WO2001022888A1 - Retaining structure for anatomical canal, in particular a vessel - Google Patents

Retaining structure for anatomical canal, in particular a vessel Download PDF

Info

Publication number
WO2001022888A1
WO2001022888A1 PCT/FR2000/002675 FR0002675W WO0122888A1 WO 2001022888 A1 WO2001022888 A1 WO 2001022888A1 FR 0002675 W FR0002675 W FR 0002675W WO 0122888 A1 WO0122888 A1 WO 0122888A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
slot
tube
vessel
length
Prior art date
Application number
PCT/FR2000/002675
Other languages
French (fr)
Inventor
Stefano Ricci
Original Assignee
Laboratoire Innothera
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 Laboratoire Innothera filed Critical Laboratoire Innothera
Priority to AU76679/00A priority Critical patent/AU7667900A/en
Publication of WO2001022888A1 publication Critical patent/WO2001022888A1/en

Links

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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3962—Markers, e.g. radio-opaque or breast lesions markers palpable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image

Definitions

  • the invention relates to a support structure for an anatomical canal. It applies in particular to the containment of a vessel, in particular in phlebology to remedy the undesirable dilation of a vein.
  • this pathology is often the consequence of dilation of the butt and not of a lesion of the valve.
  • Patients who have valve insufficiency with healthy valves can thus benefit from a reduction in the diameter of the arch, and numerous external plastic techniques have been proposed for this purpose over the past fifteen years, with or without using an additional device installed.
  • the techniques not using an implanted accessory one can cite: the plasty with the fascia lata, the plication of the great saphenous vein, or the ligature of the saphenous vein.
  • One of the aims of the invention is to overcome these drawbacks, by proposing a compression structure which is easy to apply and whose effectiveness does not depend on the skill of the surgeon, which is also easy to remove if necessary and which, moreover, can be manufactured at low cost.
  • the invention proposes to produce a split tubular retractable sleeve, with a slot extending from one end to the other of the sleeve.
  • the sleeve is made of an elastically deformable material (unlike, for example, PTFE or the various materials used until now) capable of urging the wall of the channel radially inwards (unlike in particular the various types of clips or sleeves to be clamped by an external stress) in a substantially uniform manner on the periphery of this wall.
  • the material is also chosen so that, in the absence of external stress, the sleeve returns to its original coiled shape by the simple effect of the intrinsic elasticity of said material.
  • the slot of the sleeve is a helical slot, the pitch of which can be chosen, as a function of the diameter of the length of the sleeve, so as to form at least two complete turns.
  • Such a sleeve can in particular be produced from a silicone tube, by cutting a length in this tube and then cutting this length of tube to form the slot.
  • the material of the sleeve is very advantageously a silicone elastomer, more precisely an elastomer based on organosilicon / organosiloxane polymers such as Silastic (registered trademark of Dow Corning Corporation).
  • Figure 1 is a side view, along ll of Figure 2, of the compression structure according to the invention.
  • Figure 2 is an end view, along ll-ll of Figure 1, of the same structure.
  • Figure 3 is a sectional view, along III-III of Figure 2, of the same structure.
  • Figure 4 shows how the structure of Figures 1 to 3 can be stressed and unwound to allow its installation.
  • Figure 5 shows the configuration of the venous network with the structure of the invention placed around the arch of the long saphenous vein.
  • Figures 6 to 8 illustrate various alternative embodiments of the structure of the invention.
  • the structure 10 of the invention illustrated in FIGS. 1 to 3 is produced from a tube 12, cylindrical with an axis of revolution 14, by cutting a length from this tube so to individualize a sleeve 10.
  • This tube is, for example, in the application considered for reducing the caliber of the saphenous arch, a tube 1 mm thick with an internal channel of 6 mm in diameter, from which has been cut a length of 2 cm (these dimensions are of course not limiting).
  • This length of tube is then cut so as to make a slot 16 there from one end to the other of the tube.
  • the slot 16 is very advantageously a helical slot, formed for example over two complete turns in the above example of a tube length of 2 cm.
  • the elastically deformable material of the structure is very advantageously an elastomer based on organosilicon / organosiloxane polymers such as Silastic (registered trademark of Dow Corning Corporation).
  • Silastic registered trademark of Dow Corning Corporation
  • this material which is also commonly used in medicine and surgery given its excellent biocompatibility, has the advantage of not creating adhesions between the sleeve and the vessel, and moreover , promotes the appearance of a sheath of reactive connective tissue on the wall of the vessel such that, after a few weeks or a few months, the vein remains continuous even if the elastic sleeve is removed.
  • the flexibility of the elastically deformable material, combined with the helical cutting, makes it possible to benefit from the shape memory linked to the tubular structure.
  • the surgeon just has to unroll the sleeve in the manner of a coil by pulling it by its two ends, as illustrated by the arrows 18 in FIG. 4, then to wrap it around the dilated region, the sleeve resuming its original coiled shape by the simple effect of the intrinsic elasticity of the material which composes it (effect of "shape memory" of the material) ..
  • This ensures self-positioning of the sleeve, without the using any instrument or accessory such as pliers or the like, by the simple effect of shape memory provided by the helical structure and the elastically deformable material.
  • the withdrawal is carried out exactly in reverse, by unrolling the sleeve to separate it from the vessel.
  • the sleeve can therefore be removed very easily, without vascular trauma, and does not produce a stenosing effect.
  • the helical shape notably makes it possible to very easily remove the sleeve through a small incision, which makes it possible to leave the newly formed reactive connective tissue sheath practically intact.
  • Figure 5 illustrates the venous network, with the butt 20 of the saphenous vein 22, the ostial valve 24, the pre-ostial valve 25 located 2 to 4 cm upstream, the common femoral vein 26, as well as branches 28 , 30 of the butt.
  • the fitting of the sleeve 10 around the butt 20 makes it possible to reduce the size of the latter and thus to make the valves 24 and 25 continuous by reducing the size of the vein around these valves.
  • the slot 16 formed from one end to the other of the sleeve 10 can take another shape than the helical shape which has just been described, for example a zigzag shape as illustrated in figure 6, or a staircase shape as illustrated in figure 7
  • the helical shape is however that which allows to exert on the wall of the vessel the most regular stress (the most isotropic), and therefore a priori the most physiologically acceptable
  • this characteristic allows place the sleeve around the vein without having to give it a particular orientation (orientation in rotation around the axis 14)
  • the tube used to make the sleeve 10 is a convex tube in its middle part instead of being a cylindrical tube, the shape of the sleeve being able to be thus adapted to the particular morphology of the stock (or other channel whose caliber is to be reduced), if the cylindrical shape is not judged optimal.
  • particular application described above is not limiting, and other indications may be considered, in phlebology or in other fields
  • the structure of the invention can be used to treat deep valve incontinence It can also be considered for the treatment of saphenous venous insufficiency during CHIVA (Conservative and Hemodynamic Method of Venous Insufficiency in Ambulatory ), eliminating in particular the need for the 2 nd time of CHIVA 2 (interruption of the butt stock in a second time due to a perforating fault of satisfactory reentry at the time of the disconnection of the collaterals) It can be associated with sclerosis of the saphenous trunks, and could be used as a calibrated means of constriction of the incontinence with atrophied valves , if future studies demonstrate the effectiveness of this method
  • the structure of the invention can be used in indications such as the control of the dilation of arteriovenous fistulas and the correction of phenomena linked to venous aneurisms, in particular the aneurysm of the vein pophtée, or the treatment of arterial aneurysms.
  • the structure of the invention can be used to mechanically create stenoses on various anatomical channels (veins, ureters, common bile duct, intestine) with the advantage of being able to be easily removed without significant alteration of the surrounding tissues .

Abstract

The invention concerns a structure comprising a retractable sleeve (10) designed to be set around the vessel (20), the sleeve being a slit tubular sleeve, with a slit (16), extending from one end of the sleeve to the other, and made of an elastically deformable material capable of stressing radially inwards the wall of the canal (20) in substantially uniform manner on the periphery of said wall, said material being further selected such that, when there is no stress, the sleeve recovers its original wound shape by mere effect of the intrinsic elasticity of said material. The sleeve material is a silicon elastomer such as an elastomer based on organosilicon/organosiloxane polymers.

Description

Structure de contention d'un canal anatomique, notamment d'un vaisseau Contention structure of an anatomical canal, especially a vessel
L'invention concerne une structure de contention d'un canal anatomique. Elle s'applique en particulier à la contention d'un vaisseau, notamment en phlébologie pour remédier à la dilatation indésirable d'une veine. Ainsi, si l'on prend le cas de l'incompétence de la crosse de la saphène interne, cette pathologie est souvent la conséquence d'une dilatation de la crosse et non d'une lésion de la valvule. Les patients qui ont une insuf- fisance valvulaire avec des valves saines peuvent ainsi bénéficier d'une réduction du diamètre de la crosse, et de nombreuses techniques de plas- tie externe ont été proposées à cet effet depuis une quinzaine d'années, avec ou sans utilisation d'un dispositif additionnel implanté. Parmi les techniques ne faisant pas appel à un accessoire implanté, on peut citer : la plastie avec le fascia lata, la plicature de la grande saphène, ou la ligature de la saphène.The invention relates to a support structure for an anatomical canal. It applies in particular to the containment of a vessel, in particular in phlebology to remedy the undesirable dilation of a vein. Thus, if we take the case of incompetence of the long saphenous arch, this pathology is often the consequence of dilation of the butt and not of a lesion of the valve. Patients who have valve insufficiency with healthy valves can thus benefit from a reduction in the diameter of the arch, and numerous external plastic techniques have been proposed for this purpose over the past fifteen years, with or without using an additional device installed. Among the techniques not using an implanted accessory, one can cite: the plasty with the fascia lata, the plication of the great saphenous vein, or the ligature of the saphenous vein.
Parmi les techniques faisant appel à des accessoires de plastie, on peut citer : la pose d'un anneau en une fibre polyester telle que le Dacron (marque déposée de E. I. Du Pont de Nemours and Company), la pose d'un manchon en PTFE, la plastie externe de la saphène avec renforcement par un matériau formé de fibres plastiques telles que du Marlex (marque déposée de Phillips Petroleum Company) maintenu et fixé en place au moyen de clips, ou encore, plus récemment, la technique dite "Venocuff" consistant à entourer la veine par un ruban qui est ensuite ser- ré en place au moyen d'un système de blocage comparable à celui des serre-câbles utilisés en électricité, cette dernière technique étant aujourd'hui la plus répandue pour ce type d'intervention.Among the techniques using plastic accessories, we can cite: the installation of a ring in a polyester fiber such as Dacron (registered trademark of EI Du Pont de Nemours and Company), the installation of a PTFE sleeve , the external saphenous plasty with reinforcement by a material formed of plastic fibers such as Marlex (registered trademark of Phillips Petroleum Company) maintained and fixed in place by clips, or even, more recently, the technique called "Venocuff" consisting of surrounding the vein with a ribbon which is then tightened in place by means of a blocking system comparable to that of cable ties used in electricity, the latter technique being the most widespread today for this type of intervention.
Ces diverses techniques, notamment celle qui consiste à entourer la zone dilatée par un manchon ou un ruban en matériau souple qui est ensuite serré autour de la veine de manière à réaliser la réduction de calibre souhaitée, présentent cependant tout l'inconvénient d'être délicates à mettre en œuvre, tant pour leur pose que pour leur retrait, et nécessitent une intervention chirurgicale relativement invasive. Par exemple, la pose d'un dispositif "Venocuff doit être opérée sous con- frôle Doppler, notamment pour la mise en tension du clip. De plus, cette technique est coûteuse, tant du point de vue matériel (ruban, clips, instrumentation spécifique) que des moyens humains et opératoires nécessaires à la réussite de l'intervention.These various techniques, in particular that which consists of surrounding the dilated zone with a sleeve or a ribbon of flexible material which is then tightened around the vein so as to achieve the desired reduction in size, have all the disadvantage of being delicate. to be implemented, both for their installation and for their removal, and require a relatively invasive surgical intervention. For example, the installation of a "Venocuff device must be operated under Doppler control, in particular for tensioning the clip. In addition, this technique is expensive, both from the material point of view (tape, clips, specific instrumentation) and the human and operational means necessary for the success of the intervention.
L'un des buts de l'invention est de pallier ces inconvénients, en proposant une structure de contention aisée à poser et dont l'efficacité ne dépende pas de l'habileté du chirurgien, qui soit également aisée à retirer si nécessaire et qui, au surplus, puisse être fabriquée à faible coût. L'invention propose à cet effet de réaliser un manchon rétractable tubu- laire fendu, avec une fente s'étendant d'une extrémité à l'autre du man- chon. Le manchon est en un matériau élastiquement deformable (à la différence par exemple du PTFE ou des divers matériaux employés jusqu'à présent) apte à solliciter radialement vers l'intérieur la paroi du canal (à la différence notamment des divers types de clips ou manchons à serrer par une sollicitation externe) de manière sensiblement uniforme sur la péri- phérie de cette paroi. Le matériau est en outre choisi de manière que, en l'absence de sollicitation extérieure, le manchon reprenne sa forme enroulée originelle par le simple effet de l'élasticité intrinsèque dudit matériau. Très avantageusement, la fente du manchon est une fente hélicoïdale, dont le pas peut être choisi, en fonction du diamètre de la longueur du manchon, de manière à former au moins deux tours complets. Un tel manchon peut notamment être réalisé à partir d'un tube de silicone, par découpe d'une longueur dans ce tube puis entaille de cette longueur de tube pour y former la fente. Le matériau du manchon est très avantageusement un elastomère de silicone, plus précisément un elastomère à base de polymères d'organosili- cones/organosiloxanes tel que le Silastic (marque déposée de Dow Corning Corporation).One of the aims of the invention is to overcome these drawbacks, by proposing a compression structure which is easy to apply and whose effectiveness does not depend on the skill of the surgeon, which is also easy to remove if necessary and which, moreover, can be manufactured at low cost. To this end, the invention proposes to produce a split tubular retractable sleeve, with a slot extending from one end to the other of the sleeve. The sleeve is made of an elastically deformable material (unlike, for example, PTFE or the various materials used until now) capable of urging the wall of the channel radially inwards (unlike in particular the various types of clips or sleeves to be clamped by an external stress) in a substantially uniform manner on the periphery of this wall. The material is also chosen so that, in the absence of external stress, the sleeve returns to its original coiled shape by the simple effect of the intrinsic elasticity of said material. Very advantageously, the slot of the sleeve is a helical slot, the pitch of which can be chosen, as a function of the diameter of the length of the sleeve, so as to form at least two complete turns. Such a sleeve can in particular be produced from a silicone tube, by cutting a length in this tube and then cutting this length of tube to form the slot. The material of the sleeve is very advantageously a silicone elastomer, more precisely an elastomer based on organosilicon / organosiloxane polymers such as Silastic (registered trademark of Dow Corning Corporation).
00
D'autres caractéristiques et avantages de l'invention apparaîtront à la lecture de la description ci-dessous d'un exemple préférentiel de mise en œuvre de l'invention, en référence aux dessins annexés. La figure 1 est une vue de côté, selon l-l de la figure 2, de la structure de contention selon l'invention. La figure 2 est une vue de bout, selon ll-ll de la figure 1 , de cette même structure.Other characteristics and advantages of the invention will appear on reading the description below of a preferred example of implementation of the invention, with reference to the accompanying drawings. Figure 1 is a side view, along ll of Figure 2, of the compression structure according to the invention. Figure 2 is an end view, along ll-ll of Figure 1, of the same structure.
La figure 3 est une vue en coupe, selon lll-lll de la figure 2, de cette même structure. La figure 4 montre la manière dont la structure des figures 1 à 3 peut être sollicitée et déroulée pour permettre sa pose.Figure 3 is a sectional view, along III-III of Figure 2, of the same structure. Figure 4 shows how the structure of Figures 1 to 3 can be stressed and unwound to allow its installation.
La figure 5 montre la configuration du réseau veineux avec la structure de l'invention placée autour de la crosse de la saphène interne. Les figures 6 à 8 illustrent diverses variantes de réalisation de la structure de l'invention.Figure 5 shows the configuration of the venous network with the structure of the invention placed around the arch of the long saphenous vein. Figures 6 to 8 illustrate various alternative embodiments of the structure of the invention.
00
Dans sa forme préférentielle, la plus simple, la structure 10 de l'invention illustrée sur les figures 1 à 3 est réalisée à partir d'un tube 12, cylindrique de révolution d'axe 14, en découpant dans ce tube une longueur de manière à individualiser un manchon 10.In its preferred, simplest form, the structure 10 of the invention illustrated in FIGS. 1 to 3 is produced from a tube 12, cylindrical with an axis of revolution 14, by cutting a length from this tube so to individualize a sleeve 10.
Ce tube est par exemple, dans l'application considérée de réduction du calibre de la crosse de la saphène, un tube de 1 mm d'épaisseur avec un canal interne de 6 mm de diamètre, dans lequel a été découpée une lon- gueur de 2 cm (ces dimensions n'étant bien entendu pas limitatives).This tube is, for example, in the application considered for reducing the caliber of the saphenous arch, a tube 1 mm thick with an internal channel of 6 mm in diameter, from which has been cut a length of 2 cm (these dimensions are of course not limiting).
Cette longueur de tube est ensuite entaillée de manière à y pratiquer une fente 16 d'une extrémité à l'autre du tube.This length of tube is then cut so as to make a slot 16 there from one end to the other of the tube.
La fente 16 est très avantageusement une fente hélicoïdale, formée par exemple sur deux tours complets dans l'exemple ci-dessus d'une lon- gueur de tube de 2 cm.The slot 16 is very advantageously a helical slot, formed for example over two complete turns in the above example of a tube length of 2 cm.
Le matériau élastiquement deformable de la structure est très avantageusement un elastomère à base de polymères d'organosilicones/organosilo- xanes tel que le Silastic (marque déposée de Dow Corning Corporation). L'expérimentation a en effet montré que ce matériau, qui est par ailleurs couramment utilisé en médecine et en chirurgie compte tenu de son excellente biocompatibilité, présente l'avantage de ne pas créer d'adhérences entre le manchon et le vaisseau, et de plus, favorise l'apparition d'une gaine de tissu conjonctif réactionnel sur la paroi du vaisseau telle que, après quelques semaines ou quelques mois, la veine demeure continente même si l'on retire le manchon élastique. La souplesse du matériau élastiquement deformable, combinée à la découpe hélicoïdale, permet de bénéficier de la mémoire de forme liée à la structure tubulaire.The elastically deformable material of the structure is very advantageously an elastomer based on organosilicon / organosiloxane polymers such as Silastic (registered trademark of Dow Corning Corporation). Experimentation has indeed shown that this material, which is also commonly used in medicine and surgery given its excellent biocompatibility, has the advantage of not creating adhesions between the sleeve and the vessel, and moreover , promotes the appearance of a sheath of reactive connective tissue on the wall of the vessel such that, after a few weeks or a few months, the vein remains continuous even if the elastic sleeve is removed. The flexibility of the elastically deformable material, combined with the helical cutting, makes it possible to benefit from the shape memory linked to the tubular structure.
Ainsi, pour la pose, il suffit au chirurgien de dérouler le manchon à la ma- nière d'un serpentin en le tirant par ses deux extrémités, comme illustré par les flèches 18 sur la figure 4, puis de l'enrouler autour de la région dilatée, le manchon reprenant sa forme enroulée originelle par le simple effet de l'élasticité intrinsèque du matériau qui le compose (effet de "mémoire de forme" du matériau).. On assure ainsi un auto-positionnement du manchon, sans l'aide d'aucun instrument ni accessoire tel que pince ou autre, par le simple effet de la mémoire de forme procurée par la structure hélicoïdale et le matériau élastiquement deformable. Le retrait s'effectue exactement à l'inverse, en déroulant le manchon pour le séparer du vaisseau. Le manchon peut donc être retiré très aisément, sans traumatisme vasculaire, et ne produit pas d'effet sténosant. La forme en hélice permet notamment de retirer très aisément le manchon au travers d'une incision de petite dimension, ce qui permet de laisser pratiquement intacte la gaine de tissu conjonctif réactionnel nouvellement for- mée.Thus, for fitting, the surgeon just has to unroll the sleeve in the manner of a coil by pulling it by its two ends, as illustrated by the arrows 18 in FIG. 4, then to wrap it around the dilated region, the sleeve resuming its original coiled shape by the simple effect of the intrinsic elasticity of the material which composes it (effect of "shape memory" of the material) .. This ensures self-positioning of the sleeve, without the using any instrument or accessory such as pliers or the like, by the simple effect of shape memory provided by the helical structure and the elastically deformable material. The withdrawal is carried out exactly in reverse, by unrolling the sleeve to separate it from the vessel. The sleeve can therefore be removed very easily, without vascular trauma, and does not produce a stenosing effect. The helical shape notably makes it possible to very easily remove the sleeve through a small incision, which makes it possible to leave the newly formed reactive connective tissue sheath practically intact.
On notera que, du point de vue de la déformabilité mécanique, la structure du manchon rend celui-ci parfaitement réversible - à la différence, ici encore, des clips ou autres dispositifs analogues jusqu'à présent utilisés. La figure 5 illustre le réseau veineux, avec la crosse 20 de la saphène in- terne 22, la valvule ostiale 24, la valvule pré-ostiale 25 située 2 à 4 cm en amont, la veine fémorale commune 26, ainsi que des branches 28, 30 de la crosse.It will be noted that, from the point of view of mechanical deformability, the structure of the sleeve makes it perfectly reversible - unlike, here again, clips or other similar devices hitherto used. Figure 5 illustrates the venous network, with the butt 20 of the saphenous vein 22, the ostial valve 24, the pre-ostial valve 25 located 2 to 4 cm upstream, the common femoral vein 26, as well as branches 28 , 30 of the butt.
La pose du manchon 10 autour de la crosse 20 permet de réduire le calibre de cette dernière et de rendre ainsi continentes les valvules 24 et 25 par réduction du calibre de la veine autour de ces valvules.The fitting of the sleeve 10 around the butt 20 makes it possible to reduce the size of the latter and thus to make the valves 24 and 25 continuous by reducing the size of the vein around these valves.
La simplicité de mise en place de la structure de l'invention permet d'envisager une technique opératoire peu invasive, avec une incision de très faible longueur, ou encore à distance par une technique de ponction et endoscopie combinées. Une étude expérimentale a été réalisée sur quatre brebis, en enroulant des structures ayant les dimensions indiquées plus haut (longueur 2 cm, diamètre intérieur 6 mm, épaisseur de paroi 1 mm, fente hélicoïdale sur deux tours complets) autour de sept veines jugulaires et d'une artère carotide. Les structures ont été laissées en place pendant six mois, puis les animaux ont été sacrifiés et les vaisseaux objet de l'étude ont été disséqués et étudiés à l'échelle macroscopique et microscopique. Par ailleurs, des échographies et phlébographies des sites opérés ont été effectuées juste après l'intervention et six mois après. Tous les animaux ont survécu à l'opération, et aucune sténose ni thrombose n'ont pu être radiologiquement détectées. La réaction périvasculaire a été très limitée et il n'y a pas eu formation d'adhérences avec la veine ni avec les tissus périveineux, ce qui a permis de retirer la structure aisément, sans traumatisme vasculaire. Par ailleurs, l'histologie des sites opé- ratoires n'a révélé que des réactions inflammatoires insignifiantes.The simplicity of setting up the structure of the invention makes it possible to envisage a minimally invasive operating technique, with an incision of very short length, or even remotely by a combined puncture and endoscopy technique. An experimental study was carried out on four sheep, by rolling up structures having the dimensions indicated above (length 2 cm, internal diameter 6 mm, wall thickness 1 mm, helical slit over two complete turns) around seven jugular veins and a carotid artery. The structures were left in place for six months, then the animals were sacrificed and the vessels under study were dissected and studied on a macroscopic and microscopic scale. In addition, ultrasounds and phlebographies of the operated sites were carried out just after the intervention and six months later. All animals survived the operation, and no stenosis or thrombosis could be detected radiologically. The perivascular reaction was very limited and there was no formation of adhesions with the vein or with the periveinous tissues, which made it possible to remove the structure easily, without vascular trauma. In addition, the histology of the operating sites revealed only insignificant inflammatory reactions.
Surtout, on a constaté à l'endroit des sites opérés la formation d'une légère gaine de tissu conjonctif réactionnel, qui pourrait assurer un calibre constant même après retrait du manchon élastique. Divers perfectionnement de l'invention peuvent être envisagés, par exem- pie :Above all, it has been observed at the site of the operated sites the formation of a slight sheath of reactive connective tissue, which could ensure a constant gauge even after removal of the elastic sleeve. Various improvements of the invention can be envisaged, for example:
- un marquage radio-opaque du manchon,- radiopaque marking of the sleeve,
- une ou plusieurs bulles d'air incorporées dans le matériau ou à chacune des extrémités du manchon pour permettre la détection de celui- ci par les méthodes ultrasonores (échographie par exemple), - une boule ou autre protubérance formée à chacune des deux extrémités de l'hélice du manchon, pour permettre au praticien de détecter et repérer la position du manchon au travers de la peau par simple palpation.- one or more air bubbles incorporated in the material or at each end of the sleeve to allow detection of the latter by ultrasonic methods (ultrasound for example), - a ball or other protuberance formed at each of the two ends of the sleeve propeller, to allow the practitioner to detect and locate the position of the sleeve through the skin by simple palpation.
- l'incorporation au manchon d'un réservoir gonflable permettant d'ajus- ter la pression de contention, etc.- the incorporation in the sleeve of an inflatable tank allowing the compression pressure to be adjusted, etc.
Diverses variantes de réalisation du manchon de l'invention peuvent être envisagées.Various alternative embodiments of the sleeve of the invention can be envisaged.
Ainsi, la fente 16 formée d'une extrémité à l'autre du manchon 10 (pour permettre son placement autour du vaisseau) peut prendre une autre forme que la forme hélicoïdale que l'on vient de décrire, par exemple une forme en zigzag comme illustré figure 6, ou une forme en escalier comme illustré figure 7Thus, the slot 16 formed from one end to the other of the sleeve 10 (to allow its placement around the vessel) can take another shape than the helical shape which has just been described, for example a zigzag shape as illustrated in figure 6, or a staircase shape as illustrated in figure 7
La forme en hélice est cependant celle qui permet d'exercer sur la paroi du vaisseau la sollicitation la plus régulière (la plus isotrope), et donc a priori la plus acceptable physiologiquement De plus, du point de vue du praticien, cette caractéristique permet de placer le manchon autour de la veine sans devoir lui donner une orientation particulière (orientation en rotation autour de l'axe 14) Dans une autre variante, illustrée figure 8, le tube servant à réaliser le manchon 10 est un tube bombé dans sa partie médiane au heu d'être un tube cylindrique, la forme du manchon pouvant être ainsi adaptée à la morphologie particulière de la crosse (ou autre canal dont on souhaite réduire le calibre), si la forme cylindrique n'est pas jugée optimale Par ailleurs, l'application particulière décrite plus haut n'est pas limitative, et d'autres indications peuvent être envisagées, en phlebologie ou dans d'autres domainesThe helical shape is however that which allows to exert on the wall of the vessel the most regular stress (the most isotropic), and therefore a priori the most physiologically acceptable In addition, from the point of view of the practitioner, this characteristic allows place the sleeve around the vein without having to give it a particular orientation (orientation in rotation around the axis 14) In another variant, illustrated in FIG. 8, the tube used to make the sleeve 10 is a convex tube in its middle part instead of being a cylindrical tube, the shape of the sleeve being able to be thus adapted to the particular morphology of the stock (or other channel whose caliber is to be reduced), if the cylindrical shape is not judged optimal. particular application described above is not limiting, and other indications may be considered, in phlebology or in other fields
En ce qui concerne la phlebologie, outre le traitement de l'insuffisance valvulaire par réduction du calibre de la crosse (qui concerne environ 10 % des patients avec incontinence de la saphène interne, et plus préci- sèment ceux qui présentent une insuffisance valvulaire à lambeaux sains), la structure de l'invention peut être utilisée pour traiter des incontinences valvulaires profondes Elle peut être également envisagée pour le traitement de l'insuffisance veineuse de la saphène au cours du CHIVA (méthode Conservatrice et Hémodynamique de l'Insuffisance Veineuse en Ambulatoire), éliminant en particulier la nécessité du 2e temps de la CHIVA 2 (interruption de la crosse dans un deuxième temps en faute perforante de rentrée satisfaisante au moment de la déconnexion des collatérales) Elle peut être associée à la sclérose des troncs saphènes, et pourrait être utilisée comme moyen de rétrécissement calibré de la crosse in- continente à valvules atrophiées, si de futures études démontraient l'efficacité de cette méthodeWith regard to phlebology, in addition to the treatment of valve insufficiency by reduction of the caliber of the arch (which concerns approximately 10% of patients with saphenous internal incontinence, and more precisely those who have valve flap insufficiency healthy), the structure of the invention can be used to treat deep valve incontinence It can also be considered for the treatment of saphenous venous insufficiency during CHIVA (Conservative and Hemodynamic Method of Venous Insufficiency in Ambulatory ), eliminating in particular the need for the 2 nd time of CHIVA 2 (interruption of the butt stock in a second time due to a perforating fault of satisfactory reentry at the time of the disconnection of the collaterals) It can be associated with sclerosis of the saphenous trunks, and could be used as a calibrated means of constriction of the incontinence with atrophied valves , if future studies demonstrate the effectiveness of this method
Toujours dans le domaine vasculaire, la structure de l'invention peut être utilisée dans des indications telles que le contrôle de la dilatation des fistules artéro-veineuses et la correction de phénomènes liés à des anévπs- mes veineux, notamment l'anévrisme de la veine pophtée, ou encore le traitement des anévrismes artériels.Still in the vascular field, the structure of the invention can be used in indications such as the control of the dilation of arteriovenous fistulas and the correction of phenomena linked to venous aneurisms, in particular the aneurysm of the vein pophtée, or the treatment of arterial aneurysms.
Dans le domaine de la chirurgie expérimentale, la structure de l'invention peut être utilisée pour créer mécaniquement des sténoses sur divers canaux anatomiques (veines, uretères, cholédoque, intestin) avec l'avantage de pouvoir être aisément retiré sans altération significative des tissus environnants. In the field of experimental surgery, the structure of the invention can be used to mechanically create stenoses on various anatomical channels (veins, ureters, common bile duct, intestine) with the advantage of being able to be easily removed without significant alteration of the surrounding tissues .

Claims

REVENDICATIONS
1. Une structure de contention d'un canal anatomique, notamment d'un vaisseau, comprenant un manchon rétractable apte à être posé autour de ce canal, caractérisé en ce que le manchon (10) est un manchon tubulaire fendu, avec une fente (16) s'étendant d'une extrémité à l'autre du manchon, et en ce que le manchon est en un matériau élastiquement deformable apte à solliciter radialement vers l'intérieur la paroi du canal (20) de manière sensiblement uniforme sur la périphérie de cette paroi, ce matériau étant en outre choisi de manière que, en l'absence de sollicitation extérieure, le manchon reprenne sa forme enroulée originelle par le simple effet de l'élasticité intrinsèque dudit matériau.1. A containment structure of an anatomical channel, in particular of a vessel, comprising a retractable sleeve capable of being placed around this channel, characterized in that the sleeve (10) is a split tubular sleeve, with a slot ( 16) extending from one end to the other of the sleeve, and in that the sleeve is made of an elastically deformable material capable of urging the wall of the channel (20) radially inwards substantially uniformly around the periphery of this wall, this material being also chosen so that, in the absence of external stress, the sleeve resumes its original coiled shape by the simple effect of the intrinsic elasticity of said material.
2. La structure de la revendication 1 , dans laquelle le manchon est réalisé à partir d'un tube de silicone, par découpe d'une longueur dans ce tube puis entaille de cette longueur de tube pour y former la fente.2. The structure of claim 1, wherein the sleeve is made from a silicone tube, by cutting a length in this tube and then cutting this length of tube to form the slot.
3. La structure de la revendication 1 , dans laquelle la fente (16) est une fente hélicoïdale.3. The structure of claim 1, wherein the slot (16) is a helical slot.
4. La structure de la revendication 3, dans laquelle le pas d'hélice de la fente (16) est choisi, en fonction du diamètre de la longueur du manchon, de manière que la fente forme au moins deux tours d'une extrémité à l'autre du manchon.4. The structure of claim 3, wherein the helical pitch of the slot (16) is chosen, depending on the diameter of the length of the sleeve, so that the slot forms at least two turns from one end to the other of the sleeve.
5. La structure de la revendication 1 , dans laquelle le matériau du manchon est un elastomère de silicone.5. The structure of claim 1, wherein the sleeve material is a silicone elastomer.
6. La structure de la revendication 5, dans laquelle l'élastomère de silico- ne est un elastomère à base de polymères d'organosilicones/organosilo- xanes. 6. The structure of claim 5, in which the silica elastomer is an elastomer based on organosilicon / organosiloxane polymers.
PCT/FR2000/002675 1999-09-27 2000-09-27 Retaining structure for anatomical canal, in particular a vessel WO2001022888A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU76679/00A AU7667900A (en) 1999-09-27 2000-09-27 Retaining structure for anatomical canal, in particular a vessel

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
FR99/11999 1999-09-27
FR9911999A FR2798840A1 (en) 1999-09-27 1999-09-27 Retaining structure for an anatomical canal, in particular, a blood vessel takes the form of an elastic slit tube which is placeable around the canal or blood vessel, and is capable of assuming its original shape
FR9914386A FR2798838A1 (en) 1999-09-27 1999-11-16 STRUCTURE FOR CONTAINING AN ANATOMICAL CHANNEL, IN PARTICULAR A VESSEL
FR99/14386 1999-11-16

Publications (1)

Publication Number Publication Date
WO2001022888A1 true WO2001022888A1 (en) 2001-04-05

Family

ID=26235118

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/FR2000/002675 WO2001022888A1 (en) 1999-09-27 2000-09-27 Retaining structure for anatomical canal, in particular a vessel

Country Status (3)

Country Link
AU (1) AU7667900A (en)
FR (2) FR2798840A1 (en)
WO (1) WO2001022888A1 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6328689B1 (en) 2000-03-23 2001-12-11 Spiration, Inc., Lung constriction apparatus and method
US6860847B2 (en) * 2001-07-10 2005-03-01 Spiration, Inc. Constriction device viewable under X ray fluoroscopy
US6491706B1 (en) * 2001-07-10 2002-12-10 Spiration, Inc. Constriction device including fixation structure
US20080287965A1 (en) * 2007-05-17 2008-11-20 Richard Ducharme Radiopaque band ligator

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3726279A (en) * 1970-10-08 1973-04-10 Carolina Medical Electronics I Hemostatic vascular cuff
WO1988000455A1 (en) * 1986-07-17 1988-01-28 Quotidian No. 100 Pty. Limited Control of blood flow to an organ
US4881939A (en) * 1985-02-19 1989-11-21 The Johns Hopkins University Implantable helical cuff
DE3939840A1 (en) * 1989-12-01 1991-06-06 Zeljko Milosevic IMPLANTABLE OCCLUDER
WO1996038090A1 (en) * 1995-06-01 1996-12-05 Moskovsky Gosudarstvenny Institut Stali I Splavov Tekhnologichesky Universitet Method of extravascular correction of the function of incompetent vein valves and an extravascular corrector for that purpose

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3150666A (en) * 1963-01-07 1964-09-29 Louis H Averbach Umbilical cord ligation device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3726279A (en) * 1970-10-08 1973-04-10 Carolina Medical Electronics I Hemostatic vascular cuff
US4881939A (en) * 1985-02-19 1989-11-21 The Johns Hopkins University Implantable helical cuff
WO1988000455A1 (en) * 1986-07-17 1988-01-28 Quotidian No. 100 Pty. Limited Control of blood flow to an organ
DE3939840A1 (en) * 1989-12-01 1991-06-06 Zeljko Milosevic IMPLANTABLE OCCLUDER
WO1996038090A1 (en) * 1995-06-01 1996-12-05 Moskovsky Gosudarstvenny Institut Stali I Splavov Tekhnologichesky Universitet Method of extravascular correction of the function of incompetent vein valves and an extravascular corrector for that purpose

Also Published As

Publication number Publication date
AU7667900A (en) 2001-04-30
FR2798838A1 (en) 2001-03-30
FR2798840A1 (en) 2001-03-30

Similar Documents

Publication Publication Date Title
CA2424319C (en) Vascular occlusion device, apparatus and method for using same
FR2646088A1 (en) INFLATABLE ENVELOPE FOR ELONGATION OF BIOLOGICAL TISSUES
EP0843538B1 (en) Stent for expanding physiological vessels
EP0566807B1 (en) Self expanding vascular endoprosthesis
EP1531756B1 (en) Surgical prosthesis-forming device used to implant an organ support in a mammal
FR2929835A1 (en) SURGICAL ATTACHMENT FOR ATTACHING A HERNIA PROSTHESIS
EP0869750A1 (en) Kit for surgical treatment of intracorporal lumens
WO1994004096A1 (en) Expansible tubular prosthesis
EP2005918B1 (en) Tubular prosthesis and associated kit
WO2001022888A1 (en) Retaining structure for anatomical canal, in particular a vessel
FR2788216A1 (en) Blood vessel obturator or stent comprises catheter and series of rings able to deploy radially to inner diameter of blood vessel
FR2914178A1 (en) Reinforcement implantable prosthesis i.e. parietal prosthesis, for e.g. anesthesia patient, has fixation unit passed via attachment orifice and supported against biological tissue at periphery of orifice to form anti-return unit
FR2979229A1 (en) ENDOPROTHESIS FENESTRATION DEVICE
EP0299002B1 (en) Tissue expansion prosthesis
FR2979228A1 (en) UNIVERSAL AORTIC ENDOPROTHESIS
EP0941038B1 (en) MEDICAL SET FOR INTERVENTION ON AN ANATOMICAL DUCT and appertaining SEALING RING
EP2127614B1 (en) Anchoring and guiding device, manufacturing method and associated implant
EP2451362B1 (en) Implantable device for bringing together anatomical structures, in particular in hiatal hernia treatment
FR2867380A1 (en) A device for the repair of ruptured tendons comprises one or two needles and 60-80 cm of a supple thread in a resilient biodegradable polymer, preferably polylactic acid or polyglycolic acid
WO2001097716A1 (en) Metal sheet sealing system for an internal vascular prosthesis
FR3062792A1 (en) DEVICE FOR THE INSTALLATION OF A FLEXIBLE PROSTHESIS AND CORRESPONDING PROSTHESIS
WO2021160966A1 (en) Device for applying traction to the tube of a catheter for haemostasis of the prostatic cavity following surgery for benign prostatic hyperplasia
EP1800618B1 (en) Surgical prosthesis forming device used to implant an organ support in a mammal
EP2257329A1 (en) Guide for catheterism
EP2103261A1 (en) Implantable device

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AE AL AU BA BB BG BR CA CN CR CU CZ DM EE GD GE HR HU ID IL IN IS JP KP KR LC LK LR LT LV MA MG MK MN MX NO NZ PL RO SG SI SK TR TT TZ UA US UZ VN YU ZA

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: JP