WO2024046551A1 - Avp device with lobe/segment designed to fill aneurysm sac - Google Patents

Avp device with lobe/segment designed to fill aneurysm sac Download PDF

Info

Publication number
WO2024046551A1
WO2024046551A1 PCT/EP2022/074175 EP2022074175W WO2024046551A1 WO 2024046551 A1 WO2024046551 A1 WO 2024046551A1 EP 2022074175 W EP2022074175 W EP 2022074175W WO 2024046551 A1 WO2024046551 A1 WO 2024046551A1
Authority
WO
WIPO (PCT)
Prior art keywords
sac
segment
aneurysm
occluding
metallic body
Prior art date
Application number
PCT/EP2022/074175
Other languages
French (fr)
Inventor
Fearghal O'Connor
Michael Whelan
Ciaran GILES
Original Assignee
Clearstream Technologies Limited
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 Clearstream Technologies Limited filed Critical Clearstream Technologies Limited
Priority to PCT/EP2022/074175 priority Critical patent/WO2024046551A1/en
Publication of WO2024046551A1 publication Critical patent/WO2024046551A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • 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
    • A61B17/1214—Coils or wires
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • 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
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • 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
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • 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
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/1219—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices expandable in contact with liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A61B17/12045—Type of occlusion temporary occlusion double occlusion, e.g. during anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00893—Material properties pharmaceutically effective
    • 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
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12095—Threaded connection

Definitions

  • AVP device with lobe/segment designed to fill aneurysm sac
  • the present invention relates to an aneurysm embolization device and method.
  • an Amplatzer vascular plug also known as an AVP
  • AVP is a vascular occlusion device which can be used in peripheral vasculature.
  • the Amplatzer vascular plug includes a collapsible and expandable mesh having a plurality of braided metal strands and is able to expand and contract or retract between a deliverable configuration, for being housed inside a lumen of a delivery catheter, and an expanded configuration. In the expanded configuration, the Amplatzer vascular plug may occlude a blood vessel for a vascular occlusion.
  • An aneurysm is a specific vascular disease, in which an abnormal blood-filled bulge of a blood vessel forms an aneurysm sac, which may result from weakening of the vessel wall.
  • the aneurysm involves a risk of rupture, which leads to uncontrolled bleeding.
  • an aneurysm embolization operation includes filling in of the aneurysm sac with an aneurysm sac filler.
  • a physician fills in the aneurysm sac with a coil.
  • the physician needs a first coil device, typically a catheter, in order to position a tip of the coil in vicinity of the neck of the aneurysm sac, and a second coil device to orient the tip of the coil towards the aneurysm sac, and to make sure that the coil is pushed inside the aneurysm sac and not in the blood vessel. Since it is necessary, in order to perform a successful occlusion, to use multiple coil devices, the process of aneurysm embolization is generally known as a complex operation, and the risks of failure are high.
  • the above-mentioned Amplatzer vascular plug is not suitable for being used for aneurysm embolization.
  • the Amplatzer vascular plug suffers from the same drawback as the coil, which is that multiple devices such as catheters are needed in order to successfully occlude an aneurysm.
  • the geometry of the Amplatzer vascular plug is not adapted for being anchored in an aneurysm sac. For that reason, Amplatzer vascular plugs are usually not used as aneurysm embolization devices.
  • an aneurysm embolization device for filling in an aneurysm sac includes:
  • an anchoring segment including an expandable metallic body, the expandable metallic body including a collapsible and expandable mesh having a plurality of braided metal strands, the expandable metallic body being configured for implantation in a blood vessel of a vascular system, being configured to expand and contract between a deliverable configuration and an expanded configuration and having, in the expanded configuration, a distal region, a proximal region opposite the distal region and an intermediate region transitioning from the distal region to the proximal region, the expandable metallic body being configured so that the intermediate region radially contacts a wall of a blood vessel, when it is expanded in a blood vessel in which the anchoring segment is implanted, and
  • the sac-occluding segment attached to the anchoring segment on a side of the distal region, the sac-occluding segment being configured to fill an aneurysm sac after that the anchoring segment is implanted in a vascular system.
  • an aneurysm embolization method comprising, in this order:
  • an anchoring segment including an expandable metallic body, the expandable metallic body including a collapsible and expandable mesh having a plurality of braided metal strands, the expandable metallic body being in a deliverable configuration
  • the expandable metallic body to an expanded configuration so that it has a distal region, a proximal region opposite the distal region and an intermediate region transitioning from the distal region to the proximal region, the intermediate region radially contacting a wall of the blood vessel, and - deploying a sac-occluding segment in an aneurysm sac of the aneurysm, the sac- occluding segment being attached to the anchoring segment on a side of the distal region, so that the sac-occluding segment fills in the aneurysm sac.
  • FIG. 1 shows a schematic view of an aneurysm embolization device positioned in vicinity of an aneurysm sac, in which the aneurysm embolization device is still housed in a delivery catheter,
  • FIG. 2 is a cross-sectional view of the aneurysm embolization device of Fig. 1 taken along lines II-II of Fig. 1,
  • FIG. 3 is a schematic view of the aneurysm embolization device of Figs. 1 and 2, in which the anchoring segment of the aneurysm embolization device is out of the delivery catheter and in the expanded configuration,
  • FIG. 4 is a schematic view of the aneurysm embolization device of Figs. 1 to 3, in which a delivery tip is oriented towards the aneurysm sac,
  • FIG. 5 is a schematic view of the aneurysm embolization device of Figs. 1 to 4, in which a sac-occluding segment of the aneurysm embolization device fills in the aneurysm sac,
  • FIG. 6 is a detailed view of the attachment and detachment mechanism between the anchoring segment and the sac-occluding segment of the aneurysm embolization device
  • FIG. 7 is a schematic view of the aneurysm embolization device of Figs. 1 to 6, in which the anchoring segment is still deployed, and the sac-occluding segment is detached from the anchoring segment,
  • FIG. 8 is a schematic view of the aneurysm embolization device of Figs. 1 to 7, when the anchoring segment is contracted and removed from the vascular system,
  • FIG. 9 is a flow chart illustrating an aneurysm embolization method implemented by means of the aneurysm embolization device of Figs. 1 to 8,
  • FIG. 10 is a flow chart illustrating another aneurysm embolization method
  • - Fig. 11 is a schematic view of an aneurysm embolization device according to one or more embodiments shown and described herein
  • - Fig. 12 is a schematic view of an aneurysm embolization device according to one or more embodiments shown and described herein
  • FIG. 13 is a schematic view of another aneurysm embolization device according to one or more embodiments shown and described herein,
  • FIG. 14 is a schematic view of another aneurysm embolization device according to one or more embodiments shown and described herein,
  • FIG. 15 is a detailed view of the attachment and detachment mechanism of the aneurysm embolization device of Fig. 14,
  • FIG. 16 is a schematic view of an aneurysm embolization device according to one or more embodiments shown and described herein, and
  • FIG. 17 is a schematic view of another aneurysm embolization device according to one or more embodiments shown and described herein.
  • an aneurysm embolization device and an aneurysm embolization method involve an anchoring segment including an expandable metallic body and a sac-occluding segment attached to the anchoring segment on a side of the distal region and configured to fill an aneurysm sac after that the anchoring segment is implanted in a vascular system.
  • This improves anchoring of the aneurysm embolization device, making it no longer required to use at least two different devices in order to properly fill an aneurysm sac.
  • the use of an anchoring segment including an expandable metallic body is particularly advantageous since it is quick to expand and contract and shows a reduced risk of misuse by a physician.
  • an anchoring segment involves no risk that the ball stent would burst. This is particularly interesting in the context of an aneurysm embolization device, since the physician generally intends to occlude the aneurysm but wishes to avoid occluding the vessel in vicinity of the aneurysm.
  • Various aspects of the present disclosure include a hypotube, a delivery tip and an aperture provided at the delivery tip. Such features improve the deliverability of the sac-occluding segment, which makes it even easier for the physician to fill the aneurysm sac.
  • Various aspects of the present disclosure include attachment and detachment mechanisms which are advantageous because they allow firmly attaching the sac- occluding segment in a simple and reliable manner, which is of particular importance in the present context because the sac-occluding segment is intended to be pushed in a direction which is different to that of the vessel and which is different to the longitudinal direction of a delivery catheter positioning the anchoring segment in the blood vessel.
  • Figs. 1 to 8 show an aneurysm embolization device 100 according to one or more embodiments shown and described herein may be implemented.
  • the aneurysm embolization device 100 may be received in a blood vessel 102.
  • the blood vessel 102 may include an aneurysm 104 forming an aneurysm sac 105.
  • the aneurysm sac 105 may include an aneurysm neck 106 and an aneurysm dome 108.
  • the aneurysm embolization device 100 may fill the aneurysm sac 105.
  • the aneurysm embolization device 100 may include a delivery catheter 110.
  • the delivery catheter 110 may include a cylindrical wall 112 which may define a lumen 114. As shown in Fig. 2, an axial cross-section of the cylindrical wall 112 may be circular.
  • the delivery catheter 110 may include one or more radiopaque bands 116.
  • the radiopaque band 116 may be a circumferential continuous band provided on an outside surface of the cylindrical wall 112.
  • the radiopaque band 116 may be provided in vicinity of a tip of the delivery catheter 110.
  • the aneurysm embolization device 100 may include an anchoring segment 118.
  • the anchoring segment 118 may be housed in the lumen 114 before deployment of the aneurysm embolization device 100 in the blood vessel 102.
  • the anchoring segment 118 may be removed from the blood vessel 102 after the filling in of the aneurysm sac 105 is completed.
  • the anchoring segment 118 may include an expandable metallic body 120.
  • the expandable metallic body 120 may include a collapsible and expandable mesh having a plurality of braided metal strands 121 (partially depicted in Figs. 1 and 3).
  • the expandable metallic body 120 may expand into in an expanded configuration as shown in Figs. 3, 4 and 5.
  • the expandable metallic body 120 may contract or retract into a deliverable configuration as shown in Figs. 1 and 2. When the expandable metallic body 120 is contracted or retracted in the deliverable configuration as shown by Figs. 1 and 2, it may be housed in the lumen 114.
  • the expandable metallic body 120 is in the expanded configuration as shown by Figs.
  • the expandable metallic body 120 may expand when it is extended and contract when it is retracted. The expansion of the expandable metallic body 120 may occur when it is expanded past the tip of the catheter 110, and vice-versa when retracted and pulled inside the catheter tip.
  • the proximal region 122 and the distal region 124 may be opposite to each other.
  • the intermediate region 126 may transition from the distal region 124 to the proximal region 122.
  • the proximal region 122 may be, with respect to the distal region 124, in vicinity of the delivery catheter 110.
  • the distal region 124 may be, with respect to the proximal region 122, in vicinity of the aneurysm 104.
  • the intermediate region 126 may radially contact a wall of the blood vessel 102 as shown in Figs. 3, 4 and 5. By doing so, the expandable metallic body 120 may anchor the anchoring segment 118 with respect to the blood vessel 102.
  • the anchoring segment may include a prothrombogenic compound 128.
  • the prothrombogenic compound 128 may be coated on an exterior surface of the intermediate region 126. By doing so, the prothrombogenic compound 128 may radially contact the wall of the blood vessel 102 and may speed up occlusion of the blood vessel 102, in case the anchoring segment 118 is to be left in the blood vessel 102 for vascular occlusion after deployment of the aneurysm embolization device 100 in the aneurysm 104.
  • the anchoring segment 118 may include a vascular endothelial growth factor compound 130.
  • the vascular endothelial growth factor compound 130 may be coated on an exterior surface of the intermediate region 126. By doing so, the vascular endothelial growth factor compound 130 may radially contact a wall of the blood vessel 102 and aid the natural formation of the vascular walls that seal off the vascular plug.
  • the anchoring segment 118 may further include a hypotube 132.
  • the hypotube 132 may include a proximal portion 134, a curved portion 136, a delivery portion 138 and a delivery tip 140.
  • the hypotube 132 may extend through the expandable metallic body 120 at least between the proximal region 122 and the distal region 124.
  • the hypotube 132 may further extend from the distal region 124 towards the aneurysm 104.
  • the hypotube 132 may have an axial cross-section profile smaller than an axial cross-section profile of the expandable metallic body 120 in the deliverable configuration. By doing so, the hypotube 132 may remain at least partially inside the expandable metallic body 120 in order to be positioned in the blood vessel when the anchoring segment 118 is positioned in the blood vessel 102.
  • the proximal portion 134 may be rectilinear and parallel to a center axis of the delivery catheter 110.
  • the curved portion 136 may be flexible and have a bending elasticity in order to form different angles or radii of curvature. In particular, the angle formed by the curved portion 136 may be less important when the anchoring segment 118 is received in the delivery catheter 110, as shown in Figs. 1 and 2, than when the anchoring segment 118 is pushed out of the delivery catheter 110 and when the expandable metallic body 120 is in the expanded configuration.
  • the delivery portion 138 may be rectilinear.
  • the proximal portion 134 may extend between the proximal region 122 and the distal region 124 and may further extend from the distal region 124 towards the aneurysm 104.
  • the curved portion 136, the delivery portion 138 and the delivery tip 140 may be closer to the distal region 124 than to the proximal region 122.
  • the curved portion 136, the delivery portion 138 and the delivery tip 140 may be provided on a side of the expandable metallic body 120 which is a side of the distal region 124.
  • the delivery portion 138 may form an angle with respect to the proximal portion 134. In the present application, the angle of the delivery portion 138 is the acute angle a (see Figs.
  • the delivery tip 140 may be oriented towards a particular location of the wall of the blood vessel 102, such as the aneurysm sac 105.
  • the delivery tip 140 may include an aperture 147 (Fig. 6).
  • the aperture 147 may correspond to a frontal axial end of the delivery portion 138.
  • the aperture 147 may define a deployment direction intersecting a center axis of the proximal portion 134 of the hypotube 132.
  • the anchoring segment 118 may include one or more radiopaque bands 141.
  • the radiopaque bands 141 may be provided on the hypotube 132. As shown in Fig. 2, the radiopaque bands 141 may be provided in vicinity of the delivery tip 140.
  • the aneurysm embolization device 100 further includes a sac-occluding segment 142.
  • the sac-occluding segment 142 may include a coil.
  • the coil can be formed by a wire, e.g. metallic, which is flexible in bending and can therefore bend around itself in order to fill the aneurysm sac with an optimal filling density while being easily deliverable.
  • the sac-occluding segment 142 may be configured to fill the aneurysm sac 105 after that the anchoring segment 118 is implanted in the blood vessel 102.
  • the sac-occluding segment 142 may be housed in the hypotube 132 before deployment of the sac-occluding segment 142.
  • the sac-occluding segment 142 may be configured to be deployed into the aneurysm sac 105 from the delivery tip 140 of the hypotube 132.
  • the sac-occluding segment 142 may include a prothrombogenic compound 144.
  • the prothrombogenic compound 144 may be coated on an exterior surface of the sac-occluding segment 142.
  • the prothrombogenic compound 144 may be coated on an exterior surface of the coil 142.
  • the sac-occluding segment 142 may include a vascular endothelial growth factor compound 146.
  • the vascular endothelial growth factor compound 146 may be coated on an exterior surface of the sac-occluding segment 142.
  • the vascular endothelial growth factor compound 146 may be coated on an exterior surface of the coil 142.
  • the aneurysm embolization device 100 may include an attachment and detachment mechanism 148.
  • the attachment and detachment mechanism 148 may include a screw mechanism including a male screw 150 attached to the hypotube 132 of the anchoring segment 118, and a female screw 152 attached to the sac-occluding segment 142.
  • the screw mechanism may have a different configuration, such as a male screw attached to the sac-occluding segment 142 and a female screw attached to the hypotube 132 of the anchoring segment 118.
  • the anchoring segment 118 and the sac-occluding segment 142 may be releasably attached to each other.
  • an aneurysm embolization method according to one or more embodiments shown and described herein may be implemented.
  • the aneurysm embolization method of Fig. 9 may be implemented using the aneurysm embolization device 100 of Figs. 1 to 8.
  • the aneurysm embolization method may include a first main step S10 of delivering, in the blood vessel 102, the anchoring segment 118.
  • the anchoring segment 118 may, in this step, include the expandable metallic body 120 in the deliverable configuration.
  • the main step S10 may include a first step Si l of positioning the delivery catheter 110 in the blood vessel 102 as shown in Fig. 1.
  • the delivery catheter 110 may be inside the blood vessel 102 and the anchoring segment 118 may be in the lumen 114 as shown by Fig. 1.
  • the main step S10 may include a second step S12 of monitoring a position of the radiopaque bands 116 and 141.
  • the main step S10 may include a further step S13 of pushing the anchoring segment 118 out of the delivery catheter 110.
  • the exemplary method of Fig. 9 may include a further main step S20 of expanding the expandable metallic body 120 from the deliverable configuration to the expanded configuration.
  • the step S20 may be immediately performed after that the anchoring segment 118 is pushed out of the delivery catheter.
  • the aneurysm embolization method and the expandable metallic body 120 may be designed so that no further action is required from the physician in order to cause expansion of the expandable metallic body 120 once it is pushed out of the delivery catheter 110.
  • the expandable metallic body 120 may be resilient and spring to the expanded configuration once it is released from the delivery catheter, and/or it may be formed from a memory-shape material.
  • the expandable metallic body 120 may be in the expanded configuration, so that it may have the distal region 124, the proximal region 122 opposite the distal region 124, and the intermediate region transitioning from the distal region 124 to the proximal region 122.
  • the intermediate region 126 may radially contact a wall of the blood vessel 102.
  • the aneurysm embolization device 100 and the anchoring segment 118 may be in the configuration as shown by Fig. 3.
  • the curved portion 136 may be further relaxed in such a position that the delivery portion 138 and the proximal portion 134 form a larger (acute) angle a with respect to the axis 135 than before the main step S20.
  • the delivery tip 140 may be radially offset with respect to a center axis of the delivery catheter 110.
  • the exemplary aneurysm embolization method may include a further main step S30 of deploying the sac-occluding segment 142 in the aneurysm sac 105. By doing so, the sac-occluding segment 142 may fill the aneurysm sac 105.
  • the main step S30 may include a first step S31 of positioning the delivery tip 140 with respect to the aneurysm sac 105. More specifically, in the configuration of Fig. 3, which may be the configuration after the main step S20, the delivery tip 140 may point towards a direction different from the direction towards the aneurysm sac 105. Therefore, the step S31 may include pivoting the hypotube 132 with respect to the anchoring segment 118, so that the delivery tip 140 points towards the aneurysm sac 105. The pivoting action may be accomplished manually. For example, the physician may, in the meantime, monitor a position of the radiopaque bands 116 and/or 141.
  • the manual pivoting may be accomplished by means of a knob (not depicted), for example on the delivery catheter 110, and of a torque transmission mechanism (not depicted) inside the delivery catheter 110 which may mechanically connect the knob and the hypotube 132 to each other.
  • a knob for example on the delivery catheter 110
  • a torque transmission mechanism (not depicted) inside the delivery catheter 110 which may mechanically connect the knob and the hypotube 132 to each other.
  • the anchoring segment 118 when pivoting the hypotube 132, the axial position of the hypotube is not modified and the step of positioning the delivery tip 140 may be implemented with a great precision.
  • the aneurysm embolization device 100 and the hypotube 132 of the anchoring segment 118 may be in the configuration shown by Fig. 4.
  • the main step S30 may include a further step S32 of sliding the sac-occluding segment 142 inside the hypotube 132.
  • the sac-occluding segment 142 may be a coil and the step S32 includes sliding a flexible wire adapted to form a coil inside the hypotube 132. By doing so, the sac-occluding segment 142 may be directed by the delivery tip 140 towards the aneurysm sac 105.
  • the main step S30 may include a further step S33 of passing the sac-occluding segment 142 into the aneurysm sac 105 from the delivery tip 140.
  • the step S33 may include passing the sac-occluding segment 142 through the aperture 147. By doing so, the sac-occluding segment 142 may be directed towards the aneurysm sac 105 and may fill the aneurysm sac 105.
  • the step S33 may be implemented until the aneurysm sac 105 is occluded. After the step S33, the sac-occluding segment 142 may fill the aneurysm sac 105 and still be attached to the anchoring segment 118 as shown by Fig. 5.
  • the main step S30 may include a further step S34 of detaching the sac-occluding segment 142 from the anchoring segment 118.
  • the attachment and detachment mechanism may be actuated so that the male screw 150 and the female screw 152 are unscrewed from each other.
  • the sac-occluding segment 142 and the anchoring segment 118 may be in the same configuration as that of after the step S33, except that they are detached from each other, as shown by Fig. 7.
  • the main step S30 may include a further step S35 of collapsing the expandable metallic body 120.
  • the expandable metallic body 120 being made of a collapsible and expandable mesh having a plurality of braided metal strands, a physician may contract the expandable metallic body 120 only by pulling the anchoring segment 118 inside the lumen 114 of the delivery catheter 110. Contracting the expandable metallic body 120 may be implemented easily by virtue of the fact that it may be resilient and spring to the expanded configuration once it is released from the delivery catheter, and/or foldable in such a way that pulling back the expandable metallic body 120 decreases the volume thereof to such an extent that it may be accommodated in the lumen 114.
  • the main step S30 may include a further step S36 of removing the anchoring segment 118 from the blood vessel 102.
  • the aneurysm embolization device 100 and the sac-occluding segment 142 may be in the configuration shown by Fig- 8.
  • Fig. 10 shows an exemplary aneurysm embolization method according to one or more embodiments described herein.
  • the exemplary aneurysm embolization method of Fig. 10 may include, instead of the main step S30 of the exemplary embolization method of Fig. 9, a main step S40 of leaving the anchoring segment 118 in the blood vessel 102 for vascular occlusion after deployment of the sac-occluding segment 142 in the aneurysm sac 105.
  • the main step S40 may include the steps S31, S32 and S33 of the main step S30 of the method of Fig. 9.
  • the main step S40 may be provided without the steps S34, S35 and S36 of the main step S30 of the method of Fig. 9.
  • aneurysm embolization device 100 of Figs. 1 to 8 it is possible to use the aneurysm embolization device 100 of Figs. 1 to 8 in order to occlude each of an aneurysm and a blood vessel. Thanks to the method of Fig. 10, the aneurysm 104 and the blood vessel 102 may be occluded by the aneurysm embolization device 100.
  • Fig. 11 shows an exemplary aneurysm embolization device 160 according to one or more embodiments described herein.
  • the exemplary aneurysm embolization device 160 may include an additional expandable metallic body 162.
  • the additional expandable metallic body 162 may include a collapsible and expandable mesh having a plurality of braided metal strands.
  • the additional expandable metallic body 162 may be configured to expand and contract between a deliverable configuration and an expanded configuration.
  • the additional expandable metallic body 162 may be housed, when it is in the deliverable configuration, inside the lumen 114 of the delivery catheter 110.
  • the additional expandable metallic body 162 may be identical to the expandable metallic body 120. Further to the additional expandable metallic body 162, a third, a fourth, ... and an n-th expandable metallic body (not shown) may be provided.
  • the additional expandable metallic body 162 may be attached to the distal region 124 of the expandable metallic body 120.
  • a further attachment and detachment mechanism 164 may be provided between the expandable metallic body 120 and the additional expandable metallic body 162.
  • the aneurysm embolization device 160 may improve anchoring of the device 160 during embolization of the aneurysm sac 105.
  • one or more of the expandable metallic bodies 120, 162 may be left in the blood vessel 102 after deployment of the sac-occluding segment 142 in the aneurysm sac 105.
  • a vascular occlusion of the blood vessel 102 may be performed using the aneurysm embolization device 160, in addition to embolization of the aneurysm 104.
  • Fig. 12 shows an exemplary aneurysm embolization device 170 according to one or more embodiments described herein.
  • the exemplary aneurysm embolization device 170 may be in a configuration in which the sac-occluding segment 142 is deployed and fills in the aneurysm sac 105.
  • the sac-occluding segment 142 may include a mesh.
  • the mesh may be expandable.
  • the mesh may be provided in replacement of the coil.
  • the sac-occluding segment 142 may further include a closed cage 172.
  • the closed cage 172 may include a proximal area 174 which may be configured to fill the neck 106. In such a case, the proximal area 174 may form a limit between the blood vessel 102 and the aneurysm sac 105.
  • the closed cage 172 may include a distal area 178.
  • the distal area 178 may have a semispherical shape.
  • the distal area 178 may abut against the dome 108 of the aneurysm sac 105.
  • Fig. 13 shows an exemplary aneurysm embolization device 180 according to one or more embodiments described herein.
  • the exemplary aneurysm embolization device 180 may include a membrane 182.
  • the membrane 182 may be expandable.
  • the membrane 182 may be provided in addition to the mesh of the sac-occluding segment 142 of the aneurysm embolization device of Fig. 12.
  • the membrane 182 may also be provided in replacement of the mesh.
  • Fig. 14 and Fig. 15 show an exemplary aneurysm embolization device 190 according to one or more embodiments described herein.
  • the exemplary aneurysm embolization device 190 may include a hydrogel 192.
  • the hydrogel 192 may be provided in addition to a mesh and/or a membrane, or in replacement of a mesh and/or a membrane.
  • the hydrogel 192 may fill the aneurysm sac 105 in order to perform embolization of the aneurysm 104.
  • the aneurysm embolization device 190 may include an attachment and detachment mechanism 194 including a connecting rod 196 and a thicker portion 198.
  • an attachment and detachment mechanism 194 including a connecting rod 196 and a thicker portion 198.
  • Fig. 16 shows an exemplary aneurysm embolization device 200 according to one or more embodiments described herein.
  • the exemplary aneurysm embolization device 200 may include an attachment and detachment mechanism 202.
  • the attachment and detachment mechanism 202 may include a first interlock hook 204 and a second interlock hook 206.
  • the first interlock hook 204 may be attached to the delivery tip 140 of the hypotube 132.
  • the second interlock hook 206 may be attached to the sac-occluding segment 142.
  • the attachment and detachment mechanism 202 may releasably attach the anchoring segment 118 to the sac-occluding segment 142.
  • the aneurysm embolization device 210 may be in a configuration in which the sac-occluding segment 142 is deployed in the aneurysm sac 105.
  • the sac-occluding segment 142 may include an open-ended cage 212.
  • the open- ended cage 212 may have a shape similar to that of the proximal area 174 of the closed cage 172.
  • the open-ended cage 212 may fill the neck 106 of the aneurysm 104.
  • the word “fill” shall be understood as being deployed within a certain volume so as to occupy at least a portion of said volume.
  • the term "temporary implantation” means that the object in question is designed to remain implanted only for a typical period of time corresponding to the filling of an aneurysm sac by a physician.

Abstract

An aneurysm embolization device for filling in an aneurysm sac includes: - an anchoring segment including an expandable metallic body, the expandable metallic body including a collapsible and expandable mesh having a plurality of braided metal strands, the expandable metallic body being configured for implantation in a blood vessel of a vascular system, being configured to expand and contract between a deliverable configuration and an expanded configuration and having, in the expanded configuration, a distal region, a proximal region opposite the distal region and an intermediate region transitioning from the distal region to the proximal region, the expandable metallic body being configured so that the intermediate region radially contacts a wall of a blood vessel, when it is expanded in a blood vessel in which the anchoring segment is implanted, and - a sac-occluding segment attached to the anchoring segment on a side of the distal region, the sac-occluding segment being configured to fill an aneurysm sac after that the anchoring segment is implanted in a vascular system

Description

AVP device with lobe/segment designed to fill aneurysm sac
Technical Field
[0001] The present invention relates to an aneurysm embolization device and method.
Background
[0002] In order to treat various vascular diseases, it is known to use an occlusion device. For example, an Amplatzer vascular plug, also known as an AVP, is a vascular occlusion device which can be used in peripheral vasculature. The Amplatzer vascular plug includes a collapsible and expandable mesh having a plurality of braided metal strands and is able to expand and contract or retract between a deliverable configuration, for being housed inside a lumen of a delivery catheter, and an expanded configuration. In the expanded configuration, the Amplatzer vascular plug may occlude a blood vessel for a vascular occlusion.
[0003] An aneurysm is a specific vascular disease, in which an abnormal blood-filled bulge of a blood vessel forms an aneurysm sac, which may result from weakening of the vessel wall. The aneurysm involves a risk of rupture, which leads to uncontrolled bleeding.
[0004] To treat this disease, an aneurysm embolization operation includes filling in of the aneurysm sac with an aneurysm sac filler. Typically, a physician fills in the aneurysm sac with a coil. To do so, the physician needs a first coil device, typically a catheter, in order to position a tip of the coil in vicinity of the neck of the aneurysm sac, and a second coil device to orient the tip of the coil towards the aneurysm sac, and to make sure that the coil is pushed inside the aneurysm sac and not in the blood vessel. Since it is necessary, in order to perform a successful occlusion, to use multiple coil devices, the process of aneurysm embolization is generally known as a complex operation, and the risks of failure are high.
[0005] The above-mentioned Amplatzer vascular plug is not suitable for being used for aneurysm embolization. In particular, the Amplatzer vascular plug suffers from the same drawback as the coil, which is that multiple devices such as catheters are needed in order to successfully occlude an aneurysm. Furthermore, the geometry of the Amplatzer vascular plug is not adapted for being anchored in an aneurysm sac. For that reason, Amplatzer vascular plugs are usually not used as aneurysm embolization devices.
[0006] There is therefore a need for providing a device or a method which would facilitate the operation of aneurysm embolization, in particular by making it no longer required to use a plurality of devices in order to perform a successful occlusion.
Summary of Invention
[0007] According to a first aspect of the present disclosure, an aneurysm embolization device for filling in an aneurysm sac includes:
- an anchoring segment including an expandable metallic body, the expandable metallic body including a collapsible and expandable mesh having a plurality of braided metal strands, the expandable metallic body being configured for implantation in a blood vessel of a vascular system, being configured to expand and contract between a deliverable configuration and an expanded configuration and having, in the expanded configuration, a distal region, a proximal region opposite the distal region and an intermediate region transitioning from the distal region to the proximal region, the expandable metallic body being configured so that the intermediate region radially contacts a wall of a blood vessel, when it is expanded in a blood vessel in which the anchoring segment is implanted, and
- a sac-occluding segment attached to the anchoring segment on a side of the distal region, the sac-occluding segment being configured to fill an aneurysm sac after that the anchoring segment is implanted in a vascular system.
[0008] According to a second aspect of the present disclosure, there is provided an aneurysm embolization method comprising, in this order:
- delivering, in a blood vessel of a vascular system, an anchoring segment including an expandable metallic body, the expandable metallic body including a collapsible and expandable mesh having a plurality of braided metal strands, the expandable metallic body being in a deliverable configuration,
- expanding the expandable metallic body to an expanded configuration so that it has a distal region, a proximal region opposite the distal region and an intermediate region transitioning from the distal region to the proximal region, the intermediate region radially contacting a wall of the blood vessel, and - deploying a sac-occluding segment in an aneurysm sac of the aneurysm, the sac- occluding segment being attached to the anchoring segment on a side of the distal region, so that the sac-occluding segment fills in the aneurysm sac.
Brief Description of Drawings
[0009] To enable better understanding of the present disclosure, and to show how the same may be carried into effect, reference will now be made, by way of example only, to the accompanying schematic drawings, in which
- Fig. 1 shows a schematic view of an aneurysm embolization device positioned in vicinity of an aneurysm sac, in which the aneurysm embolization device is still housed in a delivery catheter,
- Fig. 2 is a cross-sectional view of the aneurysm embolization device of Fig. 1 taken along lines II-II of Fig. 1,
- Fig. 3 is a schematic view of the aneurysm embolization device of Figs. 1 and 2, in which the anchoring segment of the aneurysm embolization device is out of the delivery catheter and in the expanded configuration,
- Fig. 4 is a schematic view of the aneurysm embolization device of Figs. 1 to 3, in which a delivery tip is oriented towards the aneurysm sac,
- Fig. 5 is a schematic view of the aneurysm embolization device of Figs. 1 to 4, in which a sac-occluding segment of the aneurysm embolization device fills in the aneurysm sac,
- Fig. 6 is a detailed view of the attachment and detachment mechanism between the anchoring segment and the sac-occluding segment of the aneurysm embolization device,
- Fig. 7 is a schematic view of the aneurysm embolization device of Figs. 1 to 6, in which the anchoring segment is still deployed, and the sac-occluding segment is detached from the anchoring segment,
- Fig. 8 is a schematic view of the aneurysm embolization device of Figs. 1 to 7, when the anchoring segment is contracted and removed from the vascular system,
- Fig. 9 is a flow chart illustrating an aneurysm embolization method implemented by means of the aneurysm embolization device of Figs. 1 to 8,
- Fig. 10 is a flow chart illustrating another aneurysm embolization method,
- Fig. 11 is a schematic view of an aneurysm embolization device according to one or more embodiments shown and described herein, - Fig. 12 is a schematic view of an aneurysm embolization device according to one or more embodiments shown and described herein,
- Fig. 13 is a schematic view of another aneurysm embolization device according to one or more embodiments shown and described herein,
- Fig. 14 is a schematic view of another aneurysm embolization device according to one or more embodiments shown and described herein,
- Fig. 15 is a detailed view of the attachment and detachment mechanism of the aneurysm embolization device of Fig. 14,
- Fig. 16 is a schematic view of an aneurysm embolization device according to one or more embodiments shown and described herein, and
- Fig. 17 is a schematic view of another aneurysm embolization device according to one or more embodiments shown and described herein.
Description of Embodiments
[0010] According to the present disclosure, an aneurysm embolization device and an aneurysm embolization method involve an anchoring segment including an expandable metallic body and a sac-occluding segment attached to the anchoring segment on a side of the distal region and configured to fill an aneurysm sac after that the anchoring segment is implanted in a vascular system. This improves anchoring of the aneurysm embolization device, making it no longer required to use at least two different devices in order to properly fill an aneurysm sac. In particular, the use of an anchoring segment including an expandable metallic body is particularly advantageous since it is quick to expand and contract and shows a reduced risk of misuse by a physician. Compared in particular to an inflatable device such as a ball stent, such an anchoring segment involves no risk that the ball stent would burst. This is particularly interesting in the context of an aneurysm embolization device, since the physician generally intends to occlude the aneurysm but wishes to avoid occluding the vessel in vicinity of the aneurysm.
[0011] Various aspects of the present disclosure include a hypotube, a delivery tip and an aperture provided at the delivery tip. Such features improve the deliverability of the sac-occluding segment, which makes it even easier for the physician to fill the aneurysm sac. [0012] Various aspects of the present disclosure include attachment and detachment mechanisms which are advantageous because they allow firmly attaching the sac- occluding segment in a simple and reliable manner, which is of particular importance in the present context because the sac-occluding segment is intended to be pushed in a direction which is different to that of the vessel and which is different to the longitudinal direction of a delivery catheter positioning the anchoring segment in the blood vessel.
[0013] Figs. 1 to 8 show an aneurysm embolization device 100 according to one or more embodiments shown and described herein may be implemented. The aneurysm embolization device 100 may be received in a blood vessel 102. The blood vessel 102 may include an aneurysm 104 forming an aneurysm sac 105. The aneurysm sac 105 may include an aneurysm neck 106 and an aneurysm dome 108. The aneurysm embolization device 100 may fill the aneurysm sac 105.
[0014] The aneurysm embolization device 100 may include a delivery catheter 110. The delivery catheter 110 may include a cylindrical wall 112 which may define a lumen 114. As shown in Fig. 2, an axial cross-section of the cylindrical wall 112 may be circular.
[0015] The delivery catheter 110 may include one or more radiopaque bands 116. The radiopaque band 116 may be a circumferential continuous band provided on an outside surface of the cylindrical wall 112. The radiopaque band 116 may be provided in vicinity of a tip of the delivery catheter 110.
[0016] The aneurysm embolization device 100 may include an anchoring segment 118. The anchoring segment 118 may be housed in the lumen 114 before deployment of the aneurysm embolization device 100 in the blood vessel 102. The anchoring segment 118 may be removed from the blood vessel 102 after the filling in of the aneurysm sac 105 is completed.
[0017] The anchoring segment 118 may include an expandable metallic body 120. The expandable metallic body 120 may include a collapsible and expandable mesh having a plurality of braided metal strands 121 (partially depicted in Figs. 1 and 3). The expandable metallic body 120 may expand into in an expanded configuration as shown in Figs. 3, 4 and 5. The expandable metallic body 120 may contract or retract into a deliverable configuration as shown in Figs. 1 and 2. When the expandable metallic body 120 is contracted or retracted in the deliverable configuration as shown by Figs. 1 and 2, it may be housed in the lumen 114. When the expandable metallic body 120 is in the expanded configuration as shown by Figs. 3, 4 and 5, it may extend outside of the lumen 114 and it may include a proximal region 122, a distal region 124 and an intermediate region 126. That is, the expandable metallic body 120 may expand when it is extended and contract when it is retracted. The expansion of the expandable metallic body 120 may occur when it is expanded past the tip of the catheter 110, and vice-versa when retracted and pulled inside the catheter tip. The proximal region 122 and the distal region 124 may be opposite to each other. The intermediate region 126 may transition from the distal region 124 to the proximal region 122. The proximal region 122 may be, with respect to the distal region 124, in vicinity of the delivery catheter 110. The distal region 124 may be, with respect to the proximal region 122, in vicinity of the aneurysm 104. When the expandable metallic body 120 is expanded in the blood vessel 102, the intermediate region 126 may radially contact a wall of the blood vessel 102 as shown in Figs. 3, 4 and 5. By doing so, the expandable metallic body 120 may anchor the anchoring segment 118 with respect to the blood vessel 102.
[0018] As visible in Fig. 3, the anchoring segment may include a prothrombogenic compound 128. The prothrombogenic compound 128 may be coated on an exterior surface of the intermediate region 126. By doing so, the prothrombogenic compound 128 may radially contact the wall of the blood vessel 102 and may speed up occlusion of the blood vessel 102, in case the anchoring segment 118 is to be left in the blood vessel 102 for vascular occlusion after deployment of the aneurysm embolization device 100 in the aneurysm 104.
[0019] As shown in Fig. 3, the anchoring segment 118 may include a vascular endothelial growth factor compound 130. The vascular endothelial growth factor compound 130 may be coated on an exterior surface of the intermediate region 126. By doing so, the vascular endothelial growth factor compound 130 may radially contact a wall of the blood vessel 102 and aid the natural formation of the vascular walls that seal off the vascular plug.
[0020] The anchoring segment 118 may further include a hypotube 132. The hypotube 132 may include a proximal portion 134, a curved portion 136, a delivery portion 138 and a delivery tip 140. The hypotube 132 may extend through the expandable metallic body 120 at least between the proximal region 122 and the distal region 124. The hypotube 132 may further extend from the distal region 124 towards the aneurysm 104. As visible in Fig. 2, the hypotube 132 may have an axial cross-section profile smaller than an axial cross-section profile of the expandable metallic body 120 in the deliverable configuration. By doing so, the hypotube 132 may remain at least partially inside the expandable metallic body 120 in order to be positioned in the blood vessel when the anchoring segment 118 is positioned in the blood vessel 102.
[0021] The proximal portion 134 may be rectilinear and parallel to a center axis of the delivery catheter 110. The curved portion 136 may be flexible and have a bending elasticity in order to form different angles or radii of curvature. In particular, the angle formed by the curved portion 136 may be less important when the anchoring segment 118 is received in the delivery catheter 110, as shown in Figs. 1 and 2, than when the anchoring segment 118 is pushed out of the delivery catheter 110 and when the expandable metallic body 120 is in the expanded configuration. The delivery portion 138 may be rectilinear. The proximal portion 134 may extend between the proximal region 122 and the distal region 124 and may further extend from the distal region 124 towards the aneurysm 104. The curved portion 136, the delivery portion 138 and the delivery tip 140 may be closer to the distal region 124 than to the proximal region 122. The curved portion 136, the delivery portion 138 and the delivery tip 140 may be provided on a side of the expandable metallic body 120 which is a side of the distal region 124. The delivery portion 138 may form an angle with respect to the proximal portion 134. In the present application, the angle of the delivery portion 138 is the acute angle a (see Figs. 1 and 3) measured with an axis 135 of the proximal portion 134. The axis 135 may be an extension of an axis of symmetry of the proximal portion 134. By virtue of this configuration, the delivery tip 140 may be oriented towards a particular location of the wall of the blood vessel 102, such as the aneurysm sac 105.
[0022] The delivery tip 140 may include an aperture 147 (Fig. 6). The aperture 147 may correspond to a frontal axial end of the delivery portion 138. The aperture 147 may define a deployment direction intersecting a center axis of the proximal portion 134 of the hypotube 132.
[0023] The anchoring segment 118 may include one or more radiopaque bands 141. The radiopaque bands 141 may be provided on the hypotube 132. As shown in Fig. 2, the radiopaque bands 141 may be provided in vicinity of the delivery tip 140. [0024] The aneurysm embolization device 100 further includes a sac-occluding segment 142. The sac-occluding segment 142 may include a coil. The coil can be formed by a wire, e.g. metallic, which is flexible in bending and can therefore bend around itself in order to fill the aneurysm sac with an optimal filling density while being easily deliverable. The sac-occluding segment 142 may be configured to fill the aneurysm sac 105 after that the anchoring segment 118 is implanted in the blood vessel 102. In this regard, the sac-occluding segment 142 may be housed in the hypotube 132 before deployment of the sac-occluding segment 142. The sac-occluding segment 142 may be configured to be deployed into the aneurysm sac 105 from the delivery tip 140 of the hypotube 132.
[0025] As visible in Fig. 2, the sac-occluding segment 142 may include a prothrombogenic compound 144. The prothrombogenic compound 144 may be coated on an exterior surface of the sac-occluding segment 142. In particular, the prothrombogenic compound 144 may be coated on an exterior surface of the coil 142. By virtue of this arrangement, occlusion of the aneurysm sac 105 may be speeded up.
[0026] As shown in Fig. 2, the sac-occluding segment 142 may include a vascular endothelial growth factor compound 146. The vascular endothelial growth factor compound 146 may be coated on an exterior surface of the sac-occluding segment 142. In particular, the vascular endothelial growth factor compound 146 may be coated on an exterior surface of the coil 142. By virtue of this arrangement, natural formation of the vascular walls that seal off the aneurysm sac 105 may be aided.
[0027] As visible in the schematic view of Fig. 5 and in the detailed view of Fig. 6, the aneurysm embolization device 100 may include an attachment and detachment mechanism 148. The attachment and detachment mechanism 148 may include a screw mechanism including a male screw 150 attached to the hypotube 132 of the anchoring segment 118, and a female screw 152 attached to the sac-occluding segment 142. Naturally, the screw mechanism may have a different configuration, such as a male screw attached to the sac-occluding segment 142 and a female screw attached to the hypotube 132 of the anchoring segment 118. By virtue of this arrangement, the anchoring segment 118 and the sac-occluding segment 142 may be releasably attached to each other.
[0028] As shown in Fig. 9, an aneurysm embolization method according to one or more embodiments shown and described herein may be implemented. The aneurysm embolization method of Fig. 9 may be implemented using the aneurysm embolization device 100 of Figs. 1 to 8.
[0029] The aneurysm embolization method may include a first main step S10 of delivering, in the blood vessel 102, the anchoring segment 118. The anchoring segment 118 may, in this step, include the expandable metallic body 120 in the deliverable configuration.
[0030] More specifically, the main step S10 may include a first step Si l of positioning the delivery catheter 110 in the blood vessel 102 as shown in Fig. 1. After the step SI 1, the delivery catheter 110 may be inside the blood vessel 102 and the anchoring segment 118 may be in the lumen 114 as shown by Fig. 1.
[0031] The main step S10 may include a second step S12 of monitoring a position of the radiopaque bands 116 and 141.
[0032] The main step S10 may include a further step S13 of pushing the anchoring segment 118 out of the delivery catheter 110.
[0033] The exemplary method of Fig. 9 may include a further main step S20 of expanding the expandable metallic body 120 from the deliverable configuration to the expanded configuration. The step S20 may be immediately performed after that the anchoring segment 118 is pushed out of the delivery catheter. The aneurysm embolization method and the expandable metallic body 120 may be designed so that no further action is required from the physician in order to cause expansion of the expandable metallic body 120 once it is pushed out of the delivery catheter 110. For example, the expandable metallic body 120 may be resilient and spring to the expanded configuration once it is released from the delivery catheter, and/or it may be formed from a memory-shape material.
[0034] After the main step S20, the expandable metallic body 120 may be in the expanded configuration, so that it may have the distal region 124, the proximal region 122 opposite the distal region 124, and the intermediate region transitioning from the distal region 124 to the proximal region 122. The intermediate region 126 may radially contact a wall of the blood vessel 102. At the end of the main step S20, the aneurysm embolization device 100 and the anchoring segment 118 may be in the configuration as shown by Fig. 3. [0035] In particular, after the main step S20, the curved portion 136 may be further relaxed in such a position that the delivery portion 138 and the proximal portion 134 form a larger (acute) angle a with respect to the axis 135 than before the main step S20. The delivery tip 140 may be radially offset with respect to a center axis of the delivery catheter 110.
[0036] The exemplary aneurysm embolization method may include a further main step S30 of deploying the sac-occluding segment 142 in the aneurysm sac 105. By doing so, the sac-occluding segment 142 may fill the aneurysm sac 105.
[0037] The main step S30 may include a first step S31 of positioning the delivery tip 140 with respect to the aneurysm sac 105. More specifically, in the configuration of Fig. 3, which may be the configuration after the main step S20, the delivery tip 140 may point towards a direction different from the direction towards the aneurysm sac 105. Therefore, the step S31 may include pivoting the hypotube 132 with respect to the anchoring segment 118, so that the delivery tip 140 points towards the aneurysm sac 105. The pivoting action may be accomplished manually. For example, the physician may, in the meantime, monitor a position of the radiopaque bands 116 and/or 141. The manual pivoting may be accomplished by means of a knob (not depicted), for example on the delivery catheter 110, and of a torque transmission mechanism (not depicted) inside the delivery catheter 110 which may mechanically connect the knob and the hypotube 132 to each other. By virtue of the anchoring segment 118, when pivoting the hypotube 132, the axial position of the hypotube is not modified and the step of positioning the delivery tip 140 may be implemented with a great precision. At the end of the step S31, the aneurysm embolization device 100 and the hypotube 132 of the anchoring segment 118 may be in the configuration shown by Fig. 4.
[0038] The main step S30 may include a further step S32 of sliding the sac-occluding segment 142 inside the hypotube 132. For example, the sac-occluding segment 142 may be a coil and the step S32 includes sliding a flexible wire adapted to form a coil inside the hypotube 132. By doing so, the sac-occluding segment 142 may be directed by the delivery tip 140 towards the aneurysm sac 105.
[0039] The main step S30 may include a further step S33 of passing the sac-occluding segment 142 into the aneurysm sac 105 from the delivery tip 140. The step S33 may include passing the sac-occluding segment 142 through the aperture 147. By doing so, the sac-occluding segment 142 may be directed towards the aneurysm sac 105 and may fill the aneurysm sac 105. The step S33 may be implemented until the aneurysm sac 105 is occluded. After the step S33, the sac-occluding segment 142 may fill the aneurysm sac 105 and still be attached to the anchoring segment 118 as shown by Fig. 5.
[0040] The main step S30 may include a further step S34 of detaching the sac-occluding segment 142 from the anchoring segment 118. To do so, the attachment and detachment mechanism may be actuated so that the male screw 150 and the female screw 152 are unscrewed from each other. After the step S34, the sac-occluding segment 142 and the anchoring segment 118 may be in the same configuration as that of after the step S33, except that they are detached from each other, as shown by Fig. 7.
[0041] The main step S30 may include a further step S35 of collapsing the expandable metallic body 120. Thanks to the expandable metallic body 120 being made of a collapsible and expandable mesh having a plurality of braided metal strands, a physician may contract the expandable metallic body 120 only by pulling the anchoring segment 118 inside the lumen 114 of the delivery catheter 110. Contracting the expandable metallic body 120 may be implemented easily by virtue of the fact that it may be resilient and spring to the expanded configuration once it is released from the delivery catheter, and/or foldable in such a way that pulling back the expandable metallic body 120 decreases the volume thereof to such an extent that it may be accommodated in the lumen 114.
[0042] The main step S30 may include a further step S36 of removing the anchoring segment 118 from the blood vessel 102. After the step S36, the aneurysm embolization device 100 and the sac-occluding segment 142 may be in the configuration shown by Fig- 8.
[0043] Fig. 10 shows an exemplary aneurysm embolization method according to one or more embodiments described herein. The exemplary aneurysm embolization method of Fig. 10 may include, instead of the main step S30 of the exemplary embolization method of Fig. 9, a main step S40 of leaving the anchoring segment 118 in the blood vessel 102 for vascular occlusion after deployment of the sac-occluding segment 142 in the aneurysm sac 105. The main step S40 may include the steps S31, S32 and S33 of the main step S30 of the method of Fig. 9. The main step S40 may be provided without the steps S34, S35 and S36 of the main step S30 of the method of Fig. 9. [0044] By virtue of the exemplary method of Fig. 10, it is possible to use the aneurysm embolization device 100 of Figs. 1 to 8 in order to occlude each of an aneurysm and a blood vessel. Thanks to the method of Fig. 10, the aneurysm 104 and the blood vessel 102 may be occluded by the aneurysm embolization device 100.
[0045] Fig. 11 shows an exemplary aneurysm embolization device 160 according to one or more embodiments described herein. The exemplary aneurysm embolization device 160 may include an additional expandable metallic body 162. The additional expandable metallic body 162 may include a collapsible and expandable mesh having a plurality of braided metal strands. The additional expandable metallic body 162 may be configured to expand and contract between a deliverable configuration and an expanded configuration. The additional expandable metallic body 162 may be housed, when it is in the deliverable configuration, inside the lumen 114 of the delivery catheter 110. The additional expandable metallic body 162 may be identical to the expandable metallic body 120. Further to the additional expandable metallic body 162, a third, a fourth, ... and an n-th expandable metallic body (not shown) may be provided.
[0046] The additional expandable metallic body 162 may be attached to the distal region 124 of the expandable metallic body 120. A further attachment and detachment mechanism 164 may be provided between the expandable metallic body 120 and the additional expandable metallic body 162.
[0047] By virtue of this arrangement, the aneurysm embolization device 160 may improve anchoring of the device 160 during embolization of the aneurysm sac 105. In addition, one or more of the expandable metallic bodies 120, 162 may be left in the blood vessel 102 after deployment of the sac-occluding segment 142 in the aneurysm sac 105. By doing so, a vascular occlusion of the blood vessel 102 may be performed using the aneurysm embolization device 160, in addition to embolization of the aneurysm 104.
[0048] Fig. 12 shows an exemplary aneurysm embolization device 170 according to one or more embodiments described herein. The exemplary aneurysm embolization device 170 may be in a configuration in which the sac-occluding segment 142 is deployed and fills in the aneurysm sac 105. The sac-occluding segment 142 may include a mesh. The mesh may be expandable. The mesh may be provided in replacement of the coil.
[0049] The sac-occluding segment 142 may further include a closed cage 172. The closed cage 172 may include a proximal area 174 which may be configured to fill the neck 106. In such a case, the proximal area 174 may form a limit between the blood vessel 102 and the aneurysm sac 105.
[0050] The closed cage 172 may include a distal area 178. The distal area 178 may have a semispherical shape. The distal area 178 may abut against the dome 108 of the aneurysm sac 105.
[0051] Fig. 13 shows an exemplary aneurysm embolization device 180 according to one or more embodiments described herein. The exemplary aneurysm embolization device 180 may include a membrane 182. The membrane 182 may be expandable. The membrane 182 may be provided in addition to the mesh of the sac-occluding segment 142 of the aneurysm embolization device of Fig. 12. The membrane 182 may also be provided in replacement of the mesh.
[0052] Fig. 14 and Fig. 15 show an exemplary aneurysm embolization device 190 according to one or more embodiments described herein. The exemplary aneurysm embolization device 190 may include a hydrogel 192. The hydrogel 192 may be provided in addition to a mesh and/or a membrane, or in replacement of a mesh and/or a membrane. The hydrogel 192 may fill the aneurysm sac 105 in order to perform embolization of the aneurysm 104.
[0053] As shown on the detailed figure 15, the aneurysm embolization device 190 may include an attachment and detachment mechanism 194 including a connecting rod 196 and a thicker portion 198. By virtue of this arrangement, when the anchoring segment 118 is contracted and pulled back in the delivery catheter 110, the connecting rod 196 may break at the thicker portion 198 and the hydrogel 192 may be detached from the anchoring segment 118.
[0054] Fig. 16 shows an exemplary aneurysm embolization device 200 according to one or more embodiments described herein. The exemplary aneurysm embolization device 200 may include an attachment and detachment mechanism 202. The attachment and detachment mechanism 202 may include a first interlock hook 204 and a second interlock hook 206. The first interlock hook 204 may be attached to the delivery tip 140 of the hypotube 132. The second interlock hook 206 may be attached to the sac-occluding segment 142. By virtue of this arrangement, the attachment and detachment mechanism 202 may releasably attach the anchoring segment 118 to the sac-occluding segment 142. [0055] Fig. 17 shows an exemplary aneurysm embolization device 210 according to one or more embodiments described herein. The aneurysm embolization device 210 may be in a configuration in which the sac-occluding segment 142 is deployed in the aneurysm sac 105. The sac-occluding segment 142 may include an open-ended cage 212. The open- ended cage 212 may have a shape similar to that of the proximal area 174 of the closed cage 172. The open-ended cage 212 may fill the neck 106 of the aneurysm 104.
[0056] In the present application, the word “fill” shall be understood as being deployed within a certain volume so as to occupy at least a portion of said volume.
[0057] In the present application, the term "temporary implantation" means that the object in question is designed to remain implanted only for a typical period of time corresponding to the filling of an aneurysm sac by a physician.
[0058] All of the above are fully within the scope of the present disclosure and are considered to form the basis for alternative embodiments in which one or more combinations of the above-described features are applied, without limitation to the specific combination disclosed above.
[0059] In light of this, there will be many alternatives which implement the teaching of the present disclosure. It is expected that one skilled in the art will be able to modify and adapt the above disclosure to suit his own circumstances and requirements within the scope of the present disclosure, while retaining some or all technical effects of the same, either disclosed or derivable from the above, in light of his common general knowledge in this art. All such equivalence, modifications or adaptations fall within the scope of the present disclosure.

Claims

Claims
1. An aneurysm embolization device for filling in an aneurysm sac, the aneurysm embolization device including:
- an anchoring segment including an expandable metallic body, the expandable metallic body including a collapsible and expandable mesh having a plurality of braided metal strands, the expandable metallic body being configured for implantation in a blood vessel of a vascular system, being configured to expand and contract between a deliverable configuration and an expanded configuration and having, in the expanded configuration, a distal region, a proximal region opposite the distal region and an intermediate region transitioning from the distal region to the proximal region, the expandable metallic body being configured so that the intermediate region radially contacts a wall of a blood vessel, when it is expanded in a blood vessel in which the anchoring segment is implanted, and
- a sac-occluding segment attached to the anchoring segment on a side of the distal region, the sac-occluding segment being configured to fill an aneurysm sac after that the anchoring segment is implanted in a vascular system.
2. The aneurysm embolization device of claim 1, wherein the expandable metallic body is configured for temporary implantation in the vascular system.
3. The aneurysm embolization device of claim 1 or 2, wherein the anchoring segment is configured to be removed after filling in of the aneurysm sac by the sac- occluding segment is completed.
4. The aneurysm embolization device of any one of claims 1 to 3, wherein the anchoring segment further includes a hypotube extending through the expandable metallic body at least between the proximal region and the distal region, the sac-occluding segment being housed in the hypotube before it is deployed.
5. The aneurysm embolization device of claim 4, wherein the hypotube has an axial cross-segment profile smaller than an axial cross-segment profile of the expandable metallic body in the deliverable configuration.
6. The aneurysm embolization device of claim 4 or 5, wherein the hypotube includes a delivery tip adjacent to the distal region of the expandable metallic body, the sac-occluding segment being configured to be deployed into the aneurysm sac from the delivery tip.
7. The aneurysm embolization device of claim 6, wherein the delivery tip includes an aperture defining a deployment direction intersecting a center axis of the expandable metallic body, the hypotube being able to pivot around the center axis.
8. The aneurysm embolization device of any one of claims 1 to 7, wherein the anchoring segment further includes an additional expandable metallic body attached to the distal region of the expandable metallic body, the additional expandable metallic body having a plurality of braided metal strands, being configured for implantation in a blood vessel of a vascular system, and being configured to expand and contract between a deliverable configuration and an expanded configuration.
9. The aneurysm embolization device of any one of claims 1 to 8, wherein the sac-occluding segment comprises a closed cage comprising a proximal area configured to fill a neck of the aneurysm sac and a distal area configured to abut against a dome of the aneurysm sac.
10. The aneurysm embolization device of any one of claims 1 to 9, wherein the sac-occluding segment comprises an open-ended cage configured to fill a neck of the aneurysm sac.
11. The aneurysm embolization device of any one of claims 1 to 10, wherein the sac-occluding segment comprises a coil.
12. The aneurysm embolization device of any one of claims 1 to 11, wherein the sac-occluding segment comprises a mesh.
13. The aneurysm embolization device of any one of claims 1 to 12, wherein the sac-occluding segment comprises a membrane.
14. The aneurysm embolization device of any one of claims 1 to 13, wherein the sac-occluding segment comprises a hydrogel.
15. The aneurysm embolization device of any one of claims 1 to 14, further including an attachment and detachment mechanism configured to releasably attach the anchoring segment to the sac-occluding segment.
16. The aneurysm embolization device of claim 15, wherein the attachment and detachment mechanism includes a screw mechanism.
17. The aneurysm embolization device of claim 15 or 16, wherein the attachment and detachment mechanism includes a pair of interlocking coils.
18. The aneurysm embolization device of any one of claims 1 to 17, wherein the anchoring segment comprises a prothrombogenic compound coated on an exterior surface of the intermediate region.
19. The aneurysm embolization device of any one of claims 1 to 18, wherein the sac-occluding segment comprises a prothrombogenic compound coated on an exterior surface thereof.
20. The aneurysm embolization device of any one of claims 1 to 19, wherein the anchoring segment comprises a vascular endothelial growth factor compound coated on an exterior surface of the intermediate region.
21. The aneurysm embolization device of any one of claims 1 to 20, wherein the sac-occluding segment comprises a vascular endothelial growth factor compound coated on an exterior thereof.
22. The aneurysm embolization device of any one of claims 1 to 21, further including a delivery catheter configured to deliver the anchoring segment in a blood vessel of a vascular system.
23. The aneurysm embolization device of claim 22, wherein the delivery catheter includes at least one radiopaque band.
24. The aneurysm embolization device of any one of claims 1 to 23, wherein the anchoring segment includes at least one radiopaque band.
25. An aneurysm embolization method comprising, in this order:
- delivering, in a blood vessel of a vascular system, an anchoring segment including an expandable metallic body, the expandable metallic body including a collapsible and expandable mesh having a plurality of braided metal strands, the expandable metallic body being in a deliverable configuration,
- expanding the expandable metallic body to an expanded configuration so that it has a distal region, a proximal region opposite the distal region and an intermediate region transitioning from the distal region to the proximal region, the intermediate region radially contacting a wall of the blood vessel, and
- deploying a sac-occluding segment in an aneurysm sac of the aneurysm, the sac- occluding segment being attached to the anchoring segment on a side of the distal region, so that the sac-occluding segment fills in the aneurysm sac.
26. The aneurysm embolization method of claim 25, wherein the anchoring segment is left in the blood vessel for vascular occlusion after deployment of the sac- occluding segment in the aneurysm sac.
27. The aneurysm embolization method of claim 25, further comprising, after deployment of the sac-occluding segment in the aneurysm sac:
- detaching the sac-occluding segment from the anchoring segment,
- collapsing the expandable metallic body of the anchoring segment, and
- removing the anchoring segment from the vascular system.
28. The aneurysm embolization method of any one of claims 25 to 27, wherein the anchoring segment further includes an hypotube extending through the expandable metallic body at least between the proximal region and the distal region, the hypotube having a delivery tip, and wherein deploying the sac-occluding segment includes positioning the delivery tip with respect to the aneurysm sac, sliding the sac-occluding segment inside the hypotube and passing the sac-occluding segment into the aneurysm sac from the delivery tip.
29. The aneurysm embolization method of claim 28, wherein the delivery tip includes an aperture defining a deployment direction intersecting a center axis of the expandable metallic body, and wherein positioning the delivery tip with respect to the aneurysm sac includes pivoting the hypotube around the center axis so that the aperture faces a neck of the aneurysm sac.
30. The aneurysm embolization method of any one of claims 25 to 29, wherein the anchoring segment includes at least one radiopaque band, and wherein delivering the anchoring segment includes monitoring a position of the radiopaque band with respect to the vascular system.
31. The aneurysm embolization method of any one of claims 25 to 30, wherein the anchoring segment is housed in a lumen of a delivery catheter with the expandable metallic body in the deliverable configuration, and delivering the anchoring segment includes:
- positioning the delivery catheter in the blood vessel, and
- pushing the anchoring segment out of the delivery catheter.
32. The aneurysm embolization method of claim 31, wherein the delivery catheter includes at least one radiopaque band, and wherein delivering the anchoring segment includes monitoring a position of the radiopaque band with respect to the vascular system.
PCT/EP2022/074175 2022-08-31 2022-08-31 Avp device with lobe/segment designed to fill aneurysm sac WO2024046551A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2022/074175 WO2024046551A1 (en) 2022-08-31 2022-08-31 Avp device with lobe/segment designed to fill aneurysm sac

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2022/074175 WO2024046551A1 (en) 2022-08-31 2022-08-31 Avp device with lobe/segment designed to fill aneurysm sac

Publications (1)

Publication Number Publication Date
WO2024046551A1 true WO2024046551A1 (en) 2024-03-07

Family

ID=83361119

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2022/074175 WO2024046551A1 (en) 2022-08-31 2022-08-31 Avp device with lobe/segment designed to fill aneurysm sac

Country Status (1)

Country Link
WO (1) WO2024046551A1 (en)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040153120A1 (en) * 2003-02-03 2004-08-05 Seifert Paul S. Systems and methods of de-endothelialization
WO2007006139A1 (en) * 2005-07-12 2007-01-18 Smart Biotech Inc. Aneurysm occlusion device
US20100106240A1 (en) * 2008-10-20 2010-04-29 IMDS, Inc. Systems and Methods for Aneurysm Treatment and Vessel Occlusion
US20180110797A1 (en) * 2016-10-21 2018-04-26 Covidien Lp Injectable scaffold for treatment of intracranial aneurysms and related technology
US20180325706A1 (en) * 2015-01-20 2018-11-15 Neurogami Medical, Inc. Vascular implant
WO2021092618A1 (en) * 2019-11-04 2021-05-14 Covidien Lp Devices, systems, and methods for treatment of intracranial aneurysms

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040153120A1 (en) * 2003-02-03 2004-08-05 Seifert Paul S. Systems and methods of de-endothelialization
WO2007006139A1 (en) * 2005-07-12 2007-01-18 Smart Biotech Inc. Aneurysm occlusion device
US20100106240A1 (en) * 2008-10-20 2010-04-29 IMDS, Inc. Systems and Methods for Aneurysm Treatment and Vessel Occlusion
US20180325706A1 (en) * 2015-01-20 2018-11-15 Neurogami Medical, Inc. Vascular implant
US20180110797A1 (en) * 2016-10-21 2018-04-26 Covidien Lp Injectable scaffold for treatment of intracranial aneurysms and related technology
WO2021092618A1 (en) * 2019-11-04 2021-05-14 Covidien Lp Devices, systems, and methods for treatment of intracranial aneurysms

Similar Documents

Publication Publication Date Title
US11045204B2 (en) Vascular remodeling device
EP1494619B1 (en) Devices for retaining vaso-occlussive devices within an aneurysm
EP3260089B1 (en) Apparatus for delivering a braided stent with expansion rings
KR101877586B1 (en) Implant for influencing the blood flow in arteriovenous malformations
US9072620B2 (en) Protuberant aneurysm bridging device deployment method
EP2777642B1 (en) Braided stent with expansion ring
US20050251200A1 (en) Device for closure of a vascular defect and method for treating the same
CN112807046A (en) Implant delivery system with braided cup formation
EP3718491A2 (en) Aneurysm treatment device
WO2024046551A1 (en) Avp device with lobe/segment designed to fill aneurysm sac
CN113069170A (en) Aneurysm occlusion device
CN116648201B (en) Vascular occlusion device and method of manufacturing the same
US20230074470A1 (en) Intrasaccular Flow Diverter
CN116035640A (en) Medical implant and preparation method thereof
CN115052535A (en) Implant for treating aneurysms
CN110662513A (en) Delivery system for deploying self-expanding tubes and method of deploying self-expanding tubes

Legal Events

Date Code Title Description
DPE2 Request for preliminary examination filed before expiration of 19th month from priority date (pct application filed from 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22772849

Country of ref document: EP

Kind code of ref document: A1