WO2014128313A1 - Device for supporting and positioning occlusive elements - Google Patents

Device for supporting and positioning occlusive elements 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
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WO
WIPO (PCT)
Prior art keywords
tubular structure
aneurysm
device
distal end
device according
Prior art date
Application number
PCT/ES2013/070109
Other languages
Spanish (es)
French (fr)
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/en
Publication of WO2014128313A1 publication Critical patent/WO2014128313A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118Occluding 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • A61B2017/12054Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12063Details concerning the detachment of the occluding device from the introduction device electrolytically detachable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, 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
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966Radiopaque markers visible in an X-ray image
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/823Stents, different from stent-grafts, adapted to cover an aneurysm

Abstract

The invention relates to a device for supporting and positioning occlusive coil or spiral-type elements for the endovascular embolisation of aneurysms, said device comprising an essentially tubular structure (1) in the form of a network or mesh of threads (2) of a surgically appropriate material, said tubular structure (1) having a distal end (3) and a proximal end (4), the distal end (3) corresponding to the end of the tubular structure (1) inserted into the aneurysmal sac (10) and the proximal end (4) corresponding to the part of the tubular structure opposing the aneurysm, where the distal (3) and the proximal (4) ends of the tubular structure (1) are integrally connected with structural continuity via a narrowing or a neck (6), the distal end (3) having a funnel or trumpet (5) shape stretched in relation to the diameter of the tubular structure (1) and deployable towards the inside of the aneurysm.

Description

DEVICE SUPPORT AND PLACEMENT OF ELEMENTS Occlusive

OBJECT OF THE INVENTION

In general, the present invention relates to a support device and placement of occlusive elements, such as coils or spiral type usually employed in endovascular embolization of aneurysms. The device of the invention is intended for the positioning and anchoring of such occlusive elements, for example in intracranial aneurysms with wide necks, mainly located in vascular bifurcations.

BACKGROUND OF THE INVENTION

Currently, embolization is the treatment usually applied for treating aneurysms and other malformations of blood vessels in the brain due to its minimally invasive nature because it has shown better results than surgical treatment (International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 Patients with intracranial aneurysms ruptured: a randomized trial, Lancet 2002; 360: 1267-1274). In this regard, an aneurysm is a bulge or sac that develops in an artery because the vessel wall is weak. A bulging brain aneurysm can compress surrounding nerves and brain tissue, resulting in neurological deficit, Cerebral Palsy isis cranial nerve or intracranial hypertension manifested by headache, nausea and vomiting. If the cerebral aneurysm because of an opening in the wall, extravasation of blood (hemorrhage) Intracranial occurs breaks, which is a very serious disease that can cause severe neurological damage or death in a high percentage.

Briefly, in a process of coiling, guided by images obtained with X-ray, a microcatheter is inserted through the skin into an artery and is guided to the aneurysm sac, inserting one or more coils through the microcatheter inside, where they are anchored. The body responds by thrombosis and subsequent scarring around the coil, which helps to block the flow of blood into the aneurysm, preventing thus breaking. However, it is known that the effect of coil embolization varies the size and shape of the aneurysm. Thus, 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 aneurysms with wide necks have been incorporating other technologies such as embolic protection balloon (Remodeling), coils retaining cuel the (TRISPAN) or stent placement in the neck aneurysmal.

While coils proved effective in small aneurysms with defined small necks and continents, since the flow within the aneurysm was i nterru m ask for the clogging m NCAS i ca, what ue prom OVIA the bosi trom s intra-aneurysmal, aneurysms larger with wide collars and no continents, had more difficulty a complete obliteration of the neck, with the risk of coil migration into the lumen of the carrier artery (José Tevah C, "endovascular treatment of cerebral aneurysms: the beginning makes 30 years and its current development, "Chilean Journal of Radiology Vol 9 No. 2, 2003;.. pp 78-85)..

To avoid the risk of the coils or spirals migrate into the carrier artery effect "drag" the same blood flow because the aneurysm neck is larger than the diameter of the coils themselves, the microcoils controlled release were designed, where the spiral is fastened to mandrel pushes along the microcatheter and can be released at the operator only when positioned and / or repositioned in a stable condition, such as system I DC, Interlockable Detachable coil, of Target Therapeutics, that advances and remove the "coil" in the aneurysm before final release (HS Cekirge, Saatci I., Firat MM, F. Balkanci 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 of Radiology, Hacettepe University Hospital, Sihhiye Ankara, Turkey) .

Guglielmi et al. (Guglielmi G, Vihuela F, Sepetkai I et al: "Electro-thrombosls of saccular aneurysms endovascularly approach, part I: Electrochemical basis, technique and experimental results," J Neurosurg 1991; 75: 1-7) described the design and application in animal models of microcoil extremely soft, pliable and atraumatic called GDC (Guglielmi Detachable Coi!). In this case, curves were preformed coil and this was attached to a steel guide by a welded joint by microengineering techniques, allowing its progression inside the microcatheter. O nce positioned in a satisfactory situation, impersonating a small electric current through the mandrel causing electrolysis of the welding and subsequent release of the spiral.

Moret et al. (Moret J, Picard L, Mawad M et al, "A critical study on endovascular treatment of berry aneurysms", Proccedings from the 28th Annual Meeting of the American Society of Neuroradiology, Los Angeles 1990;.. P. 35; Moret J , Cognard C, Weil a, Castsings L, King A., "Reconstruction technique in the treatment of wide-neck aneurysms intracranial: long-te rm ngiographic to clinica l nd results," J Neuroradiol 1997; 24: 30-44) d esarrol laron technique bolización em wide neck aneurysm, they called "Remodeling", through a protection balloon to facilitate location of the coils in position and prevent intraaneurimática output bearer vessel.

Currently, for treatment with coils of Wide neck aneurysms, have begun to develop various types of metal mesh or intracranial stents, devices already known coronary revascularization therapy, carotid and peripheral vessels (see for example EP 98124245.6, "Aortic graph" "), which have specific qualities in terms of flexibility, and allowing be placed against the aneurysm creating a neck support coils, which can be placed through the stent mesh.

00948716.6 EP, "Stent Adapted for tangle-free deploymenf, relates to a stent capable of adopting an expanded or retracted based on available inside structure of a number of expanders shaped elements fan blade configuration.

US 7651524, "Flexible stenf, describes a stent comprising multiple ring shaped members flakes arranged in axial direction and interconnected to each other. The EP0757904," Implantable prosthesis for a human or animals vessel: such as stent or aneurysm prosthesis " describes a prosthesis intended to be im planted in a human or animal duct to ensure a step in said conduit. This prosthesis has a tubular surface with a tube axis, comprising several filaments with corrugations, which are wound to define a tubular surface forming a series of undulations these rings advantageously zigzag, staggered in the length of the prosthesis.

In view of the prior art, it would be desirable to have a device specially adapted for the support and placement of occlusive element coils type or spiral, particularly intracranial aneurysms with wide necks, mainly located in vascular bifurcations, removable by electrolysis, and whose morphology allows retaining said coils in the aneurysm in order to avoid escape into afferent arteries and efferent and also allow to perform the embolization procedure aneurysm more stable and predictable way, thanks to its ease of capacity management and repositioning and release.

DESCRIPTION OF THE INVENTION

Therefore, the object of the present invention to provide a support device and placement of occlusive element coils type or coils within an aneurysm i ntracraneal of cuel widthwise pri nci Local pally lifted in vascular bifurcations, removable by electrolysis, and whose shape allows retaining said coils in the aneurysm, easy handling and capable of repositioning and release. The device of the invention is formed based on a structure of essentially tubular elastic mesh made of a material with shape memory has a widened at one end or distal end configuration, which is placed in the aneurysm neck to retain coils within, an intermediate portion that allows passage of a microcatheter and joining the flared distal end to a second end or proximal end, the shape of the latter is substantially similar to a stent, which allows anchor and stabilize the device in the afferent artery aneurysm.

EXPLANATION OF THE FIGURES

The invention is described based on the accompanying drawings, in which: Figure 1: Schematic design of the device i nvención according to a preferred embodiment thereof inserted in a vessel bifurcation.

Figure 2: Diagram of the positioning of the device and release of coils within an aneurysm.

PREFERRED EMBODIMENT OF THE INVENTION.

Although the device of the invention is described in connection with the embolization of intracranial aneurysm wide neck, the skilled artisan will understand that its application is not limited to this case, where multiple possible applications thereof, for example if mechanical thrombectomy (thrombectomy) for the treatment of ischemic stroke, if necessary varying in their size and adapted to the anatomy of each particular patient.

Referring to Figure 1, the device of the invention is a structure of substantially tubular shape (1) formed from a network or mesh of threads (2) of a suitable, elastic and thermal memory surgically material. The tubular structure (1) having a distal end (3) and a proximal end (4), constituting the distal end (3) the part corresponding to the end of the tubular structure (1) that is inserted into the aneurysmal sac (10) and forming the proximal end (4) of the tubular structure opposite the aneurysm, this is one that remains in the afferent artery. Both proximal distal ends (3) and (4) of the tubular structure (1) are integrally and structural continuity together joined by a narrowing or neck (6).

As seen in Figure 1, once inserted, the distal end (3) has a funnel-shaped or trumpet (5) widened with respect to the diameter of the tubular structure (1) and deployed into the aneurysm sac ( 10). Thus, the distal end (3) is inserted through aneurysm neck (1: 1), in the aneurysmal sac (10) in order to retain the coils (12) therein allowing complete closure of the aneurysm and avoiding the coils afferent and efferent invade arteries. Meanwhile, narrowing or neck (6) has a suitable diameter to allow passage of a microcatheter (13) from which the coils (12) inside the aneurysm are released, and finally, the proximal end (4 ) allows to anchor and stabilize the device in the afferent artery. To facilitate guiding the device inside the afferent artery, the proximal end (4) of the device has an element removably guiding (7) attached to the tubular structure, so that it is possible to release the device at the site right and recovery of the guide, for example by a similar stent commonly used in the electrolysis system with removable devices. In one embodiment, the connection between the separable element guiding means (7) and the device is a releasable bonding welding electrolysis.

In a preferred embodiment, the tubular structure (1) formed from a network or mesh of threads (2) is manufactured in an elastic shape memory alloy such as a titanium-nickel alloy Nitinol type.

To facilitate insertion into the afferent artery, the distal end (3) of the device of the invention is capable of being folded inside the microcatheter being deployed once it has been introduced into the aneurysm sac (10), inserting said microcatheter.

If the tubular structure (1) is made of an elastic memory alloy Nitinol shape type and because this material is radiolucent, the device optionally has markers platinum at its distal end (3), neck (6) and at its proximal end (4), allowing placement of the device in precise position.

In an embodiment, first the measure to have the device of the invention, so that it fits to the anatomy of the arteries and the aneurysm to be embolized, for example based on the action taken is selected by rotational angiography with 3D reconstruction. the aneurysm with m icrocatéter and the guide element is catheterized with standard techniques. Very gently, the device is made up by the afferent artery using the guide element, its distal end deployed within the aneurysm so that said distal end widens adapting to the aneurysm neck. Thanks to the guide element and the elasticity of the tubular structure forming the device, it can be repositioned until the site determined by the interventional neuroradiologist. Once positioned the distal end of the neck of the aneurysm, it continues releasing the remainder of the device to be anchored in the afferent artery. A microcatheter device neck is crossed and the aneurysmal sac then being filled with coils by standard technique is catheterized. Once embolized aneurysm, it proceeds to release the device.

Claims

What is claimed
1. Device support and positioning elements occlusive coils or spiral type for endovascular embolization of aneurysms comprising a substantially tubular structure (1) in network or mesh of threads (2) of a suitable elastic material surgically shape memory , said tubular structure (1) a distal end (3) and a proximal end (4), constituting the distal end (3) the part corresponding to the end of the tubular structure (1) that is inserted into the aneurysmal sac (10 ) through a microcatheter and constituting the proximal end (4) of the opposite aneurysm tubular structure, that is one that remains in the artery afferent, wherein both proximal distal ends (3) and (4) of the tubular structure (1) are integrally and structural continuity together joined by a narrowing or neck (6), wherein the distal end (3) a funnel or trumpet shaped (5) widened with respect to diameter of the tubular structure (1) and deployable into the aneurysm.
2. Device according to claim 1, characterized in that the constriction or neck (6) has a suitable diameter to allow passage of a microcatheter from which coils are released into the aneurysm, and, finally, the proximal end (4) It allows to anchor and stabilize the device in the afferent artery.
3. Device according to claim 1, wherein the distal end (3) is capable of being folded inside a microcatheter and deployed from this once introduced into the aneurysm sac (10).
4. Device according to claim 1, wherein the proximal end (4) has a separable element guide (7) attached to the tubular structure (1) allowing the release of the device.
5. Device according to claim 4, characterized in that the connection element detachably guided (7) and the device is a releasable bonding welding electrolysis.
6. Device according to any of claims 1 to 4, wherein the tubular structure (1) formed from a network or mesh of threads (2) is made of a nickel-titanium shape memory elastic.
7. Device according to claim 6, characterized in that at its distal end (3), neck (6) and at its proximal end (4) has a platinum markers that facilitate its placement in the precise position.
PCT/ES2013/070109 2013-02-21 2013-02-21 Device for supporting and positioning occlusive elements WO2014128313A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/ES2013/070109 WO2014128313A1 (en) 2013-02-21 2013-02-21 Device for supporting and positioning occlusive elements

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/ES2013/070109 WO2014128313A1 (en) 2013-02-21 2013-02-21 Device for supporting and positioning occlusive elements

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0757904A1 (en) 1995-08-03 1997-02-12 B. Braun Celsa Implantable prosthesis for a human or animal vessel such as steut or ameurysm prosthesis
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 (en) * 2005-12-31 2007-07-12 Levy Elad I Bifurcation aneurysm treatment stent with distal web
US20070270902A1 (en) * 2004-09-17 2007-11-22 Slazas Robert R Thin Film Metallic Devices for Plugging Aneurysms or Vessels
DE102008028308A1 (en) * 2007-10-18 2009-04-23 Acandis Gmbh & Co. Kg Vascular implant for treating cerebral posterior circulation aneurysm, has lattice structure with deflection unit forming cone with apex that faces structure or three-dimensional curvature that extends towards axial end of structure
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 (en) 1995-08-03 1997-02-12 B. Braun Celsa Implantable prosthesis for a human or animal vessel such as steut or ameurysm prosthesis
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 (en) * 2005-12-31 2007-07-12 Levy Elad I Bifurcation aneurysm treatment stent with distal web
DE102008028308A1 (en) * 2007-10-18 2009-04-23 Acandis Gmbh & Co. Kg Vascular implant for treating cerebral posterior circulation aneurysm, has lattice structure with deflection unit forming cone with apex that faces structure or three-dimensional curvature that extends towards axial end of structure
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

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