ENDOVEINOUS TREATMENT ASSEMBLY AND DEVICE

Abstract

The endovenous treatment assembly comprises a wire element (1) for delivering treatment doses, such as for example an optical fiber, which is flexible and capable of being inserted, over part of its length, longitudinally into a vein (V), and a positioning and guiding part (2A), which is integral with the wire element (1) for delivering treatment doses so as to allow manipulation of the wire element (1) for delivering treatment doses by means of this part (2A), the wire element (1) for delivering treatment doses being able to slide in the direction of its length relative to said part (2A);the part (2A) comprises first means for guiding in translation a first portion (110a) of the wire element (1) for delivering treatment doses in the direction of its length and first mechanical assembly means (202, 203) allowing its removable mounting relative to a drive system (4), such that said first portion (110a) of the wire element (1) for delivering treatment doses can be positioned and guided by means of this part (2A) relative to the drive means of the drive system (4) for driving the wire element (1) for delivering treatment doses in the direction of its length at least in a first direction (R).;

Description

Technical field The present invention relates to the field of endovenous treatment, by delivery into the vein of a treatment dose, by means of a flexible wire element. The treatment dose may, in a non-limiting and non-exhaustive manner, be a dose of energy, delivered for example in the form of electromagnetic radiation, by means of sound or ultrasound waves, radiofrequency waves, or be a dose of thermal energy delivered by radiation and / or by contact, or a dose of a product allowing treatment of the vein. The flexible wire element may be hollow or solid, and may in particular, in a non-limiting and non-exhaustive manner, be an optical fiber, a cable-type wire element or a flexible probe or a flexible cannula. Prior art In the field of endovenous treatment, it is known to treat a vein by delivering treatment doses into the vein by means of a flexible wire element, which is inserted longitudinally into the vein, and whose withdrawal movement must be controlled during treatment. More particularly, in the field of endovenous laser therapy, better known by the acronym EVLT, it is common to treat a vein by means of an endovenous laser (for example, endovenous laser occlusion of saphenous varices), the flexible wire element of which is an optical fiber used to emit electromagnetic radiation into the vein. For other types of endovenous treatment, the flexible wire element may, in a non-limiting and non-exhaustive manner, also be a flexible cable or probe or a flexible cannula. Examples of endovenous treatment devices are described for example in the following publications: US 2005 / 0131400, US2008 / 0097224, US2008 / 0097408, US 6,814,727. Usually, the withdrawal of the flexible wire element inserted longitudinally into the vein, and for example of the optical fiber, can be controlled during treatment by the practitioner by means of a motorized drive system, also called a withdrawal system, making it possible to pull longitudinally on the rearmost part (furthest from the patient's body) of the flexible wire element while controlling the withdrawal speed. This withdrawal can, depending on the case, be carried out continuously or step by step. The motorized withdrawal systems commonly used comprise drive means in the form of at least one pair of drive rollers (or rollers) between which the flexible wire element passes and which allow the wire element to be driven by friction. Flexible wire dose delivery elements, such as an optical fiber, are generally single-use consumables, which are discarded once they have been used. In practice, for each treatment the practitioner removes the flexible wire dose delivery element, such as an optical fiber, from its sterile packaging and must correctly position by hand a portion of this flexible wire element between the drive rollers of the drive system. These operations of handling and positioning the flexible wire dose delivery element relative to the drive rollers of the drive system are restrictive and tedious for the practitioner and may also cause accidental damage to the flexible wire dose delivery element, particularly when it is an optical fiber. In addition, it may happen that the practitioner does not correctly position the flexible wire dose delivery element relative to the drive rollers of the drive system on the first attempt and that he has to start again several times. Furthermore, it is advantageous to be able to implement a wire element having a significant length, so as to be able to easily move, outside the sterile operating field, the motorized drive system and the treatment dose delivery system, such as for example the laser source in the case of an endovenous laser. However, this significant length of the wire element poses a problem of space requirement, particularly during operations to remove the wire element. Objective of the invention An objective of the invention is to propose in the field of endovenous treatment a new technical solution which makes it possible to simplify and make more reliable the operations of handling and positioning the flexible wire element for delivering the treatment doses in relation to the drive means of the drive system of an endovenous device. Summary of the invention This objective is achieved by an endovenous treatment assembly comprising a wired element for delivering treatment doses, which is flexible and capable of being inserted, over part of its length, longitudinally into a vein, and a positioning and guiding part, which is integral with the wired element for delivering treatment doses so as to allow manipulation of the wired element for delivering treatment doses by means of this positioning and guiding part, the wired element for delivering treatment doses being able to slide in the direction of its length relative to said positioning and guiding part;said positioning and guiding part comprises first means for guiding in translation a first portion of the wire element for delivering treatment doses in the direction of its length and first mechanical assembly means allowing its removable mounting relative to a drive system, such that said first portion of the wire element for delivering treatment doses can be positioned and guided by means of this positioning and guiding part relative to the; drive means of the drive system for driving the wire element for delivering treatment doses in the direction of its length at least in a first direction. More particularly, the whole of the invention may comprise the following additional and optional features, taken individually, or in combination with each other: - the first mechanical assembly methods allow rapid, tool-free assembly of the positioning and guiding part. - the assembly comprises second means for guiding a second portion of the wire element for delivering treatment doses. - the second guide means guide in translation this second portion of the wire element for delivering treatment doses by making it perform at least a quarter turn and preferably at least a half turn. - the second guiding means are an integral part of the positioning and guiding part. - the wire element for delivering treatment doses comprises a third portion, which extends to the rear end of the wire element for delivering treatment doses, and which is not integral with the positioning and guiding part or which is integral with the positioning and guiding part but can be separated from this positioning and guiding part. - the assembly comprises a coupler which is attached to the rear end of the wired treatment dose delivery element and which allows the wired treatment dose delivery element to be connected to a treatment dose source. - the positioning and guiding part is a single-piece part, and more particularly a molded part. - the positioning and guiding part is made up of a monolithic assembly. - the assembly comprises a flexible guide threaded onto a front portion of the wire element for delivering treatment doses, said wire element for delivering treatment doses being able to slide longitudinally relative to the flexible guide. - the rear end of the flexible guide is integral with the positioning and guiding part, so as to axially block the rear part of the flexible guide at least in the first driving direction of the wire element for delivering treatment doses, and preferably also in the direction opposite to the driving direction of the wire element for delivering treatment doses. - the assembly comprises a storage support, on which is wound all or part of the front portion of the wired element for delivering treatment doses which extends from the front end of the wired element for delivering doses to said first portion of the wired element for delivering treatment doses. - the flexible guide and the part of the wire element for delivering treatment doses threaded into the flexible guide are wound onto the storage medium. - the storage medium and the positioning and guiding part are separate or in which the storage medium and the positioning and guiding part are assembled and separable from each other. - the wired element for delivering treatment doses is an optical fiber. - The assembly further includes a holding system which makes it possible to temporarily hold the front end part of the flexible guide relative to a patient's body, close to the insertion zone of the wire element for delivering treatment doses. - the holding system comprises a holding part, which is fixed or capable of being fixed to the front end part of the flexible guide, and which is adapted to be applied to a patient's body so as to temporarily hold the front end of the guide relative to a patient's body, close to the insertion area of ​​the treatment dose delivery wire element. - the holding system comprises fixing means which make it possible to temporarily fix the holding part applied to the body of a patient near the insertion point of the wired element for delivering treatment doses, and preferably which comprise an adhesive capable of being stuck to the skin. - the positioning and guiding part, the wire element for delivering treatment doses, where applicable the flexible guide, and where applicable the storage support, are sterile and placed in airtight packaging. The invention also relates to an endovenous treatment device comprising an above-mentioned assembly and a drive system, preferably motorized, which comprises drive means, the device further comprising second mechanical assembly means adapted to cooperate with the first mechanical assembly means of the positioning and guiding part, so as to allow said removable mounting of the positioning and guiding part relative to the drive system. More particularly, the device of the invention may include the following additional and optional features, taken in isolation, or in combination with each other: - the second mechanical assembly means are integral or form an integral part of the drive system. - the drive system comprises at least one pair of drive rollers and the second mechanical assembly means are adapted to cooperate with the first mechanical assembly means of the positioning and guiding part, so as to allow the positioning of the first portion of the wire element of delivery of treatment doses between the drive rollers. - The endovenous treatment device further comprises a treatment dose source capable of being connected to the rear end of the treatment dose delivery wire element. - the drive system and the treatment dose source are an integral part of a single monolithic assembly. - the wired element for delivering treatment doses is an optical fiber and the source of treatment doses is a source of electromagnetic radiation. The invention also relates to a use of the above-mentioned assembly or the above-mentioned endovenous treatment device for treating a vein, and in particular for treating a vein by means of electromagnetic radiation. The invention also relates to a method for preparing an above-mentioned endovenous treatment device or an endovenous treatment method using the above-mentioned endovenous treatment device, during which the positioning and guiding part is removably mounted relative to the drive system, and preferably on the drive system, such that a first portion of the wire element for delivering treatment doses is positioned relative to the drive means of the drive system and can be driven at least in a first drive direction. Brief description of the drawings The characteristics and advantages of the invention will appear more clearly on reading the detailed description below of a particular variant embodiment of the invention, which particular variant embodiment is described by way of non-limiting and non-exhaustive example of the invention, and with reference to the appended drawings in which: - figure 1 is an overall schematic view showing an example of implementation of an endovenous treatment device of the invention, of the endovenous laser type, for treating a vein with laser of one leg, - figure 2 is an isometric view of a particular variant of an endovenous treatment assembly of the invention, packaged in its transport and / or storage configuration, - Figure 3 is an isometric view of the assembly of Figure 2, once the storage support is separated from the positioning and guiding part, and the positioning and guiding part is mounted on a drive system, - Figure 4 is an isometric view of the storage medium (without the optical fiber and without the sheath) of the assembly of Figure 2, - Figure 5 represents an example of a drive system, - figure 6 is an isometric view of the assembly of figure 3 during assembly of the positioning and guidance part on the drive system of figure 5, - figure 7 is an isometric view of the assembly of figure 3, once the positioning and guiding part is mounted on the drive system, - figure 8 is a detailed view showing the fixing of the rear part of the sheath on the positioning and guiding part, - Figure 9 is a cross-sectional view showing the indexing of the assembly tabs of the positioning and guiding part relative to the drive system, Figure 10 is an isometric view of an exemplary sheath retention system positioned and secured to a human body part, with the optical fiber inserted through the skin, - figure 11 is a longitudinal sectional view of figure 10, showing in particular the vein and the optical fiber inserted into the vein, - Figure 12 is an isometric view illustrating a step of inserting the front end part of the optical fiber into a vein, by means of an introduction catheter, - Figure 13 is an isometric view showing the introducer catheter of Figure 12, withdrawn from the vein, after the front end of the optical fiber has been introduced into a vein. Detailed description Figure 1 schematically shows an endovenous treatment device with controlled withdrawal, in accordance with the invention, in use for the treatment of a vein. This controlled withdrawal endovenous treatment device includes: - a flexible wire element 1 for delivering treatment doses into the vein, which flexible wire element 1 is an optical fiber in the particular example described in detail below, - a motorized drive system 4 which allows controlled and backward pulling (direction R) on the optical fiber 1, - a positioning and guiding part 2A which will be described in detail below, and which allows rapid and reliable positioning and translational guidance of the optical fiber 1 relative to the drive means of the motorized drive system 4, - a source of electromagnetic radiation L, of the laser source type, which is coupled to the rear end 1a of the optical fiber 1, - a flexible guide sheath 3, which surrounds and guides the optical fiber 1 over a front portion of its length, the optical fiber 1 being able to slide longitudinally relative to the sheath 3. Referring to Figure 1, the flexible guide sheath 3 has a rear end portion 31 and opposite a front end portion 30, which ends in a front opening 30a allowing the passage of the optical fiber 1. The optical fiber 1 is threaded into the guide sheath 3, such that the guide sheath 3 surrounds and guides the optical fiber 1 over a portion of its length, with a rear portion 11 of the optical fiber 1 and opposite a front portion 10 of the optical fiber 1 positioned outside the guide sheath 3. The front end of the optical fiber 1 which allows the emission of electromagnetic radiation in the vein is thus positioned outside the guide sheath 3. The rear end part 31 of the flexible sheath is integral with the positioning and guiding part 2A, so as to axially block this rear part 31 of the guiding sheath 3, relative to the optical fiber 1, at least in the withdrawal direction R of the optical fiber 1, and preferably also in the opposite direction of advancement F of the optical fiber 1, the optical fiber 1 being able to slide longitudinally relative to the guiding sheath 3. The motorized drive system 4 thus makes it possible to pull the optical fiber 1 backwards (arrow R) by making it slide relative to the sheath 3. The sheath 3 must allow the optical fiber 1 to slide with preferably a minimum of friction and must preferably be biocompatible. The inner diameter of the sheath 3 must also be adjusted relative to the outer diameter of the optical fiber 1, in order to limit the radial displacements of the optical fiber 1 in the sheath 3 and allow efficient transmission of longitudinal movements. If the difference between the inner diameter of the sheath 3 and the outer diameter of the optical fiber 1 is too large, a detrimental latency time may occur between the moment when the motor of the drive system 4 is activated and the moment when the actual withdrawal of the fiber relative to the sheath is observed.As non-limiting and non-exhaustive examples, with an optical fiber 1 having an external diameter of 900 pm, a sheath 3 having for example an internal diameter of 1000 pm will be used, and with an optical fiber 1 having an external diameter of 600 pm, a sheath 3 having for example an internal diameter of 700 pm will be used. Different materials can be used for the sheath 3, including, but not limited to, the following materials: silicone, polyurethane, PTFE, PET, ETFE, latex, thermoplastic elastomer. In the particular embodiment variant of Figure 1, but in a non-limiting manner of the invention, the device also comprises a holding system 5 which makes it possible to temporarily fix the front end part 30 of the guide sheath 3 on the body C of a patient (in this case in Figure 1 and in a non-limiting manner on a leg) near the insertion point 7 of the optical fiber in the body C. It should be noted that within the scope of the invention, the flexible guide sheath 3 and / or the holding part 5 are optional and may not be implemented in another variant embodiment of the invention. The drive system 4 comprises two pairs of rotary drive rollers 40, 41, between which a first rectilinear portion 110a of the optical fiber 1 is positioned and guided by the part 2A. The rollers 40 are, for example, motorized drive rollers and the rollers 41 are, for example, rollers mounted to rotate freely. These rotary drive rollers 40, 41 make it possible to drive the optical fiber 1 backwards (direction R) by friction at a controlled speed which depends on the speed of rotation of the rollers 40, 41 during the operation of controlled withdrawal of the optical fiber relative to the vein to be treated. In another alternative embodiment, the drive system 4 may comprise only a pair of rotary drive rollers 40, 41. More generally, the rotary drive rollers 40, 41 may be replaced by any equivalent means fulfilling the function of driving the optical fiber. In the embodiment variant of Figure 1, the drive system 4 for the controlled withdrawal of the optical fiber 1 and the source of electromagnetic radiation L are advantageously an integral part of the same monolithic assembly E. In another embodiment variant, the drive system 4 can however be separate and remote from the source of electromagnetic radiation L. With reference to figures 2 and 3, in this particular embodiment, the endovenous device also comprises a storage support 2B on which are wound all or part of the portion of the optical fiber 1 which extends from the front end of the optical fiber 1 to said first portion 110a of the optical fiber 1 and all or part of the flexible sheath 3 threaded onto the optical fiber 1. This storage support 2B makes it easier to transport, store and handle the optical fiber 1. In the particular embodiment illustrated in Figures 2 to 4, this storage support 2B and the positioning and guiding part 2A are separate, and can more particularly be superimposed flat on each other so as to limit their bulk during transport. More particularly, this storage support 2B and the positioning and guiding part 2A can in an embodiment variant be temporarily assembled for example by clipping, and be easily separable. The assembly of Figure 2 is preferably packaged for transport in a hermetic packaging (not shown), for example a bag or a blister pack, after having been previously sterilized. This assembly of Figure 2 is removed from its packaging by the practitioner in the sterile operating field, before carrying out the endovenous treatment. This assembly of Figure 2 can advantageously, but not necessarily, be disposable and single-use. In the particular embodiment illustrated in the figures, the storage medium 2B forms (figure 4) a rigid part in the shape of a four-armed cross 21a, for example a single-piece plastic part. The sheath 3 and the optical fiber 1 are wound on this cross (figure 2), being inserted and locked between elastic clips 21b at each end of the arms 21a of the cross. Once the storage medium 2B is separated from the positioning and guiding part 2A (figure 3), the sheath 3 and the portion of the optical fiber 1 wound on this storage medium 2B can be easily removed manually from the 2B storage medium by an operator and unrolled for use. Within the scope of the invention, any other shape and / or any type of material for producing this part serving as a storage support 2B is conceivable. Furthermore, within the scope of the invention, this storage support 2B is optional, the endovenous assembly being able to comprise only the positioning and guiding part 2A and the wire element 1 for delivering treatment doses, threaded where appropriate onto a flexible guide 3. In the particular embodiment of the attached figures, the positioning and guiding part 2A is a rigid, single-piece flat part, for example a molded plastic part. Any other shape and / or any other material for producing this positioning and guiding part 2A is possible. The positioning and guiding part 2A is not necessarily a single piece and may, in another variant, be constituted by a rigid and monolithic assembly of several elements together. The sheath 3 comprises at its rear end 31 a connector 6 (figures 8) which is adapted to be fitted onto the positioning and guiding part 2A, so as to make the rear end 31 of the sheath 3 integral with the positioning and guiding part 2A, obtaining axial locking of the rear part of the sheath 3 at least in the first direction of withdrawal R towards the rear of the wire element 1 for delivering treatment doses, and preferably also in the direction F (towards the front) opposite to the direction of withdrawal R of the optical fiber 1. This connector 6 can also, but not necessarily, be permanently fixed to the part 2A, for example by gluing. The rear portion 11 of the optical fiber 1 which protrudes from the rear end of the sheath 3 is secured to the positioning and guiding part 2a, so as to allow the manipulation of the optical fiber 1 by means of this positioning and guiding part 2A, and the optical fiber 1 can slide in the direction of its length relative to said positioning and guiding part 2A, being partly guided by this part 2A, as will now be detailed. More particularly, with reference in particular to FIG. 2, the rear portion 11 of the optical fiber 1 comprises a first portion 110a of optical fiber 1, which extends towards the rear of the optical fiber 1 from the rear end of the sheath 3 provided with the connector 6, and which is preferably rectilinear. The positioning and guiding part 2A comprises first guiding means in the form of three guiding elements 200a, 200b, 200c, which are aligned and into which this first portion 110a of optical fiber 1 is threaded. These guiding elements 200a, 200b, 200c make it possible to secure the optical fiber 1 to the part 2A by guiding the optical fiber 1 in translation in this first rectilinear portion 110a, when the optical fiber 1 slides in the direction of its length relative to the part 2A. In this variant, the first portion 110a of optical fiber 1 extends rearwardly by a second portion 110b (figure 6), and the part 2A comprises second guide means 201, which make it possible to secure the optical fiber 1 to the part 2A and to guide the optical fiber 1 in translation in this second portion 110b, when the optical fiber 1 slides in the direction of its length relative to the part 2A. More particularly, in this variant embodiment this second portion 110b is curved, the second guide means guiding in translation this second portion 110b of the optical fiber 1 by advantageously making it perform a half-turn. The second portion 110b of optical fiber 1 extends to the rear end 1a of the optical fiber 1 by a third portion 110c (Figures 2 and 6). At this rear end of the optical fiber 1 is fixed an optical coupler 112 for coupling the optical fiber to the laser source L. In this embodiment variant, this third portion 110c of the optical fiber optical fiber 1 and the optical coupler 112 are temporarily secured to the part 2A, being fitted into the part 2A and can be easily removed manually from the part 2A by an operator (figure 3) and be unwound in order to couple the optical fiber 1 to the laser source L. In another embodiment, this third portion 110c of the optical fiber 1 and the optical coupler 112 can be permanently separated from the part 2A. With reference to Figure 2, the positioning and guiding part 2A comprises first mechanical assembly means 202, 203 capable of cooperating with second mechanical assembly means 42, 43, which in this variant are an integral part of the drive system 4 (Figures 5 and 9). These first 202, 203 and second 42, 43 mechanical assembly means allow a removable, rapid and tool-free mounting of the positioning and guiding part 2A relative to the drive system 4, and more particularly in this variant a removable, rapid and tool-free mounting of the part 2A on the drive system 4. Once the positioning and guiding part 2A is mounted relative to the drive system 4, said first portion 110a of the optical fiber 1 is positioned between the drive rollers 40, 41 of the drive system 4 for the rearward friction drive (arrow R) of the optical fiber 1 by the drive rollers 40, 41. In this particular variant embodiment and in a non-limiting manner of the invention, with reference to Figures 2 and 9, the first mechanical assembly means comprise a recess 203 in the part 2A and two assembly tabs 202 which are an integral part of the part 2A and which comprise at least on one face a hemispherical housing 202a (Figure 9). With reference to Figures 5, 6, 7 and 9, in this variant the second mechanical assembly means are an integral part of the drive system 4 and comprise a hooking element 43, which is adapted to cooperate with the recess 203 in the part 2A and two indexing elements 42 for each assembly tab 202 (Figure 9), which are positioned on either side of the assembly tab 202, when the part 2A is mounted on the drive system 4. With reference to Figure 9, each indexing element 42 comprises a ball 42a which is resiliently pushed back towards the assembly tab 202 in the locking position of Figure 9, by a spring (not visible) housed in a cylindrical body 42b. When the part 2A is mounted on the drive system 4, one of the two balls 42a (right-hand ball in Figure 9) is resiliently pushed back so as to be housed partly in the hemispherical housing 202a of the assembly tab 202 and the other ball 42a (left-hand ball in Figure 9) is resiliently pushed back so as to bear against the assembly tab 202. Initially, with reference to Figure 2, the largest portion of the optical fiber 1 surrounded by the sheath 3 is packaged by being wound on the storage medium 2B. The connector at the rear end 31 of the sheath 3 is secured to the positioning and guiding part 2A, as previously described. The rear portion 11 of the optical fiber 1 without sheath 3 is secured to the positioning and guiding part 2A, as previously described; the storage medium 2B is superimposed with the positioning and guiding part 2A. The assembly is thus compact, and can be easily handled and / or stored and / or transported. To position the optical fiber 1 of this assembly relative to the drive system 4, the following procedure is used. If necessary, the storage support 2B and the positioning and guiding part 2A are separated. The third portion 110c of the optical fiber carrying the optical coupler 112 at its end is removed from the positioning and guiding part 2A (figure 3). The positioning and guiding part 2A with the optical fiber 1 is mounted on the drive system 4, which makes it possible to easily, quickly and precisely position the first rectilinear portion 110a of the optical fiber between the drive rollers 40, 41. In this particular embodiment variant, this assembly is carried out in two phases. In a first phase (figure 6) the part 2A is positioned relative to the drive system 4, by aligning the recess 203 of the part 2A vertically and horizontally relative to the hooking element 43, as illustrated in figure 6. In a second phase (figure 7), the part 2A is lowered vertically relative to the drive system 4, so as to insert the upper edge of the recess 203 into the hooking element 43. During this downward movement, the assembly tabs 202 are positioned between their indexing elements 42. This descent of the part 2A is carried out into the indexing position of figure 9. This removable mounting of the part 2A allows an operator to quickly and reliably position the first portion 110a of the optical fiber 1 between the drive rollers 40, 41. When these rollers 40, 42 drive the optical fiber 1 by pulling on this first portion 110a, the optical fiber 1 slides relative to the sheath 3 while being guided by the guide means 200a, 200b, 200c and 201 of the part 2A. Once the part 2A has been mounted, it is then sufficient to fix the front part 30 of the sheath 3 to the holding part 50 of the holding system 5 (figure 10) and the device is then ready to be used to carry out an endovenous treatment, for example and in a non-limiting manner of the invention in the following manner. (a) The front end part 30 of the sheath is fixed relative to the body C, by fixing the holding part 50 on the human body C near the insertion point 7 of the optical fiber 1, for example by means of an adhesive 51 (figure 10). (b) A hollow needle, commonly called a puncture needle, is inserted in the usual manner through the skin and into the vein V to be treated. The tip of the needle is located by ultrasound using an ultrasound probe. The insertion point of this needle corresponds to the insertion point 7 mentioned above. (c) A guide wire is inserted into this hollow needle into the vein to be treated, then the needle is withdrawn. (d) An introducer catheter 8 is threaded over the guidewire to the entrance of vein V and the guidewire is withdrawn (Figure 12). (e) Once the introduction catheter 8 is in place (figure 12), the front end portion 10 of the optical fiber 1, which protrudes outside the front end portion 30 of the sheath 3, is inserted into the introduction catheter 8 and the optical fiber 1 is slid forward relative to the sheath 3, until the end of the front end portion 10 of the optical fiber 1 penetrates longitudinally into the vein V and progresses longitudinally in the vein V to the area to be treated furthest from the insertion point 7. During this operation, the drive motor of the rollers of the drive system 4 is disengaged. (f) Once the optical fiber 1 has been introduced and positioned in the vein V, the catheter 8 is removed from the vein V by sliding it backwards over the optical fiber 1 (Figure 13). Optionally, the catheter 8 is removed from the optical fiber 1, for example by splitting it in two in the case of a tearable catheter. Alternatively, the catheter can be removed at the end of the treatment procedure. The practitioner can then carry out the endovenous treatment in the usual manner by manually actuating the laser source L, in order to emit electromagnetic radiation into the vein in the region of the end of the proximal part of the optical fiber 1 and by controlling the continuous or step-by-step withdrawal of the optical fiber 1 by means of the motorized withdrawal system 4. Thanks to the guide sheath 3, the front end part 30 of which is temporarily fixed to the body C, close to the insertion point 7 of the optical fiber 1, and the rear end part 31 of which is axially blocked relative to the optical fiber 1 by means of the connector 6, the endovenous treatment can advantageously be carried out without the optical fiber 1 is not stretched and reducing the risk of accidental movement of the optical fiber relative to the vein being treated. Once the laser treatment is complete, the optical fiber 1 is completely removed from the vein and the holding system 5 is detached from the human body. The practitioner can then disconnect the optical fiber 1 from the laser source L, and remove the part 2A with the optical fiber 1 from the drive system 4. In the embodiment variant of Figure 1, the rear portion 11 of the optical fiber 1 is advantageously guided and returned forwards by the second guide means 201 of the part 2A, thanks to the half-turn made by the second rear portion 110b of the fiber 1. Thus, when withdrawing the optical fiber 1 backwards (arrow R), the optical fiber 1 being held and guided by the second guide means 201, the risks of accidental snagging in the optical fiber by a person or an object are avoided. More generally, the second guide means 201 may be designed to guide in translation this second portion 110b of the wire element 1 for delivering treatment doses by making it perform at least a quarter turn. In another alternative embodiment, the second portion 101b of the optical fiber 1 which is guided so as to make at least a quarter turn is not necessarily located in the rear extension of the first portion 101a of the optical fiber 1, but can be positioned in the front extension of the first portion 101a of the optical fiber 1. Furthermore, the second guide means 202 are not necessarily an integral part of the part 2A, but could be guide means distinct and separate from this part 2A. Preferably, the second mechanical assembly means 42, 43 are integral or form an integral part of the drive system 4. However, in another alternative embodiment, the second mechanical assembly means 42, 43 may be separated from the system. drive system 4 and may for example be fixed or form an integral part of a table-type support, on which the drive system 4 would be placed. The invention is not limited to an endovenous laser treatment device. In other embodiments covered by the invention, the optical fiber may be replaced by a wire element (solid or hollow), for example of the cable or flexible probe or flexible cannula type. The treatment is not necessarily a laser treatment, but may be any treatment by delivery of treatment doses into the vein, and in particular doses of energy, delivered for example in the form of electromagnetic radiation, by means of sound or ultrasound waves, radiofrequency waves, or doses of thermal energy delivered by radiation and / or by contact, or doses of a product, for example liquid, semi-liquid or foamy, allowing treatment of the vein. The withdrawal system 4 can more generally be replaced by any drive system making it possible to drive the wire element 1 for delivering treatment doses in at least one given drive direction R. This drive system 4 of the device is not necessarily motorized, but could be a manually operated drive system. In the context of the invention, the guide sheath 3 can be replaced by any equivalent flexible guide fulfilling the same guiding function as the sheath 3. For example, and in a non-exhaustive manner, the sheath 3 can be replaced by a flexible guide in the form of a gutter, and having for example a U-shaped cross-section, or by a flexible wire guide twisted around the optical fiber 1 or equivalent, or by a flexible guide which is magnetized to allow its attachment to the wire element 1 for delivering the treatment doses. The flexible guide 3 is not necessarily made of a single piece but may consist of several assembled elements. For example, the guide 3 may comprise a flexible guide sheath or equivalent to the front end of which a rigid introduction catheter would be fixed, the holding system 5 making it possible to temporarily hold this introduction catheter on the patient's body. The holding system 5 may comprise only the holding part 50 or equivalent and may not comprise the fixing means 51 or equivalent. In this case, the holding part 50 is used to temporarily manually hold the proximal end portion 30 of the guide 3 relative to the patient's body near the insertion point 7 of the wire element 1 for delivering treatment doses. The holding system may comprise fixing means making it possible to temporarily fix the proximal end portion 30 of the guide 3 to the body of a patient, near the insertion zone 7 of the wire element 1 for delivering treatment doses, without using the holding part 50. For example, the holding system may be formed of one or more adhesives capable of being applied directly to the front end portion 30 of the guide 3 and of being stuck to the body of the patient to temporarily fix the front end portion 30 of the guide 3 relative to the body of the patient near the insertion point 7 of the wire element 1 for delivering treatment doses.

Claims

CLAIMS 1. Endovenous treatment assembly comprising a wire element (1) for delivering treatment doses, which is flexible and capable of being inserted, over part of its length, longitudinally into a vein (V), and a positioning and guiding part (2A), which is integral with the wire element (1) for delivering treatment doses so as to allow the manipulation of the wire element (1) for delivering treatment doses by means of this positioning and guiding part (2A), said positioning and guiding part (2A) comprising first means (200a, 200b, 200c) for guiding in translation a first portion (110a) of the wire element (1) for delivering treatment doses in the direction of its length and the wire element (1) for delivering treatment doses being able to slide in the direction of its length relative to these first means (200a, 200b, 200c) for guiding in translation said positioning and guiding part (2A), and said positioning and guiding part (2A) comprising first mechanical assembly means (202, 203) allowing its removable mounting relative to a drive system (4),such that said first portion (110a) of the wire element (1) for delivering treatment doses can be positioned and guided by means of this positioning and guiding part (2A) relative to the drive means of the drive system (4) and can be driven in the direction of its length by the drive means of the drive system (4) for driving the wire element (1) for delivering treatment doses in the direction of its length at least in a first direction (R)., 30 2. Assembly according to any one of the preceding claims comprising second guide means (201) of a second portion of the wire element (1) for delivering treatment doses.

3. Assembly according to claim 2, in which the second guide means (201) guide in translation this second portion of the wire element (1) for delivering treatment doses by making it perform at least a quarter turn and preferably at least a half turn.

4. Assembly according to any one of claims 2 or 3, in which the second guide means (201) form an integral part of the positioning and guide part (2A).

5. Assembly according to any one of claims 2 to 4, in which the wire element (1) for delivering treatment doses comprises a third portion (110c), which extends to the rear end of the element. wired (1) for delivering treatment doses, and which is not integral with the positioning and guiding part (2A) or which is integral with the positioning and guiding part (2A) but can be separated from this positioning and guiding part (2A). 20 6. An assembly according to any one of the preceding claims comprising a coupler (112) which is fixed to the rear end (1a) of the wired element (1) for delivering treatment doses and which makes it possible to connect the wired element (1) for delivering treatment doses to a source of treatment doses (L).

7. Assembly according to any one of the preceding claims, in which the positioning and guiding part (2A) is a single-piece part, and more particularly a molded part. 30 positioning and guiding part (2A) is made up of a monolithic assembly.

9. Assembly according to any one of the preceding claims, 5 comprising a flexible guide (3) threaded onto a front portion of the wire element (1) for delivering treatment doses, said wire element (1) for delivering treatment doses being able to slide longitudinally relative to the flexible guide (3). 10 10. Assembly according to claim 9, in which the rear end (31) of the flexible guide (3) is integral with the positioning and guiding part (2A), so as to axially block the rear part of the flexible guide (3) at least in the first driving direction (R) of the wire element (1) for delivering treatment doses, and preferably 15 also in the direction (F) opposite to the driving direction (R) of the wire element (1) for delivering treatment doses.

11. Assembly according to any one of the preceding claims, comprising a storage medium (28), on which is wound all or part of the front portion of the wire element (1) for delivering treatment doses which extends from the front end of the wire element (1) for delivering doses to said first portion (110a) of the wire element (1) for delivering treatment doses, 25 12. Assembly according to claim 11 and any one of claims 9 and 10 in which the flexible guide (3) and the part of the wire element (1) for delivering treatment doses threaded into the flexible guide (3) are wound on the storage support (28). guide are separated or in which the storage support (2B) and the positioning and guide part (2A) are assembled and separable from each other. s 14. Assembly according to any one of the preceding claims, in which the wire element (1) for delivering treatment doses is an optical fiber.

16. Assembly according to any one of the preceding claims, 1 o further comprising a holding system (5) which makes it possible to temporarily hold the front end part (30) of the flexible guide (3) relative to the body of a patient, close to the insertion zone (7) of the wire element (1) for delivering treatment doses. 15 16. Assembly according to claim 15, in which the holding system (5) comprises a holding part (50), which is fixed or capable of being fixed to the front end part (30) of the flexible guide (3), and which is adapted to be able to be applied to the body of a patient so as to temporarily hold the front end part (30) of the guide (3) relative to the body of a patient, close to the insertion zone (7) of the wire element (1) for delivering treatment doses.

17. Assembly according to claim 16, in which the holding system (5) comprises fixing means (51) which make it possible to temporarily fix the holding part (50) applied to the body of a patient near the insertion point (7) of the wire element (1) for delivering treatment doses, and preferably which comprise an adhesive capable of being stuck to the skin. delivery of treatment doses (1), where applicable the flexible guide (3), and where applicable the storage medium (2B), are sterile and placed in airtight packaging. 5 19. Endovenous treatment device comprising an assembly referred to in any one of the preceding claims and a drive system (4), preferably motorized, which comprises drive means (40, 41), the device further comprising second mechanical assembly means (42, 43) adapted to cooperate with the first mechanical assembly means (202, 203) of the part of positioning and guiding (2A), so as to allow said removable mounting of the positioning and guiding part (2A) relative to the drive system (4), 15 20. Endovenous treatment device according to claim 19, in which the second mechanical assembly means (42, 43) are integral or form an integral part of the drive system (4), 21. Endovenous treatment device according to claim 19 or 20, in which the drive system (4) comprises at least one pair of drive rollers (40, 41) and the second mechanical assembly means (42, 43) are adapted to cooperate with the first mechanical assembly means (202, 203) of the positioning and guiding part (2A), so as to allow the positioning of the first portion (110a) of the wire element (1) for delivering treatment doses between the drive rollers (40, 41).

22. Endovenous treatment device according to any one of claims 19 to 21, further comprising a source of treatment doses (L) capable of being connected to the rear end of the element wired (1) for delivering treatment doses.

23. Endovenous treatment device according to claim 22, wherein the drive system (4) and the treatment dose source 5 (L) are an integral part of the same monolithic assembly (E).

24. Endovenous treatment device according to any one of claims 22 to 23, wherein the wire element (1) for delivering treatment doses is an optical fiber and the source of treatment doses (L) is a source of electromagnetic radiation.

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