WO2019036298A1 - FLOW MITIGATION DEVICE - Google Patents

FLOW MITIGATION DEVICE Download PDF

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Publication number
WO2019036298A1
WO2019036298A1 PCT/US2018/046263 US2018046263W WO2019036298A1 WO 2019036298 A1 WO2019036298 A1 WO 2019036298A1 US 2018046263 W US2018046263 W US 2018046263W WO 2019036298 A1 WO2019036298 A1 WO 2019036298A1
Authority
WO
WIPO (PCT)
Prior art keywords
mesh
segment
embolic device
screen
coil
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2018/046263
Other languages
English (en)
French (fr)
Inventor
Be Thi LE
Tae Hee CHO
Regina Coeli VELASCO
Armando Garza
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
INCUMEDX Inc
Original Assignee
INCUMEDX Inc
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 INCUMEDX Inc filed Critical INCUMEDX Inc
Priority to EP18760183.6A priority Critical patent/EP3668417B1/en
Priority to CN201880053135.0A priority patent/CN111031936B/zh
Priority to JP2020509084A priority patent/JP7356965B2/ja
Priority to EP22193797.2A priority patent/EP4119066A1/en
Priority to ES18760183T priority patent/ES2929060T3/es
Priority to CN202311247215.9A priority patent/CN117297691A/zh
Publication of WO2019036298A1 publication Critical patent/WO2019036298A1/en
Anticipated expiration legal-status Critical
Priority to JP2023160181A priority patent/JP7834697B2/ja
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/12154—Coils or wires having stretch limiting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/146—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/823—Stents, different from stent-grafts, adapted to cover an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/04—Materials for stopping bleeding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/16—Materials with shape-memory or superelastic properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/36—Materials or treatment for tissue regeneration for embolization or occlusion, e.g. vaso-occlusive compositions or devices

Definitions

  • an aneurysm is a swelling or bulge that forms a cavity in the wall of a blood vessel.
  • One type of aneurysm is a cerebral aneurysm, which forms in an artery of the brain.
  • a cerebral aneurysm may develop suddenly without initial symptoms, and can cause extreme pain.
  • the patient dies suddenly upon development of the cerebral aneurysm; in another 15% of cerebral aneurysm cases, the patient dies under medical treatment; and in 30% of cerebral aneurysm cases, the patient survives after treatment but feels an acute aftereffect.
  • a cerebral aneurysm (or any aneurysm) is a very concerning development.
  • the present invention relates to an improved embolic device that achieves a desired porosity without compromising as much compliance as conventional devices.
  • the device leverages the fact that the desired porosity is only required at certain discrete section(s) along the length of the device (sometimes referred to herein as "porosity sections"), e.g., the section of the device that blocks the neck (or opening) of the aneurysm when the device is deployed.
  • the term "porosity section” refers to a portion of the device having a desired porosity. In some instances, this desired porosity of the porosity section is greater than the porosity of the remaining sections of the device, but the opposite is also true in some cases.
  • embodiments of the invention feature an embolic device for use in treating a vascular disorder.
  • the embolic device can include a first coil segment, a second coil segment, and a mesh-screen segment disposed between the first coil segment and the second coil segment along a length of the embolic device.
  • each of the first and second coil segments includes a helically wound wire.
  • the first and second coil segments each have a greater compliance than the mesh-screen segment.
  • the mesh-screen segment has a greater porosity than each of the first and second coil segments.
  • the mesh-screen segment can be 60% to 80% porous.
  • FIG. 1 is an image of an exemplary conventional embolic device formed from a braided wire
  • FIG. 6 is a top schematic view of an extension portion used to attach portions of an embolic device, according to one embodiment of the invention.
  • FIG. 7 is an image of an exemplary embolic device being inserted into a microcatheter, according to one embodiment of the invention.
  • FIGS. 8A-8M are images of an exemplary embolic device in a deployed configuration and in various stages of deployment, according to various embodiments of the invention.
  • the desired porosity is only necessary at limited discrete portions along the length of the device.
  • the desired porosity need only be achieved at the portions of the device that interact with (and therefore affect) the blood flowing into the aneurysm.
  • these portions are the portions of the device that, when the device is deployed, are located across the opening between the blood vessel and the cavity of the aneurysm
  • portions of the device i.e., those that do not interact with or affect the blood flowing into the aneurysm, need not have the desired porosity.
  • portions that do not interact with or affect the blood flowing into the aneurysm include portions of the device that, when the device is deployed, are located in the middle of the cavity or along the interior wall of the cavity.
  • the portions of the device that need not have the desired porosity can be configured differently than the porosity sections; for example, they can be configured to be significantly more compliant than the porosity sections, which can increase the overall compliance of the entire device.
  • the porosity section(s) 102 and the compliance section(s) 104 are arranged in a serially alternating fashion along the length of the device 100.
  • the device 100 can include a compliance section 104, followed by a porosity section 102, followed by another compliance section 104, and optionally followed by another porosity section 102, etc.
  • the porosity section(s) 102 and compliance section(s) 104 can be arranged using any other arrangement.
  • multiple porosity sections 102 can be arranged adjacent to each other and/or multiple compliance sections 104 can be arranged adjacent to each other.
  • the arrangement of the porosity section(s) 102 and the compliance sections(s) 104 is constant (e.g., repetitive) along the entire length of the device 100. In other cases, the arrangement of the porosity section(s) 102 and the compliance section(s) 104 differs along the length of the device 100. For example, at certain locations the sections 102, 104 can be arranged in a serially alternating fashion, while at other locations the sections can be arranged with multiple porosity sections 102 and/or multiple compliance sections 104 adjacent to one another.
  • the compliance sections 104 can take any form that results in the sections 104 being more compliant than the porosity section 102.
  • the compliance sections 104 can be formed from braided wire and/or mesh segments, but with less material or otherwise configured such that they have greater compliance than the porosity section 102.
  • thermomechanical properties that can differ between the compliance sections 104 and the porosity section 102 includes (i) strength, ductility, and/or toughness as a function of prior hot and/or cold working heat treatment, (ii) austenitic phase transformation temperature, and (iii) super-elasticity and shape memory properties (e.g., stress-strain behavior as a function of temperature and/or prior hot and/or cold working heat treatment). Many other examples of thermomechanical properties are also possible.
  • a single compliance section 104 and/or porosity section 102 can have different properties at different locations.
  • a porosity section 102 can have a thermomechanical property having a first value near its center and a different value near its perimeter.
  • thermomechanical (or other) properties within the device 100 is that it can allow the device to be tuned to achieve desired deployment (or other performance) characteristics, e.g., by adjusting the phase transformation temperatures and/or expansion force characteristics at various locations of the device 100.
  • any two components (or locations thereof) of the device 100 can also have the same property as each other.
  • the layers can have different widths
  • the layers can have the same width.
  • the gap can exist in either the y-axis direction (shown in FIG. 3) or the x- axis direction.
  • gaps in the x-axis direction can be formed by through-thickness perforations formed in the mesh-screen segment 102.
  • Exemplary through-thickness perforations 108 are shown in FIG. 2.
  • FIGS. 4 A and 4B illustrate an exemplary configuration of a mesh-screen segment 102.
  • FIG. 4A is a top view of the mesh-screen segment 102 showing layers 402, 404, and 406.
  • FIG. 4B is a perspective view of the mesh-screen segment 102 showing that layers 402 and 404 have different thicknesses and that at least a portion of each of the layers 402, 404, and 406 exist in different planes.
  • the coupling feature 604 on either end of the mesh-screen extension 602 can be different (e.g., one coupling feature can be adapted to attach to a coil segment 104 and a different coupling feature can be adapted to attach to a delivery pusher).
  • the embolic device 100 can form a secondary shape.
  • the formation of a secondary shape upon deployment into the vascular disorder is caused by a shape-memory nature of the material (e.g., nitinol) used to form at least a portion of the embolic device 100 (e.g., the compliance sections 104).
  • the secondary shape can be any shape desirable to treat the aneurysm.
  • the shape can include a porosity section 102 disposed across a neck of the aneurysm and the compliance sections 104 arranged in the middle of the aneurysm cavity and/or along an interior wall of the aneurysm cavity, as may be desirable for treating the aneurysm.
  • FIGS. 8A-8M Exemplary images of the embolic device 100 formed into a secondary shape are shown in FIGS. 8A-8M.
  • images 8C-8M the images depict the embolic device 100 being deployed from a microcatheter 702.
  • images 8H-8M the images depict the embolic device 100 at various stages of deployment within a glass model aneurysm sac 802, which models the environment of an aneurysm within the body.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Reproductive Health (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurosurgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Epidemiology (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)
PCT/US2018/046263 2017-08-17 2018-08-10 FLOW MITIGATION DEVICE Ceased WO2019036298A1 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
EP18760183.6A EP3668417B1 (en) 2017-08-17 2018-08-10 Flow attenuation device
CN201880053135.0A CN111031936B (zh) 2017-08-17 2018-08-10 流动衰减装置
JP2020509084A JP7356965B2 (ja) 2017-08-17 2018-08-10 流れ減衰装置
EP22193797.2A EP4119066A1 (en) 2017-08-17 2018-08-10 Flow attenuation device
ES18760183T ES2929060T3 (es) 2017-08-17 2018-08-10 Dispositivo de atenuación del flujo
CN202311247215.9A CN117297691A (zh) 2017-08-17 2018-08-10 用于在治疗血管疾病中使用的栓塞装置
JP2023160181A JP7834697B2 (ja) 2017-08-17 2023-09-25 流れ減衰装置

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762546809P 2017-08-17 2017-08-17
US62/546,809 2017-08-17

Publications (1)

Publication Number Publication Date
WO2019036298A1 true WO2019036298A1 (en) 2019-02-21

Family

ID=63405445

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2018/046263 Ceased WO2019036298A1 (en) 2017-08-17 2018-08-10 FLOW MITIGATION DEVICE

Country Status (6)

Country Link
US (2) US11071551B2 (https=)
EP (2) EP4119066A1 (https=)
JP (2) JP7356965B2 (https=)
CN (2) CN117297691A (https=)
ES (1) ES2929060T3 (https=)
WO (1) WO2019036298A1 (https=)

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