral grinding, allowing the needle to be converted into an optical sectioning tool. This concerns the field of tissue or tumor cleaning, whether in the surgical field or in medical practice procedures such as laser conization for stages I and II, which are not treated in the operating room due to the cost. Thus, in this application, the tool can be used to treat small precancerous lesions in medical practice with local anesthesia and long needles, thereby statistically improving the prognosis. If the treatment is considered insufficient after the first histological biopsy, this treatment can always be completed or repeated outside the operating room at low cost. The same applies, for example, to dermatological surgery (removal of ulcers, removal of small benign tumors under local anesthesia).

[0110] Laser light sources require moderate power for this application, for example around 10-15 W in the field of small portable lasers.

[0111] It may therefore be advantageous, particularly for greater precision, for the light guide, e.g. an optical fiber, to extend beyond the support, e.g. a needle. The fiber can be expected to protrude 0-1 cm, preferably about 5 mm. To protect the optical fiber during puncture, means may be provided for retracting the fiber into the needle, as well as for extending the optical fiber beyond the distal end of the needle to the working position.

[0112] Means may also be provided for rotating the light guide relative to other parts of the instrument, for example relative to the support, especially in the case of needles containing optical fibers, or relative to the connecting means, especially in the case of needles internally clad with silica, thus allowing easy circumferential procedures.

[0113] The device according to the invention can also be used for other vascular applications, for example for the sclerosis of varicose veins in the lower extremities, but also for pelvic or esophageal varicose veins (intraoperative), hemorrhoids, or for the sclerosis of blood vessels during surgery or for occlusion by vascular anastomosis.The device according to the invention can also be used for tissue perforation or as an alternative to biological adhesives such as cyanoacrylates, for any intravascular embolization, in particular congenital or acquired fistulas, or venous embolization, in particular malformations or hemangiomas, or lymphatic obstruction causing ulcers.

[0114] Other applications include tissue destruction, especially when high precision is required. Thus, in dermatology, the use of lasers with a wavelength of 980 nm, or the water absorption wavelengths of erbium and holmium at 2940 and 2140 μm, makes the device according to the invention particularly effective for the treatment of condylomata, warts and other skin lesions. The scars are of better quality than those obtained using other techniques.

[0115] In connection with cell destruction, other applications may also include contact tissue irrigation, for example applied to ulcers. The device according to the invention may also be used for destruction of tissue metastases, for example in the liver, which is more ergonomic and less costly than radiofrequency. Laser tissue destruction involves the absorption of photons in the tissue with a secondary conversion to heat. Since this absorption targets certain tissue-specific molecular components (chromophores), the thermomechanical effect is more specific than other thermal tissue heating processes, such as radiofrequency (thermal effect). This specificity paves the way for new laser applications, such as photodynamic therapy, for example in oncology.

[0116] The use of a rigid support for the light guide allows more precise movements and better handling. The lesions caused by the treatment are therefore more precise. Biological stimulation improves healing. Since carbonization involves temperatures of over 350 or 400 ° C, up to about 600 ° C, tissue incandescence, bleeding is reduced and the risk of infection is also reduced. Postoperative pain is also reduced, especially in the case of ulcer irrigation, and there are fewer postoperative infections. There is a secondary inhibition of inflammatory and pain-producing factors in the nerve endings.

[0117] Additionally, parameters such as wavelength, radiation and exposure time between each shot, fluence, irradiance, continuous or pulsed mode (single or multiple), or destruction areas due to light scattering at the end of the light guide can be set.

[0118] From reading this application, it will be readily appreciated that the features of the invention, as generally described and illustrated in the figures, could be arranged and designed in a wide variety of different configurations. Thus, the description of the invention and the accompanying drawings are not intended to limit the scope of the invention, but are merely representative of selected embodiments.

[0119] Those skilled in the art will understand that technical features of a given embodiment can actually be combined with features of another embodiment, unless expressly stated to the contrary or unless the features are clearly incompatible. Moreover, a technical feature described in a given embodiment may be considered separately from other features of that embodiment, unless expressly stated otherwise.

[0120] It should be clear to those skilled in the art that the present invention allows for embodiments in many other specific forms without departing from the field defined by the appended claims, which should be considered as examples only and the invention should not be limited to the above details. [Explanation of symbols]

[0121] 1. Equipment 2. Light guides (optical fibres, hollow fibres or reflective coatings) 21. Distal end of light guide 210. Polished area of ​​distal end of light guide 212. Active surface tubular support (or needle) of light guide 31. Slanted distal end of support 310. Abrasive region at the distal end of the support 311. Support orifice 312. Side orifice of support 3121. Chamfering (or grinding) of side orifices of supports 313. Second bevel or polish of support (either side or center) 314. Distal depression of supporting orifice (lateral or central, hemispherical or triangular). 315. Reflective polished inner surface of support 4. Connection Method 41. Connection or crimping tube 411. Crimping point 42.Connecting pipe support 43. Mounting Ring 44. SMA Lock (Threaded Ferrule) 45. SMA connector support 46. ​​SMA Connector 6. Tissue or organ 7. Optical Cable 8. Distal end of the instrument 10.Light source V. Blood vessels H. Distal grinding height of supports and guides B. Arrow angle at the distal end of the support C. Grinding angle of the second lateral bevel at the distal end G. Grinding angle of the second central bevel at the distal end D. The angle of inclination of the inclined distal end of the support E. Curvature angle of support F. Chamfer angle of the side orifice of the support

Claims

1. A medical instrument (1) with a free distal end intended to penetrate a tissue or organ (6) and / or a blood vessel (V) and a proximal end connectable to a light source (10), said instrument comprising a tubular support (3) in which at least one light guide (2) is mounted, said support (3) comprising a beveled distal end (31) with at least one orifice forming a first optical outlet for a substantially frontal emission of light by said guide (2) via said first optical outlet, said instrument comprising at least one machining operation on a distal part of said instrument for deflecting light.

1. A medical device (1), comprising at least one optical deflection means (210, 310, 312, 313, 314, 315) of the light forming a second optical outlet for emission, characterized in that the medical device (1) comprises at least a first reflective and / or concave polishing, the first polishing configured for converging the light, and a second reflective and / or convex polishing, the second polishing configured for diverging the light, the first and second polishing operations being performed on the light guide (2) and / or on the support (3).

2. The medical instrument (1) according to claim 1, wherein the light guide (2) comprises an optical fiber.

3. The medical instrument (1) according to claim 2, wherein the optical fibre is hollow and is associated with a CO2 laser source.

4. The medical device (1) according to claim 1, wherein the light guide (2) comprises a reflective coating on the inner wall of the tubular support (3).

5. The medical instrument (1) according to any one of claims 1 to 4, wherein the beveled distal end (31) of the support (3) is sharpened sagittally to a sharpening angle (B) which imparts cutting and penetrating properties.

6. The medical instrument (1) according to any one of claims 1 to 5, wherein at least one distal portion is curved according to a radius of curvature (E) to facilitate manipulation of the instrument from outside the tissue or organ (6).

7. The medical device (1) according to any one of claims 1 to 6, wherein the optical deflection means comprises at least one lateral orifice (312) in the wall of the support near the distal end (31), said lateral orifice (312) comprising at least one chamfer (3121) within the thickness of the wall of the support (3) and providing an optical deflection angle (F) which either flares outward to form a diverging deflection means or flares inward to form a converging deflection means.

8. The medical device (1) according to any one of the preceding claims, wherein the light deflection means is a divergent deflection means comprising a convex grinding performed on a light guiding ball placed on the surface of the light guide (3).

9. The medical device (1) according to any one of claims 1 to 8, wherein the distal end (21) of the light guide (2), e.g. a cross-sectioned or bevelled bare-end optical fibre or a hollow fibre, is positioned back from the bevelled distal end (31) of the support (3), so that a reflective polished inner surface (315) within the bevelled distal end (31) of the support (3) acts as a reflective tool forming an optical deflection means.

10. The medical device (1) according to any one of claims 1 to 9, wherein the inclined distal end (31) of the support (3) comprises a circumferential polished area (310) on a surface of the inclined portion at an inclination angle (A) and a second inclined portion obtained by a second polishing (313) of a portion of the polished area (310).

11. The medical instrument (1) according to claim 10, wherein the second polishing (313) is performed on a lateral portion of the polishing area (310) to provide a lateral optical deflection angle (C).

12. The medical instrument (1) of claim 10, wherein the second abrasion (313) is the entire circumference of the abrasive area (310) and provides a distal optical deflection angle (D).

13. The medical instrument (1) according to claim 10, wherein the second polishing (313) is performed on a central and apical portion of the polishing area (310) to provide a apical optical deflection angle (G).

14. The medical instrument (1) of claim 13, wherein the second polishing (313) is performed at a height (H1, H2) determined to also obtain a polished area (210) of the distal end of the light guide (2), resulting in two optical deflection angles (G) and a deformed active surface (212) of the light guide (2).

15. The medical device (1) according to any one of claims 1 to 9, wherein the inclined distal end (31) of the support (3) has a circumferential polished area (310) on the surface of the inclined portion at an inclination angle (A) and comprises at least one hemispherical or triangular depression (314) forming at least one optical deflection means either at the side or in the middle and at the apex.

16. The medical device (1) according to any one of the preceding claims, wherein the distal end of the light guide (2) is housed inside the support (3) and is set back from the distal end (31) of the support by a distance of at least 1-10 mm.

17. A medical instrument (1) according to any one of the preceding claims, wherein the instrument comprises two light guides, preferentially two optical fibres, one of said guides carrying diverging optical deflection means, e.g. a convex polish, and the other of said guides carrying converging optical deflection means, e.g. a concave polish.

18. The medical device (1) according to any one of the preceding claims, wherein said light guide (2) comprises both divergent and convergent optical deflection means.

19. The medical device (1) according to any one of the preceding claims, wherein said support (3) comprises both divergent and convergent optical deflection means.

20. Device (1) according to any one of the preceding claims, characterized in that it comprises means for rotating and / or advancing the light guide (2) and / or the support (3), in particular relative to one another.

21. The device according to any one of the preceding claims, characterized in that it comprises at least one marking for verifying correct positioning of the device.

22. The medical device (1) according to any one of the preceding claims, wherein at least one coloured filter is arranged in the optical path.

23. The medical device (1) according to any one of the preceding claims, wherein said support is made of a biologically neutral material, preferably selected from stainless steel or aluminium.

24. The medical device (1) according to claim 23, wherein the support has a distal coating of a material with enhanced thermal conductivity.

25. The medical device (1) according to any one of the preceding claims, wherein the light guide is an optical fibre reflecting wavelengths between 200 nm and 5 μm.

26. The medical device (1) according to any one of the preceding claims, wherein the light guide is a coating on the inner surface of the support forming an internal reflective tube reflecting wavelengths between 200 nm and 11 μm, preferably between 5 μm and 11 μm.

27. The medical device (1) according to any one of the preceding claims, wherein said light guide is a doped optical fibre with an outer diameter of 50-1000 μm, preferably 50-150 μm, preferably 75-125 μm.

28. The medical device (1) according to any one of the preceding claims, wherein the support (3) has a length of 10-120 mm, the outer diameter of the guide is 100-4000 μm, preferably 50-1000 μm, the outer diameter of the needle is 200-5000 μm, preferably 450 μm-1000 μm, and the distal end (31) of the support (3) is inclined with an inclination angle (A) of 10-20°.

29. The medical instrument (1) according to any one of the preceding claims, comprising, together with the light vector and said light source, an electronic accounting device for calibrating the power of the beam at the needle outlet.

30. The medical device (1) according to any one of the preceding claims, wherein the guide aperture, preferably the aperture number of said fibre, is between 15° and 40°, preferably between 20° and 35° and more preferentially between 23° and 32°.

31. The medical instrument (1) according to any one of claims 1 to 30, wherein the instrument comprises two channels, either a double channel in the support (3) or a channel in the support (3) associated with another channel of another instrument, and the assembly is coupled to a thermocouple measuring device for measuring the temperature at the distal end (31) of the support (3).

32. 32. The medical instrument (1) according to claim 31, further comprising an alarm system when the measured temperature value exceeds a predefined threshold value.

33. The medical device (1) according to any one of the preceding claims, further comprising a thermal reagent configured to react when the device reaches a predetermined temperature, in order to make overheating visible.

34. The medical instrument (1) according to any one of claims 1 to 33, wherein the light guide (2) comprises a plurality of different optical fibres, with different optical deflection means from one fibre to another, the instrument being coupled at the light source to a multiplexer for performing optical diagnostics by differential collection of signals from the different fibres.

35. A method for detecting toxic products in food control by chromophore detection using a medical device (1) according to any one of the preceding claims.

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