WO2014184489A1 - Endovascular surgery device - Google Patents

Endovascular surgery device Download PDF

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Publication number
WO2014184489A1
WO2014184489A1 PCT/FR2014/051114 FR2014051114W WO2014184489A1 WO 2014184489 A1 WO2014184489 A1 WO 2014184489A1 FR 2014051114 W FR2014051114 W FR 2014051114W WO 2014184489 A1 WO2014184489 A1 WO 2014184489A1
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WO
WIPO (PCT)
Prior art keywords
balloon
catheter
clot
orifice
radial
Prior art date
Application number
PCT/FR2014/051114
Other languages
French (fr)
Inventor
Antonino MACHI
Original Assignee
Machi Antonino
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 Machi Antonino filed Critical Machi Antonino
Publication of WO2014184489A1 publication Critical patent/WO2014184489A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B17/22032Gripping instruments, e.g. forceps, for removing or smashing calculi having inflatable gripping elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/12036Type of occlusion partial occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22034Gripping instruments, e.g. forceps, for removing or smashing calculi for gripping the obstruction or the tissue part from inside
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M2025/0042Microcatheters, cannula or the like having outside diameters around 1 mm or less
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1095Balloon catheters with special features or adapted for special applications with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1097Balloon catheters with special features or adapted for special applications with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon

Definitions

  • the present invention relates to a device for endovascular surgery. It is particularly applicable to the field of vascular surgery, interventional neuroradiology, interventional radiology, interventional cardiology, endovascular neurosurgery, endovascular surgery, mechanical thrombectomy, endovascular thrombectomy, and thrombus extraction including endovascular.
  • angioplasty, thrombectomy consist of a deflated angioplasty balloon mounted on a microcatheter.
  • the micro catheter is introduced into the blood vessel with a thrombus so as to place the balloon deflated facing the thrombus.
  • the balloon is then inflated with a liquid introduced into the microcatheter, so as to crush the thrombus against the wall of the blood vessel to restore blood flow into the blood vessel.
  • the system for treating arterial thrombosis comprises a helical wire which, when compressed on its longitudinal axis, deploys until touching the walls of the blood vessel and forming a blood clot trap displaced along a blood vessel so as to capture the blood clot upon removal from the system. If these systems can recover the main blood clot, they do not prevent blood clots from roaming freely the body, which can lead to a thromboembolic complication. In any case, this type of device is no longer used today because of the low rate of effectiveness and arterial recanalisation and the high rate of complication related to its use.
  • an extractor stent consisting of a metal frame bent around an axis is deployed so that the outer armature matches the contours of the treated blood vessel. Then, in a second step, the expanded stent is pulled to the opening through which the catheter has been inserted to capture an arterial thrombus placed against a wall of the blood vessel.
  • these systems are dangerous to use in the case where the thrombosis includes a calcified portion under a soft part, also called plaque thrombosis. Indeed, the tearing that can cause tearing of the calcified part can lead to arterial tearing.
  • an extractor stent can not always be used to perform thrombus extraction. In addition, the surgeon has no control over the interaction between the device and the thrombus.
  • the current balloon assisted remodeling in French
  • systems consist in deploying a catheter opposite an aneurysm, causing the expansion a balloon mounted on the catheter and introducing a secondary catheter into the aneurysm along the inflated balloon.
  • Such systems have the advantage of supporting the embolization material deployed inside the aneurysmal pocket, however they have the disadvantage of blocking the passage of fluids in the blood vessel when the balloon is inflated, which can be the cause of cerebral ischemia.
  • the present invention aims to remedy all or part of these disadvantages.
  • the present invention relates to an endovascular surgical device, which comprises:
  • a catheter comprising a conduit configured to conduct at least one fluid, a balloon whose internal volume is connected to a conduit of the catheter and configured to be inflated or deflated according to the pressure of the fluid in the catheter duct,
  • the balloon is provided with at least one radial orifice surrounded by a wall to fragment at least a portion of the clot, each said radial orifice receiving at least a fragmented portion of the clot during the swelling of the balloon and retaining at least a fragmented portion of the clot during deflation, at least partially, of the balloon.
  • the presence of at least one radial port captures a portion of the blood clot upon deflation of the balloon, wherein the portion of the blood clot is subsequently extracted with the catheter of the treated blood vessel.
  • the risk of damage to the blood vessel is reduced, both when the device is placed in position opposite the endovascular clot and when the balloon is deployed.
  • the force to be applied is reduced because it is a fluid that conveys the pressure in the balloon.
  • it is possible to treat thrombosis with a calcified portion by eliminating the risks associated with tearing thrombosis due to the expandable material of the balloon on the one hand, and the capture of the thrombosis by swelling and deflating.
  • the present invention allows, beyond compression of the thrombus and reopening of the blood vessel, to capture some or all of the thrombus that has been the cause of endovascular occlusion by improving the hemodynamics of the treated vessel and reducing the risk of embolic migration that can cause a thromboembolic complication.
  • At least one balloon port is a blind radial port.
  • the balloon forms an at least partially inflated hollow volume, at least one balloon port passing through the balloon to connect the hollow volume to the exterior of the balloon.
  • the device object of the present invention comprises an axial orifice passing through the balloon to allow the passage of a blood flow.
  • the device of the present invention comprises means for retaining a blood clot in the hollow volume of the balloon when the balloon is inflated, the hollow volume being at least partially formed by the axial orifice.
  • the retention means is a mesh obstructing at least one end of the axial orifice.
  • the retention means is a diaphragm positioned on at least one end of the axial orifice.
  • At least one balloon port is an orifice configured to pass a secondary catheter when the balloon is inflated.
  • the balloon is connected to the catheter at the periphery of the balloon.
  • the balloon has an axial orifice, to allow an optimal size of the light of the axial orifice.
  • the balloon is connected to the catheter at the balloon axis.
  • At least one wall between two radial orifices has an outwardly convex shape of the balloon so as to fragment a clot upon inflation of the balloon.
  • FIG. 1 represents, schematically and in perspective, a first particular embodiment of the device that is the subject of the present invention
  • FIG. 2 represents, schematically and in perspective, a second particular embodiment of the device that is the subject of the present invention
  • FIG. 3 represents, schematically and in perspective, a third particular embodiment of the device that is the subject of the present invention.
  • FIG. 4 represents, schematically and in perspective, a fourth particular embodiment of the device that is the subject of the present invention.
  • FIG. 5 represents, schematically and in section, a first view of a seventh particular embodiment of the device that is the subject of the present invention
  • FIG. 6 represents, schematically and in section, a second view of the seventh particular embodiment of the device that is the subject of the present invention.
  • FIG. 7 represents, schematically and in section, a third view of the seventh particular embodiment of the device that is the subject of the present invention
  • FIG. 8 represents, schematically and in section, a fourth view of the seventh particular embodiment of the device that is the subject of the present invention
  • FIG. 9 represents, schematically and in section, a fifth view of the seventh particular embodiment of the device that is the subject of the present invention.
  • FIG. 10 represents, in the form of a logic diagram, steps of a particular embodiment of a method of endovascular surgery
  • FIG. 11 represents, schematically and in section, a fifth particular embodiment of the device that is the subject of the present invention.
  • FIG. 12 represents, in the form of a logic diagram, steps of a particular embodiment of a method of treating an aneurysm.
  • ifice is used both for a cavity in a surface and a gap between reliefs placed on a surface.
  • FIG. 1 shows a particular embodiment of the device 10 which is the subject of the present invention.
  • This device 10 comprises:
  • a catheter 105 comprising a conduit 1 10 and
  • a balloon 1 comprising at least one radial orifice 125.
  • the conduit 1 10 is configured to conduct at least one fluid, for example a liquid pushed by a syringe, not shown.
  • This conduit 10 is supported by the catheter 105 and the conduit 1 is connected to the balloon 1 on the periphery of the balloon 1 15.
  • the balloon 1 is made of a plastic and elastic material, for example.
  • This balloon 1 comprises at least one radial orifice 125 opening on an outer face of the balloon 1 15.
  • the inner volume of the balloon 1 15 is connected to the conduit 1 10 of the catheter 105 and this balloon 1 15 is configured to be inflated or deflated in This is a function of the fluid pressure in the catheter conduit 105. As the fluid pressure increases, the balloon 1 inflates. Conversely, as the fluid pressure decreases, the balloon 1 deflates.
  • the pressure of the fluid is controlled by the implementation of a syringe with a needle connected to the conduit 1 10.
  • a syringe By pushing a piston of the syringe, the The volume containing the fluid decreases and the fluid pressure increases and the balloon 1 inflates.
  • the plunger of the syringe By pulling the plunger of the syringe, the fluid pressure decreases and the balloon 1 deflates.
  • the balloon 1 forms a hollow volume once at least partially inflated, at least one port 125 of the balloon 1 passing through the balloon 1 to connect the hollow volume to the outside of the balloon 1 15.
  • the radial orifice 125 is configured to allow the passage of a secondary catheter.
  • this radial orifice 125 is configured to receive at least a portion of a clot during swelling of the balloon 1 and to retain at least a portion of the clot during the at least partial deflation of the balloon 1 15.
  • the radial orifice 125 comprises, for example, a honeycomb structure partially obstructing the passage between the two longitudinal ends of the balloon 1 15.
  • some radial orifices 125 are blind, that is to say that radial orifices 125 have only one opening on the outside of the balloon 1 15.
  • At least one orifice 125 is surrounded by a wall 1 to fragment at least a portion 120 of the clot when the balloon 1 is inflated and the wall 120 is pressed against the blood clot adhered to a wall of an artery of a user.
  • At least one wall 120 between two radial orifices 125 has an outwardly convex shape of the balloon so as to fragment a clot during inflation of the balloon.
  • an axial section of the balloon 1 has triangular-shaped walls 120 facing outwardly of the balloon 1, so as to fragment the blood clot by means of a tip of at least one triangle and to retain the fragment through at the flat part of said triangle.
  • the common walls 120 surrounding at least two ports are oriented toward each other to decrease the pressure surface, between the walls 120, exerted during balloon inflation.
  • These orifices 125 are configured to receive at least a portion of a blood clot upon inflation of the balloon 1 and to retain at least a portion of the clot upon the at least partial deflation of the balloon 1 15.
  • the balloon 1 is configured to be inflated to a diameter similar to the diameter of the blood vessel in which the device 10 is positioned.
  • the opening 125 of the orifices 125 tear the blood clot fixed to the wall of the treated blood vessel and receive pieces of the clot in the radial orifices 125.
  • the pieces received by the radial orifices 125 are retained in the radial orifices 125. They are then extracted from the blood vessel to be treated by removal of the catheter 105 carrying the balloon 1 15.
  • the walls of the radial ports 125 are configured to facilitate retention of a blood clot.
  • the wall of an orifice 125 comprises, for example, spikes whose tips are oriented in a direction opposite to the opening of said orifice 125. In this way, the spikes do not interfere with the entry of a blood clot into the opening. 125 but allow to retain the blood clot more effectively in the orifice 125.
  • the balloon 1 has a balloon stretch resistance gradient 1 15 so that the center of the balloon 1 stretches more than the ends of this balloon 1 when the balloon 1 15 is inflated.
  • FIG. 2 shows a second particular embodiment of the device 20 of the present invention.
  • This device 20 is similar to the device 10 described in FIG. In this configuration, the conduit 210 is connected to the balloon 215 at the center of the balloon 215 when it is deployed.
  • FIG. 3 shows a third particular embodiment of the device 30 of the present invention.
  • This device 30 is similar to the device 10 described in FIG.
  • This device 30 comprises, in addition to the catheter 305, the conduit 310, the balloon 315 and the radial orifices 325, an axial orifice 320 configured to allow the passage of a secondary catheter.
  • this axial orifice 320 is configured to receive at least a portion of a clot during swelling of the balloon 315 and to retain at least a portion of the clot during deflation, at least partially, of the balloon 315.
  • the axial orifice 320 comprises, for example, a cellular structure partially obstructing the passage between the two longitudinal ends of the balloon 315.
  • the radial orifices 325 are not blind and communicate with the axial orifice 320.
  • the blood clot pieces are received and retained by the axial aperture 320.
  • the pieces of blood clot enter the axial orifice 320 through the openings at the longitudinal ends of the balloon 315 or the radial openings 325.
  • FIG. 4 shows a fourth particular embodiment of the device 40 which is the subject of the present invention.
  • This device 40 is similar to the device 30 described in FIG. 2.
  • This device 40 comprises:
  • a catheter 405 comprising a duct 410
  • a balloon 415 comprising a plurality of radial orifices 425 and an axial orifice 420.
  • the duct 410 is connected to the balloon 415 at the axis of the balloon 415.
  • this duct 410 is connected to the balloon 415 by eight secondary ducts 430 four of which at each longitudinal opening of the balloon 415
  • this device 40 has a number of ducts greater than eight, so as to form a mesh in the 420 axial orifice. This mesh allows a better retention of blood clots that are received in the mesh.
  • the balloon 315 forms a hollow volume when this balloon 315 is inflated.
  • This hollow volume is at least partially formed by the axial orifice 320 to allow the passage of a blood flow.
  • the device 40 comprises a means 430 for retaining a blood clot in a hollow volume of the balloon 415 when the balloon is inflated, the hollow volume being at least partially formed by the axial orifice 420.
  • This retention means 430 is, for example, a mesh obstructing at least one end of the axial orifice or a diaphragm positioned on at least one end of the axial orifice (420).
  • FIGS. 5 to 9 show a fifth particular embodiment of the device 60 which is the subject of the present invention.
  • FIG. 5 shows a blood vessel 610 and a blood clot 605 bonded to the wall 610 of the blood vessel.
  • FIG. 6 shows a fifth particular embodiment of the device 60 which is the subject of the present invention.
  • This device 60 comprises:
  • a catheter 615 comprising a conduit 620
  • a deflated balloon 625 comprising a plurality of radial orifices.
  • the conduit 620 is configured to conduct at least one fluid.
  • This conduit 620 is supported by the catheter 625 and the conduit 620 is connected to the balloon 625 on the periphery of the balloon 625.
  • the balloon 625 is made of a shape memory elastic material, for example.
  • This balloon 625 has a plurality of blind radial ports having an opening on the outside of the balloon 625.
  • the inner volume of the balloon 625 is connected to the conduit 620 of the catheter 625 and this balloon 625 is configured to be inflated or deflated according to the fluid pressure in the conduit 620 of the catheter 625.
  • the balloon 625 inflates and, conversely, as the fluid pressure decreases, the balloon 625 deflates.
  • the pressure of the fluid is controlled by the implementation of a syringe (not shown), a needle of which is connected to the conduit 620.
  • a syringe By pushing a piston of the syringe, the volume containing the fluid decreases and the fluid pressure increases; which inflates the balloon.
  • the plunger of the syringe the fluid pressure decreases, deflating the balloon.
  • the radial ports are configured to receive at least a portion of a clot upon inflation of balloon 625 and to retain at least a portion of the clot upon at least partial deflation of balloon 625.
  • the deflated balloon 625 is placed opposite the clot 605, as seen in FIG.
  • FIG. 7 shows the balloon 625 inflated to crush the blood clot 605 against the wall 610 of the blood vessel to which the clot 605 is attached. Upon squeezing blood clot 605 against wall 610, clot 605 tears and torn portions are received in the radial ports of balloon 625.
  • FIG. 8 shows the balloon 625 partially deflated.
  • the portions received in the radial orifices are retained in said radial orifices.
  • the blood clot 605 is at least partially removed from the wall 610 of the blood vessel and the removed blood clot pieces 605 do not move freely in the vascular system of the treated patient.
  • FIG. 9 shows the blood vessel treated after the treatment performed by the device 60.
  • the remaining mass of the blood clot 605 in the vessel blood is low compared to the initial mass of the blood clot 605 shown in FIG.
  • FIG. 10 shows a particular embodiment of the method 70 of endovascular surgery.
  • This method 70 comprises:
  • a step 830 for retracting the catheter is a step 830 for retracting the catheter.
  • the step 805 of introducing a catheter is performed, for example, by perforation of a wall of the blood vessel and insertion of the catheter.
  • the catheter includes a conduit configured to conduct at least one fluid, and a balloon having at least one radial port and an axial port.
  • the balloon carried by the catheter is positioned facing the clot, the inner volume of the balloon being connected to the catheter duct.
  • the balloon inflation step 810 is performed, for example, by increasing the fluid pressure in the catheter conduit to expand at least one axial and radial orifice to receive at least a portion of the clot.
  • the pressure of the fluid is increased, for example, by the actuation of a piston of a syringe connected to the catheter conduit.
  • the step 815 of inserting a secondary catheter is performed, for example, by a second perforation of the wall of the blood vessel and by the insertion of the secondary catheter.
  • This secondary catheter is inserted into the axial bore of the balloon and the catheter integrally passes through the axial port to effect treatment upstream or downstream of the blood vessel relative to the balloon.
  • the extraction step 820 is performed, for example, by a user pulling the secondary catheter so that the secondary catheter leaves the treated blood vessel.
  • Step 825 of at least partial deflation of the balloon to retain at least a portion of the clot is achieved, for example, by the actuation of the piston of the syringe, so as to increase the volume containing the fluid. In this way, the pressure in the balloon decreases as desired by the user operating the plunger of the syringe.
  • the step 830 of retracting the catheter to extract each portion of the clot retained in the at least partially deflated balloon is performed, for example, by a user pulling the catheter so that the catheter leaves the blood vessel through the perforated hole in the catheter. during the introductory step 805.
  • the method 70 does not include a step 815 for inserting a secondary catheter or step 820 for extracting the secondary catheter.
  • the balloon does not necessarily have an axial orifice but it comprises at least one axial and / or radial orifice.
  • FIG. 11 shows a particular embodiment of the device 90 which is the subject of the present invention.
  • the device 90 is configured to facilitate the treatment of an endovascular aneurysm.
  • the device 90 comprises:
  • a secondary catheter 1 130 configured to release springs 1 135 in the aneurysm 1 105.
  • the balloon 1125 has an axial port longitudinally extending through the balloon 1125 and allowing the blood flow to continue even when the balloon 1125 is inflated.
  • the balloon 1125 is positioned opposite the aneurysm 1 105.
  • the balloon 1 125 is then inflated, as shown in Figure 1 1.
  • a secondary catheter 1 130 is positioned along the balloon 1125 inflated between the wall 11 of the blood vessel and the balloon 1125 so that the longitudinal opening of the catheter is oriented towards the interior of the catheter.
  • Springs 1 135 are injected into the aneurysm 1 105 by the application of pressure, by the surgeon, on a syringe containing the springs 1 135 and connected to the catheter 1 130 secondary.
  • the springs 1 135 fill the aneurysm 1 105 so as to reshape the blood vessel.
  • the secondary catheter 110 is removed from the blood vessel, and then the balloon 1125 is deflated.
  • balloon 1125 is removed from the blood vessel and the blood vessel is closed by the surgeon.
  • FIG. 12 shows a particular embodiment of the method 80 for treating an aneurysm. This method 80 comprises:
  • the step 905 of introducing a catheter is performed, for example, by the perforation of a wall of the blood vessel and the insertion of the catheter.
  • the catheter includes a conduit configured to conduct at least one fluid, and a balloon having at least one radial port and an axial port.
  • the balloon carried by the catheter is positioned facing an aneurysm, the inner volume of the balloon being connected to the catheter duct.
  • the balloon inflation step 910 is performed, for example, by increasing the fluid pressure in the catheter conduit to expand at least one axial and radial port to receive at least a portion of the clot.
  • the pressure of the fluid is increased, for example, by the actuation of a piston of a syringe connected to the catheter conduit.
  • the balloon is configured, for example, to act on blood vessels three millimeters in diameter.
  • the ratio between the surface of the radial openings formed in the outer surface of the balloon on this outer surface is, in the inflated position, less than three quarters and, preferably, one half. This allows the retention of a clot while the balloon is being deflated.
  • a spring metallic would have a ratio greater than nine tenths and would tend to shred the clot during its folding.
  • a balloon extends in all directions as it swells.
  • the clot is crushed substantially isotropically and therefore does not tend to tear.
  • the deformation of a metal spring would cause the radial compression of the clot and its longitudinal elongation, which could shred it,
  • the shape of the radial openings and / or the edges of these openings is, in variants, configured to facilitate the cutting and / or the retention of the clot, whether during the balloon inflation or during a displacement of the balloon.
  • the step 915 of inserting a secondary catheter is performed, for example, by a second perforation of the wall of the blood vessel and by the insertion of the secondary catheter.
  • This secondary catheter is inserted into the axial bore of the balloon so as to also pass through a radial bore of the balloon.
  • the coil deployment step 920 is performed, for example, by inserting a syringe needle into a lumen of the catheter. Then, a user actuates a piston of the syringe so as to push the turns into the catheter and, thus, to push the turns out of the opening of the catheter located opposite the aneurysm. These turns are configured to fill the aneurysm.
  • the extraction step 925 is performed, for example, by a user pulling the secondary catheter so that the secondary catheter leaves the treated blood vessel.
  • Step 930 of at least partial deflation of the balloon to retain at least a portion of the clot is achieved, for example, by the actuation of the piston of the syringe, so as to increase the volume containing the fluid. In this way, the pressure in the balloon decreases as desired by the user operating the piston.
  • the step 935 of retracting the catheter to extract each portion of the clot retained in the at least partially deflated balloon is performed, for example, by a user pulling the catheter so that the catheter leaves the blood vessel through the perforated hole in the catheter. during the introductory step 805.

Abstract

The invention relates to an endovascular surgery device (20) which comprises: a catheter (205) comprising a pipe (210) configured to route at least one fluid, a balloon (215) having an inner space which is connected to a pipe of the catheter and configured to be inflated or deflated depending on the pressure of the fluid in the pipe of the catheter. The balloon is provided with at least one radial opening (225) surrounded by a wall (230) in order to fragment at least part of the clot, wherein each of said radial openings receives at least one fragmented part of the clot upon inflation of the balloon and retains at least one fragmented part of the clot when the balloon is at least partially delated. In some embodiments, at least one opening (425) of the small balloon is a radial blind opening.

Description

DISPOSITIF DE CHIRURGIE ENDOVASCULAIRE  DEVICE FOR ENDOVASCULAR SURGERY
DOMAINE TECHNIQUE DE L'INVENTION TECHNICAL FIELD OF THE INVENTION
La présente invention vise un dispositif de chirurgie endovasculaire. Elle s'applique notamment au domaine de la chirurgie vasculaire, de la neuroradiologie interventionnelle, de la radiologie interventionnelle, de la cardiologie interventionnelle, de la neurochirurgie endovasculaire, de la chirurgie endovasculaire, de la thrombectomie mécanique, de la thrombectomie endovasculaire et de l'extraction de thrombus notamment endovasculaire.  The present invention relates to a device for endovascular surgery. It is particularly applicable to the field of vascular surgery, interventional neuroradiology, interventional radiology, interventional cardiology, endovascular neurosurgery, endovascular surgery, mechanical thrombectomy, endovascular thrombectomy, and thrombus extraction including endovascular.
ETAT DE LA TECHNIQUE STATE OF THE ART
Des systèmes actuels de traitement d'une thrombose endovasculaire Current systems for treating endovascular thrombosis
(angioplastie, thrombectomie) sont composés d'un ballonnet d'angioplastie dégonflé monté sur un micro cathéter. Le micro cathéter est introduit dans le vaisseau sanguin comportant un thrombus de manière à placer le ballonnet dégonflé en regard du thrombus. Le ballonnet est ensuite gonflé par un liquide introduit dans le micro cathéter, de manière à écraser le thrombus contre la paroi du vaisseau sanguin pour restaurer le flux sanguin dans le vaisseau sanguin. (angioplasty, thrombectomy) consist of a deflated angioplasty balloon mounted on a microcatheter. The micro catheter is introduced into the blood vessel with a thrombus so as to place the balloon deflated facing the thrombus. The balloon is then inflated with a liquid introduced into the microcatheter, so as to crush the thrombus against the wall of the blood vessel to restore blood flow into the blood vessel.
Un des inconvénients de ces systèmes est que les morceaux de caillot sanguin déchirés par le gonflement du ballonnet d'angioplastie sont ensuite emportés par le flux sanguin s'écoulant dans le vaisseau sanguin et que ces morceaux de caillot sanguin peuvent devenir la source de nouvelles thromboses ou d'autres problèmes vasculaires appelés complications thromboemboliques.  One of the drawbacks of these systems is that the blood clot pieces torn by the swelling of the angioplasty balloon are then washed away by the blood flowing into the blood vessel and these pieces of blood clot can become the source of new thromboses. or other vascular problems called thromboembolic complications.
Dans d'autres systèmes actuels, tels que celui présenté dans la demande de brevet EP 2 399 525, le système de traitement d'une thrombose artérielle comporte un fil de métal en hélice qui, une fois compressé sur son axe longitudinal, se déploie jusqu'à toucher les parois du vaisseau sanguin et forme un piège à caillot sanguin déplacé le long d'un vaisseau sanguin de manière à capturer le caillot sanguin lors du retrait du système. Si ces systèmes permettent de récupérer le principal du caillot sanguin, ils n'évitent pas que des morceaux du caillot sanguin parcourent librement l'organisme, ce qui peut entraîner une complication thromboembolique. Dans tout les cas, ce type de dispositifs n'est plus utilisé aujourd'hui à cause du faible taux d'efficacité et de recanalisation artérielle et de l'important taux de complication lié à son utilisation. In other current systems, such as the one presented in the patent application EP 2,399,525, the system for treating arterial thrombosis comprises a helical wire which, when compressed on its longitudinal axis, deploys until touching the walls of the blood vessel and forming a blood clot trap displaced along a blood vessel so as to capture the blood clot upon removal from the system. If these systems can recover the main blood clot, they do not prevent blood clots from roaming freely the body, which can lead to a thromboembolic complication. In any case, this type of device is no longer used today because of the low rate of effectiveness and arterial recanalisation and the high rate of complication related to its use.
Dans d'autres systèmes actuels, tels que celui présenté dans le brevet WO In other current systems, such as that presented in the WO patent
2009/1 14046, un stent extracteur composé d'une armature métallique repliée autour d'un axe est déployé de manière à ce que l'armature externe épouse les contours du vaisseau sanguin traitée. Puis, dans un second temps, le stent déployé est tracté jusqu'à l'ouverture par lequel le cathéter a été inséré de manière à capter un thrombus artériel placée contre une paroi du vaisseau sanguin. Cependant, ces systèmes sont dangereux à utiliser dans le cas où la thrombose comporte une partie calcifiée sous une partie molle, aussi appelé thrombose sur plaque. En effet, le déchirement que peut provoquer l'arrachement de la partie calcifiée peut conduire à un déchirement artériel. Pour ces raisons, un stent extracteur ne peut pas toujours être employé pour réaliser l'extraction d'un thrombus. De plus, le chirurgien ne dispose d'aucune maîtrise de l'interaction entre le dispositif et le thrombus. 2009/1 14046, an extractor stent consisting of a metal frame bent around an axis is deployed so that the outer armature matches the contours of the treated blood vessel. Then, in a second step, the expanded stent is pulled to the opening through which the catheter has been inserted to capture an arterial thrombus placed against a wall of the blood vessel. However, these systems are dangerous to use in the case where the thrombosis includes a calcified portion under a soft part, also called plaque thrombosis. Indeed, the tearing that can cause tearing of the calcified part can lead to arterial tearing. For these reasons, an extractor stent can not always be used to perform thrombus extraction. In addition, the surgeon has no control over the interaction between the device and the thrombus.
Par ailleurs, dans le traitement d'anévrismes artériels, les systèmes actuels de ballon assisted remodelling (« remodelage assisté par une ballonnet » en français) dits d'emprisonnement consistent à déployer un cathéter en regard d'un anévrisme, de provoquer l'expansion d'un ballonnet monté sur le cathéter et d'introduire un cathéter secondaire dans l'anévrisme en longeant le ballonnet gonflé. De tels systèmes ont l'avantage de supporter le matériel d'embolisation déployé à l'intérieur de la poche anévrismale, en revanche ils ont le désavantage de bloquer le passage de fluides dans le vaisseau sanguin lorsque le ballonnet est gonflé, ce qui peut être la cause d'une ischémie cérébrale.  Moreover, in the treatment of arterial aneurysms, the current balloon assisted remodeling ("balloon-assisted remodeling" in French) systems consist in deploying a catheter opposite an aneurysm, causing the expansion a balloon mounted on the catheter and introducing a secondary catheter into the aneurysm along the inflated balloon. Such systems have the advantage of supporting the embolization material deployed inside the aneurysmal pocket, however they have the disadvantage of blocking the passage of fluids in the blood vessel when the balloon is inflated, which can be the cause of cerebral ischemia.
OBJET DE L'INVENTION OBJECT OF THE INVENTION
La présente invention vise à remédier à tout ou partie de ces inconvénients. A cet effet, selon un premier aspect, la présente invention vise un dispositif de chirurgie endovasculaire, qui comporte :  The present invention aims to remedy all or part of these disadvantages. For this purpose, according to a first aspect, the present invention relates to an endovascular surgical device, which comprises:
- un cathéter comportant un conduit configuré pour conduire au moins un fluide, - un ballonnet dont le volume intérieur est relié à un conduit du cathéter et configuré pour être gonflé ou dégonflé en fonction de la pression du fluide dans le conduit du cathéter, a catheter comprising a conduit configured to conduct at least one fluid, a balloon whose internal volume is connected to a conduit of the catheter and configured to be inflated or deflated according to the pressure of the fluid in the catheter duct,
le ballonnet est muni d'au moins un orifice radial entouré par une paroi pour fragmenter au moins une partie du caillot, chaque dit orifice radial recevant au moins une partie fragmentée du caillot lors du gonflement du ballonnet et retenant au moins une partie fragmentée du caillot lors du dégonflement, au moins partiel, du ballonnet.  the balloon is provided with at least one radial orifice surrounded by a wall to fragment at least a portion of the clot, each said radial orifice receiving at least a fragmented portion of the clot during the swelling of the balloon and retaining at least a fragmented portion of the clot during deflation, at least partially, of the balloon.
La présence d'au moins un orifice radial permet de capturer une partie du caillot sanguin lors du dégonflement du ballonnet, ladite partie du caillot sanguin étant ensuite extraite avec le cathéter du vaisseau sanguin traitée. De plus, puisqu'on met en œuvre un ballonnet, le risque de lésion du vaisseau sanguin est réduit, tant lors de la mise en position du dispositif en regard du caillot endovasculaire que lors du déploiement du ballonnet. Enfin, la force à appliquer est réduite car c'est un fluide qui véhicule la pression dans le ballonnet. De surcroit, il est possible de traiter une thrombose comportant une partie calcifiée en éliminant les risques liés à l'arrachement de la thrombose en raison de la matière extensible du ballonnet d'une part, et de la capture de la thrombose par gonflement et dégonflement du ballonnet, bien moins violente pour le vaisseau sanguin, d'autre part. En comparaison avec un ballonnet d'angioplastie classique et les systèmes de type stent retrievers, la présente invention permet, au-delà de la compression du thrombus et de la réouverture du vaisseau sanguin, de capturer une partie ou la totalité du thrombus qui a été la cause de l'occlusion endovasculaire en améliorant l'hémodynamique du vaisseau traité et on réduisant le risque de migration embolique pouvant provoquer une complication thromboembolique.  The presence of at least one radial port captures a portion of the blood clot upon deflation of the balloon, wherein the portion of the blood clot is subsequently extracted with the catheter of the treated blood vessel. In addition, since a balloon is used, the risk of damage to the blood vessel is reduced, both when the device is placed in position opposite the endovascular clot and when the balloon is deployed. Finally, the force to be applied is reduced because it is a fluid that conveys the pressure in the balloon. In addition, it is possible to treat thrombosis with a calcified portion by eliminating the risks associated with tearing thrombosis due to the expandable material of the balloon on the one hand, and the capture of the thrombosis by swelling and deflating. the balloon, much less violent for the blood vessel, on the other hand. In comparison with a conventional angioplasty balloon and retrieval stent systems, the present invention allows, beyond compression of the thrombus and reopening of the blood vessel, to capture some or all of the thrombus that has been the cause of endovascular occlusion by improving the hemodynamics of the treated vessel and reducing the risk of embolic migration that can cause a thromboembolic complication.
Dans des modes de réalisation, au moins un orifice du ballonnet est un orifice radial borgne.  In embodiments, at least one balloon port is a blind radial port.
Ces modes de réalisation permettent, lors du gonflement du ballonnet, de faire pénétrer une partie du caillot sanguin dans l'orifice radial borgne. Lors du dégonflement du ballonnet, la partie du caillot sanguin dans l'orifice radial borgne est capturée et peut être retirée du vaisseau sanguin avec le cathéter.  These embodiments allow, during balloon inflation, to penetrate part of the blood clot into the blind radial orifice. When deflating the balloon, the portion of the blood clot in the blind radial port is captured and can be removed from the blood vessel with the catheter.
Dans des modes de réalisation, le ballonnet forme un volume creux une fois au moins partiellement gonflé, au moins un orifice du ballonnet traversant le ballonnet pour relier le volume creux à l'extérieur du ballonnet. Ces modes de réalisation permettent de retenir une partie fragmentée caillot sanguin dans le volume creux formé lorsque le ballonnet est gonflé. In embodiments, the balloon forms an at least partially inflated hollow volume, at least one balloon port passing through the balloon to connect the hollow volume to the exterior of the balloon. These embodiments retain a fragmented blood clot portion in the hollow volume formed when the balloon is inflated.
Dans des modes de réalisation, le dispositif objet de la présente invention comporte un orifice axial traversant le ballonnet pour permettre le passage d'un flux sanguin.  In embodiments, the device object of the present invention comprises an axial orifice passing through the balloon to allow the passage of a blood flow.
Ces modes de réalisation permettent le passage d'un flux sanguin à travers le ballonnet de manière à éviter des risques de santé sur un utilisateur sur lequel le dispositif objet de la présente invention est utilisé.  These embodiments allow the passage of a blood flow through the balloon so as to avoid health risks on a user on which the device object of the present invention is used.
Dans des modes de réalisation, le dispositif objet de la présente invention comporte un moyen de rétention d'un caillot sanguin dans le volume creux du ballonnet lorsque le ballonnet est gonflé, le volume creux étant au moins partiellement formé par l'orifice axial.  In embodiments, the device of the present invention comprises means for retaining a blood clot in the hollow volume of the balloon when the balloon is inflated, the hollow volume being at least partially formed by the axial orifice.
L'avantage de ces modes de réalisation est qu'ils permettent d'éviter qu'un fragment de caillot sanguin dans le volume creux s'échappe du volume creux lorsque le ballonnet est gonflé.  The advantage of these embodiments is that they prevent a blood clot fragment in the hollow volume from escaping from the hollow volume when the balloon is inflated.
Dans des modes de réalisation, le moyen de rétention est un maillage obstruant au moins une extrémité de l'orifice axial.  In embodiments, the retention means is a mesh obstructing at least one end of the axial orifice.
Ces modes de réalisation ont l'avantage de permettre de retenir un fragment de caillot sanguin sans nuire au passage du flux sanguin à travers l'orifice axial.  These embodiments have the advantage of allowing to retain a blood clot fragment without impairing the passage of blood flow through the axial orifice.
Dans des modes de réalisation, le moyen de rétention est un diaphragme positionné sur au moins une extrémité de l'orifice axial.  In embodiments, the retention means is a diaphragm positioned on at least one end of the axial orifice.
Ces modes de réalisation ont l'avantage de permettre de retenir un fragment de caillot sanguin sans nuire au passage du flux sanguin à travers l'orifice axial.  These embodiments have the advantage of allowing to retain a blood clot fragment without impairing the passage of blood flow through the axial orifice.
Dans des modes de réalisation, au moins un orifice du ballonnet est un orifice configuré pour laisser passer un cathéter secondaire lorsque le ballonnet est gonflé.  In embodiments, at least one balloon port is an orifice configured to pass a secondary catheter when the balloon is inflated.
Les avantages de ces modes de réalisation sont qu'ils permettent, d'une part, de laisser le sang s'écouler lors du gonflement du ballonnet et, d'autre part, de réaliser un autre traitement dans le vaisseau sanguin par le biais d'un second cathéter en maintenant le vaisseau sanguin en position grâce au ballonnet gonflé.  The advantages of these embodiments are that they allow, on the one hand, to allow the blood to flow during the balloon swelling and, on the other hand, to perform another treatment in the blood vessel through a second catheter keeping the blood vessel in position with the inflated balloon.
Dans des modes de réalisation, le ballonnet est relié au cathéter au niveau de la périphérie du ballonnet.  In embodiments, the balloon is connected to the catheter at the periphery of the balloon.
Ces modes de réalisation ont l'avantage, dans le cas où le ballonnet comporte un orifice axial, de permettre une taille optimale de la lumière de l'orifice axial. Dans des modes de réalisation, le ballonnet est relié au cathéter au niveau de l'axe du ballonnet. These embodiments have the advantage, in the case where the balloon has an axial orifice, to allow an optimal size of the light of the axial orifice. In embodiments, the balloon is connected to the catheter at the balloon axis.
L'avantage de ces modes de réalisation est qu'ils permettent une expansion plus homogène du ballonnet lors du gonflement du ballonnet.  The advantage of these embodiments is that they allow a more homogeneous expansion of the balloon during inflation of the balloon.
Dans des modes de réalisation, au moins une paroi entre deux orifices radiaux présente une forme convexe vers l'extérieur du ballonnet de manière à fragmenter un caillot lors du gonflement du ballonnet.  In embodiments, at least one wall between two radial orifices has an outwardly convex shape of the balloon so as to fragment a clot upon inflation of the balloon.
Ces modes de réalisation ont l'avantage de permettre une fragmentation facilitée du caillot sanguin.  These embodiments have the advantage of facilitating fragmentation of the blood clot.
BREVE DESCRIPTION DES FIGURES BRIEF DESCRIPTION OF THE FIGURES
D'autres avantages, buts et caractéristiques de l'invention ressortiront de la description qui suit d'au moins un mode de réalisation particulier du dispositif de chirurgie endovasculaire, en regard des dessins annexés, dans lesquels :  Other advantages, aims and features of the invention will emerge from the following description of at least one particular embodiment of the endovascular surgical device, with reference to the appended drawings, in which:
- la figure 1 représente, schématiquement et en perspective, un premier mode de réalisation particulier du dispositif objet de la présente invention,  FIG. 1 represents, schematically and in perspective, a first particular embodiment of the device that is the subject of the present invention,
- la figure 2 représente, schématiquement et en perspective, un deuxième mode de réalisation particulier du dispositif objet de la présente invention, FIG. 2 represents, schematically and in perspective, a second particular embodiment of the device that is the subject of the present invention,
- la figure 3 représente, schématiquement et en perspective, un troisième mode de réalisation particulier du dispositif objet de la présente invention, FIG. 3 represents, schematically and in perspective, a third particular embodiment of the device that is the subject of the present invention,
- la figure 4 représente, schématiquement et en perspective, un quatrième mode de réalisation particulier du dispositif objet de la présente invention, FIG. 4 represents, schematically and in perspective, a fourth particular embodiment of the device that is the subject of the present invention,
- la figure 5 représente, schématiquement et en coupe, une première vue d'un septième mode de réalisation particulier du dispositif objet de la présente invention, FIG. 5 represents, schematically and in section, a first view of a seventh particular embodiment of the device that is the subject of the present invention,
- la figure 6 représente, schématiquement et en coupe, une deuxième vue du septième mode de réalisation particulier du dispositif objet de la présente invention,  FIG. 6 represents, schematically and in section, a second view of the seventh particular embodiment of the device that is the subject of the present invention,
- la figure 7 représente, schématiquement et en coupe, une troisième vue du septième mode de réalisation particulier du dispositif objet de la présente invention, - la figure 8 représente, schématiquement et en coupe, une quatrième vue du septième mode de réalisation particulier du dispositif objet de la présente invention, FIG. 7 represents, schematically and in section, a third view of the seventh particular embodiment of the device that is the subject of the present invention, FIG. 8 represents, schematically and in section, a fourth view of the seventh particular embodiment of the device that is the subject of the present invention,
- la figure 9 représente, schématiquement et en coupe, une cinquième vue du septième mode de réalisation particulier du dispositif objet de la présente invention,  FIG. 9 represents, schematically and in section, a fifth view of the seventh particular embodiment of the device that is the subject of the present invention,
- la figure 10 représente, sous forme d'un logigramme, des étapes d'un mode de réalisation particulier d'un procédé de chirurgie endovasculaire,  FIG. 10 represents, in the form of a logic diagram, steps of a particular embodiment of a method of endovascular surgery,
- la figure 1 1 représente, schématiquement et en coupe, un cinquième mode de réalisation particulier du dispositif objet de la présente invention et  FIG. 11 represents, schematically and in section, a fifth particular embodiment of the device that is the subject of the present invention and
- la figure 12 représente, sous forme d'un logigramme, des étapes d'un mode de réalisation particulier d'un procédé de traitement d'un anévrisme.  FIG. 12 represents, in the form of a logic diagram, steps of a particular embodiment of a method of treating an aneurysm.
DESCRIPTION D'EXEMPLES DE REALISATION DE L'INVENTION DESCRIPTION OF EXAMPLES OF EMBODIMENT OF THE INVENTION
On note, dès à présent, que les figures ne sont pas à l'échelle.  As of now, we note that the figures are not to scale.
On appelle « orifice » aussi bien une cavité dans une surface qu'un interstice entre des reliefs posés sur une surface.  The term "orifice" is used both for a cavity in a surface and a gap between reliefs placed on a surface.
On observe sur la figure 1 , un mode de réalisation particulier du dispositif 10 objet de la présente invention. Ce dispositif 10 comporte :  FIG. 1 shows a particular embodiment of the device 10 which is the subject of the present invention. This device 10 comprises:
- un cathéter 105 comportant un conduit 1 10 et  a catheter 105 comprising a conduit 1 10 and
- un ballonnet 1 15 comportant au moins un orifice radial 125.  a balloon 1 comprising at least one radial orifice 125.
Le conduit 1 10 est configuré pour conduire au moins un fluide, par exemple un liquide poussé par une seringue, non représentée. Ce conduit 1 10 est supporté par le cathéter 105 et le conduit 1 10 est connecté au ballonnet 1 15 sur la périphérie du ballonnet 1 15. Le ballonnet 1 15 est réalisé dans une matière plastique et élastique, par exemple. Ce ballonnet 1 15 comporte au moins un orifice radial 125 débouchant sur une face extérieure du ballonnet 1 15. Le volume intérieur du ballonnet 1 15 est relié au conduit 1 10 du cathéter 105 et ce ballonnet 1 15 est configuré pour être gonflé ou dégonflé en fonction de la pression du fluide dans le conduit 1 10 du cathéter 105. Lorsque la pression du fluide augmente, le ballonnet 1 15 gonfle. A l'inverse, lorsque la pression du fluide diminue, le ballonnet 1 15 dégonfle. La pression du fluide est commandée par la mise en œuvre d'une seringue dont une aiguille est connectée au conduit 1 10. En poussant un piston de la seringue, le volume contenant le fluide diminue et la pression du fluide augmente et le ballonnet 1 15 se gonfle. En tirant le piston de la seringue, la pression du fluide diminue et le ballonnet 1 15 se dégonfle. The conduit 1 10 is configured to conduct at least one fluid, for example a liquid pushed by a syringe, not shown. This conduit 10 is supported by the catheter 105 and the conduit 1 is connected to the balloon 1 on the periphery of the balloon 1 15. The balloon 1 is made of a plastic and elastic material, for example. This balloon 1 comprises at least one radial orifice 125 opening on an outer face of the balloon 1 15. The inner volume of the balloon 1 15 is connected to the conduit 1 10 of the catheter 105 and this balloon 1 15 is configured to be inflated or deflated in This is a function of the fluid pressure in the catheter conduit 105. As the fluid pressure increases, the balloon 1 inflates. Conversely, as the fluid pressure decreases, the balloon 1 deflates. The pressure of the fluid is controlled by the implementation of a syringe with a needle connected to the conduit 1 10. By pushing a piston of the syringe, the The volume containing the fluid decreases and the fluid pressure increases and the balloon 1 inflates. By pulling the plunger of the syringe, the fluid pressure decreases and the balloon 1 deflates.
Le ballonnet 1 15 forme un volume creux une fois au moins partiellement gonflé, au moins un orifice 125 du ballonnet 1 15 traversant le ballonnet 1 15 pour relier le volume creux à l'extérieur du ballonnet 1 15.  The balloon 1 forms a hollow volume once at least partially inflated, at least one port 125 of the balloon 1 passing through the balloon 1 to connect the hollow volume to the outside of the balloon 1 15.
L'orifice radial 125 est configuré pour permettre le passage d'un cathéter secondaire. De plus, cet orifice radial 125 est configuré pour recevoir au moins une partie d'un caillot lors du gonflement du ballonnet 1 15 et pour retenir au moins une partie du caillot lors du dégonflement, au moins partiel, du ballonnet 1 15. A cet effet, l'orifice radial 125 comporte, par exemple, une structure alvéolaire obstruant partiellement le passage entre les deux extrémités longitudinales du ballonnet 1 15.  The radial orifice 125 is configured to allow the passage of a secondary catheter. In addition, this radial orifice 125 is configured to receive at least a portion of a clot during swelling of the balloon 1 and to retain at least a portion of the clot during the at least partial deflation of the balloon 1 15. At this Indeed, the radial orifice 125 comprises, for example, a honeycomb structure partially obstructing the passage between the two longitudinal ends of the balloon 1 15.
Dans des variantes, certains orifices 125 radiaux sont borgnes, c'est-à-dire que les orifices radiaux 125 n'ont qu'une ouverture donnant sur l'extérieur du ballonnet 1 15.  In variants, some radial orifices 125 are blind, that is to say that radial orifices 125 have only one opening on the outside of the balloon 1 15.
Au moins un orifice 125 est entouré par une paroi 1 20 pour fragmenter au moins une partie 120 du caillot lorsque le ballonnet 1 15 est gonflé et que la paroi 120 est pressée contre le caillot sanguin collé à une paroi d'une artère d'un utilisateur.  At least one orifice 125 is surrounded by a wall 1 to fragment at least a portion 120 of the clot when the balloon 1 is inflated and the wall 120 is pressed against the blood clot adhered to a wall of an artery of a user.
Au moins une paroi 120 entre deux orifices radiaux 125 présente une forme convexe vers l'extérieur du ballonnet de manière à fragmenter un caillot lors du gonflement du ballonnet.  At least one wall 120 between two radial orifices 125 has an outwardly convex shape of the balloon so as to fragment a clot during inflation of the balloon.
Dans des variantes, une section axiale du ballonnet 1 15 présente des parois 120 à forme triangulaires orientées vers l'extérieur du ballonnet 1 15 de manière à fragmenter le caillot sanguin grâce à une pointe d'au moins un triangle et à retenir le fragment grâce à la partie plate dudit triangle. Dans d'autres variantes, les parois 120 communes entourant au moins deux orifices sont orientées l'une vers l'autre pour diminuer la surface de pression, entre les parois 120, exercée lors du gonflement du ballonnet.  In variants, an axial section of the balloon 1 has triangular-shaped walls 120 facing outwardly of the balloon 1, so as to fragment the blood clot by means of a tip of at least one triangle and to retain the fragment through at the flat part of said triangle. In other embodiments, the common walls 120 surrounding at least two ports are oriented toward each other to decrease the pressure surface, between the walls 120, exerted during balloon inflation.
Ces orifices 125 sont configurés pour recevoir au moins une partie d'un caillot sanguin lors du gonflement du ballonnet 1 15 et pour retenir au moins une partie du caillot lors du dégonflement, au moins partiel, du ballonnet 1 15. Le ballonnet 1 15 est configuré pour être gonflé jusqu'à occuper un diamètre similaire au diamètre du vaisseau sanguin dans laquelle le dispositif 10 est positionnée. Lorsque le ballonnet 1 15 se gonfle, les ouvertures des orifices 125 déchirent le caillot sanguin fixé à la paroi du vaisseau sanguin traitée et reçoivent des morceaux du caillot dans les orifices 125 radiaux. Lors du dégonflement du ballonnet 1 15, les morceaux reçus par les orifices 125 radiaux sont retenus dans les orifices 125 radiaux. Ils sont ensuite extraits du vaisseau sanguin à traiter par retrait du cathéter 105 portant le ballonnet 1 15. These orifices 125 are configured to receive at least a portion of a blood clot upon inflation of the balloon 1 and to retain at least a portion of the clot upon the at least partial deflation of the balloon 1 15. The balloon 1 is configured to be inflated to a diameter similar to the diameter of the blood vessel in which the device 10 is positioned. When the balloon The opening 125 of the orifices 125 tear the blood clot fixed to the wall of the treated blood vessel and receive pieces of the clot in the radial orifices 125. During deflation of the balloon 1 15, the pieces received by the radial orifices 125 are retained in the radial orifices 125. They are then extracted from the blood vessel to be treated by removal of the catheter 105 carrying the balloon 1 15.
Dans des variantes, les parois des orifices 125 radiaux sont configurées pour faciliter la retenue d'un caillot sanguin. La paroi d'un orifice 125 comporte, par exemple, des piques dont les pointes sont orientées dans une direction opposée à l'ouverture dudit orifice 125. De cette manière, les piques entravent peu l'entée d'un caillot sanguin dans l'orifice 125 mais permettent de retenir le caillot sanguin plus efficacement dans l'orifice 125.  In variants, the walls of the radial ports 125 are configured to facilitate retention of a blood clot. The wall of an orifice 125 comprises, for example, spikes whose tips are oriented in a direction opposite to the opening of said orifice 125. In this way, the spikes do not interfere with the entry of a blood clot into the opening. 125 but allow to retain the blood clot more effectively in the orifice 125.
Dans des variantes, le ballonnet 1 15 présente un gradient de résistance à l'étirement du ballonnet 1 15 de manière à ce que le centre du ballonnet 1 15 s'étire plus que les extrémités de ce ballonnet 1 15 lorsque le ballonnet 1 15 est gonflé.  In alternative embodiments, the balloon 1 has a balloon stretch resistance gradient 1 15 so that the center of the balloon 1 stretches more than the ends of this balloon 1 when the balloon 1 15 is inflated.
On observe, sur la figure 2, un deuxième mode de réalisation particulier du dispositif 20 objet de la présente invention. Ce dispositif 20 est similaire au dispositif 10 décrit en figure 1 . Dans cette configuration, le conduit 210 est relié au ballonnet 215 au niveau du centre du ballonnet 215 lorsque celui ci est déployé.  FIG. 2 shows a second particular embodiment of the device 20 of the present invention. This device 20 is similar to the device 10 described in FIG. In this configuration, the conduit 210 is connected to the balloon 215 at the center of the balloon 215 when it is deployed.
On observe, sur la figure 3, un troisième mode de réalisation particulier du dispositif 30 objet de la présente invention. Ce dispositif 30 est similaire au dispositif 10 décrit en figure 1 . Ce dispositif 30 comporte, en plus du cathéter 305, du conduit 310, du ballonnet 315 et des orifices 325 radiaux, un orifice axial 320 configuré pour permettre le passage d'un cathéter secondaire. De plus, cet orifice axial 320 est configuré pour recevoir au moins une partie d'un caillot lors du gonflement du ballonnet 315 et pour retenir au moins une partie du caillot lors du dégonflement, au moins partiel, du ballonnet 315. A cet effet, l'orifice axial 320 comporte, par exemple, une structure alvéolaire obstruant partiellement le passage entre les deux extrémités longitudinales du ballonnet 315.  FIG. 3 shows a third particular embodiment of the device 30 of the present invention. This device 30 is similar to the device 10 described in FIG. This device 30 comprises, in addition to the catheter 305, the conduit 310, the balloon 315 and the radial orifices 325, an axial orifice 320 configured to allow the passage of a secondary catheter. In addition, this axial orifice 320 is configured to receive at least a portion of a clot during swelling of the balloon 315 and to retain at least a portion of the clot during deflation, at least partially, of the balloon 315. For this purpose, the axial orifice 320 comprises, for example, a cellular structure partially obstructing the passage between the two longitudinal ends of the balloon 315.
Dans des variantes, les orifices 325 radiaux ne sont pas borgnes et communiquent avec l'orifice 320 axial. Dans ces variantes, les morceaux de caillot sanguin sont reçus et retenus par l'orifice 320 axial. Les morceaux de caillot sanguin entrent dans l'orifice 320 axial par le biais des ouvertures aux extrémités longitudinales du ballonnet 315 ou des orifices 325 radiaux. In variants, the radial orifices 325 are not blind and communicate with the axial orifice 320. In these variants, the blood clot pieces are received and retained by the axial aperture 320. The pieces of blood clot enter the axial orifice 320 through the openings at the longitudinal ends of the balloon 315 or the radial openings 325.
On observe, sur la figure 4, un quatrième mode de réalisation particulier du dispositif 40 objet de la présente invention. Ce dispositif 40 est similaire au dispositif 30 décrit en figure 2. Ce dispositif 40 comporte :  FIG. 4 shows a fourth particular embodiment of the device 40 which is the subject of the present invention. This device 40 is similar to the device 30 described in FIG. 2. This device 40 comprises:
- un cathéter 405 comportant un conduit 410,  a catheter 405 comprising a duct 410,
- un ballonnet 415 comportant une pluralité d'orifices 425 radiaux et un orifice 420 axial.  a balloon 415 comprising a plurality of radial orifices 425 and an axial orifice 420.
La particularité du dispositif 40 est que le conduit 410 est relié au ballonnet 415 au niveau de l'axe du ballonnet 415. Par exemple, ce conduit 410 est relié au ballonnet 415 par huit conduits 430 secondaires dont quatre à chaque ouverture longitudinale du ballonnet 415. Alternativement, ce dispositif 40 en comporte un nombre de conduits supérieur à huit, de manière à former un maillage dans l'orifice 420 axial. Ce maillage permet une meilleure rétention de caillots sanguins qui sont reçus dans le maillage.  The particularity of the device 40 is that the duct 410 is connected to the balloon 415 at the axis of the balloon 415. For example, this duct 410 is connected to the balloon 415 by eight secondary ducts 430 four of which at each longitudinal opening of the balloon 415 Alternatively, this device 40 has a number of ducts greater than eight, so as to form a mesh in the 420 axial orifice. This mesh allows a better retention of blood clots that are received in the mesh.
Dans des variantes, le ballonnet 315 forme un volume creux lorsque ce ballonnet 315 est gonflé. Ce volume creux est au moins partiellement formé par l'orifice axial 320 pour permettre le passage d'un flux sanguin.  In variants, the balloon 315 forms a hollow volume when this balloon 315 is inflated. This hollow volume is at least partially formed by the axial orifice 320 to allow the passage of a blood flow.
Le dispositif 40 comporte un moyen 430 de rétention d'un caillot sanguin dans un volume creux du ballonnet 415 lorsque le ballonnet est gonflé, le volume creux étant au moins partiellement formé par l'orifice axial 420.  The device 40 comprises a means 430 for retaining a blood clot in a hollow volume of the balloon 415 when the balloon is inflated, the hollow volume being at least partially formed by the axial orifice 420.
Ce moyen de rétention 430 est, par exemple, un maillage obstruant au moins une extrémité de l'orifice axial ou un diaphragme positionné sur au moins une extrémité de l'orifice axial (420).  This retention means 430 is, for example, a mesh obstructing at least one end of the axial orifice or a diaphragm positioned on at least one end of the axial orifice (420).
On observe, sur les figures 5 à 9, un cinquième mode de réalisation particulier du dispositif 60 objet de la présente invention. En particulier, on observe sur la figure 5 un vaisseau sanguin de paroi 610 et un caillot sanguin 605 collé à la paroi 610 du vaisseau sanguin.  FIGS. 5 to 9 show a fifth particular embodiment of the device 60 which is the subject of the present invention. In particular, FIG. 5 shows a blood vessel 610 and a blood clot 605 bonded to the wall 610 of the blood vessel.
On observe, sur la figure 6, un cinquième mode de réalisation particulier du dispositif 60 objet de la présente invention. Ce dispositif 60 comporte :  FIG. 6 shows a fifth particular embodiment of the device 60 which is the subject of the present invention. This device 60 comprises:
- un cathéter 615 comportant un conduit 620,  a catheter 615 comprising a conduit 620,
- un ballonnet 625 dégonflé comportant une pluralité d'orifices radiaux. Le conduit 620 est configuré pour conduire au moins un fluide. Ce conduit 620 est supporté par le cathéter 625 et le conduit 620 est connecté au ballonnet 625 sur la périphérie du ballonnet 625. Le ballonnet 625 est réalisé dans une matière élastique à mémoire de forme, par exemple. Ce ballonnet 625 comporte une pluralité d'orifices radiaux borgnes comportant une ouverture sur l'extérieur du ballonnet 625. Le volume intérieur du ballonnet 625 est relié au conduit 620 du cathéter 625 et ce ballonnet 625 est configuré pour être gonflé ou dégonflé en fonction de la pression du fluide dans le conduit 620 du cathéter 625. Lorsque la pression du fluide augmente, le ballonnet 625 gonfle et, à l'inverse, lorsque la pression du fluide diminue, le ballonnet 625 dégonfle. La pression du fluide est commandée par la mise en œuvre d'une seringue (non représentée) dont une aiguille est connectée au conduit 620. En poussant un piston de la seringue, le volume contenant le fluide diminue et la pression du fluide augmente, ce qui gonfle le ballonnet. En tirant le piston de la seringue, la pression du fluide diminue, ce qui dégonfle le ballonnet. a deflated balloon 625 comprising a plurality of radial orifices. The conduit 620 is configured to conduct at least one fluid. This conduit 620 is supported by the catheter 625 and the conduit 620 is connected to the balloon 625 on the periphery of the balloon 625. The balloon 625 is made of a shape memory elastic material, for example. This balloon 625 has a plurality of blind radial ports having an opening on the outside of the balloon 625. The inner volume of the balloon 625 is connected to the conduit 620 of the catheter 625 and this balloon 625 is configured to be inflated or deflated according to the fluid pressure in the conduit 620 of the catheter 625. As the fluid pressure increases, the balloon 625 inflates and, conversely, as the fluid pressure decreases, the balloon 625 deflates. The pressure of the fluid is controlled by the implementation of a syringe (not shown), a needle of which is connected to the conduit 620. By pushing a piston of the syringe, the volume containing the fluid decreases and the fluid pressure increases; which inflates the balloon. By pulling the plunger of the syringe, the fluid pressure decreases, deflating the balloon.
Les orifices radiaux sont configurés pour recevoir au moins une partie d'un caillot lors du gonflement du ballonnet 625 et pour retenir au moins une partie du caillot lors du dégonflement, au moins partiel, du ballonnet 625.  The radial ports are configured to receive at least a portion of a clot upon inflation of balloon 625 and to retain at least a portion of the clot upon at least partial deflation of balloon 625.
Lors de la chirurgie endovasculaire 605 dans un vaisseau sanguin, le ballonnet 625 dégonflé est placé en vis-à-vis du caillot 605, comme on le voit dans la figure 6.  During endovascular surgery 605 in a blood vessel, the deflated balloon 625 is placed opposite the clot 605, as seen in FIG.
On observe, sur la figure 7, le ballonnet 625 gonflé de manière à écraser le caillot sanguin 605 contre la paroi 610 du vaisseau sanguin auquel le caillot 605 est fixé. Lors de l'écrasement du caillot sanguin 605 contre la paroi 610, le caillot 605 se déchire et les parties déchirées sont reçues dans les orifices radiaux du ballonnet 625.  FIG. 7 shows the balloon 625 inflated to crush the blood clot 605 against the wall 610 of the blood vessel to which the clot 605 is attached. Upon squeezing blood clot 605 against wall 610, clot 605 tears and torn portions are received in the radial ports of balloon 625.
On observe, sur la figure 8, le ballonnet 625 partiellement dégonflé. Lors du dégonflement du ballonnet 625, les parties reçues dans les orifices radiaux sont retenues dans lesdits orifices radiaux. De cette manière, le caillot sanguin 605 est au moins partiellement ôté de la paroi 610 du vaisseau sanguin et les morceaux de caillot sanguin 605 ôtés ne se déplacent pas librement dans le système vasculaire du patient traité.  FIG. 8 shows the balloon 625 partially deflated. During deflation of the balloon 625, the portions received in the radial orifices are retained in said radial orifices. In this manner, the blood clot 605 is at least partially removed from the wall 610 of the blood vessel and the removed blood clot pieces 605 do not move freely in the vascular system of the treated patient.
On observe, sur la figure 9, le vaisseau sanguin traité une fois le traitement réalisé par le dispositif 60. La masse restante du caillot sanguin 605 dans le vaisseau sanguin est faible en comparaison à la masse initiale du caillot sanguin 605 illustré sur la figure 5. FIG. 9 shows the blood vessel treated after the treatment performed by the device 60. The remaining mass of the blood clot 605 in the vessel blood is low compared to the initial mass of the blood clot 605 shown in FIG.
On observe, sur la figure 10, un mode de réalisation particulier du procédé 70 de chirurgie endovasculaire. Ce procédé 70 comporte :  FIG. 10 shows a particular embodiment of the method 70 of endovascular surgery. This method 70 comprises:
- une étape 805 d'introduction d'un cathéter dans un vaisseau sanguin comportant un caillot sanguin fixé à une paroi du vaisseau sanguin,  a step 805 of introducing a catheter into a blood vessel comprising a blood clot attached to a wall of the blood vessel,
- une étape 810 de gonflement du ballonnet,  a step 810 of balloon inflation,
- une étape 815 d'insertion d'un cathéter secondaire afin de réaliser un traitement sur un autre caillot artériel,  a step 815 for inserting a secondary catheter in order to perform a treatment on another arterial clot,
- une étape 820 de d'extraction du cathéter secondaire une fois le traitement terminé,  a step 820 of extraction of the secondary catheter after the treatment is completed,
- une étape 825 de dégonflement du ballonnet et  a step 825 of deflating the balloon and
- une étape 830 de rétractation du cathéter.  a step 830 for retracting the catheter.
L'étape 805 d'introduction d'un cathéter est réalisée, par exemple, par la perforation d'une paroi du vaisseau sanguin et par l'insertion du cathéter. Ce cathéter comporte un conduit, configuré pour conduire au moins un fluide, et un ballonnet comportant au moins un orifice radial et un orifice axial. Au cours de cette étape 805, on positionne le ballonnet porté par le cathéter en regard du caillot, le volume intérieur du ballonnet étant relié au conduit du cathéter.  The step 805 of introducing a catheter is performed, for example, by perforation of a wall of the blood vessel and insertion of the catheter. The catheter includes a conduit configured to conduct at least one fluid, and a balloon having at least one radial port and an axial port. During this step 805, the balloon carried by the catheter is positioned facing the clot, the inner volume of the balloon being connected to the catheter duct.
L'étape 810 de gonflement de ballonnet est réalisée, par exemple, en augmentant la pression du fluide dans le conduit du cathéter pour dilater au moins un orifice axial et radial pour qu'il reçoive au moins une partie du caillot. La pression du fluide est augmentée, par exemple, par l'actionnement d'un piston d'une seringue connectée au conduit du cathéter.  The balloon inflation step 810 is performed, for example, by increasing the fluid pressure in the catheter conduit to expand at least one axial and radial orifice to receive at least a portion of the clot. The pressure of the fluid is increased, for example, by the actuation of a piston of a syringe connected to the catheter conduit.
L'étape 815 d'insertion d'un cathéter secondaire est réalisée, par exemple, par une seconde perforation de la paroi du vaisseau sanguin et par l'insertion du cathéter secondaire. Ce cathéter secondaire est inséré dans l'orifice axial du ballonnet et le cathéter traverse intégralement l'orifice axial de manière réaliser un traitement en amont ou en aval du vaisseau sanguin par rapport au ballonnet.  The step 815 of inserting a secondary catheter is performed, for example, by a second perforation of the wall of the blood vessel and by the insertion of the secondary catheter. This secondary catheter is inserted into the axial bore of the balloon and the catheter integrally passes through the axial port to effect treatment upstream or downstream of the blood vessel relative to the balloon.
L'étape 820 d'extraction est réalisée, par exemple, par un utilisateur tirant le cathéter secondaire de manière à ce que le cathéter secondaire quitte le vaisseau sanguin traité. L'étape 825 de dégonflement, au moins partiel, du ballonnet pour retenir au moins une partie du caillot est réalisée, par exemple, par l'actionnement du piston de la seringue, de manière à augmenter le volume contenant le fluide. De cette manière, la pression dans le ballonnet diminue à la guise de l'utilisateur actionnant le piston de la seringue. The extraction step 820 is performed, for example, by a user pulling the secondary catheter so that the secondary catheter leaves the treated blood vessel. Step 825 of at least partial deflation of the balloon to retain at least a portion of the clot is achieved, for example, by the actuation of the piston of the syringe, so as to increase the volume containing the fluid. In this way, the pressure in the balloon decreases as desired by the user operating the plunger of the syringe.
L'étape 830 de rétractation du cathéter pour extraire chaque partie du caillot retenue dans le ballonnet au moins partiellement dégonflé est réalisée, par exemple, par un utilisateur tirant le cathéter de manière à ce que le cathéter quitte le vaisseau sanguin par le trou perforé au cours de l'étape 805 d'introduction.  The step 830 of retracting the catheter to extract each portion of the clot retained in the at least partially deflated balloon is performed, for example, by a user pulling the catheter so that the catheter leaves the blood vessel through the perforated hole in the catheter. during the introductory step 805.
Dans des variantes, le procédé 70 ne comporte pas d'étape 815 d'insertion d'un cathéter secondaire ni d'étape 820 d'extraction du cathéter secondaire. Dans ces variantes, le ballonnet ne comporte pas nécessairement d'orifice axial mais il comporte au moins un orifice axial et/ou radial.  In variants, the method 70 does not include a step 815 for inserting a secondary catheter or step 820 for extracting the secondary catheter. In these variants, the balloon does not necessarily have an axial orifice but it comprises at least one axial and / or radial orifice.
On observe, sur la figure 1 1 , un mode de réalisation particulier du dispositif 90 objet de la présente invention. Dans cette configuration, le dispositif 90 est configuré pour faciliter le traitement d'un anévrisme 1 105 endovasculaire. Le dispositif 90 comporte :  FIG. 11 shows a particular embodiment of the device 90 which is the subject of the present invention. In this configuration, the device 90 is configured to facilitate the treatment of an endovascular aneurysm. The device 90 comprises:
- un premier cathéter 1 1 15 sur lequel est monté un ballonnet 1 125 alimenté par un conduit 1 120  a first catheter 1 1 15 on which is mounted a balloon 1 125 fed by a conduit 1 120
- un cathéter 1 130 secondaire configuré pour relâcher des ressorts 1 135 dans l'anévrisme 1 105.  - A secondary catheter 1 130 configured to release springs 1 135 in the aneurysm 1 105.
Le ballonnet 1 125 comporte un orifice axial traversant de façon longitudinale le ballonnet 1 125 et permettant au flux sanguin de se poursuivre même quand le ballonnet 1 125 est gonflé.  The balloon 1125 has an axial port longitudinally extending through the balloon 1125 and allowing the blood flow to continue even when the balloon 1125 is inflated.
Pour traiter l'anévrisme 1 105, le ballonnet 1 125 est positionné en regard de l'anévrisme 1 105. Le ballonnet 1 125 est ensuite gonflé, comme illustré dans la figure 1 1 . Puis, un cathéter 1 130 secondaire est positionné en longeant le ballonnet 1 125 gonflé entre la paroi 1 1 10 du vaisseau sanguin et le ballonnet 1 125 de manière à ce que l'ouverture longitudinale du cathéter soit orientée vers l'intérieur de l'anévrisme 1 105. Des ressorts 1 135 sont injectés dans l'anévrisme 1 105 par l'application d'une pression, par le chirurgien, sur une seringue contenant les ressorts 1 135 et connectée au cathéter 1 130 secondaire. Les ressorts 1 135 remplissent l'anévrisme 1 105 de manière à remodeler le vaisseau sanguin. Une fois les ressorts 1 135 en place, le cathéter 1 130 secondaire est extrait du vaisseau sanguin, puis le ballonnet 1 125 est dégonflé. Finalement, le ballonnet 1 125 est extrait du vaisseau sanguin et le vaisseau sanguin est refermé par le chirurgien. To treat the aneurysm 1110, the balloon 1125 is positioned opposite the aneurysm 1 105. The balloon 1 125 is then inflated, as shown in Figure 1 1. Then, a secondary catheter 1 130 is positioned along the balloon 1125 inflated between the wall 11 of the blood vessel and the balloon 1125 so that the longitudinal opening of the catheter is oriented towards the interior of the catheter. Aneurysm 1 105. Springs 1 135 are injected into the aneurysm 1 105 by the application of pressure, by the surgeon, on a syringe containing the springs 1 135 and connected to the catheter 1 130 secondary. The springs 1 135 fill the aneurysm 1 105 so as to reshape the blood vessel. Once the springs 1 135 in Instead, the secondary catheter 110 is removed from the blood vessel, and then the balloon 1125 is deflated. Finally, balloon 1125 is removed from the blood vessel and the blood vessel is closed by the surgeon.
On observe, sur la figure 12, un mode de réalisation particulier du procédé 80 de traitement d'un anévrisme. Ce procédé 80 comporte :  FIG. 12 shows a particular embodiment of the method 80 for treating an aneurysm. This method 80 comprises:
- une étape 905 d'introduction d'un cathéter dans un vaisseau sanguin comportant un anévrisme,  a step 905 for introducing a catheter into a blood vessel comprising an aneurysm,
- une étape 910 de gonflement du ballonnet,  a step 910 for inflating the balloon,
- une étape 915 d'insertion d'un cathéter secondaire de manière à traverser un orifice radial et un orifice axial afin qu'une ouverture du second cathéter soit en vis-à-vis de l'anévrisme,  a step 915 for inserting a secondary catheter so as to pass through a radial orifice and an axial orifice so that an opening of the second catheter is vis-à-vis the aneurysm,
- une étape 920 de déploiement de spires de manière à combler l'anévrisme, a step 920 of deployment of turns so as to fill the aneurysm,
- une étape 925 d'extraction du cathéter secondaire, a step 925 for extracting the secondary catheter,
- une étape 930 de dégonflement, au moins partiel, du ballonnet, pour retenir au moins une partie du caillot et  a step 930 of deflating, at least partially, of the balloon, to retain at least a portion of the clot and
- une étape 935 de rétractation du cathéter pour extraire chaque partie du caillot retenue dans le ballonnet au moins partiellement dégonflé.  a step 935 of retracting the catheter to extract each part of the clot retained in the at least partially deflated balloon.
L'étape 905 d'introduction d'un cathéter est réalisée, par exemple, par la perforation d'une paroi du vaisseau sanguin et par l'insertion du cathéter. Ce cathéter comporte un conduit, configuré pour conduire au moins un fluide, et un ballonnet comportant au moins un orifice radial et un orifice axial. Au cours de cette étape 905, on positionne le ballonnet porté par le cathéter en regard d'un anévrisme, le volume intérieur du ballonnet étant relié au conduit du cathéter.  The step 905 of introducing a catheter is performed, for example, by the perforation of a wall of the blood vessel and the insertion of the catheter. The catheter includes a conduit configured to conduct at least one fluid, and a balloon having at least one radial port and an axial port. During this step 905, the balloon carried by the catheter is positioned facing an aneurysm, the inner volume of the balloon being connected to the catheter duct.
L'étape 910 de gonflement de ballonnet est réalisée, par exemple, en augmentant la pression du fluide dans le conduit du cathéter pour dilater au moins un orifice axial et radial pour qu'il reçoive au moins une partie du caillot. La pression du fluide est augmentée, par exemple, par l'actionnement d'un piston d'une seringue connectée au conduit du cathéter. Le ballonnet est configuré, par exemple, pour pouvoir agir sur des vaisseaux sanguins de trois millimètres de diamètre. Par exemple, le ratio entre la surface des ouvertures radiales formées dans la surface externe du ballonnet sur cette surface externe est, en position gonflée, inférieure à trois quarts et, préférentiellement à un demi. Ce qui permet la rétention d'un caillot pendant que le ballonnet est en cours de dégonflement. Au contraire, un ressort métallique aurait un ratio supérieur à neuf dixième et aurait tendance à déchiqueter le caillot pendant son repliement. The balloon inflation step 910 is performed, for example, by increasing the fluid pressure in the catheter conduit to expand at least one axial and radial port to receive at least a portion of the clot. The pressure of the fluid is increased, for example, by the actuation of a piston of a syringe connected to the catheter conduit. The balloon is configured, for example, to act on blood vessels three millimeters in diameter. For example, the ratio between the surface of the radial openings formed in the outer surface of the balloon on this outer surface is, in the inflated position, less than three quarters and, preferably, one half. This allows the retention of a clot while the balloon is being deflated. On the contrary, a spring metallic would have a ratio greater than nine tenths and would tend to shred the clot during its folding.
Finalement, contrairement à des systèmes utilisant un ressort métallique déformé par contraction longitudinale pour épouser les parois d'un vaisseau sanguin, un ballonnet s'étend selon toutes les directions lors de son gonflement. De plus, lors du dégonflement, le caillot est écrasé de manière sensiblement isotrope et n'a donc pas tendance à se déchirer. Au contraire, la déformation d'un ressort métallique provoquerait la compression radiale du caillot et son élongation longitudinale, ce qui pourrait le déchiqueter,  Finally, unlike systems using a metal spring deformed by longitudinal contraction to fit the walls of a blood vessel, a balloon extends in all directions as it swells. In addition, during deflation, the clot is crushed substantially isotropically and therefore does not tend to tear. On the contrary, the deformation of a metal spring would cause the radial compression of the clot and its longitudinal elongation, which could shred it,
On note que la forme des ouvertures radiales et/ou des bords de ces ouvertures est, dans des variantes, configurée pour faciliter la découpe et/ou la rétention du caillot, que ce soit lors du gonflement du ballonnet ou lors d'un déplacement du ballonnet.  Note that the shape of the radial openings and / or the edges of these openings is, in variants, configured to facilitate the cutting and / or the retention of the clot, whether during the balloon inflation or during a displacement of the balloon.
L'étape 915 d'insertion d'un cathéter secondaire est réalisée, par exemple, par une seconde perforation de la paroi du vaisseau sanguin et par l'insertion du cathéter secondaire. Ce cathéter secondaire est inséré dans l'orifice axial du ballonnet de manière à également traverser un orifice radial du ballonnet.  The step 915 of inserting a secondary catheter is performed, for example, by a second perforation of the wall of the blood vessel and by the insertion of the secondary catheter. This secondary catheter is inserted into the axial bore of the balloon so as to also pass through a radial bore of the balloon.
L'étape 920 de déploiement de spires est réalisée, par exemple, par l'insertion dans une lumière du cathéter d'une aiguille de seringue. Puis, un utilisateur actionne un piston de la seringue de manière à pousser les spires dans le cathéter et, donc, de manière à pousser les spires hors de l'ouverture du cathéter situé en regard de l'anévrisme. Ces spires sont configurées pour combler l'anévrisme.  The coil deployment step 920 is performed, for example, by inserting a syringe needle into a lumen of the catheter. Then, a user actuates a piston of the syringe so as to push the turns into the catheter and, thus, to push the turns out of the opening of the catheter located opposite the aneurysm. These turns are configured to fill the aneurysm.
L'étape 925 d'extraction est réalisée, par exemple, par un utilisateur tirant le cathéter secondaire de manière à ce que le cathéter secondaire quitte le vaisseau sanguin traité.  The extraction step 925 is performed, for example, by a user pulling the secondary catheter so that the secondary catheter leaves the treated blood vessel.
L'étape 930 de dégonflement, au moins partiel, du ballonnet pour retenir au moins une partie du caillot est réalisée, par exemple, par l'actionnement du piston de la seringue, de manière à augmenter le volume contenant le fluide. De cette manière, la pression dans le ballonnet diminue à la guise de l'utilisateur actionnant le piston.  Step 930 of at least partial deflation of the balloon to retain at least a portion of the clot is achieved, for example, by the actuation of the piston of the syringe, so as to increase the volume containing the fluid. In this way, the pressure in the balloon decreases as desired by the user operating the piston.
L'étape 935 de rétractation du cathéter pour extraire chaque partie du caillot retenue dans le ballonnet au moins partiellement dégonflé est réalisée, par exemple, par un utilisateur tirant le cathéter de manière à ce que le cathéter quitte le vaisseau sanguin par le trou perforé au cours de l'étape 805 d'introduction.  The step 935 of retracting the catheter to extract each portion of the clot retained in the at least partially deflated balloon is performed, for example, by a user pulling the catheter so that the catheter leaves the blood vessel through the perforated hole in the catheter. during the introductory step 805.

Claims

REVENDICATIONS
1 . Dispositif (10, 30, 40, 60) de chirurgie endovasculaire, qui comporte : 1. Device (10, 30, 40, 60) for endovascular surgery, which comprises:
- un cathéter (105, 305, 405, 615) comportant un conduit (1 10, 310, 410, 620) configuré pour conduire au moins un fluide,  a catheter (105, 305, 405, 615) comprising a conduit (1 10, 310, 410, 620) configured to conduct at least one fluid,
- un ballonnet (1 15, 315, 415, 625) dont le volume intérieur est relié à un conduit du cathéter et configuré pour être gonflé ou dégonflé en fonction de la pression du fluide dans le conduit du cathéter,  a balloon (1, 15, 315, 415, 625) whose interior volume is connected to a catheter duct and configured to be inflated or deflated according to the fluid pressure in the catheter duct,
caractérisé en ce que le ballonnet est muni d'au moins un orifice radial (125, 325, 425) entouré par une paroi (120, 220, 330, 435, 635) pour fragmenter au moins une partie du caillot, chaque dit orifice radial recevant au moins une partie fragmentée du caillot lors du gonflement du ballonnet et retenant au moins une partie fragmentée du caillot lors du dégonflement, au moins partiel, du ballonnet. characterized in that the balloon is provided with at least one radial orifice (125, 325, 425) surrounded by a wall (120, 220, 330, 435, 635) for fragmenting at least a portion of the clot, each said radial orifice receiving at least a fragmented portion of the clot upon inflation of the balloon and retaining at least a fragmented portion of the clot upon at least partial deflation of the balloon.
2. Dispositif (10, 20, 30, 40, 60) selon la revendication 1 , dans lequel au moins un orifice (125, 225, 325, 425) du ballonnet (1 15, 215, 315, 415) est un orifice radial borgne. The device (10, 20, 30, 40, 60) according to claim 1, wherein at least one port (125, 225, 325, 425) of the balloon (115, 215, 315, 415) is a radial orifice. blind.
3. Dispositif (10, 20, 30, 40, 60) selon l'une des revendications 1 ou 2, dans lequel le ballonnet (1 15, 315, 415, 625) forme un volume creux une fois au moins partiellement gonflé, au moins un orifice (125, 325, 425) du ballonnet traversant le ballonnet pour relier le volume creux à l'extérieur du ballonnet. 3. Device (10, 20, 30, 40, 60) according to one of claims 1 or 2, wherein the balloon (1 15, 315, 415, 625) forms a hollow volume once at least partially inflated, at at least one port (125, 325, 425) of the balloon passing through the balloon for connecting the hollow volume to the outside of the balloon.
4. Dispositif (30, 40, 60, 90) selon l'une des revendications 1 à 3, qui comporte un orifice axial (320, 420) traversant le ballonnet pour permettre le passage d'un flux sanguin. 4. Device (30, 40, 60, 90) according to one of claims 1 to 3, which comprises an axial orifice (320, 420) passing through the balloon to allow the passage of a blood flow.
5. Dispositif (40) selon les revendications 3 et 4, qui comporte un moyen (430) de rétention d'un caillot sanguin dans le volume creux du ballonnet (415) lorsque le ballonnet est gonflé, le volume creux étant au moins partiellement formé par l'orifice axial (420). 5. Device (40) according to claims 3 and 4, which comprises means (430) for retaining a blood clot in the hollow volume of the balloon (415) when the balloon is inflated, the hollow volume being at least partially formed through the axial orifice (420).
6. Dispositif (40) selon la revendication 5, dans lequel le moyen (430) de rétention est un maillage obstruant au moins une extrémité de l'orifice axial (420). 6. Device (40) according to claim 5, wherein the means (430) of retention is a mesh obstructing at least one end of the axial orifice (420).
7. Dispositif (30, 40, 60) selon la revendication 5, dans lequel le moyen (415) de rétention est un diaphragme positionné sur au moins une extrémité de l'orifice axial7. Device (30, 40, 60) according to claim 5, wherein the means (415) of retention is a diaphragm positioned on at least one end of the axial orifice
(420). (420).
8. Dispositif (30, 40) selon l'une des revendications 1 à 7, dans lequel au moins un orifice (320, 325, 420, 425) du ballonnet est un orifice configuré pour laisser passer un cathéter secondaire lorsque le ballonnet (315, 415) est gonflé. The device (30, 40) according to one of claims 1 to 7, wherein at least one port (320, 325, 420, 425) of the balloon is an orifice configured to pass a secondary catheter when the balloon (315 , 415) is inflated.
9. Dispositif (10, 30, 60) selon l'une des revendications 1 à 8, dans lequel le ballonnet (1 15, 315, 625) est relié au cathéter (105, 305, 615) au niveau de l'axe du ballonnet. 9. Device (10, 30, 60) according to one of claims 1 to 8, wherein the balloon (1 15, 315, 625) is connected to the catheter (105, 305, 615) at the axis of the balloon.
10. Dispositif (20, 40, 90) selon l'une des revendications 1 à 9, dans lequel le ballonnet (215, 415, 1 125) est relié au cathéter (205, 405, 1 1 15) au niveau de la périphérie du ballonnet. The device (20, 40, 90) according to one of claims 1 to 9, wherein the balloon (215, 415, 115) is connected to the catheter (205, 405, 1115) at the periphery. of the balloon.
1 1 . Dispositif (10, 20, 30, 40, 60) selon l'une des revendications 1 à 10, dans lequel au moins une paroi (120, 220, 330, 435, 635) entre deux orifices radiaux (125, 225, 325, 425) présente une forme convexe vers l'extérieur du ballonnet de manière à fragmenter un caillot lors du gonflement du ballonnet. 1 1. Device (10, 20, 30, 40, 60) according to one of claims 1 to 10, wherein at least one wall (120, 220, 330, 435, 635) between two radial orifices (125, 225, 325, 425) has an outwardly convex shape of the balloon so as to fragment a clot during inflation of the balloon.
PCT/FR2014/051114 2013-05-13 2014-05-13 Endovascular surgery device WO2014184489A1 (en)

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FR1354281 2013-05-13
FR1354281A FR3005404B1 (en) 2013-05-13 2013-05-13 DEVICE AND METHOD FOR ENDOVASCULAR SURGERY

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