FR3074691A1 - IMPLANTABLE LOCALIZED ILLUMINATION DEVICE WITH IMPROVED ARCHITECTURE - Google Patents

Abstract

The invention relates to an implantable illumination device, intended to be implanted in a living being to illuminate in a localized manner an area of said living being, said device comprising a probe (1) said architecture being characterized in that it is realized in from: - an optical fiber which comprises a core (10), a coating (11) and a protective sheath (12), - a coating (13, 130), - said architecture comprising: - several successive sections along its axis longitudinal, each section having a section (Sc to S4 or Sc to S30) with several concentrically superimposed layers, wherein each section has a superimposed multilayer section distinct from the section of each adjacent section.

Description

The present invention relates to an illumination device intended to be implanted at least in part in a living being in order to locally illuminate at least one area of the living being.

State of the art

For the treatment of certain pathologies of a living being, it has been imagined to optically stimulate an internal area of a living being. For this, devices have been proposed which comprise a light source and which are implanted at least in part or totally in the living being in order to illuminate the desired area.

We have notably noticed the interest of such devices for illuminating / irradiating optically certain areas of the human brain.

However, given the risks associated with the implantation of such a device in the brain, it is understood that such a device must be perfectly designed.

Such a device is known from patent application US2012 / 259393A1. The solution presented in this document is not successful.

Another solution is known from patent application WO2016 / 102351A1. The solution presented in this document is inflexible and difficult to implement without risking damage to the tissues of the implanted patient.

The object of the invention is to propose an illumination device intended to be implanted at least in part in a living being, in particular for illuminating one or more areas of his brain, said device having an architecture adapted to fulfill such a role. In particular, it must fulfill one or more of the following objectives: Use bio-compatible materials;

- Minimize medical risks during implantation and explantation;

- Ensure the aesthetic and physical comfort of the patient;

Be easy to manufacture and easily reproducible to manufacture; Allow effective treatment;

Statement of the invention

This object is achieved by an implantable illumination device, intended to be implanted in a living being in order to locally illuminate an area of said living being, said device comprising a probe having an architecture elongated along an axis between a proximal end and an end distal, said architecture being produced from:

- an optical fiber which includes a core, a coating and a protective sheath,

- a coating,

- and said architecture comprising:

several successive sections along its longitudinal axis, each section having a section with several layers concentrically superposed, in which each section comprises a section with several superposed layers distinct from the section of each adjacent section,

at least a first section along which said optical fiber is coated with the coating, at least a second section extending said first section, in which said optical fiber is stripped to remove its protective sheath so as to leave only its core and its optical coating coated by the coating and in order to improve the flexibility and sealing of the probe over at least a non-zero part of its length.

According to one feature, the device comprises a first section, the section of which comprises a first layer comprising the optical fiber core, a second layer comprising the coating of optical fiber, a third layer comprising the protective sheath of optical fiber, a fourth layer comprising the coating and a fifth outer layer composed of a tube.

According to another particularity, the device comprises a second section extending said first section and the section of which comprises a first layer comprising the core of said optical fiber, a second layer formed from the coating of optical fiber, a third layer comprising said coating and a fourth layer comprising said tube.

According to another particularity, the device comprises a third section extending said second section and the section of which comprises a first layer comprising said coating and a second layer comprising said tube.

According to another particular feature, the device comprises a fourth section extending said third section and the section of which comprises said coating.

According to another particular feature, the fourth section comprises the distal end of the probe and in that this distal end is configured so as to be atraumatic.

According to another particularity, the fourth section is glued to the third section.

According to another particular feature, the fourth section is formed by depositing a drop of silicone in liquid form on said third section.

According to another particular feature, the device comprises a silicone plug inserted at the end of the tube and comprising said fourth section and said third section.

In another feature, the tube is made of a radiopaque material.

According to another particularity, the device comprises a first section, the section of which comprises a first layer comprising the optical fiber core, a second layer comprising the coating of optical fiber, a third layer comprising the protective sheath of optical fiber, a fourth layer comprising the coating overmolded on the optical fiber.

According to another particularity, the device comprises a second section extending said first section and the section of which comprises a first layer comprising the core of said optical fiber, a second layer formed from the coating of the optical fiber, a third layer comprising said coating.

According to another particular feature, the device comprises a third section extending said second section and the section of which comprises said coating.

According to another particular feature, the third section comprises the distal end of the probe and in that this distal end is configured so as to be atraumatic.

According to another particularity, the coating is made of a material chosen from silicone and polyurethane.

According to another particular feature, the coating of the fiber is made of a material of the fluoro-acrylate type.

According to another particularity, the protective sheath is made of ETFE.

According to another particularity, the device comprises a connection section, located upstream of the first section, the section of which comprises a first layer formed from the core of the fiber, a second layer formed from the coating of optical fiber, a third layer formed from an adhesive and a fourth layer formed by a ferrule.

According to another particular feature, the device comprises a light source to which said probe is optically connected by its proximal end.

According to another particular feature, the device comprises a stop member associated with at least one spacer for adjusting the insertion of the probe and the position of its distal end.

Brief description of the figures

Other characteristics and advantages will appear in the detailed description which follows, made with reference to the appended drawings in which:

FIG. 1A represents, seen according to an axial longitudinal section and several transverse sections, the architecture of the implantable illumination device of the invention, according to a first embodiment;

FIG. 1B represents, seen in an axial longitudinal section and several transverse sections, the architecture of the implantable illumination device of the invention, according to a second embodiment;

FIG. 2 represents the multilayer structure of an optical fiber of the HCS type;

FIGS. 3A to 3C represent different alternative embodiments of a centering member used in the probe of the device of the invention

FIGS. 4A to 4C represent different alternative embodiments of an optical return system used in the device of the invention;

FIG. 5 illustrates different solutions for producing the optical output; FIGS. 6A and 6B illustrate a principle for adjusting the positioning of the probe;

Detailed description of at least one embodiment

The invention relates to an implantable illumination device.

It will aim to achieve tissue illumination for the purpose of neuroprotection, stimulation, or for an opto-genetic purpose.

In particular, the device will be perfectly adapted to ensure localized ventricular illumination of the brain. It can be used in the treatment of neurodegenerative diseases such as Parkinson's disease. Of course, it can be applied to other pathologies and can be used for implantation in any area of the body of a living being.

The device is advantageously described for the optical stimulation of an area of the brain.

The particularity of the device of the invention is in particular to allow optical stimulation from a flexible solution, sufficiently fine (1 to 2.5 mm, ideally between 1.25 and 1.3 to be adapted to the tools of DBS- Deep Brain Stimulation) to be inserted into the third ventricle or in contact with any other area of the brain that is accessible surgically without a stereotaxic tool, once a ventricular guide or catheter (Renishaw neuro-guide or ventricular catheter equipped with a Rickham-Ommaya , or any other suitable guidance solution) has been previously positioned between the cranial box and the third ventricle.

The device comprises a probe 1. The probe 1 has an elongated architecture along a longitudinal axis when it is not bent. In other words, the probe is in the form of a rod having a certain degree of flexibility and elastic deformation. The rod thus has two ends, a proximal end forming an optical input intended to receive light radiation from a light source 2 and a distal end comprising an optical output by which light radiation is transmitted towards the area to illuminating / treated.

The probe may be flexibly deformed in flexion to form an angle between 30 ° and 110 ° relative to its initial straight shape in the rest state, preferably 90 °, then forming an elbow at the passage between the outside. of the skull and the brain.

The light source 2 is advantageously part of the device.

The source can emit in a wavelength range between 650nm and 1070nm for neuroprotection or 450nm at 650nm for optogenetics. The source 2 will advantageously be supplied by a battery and controlled by a control unit 3 so as to generate a direct electric current or pulses at a given frequency. The source can be integrated into a neuro-stimulator or be remote.

The light source 2 can be a laser diode, a light-emitting diode or any other solution suitable for optical coupling in the probe.

The control unit 3 of said light source 2 advantageously forms part of the device.

The light source 2 and the control unit 3 can be combined in the same housing.

The device may include an optical base connected to the light source.

The optical base can be arranged on said housing.

The probe 1 has a complementary connector forming its optical input, arranged to connect (respectively disconnect) on said optical base.

The rod forming the probe 1 advantageously has a circular section of external diameter which may be between 1 and 2.5 mm depending on the embodiment.

The device has a perfectly waterproof architecture. The diameter of the probe is advantageously constant over the entire length of the probe (except at the level of its stop system - see below).

The end of the probe forming the optical output advantageously has a so-called atraumatic shape. It will be a matter of giving it a shape without a protruding edge. It may for example be a hemispherical, oblong or equivalent type.

Along its axis, the architecture of probe 1 has a section whose composition with several concentric layers varies.

The probe thus comprises several successive sections (Sc to S4 or Sc to S30) between its optical input and its optical output. Each section has a specific structure with several concentric layers.

The probe includes an optical fiber.

With reference to FIG. 2, the optical fiber may comprise a core 10 of silica type, of sapphire type or of plastic type (acrylate or any other suitable material) and an optical coating 11 (cladding) produced around the heart.

The coating can be made of plastic material, for example in a material of the fluoro-acrylate type, in a material of the silica type or other material of suitable index.

The optical fiber may include a mechanical protective sheath 12 around its coating.

The protective sheath 12 can be made of a material of ethylene tetrafluoroethylene (ETFE) type.

This will involve, for example, having an optical fiber of the HCS (Hard Clad Silica) type. Of course, any other architecture could be envisaged.

However, this type of fiber presents a risk of delamination between its ETFE sheath and its coating of Fluoro-acrylate.

To remedy this risk and to improve the flexibility of the probe, it is proposed to strip the fiber on the distal side over a sufficient length (for example 5 to 70 mm). The optical fiber is thus stripped to remove its protective sheath 12 and retain only its core and its optical coating.

The stripping length is adapted according to the length implanted in the brain, for example 70mm to reach the floor of the 3rd ventricle.

Advantageously, it is also proposed to strip the part of the optical fiber bonded in the ferrule at the optical input in order to guarantee proper centering of the fiber in this connector.

In the following description, the silicone used to make the device may be replaced by a flexible polyurethane type material having the same qualities, in particular optical properties and stability over time. For simplicity, we will however refer to a silicone type material.

From the fiber as described above, two separate embodiments are possible.

In a first embodiment, the probe comprises a tube 14, for example made of silicone, defining a central channel. The external diameter of the section of the tube 14 defines the maximum diameter of the section of the probe (except at the level of its stop system - see below). The silicone forming the tube is chosen with suitable mechanical characteristics. It may be of the optical or non-optical type (that is to say transparent or opaque). For example, the tube will be made of a MED 4765 type silicone.

The optical fiber is inserted into the central channel of the tube 14. Over the entire length of the probe, silicone 13 is advantageously added to the tube 14, by injection or other manufacturing principle, so as to coat the various elements present in the tube and thus impart a perfect seal to the probe vis-à-vis the treated area. This injected silicone is advantageously of the optical type (that is to say having an optical transparency and a refractive index adapted to the core of the optical fiber and to the physiological liquid - refractive index between

1.33 and 1.46, preferably 1.41 - MED 6233 silicone).

The fiber can be previously treated (primer, plasma treatment, etc.) to guarantee good adhesion of the silicone 13, 130 during manufacture.

In a second embodiment, a silicone overmolding is carried out directly around the fiber, coming to coat it. The silicone molded around the fiber thus imparts a perfect seal to the probe vis-à-vis the treated area.

First realization - Figure 1A

In a nonlimiting manner, with reference to FIG. 1A, in the first embodiment mentioned above, the probe thus has different sections, each section having a specific cross section. This architecture thus makes it possible to give different levels of flexibility, mechanical protection and sealing to the probe along its axis.

Starting from the inner layer closest to the axis and going towards the outer layer, the furthest from the axis of the probe, the different sections are described below.

The probe comprises a connection section (section Sc) advantageously forming the optical input of the device.

The connection section includes:

a first layer formed from the core 10 of the optical fiber;

- a second layer formed of the coating 11 of the optical fiber;

- A third layer formed of an epoxy type adhesive 15;

- a fourth layer formed by a ferrule 16 allowing the optical connection with the light source; the epoxy glue allows to stick the ferrule on the second layer (coating of the optical fiber). On this connection section, it is proposed to strip the optical fiber over at least part of its length in order to remove its protective sheath and allow bonding of the ferrule.

The probe has a first section (section S1), extending the connection section.

This first section includes:

a first layer formed from the core 10 of the fiber;

- a second layer formed of the coating 11 of the optical fiber;

- a third layer formed by the protective sheath 12 of the optical fiber;

- A fourth layer composed of the coating 13 made of silicone;

a fifth layer formed from the tube 14;

This first section is intended to remain in the extra-cortical area of the living being and will be bent during its implantation at this level. The first layer, the second layer and the third layer form the optical fiber as described above. To improve mechanical protection, the fiber protection sheath is maintained on this first section.

The probe has a second section (section S2) extending the first section in the direction from the optical input to the optical output of the probe.

This second section includes:

a first layer formed from the core 10 of the fiber;

- a second layer formed of the coating 11 of the optical fiber;

a third layer formed from the silicone coating 13;

- a fourth layer formed from the tube 14;

The second section is intended to penetrate the intracerebral zone. It is on this second section that the optical fiber is stripped to remove its protective sheath 12, thereby making this section more flexible and waterproof.

The probe has a third section (section S3) extending the second section in the direction from the optical input to the optical output of the probe.

This third section includes:

a first layer formed by the coating 13 made of silicone;

a second layer formed from the tube 14;

It is thus noted that the end of the optical fiber delimits the end of the second section and that the tube 14 is extended in the third section S3. The length L (typically 1.5mm to 2.5mm) between the end of the tube 13 and the end of the heart 10 of the fiber on the distal side, in particular makes it possible to adjust the power density at the output of the probe.

The probe has a fourth section (section S4) extending the third section in the direction from the optical input to the optical output of the probe.

This fourth section includes:

- A layer formed by the coating 13 of silicone;

This fourth section comprises the end of the probe forming the optical output. Note that the end of the tube defines the end of the third section.

This fourth section S4 advantageously ends with an atraumatic end. The light coming from the heart of the optical fiber crosses this fourth section. Depending on the intended application, this fourth section may include or act as an optical diffuser.

Second realization - Figure 1B

This second embodiment differs from the first embodiment in that the tube 14 is replaced by a complete silicone overmolding. The process used will thus be distinct. It will not be a question of filling the tube with silicone but of making a silicone overmolding around the optical fiber.

In this second embodiment, starting from the inner layer closest to the axis and going towards the outer layer, the furthest from the axis of the probe, the different sections are described below.

The probe has the same connection section (section Sc) advantageously forming the optical input of the device.

The connection section includes:

a first layer formed from the core 10 of the optical fiber;

- a second layer formed of the coating 11 of the optical fiber;

- A third layer formed of an epoxy type adhesive 15;

- a fourth layer formed by a ferrule 16 allowing the optical connection with the light source; the epoxy adhesive makes it possible to stick the ferrule on the second layer (coating of the optical fiber);

On this connection section, it is proposed to strip the optical fiber over at least part of its length in order to remove its protective sheath and allow bonding of the ferrule.

The probe has a first section (section S10), extending the connection section.

This first section includes:

a first layer formed from the core 10 of the fiber;

- a second layer formed of the coating 11 of the optical fiber;

- a third layer formed by the protective sheath 12 of the optical fiber;

- A fourth layer composed of the coating 130 of silicone overmolded around the fiber;

This first section is intended to remain in the extra-cortical area of the living being and will be bent during its implantation at this level. The first layer, the second layer and the third layer form the optical fiber as described above. To improve mechanical protection, the fiber protection sheath is maintained on this first section.

The probe has a second section (section S20) extending the first section in the direction from the optical input to the optical output of the probe.

This second section includes:

a first layer formed from the core 10 of the fiber;

- a second layer formed of the coating 11 of the optical fiber;

a third layer formed of the silicone coating 130;

The second section is intended to penetrate the intracerebral zone. It is on this second section that the optical fiber is stripped to remove its protective sheath 12, thereby making this section more flexible and waterproof.

The probe has a third section (section S30) extending the second section in the direction from the optical input to the optical output of the probe.

This third section includes:

a first layer formed of the silicone coating 130;

In this embodiment, this third section S30 includes the end of the probe forming the optical output.

This third section S30 advantageously ends with an atraumatic end. The light coming from the heart of the optical fiber crosses this third section. Depending on the intended application, this third section may include or act as an optical diffuser.

In order to guarantee the correct positioning of the fiber in the center of the probe, spacers (rings, spirals, etc.) can be positioned regularly along the fiber. These spacers will preferably be made of the same material as the silicone overmolding 130.

According to a particular aspect of the invention, in the two embodiments, it should be understood that the first section (sections S1, S10) and the second section (sections S2, S20) allow the probe 1 to have an architecture which is both sufficiently flexible and flexible in the implanted area to avoid any impact or trauma on the tissues and sufficiently rigid outside the implanted area to avoid any rupture.

According to a particular aspect of the invention, the coating 13, 130 and the protective sheath 12 have distinct mechanical characteristics and their functions are also very distinct. The coating layer makes it possible in particular to provide the probe with sealing characteristics which the protective sheath of the optical fiber cannot provide and to give the probe its atraumatic end.

Without limitation, for the various components of the probe, there will be the following mechanical characteristics:

ETFE: Hardness from 62 to 72 Shore D, Young's modulus ranging from 300 to 800MPa.

- Silicone: Hardness from 30 to 80 Shore A (preferably 50), Young's modulus ranging from 1 to 2 MPa.

Furthermore, the withdrawal of the protective sheath 12 over part of the length of the probe, as proposed above, can have several advantages. A first advantage lies in the improvement of the flexibility of the probe at the level of the stripped section. A second advantage lies in improving the seal, making it possible to avoid any introduction of liquid. Indeed, it turns out in particular that silicone is a material which adheres better to the coating layer of the optical fiber than to its protective sheath (made of ETFE).

To facilitate the determination of the quantity of light leaving the probe, a good positioning in length and in centering of the fiber in the probe is necessary. Advantageously, the second section can thus comprise a member 17 for centering the core 10 of the fiber and its coating 11, positioned around the stripped optical fiber. This centering member can be made of radio-opaque material (for example: platinum, stainless steel) in order to allow precise control of the positioning of the probe by radiography during surgery or to perform post-surgical monitoring.

In the first embodiment (section S2 ′), this centering member 17 is arranged to bear on the one hand against the coating 11 of the optical fiber and on the other hand to be separated from the tube 14 by a coating layer 13 silicone.

In the second embodiment (section S20 '), the silicone 130 also coats the centering member 17, in addition to the optical fiber.

This centering member will in particular play the role of a wedge for the optical fiber (10 + 11) whether in the tube 14 during the filling process or during overmolding.

The centering member 17 may include a sleeve 170 having a longitudinal central channel 171 into which the core of the optical fiber and its coating are inserted (FIGS. 3A and 3B).

The sleeve may have one or more lateral lateral grooves 172, for example longitudinal (FIG. 3B) or helical. Each groove 172 is arranged to allow the silicone to flow into the tube 14 during filling in the case of the first embodiment and to serve as an anchor in the case of the second embodiment.

The centering member 17 may comprise a part 173 in the form of a helix (designated spiral wedge below) which is wound around the heart 10 of the optical fiber and its coating 11 (FIG. 3C). This embodiment will be particularly advantageous when the probe is implemented by overmolding and the spiral wedge is made of silicone. To facilitate the fabrication of the probe by guaranteeing the centering of the fiber and the feasibility of overmolding, without making any recovery on the final part, this shim can be previously produced and assembled on the optical fiber before being placed in the overmolding mold. . The spiral wedge will also maintain relative flexibility over the entire length of the probe.

Without limitation, the spiral block, made of biocompatible material, can be made of stainless steel wire, iridescent platinum, or by extrusion of silicone or acrylate.

This spiral wedge may have a square, rectangular section or a substantially square section whose two opposite sides are curved. One of these two sides thus has a radius of curvature adapted to the external diameter of the optical fiber (core + coating) and the other of these two sides can have a radius of curvature adapted to the internal diameter of the tube 14. This solution will in particular allow it to better fit the contours of the tube and the fiber and limit the risks of incipient fractures.

The spiral wedge can be of variable length. It can extend from the connection section to the end of the optical fiber, on the distal side. Distal side, it can be interrupted at the same level as the stimulation optical fiber or upstream with respect to the optical direction.

The centering member 17 will advantageously be produced with a radiopaque marking so as to allow control of the correct positioning of the probe during installation in surgery.

The device may include at least one optical feedback system making it possible to transmit a measurement of the optical power generated at the end of the probe. This optical feedback solution can be used in the context of the first embodiment and the second embodiment.

This system comprises at least one optical fiber 18 advantageously wound in a helix around the optical fiber (10, 11) for stimulation, to recover an optical signal from the optical output towards the optical input. It will thus provide, in addition or as an alternative, the role of the centering member as defined above and shown in FIG. 3C and its shape will not constitute an obstacle to the flow of the silicone 13 during overmolding. On the side of the optical input, the return optical fiber is advantageously taken in the ferrule and is assembled in the optical connector which is intended to be connected in the optical base.

This return optical fiber 18 can have different configurations:

- a circular section core and a circular section coating (180 FIG. 4A);

- A heart of circular section and a covering having a section of rectangular shape, advantageously of square shape (181 - Figure 4B);

- A heart of circular section and a covering having a substantially square section, the two opposite sides of which are curved (184 FIG. 4C). One of these two sides can thus have a radius of curvature R1 adapted to the external radius of curvature of the optical fiber (core + coating) and the other of these two sides can have a radius of curvature R2 adapted to the radius of curvature internal of the tube 14. This solution will make it possible in particular to better conform to the contours of the tube and of the fiber and to limit the risks of incipient rupture.

The system can also comprise two return optical fibers 182,183, wound in a helix around the stimulation optical fiber (FIG. 4D). The two optical fibers may have a cross-section of shape and / or identical or different dimensions, for example with a circular cross-section heart and a coating as defined above in connection with FIGS. 4A to 4C. Likewise, they can supplement an existing centering member or replace it to maintain and center the optical fiber during manufacture.

Each return optical fiber has an optical input end through which the optical signal is picked up and an optical output end through which the captured optical signal is picked up.

The two helices formed by the two optical fibers advantageously have an identical helix pitch and are interlaced around the stimulation optical fiber.

The two fibers 182, 183 may terminate at a different distance from the distal end of the probe in order to evaluate the optical return at different distances from the emission point. On the proximal side, the two return optical fibers are advantageously taken in the ferrule and assembled in the optical connector which is intended to be connected in the optical base.

The stimulation optical fiber and the two return optical fibers are embedded at least over part or over the entire length of the probe in the silicone coating, preferably over the entire length of the probe, whether in the within the framework of the first realization or within the framework of the second realization.

According to a particular aspect of the invention, the spiral wedge solution (in the form of a return optical fiber or not) makes it possible in particular to limit the sliding of the two elements against each other, in particular when the probe is bent.

With reference to FIG. 5, in the first embodiment with a tube 14, several solutions can be envisaged to form the last section (section S4) of the device, at its distal end:

- A: A first solution consists in gluing a piece 19 full of hemispherical (or oblong) silicone at the end of the third section (section S3); fiber centering can be achieved by a specific centering member 17 as described above;

B: A second solution consists in depositing by surface tension a drop 20 of silicone on the end of the third section; Fiber centering can be achieved by a specific centering member 17; This solution can be implemented when filling the tube or a posteriori.

C: A third solution consists in making a full piece 21 of silicone (epoxy or any other stable material in the tissues) by molding so as to form a stopper of optical quality coming to sink into the tube of the second section up to the end of the optical fiber; fiber centering (core + coating) can be achieved by a specific centering member 17;

D: A fourth solution consists in making a full piece 22 of silicone (epoxy or any other material stable in the tissues - transparent or diffusing depending on the intended application) by molding and bringing it by gluing so as to sink into the tube until it surrounds the end of the fiber; the part also has an internal channel into which the end of the fiber can be inserted (core + coating), then playing the role of the centering member; The tube 14 may be of the radioopaque type.

In the first embodiment of the optical probe, according to a particular feature, the distance (L) between the end of the tube 13 and the end of the core of the optical fiber on the distal side allows to play on the power density at the end of the device. The tube being made of non-optical silicone, it will be necessary to ensure that the third section (section S3) is not too long in order to avoid that the light ray leaving the optical fiber (at the level of the second section - section S2 ) does not strike the inner wall of the tube 14. This distance will for example be 2.5mm (with a possible variation of +/- 0.25mm).

The device may include a stop system intended to adjust the level of insertion of the probe during implantation (FIGS. 6A and 6B). This solution allows manual placement of the probe, without risk to the patient, and applies to both embodiments of the device.

This stop system is intended to come into abutment against the surface of the Neuroguide previously positioned and fixed on the cranial box during implantation and thus makes it possible to stop and adjust the level of penetration of the device.

This system can be glued or integrated into the optical probe according to the embodiment.

This system comprises a member, such as a sleeve 23, fixed on the tube 14 of the device or on the molding coating 130 and one or more spacers 24a, 24b of different lengths disposed between said member and the extra-cortical area for adjust the insertion length of the probe. FIG. 6A thus represents a first configuration with a spacer 24a of a first length and FIG. 6B represents a second configuration with a spacer 24b of a length distinct from that of the first configuration. By varying the length of the spacer, it is thus possible to adjust the position of the stop formed by the sleeve 23 against another stop.

The sleeve 23 can be made of different materials, silicone, metal (titanium, stainless steel), or plastic (PEEK for PolyEtherEtherKetone) ...

The invention thus has numerous advantages, including:

A probe perfectly suited to long-term implantation, at the same time waterproof, solid and flexible in the particularly sensitive area;

The use of different types of optical quality materials (silicone, PU, etc.) as described above, allows the creation of a device compatible with placement in the brain and particularly in the third ventricle by the way. by one of the lateral ventricles;

An easy to manufacture solution, whether by injection into the tube or by overmolding;

A reliable solution, obtained in particular thanks to a perfect positioning of the different elements, thanks to the centering member;

A probe allowing effective treatment, in particular thanks to the optical return solution, the latter being moreover particularly compact;

Claims (20)

1. An implantable illumination device, intended to be implanted in a living being in order to locally illuminate an area of said living being, said device comprising a probe (1) having an architecture elongated along an axis between a proximal end and a distal end , said architecture being characterized in that it is produced from: - an optical fiber which comprises a core (10), a coating (11) and a protective sheath (12), - a coating (13, 130), - and in that said architecture comprises: - several successive sections along its longitudinal axis, each section having a section (Sc to S4 or Sc to S30) with several layers concentrically superposed, in which each section comprises a section with several superimposed layers distinct from the section of each adjacent section , - At least a first section along which said optical fiber is coated with the coating (13, 130), at least a second section extending said first section, in which said optical fiber is stripped to remove its protective sheath so as to leave only its core and its optical coating coated by the coating and in order to improve the sealing and the flexibility of the probe over at least a non-zero part of its length. 2. Device according to claim 1, characterized in that it comprises a first section, the section (S1) of which comprises a first layer comprising the core (10) of optical fiber, a second layer comprising the coating (11) of optical fiber , a third layer comprising the protective sheath (12) of optical fiber, a fourth layer comprising the coating (13) and a fifth external layer composed of a tube (14). 3. Device according to claim 2, characterized in that it comprises a second section extending said first section and the section (S2) of which comprises a first layer comprising the core (10) of said optical fiber, a second layer formed by the coating (11) of the optical fiber, a third layer comprising said coating (13) and a fourth layer comprising said tube (14). 4. Device according to claim 3, characterized in that it comprises a third section extending said second section and the section (S3) of which comprises a first layer comprising said coating (13) and a second layer comprising said tube (14). 5. Device according to claim 4, characterized in that it comprises a fourth section extending said third section and the section (S4) of which includes said coating (13). 6. Device according to claim 5, characterized in that the fourth section comprises the distal end of the probe and in that this distal end is configured so as to be atraumatic. 7. Device according to claim 5 or 6, characterized in that the fourth section is glued to the third section. 8. Device according to claim 5 or 6, characterized in that the fourth section is formed by depositing a drop of silicone in liquid form on said third section. 9. Device according to claim 5 or 6, characterized in that it comprises a silicone plug inserted at the end of the tube and comprising said fourth section and said third section. 10. Device according to claim 9, characterized in that the tube is made of a radiopaque material. 11. Device according to claim 1, characterized in that it comprises a first section, the section (S10) of which comprises a first layer comprising the core (10) of optical fiber, a second layer comprising the coating (11) of optical fiber , a third layer comprising the protective sheath (12) of optical fiber, a fourth layer comprising the coating (130) overmolded on the optical fiber. 12. Device according to claim 11, characterized in that it comprises a second section extending said first section and the section (S20) of which comprises a first layer comprising the core (10) of said optical fiber, a second layer formed by the coating (11) of the optical fiber, a third layer comprising said coating (130). 13. Device according to claim 12, characterized in that it comprises a third section extending said second section and the section (S30) of which includes said coating (13). 14. Device according to claim 13, characterized in that the third section comprises the distal end of the probe and in that this distal end is configured so as to be atraumatic. 15. Device according to one of claims 1 to 14, characterized in that the coating is made of a material chosen from silicone and polyurethane. 16. Device according to one of claims 1 to 15, characterized in that the coating of the fiber is made of a material of the fluoro-acrylate type. 17. Device according to one of claims 1 to 16, characterized in that the protective sheath is made of ETFE. 18. Device according to one of claims 1 to 17, characterized in that it comprises a connection section, located upstream of the first section, the section (Sc) of which comprises a first layer formed from the core of the fiber, a second layer formed of the fiber optic coating, a third layer formed of an adhesive and a fourth layer formed of a ferrule. 19. Device according to one of claims 1 to 18, characterized in that it comprises a light source (2) to which said probe is optically connected by its proximal end. 20. Device according to one of claims 1 to 19, characterized in that it comprises a stop member associated with at least one spacer for adjusting the insertion of the probe and the position of its distal end. 1/5