EP0825825A1

EP0825825A1 - Instrument intended to the location of veins by means of optical fibers and to the simultaneous ablation thereof

Info

Publication number: EP0825825A1
Application number: EP96917527A
Authority: EP
Inventors: Pierre-Louis Choukroun
Original assignee: MXM SAS
Current assignee: MXM SAS
Priority date: 1995-05-22
Filing date: 1996-05-22
Publication date: 1998-03-04
Also published as: WO1996037143A1; US6013073A; FR2734468B1; AU6006996A; FR2734468A1

Abstract

The invention relates to instruments which are intended to proceed to the medical examination of the body conduits visually by using a lighting device and which can also, optionally, operate surgically within said conduits. The present invention relates to an instrument which is mainly intended to the location of veins and, at the same time to the ablation, and of which the elongate central body (10) has at least one optical fiber (1) connected at one end to a light source (2); said instrument, according to the invention, is such that said optical fiber (1) is a fiber which diffuses light laterally and gradually with respect to its axis XX' and which is provided at its distal extremity not connected to the light source (2) with a transparent head (4) having an external diameter larger than that of said central body (10).

Description

Instrument intended to locate veins by optical fiber and to ablate them at the same time.

The present invention relates to an instrument intended mainly for locating veins by optical fiber and for their ablation at the same time.

The technical sector of the invention is that of instruments for carrying out the medical examination of the ducts of the body by visual examination with an illumination device and which may also make it possible, depending on the case, to intervene surgically in said ducts.

The main application of the invention is the identification of venous lines for the extraction of varicose veins by various venous techniques which are currently:

* or exo-veining carried out in different ways: - by a stripper fitted with a ball which "tears off" the vein and takes it off from the peri-venous tissues: this technique is described in patent application No. FR 2.133.338 published on October 30, 1972, thanks to

“An instrument for the surgical 'linkage' of veins in synthetic plastic material”; - by exo-stripping devices using rings whose action is similar to that of the stripper;

- by hook phlebectomies which attracts the vein by a mini-incision and, by traction and dissection, externalizes it, making it possible to withdraw it by incisions in variable number. * Either by endo-veining which ensures the inversion of a "glove finger" or invagination of the vein, which is removed by traction inside the vascular lumen, this method being less traumatic for the peri-venous nervous structures. The same principle is applied during stripping on stems. • However, all these methods come up against a problem of identifying venous paths and require dissection, the difficulty of which increases with overweight, edema, skin condition, the presence of trophic disorders or hypodermitis . To date, we use, to carry out such identification, the clinical examination and the pre-operative echo-doppler allowing better to locate and draw directly on the skin the venous paths, but these tracings, made on the standing subject , are offset during the intervention where the patient is in supine or ventral position.

There are also known techniques for locating by internal and point lighting of the body, using optical fibers which are introduced from outside the body into the chosen duct, such as a vein: an external light source is then connected to the end of the fibers located outside the body, and these guide the light to their other distal end, that is to say the one which has penetrated into said duct and the most distant from said light source, where they illuminate then the vein around their end like a spotlight. Such a technique is described in patent application No. DE 3,603,782 published on October 15, 1987 which teaches a probe comprising, on the one hand a central channel for introducing liquids, and on the other hand optical fibers distributed at the periphery of this channel and located in the thickness of the wall of the probe, to illuminate at the end of the latter, in the event of blockage during the progression of a surgical intervention instrument in the vein: can then identify from outside the body by transillumination, that is to say by transmission of light through the tissues, the level of blockage and decide what action to take; it is therefore only a punctual locating instrument, and which does not allow the varicose veins to be extracted, either by exo-vein or by endo-vein, which require another instrument as described above and who is precisely the one who could have blocked in the vein

The problem is then to be able to essentially, on the one hand locate at the same time the whole of a venous path, in order to bring a third dimension to the operator who would then see the light path marked out on the surface and in depth, and on the other hand with the same instrument, to practice strikes which are at the same time complete, selective and esthetic thanks in particular to the said luminous line which directs exactly the seat of the incision and the dissection of the vein. One solution to the problem posed is an instrument for locating veins, and composed of an elongated central body made up of at least one optical fiber connected at one end to a light source, said optical fiber being a fiber diffusing light laterally and radially with respect to its axis XX '; said central body is provided at its distal end not connected to the light source, with a transparent head with an external diameter greater than that of the central body; in a preferred embodiment, said central body comprises only a single monobloc optical fiber made of polymer and preferably of polymethyl methacrylate. Said transparent end head may be a rounded cylinder in the shape of an ogive; in addition, the last few, for example 5 centimeters from the central body behind said transparent head, may be in the form of a helix or a twist, in order to have a dilation effect on the vein, thus promoting the progression of the instrument in it.

In a particular embodiment, said instrument may include a hollow operating channel disposed along said central body for the injection of liquid products near the transparent head of its distal end, where its orifice is then protected by the rear shoulder of the head.

This also allows securing by a simple loop that can slide around the central body of the instrument and then abut against said shoulder, a wire for the extraction of the vein by invagination and, according to a particular mode of embodiment, said instrument also includes a warhead which covers said transparent head with a distal end and can then allow exo-veining or a conventional linkage.

The result is a new instrument intended both for the simultaneous identification of the entire path of the veins by transillumination of the latter and for the ablation of the varicose veins by different techniques, which no instrument has permitted to date.

The optical fiber or fibers diffusing the light laterally and radially with respect to their axis, in fact allow lighting total of the entire path of said vein, the transparent head of the distal end makes it possible to cross the venous valves and to immobilize therein a wire for stripping by invagination, that is to say by inversion of the vein like a glove which can then be produced during the same vein lighting intervention; and thanks to the hollow operating channel arranged along the central body, it is possible, if necessary, to introduce contrast or sclerosing liquids according to the type of intervention desired.

Such side-lit optical fibers are described by way of example in patent application No. FR 2,714,147 published on June 23, 1995, which teaches a cylindrical optical fiber structure providing lateral emergence of light, thanks to a certain area of its outer surface, comprising a large number of closely spaced alterations and of very small dimensions relative to the diameter of the fiber, each of the alterations causing a punctual emergence of the light conveyed; the fiber thus appears globally luminous and the surface density of the alterations varies according to the direction of propagation of the light flux, in order to obtain a substantially constant light density over the entire length of the fiber; other methods of manufacturing such fibers, may be that described in PCT patent application No. 93/06769 published on April 15, 1993, which describes a "candle" system, which certainly is not an optical fiber, but which allows lateral light scattering thanks to metallic micro-particles dispersed in said plastic, and which allows the reflection of light which can penetrate into said plastic towards and outside the walls of the latter.

All the features combined in the present invention, even if some are known but separately for other devices and applications, thus provides assistance and a possibility of intervention that no instrument has brought to date, and is proposes thus to make easier, more "brilliant" and more "enlightened" the phlebectomic gesture. As indicated previously, the instruments for illuminating the veins are certainly known since engioscopes make it possible to visualize the valves and the ostium of the veins, but the simultaneous transillumination over the entire path of the veins to promote them, at the same time operating the extraction is the first description according to the present invention.

Another advantage of the invention is to prevent "false routes" from the instrument or stripper: these "false routes" are quite frequent with conventional instruments which can occur, either by perforation of the venous wall, or by engagement of the instrument in a co-lateral already sectioned, or again by engagement in a vein different from the vein to be extracted. The light guide indicates the correct path since it is always lit over the entire length of the fiber serving at the same time as a stripper, and therefore makes it possible to carry out the desired veining, without risk of "false route".

In addition, this path is determined in three dimensions, which makes it possible to inject precisely and at the right depth from the outside, local anesthetic products increasingly used in this surgery, which is indeed often an outpatient surgery. . In addition, the quantity of local anesthetics can be reduced thanks to more precise targeting of the injection site.

The instrument thus generally manufactured is for single use: it must be used under a guarantee of sterilization which gives it total safety in use. We could cite other advantages of this invention, but those mentioned above already show enough to prove its novelty and interest.

The description and the figures below represent an exemplary embodiment of the invention, but are in no way limiting: other embodiments are possible, within the scope and scope of this invention, in particular in the shape of the distal end head, in the number of optical fibers used and the arrangement of the working channel. Figure 1 is an overview of an example of an instrument according to the invention.

Figure 2 is a more detailed view of the part of the central body of the instrument of Figure 1. Said instrument consists mainly of a central body

10 elongated, constituted by at least one cable or optical fiber 1 with lateral diffusion 12, like that described in the application No. FR 2.714.147 cited above, consisting of a core which, in the fibers known to date, is essentially in flexible, flexible and resistant polymer, such as polymethyl methacrylate, but could be of another biocompatible material, such as polycarbonate.

This cable or optical fiber is connected at one end to a light source 2 by a sheathed adapter tip 3.

The optical generators and such light sources 2 are present in each operating room of any hospital center: it is possible to use either halogen or metal halide light generators in white, blue or green color.

The lateral diffusion optical fiber system 12 has intrinsic physical qualities: cold light, total absence of electric current, possibility of operating without risk in a humid environment or in immersion. This eliminates thermal effects and the risk of explosion, electric shock or alteration of surrounding structures.

The length of the instrument, of its central body or of the optical fiber can be from 0.80 to 1.20 meters and the diameter of the central body or of said optical fiber when there is only one is 1.5 to 2.5 millimeters depending on the size of the vein to be lit and extracted.

In a particular embodiment, the instrument is further provided with an operating channel 8, as shown in section in FIG. 2, and which makes it possible to optionally inject, by the same end situated outside the body , once the instrument has been placed in a vein, that the light source 2, using a simple plastic syringe, for example with a plunger, introduced by a nozzle 6, liquid products, such as as dyes, radiological or sclerosing products which will then be discharged 9, at the other distal end of the instrument, near the transparent head 4 placed at the end of the central body 10.

This head 4 of the instrument can be of cylindrical shape whose length can be from 8 to 15 millimeters with a diameter of 3 to 3.5 millimeters, rounded in a warhead at its end and allowing the stowage behind the shoulder 11 thus created by the difference in diameter, of a wire for the extraction of the vein by invagination.

This wire must remain long so that in the event of a vein rupture, the veining is carried out in the opposite direction.

To perform a conventional stripping, a warhead 5 which can be split on the side 7 and made of plastic with a diameter of 7 to 15 millimeters, can be adaptable by any click system combined with said slot 7, on the head 4 or just as well at the other end of the fiber 1 and then allowing exo-veining in one direction or the other.

Said central body 10 can also be made up:

- either of a single monoblock fiber 1,

- Either a single fiber and an operating channel placed laterally with respect to this fiber 1, as in the embodiment of Figures 1 and 2 attached, which operating channel could also be optionally drilled in said optical fiber ,

- Either several adjoining parallel fibers, twisted together and / or bonded and held together by any biocompatible transparent material such as glue based on acrylic varnish, or by ultrasonic welding and said operating channel 8 can be assembled in said bundle composed of said fibers.

In all cases, the whole of said central body 10 must be in one piece; when it is made up of a single optical fiber 1 with said working channel placed laterally with respect thereto, this channel 8 may form a protrusion then slightly increasing the overall diameter or be arranged in a longitudinal groove which would be dug out along said optical fiber 1. The instrument can also facilitate other veining techniques by ensuring three-dimensional identification: hook phlebectomies, rod veining, wick veining, veining and sclerosis.

It can help in the localization of injections of local anesthetics, which will be administered exactly in the useful site, both in area and in depth.

Claims

CLAIMS 1. Instrument intended to locate and ablate veins at the same time, and composed of an elongated central body (10) consisting of at least one optical fiber (1) connected at one end to a light source ( 2), characterized in that said optical fiber (1) is a light-scattering fiber laterally and radially with respect to its axis XX 'and said central body (10) is provided at its distal end not connected to the light source (2 ) a transparent head (4) with an external diameter greater than that of the central body (10).

2. Instrument according to claim 1, characterized in that it comprises only a single optical fiber (1) in one piece made of polymer.

3. Instrument according to claim 1, characterized in that it comprises several optical fibers (1) joined and held together by any transparent biocompatible material.

4. Instrument according to any one of claims 1 to 3, characterized in that said transparent head (4) is a transparent cylinder (4) rounded in a warhead.

5. Instrument according to any one of claims 1 to 4, characterized in that said optical fiber (1) is made of polymethylmethacrylate.

6. Instrument according to any one of claims 1 to

5, characterized in that it comprises a hollow operating channel (6), disposed along said central body (10) for the injection of liquid products near the transparent head (4) at the distal end of said central body ( 10).

7. Instrument according to any one of claims 1 to

6, characterized in that it comprises a warhead (5) with a diameter of at least 7 millimeters, which covers the transparent head (4) at the distal end of said central body (10).

8. Instrument according to any one of claims 1 to

7, characterized in that the diameter of its central body (10) is 1.5 to 2.5 millimeters.

9. Instrument according to any one of claims 1 to 8, characterized in that the last centimeters of the central body (10), behind the transparent head (4), are in the form of a helix or a twist.