WO2023230302A1 - Système d'ablation de lumière et méthode de traitement des varices le mettant en œuvre - Google Patents

Système d'ablation de lumière et méthode de traitement des varices le mettant en œuvre Download PDF

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Publication number
WO2023230302A1
WO2023230302A1 PCT/US2023/023647 US2023023647W WO2023230302A1 WO 2023230302 A1 WO2023230302 A1 WO 2023230302A1 US 2023023647 W US2023023647 W US 2023023647W WO 2023230302 A1 WO2023230302 A1 WO 2023230302A1
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WO
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Prior art keywords
lumen
ablation
balloon
access
conduit
Prior art date
Application number
PCT/US2023/023647
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English (en)
Inventor
Kevin T. Lie
Original Assignee
Lie Kevin T
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Publication date
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Publication of WO2023230302A1 publication Critical patent/WO2023230302A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00008—Vein tendon strippers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/12127—Double occlusion, e.g. for creating blood-free anastomosis site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22067—Blocking; Occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320004—Surgical cutting instruments abrasive
    • A61B2017/320012—Brushes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320741—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/007—Auxiliary appliance with irrigation system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A61M2025/1015—Multiple balloon catheters having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters

Definitions

  • the invention relates to a lumen ablation system and method of treating varicose veins with said lumen ablation system.
  • Varicose veins are typically treated with a sclerosant that is injected into the vein and/or by ablation.
  • the sclerosant is not isolated within the lumen and therefore can be reduced in concentration in a desired section of the lumen. Also, ablation can lead to debris that can travel along the lumen and cause clotting.
  • the invention is directed to a lumen ablation system and method of treating varicose veins with said lumen ablation system.
  • An exemplary lumen ablation system utilizes a pair of balloons to isolate a section of lumen for treatment.
  • An access balloon that is a toroid balloon with an access balloon aperture is configured proximal to a lumen access aperture.
  • An isolation balloon is configured an offset distance from the access balloon to form an isolated lumen between the two inflated balloons.
  • the isolation balloon may be translated along a guide wire that extends through an access port and also through the access balloon aperture.
  • An ablation treatment apparatus is translated into the isolated lumen through the access port and also through the access balloon aperture.
  • the ablation treatment apparatus has an ablation implement, such as an ablation brush comprising a plurality of tines extending radially outward from the ablation conduit.
  • the ablation treatment apparatus may be configured on a distal end of a catheter and the catheter may provide a conduit for aspirating the isolated lumen and/or delivering therapeutic agent into the isolated lumen.
  • the isolated lumen may be ablated by moving the ablation treatment apparatus back and forth with the therapeutic agent, such as a sclerosant therein.
  • An exemplary access port is configured through a lumen access aperture and is configured over a guidewire that extends through the access port conduit and into the lumen.
  • the access to the lumen may be created by first puncturing the lumen wall with a needle.
  • An introducer sheath may then be configured down over the needle and into the lumen.
  • An exemplary introducer sheath has a needle conduit to enable the introducer sheath to translate over the needle.
  • an exemplary introducer sheath has a guide wire deflector with opposing surfaces that are configured to direct the guide wire in either direction along the lumen.
  • the guide wire deflector may be a generally dome shaped deflector that extends up into the introducer sheath conduit.
  • a pair of guide wire apertures may be configured to align with the opposing deflecting surfaces of the guide wire deflector.
  • the opposing surfaces of the guide wire deflector may be curved surfaces and may be concave curved surfaces. Fluoroscopy may be used to ensure that the guide wire is directed in a desired direction along the lumen.
  • An exemplary access balloon may be coupled on a distal end of the access port and an access balloon inflation conduit may extend along the access port to an access balloon interface for inflating and deflating the access balloon.
  • the access balloon, access balloon inflation conduit and/or the access balloon interface may be part of the access port.
  • the access balloon is a toroid balloon having a toroid shape with a access balloon aperture therethrough to allow introduction and removal of the guide wire, insolation balloon and ablation treatment apparatus therethrough.
  • An access port conduit may be in fluid communication with the access balloon aperture to enable a smooth interface for the introduction of components into the lumen.
  • An isolation balloon may be an over-wire balloon that extends around the guide wire.
  • An isolation balloon inflation conduit may be coupled directly with the isolation balloon and may act as a shaft to push the isolation balloon along the guide wire to an offset distance from the access balloon.
  • the isolation balloon conduit may be coupled with an isolation balloon interface to enable introduction of an inflation fluid into the isolation balloon to inflate the isolation balloon.
  • An exemplary ablation treatment apparatus comprises ablation aperture to allow a flow of therapeutic agent into the lumen, such as sclerosant.
  • the ablation treatment apparatus may have one or more apertures through the ablation conduit wall, or apertures that are radial to the length of the ablation conduit.
  • an ablation aperture may be configured in a distal end of the ablation conduit.
  • the location of the ablation apertures with respect to the ablation implement may prevent sealing off of the ablation apertures during aspiration of the lumen.
  • the agent apertures in the ablation treatment apparatus may be configured in the ablation conduit wall distal from the ablation implement or between tines of the ablation implement to prevent the lumen from collapsing down over the agent apertures.
  • the ablation treatment apparatus may be on a distal end of an ablation catheter to allow aspiration of the lumen and also introduction of the therapeutic agent into the lumen via an ablation interface.
  • An exemplary ablation treatment apparatus has an ablation implement configured to ablate or injure the inside surface of the lumen wall by scraping along the inside surface of the lumen wall.
  • An exemplary ablation implement comprises a plurality of tines that extend radially outward from the ablation conduit, thereby forming an ablation brush. The individual tines may enable the isolation balloon inflation conduit to move between the tines as the ablation implement is moved back and forth to ablate the lumen.
  • the lumen may be aspirated to cause the lumen to collapse, which may increase the effectiveness of the physical ablation via the ablation implement.
  • the access port may be used to aspirate the lumen initially and then the ablation treatment apparatus may be used to aspirate the lumen and may be moved between the access balloon and isolation balloon to provide effective aspiration and also collapse of the lumen.
  • the therapeutic agent may be introduced into the lumen and retained between the isolation balloon and the access balloon.
  • the ablation implement may be moved back and forth within the isolated lumen after the introduction of the therapeutic agent.
  • the lumen may be aspirated after introduction of the therapeutic agent and after ablation to remove the therapeutic agent and any debris from the ablation process.
  • a lumen as used herein, may be a vasculature lumen, such as a vein or artery, or other lumen within the body such as any lumen in the digestive track including intestine, urethra and the like.
  • Figure 1 shows a side cross sectional view of a lumen, such as a vein, and a lumen ablation system with an ablation treatment apparatus configured between an access balloon and an isolation balloon to treat the inside of the isolated lumen wall with therapeutic agent and with a physical ablation implement, such as a brush.
  • a lumen such as a vein
  • an ablation treatment apparatus configured between an access balloon and an isolation balloon to treat the inside of the isolated lumen wall with therapeutic agent and with a physical ablation implement, such as a brush.
  • Figure 2 shows a side view of an introducer sheath for a guide wire having a deflector to enable the guide wire to be guided in opposing directions along the lumen.
  • Figure 3 shows a front view of the introducer sheath shown in FIG. 2 having a guide wire access aperture in the wall of the introducer sheath with the deflector configure within and extending up from the distal end of the introducer sheath.
  • Figure 4 shows an introducer sheath as depicted in FIG. 2 and 3 now configured through a lumen access aperture in the lumen wall of a lumen, such as a vein, and a guide wire being directed in a first direction along the lumen.
  • Figure 5 shows the introducer sheath shown in FIG. 4 but with the guide wire now being deflected by the guide wire deflector in a second direction along the lumen, opposite the first direction shown in FIG. 4.
  • Figure 6 shows an access port configured in a lumen access aperture in the lumen wall with an access balloon, a toroid balloon, configured on the distal end of the access port with an access balloon aperture for introducing a guidewire, an isolation balloon and also the ablation treatment apparatus therethrough.
  • Figure 7 shows the lumen ablation system shown in FIG. 6, with the access balloon inflated by the access-balloon interface and the guide wire being introduced into the lumen through the access port, and the access balloon aperture.
  • Figure 8 shows the lumen ablation system shown in FIG. 7, with an isolation balloon, an over-wire balloon, being inflated by the isolation-balloon interface.
  • Figure 9 shows the lumen ablation system shown in FIG. 8, with the isolation balloon now inflated to produce an isolated lumen between the isolation balloon and the access balloon.
  • Figure 10 shows the lumen ablation system shown in FIG. 9, with the access interface aspirating the isolated lumen to remove the blood from the isolated lumen.
  • Figure 11 shows the lumen ablation system shown in FIG. 10, with the ablation treatment apparatus configured over the guidewire and being introduced through the access port.
  • Figure 12 shows the lumen ablation system shown in FIG. 11 , with the ablation treatment apparatus introduced into the isolated lumen through the access port and aspirating the isolated lumen to further collapse the lumen through the ablation interface.
  • Figure 13 shows the lumen ablation system shown in FIG. 12 with the ablation treatment apparatus further introduced toward the isolation balloon and aspirating to collapse the lumen down between the isolation balloon and the access balloon.
  • Figure 14 shows the lumen ablation system shown in FIG. 13, with the ablation treatment apparatus introducing therapeutic agent through the therapeutic agent conduit and out of the ablation treatment apparatus into the isolated lumen.
  • Figure 15 shows the lumen ablation system shown in FIG. 14, with the ablation treatment apparatus being translated back and forth within the isolated lumen to ablate the lumen having therapeutic agent therein.
  • Figure 16 shows the lumen ablation system shown in FIG. 15, with vacuum being drawn through the ablation treatment apparatus to remove therapeutic agent and any debris within the isolated lumen and to collapse the isolated lumen.
  • Figure 17 shows the lumen ablation system shown in FIG. 16, with the ablation treatment apparatus withdrawn from the lumen and the isolated lumen collapsed.
  • Figure 18 shows the lumen ablation system shown in FIG. 17, with the isolation balloon collapsed for removal.
  • Figure 19 shows the lumen ablation system shown in FIG. 18, with the isolation balloon removed and the isolated lumen collapsed.
  • the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having” or any other variation thereof, are intended to cover a non-exclusive inclusion.
  • a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
  • use of "a” or “an” are employed to describe elements and components described herein. This is done merely for convenience and to give a general sense of the scope of the invention. This description should be read to include one or at least one and the singular also includes the plural unless it is obvious that it is meant otherwise.
  • an ablation treatment apparatus 10 is configured in an isolated lumen 28 between an access balloon 32 and an isolation balloon 50 to treat the interior surface 24 of the lumen wall 23 with therapeutic agent 80.
  • the therapeutic agent 80 is delivered through the agent conduit to the ablation treatment apparatus 60 having agent apertures 68 to dispense the therapeutic agent into the isolated lumen 28.
  • the ablation treatment apparatus 60 also has an ablation implement 70, such as an ablation brush 71 comprising a plurality of tines 73 that extend radially outward from the ablation conduit wall 65 and configured to physical ablate the interior surface 24 of the lumen wall 23 when the ablation treatment apparatus is moved back and forth within the isolated lumen 28.
  • the therapeutic agent 80 is retained within the isolated lumen along with any plague that may be dislodged from the lumen wall during the ablation process.
  • the ablation treatment apparatus 60 and isolation balloon are guided into the lumen by a guide wire 40 that extends through the access port 30, and the access balloon aperture 36 in the access balloon 32.
  • the guide wire 40 extends through the ablation treatment apparatus 60, the access balloon aperture 36 in the access balloon 32 to a distal end 42 within the lumen 20.
  • the guide wire has a proximal end 44 that may be used to manipulate the guide wire along the lumen.
  • the isolation balloon 50 is guided along the guide wire 40 and is inflated by the introduction of inflation fluid through the isolation balloon inflation conduit 55 delivered by the inflation balloon interface 58. Inflation of the isolation balloon and the access balloon 32 produces the isolated lumen 28.
  • the access balloon 32 is configured on the distal end of the access port 30 and is inflated by the introduction of inflation fluid through the access balloon inflation conduit 35 delivered by the access balloon interface 38 that may be part of the access port 30.
  • the ablation treatment apparatus 60 is introduced through the access port 30, through the access balloon aperture 36 along the guide wire 40 and may be configured on or as part of an ablation catheter 61 that forms a therapeutic agent conduit 62 extending from the ablation treatment apparatus 60 to the ablation interface 63.
  • the ablation interface may be used to move the ablation treatment apparatus 60 into and within the isolated lumen 28 and may also be used to aspirate the isolated lumen as well as deliver therapeutic agent, such as sclerosant into the isolated lumen.
  • the therapeutic agent 80 is delivered to the ablation treatment apparatus 60 through the therapeutic agent conduit 62 by agent apertures 68 in the ablation treatment apparatus 60 via the therapeutic ablation interface 63, which may be a syringe or valve.
  • the ablation treatment apparatus 60 may have agent apertures in the ablation conduit wall and also an end aperture 66 on the distal end of the ablation treatment apparatus 60.
  • the ablation implement 70 such as an ablation brush 71 , is coupled with the ablation conduit 64 formed by an ablation conduit wall 65.
  • the therapeutic agent 80 is delivered through agent apertures 68 in the ablation treatment apparatus 60, such as in the ablation conduit wall 65 or in the distal end of the ablation conduit 64.
  • access to the lumen may be initiated by a needle 89 that punctures through the lumen wall 23 from the exterior surface 22 to the interior surface 24 of the lumen wall.
  • An introducer sheath 90 may then be configured over the needle and pushed through the lumen wall to provide access to the lumen 20.
  • the needle may extend through the needle conduit 99 in the guide wire deflector 96, configured on the distal end 98 of introducer sheath 90.
  • the guide wire deflector 96 has opposing curved surfaces 97 that are configured to guide the guide wire 40 in opposing directions and out one of the guide wire apertures 94, 94’ in the introducer wall 92. As shown in FIG.
  • the needle conduit 99 is centrally configured in the guide wire deflector 96.
  • the guide wire 40 is being deflected by the guide wire deflector 96 and introduced through the guide wire aperture 94 in a first direction down the lumen 20 and as shown in FIG. 5 the guide wire 40 is being deflected by the guide wire deflector 96 and introduced through the guide wire aperture 94’ guided in a second direction down the lumen, opposite the first direction.
  • an access port 30 is configured in a lumen access aperture 26 in the lumen wall 23 with an access balloon 32, a toroid balloon 34, configured on the distal end of the access port with an access balloon aperture 36 for introducing a guidewire, an isolation balloon and also the ablation treatment apparatus therethrough.
  • the access balloon 32 is not inflated and does not occlude the lumen 20.
  • the access balloon may be coupled to the access port 30 and the access port may include the access-balloon interface 38.
  • the access balloon 32 has been inflated through the introduction of inflation fluid from the access balloon inflation conduit 35 and the access balloon interface 38.
  • the lumen ablation system 10 has the distal end 42 of the guide wire 40 being introduced into the lumen 20 through the access port 30 and the access balloon aperture 36, in the access balloon 32.
  • the access balloon has been inflated through the introduction of inflation fluid from the access balloon inflation conduit 35 and the access balloon interface 38.
  • a syringe may be coupled with the access balloon interface to introduce the inflation fluid into the toroid balloon 34 forming the access balloon 32.
  • the lumen ablation system 10 has the isolation balloon 50 introduced into the lumen 20 through the access port 30, and the access balloon aperture 36 in the access balloon 32.
  • the isolation balloon 50 is being inflated by the introduction of an inflation fluid through the isolation balloon inflation conduit 55 via the isolation balloon interface 58.
  • the isolation balloon inflation conduit may act as a shaft to push the inflation balloon 50 along the guidewire 40.
  • the inflation balloon may be an over-wire balloon that extends over or around the guidewire.
  • a syringe may be coupled with the isolation balloon interface to inject inflation fluid, such as saline or water, into the isolation balloon 50 to expand the isolation balloon wall 52 against the interior surface 24 of the lumen wall 23.
  • the lumen ablation system 10 has the isolation balloon 50 now inflated to produce an isolated lumen 28 having a length 51 between the isolation balloon 50 and the access balloon 32.
  • the isolated lumen will prevent therapeutic agent and thrombus or other debris from the ablation process from traveling along the lumen.
  • the isolation balloon is configured an offset distance 51 from the access balloon 32 to create the isolated lumen 28.
  • the isolated lumen 28 is being aspirated by the accessballoon interface 31 , as indicated by the large bold arrow extending from the access balloon interface, to remove the blood from the isolated lumen.
  • the ablation treatment apparatus 50 is configured over the guidewire 40 and is being introduced through the access port 30.
  • the lumen ablation system 10 has the ablation treatment apparatus 60 introduced into the isolated lumen 28 through the access port 30 and through the access balloon aperture 36 in the access balloon 32.
  • the isolated lumen is being further aspirated to remove any additional blood and to collapse the isolated lumen through the agent apertures in the ablation treatment apparatus 68.
  • the ablation treatment apparatus may have an agent aperture on the distal end 69.
  • the ablation treatment apparatus 60 may be moved to the isolation balloon and then withdrawn while the lumen is aspirated to remove blood and collapse the isolated lumen 28.
  • the ablation treatment apparatus 60 is translated further toward the isolation balloon 50 and ismaspirating the lumen 20 to cause it to collapse down between the isolation balloon and access balloon.
  • therapeutic agent 80 is being introduced into the isolated lumen 28 by the ablation treatment apparatus 60 through the ablation interface 63 as indicated by the large arrow.
  • the therapeutic agent 80 is being dispense from agent apertures 68 in the ablation treatment apparatus 60, such as in the ablation conduit wall 65 or in the distal end of the ablation conduit 64.
  • the ablation treatment apparatus 60 is being translated back and forth within the isolated lumen 28 to ablate the lumen having therapeutic agent 80 therein.
  • the ablation implement 70 such as a ablation brush 71 extends radially outward from the ablation conduit 64.
  • the ablation brush may comprise a plurality of individual tines 73 that enable sliding past the isolation balloon inflation conduit 55.
  • the therapeutic agent 80 and any debris is being withdrawn from the isolated lumen 28 by a vacuum drawn through the ablation treatment apparatus, such as though the agent apertures 68 in the conduit wall 65 of the agent conduit 62.
  • the agent apertures 68 may be configured through the ablation conduit wall 65 and on the distal end of the ablation conduit 64 and this may be an effective location to withdraw fluid from the lumen as the ablation implement 70 may prevent the lumen from sealing off the agent apertures. With the agent apertures located just distal the ablation implement 70, the ablation implement, extending radially outward from the ablation conduit wall 65, will prevent sealing off of the agent apertures 68.
  • the lumen 20 has been collapsed by the vacuum drawn through the ablation treatment apparatus 60. Collapsing the lumen wall may be desired in varicose vein treatment applications.
  • the ablation treatment apparatus 60 has been withdrawn from the isolated lumen through the access-balloon aperture 36 in the access balloon 30 and through the access port 30.
  • the isolation balloon 50 is collapsed for removal.
  • the isolation balloon 50 is removed and the isolated lumen 28 is collapsed.
  • the access balloon 32 is deflated for removal of the access port 30 and access balloon 32 through the lumen access aperture 26.

Abstract

L'invention concerne un système d'ablation de lumière constituant une méthode de traitement des varices avec une paire de ballonnets pour isoler une section de lumière. Un ballonnet d'accès toroïdal est configuré à proximité d'une ouverture d'accès à la lumière. Un ballonnet d'isolation est configuré à une distance décalée du ballonnet d'accès pour former une lumière isolée entre les deux ballonnets gonflés. Le ballonnet d'isolation peut être translaté le long d'un fil guide qui s'étend à travers un orifice d'accès et également à travers l'ouverture de ballonnet d'accès toroïdal. Un appareil de traitement par ablation pourvu d'un instrument d'ablation, tel qu'une brosse d'ablation dont les dents s'étendent radialement vers l'extérieur à partir du conduit d'ablation, est translaté dans la lumière isolée. L'appareil de traitement d'ablation peut être configuré sur un cathéter ayant un conduit pour aspirer la lumière avec un agent thérapeutique. L'ablation de la lumière isolée peut être réalisée par déplacement de l'appareil de traitement par ablation à l'intérieur de l'agent thérapeutique, tel qu'un sclérosant.
PCT/US2023/023647 2022-05-26 2023-05-26 Système d'ablation de lumière et méthode de traitement des varices le mettant en œuvre WO2023230302A1 (fr)

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Citations (6)

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US20020026145A1 (en) * 1997-03-06 2002-02-28 Bagaoisan Celso J. Method and apparatus for emboli containment
US20020029031A1 (en) * 1996-05-20 2002-03-07 Bagaoisan Celso J. Methods for emboli containment
US20020052638A1 (en) * 1996-05-20 2002-05-02 Gholam-Reza Zadno-Azizi Method and apparatus for emboli containment
US6569147B1 (en) * 1996-07-26 2003-05-27 Kensey Nash Corporation Systems and methods of use for delivering beneficial agents for revascularizing stenotic bypass grafts and other occluded blood vessels and for other purposes
US20060200191A1 (en) * 1996-05-20 2006-09-07 Gholam-Reza Zadno-Azizi Method and apparatuses for treating an intravascular occlusion
US20140277002A1 (en) * 2013-03-13 2014-09-18 The Spectranetics Corporation Assisted cutting balloon

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020029031A1 (en) * 1996-05-20 2002-03-07 Bagaoisan Celso J. Methods for emboli containment
US20020052638A1 (en) * 1996-05-20 2002-05-02 Gholam-Reza Zadno-Azizi Method and apparatus for emboli containment
US20060200191A1 (en) * 1996-05-20 2006-09-07 Gholam-Reza Zadno-Azizi Method and apparatuses for treating an intravascular occlusion
US6569147B1 (en) * 1996-07-26 2003-05-27 Kensey Nash Corporation Systems and methods of use for delivering beneficial agents for revascularizing stenotic bypass grafts and other occluded blood vessels and for other purposes
US20020026145A1 (en) * 1997-03-06 2002-02-28 Bagaoisan Celso J. Method and apparatus for emboli containment
US20140277002A1 (en) * 2013-03-13 2014-09-18 The Spectranetics Corporation Assisted cutting balloon

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