WO1997021400A1 - Device for implanting a vascular endoprosthesis - Google Patents

Device for implanting a vascular endoprosthesis Download PDF

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Publication number
WO1997021400A1
WO1997021400A1 PCT/FR1996/001986 FR9601986W WO9721400A1 WO 1997021400 A1 WO1997021400 A1 WO 1997021400A1 FR 9601986 W FR9601986 W FR 9601986W WO 9721400 A1 WO9721400 A1 WO 9721400A1
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WO
WIPO (PCT)
Prior art keywords
distal
proximal
balloon
catheter
shield
Prior art date
Application number
PCT/FR1996/001986
Other languages
French (fr)
Inventor
Yves François GUERIN
Original Assignee
Guerin Yves Francois
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 Guerin Yves Francois filed Critical Guerin Yves Francois
Publication of WO1997021400A1 publication Critical patent/WO1997021400A1/en

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Classifications

    • 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
    • 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
    • A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Definitions

  • the present invention relates to a device for implanting a stent of the balloon expandable type, said device comprising:
  • a flexible, elongated catheter having a distal end and a proximal end
  • an inflatable balloon integral with the catheter and adjacent to the distal end thereof, the balloon having a distal end and a proximal end and having a first outside diameter in the deflated state and a second outside diameter in the inflated state ,
  • distal shield secured to the catheter and adjacent to the distal end of the balloon, said distal shield having an outer diameter progressively decreasing towards the distal end of the catheter, from a maximum outer diameter which, under normal conditions of use, is intermediate between said first and second outer diameters of the balloon,
  • a proximal shield secured to the catheter and adjacent to the proximal end of the balloon, said proximal shield having an outside diameter progressively decreasing towards the proximal end of the catheter, from a maximum outside diameter which, under normal conditions of use, is intermediate between said first and second outer diameters of the balloon.
  • distal and proximal shields have the form of flexible caps surrounding the distal end respectively. and the proximal end of the balloon or housed within these distal and proximal ends, respectively, as appropriate.
  • the caps are concave towards each other, that is to say respectively towards the proximal end of the catheter and towards the distal end of the latter, and delimited towards each other by a sharp edge defining their maximum outside diameter.
  • the stent in the unexpanded state is placed on the balloon in the deflated state, between the distal and proximal shields, leaving the stent directly exposed to the outside, that is to say without coating it with a retractable protective sheath as proposed for example by British patent application No. 2,196,857 or international patent application No. WO 9423669.
  • the role of the distal and proximal shields is to ensure, in the absence of such a sheath, protection of the endoprosthesis against a sliding on the balloon when then, the catheter is introduced by its end distally in a vessel to bring the balloon with the endoprosthesis to the location of a vascular lesion that one wishes to treat by angioplasty and, for this protection purpose, the maximum outside diameters of the distal and proximal shields are at less equal to the outside diameter of the stent in the unexpanded state.
  • the balloon and the endoprosthesis have reached the level of the vascular lesion to be treated, the balloon is inflated, which expands the endoprosthesis by plastic deformation, which brings it to an internal diameter greater than the maximum external diameter of the shield. distal. Therefore, after having deflated the balloon, the catheter can be removed from the vessel by a pull applied to the proximal end of the catheter, the distal shield easily passing through the prosthesis.
  • the catheter In the device known from American Patent No. 5,108,416 and European Patent Application No.
  • the distal and proximal shields are described as flexible and this flexibility allows them, when they are outside the balloon and respectively envelop the distal end and the proximal end thereof, to expand with the balloon during inflation thereof, the shields being however elastically biased towards their conformation corresponding to the deflated state of the balloon to accompany then the latter during its deflation and release the endoprosthesis in particular for the withdrawal of the catheter.
  • the flexibility of the distal and proximal shields is also mentioned in the case of distal and proximal shields housed inside. of the balloon, while the shields do not then have to expand during inflation of the balloon, and this flexibility is then exerted in the direction of a narrowing of the distal and proximal shields.
  • anterograde is understood here to mean a movement of progression in the direction of the blood flow in the vessel and by retrograde a movement of recoil, in the direction opposite to the blood flow.
  • the distal and proximal shields When the distal and proximal shields are housed inside the balloon, the latter certainly isolates the wall of the vessel from the abovementioned edges, but these create in the deflated balloon edges certainly less aggressive but which, d on the one hand, still present the aforementioned risks and, on the other hand, involve a risk of deterioration of the balloon by a concentration of stresses at their level; indeed, it should be borne in mind that the inflatable balloon is a particularly vulnerable component of the device.
  • the object of the present invention is to remedy these drawbacks and, to this end, the present invention provides a device of the type indicated in the preamble, characterized in that the distal and proximal shields have an outer diameter progressively decreasing respectively towards the end proximal to the catheter and toward the distal end thereof, from said respective maximum outside diameter.
  • the device also comprises a stent of the balloon expandable type, enveloping the balloon in the unexpanded state.
  • the deflated state between the distal and proximal shields, said endoprosthesis being directly exposed towards the outside, having in the unexpanded state an outside diameter at most equal to said maximum outside diameters of the distal and proximal shields and being capable of presenting to the expanded state an inner diameter greater than said maximum outer diameter of the distal shield.
  • the aforementioned conformation, characteristic of the invention, of the distal and proximal shields makes it possible to avoid that the latter constitute an obstacle to the progression of the catheter inside a vessel, that this progression s '' performs in an anterograde direction as is the case on the path leading to the lesion to be treated, or in a retrograde direction, as may be the case locally either in case of difficulty along the aforementioned trajectory, or to adjust the position of the stent relative to the lesion to be treated before inflating the balloon, or even over the entire aforementioned path to withdraw the stent by traction on the catheter in the event of implantation failure, and as c 'is the case for extracting the catheter after placement of the stent and deflation of the balloon; in addition, this conformation does not run any risk of additional injury or worsening of the lesion to be treated.
  • the progression of the balloon carrying the stent inside a vessel as well as their precise positioning relative to the lesion to be treated can be easily determined if the device comprises radiopaque marking means occupying a determined position relative to the distal and proximal ends of the balloon.
  • the distal and proximal shields avoid a risk of entanglement of the distal or proximal end of the endoprosthesis in the wall of the vessel, in particular in the possible curves of this one, and retain the endoprosthesis against a sliding on the balloon.
  • the removal of the unexpanded stent, by applying traction to the catheter does not present any difficulty, including when the catheter has been introduced into the vessel by the via a guide catheter or a lead probe.
  • the maximum diameter of the distal and proximal shields can be chosen to be sufficiently greater than the outside diameter of the stent in the unexpanded state to limit the possibilities of its contact with irregularities in the surfaces of the vessel wall during the path inside the vessel then, with regard to the distal shield, to cause a predilatation of the area of the lesion to be treated prior to the arrival of the stent in this area and to its implantation by inflation of the balloon .
  • one or each of the proximal and distal shields namely in practice at least the distal shield, to be substantially incompressible under normal conditions of use, although a certain compressibility may be admitted.
  • elastic of one and / or the other of the distal and proximal shields this elastic compressibility being limited so that the latter retain a maximum external diameter greater than the first external diameter of the balloon as well as at least equal to the external diameter of the stent in the unexpanded state, under normal conditions of use; this limited elastic compressibility can in particular accompany a flexibility that preferably has at least one of the distal and proximal shields in order to facilitate the crossing of possible curves of the vessel without risk of catching on the wall thereof.
  • normal conditions of use is understood here to mean the conditions prior to introduction into a vessel as well as the conditions to which the device, and in particular its distal and proximal shields, is subjected during its progression in the vessel including its arrival in the area of the lesion to be treated.
  • a device according to the invention can find an application in the treatment of all vascular lesions, and in particular coronary, and that it is very particularly suitable for angioplasty on saphenous bypass lesions given its low aggressiveness towards the vessel wall.
  • the maximum external diameter of the proximal shield a value greater or less than that of the maximum external diameter of the distal shield, but, as a general rule, these two maximum external diameters can be substantially equal.
  • the distal shield is advantageously more tapered distally than proximally and can be overall more tapered than the proximal shield considered distally as proximally, taking into account its head position during the anterograde progression of the catheter in a vessel, and it is this is usually longer than the proximal shield.
  • the balloon can be entirely located between the end proximal of the distal shield and the distal end of the proximal shield, which has the disadvantage of causing a certain spacing of the distal and proximal shields vis-à-vis the stent in the unexpanded state, taking into account this that practical considerations of the realization of the balloon make it possible to inflate it with a uniform outside diameter only in an intermediate zone between its distal and proximal ends so that only this intermediate zone can be covered by the endoprosthesis, as is known to a person skilled in the art.
  • the balloon has a distal tubular extension. enveloping at least the proximal end of the distal shield and / or a proximal tubular extension enveloping at least the distal end of the proximal shield.
  • the distal tubular extension of the balloon can envelop the distal shield up to its distal end by closely fitting the distal shield, at least over its maximum outside diameter and its distal end, in the deflated state of the balloon, and / or the proximal tubular extension of the balloon envelops the proximal shield up to its proximal end by closely fitting the proximal shield, at least over its maximum outside diameter and its proximal end, in the deflated state of the balloon.
  • the shape of the distal and proximal ends of the distal and proximal shields can vary to a large extent as long as it respects the abovementioned decrease in outer diameter.
  • the proximal shield has a convex, rounded distal end and / or the distal shield has a convex, rounded proximal end; this convex, rounded shape may for example be approximately hemispherical.
  • the proximal shield can have a convex proximal end which can be rounded, for example approximately hemispherical, or even substantially frustoconical.
  • the distal shield may have a convex, substantially frustoconical or even rounded distal end, for example approximately hemispherical.
  • auxiliary inflatable balloon secured to the catheter and disposed between the distal shield and the distal end of the catheter, the auxiliary balloon having third and fourth outer diameters, respectively in the deflated state and in the inflated state, respectively less and at least equal to said maximum outer diameter of the distal shield,
  • an auxiliary channel for transferring an inflation fluid from the auxiliary balloon, along the catheter, between an area adjacent to the proximal end of the catheter and the auxiliary balloon.
  • Such an auxiliary inflatable balloon makes it possible to predilate the lesion, prior to the passage of the distal shield then of the deflated balloon carrying the unexpanded stent, in the case of stenoses which are too tight and / or too rigid to be able to be crossed without difficulty by the distal shield .
  • this predilatation is ensured by the distal shield to which it is then preferred to give for this purpose a substantially frustoconical conformation at its distal end, which is the first to engage in the area of the lesion.
  • the catheter may comprise a channel for receiving a flexible sliding wire forming a dilation guide, at least from the shield proximal to the distal end of the catheter, or alternatively the catheter may include a dilation guide integrated in the form of a guide tip, integral with the catheter and extending the latter at its distal end, it being understood that any arrangement known in itself of a person skilled in the art can be adopted, generally, to increase the so-called "pushability" of the device.
  • the practical embodiment of the distal and proximal shields can itself vary to a large extent while respecting the characteristic conformation of the present invention.
  • one or each of the proximal and distal shields can have a wall defining its outside diameter and delimiting a cavity towards the catheter, or even be full between its outside diameter. and the catheter.
  • one or each of the proximal and distal shields can be produced in one piece with the catheter, or even in one piece with the balloon, it being understood that an embodiment in separate form, attached both to the catheter and to the balloon does not depart from the scope of the present invention.
  • the term “balloon” is generally understood here to mean the balloon intended to cause the expansion of the endoprosthesis, but these indications as to the manufacture of the device according to the invention can, where appropriate, also apply to the possible auxiliary balloon of predilatation. .
  • the shields are produced by overmolding a thermoplastic material on the catheter, so as to establish a direct connection with the latter, or even by application of a thermosetting material, for example a two-component urethane adhesive.
  • a thermosetting material for example a two-component urethane adhesive.
  • the distal and proximal shields can also be produced by introducing the catheter, made of thermoplastic material, into a mold having the imprint of the distal and proximal shields, suitably shaped and arranged, then by heating the catheter and placing it internally under pressure to make the distal and proximal shields by blowing into the mold from the catheter itself; it is also possible to produce the proximal and distal shields by locally heating, in the corresponding zones, the catheter also made of a thermoplastic material and by compressing in the proximal direction the distal end of the catheter to cause an increase in the external diameter of the latter in heated areas.
  • the distal and proximal shields have a wall made in one piece with the catheter, this wall defining the outside diameter of the shields, in particular their maximum outside diameter, and delimiting a cavity towards the catheter, in practice a cavity open towards the interior of the latter.
  • the shields can also be produced by creating a balloon preform of thermoplastic material, by providing an appropriate addition of material in the zone of this preform corresponding to the distal and proximal end of the balloon, and then by shaping the balloon by blowing such so that it has a thickening of its wall, creating the distal and proximal shields, at its distal and proximal ends, respectively.
  • the balloon can then be fixed to the catheter by means of the shields, by any conventional method such as heat sealing, ultrasonic welding or bonding, naturally under conditions suitable for ensuring the sealing of the balloon. In such a case, the distal and proximal shields are full between their outside diameter and the catheter, and made in one piece with the balloon.
  • the materials used, apart from the case where the shields are made of thermosetting material, can be thermoplastic materials, in particular thermoplastic polymers such as polyolefins, polyamides, polyesters, etc., and in particular polyethylene, Nylon®, polyethylene terephthalate and copolymers of these families of polymers.
  • thermoplastic polymers such as polyolefins, polyamides, polyesters, etc.
  • polyethylene Nylon®, polyethylene terephthalate and copolymers of these families of polymers.
  • polyethylene terephthalate or Nylon® for the balloon, although these examples are in no way limiting .
  • the distal and proximal shields and the balloon it is preferable to fix the distal and proximal shields and the balloon to the catheter by gluing, in the form of separate pieces or having made distal and proximal shields in one piece with the balloon, for reasons of ease of placement. in place of the distal and proximal shields and the balloon on the catheter.
  • the balloon has sufficient elasticity to allow it to be placed on the catheter while the latter already has the proximal and distal shields, made for example in one piece with the catheter, this elasticity being sufficient to allow the passage of at least one of the distal and proximal shields through the balloon.
  • FIG. 1 to 3 show, in side elevation, three non-limiting examples of device according to the invention, carrying a stent of type expandable by balloon, enveloping in the unexpanded state the balloon in the deflated state; the device illustrated in these three examples is more particularly adapted dimensionally to coronary angioplasty, but a person skilled in the art will understand that there should be no limitation as to the applications of a device according to the invention, and will adopt the provisions which will be described in terms of other applications without departing from the scope of the present invention.
  • FIG. 4 shows a view of the device of Figure 1, in section through a plane identified in IV-IV in this Figure 1.
  • FIG. 5 to 7 show the device illustrated in Figure 1, in section through a plane marked in VV in Figure 4 and forming a plane of symmetry, the device being illustrated in these figures respectively in the same state as in Figure 1, in a state of inflation of the balloon and expansion of the stent inside a vessel and in the state of deflation of the balloon with persistence of the expanded state of the stent, prior to removal of the device.
  • FIG. 8 shows a view of the device illustrated in Figure 2, in section through a plane marked in VIII-VIII in this Figure 2.
  • FIGS. 5 to 7 show a view of the device illustrated in Figure 2, in section through a plane marked in IX-1X in Figure 8, and constituting a plane of symmetry for the device, the device being illustrated in states corresponding respectively to those of FIGS. 5 to 7 as regards the device of FIG. 1.
  • FIG. 12 shows a view of the device illustrated in Figure 3, in section through a plane marked in XII-XII in Figure 3.
  • - Figure 13 shows a view of the device illustrated in Figure 3, in section by a plane identified in XIII-XII1 in FIG. 12, this plane constituting a plane of symmetry for the device, which is seen in the same state as the device in FIG. 1 in FIG. 5.
  • Figures 14, 15 and 16 illustrate, in views similar to those of Figures 3, 12 and 13, respectively, an alternative embodiment of the device illustrated in the latter;
  • Figures 1 5 and 1 6 respectively show sectional views along the plane XV-XV of Figure 14 and along the plane XVI-XVI of Figure 15.
  • Figures 1 to 3 illustrate three variants of the same device according to the invention 1, comprising a flexible catheter 2, elongated, having a proximal end 3 intended to remain outside the body of a patient to be treated and a distal end 4 intended to be introduced into a vessel of the patient and to progress in this vessel in the anterograde direction 5, that is to say in the direction of the blood flow, until a vascular lesion to be treated, under the effect of a thrust applied to the proximal end 3, in order to bring and then implant in the area of the lesion to be treated a stent 6 of the balloon expandable type.
  • Such stents are generally made of metal wire, with a generally cylindrical shape of revolution, and can deform plastically between a contracted or unexpanded state, illustrated in Figures 1 to 3, 5, 9, 13, 16 in which they have diameters respectively inside dj ⁇ and outside d 2 , and an expanded state, illustrated in FIGS. 6, 7, 10, 1 1, in which they have diameters respectively inside d 3 and outside d 4 , the diameter d 4 being greater than the diameter d 3 itself greater than diameter d 2 , which is greater than diameter di.
  • the device 1 illustrated in FIGS. 1 and 4 to 7 will now be described more particularly.
  • a catheter 2 of the so-called “monorail” type comprising two tubular sections placed in the extension of one another by means of a proximal tube 7 and a distal tube 8, one and the other made of waterproof material.
  • the proximal tube 7 constitutes the major part of the length of the catheter 2 between its proximal 3 and distal 4 ends, starting from the proximal end 3 in the immediate vicinity of which it is retained in a rigid tubular proximal tip 9, used to apply at catheter 2 the push of introduction and progression in a vessel.
  • the proximal tube 7 internally defines a channel (not shown) for the passage of inflation fluid, in practice a liquid charged with a radiopaque contrast medium, which channel is capable of 'be connected by the proximal end 3 to a not shown source, known in itself, of such a fluid under pressure or vacuum, in a controlled manner.
  • the distal tube 8 defines a lesser part of the length of the catheter 2, between its connection 10 to the proximal tube 7 and the distal end 4 of the catheter 2, and comprises connection 10 to an area adjacent to the distal end 4 as it will be described with reference to Figures 5 to 7, two internal channels, as shown in Figure 4, on the basis of a channel 11 of inflating fluid passage, connected in leaktight manner to the abovementioned internal channel, not shown of the proximal tube 7, and a channel 12 for the passage of a flexible guide wire 13 or dilation guide, outside the proximal tube 7, that is to say able to freely follow the latter, and inside the distal tube 8, with the possibility of sliding of the latter on the guide 13, from the connection 10 of the distal tube 8 to the proximal tube 7 to the distal end 4.
  • the distal tube 8, between its connection 10 to the proximal tube 7 at the distal end 4 of the catheter, has for example a length of the order of thirty centimeters for a length total catheter 2, measured between its proximal 3 and distal 4 ends, of the order of 135 cm in an application of the device to a coronary angioplasty, these figures being indicated only by way of nonlimiting example.
  • the guide 13 is introduced into the vessel to be treated in the anterograde direction, in the case of such an application via a guide catheter or a carrier probe which will then be used to introduce catheter 2, and this beyond a lesion to be treated.
  • the distal tube 8 engaged on the guide 13 is introduced into the vessel and pushed in the same direction, by action on its proximal end 3, to the area of the lesion to be treated by sliding on the guide 13.
  • FIGS. 5 to 7 carries jointly, with a view to implementing the present invention, a certain number of components which will now be described with reference to FIGS. 5 to 7 and which are intended to jointly retain the endoprosthesis 6 in the non-state expanded during its journey to the lesion to be treated, then cause the endoprosthesis to expand to implant it in the vessel at the level of this lesion and then to allow retrograde, i.e. opposite, movement to the blood flow, from the catheter 2 inside the vessel, under the effect of a traction applied to the tip 9, without entraining in this movement the endoprosthesis in the expanded state.
  • FIGS. 5 to 7 The illustration of FIGS. 5 to 7 is limited to this zone 14, the length of which is of the order of a few centimeters from the distal end 4 and which will be assumed to be rectilinear for reasons of convenience of description, it being understood that despite the components it carries, it preferably retains a certain flexibility with a view to easier crossing of any curves of the vessel.
  • this zone 14 has a rectilinear axis 15, around which the tube 8 has an outer peripheral face 16 of cylindrical revolution around this axis, with a diameter d $ smaller than the diameter dj although close to the latter as will appear later.
  • this face 16 bears integrally, by complementarity of form and bonding, or welding, or any other suitable method of fixation, a distal shield 17 having a general shape of revolution around the axis 15 and produced here in solid form, between an inner peripheral face 18 cylindrical of revolution around the axis 15 with a diameter substantially identical to the diameter d $ to closely match the outer peripheral face 16 of the tube 8, and an outer peripheral face 19, the form of which will be specified subsequently.
  • the distal shield 17 is made of a material which is preferably flexible but substantially incompressible or possibly elastically compressible, however sufficiently limited under normal conditions of use, that is to say even when it is possibly brought to undergo a compression during the progression of the zone 14 in a vessel, so that this distal shield 17 permanently retains a maximum outside diameter d 5 which, increased by twice the thickness e of a tubular wall which covers in this example the shield distal 17 as it will appear further on and must be considered as an integral part of this shield during the movements of zone 14 of catheter 2 in a vessel, as it will also appear further, ie at least equal, and preferably greater than the diameter d 2, although lower at $ diameter d, with the general shape of the outer peripheral face 19 which will be of written now.
  • this outer peripheral face 19 has an outer diameter which decreases progressively, from the maximum outer diameter d, on the one hand towards the distal end 4 of the catheter 2 and on the other hand towards the proximal end thereof so as to define, respectively on either side of a circle 22 having the diameter d 6 , a distal end 20 and a proximal end 21 of the shield 17, one and the other convex.
  • the shield 17 is delimited by respective convex zones 23, 24 of the external peripheral face 19.
  • the zone 23 is substantially frustoconical of revolution around the axis 15, with a decreasing diameter from the circle 22 to the immediate proximity of the distal end 4 at which this zone 23 is connected to the inner peripheral face 18, and the zone 24 is rounded, for example approximately hemispherically, between the circle 22 and its connection to the inner peripheral face 18.
  • the outer peripheral face 16 of the tube 8 of the catheter 2 carries securely, at all points identical to the way which it carries the distal shield 17, a proximal shield 25 which could be different from the distal shield 17 but is identical to the latter in the nonlimiting example illustrated, while being placed in an opposite orientation.
  • the proximal shield 25, having a general shape of revolution around the axis 15, is delimited towards the latter by a cylindrical inner peripheral face 26 and in the direction of a distance from it by a face external device 27 having in a circle 28 a maximum diameter d - which, in this example, is equal to the diameter dg and, more generally, in this example according to which a tubular wall of thickness e also covers the proximal shield 25 as it will appear further on, is such that the sum of the diameter d 7 and twice the thickness e is permanently at least equal and preferably greater than the diameter d 2 although less than the diameter d 3 .
  • the outer peripheral face 27 has a zone 29 delimiting a distal end 30 of the proximal shield 25 and having a diameter which decreases progressively towards the distal end 4, so as to define a convex, rounded shape, for example approximately hemispherical, towards the distal end 4 of the catheter 2.
  • the outer peripheral face 27 of the proximal shield 25 has a zone 3 1 delimiting a proximal end 32 of the distal shield 25 and having a decreasing diameter gradually towards the proximal end of the catheter, so as to define a convex shape, here substantially frustoconical of revolution around the axis 15, for the outer peripheral face 27 around the proximal end 31 of the proximal shield 25.
  • the zones 29 and 31 of the outer peripheral face 27 are connected to the outer peripheral face 26 respectively towards the distal end 4 of the catheter 2 and towards the proximal end of the latter.
  • the shield 25 is fixed to the tube 8 of the catheter 2 by any suitable means such as gluing or welding.
  • the area 31 of the outer peripheral face 27 of the proximal shield 25 could have a shape similar to that of the area 29 of this face, the proximal shield 25 then being shorter , along axis 15, as the distal shield 17.
  • the circles 22 and 28 preferably do not constitute edges of the external peripheral faces 19 and 27, the transition between the zones 23 and 24, on the one hand, 29 and 31, on the other hand being effected with a regular curvature, without angular point.
  • the length ⁇ ⁇ measured along the axis 15 between the distal shields 17 and proximal 25 is greater than the length 1 2 presented by the endoprosthesis 6 in the contracted state but practically equal to this length 1 2 , along an axis of this endoprosthesis coincident with the axis 15 when the endoprosthesis 6 is secured in the contracted state with the catheter 2 in the zone 14 thereof.
  • the endoprosthesis 6 in the unexpanded state is retained coaxially between the two shields 17 and 25, being as close as possible to one and the other, with a view to its routing in the area of a lesion to be treated.
  • the outer peripheral face 16 of the tube 8 is wrapped tightly, between the two shields 17 and 25, with a flexible, leaktight, elastically extensible tubular wall defining an inflatable balloon 33 by means of which the endoprosthesis 6 is carried integrally by the outer peripheral face 16 of the tube 8.
  • the internal diameter d ⁇ of the stent 6 in the unexpanded state is substantially equal to the sum of the diameter d 5 of the peripheral face outer 16 of the tube 8 and twice as uniform in thickness as the wall of the balloon 33, so that the stent 6 in the unexpanded state is retained on this wall by friction while this wall closely matches the face external device 16 between the two shields 17 and 25, which the balloon 33 adjoins respectively by a distal end 85 and by a proximal end 86.
  • the balloon 33 has, beyond its distal and proximal ends, tubular extensions respectively distal 34 and proximal 35, of substantially the same thickness e, of wall closely matching respectively the outer peripheral face 19 of the distal shield 17 and the face external peripheral 27 of the proximal shield 25 as well as, respectively, a zone 36 of the external peripheral face 16 of the tube 8 left free by the distal shield 17 in the immediate vicinity of the distal end 4 of the tube 8 and a zone 37 of this face 16 located in the immediate vicinity of the proximal endpiece 25, on the proximal side thereof.
  • the distal and proximal tubular extensions 34, 35 of the balloon 33 are produced in a single piece with the latter and have the same sealing, flexibility and elasticity characteristics, and they are tightly fixed to the tube 8 respectively in zone 36 and in zone 37 so as to seal the balloon 33 relative to the tube 8.
  • the tubular extensions 34, 35 could also be fixed in a sealed manner respectively to zone 23 of the outer peripheral face 19 of the distal shield 17 and the zone 31 of the external peripheral face 27 of the proximal shield 25, the two shields 17 and 25 then having to be themselves sealed and connected in a sealed manner to the face 16 of the tube 8.
  • the channel 1 1 inflating fluid inlet opens inside the balloon 33, that is to say in the outer peripheral face 16 of the tube 8, between the distal shields 17 and proximal 25, by a lumen 40 or by any another form of passage, for example by distributed orifices, not illustrated, while the channel 12 receiving the guide 13 remains isolated in a sealed manner with respect to the channel 1 1 and this light 40, to extend up to distal end 4 of catheter 2.
  • zone 14 of the catheter 2 reaches the zone 39 of the lesion to be treated, which can be seen thanks to the presence of radiopaque marker means 41, 42 here arranged inside the distal shields 17 and proximal 25 although other locations can be chosen as soon as they are located in a predetermined manner relative to the balloon 33 and to the stent 6 which it carries, pressure is caused by inflation fluid in the channel 1 1 inflation of the balloon 33 between the distal shields 17 and proximal 25 and around the proximal ends 21 and distal 30, at least, naturally while retaining the seal vis-à-vis the outer peripheral face 16 of the tube 8 As shown in FIG.
  • this inflation is accompanied by a plastic expansion of the endoprosthesis 6 which is applied against the wall 38 of the vessel in the area 39 and if necessary causes the expansion of this wall 38.
  • up to the diameter d 4 obtained when the balloon 33 externally has the diameter d 3 , greater than the diameters of and d 12 constituting respectively the sum of the diameter d, or of the diameter d 7 and double of thickness e. Then, when the balloon 33 is then deflated as shown in FIG.
  • the prosthesis 6 plastically deformed externally retains the diameter d 4 while maintaining the wall 38 at this diameter in the area of the lesion 39, and internally retains the diameter d 3 so that, taking into account the relationship of the latter with the diameter of the in particular, it is possible by a retrograde movement, that is to say in the opposite direction to direction 5, to extract the catheter 2 by freely passing the distal shield 17, coated with the tubular extension 22, inside the stent 6 without risking it. This passage is facilitated by the convex shape of the proximal end 21 of the distal shield 17, which the distal tubular extension 34 of the balloon 33 then closely follows again.
  • FIG. 1 illustrates the case of a catheter 2 of the so-called “coaxial” type, comprising from one to the other of its proximal 3 and distal 4 ends three mutually sealed channels, at the rate of two inlet channels 43, 44 of inflation fluid under pressure, in relation to the presence of two inflatable balloons in this example, and of a channel 45 situated between these two channels 43 and 44 and accommodating, in a relation of guidance to relative sliding, an expansion guide 13 at all points similar to the dilation guide illustrated in FIG. 1 except that it thus traverses the catheter 2 from one to the other of its proximal 3 and distal ends 4.
  • the catheter 2 consists of a single tube 46 made of impermeable material, provided at its proximal end 3, with a nozzle 47 comprising in the direct extension of the channel 45 an orifice not shown for passage of the guide 13 and laterally two fittings 87, 88 for connection with a source of inflation fluid under pressure or under vacuum in a controlled manner, respectively for channel 43 and for channel 44.
  • a source of inflation fluid under pressure or under vacuum in a controlled manner, respectively for channel 43 and for channel 44.
  • the structure of the catheter 2 in its distal zone 14 will be described with reference to FIGS. 9 to 1 1. It will also be assumed in this case that, although the catheter 2, with the components which it carries, may have a certain flexibility in its zone 14, it is rectilinear in this zone so that the tube 46 has there an external peripheral face 48 cylindrical of revolution around an axis 55. In the immediate vicinity of the distal end 4 of the catheter, this outer peripheral face 48 is tightly wrapped by a flexible, leaktight, elastically extensible tubular wall defining a pre-expansion balloon 49.
  • This balloon is tightly secured to the outer peripheral face 48 of the tube 43, itself sealed, in an area annular 50 directly adjoining the distal end 4, for example by gluing or welding, as well as in an annular zone 5 1 spaced from this zone 40 and which will be detai later.
  • zones 50 and 5 1 opens out inside the balloon 49, through a lumen 52 or any other form of passage arranged in the outer peripheral face 48 of the tube 46, the channel 44 which makes it possible to introduce inflation fluid under pressure inside the balloon 49 and thus causing the passage thereof, a deflated state in which it closely matches the outer peripheral face 48 of the tube 46, externally having a diameter ds equal to the sum of the diameter d ij of the outer peripheral face 48 of the tube 46 and twice the thickness e j of its wall, at the diameter d 4 , constituting the outside diameter of the endoprosthesis 6 in the expanded state or the inside diameter of the wall 38 of the vessel to be treated, it being understood that the balloon 49 may have, in the inflated state, when it is not engaged in a vessel, a diameter greater than the diameter d 4 .
  • a momentary inflation of the balloon 49 when it is at the level of the lesion 39 to be treated makes it possible to apply a predilatation to it which, after deflation of this balloon 49, will then make it easier to engage a distal shield 53, which will now be described, then the endoprosthesis 6 before expansion thereof.
  • the area 51 of the balloon 49 is constituted in this example by the distal shield 53, produced in one piece with the balloon 49; more precisely, the area 51 is defined by the distal end of an inner peripheral face 54 of the distal shield 53, which face 54 is cylindrical of revolution around the axis 55 with a diameter substantially identical to the diameter d ⁇ and secured to sealingly with the outer peripheral face 48 of the tube 46 by any suitable means such as welding or bonding.
  • the distal shield 53 is, in this example as in that of FIGS. 5 to 7, solid and possibly slightly elastically compressible between its outer peripheral face 54 and an outer peripheral face 55 which, like the outer peripheral face 19 of the distal shield 17 described in with reference to FIGS. 5 to 7, presents a general form of revolution, here around the axis 55, with diameters decreasing respectively towards the distal end 4 of the catheter 2 and towards the proximal end of the latter, from d 'a maximum diameter d 9 which it presents along a circle 56.
  • This maximum external diameter dg of the distal shield 55 is at least equal to, and preferably greater than the diameter d 2 defined as the external diameter of the endoprosthesis 6 in the unexpanded state, and less than the inside diameter d 3 than the stent 6 in the expanded state.
  • the outer peripheral face 55 of the distal shield 53 has zones 57, 58 convex, rounded and for example approximately hemispherical, defining with the inner peripheral face 54 of the distal shield 53 respectively distal 59 and proximal 60 ends thereof.
  • the distal end 59 of the distal shield 53 is connected directly, in one piece, to the dilatation balloon 49 while the proximal end 60 of this distal shield 53 is connected in one piece with another inflatable balloon located opposite the dilation balloon 49 relative to the distal shield 53 and for its part intended to ensure the retention deflated of the stent 6 in the unexpanded state and, by inflation, the expansion and implantation of this stent 6 in the area 39 of the lesion to be treated.
  • the balloon 61 is in the form of a flexible, tight, elastically extensible wall, closely matching the external peripheral face 48 of the tube 46 in the deflated state, illustrated in FIGS. 9 and 11.
  • the wall defining the balloon 61 has a cylindrical outer peripheral face of revolution around the axis 15 with a uniform diameter substantially equal to the inside diameter d ⁇ of the stent 6 in the unexpanded state, which corresponds to the sum of the diameter d 13 and twice the thickness e 2 of the wall of the balloon 61.
  • the balloon 61 is tightly secured to the outer peripheral face 48 of the tube 46 by a distal end 62, in practice consisting of a zone of proximal end of the inner peripheral face 54 of the distal shield 53, and by a proximal end, annular 63, constituted by a distal end zone of an inner peripheral face 64 of a proximal shield 65 produced in this example in one piece with the balloon 61, the distal shield 53 and the balloon 49.
  • the balloon 61 has in this example, between its distal 62 and proximal 63 ends, a length I 3 considerably greater than the length 1 2 of the stent 6 in the unexpanded state and the stent 6 is arranged, in the unexpanded state, centrally between the distal shields 53 and proximal 65. It will be observed that the length I 3 of the balloon 61 corresponds to the mutual spacing of these shields.
  • the proximal shield 65 is in every way similar to the distal shield 53 to which it is identical in the example illustrated.
  • cylindrical of revolution about the axis 55 with a diameter substantially equal to the diameter d 1 3 of the outer peripheral face 48 of the tube 46, with which it is secured in leaktight manner at this peripheral face.
  • inner 64 by any means such as bonding or welding, it has an outer peripheral face 67 of revolution about the axis 55 with diameters which decrease progressively respectively towards the distal end 4 of the catheter and towards the proximal end of the latter, respectively in a zone 68 and in a zone 69 of the external peripheral face 67, from a maximum external diameter d 10 which, in this example, is equal to the diameter d 9 and respects the same conditions as this vis-à-vis the diameters d 2 and d 3 of the stent 6.
  • the zones 68 and 69 define for the proximal shield 65, full between its peri interior 64 and exterior 67 spheres, distal 70 and proximal 71 ends convex respectively towards the distal end 4 of the catheter 2 and towards the proximal end thereof, and more precisely approximately hemispherical.
  • radio-opaque marking means 72
  • stent 6 which it carries, and for example situated respectively inside the distal shield 53 and inside the proximal shield 65, allow to locate the zone 1 4 as the catheter 2 progresses inside a vessel.
  • This progression makes it possible to bring the stent 6 in the unexpanded state, on the uninflated balloon 61, to the level of the lesion 39 to be treated then, by inflating the balloon 61, to expand the stent 6 until 'that it internally has the diameter d 3 , then reached externally by the balloon 61 in its zone carrying the stent 6, and externally the diameter d 4 according to which the stent 6 rests on the wall 38 of the vessel, as shown in FIG. 10.
  • the endoprosthesis 6 being thus implanted, and tending to keep the conformation obtained due to the plastic nature of its expansion deformation, it is then possible to deflate the balloon 61 so that it again has the outside diameter d] and that the maximum outside diameter of the zone 14 is defined by the diameters d t o and dg, which are less than the diameter d 3 of the endoprosthesis 6. Then, the latter can be passed through in particular by the distal shield 53, by a traction applied to the the proximal end 3 of the catheter 2, and thus extract the latter from the vessel without the risk of entraining the endoprosthesis 6 at the same time, in particular by virtue of the convex shape of the proximal end 60 of the distal shield 53.
  • the balloon 61 for transporting and expanding the stent 6 is made in one piece with the distal 53 and proximal 65 shields, as well as the dilation balloon 49; it will be observed that the latter, which is optional, could also be provided in an independent form of the distal shield, in particular in the case of the embodiment of the invention described with reference to FIGS. 1 and 4 to 7, case in which it could be made in one piece with the balloon 33 and its tubular extensions 34 and 35.
  • the catheter 2 is in the form of a single tube 75, in sealed material, having from one to the other of its proximal 3 and distal 4 ends a single channel 76 for passage of inflation fluid under pressure.
  • the tube 75 In the immediate vicinity of the proximal end 3 of the catheter 2, the tube 75, at any point comparable to the proximal tube 7 described with reference to FIG. 1, bears an end piece identical to the end piece 9 and therefore designated by the same reference, to ensure the connection of channel 76 to a source of inflation fluid under pressure or under vacuum, in a controlled manner.
  • the tube 75 In its distal zone 14, directly adjacent to the distal end 4 of the catheter 2, the tube 75 has a conformation which will now be described with reference to FIG. 13.
  • the tube 75 is closed in a sealed manner, for example by localized fusion, around the end piece 74 which it thus retains.
  • the balloon 33 and its tubular extensions 34 and 35 are found up to zones 36 and 37, as they have been described with reference to FIG. 5, the zones 36 and 37 constituting in this example annular zones of sealed connection of the tubular extensions 34 and 35, respectively, with an external peripheral face 77 of the tube 75. If it is assumed that zone 14 is rectilinear, although it is flexible, this face 77 is commonly cylindrical of revolution about an axis 78 with the diameter d $ as it has been defined in relation to the example of FIGS.
  • the balloon 33 of its tubular extensions 34 and 35 respectively distal and proximal, with the stent 6 and with the distal and proximal shields, here 79 and 80, and with the catheter tube, here 75, between them, a lumen 81 being arranged between these two shields, in the outer peripheral face 77 here cylindrical of the tube 75, to allow the passage of inflation fluid under pressure from the channel 76 towards the inside of the balloon 33 and thus cause the inflation thereof.
  • the light 81 could be provided in several copies distributed angularly around the axis 78, or be replaced by any other passage means such as an orifice or, preferably, several orifices arranged in a distributed manner in the tube 75, between the two shields.
  • the two shields 79 and 80 are not full, unlike the shields 17 and 25, but define a respective cavity 82, 83 widely open towards the axis 78 and constituting in practice a localized widening of the channel 76.
  • the two end pieces 79 and 80 are in this case constituted by the localized radial expansion of a wall 84 of thickness e ⁇ , substantially constant, which gives great simplicity to this embodiment of the invention.
  • the position of the radiopaque means 41, 42 for marking cannot be, in this case, identical to that which has been described with reference to FIGS. 5 to 7, but it is nevertheless possible to provide such radiopaque means, by example on the outer peripheral face 77 of the tube 78, between the distal shields 79 and proximal shields 80, respectively in the immediate vicinity of each of them, that is to say at the level of the distal 85 and proximal 86 ends of the balloon 33
  • the mode of use of the device according to the invention illustrated in FIGS. 3, 12, 13 is in every respect identical to that of the device. illustrated in Figures 1 and 4 to 7.
  • FIGS. 3, 12, 13 could also cooperate with an expansion guide, according to a variant illustrated in Figures 14 to 16, as well as the designs of the distal zone 14 described with reference to Figures 1, 4 to 7 and Figures 2, 8 to 1 1, respectively, could accommodate either general design of the "monorail” type or of the "coaxial” type of the catheter or else of the absence of a dilation guide 13, with adaptations which fall within the normal aptitudes of a person skilled in the art.
  • the tube 89 thus extends over the whole of the distal zone 14 of the catheter 2, up to the distal end 4 of the latter, at the level of which it is secured in a sealed manner, for example by welding or gluing, with the tube 77, inside the zone 36, so as to seal the channel 76 at the distal end 4 of the catheter; on the other hand, the tube 89 remains open at this distal end 4 to allow the passage of the expansion guide 13, which is in all points identical to that which has been described with reference to FIGS. 1 to 1 1 and can slide freely with the inside a channel 90 which internally delimits the tube 89.
  • the tube 89 can extend, coaxially and jointly with the tube 75, up to this proximal end 3 at the level of which the tubes 75 and 89 are provided with a coaxial tip 91 ensuring on the one hand the guidance of the expansion guide 13 in sliding, in direct extension of the tubes 75 and 89, and on the other hand the sealed connection of the channel 76, located between the tubes 89 and 78, to a source of inflation fluid under pressure or under vacuum, in a controlled manner, and this by means of a lateral connection 92 at any point similar to the lateral connections 87 and 88 of the tip 47 of the catheter 2 illustrated in FIG. 2.
  • the two tubes 75 and 89 may thus extend towards the proximal end 3 of the catheter 2 only over part of the length of the latter, from its distal zone 14, namely up to a zone 93 at any point comparable to the connector 10 of the device illustrated in FIG. 1.
  • the tube 89 presents on the outside of the tube 75, opposite from which it is sealed at this level in order to preserve the leaktightness of the inflation fluid passage channel 76, an unreferenced orifice for exit from the dilation guide 13.
  • the catheter 2 is defined exclusively by the tube 75 whose channel 76 for inflating fluid passage is then in all points identical to what is illustrated in FIG. 12, and the tube 75 is provided in the immediate vicinity of the end proximal 3 of a tip 9, identical to that which has has been described with reference to FIG. 1, to ensure the connection of the channel 76 to a source of inflation fluid under pressure or under vacuum, in a controlled manner.
  • the tube 89 can be introduced into the tube 77 and secured to the distal end 4 thereof and, if necessary, in the connection zone 93 after the shields have been made in the tube 77 distal 79 and proximal 80, for example by one or the other of the thermoforming methods described in the preamble.
  • the diameter of which is generally between 2.0 to 4.0 or even 5.0 mm and for a length of the lesion of the order of a few millimeters to a few centimeters, the following numerical values can be adopted:
  • length lj from 10 to 40 mm, adapted to the length 1 2 of the stent 6.

Abstract

A device for implanting a balloon-expandable vascular endoprosthesis. The device comprises a catheter (2) with one end having an inflatable balloon (33) which, when uninflated, receives an unexpanded endoprosthesis (6) between two spacers (17, 25) having a maximum intermediate diameter (d11, d12) between the outer diameter (d2) of the unexpanded endoprosthesis (6) and the inner diameter of the expanded endoprosthesis (6). The spacers (17, 25) have a gradually decreasing diameter on either side of their maximum diameter (d11, d12). The device is useful in angioplasty.

Description

DISPOSITIF D'IMPLANTATION D'UNE ENDOPROTHESIi VASCULAIRF.DEVICE FOR IMPLANTING A VASCULAR ENDOPROTHESIS.
La présente invention concerne un dispositif d'implantation d'une endoprothèse vasculaire de type expansible par ballonnet, ledit dispositif comportant :The present invention relates to a device for implanting a stent of the balloon expandable type, said device comprising:
- un cathéter flexible, allongé, possédant une extrémité distale et une extrémité proximale,- a flexible, elongated catheter having a distal end and a proximal end,
- un ballonnet gonflable solidaire du cathéter et adjacent à l'extrémité distale de celui-ci, le ballonnet possédant une extrémité distale et une extrémité proximale et présentant un premier diamètre extérieur à l'état dégonflé et un deuxième diamètre extérieur à l'état gonflé,- an inflatable balloon integral with the catheter and adjacent to the distal end thereof, the balloon having a distal end and a proximal end and having a first outside diameter in the deflated state and a second outside diameter in the inflated state ,
- un canal de transfert d'un fluide de gonflage du ballonnet, le long du cathéter, entre une zone adjacente à l'extrémité proximale du cathéter et le ballonnet,a channel for transferring a balloon inflation fluid, along the catheter, between an area adjacent to the proximal end of the catheter and the balloon,
- un bouclier distal solidaire du cathéter et adjacent à l'extrémité distale du ballonnet, ledit bouclier distal présentant un diamètre extérieur décroissant progressivement vers l'extrémité distale du cathéter, à partir d'un diamètre extérieur maximal qui, dans des conditions normales d'utilisation, est intermédiaire entre lesdits premier et deuxième diamètres extérieurs du ballonnet,- a distal shield secured to the catheter and adjacent to the distal end of the balloon, said distal shield having an outer diameter progressively decreasing towards the distal end of the catheter, from a maximum outer diameter which, under normal conditions of use, is intermediate between said first and second outer diameters of the balloon,
- un bouclier proximal solidaire du cathéter et adjacent à l'extrémité proximale du ballonnet, ledit bouclier proximal présentant un diamètre extérieur décroissant progressivement vers l'extrémité proximale du cathéter, à partir d'un diamètre extérieur maximal qui, dans des conditions normales d'utilisation, est intermédiaire entre lesdits premier et deuxième diamètres extérieurs du ballonnet.a proximal shield secured to the catheter and adjacent to the proximal end of the balloon, said proximal shield having an outside diameter progressively decreasing towards the proximal end of the catheter, from a maximum outside diameter which, under normal conditions of use, is intermediate between said first and second outer diameters of the balloon.
Un tel dispositif est décrit dans le brevet américain N° 5 108 416 et la demande de brevet européen N° 0 442 657, dans un mode de réalisation dans lequel les boucliers distal et proximal présentent la forme de capuchons flexibles entourant respectivement l'extrémité distale et l'extrémité proximale du ballonnet ou logés à l'intérieur de ces extrémités distale et proximale, respectivement, selon le cas. Les capuchons sont concaves l'un vers l'autre, c'est-à-dire respectivement vers l'extrémité proximale du cathéter et vers l'extrémité distale de celui-ci, et délimités l'un vers l'autre par une arête vive définissant leur diamètre extérieur maximal.Such a device is described in US Patent No. 5,108,416 and European Patent Application No. 0 442 657, in an embodiment in which the distal and proximal shields have the form of flexible caps surrounding the distal end respectively. and the proximal end of the balloon or housed within these distal and proximal ends, respectively, as appropriate. The caps are concave towards each other, that is to say respectively towards the proximal end of the catheter and towards the distal end of the latter, and delimited towards each other by a sharp edge defining their maximum outside diameter.
Pour implanter une endoprothèse vasculaire de type expansible par ballonnet au moyen d'un tel dispositif, on place l 'endoprothèse à l'état non expansé sur le ballonnet à l'état dégonflé, entre les boucliers distal et proximal, en laissant l'endoprothèse directement exposée vers l'extérieur, c'est-à-dire sans la revêtir d'une gaine rétractile de protection comme le propose par exemple la demande de brevet britannique N° 2 196 857 ou la demande internationale de brevet N" WO 9423669. Le rôle des boucliers distal et proximal est d'assurer, en l'absence d'une telle gaine, une protection de l'endoprothèse à l'encontre d'un glissement sur le ballonnet lorsqu'ensuite, on introduit le cathéter par son extrémité distale dans un vaisseau pour amener le ballonnet avec l'endoprothèse à l'emplacement d'une lésion vasculaire que l'on souhaite traiter par angioplastie et, dans ce but de protection, les diamètres extérieurs maximaux des boucliers distal et proximal sont au moins égaux au diamètre extérieur de l'endoprothèse à l'état non expansé. Une fois le ballonnet et l'endoprothèse parvenus au niveau de la lésion vasculaire à traiter, on provoque le gonflage du ballonnet qui expanse l'endoprothèse en la déformant plastiqucment, ce qui l'amène à un diamètre intérieur supérieur au diamètre extérieur maximal du bouclier distal. De ce fait, ensuite, après avoir dégonflé le ballonnet, on peut extraire le cathéter du vaisseau par une traction appliquée à l'extrémité proximale du cathéter, le bouclier distal traversant sans difficulté la prothèse. Dans le dispositif connu du fait du brevet américain N° 5 108 416 et de la demande de brevet européen N° 0 442 657, les boucliers distal et proximal sont décrits comme flexibles et cette flexibilité leur permet, lorsqu'ils sont extérieurs au ballonnet et enveloppent respectivement l'extrémité distale et l'extrémité proximale de celui-ci, de s'expanser avec le ballonnet lors du gonflage de celui-ci, les boucliers étant toutefois rappelés élastiquement vers leur conformation correspondant à l'état dégonflé du ballonnet pour accompagner ensuite celui-ci lors de son dégonflage et libérer l'endoprothèse notamment en vue du retrait du cathéter. La flexibilité des boucliers distal et proximal est également mentionnée dans le cas de boucliers distal et proximal logés à l'intérieur du ballonnet, alors que les boucliers n'ont pas alors à s'expanser lors du gonflage du ballonnet, et cette flexibilité s'exerce alors dans le sens d'un rétrécissement des boucliers distal et proximal.To implant a balloon-type stent using such a device, the stent in the unexpanded state is placed on the balloon in the deflated state, between the distal and proximal shields, leaving the stent directly exposed to the outside, that is to say without coating it with a retractable protective sheath as proposed for example by British patent application No. 2,196,857 or international patent application No. WO 9423669. The role of the distal and proximal shields is to ensure, in the absence of such a sheath, protection of the endoprosthesis against a sliding on the balloon when then, the catheter is introduced by its end distally in a vessel to bring the balloon with the endoprosthesis to the location of a vascular lesion that one wishes to treat by angioplasty and, for this protection purpose, the maximum outside diameters of the distal and proximal shields are at less equal to the outside diameter of the stent in the unexpanded state. Once the balloon and the endoprosthesis have reached the level of the vascular lesion to be treated, the balloon is inflated, which expands the endoprosthesis by plastic deformation, which brings it to an internal diameter greater than the maximum external diameter of the shield. distal. Therefore, after having deflated the balloon, the catheter can be removed from the vessel by a pull applied to the proximal end of the catheter, the distal shield easily passing through the prosthesis. In the device known from American Patent No. 5,108,416 and European Patent Application No. 0 442 657, the distal and proximal shields are described as flexible and this flexibility allows them, when they are outside the balloon and respectively envelop the distal end and the proximal end thereof, to expand with the balloon during inflation thereof, the shields being however elastically biased towards their conformation corresponding to the deflated state of the balloon to accompany then the latter during its deflation and release the endoprosthesis in particular for the withdrawal of the catheter. The flexibility of the distal and proximal shields is also mentioned in the case of distal and proximal shields housed inside. of the balloon, while the shields do not then have to expand during inflation of the balloon, and this flexibility is then exerted in the direction of a narrowing of the distal and proximal shields.
Toutefois, cette possibilité de rétrécissement des boucliers distal et proximal est nécessairement limitée si l'on désire que les boucliers remplissent leur rôle de protection de l'endoprothèse à l'état non expansé, sur le ballonnet à l'état dégonflé, pendant le trajet dans un vaisseau et, par conséquent, il y a lieu de considérer que l'arête que les boucliers distal et proximal présentent l'un vers l'autre dans ces conditions est relativement rigide.However, this possibility of narrowing of the distal and proximal shields is necessarily limited if it is desired that the shields fulfill their role of protecting the stent in the unexpanded state, on the balloon in the deflated state, during the journey. in a vessel and, therefore, it should be considered that the edge that the distal and proximal shields present towards each other under these conditions is relatively rigid.
Or, cette arête est directement exposée vers l'extérieur lorsque les boucliers distal et proximal enveloppent extérieurement le ballonnet et elle crée ainsi un obstacle au mouvement antérograde ou rétrograde du cathéter dans le vaisseau, voire des risques de lésion de celui-ci et notamment d'aggravation de la lésion à traiter lorsque le ballonnet portant l'endoprothèse parvient dans la zone de cette lésion ; on entend ici par antérograde un mouvement de progression dans le sens du flux sanguin dans le vaisseau et par rétrograde un mouvement de recul, en sens opposé au flux sanguin. Lorsque les boucliers distal et proximal sont logés à l'intérieur du ballonnet, celui-ci isole certes la paroi du vaisseau des arêtes précitées, mais celles-ci créent dans le ballonnet à l'état dégonflé des arêtes certes moins agressives mais qui, d'une part, présentent encore les risques précités et, d'autre part, entraînent un risque de détérioration du ballonnet par une concentration de contraintes à leur niveau ; il y a lieu, en effet, de garder à l'esprit que le ballonnet gonflable est un composant particulièrement vulnérable du dispositif.However, this edge is directly exposed towards the outside when the distal and proximal shields externally envelop the balloon and it thus creates an obstacle to the anterograde or retrograde movement of the catheter in the vessel, or even risks of lesion of the latter and in particular of aggravation of the lesion to be treated when the balloon carrying the endoprosthesis reaches the area of this lesion; anterograde is understood here to mean a movement of progression in the direction of the blood flow in the vessel and by retrograde a movement of recoil, in the direction opposite to the blood flow. When the distal and proximal shields are housed inside the balloon, the latter certainly isolates the wall of the vessel from the abovementioned edges, but these create in the deflated balloon edges certainly less aggressive but which, d on the one hand, still present the aforementioned risks and, on the other hand, involve a risk of deterioration of the balloon by a concentration of stresses at their level; indeed, it should be borne in mind that the inflatable balloon is a particularly vulnerable component of the device.
Ces considérations amènent à limiter à une valeur minimale le diamètre extérieur maximal que présentent les boucliers distal et proximal dans leur état correspondant à l'état dégonflé du ballonnet, c'est-à-dire à rapprocher au maximum ce diamètre extérieur maximal du diamètre extérieur de l'endoprothèse à l'état non expansé, si bien que ces boucliers distal et proximal ne peuvent assurer que partiellement leur rôle de protection de l'endoprothèse à l'état non expansé, en n'empêchant pas son contact avec des irrégularités de surface de la paroi du vaisseau, et que le bouclier distal ne peut assurer aucun rôle de prédilatation du vaisseau, dans la zone de la lésion à traiter, préalablement à l'implantation de l'endoprothèse par gonflement du ballonnet.These considerations lead to limiting to a minimum value the maximum external diameter presented by the distal and proximal shields in their state corresponding to the deflated state of the balloon, that is to say as close as possible to this maximum external diameter of the external diameter. of the stent in the unexpanded state, so that these distal and proximal shields can only partially fulfill their role of protecting the stent in the unexpanded state, by not preventing its contact with irregularities of surface of the vessel wall, and the distal shield cannot perform any predilating role of the vessel, in the area of the lesion to be treated, prior to implantation of the stent by balloon inflation.
Le but de la présente invention est de remédier à ces inconvénients et, à cet effet, la présente invention propose un dispositif du type indiqué en préambule, caractérisé en ce que les boucliers distal et proximal présentent un diamètre extérieur décroissant progressivement respectivement vers l'extrémité proximale du cathéter et vers l'extrémité distale de celui-ci, à partir dudit diamètre extérieur maximal respectif.The object of the present invention is to remedy these drawbacks and, to this end, the present invention provides a device of the type indicated in the preamble, characterized in that the distal and proximal shields have an outer diameter progressively decreasing respectively towards the end proximal to the catheter and toward the distal end thereof, from said respective maximum outside diameter.
Comme dans l'Art antérieur, au plus tard immédiatement avant l'introduction de l'extrémité distale du cathéter dans un vaisseau, le dispositif comporte en outre une endoprothèse vasculaire de type expansible par ballonnet, enveloppant à l'état non expansé le ballonnet à l'état dégonflé, entre les boucliers distal et proximal, ladite endoprothèse étant directement exposée vers l'extérieur, présentant à l'état non expansé un diamètre extérieur au plus égal auxdits diamètres extérieurs maximaux des boucliers distal et proximal et étant susceptible de présenter à l'état expansé un diamètre intérieur supérieur audit diamètre extérieur maximal du bouclier distal.As in the prior art, at the latest immediately before the introduction of the distal end of the catheter into a vessel, the device also comprises a stent of the balloon expandable type, enveloping the balloon in the unexpanded state. the deflated state, between the distal and proximal shields, said endoprosthesis being directly exposed towards the outside, having in the unexpanded state an outside diameter at most equal to said maximum outside diameters of the distal and proximal shields and being capable of presenting to the expanded state an inner diameter greater than said maximum outer diameter of the distal shield.
Un Homme du métier comprendra aisément que la conformation précitée, caractéristique de l'invention, des boucliers distal et proximal permet d'éviter que ces derniers constituent un obstacle à la progression du cathéter à l'intérieur d'un vaisseau, que cette progression s'effectue dans un sens antérograde comme c'est le cas sur le trajet qui mène à la lésion à traiter, ou en sens rétrograde, comme ce peut être le cas localement soit en cas de difficulté le long de la trajectoire précitée, soit pour ajuster la position de l'endoprothèse par rapport à la lésion à traiter préalablement au gonflage du ballonnet, ou encore sur la totalité du trajet précité pour retirer l'endoprothèse par traction sur le cathéter en cas d'échec de l'implantation, et comme c'est le cas pour extraire le cathéter après la pose de l'endoprothèse et le dégonflement du ballonnet ; en outre, cette conformation ne fait courir aucun risque de lésion supplémentaire ou d'aggravation de la lésion à traiter. On remarquera que, comme c'est également dans le cas de l'Art antérieur, la progression du ballonnet portant l'endoprothèse à l'intérieur d'un vaisseau de même que leur positionnement précis par rapport à la lésion à traiter peuvent être aisément déterminés si le dispositif comporte des moyens de marquage radio-opaque occupant une position déterminée par rapport aux extrémités distale et proximale du ballonnet.A person skilled in the art will readily understand that the aforementioned conformation, characteristic of the invention, of the distal and proximal shields makes it possible to avoid that the latter constitute an obstacle to the progression of the catheter inside a vessel, that this progression s '' performs in an anterograde direction as is the case on the path leading to the lesion to be treated, or in a retrograde direction, as may be the case locally either in case of difficulty along the aforementioned trajectory, or to adjust the position of the stent relative to the lesion to be treated before inflating the balloon, or even over the entire aforementioned path to withdraw the stent by traction on the catheter in the event of implantation failure, and as c 'is the case for extracting the catheter after placement of the stent and deflation of the balloon; in addition, this conformation does not run any risk of additional injury or worsening of the lesion to be treated. It will be noted that, as is also the case in the prior art, the progression of the balloon carrying the stent inside a vessel as well as their precise positioning relative to the lesion to be treated can be easily determined if the device comprises radiopaque marking means occupying a determined position relative to the distal and proximal ends of the balloon.
Aussi bien lors d'une progression en sens antérograde que lors d'une progression en sens rétrograde, et alors que l'endoprothèse se trouve à l'état non expansé sur le ballonnet, à l'état dégonflé, les boucliers distal et proximal évitent un risque d'accrochage de l'extrémité distale ou proximale de l'endoprothèse dans la paroi du vaisseau, notamment dans les courbes éventuelles de celui-ci, et retiennent l'endoprothèse à rencontre d'un coulissement sur le ballonnet. En particulier, en cas d'échec de l'implantation, le retrait de l'endoprothèse non expansée, par application d'une traction au cathéter, ne présente pas de difficulté, y compris lorsque le cathéter a été introduit dans le vaisseau par l'intermédiaire d'un cathéter-guide ou d'une sonde porteuse. En outre, le diamètre maximal des boucliers distal et proximal peut être choisi suffisamment supérieur au diamètre extérieur de l'endoprothèse à l'état non expansé pour limiter les possibilités de contact de celle-ci avec des irrégularités de surfaces de la paroi du vaisseau pendant le trajet à l'intérieur du vaisseau puis, en ce qui concerne le bouclier distal, pour provoquer une prédilatation de la zone de la lésion à traiter préalablement à l'arrivée de l'endoprothèse dans cette zone et à son implantation par gonflage du ballonnet.Both during anterograde progression and during retrograde direction, and while the stent is in the unexpanded state on the balloon, in the deflated state, the distal and proximal shields avoid a risk of entanglement of the distal or proximal end of the endoprosthesis in the wall of the vessel, in particular in the possible curves of this one, and retain the endoprosthesis against a sliding on the balloon. In particular, in the event of implantation failure, the removal of the unexpanded stent, by applying traction to the catheter, does not present any difficulty, including when the catheter has been introduced into the vessel by the via a guide catheter or a lead probe. In addition, the maximum diameter of the distal and proximal shields can be chosen to be sufficiently greater than the outside diameter of the stent in the unexpanded state to limit the possibilities of its contact with irregularities in the surfaces of the vessel wall during the path inside the vessel then, with regard to the distal shield, to cause a predilatation of the area of the lesion to be treated prior to the arrival of the stent in this area and to its implantation by inflation of the balloon .
A cet effet, on peut prévoir que l'un ou chacun des boucliers proximal et distal, à savoir en pratique au moins le bouclier distal, soit sensiblement incompressible dans des conditions normales d'utilisation, bien que l'on puisse admettre une certaine compressibilité élastique de l'un et/ou l'autre des boucliers distal et proximal, cette compressibilité élastique étant limitée de telle sorte que ces derniers conservent un diamètre extérieur maximal supérieur au premier diamètre extérieur du ballonnet ainsi qu'au moins égal du diamètre extérieur de l'endoprothèse à l'état non expansé, dans des conditions normales d'utilisation ; cette compressibilité élastique limitée peut notamment accompagner une souplesse que présente de préférence l'un au moins des boucliers distal et proximal afin de faciliter le franchissement de courbes éventuelles du vaisseau sans risque d'accrochage de la paroi de celui-ci. On entend ici par "conditions normales d'utilisation " les conditions préalables à l'introduction dans un vaisseau ainsi que les conditions auxquelles le dispositif, et en particulier ses boucliers distal et proximal, est soumis pendant sa progression dans le vaisseau y compris à son arrivée dans la zone de la lésion à traiter.To this end, provision may be made for one or each of the proximal and distal shields, namely in practice at least the distal shield, to be substantially incompressible under normal conditions of use, although a certain compressibility may be admitted. elastic of one and / or the other of the distal and proximal shields, this elastic compressibility being limited so that the latter retain a maximum external diameter greater than the first external diameter of the balloon as well as at least equal to the external diameter of the stent in the unexpanded state, under normal conditions of use; this limited elastic compressibility can in particular accompany a flexibility that preferably has at least one of the distal and proximal shields in order to facilitate the crossing of possible curves of the vessel without risk of catching on the wall thereof. The term “normal conditions of use” is understood here to mean the conditions prior to introduction into a vessel as well as the conditions to which the device, and in particular its distal and proximal shields, is subjected during its progression in the vessel including its arrival in the area of the lesion to be treated.
On comprendra aisément qu'un dispositif selon l'invention puisse trouver une application dans le traitement de toutes les lésions vasculaires, et notamment coronaires, et qu'il est tout particulièrement adapté à une angioplastie sur les lésions des pontages saphènes compte tenu de sa faible aggressivité envers la paroi du vaisseau.It will easily be understood that a device according to the invention can find an application in the treatment of all vascular lesions, and in particular coronary, and that it is very particularly suitable for angioplasty on saphenous bypass lesions given its low aggressiveness towards the vessel wall.
Diverses considérations de l'Homme du métier peuvent amener à donner au diamètre extérieur maximal du bouclier proximal une valeur supérieure ou inférieure à celle du diamètre extérieur maximal du bouclier distal mais, en règle générale, ces deux diamètres extérieurs maximaux peuvent être sensiblement égaux. Par contre, le bouclier distal est avantageusement plus effilé distalement que proximalement et peut être globalement plus effilé que le bouclier proximal considéré distalement comme proximalement, compte tenu de sa position de tête lors de la progression antérograde du cathéter dans un vaisseau, et il est de ce fait généralement plus long que le bouclier proximal.Various considerations of a person skilled in the art can lead to giving the maximum external diameter of the proximal shield a value greater or less than that of the maximum external diameter of the distal shield, but, as a general rule, these two maximum external diameters can be substantially equal. On the other hand, the distal shield is advantageously more tapered distally than proximally and can be overall more tapered than the proximal shield considered distally as proximally, taking into account its head position during the anterograde progression of the catheter in a vessel, and it is this is usually longer than the proximal shield.
Dans le cas du dispositif selon l'invention comme dans le cas de l'Art antérieur illustré par le brevet américain N° 5 108 416 et la demande de brevet européen N° 0 442 657, le ballonnet peut être intégralement situé entre l'extrémité proximale du bouclier distal et l'extrémité distale du bouclier proximal, ce qui a l'inconvénient d'entrainer un certain espacement des boucliers distal et proximal vis-à-vis de l'endoprothèse à l'état non expansé, compte tenu de ce que des considérations pratiques de réalisation du ballonnet font que le gonflage de celui-ci ne peut s'effectuer avec un diamètre extérieur uniforme que dans une zone intermédiaire entre ses extrémités distale et proximale si bien que seule cette zone intermédiaire peut être couverte par l'endoprothèse, comme il est connu d'un Homme du métier. On préfère par conséquent, afin de rapprocher au maximum le bouclier distal et/ou le bouclier proximal vis- à-vis de l'endoprothèse, de prévoir comme il est connu de l'Art antérieur précité que le ballonnet possède une extension tubulaire distale enveloppant au moins l'extrémité proximale du bouclier distal et/ou une extension tubulaire proximale enveloppant au moins l'extrémité distale du bouclier proximal. Avantageusement, l'extension tubulaire distale du ballonnet peut envelopper le bouclier distal jusqu'à son extrémité distale en épousant étroitement le bouclier distal, au moins sur son diamètre extérieur maximal et son extrémité distale, à l'état dégonflé du ballonnet, et/ou l'extension tubulaire proximale du ballonnet enveloppe le bouclier proximal jusqu'à son extrémité proximale en épousant étroitement le bouclier proximal, au moins sur son diamètre extérieur maximal et son extrémité proximale, à l'état dégonflé du ballonnet. Dans un tel cas, on prend en compte la somme du diamètre extérieur maximal effectif du bouclier distal ou proximal, respectivement, et du double de l'épaisseur de paroi de l'extension tubulaire correspondante à titre de diamètre extérieur maximal du bouclier distal ou proximal dans les comparaisons, ci-dessus, entre ce diamètre, d'une part, les premier et deuxième diamètres extérieurs du ballonnet, le diamètre extérieur de l'endoprothèse à l'état non expansé et son diamètre intérieur à l'état expansé, d'autre part.In the case of the device according to the invention as in the case of the prior art illustrated by the American patent N ° 5 108 416 and the European patent application N ° 0 442 657, the balloon can be entirely located between the end proximal of the distal shield and the distal end of the proximal shield, which has the disadvantage of causing a certain spacing of the distal and proximal shields vis-à-vis the stent in the unexpanded state, taking into account this that practical considerations of the realization of the balloon make it possible to inflate it with a uniform outside diameter only in an intermediate zone between its distal and proximal ends so that only this intermediate zone can be covered by the endoprosthesis, as is known to a person skilled in the art. It is therefore preferred, in order to bring the distal shield and / or the proximal shield as close as possible to the endoprosthesis, to provide, as is known from the aforementioned prior art, that the balloon has a distal tubular extension. enveloping at least the proximal end of the distal shield and / or a proximal tubular extension enveloping at least the distal end of the proximal shield. Advantageously, the distal tubular extension of the balloon can envelop the distal shield up to its distal end by closely fitting the distal shield, at least over its maximum outside diameter and its distal end, in the deflated state of the balloon, and / or the proximal tubular extension of the balloon envelops the proximal shield up to its proximal end by closely fitting the proximal shield, at least over its maximum outside diameter and its proximal end, in the deflated state of the balloon. In such a case, we take into account the sum of the maximum effective outside diameter of the distal or proximal shield, respectively, and twice the wall thickness of the corresponding tubular extension as the maximum outside diameter of the distal or proximal shield. in the comparisons, above, between this diameter, on the one hand, the first and second outer diameters of the balloon, the outer diameter of the stent in the unexpanded state and its inner diameter in the expanded state, d 'somewhere else.
Naturellement, la forme des extrémités distale et proximale des boucliers distal et proximal peut varier dans une large mesure dès lors qu'elle respecte la décroissance précitée de diamètre extérieur.Naturally, the shape of the distal and proximal ends of the distal and proximal shields can vary to a large extent as long as it respects the abovementioned decrease in outer diameter.
Ainsi, selon un mode de mise en oeuvre préféré de la présente invention, le bouclier proximal possède une extrémité distale convexe, arrondie et/ou le bouclier distal possède une extrémité proximale convexe, arrondie ; cette forme convexe, arrondie peut être par exemple approximativement hémisphérique.Thus, according to a preferred embodiment of the present invention, the proximal shield has a convex, rounded distal end and / or the distal shield has a convex, rounded proximal end; this convex, rounded shape may for example be approximately hemispherical.
De même, le bouclier proximal peut posséder une extrémité proximale convexe qui peut être arrondie, par exemple approximativement hémisphérique, ou encore sensiblement tronconique. De même, le bouclier distal peut posséder une extrémité distale convexe, sensiblement tronconique ou encore arrondie et par exemple approximativement hémisphérique.Similarly, the proximal shield can have a convex proximal end which can be rounded, for example approximately hemispherical, or even substantially frustoconical. Likewise, the distal shield may have a convex, substantially frustoconical or even rounded distal end, for example approximately hemispherical.
Cette dernière conformation est préférée lorsque, selon une variante de réalisation du dispositif selon l'invention, celui-ci comporte en outre : - un ballonnet gonflable auxiliaire solidaire du cathéter et disposé entre le bouclier distal et l'extrémité distale du cathéter, le ballonnet auxiliaire présentant des troisième et quatrième diamètres extérieurs, respectivement à l'état dégonflé et à l 'état gonflé, respectivement inférieur et au moins égal audit diamètre extérieur maximal du bouclier distal,This latter configuration is preferred when, according to an alternative embodiment of the device according to the invention, it further comprises: - an auxiliary inflatable balloon secured to the catheter and disposed between the distal shield and the distal end of the catheter, the auxiliary balloon having third and fourth outer diameters, respectively in the deflated state and in the inflated state, respectively less and at least equal to said maximum outer diameter of the distal shield,
- un canal auxiliaire de transfert d'un fluide de gonflage du ballonnet auxiliaire, le long du cathéter, entre une zone adjacente à l'extrémité proximale du cathéter et le ballonnet auxiliaire.an auxiliary channel for transferring an inflation fluid from the auxiliary balloon, along the catheter, between an area adjacent to the proximal end of the catheter and the auxiliary balloon.
Un tel ballonnet gonflable auxiliaire permet de prédilater la lésion, préalablement au passage du bouclier distal puis du ballonnet dégonflé portant l'endoprothèse non expansée, dans le cas de sténoses trop serrées et/ou trop rigides pour pouvoir être franchies sans difficulté par le bouclier distal.Such an auxiliary inflatable balloon makes it possible to predilate the lesion, prior to the passage of the distal shield then of the deflated balloon carrying the unexpanded stent, in the case of stenoses which are too tight and / or too rigid to be able to be crossed without difficulty by the distal shield .
En l'absence de ce ballonnet gonflable auxiliaire, cette prédilatation est assurée par le bouclier distal auquel on préfère alors donner à cet effet une conformation sensiblement tronconique à son extrémité distale, qui est la première à s'engager dans la zone de la lésion.In the absence of this auxiliary inflatable balloon, this predilatation is ensured by the distal shield to which it is then preferred to give for this purpose a substantially frustoconical conformation at its distal end, which is the first to engage in the area of the lesion.
Naturellement, de façon connue en elle-même, la progression du dispositif à l'intérieur d'un vaisseau, laquelle s'effectue par une poussée appliquée à l'extrémité proximale du cathéter, à l'extérieur du vaisseau, est avantageusement facilitée par toute disposition connue d'un Homme du métier et, en particulier, le cathéter peut comporter un canal de réception d'un fil flexible coulissant formant guide de dilatation, au moins du bouclier proximal à l'extrémité distale du cathéter, ou bien le cathéter peut comporter un guide de dilatation intégré sous forme d'un embout de guidage, solidaire du cathéter et prolongeant celui-ci à son extrémité distale, étant entendu que toute disposition connue en elle-même d'un Homme du métier peut être adoptée, de façon générale, pour augmenter ce que l'on appelle la "poussabilité" du dispositif. Le mode de réalisation pratique des boucliers distal et proximal peut lui-même varier dans une large mesure tout en respectant la conformation caractéristique de la présente invention.Naturally, in a manner known per se, the progression of the device inside a vessel, which is effected by a push applied to the proximal end of the catheter, outside the vessel, is advantageously facilitated by any arrangement known to a person skilled in the art and, in particular, the catheter may comprise a channel for receiving a flexible sliding wire forming a dilation guide, at least from the shield proximal to the distal end of the catheter, or alternatively the catheter may include a dilation guide integrated in the form of a guide tip, integral with the catheter and extending the latter at its distal end, it being understood that any arrangement known in itself of a person skilled in the art can be adopted, generally, to increase the so-called "pushability" of the device. The practical embodiment of the distal and proximal shields can itself vary to a large extent while respecting the characteristic conformation of the present invention.
Ainsi, l'un ou chacun des boucliers proximal et distal peut posséder une paroi définissant son diamètre extérieur et délimitant une cavité vers le cathéter, ou encore être plein entre son diamètre extérieur et le cathéter. De même, l'un ou chacun des boucliers proximal et distal peut être réalisé en une pièce avec le cathéter, ou encore en une pièce avec le ballonnet, étant entendu qu'une réalisation sous forme séparée, rapportée aussi bien sur le cathéter que sur le ballonnet ne sort pas du cadre de la présente invention. On entend ici généralement par "ballonnet" le ballonnet destiné à provoquer l'expansion de l'endoprothèse, mais ces indications quant à la fabrication du dispositif selon l'invention peuvent le cas échéant s'appliquer également à l'éventuel ballonnet auxiliaire de prédilatation. On peut par exemple prévoir que les boucliers soient réalisés par surmoulage d'une matière thermoplastique sur le cathéter, de façon à établir une liaison directe avec ce dernier, ou encore par application d'un matériau thermodurcissable, par exemple une colle urethane à deux composants, sur le cathéter après fixation du ballonnet sur celui-ci, même dans le cas de boucliers distal et proximal logés à l'intérieur du ballonnet puisqu'il est possible, dans un tel cas, d'introduire le matériau thermodurcissable au moyen d'une aiguille fine, par le canal de gonflage du ballonnet ou par l'extrémité distale du cathéter avant, le cas échéant, de fermer celle-ci. Dans de tels cas, les boucliers proximal et distal sont pleins entre leur diamètre extérieur et le cathéter et distincts aussi bien du cathéter que du ballonnet bien que solidaires de l'un et l'autre.Thus, one or each of the proximal and distal shields can have a wall defining its outside diameter and delimiting a cavity towards the catheter, or even be full between its outside diameter. and the catheter. Similarly, one or each of the proximal and distal shields can be produced in one piece with the catheter, or even in one piece with the balloon, it being understood that an embodiment in separate form, attached both to the catheter and to the balloon does not depart from the scope of the present invention. The term “balloon” is generally understood here to mean the balloon intended to cause the expansion of the endoprosthesis, but these indications as to the manufacture of the device according to the invention can, where appropriate, also apply to the possible auxiliary balloon of predilatation. . It is for example possible to provide that the shields are produced by overmolding a thermoplastic material on the catheter, so as to establish a direct connection with the latter, or even by application of a thermosetting material, for example a two-component urethane adhesive. , on the catheter after fixing the balloon on it, even in the case of distal and proximal shields housed inside the balloon since it is possible, in such a case, to introduce the thermosetting material by means of a fine needle, through the inflation channel of the balloon or through the distal end of the catheter before, if necessary, closing the latter. In such cases, the proximal and distal shields are full between their outside diameter and the catheter and distinct from both the catheter and the balloon although integral with each other.
On peut également réaliser les boucliers distal et proximal en introduisant le cathéter, réalisé en matière thermoplastique, dans un moule présentant l'empreinte des boucliers distal et proximal , convenablement conformée et disposée, puis en chauffant le cathéter et en le plaçant intérieurement sous pression pour réaliser les boucliers distal et proximal par soufflage dans le moule à partir du cathéter lui- même ; on peut aussi réaliser les boucliers proximal et distal en chauffant localement, dans les zones correspondantes, le cathéter également réalisé en un matériau thermoplastique et en comprimant en sens proximal l'extrémité distale du cathéter pour provoquer une augmentation du diamètre extérieur de celui-ci dans les zones chauffées. Dans de tels cas, les boucliers distal et proximal possèdent une paroi réalisée en une pièce avec le cathéter, cette paroi définissant le diamètre extérieur des boucliers, notamment leur diamètre extérieur maximal, et délimitant une cavité vers le cathéter, en pratique une cavité ouverte vers l'intérieur de ce dernier.The distal and proximal shields can also be produced by introducing the catheter, made of thermoplastic material, into a mold having the imprint of the distal and proximal shields, suitably shaped and arranged, then by heating the catheter and placing it internally under pressure to make the distal and proximal shields by blowing into the mold from the catheter itself; it is also possible to produce the proximal and distal shields by locally heating, in the corresponding zones, the catheter also made of a thermoplastic material and by compressing in the proximal direction the distal end of the catheter to cause an increase in the external diameter of the latter in heated areas. In such cases, the distal and proximal shields have a wall made in one piece with the catheter, this wall defining the outside diameter of the shields, in particular their maximum outside diameter, and delimiting a cavity towards the catheter, in practice a cavity open towards the interior of the latter.
On peut encore réaliser les boucliers en créant une préforme de ballonnet en matériau thermoplastique, en prévoyant un surcroît approprié de matériau dans la zone de cette préforme correspondant aux extrémité distale et proximale du ballonnet, et en mettant ensuite en forme le ballonnet par soufflage de telle sorte qu'il présente un surépaississement de sa paroi, créant les boucliers distal et proximal, à ses extrémités distale et proximale, respectivement. Le ballonnet peut ensuite être fixé au cathéter par l'intermédiaire des boucliers, par tout procédé conventionnel tel qu'une thermosoudure, une soudure par ultrasons ou un collage, naturellement dans des conditions propres à assurer l'étanchéité du ballonnet. Dans un tel cas, les boucliers distal et proximal sont pleins entre leur diamètre extérieur et le cathéter, et réalisés en une pièce avec le ballonnet. Les matériaux utilisés, hormis le cas où l'on réalise les boucliers en matériau thermodurcissable, peuvent être des matériaux thermoplastiques, en particulier des polymères thermoplastiques tels que les polyoléfines, les polyamides, les polyesters, etc., et en particulier le polyéthylène, le Nylon® , le téréphtalate de polyéthylène et des copolymères de ces familles de polymères. En particulier, si les pressions mises en oeuvre lors du gonflage du ballonnet sont importantes, par exemple de l'ordre de 20 atmosphères, on préfère utiliser le téréphtalate de polyéthylène ou le Nylon® pour le ballonnet, bien que ces exemples ne soient nullement limitatifs. Dans un tel cas, on préfère fixer les boucliers distal et proximal et le ballonnet sur le cathéter par collage, sous forme de pièces distinctes ou en ayant réalisé des boucliers distal et proximal en une pièce avec le ballonnet, pour des raisons de facilité de mise en place des boucliers distal et proximal et du ballonnet sur le cathéter. Lorsqu'on utilise pour le ballonnet un polyéthylène basse pression, le ballonnet présente une élasticité suffisante pour permettre sa mise en place sur le cathéter alors que celui-ci présente déjà les boucliers proximal et distal, réalisés par exemple en une pièce avec le cathéter, cette élasticité étant suffisante pour permettre le passage d'au moins l'un des boucliers distal et proximal par le ballonnet. Naturellement, ces modes de fabrication d'un dispositif selon l'invention ne constituent que des exemples non limitatifs, et d'autres modes de fabrication pourront être choisis sans que l'on sorte pour autant du cadre de la présente invention.The shields can also be produced by creating a balloon preform of thermoplastic material, by providing an appropriate addition of material in the zone of this preform corresponding to the distal and proximal end of the balloon, and then by shaping the balloon by blowing such so that it has a thickening of its wall, creating the distal and proximal shields, at its distal and proximal ends, respectively. The balloon can then be fixed to the catheter by means of the shields, by any conventional method such as heat sealing, ultrasonic welding or bonding, naturally under conditions suitable for ensuring the sealing of the balloon. In such a case, the distal and proximal shields are full between their outside diameter and the catheter, and made in one piece with the balloon. The materials used, apart from the case where the shields are made of thermosetting material, can be thermoplastic materials, in particular thermoplastic polymers such as polyolefins, polyamides, polyesters, etc., and in particular polyethylene, Nylon®, polyethylene terephthalate and copolymers of these families of polymers. In particular, if the pressures used during inflation of the balloon are high, for example of the order of 20 atmospheres, it is preferred to use polyethylene terephthalate or Nylon® for the balloon, although these examples are in no way limiting . In such a case, it is preferable to fix the distal and proximal shields and the balloon to the catheter by gluing, in the form of separate pieces or having made distal and proximal shields in one piece with the balloon, for reasons of ease of placement. in place of the distal and proximal shields and the balloon on the catheter. When a low pressure polyethylene is used for the balloon, the balloon has sufficient elasticity to allow it to be placed on the catheter while the latter already has the proximal and distal shields, made for example in one piece with the catheter, this elasticity being sufficient to allow the passage of at least one of the distal and proximal shields through the balloon. Naturally, these methods of manufacturing a device according to the invention constitute only nonlimiting examples, and other manufacturing methods may be chosen without departing from the scope of the present invention.
D'autres caractéristiques et avantages du dispositif selon l'invention ressortiront de la description ci-dessous, relative à un certain nombre d'exemples non limitatifs de réalisation.Other characteristics and advantages of the device according to the invention will emerge from the description below, relating to a certain number of nonlimiting exemplary embodiments.
- Les figures 1 à 3 montrent, en élévation latérale, trois exemples non limitatifs de dispositif selon l'invention, portant une endoprothèse vasculaire de type expansible par ballonnet, enveloppant à l'état non expansé le ballonnet à l'état dégonflé ; le dispositif illustré dans ces trois exemples est plus particulièrement adapté dimensionnellement à une angioplastie coronaire, mais un Homme du métier comprendra qu'il ne doit en découler aucune limitation quant aux applications d'un dispositif selon l'invention, et adoptera les dispositions qui vont être décrites en fonction d'autres applications sans sortir pour autant du cadre de la présente invention.- Figures 1 to 3 show, in side elevation, three non-limiting examples of device according to the invention, carrying a stent of type expandable by balloon, enveloping in the unexpanded state the balloon in the deflated state; the device illustrated in these three examples is more particularly adapted dimensionally to coronary angioplasty, but a person skilled in the art will understand that there should be no limitation as to the applications of a device according to the invention, and will adopt the provisions which will be described in terms of other applications without departing from the scope of the present invention.
- La figure 4 montre une vue du dispositif de la figure 1 , en coupe par un plan repéré en IV- IV à cette figure 1.- Figure 4 shows a view of the device of Figure 1, in section through a plane identified in IV-IV in this Figure 1.
- Les figures 5 à 7 montrent le dispositif illustré à la figure 1 , en coupe par un plan repéré en V-V à la figure 4 et formant plan de symétrie, le dispositif étant illustré sur ces figures respectivement dans le même état qu'à la figure 1 , dans un état de gonflage du ballonnet et d'expansion de l'endoprothèse à l'intérieur d'un vaisseau et à l'état de dégonflage du ballonnet avec persistance de l 'état expansé de l 'endoprothèse, préalablement au retrait du dispositif.- Figures 5 to 7 show the device illustrated in Figure 1, in section through a plane marked in VV in Figure 4 and forming a plane of symmetry, the device being illustrated in these figures respectively in the same state as in Figure 1, in a state of inflation of the balloon and expansion of the stent inside a vessel and in the state of deflation of the balloon with persistence of the expanded state of the stent, prior to removal of the device.
- La figure 8 montre une vue du dispositif illustré à la figure 2, en coupe par un plan repéré en VIII-VIII à cette figure 2.- Figure 8 shows a view of the device illustrated in Figure 2, in section through a plane marked in VIII-VIII in this Figure 2.
- Les figures 9 à 1 1 montrent une vue du dispositif illustré à la figure 2, en coupe par un plan repéré en IX-1X à la figure 8, et constituant un plan de symétrie pour le dispositif, le dispositif étant illustré dans des états correspondant respectivement à ceux des figures 5 à 7 en ce qui concerne le dispositif de la figure 1.- Figures 9 to 1 1 show a view of the device illustrated in Figure 2, in section through a plane marked in IX-1X in Figure 8, and constituting a plane of symmetry for the device, the device being illustrated in states corresponding respectively to those of FIGS. 5 to 7 as regards the device of FIG. 1.
- La figure 12 montre une vue du dispositif illustré à la figure 3, en coupe par un plan repéré en XII-XII à la figure 3. - La figure 13 montre une vue du dispositif illustré à la figure 3 , en coupe par un plan repéré en XIII-XII1 à la figure 12, ce plan constituant un plan de symétrie pour le dispositif, lequel est vu dans le même état que le dispositif de la figure 1 à la figure 5.- Figure 12 shows a view of the device illustrated in Figure 3, in section through a plane marked in XII-XII in Figure 3. - Figure 13 shows a view of the device illustrated in Figure 3, in section by a plane identified in XIII-XII1 in FIG. 12, this plane constituting a plane of symmetry for the device, which is seen in the same state as the device in FIG. 1 in FIG. 5.
- Les figures 14, 15 et 16 illustrent, en des vues analogues à celles des figures 3, 12 et 13, respectivement, une variante de réalisation du dispositif illustré sur ces dernières ; les figures 1 5 et 1 6 montrent respectivement des vues en coupe selon le plan XV-XV de la figure 14 et selon le plan XVI-XVI de la figure 15.- Figures 14, 15 and 16 illustrate, in views similar to those of Figures 3, 12 and 13, respectively, an alternative embodiment of the device illustrated in the latter; Figures 1 5 and 1 6 respectively show sectional views along the plane XV-XV of Figure 14 and along the plane XVI-XVI of Figure 15.
Ces figures ont pour but d'illustrer diverses possibilités de réalisation d'un dispositif selon l'invention et de ses composants sur trois exemples de dispositif complet. Il est bien entendu qu'un Homme du métier pourra combiner différemment les caractéristiques de ces différentes variantes de réalisation sans sortir pour autant du cadre de la présente invention. Les figures 1 à 3, notamment, illustrent trois variantes d'un même dispositif selon l'invention 1 , comportant un cathéter 2 flexible, allongé, possédant une extrémité proximale 3 destinée à rester à l'extérieur du corps d'un patient à traiter et une extrémité distale 4 destinée à être introduite dans un vaisseau du patient et à progresser dans ce vaisseau dans le sens antérograde 5, c'est-à-dire dans le sens du flux sanguin, jusqu'à une lésion vasculaire à traiter, sous l'effet d'une poussée appliquée à l'extrémité proximale 3, afin d'amener puis d'implanter dans la zone de la lésion à traiter une endoprothèse vasculaire 6 de type expansible par ballonnet. Il existe de nombreux types d'endoprothèses vasculaires ainsi expansibles par ballonnet et la figuration adoptée aux figures 1 à 3 comme aux figures 5 à 7, 9 à 1 1 et 13 pour une telle endoprothèse est purement symbolique. De telles endoprothèses sont généralement réalisées en fil métallique, avec une forme générale cylindrique de révolution, et peuvent se déformer plastiquement entre un état contracté ou non expansé, illustré aux figures 1 à 3, 5, 9, 13, 16 dans lequel elles présentent des diamètres respectivement intérieur d j^ et extérieur d2 , et un état expansé, illustré aux figures 6, 7, 10, 1 1 , dans lequel elles présentent des diamètres respectivement intérieur d3 et extérieur d4, le diamètre d4 étant supérieur au diamètre d3 lui-même supérieur au diamètre d2 , qui est supérieur au diamètre d i . L'épaisseur de l'endoprothèse 6, définie comme la moitié de la différence entre les diamètres d2 et di ou d4 et d3, ne dépasse généralement pas quelques centièmes de millimètres mais la forme de l'endoprothèse 6 à l'état non expansé comme à l'état expansé est stable et, en particulier, son maintien à l'état non expansé ne nécessite aucun moyen accessoire tel qu'une gaine l'enveloppant extérieurement ou un noyage dans un gel hémosoluble, comme c'est le cas pour d'autres types d'endoprothèse.The purpose of these figures is to illustrate various possibilities for producing a device according to the invention and its components on three examples of a complete device. It is understood that a person skilled in the art may combine the characteristics of these different embodiments differently without thereby departing from the scope of the present invention. Figures 1 to 3, in particular, illustrate three variants of the same device according to the invention 1, comprising a flexible catheter 2, elongated, having a proximal end 3 intended to remain outside the body of a patient to be treated and a distal end 4 intended to be introduced into a vessel of the patient and to progress in this vessel in the anterograde direction 5, that is to say in the direction of the blood flow, until a vascular lesion to be treated, under the effect of a thrust applied to the proximal end 3, in order to bring and then implant in the area of the lesion to be treated a stent 6 of the balloon expandable type. There are many types of stents thus expandable by balloon and the figuration adopted in Figures 1 to 3 as in Figures 5 to 7, 9 to 1 1 and 13 for such a stent is purely symbolic. Such stents are generally made of metal wire, with a generally cylindrical shape of revolution, and can deform plastically between a contracted or unexpanded state, illustrated in Figures 1 to 3, 5, 9, 13, 16 in which they have diameters respectively inside dj ^ and outside d 2 , and an expanded state, illustrated in FIGS. 6, 7, 10, 1 1, in which they have diameters respectively inside d 3 and outside d 4 , the diameter d 4 being greater than the diameter d 3 itself greater than diameter d 2 , which is greater than diameter di. The thickness of the stent 6, defined as half the difference between the diameters d 2 and di or d 4 and d 3 , generally does not exceed a few hundredths of a millimeter but the shape of the stent 6 in the state unexpanded as in the expanded state is stable and, in particular, its maintenance in the unexpanded state does not require any accessory means such as a sheath enveloping it externally or drowning in a hemosoluble gel, as is the case. case for other types of stents.
On décrira à présent plus particulièrement le dispositif 1 illustré aux figures 1 et 4 à 7.The device 1 illustrated in FIGS. 1 and 4 to 7 will now be described more particularly.
Ces figures illustrent un cathéter 2 de type dit "monorail", comportant deux tronçons tubulaires placés dans le prolongement l'un de l'autre à raison d'un tube proximal 7 et d'un tube distal 8, l'un et l'autre réalisés en matériau étanche. Le tube proximal 7 constitue la majeure partie de la longueur du cathéter 2 entre ses extrémités proximale 3 et distale 4, à partir de l'extrémité proximale 3 à proximité immédiate de laquelle il est retenu dans un embout proximal tubulaire 9 rigide, servant à appliquer au cathéter 2 la poussée d'introduction et de progression dans un vaisseau. De façon non illustrée mais connue d'un Homme du métier, le tube proximal 7 définit intérieurement un canal non représenté de passage de fluide de gonflage, en pratique un liquide chargé d'un produit de contraste radio-opaque, lequel canal est susceptible d'être raccordé par l'extrémité proximale 3 à une source non représentée, connue en elle- même, d'un tel fluide sous pression ou en dépression, de façon commandée. Le tube distal 8 définit une moindre partie de la longueur du cathéter 2, entre son raccordement 10 au tube proximal 7 et l'extrémité distale 4 du cathéter 2, et comporte du raccordement 10 à une zone adjacente à l'extrémité distale 4 comme il sera décrit en référence aux figures 5 à 7, deux canaux internes, comme le montre la figure 4, à raison d'un canal 1 1 de passage de fluide de gonflage, raccordé de façon étanche au canal interne précité, non représenté du tube proximal 7, et d'un canal 12 de passage d'un fil flexible 13 de guidage ou guide de dilatation, extérieur au tube proximal 7, c'est-à-dire pouvant longer celui-ci librement, et intérieur au tube distal 8, avec possibilité de coulissement de ce dernier sur le guide 13, depuis le raccordement 10 du tube distal 8 au tube proximal 7 jusqu'à l'extrémité distale 4. Le tube distal 8, entre son raccordement 10 au tube proximal 7 à l'extrémité distale 4 du cathéter, présente par exemple une longueur de l'ordre d'une trentaine de centimètres pour une longueur totale du cathéter 2, mesurée entre ses extrémités proximale 3 et distale 4, de l'ordre de 135 cm dans une application du dispositif à une angioplastie coronaire, ces chiffres étant indiqués qu'à titre d'exemple non limitatif. De façon connue d'un Homme du métier, le guide 13 est introduit dans le vaisseau à traiter en sens antérograde, dans le cas d'une telle application par l'intermédiaire d'un cathéter guide ou d'une sonde porteuse qui servira ensuite à introduire le cathéter 2, et ceci jusqu'au- delà d'une lésion à traiter. Ensuite, le tube distal 8 engagé sur le guide 13 est introduit dans le vaisseau et poussé dans le même sens, par action sur son extrémité proximale 3, jusqu'à la zone de la lésion à traiter en coulissant sur le guide 13. Dans une zone distale 14, adjacente à l'extrémité 4, le tube distalThese figures illustrate a catheter 2 of the so-called "monorail" type, comprising two tubular sections placed in the extension of one another by means of a proximal tube 7 and a distal tube 8, one and the other made of waterproof material. The proximal tube 7 constitutes the major part of the length of the catheter 2 between its proximal 3 and distal 4 ends, starting from the proximal end 3 in the immediate vicinity of which it is retained in a rigid tubular proximal tip 9, used to apply at catheter 2 the push of introduction and progression in a vessel. In a manner not illustrated but known to a person skilled in the art, the proximal tube 7 internally defines a channel (not shown) for the passage of inflation fluid, in practice a liquid charged with a radiopaque contrast medium, which channel is capable of 'be connected by the proximal end 3 to a not shown source, known in itself, of such a fluid under pressure or vacuum, in a controlled manner. The distal tube 8 defines a lesser part of the length of the catheter 2, between its connection 10 to the proximal tube 7 and the distal end 4 of the catheter 2, and comprises connection 10 to an area adjacent to the distal end 4 as it will be described with reference to Figures 5 to 7, two internal channels, as shown in Figure 4, on the basis of a channel 11 of inflating fluid passage, connected in leaktight manner to the abovementioned internal channel, not shown of the proximal tube 7, and a channel 12 for the passage of a flexible guide wire 13 or dilation guide, outside the proximal tube 7, that is to say able to freely follow the latter, and inside the distal tube 8, with the possibility of sliding of the latter on the guide 13, from the connection 10 of the distal tube 8 to the proximal tube 7 to the distal end 4. The distal tube 8, between its connection 10 to the proximal tube 7 at the distal end 4 of the catheter, has for example a length of the order of thirty centimeters for a length total catheter 2, measured between its proximal 3 and distal 4 ends, of the order of 135 cm in an application of the device to a coronary angioplasty, these figures being indicated only by way of nonlimiting example. In a manner known to a person skilled in the art, the guide 13 is introduced into the vessel to be treated in the anterograde direction, in the case of such an application via a guide catheter or a carrier probe which will then be used to introduce catheter 2, and this beyond a lesion to be treated. Then, the distal tube 8 engaged on the guide 13 is introduced into the vessel and pushed in the same direction, by action on its proximal end 3, to the area of the lesion to be treated by sliding on the guide 13. In a distal area 14, adjacent to end 4, the distal tube
8 porte solidairement, en vue de la mise en oeuvre de la présente invention, un certain nombre de composants qui vont être décrits à présent en référence aux figures 5 à 7 et qui sont destinés à retenir solidairement l'endoprothèse 6 à l'état non expansé pendant son trajet jusqu'à la lésion à traiter, puis à provoquer l'expansion de l'endoprothèse pour l'implanter dans le vaisseau au niveau de cette lésion et à autoriser ensuite un mouvement rétrograde, c'est-à-dire opposé au flux sanguin, du cathéter 2 à l'intérieur du vaisseau, sous l'effet d'une traction appliquée à l'embout 9, sans entraîner dans ce mouvement l'endoprothèse à l'état expansé.8 carries jointly, with a view to implementing the present invention, a certain number of components which will now be described with reference to FIGS. 5 to 7 and which are intended to jointly retain the endoprosthesis 6 in the non-state expanded during its journey to the lesion to be treated, then cause the endoprosthesis to expand to implant it in the vessel at the level of this lesion and then to allow retrograde, i.e. opposite, movement to the blood flow, from the catheter 2 inside the vessel, under the effect of a traction applied to the tip 9, without entraining in this movement the endoprosthesis in the expanded state.
L'illustration des figures 5 à 7 est limitée à cette zone 14 dont la longueur est de l'ordre de quelques centimètres à partir de l'extrémité distale 4 et que l'on supposera rectiligne pour des raisons de commodité de description, étant entendu qu'en dépit des composants qu'elle porte, elle conserve de préférence une certaine flexibilité en vue d'un franchissement plus facile de courbes, éventuelles du vaisseau.The illustration of FIGS. 5 to 7 is limited to this zone 14, the length of which is of the order of a few centimeters from the distal end 4 and which will be assumed to be rectilinear for reasons of convenience of description, it being understood that despite the components it carries, it preferably retains a certain flexibility with a view to easier crossing of any curves of the vessel.
On considérera en particulier que l'ensemble de cette zone 14 présente un axe rectiligne 15, autour duquel le tube 8 présente une face périphérique extérieure 16 cylindrique de révolution autour de cet axe, avec un diamètre d$ inférieur au diamètre dj bien que proche de celui-ci comme il apparaîtra plus loin.It will be considered in particular that the whole of this zone 14 has a rectilinear axis 15, around which the tube 8 has an outer peripheral face 16 of cylindrical revolution around this axis, with a diameter d $ smaller than the diameter dj although close to the latter as will appear later.
A proximité immédiate de l'extrémité distale 14, cette face 16 porte de façon solidaire, par complémentarité de forme et collage, ou soudure, ou tout autre procédé de fixation approprié, un bouclier distal 17 présentant une forme générale de révolution autour de l'axe 15 et réalisé ici sous forme pleine, entre une face périphérique intérieure 18 cylindrique de révolution autour de l'axe 15 avec un diamètre sensiblement identique au diamètre d$ pour épouser étroitement la face périphérique extérieure 16 du tube 8, et une face périphérique extérieure 19 dont la forme sera précisée par la suite. Le bouclier distal 17 est réalisé en un matériau de préférence flexible mais sensiblement incompressible ou éventuellement élastiquement compressible, toutefois de façon suffisamment limitée dans des conditions normales d'utilisation, c'est-à- dire même lorsqu'il est éventuellement amené à subir une compression lors de la progression de la zone 14 dans un vaisseau, pour que ce bouclier distal 17 conserve en permanence un diamètre extérieur maximal d5 qui, augmenté du double de l'épaisseur e d'une paroi tubulaire qui recouvre dans cet exemple le bouclier distal 17 comme il apparaîtra plus loin et doit être considérée comme faisant partie intégrante de ce bouclier pendant les déplacements de la zone 14 du cathéter 2 dans un vaisseau, comme il apparaîtra également plus loin, soit au moins égal, et de préférence supérieur au diamètre d2 , bien qu'inférieur au diamètre d$ , avec la forme générale de la face périphérique extérieure 19 qui va être décrite à présent.In the immediate vicinity of the distal end 14, this face 16 bears integrally, by complementarity of form and bonding, or welding, or any other suitable method of fixation, a distal shield 17 having a general shape of revolution around the axis 15 and produced here in solid form, between an inner peripheral face 18 cylindrical of revolution around the axis 15 with a diameter substantially identical to the diameter d $ to closely match the outer peripheral face 16 of the tube 8, and an outer peripheral face 19, the form of which will be specified subsequently. The distal shield 17 is made of a material which is preferably flexible but substantially incompressible or possibly elastically compressible, however sufficiently limited under normal conditions of use, that is to say even when it is possibly brought to undergo a compression during the progression of the zone 14 in a vessel, so that this distal shield 17 permanently retains a maximum outside diameter d 5 which, increased by twice the thickness e of a tubular wall which covers in this example the shield distal 17 as it will appear further on and must be considered as an integral part of this shield during the movements of zone 14 of catheter 2 in a vessel, as it will also appear further, ie at least equal, and preferably greater than the diameter d 2, although lower at $ diameter d, with the general shape of the outer peripheral face 19 which will be of written now.
D'une façon caractéristique de la présente invention, cette face périphérique extérieure 19 présente un diamètre extérieur qui décroît progressivement, à partir du diamètre extérieur maximal dç, d'une part vers l'extrémité distale 4 du cathéter 2 et d'autre part vers l'extrémité proximale de celui-ci de façon à définir, respectivement de part et d'autre d'un cercle 22 présentant le diamètre d6, une extrémité distale 20 et une extrémité proximale 21 du bouclier 17, l'une et l'autre convexes.Typically of the present invention, this outer peripheral face 19 has an outer diameter which decreases progressively, from the maximum outer diameter d, on the one hand towards the distal end 4 of the catheter 2 and on the other hand towards the proximal end thereof so as to define, respectively on either side of a circle 22 having the diameter d 6 , a distal end 20 and a proximal end 21 of the shield 17, one and the other convex.
Plus précisément, entre le cercle 22 et la proximité immédiate de l'extrémité distale 4 du cathéter 2 et à l'opposé de cette extrémité distale 4 par rapport au cercle 22, le bouclier 17 est délimité par des zones respectives convexes 23, 24 de la face périphérique extérieure 19. Dans cet exemple, la zone 23 est sensiblement tronconique de révolution autour de l'axe 15, avec un diamètre décroissant du cercle 22 jusqu'à la proximité immédiate de l'extrémité distale 4 au niveau de laquelle cette zone 23 se raccorde à la face périphérique intérieure 18, et la zone 24 est arrondie, par exemple approximativement hémisphériquement, entre le cercle 22 et son raccordement à la face périphérique intérieure 18.More specifically, between the circle 22 and the immediate proximity of the distal end 4 of the catheter 2 and opposite this distal end 4 with respect to the circle 22, the shield 17 is delimited by respective convex zones 23, 24 of the external peripheral face 19. In this example, the zone 23 is substantially frustoconical of revolution around the axis 15, with a decreasing diameter from the circle 22 to the immediate proximity of the distal end 4 at which this zone 23 is connected to the inner peripheral face 18, and the zone 24 is rounded, for example approximately hemispherically, between the circle 22 and its connection to the inner peripheral face 18.
A une distance li de l'extrémité proximale 21 du bouclier distal 17, cette distance l χ étant mesurée suivant l'axe 15, la face périphérique extérieure 16 du tube 8 du cathéter 2 porte de façon solidaire, en tout point identique à la façon dont elle porte le bouclier distal 17, un bouclier proximal 25 qui pourrait être différent du bouclier distal 17 mais est identique à celui-ci dans l'exemple non limitatif illustré, tout en étant placé dans une orientation opposée.At a distance li from the proximal end 21 of the distal shield 17, this distance l χ being measured along the axis 15, the outer peripheral face 16 of the tube 8 of the catheter 2 carries securely, at all points identical to the way which it carries the distal shield 17, a proximal shield 25 which could be different from the distal shield 17 but is identical to the latter in the nonlimiting example illustrated, while being placed in an opposite orientation.
Plus précisément, le bouclier proximal 25 , présentant une forme générale de révolution autour de l'axe 15, est délimité vers ce dernier par une face périphérique intérieure cylindrique 26 et dans le sens d'un éloignement par rapport à celui-ci par une face périphérique extérieure 27 présentant suivant un cercle 28 un diamètre maximal d - qui, dans cet exemple, est égal au diamètre dg et, de façon plus générale, dans cet exemple selon lequel une paroi tubulaire d'épaisseur e recouvre également le bouclier proximal 25 comme il apparaîtra plus loin, est tel que la somme du diamètre d7 et du double de l'épaisseur e soit en permanence au moins égale et de préférence supérieure au diamètre d 2 bien qu'inférieurs au diamètre d3. A partir de ce cercle 28 et vers l'extrémité distale 4, la face périphérique extérieure 27 présente une zone 29 délimitant une extrémité distale 30 du bouclier proximal 25 et présentant un diamètre qui décroît progressivement vers l'extrémité distale 4, de façon à définir une forme convexe, arrondie et par exemple approximativement hémisphérique, vers l'extrémité distale 4 du cathéter 2. De l'autre côté du cercle 28, la face périphérique extérieure 27 du bouclier proximal 25 présente une zone 3 1 délimitant une extrémité proximale 32 du bouclier distal 25 et présentant un diamètre qui décroît progressivement vers l'extrémité proximale du cathéter, de façon à définir une forme convexe, ici sensiblement tronconique de révolution autour de l'axe 15, pour la face périphérique extérieure 27 autour de l'extrémité proximale 31 du bouclier proximal 25. Les zones 29 et 31 de la face périphérique extérieure 27 se raccordent à la face périphérique extérieure 26 respectivement vers l'extrémité distale 4 du cathéter 2 et vers l'extrémité proximale de celui-ci. Le bouclier 25 est fixé au tube 8 du cathéter 2 par tous moyens appropriés tels qu'un collage ou une soudure. Dans une variante non représentée, au lieu d'être sensiblement tronconique, la zone 31 de la face périphérique extérieure 27 du bouclier proximal 25 pourrait présenter une forme similaire à celle de la zone 29 de cette face, le bouclier proximal 25 étant alors plus court, suivant l'axe 15, que le bouclier distal 17.More specifically, the proximal shield 25, having a general shape of revolution around the axis 15, is delimited towards the latter by a cylindrical inner peripheral face 26 and in the direction of a distance from it by a face external device 27 having in a circle 28 a maximum diameter d - which, in this example, is equal to the diameter dg and, more generally, in this example according to which a tubular wall of thickness e also covers the proximal shield 25 as it will appear further on, is such that the sum of the diameter d 7 and twice the thickness e is permanently at least equal and preferably greater than the diameter d 2 although less than the diameter d 3 . From this circle 28 and towards the distal end 4, the outer peripheral face 27 has a zone 29 delimiting a distal end 30 of the proximal shield 25 and having a diameter which decreases progressively towards the distal end 4, so as to define a convex, rounded shape, for example approximately hemispherical, towards the distal end 4 of the catheter 2. On the other side of the circle 28, the outer peripheral face 27 of the proximal shield 25 has a zone 3 1 delimiting a proximal end 32 of the distal shield 25 and having a decreasing diameter gradually towards the proximal end of the catheter, so as to define a convex shape, here substantially frustoconical of revolution around the axis 15, for the outer peripheral face 27 around the proximal end 31 of the proximal shield 25. The zones 29 and 31 of the outer peripheral face 27 are connected to the outer peripheral face 26 respectively towards the distal end 4 of the catheter 2 and towards the proximal end of the latter. The shield 25 is fixed to the tube 8 of the catheter 2 by any suitable means such as gluing or welding. In a variant not shown, instead of being substantially frustoconical, the area 31 of the outer peripheral face 27 of the proximal shield 25 could have a shape similar to that of the area 29 of this face, the proximal shield 25 then being shorter , along axis 15, as the distal shield 17.
On remarquera que les cercles 22 et 28 ne constituent de préférence pas des arêtes des faces périphériques extérieures 19 et 27, la transition entre les zones 23 et 24, d'une part, 29 et 31 , d'autre part s'effectuant avec une courbure régulière, sans point anguleux.It will be noted that the circles 22 and 28 preferably do not constitute edges of the external peripheral faces 19 and 27, the transition between the zones 23 and 24, on the one hand, 29 and 31, on the other hand being effected with a regular curvature, without angular point.
La longueur \ ι mesurée suivant l'axe 15 entre les boucliers distal 17 et proximal 25 est supérieure à la longueur 12 que présente l'endoprothèse 6 à l'état contracté mais pratiquement égale à cette longueur 12 , selon un axe de cette endoprothèse confondu avec l'axe 15 lorsque l'endoprothèse 6 est solidarisée à l'état contracté avec le cathéter 2 dans la zone 14 de celui-ci.The length \ ι measured along the axis 15 between the distal shields 17 and proximal 25 is greater than the length 1 2 presented by the endoprosthesis 6 in the contracted state but practically equal to this length 1 2 , along an axis of this endoprosthesis coincident with the axis 15 when the endoprosthesis 6 is secured in the contracted state with the catheter 2 in the zone 14 thereof.
En effet, l'endoprothèse 6 à l'état non expansé est retenue coaxialement entre les deux boucliers 17 et 25, en étant aussi proche que possible de l'un et l'autre, en vue de son acheminement dans la zone d'une léson à traiter.Indeed, the endoprosthesis 6 in the unexpanded state is retained coaxially between the two shields 17 and 25, being as close as possible to one and the other, with a view to its routing in the area of a lesion to be treated.
A cet effet, la face périphérique extérieure 16 du tube 8 est enveloppée étroitement, entre les deux boucliers 17 et 25, d'une paroi tubulaire souple, étanche, élastiquement extensible définissant un ballonnet gonflable 33 par l'intermédiaire duquel l'endoprothèse 6 est portée solidairement par la face périphérique extérieure 16 du tube 8. Λ cet effet, le diamètre intérieur d \ de l'endoprothèse 6 à l'état non expansé est sensiblement égal à la somme du diamètre d5 de la face périphérique extérieure 16 du tube 8 et du double d'une épaisseur uniforme e que présente la paroi du ballonnet 33, si bien que l'endoprothèse 6 à l'état non expansé est retenue sur cette paroi par friction alors que cette paroi épouse étroitement la face périphérique extérieure 16 entre les deux boucliers 17 et 25, que le ballonnet 33 jouxte respectivement par une extrémité distale 85 et par une extrémité proximale 86.To this end, the outer peripheral face 16 of the tube 8 is wrapped tightly, between the two shields 17 and 25, with a flexible, leaktight, elastically extensible tubular wall defining an inflatable balloon 33 by means of which the endoprosthesis 6 is carried integrally by the outer peripheral face 16 of the tube 8. For this purpose, the internal diameter d \ of the stent 6 in the unexpanded state is substantially equal to the sum of the diameter d 5 of the peripheral face outer 16 of the tube 8 and twice as uniform in thickness as the wall of the balloon 33, so that the stent 6 in the unexpanded state is retained on this wall by friction while this wall closely matches the face external device 16 between the two shields 17 and 25, which the balloon 33 adjoins respectively by a distal end 85 and by a proximal end 86.
Dans cet exemple, le ballonnet 33 présente au-delà de ses extrémités distale et proximale des extensions tubulaires respectivement distale 34 et proximale 35, sensiblement de même épaisseur e, de paroi épousant étroitement respectivement la face périphérique extérieure 19 du bouclier distal 17 et la face périphérique extérieure 27 du bouclier proximal 25 ainsi que, respectivement, une zone 36 de la face périphérique extérieure 16 du tube 8 laissée libre par le bouclier distal 17 à proximité immédiate de l'extrémité distale 4 du tube 8 et une zone 37 de cette face 16 située à proximité immédiate de l'embout proximal 25, du côté proximal de celui-ci.In this example, the balloon 33 has, beyond its distal and proximal ends, tubular extensions respectively distal 34 and proximal 35, of substantially the same thickness e, of wall closely matching respectively the outer peripheral face 19 of the distal shield 17 and the face external peripheral 27 of the proximal shield 25 as well as, respectively, a zone 36 of the external peripheral face 16 of the tube 8 left free by the distal shield 17 in the immediate vicinity of the distal end 4 of the tube 8 and a zone 37 of this face 16 located in the immediate vicinity of the proximal endpiece 25, on the proximal side thereof.
On entend ici par "épouser étroitement" le fait d'épouser sans pli, en assurant un contact mutuel intime.Here we mean by "closely marrying" the fact of marrying without wrinkles, ensuring intimate mutual contact.
Les extensions tubulaires distalc et proximale 34, 35 du ballonnet 33 sont réalisées en une seule pièce avec celui-ci et présentent les mêmes caractéristiques d'étanchéité, de souplesse et d'élasticité, et elles sont fixées de façon étanche au tube 8 respectivement dans la zone 36 et dans la zone 37 de façon à assurer une étanchéité du ballonnet 33 par rapport au tube 8. Les extensions tubulaires 34, 35 pourraient être également fixées de façon étanche respectivement à la zone 23 de la face périphérique extérieure 19 du bouclier distal 17 et la zone 31 de la face périphérique extérieure 27 du bouclier proximal 25, les deux boucliers 17 et 25 devant alors être eux-mêmes étanches et raccordés de façon étanche à la face 16 du tube 8. On observera que, dans la mesure où le double de l'épaisseur e s'ajoute aux diamètres dg et d7 lorsque le ballonnet 33 comporte ainsi des extensions tubulaires 34 et 35 enveloppant respectivement le bouclier distal 17 et le bouclier proximal 25, pour définir des diamètres extérieurs maximaux hors tout d 11, d ι2 de ces derniers, en pratique au niveau des cercles 22 et 28, qui sont au moins égaux et de préférence supérieurs au diamètre d 2, l'endoprothèse 6 à l'état non expansé, enveloppant le ballonnet 33 épousant étroitement la face périphérique extérieure 16 du tube 8, est retenue à rencontre d'un coulissement sur le ballonnet 33 par les boucliers distal 17 et proximal 25 qui, en écartant l'endoprothèse 6 de la paroi du vaisseau respectivement de part et d'autre de l'endoprothèse 6, évitent que celle-ci ne s'accroche à la paroi du vaisseau.The distal and proximal tubular extensions 34, 35 of the balloon 33 are produced in a single piece with the latter and have the same sealing, flexibility and elasticity characteristics, and they are tightly fixed to the tube 8 respectively in zone 36 and in zone 37 so as to seal the balloon 33 relative to the tube 8. The tubular extensions 34, 35 could also be fixed in a sealed manner respectively to zone 23 of the outer peripheral face 19 of the distal shield 17 and the zone 31 of the external peripheral face 27 of the proximal shield 25, the two shields 17 and 25 then having to be themselves sealed and connected in a sealed manner to the face 16 of the tube 8. It will be observed that, insofar as twice the thickness e is added to the diameters dg and d 7 when the balloon 33 thus has tubular extensions 34 and 35 respectively enveloping the distal shield 17 and the proximal shield 25, in order to define maximum overall outside diameters d 11 , d ι 2 of the latter, in practice at the level of the circles 22 and 28, which are at least equal and preferably greater than the diameter d 2 , the endoprosthesis 6 in the unexpanded state, enveloping the balloon 33 closely matching the external peripheral face 16 of the tube 8, is retained against sliding against the balloon 33 by the distal 17 and proximal shields 25 which, by spreading the endoprosthesis 6 from the wall of the vessel respectively on either side of the endoprosthesis 6, prevent it from clinging to the wall of the vessel.
Afin de permettre un gonflage du ballonnet 33 et, grâce à ce gonflage, une expansion plastique de l'endoprothèse 6 jusqu'à ce que cette dernière vienne expanser la paroi 38 du vaisseau dans la zone 39 de la lésion à traiter, le canal 1 1 d'arrivée de fluide de gonflage débouche à l'intérieur du ballonnet 33, c'est-à-dire dans la face périphérique extérieure 16 du tube 8, entre les boucliers distal 17 et proximal 25, par une lumière 40 ou par toute autre forme de passage, par exemple par des orifices répartis, non illustrés, alors que le canal 12 recevant le guide 13 reste isolé de façon étanche vis-à-vis du canal 1 1 et de cette lumière 40, pour se prolonger jusqu'à l'extrémité distale 4 du cathéter 2.In order to allow inflation of the balloon 33 and, thanks to this inflation, a plastic expansion of the stent 6 until the latter expands the wall 38 of the vessel in the area 39 of the lesion to be treated, the channel 1 1 inflating fluid inlet opens inside the balloon 33, that is to say in the outer peripheral face 16 of the tube 8, between the distal shields 17 and proximal 25, by a lumen 40 or by any another form of passage, for example by distributed orifices, not illustrated, while the channel 12 receiving the guide 13 remains isolated in a sealed manner with respect to the channel 1 1 and this light 40, to extend up to distal end 4 of catheter 2.
Ainsi, lorsque la zone 14 du cathéter 2 parvient dans la zone 39 de la lésion à traiter, ce que l'on peut constater grâce à la présence de moyens marqueurs radio-opaques 41 , 42 ici aménagés à l'intérieur des boucliers distal 17 et proximal 25 bien que d'autres emplacements puissent être choisis dès lors qu'ils sont localisés de façon prédéterminée par rapport au ballonnet 33 et à l'endoprothèse 6 qu'elle porte, on provoque par mise en pression du fluide de gonflage dans le canal 1 1 un gonflage du ballonnet 33 entre les boucliers distal 17 et proximal 25 et autour des extrémités proximale 21 et distale 30, au moins, naturellement tout en conservant l'étanchéité vis-à-vis de la face périphérique extérieure 16 du tube 8. Comme le montre la figure 6, ce gonflage s'accompagne d'une expansion plastique de l'endoprothèse 6 qui vient s'appliquer contre la paroi 38 du vaisseau dans la zone 39 et provoque le cas échéant l'expansion de cette paroi 38, dans la zone 39 de la lésion à traiter, jusqu'au diamètre d4, obtenu lorsque le ballonnet 33 présente extérieurement le diamètre d 3, supérieur aux diamètres d u et d 12 constituant respectivement la somme du diamètre dç, ou du diamètre d7 et du double de l'épaisseur e. Alors, lorsqu'on dégonfle ensuite le ballonnet 33 comme le montre la figure 7, la prothèse 6 déformée plastiquement conserve extérieurement le diamètre d 4 en maintenant la paroi 38 à ce diamètre dans la zone de la lésion 39, et conserve intérieurement le diamètre d3 si bien que, compte tenu de la relation de celui-ci avec le diamètre d u notamment, on peut par un mouvement rétrograde, c'est-à-dire en sens opposé au sens 5, extraire le cathéter 2 en faisant passer librement le bouclier distal 17, revêtu de l'extension tubulaire 22, à l'intérieur de l'endoprothèse 6 sans risquer d'entraîner celle-ci. Ce passage est facilité par la forme convexe de l'extrémité proximale 21 du bouclier distal 17, que l'extension tubulaire distale 34 du ballonnet 33 épouse alors à nouveau étroitement.Thus, when the zone 14 of the catheter 2 reaches the zone 39 of the lesion to be treated, which can be seen thanks to the presence of radiopaque marker means 41, 42 here arranged inside the distal shields 17 and proximal 25 although other locations can be chosen as soon as they are located in a predetermined manner relative to the balloon 33 and to the stent 6 which it carries, pressure is caused by inflation fluid in the channel 1 1 inflation of the balloon 33 between the distal shields 17 and proximal 25 and around the proximal ends 21 and distal 30, at least, naturally while retaining the seal vis-à-vis the outer peripheral face 16 of the tube 8 As shown in FIG. 6, this inflation is accompanied by a plastic expansion of the endoprosthesis 6 which is applied against the wall 38 of the vessel in the area 39 and if necessary causes the expansion of this wall 38. , in the zone 39 of the lesion to be treated, up to the diameter d 4 , obtained when the balloon 33 externally has the diameter d 3 , greater than the diameters of and d 12 constituting respectively the sum of the diameter d, or of the diameter d 7 and double of thickness e. Then, when the balloon 33 is then deflated as shown in FIG. 7, the prosthesis 6 plastically deformed externally retains the diameter d 4 while maintaining the wall 38 at this diameter in the area of the lesion 39, and internally retains the diameter d 3 so that, taking into account the relationship of the latter with the diameter of the in particular, it is possible by a retrograde movement, that is to say in the opposite direction to direction 5, to extract the catheter 2 by freely passing the distal shield 17, coated with the tubular extension 22, inside the stent 6 without risking it. This passage is facilitated by the convex shape of the proximal end 21 of the distal shield 17, which the distal tubular extension 34 of the balloon 33 then closely follows again.
On observera que le fait de prévoir des extensions tubulaires distale et proximale du ballonnet permet de rapprocher au maximum l'un de l'autre les boucliers distal 17 et proximal 25 , c'est-à-dire de réduire la longueur l j à une valeur pratiquement identique à la longueur 12 en reportant autour des boucliers distal 17 et proximal 25 les transitions entre le ballonnet 33 en cours de gonflage ou à l'état gonflé et les zones 36, 37 de raccordement étanche au tube 8 ou, le cas échéant, aux zones 23 et 3 1 des faces périphériques extérieures 19 et 27 des boucliers distal 17 et proximal 25, et en permettant ainsi un gonflage de l'ensemble du ballonnet 33 jusqu'au diamètre extérieur d j entre les deux boucliers 17 et 25 , c'est-à- dire sur la longueur \χ qui peut ainsi être pratiquement égale à la longueur 12 de l'endoprothèse 6.It will be observed that the fact of providing distal and proximal tubular extensions of the balloon makes it possible to bring the distal 17 and proximal 25 shields as close as possible to each other, that is to say to reduce the length lj to a value practically identical to the length 1 2 by transferring around the distal shields 17 and proximal shields 25 the transitions between the balloon 33 during inflation or in the inflated state and the zones 36, 37 of tight connection to the tube 8 or, where appropriate , in zones 23 and 3 1 of the outer peripheral faces 19 and 27 of the distal shields 17 and proximal 25, and thus allowing inflation of the whole of the balloon 33 to the outer diameter dj between the two shields 17 and 25, c 'i.e. the length \ χ which can thus be substantially equal to the length 1 2 of the stent 6.
On peut cependant prévoir d'autres dispositions dans la zone distale 14 du cathéter 8, comme le montrent les figures 2 et 8 à 10 auxquelles on se référera à présent.However, other arrangements can be made in the distal zone 14 of the catheter 8, as shown in FIGS. 2 and 8 to 10 which will now be referred to.
Ces figures illustrent le cas d'un cathéter 2 de type dit "coaxial", comportant de l'une à l'autre de ses extrémités proximale 3 et distale 4 trois canaux étanchéifiés mutuellement, à raison de deux canaux 43 , 44 d'arrivée de fluide de gonflage sous pression, en relation avec la présence de deux ballonnets gonflables dans cet exemple, et d'un canal 45 situé entre ces deux canaux 43 et 44 et logeant, dans une relation de guidage au coulissement relatif, un guide de dilatation 13 en tout point semblable au guide de dilatation illustré à la figure 1 si ce n'est qu'il parcourt ainsi le cathéter 2 de l'une à l'autre de ses extrémités proximale 3 et distale 4. Dans ce cas, le cathéter 2 est constitué d'un tube unique 46 en matériau étanche, muni à son extrémité proximale 3, d'un embout 47 comportant dans le prolongement direct du canal 45 un orifice non illustré de passage du guide 13 et latéralement deux raccords 87, 88 de liaison avec une source de fluide de gonflage sous pression ou en dépression de façon commandée, respectivement pour le canal 43 et pour le canal 44. Une telle structure est bien connue d'un Homme du métier et ne sera pas davantage détaillée.These figures illustrate the case of a catheter 2 of the so-called "coaxial" type, comprising from one to the other of its proximal 3 and distal 4 ends three mutually sealed channels, at the rate of two inlet channels 43, 44 of inflation fluid under pressure, in relation to the presence of two inflatable balloons in this example, and of a channel 45 situated between these two channels 43 and 44 and accommodating, in a relation of guidance to relative sliding, an expansion guide 13 at all points similar to the dilation guide illustrated in FIG. 1 except that it thus traverses the catheter 2 from one to the other of its proximal 3 and distal ends 4. In in this case, the catheter 2 consists of a single tube 46 made of impermeable material, provided at its proximal end 3, with a nozzle 47 comprising in the direct extension of the channel 45 an orifice not shown for passage of the guide 13 and laterally two fittings 87, 88 for connection with a source of inflation fluid under pressure or under vacuum in a controlled manner, respectively for channel 43 and for channel 44. Such a structure is well known to a person skilled in the art and will not be more detailed.
Par contre, on va décrire la structure du cathéter 2 dans sa zone distale 14 en se référant aux figures 9 à 1 1. On supposera également dans ce cas que, bien que le cathéter 2, avec les composants qu'il porte, puisse présenter une certaine flexibilité dans sa zone 14, il est rectiligne dans cette zone si bien que le tube 46 y présente une face périphérique extérieure 48 cylindrique de révolution autour d'un axe 55. A proximité immédiate de l'extrémité distale 4 du cathéter, cette face périphérique extérieure 48 est enveloppée étroitement par une paroi tubulaire souple, étanche, élastiquement extensible, définissant un ballonnet de prédilatation 49. Ce ballonnet est solidarisé de façon étanche avec la face périphérique extérieure 48 du tube 43, lui-même étanche, dans une zone annulaire 50 jouxtant directement l'extrémité distale 4, par exemple par collage ou soudure, ainsi que dans une zone annulaire 5 1 écartée de cette zone 40 et qui sera détaillée ultérieurement. Entre les zones 50 et 5 1 débouche à l'intérieur du ballonnet 49, par une lumière 52 ou toute autre forme de passage aménagé dans la face périphérique extérieure 48 du tube 46, le canal 44 qui permet d'introduire du fluide de gonflage sous pression à l'intérieur du ballonnet 49 et de provoquer ainsi le passage de celui-ci, d'un état dégonflé dans lequel il épouse étroitement la face périphérique extérieure 48 du tube 46 , en présentant extérieurement un diamètre ds égal à la somme du diamètre d ij de la face périphérique extérieure 48 du tube 46 et du double de l'épaisseur e j de sa paroi, au diamètre d4, constituant le diamètre extérieur de l'endoprothèse 6 à l'état expansé ou encore le diamètre intérieur de la paroi 38 du vaisseau à traiter, étant entendu que le ballonnet 49 peut présenter à l'état gonflé, lorsqu'il n'est pas engagé dans un vaisseau, un diamètre supérieur au diamètre d4. Un gonflage momentané du ballonnet 49 lorsqu'il se trouv e au niveau de la lésion 39 à traiter permet d'appliquer à celle-ci une prédilatation qui, après dégonflage de ce ballonnet 49, permettra d'y engager ensuite plus facilement un bouclier distal 53, qui va être décrit à présent, puis l'endoprothèse 6 avant expansion de celle-ci. La zone 51 du ballonnet 49 est constituée dans cet exemple par le bouclier distal 53, réalisé d'une pièce avec le ballonnet 49 ; plus précisément, la zone 51 est définie par l'extrémité distale d'une face périphérique intérieure 54 du bouclier distal 53, laquelle face 54 est cylindrique de révolution autour de l'axe 55 avec un diamètre sensiblement identique au diamètre d ^ et solidarisée de façon étanche avec la face périphérique extérieure 48 du tube 46 par tout moyen approprié tel que soudure ou collage.On the other hand, the structure of the catheter 2 in its distal zone 14 will be described with reference to FIGS. 9 to 1 1. It will also be assumed in this case that, although the catheter 2, with the components which it carries, may have a certain flexibility in its zone 14, it is rectilinear in this zone so that the tube 46 has there an external peripheral face 48 cylindrical of revolution around an axis 55. In the immediate vicinity of the distal end 4 of the catheter, this outer peripheral face 48 is tightly wrapped by a flexible, leaktight, elastically extensible tubular wall defining a pre-expansion balloon 49. This balloon is tightly secured to the outer peripheral face 48 of the tube 43, itself sealed, in an area annular 50 directly adjoining the distal end 4, for example by gluing or welding, as well as in an annular zone 5 1 spaced from this zone 40 and which will be detai later. Between zones 50 and 5 1 opens out inside the balloon 49, through a lumen 52 or any other form of passage arranged in the outer peripheral face 48 of the tube 46, the channel 44 which makes it possible to introduce inflation fluid under pressure inside the balloon 49 and thus causing the passage thereof, a deflated state in which it closely matches the outer peripheral face 48 of the tube 46, externally having a diameter ds equal to the sum of the diameter d ij of the outer peripheral face 48 of the tube 46 and twice the thickness e j of its wall, at the diameter d 4 , constituting the outside diameter of the endoprosthesis 6 in the expanded state or the inside diameter of the wall 38 of the vessel to be treated, it being understood that the balloon 49 may have, in the inflated state, when it is not engaged in a vessel, a diameter greater than the diameter d 4 . A momentary inflation of the balloon 49 when it is at the level of the lesion 39 to be treated makes it possible to apply a predilatation to it which, after deflation of this balloon 49, will then make it easier to engage a distal shield 53, which will now be described, then the endoprosthesis 6 before expansion thereof. The area 51 of the balloon 49 is constituted in this example by the distal shield 53, produced in one piece with the balloon 49; more precisely, the area 51 is defined by the distal end of an inner peripheral face 54 of the distal shield 53, which face 54 is cylindrical of revolution around the axis 55 with a diameter substantially identical to the diameter d ^ and secured to sealingly with the outer peripheral face 48 of the tube 46 by any suitable means such as welding or bonding.
Le bouclier distal 53 est, dans cet exemple comme dans celui des figures 5 à 7, plein et éventuellement légèrement compressible élastiquement entre sa face périphérique extérieure 54 et une face périphérique extérieure 55 qui, comme la face périphérique extérieure 19 du bouclier distal 17 décrit en référence aux figures 5 à 7, présente une forme générale de révolution, ici autour de l'axe 55, avec des diamètres décroissant respectivement vers l'extrémité distale 4 du cathéter 2 et vers l'extrémité proximale de celui-ci, à partir d'un diamètre maximal d9 qu'il présente le long d'un cercle 56. Ce diamètre extérieur maximal dg du bouclier distal 55 est au moins égal, et de préférence supérieur au diamètre d 2 défini comme le diamètre extérieur de l'endoprothèse 6 à l'état non expansé, et inférieur au diamètre intérieur d3 que l'endoprothèse 6 à l'état expansé.The distal shield 53 is, in this example as in that of FIGS. 5 to 7, solid and possibly slightly elastically compressible between its outer peripheral face 54 and an outer peripheral face 55 which, like the outer peripheral face 19 of the distal shield 17 described in with reference to FIGS. 5 to 7, presents a general form of revolution, here around the axis 55, with diameters decreasing respectively towards the distal end 4 of the catheter 2 and towards the proximal end of the latter, from d 'a maximum diameter d 9 which it presents along a circle 56. This maximum external diameter dg of the distal shield 55 is at least equal to, and preferably greater than the diameter d 2 defined as the external diameter of the endoprosthesis 6 in the unexpanded state, and less than the inside diameter d 3 than the stent 6 in the expanded state.
Plus précisément, respectivement vers l'extrémité distale 4 du cathéter 2 et vers l'extrémité proximale de celui-ci, respectivement de part et d'autre du cercle 56, la face périphérique extérieure 55 du bouclier distal 53 présente des zones 57, 58 convexes, arrondies et par exemple approximativement hémisphériques , définissant avec la face périphérique intérieure 54 du bouclier distal 53 des extrémités respectivement distale 59 et proximale 60 de celui-ci.More specifically, respectively towards the distal end 4 of the catheter 2 and towards the proximal end thereof, respectively on either side of the circle 56, the outer peripheral face 55 of the distal shield 53 has zones 57, 58 convex, rounded and for example approximately hemispherical, defining with the inner peripheral face 54 of the distal shield 53 respectively distal 59 and proximal 60 ends thereof.
L'extrémité distale 59 du bouclier distal 53 se raccorde directement, en une pièce, au ballonnet de dilatation 49 alors que l'extrémité proximale 60 de ce bouclier distal 53 se raccorde en une pièce avec un autre ballonnet gonflable situé à l'opposé du ballonnet de dilatation 49 par rapport au bouclier distal 53 et quant à lui destiné à assurer à l'état dégonflé la retenue de l'endoprothèse 6 à l'état non expansé et, par gonflage, l'expansion et l'implantation de cette endoprothèse 6 dans la zone 39 de la lésion à traiter.The distal end 59 of the distal shield 53 is connected directly, in one piece, to the dilatation balloon 49 while the proximal end 60 of this distal shield 53 is connected in one piece with another inflatable balloon located opposite the dilation balloon 49 relative to the distal shield 53 and for its part intended to ensure the retention deflated of the stent 6 in the unexpanded state and, by inflation, the expansion and implantation of this stent 6 in the area 39 of the lesion to be treated.
A cet effet, le ballonnet 61 se présente sous la forme d'une paroi souple, étanche, élastiquement extensible, épousant étroitement la face périphérique extérieure 48 du tube 46 à l'état dégonflé, illustré aux figures 9 et 11. Dans cet état dégonflé, la paroi définissant le ballonnet 61 présente une face périphérique extérieure cylindrique de révolution autour de l'axe 15 avec un diamètre uniforme sensiblement égal au diamètre intérieur d γ de l'endoprothèse 6 à l'état non expansé, ce qui correspond à la somme du diamètre d 13 et du double de l'épaisseur e2 de la paroi du ballonnet 61.To this end, the balloon 61 is in the form of a flexible, tight, elastically extensible wall, closely matching the external peripheral face 48 of the tube 46 in the deflated state, illustrated in FIGS. 9 and 11. In this deflated state , the wall defining the balloon 61 has a cylindrical outer peripheral face of revolution around the axis 15 with a uniform diameter substantially equal to the inside diameter d γ of the stent 6 in the unexpanded state, which corresponds to the sum of the diameter d 13 and twice the thickness e 2 of the wall of the balloon 61.
Le ballonnet 61 est solidarisé de façon étanche avec la face périphérique extérieure 48 du tube 46 par une extrémité distale 62, en pratique constituée par une zone d'extrémité proximale de la face périphérique intérieure 54 du bouclier distal 53, et par une extrémité proximale, annulaire 63, constituée par une zone d'extrémité distale d'une face périphérique intérieure 64 d'un bouclier proximal 65 réalisé dans cet exemple en une pièce avec le ballonnet 61 , le bouclier distal 53 et le ballonnet 49. Entre les extrémités distale 62 et proximale 63 du ballonnet 61 débouche dans la face périphérique extérieure 48 du tube 46 une lumière 66 ou toute autre forme de passage communiquant avec le canal 43 et permettant d'assurer le gonflage du ballonnet 61 par du fluide de gonflage sous pression introduit par l'intermédiaire du canal 43.The balloon 61 is tightly secured to the outer peripheral face 48 of the tube 46 by a distal end 62, in practice consisting of a zone of proximal end of the inner peripheral face 54 of the distal shield 53, and by a proximal end, annular 63, constituted by a distal end zone of an inner peripheral face 64 of a proximal shield 65 produced in this example in one piece with the balloon 61, the distal shield 53 and the balloon 49. Between the distal ends 62 and proximal 63 of the balloon 61 opens into the external peripheral face 48 of the tube 46 a lumen 66 or any other form of passage communicating with the channel 43 and making it possible to inflate the balloon 61 by inflation fluid under pressure introduced by the through channel 43.
Pour permettre à ce gonflage de s'effectuer jusqu'à un diamètre extérieur du ballonet 6 correspondant au diamètre intérieur d3 de l'endoprothèse 6, comme le montre la figure 10, dans toute la zone du ballonnet 61 portant l'endoprothèse 6, tout en assurant au ballonnet 61 un diamètre intérieur égal au diamètre d 13 à son raccordement avec les boucliers distal 53 et proximal 65, le ballonnet 61 présente dans cet exemple, entre ses extrémités distale 62 et proximale 63 , une longueur I 3 largement supérieure à la longueur 12 de l'endoprothèse 6 à l'état non expansé et l'endoprothèse 6 est disposée, à l 'état non expansé, centralement entre les boucliers distal 53 et proximal 65. On observera que la longueur I3 du ballonnet 61 correspond à l'espacement mutuel de ces boucliers.To allow this inflation to take place up to an outside diameter of the balloon 6 corresponding to the inside diameter d 3 of the stent 6, as shown in FIG. 10, throughout the area of the balloon 61 carrying the stent 6, while ensuring that the balloon 61 has an internal diameter equal to the diameter d 13 at its connection with the distal 53 and proximal shields 65, the balloon 61 has in this example, between its distal 62 and proximal 63 ends, a length I 3 considerably greater than the length 1 2 of the stent 6 in the unexpanded state and the stent 6 is arranged, in the unexpanded state, centrally between the distal shields 53 and proximal 65. It will be observed that the length I 3 of the balloon 61 corresponds to the mutual spacing of these shields.
Le bouclier proximal 65 est en tout point similaire au bouclier distal 53 auquel il est identique dans l'exemple illustré. Outre sa face périphérique intérieure 64, cylindrique de révolution autour de l'axe 55 avec un diamètre sensiblement égal au diamètre d 1 3 de la face périphérique extérieure 48 du tube 46, avec lequel il est solidarisé de façon étanche au niveau de cette face périphérique intérieure 64 par tout moyen tel qu'un collage ou une soudure, il présente une face périphérique extérieure 67 de révolution autour de l'axe 55 avec des diamètres qui décroissent progressivement respectivement vers l'extrémité distale 4 du cathéter et vers l'extrémité proximale de celui-ci, respectivement dans une zone 68 et dans une zone 69 de la face périphérique extérieure 67, à partir d'un diamètre extérieur maximal d 10 qui, dans cet exemple, est égal au diamètre d9 et respecte les mêmes conditions que celui-ci vis-à-vis des diamètres d 2 et d3 de l'endoprothèse 6. Dans cet exemple, les zones 68 et 69 définissent pour le bouclier proximal 65, plein entre ses faces périphériques intérieure 64 et extérieure 67, des extrémités distale 70 et proximale 71 convexes respectivement vers l'extrémité distale 4 du cathéter 2 et vers l'extrémité proximale de celui-ci, et plus précisément approximativement hémisphériques. Avantageusement, des moyens radio-opaques de marquage 72,The proximal shield 65 is in every way similar to the distal shield 53 to which it is identical in the example illustrated. In addition to its inner peripheral face 64, cylindrical of revolution about the axis 55 with a diameter substantially equal to the diameter d 1 3 of the outer peripheral face 48 of the tube 46, with which it is secured in leaktight manner at this peripheral face. inner 64 by any means such as bonding or welding, it has an outer peripheral face 67 of revolution about the axis 55 with diameters which decrease progressively respectively towards the distal end 4 of the catheter and towards the proximal end of the latter, respectively in a zone 68 and in a zone 69 of the external peripheral face 67, from a maximum external diameter d 10 which, in this example, is equal to the diameter d 9 and respects the same conditions as this vis-à-vis the diameters d 2 and d 3 of the stent 6. In this example, the zones 68 and 69 define for the proximal shield 65, full between its peri interior 64 and exterior 67 spheres, distal 70 and proximal 71 ends convex respectively towards the distal end 4 of the catheter 2 and towards the proximal end thereof, and more precisely approximately hemispherical. Advantageously, radio-opaque marking means 72,
73, occupant une position déterminée par rapport au ballonnet 61 et par conséquent par rapport à l'endoprothèse 6 qu'il porte, et par exemple situés respectivement à l'intérieur du bouclier distal 53 et à l'intérieur du bouclier proximal 65, permettent de localiser la zone 1 4 au fur et à mesure de la progression du cathéter 2 à l'intérieur d'un vaisseau.73, occupying a determined position with respect to the balloon 61 and consequently with respect to the stent 6 which it carries, and for example situated respectively inside the distal shield 53 and inside the proximal shield 65, allow to locate the zone 1 4 as the catheter 2 progresses inside a vessel.
Cette progression permet d'amener l'endoprothèse 6 à l'état non expansé, sur le ballonnet 61 non gonflé, jusqu'au niveau de la lésion 39 à traiter puis, en gonflant le ballonnet 61 , d'expanser l'endoprothèse 6 jusqu'à ce qu'elle présente intérieurement le diamètre d 3 , alors atteint extérieurement par le ballonnet 61 dans sa zone portant l'endoprothèse 6, et extérieurement le diamètre d4 selon lequel l'endoprothèse 6 s'appuie sur la paroi 38 du vaisseau, comme le montre la figure 10.This progression makes it possible to bring the stent 6 in the unexpanded state, on the uninflated balloon 61, to the level of the lesion 39 to be treated then, by inflating the balloon 61, to expand the stent 6 until 'that it internally has the diameter d 3 , then reached externally by the balloon 61 in its zone carrying the stent 6, and externally the diameter d 4 according to which the stent 6 rests on the wall 38 of the vessel, as shown in FIG. 10.
L'endoprothèse 6 étant ainsi implantée, et tendant à conserver la conformation obtenue du fait du caractère plastique de sa déformation d'expansion, on peut alors dégonfler le ballonnet 61 si bien qu'il présente à nouveau extérieurement le diamètre d ] et que le diamètre extérieur maximal de la zone 14 est défini par les diamètres d to et dg, inférieurs au diamètre d3 de l'endoprothèse 6. Alors, on peut faire traverser cette dernière notamment par le bouclier distal 53, par une traction appliquée à l'extrémité proximale 3 du cathéter 2, et extraire ainsi celui-ci du vaisseau sans risque d'entrainer en même temps l'endoprothèse 6, notamment grâce à la forme convexe de l'extrémité proximale 60 du bouclier distal 53. Dans cet exemple, le ballonnet 61 de transport et d'expansion de l'endoprothèse 6 est réalisé en une pièce avec les boucliers distal 53 et proximal 65, ainsi que le ballonnet de dilatation 49 ; on observera que ce dernier, qui présente un caractère facultatif, pourrait également être prévu sous forme indépendante du bouclier distal, notamment dans le cas du mode de mise en oeuvre de l'invention décrit en référence aux figures 1 et 4 à 7, cas dans lequel il pourrait être réalisé en une pièce avec le ballonnet 33 et ses extensions tubulaires 34 et 35.The endoprosthesis 6 being thus implanted, and tending to keep the conformation obtained due to the plastic nature of its expansion deformation, it is then possible to deflate the balloon 61 so that it again has the outside diameter d] and that the maximum outside diameter of the zone 14 is defined by the diameters d t o and dg, which are less than the diameter d 3 of the endoprosthesis 6. Then, the latter can be passed through in particular by the distal shield 53, by a traction applied to the the proximal end 3 of the catheter 2, and thus extract the latter from the vessel without the risk of entraining the endoprosthesis 6 at the same time, in particular by virtue of the convex shape of the proximal end 60 of the distal shield 53. In this example, the balloon 61 for transporting and expanding the stent 6 is made in one piece with the distal 53 and proximal 65 shields, as well as the dilation balloon 49; it will be observed that the latter, which is optional, could also be provided in an independent form of the distal shield, in particular in the case of the embodiment of the invention described with reference to FIGS. 1 and 4 to 7, case in which it could be made in one piece with the balloon 33 and its tubular extensions 34 and 35.
On peut cependant également prévoir de réaliser les boucliers distal et proximal en une pièce non pas avec le ballonnet de transport et d'expansion de l'endoprothèse 6, mais avec le cathéter lui-même et on a illustré un tel mode de mise en oeuvre de l'invention aux figures 3, 12 et 13.However, it is also possible to provide for the distal and proximal shields in one piece not with the transport and expansion balloon of the stent 6, but with the catheter itself and such an embodiment has been illustrated. of the invention in Figures 3, 12 and 13.
Ces figures illustrent en outre l'exemple d'un cathéter ne nécessitant pas de guide de dilatation coulissant et portant simplement de façon solidaire, à son extrémité distale 4, un guide de dilatation intégré, sous la forme d'un embout de guidage 74 le prolongeant à ce niveau, en porte-à-faux.These figures further illustrate the example of a catheter not requiring a sliding dilation guide and simply carrying integrally, at its distal end 4, an integrated dilation guide, in the form of a guide tip 74 the extending at this level, overhanging.
Dans un tel cas et en l'absence de ballonnet de dilatation analogue au ballonnet 49 de l'exemple décrit en référence aux figures 2 et 8 à 1 1, le cathéter 2 se présente sous la forme d'un tube unique 75, en matériau étanche, présentant de l'une à l'autre de ses extrémités proximale 3 et distale 4 un canal unique 76 de passage de fluide de gonflage sous pression. A proximité immédiate de l'extrémité proximale 3 du cathéter 2, le tube 75, en tout point comparable au tube proximal 7 décrit en référence à la figure 1, porte solidairement un embout identique à l'embout 9 et par conséquent désigné par la même référence, pour assurer le raccordement du canal 76 à une source de fluide de gonflage sous pression ou en dépression, de façon commandée.In such a case and in the absence of a dilation balloon similar to the balloon 49 of the example described with reference to FIGS. 2 and 8 to 11, the catheter 2 is in the form of a single tube 75, in sealed material, having from one to the other of its proximal 3 and distal 4 ends a single channel 76 for passage of inflation fluid under pressure. In the immediate vicinity of the proximal end 3 of the catheter 2, the tube 75, at any point comparable to the proximal tube 7 described with reference to FIG. 1, bears an end piece identical to the end piece 9 and therefore designated by the same reference, to ensure the connection of channel 76 to a source of inflation fluid under pressure or under vacuum, in a controlled manner.
Dans sa zone distale 14, directement adjacente à l'extrémité distale 4 du cathéter 2, le tube 75 présente une conformation qui va être décrite à présent en référence à la figure 13.In its distal zone 14, directly adjacent to the distal end 4 of the catheter 2, the tube 75 has a conformation which will now be described with reference to FIG. 13.
On observera en premier lieu qu'à l'extrémité distale 4 du cathéter 2, le tube 75 est obturé de façon étanche, par exemple par fusion localisée, autour de l'embout 74 qu'il retient ainsi. On observera également que l'on retrouve dans cet exemple, à l'identique, le ballonnet 33 et ses extensions tubulaires 34 et 35 jusqu'aux zones 36 et 37, tels qu'ils ont été décrits en référence à la figure 5, les zones 36 et 37 constituant dans cet exemple des zones annulaires de raccordement étanche des extensions tubulaires 34 et 35 , respectivement, avec une face périphérique extérieure 77 du tube 75. Si l'on suppose que la zone 14 est rectiligne, bien qu'elle soit flexible, cette face 77 est de façon courante cylindrique de révolution autour d'un axe 78 avec le diamètre d$ tel qu'il a été défini en relation avec l'exemple des figures 1 , 2, 5 à 7, à savoir entre l'extrémité distale 4 du cathéter 2 et un bouclier distal 79 en tout point identique, extérieurement, au bouclier distal 17, entre ce bouclier 79 et un bouclier proximal 80 quant à lui en tout point identique, extérieurement, au bouclier proximal 25, et de façon courante entre ce bouclier proximal 80 et l'extrémité proximale 3 du cathéter 2 si l'on suppose que celui-ci est dans une conformation rectiligne et présente de l'une à l'autre de ses extrémités proximale 3 et distale 4 une symétrie de révolution autour de l'axe 78.It will first be observed that at the distal end 4 of the catheter 2, the tube 75 is closed in a sealed manner, for example by localized fusion, around the end piece 74 which it thus retains. It will also be observed that in this example, identical, the balloon 33 and its tubular extensions 34 and 35 are found up to zones 36 and 37, as they have been described with reference to FIG. 5, the zones 36 and 37 constituting in this example annular zones of sealed connection of the tubular extensions 34 and 35, respectively, with an external peripheral face 77 of the tube 75. If it is assumed that zone 14 is rectilinear, although it is flexible, this face 77 is commonly cylindrical of revolution about an axis 78 with the diameter d $ as it has been defined in relation to the example of FIGS. 1, 2, 5 to 7, namely between the distal end 4 of the catheter 2 and a distal shield 79 at any point identical, externally, to the distal shield 17, between this shield 79 and a proximal shield 80 meanwhile at all point identical, externally, to the proximal shield 25, and common way between this proxim shield al 80 and the proximal end 3 of the catheter 2 if it is assumed that it is in a rectilinear conformation and has from one to the other of its proximal 3 and distal 4 ends a symmetry of revolution around the axis 78.
Compte tenu de l'identité des formes extérieures des boucliers distal 79 et proximal 80 avec celles des boucliers distal 17 et proximal 25, on retrouve à la figure 13, à l'identique, les parties des boucliers 17 et 25 désignés respectivement par les références numériques 19 à 24 et 27 à 32, les diamètres dg et d7l d i j et d12, la longueur li séparant mutuellement les deux boucliers, de même que l'on retrouve le mode de coopération, décrit en référence aux figures 5 à 7, du ballonnet 33, de ses extensions tubulaires 34 et 35 respectivement distale et proximale, avec l'endoprothèse 6 et avec les boucliers distal et proximal, ici 79 et 80, et avec le tube de cathéter, ici 75, entre eux, une lumière 81 étant aménagée entre ces deux boucliers, dans la face périphérique extérieure 77 ici cylindrique du tube 75, pour autoriser le passage de fluide de gonflage sous pression du canal 76 vers l'intérieur du ballonnet 33 et provoquer ainsi le gonflage de celui-ci. La lumière 81 pourrait être prévue en plusieurs exemplaires répartis angulairement autour de l'axe 78, ou être remplacée par tout autre moyen de passage tel qu'un orifice ou, de préférence, plusieurs orifices aménagés de façon répartie dans le tube 75 , entre les deux boucliers. Par contre, les deux boucliers 79 et 80 ne sont pas pleins, contrairement aux boucliers 17 et 25, mais définissent une cavité respective 82, 83 largement ouverte vers l'axe 78 et constituant en pratique un élargissement localisé du canal 76.Given the identity of the external shapes of the distal 79 and proximal 80 shields with those of the distal 17 and proximal 25 shields, we find in FIG. 13, identically, the parts of the shields 17 and 25 designated respectively by the references numeric 19 to 24 and 27 to 32, the diameters dg and d 7l dij and d 12 , the length li separating the two shields mutually, just as we find the mode of cooperation, described with reference to FIGS. 5 to 7, of the balloon 33, of its tubular extensions 34 and 35 respectively distal and proximal, with the stent 6 and with the distal and proximal shields, here 79 and 80, and with the catheter tube, here 75, between them, a lumen 81 being arranged between these two shields, in the outer peripheral face 77 here cylindrical of the tube 75, to allow the passage of inflation fluid under pressure from the channel 76 towards the inside of the balloon 33 and thus cause the inflation thereof. The light 81 could be provided in several copies distributed angularly around the axis 78, or be replaced by any other passage means such as an orifice or, preferably, several orifices arranged in a distributed manner in the tube 75, between the two shields. On the other hand, the two shields 79 and 80 are not full, unlike the shields 17 and 25, but define a respective cavity 82, 83 widely open towards the axis 78 and constituting in practice a localized widening of the channel 76.
En effet, les deux embouts 79 et 80 sont dans ce cas constitués par l'expansion radiale localisée d'une paroi 84 d'épaisseur e^, sensiblement constante, ce qui confère d'une grande simplicité à ce mode de mise en oeuvre de l'invention.Indeed, the two end pieces 79 and 80 are in this case constituted by the localized radial expansion of a wall 84 of thickness e ^, substantially constant, which gives great simplicity to this embodiment of the invention.
Naturellement, la position des moyens radio-opaques 41 , 42 de marquage ne peut pas être, dans ce cas, identique à celle qui a été décrite en référence aux figures 5 à 7 mais on peut néanmoins prévoir de tels moyens radio-opaques, par exemple sur la face périphérique extérieure 77 du tube 78, entre les boucliers distal 79 et proximal 80, respectivement à proximité immédiate de chacun d'entre eux, c'est-à-dire au niveau des extrémités distale 85 et proximale 86 du ballonnet 33. Un Homme du métier comprendra aisément que, si l'on excepte l'absence de guide de dilatation, le mode d'utilisation du dispositif selon l'invention illustré aux figures 3, 12, 13 est cn tout point identique à celui du dispositif illustré aux figures 1 et 4 à 7.Naturally, the position of the radiopaque means 41, 42 for marking cannot be, in this case, identical to that which has been described with reference to FIGS. 5 to 7, but it is nevertheless possible to provide such radiopaque means, by example on the outer peripheral face 77 of the tube 78, between the distal shields 79 and proximal shields 80, respectively in the immediate vicinity of each of them, that is to say at the level of the distal 85 and proximal 86 ends of the balloon 33 A person skilled in the art will easily understand that, except for the absence of a dilation guide, the mode of use of the device according to the invention illustrated in FIGS. 3, 12, 13 is in every respect identical to that of the device. illustrated in Figures 1 and 4 to 7.
Il est bien entendu, toutefois, que le dispositif illustré aux figures 3, 12, 13 pourrait également coopérer avec un guide de dilatation, selon une variante illustrée aux figures 14 à 16, de même que les conceptions de la zone distale 14 décrites en référence aux figures 1 , 4 à 7 et aux figures 2, 8 à 1 1 , respectivement, pourraient s'accommoder indifféremment d'une conception générale de type "monorail" ou de type "coaxial" du cathéter ou encore d'une absence de guide de dilatation 13, moyennant des adaptations qui relèvent des aptitudes normales d'un Homme du métier.It is understood, however, that the device illustrated in FIGS. 3, 12, 13 could also cooperate with an expansion guide, according to a variant illustrated in Figures 14 to 16, as well as the designs of the distal zone 14 described with reference to Figures 1, 4 to 7 and Figures 2, 8 to 1 1, respectively, could accommodate either general design of the "monorail" type or of the "coaxial" type of the catheter or else of the absence of a dilation guide 13, with adaptations which fall within the normal aptitudes of a person skilled in the art.
On retrouve à l'identique, et sous les mêmes références numériques, aux figures 14 à 16, l'ensemble des dispositions décrites à propos de la zone 14 en référence aux figures 3, 12 et 13, si ce n'est que l'embout de guidage 74 est absent et que, en vue de la réception d'un guide de dilatation 13 monté au coulissement à l'intérieur du cathéter 2, au moins dans la zone 14 de celui-ci, on a prévu des dispositions qui vont être décrites à présent. A l'intérieur du canal 76 de passage de fluide de gonflage, défini par le tube 78, est monté coaxialement ou approximativement coaxialement un tube également souple, étanche 89 présentant un diamètre extérieur, non référencé, inférieur au diamètre intérieur, également non référencé, du tube 78 de telle sorte qu'entre les deux tubes 89 et 78 subsiste une partie annulaire du canal 76, destinée au passage du fluide de gonflage.We find identically, and under the same reference numerals, in Figures 14 to 16, all of the arrangements described with respect to zone 14 with reference to Figures 3, 12 and 13, except that the guide tip 74 is absent and that, with a view to receiving a dilation guide 13 mounted for sliding inside the catheter 2, at least in the zone 14 thereof, provision has been made which will be described now. Inside the inflation fluid passage channel 76, defined by the tube 78, is mounted coaxially or approximately coaxially an equally flexible, leaktight tube 89 having an outside diameter, not referenced, less than the inside diameter, also not referenced, of the tube 78 so that between the two tubes 89 and 78 there remains an annular part of the channel 76, intended for the passage of the inflation fluid.
Le tube 89 s'étend ainsi sur la totalité de la zone distale 14 du cathéter 2, jusqu'à l'extrémité distale 4 de celui-ci, au niveau de laquelle il est solidarisé de façon étanche, par exemple par soudure ou collage, avec le tube 77, à l'intérieur de la zone 36, de façon à fermer de façon étanche le canal 76 à l'extrémité distale 4 du cathéter ; par contre, le tube 89 reste ouvert à cette extrémité distale 4 pour autoriser le passage du guide de dilatation 13, qui est en tout point identique à celui qui a été décrit en référence aux figures 1 à 1 1 et peut coulisser librement à l'intérieur d'un canal 90 que délimite intérieurement le tube 89. Vers l'extrémité proximale 3 du cathéter 2 et comme le montre la partie inférieure de la figure 14, le tube 89 peut s'étendre, coaxialement et conjointement avec le tube 75, jusqu'à cette extrémité proximale 3 au niveau de laquelle les tubes 75 et 89 sont munis d'un embout coaxial 91 assurant d'une part le guidage du guide de dilatation 13 au coulissement, dans le prolongement direct des tubes 75 et 89, et d'autre part le raccordement étanche du canal 76, situé entre les tubes 89 et 78, à une source de fluide de gonflage sous pression ou en dépression, de façon commandée, et ceci au moyen d'un raccord latéral 92 en tout point semblable aux raccords latéraux 87 et 88 de l'embout 47 du cathéter 2 illustré à la figure 2.The tube 89 thus extends over the whole of the distal zone 14 of the catheter 2, up to the distal end 4 of the latter, at the level of which it is secured in a sealed manner, for example by welding or gluing, with the tube 77, inside the zone 36, so as to seal the channel 76 at the distal end 4 of the catheter; on the other hand, the tube 89 remains open at this distal end 4 to allow the passage of the expansion guide 13, which is in all points identical to that which has been described with reference to FIGS. 1 to 1 1 and can slide freely with the inside a channel 90 which internally delimits the tube 89. Towards the proximal end 3 of the catheter 2 and as shown in the lower part of FIG. 14, the tube 89 can extend, coaxially and jointly with the tube 75, up to this proximal end 3 at the level of which the tubes 75 and 89 are provided with a coaxial tip 91 ensuring on the one hand the guidance of the expansion guide 13 in sliding, in direct extension of the tubes 75 and 89, and on the other hand the sealed connection of the channel 76, located between the tubes 89 and 78, to a source of inflation fluid under pressure or under vacuum, in a controlled manner, and this by means of a lateral connection 92 at any point similar to the lateral connections 87 and 88 of the tip 47 of the catheter 2 illustrated in FIG. 2.
Cependant, comme le^montre la partie supérieure de la figure 14, les deux tubes 75 et 89 peuvent ne s'étendre ainsi vers l'extrémité proximale 3 du cathéter 2 que sur une partie de la longueur de celui-ci, à partir de sa zone distale 14, à savoir jusqu'à une zone 93 en tout point comparable au raccord 10 du dispositif illustré à la figure 1. Dans cette zone 93, le tube 89 présente à l'extérieur du tube 75, vis-à-vis duquel il est étanchéifié à ce niveau afin de préserver l'étanchéité du canal 76 de passage de fluide de gonflage, un orifice non référencé de sortie du guide de dilatation 13. Entre la zone de raccordement 93 et l'extrémité proximale 3 du cathéter 2, le cathéter 2 est défini exclusivement par le tube 75 dont le canal 76 de passage de fluide de gonflage est alors en tout point identique à ce qui est illustré à la figure 12, et le tube 75 est muni à proximité immédiate de l'extrémité proximale 3 d'un embout 9, identique à celui qui a été décrit en référence à la figure 1 , pour assurer le raccordement du canal 76 à une source de fluide de gonflage sous pression ou en dépression, de façon commandée.However, as the ^ shows the upper part of FIG. 14, the two tubes 75 and 89 may thus extend towards the proximal end 3 of the catheter 2 only over part of the length of the latter, from its distal zone 14, namely up to a zone 93 at any point comparable to the connector 10 of the device illustrated in FIG. 1. In this zone 93, the tube 89 presents on the outside of the tube 75, opposite from which it is sealed at this level in order to preserve the leaktightness of the inflation fluid passage channel 76, an unreferenced orifice for exit from the dilation guide 13. Between the connection zone 93 and the proximal end 3 of the catheter 2 , the catheter 2 is defined exclusively by the tube 75 whose channel 76 for inflating fluid passage is then in all points identical to what is illustrated in FIG. 12, and the tube 75 is provided in the immediate vicinity of the end proximal 3 of a tip 9, identical to that which has has been described with reference to FIG. 1, to ensure the connection of the channel 76 to a source of inflation fluid under pressure or under vacuum, in a controlled manner.
On observera que le tube 89 peut être introduit dans le tube 77 et solidarisé à l'extrémité distale 4 de celui-ci et, le cas échéant, dans la zone de raccordement 93 après que l'on ait réalisé dans le tube 77 les boucliers distal 79 et proximal 80, par exemple par l'un ou l'autre des procédés de thermoformage décrits en préambule.It will be observed that the tube 89 can be introduced into the tube 77 and secured to the distal end 4 thereof and, if necessary, in the connection zone 93 after the shields have been made in the tube 77 distal 79 and proximal 80, for example by one or the other of the thermoforming methods described in the preamble.
On peut ainsi, par ce procédé particulièrement simple et économique, réaliser aussi bien des cathéters avec guide de dilatation intégré 74, comme le montre la figure 13, que des cathéters munis d'un guide de dilatation coulissant 13, soit de type dit "monorail", comme le montre la partie supérieure de la figure 14, soit de type "coaxial" comme le montre le partie inférieure de cette figure 14.It is thus possible, by this particularly simple and economical method, to produce both catheters with integrated dilation guide 74, as shown in FIG. 13, as well as catheters provided with a sliding dilation guide 13, either of the so-called "monorail" type. ", as shown in the upper part of FIG. 14, or of the" coaxial "type as shown in the lower part of this FIG. 14.
Un Homme du métier comprendra aisément que les trois modes de mise en oeuvre de l'invention qui viennent d'être décrits ne constituent que des exemples non limitatifs, par rapport auxquels on pourra prévoir de nombreuses variantes sans sortir pour autant du cadre de l'invention, notamment en combinant les dispositions qui viennent d'être décrites, dans la mesure de leur compatibilité.A person skilled in the art will readily understand that the three embodiments of the invention which have just been described constitute only non-limiting examples, with respect to which one may provide many variants without departing from the scope of the invention, in particular by combining the provisions which have just been described, to the extent of their compatibility.
Ces variantes pourront porter sur la structure mêm e du dispositif, de même qu'elles pourront porter sur ses dimensions.These variants may relate to the same structure of the device, just as they may relate to its dimensions.
A titre d'exemple non limitatif, pour un dispositif selon l'invention destiné au traitement d'une lésion sur une artère coronaire, dont le diamètre se situe généralement entre 2,0 à 4,0 voire 5,0 mm et pour une longueur de la lésion de l'ordre de quelques millimètres à quelques centimètres, on peut adopter les valeurs numériques suivantes :By way of nonlimiting example, for a device according to the invention intended for the treatment of a lesion on a coronary artery, the diameter of which is generally between 2.0 to 4.0 or even 5.0 mm and for a length of the lesion of the order of a few millimeters to a few centimeters, the following numerical values can be adopted:
- longueur 12 de l'endoprothèse 6 : de 5 à 40 mm- length 1 2 of the stent 6: from 5 to 40 mm
- cathéter-guide (non illustré) utilisé pour l'introduction dans l'artère :- guide catheter (not shown) used for introduction into the artery:
* diamètre extérieur : de 2,0 à 3,0 mm,* outer diameter: from 2.0 to 3.0 mm,
* diamètre intérieur : de 1 ,6 à 2,7 mm, - boucliers distal et proximal 17, 25, 53, 65, 79, 80 :* inner diameter: from 1.6 to 2.7 mm, - distal and proximal shields 17, 25, 53, 65, 79, 80:
* diamètre extérieur maximal dg, d7, dg, di o : de 1 à 2 mm,* maximum outside diameter dg, d 7 , dg, di o: from 1 to 2 mm,
* longueur I3 , U _ I5 , lg : de 5 à 20 mm,* length I 3 , U _ I 5 , lg: from 5 to 20 mm,
- diamètre du guide de dilatation 13 et du canal 12, 45, 90 destiné à le recevoir : de 0,3 à 0,5 mm, - ballonnet 33, 61 d'expansion de l'endoprothèse 6 :- diameter of the dilation guide 13 and of the channel 12, 45, 90 intended to receive it: from 0.3 to 0.5 mm, - balloon 33, 61 for expanding the stent 6:
* diamètre dj : de 0,5 à 1,5 mm,* diameter dj: from 0.5 to 1.5 mm,
* diamètre d3 : de 2,0 à 5 mm.* diameter d3: from 2.0 to 5 mm.
* longueur l j : de 10 à 40 mm, adaptée à la longueur 12 de l'endoprothèse 6.* length lj: from 10 to 40 mm, adapted to the length 1 2 of the stent 6.
Dans le cas d'un dispositif destiné au traitement d'une lésion dans une artère périphérique, dont le diamètre peut varier de quelques millimètres à plusieurs centimètres, ces chiffres seront adaptés sans difficulté par un Homme du métier.In the case of a device intended for the treatment of a lesion in a peripheral artery, the diameter of which can vary from a few millimeters to several centimeters, these figures will be adapted without difficulty by a person skilled in the art.
Naturellement, ces chiffres sont donnés exclusivement à titre d'exemple non limitatif. Naturally, these figures are given exclusively by way of nonlimiting example.

Claims

REVENDICATIONS
1. Dispositif d'implantation d'une endoprothèse vasculaire (6) de type expansible par ballonnet, ledit dispositif comportant :1. Device for implanting a stent (6) of the balloon expandable type, said device comprising:
- un cathéter (2) flexible, allongé, possédant une extrémité distale (4) et une extrémité proximale (3),- a flexible, elongated catheter (2) having a distal end (4) and a proximal end (3),
- un ballonnet gonflable (33, 61 ) solidaire du cathéter (2) et adjacent à l'extrémité distale (4) de celui-ci, le ballonnet (33, 61 ) possédant une extrémité distale (62, 85) et une extrémité proximale (63, 86) et présentant un premier diamètre extérieur (djj à l'état dégonflé et un deuxième diamètre extérieur (d3) à l'état gonflé,- an inflatable balloon (33, 61) integral with the catheter (2) and adjacent to the distal end (4) thereof, the balloon (33, 61) having a distal end (62, 85) and a proximal end (63, 86) and having a first external diameter (djj in the deflated state and a second external diameter (d 3 ) in the inflated state,
- un canal ( 1 1 , 43, 76) de transfert d'un fluide de gonflage du ballonnet ( 33, 61 ), le long du cathéter (2), entre une zone adjacente à l'extrémité proximale (3) du cathéter (2) et le ballonnet (33, 61 ),- a channel (11, 43, 76) for transferring an inflation fluid from the balloon (33, 61), along the catheter (2), between an area adjacent to the proximal end (3) of the catheter ( 2) and the balloon (33, 61),
- un bouclier distal ( 17, 53, 79) solidaire du cathéter (2) et adjacent à l'extrémité distale (62, 85) du ballonnet, ledit bouclier distal ( 15, 53, 79) présentant un diamètre extérieur décroissant progressivement vers l'extrémité distale (4) du cathéter (2), à partir d'un diamètre extérieur maximal (d u, dg) qui, dans des conditions normales d'utilisation, est intermédiaire entre lesdits premier et deuxième diamètres extérieurs (d j , d3) du ballonnet (33, 61),- a distal shield (17, 53, 79) integral with the catheter (2) and adjacent to the distal end (62, 85) of the balloon, said distal shield (15, 53, 79) having an outer diameter progressively decreasing towards the distal end (4) of the catheter (2), from a maximum external diameter (du, dg) which, under normal conditions of use, is intermediate between said first and second external diameters (dj, d 3 ) balloon (33, 61),
- un bouclier proximal (25, 65, 80) solidaire du cathéter (2) et adjacent à l'extrémité proximale (63, 86) du ballonnet (33, 61 ), ledit bouclier proximal (25, 65, 80) présentant un diamètre extérieur décroissant progressivement vers l'extrémité proximale (3) du cathéter (2), à partir d'un diamètre extérieur maximal (d 1 2 , d jo ) qui, dans des conditions normales d'utilisation, est intermédiaire entre lesdits premier et deuxième diamètres extérieurs (d1; d3) du ballonnet (33, 61), caractérisé en ce que les boucliers distal ( 15, 53 , 79) et proximal- a proximal shield (25, 65, 80) integral with the catheter (2) and adjacent to the proximal end (63, 86) of the balloon (33, 61), said proximal shield (25, 65, 80) having a diameter outside progressively decreasing towards the proximal end (3) of the catheter (2), from a maximum outside diameter (d 1 2 , d jo) which, under normal conditions of use, is intermediate between said first and second outer diameters (d 1; d 3 ) of the balloon (33, 61), characterized in that the distal (15, 53, 79) and proximal shields
(25, 65, 80) présentent un diamètre extérieur décroissant progressivement respectivement vers l'extrémité proximale (3 ) du cathéter ( 2 ) et vers l'extrémité distale (4) de celui-ci, à partir dudit diamètre extérieur maximal respectif (dn , dg , d12 , d10).(25, 65, 80) have an outer diameter progressively decreasing respectively towards the proximal end (3) of the catheter (2) and towards the distal end (4) thereof, from said respective maximum outside diameter (d n , dg, d 12 , d 10 ).
2. Dispositif selon la revendication 1, caractérisé en ce qu'il comporte une endoprothèse vasculaire ( 6) de type expansible par ballonnet, enveloppant à l'état non expansé le ballonnet (33, 61 ) à l'état dégonflé, entre les boucliers distal ( 15, 53, 79) et proximal (25, 65, 80), ladite endoprothèse (6) étant directement exposée vers l'extérieur, présentant à l'état non expansé un diamètre extérieur (d2 ) au plus égal auxdits diamètres extérieurs maximaux (d u , dg , d 12 , djo) des boucliers distal2. Device according to claim 1, characterized in that it comprises a stent (6) of type expandable by balloon, wrapping in the unexpanded state the balloon (33, 61) in the deflated state, between the distal (15, 53, 79) and proximal (25, 65, 80) shields, said endoprosthesis (6) being directly exposed towards the outside, having in the unexpanded state an outside diameter (d 2 ) at most equal to said maximum outside diameters (d u , dg, d 12 , djo) of the distal shields
( 15, 53, 79) et proximal (25, 65, 80) et étant susceptible de présenter à l'état expansé un diamètre intérieur (d3) supérieur audit diamètre extérieur maximal (dn, dg) du bouclier distal ( 17, 53, 79).(15, 53, 79) and proximal (25, 65, 80) and being capable of exhibiting in the expanded state an internal diameter (d 3 ) greater than said maximum external diameter (dn, dg) of the distal shield (17, 53 , 79).
3. Dispositif selon la revendication 1 , caractérisé en ce que lesdits diamètres extérieurs maximaux (d u , dg , d ι2 , dio) des boucliers distal3. Device according to claim 1, characterized in that said maximum external diameters (d u , dg, d ι 2 , dio) of the distal shields
( 17, 53, 79) et proximal (25, 65, 80) sont sensiblement égaux.(17, 53, 79) and proximal (25, 65, 80) are substantially equal.
4. Dispositf selon la revendication 1 , caractérisé en ce que le ballonnet (61 ) est intégralement situé entre l'extrémité proximale (60) du bouclier distal (53) et l'extrémité distale (70) du bouclier proximal (65). 4. Device according to claim 1, characterized in that the balloon (61) is integrally located between the proximal end (60) of the distal shield (53) and the distal end (70) of the proximal shield (65).
5. Dispositif selon la revendication 1, caractérisé en ce que le ballonnet (33) possède une extension tubulaire distale (34) enveloppant au moins l'extrémité proximale (21 ) du bouclier distal ( 17, 79).5. Device according to claim 1, characterized in that the balloon (33) has a distal tubular extension (34) enveloping at least the proximal end (21) of the distal shield (17, 79).
6. Dispositif selon la revendication 1 , caractérisé en ce que le ballonnet (33 ) possède une extension tubulaire proximale (35 ) enveloppant au moins l'extrémité distale (30) du bouclier proximal (25, 80).6. Device according to claim 1, characterized in that the balloon (33) has a proximal tubular extension (35) enveloping at least the distal end (30) of the proximal shield (25, 80).
7. Dispositif selon la revendication 1 , caractérisé en ce que le ballonnet (33 ) possède des extensions tubulaires distale (34) et proximale ( 35 ) enveloppant au moins l'extrémité proximale (21 ) du bouclier distal ( 17, 79) et l'extrémité distale (30) du bouclier proximal (25, 30), respectivement. 7. Device according to claim 1, characterized in that the balloon (33) has distal (34) and proximal (35) tubular extensions enveloping at least the proximal end (21) of the distal shield (17, 79) and l distal end (30) of the proximal shield (25, 30), respectively.
8. Dispositif selon l'une quelconque des revendications 5 et 7, caractérisé en ce que l'extension tubulaire distale (34) du ballonnet (33) enveloppe le bouclier distal ( 17, 79) jusqu'à son extrémité distale (20) en épousant étroitement le bouclier distal ( 17, 79), au moins sur son diamètre extérieur maximal (dg) et son extrémité distale (20), à l'état dégonflé du ballonnet (33).8. Device according to any one of claims 5 and 7, characterized in that the distal tubular extension (34) of the balloon (33) envelops the distal shield (17, 79) up to its distal end (20) in closely fitting the distal shield (17, 79), at least over its maximum outside diameter (dg) and its distal end (20), in the deflated state of the balloon (33).
9. Dispositif selon l'une quelconque des revendications 6 et 7, caractérisé en ce que l'extension tubulaire proximale (35 ) du ballonnet (33 ) enveloppe le bouclier proximal (25, 80) jusqu'à son extrémité proximale (32 ) en épousant étroitement le bouclier proximal (25, 80), au moins sur son diamètre extérieur maximal (d7) et son extrémité proximale ( 32), à l'état dégonflé du ballonnet (33).9. Device according to any one of claims 6 and 7, characterized in that the proximal tubular extension (35) of the balloon (33) envelops the proximal shield (25, 80) up to its proximal end (32) in closely fitting the proximal shield (25, 80), at least on its maximum outside diameter (d 7 ) and its proximal end (32), in the deflated state of the balloon (33).
10. Dispositif selon la revendication 1 , caractérisé en ce que le bouclier proximal (25, 65, 80) possède une extrémité distale (30, 70) convexe, arrondie.10. Device according to claim 1, characterized in that the proximal shield (25, 65, 80) has a distal end (30, 70) convex, rounded.
1 1. Dispositif selon la revendication 1 , caractérisé en ce que le bouclier distal ( 17, 55, 79) possède une extrémité proximale (21 , 60) convexe, arrondie.1 1. Device according to claim 1, characterized in that the distal shield (17, 55, 79) has a proximal end (21, 60) convex, rounded.
12. Dispositif selon la revendication 1 , caractérisé en ce que le bouclier proximal (65) possède une extrémité proximale (71) convexe, arrondie.12. Device according to claim 1, characterized in that the proximal shield (65) has a convex, rounded proximal end (71).
13. Dispositif selon la revendication 1 , caractérisé en ce que le bouclier proximal (25, 80) possède une extrémité proximale (32) convexe, sensiblement tronconique.13. Device according to claim 1, characterized in that the proximal shield (25, 80) has a proximal end (32) convex, substantially frustoconical.
14. Dispositif selon la revendication 1 , caractérisé en ce que le bouclier distal ( 17, 79) possède une extrémité distale (20) convexe, sensiblement tronconique.14. Device according to claim 1, characterized in that the distal shield (17, 79) has a distal end (20) convex, substantially frustoconical.
15. Dispositif selon la revendication 1, caractérisé en ce que le bouclier distal (53) possède une extrémité distale (59) convexe, arrondie.15. Device according to claim 1, characterized in that the distal shield (53) has a distal end (59) convex, rounded.
16. Dispositif selon la revendication 1 , caractérisé en ce qu'il comporte : - un ballonnet gonflable auxiliaire (49) solidaire du cathéter (2) et disposé entre le bouclier distal (53 ) et l'extrémité distale (4) du cathéter (2), le ballonnet auxiliaire (49) présentant des troisième et quatrième diamètres extérieurs (d8, d4), respectivement à l'état dégonflé et à l'état gonflé, respectivement inférieur et au moins égal audit diamètre extérieur maximal (dg) du bouclier distal,16. Device according to claim 1, characterized in that it comprises: - an auxiliary inflatable balloon (49) integral with the catheter (2) and disposed between the distal shield (53) and the distal end (4) of the catheter ( 2), the auxiliary balloon (49) having third and fourth outer diameters (d 8 , d 4 ), respectively in the deflated state and in the inflated state, respectively less and at least equal to said maximum outer diameter (dg) of the distal shield,
- un canal auxiliaire (44) de transfert d'un fluide de gonflage du ballonnet auxiliaire (49), le long du cathéter (2), entre une zone adjacente à l'extrémité proximale (3) du cathéter (2) et le ballonnet auxiliaire (49).- an auxiliary channel (44) for transferring an inflation fluid from the auxiliary balloon (49), along the catheter (2), between an area adjacent to the proximal end (3) of the catheter (2) and the balloon auxiliary (49).
17. Dispositif selon la revendication 1 , caractérisé en ce que le cathéter (2) comporte un canal ( 12, 45) de réception d'un guide de dilatation coulissant17. Device according to claim 1, characterized in that the catheter (2) comprises a channel (12, 45) for receiving a sliding expansion guide
( 13), au moins du bouclier proximal (25, 65, 80) à l'extrémité distale (4) du cathéter (2).(13), at least from the proximal shield (25, 65, 80) to the distal end (4) of the catheter (2).
18. Dispositif selon la revendication 1, caractérisé en ce que le cathéter comporte un embout de guidage (74), solidaire du cathéter (2) et prolongeant celui-ci à son extrémité distale (4), en formant un guide de dilatation intégré.18. Device according to claim 1, characterized in that the catheter comprises a guide tip (74), integral with the catheter (2) and extending it at its distal end (4), forming an integrated expansion guide.
19. Dispositif selon la revendication 1 , caractérisé en ce que l'un, au moins, des boucliers proximal (80) et distal (79) possède une paroi (84) définissant son diamètre extérieur (dg, d7) et délimitant une cavité (82, 83) vers le cathéter (2).19. Device according to claim 1, characterized in that at least one of the proximal (80) and distal (79) shields has a wall (84) defining its outside diameter (dg, d 7 ) and delimiting a cavity (82, 83) to the catheter (2).
20. Dispositif selon la revendication 1 , caractérisé en ce que l'un, au moins, des boucliers proximal (25, 65) et distal ( 17, 53) est plein entre son diamètre extérieur (dg, d7 dg, dio) et le cathéter (2). 20. Device according to claim 1, characterized in that at least one of the proximal (25, 65) and distal (17, 53) shields is full between its outside diameter (dg, d 7 dg, dio) and the catheter (2).
21. Dispositif selon la revendication 1 , caractérisé en ce que l'un, au moins, des boucliers proximal ( 80) et distal (79) est réalisé en une pièce avec le cathéter (2).21. Device according to claim 1, characterized in that at least one of the proximal (80) and distal (79) shields is made in one piece with the catheter (2).
22. Dispositif selon la revendication 1 , caractérisé en ce que l'un, au moins, des boucliers proximal (65) et distal (53) est réalisé en une pièce avec le ballonnet (61 ).22. Device according to claim 1, characterized in that at least one of the proximal (65) and distal (53) shields is produced in one piece with the balloon (61).
23. Dispositif selon la revendication 1 , caractérisé en ce que l'un, au moins, des boucliers proximal (25, 65, 80) et distal ( 17, 53 , 79) est sensiblement incompressible dans des conditions normales d'utilisation.23. Device according to claim 1, characterized in that at least one of the proximal (25, 65, 80) and distal (17, 53, 79) shields is substantially incompressible under normal conditions of use.
24. Dispositif selon la revendication 1 , caractérisé en ce que l'un, au moins, des boucliers proximal (25, 65, 80) et distal ( 17, 53, 79) est élastiquement compressible en conservant un diamètre extérieur maximal (d 1 1 ; dg^^, d 10) supérieur au premier diamètre extérieur (d jj du ballonnet (33, 61 ) dans des conditions normales d'utilisation.24. Device according to claim 1, characterized in that at least one of the proximal (25, 65, 80) and distal (17, 53, 79) shields is elastically compressible while retaining a maximum outside diameter (d 1 1; dg ^^, d 10 ) greater than the first outer diameter (d dj of the balloon (33, 61) under normal conditions of use.
25. Dispositif selon la revendication 2, caractérisé en ce que l'un, au moins, des boucliers proximal (25, 65, 80) et distal ( 17, 53, 79) est élastiquement compressible en conservant un diamètre extérieur maximal (d 1 1 ) dgι d12, d 10) au moins égal au diamètre extérieur (d2 ) de l'endoprothèse (6) à l'état non expansé.25. Device according to claim 2, characterized in that at least one of the proximal (25, 65, 80) and distal (17, 53, 79) shields is elastically compressible while retaining a maximum outside diameter (d 1 1) dg ι d 12 , d 10 ) at least equal to the outside diameter (d 2 ) of the stent (6) in the unexpanded state.
26. Dispositif selon la revendication 1 , caractérisé en ce qu'il comporte des moyens de marquage radio-opaques (41 , 42) occupant une position déterminée par rapport aux extrémités distale (62, 85 ) et proximale (63, 86) du ballonnet (33, 61 ). 26. Device according to claim 1, characterized in that it comprises radiopaque marking means (41, 42) occupying a determined position relative to the distal (62, 85) and proximal (63, 86) ends of the balloon (33, 61).
PCT/FR1996/001986 1995-12-11 1996-12-11 Device for implanting a vascular endoprosthesis WO1997021400A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR95/14634 1995-12-11
FR9514634 1995-12-11

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WO1997021400A1 true WO1997021400A1 (en) 1997-06-19

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Publication number Priority date Publication date Assignee Title
EP1000591A3 (en) * 1998-11-16 2000-06-07 Cordis Corporation Balloon catheter and stent delivery system having enhanced stent retention
WO2000074597A1 (en) * 1999-06-07 2000-12-14 Scimed Life Systems, Inc. Radiopaque marker bands
WO2000078249A1 (en) * 1999-06-17 2000-12-28 Scimed Life Systems, Inc. Stent securement by balloon modification
EP1132059A1 (en) * 2000-03-07 2001-09-12 Cordis Corporation Balloon catheter with balloon shoulders
US6289568B1 (en) 1998-11-16 2001-09-18 Cordis Corporation Method for making a balloon catheter stent deployment system
US6293959B1 (en) 1998-11-16 2001-09-25 Cordis Corporation Balloon catheter and stent delivery system having enhanced stent retention and method
WO2001070134A2 (en) * 2000-03-17 2001-09-27 Advanced Cardiovascular Systems, Inc. Stent delivery catheter with bumpers for improved retention of balloon expandable stents
US6464718B1 (en) 1998-11-16 2002-10-15 Cordis Corporation Balloon catheter for stent delivery having microchannels and method
WO2003000332A1 (en) * 2001-06-25 2003-01-03 Cube Medical A/S Balloon catheter
US6942681B2 (en) 2001-02-16 2005-09-13 Cordis Corporation Method of balloon catheter stent delivery system with ridges
EP1772116A3 (en) * 2005-10-06 2007-10-17 Cordis Corporation Stent delivery system using a steerable guide wire.
WO2008063261A1 (en) * 2006-11-20 2008-05-29 Boston Scientific Limited Semi rigid edge protection design for stent delivery system
US7572270B2 (en) 2001-02-16 2009-08-11 Cordis Corporation Balloon catheter stent delivery system with ridges
CN110101959A (en) * 2019-05-09 2019-08-09 宜昌市中心人民医院 Thrombolysis foley's tube preparation method
US10463519B2 (en) 2014-04-09 2019-11-05 Cook Medical Technologies Llc Delivery system for implantable medical device

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Cited By (20)

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Publication number Priority date Publication date Assignee Title
US6289568B1 (en) 1998-11-16 2001-09-18 Cordis Corporation Method for making a balloon catheter stent deployment system
US6293959B1 (en) 1998-11-16 2001-09-25 Cordis Corporation Balloon catheter and stent delivery system having enhanced stent retention and method
US6464718B1 (en) 1998-11-16 2002-10-15 Cordis Corporation Balloon catheter for stent delivery having microchannels and method
EP1000591A3 (en) * 1998-11-16 2000-06-07 Cordis Corporation Balloon catheter and stent delivery system having enhanced stent retention
WO2000074597A1 (en) * 1999-06-07 2000-12-14 Scimed Life Systems, Inc. Radiopaque marker bands
WO2000078249A1 (en) * 1999-06-17 2000-12-28 Scimed Life Systems, Inc. Stent securement by balloon modification
US6280412B1 (en) 1999-06-17 2001-08-28 Scimed Life Systems, Inc. Stent securement by balloon modification
EP1132059A1 (en) * 2000-03-07 2001-09-12 Cordis Corporation Balloon catheter with balloon shoulders
WO2001070134A2 (en) * 2000-03-17 2001-09-27 Advanced Cardiovascular Systems, Inc. Stent delivery catheter with bumpers for improved retention of balloon expandable stents
WO2001070134A3 (en) * 2000-03-17 2002-06-20 Advanced Cardiovascular System Stent delivery catheter with bumpers for improved retention of balloon expandable stents
US7572270B2 (en) 2001-02-16 2009-08-11 Cordis Corporation Balloon catheter stent delivery system with ridges
US6942681B2 (en) 2001-02-16 2005-09-13 Cordis Corporation Method of balloon catheter stent delivery system with ridges
WO2003000332A1 (en) * 2001-06-25 2003-01-03 Cube Medical A/S Balloon catheter
EP1772116A3 (en) * 2005-10-06 2007-10-17 Cordis Corporation Stent delivery system using a steerable guide wire.
US9254211B2 (en) 2005-10-06 2016-02-09 Cordis Corporation Stent delivery system using a steerable guide wire
WO2008063261A1 (en) * 2006-11-20 2008-05-29 Boston Scientific Limited Semi rigid edge protection design for stent delivery system
US8795346B2 (en) 2006-11-20 2014-08-05 Boston Scientific Scimed, Inc. Semi rigid edge protection design for stent delivery system
US10463519B2 (en) 2014-04-09 2019-11-05 Cook Medical Technologies Llc Delivery system for implantable medical device
CN110101959A (en) * 2019-05-09 2019-08-09 宜昌市中心人民医院 Thrombolysis foley's tube preparation method
CN110101959B (en) * 2019-05-09 2021-03-30 宜昌市中心人民医院 Method for preparing thrombolytic balloon catheter

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