WO2017105479A1 - Système d'implant vasculaire et procédés avec zones de séparation souple - Google Patents

Système d'implant vasculaire et procédés avec zones de séparation souple Download PDF

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Publication number
WO2017105479A1
WO2017105479A1 PCT/US2015/066605 US2015066605W WO2017105479A1 WO 2017105479 A1 WO2017105479 A1 WO 2017105479A1 US 2015066605 W US2015066605 W US 2015066605W WO 2017105479 A1 WO2017105479 A1 WO 2017105479A1
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WO
WIPO (PCT)
Prior art keywords
implant
helical coil
distal end
core wire
proximal end
Prior art date
Application number
PCT/US2015/066605
Other languages
English (en)
Inventor
Jake Le
David A. Ferrera
Dawson LE
Randall TAKAHASHI
George Martinez
Original Assignee
Blockade Medical, LLC
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 Blockade Medical, LLC filed Critical Blockade Medical, LLC
Priority to US15/537,881 priority Critical patent/US20180271533A1/en
Priority to CN201580085817.6A priority patent/CN108697425A/zh
Priority to JP2018551747A priority patent/JP2019502513A/ja
Priority to KR1020187020366A priority patent/KR102359744B1/ko
Priority to EP15910944.6A priority patent/EP3389510A4/fr
Priority to PCT/US2015/066605 priority patent/WO2017105479A1/fr
Publication of WO2017105479A1 publication Critical patent/WO2017105479A1/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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—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
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • 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
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • 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
    • A61L31/18—Materials at least partially X-ray or laser opaque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, 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

Definitions

  • the field of the Invention generally relates to medical devices for the treatment of vascular abnormalities.
  • Hemorrhagic stroke may occur as a result of a subarachnoid hemorrhage (SAH), which occurs when a blood vessel on. the brain's surface ruptures, leaking blood into the space between the brain and the skull.
  • SAH subarachnoid hemorrhage
  • a cerebral hemorrhage occurs when a defective artery in the brain bursts and floods the surrounding tissue with blood.
  • Arterial brain hemorrhage is often caused by a head injury or a burst aneurysm, which may result from high blood pressure.
  • a artery rupturing in one part of the brain can release blood that co ies in contact with arteries in other portions of the brain.
  • Neurovascular embolization is to isolate ruptured or rupture-prone neurovascular abnormalities including aneurysms and AVIV!s (arterio-venous malformations) from the cerebral circulation in order to prevent a primary or secondary hemorrhage into the intracranial space,
  • Cerebrovascular embolization may be accomplished through the transcatheter deployment of one or several emboiiziog agents in an amount sufficient to halt internal blood flow and lead to death of the lesion.
  • embolic agents have Been approved for neurovascular indications including glues, liquid embolics, occlusion balloons, platinum and stainless steel microcolls (with and without attached fibers), and polyvinyl alcohol particles.
  • iorocGiis are the most commonly employed device for embolization of neurovascular lesions, with rrtserocoi!sng techniques employed in the majority of endova : scuiar repair procedures involving cerebral aneurysms and for many cases involving permanent AVM occlusions, ' Neurovascular stents may be employed for the containment of embolic coils. Other devices such as flow diversion implants or flow disrupter implants are used in certain types of aneurysms,
  • Aortic aneurysms are commonly treatment with stent grafts.
  • a variety of stents are used for the treatment of atherosclerotic, and other diseases of the vessels of the body.
  • Detachable balloons have been used for both aneurysm occlusion and vessel occlusion.
  • Vascular issues are addressed with and by novel enhanced systems with accurate and ready detachabifity among other features for addressing, for example, acute stroke issues wth due alacrity.
  • FIG, 2 is a perspective view of a protective shipping tube for the vasoocdusive implant system of FIG. 1.
  • FIG. 3 is a detailed view of a distal tip portion of the vasoocdusive implant system of FIG. i, taken from within circle 3.
  • FIG. 3A is a detailed view of the distal portion of a vasoocdusive implant system with a flexible detachment zone.
  • FIG. 38 is a detailed view of the distal portion of a vasoocdusive implant system with a flexible detachment zone
  • FIG. 30 shows a vasoocdusive implant system with a flexible detachment sone compared to a vasoocdusive implant system without a flexible detachment 2one.
  • FIG. 4 is perspective view of a vasoocdusive implant according to one embodiment of the invention.
  • FIG. 5 is a perspective of a vasoocdusive implant according to another embodiment of the Invention.
  • FIG, 8 is a perspective of a vasoocciussve implant according to another embodiment of the invention.
  • FIG. 7 is a sectional view of FIG. 1 , taken along line 7-7.
  • FIG. 8 is a sectional view of FIG. 1 , taken along line 8-8.
  • P01S] F!G. 9 is a detailed view of a transition portion of the vasoocclusive implant system depicted in FIG. 8. taken from within circle 9.
  • FIG. 10 is a perspective view of a mandrel for forming a vasoocclusive implant according to an embodiment of the Invention.
  • FIG. 11 is a perspective view of an electrical power supply configured to electrically couple to an electrolytically detachable implant assembly.
  • FIG. 12 is a circuit diagram of the electrical power supply coupled to an electrolytically detachable implant assembly that is inserted within a patient.
  • FIG. 13 is a graphical illustration of electrical characteristics of the electrical power supply ove time during the detachment of an electrically detachable implant
  • FIG. 14 is a sectional view of a vasoocclusive implant system having a decreased stiffness at a regio near the detachment zone.
  • FIGS 15A- 15G are a sequence of drawings schematically iustraf ing the steps of occluding an aneurysm using the vasoocclusive implant systems of FIGS. 1-14.
  • FIGS 1BA-16G show deployment sequences of occluding and aneurysm with an expandable flow disrupter device making use of certain embodiments of the electrolytic detachment system of the vasoocclusive implant systems of FIGS. 1-14.
  • the present disclosure provides improved vasoocclusive implants and related devices, methods, and systems fo addressing cerebral aneurysms and other vascular issues.
  • the following patents and publications are expressly Incorporated herein by reference in their entireties: United States Patent Serial Number 8,002,822; International Patent Publication WO 2005/0122961, filed June 13, 2005; United States Provisional Patent Application Serial Number 81/811,055, filed April 11 , 2013; United States Provisional Patent Application Serial Number 61/838,240, filed October 18, 2013; and United States Provisional Patent Application Serial Number 81/917,854, filed December 18, 2013.
  • Th treatment of ruptured and unruptured intracranial aneurysms wit the use of transluminally-deiivered occlusive mierocolis has a relatively low morbidity ' and mortality rate in comparison with surgical clipping.
  • icrocoils are typically delivered into the aneurysm one at a time, and it is of critical important that each microcoil be visible, for example by fluoroscopy, and that if microcoil is not delivered into a desirable position, that it may be safely and easily withdrawn from the aneurysm.
  • a microcatbeter Is placed so that its tip is adjacent the neck of the aneurysm, and the microcoils are delivered through the lumen of the mierocatheter.
  • Microcatheter design, placement, and ti orientation are all important factors in determining ho well the microcatheter will support the delivery, and if needed, removal, of the microcoil to and from the aneurysm. If excessive resistance is met during the delivery of the microcoil, the microcatheter may ""back out", thus; losing its supporting position and/o orientation in relation to the aneurysm.
  • microcoil stretching of this nature can be expensive to the neurointerventionalist performing the procedure, as this microcoil will need to be discarded and replaced, but it may also
  • stretched colls may also e prone to being trapped, breaking, or inadvertently interlocking with other microeoils, already placed within the aneurysm.
  • a stretched microcoil ih ⁇ t is partially within a multi-coil mass inside the aneurysm and partially within the microcatheter, and that cannot be furthe advanced or retracted, may necessitate an emergency craniotomy and very invasive microsurgical rescue procedure.
  • Potential transcatheter methods for salvaging a stretched coil are less than desirable. They consist of either tacking the stretched coil to the inner wall of the parent artery with a stent, using a snare device to grasp and remove the stretched coil portion that is within the aneurysm, or placing the patient on long term antiplatelet therapy,
  • Placement of a first "framing" microcoil within an aneurysm is often done using a three-dimensional, or "complex " , microcoil (a microcoil which is wound around a plurality of axes).
  • the initial framing microcoil is the base structure into which later "filling" microcoiis ar packed.
  • the first microcoil placed into a completel uncoiled aneurysm eve if if ss a three-dimensional or complex microeoll, the first loop of the microcoil ma exit from the aneurysm after it has entered, instead of looping several times around the inside of the aneurysm.
  • IVIiorocoiis may migrate out of the aneurysm either during the coiling procedure, or at a later date following the procedure.
  • the migrated loop or loops of the microcoil can be a nidus for potentially fatal thromboembolism.
  • the migration of portions of microcoiis may be due to incomplete packing of the microcoil info the ooil mass within the aneurysm.
  • incomplete packing of microcoi!s, particularly at the neck of the aneurysm may cause ineomplete thrombosis, and thus leave the aneurysm prone to rupture, or in the case of previously ruptured aneurysms, re-rupture.
  • aneurysms wit incomplete micro-coil packing at the neck may nevert eless initially thrombose completely. However, they may stili be prone to recanalization, via the dynamic characteristics of a thromboembo!us, Compaction of the coil mass with the aneurysm is another factor which may cause recanaiization.
  • the inability to pack enough coif mass into the aneurysm, due to coi! stiffness or shape is a possible reason for an insufficient coil mass.
  • Detachable microcoiis are offered by several different manufactures, using a variety of detachment systems. Through alt detachment, systems involve some dynamic process, some systems involve more physical movement of the system than others, Mechanical detachment systems, using pressure, unscrewing, axial pistoning release, tend to cause a finite amount of movement of the implant at the aneurysm during detachment. in intracranial aneurysms, movement of this nature is typicall undesirable. Any force which can potentially caus microcoil movement or migration should be avoided.
  • Non-mechanical systems chemical, temperature, electrolytic
  • Non-mechanical systems have inherently less movement, but often suffer from less consistency, for example, a consistent short duration for a coil to detach.
  • detachable microcoi! systems include a detachment module (power supply, etc. ⁇ that is typically attached to an I pole near the procedure table. There is usually a cable or conduit that connects the non-sterile module to the sterile microcoi! implant and delivery wire.
  • the attending intervenfionaist usually most ask a person in the room, who is not "scrubbed" for the procedure, to push the detacti button on the module in order to cause the detachment to occur ,
  • FIG, 1 illustrates a vasoocciysive Implant system 100 comprising microcoil implant 102 detachab!y coupled to a pusher member 104.
  • the pusher member 104 includes a core wire 106, extending the length of the pusher member 104, and made from a biocompatible material such as stainless steel, for example 304 series stainless steel.
  • the core wir 106 diameter at a proximal end 108 may be between .008" and .018", and more particularly between .010" and .012",
  • An electrically insulated region 1 10 of the pusher member 104 extends a majorit of the core wire 106 length, betwee a first point 1 12, approximately 10 cm from the extreme proximal end of the core wire 108 and a second point 114, near the distal end 118 of the core wire 106, Directly covering the surface of the core wire 106 Is a polymeric coating 1 18 t for example PTFE ⁇ polytefrafluorQ ethylene), Paryiene or polyimide, and having a thickness of about .00005" to about .0010", or mor particularly .0001" to .9005.
  • a polymeric co tube 120 Is secured over the core wire 100 and the polymeric coating 118,
  • the polymeric cover tube 120 may comprise polyethylene ferephthalate (PET) shrink tubing that is heat shrunk over the core wire 106 (and optionally, also over th polymeric coating 1 18) while maintaining a tension of the ends of the tubing.
  • a marker coil 122 (FIG. 9) may be sandwiched between the core wire 106 and the polymeric cover tube 120. for example, by placing the marker coil 122 over the core wire 106 or over the polymeric coating 118, and heat- shrinking or bonding the polymeric cover tube 120 over them.
  • the core wire 06 may have transition zones, including tapers, where the diameter decreases from its diameter at th proximal end 108 to a diameter el for example, ,005 s to .008" throughout a portion of the electrically insulated region 110 of the pusher member 104.
  • the diameter of the core wire 108 at the distal end 116 may be .002" to .003", including the- portion of the distal end 118 that is outside of the electrically insulated region 1 0 of the pusher member 104.
  • a ti 124 may be applied to the polymeric cover tube 120 in order to complete the electrically insulated region 110. This is described in more detail with relation to FIG. 9.
  • the microeoil implant 102 is defachafoly coupled to the pusher member 104 via a coupling joint 126, which is described in more detail with relation to FIG. 7.
  • FIG, 3 illustrates a coil assembly 128 of the microeoil implant 102 (shortened for sake of easier depiction).
  • An embolic coil 130 may be constructed of platinum or a platinum alloy, for example, 92% platinum/8% Tungsten, and close wound from wire 144 having a diameter between .001" and .004", or more particularly between .00125 " to .00325".
  • the coll may have a lengt (when straight) of between 0.5 cm and 50 cm, or more particularly- between 1 -cm and 40 cm.
  • the embolic coil 130 is formed in to one of severs! possible shapes, as described In more detail in relation to FIGS. 4-6 and FIG. 1Q.
  • a tether 132 is tied between a proximal end 134 and a distal end 138 of the embolic coil 130.
  • the tether may be formed of a thermoplastic elastomer such as Engage ® , or a polyester strand, such as diameter polyethylene ferephthaiafe (PET),
  • the diameter of the tether 132 may be .0015" to .0030", or more particularly .0022" for the Engage strand.
  • the diameter of the tether 132 may be .00075" to .0015", or more particularly ,0010" for the PET strand.
  • the primary outer diameter of the embolic coif 130 may be between .009" and .019".
  • a two reduced diameter portions 138, 140 are created in certain winds of the embolic coil 30, for example by carefull pinching and shaping with fine tweezers.
  • a tip encapsulation 146 comprising an adhesive or an epoxy, for example, an ultraviolet* curable adhesive, a urethane adhesive, a ready-mixed two-part epoxy, or a frozen and defrosted two-part epoxy, is applied, securing the one or more knots 147, 14S to the reduced diameter portion 140 s and forming a substantially hemispherical tip 150.
  • the tether With a sufficient amount of slack/tension laced on the tether 132, the tether is tied in one or more knots 151 , 152 to the reduced diameter portion 138.
  • a cylindrical encapsulation 154 also comprising an adhesive or an epoxy, is applied, securing the one or mor knots 151 , 152 to the reduced diameter portion 138,
  • the cylindrical encapsulation 154 provides electrical isolation of the embolic coll 130 from the core wire 106, and thus allows for a simpler geometry of the materials involved in the electrolysis during detachment.
  • the tether 132 serves as a stretch-resistant member to minimize stretching of the embolic coil 130.
  • the tether 132 may be made from a multi-filar or stranded polymer or a n icrocable,
  • an introducer tube 155 having an inner lumen 156 with a diamete slightly larger than the maximum outer diameter of the microcoil implant 102 and pusher member 104 of the vasoocciusive implant system 100 is used to straighten a shaped embolic coil 130, and to insert the vasoocciusive implant system 100 into a lumen of a microcatheter.
  • the vasoocciusive implant system 100 is packaged with and is handled outside of the patient's body within the inner lumen 156 of the introducer tube 155.
  • the vasoocciusive implant system 100 and introducer tube 55 are packaged for sterilization by placing them within a protective shipping tube 158, shew* in FIG. 2,
  • the proximal end 108 of the pusher ember 104 is held axiaily secure by a soft clip 160.
  • FIG. 3A shows an embodiment of the microcoil implant system 300 including a flexible detachment zone.
  • This Implant system comprises a microcoil implant 302 detachabiy coupled to a pusher member 304, Including a core wire 306 coated with a polymeric coating 318 and covered with a polymeric cover tube 320, The polymeric coating 318, polymeric cover tube 320, and a tip 324 formed of an adhesive of epoxy, constitute an electrically insulated region.
  • Th implant system 300 is similar to the asoocclusiv implant system 100 of FIG. 1 , except for a modified configuration of the embolic coil 330 in relation to the detachment zone 362.
  • the core wire 308 extends out of the distal end of the pushing member 304.
  • An uninsulated region of the core wire comprises the detachment zone 362,
  • the detachment zone 362 Is the sacrificial portion of the vasoocclusive implant system that allows the microcoii implant 302 to be detached from the pusher member 306, Distal to the detachment zone 382, a coupler coil 366 Is wrapped around the core wire 306 and is positioned coaxially within the embolic coil 330.
  • the embolic coil 330 and coupler coil 366 are electrically insulated from each other by a cylindrical polymeric coating 354 or encapsulation.
  • the encapsulation 354 can be a UV adhesive, for example.
  • the cylindrical encapsulation 354 provides electrical isolation of the embolic coil 330 from the core wire 306, and thus allows for a simpler geometry of the materials involved in the electrolysis during detachment.
  • This coaxial arrangement creates a stiff zone (represented with dotted lines) that Is significantly shorter than prior art stiff (non- bendable) zones, which are often greater than .040" in length.
  • the configuration shown in FIG. 3A has a stiff zone of between .010" and .030" in length,
  • the embolic coll and core wire are coupled together with a coupler coil and a potted sectio of epoxy or other insulating material.
  • the core wire 306 extends through a proximal portion of the embolic coil 330.
  • a tether 332 connects a proximal and distal portion of the embolic coil 330.
  • the configuration shown in FIG, 3A .allow the proximal portion of the embolic coil 330 to be more flexible.
  • FIG. 3B shows the device of FIG. 3A in a flexed position.
  • the flexible zone is immediately distal to the coupler coil (not shown) positioned ooaxially within the proximal portion of the embolic colt
  • Th rigid or stiff zone Is onl about .020" (plus or minus .010").
  • FIG. 3 gives shows a comparison of the flexibility of the implant in the system 100 (sown in FIG. 1 ⁇ and system 300 (shown In FIG. 3).
  • the system 300 has a shortened stiff region, wherein the coupling coil is placed within the embolic coil 330.
  • System 100 has an epoxy insulated region situated between the proximal portion of the embolic coil 130 and the distal portion of th coupling joint 128. Th shorter epoxy region of system 300 allows the embolic coil 330 to begin flexion more proxirnaily as compared to system 100, where flexion occurs more distally down the length of the implant
  • implant system 300 provides an approximately 50% reduction in length of the stlffer insulated bond section and a shorter and smaller coupler coil, as compared to embodiments having a potted epoxy section between the coupler coil and the embolic coil.
  • the result is a softer and more flexible proximal portion of the embolic coil, which improves deliverabiiity and reduces microoatheter kickback during an implantation procedure.
  • the increased flexibility of the device allows greater eonformability of the microcoil in the tight spaces of a vascular aneurysm.
  • the configuration with the flexible detachment zone created significantly increases flexibility of the microcoil implant as it is being delivered into an aneurysm from a mierocathefer.
  • the increased flexibility and maneuverability make it much less likely to cause the microcatheter to lose its position at the neck of the aneurysm, thereby reducing th incidence of misplaced microcosls and the complications that arise therefrom.
  • the flexible microcoil implant is more capabl of conforming to the shape of a vascular cavity of Interest during delivery.
  • the coaxial configuration of the coils provides the added benefit of offering a lower profile detachment zon 382. leading to increased first-button detachment consistency.
  • the cylindrical insulation region maintains effective eiectrical Insulation between the embolic coil and the detachment zone.
  • FIGS. 4-6 illustrate vasoocclusive Implants according to three different embodiments of the invention.
  • FIG. 4 illustrates a framing microcoil implant 200 made from an embolic coil 201 and having a box shape which approximates a spheroid when placed within an aneurysm.
  • Loops 202, 204, 206, 208, .210, .212 are wound on three axes: an X-axis extending in the negative direction ( ⁇ X) and a positive direction from a coordinate original (O), a Y-axis extending in the negative direction (-Y) and a positive direction (+Y) from the coordinate origin (O), and an Z-axls extending in the negative direction ( • -2) and a positive direction (+Z) from the coordinate origin (G).
  • a first loop 202 having a diameter begins at a first end 214 of the embolic coil 201 and extends around the *X-axis i a direction 218. As depicted in FIG.
  • the first loop 202 includes approximately 11 ⁇ 2 revolutions, but may (along with the other loops 204, 206, 20E, 210, 212 ⁇ include between 1 ⁇ 2 revolution and 10 revolutions.
  • the second loop 204 having a diameter D2 continues from loop 202 and extends around the -Y --axis in a direction 218.
  • the third loop 206 then extends around the +Z-axls I a direction 220.
  • the fourth loo 208 then extends around the __X-axss in a direction 222.
  • the fifth loop 210 then extends around the +Y-a fs in a directio 224, And finally, the sixth loo 212 extends around the . Z-axis In a direction 228. As seen in FIG.
  • th coupling joint 126 is formed at a second end 228 of the embolic coil 201 .
  • the precise configuration of loops shown in FIG. 4 is for illustrative purposes, and Is not meant to imply any limitation.
  • the implant can take other generally spheroid forms comprising different numbers and configurations of loops, f3 ⁇ 404 ⁇ J Framing microcoil implant 200 is configured for being the initial microcoil placed within an aneurysm * and therefore, in this embodiment, loops 204, 206, 208, 210, and 212 all have s diameter approximately equal to D2.
  • the first loop 202 is configured to be the first loo introduced info the artery, and in order to maximize the ability of the microcoil Implant 200 to stay within the aneurysm during coiling, t e diameter Di of the first loop 202 is to between 85% and 75% of the diamer Da, and more particularly, about 70% of the diameter of D2, Assuming that D2 is chosen to approximate the diameter of the aneurysm, when the first loop 202 of the microcoil implant 200 is Inserted within the aneurysm, as if makes it way cirounifereiifially around the wall of the aneurysm f it will undershoot the diameter of the aneurysm if and when it passes over the opening at th aneurysm neck, and thus will remain within the confined of the aneurysm.
  • the choice of the tether 132 can be important for creating a microcoil implant 200 that behaves well as a framing mierocoil, framing the aneurysm and creating a supportive lattic to aid subsequent coiling, both packing and finishing.
  • the tether 132 may b made from .0009" diameter PET thread in miorocoil implants 200 having a diameter D2 of 5 mm or less, w ite the tether 132 may be made from ,0022" diameter Engage thread In mi ' erocoil implants 200 having a diameter D2 of 5 mm. or more.
  • the diameter .of the wire 144 may be chosen as .0015" in.011 " diameter embolic coils 130 and .002" in .012" diameter embolic coils 130.
  • the .01 1 " embolic coils 130 may be chose for the constructio df microcoi implants 200 having a diameter D2 of 4.S mm or less, and the .012" diameter embolic coils 130 may be chosen for the construction of microcoil implants 200 having a diameter D2 of 4,5 mm or more.
  • additional framing microcoil models may be mad having .013" or larger embolic coils 130 wound with .002" and larger wire 144.
  • colling procedure need not necessarily use only one framing microcoil, and that during the implantation procedure, one or more framing microcoils may be used to set up the aneurysm for filling microcoils and finishing microcoils.
  • a mandrel 500 for forming a vasocceiusive implant has six arms 502, 50 5 508, 508, 510, 512 which are used for creating the loops 202, 204, 206, 208, 210, 212 of the microcoil implant 200 of FIG. 4.
  • the first loop 202 is used for creating the loops 202, 204, 206, 208, 210, 212 of the microcoil implant 200 of FIG. 4.
  • the wi e 144 of the embolic coil 130 is pulled into a straight extension 516 for length at the first end 214 (FIG.
  • a weight 520 is attached to an extrem end 522 of the embolic coil 130 and the mandrel 500 is rotated In direction 526 with respect to the X ⁇ axls 524, causing the first loo 202 to be formed.
  • the position of the mandrel 500 is then adjusted prior to the forming of each consecutive loop, so that whichever arm/axis that the current loop is being formed upon is approximately parallel to the ground, with the weight .520 pulling an extending length 526 of the embolic coil 130 taut in a perpendicular direction to the floor (in the manner of a plumb line).
  • the second end 228 (FIG. 4) is secured by stretching a length of the wire 144 and attaching it to a securing element 528 at an end 530 of arm 5 2,
  • the formed loops 202, 204, 208, 208, 210, 212 of the mteroeoil implant 200 are now held securely on the mandrel 500, and the shape of the loops Is set by placing them into a furnace, for example at 7G0 for 45 minutes.
  • the formed loops of the microcoii Implant 200 are carefully removed from the mandrel 500, and the rest of the manufacturing steps of the microcoii implant 20Q ⁇ 102 and vasoocclusive implant system 100 are performed.
  • the diameter of the first arm 502 o the mandrel S00 is approximately 70% of the diameter of eac of the other arms 504, 506, 60S, 510, 512, in order to create a first loop 202 that Is approximately 70% the diameter of the other loops 204, 206, 208, 210, 212,
  • FIG. 5 illustrates a filling microcoii implant 300 having a helical shape.
  • the filling microcoii implant 300 is manirfactyred In a similar winding and setting technique as the framing microcoii implant 200, but the helical loops 302 of the filling microcoii implant 300 ar wound on a single cylindrical mandrel (not shown).
  • Th framing microcoii implant 200 is formed from an embolic soil 130 having a first end 314 and a second end 328,
  • the tether 132 (FIG- 3) of the filling microcoii implant 300 can be construed from a variety of materials, including a thermoplastic elastomer such as
  • the diameter of the tethe 132 formed from Engage may range from .002" to
  • the wire 144 used in making the emhollc coil 130 used to construct the filling microcoii implant 300 may be 92/8 Pt W wir of a diameter between about .00175" and .00275", and more particularly between .002" and
  • the outer d ameter of the embolic coil 130 of the filing microcoii implant 300 may be between .011" and .013", more particularly about .012 :1 .
  • One or more filling microcoii implants 300 can be used after one or more framing coil implants 200 have been placed in the aneurysm, to pack and fill as much volume of the aneurysm as possible.
  • the comparativel soft nature of the filling microcoii implants 300 allows a sufficient amount of packing to achieve good thrombosis and occlusion, without creating potentially dangerous stresses on the wail of the aneurysm that could potentially least to rupture (or re-rupture).
  • a helically shaped microcoii as a filling mtcr oo ' il implant 300, they may also be used as a finishing mierocGil Implant, which is the last one or more implant that are placed at the neck of the aneurysm to engage well with the cos! mass white maximizing the filling volume at the neck of the aneurysm.
  • finishing microc i!s are typically smaller, having an outer diameter of about ,010", and being wound from 92/8 Pt W wire having a diameter of between 001 " to .00175", more particularly between ,00126" and .0015".
  • the tether 132 used In a helical finishing microeoil may comprise .001 " PET thread.
  • FIG. 8 illustrates a complex microeoil implant 400, having a first loop 402, second loop 404, third loop 406, fourth loop 408, fifth loop 410, and sixth loop 412, wend in three axes, much like the microeoil implant 200 of FIG. 4.
  • the diameter f3 ⁇ 4 of the first loop 402 is about the same as the diameter D of each of the other loops 404, 406, 408, 410, 412 would include a first a m 502 having a similar diameter to the other arms 504, 506, 508, 510, 512.
  • a complex microeoil implant 400 of this construction ma he used as a framing microeoil implant, but may alternatively be used as a finishing microeoil implant.
  • FIG. 7 illustrates the coupling joint 126, the tip 124 of the vasooccluslve implant system 100 of FIG. 1 , and a detachment zone 162 between the tip 124 and the coupling joint 126.
  • the detachment zone 182 is the orsfy portion of the core wire 106 other than the proximal end 108 that is not covered with the electrically insulated region 110, and the only one of the two non-insulated portions of the core wire 108 that Is configured t be placed within the bloodstream of the patient.
  • FIGS, 1 1-13 illustrates the coupling joint 126, the tip 124 of the vasooccluslve implant system 100 of FIG. 1 , and a detachment zone 162 between the tip 124 and the coupling joint 126.
  • the detachment zone 182 is the orsfy portion of the core wire 106 other than the proximal end 108 that is not covered with the electrically insulated region 110, and the only one of the two non-insulated
  • the detachment zon® 182 Is the sacrificial portion of the vasooccluslve implant system 1 0 that allows the microeoil implant 102 to be detached from the pusher member 104.
  • the tether 132, the embolic coil 130 (not pictured) and the core wire 106 are coupled together with a coupler coil 166 and a potted section 164, fo example UV adhesive or other adhesives or epoxy.
  • the coup er coil 68 may be made from .001" to .002" diameter platinum/tungsten (92%/8%) wire and have an outer diameter of .008" to .009", or more particularly, .007 ' to .008".
  • the coupler coil 186 may be attached to the core wire 106 win solder, such as silver solder or gold solder.
  • FIGS. 8 and 0 illustrate a section of the pusher member 104 approximate 3 mm from the detachment zone 162.
  • a marker coil 122 comprising a close wound portion 188 and stretched portion 170 is sandwiched between the core w re 108 and the polymeric cover tube 120.
  • the marker coil 122 may be constructed from .002" diameter platinum/tungsten (92%/8%) wire and have an outer diameter of .008".
  • the close wound portion 188 is more radiopaque than the stretched portion 170, and thus is used as a visual guide to assure that the detachment zone 162 is just outside of the microcatheter during the detachment process.
  • the marker coil 122 may be attached to th core wire 108 with solder, such as silver solder or gold solder.
  • FIG. 12 illustrates an electrical power supply 700 for electrically coupling to the vasoocclusfve implant assembly 100 of FIG. 1.
  • the electrical power supply 700 comprises a battery-powered power supply module 702 having a pole clamp 704, for attaching to an IV pole, and a control module 706.
  • the control module 708 includes an on/off button 718 and first and second electrical clips 712, 714, providing first and second electrodes 708, 710.
  • the control module 706 is electrically connected to the power supply module 702 via an electrical cable 718, and the first and second electrical clips 712, 714 are each connected to the control module 708 via Insulated electrical wires 720, 722.
  • f3 ⁇ 4SS3J Turning to FIG. 12, a circuit diagram 800 of the electrical power suppl 700 of FIG.
  • the electrode 708 is positivel charged and Is represented by a terminal connection 802, at which the first electrode 708 of the first clip 712 is connected to the uninsulated proximal end 108 of the core wire 106 of the pusher member 1 4,
  • the electrode 710 is negativel charged and is represented by a terminal connection 804, at which the second electrode 710 of the second clip 714 is connected to a conductive needle or probe, whose tip is inserted into the patient, for example at the groin or shoulder areas.
  • a constant current source 806 powered by a controlled DC voltage source 808 is run through a system resistor 810 and the parallel resistance in the patient, current passing through the core wire 108 and the patient, via the uninsulated detachment zone 182 (FIG. 7).
  • a constant current (i) 902 is maintained over time (t) 5 with the controlled DC voltage source 808 increasing the voltage 904 as the tota resistance increases due to the electrolytic dissolution of the stainless steel at the detachment zone 162. Whe the detachment zone 182 in completely obliterated, th voltage 90 is forced upward in a spike 908, triggering a notification of detachment,
  • FIG. 14 illustrates a vasooeelusive implant system 1100 comprising a microcoil implant 1102 defachabJy coupled to a pusher member 1104, including a stainless steel core wire 1106 coated with a polymeric coating 1118 and covered with a polymeric cover tube 1120.
  • the polymeric coating 1118, polymeric cover tube 1120, and a ti 1124, formed of an adhesive of epoxy, constitute an electrically insulated region 110.
  • the vasoocelusive implant system 1100 is similar to th vasoocelusive implant system 100 of FIG. 1 , except for a modified construction at a coupling joint 1 28 where the mlcroooii implant 1102 and the pushed member 1104 are coupled together, as depicted in FIG. 14.
  • a tether 1132 is tied in a knot 1152 to a reduced diameter portion 1138 of an embolic coil 1130.
  • a coupler coil 1168 is attached to the core wire 1108 and inserted inside the embolic coil 1130 in a coaxial configuration.
  • a cylindrical encapsulation 1154 is applied (for example with a UV adhesive) to join the core wire 1106, coupler coil 1166, embolic coil 1130 and tether 1132 together.
  • the cylindrical encapsulation 1154 provides electrical isolation of the embolic coil 1130 from the core wire 1108, and thus allows for simpler geometry of th materials involved in the electrolysis during detachment.
  • This coaxial arrangement creates a stiff zone 172 that is significantly shorter than prior art stiff (non-bendsble) zones, which are often greater than .040" in length.
  • a stiff zone of between .015" and .030" can he created, and more particularly, between .020" and .025".
  • FIG. 1SA through 1 SG illustrate use of the vasoocciusive implant system of FIG, 1 to implant a microcoil implant 16,
  • the coil Prior to implantation, the coil is coupled to the pusher member 14 as illustrated in FIG, 1 , ose]
  • a microcatheter 12 Is introduced into the vasculature using a percutaneous access point, and it is advanced to the cerebral vasculature.
  • a guide catheter and/or guide wire may be used to facilitate advancement of the microcatheter 12.
  • the microcatheter 12 is advanced until Its distal end is positioned at the aneurysm A, as seen in FIG. 1 SA.
  • O0S7 The microcoil implant 16 is advanced through the microcatheter 12 to the aneurysm A, as seen In FIG. 15B.
  • the microcoil implant 18 arid the pusher member 14 may be pre-posltioiied within the microcatheter 12 prior to introduction of the microcatheter 12 into the vasculature, or they may be passed into the proximal opening of the microcatheter lumen after the microcatheter 12 has been positioned within the body.
  • the pusher member 14 is advanced within th microcatheter 12 to deploy the microcoil implant 16 from the microcatheter 12 into the aneurysm A.
  • the microcoil implant 18 exists the microcatheter 12, it assumes It secondary shape as shown in FIG. 15C.
  • the microcoil implant 16 is positioned so that the detachment zone (182 in FIG, 7) is positioned Just outside of the microcatheter 16, as seen In FIG. 15D. In order to achieve this, a slight introduction forc may be placed on th pusher member 14 while slight traction is applied on the microcatheter 16. The microcoil implant 16 Is then electroJytfcaHy detached from the pusher member 14, as seen- in FIG, 15E, and the pusher member 14 is removed from the microcatheter, as seen in FIG. -1.5F.
  • FIGS. 15B through 15F show a deployment sequence of occluding an aneurysm using an expandable flow disrupter device making use of certain embodiments of the electrolytic detachment system of the vasoocelusive implant systems of FIGS. 1-14.
  • Delivery and deployment of the implant device 10 discussed herein may be earned out by first compressing the implant device 10, or any other suitable implantable medical devic for treatment of a patient's vasculature as discussed above. While disposed within the mlerocatbeter 51 or other suitable delivery device, 'filamentary elements of layers 40 may take o an elongated, noneverted configuratio substantially parallel to each other and to a longitudinal axis of the microcatheter 51.
  • the distal ends of the filamentary elements may then axlally contract towards each other, so as to assume the globular everted configuration within the vascular defect 60 as shown in FIG. 168,
  • the Implant device 10 may then be delivered to a desired treatment site while disposed within the microcathefer 51 , and then ejected or otherwise deployed from a distal end of the microcatheter 51.
  • the miocrocatheter 51 may first he navigated to a desired treatment site over a guidewire 59 or by other suitable navigation techniques.
  • the distal end of the microcatheter 51 may be positioned such that a distal port of the microcatheter 51 is directed towards or disposed within a vascular defect 80 to he treated and the guidewire 59 withdrawn.
  • Th implant device 10 secured to the delivery apparatus 02 may then be radially constrained, inserted into s proximal portion of the Inner lumen of the microcatheter 51 , and disfail advanced to the vascular defect 80 through the inner lumen.
  • the implant device 10 may be deployed out of the distal end of the microoatheter 51 , thus allowing the device to begin to radially expand as shown in FIG. 18C.
  • the implant device 10 may start to expand to an expanded state within the vascular defect 80, but may be at least partially constrained b an interior surface of the vascular defect 60. At this tim the implant device 10 may be detached from the delivery apparatus 92.
  • a variety of other vascula implants may make use of certain embodiment of the electrolytic detachment system of the vasoqcclysive Implant systems of FIGS. 1- 14..
  • tubular implants such as stents or tubular flow diversion implants may be implanted to occlude an artery on their own s or in combination with embolic microcoi!s or liquid embolics.
  • Stent grafts may be implanted, for example in an aneurysm of the abdominal aorta, which incorporate the detachment system of the present invention.
  • Aneurysm neck-blocking implants which incorporate the detachment system of the present invention may also be implanted.

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Abstract

Des problèmes vasculaires sont abordés avec des systèmes, des dispositifs et des procédés de pose d'implants avec une capacité à se détacher précise et prête, parmi d'autres caractéristiques, pour traiter, par exemple, des problèmes d'attaque aigüe avec la rapidité nécessaire.
PCT/US2015/066605 2014-12-18 2015-12-18 Système d'implant vasculaire et procédés avec zones de séparation souple WO2017105479A1 (fr)

Priority Applications (6)

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US15/537,881 US20180271533A1 (en) 2014-12-18 2015-12-18 Vascular Implant System and Processes with Flexible Detachment Zones
CN201580085817.6A CN108697425A (zh) 2015-12-18 2015-12-18 具有可弯曲的分离区的血管植入系统和过程
JP2018551747A JP2019502513A (ja) 2015-12-18 2015-12-18 可撓性離脱領域を有する血管インプラントシステムおよびプロセス
KR1020187020366A KR102359744B1 (ko) 2015-12-18 2015-12-18 가요성 분리 영역을 이용하는 혈관용 이식 시스템 및 혈관용 이식 프로세스
EP15910944.6A EP3389510A4 (fr) 2015-12-18 2015-12-18 Système d'implant vasculaire et procédés avec zones de séparation souple
PCT/US2015/066605 WO2017105479A1 (fr) 2015-12-18 2015-12-18 Système d'implant vasculaire et procédés avec zones de séparation souple

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CN108814670A (zh) * 2018-10-12 2018-11-16 微创神通医疗科技（上海）有限公司 植入物及栓塞装置
WO2020206147A1 (fr) * 2019-04-05 2020-10-08 Balt Usa Systèmes de détachement optimisés basés sur un effet de levier provenant d'un ciblage de locus électrique et dispositifs médicaux associés
US10888414B2 (en) 2019-03-20 2021-01-12 inQB8 Medical Technologies, LLC Aortic dissection implant
WO2021011494A1 (fr) * 2019-07-13 2021-01-21 Balt Usa Améliorations de systèmes coaxiaux de détachement de spirale basés sur une spirale de ciblage et d'absorption de choc
EP3858263A4 (fr) * 2018-10-09 2021-12-08 MicroPort NeuroTech (Shanghai) Co., Ltd. Dispositif d'embolisation et ses spires de ressort

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CN107374690A (zh) * 2017-08-16 2017-11-24 微创神通医疗科技（上海）有限公司 栓塞线圈输送装置及其制备方法
CN114176697B (zh) * 2021-12-20 2024-07-05 神遁医疗科技(上海)有限公司 一种栓塞物及其制备方法

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US20090163780A1 (en) * 2007-12-21 2009-06-25 Microvention, Inc. System And Method For Locating Detachment Zone Of A Detachable Implant
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Cited By (7)

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Publication number Priority date Publication date Assignee Title
EP3858263A4 (fr) * 2018-10-09 2021-12-08 MicroPort NeuroTech (Shanghai) Co., Ltd. Dispositif d'embolisation et ses spires de ressort
JP2022504758A (ja) * 2018-10-09 2022-01-13 マイクロポート・ニューロテック（シャンハイ）・カンパニー・リミテッド 塞栓装置およびそのコイル
JP7340603B2 (ja) 2018-10-09 2023-09-07 マイクロポート・ニューロテック（シャンハイ）・カンパニー・リミテッド 塞栓装置およびそのコイル
CN108814670A (zh) * 2018-10-12 2018-11-16 微创神通医疗科技（上海）有限公司 植入物及栓塞装置
US10888414B2 (en) 2019-03-20 2021-01-12 inQB8 Medical Technologies, LLC Aortic dissection implant
WO2020206147A1 (fr) * 2019-04-05 2020-10-08 Balt Usa Systèmes de détachement optimisés basés sur un effet de levier provenant d'un ciblage de locus électrique et dispositifs médicaux associés
WO2021011494A1 (fr) * 2019-07-13 2021-01-21 Balt Usa Améliorations de systèmes coaxiaux de détachement de spirale basés sur une spirale de ciblage et d'absorption de choc

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EP3389510A1 (fr) 2018-10-24
EP3389510A4 (fr) 2019-10-23
CN108697425A (zh) 2018-10-23
KR102359744B1 (ko) 2022-02-08
JP2019502513A (ja) 2019-01-31
KR20180103065A (ko) 2018-09-18

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