FR3095765A1 - Introducer catheter and specific guide for endovenous laser treatment, and method of assisting the placement of this introducer catheter - Google Patents

Abstract

"Introducer-catheter and specific guide for endovenous laser treatment, and method of assisting in placing this introducer catheter" Introducer catheter (2) used to introduce a laser treatment optical fiber (F) into a varicose vein a patient from a point identified on his skin, comprising a first element (20) acting as a needle and a second element (21) acting as an introducer of this fiber (F). In a first embodiment, this introducer catheter may include a non-return valve and perform both the function of a needle and the function of an introducer. Other embodiments of this introducer catheter can implement a long needle previously inserted into a part acting as a dilator itself inserted into the second introducer element, or even a first short catheter element acting as a needle. and dilator and a second element acting as an introducer and being arranged to receive in insertion said first catheter element. See Figure 1

Description

Catheter-introducer and specific guide for endovenous laser treatment, and method for assisting the placement of this catheter-introducer

The present invention relates to a laser fiber introducer catheter used in endovenous laser treatment. It is also aimed at a specific guide, as well as a procedure for assisting with the placement of this introducer catheter.

The technical field of the invention is in particular that of the treatment and elimination of varicose veins.

State of the prior art

Endovenous laser treatment of varicose veins has been practiced for many years. It implements desilets ^® designed to allow a laser fiber suitable to penetrate a vein to guide a beam of coherent laser light towards a predetermined zone of a vein. In practice, these introducers are introduced into a vein by means of needles and devices performing a guiding function (guides).

Document US 8,454,586 B2 (Anastasie) thus discloses a laser instrument for performing vascular occlusions, in particular in intravenous treatments. This instrument has a needle in which a guide has been inserted. This needle is introduced into a varicose vein so as to penetrate the guide into the latter, then a dilator and an introducer. The guide is then removed and an optical fiber is then inserted into the introducer.

US 6,520,975 B2 (Branco) discloses an endoluminal device for removing anatomical structures such as vascular structures under endoscopic visualization of the process from the anatomical structure or surgical region of interest, using a small number of small incisions

Document WO2006/052558A2 discloses a device for treating varicose veins or the great saphenous vein, implementing infrared laser radiation in the 1.2 to 2.2 μm band inside a vein. This device uses a laser beam guided through a fiber optic catheter (short).

These endovenous laser treatment techniques have in common that they implement the well-known Seldinger technique. In this technique, one generally implements a needle, a guide, a dilator and an introducer during seven stages. We first perform 1) a puncture of the varicose vein with the needle; 2) placement of the guide using the needle in the varices; 3) the needle is then withdrawn leaving the guide in place; 4) placement of an introducer with a dilator over the guide; 5) close micro-anesthesia of the skin and micro-incision at the entry point of the guide; 6) Push the introducer and the dilator over the guide into the varices; 7) the guidewire and the dilator are then removed and the introducer is left in place.

However, it turns out that practitioners performing endovenous laser treatments and implementing this Seldinger technique sometimes encounter difficulties in introducing the guides into the varicose veins and in addition are confronted with the risk of these guides being released.

The object of the present invention is to propose a new concept of introducer catheter for endovenous laser treatment, which is more ergonomic and safer than existing catheters.

This objective is achieved with an introducer catheter used to introduce a laser treatment optical fiber into a patient's varicose vein from a puncture point located on the patient's skin. According to the invention, this catheter-introducer comprises a first element acting as a needle and a second element acting as an introducer of said fibre.

In a first version of the invention, the introducer-catheter comprises a short catheter with a non-return valve, this introducer-catheter performing both the function of needle and the function of introducer and being arranged to receive in insertion an optical fiber for endovenous laser treatment.

In a second version of the invention, the catheter-introducer comprises a first catheter element acting as a needle and a dilator and a second element acting as an introducer and being arranged to receive the first catheter element by insertion, this first element catheter being arranged to be withdrawn from the second introducer element before insertion of the optical fiber into the varicose vein via this second introducer element.

In a third version of the invention, the first needle element comprises a long needle previously inserted into a part acting as a dilator itself inserted into the second introducer element, this long needle being arranged to be withdrawn with the dilator from the second element introducer before insertion of the laser treatment optical fiber into the varicose vein via this second introducer element.

The introducer catheter according to the invention is also advantageously arranged to be guided by means of a specific insertable guide element after having withdrawn the needle.

This guide element, short and of large caliber, includes a means to prevent its release into the varicose vein, as well as a perfectly rounded tip. It is intended to guide an introducer catheter according to the invention, with a view to ascending a varicose tortuosity, and it is arranged to be inserted into the second introducer element or into the valve catheter.

In a particularly advantageous embodiment, the specific guide according to the invention further comprises means for adjusting the exit length of said guide from the second introducer element. These length adjustment means comprise an adjustable ring.

The specific guide according to the invention comprises means for preventing said guide from being released into the varicose vein, for example in the form of a ring placed at a distal end of said guide. This guide can be preset with non-adjustable crimp rings.

An introducer catheter according to the invention can be implemented in endovenous laser treatment equipment comprising a laser source provided to produce a laser beam of predetermined wavelength, a laser optical fiber provided to guide this laser beam from said source to an area of interest within a varicose vein of a human or animal subject. It is through this or these introducer catheters that the laser fiber will be introduced into the varicose vein and brought to all the areas to be treated.

Indeed, this endovenous laser treatment equipment may also comprise a plurality of introducer catheters inserted at predetermined points of a varicose vein and provided to successively receive the laser fiber.

According to another aspect of the invention, there is proposed a method for assisting the placement of introducer-catheters according to the invention, comprising ultrasound marking of a varicose vein which will be subjected to endovenous laser treatment, implementing ultrasound equipment comprising (i) an ultrasound probe intended to be applied to a lower limb of a patient so as to follow said varicose vein and (ii) a screen for displaying an ultrasound image of said varicose vein, characterized in that that said varicose vein constitutes a single reference element for orienting said echographic image on said screen, and in that said varicose vein is visualized on said screen in the same position as when said varicose vein will be subjected to said endovenous laser treatment.

The visualization of the varicose vein on the screen of the ultrasound equipment must be carried out from the distal end of the said varicose vein towards the proximal end of the said varicose vein.

The assistance method according to the invention can advantageously provide assistance in determining the successive locations of introducer catheters along the varicose vein being viewed, assistance with orientation to the left or to the right of an introducer catheter in a varicose vein being viewed.

Assisting in the orientation of an introducer catheter may include, in response to capture by the ultrasound probe of an introducer catheter engaged in a varicose vein in a determined orientation (left or right), visualization, on the screen of the ultrasound equipment, said introducer catheter as arriving according to said same determined orientation.

The assistance method according to the invention may further comprise a step of assistance in marking a first puncture point at the level of a varicose vein, a step of assistance in marking an axis of the varicose vein, and a step for assisting in the marking of an additional puncture point, upstream of the first puncture point.

Thus, practitioners now have an introducer catheter that involves fewer manipulations than current devices, and does not require a puncture needle, a dilator, or a systematic guide. Furthermore, it is always possible to use with an introducer catheter according to the invention a specific guide when necessary, essentially to lift varicose tortuosity.

The laser fiber is retained by the valve of the short valved catheter or introducer, unlike a conventional catheter, which allows it to be kept positioned at the desired location without assistance.

When a guide is used, this guide is secured to avoid any risk of dropping. In addition, the risk of infection is then significantly reduced because this guide is very short. In addition, there is no need for staff to hold the guide.

There is no more blood on the operating table because we no longer use a puncture needle. The laser fiber cannot slide freely through the introducer because it contains a valve. Positioned at the desired location, for example at the sapheno-femoral junction, the laser fiber is subject to less movement and is retained by the valve of the short valved catheter or the introducer.

The present invention makes it possible to implement a faster endovenous laser treatment. In fact, the technique for placing the introducer-catheters according to involvement involves fewer manipulations than Seldinger's previous technique and it does not require a puncture needle, dilator or systematic guide except for the treatment of tortuosity for which a new concept of specific guide is proposed within the framework of the present invention.

Thus, an endovenous laser treatment implementing an introducer catheter according to the invention provides more safety for the patient than previous practices insofar as there is no longer any risk of an unsecured guide being released, and where there is less risk of infection due to a short operating sector even in the case of the use of a specific guide because the latter is short. In addition, the non-use of a puncture needle results in the absence of blood on the table and high visibility of the material.

The introducer catheter according to the invention can be used for the treatment:

• rectilinear saphenous trunks,
• saphenous trunks with varicose dilatations, segment in bayonets, blind segments. As the introducer catheters and specific guidewires are rigid, they are easily ultrasound guided. They can therefore easily pass these varicose deformities without perforating the varicose wall and without inducing thrombosis. Multiple introductions can be performed to treat these saphenous trunks with deformities,
• very short proximal saphenous trunks, thanks to a 4 or 5 cm introducer catheter without a guide,
• rectilinear varicose tributaries,
• tortuous varicose tributaries, thanks to the introducer equipped with the specific guide, by ascending the varicose tortuosities. Multiple introductions can be made to treat these tortuous tributaries,
• of a short segment of varicose vein, thanks to an introduction 3 cm upstream of this varicose segment.

Thus, the present invention provides a new technique for placing a venous introducer with specific equipment and without the use of a guide, for veins or varicose veins without major tortuosity. A specific venous guide can be used for varicose tortuosity.

This new technique makes it simpler, faster and safer to catheterize varices for endovenous treatments, especially for endovenous laser with multiple introductions. It increases the feasibility of treatments and allows complete treatments without having the disadvantages of techniques with guides.

Description of figures

Other advantages and particularities of the invention will appear on reading the detailed description of implementations and non-limiting embodiments, and of the following appended drawings:

FIG. 1 is a cross-sectional view of an introducer catheter: short catheter with anti-reflux (blood) valve, in a first embodiment of the invention;

FIG. 2 is a schematic sectional view of a catheter, an introducer and a catheter-introducer assembly, in a third embodiment of the invention;

Figure 3 is a schematic sectional view of a needle, a dilator and an introducer, in a second embodiment of the invention;

Figure 4 is a schematic sectional view of a specific guide according to the invention, alone and then inserted into an introducer;

FIGS. 5A, 5B and 6 respectively illustrate the first, second and third implementation steps of an introducer catheter according to the invention;

FIGS. 7 and 8 illustrate a particular step of the method for assisting with positioning according to the invention, dedicated to marking a first puncture point;

FIG. 9 illustrates ultrasound guidance of an introducer catheter according to the invention in a varicose vein;

FIG. 10 illustrates a particular implementation of the assistance method according to the invention, such that the bevel of the catheter always remains under the ultrasound probe;

FIG. 11 illustrates a particular step of the assistance method according to the invention, implementing a process for vibrating the catheter-introducer according to the invention;

FIG. 12 illustrates how the assistance method according to the invention can make it possible to avoid a particular situation in which an introducer catheter would perforate a deep part of the varicose vein;

FIG. 13 illustrates a particular situation of invagination of the vein wall around the introducer catheter according to the invention;

FIG. 14 illustrates an implementation of the method for assisting the placement of several introducer catheters according to the invention; And

FIG. 15 represents an operating station suitable for endovenous laser treatments implementing specific introducer catheters and guides according to the invention.

Detailed embodiments

These embodiments being in no way limiting, variants of the invention may in particular be considered comprising only a selection of characteristics described or illustrated below isolated from the other characteristics described or illustrated (even if this selection is isolated within a phase comprising these other characteristics), if this selection of characteristics is sufficient to confer a technical advantage or to differentiate the invention from the state of the prior art. This selection includes at least one preferably functional feature without structural details, and/or with only part of the structural details if only this part is sufficient to confer a technical advantage or to differentiate the invention from the state of the art anterior.

We will first describe kits of materials allowing the implementation of an introducer catheter according to the invention.

Several specific kits are available with:

- different catheters of varying calibers and lengths depending on the kit, with or without valves,

- different introducers: 5 F, 6 F, of variable lengths depending on the kit (4 to 11 cm). It should be noted that the catheter of the kit must be placed in the introducer of the kit before the start of treatment, and

- various specific guides that are very short, rigid, of large caliber and with perfectly rounded tips, sometimes referred to as "blunt tips".

These specific guides are secured by a device making release impossible. Their dimensions vary depending on the kit: for example a caliber of about 2 mm, and a length of about 16 cm.

The guide always exceeds the introducer of the corresponding kit by 0.5 cm by pre-adjustment, but this guide is adjustable by means of a key included in the kit, and it can exceed the introducer by 0.3 to 3 cm.

In a first embodiment illustrated by FIG. 1, an introducer catheter 2 according to the invention is obtained by using a short valved catheter comprising a needle element 20 with a bevelled end 20', this short catheter serving as an introducer element 21 and incorporating a non-return valve V.

The catheter 2 has a gauge adapted to receive an optical fiber F inserted into the catheter which serves as introducer element 21, after removal of the needle 20. The non-return valve V then fills the entire gap between the optical fiber F and the internal wall of the introducer element 21, thus preventing the blood from flowing back upstream of the catheter which serves as the introducer element 21, while allowing the fiber F to slide inside this introducer element 21.

In a second embodiment illustrated by FIG. 2, the introducer-catheter according to the invention can be made by inserting a catheter 2', provided at its end with a bevel 20', into an introducer 3 to make a introducer catheter 1.

In a third embodiment illustrated by FIG. 3, the introducer-catheter 10 according to the invention can be produced by inserting a needle 4 into a dilator 5 itself inserted into an introducer 6. This device 10 is provided with a valve provided to prevent backflow of blood.

In the case of treatment of varicose tortuosity, a specific guide is used as described in FIG. 4. This specific guide 300 has a short length of between 8 and 20 cm, typically 16 to 17.5 cm, a large having a substantially circular section with a diameter substantially between 1.2 and 2.2 mm, typically 1.8 to 2 mm, and a perfectly rounded end 311.

This specific guide 300 comprises a cylindrical body 310 provided with a first adjustable ring 312 provided to adjust the extent of its exit from the introducer 3, for example between 0.3 and 3 cm, and a second fixed ring 313 arranged at its extravascular end and designed to prevent the release of the guide 300 into the varicose vein.

A description will now be given, with reference to FIG. 15, of an embodiment of an operating station 100 dedicated to endovenous laser treatment and in which specific introducer catheters and guides according to the invention are employed by a practitioner performing this treatment. .

This operating station 100 is organized around a dedicated intervention table 530 and includes:

- a piece of furniture 560 receiving in its upper part, an ultrasound unit 520, a monitoring monitor 510, a sedation control unit 511, a support 561 for mapping the varicose veins to be treated on a patient, and in its lower part a support 512 for an oxygen bottle, a support 515 for a bottle of MEOPA (equimolar oxygen-nitrous oxide mixture), a bin 523 for contaminating waste and a bin 524 for other waste,

- a piece of furniture 540 receiving a laser unit 541 and a pump unit 542 provided to allow anesthesia by peri-venous tumescence,

- two small rolling tables 550,551 provided to receive on their upper plate respectively, the treatment set 2 and the field set 3.

The intervention table 530 is provided with a system 535 allowing its height to be adjusted, and comprises a central part 531, a reclining backrest 534 and two independent parts 532, 533 for receiving each of the two lower limbs of the patient with variable inclinations. This operating table is motorized to adjust the different inclinations and the height of the table, and it is controlled from a set 58 of pedals that can be operated by the practitioner seated on a stool 57 which is itself height-adjustable by foot.

The intervention table 530 is also provided on one of its sides with a bracket 513 to receive the probe 521 of the ultrasound unit 520, and on the other side with an armrest 538 provided to receive the arm of a patient. A second bracket can be provided to receive an infusion bag, as well as a hoop 56 fixed to the table 530 on the side opposite that where the practitioner is located and provided to support a secondary screen 62 for viewing images of the ultrasound unit 520 and a lighting device 59 for the intervention scene, for example Scialytic® lighting.

A connecting cable between the ultrasound unit 520 and the secondary screen 62 can be arranged at least partly inside a tube constituting the arch 56. This cable can be shielded to ensure transmission of image immune to electromagnetic interference. The arch 56 can also incorporate a power cable for the lighting device 59.

The operating station 100 is thus configured so that it allows a practitioner to perform an endovenous laser treatment alone under the best conditions of efficiency, using only two pairs of gloves.

We will now describe a method of ultrasound marking of varicose veins, implemented prior to the placement of the introducer catheters.

The working reference in ultrasound is often the scanner, and consequently, in ultrasound. If the patient is in the supine position, the mark on the ultrasound probe indicates the right of the patient and the left of the echo-Doppler screen (for example: to examine a large saphenous vein).

But it is the opposite if the patient is in the prone position, the left of the patient indicating the left of the screen (for example, for the short saphenous vein). For the lateral and medial sides of the legs, practitioners have different ways of proceeding. It should be noted that in the ultrasound method, the varicose vein will always be examined in cross section.

The ultrasound marking method makes it possible to achieve a good 3D reconstruction of the varicose veins in the brain of the doctor who examines the varicose veins, and therefore a good pre-treatment skin marking.

This same doctor will therefore be able to better visualize the progress of his endovenous laser treatment of varicose veins, even if the varicose vein is complex and he treats several trunks and several varicose tributaries.

The varicose vein should be the only reference element. The practitioner looks at the varicose vein on ultrasound, in the same position as when it will be pricked on ultrasound, and always from distal to proximal.

The ultrasound probe mark indicates the left of the varice, and the left of the varice always remains at the left of the screen.

It is the patient who turns if necessary, do not take into account the right or the left of the patient. For example, consider treating a small right saphenous varicose vein, then the communicating inter saphenous vein, then the great right saphenous vein.

The marking begins while the patient is in the prone position, then continues in the supine position. The placement of the introducer catheters will follow the same chronology.

With this method, during the endovenous laser treatment, the orientation of the introducer catheters is very simple: if one wants to orient an introducer catheter to the left in the varicose vein, it is tilted to the left under the ultrasound probe, and we'll see it coming to the left of the ultrasound screen.

Sterile marking is performed while the patient is installed in prone position, just before the puncture of the varicose vein. This marking is essential because it specifies the marking carried out the day before or the morning of the treatment, this marking having been carried out in the "treatment position" (not standing), and while the movements of the patient's tissues modify the position of the varicose veins by in relation to the skin and therefore in relation to skin marks.

For the implementation of an ultrasound probe, a compress impregnated with water will be used instead of an ultrasound gel which reduces the skin marker.

We will now describe several characteristic steps of the aforementioned marking method, it being recalled that the varicose vein is always examined in cross section:

1) is carried out, with reference to Figures 7 and 8, a marking of a first point 11, which will be the puncture point. An ultrasound probe 61, connected to ultrasound equipment 60 provided with a screen 62, is placed by the practitioner perpendicular to the skin 8. The tip 71 of a marking pen 70 is slid under the probe. ultrasound 61 just above the varicose vein 9, and this point 71 must print a depression of the skin 8, which must be reflected on the screen 62 by a clearly visible flattening of the marked varicose vein 9. Otherwise, the point 71 is moved of the marking pen 70 to be exactly above the varicose vein 9.

2) the axis of the varicose vein is then marked with a second point which is marked in the same way 5 cm downstream of the first point.

3) A line is drawn between the 2 points to visualize the axis of the varicose vein.

4) If necessary, in particular for technical reasons, it is possible to prick the skin along the same axis at a distance of approximately 2 to 3 cm upstream of the first marking point, therefore, 2 to 3 cm from the place where the varicose vein will be penetrated. These 2-3 cm will be ultrasound guided intracutaneously along the same axis that was defined by the two points.

We will now describe, with reference to Figures 5A, 5B and 6, the main steps of a method of implementing introducer catheters according to the invention.

In a first step illustrated by FIG. 5A, the practitioner performs a local micro-anesthesia of the puncture point 11 which has been marked beforehand on the skin 8 of the patient by the ultrasound marking technique which has just been described.

For catheters with a width of 16 G gauge (reference commonly used in the catheter and medical equipment trade), local micro-anaesthesia is sufficient. For 14G or 13G gauge width catheters and 5F or 6F type introducers, a micro-incision is added to the local micro-anesthesia to be made strictly perpendicular to the skin:

- either a micro-incision with a 16 G needle,

- or a 1 mm micro-incision with an ophthalmology scalpel blade 7 type No11.

In a second step illustrated by FIG. 5B, the practitioner introduces the introducer catheter 10, while being ultrasound guided. It is important to note that this catheter-introducer 10 illustrated by FIG. 3 and shown in FIGS. introducer catheter 1 of Figure 2.

The ultrasound probe 61, as described previously, is covered with ultrasound gel, then it is rested. The introducer catheter 10 is introduced into the top beveled micro-incision and is pushed in about 3 mm. The practitioner's right hand holds the introducer catheter 10, while his left hand stretches the skin 8.

The ultrasound gel is then spread on the skin along the axis defined by the echo-marking. Then the introducer catheter 10 is pushed under ultrasound control.

The ultrasound probe 61 is held by the first three fingers of the left hand of a right-handed practitioner. It touches the skin without compressing it otherwise the flexible varicose vein 9 becomes invisible. The three points of support and feeling for guidance are the last two folded fingers and the ulnar edge of the left hand.

With reference to FIG. 9, an angle of approximately 30° is given to the catheter-introducer 10 with respect to the skin 8 and the ultrasound probe 61 is inclined by 120° with respect to the skin 8, this to keep a optimum angle of 90° (120°-30°=90°) between the introducer catheter 10 and the ultrasound probe 61, which makes the introducer catheter 10 perfectly visible on the screen 62 intracutaneously, especially at the level of its 20' bevel.

Keep the bevel of the introducer catheter under the ultrasound probe. To properly visualize the varicose vein 9, the ultrasound probe is placed at 90° in relation to the skin 8. There is therefore a small constant scan (120° to optimize the view of the catheter, 90° for the varicose vein 9), all this at the same time as the displacement of the ultrasound probe 61 as the progress of the introducer catheter 10 in the varicose vein 9, so that the bevel 20 of the introducer catheter 10 always remains under the probe of ultrasound 61, with reference to Figure 10. Depending on the angular orientation of the ultrasound probe, the screen 62 specifically visualizes the introducer catheter centered inside the varicose vein 9.

When the sensation of the penetration of the varicose vein is realized (sensation of a jump, of a vibration), it will be checked by a light tapping of the catheter-introducer 1 by a finger 13 of the practitioner, so as to see it vibrate very freely the bevel of the introducer catheter 1 in the vascular lumen 9, with reference to Figure 11.

If it does not vibrate, there are two possibilities:

- the introducer catheter 10 has perforated a deep part of the varicose vein 9, as shown in figure 12. It must be withdrawn slightly and realigned in the center of the varicose vein 9 then complete the catheterization well centered. Verification of the centering is obtained by the vibration of the 20' bevel and a reflux of blood.

- The introducer catheter has not yet perforated the varicose wall which is very flexible, there is an invagination of the venous wall around the catheter (6) as shown in figure 13. It is therefore necessary to continue the penetration of the bevel 20' centered in the vascular lumen until you feel the perforation of the varicose wall. Verification of the centering is obtained by vibrating, by a finger 13 applied to the proximal end of the introducer catheter 10, of the bevel 20' and a reflux of blood.

The introducer catheter 10 is then pushed along its entire length or over a chosen length. A specific short guide (not shown) may be useful for verification, but this is not essential. An upstream introduction of the varicose light (2 to 3 cm) can be used.

The introducer catheter 1 is pushed strictly intracutaneously over these 2 to 3 cm, which brings it to the varicose lumen. This makes it possible to have a good fit of the introducer in the skin, to catheterize short rectilinear segments of varicose vein, and during laser treatment, to keep the laser active until the last millimeter of varicose vein.

To place several introducer catheters, always start with the most distal introducer catheter and end with the most proximal introducer catheter, with reference to figure 14. Failing this, a proximal introducer catheter can hinder or prevent the positioning of the ultrasound probe necessary to visualize the rise of the distal introducer catheter.

For the following special cases in which the very short proximal saphenous segments, even located 7 cm from the sapheno-femoral or sapheno-popliteal junctions, can be treated (with a very short introducer catheter without a guide) maintaining good fiber positioning and without bleeding on the table, the introduction is done in this case 2 or 3 cm upstream of the varicose segment, intracutaneously so that part of the introducer remains well maintained in the skin.

For varicose tortuosity, a non-tortuous segment of about 3 cm must be identified, catheterized with the introducer catheter, and the catheter replaced with the specific guide.

Then under ultrasound control, the varicose tortuosity must be lifted with the help of skin traction. The perfectly rounded large end of the specific short guide allows the introducer to be pushed without damaging the varicose vein.

If the rectilinear segment of the varicose tortuosity is very short, the introduction can be made 2 or 3 cm upstream of the varicose lumen, to advance the introducer catheter to the small rectilinear segment.

If a tortuosity is impassable, one proceeds as for the first introduction by making a second introduction and according to the same procedure as above. As many introductions are made as necessary to achieve a complete treatment.

As soon as the introducer-catheter(s) are placed in the varicose vein, the blood reflux is controlled in all the introductions, the needle(s), catheters and guides are removed in a third step illustrated by figure 6. A laser fiber 12 can then be introduced into the first part of the varicose vein 9 to be treated.

Of course, the invention is not limited to the examples which have just been described and many adjustments can be made to these examples without departing from the scope of the invention. Of course, the different characteristics, forms, variants and embodiments of the invention can be associated with each other in various combinations insofar as they are not incompatible or exclusive of each other. In particular, all the variants and embodiments described above can be combined with each other.

Claims (11)

Introducer catheter (1,2,10) used to introduce a laser treatment optical fiber (F) into a varicose vein of a patient from a point located on the skin of said patient, comprising a first element (20,4 ) acting as a needle and a second element (3,6,21) acting as an introducer of said fiber (F). Catheter-introducer (2) according to claim 1, characterized in that it further comprises a non-return valve (V), said catheter-introducer (2) ensuring both the function of needle and the function of introducer and being arranged to receive in insertion an optical fiber (F) for an endovenous laser treatment. Introducer catheter (1) according to Claim 1, characterized in that it comprises a first short catheter element acting as a needle and a dilator (2') and a second element acting as an introducer (3) and being arranged to receive said first catheter element (2') for insertion, said first catheter element (2') being arranged to be withdrawn from said introducer element (3) before insertion of the optical fiber into the varicose vein via said second introducer element (3). Introducer catheter (10) according to Claim 1, characterized in that the first needle element comprises a long needle (4) previously inserted into a part (5) acting as a dilator which is itself inserted into the second introducer element (6) , said long needle (4) being arranged to be withdrawn with said dilator (5) from said second introducer element (6) before insertion of the laser treatment optical fiber into the varicose vein via said second introducer element (6). Specific guide intended to guide an introducer-catheter according to any one of claims 2 to 4, with a view to ascending a varicose tortuosity, arranged to be inserted into the second introducer element of said introducer-catheter. Specific guide according to Claim 5, characterized in that it has a length substantially between 8 and 20 cm. Specific guide according to one of Claims 5 or 6, characterized in that it has a substantially circular section with a diameter substantially between 1.2 and 2.2 mm. Specific guide according to any one of Claims 5 to 7, characterized in that it also comprises means for adjusting the length of exit of the said guide from the second introducer element. Specific guide according to Claim 8, characterized in that the length adjustment means comprise an adjustable ring. Specific guide according to any one of Claims 5 to 9, characterized in that it also comprises means for preventing said guide from being released into the varicose vein. Specific guide according to Claim 10, characterized in that the release prevention means comprise a ring arranged at a distal end of the said guide.