WO2014128313A1 - Dispositif de support et de placement d'éléments occlusifs - Google Patents

Dispositif de support et de placement d'éléments occlusifs Download PDF

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Publication number
WO2014128313A1
WO2014128313A1 PCT/ES2013/070109 ES2013070109W WO2014128313A1 WO 2014128313 A1 WO2014128313 A1 WO 2014128313A1 ES 2013070109 W ES2013070109 W ES 2013070109W WO 2014128313 A1 WO2014128313 A1 WO 2014128313A1
Authority
WO
WIPO (PCT)
Prior art keywords
tubular structure
aneurysm
distal end
neck
proximal end
Prior art date
Application number
PCT/ES2013/070109
Other languages
English (en)
Spanish (es)
Inventor
Carlos CASTAÑO DUQUE
Original Assignee
Castaño Duque Carlos
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 Castaño Duque Carlos filed Critical Castaño Duque Carlos
Priority to PCT/ES2013/070109 priority Critical patent/WO2014128313A1/fr
Publication of WO2014128313A1 publication Critical patent/WO2014128313A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—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
    • A61B17/12099—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
    • A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • 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
    • 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
    • A61B2017/00867—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, 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
    • A61B2017/12063—Details concerning the detachment of the occluding device from the introduction device electrolytically detachable
    • 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

Definitions

  • the present invention relates to a support device and placement of occlusive elements, such as coils or spirals of the type commonly used in endovascular aneurysm embolization.
  • the device of the invention is intended for the placement and anchoring of such occlusive elements, for example, in wide-necked intracranial aneurysms, mainly located in vascular bifurcations.
  • embolization is the treatment usually applied for the treatment of aneurysms and other malformations of blood vessels in the brain due to its minimally invasive nature since it has shown better results than surgical treatment (International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomized trial, Lancet 2002; 360: 1267-74).
  • ISAT International Subarachnoid Aneurysm Trial
  • an aneurysm is a bulge or sac that develops in an artery because the vessel wall is weak.
  • a bulky aneurysm in the brain can compress the surrounding nerves and brain tissue, resulting in neurological focality, cranial nerve paralysis or endocranial hypertension that manifests with headache, nausea and vomiting. If the cerebral aneurysm ruptures, due to an opening in the wall, an extracranial blood (hemorrhage) occurs intracranial, which constitutes a very serious pathology that can cause significant neurological sequelae or death in a high percentage.
  • a microcatheter in an endovascular embolization procedure, guided by images obtained with X-rays, a microcatheter is inserted through the skin into an artery and sent to the aneurysm sac, inserting one or more coils through the microcatheter inside, where they are anchored.
  • the body responds by producing a thrombosis and subsequent scarring around the coil, which helps obstruct the flow of blood into the aneurysm, thus preventing it from rupturing.
  • embolization with coils varies according to the size and shape of the aneurysm.
  • embolization of small aneurysms with small necks has better results than the corresponding embolization of large or giant aneurysms with wide necks. Therefore, in the particular case of intracranial wide neck aneurysms, other technologies such as embolization with protective balloon (Remodeling), colloid retention coils (Trispan) or with placement of a stent at neck level have been incorporated aneurysm
  • the controlled detachment micro-spirals were designed, where the spiral is attached to the mandrel that pushes it along the microcatheter, and can be released at the operator's discretion only when it is positioned and / or repositioned in a stable situation, as is the case of the I DC system, Interlockable Detachable Coil, of Target Therapeutics, which allows the coil to be advanced and removed inside the aneurysm before its definitive detachment (Cekirge HS, Saatci I., Firat MM, Balkanci F., Besim A., AJNR A m J Neuroradiol, 1996 Oct, 17 (9): 1651-7, "Interlocking detachable coil occlusion in the endovascular treatment of intracranial aneurysms: preliminary / results.”, Department
  • Guglielmi et al. (Guglielmi G, Vihuela F, Sepetkai I et al: "Electro-thrombosls of saccular aneurysms via endovascular approach, part I: Electrochemical basis, technique and experimental results", J Neurosurg 1991; 75: 1-7) described the design and application in animal models of an extremely smooth microspiral, Foldable and atraumatic called GDC (Guglielmi Detachable Coi!). In this case, the coil curves were preformed and it was fixed to a steel guide by a welded joint using microengineering techniques, which allowed its progression inside the microcatheter. Once positioned in a satisfactory situation, a small electric current was passed through the mandrel causing electrolysis of the weld point and consequently the release of the spiral.
  • EP 00948716.6 "Stent adapted for tangle-free deploymenf, refers to a stent capable of adopting an expanded or retracted configuration based on having in its interior structure a series of extension elements in the form of a fan blade.
  • US 7651524 “Flexible stenf, describes a stent comprising multiple annular members in the form of scales arranged in axial direction and interconnected to each other.
  • EP0757904 Implantable prosthesis for a human or animal vessel such as stent or aneurysm prosthesis ", describes a prosthesis intended to be implanted in a human or animal conduit to ensure a passage in said conduit. It has a tubular surface with a tube axis, comprising several filaments with undulations, which are wound to define a tubular surface, these undulations forming a series of rings, advantageously in zigzag, staggered in the length of the prosthesis.
  • a device specially adapted for the support and placement of coils or spiral occlusive elements particularly in wide-necked intracranial aneurysms, mainly located in vascular bifurcations, removable by electrolysis, and whose morphology allows retaining said coils inside the aneurysm in order to prevent their exit to the afferent and efferent arteries and also allows the aneurysm embolization procedure to be carried out in a more stable and predictable way, thanks to its ease of handling and repositioning and release capacity.
  • the object of the present invention is to provide a support and placement device for coils or spiral occlusive elements inside a wide-necked intracranial aneurysm, primarily located on vascular bifurcations, removable by electrolysis, and whose shape allows retaining said coils inside the aneurysm, easy to use and with repositioning and releasing capacity.
  • the device of the invention is formed on the basis of an essentially tubular elastic mesh structure made of a memory-shaped material that has a widened configuration at one of its ends or distal end, which is placed on the aneurysm neck.
  • an intermediate part that allows the passage of a microcatheter and that joins the widened distal end to a second or proximal end, the latter being essentially similar to that of a stent, which allows anchoring and stabilize the device in the afferent artery of the aneurysm.
  • Figure 1 Scheme of the design of the invention device according to a preferred embodiment of the same insert in a vascular bifurcation.
  • Figure 2 Scheme of the positioning of the device and release of the coils inside an aneurysm.
  • the device of the invention is described in relation to the embolization of a wide neck intracranial aneurysm, the person skilled in the art will understand that its application is not limited to this case, multiple applications thereof being possible, for example in the case of mechanical thrombectomy (thrombus extraction) for the treatment of ischemic stroke, varying if necessary in terms of size and adapting to the anatomy of each particular patient.
  • thrombectomy thrombus extraction
  • the device of the invention consists of an essentially tubular structure (1) formed from a net or wire mesh (2) of a surgically suitable, elastic and thermal memory material.
  • the tubular structure (1) has a distal end (3) and a proximal end (4), the distal end (3) constituting the part corresponding to the end of the tubular structure (1) that is inserted into the aneurysmal sac (10) and the proximal end (4) constituting the part of the tubular structure opposite the aneurysm, that is, the one that remains in the afferent artery.
  • Both distal (3) and proximal (4) ends of the tubular structure (1) are integrally and structurally connected to each other by a narrowing or neck (6).
  • the distal end (3) has a funnel or trumpet shape (5) widened with respect to the diameter of the tubular structure (1) and deployed into the aneurysm sac ( 10).
  • the distal end (3) is inserted, through the neck of the aneurysm (1 1), into the aneurysm sac (10) in order to retain the coils (12) inside allowing the complete closure of the aneurysm and avoiding that the coils invade the afferent and efferent arteries.
  • the narrowing or neck (6) has a suitable diameter to allow the passage of a microcatheter (13) from which the coils (12) are released inside the aneurysm, and, finally, the proximal end (4 ) allows to anchor and stabilize the device in the afferent artery.
  • the proximal end (4) of the device has a detachable guiding element (7) attached to the tubular structure, so that the release of the device into the site is possible adequate and recovery of the guide, for example by a system similar to that usually used in removable stent devices with electrolysis.
  • the joint between the detachable guiding element (7) and the device is a weld joint releasable by electrolysis.
  • the tubular structure (1) formed from a net or wire mesh (2) is made of an elastic alloy with shape memory, such as a nitinol nickel-titanium alloy.
  • the distal end (3) of the device of the invention is capable of folding inside the microcatheter, being deployed once it has been introduced into the aneurysmal sac (10), with the insertion of said microcatheter
  • the tubular structure (1) is made of an elastic alloy with a Nitinol-type shape memory and because this material is radiolucent, the device optionally has platinum markers at its distal end (3), neck (6) and at its proximal end (4), allowing the placement of the device in the precise position.
  • the measure of the device of the invention must be selected in the first place, so that it adapts to the anatomy of the arteries and the aneurysm to be embolized, for example based on the measurements taken by Rotational angiography with 3D reconstruction.
  • the aneurysm is catheterized with a microcatheter and the guiding element with standard techniques. With great delicacy, the device is made to ascend through the afferent artery by means of the guiding element, its distal end being deployed within the aneurysm, so that said distal end widens adapting to the aneurysm neck.
  • the guiding element and the elasticity of the tubular structure that makes up the device can be repositioned until it is at the site determined by the interventional neurradiologist.
  • the rest of the device is still released to anchor it in the afferent artery.
  • the neck of the device is franked and catheterize the aneurysm sac, then fill with coils using the standard technique. Once the aneurysm is embolized, the device is released.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Neurosurgery (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un dispositif de support et de placement d'éléments occlusifs de type coils ou spirales pour l'embolisation endovasculaire d'anévrismes, comprenant une structure essentiellement tubulaire (1) en filet ou maillage de fils (2) composé d'un matériau de qualité chirurgicale, laquelle structure tubulaire (1) présente une extrémité distale (3) et une extrémité proximale (4), l'extrémité distale (3) correspondant à l'extrémité de la structure tubulaire (1) qui est insérée dans le sac anévrismal (10) et l'extrémité proximale (4) correspondant à la partie de la structure tubulaire qui est opposée à l'anévrisme. Les deux extrémités, distale (3) et proximale (4), de la structure tubulaire (1) sont reliées intégralement et selon une continuité structurale par un rétrécissement ou collet (6). L'extrémité distale (3) présente une forme d'entonnoir ou de trompette (5) élargie par rapport au diamètre de la structure tubulaire (1) et dépliable vers l'intérieur de l'anévrisme.
PCT/ES2013/070109 2013-02-21 2013-02-21 Dispositif de support et de placement d'éléments occlusifs WO2014128313A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/ES2013/070109 WO2014128313A1 (fr) 2013-02-21 2013-02-21 Dispositif de support et de placement d'éléments occlusifs

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/ES2013/070109 WO2014128313A1 (fr) 2013-02-21 2013-02-21 Dispositif de support et de placement d'éléments occlusifs

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112153946A (zh) * 2018-04-04 2020-12-29 因库麦迪斯有限公司 具有改进的颈部覆盖的栓塞装置

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0757904A1 (fr) 1995-08-03 1997-02-12 B. Braun Celsa Prothèse implantable dans un conduit humain ou animal, telle qu'un élargisseur de paroi, ou une prothèse pour anévrisme
US20030195553A1 (en) * 2002-04-12 2003-10-16 Scimed Life Systems, Inc. System and method for retaining vaso-occlusive devices within an aneurysm
US20060064151A1 (en) * 2004-09-22 2006-03-23 Guterman Lee R Cranial aneurysm treatment arrangement
WO2007079402A2 (fr) * 2005-12-31 2007-07-12 Levy Elad I Endoprothese permettant de traiter un anevrisme d'embranchement pourvue d'une toile distale
US20070270902A1 (en) * 2004-09-17 2007-11-22 Slazas Robert R Thin Film Metallic Devices for Plugging Aneurysms or Vessels
DE102008028308A1 (de) * 2007-10-18 2009-04-23 Acandis Gmbh & Co. Kg Vaskuläres Implantat und Verfahren zum Herstellen eines derartigen Implantats
US7651524B2 (en) 2005-03-30 2010-01-26 Terumo Kabushiki Kaisha Flexible stent
US20120143237A1 (en) * 2010-12-06 2012-06-07 Tyco Healthcare Group Lp Vascular remodeling device

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0757904A1 (fr) 1995-08-03 1997-02-12 B. Braun Celsa Prothèse implantable dans un conduit humain ou animal, telle qu'un élargisseur de paroi, ou une prothèse pour anévrisme
US20030195553A1 (en) * 2002-04-12 2003-10-16 Scimed Life Systems, Inc. System and method for retaining vaso-occlusive devices within an aneurysm
US20070270902A1 (en) * 2004-09-17 2007-11-22 Slazas Robert R Thin Film Metallic Devices for Plugging Aneurysms or Vessels
US20060064151A1 (en) * 2004-09-22 2006-03-23 Guterman Lee R Cranial aneurysm treatment arrangement
US7651524B2 (en) 2005-03-30 2010-01-26 Terumo Kabushiki Kaisha Flexible stent
WO2007079402A2 (fr) * 2005-12-31 2007-07-12 Levy Elad I Endoprothese permettant de traiter un anevrisme d'embranchement pourvue d'une toile distale
DE102008028308A1 (de) * 2007-10-18 2009-04-23 Acandis Gmbh & Co. Kg Vaskuläres Implantat und Verfahren zum Herstellen eines derartigen Implantats
US20120143237A1 (en) * 2010-12-06 2012-06-07 Tyco Healthcare Group Lp Vascular remodeling device

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
"International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial", LANCET, vol. 360, 2002, pages 1267 - 74
CEKIRGE H.S.; SAATCI I.; FIRAT M.M.; BALKANCI F.; BESIM A.: "Interlocking detachable coil occlusion in the endovascular treatment of intracranial aneurysms: preliminary results", AJNR AM J NEURORADIOL, vol. 17, no. 9, October 1996 (1996-10-01), pages 1651 - 7
GUGLIELMI G; VIÑUELA F; SEPETKAI I ET AL.: "Electro-thrombosis of saccular aneurysms via endovascular approach, part I: Electrochemical basis, technique and experimental results", J NEUROSURG, vol. 75, 1991, pages 1 - 7
JOSÉ TEVAH C.: "Tratamiento endovascular de los aneurismas cerebrales: sus comienzos hace 30 anos y su desarrollo actual", REVISTA CHILENA DE RADIOLOGIA, vol. 9, no. 2, 2003, pages 78 - 85
MORET J; COGNARD C; WEIL A; CASTSINGS L; REY A.: "Reconstruction technique in the treatment of wide-neck intracranial aneurysms: long-term angiographic and clinical results", J NEURORADIOL, vol. 24, 1997, pages 30 - 44
MORET J; PICARD L; MAWAD M ET AL.: "A critical study on endovascular treatment of berry aneurysms", PROCEEDINGS FROM THE 28TH. ANNUAL MEETING OF THE AMERICAN SOCIETY OF NEURORADIOLOGY, LOS ANGELES, 1990, pages 35

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112153946A (zh) * 2018-04-04 2020-12-29 因库麦迪斯有限公司 具有改进的颈部覆盖的栓塞装置
CN112153946B (zh) * 2018-04-04 2024-05-28 因库麦迪斯有限公司 具有改进的颈部覆盖的栓塞装置

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