WO1990013263A1 - Catheter using energy produced by a laser - Google Patents

Catheter using energy produced by a laser Download PDF

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Publication number
WO1990013263A1
WO1990013263A1 PCT/FR1990/000300 FR9000300W WO9013263A1 WO 1990013263 A1 WO1990013263 A1 WO 1990013263A1 FR 9000300 W FR9000300 W FR 9000300W WO 9013263 A1 WO9013263 A1 WO 9013263A1
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WO
WIPO (PCT)
Prior art keywords
tubular body
optical fiber
catheter
catheter according
lumen
Prior art date
Application number
PCT/FR1990/000300
Other languages
French (fr)
Inventor
Robert Lee Cannon, Iii
Original Assignee
Kaysersberg, S.A.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kaysersberg, S.A. filed Critical Kaysersberg, S.A.
Publication of WO1990013263A1 publication Critical patent/WO1990013263A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A61B18/245Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter for removing obstructions in blood vessels or calculi
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22072Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033Abutting means, stops, e.g. abutting on tissue or skin

Definitions

  • the invention relates to a catheter comprising, inside a flexible tubular body, an optical fiber or a bundle of fibers by means of which laser energy can be applied to destroy tissue obstructing a blood vessel or the like. human body cavity.
  • the targets affected by this type of treatment are urinary, gallstones, or parotid calculi, calcifications of heart valves, pulmonary embolism and various vascular obstructions.
  • urinary, gallstones, or parotid calculi calcifications of heart valves
  • pulmonary embolism calcifications of heart valves
  • various vascular obstructions we note in particular stenoses and thromboses of the coronary arteries.
  • the second generation of devices uses an advanced heating method, according to which laser energy is not applied directly to the lesion but on a metal tip which is heated to a temperature high enough to cause tissue fusion.
  • EP 195375 discloses a laser catheter comprising a fiber or a bundle of fibers disposed inside a catheter terminated by a transparent protective screen. The shooting is carried out through the latter, the distance of which at the distal end of the optical fiber determines the size of the light impact.
  • This catheter is used by bringing the screen into contact with the plate to be treated. Gn thus prevents the blood from interfering between the end of the laser and the target by generating adverse reactions.
  • a constant and predetermined spacing is guaranteed between painted the optical firm and Is plate, which better controls the amount of energy applied to it.
  • the diameter of the catheter is found to be substantially larger than that of the optical fiber it contains. It follows that this concept does not seem to authorize the production of a device allowing access to vessels of small diameter nor to progress very deeply inside the plate under treatment. Furthermore, if we want to incorporate a means for guiding the catheter, we are led to a significant complication of the device.
  • the invention proposes to provide a laser catheter having both a distal end the diameter of which is as close as possible to that of the optical fiber, and means allowing precise guidance towards the operating site so as to bring the end of the optical fiber at the desired point, and in particular in contact with the lesion to be treated.
  • the catheter is characterized in that the optical fiber is movable inside the tubular body between an active position where it is capable of transmitting light energy to the material to be treated and an inactive position where it is set back from the distal end of the tubular body and frees a channel to in particular allow the passage of a guide wire.
  • the device of the invention thus allows the use of known techniques for the precise positioning of the catheter, that is to say, the preliminary introduction into the cavity of a guide wire up to the lesion, then the advancement of the catheter coaxially with the guidewire to the same site.
  • the channel in the distal end region is used for the passage of either the guide wire or the optical fiber.
  • Another object of the invention is to provide a catheter the position of the optical fiber of which can be determined in a simple and precise manner. We arrive at this goal by providing a first r -yen stop solidarity that the optical fiber and a second stop means integral with the tubular body cooperating with one another to immobilize the optical fiber in an axial direction of the tubular body.
  • the first stop means is constituted by the downstream end of the sheath with which the optical fiber is coated
  • the second stop means is constituted by the upstream end of a ring attached to inside the tubular body.
  • a subject of the invention is also a means for safely guiding the optical fiber inside the tubular body. This objective is achieved by providing a portion of tubular body, extending the main tubular body, the lumen of which allows the passage of the optical fiber or a guide wire but not both simultaneously.
  • - Figure 1 is a partial view, in longitudinal section, of the tubular body constituting the laser catheter according to the invention
  • - Figure 2 is an enlarged view, in cross section along AA, of the tubular body of Figure 1 comprising an optical fiber and a guide;
  • FIG. 3 is a partial view, enlarged and in longitudinal section, of the distant end of the catheter with the optical fiber in the operating position;
  • the laser catheter identified by the general reference 1, is composed of a tubular body 3. with a longitudinal lumen 5 open at its two ends.
  • the proximal end not shown, is provided with suitable means for connection to a laser energy source, to the various means for supplying fluids necessary for the treatment as well as to the means controlling the movement of the various organs of the device.
  • the tubular body is made of a flexible material such as a pclyc icrure of vinyl, a polytetrafluoroethylene, a polyethylene, etc.
  • the tubular body ends in a terminal tubular portion 31 whose longitudinal light is an extension of the light with a smaller diameter.
  • An intermediate section $ 2 of connection between the body 3 and the portion 3 is pierced with a lumen 2 whose diameter decreases progressively from lumen 5 to lumen 51.
  • This lumen 2 is for example frustoconical.
  • the tubular portion 31 ends itself, on the side opposite to the section 32, by a plug 33 pierced with an opening 35 d diameter at most equal to that of the lumen 1-
  • This plug constitutes the distal end of the catheter. It can be made of the same material as the tubular body 32 and can then be obtained quite simply by deformation of the walls of the tube or else by molding. It can also be made of another material, for example a softer material, such as silicone rubber, and then be attached to the tube 3.
  • This variant relates to applications, in the region of the heart in particular where it is a question of reducing the risk of damage to the small vessels during the positioning of the catheter.
  • a material opaque to X-rays suitable for this application is stainless steel.
  • This ring provides a channel l communicating the light 51 with the opening 35. and an abutment surface 43 facing upstream.
  • upstream and downstream refer to the direction of propagation of the light wave in the optical fiber from the proximal end, not shown, to the distal end.
  • the lumen 5 of the tubular body 3 is of sufficient diameter to accommodate an optical fiber 60 and a guide element 70, as can be seen in FIG. 2.
  • This guide element can be a stainless steel wire wound in a helix, or any other equivalent element that is usually used for coaxial catheter guidance in the sar. ⁇ r ir.s.
  • the lumen 51 of the tubular portion 31 is of sufficient diameter to accommodate the guide element or else the optical fiber, but not both.
  • the optical fiber 60 known per se, is composed of a fiber or a bundle of fibers 61 of a material, glass or plastic, capable of transmitting the energy of a laser beam or any other radiation. of the same type, generally coated with a protective sheath 63.
  • the guide element 70 it is chosen so that its transverse dimensions are at most equal to that of the bare fiber or fiber bundle 61, for the reason given below.
  • the channel 41 formed by the ring 40 is, as can be seen in FIG. 3, of sufficient diameter to allow the passage of the guide element 70 along which the tubular body is slid to the treatment site, or the optical fiber 6l disengaged from its protective sheath 63-
  • the channel 4l is too narrow for the complete optical fiber to be slid into it, that is to say coated in its sheath.
  • FIG. 3 thus represents the end of the catheter with the optical fiber in the operating position.
  • the fiber has been stripped over a length determined so that its end 67 is located substantially in the plane of the opening 35.
  • a first stop means 65 is in abutment against the surface stop 43, forming a second stop means.
  • the abutment surface is inclined relative to the axis of the tube so as to facilitate the entry of the fiber or the guide wire into the channel 41.
  • the angle of inclination must not be too small so as not to affect the accuracy of the positioning of the fiber. In fact his choice results from a compromise between the two needs.
  • the first stop means 65 integral with the optical fiber, and constituted, according to the example shown, by the end of the sheath of the optical fiber, could thus be produced by any other mcven é ⁇ uivaie ⁇ t such as a ba ⁇ r e ranscrtée on fiber elie- ⁇ iIMO.
  • the ring 40 will preferably include passages sufficient for the fluids, such as for example a physiological liquid for moving the blood or else a contrast liquid for viewing by radioscopy the effect of the treatment. One can dig, for this purpose longitudinal or helical grooves in the wall of the channel 41 or in the mass of the ring itself. These passages have not been shown in the figures.
  • the ring 40 is a simple embodiment of the end of the catheter. However, it can be replaced by bosses, in a longitudinal general direction, circumferentially spaced so as to provide, in addition to the channel 41, axial or helical passages to facilitate the flow of the liquid to be infused in the treatment zone. The bosses will then cooperate with one another to define said second stop means 43.
  • a catheter according to the invention was made, the tubular body of which has an outside diameter of 1.33 ⁇ m (CH.4) and the tubular end portion a diameter of 1 mm (CH3).
  • the channel 4l allows the accommodation of an optical fiber of 0.45 mm in diameter.
  • the catheter can be used according to different procedures depending on the obstruction to be practiced and the preferences of the practitioner.
  • an operating mode can comprise the following steps: A- The guide element 70 is first introduced into the cavity or the blood vessel until its distal end reaches the zone where the obstruction to be treated;
  • B- The tubular body is slid coaxially along the guide until its distal end arrives at the site;
  • C- We can monitor the positioning of the guide and the tubular body by fluoroscopy, by injecting through the light a radiopaque fluid allowing the visualization of the cavity and its obstruction, according to known techniques;
  • the catheter may include an inflatable balloon by means of which it is possible to immobilize the end of the catheter relative to the walls of the cavity.
  • the annular balloon, around the tubular body, is supplied with fluid for inflation from a duct housed inside it.
  • Balloon catheters are well known in the art; there is no need to expand on the description.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Otolaryngology (AREA)
  • Electromagnetism (AREA)
  • Optics & Photonics (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Laser Surgery Devices (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

The catheter includes at least one optic fibre drawn into the interior of a tubular body, and movable between an active position where it is able to transmit energy coming from a laser beam, and an inactive position in which it has been withdrawn into the tubular body. Said optic fibre then frees a channel (41) to allow through a guiding wire in particular. The fibre includes a stop means (65) cooperating with a stop (43) set into the tubular body in such a way as to ensure accurate positioning of its end in relation to the catheter. Application: unblocking of blood vessels or other cavities in the human body.

Description

CATHETER A LASER LASER CATHETER
L'invention se rapporte à un cathéter comportant, à l'intérieur d'un corps tubulaire flexible, une fibre optique ou un faisceau de fibres par le moyen duquel on peut appliquer l'énergie laser pour détruire des tissus obstruant un vaisseau sanguin ou autre cavité du corps humain.The invention relates to a catheter comprising, inside a flexible tubular body, an optical fiber or a bundle of fibers by means of which laser energy can be applied to destroy tissue obstructing a blood vessel or the like. human body cavity.
L'emploi de laser comme source d'énergie pour détruire des cibles déterminées dans le corps n'est pas nouveau. Les premiers scalpels au laser C0_ ainsi que leur couplage à des guides lumineux à fibre optique remontent à i960.The use of laser as an energy source to destroy specific targets in the body is not new. The first C0_ laser scalpels and their coupling to fiber optic light guides date back to i960.
Les cibles concernées par ce type de traitement sont les calculs urinaires, biliaires, ou de la parotide, les calcifications de valves cardiaques, les embolies pulmonaires et diverses obstructions vasculaires. Parmi ces dernières, on note en particulier les sténoses et les thromboses des artères coronaires.The targets affected by this type of treatment are urinary, gallstones, or parotid calculi, calcifications of heart valves, pulmonary embolism and various vascular obstructions. Among these, we note in particular stenoses and thromboses of the coronary arteries.
La seconde génération d'appareils utilise une méthode par chauffage de pointe, selon laquelle l'énergie laser n'est pas appliquée directement sur la lésion mais sur une pointe métallique qui est chauffée à une température suffisamment élevée pour entrainer la fusion des tissus. La chaleur rayonnant dans toutes les directions, il se produit toutefois des effets secondaires indésirables résultant de la carbonisation des tissus sains.The second generation of devices uses an advanced heating method, according to which laser energy is not applied directly to the lesion but on a metal tip which is heated to a temperature high enough to cause tissue fusion. The heat radiating in all directions, however, there are undesirable side effects resulting from the charring of healthy tissue.
L'approche la plus récente consiste à utiliser des lasers puisés dont chaque impulsion est susceptible de vaporiser une fine couche de tissu d'environ 6 à 10 micromètres, on peut alors en contrôler la profondeur de pénétration par le nombre d'impulsions produites. On connait par le brevet EP 195375 un cathéter à laser comprenant une fibre ou un faisceau de fibres disposé à l'intérieur d'un cathéter terminé par un écran protecteur transparent. Le tir est effectué au travers de ce dernier dont la distance à l'extrémité distale de la fibre optique détermine la taille de l'impact lumineux.The most recent approach consists in using pulsed lasers, each pulse of which is capable of vaporizing a thin layer of tissue of approximately 6 to 10 micrometers, we can then control the depth of penetration by the number of pulses produced. EP 195375 discloses a laser catheter comprising a fiber or a bundle of fibers disposed inside a catheter terminated by a transparent protective screen. The shooting is carried out through the latter, the distance of which at the distal end of the optical fiber determines the size of the light impact.
On met en oeuvre ce cathéter en amenant l'écran au contact de la plaque à traiter. Gn évite ainsi que du sang ne vienne interférer entre l'extrémité du laser et la cible en engendrant des réactions indésirables. En outre, on garantit un espacement constant et prédéterminé entre a peinte ce la firre optique et Is plaque, qui permet de mieux maitriser la quantité d'énergie appliquée à cette dernière. Cependant du fait de cet espacement, qui est une caractéristique même du brevet mentionné, le diamètre du cathéter se trouve être sensiblement plus important que celui de la fibre optique qu'il contient. Il s'ensuit que ce concept ne semble pas autoriser la réalisation d'un dispositif permettant d'accéder à des vaisseaux de faible diamètre ni de progresser très profondément à l'intérieur de la plaque en traitement. Par ailleurs, si on veut y incorporer un moyen de guidage du cathéter, on est conduit à une complication importante du dispositif.This catheter is used by bringing the screen into contact with the plate to be treated. Gn thus prevents the blood from interfering between the end of the laser and the target by generating adverse reactions. In addition, a constant and predetermined spacing is guaranteed between painted the optical firm and Is plate, which better controls the amount of energy applied to it. However, because of this spacing, which is a very characteristic of the patent mentioned, the diameter of the catheter is found to be substantially larger than that of the optical fiber it contains. It follows that this concept does not seem to authorize the production of a device allowing access to vessels of small diameter nor to progress very deeply inside the plate under treatment. Furthermore, if we want to incorporate a means for guiding the catheter, we are led to a significant complication of the device.
L'invention se propose de fournir un cathéter à laser présentant à la fois une extrémité distale dont le diamètre est aussi proche que possible de celui de la fibre optique, et des moyens permettant un guidage précis vers le site opératoire de façon à amener l'extrémité de la fibre optique au point désiré, et en particulier au contact de la lésion à traiter.The invention proposes to provide a laser catheter having both a distal end the diameter of which is as close as possible to that of the optical fiber, and means allowing precise guidance towards the operating site so as to bring the end of the optical fiber at the desired point, and in particular in contact with the lesion to be treated.
Conformément à l'invention, le cathéter est caractérisé en ce que la fibre optique est mobile à l'intérieur du corps tubulaire entre une position active où elle est susceptible de transmettre l'énergie lumineuse à la matière à traiter et une position inactive où elle est en retrait par rapport à l'extrémité distale du corps tubulaire et libère un canal pour notamment permettre le passage d'un fil de guidage.According to the invention, the catheter is characterized in that the optical fiber is movable inside the tubular body between an active position where it is capable of transmitting light energy to the material to be treated and an inactive position where it is set back from the distal end of the tubular body and frees a channel to in particular allow the passage of a guide wire.
Le dispositif de l'invention permet ainsi l'emploi de techniques connues pour le positionnement précis du cathéter, c'est-à-dire, l'introduction préliminaire dans la cavité d'un fil de guidage jusqu'à la lésion, puis l'avancement du cathéter coaxialement au fil de guidage jusqu'au même site.The device of the invention thus allows the use of known techniques for the precise positioning of the catheter, that is to say, the preliminary introduction into the cavity of a guide wire up to the lesion, then the advancement of the catheter coaxially with the guidewire to the same site.
Le canal ménagé dans la zone d'extrémité distale sert au passage soit du fil de guidage soit de la fibre optique. Il s'ensuit un encombrement minimum du cathéter, et l'assurance que l'extrémité de la fibre optique pourra être avancée aussi loin qu'il est nécessaire pour venir au contact de la lésion et éviter la vaporisation de sang intercalaire ou bien de tissu sain. L'invention a également pour objet de fournir un cathéter dont la position de la fibre optique puisse être déterminée de façon simple et précise. On parvient à cet objectif en prévoyant un premier r -yen d'arrêt solidaire ce la fibre optique et un deuxième moyen d'arrêt solidaire du corps tubulaire coopérant entre eux pour immobiliser la fibre optique dans une direction axiale du corps tubulaire.The channel in the distal end region is used for the passage of either the guide wire or the optical fiber. This results in a minimum space requirement of the catheter, and the assurance that the end of the optical fiber can be advanced as far as it is necessary to come into contact with the lesion and avoid the vaporization of intercalated blood or else of tissue. healthy. Another object of the invention is to provide a catheter the position of the optical fiber of which can be determined in a simple and precise manner. We arrive at this goal by providing a first r -yen stop solidarity that the optical fiber and a second stop means integral with the tubular body cooperating with one another to immobilize the optical fiber in an axial direction of the tubular body.
Grâce à ce moyen, on permet une mise en place simple et précise de la fibre optique par rapport au corps tubulaire dont on a pu déterminer au préalable la position par rapport à la lésion.Thanks to this means, a simple and precise positioning of the optical fiber is allowed relative to the tubular body whose position relative to the lesion has been determined beforehand.
Selon un mode de réalisation particulier, le premier moyen d'arrêt est constitué par l'extrémité aval de la gaine dont est enrobée la fibre optique, et le deuxième moyen d'arrêt est constitué par l'extrémité amont d'une bague rapportée à l'intérieur du corps tubulaire.According to a particular embodiment, the first stop means is constituted by the downstream end of the sheath with which the optical fiber is coated, and the second stop means is constituted by the upstream end of a ring attached to inside the tubular body.
L'invention a également pour objet un moyen permettant d'assurer avec sécurité le guidage de la fibre optique à l'intérieur du corps tubulaire. On parvient à cet objectif en prévoyant une portion de corps tubulaire, prolongeant le corps tubulaire principal, dont la lumière permet le passage de la fibre optique ou d'un fil de guidage mais pas des deux simultanément.A subject of the invention is also a means for safely guiding the optical fiber inside the tubular body. This objective is achieved by providing a portion of tubular body, extending the main tubular body, the lumen of which allows the passage of the optical fiber or a guide wire but not both simultaneously.
La description, qui va suivre d'un mode de réalisation non limitatif de l'invention, se réfère aux dessins annexés, sur lesquels :The description which follows of a nonlimiting embodiment of the invention refers to the appended drawings, in which:
- la figure 1 est une vue partielle, en coupe longitudinale, du corps tubulaire constituant le cathéter à laser conforme à 1'invention; - la figure 2 est une vue agrandie, en coupe transversale selon AA, du corps tubulaire de la figure 1 comportant une fibre optique et un guide ;- Figure 1 is a partial view, in longitudinal section, of the tubular body constituting the laser catheter according to the invention; - Figure 2 is an enlarged view, in cross section along AA, of the tubular body of Figure 1 comprising an optical fiber and a guide;
- la figure 3 est une vue partielle, agrandie et en coupe longitudinale, de l'extrémité distante du cathéter avec la fibre optique en position de fonctionnement;- Figure 3 is a partial view, enlarged and in longitudinal section, of the distant end of the catheter with the optical fiber in the operating position;
Le cathéter à laser, repéré par la référence générale 1, est composé d'un corps tubulaire 3. avec une lumière longitudinale 5 ouverte à ses deux extrémités. L'extrémité proximale, non représentée, est pourvue des moyens appropriés pour le raccordement à une source d'énergie laser, aux divers moyens d'alimentation en fluides nécessaires au traitement ainsi qu'aux moyens commandant le déplacement des différents organes du dispositif. Le corps tubulaire est réalisé en un matériau souple tel qu'un pclyc icrure de vinyle, un polytétrafluoréthylène, un polyéthylène, etc .. Comme on le voit sur la figure 1, sur laquelle n'est reproduite que la portion d'extrémité distante du dispositif, le corps tubulaire se termine par une portion tubulaire 31 terminale dont la lumière longitudinale est dans le prolongement de la lumière avec un diamètre plus petit. Un tronçon intermédiaire $2 de raccordement entre le corps 3 et la portion 3 est percé d'une lumière 2 dont le diamètre décroit progressivement de la lumière 5 à la lumière 51. Cette lumière 2 est par exemple tronconique. la portion tubulaire 31 se termine elle-même, du côté opposé au tronçon 32, par un bouchon 33 percé d'une ouverture 35 d diamètre au plus égal à celui de la lumière 1- Ce bouchon constitue l'extrémité distale du cathéter. Il peut être réalisé dans la même matière que le corps tubulaire 32 et être alors obtenu tout simplement par déformation de parois du tube ou bien par moulage. Il peut être également réalisé dans une autre matière, par exemple une matière plus souple, tel que le caoutchouc silicone, et être alors rapporté sur le tube 3 . Cette variante concerne les applications, dans la région du coeur en particulier où il s'agit de réduire le risque de dommages aux petits vaisseaux pendant la mise en place du cathéter.The laser catheter, identified by the general reference 1, is composed of a tubular body 3. with a longitudinal lumen 5 open at its two ends. The proximal end, not shown, is provided with suitable means for connection to a laser energy source, to the various means for supplying fluids necessary for the treatment as well as to the means controlling the movement of the various organs of the device. The tubular body is made of a flexible material such as a pclyc icrure of vinyl, a polytetrafluoroethylene, a polyethylene, etc. As can be seen in FIG. 1, in which only the distant end portion of the device is reproduced, the tubular body ends in a terminal tubular portion 31 whose longitudinal light is an extension of the light with a smaller diameter. An intermediate section $ 2 of connection between the body 3 and the portion 3 is pierced with a lumen 2 whose diameter decreases progressively from lumen 5 to lumen 51. This lumen 2 is for example frustoconical. the tubular portion 31 ends itself, on the side opposite to the section 32, by a plug 33 pierced with an opening 35 d diameter at most equal to that of the lumen 1- This plug constitutes the distal end of the catheter. It can be made of the same material as the tubular body 32 and can then be obtained quite simply by deformation of the walls of the tube or else by molding. It can also be made of another material, for example a softer material, such as silicone rubber, and then be attached to the tube 3. This variant relates to applications, in the region of the heart in particular where it is a question of reducing the risk of damage to the small vessels during the positioning of the catheter.
Immédiatement en amont du bouchon 33. une bague 40 de rétrécissement de la lumière 5 . en un matériau de préférence opaque au rayonnement X, est rapportée à l'intérieur de la portion tubulaire 3 - Un matériau opaque au rayonnement X convenant pour cette application est l'acier inoxydable. Cette bague ménage un canal l faisant communiquer la lumière 51 avec l'ouverture 35. et une surface de butée 43 tournée vers l'amont. Dans la suite deImmediately upstream of the plug 33. a ring 40 for narrowing the lumen 5. in a material preferably opaque to X-rays, is added to the interior of the tubular portion 3 - A material opaque to X-rays suitable for this application is stainless steel. This ring provides a channel l communicating the light 51 with the opening 35. and an abutment surface 43 facing upstream. In the following
.l'exposé, les termes "amont" et "aval" se réfèrent au sens de propagation de l'onde lumineuse dans la fibre optique depuis l'extrémité proximale, non représentée, jusqu'à l'extrémité distale.. The description, the terms "upstream" and "downstream" refer to the direction of propagation of the light wave in the optical fiber from the proximal end, not shown, to the distal end.
La lumière 5 du corps tubulaire 3 est de diamètre suffisant pour loger une fibre optique 60 et un élément de guidage 70, comme on peut le voir sur la figure 2. Cet élément de guidage peut être un fil métallique en acier inoxydable enroulé en hélice, ou tout autre élément équivalent que l'on utilise usuellement pour le guidage coaxial de cathéter dans les 'vaisseaux sar.εr ir.s. La lumière 51 de la portion tubulaire 31 est de diamètre suffisant pour loger 1'élément de guidage ou bien la fibre optique mais pas les deux à la fois. On observe que la fibre optique 60, connue en soi, est composée d'une fibre ou d'un faisceau de fibres 61 en un matériau, verre ou plastique, capable de transmettre l'énergie d'un faisceau laser ou de tout autre rayonnement du même type, enrobée généralement d'une gaine de protection 63- Quant à l'élément de guidage 70, il est choisi de sorte que son encombrement transversal soit au plus égal à celui de la fibre ou du faisceau fibres 61 dénudé, pour la raison indiquée ci-après.The lumen 5 of the tubular body 3 is of sufficient diameter to accommodate an optical fiber 60 and a guide element 70, as can be seen in FIG. 2. This guide element can be a stainless steel wire wound in a helix, or any other equivalent element that is usually used for coaxial catheter guidance in the sar.εr ir.s. The lumen 51 of the tubular portion 31 is of sufficient diameter to accommodate the guide element or else the optical fiber, but not both. It is observed that the optical fiber 60, known per se, is composed of a fiber or a bundle of fibers 61 of a material, glass or plastic, capable of transmitting the energy of a laser beam or any other radiation. of the same type, generally coated with a protective sheath 63. As for the guide element 70, it is chosen so that its transverse dimensions are at most equal to that of the bare fiber or fiber bundle 61, for the reason given below.
Le canal 4l ménagé par la bague 40 est, comme on le voit à la figure 3. de diamètre suffisant pour permettre le passage de l'élément de guidage 70 le long duquel on glisse le corps tubulaire jusqu'au site de traitement, ou de la fibre optique 6l dégagée de sa gaine de protection 63- Cependant, le canal 4l est trop étroit pour que l'on puisse y glisser la fibre optique complète, c'est-à-dire enrobée dans sa gaine.The channel 41 formed by the ring 40 is, as can be seen in FIG. 3, of sufficient diameter to allow the passage of the guide element 70 along which the tubular body is slid to the treatment site, or the optical fiber 6l disengaged from its protective sheath 63- However, the channel 4l is too narrow for the complete optical fiber to be slid into it, that is to say coated in its sheath.
La figure 3 représente ainsi l'extrémité du cathéter avec la fibre optique en position de fonctionnement. La fibre à été dénudée sur une longueur déterminée de façon que son extrémité 67 soit située sensiblement dans le plan de l'ouverture 35. lorsque l'extrémité de la gaine, formant un premier moyen d'arrêt 65, est en appui contre la surface de butée 43, formant un deuxième moyen d'arrêt. La surface de butée est inclinée par rapport à l'axe du tube de façon à faciliter l'entrée de la fibre ou du fil de guidage dans le canal 4l. Toutefois l'angle d'inclinaison ne doit pas être trop faible pour ne pas nuire à la précision du positionnement de la fibre. En fait son choix résulte d'un compromis entre les deux besoins. D'autres moyens d'arrêt, aussi bien pour le premier moyen d'arrêt 65 porté par la fibre optique que pour le deuxième moyen d'arrêt 43 porté par le corps tubulaire, sont bien sûr envisageables, ainsi que leur emplacement qui n'est pas limité à la zone d'extrémité distale du cathéter. Le premier moyen d'arrêt 65, solidaire de la fibre optique, et constitué, selon l'exemple représenté, par l'extrémité de la gaine de la fibre optique, pourrait ainsi être réalisé par tout autre mcven éαuivaieπt tel qu'une baεr e ranscrtée sur la fibre elie-πiême. La bague 40 comprendra, de préférence, des passages suffisants pour les fluides, tel que par exemple un liquide physiologique pour le déplacement du sang ou bien un liquide de contraste pour la visualisation par radioscopie de l'effet du traitement. On peut creuser, dans ce but des rainures longitudinales ou hélicoïdales dans la paroi du canal 4l ou bien dans la masse de la bague elle même. Ces passages n'ont pas été représentés sur les figures.FIG. 3 thus represents the end of the catheter with the optical fiber in the operating position. The fiber has been stripped over a length determined so that its end 67 is located substantially in the plane of the opening 35. when the end of the sheath, forming a first stop means 65, is in abutment against the surface stop 43, forming a second stop means. The abutment surface is inclined relative to the axis of the tube so as to facilitate the entry of the fiber or the guide wire into the channel 41. However, the angle of inclination must not be too small so as not to affect the accuracy of the positioning of the fiber. In fact his choice results from a compromise between the two needs. Other stop means, both for the first stop means 65 carried by the optical fiber and for the second stop means 43 carried by the tubular body, are of course conceivable, as well as their location which does not is not limited to the distal end area of the catheter. The first stop means 65, integral with the optical fiber, and constituted, according to the example shown, by the end of the sheath of the optical fiber, could thus be produced by any other mcven éαuivaieπt such as a baεr e ranscrtée on fiber elie-πiême. The ring 40 will preferably include passages sufficient for the fluids, such as for example a physiological liquid for moving the blood or else a contrast liquid for viewing by radioscopy the effect of the treatment. One can dig, for this purpose longitudinal or helical grooves in the wall of the channel 41 or in the mass of the ring itself. These passages have not been shown in the figures.
La bague 40 est un exemple de réalisation simple de l'extrémité du cathéter. Cependant elle peut être remplacée par des bossages, à direction générale longitudinale, espacés circonférentiellement de façon à ménager, au surplus du canal 4l, des passages axiaux ou hélicoïdaux pour faciliter l'écoulement du liquide à infuser dans la zone de traitement. Les bossages coopéreront alors entre eux pour définir ledit deuxième moyen d'arrêt 43.The ring 40 is a simple embodiment of the end of the catheter. However, it can be replaced by bosses, in a longitudinal general direction, circumferentially spaced so as to provide, in addition to the channel 41, axial or helical passages to facilitate the flow of the liquid to be infused in the treatment zone. The bosses will then cooperate with one another to define said second stop means 43.
On a confectionné un cathéter conforme à l'invention dont le corps tubulaire a un diamètre extérieur de 1,33 &™ (CH.4) et la portion tubulaire d'extrémité un diamètre de 1 mm (CH3). Le canal 4l permet le logement d'une fibre optique de 0,45 mm de diamètre. On peut utiliser le cathéter selon différents modes opératoires dépendant de la désobstruction à pratiquer et des préférences du praticien.A catheter according to the invention was made, the tubular body of which has an outside diameter of 1.33 μm (CH.4) and the tubular end portion a diameter of 1 mm (CH3). The channel 4l allows the accommodation of an optical fiber of 0.45 mm in diameter. The catheter can be used according to different procedures depending on the obstruction to be practiced and the preferences of the practitioner.
Par exemple, un mode opératoire peut comprendre les étapes suivantes : A- On introduit tout d'abord l'élément de guidage 70 dans la cavité ou le vaisseau sanguin jusqu'à ce que son extrémité distale parvienne dans la zone où se trouve l'obstruction à traiter ;For example, an operating mode can comprise the following steps: A- The guide element 70 is first introduced into the cavity or the blood vessel until its distal end reaches the zone where the obstruction to be treated;
B- On glisse le corps tubulaire coaxialement le long du guide jusqu'à ce que son extrémité distale arrive sur le site; C- On peut surveiller la mise en place du guide et du corps tubulaire par fluoroscopie, en injectant au travers de la lumière un fluide radio-opaque permettant la visualisation de la cavité et de son obstruction, selon les techniques connues;B- The tubular body is slid coaxially along the guide until its distal end arrives at the site; C- We can monitor the positioning of the guide and the tubular body by fluoroscopy, by injecting through the light a radiopaque fluid allowing the visualization of the cavity and its obstruction, according to known techniques;
D- Une fois l'extrémité distale du cathéter positionnée avec précision par rapport à la cible visée, et le cas échéant immobilisée au moyen d'un ballonnet si elle en est pourvue, on retire le guide de quelques centimètres dans la lumière 5 pour libérer la lumière 1 ; E- On pousse la fibre optique dans la lumière 5 jusqu'à ce que le premier moyen d'arrêt 6 vienne en appui contre le deuxième moyen d'arrêt 43. L'extrémité de la fibre optique se trouve alors en place. F- on traite la lésion en appliquant l'énergie laser;D- Once the distal end of the catheter is positioned precisely with respect to the targeted target, and if necessary immobilized by means of a balloon if it is provided with it, the guide is withdrawn a few centimeters in the lumen 5 to release light 1; E- The optical fiber is pushed into the light 5 until the first stop means 6 comes to bear against the second stop means 43. The end of the optical fiber is then in place. F- the lesion is treated by applying laser energy;
G- On répète les opérations A à F le nombre de fois nécessaires pour obtenir la désobstruction du vaisseau.G- Repeat operations A to F the number of times necessary to obtain the unblocking of the vessel.
L'invention ne se limite pas au mode de réalisation représenté et comprend tous les équivalents ou autres moyens supplémentaires à la portée de l'homme du métier.The invention is not limited to the embodiment shown and includes all the equivalents or other additional means within the reach of those skilled in the art.
Ainsi, comme on l'a mentionné plus haut il peut comporter un ballonnet gonflable par le moyen duquel il est possible d'immobiliser l'extrémité du cathéter par rapport aux parois de la cavité. Le ballonnet de forme annulaire, autour du corps tubulaire, est alimenté en fluide pour le gonflement depuis un conduit logé à 1'intérieur de celui-ci. Les cathéters à ballonnet sont bien connus dans le domaine ; il n'est pas nécessaire d'en développer la description.Thus, as mentioned above, it may include an inflatable balloon by means of which it is possible to immobilize the end of the catheter relative to the walls of the cavity. The annular balloon, around the tubular body, is supplied with fluid for inflation from a duct housed inside it. Balloon catheters are well known in the art; there is no need to expand on the description.
Enfin cette technique peut être appliquée également aux endoscopes de visualisation ou de traitement. Finally, this technique can also be applied to viewing or processing endoscopes.

Claims

REVENDICATIONS
1. Cathéter du type comprenant au moins une fibre optique guidée à l'intérieur d'un corps tubulaire, notamment pour la désobstruction d'un vaisseau sanguin, ou autre canal du corps humain, par ablation de matière au moyen de l'énergie d'un rayonnement laser, caractérisé en ce que la fibre optique (60) est mobile à l'intérieur du corps tubulaire (3) entre une position active où elle est susceptible de transmettre l'énergie lumineuse à la matière à traiter, et une position inactive où elle est en retrait et libère un canal (4l) dans la zone d'extrémité distale du cathéter pour notamment permettre le passage d'un fil de guidage (70).1. Catheter of the type comprising at least one optical fiber guided inside a tubular body, in particular for clearing a blood vessel, or other channel of the human body, by ablation of material by means of the energy of '' laser radiation, characterized in that the optical fiber (60) is movable inside the tubular body (3) between an active position where it is capable of transmitting light energy to the material to be treated, and a position inactive where it is set back and releases a channel (4l) in the distal end zone of the catheter to in particular allow the passage of a guide wire (70).
2. Cathéter selon la revendication 1 caractérisé en ce qu'il comprend un premier moyen d'arrêt (65) solidaire de la fibre optique (60) et un deuxième moyen d'arrêt (43) solidaire du corps tubulaire (3) coopérant entre eux pour immobiliser la fibre optique dans une direction axiale du corps tubulaire.2. Catheter according to claim 1 characterized in that it comprises a first stop means (65) secured to the optical fiber (60) and a second stop means (43) secured to the tubular body (3) cooperating between them to immobilize the optical fiber in an axial direction of the tubular body.
3- Cathéter selon la revendication 2, avec une fibre optique (60) constituée d'une fibre ou d'un faisceau de fibres en matériau optique (61) enrobé dans une gaine de protection (63) . caractérisé en ce que le premier moyen d'arrêt (65) est constitué par l'extrémité de ladite gaine (63).3- catheter according to claim 2, with an optical fiber (60) consisting of a fiber or a bundle of fibers of optical material (61) embedded in a protective sheath (63). characterized in that the first stop means (65) is constituted by the end of said sheath (63).
4. Cathéter selon la revendication 2 caractérisé en ce que le premier moyen d'arrêt (65) est constitué par une bague montée sur la fibre optique (60) .4. Catheter according to claim 2 characterized in that the first stop means (65) is constituted by a ring mounted on the optical fiber (60).
5. Cathéter selon l'une des revendications 2 à 4 caractérisé en ce que le deuxième moyen d'arrêt est constitué par l'extrémité amont (43) d'un moyen de rétrécissement (40) de l'ouverture de la lumière (51) du corps tubulaire.5. Catheter according to one of claims 2 to 4 characterized in that the second stop means is constituted by the upstream end (43) of a narrowing means (40) of the opening of the lumen (51 ) of the tubular body.
6. Cathéter selon la revendication 5 caractérisé en ce que le moyen de rétrécissement est constitué par une bague (40) rapportée à l'intérieur du corps tubulaire.6. Catheter according to claim 5 characterized in that the narrowing means is constituted by a ring (40) attached to the inside of the tubular body.
7. Cathéter selon la revendication 5 caractérisé en ce que le moyen de rétrécissement est constitué de bossages sur la paroi interne de la lumière de corps tubulaire. 7. Catheter according to claim 5 characterized in that the narrowing means consists of bosses on the inner wall of the tubular body lumen.
8. Cathéter selon l'une des revendications à 7 caractérisé en ce que le moyen de rétrécissement comprend des passages supplémentaires pour les fluides.8. Catheter according to one of claims to 7 characterized in that the narrowing means comprises additional passages for fluids.
9. Cathéter selon l'une des revendications précédentes caractérisé en ce que le corps tubulaire comporte une portion tubulaire d'extrémité distale (31) dont la lumière (51) permet le passage de la fibre optique (60) ou d'un fil de guidage (70) mais pas des deux simultanément.9. Catheter according to one of the preceding claims, characterized in that the tubular body comprises a tubular portion of distal end (31) whose lumen (51) allows the passage of the optical fiber (60) or of a wire. guide (70) but not both simultaneously.
10. Cathéter selon l'une des revendications précédentes caractérisé en ce que le corps tubulaire comporte une portion tubulaire permettant de loger ensemble au moins une fibre optique (60) et un fil de guidage (70).10. Catheter according to one of the preceding claims, characterized in that the tubular body comprises a tubular portion making it possible to house at least one optical fiber (60) and a guide wire (70).
11. Cathéter selon les revendications et 10 caractérisé en ce que ladite portion tubulaire d'extrémité distale (31) est raccordée à la portion tubulaire, permettant de loger ensemble une fibre optique (60) et un fil de guidage (70),' par une portion tubulaire (32) dont le diamètre de la lumière (52) décroit progressivement jusqu'à celui de la lumière (51)-11. Catheter according to claims and 10 characterized in that said tubular portion of distal end (31) is connected to the tubular portion, making it possible to accommodate together an optical fiber (60) and a guide wire (70), by a tubular portion (32) whose diameter of the lumen (52) gradually decreases to that of the lumen (51) -
12. Cathéter selon l'une des revendications précédentes caractérisé en ce qu'il comporte un moyen d'immobilisation, par rapport aux parois de la cavité dans laquelle il est introduit, du type à ballonnet gonflable connu en soi.12. Catheter according to one of the preceding claims, characterized in that it comprises a means of immobilization, relative to the walls of the cavity into which it is introduced, of the type with an inflatable balloon known per se.
13. Cathéter selon l'une des revendications précédentes caractérisé en ce que son extrémité est réalisée en un matériau plus souple que le corps tubulaire, de manière à ne pas léser les tissus lors de la mise en place du cathéter. 13. Catheter according to one of the preceding claims, characterized in that its end is made of a more flexible material than the tubular body, so as not to damage the tissues during the positioning of the catheter.
PCT/FR1990/000300 1989-04-28 1990-04-26 Catheter using energy produced by a laser WO1990013263A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR8905759A FR2646355B1 (en) 1989-04-28 1989-04-28 LASER CATHETER
FR89/05759 1989-04-28

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WO1990013263A1 true WO1990013263A1 (en) 1990-11-15

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JP (1) JPH03505991A (en)
CA (1) CA2032155A1 (en)
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US6224570B1 (en) * 1998-02-06 2001-05-01 Possis Medical, Inc. Rheolytic thrombectomy catheter and method of using same

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3436508A1 (en) * 1983-10-07 1985-05-02 Olympus Optical Co., Ltd., Tokio/Tokyo Laser probe for an endoscope
EP0308023A2 (en) * 1987-09-15 1989-03-22 GV Medical, Inc. Inflatable tip for laser catheterisation

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3436508A1 (en) * 1983-10-07 1985-05-02 Olympus Optical Co., Ltd., Tokio/Tokyo Laser probe for an endoscope
EP0308023A2 (en) * 1987-09-15 1989-03-22 GV Medical, Inc. Inflatable tip for laser catheterisation

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FR2646355A1 (en) 1990-11-02
JPH03505991A (en) 1991-12-26
EP0424499A1 (en) 1991-05-02
FR2646355B1 (en) 1991-07-05

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