WO2015132480A1 - Device for carrying out a blood vessel bypass - Google Patents

Device for carrying out a blood vessel bypass Download PDF

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Publication number
WO2015132480A1
WO2015132480A1 PCT/FR2015/000035 FR2015000035W WO2015132480A1 WO 2015132480 A1 WO2015132480 A1 WO 2015132480A1 FR 2015000035 W FR2015000035 W FR 2015000035W WO 2015132480 A1 WO2015132480 A1 WO 2015132480A1
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WO
WIPO (PCT)
Prior art keywords
balloon
head portion
base
base portion
controllable
Prior art date
Application number
PCT/FR2015/000035
Other languages
French (fr)
Inventor
Nicolas Plowiecki
Original Assignee
Newco
Ab Medica
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 Newco, Ab Medica filed Critical Newco
Publication of WO2015132480A1 publication Critical patent/WO2015132480A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A61B17/12045—Type of occlusion temporary occlusion double occlusion, e.g. during anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/064—Blood vessels with special features to facilitate anastomotic coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1135—End-to-side connections, e.g. T- or Y-connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1045—Balloon catheters with special features or adapted for special applications for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations

Definitions

  • the present invention relates to devices for derivation on a blood vessel, which find applications for example for the implantation of a vascular prosthesis to the right of a puncture performed in a bridging vessel or for closure a vascular access path.
  • the present invention aims to provide a device for derivation on a blood vessel, which largely overcomes the disadvantages of similar devices of the prior art mentioned above.
  • the present invention relates to a device for derivation on a blood vessel, comprising: a substantially T-shaped support core comprising a base portion and a head portion, means for relier a first end of the base portion to said head portion, first inflatable balloon means associated with said head portion, controllable means for varying the size of said first balloon means in a direction which has at least one non-zero component perpendicular to said head portion, second inflatable balloon means associated with said portion of said head portion; base, and controllable means for varying the dimension of said second balloon means in a direction which has at least one non-zero component perpendicular to said base portion,
  • the means for connecting a first end of the base portion to said head portion are constituted by a base extension, a first end of said base extension being substantially integral with said first end of said portion of said base portion. base to form, with this base portion, a substantially L-shaped piece, the second end of the base extension being connected to an end of said head portion.
  • FIG. 1 is a block diagram of a first embodiment of the device according to the invention for making a derivation on a blood vessel
  • FIG. 2 is a block diagram of a second preferred embodiment of the device according to the invention for making a derivation on a blood vessel
  • FIG. 3 is a diagram making it possible to highlight part of the structure of the device in accordance with the representation according to FIGS. 1 and 2, but more particularly according to FIG. 2, this part of structure being that which is described, in the present description, as a support soul.
  • the object of the invention comprises "at least one" element having a given function
  • the embodiment described may comprise several of these elements.
  • the embodiment of the object according to the invention as illustrated has several elements of identical function and if, in the description, it is not specified that the object according to this invention must obligatorily comprise a number particular of these elements, the object of the invention may be defined as comprising "at least one" of these elements.
  • the present invention relates to a device for carrying out a derivation Dr on a blood vessel Vs, for example an artery or the like, with a view to performing a bypass or any other well-known intervention in this field of medicine. surgical.
  • the device comprises a support core 10 substantially T-shaped and substantially filamentary, a preferred example of which will be given below.
  • This support core 10 comprises a so-called “base” portion 11 and a so-called “head” portion 12, and means for connecting a first end of the base portion 11 to the head portion 12.
  • It further comprises first inflatable balloon means 21 associated with the head portion 12 and controllable means for varying the size of these first balloon means 21 in a direction that has at least one non-zero component perpendicular to the portion of the balloon. head 12.
  • the device further comprises second inflatable balloon means 22 associated with the base portion 11 and controllable means for varying the size of these second balloon means 22 in a direction that has at least a non-zero component perpendicular to the base portion 11.
  • the means for connecting a first end of the base portion 11 to the head portion 12 in the case of the embodiment illustrated in Figure 1 may be constituted, for example, by welding, gluing, molding, etc. directly between the first end of the base portion and the leading portion.
  • the means for connecting a first end of the base portion 11 to the head portion 12 are constituted by a base extension 13 whose first end is substantially integral with the first end. end of this base portion 11 to form, with this base portion, a substantially L-shaped part, the second end of the base extension 13 being connected to one end of the head portion 12 so that the
  • the support core 10 has a shape such as is schematically illustrated in FIG. 3 which represents only the three essential elements 11, 12 and 13 defined above.
  • the second end of the base extension 13 is connected to one end of the head portion 12 so that this base extension 3 makes, with the leading portion 12, an angle less than eighty. -dix degrees, preferably a very small angle of the order for example of ten degrees.
  • the head portion 12 ' the base portion 11 and the base extension 13 are in one piece consisting, for example, of a tube of catheter 30 well known in itself, for example polyamide or polyethylene.
  • the first balloon means 21 are constituted by at least one first balloon, hereinafter also referred to as 21, at least partially surrounding the head portion 12.
  • Such a balloon consists, for example, of a sleeve a flexible and relatively elastic material or essentially non-elastic material folded on itself when deflated and which unfolds under the pressure of the fluid as explained below, the two ends of which are sealingly connected to the leading portion 12 to define, between this head portion 12 and the inner wall of the sleeve, a sealed annular volume which can be filled with a fluid under pressure to inflate the sleeve, and therefore the balloon.
  • controllable means for varying the size of the first balloon means 21 in a direction that has at least one non-zero component perpendicular to the head portion 12 further comprises a through hole 51 formed in the wall of the part catheter 30 constituting the portion of the head portion 12 which is surrounded by the first balloon 21 so as to connect the inside of the catheter with the interior of the first balloon, and a first source of controllable fluid 41 whose output is connected inside the catheter 30 so as to inflate and deflate at will the first balloon 21, the fluid is preferably biocompatible, depending on the case, liquid and / or gaseous.
  • the second balloon means 22 are constituted by at least one second balloon, also referenced 22, for example of the same type as the first balloon 21, and the controllable means for varying the size of the balloon.
  • said second balloon means in a direction which has at least one non-zero component perpendicular to the base portion 1 comprises a second source of controllable fluid 42 and means for connecting the output of this second fluid source to the interior of the second balloon, for example an auxiliary line inside the catheter as schematically illustrated in Figure 2, or in parallel on it as shown in Figure 1.
  • this second balloon 22 is mounted in association with the base portion 1 surrounding it, FIGS. 1 and 2.
  • the device according to the invention further comprises stent means 50 mounted in cooperation with the first balloon means 21, specifying that these stent means are constituted by at least one stent, for example surrounding the first balloon 21 over almost its entire length, or by a combination of two stents, or more as mentioned in FIG. 2.
  • a stent is an oblong element substantially cylindrical defined along a longitudinal axis and arranged to be able to take two forms, a folded form in which it has a transverse dimension of a given first value and an unfolded shape in which it has a transverse dimension of a given second value greater than the first.
  • Such a stent is made by cuts in a tube, for example steel, these cuts allowing it to plastically deform under the effect of inflation of (the) ball (s) to take its expanded diameter, which allows it to be permeable if necessary.
  • Such a stent 50 may be positioned so that it at least partially surrounds the first balloon 21 or both the first balloon and the extension portion 13, as illustrated in FIG.
  • this device has, compared to that described in this prior art, a particularly advantageous functionality.
  • the second proximal balloon 22 is inflated first and maintained inflated to exert, through the interior of the divert vessel Dr, pressure on this divert vessel Dr and all around the optic puncture orifice Op on the vessel Vs. There is thus obtained a first relative seal at this puncture orifice Op.
  • the first balloon 21 distal ' is in turn inflated, resulting in the deployment of the stent or stents 50 and ensures a seal between the part of Dr crown of the secondary vessel Dr and the inner wall of the main vessel Vs by application of forces that seal the crown Dre against the inner wall of the main vessel.

Abstract

The present invention relates to devices for carrying out a bypass (Dr) on a blood vessel (Vs). The device according to the invention is essentially characterized in that it comprises a substantially T-shaped holding core (10) comprising a base portion (11) and a head portion (12); means for connecting a first end of the portion (11) to the portion (12); an inflatable balloon means (21) associated with the portion (12); means for changing the size of the balloon means (21) in a direction that has at least one non-zero component perpendicular to the portion (12); second inflatable balloon means (22) associated with the portion (11); and means for changing the size of the balloon means (22) in a direction that has at least one non-zero component perpendicular to the portion (11). The invention is useful for carrying out a vascular prosthesis implantation at a puncture made in a bypass vessel, for closing a vascular access path, etc.

Description

DISPOSITIF POUR REALISER UNE DERIVATION  DEVICE FOR PERFORMING A BYPASS
SUR UN VAISSEAU SANGUIN La présente invention concerne les dispositifs pour réaliser une dérivation sur un vaisseau sanguin, qui trouvent des applications par exemple pour l'implantation d'une prothèse vasculaire au droit d'une ponction effectuée dans un vaisseau de pontage ou pour la fermeture d'une voie d'accès vasculaire.  The present invention relates to devices for derivation on a blood vessel, which find applications for example for the implantation of a vascular prosthesis to the right of a puncture performed in a bridging vessel or for closure a vascular access path.
Par "dérivation", on entend, au sens de la présente description, un départ d'un vaisseau sanguin dit "secondaire" à partir d'un vaisseau sanguin dit "principal".  By "derivation" is meant, in the sense of the present description, a departure of a blood vessel called "secondary" from a blood vessel called "main".
Dans de telles applications, le problème majeur qui se pose est celui de l'étanchement du sang au niveau de la dérivation. Si cette dérivation est effectuée sans clampage, notamment du vaisseau principal, elle s'avère difficile à réaliser, notamment à cause de l'écoulement ou fuite du sang.  In such applications, the major problem that arises is the sealing of blood at the bypass. If this derivation is performed without clamping, including the main vessel, it is difficult to achieve, especially because of the flow or leakage of blood.
On connaît déjà de tels dispositifs, par exemple ceux qui sont décrits dans les US 4 840 690, DE 10 2012 024254, WO 01/17582 et EP 2 497 524  Such devices are already known, for example those described in US 4,840,690, DE 10 2012 024254, WO 01/17582 and EP 2 497 524.
Ces dispositifs de l'art antérieur tentent de résoudre le problème défini ci-dessus mais, s'ils donnent satisfaction, leur structure présente des inconvénients, essentiellement une certaine complexité qui entraîne des difficultés d'utilisation par les Praticiens lors de leur implantation sur un patient.  These devices of the prior art attempt to solve the problem defined above but, if they give satisfaction, their structure has drawbacks, essentially a certain complexity which causes difficulties of use by practitioners when they are implanted on a computer. patient.
Aussi, la présente invention a-t-elle pour but de réaliser un dispositif pour réaliser une dérivation sur un vaisseau sanguin, qui pallie en grande partie les inconvénients des dispositifs similaires de l'art antérieur évoqués ci-dessus.  Thus, the present invention aims to provide a device for derivation on a blood vessel, which largely overcomes the disadvantages of similar devices of the prior art mentioned above.
Plus précisément, la présente invention a pour objet un dispositif pour réaliser une dérivation sur un vaisseau sanguin, comportant : une âme support en forme sensiblement de T comprenant une portion de base et une portion de tête, des moyens pour rélier une première extrémité de la portion de base à ladite portion de tête, des premiers moyens de ballon gonflable associés à ladite portion de tête, des moyens commandables pour faire varier la dimension des dits premiers moyens de ballon selon une direction qui présente au moins une composante non nulle perpendiculaire à ladite portion de tête, des seconds moyens de ballon gonflable associés à ladite portion de base, et des moyens commandables pour faire varier la dimension des dits seconds moyens de ballon selon une direction qui présente au moins une composante non nulle perpendiculaire à ladite portion de base, More specifically, the present invention relates to a device for derivation on a blood vessel, comprising: a substantially T-shaped support core comprising a base portion and a head portion, means for relier a first end of the base portion to said head portion, first inflatable balloon means associated with said head portion, controllable means for varying the size of said first balloon means in a direction which has at least one non-zero component perpendicular to said head portion, second inflatable balloon means associated with said portion of said head portion; base, and controllable means for varying the dimension of said second balloon means in a direction which has at least one non-zero component perpendicular to said base portion,
caractérisé par le fait que les moyens pour relier une première extrémité de la portion de base à ladite la portion de tête sont constitués par une prolongation de base, une première extrémité de ladite prolongation de base étant solidaire sensiblement de ladite première extrémité de cette portion de base pour former, avec cette portion de base, une pièce sensiblement en forme de L, la seconde extrémité de la prolongation de base étant reliée à une extrémité de ladite la portion de tête. characterized in that the means for connecting a first end of the base portion to said head portion are constituted by a base extension, a first end of said base extension being substantially integral with said first end of said portion of said base portion. base to form, with this base portion, a substantially L-shaped piece, the second end of the base extension being connected to an end of said head portion.
D'autres caractéristiques et avantages de la présente invention apparaîtront au cours de la description suivante donnée en regard des dessins annexés à titre illustratif mais nullement limitatif, dans lesquels :  Other features and advantages of the present invention will become apparent from the following description given with reference to the accompanying drawings, by way of illustration but in no way limiting, in which:
La figure 1 est un schéma de principe d'un premier mode de réalisation du dispositif selon l'invention pour réaliser une dérivation sur un vaisseau sanguin,  FIG. 1 is a block diagram of a first embodiment of the device according to the invention for making a derivation on a blood vessel,
La figure 2 est un schéma de principe d'un second mode de réalisation préféré du dispositif selon l'invention pour réaliser une dérivation sur un vaisseau sanguin, et  FIG. 2 is a block diagram of a second preferred embodiment of the device according to the invention for making a derivation on a blood vessel, and
La figure 3 est un schéma permettant de mettre en évidence une partie de la structure du dispositif en accord avec la représentation selon les figures 1 et 2, mais plus particulièrement selon la figure 2, cette partie de structure étant celle qui est décrite, dans la présente description, comme une âme support.  FIG. 3 is a diagram making it possible to highlight part of the structure of the device in accordance with the representation according to FIGS. 1 and 2, but more particularly according to FIG. 2, this part of structure being that which is described, in the present description, as a support soul.
II est tout d'abord précisé que, sur les figures, les mêmes références désignent les mêmes éléments, quelle que soit la figure sur laquelle elles apparaissent et quelle que soit la forme de représentation de ces éléments. De même, si des éléments ne sont pas spécifiquement référencés sur l'une des figures, leurs références peuvent être aisément retrouvées en se reportant à une autre figure. It is first of all specified that, in the figures, the same references designate the same elements, whatever the figure on which they appear and whatever the form of representation of these elements. Similarly, if elements are not specifically referenced on one figures, their references can be easily found by referring to another figure.
Il est aussi précisé que les figures représentent essentiellement deux modes de réalisation de l'objet selon l'invention, mais qu'il peut en exister d'autres qui répondent à la définition de cette invention.  It is also stated that the figures essentially represent two embodiments of the object according to the invention, but that there may be others that meet the definition of this invention.
Il est en outre précisé que, lorsque, selon la définition de l'invention, l'objet de l'invention comporte "au moins un" élément ayant une fonction donnée, le mode de réalisation décrit peut comporter plusieurs de ces éléments. Réciproquement, si le mode de réalisation de l'objet selon l'invention tel qu'illustré comporte plusieurs éléments de fonction identique et si, dans la description, il n'est pas spécifié que l'objet selon cette invention doit obligatoirement comporter un nombre particulier de ces éléments, l'objet de l'invention pourra être défini comme comportant "au moins un" de ces éléments.  It is furthermore specified that, when, according to the definition of the invention, the object of the invention comprises "at least one" element having a given function, the embodiment described may comprise several of these elements. Conversely, if the embodiment of the object according to the invention as illustrated has several elements of identical function and if, in the description, it is not specified that the object according to this invention must obligatorily comprise a number particular of these elements, the object of the invention may be defined as comprising "at least one" of these elements.
II est également précisé que lorsque, dans la présente description, une expression définit à elle seule, sans mention particulière spécifique la concernant, un ensemble de caractéristiques structurelles, ces caractéristiques peuvent être prises, pour la définition de l'objet de la protection demandée, quand cela est techniquement possible, soit séparément, soit en combinaison totale et/ou partielle.  It is also specified that when, in the present description, an expression defines in itself, without specific particular mention concerning it, a set of structural characteristics, these characteristics can be taken, for the definition of the object of the protection requested, when technically possible, either separately, or in full and / or partial combination.
Il est enfin précisé que, dans la présente description, si l'adverbe "sensiblement" est associé à un qualificatif d'un moyen donné, ce qualificatif doit être compris au sens strict ou approché.  Finally, it is specified that, in the present description, if the adverb "substantially" is associated with a qualifier of a given means, this qualifier must be understood in the strict sense or approached.
En référence aux figures annexées, la présente invention est relative à un dispositif pour réaliser une dérivation Dr sur un vaisseau sanguin Vs, par exemple une artère ou analogue, en vue de réaliser un pontage ou toute autre intervention bien connue dans ce domaine de la médecine chirurgicale.  With reference to the appended figures, the present invention relates to a device for carrying out a derivation Dr on a blood vessel Vs, for example an artery or the like, with a view to performing a bypass or any other well-known intervention in this field of medicine. surgical.
Le dispositif comporte une âme support 10 en forme sensiblement de T et essentiellement filiforme, dont un exemple préférentiel sera donné ci- après. Cette âme support 10 comporte une portion dite "de base" 11 et une portion dite "de tête" 12, et des moyens pour relier une première extrémité de la portion de base 11 à la portion de tête 12. Il comporte en outre des premiers moyens de ballon gonflable 21 associés à la portion de tête 12 et des moyens commandables pour faire varier la dimension de ces premiers moyens de ballon 21 selon une direction qui présente au moins une composante non nulle perpendiculaire à la portion de tête 12. The device comprises a support core 10 substantially T-shaped and substantially filamentary, a preferred example of which will be given below. This support core 10 comprises a so-called "base" portion 11 and a so-called "head" portion 12, and means for connecting a first end of the base portion 11 to the head portion 12. It further comprises first inflatable balloon means 21 associated with the head portion 12 and controllable means for varying the size of these first balloon means 21 in a direction that has at least one non-zero component perpendicular to the portion of the balloon. head 12.
Selon une caractéristique de l'invention, le dispositif comporte en outre des seconds moyens de ballon gonflable 22 associés à la portion de base 11 et des moyens commandables pour faire varier la dimension de ces seconds moyens de ballon 22 selon une direction qui présente au moins une composante non nulle perpendiculaire à la portion de base 11.  According to one characteristic of the invention, the device further comprises second inflatable balloon means 22 associated with the base portion 11 and controllable means for varying the size of these second balloon means 22 in a direction that has at least a non-zero component perpendicular to the base portion 11.
Les moyens pour relier une première extrémité de la portion de base 11 à la portion de tête 12 dans le cas du mode de réalisation illustré sur la figure 1 peuvent être constitués, par exemple, par un soudage, un collage, un moulage, etc. directement entre la première extrémité de la portion de base et la portion de tête.  The means for connecting a first end of the base portion 11 to the head portion 12 in the case of the embodiment illustrated in Figure 1 may be constituted, for example, by welding, gluing, molding, etc. directly between the first end of the base portion and the leading portion.
Cependant, de façon préférentielle, comme illustré sur la figure 2, les moyens pour relier une première extrémité de la portion de base 11 à la portion de tête 12 sont constitués par une prolongation de base 13 dont une première extrémité est solidaire sensiblement de la première extrémité de cette portion de base 11 pour former, avec cette portion de base, une pièce sensiblement en forme de L, la seconde extrémité de la prolongation de base 13 étant, elle, reliée à une extrémité de la portion de tête 12 pour que l'âme support 10 affecte une forme comme celle qui est schématiquement illustrée sur la figure 3 qui représente uniquement les trois éléments essentiels 11 , 12 et 13 définis ci-dessus.  However, preferably, as illustrated in FIG. 2, the means for connecting a first end of the base portion 11 to the head portion 12 are constituted by a base extension 13 whose first end is substantially integral with the first end. end of this base portion 11 to form, with this base portion, a substantially L-shaped part, the second end of the base extension 13 being connected to one end of the head portion 12 so that the The support core 10 has a shape such as is schematically illustrated in FIG. 3 which represents only the three essential elements 11, 12 and 13 defined above.
De façon encore plus préférentielle, la seconde extrémité de la prolongation de base 13 est reliée à une extrémité de la portion de tête 12 de façon que cette prolongation de base 3 fasse, avec la portion de tête 12, un angle inférieur à quatre-vingt-dix degrés, avantageusement un angle très faible de l'ordre par exemple d'une dizaine de degrés.  Even more preferably, the second end of the base extension 13 is connected to one end of the head portion 12 so that this base extension 3 makes, with the leading portion 12, an angle less than eighty. -dix degrees, preferably a very small angle of the order for example of ten degrees.
Aussi, de façon très avantageuse industriellement, pour une facilité de réalisation, la portion de tête 12' la portion de base 11 et la prolongation de base 13 sont d'une seule pièce constituée, par exemple, d'un tube de cathéter 30 bien connu en lui-même, par exemple en polyamide ou en polyéthylène. Selon une réalisation très préférentielle, les premiers moyens de ballon 21 sont constitués par au moins un premier ballon, ci-après référencé aussi 21 , entourant au moins partiellement la portion de tête 12. Un tel ballon est par exemple constitué d'un manchon en un matériau souple et relativement élastique ou d'un matériau essentiellement non élastique replié sur lui-même lorsque dégonflé et qui se déplie sous la pression du fluide comme explicité ci-après, dont les deux extrémités sont liées de façon étanche à la portion de tête 12 pour délimiter, entre cette portion de tête 12 et la paroi intérieure du manchon, un volume annulaire étanche qui peut être rempli d'un fluide sous pression pour gonfler le manchon, et donc le ballon. Also, very advantageously industrially, for ease of embodiment, the head portion 12 ' the base portion 11 and the base extension 13 are in one piece consisting, for example, of a tube of catheter 30 well known in itself, for example polyamide or polyethylene. According to a very preferential embodiment, the first balloon means 21 are constituted by at least one first balloon, hereinafter also referred to as 21, at least partially surrounding the head portion 12. Such a balloon consists, for example, of a sleeve a flexible and relatively elastic material or essentially non-elastic material folded on itself when deflated and which unfolds under the pressure of the fluid as explained below, the two ends of which are sealingly connected to the leading portion 12 to define, between this head portion 12 and the inner wall of the sleeve, a sealed annular volume which can be filled with a fluid under pressure to inflate the sleeve, and therefore the balloon.
Dans ce cas, les moyens commandables pour faire varier la dimension des premiers moyens de ballon 21 selon une direction qui présente au moins une composante non nulle perpendiculaire à la portion de tête 12 comportent en outre un orifice traversant 51 réalisé dans la paroi de la partie de cathéter 30 constituant la partie de la portion de tête 12 qui est entourée par le premier ballon 21 de façon à relier l'intérieur du cathéter avec l'intérieur du premier ballon, et une première source de fluide commandable 41 dont la sortie est connectée à l'intérieur du cathéter 30 de façon à pouvoir gonfler et dégonfler à volonté le premier ballon 21 , le fluide étant de préférence biocompatible, selon les cas, liquide et/ou gazeux.  In this case, the controllable means for varying the size of the first balloon means 21 in a direction that has at least one non-zero component perpendicular to the head portion 12 further comprises a through hole 51 formed in the wall of the part catheter 30 constituting the portion of the head portion 12 which is surrounded by the first balloon 21 so as to connect the inside of the catheter with the interior of the first balloon, and a first source of controllable fluid 41 whose output is connected inside the catheter 30 so as to inflate and deflate at will the first balloon 21, the fluid is preferably biocompatible, depending on the case, liquid and / or gaseous.
De même, comme défini ci-dessus, les seconds moyens de ballon 22 sont constitués par au moins un second ballon, lui aussi référencé 22, par exemple d-u même type que le premier ballon 21 , et les moyens commandables pour faire varier la dimension de ces seconds moyens de ballon selon une direction qui présente au moins une composante non nulle perpendiculaire à la portion de base 1 comportent une seconde source de fluide commandable 42 et des moyens pour connecter la sortie de cette seconde source de fluide à l'intérieur du second ballon, par exemple une conduite annexe à l'intérieur du cathéter comme schématiquement illustré sur la figure 2, ou en parallèle sur lui comme illustré sur la figure 1.  Similarly, as defined above, the second balloon means 22 are constituted by at least one second balloon, also referenced 22, for example of the same type as the first balloon 21, and the controllable means for varying the size of the balloon. said second balloon means in a direction which has at least one non-zero component perpendicular to the base portion 1 comprises a second source of controllable fluid 42 and means for connecting the output of this second fluid source to the interior of the second balloon, for example an auxiliary line inside the catheter as schematically illustrated in Figure 2, or in parallel on it as shown in Figure 1.
De façon très préférentielle, ce second ballon 22 est monté en association avec la portion de base 1 en l'entourant, figures 1 et 2. Dans une réalisation qui peut répondre à des traitements particuliers déterminés par les Praticiens, le dispositif selon l'invention comporte en outre des moyens de stent 50 montés en coopération avec les premiers moyens de ballon 21 , en précisant que ces moyens de stent sont constitués par au moins un stent, par exemple entourant le premier ballon 21 sur presque toute sa longueur, ou par une combinaison de deux stents, ou plus comme évoqué sur la figure 2. Very preferably, this second balloon 22 is mounted in association with the base portion 1 surrounding it, FIGS. 1 and 2. In an embodiment that can respond to particular treatments determined by Practitioners, the device according to the invention further comprises stent means 50 mounted in cooperation with the first balloon means 21, specifying that these stent means are constituted by at least one stent, for example surrounding the first balloon 21 over almost its entire length, or by a combination of two stents, or more as mentioned in FIG. 2.
Il est rappelé, bien qu'il soit connu en lui-même, qu'un stent est un élément oblong essentiellement cylindrique défini selon un axe longitudinal et agencé de façon à être apte à prendre deux formes, une forme repliée dans laquelle il a une dimension transversale d'une première valeur donnée et une forme dépliée dans laquelle il a une dimension transversale d'une seconde valeur donnée supérieure à la première.  It is recalled, although it is known in itself, that a stent is an oblong element substantially cylindrical defined along a longitudinal axis and arranged to be able to take two forms, a folded form in which it has a transverse dimension of a given first value and an unfolded shape in which it has a transverse dimension of a given second value greater than the first.
Il existe plusieurs modes de réalisation possibles d'un tel stent. Mais, de façon préférentielle, il est réalisé par découpes dans un tube, par exemple en acier, ces découpes lui permettant de se déformer plastiquement sous l'effet du gonflage du (des) ballon(s) pour prendre son diamètre expansé, ce qui lui permet d'être perméable si nécessaire.  There are several possible embodiments of such a stent. But, preferably, it is made by cuts in a tube, for example steel, these cuts allowing it to plastically deform under the effect of inflation of (the) ball (s) to take its expanded diameter, which allows it to be permeable if necessary.
Un tel stent 50 peut être positionné de façon qu'il entoure au moins partiellement le premier ballon 21 ou, à la fois le premier ballon et la portion de prolongation 13, comme illustré sur la figure 2.  Such a stent 50 may be positioned so that it at least partially surrounds the first balloon 21 or both the first balloon and the extension portion 13, as illustrated in FIG.
Le dispositif décrit structurellement ci-dessus s'utilise comme celui qui est décrit dans le WO 2009065917 cité ci-avant comme appartenant à l'art antérieur à la présente invention.  The device described structurally above is used as that described in WO 2009065917 cited above as belonging to the prior art to the present invention.
Cependant, ce dispositif présente, par rapport à celui décrit dans cet art antérieur, une fonctionnalité particulièrement avantageuse.  However, this device has, compared to that described in this prior art, a particularly advantageous functionality.
Le second ballon 22 proximal est gonflé en premier et maintenu gonflé pour exercer, par l'intérieur du vaisseau de dérivation Dr, une pression sur ce vaisseau de dérivation Dr et sur tout le pourtour de l'orifice de ponction Op réalisé sur le vaisseau Vs. Il est ainsi obtenu une première étanchéité relative au niveau de cet orifice de ponction Op.  The second proximal balloon 22 is inflated first and maintained inflated to exert, through the interior of the divert vessel Dr, pressure on this divert vessel Dr and all around the optic puncture orifice Op on the vessel Vs. There is thus obtained a first relative seal at this puncture orifice Op.
Le premier ballon 21 distal 'est à son tour gonflé, ce qui entraîne le déploiement du ou des stents 50 et assure une étanchéité entre la partie en couronne Dre du vaisseau secondaire Dr et la paroi intérieure du vaisseau principal Vs par application de forces qui plaquent de façon étanche la couronne Dre contre la paroi intérieure du vaisseau principal. The first balloon 21 distal 'is in turn inflated, resulting in the deployment of the stent or stents 50 and ensures a seal between the part of Dr crown of the secondary vessel Dr and the inner wall of the main vessel Vs by application of forces that seal the crown Dre against the inner wall of the main vessel.
La combinaison des forces engendrées par le premier ballon 21 et le second ballon 22 assure très rapidement une étanchéité très satisfaisante au niveau de l'orifice de ponction Op, ce qui minimise de façon optimale les fuites de sang.  The combination of the forces generated by the first balloon 21 and the second balloon 22 very quickly ensures a very satisfactory seal at the puncture orifice Op, which minimizes the blood leakage optimally.
Il est souligné que, pour que le ou les stents puissent être bien plaqués contre la couronne Dre, il pourra être nécessaire de dégonfler partiellement le second ballon proximal 22 pour que son gonflement total ne gêne pas le déploiement du ou des stents et que la couronne Dre soit bien plaquée contre la paroi intérieure du vaisseau principal Vs. Dans un tel cas, les éventuelles fuites de sang seraient très faibles et de très courte durée, et ne nuiraient pas à l'intervention.  It is pointed out that, in order for the stent (s) to be well pressed against the Dre crown, it may be necessary to partially deflate the second proximal balloon 22 so that its total swelling does not hinder the deployment of the stent (s) and that the crown Dre is well pressed against the inner wall of the main vessel Vs. In such a case, any leakage of blood would be very small and very short, and would not harm the intervention.
Aux descriptions structurelle et fonctionnelle données ci-dessus apparaissent à l'évidence tous les avantages du dispositif selon l'invention.  The structural and functional descriptions given above clearly show all the advantages of the device according to the invention.

Claims

R E V E N D I C A T I O N S
1. Dispositif pour réaliser une dérivation (Dr) sur un vaisseau sanguin (Vs), comportant : une âme support (10) en forme sensiblement de T comprenant une portion de base (1 1 ) et une portion de tête (12), des moyens pour relier une première extrémité de la portion de base (1 1 ) à ladite portion de tête (12), des premiers moyens de ballon gonflable (21 ) associés à ladite portion de tête (12), des moyens commandables pour faire varier la dimension des dits premiers moyens de ballon (21 ) selon une direction qui présente au moins une composante non nulle perpendiculaire à ladite portion de tête (12), des seconds moyens de ballon gonflable (22) associés à ladite portion de base (11 ), et des moyens commandables pour faire varier la dimension des dits seconds moyens de ballon (22) selon une direction qui présente au moins une composante non nulle perpendiculaire à ladite portion de base (1 1 ), Apparatus for making a derivation (Dr) on a blood vessel (Vs), comprising: a substantially T-shaped support core (10) comprising a base portion (1 1) and a head portion (12), means for connecting a first end of the base portion (1 1) to said head portion (12), first inflatable balloon means (21) associated with said head portion (12), controllable means for varying the dimension of said first balloon means (21) in a direction which has at least one non-zero component perpendicular to said head portion (12), second inflatable balloon means (22) associated with said base portion (11), and controllable means for varying the size of said second balloon means (22) in a direction which has at least one non-zero component perpendicular to said base portion (1 1),
caractérisé par le fait que les moyens pour relier une première extrémité de la portion de base ( 1 ) à ladite la portion de tête (12) sont constitués par une prolongation de base (13), une première extrémité de ladite prolongation de base (13) étant solidaire sensiblement de ladite première extrémité de cette portion de base (1 1 ) pour former, avec cette portion de base, une pièce sensiblement en forme de L, la seconde extrémité de la prolongation de base (13) étant reliée à une extrémité de ladite la portion de tête (12). characterized in that the means for connecting a first end of the base portion (1) to said head portion (12) is a base extension (13), a first end of said base extension (13). ) being substantially integral with said first end of this base portion (1 1) to form, with this base portion, a substantially L-shaped piece, the second end of the base extension (13) being connected to one end said head portion (12).
2. Dispositif selon la revendication 1 , caractérisé par le fait que la seconde extrémité de la prolongation de base (13) est reliée à une extrémité de ladite portion de tête (12) de façon que cette prolongation de base (13) fasse, avec la portion de tête (12), un angle inférieur à quatre-vingt-dix degrés.  2. Device according to claim 1, characterized in that the second end of the base extension (13) is connected to one end of said head portion (12) so that this base extension (13), with the head portion (12), an angle less than ninety degrees.
3. Dispositif selon la revendication 2, caractérisé par le fait que la portion de tête (12), la portion de base (1 1 ) et la prolongation de base (13) sont d'une seule pièce.  3. Device according to claim 2, characterized in that the head portion (12), the base portion (1 1) and the base extension (13) are in one piece.
4. Dispositif selon la revendication 3, caractérisé par le fait que ladite seule pièce est constituée d'un cathéter (30). 4. Device according to claim 3, characterized in that said single piece consists of a catheter (30).
5. Dispositif selon la revendication 4, caractérisé par le fait que les premiers moyens de ballon (21 ) sont constitués par au moins un premier ballon entourant au moins partiellement ladite portion de tête (12) et que les moyens commandables pour faire varier la dimension des dits premiers moyens de ballon selon une direction qui présente au moins une composanté non nulle perpendiculaire à ladite portion de tête (12) comportent en outre un orifice traversant (51 ) réalisé dans la paroi de la partie de cathéter (30) constituant ladite portion de tête de façon à relier l'intérieur du cathéter avec l'intérieur du premier ballon, et une première source de fluide commandable (41 ) dont la sortie est connectée à l'intérieur du cathéter (30). 5. Device according to claim 4, characterized in that the first balloon means (21) are constituted by at least a first balloon at least partially surrounding said head portion (12) and that the controllable means for varying the size said first balloon means in a direction which has at least one non-zero component perpendicular to said head portion (12) further comprises a through hole (51) formed in the wall of the catheter portion (30) constituting said portion head to connect the interior of the catheter with the interior of the first balloon, and a first source of controllable fluid (41) whose output is connected to the inside of the catheter (30).
6. Dispositif selon l'une des revendications précédentes, caractérisé par le fait que les seconds moyens de ballon (22) sont constitués par au moins un second ballon, et que les moyens commandables pour faire varier la dimension des dits seconds moyens de ballon selon une direction qui présente au moins une composante non nulle perpendiculaire à ladite portion de base (1 1) comportent une seconde source de fluide commandable (42) et des moyens pour connecter la sortie de cette seconde source de fluide (42) à l'intérieur du second ballon.  6. Device according to one of the preceding claims, characterized in that the second balloon means (22) are constituted by at least one second balloon, and that the controllable means for varying the size of said second balloon means a direction having at least one non-zero component perpendicular to said base portion (11) includes a second controllable fluid source (42) and means for connecting the output of said second fluid source (42) therein of the second balloon.
7. Dispositif selon la revendication 6, caractérisé par le fait que ledit second ballon est monté en association avec ladite portion de base (1 1 ) en l'entourant.  7. Device according to claim 6, characterized in that said second balloon is mounted in association with said base portion (1 1) surrounding it.
8. Dispositif selon l'une des revendications précédentes, caractérisé par le fait qu'il comporte des moyens de stent (50) montés en coopération avec lesdits premiers moyens de ballon (21 ).  8. Device according to one of the preceding claims, characterized in that it comprises stent means (50) mounted in cooperation with said first balloon means (21).
9. Dispositif selon la revendication 8, caractérisé par le fait que les moyens de stent (50) sont constitués par au moins un stent.  9. Device according to claim 8, characterized in that the stent means (50) consist of at least one stent.
10. Dispositif selon la revendication 9 quand elle dépend de la revendication 5, caractérisé par le fait que ledit au moins un stent (50) entoure au moins partiellement ledit premier ballon ou, à la fois, le premier ballon et la portion de prolongation (13).  10. Device according to claim 9 when it depends on claim 5, characterized in that said at least one stent (50) at least partially surrounds said first balloon or both the first balloon and the extension portion ( 13).
PCT/FR2015/000035 2014-03-05 2015-02-18 Device for carrying out a blood vessel bypass WO2015132480A1 (en)

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FR14/00542 2014-03-05
FR1400542A FR3018183A1 (en) 2014-03-05 2014-03-05 DEVICE FOR PERFORMING A DERIVATION ON A BLOOD VESSEL

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EP3799831A1 (en) * 2019-10-03 2021-04-07 Institut Français des Sciences et Technologies des Transports, de l'Amenagement et des Reseaux Vascular prosthesis

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US4840690A (en) 1986-08-25 1989-06-20 Becton, Dickinson And Company Method of constructing a blood flow conduit
WO2001017582A2 (en) 1999-09-09 2001-03-15 Corvascular, Inc. Bifurcated shunt drug delivery system and methods of use
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WO2021064256A1 (en) * 2019-10-03 2021-04-08 Universite D'aix-Marseille Vascular prosthesis

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