JP2019502513A - Vascular implant system and process having a flexible withdrawal region - Google Patents

Vascular implant system and process having a flexible withdrawal region Download PDF

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Publication number
JP2019502513A
JP2019502513A JP2018551747A JP2018551747A JP2019502513A JP 2019502513 A JP2019502513 A JP 2019502513A JP 2018551747 A JP2018551747 A JP 2018551747A JP 2018551747 A JP2018551747 A JP 2018551747A JP 2019502513 A JP2019502513 A JP 2019502513A
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Prior art keywords
system
implant
distal end
coil
core wire
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JP2018551747A
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Japanese (ja)
Inventor
レ、ジェイク
フェレーラ、デイヴィッド、エイ.
レ、ドーソン
タカハシ、ランドール
マルティネス、ジョージ
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バルト ユーエスエー
バルト ユーエスエー
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Priority to PCT/US2015/066605 priority Critical patent/WO2017105479A1/en
Publication of JP2019502513A publication Critical patent/JP2019502513A/en
Application status is Pending legal-status Critical

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    • 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
    • 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
    • A61B17/12136Balloons
    • 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
    • A61B17/12145Coils or wires having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/02Inorganic materials
    • A61L31/022Metals or alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/18Materials at least partially X-ray or laser opaque
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • 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

Abstract

  Vascular problems are addressed using systems, devices, and methods for delivering implants that have accurate and easy withdrawal, along with other features, for example, to address acute stroke problems requiring urgency .

Description

  The field of the invention relates generally to medical devices for the treatment of vascular abnormalities.

  Hemorrhagic stroke may occur as a result of subarachnoid hemorrhage (SAH) that occurs when blood vessels on the surface of the brain rupture and blood leaks into the space between the brain and the skull. In contrast, cerebral hemorrhage occurs when a defective artery in the brain ruptures and the surrounding tissue overflows. Arterial cerebral hemorrhage is often caused by head injury or aneurysm rupture that can result from high blood pressure. An artery that ruptures in one part of the brain can release blood, which contacts an artery in another part of the brain. Although an arterial rupture can starve the brain tissue that is nourished by that artery, the surrounding (otherwise healthy) arteries can contract, depriving the brain structure of oxygen and nutrients The nature is also high. Thus, strokes that directly affect less important parts of the brain can spread to a much larger area and only affect important structures.

  Currently, there are two treatment options for the treatment of cerebral aneurysms in either ruptured or non-ruptured aneurysms. One option is surgical clipping. The purpose of surgical clipping is to isolate the aneurysm from normal circulation without blocking nearby small perforated arteries. The skull is opened under general anesthesia, which is called craniotomy. In order to locate the aneurysm, the brain is slowly retracted. A small clip is placed across the base or neck of the aneurysm to prevent normal blood flow. The clip acts like a small coil spring clothespin, but the clip blade remains tightly closed until pressure is applied to open the blade. The clip is made of titanium or other metallic material and remains permanently on the artery. The second option is neurovascular to isolate ruptured or ruptured neurovascular abnormalities, including aneurysms and AVMs (arteriovenous malformations), from the cerebral circulation to prevent primary or secondary bleeding into the cranial lumen Embolization.

  Cerebrovascular embolism can be achieved by transcatheter deployment of one or several embolic agents in an amount sufficient to stop internal blood flow and result in death of the lesion. Several types of embolic agents include glues, liquid embolic agents, occlusion balloons, platinum and stainless steel microcoils (with and without fibers attached), and neurovascular indications including polyvinyl alcohol particles Has been approved. Microcoils are the most commonly used device for embolization of neurovascular lesions, and microcoil technology involves the majority of endovascular repair procedures involving cerebral aneurysms and often permanent AVM occlusion. Adopted. Neurovascular stents can be used to contain embolic coils. For certain types of aneurysms, other devices are used, such as flow diversion implants or flow inhibition implants.

  Many cerebral aneurysms tend to form at the bifurcations of major blood vessels that make up the Willis annulus and lie within the submembrane space. Each year, approximately 40,000 people in the United States suffer from hemorrhagic stroke due to ruptured cerebral aneurysms, of which an estimated 50% die within a month and the rest usually experience severe sequelae neurological deficits To do. Most cerebral aneurysms are asymptomatic and remain undetected until SAH occurs. SAH is a fatal event due to the fact that many patients die before they can receive treatment with little or no signs. The most common symptom prior to vascular rupture is a sudden and severe headache.

  Other vascular abnormalities can benefit from treatment by delivery of vascular implants. An aortic aneurysm is generally treated with a stent graft. Various stents are used to treat atherosclerosis and other diseases of the body's blood vessels. Detachable balloons are used for both aneurysm occlusion and vascular occlusion.

  Vascular problems are addressed with and by a novel enhanced system with accurate and easy withdrawal, among other features for addressing, for example, acute stroke issues requiring urgency.

1 is a side view of a vaso-occlusive implant system according to an embodiment of the present invention. FIG. 2 is a perspective view of a protective shipping tube for the vaso-occlusive implant system of FIG. FIG. 3 is a detail view taken from within circle 3 of the distal tip portion of the vaso-occlusive implant system of FIG. FIG. 3 is a detailed view of a distal portion of a vaso-occlusive implant system having a flexible withdrawal region. FIG. 3 shows a vaso-occlusive implant system having a flexible detachment region as compared to a vaso-occlusive implant system without a flexible detachment region. 1 is a perspective view of a vaso-occlusive implant according to one embodiment of the present invention. FIG. FIG. 6 is a perspective view of a vaso-occlusive implant according to another embodiment of the present invention. FIG. 6 is a perspective view of a vaso-occlusive implant according to another embodiment of the present invention. FIG. 7 is a cross-sectional view taken along line 7-7 of FIG. FIG. 8 is a cross-sectional view taken along line 8-8 of FIG. FIG. 9 is a detail view taken from within circle 9 of the transition portion of the vaso-occlusive implant system shown in FIG. 1 is a perspective view of a mandrel for forming a vaso-occlusive implant according to one embodiment of the present invention. FIG. 1 is a perspective view of a mandrel for forming a vaso-occlusive implant according to one embodiment of the present invention. FIG. FIG. 5 is a perspective view of a power source configured to electrically couple with an electrolytic detachable implant assembly. FIG. 6 is a circuit diagram of a power source coupled with an electrolytic detachable implant assembly inserted into a patient's body. FIG. 6 is a graph of electrical characteristics of a power supply over time during the removal of an electrically detachable implant. 1 is a cross-sectional view of a vaso-occlusive implant system having a hardness reduction in a region near a withdrawal region. FIG. 15 is one of a series of diagrams schematically illustrating the steps of occluding an aneurysm using the vaso-occlusive implant system of FIGS. FIG. 15 is one of a series of diagrams schematically illustrating the steps of occluding an aneurysm using the vaso-occlusive implant system of FIGS. FIG. 15 is one of a series of diagrams schematically illustrating the steps of occluding an aneurysm using the vaso-occlusive implant system of FIGS. FIG. 15 is one of a series of diagrams schematically illustrating the steps of occluding an aneurysm using the vaso-occlusive implant system of FIGS. FIG. 15 is one of a series of diagrams schematically illustrating the steps of occluding an aneurysm using the vaso-occlusive implant system of FIGS. FIG. 15 is one of a series of diagrams schematically illustrating the steps of occluding an aneurysm using the vaso-occlusive implant system of FIGS. FIG. 15 is one of a series of diagrams schematically illustrating the steps of occluding an aneurysm using the vaso-occlusive implant system of FIGS. FIG. 15 illustrates an occlusion and aneurysm deployment sequence using an expandable flow obstruction device using a particular embodiment of the electrolytic detachment system of the vascular occlusion implant system of FIGS. FIG. 15 illustrates an occlusion and aneurysm deployment sequence using an expandable flow obstruction device using a particular embodiment of the electrolytic detachment system of the vascular occlusion implant system of FIGS. FIG. 15 illustrates an occlusion and aneurysm deployment sequence using an expandable flow obstruction device using a particular embodiment of the electrolytic detachment system of the vascular occlusion implant system of FIGS.

  The present disclosure provides improved vaso-occlusive implants and associated devices, methods, and systems for addressing cerebral aneurysms and other vascular problems. The following patents and publications are expressly incorporated herein by reference in their entirety: US Pat. No. 8,002,822; International Patent Publication No. WO 2005/0122961 filed on June 13, 2005. Pamphlet; US Provisional Patent Application No. 61 / 811,055 filed on April 11, 2013; US Provisional Patent Application No. 61 / 888,240 filed on October 18, 2013; And US Provisional Patent Application No. 61 / 917,854, filed December 18, 2013.

  Treatment of ruptured and unruptured intracranial aneurysms by use of occluded microcoils delivered via tube has relatively low morbidity and mortality compared to surgical clipping. However, there are still many reported drawbacks. Microcoils are typically delivered to the aneurysm one at a time, and each microcoil is visible, for example by fluoroscopy, and can be safely and easily removed from the aneurysm if the microcoil is not delivered to the desired location. It is very important that it can be extracted. The microcatheter is placed so that its tip is adjacent to the neck of the aneurysm and the microcoil is delivered through the lumen of the microcatheter.

  Microcatheter design, placement, and tip orientation are key factors that determine how well a microcatheter assists in delivering microcoils to and from an aneurysm and, if necessary, removal . If excessive resistance is reached during the delivery of the microcoil, the microcatheter may “retract and pop out” and shift its position and / or orientation in relation to the aneurysm. A complicating factor that may arise during microcoil delivery or removal is the actual stretching of the microcoil turns. For example, if the microcoil is pulled into the microcatheter while the microcatheter is in a position where a force greater than the desired force is applied to the tip of the microcoil, the microcoil can easily slide into the microcatheter. Inability to move and axial tension can significantly increase the length of the microcoil. The microcoil then loses its mechanical properties permanently and suffers from reduced radiopacity in the stretched region. Since this microcoil will need to be discarded and replaced, this type of coil extension can be expensive for the treating neurointerventionist, but the extended coil is also already in the aneurysm It can also interfere with the procedure because it can get caught, broken, or tangled unknowingly with another microcoil placed. There is also the possibility of moving other microcoils already placed in the aneurysm from the aneurysm to the parent artery, which is a serious complication. Elongated microcoils that are partly within multiple aneurysms and microcatheters that cannot be advanced or retracted further require emergency craniotomy and highly invasive microsurgical first aid Sometimes. A potential transcatheter method of retrieving an elongated coil is undesirable. They use a snare device to grasp and remove the elongated coil portion within the aneurysm, anchor the elongated coil on the inner wall of the parent artery using a stent, or long-term antiplatelet therapy To the patient.

  The placement of the first “framing” microcoil within the aneurysm is often performed using a three-dimensional or “composite” microcoil (a microcoil wound around multiple axes). The first framing microcoil is the basic structure into which the “filled” microcoil is later packed. When the first microcoil is placed in a completely non-coiled aneurysm, the first loop of the microcoil loops several times inside the aneurysm, even if it is a three-dimensional or composite microcoil Instead, you can enter the aneurysm and then exit. This is exacerbated by the absence of a previous microcoil having a structure that attempts to help the subsequently placed coil stay within the aneurysm, but the micros are all loops formed with substantially the same diameter. The coil is prone to this existing phenomenon when sought as the first framing microcoil.

  The microcoil may move from the aneurysm during the coiling procedure or at a later date following the procedure. One or more loops of the migrated microcoil can be a potentially fatal thromboembolic lesion. The movement of the microcoil portion may be due to incomplete filling of the microcoil into the coil mass within the aneurysm.

  In addition, incomplete filling of the microcoil, especially in the neck of the aneurysm, can cause incomplete thrombosis, thus leaving the aneurysm susceptible to rupture or in the case of a previously ruptured aneurysm Will rupture again. Nevertheless, certain aneurysms with incomplete microcoil filling in the neck may initially form a complete thrombus. However, they may tend to resume blood flow through the dynamic properties of thromboembolism. Coil mass and aneurysm compression are another factor that can cause blood flow resumption. The inability to fill an aneurysm with enough coil mass due to the hardness or shape of the coil is a possible cause of insufficient coil mass.

  Detachable microcoils are provided by several different manufacturers using a variety of detachment systems. All disengagement systems involve some dynamic processes, but some systems involve more physical system movement than others. Mechanical disengagement systems that use pressure, unscrewing and axial de-releasing tend to cause a limited amount of motion of the implant in the aneurysm during disengagement. In intracranial aneurysms, this type of motion is usually undesirable. Forces that can cause movement or movement of the microcoil should be avoided. Non-mechanical systems (chemistry, temperature, electrolysis) are inherently less moving, but are often plagued by low consistency, for example, a certain short duration for the coil to disengage. Although the electrical insulation of the implant coil itself helped when the average coil withdrawal time was short, there is still a discrepancy in the speed with which the coil is detached. Larger aneurysms with 10 or more coils implanted will increase the long or unpredictable withdrawal time and delay the procedure. In addition, long withdrawal times per stroke can jeopardize instability during withdrawal due to patient movement of the catheter system. For example, a system that indicates that a break has occurred by measuring current below a certain threshold is not completely trusted by others.

  Many detachable microcoil systems typically include a detachment module (such as a power supply) attached to an IV pole near the treatment table. There are typically cables or conduits that connect non-sterile modules to sterile microcoil implants and delivery wires. The attending interventionist usually needs a person in the room “not wearing scrubs” to perform the procedure and presses the release button on the module to cause the withdrawal.

  Most detachable systems have a specific structure at the junction between the pusher wire and a detachable coupled microcoil implant constructed to cause detachment. Many of these joints increase hardness because of the need for a secure bond that can be repeatedly inserted into the aneurysm and retracted into the microcatheter. Because this rigid section is in the immediate vicinity of the microcoil being implanted, the implantation process can be adversely affected, sometimes causing the microcatheter to retract and pop out, no longer providing sufficient support for microcoil insertion. Do not provide. This is especially true in aneurysms that are incorporated into tortuous blood vessel anatomy.

  FIG. 1 shows a vaso-occlusive implant system 100 comprising a microcoil implant 102 removably coupled to a pusher member 104. Pusher member 104 includes a core wire 106 that extends the length of pusher member 104 and is made of a biocompatible material, such as stainless steel, such as 304 series stainless steel. The diameter of the core wire 106 at the proximal end 108 may be between 0.008 inches and 0.018 inches, more specifically between 0.010 inches and 0.012 inches. The electrically isolated region 110 of the pusher member 104 includes a first point 112 approximately 10 cm from the extreme proximal end of the core wire 106 and a second point 114 near the distal end 116 of the core wire 106. It extends over most of the length of the core wire 106 therebetween. Directly covering the surface of the core wire 106 is from about 0.00005 inches to about 0.0010 inches, or more specifically from 0.0001 inches to 0.001 inches, such as PTFE (polytetrafluoroethylene), parylene or polyimide. A polymer coating 118 having a thickness of 0005 inches. The polymer cover tube 120 is fixed on the core wire 106 and the polymer coating 118. The polymer cover tube 120 may include a polyethylene terephthalate (PET) shrink tubing that heat shrinks over the core wire 106 (and possibly also the polymer coating 118) while maintaining tension at the end of the tubing. The marker coil 122 (FIG. 9) is connected to the core wire 106 by, for example, placing the marker coil 122 on the core wire 106 or on the polymer coating 118 and shrinking or joining the polymer cover tube 120 thereon. It may be sandwiched between the polymer cover tube 120. The core wire 106 has a transition region including a taper that decreases in diameter from its diameter at the proximal end 108 to a diameter of, for example, 0.005 inches to 0.006 inches over a portion of the electrically insulating region 110 of the pusher member 104. You may have. The diameter of the core wire 106 at the distal end 116 may be 0.002 inches to 0.003 inches, including the portion of the distal end 116 that is outside the electrically insulating region 110 of the pusher member 104. A tip 124 may be applied to the polymer cover tube 120 to complete the electrically insulating region 110. This will be described in more detail in connection with FIG. The microcoil implant 102 is releasably coupled to the pusher member 104 via a fitting 126 described in more detail with respect to FIG.

  FIG. 3 shows the coil assembly 128 of the microcoil implant 102 (shortened for simplicity). The embolic coil 130 is composed of platinum or a platinum alloy, such as 92% platinum / 8% tungsten, and adheres from a wire 144 having a diameter of 0.001 inch to 0.004 inch, particularly 0.00125 inch to 0.00325 inch. And may be wound. The coil may have a length (in the case of a straight line) between 0.5 cm and 50 cm, more preferably between 1 cm and 40 cm. Then, prior to assembly into the microcoil implant 102, the embolic coil 130 is formed into one of several possible shapes, as will be described in more detail in connection with FIGS. 4-6 and FIG. In order to minimize the extension of the embolic coil 130 of the microcoil implant 102, the tether 132 is tied between the proximal end 134 and the distal end 136 of the embolic coil 130. The tether can be formed of a thermoplastic elastomer such as Engage® or a polyester strand such as diameter polyethylene terephthalate (PET). The diameter of the tether 132 may be 0.0015 inches to 0.0030 inches, and more specifically 0.0022 inches for the engage strand. The tether 132 diameter may be 0.00075 inches to 0.0015 inches, more specifically 0.0010 inches for PET strands. The main outer diameter of embolic coil 130 may be between 0.009 inches and 0.019 inches. In order to secure the tether to the proximal end 134 and the distal end 136 of the embolic coil 130, the two reduced diameter portions are shaped by carefully sandwiching them in a particular turn of the embolic coil 130, for example with thin tweezers. 138, 140 are formed. The end 142 of the reduced diameter portion 140 is trimmed and the ether 132 is tied to one or more knots 147, 148 around the wire 144 of the reduced diameter portion 140. A tip encapsulant 146 comprising an adhesive or epoxy, such as a UV curable adhesive, a urethane adhesive, a ready-mixed two-part epoxy, or a frozen and thawed two-part epoxy is applied and one or more knots 147, 148 is fixed to the reduced diameter portion 140 to form a substantially hemispherical tip 150. With a sufficient amount of slack / tension on the tether 132, the tether is tied to the reduced diameter portion 138 with one or more knots 151, 152. A cylindrical enclosure 154, also comprising an adhesive or epoxy, is applied to secure one or more knots 151, 152 to the reduced diameter portion 138. The cylindrical enclosure 154 provides electrical insulation of the embolic coil 130 from the core wire 106, thus allowing for a simpler geometry of the material involved in electrolysis during detachment. The tether 132 serves as a stretch resistant member for minimizing the extension of the embolic coil 130. In another embodiment, the tether 132 may be made from multi-fiber or strand-like polymer or microcable.

  Referring again to FIG. 1, an introducer tube 155 having an inner lumen 156 having a diameter slightly larger than the maximum outer diameter of the microcoil implant 102 and pusher member 104 of the vascular occlusion implant system 100 includes a molded embolic coil 130. Used to straighten and insert the vaso-occlusive implant system 100 into the lumen of the microcatheter. The vaso-occlusive implant system 100 is packaged with the internal lumen 156 of the introducer tube 155 and is handled outside the patient's body therein. The vaso-occlusive implant system 100 and the introducer tube 155 are packaged for sterilization by placing them in the protective shipping tube 158 shown in FIG. The proximal end 108 of the pusher member 104 is securely held axially by a soft clip 160.

  FIG. 3B (1) illustrates an embodiment of a microcoil implant system 300 that includes a flexible release region. The implant system includes a microcoil implant 302 releasably coupled to a pusher member 304 that includes a core wire 306 coated with a polymer coating 318 and covered with a polymer cover tube 320. Polymer coating 318, polymer cover tube 320, and tip 324 formed of an epoxy adhesive constitute an electrically insulating region. Implant system 300 is similar to vaso-occlusive implant system 100 of FIG. 1 except for the configuration of embolic coil 330 modified with respect to detachment region 362. In this embodiment, the core wire 306 extends out of the distal end of the pusher member 304. The non-insulated region of the core wire includes a separation region 362. The withdrawal region 362 is a sacrificial part of the vaso-occlusive implant system that allows the microcoil implant 302 to be removed from the pusher member 306. Distal to the detachment region 362 is a coupler coil 366 wrapped around the core wire 306 and coaxially disposed within the embolic coil 330. The embolic coil 330 and the coupler coil 366 are electrically isolated from each other by a cylindrical polymer coating 354 or an encapsulant. The enclosing portion 354 may be, for example, a UV adhesive. The cylindrical enclosure 354 provides electrical insulation of the embolic coil 330 from the core wire 306, thus allowing for a simpler geometry of the material involved in electrolysis during detachment. This coaxial arrangement forms a hard region (represented by a dotted line) that is considerably shorter than prior art hard (unbent) regions, often over 0.040 inches in length. The configuration shown in FIG. 3B (1) has a rigid region with a length of 0.010 inches to 0.030 inches.

  In some other embodiments (such as FIGS. 1 and 7), the embolic coil and core wire are coupled together with a coupler coil and a potting section of epoxy or other insulating material. However, in the embodiment of FIG. 3B (1), the core wire 306 extends through the proximal portion of the embolic coil 330. Distal to the overlap region between the coupler coil 366 and the embolic coil 330, a tether 332 connects the proximal and distal portions of the embolic coil 330. The configuration shown in (1) of FIG. 3B makes the proximal portion of embolic coil 330 more flexible. Placing the coupler coil 366 coaxially within the proximal portion of the embolic coil 330 reduces the need for a rigid epoxy coupling portion. This configuration forms a flexible region just distal to the coupler coil 366 (see (2) in FIG. 3B).

  FIG. 3B (2) shows the device of FIG. 3B (1) in the bent position. The flexible region is just distal to a coupler coil (not shown) that is coaxially positioned within the proximal portion of the embolic coil. The rigid or rigid region is only about 0.020 inches (plus or minus 0.010 inches).

  FIG. 3C shows a comparison of implant flexibility in system 100 (shown in FIG. 1) and system 300 (shown in FIG. 3). System 300 has a shortened rigid region in which a coupling coil is disposed within embolic coil 330. The system 100 has an epoxy insulating region located between the proximal portion of the embolic coil 130 and the distal portion of the fitting 126. The shorter epoxy area of the system 300 allows the embolic coil 330 to begin bending more proximally compared to the system 100, with the bending occurring more distal to the length of the implant.

  The configuration of the implant system 300 shown in FIGS. 3B-3C includes a harder insulating joint and a shorter, smaller coupler coil as compared to embodiments having an epoxy portion potted between the coupler coil and the embolic coil. Reduce length by approximately 50%. As a result, the proximal portion of the embolic coil becomes softer and more flexible, which improves delivery and reduces microcatheter repulsion during the implantation procedure. The increased flexibility of the device can increase the adaptability of the microcoil in the narrow space of the vascular aneurysm. The configuration with the flexible detachment region significantly increases the flexibility of the microcoil implant when delivered from the microcatheter into the aneurysm. The increased flexibility and maneuverability makes the microcatheter much less prone to slip away from the neck of the aneurysm, thereby reducing the occurrence of microcoil misplacement and the resulting complications. Flexible microcoil implants can be more adapted to the shape of the targeted vessel lumen being delivered.

  The coaxial configuration of the coil provides the added benefit of providing a low profile release region 362, resulting in increased first button release consistency. The cylindrical insulating region maintains effective electrical insulation between the embolic coil and the detachment region.

4-6 illustrate a vaso-occlusive implant according to three different embodiments of the present invention. FIG. 4 shows a framing microcoil implant 200 made from an embolic coil 201 and having a box shape that approximates a spheroid when placed in an aneurysm. Loops 202, 204, 206, 208, 210, 212 are the X axis extending from the coordinate origin (0) in the negative direction (−X) and the positive direction (+ X), the negative direction from the coordinate origin (0) Three axes: (−Y) and the Y axis extending in the positive direction (+ Y), and the Z axis extending from the coordinate origin (0) in the negative direction (−Z) and in the positive direction (+ Z) Wrapped on top. A first loop 202 having a diameter D 1 begins at the first end 214 of the embolic coil 201 and extends around the + X axis in the direction 216. As shown in FIG. 4, the first loop 202 includes approximately 1 and 1/2 revolutions, but between 1/2 and 10 revolutions (along with the other loops 204, 206, 208, 210, 212). Can be included. A second loop 204 having a diameter D 2 is continuous from the loop 202 and extends around the −Y axis in the direction 218. The third loop 206 then extends around the + Z axis in direction 220. The fourth loop 208 then extends around the _X axis in direction 222. The fifth loop 210 then extends around the + Y axis in direction 224. And finally, the sixth loop 212 extends around the _Z axis in the direction 226. As seen in FIG. 4, following formation of the loops 202, 204, 206, 208, 210, 212, a fitting 126 is formed at the second end 228 of the embolic coil 201. The exact configuration of the loop shown in FIG. 4 is for explanation only and is not meant to be limiting. The implant can take other common spheroid shapes with different numbers and configurations of loops.

Framing microcoil implant 200 is configured such that the first micro-coils arranged in an aneurysm, therefore, in this embodiment, all loops 204, 206, 208, and 212 D 2 Have approximately equal diameters. However, the first loop 202 is configured to be the first loop introduced into the artery and the diameter of the first loop 202 is used to maximize the ability of the microcoil implant 200 to remain within the aneurysm during coiling. D 1 is between 65% of the diameter D 2 of 75%, approximately 70% of the diameter D 2 is more. Assuming that D 2 is selected to approximate the diameter of the aneurysm, the first loop 202 of the microcoil implant 200 is inserted into the aneurysm as if it moves circumferentially around the aneurysm wall. Then, if it passes through the opening of the aneurysm neck, it will not reach the diameter of the aneurysm and will therefore remain within the aneurysm confinement. In assembling the microcoil implant 200 into the vaso-occlusive implant system 100, the choice of the tether 132 selects the framing micro that forms the aneurysm skeleton and forms a support lattice to assist in subsequent coiling both in filling and finishing. It is important to form a microcoil implant 200 that behaves well as a coil. For example, the tether 132 may be in the microcoil implant 200 having a diameter of D 2 5 mm in diameter made from PET fiber 0.0009 inches, the tether 132 is microcoil implant having more than a diameter D 2 5 mm 200 may be made from an engagement yarn having a diameter of 0.0022 inches. In addition, the diameter of the wire 144 is selected as 0.0015 inch for the 0.011 inch diameter embolic coil 130 and 0.002 inch for the 0.012 inch diameter embolic coil 130 for 92/8 Pt / W. May be. Embolic coils 0.011 inch diameter 130 may be selected in the structure of the micro-coil implant 200 having a diameter of less than D 2 4.5mm, embolic coil 130 0.012 inch diameter is more than 4.5mm in diameter D 2 may be selected in the structure of the micro-coil implant 200 having a. In microcoil implant 200 having 6mm or more in diameter D 2, additional framing microcoil model with a 0.013 inch or more embolic coils 130 wound with 0.002 inch or more wires 144 may be created . Note that the coiling procedure does not necessarily require the use of only one framing microcoil, but one or more framings may be used during the implantation procedure to fill the microcoil and prepare the aneurysm to finish the microcoil. It should be noted that microcoils may be used.

  Referring to FIG. 10A, a mandrel 500 for forming a vaso-occlusive implant includes six arms 502 that are used to form the loops 202, 204, 206, 208, 210, 212 of the microcoil implant 200 of FIG. , 504, 506, 508, 510, 512. The first loop 202 is wound around the first arm 502, the second loop 204 is wound around the second arm 504, the third loop 206 is wound around the third arm 506, and the fourth loop 208 is Wrapped around the fourth arm 508, the fifth loop 210 is wound around the fifth arm 510, and the sixth loop 212 is wound around the sixth arm 512. The wire 144 of the embolic coil 130 is drawn into the linear extension 516 by a length at the first end 214 (FIG. 4) of the embolic coil 130 and fixed in the fixing element 514 at the end 518 of the first arm 502. Is done. The weight 520 is attached to the tip 522 of the embolic coil 130, and the mandrel 500 is rotated in the direction of 526 with respect to the X axis 524 to form the first loop 202. The mandrel 500 is then positioned so that the current loop is approximately parallel to the ground (like lead wires) before forming each successive loop so that the current loop is formed on any arm / axis. Adjustment is made using a weight 520 that pulls an extended length 526 of the embolic coil 130 stretched in a direction perpendicular to the floor. When the formation of the microcoil implant 200 on the mandrel 500 is complete, the second end 228 (FIG. 4) extends the length of the wire 144 and attaches it to the fixation element 528 at the end 530 of the arm 512, Fixed. The formed loops 202, 204, 206, 208, 210, 212 of the microcoil implant 200 are now securely held on the mandrel 500 and the shape of the loop is placed in the furnace for 45 minutes at 700 ° C., for example. Is cured by. After cooling to room temperature, the formed loop of microcoil implant 200 is carefully removed from mandrel 500 and the remaining manufacturing steps of microcoil implant 200, 102 and vaso-occlusive implant system 100 are performed. In the particular case of the microcoil implant 200, to form the first loop 202, the diameter of the first arm 502 of the mandrel 500 is approximately 70% of the diameter of the other loops 204, 206, 208, 210, 212. Approximately 70% of the diameter of each of the other arms 504, 506, 508, 510, 512.

  FIG. 5 shows a filled microcoil implant 300 having a helical shape. The filled microcoil implant 300 is manufactured with a winding and curing technique similar to the framing microcoil implant 200, but the helical loop 302 of the filled microcoil implant 300 is wound on a single cylindrical mandrel (not shown). It is done. Framing microcoil implant 200 is formed from an embolic coil 130 having a first end 314 and a second end 328. The tether 132 (FIG. 3) of the filled microcoil implant 300 can be interpreted from a variety of materials including thermoplastic elastomers such as engage. The diameter of the tether 132 formed from the engagement may range from 0.002 inches to 0.00275 inches, and more specifically may be 0.0022 inches. The wire 144 used in making the embolic coil 130 used to construct the filled microcoil implant 300 has a diameter of about 0.00175 inches to 0.00275 inches, more specifically 0.002 inches. To 0.00225 inch 92/8 Pt / W wire. The outer diameter of the embolic coil 130 of the filled microcoil implant 300 may be between 0.011 inches and 0.013 inches, more specifically about 0.012 inches. One or more filled microcoil implants 300 can be used to pack and fill as much aneurysm as possible after one or more framing coil implants 200 have been placed in the aneurysm. The relatively soft nature of the filled microcoil implant 300 ensures good thrombosis and occlusion without creating potentially dangerous stress in the wall of the aneurysm that can potentially lead to rupture (or re-rupture). Allows a sufficient amount of filling to be achieved. In addition to using a spiral-shaped microcoil as the filling microcoil implant 300, they are also used in the aneurysm neck to successfully engage the coil mass while maximizing the filling volume in the neck of the aneurysm. It may be used as a finished microcoil implant, which is the last one or more implants to be placed. These finished microcoils are usually smaller and have an outer diameter of about 0.010 inches, with diameters from 001 inches to. It is wound from 92/8 Pt / W having a diameter between 00175 inches, more specifically between 0.00125 inches and 0.0015 inches. The tether 132 used for the spiral finished microcoil may include 0.001 inch PET yarn.

FIG. 6 is similar to the microcoil implant 200 of FIG. 4 in three loops: a first loop 402, a second loop 404, a third loop 406, a fourth loop 408, a fifth loop 410, and a first loop. A composite microcoil implant 400 having six loops 412 is shown. However, the diameter D 3 of the first loop 402 is approximately the same as each of the diameter D of the other loops 404,406,408,410,412, similar to the other arm 504,506,508,510,512 A first arm 502 having a diameter will be included. The composite microcoil implant 400 of this structure may be used as a framing microcoil implant, but may alternatively be used as a finishing microcoil implant. Three-dimensional structural composites in many clinical situations can help better engagement of the finished microcoil implant with other coil masses due to the entanglement capability. In this way, the likelihood of the finished microcoil implant moving from the aneurysm into the parent artery is reduced.

  FIG. 7 shows the joint 126, the tip 124 of the vaso-occlusive implant system 100 of FIG. 1 and the detachment region 162 between the tip 124 and the joint 126. The detachment region 162 is the only portion of the core wire 106 other than the proximal end 108 that is not covered by the electrically insulating region 110 and is located within the patient's bloodstream of the two non-insulated portions of the core wire 106. Is the only part configured. Thus, the detachment region 162 is a sacrificial portion of the vaso-occlusive implant system 100 that allows the microcoil implant 102 to be removed from the pusher member 104, as described in accordance with FIGS. Tether 132, embolic coil 130 (not shown), and core wire 106 are coupled together with a coupler coil 166 and a potting section 164 such as, for example, UV adhesive or other adhesive or epoxy. The coupler coil 166 may be made from 0.001 inch to 0.002 inch diameter platinum / tungsten (92% / 8%) wire, from 0.006 inch to 0.009 inch, more specifically 0. It may have an outer diameter of .007 inches to 0.008 inches. Coupler coil 166 may be attached to core wire 106 with solder such as silver solder or gold solder.

  8 and 9 show a section of the pusher member 104 approximately 3 mm from the detachment region 162. A marker coil 122 having a tightly wound portion 168 and an elongated portion 170 is sandwiched between the core wire 106 and the polymer cover tube 120. The marker coil 122 may be constructed from a 0.002 inch diameter platinum / tungsten (92% / 8%) wire and may have an outer diameter of 0.008 inch. The tightly wound portion 168 is more radiopaque than the elongated portion 170 and is therefore used as a visual guide to ensure that the release region 162 is just outside the microcatheter during the release process. The marker coil 122 may be attached to the core wire 106 with solder such as silver solder or gold solder.

  FIG. 11 shows a power supply 700 for electrical coupling with the vaso-occlusive implant assembly 100 of FIG. The power supply 700 includes 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 706 includes an on / off button 716 and first and second electrical clips 712, 714 to provide 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 connected to the control module 706 via insulated electrical wires 720, 722, respectively. Yes.

  Referring to FIG. 12, which is a circuit diagram 800 of the power source 700 of FIG. 11, the electrode 708 is positively charged and is represented by the terminal connection 802, where the first electrode 708 of the first clip 712 is the pusher member 104. Connected to the non-insulated proximal end 108 of the core wire 106. The electrode 710 is negatively charged and is represented by a terminal connection 804, where the second electrode 710 of the second clip 714 is a conductive material whose tip is inserted into the patient, for example in the region of the groin or shoulder. Connected with needle or probe. A constant current source 806 powered by a controlled DC voltage source 808 passes through a parallel resistor in the system resistor 810 and the patient's body, and the current is passed through the core wire 106 and the patient via the non-isolated disconnect region 162 (FIG. 7). Flowing into. As shown in the graph 900 of FIG. 13, the constant current (i) 902 is maintained over time (t), and the controlled DC voltage source 808 increases the total resistance due to the electrolytic dissolution of stainless steel in the detachment region 162. As the voltage increases, the voltage 904 is increased. When the detachment region 162 is completely gone, the voltage 904 is forced up at the spike 906 to trigger a detachment notification.

  FIG. 14 shows a vaso-occlusive implant system 1100 comprising a microcoil implant 1102 releasably coupled to a pusher member 1104 that includes a stainless steel core wire 1106 coated with a polymer coating 1118 and covered with a polymer cover tube 1120. The polymer coating 1118, the polymer cover tube 1120, and the tip 1124, formed of an epoxy adhesive, constitute an electrically insulating region 1110. The vaso-occlusive implant system 1100 is similar to the vaso-occluded implant system 100 of FIG. 1 except for the modified structure of the joint 1126 in which the microcoil implant 1102 and the pushed-in member 1104 are coupled together, as shown in FIG. It is similar. The tether 1132 is tied to the reduced diameter portion 1138 of the embolic coil 1130 with a knot 1152. Coupler coil 1166 is attached to core wire 1106 and is inserted into embolic coil 1130 in a coaxial configuration. A cylindrical enclosure 1154 is attached (eg, using a UV adhesive) to join the core wire 1106, coupler coil 1166, embolic coil 1130, and tether 1132 together. Cylindrical enclosure 1154 provides electrical insulation of embolic coil 1130 from core wire 1106, thus allowing for a simpler geometry of the material involved in electrolysis during detachment. This coaxial arrangement forms a hard region 1172 that is much shorter than prior art hard (unbent) regions often over 0.040 inches in length. Using this coaxial arrangement, a rigid region between 0.015 inches and 0.030 inches, more specifically between 0.020 inches and 0.025 inches can be formed. This significantly increases the flexibility of the microcoil implant 1102 when delivered from the microcatheter into the aneurysm, making the microcatheter much more difficult to displace from the neck of the aneurysm.

  FIGS. 15A-15G illustrate the use of the vaso-occlusive implant system of FIG. 1 for implanting a microcoil implant 16. Prior to implantation, the coil is coupled to the pusher member 14 as shown in FIG.

  Microcatheter 12 is introduced into the vasculature using a percutaneous access point, which is advanced to the cerebral vasculature. A guide catheter and / or guide wire may be used to facilitate advancement of the microcatheter 12. As seen in FIG. 15A, the microcatheter 12 is advanced until its distal end is positioned in the aneurysm A.

  The microcoil implant 16 is advanced through the microcatheter 12 to the aneurysm A as seen in FIG. 15B. The microcoil implant 16 and pusher member 14 may be pre-positioned within the microcatheter 12 prior to introducing the microcatheter 12 into the vasculature or after the microcatheter 12 is positioned within the body. It may be passed through the proximal opening. Pusher member 14 is advanced within microcatheter 12 to deploy microcoil implant 16 from microcatheter 12 into aneurysm A. When the microcoil implant 16 exits the microcatheter 12, it takes a secondary shape as shown in FIG. 15C.

  The microcoil implant 16 is positioned so that the withdrawal region (162 in FIG. 7) is located just outside the microcatheter 16, as seen in FIG. 15D. To achieve this, a slight introduction force may be applied to the pusher member 14 while a slight traction force is applied to the microcatheter 16. The microcoil implant 16 is then electrolytically 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. 15F.

  If additional microcoil implants 16 are to be implanted, the steps of FIGS. 15B-15F are repeated. This method is repeated for each additional microcoil implant 16 that needs to fully fill the aneurysm A. Once the aneurysm is completely occluded, the microcatheter 12 is removed, as seen in FIG. 15G.

  FIGS. 16A-16B illustrate a deployment sequence that occludes an aneurysm using an expandable flow obstruction device that utilizes a particular embodiment of the electrolytic detachment system of the vaso-occlusive implant system of FIGS. Delivery and deployment of the implant device 10 discussed herein initially compresses the implant device 10 or any other suitable implantable medical device for treatment of the patient's vasculature as discussed above. May be executed. While placed in the microcatheter 51 or other suitable delivery device, the filamentous elements of the layer 40 are elongated and turned over, which are generally parallel to each other and generally parallel to the longitudinal axis of the microcatheter 51. It may take a shape that is not. When the implant device 10 is pushed out of the distal port of the microcatheter 51 or the radial restraint is removed separately, the distal end of the filamentous element is then spherical in the vascular lesion 60 as shown in FIG. 16B. They may be contracted in the axial direction toward each other so as to have an inverted configuration. The implant device 10 may then be delivered to the desired treatment site while placed within the microcatheter 51 and then released from the distal end of the microcatheter 51 or deployed separately. In other method embodiments, the microcatheter 51 may first be navigated to the desired treatment site via a guidewire 59 or by other suitable navigation techniques. The distal end of the microcatheter 51 is positioned so that the distal port of the microcatheter 51 is oriented toward or placed into the vascular disorder 60 to be treated and the guidewire 59 is withdrawn. May be. The implant device 10 secured to the delivery device 92 is then radially infarcted and inserted into the proximal portion of the internal lumen of the microcatheter 51 and advanced distally through the internal lumen to the vascular lesion 60. When the distal tip or deployment port of the delivery system is placed at a desired location adjacent to or within the vascular lesion, the implant device 10 may be deployed from the distal end of the microcatheter 51, thus the device. Can begin to expand radially as shown in FIG. 16C. As the implant device 10 emerges from the delivery device 92 or the distal end of the microcatheter 51, the implant device 10 may begin to expand into an expanded state within the vascular disorder 60, but at least partially by the internal surface of the vascular disorder 60. Can be constrained. At this point, the implant device 10 may be detached from the delivery device 92.

  Various other vascular implants can utilize specific embodiments of the electrolytic detachment system of the vaso-occlusive implant system of FIGS. For example, various tubular implants, such as stents or tubular flow diverting implants, may be implanted to occlude arteries alone or in combination with embolic microcoils or liquid embolic agents. The stent graft may be implanted, for example, in an abdominal aortic aneurysm that incorporates the withdrawal system of the present invention. An aneurysm blocking implant that incorporates the removal system of the present invention may also be implanted.

Claims (33)

  1. An elongated helical coil comprising a metal wire and having a proximal end and a distal end;
    An elongated stretch resistant member extending axially within the spiral coil and having a proximal end and a distal end, wherein the proximal end of the stretch resistant member is near the spiral coil. An elongated stretch resistant member secured to the distal end, the distal end of the stretch resistant member secured to the distal end of the helical coil;
    A coupling coil wound around the distal end of a core wire, wherein the coupling coil is axially positioned within the helical coil;
    A cylindrical region of insulating material located between the helical coil and the coupling coil configured to electrically insulate the helical coil from the core coil;
    A vascular occlusion implant.
  2.   The core wire further comprises an uninsulated electrolytic detachable region extending proximally from the cylindrical insulating region, and the implant is electrolytically detachable from a pusher member in the electrolytic detachable region. The implant according to claim 1.
  3.   Whether the helical coil is located at the proximal end and the proximal end or a first major outer diameter adjacent to a reduced diameter portion adjacent thereto, and at the distal end and the distal end Or a second major outer diameter adjacent to a reduced diameter portion adjacent thereto.
  4.   The system according to claim 1, wherein the stretch resistant member is fixed to the reduced diameter portion of the helical coil.
  5.   The system of claim 1, wherein the insulating material surrounds at least a portion of the elongated stretch resistant member.
  6.   The system of claim 1, wherein the insulating material comprises a UV curable adhesive, a two-part epoxy, or a thermoplastic.
  7.   The system of claim 1, wherein the core wire comprises stainless steel.
  8. A pusher member having a proximal end and a distal end, the pusher member comprising an elongated core wire and a polymer cover surrounding the core wire, the distal portion of the core wire being the distal end of the pusher member A pusher member extending from,
    A vascular occlusion implant system comprising an implant,
    The implant is
    An elongated helical coil comprising a metal wire and having a proximal end and a distal end;
    An elongated stretch resistant member extending axially within the spiral coil and having a proximal end and a distal end, wherein the proximal end of the stretch resistant member is near the spiral coil. An elongated stretch resistant member secured to the distal end, the distal end of the stretch resistant member secured to the distal end of the helical coil;
    A coupling coil wound around a distal end of a curing wire, wherein the coupling coil is axially positioned within the helical coil;
    A cylindrical region of insulating material located between the helical coil and the coupling coil configured to electrically insulate the helical coil from the core coil;
    A vaso-occlusive implant system comprising:
  9.   The portion of the core wire extending from the distal end of the pusher member includes an electrolytically detachable region, and the implant is configured to be electrolytically detachable from the pusher member in the electrolytically detachable region. Item 9. The system according to Item 8.
  10.   9. The system of claim 8, wherein the core wire is electrically insulated along its length except for the electrolytic detachable region and a distal region at the proximal end of the pusher member.
  11.   The core wire has a diameter in the electrolytic detachable region between 0.0015 inches and 0.0025 inches, and the electrolytic detachable region has a length between 0.002 inches and 0.008 inches. 9. The system of claim 8, comprising:
  12.   The core wire has a diameter in the electrolytic detachable region between 0.0017 inches and 0.0023 inches, and the electrolytic detachable region has a length between 0.002 inches and 0.003 inches. The system according to claim 8.
  13.   The system of claim 8, wherein the portion of the core wire proximate to the proximal end of the insulating material has an outer surface that is not electrically isolated.
  14.   The system of claim 8, further comprising a power source electrically coupled to the implant assembly at the proximal end of the pusher member.
  15.   The system of claim 14, wherein the power source has a voltage between 13.0V and 17.0V.
  16.   The system of claim 14, wherein the power source has a voltage between 16.0V and 17.0V.
  17.   The system of claim 14, wherein the power source is configured to operate with a current between 1.4 mA and 2.4 mA.
  18.   The system of claim 14, wherein the power source is configured to operate with a current between 1.8 mA and 2.2 mA.
  19.   The system of claim 14, wherein the power source comprises a direct current power source.
  20.   Whether the helical coil is located at the proximal end and the proximal end or a first major outer diameter adjacent to a reduced diameter portion adjacent thereto, and at the distal end and the distal end Or a second major outer diameter adjacent to a reduced diameter portion adjacent thereto.
  21.   21. The system of claim 20, wherein the stretch resistant member is secured to the reduced diameter portion of the helical coil.
  22.   The system of claim 8, wherein the insulating material surrounds at least a portion of the elongated stretch resistant member.
  23.   The system of claim 8, wherein the pusher member further comprises a helical coil formed from a radiopaque metal.
  24.   The system of claim 8, further comprising a radiopaque deposited positive tantalum metal.
  25.   The system of claim 8, wherein the core wire comprises stainless steel.
  26.   9. The system of claim 8, wherein the core wire has a diameter of at least between 0.008 inches and 0.018 inches at the proximal end of the elongate pusher member.
  27.   9. The system of claim 8, wherein the polymer cover comprises polyethylene terephthalate or polyethylene terephthalate shrink tubing.
  28.   The system of claim 8, wherein the insulating material comprises a UV curable adhesive, a two-part epoxy, or a thermoplastic.
  29.   The system of claim 14, further comprising a sterile cable configured to connect the power source to the implant assembly, the sterile cable comprising a sterile button, wherein the power source is activated by tactile manipulation of the sterile button.
  30. A method for treating an aneurysm comprising:
    Providing a vaso-occlusive implant system comprising:
    A pusher member having a proximal end and a distal end, the pusher member comprising an elongated core wire and a polymer cover surrounding the core wire, the distal portion of the core wire being the distal end of the pusher member A pusher member extending from,
    An elongate helical coil comprising a metal wire and having a proximal end and a distal end; elongate stretch resistant, extending axially within the helical coil and having a proximal end and a distal end A proximal end of the stretch resistant member is secured to the proximal end of the helical coil, and a distal end of the stretch resistant member is secured to the distal end of the helical coil. An elongate stretch resistant member; a coupling coil wound around a distal end of a curing wire, wherein the coupling coil is axially positioned within the helical coil; An implant comprising a helical coil and a cylindrical region of an insulating material configured to electrically insulate the coupling coil and located between the helical coil and the coupling coil;
    Comprising the steps of:
    Introducing a microcatheter containing the vaso-occlusive implant system into a patient's vasculature;
    Advancing the microcatheter to the aneurysm;
    Pushing the implant from the distal end of the microcatheter into the aneurysm until the detachment region is just outside the microcatheter;
    Electrolytically detaching the implant from the pusher member;
    A method comprising:
  31. Pushing the second implant out of the distal end of the microcatheter into the aneurysm until a disengagement region on the second implant is located just outside the microcatheter; and the second implant A step of electrolytically leaving
    32. The method of claim 30, further comprising:
  32.   32. The method of claim 30, further comprising implanting a three-dimensional framing microcoil within the aneurysm.
  33.   32. The method of claim 30, wherein the implant is electronically removed via a remote removal module.
JP2018551747A 2015-12-18 2015-12-18 Vascular implant system and process having a flexible withdrawal region Pending JP2019502513A (en)

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US5984929A (en) * 1997-08-29 1999-11-16 Target Therapeutics, Inc. Fast detaching electronically isolated implant
US9636115B2 (en) * 2005-06-14 2017-05-02 Stryker Corporation Vaso-occlusive delivery device with kink resistant, flexible distal end
CN102065779B (en) * 2007-12-21 2014-02-12 微排放器公司 System and method for locating detachment zone of detachable implant
WO2012109367A1 (en) * 2011-02-10 2012-08-16 Stryker Corporation Vaso-occlusive device delivery system
WO2015095360A1 (en) * 2013-12-18 2015-06-25 Blockade Medical, LLC Implant system and delivery method

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