WO2017105479A1

WO2017105479A1 - Vascular implant system and processes with flexible detachment zones

Info

Publication number: WO2017105479A1
Application number: PCT/US2015/066605
Authority: WO
Inventors: Jake Le; David A. Ferrera; Dawson LE; Randall TAKAHASHI; George Martinez
Original assignee: Blockade Medical, LLC
Priority date: 2015-12-18
Filing date: 2015-12-18
Publication date: 2017-06-22
Also published as: JP2019502513A; EP3389510A4; KR20180103065A; CN108697425A; EP3389510A1; KR102359744B1

Abstract

Vascular issues are addressed with systems, devices, and methods for delivering implants with accurate and ready detachability, along other features, for addressing, for example, acute stroke issues with due alacrity.

Description

VASCULAR IMPLANT SYSTEM AMD PROCESSES WITH FLEXIBLE DETACHMENT

ZONES

FIELD OF THE IMVENTfQ

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

BACKGROUND OF THE 1NVENHQN

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. In contrast, 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. Even though it is likely that a rupture in one artery could starve the brain tissue fed by that artery, ft is also likely that surrounding (otherwise healthy) arteries could become constricted, depriving their cerebral struc ures of oxygen and nutrients. Thus, a stroke that immediately affects a relatively unimportant portion of the brain may spread to a much larger area and affect mere important structures.

[Qt!©3J Currently there me two treatment options for cerebral aneur sm therapy, in either ruptured or unruptured aneurysms. One option i surgical clipping. The goal of surgical clipping is to Isolate an aneurysm from the normal circulation without blocking off any small perforating arteries nearby. Under general anesthesia, a opening is made in the skull, called a craniotomy. The brai is gently retracted to locate the aneurysm. A small clip is placed across the base, or neck, of the aneurysm to block the normal blood flow from entering. The clip works like a tiny coil-spring clothespin, in which the blades of the cli remain tightly closed until pressure is applied to open the blades. Clips are made of titanium or other metallic materials and remain o the artery permanently. The second option is neurovascular embolization, which 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,

|0§O4] 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. Several types of 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,

[00O¾ Many cerebral aneurysms tend to form at the bifurcation of major vessels that make up the circle of Willis and lie within the subarachnoid space. Each year, approximately 40,000 peopl in the U.S. suffer a hemorrhagic stroke caused by a ruptured cerebral -aneurysm, o w ich an estimated 50% die within 1 month and the remainder usually experience severe residual neurologic deficits, o t cerebral aneurysms are asymptomatic and retain undetected until an SAH occurs. An SAH is a catastrophic event due to the fact, that there Is little or no warning and many patients die before they are able to receive treatment. The most, common symptom prior to a vessel rupture Is an abrupt and sudden severe headache.

[0006] Other vascular abnormalities may benefit from treatment with delivery of vascular implants. 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.

SUMMARY OF THE INVENTION

[0007] 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.

BRIEF DESCRIPTION F THE DRAWINGS

|0®Ο83 ^ ^^{s a} side elevation view of a vasoocdusive implant system according to an embodiment of the present invention.

[0009] FIG, 2 is a perspective view of a protective shipping tube for the vasoocdusive implant system of FIG. 1.

£0010] FIG. 3 is a detailed view of a distal tip portion of the vasoocdusive implant system of FIG. i, taken from within circle 3.

[0011] FIG. 3A is a detailed view of the distal portion of a vasoocdusive implant system with a flexible detachment zone. f®012J FIG. 38 is a detailed view of the distal portion of a vasoocdusive implant system with a flexible detachment zone

[0013] FIG. 30 shows a vasoocdusive implant system with a flexible detachment sone compared to a vasoocdusive implant system without a flexible detachment 2one.

|0O14] FIG. 4 is perspective view of a vasoocdusive implant according to one embodiment of the invention.

[001 SJ FIG. 5 is a perspective of a vasoocdusive implant according to another embodiment of the Invention. |0δ1&] 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.

P01S] 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.

J¾02 IJ FIG. 10 is a perspective view of a mandrel for forming a vasoocclusive implant according to an embodiment of the Invention.

|08211 FIG. 11 is a perspective view of an electrical power supply configured to electrically couple to an electrolytically detachable implant assembly.

[00221 FIG. 12 is a circuit diagram of the electrical power supply coupled to an electrolytically detachable implant assembly that is inserted within a patient.

10023] FIG. 13 is a graphical illustration of electrical characteristics of the electrical power supply ove time during the detachment of an electrically detachable implant

P024] FIG. 14 is a sectional view of a vasoocclusive implant system having a decreased stiffness at a regio near the detachment zone. S2S] 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.

[002SJ 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.

DETAILED 0ES0 IPTIOf¾l

[0027] 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. 0028] 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. However, there are still many drawbacks that hav been reported, 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.

P029] 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. On complication that may occur during microcoif delivery or removal is the actual stretching of the winds of the microcoil For example, if the microcoil is pulled into the microcatheter while the microcatheter is i a position that causes its tip to place a larger than desired forc on a portion of th microcoil, the microcoil may not slide into the microcatheter easily, and an ax!a!iy-directed tensile force may caus a significant and permanent increase in the length of the microcoil. The microcoil will then have permanently lost its mechanical characteristics and suffered from a decrease In radio aeity in the stretched area. Coil 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

$ interfere with the procedure, as stretched colls may also e prone to being trapped, breaking, or inadvertently interlocking with other microeoils, already placed within the aneurysm. There is also the possibility of causing other microcoiis that were already placed within the aneurysm to migrate out of the aneurysm, into the parent artery, a severe complication. 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,

{30303 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. As 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. This is exacerbated by the absence of a prior microcoil, whose structure fends to help subsequently placed coils stay within the aneurysm, Microcoiis in which all loops are formed at substantially the same diameter are especially prone to this exiting phenomenon when sued as the first framing microcoil.

[0031] 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. [0032] Additionally, 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. Certain 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.

[0033] 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) have inherently less movement, but often suffer from less consistency, for example, a consistent short duration for a coil to detach. Though electrical isolation of the implant coil itself has aided in lower av rage coil detachment times, there is still some Inconsistency in how quickly the coils will detach. In a larger aneurysm that might have ten or more coils implanted, the large or unpredictable detachment times are multiplied, and delay th procedure. Additionally, a single large detachment time may risk instability during the detachment, clue to movement of the patient of the catheter system. Eyen systems that indicate that detachment has occurred, for example by the measurement of a current below a certain threshold, are no comptetely trusted by others.

[0034] Many 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 ,

[0 3S] Most detachable systems have a particular structure at a junction between a pusher wire and the detachable coupled microcoi! implant that is constructed in a manner allows the detachment to occur. Because of the need to have a secure coupling that allows repetitive insertion of the microcoil into the aneurysms and withdrawal into the microcatheter, many of these Junctions cause an increase in stiffness. Because this stiff section is immediatel proximal to the microcoi! being implanted, the implantation process ca he negatively affected, sometimes causing the microcatheter to back out, and thus no longer provide sufficient support for the microcoi! insertion. This is particularly true in aneurysms that are incorporated into a tortuous vascular anatomy,

|0O §| 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.

|GS37f 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. Then prior to assembly into the microeoil implant 102, 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. In order to minimize stretching of the embolic coil 130 of the microeoi implant 102, 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". In order to secure the tether at the proximal end 134 and distal end 136 of the embolic coll 130, 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. The end 142 of the reduced diameter portion 140 is trimmed and the ether 132 is tied in one or more knots 147, 148, around the wire 144 of the reduced diameter portio 140, 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. 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. In a separate embodiment, the tether 132 may be made from a multi-filar or stranded polymer or a n icrocable,

£9038] Turning again to FIG. 1, 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.

[0039] 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. In this embodiment, 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,

[004©1 In some other embodiments (such as FIGS. 1 and 7) the embolic coll and core wire are coupled together with a coupler coil and a potted sectio of epoxy or other insulating material. In the embodiment of FIG. 3A however, the core wire 306 extends through a proximal portion of the embolic coil 330. Distal to th region of overlap between the coupler coil 388 and 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. Placing the couple coil 366 coaxially within a proximal portio of the embolic coll 330 reduces the need for an epoxy bond section, which is stiff. This configuration creates a flexible zone immediately distal to the coupler coil 366 (see FIG. 38).

[0041] 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€ 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

[00431 The configuration of implant system 300 show in FIGS. 3A--C 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.

[0044] 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.

[O04S] 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. 4, the first loop 202 includes approximately 1½ revolutions, but may (along with the other loops 204, 206, 20E, 210, 212} include between ½ 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. 4, subsequent to the forming of the foops 202, 204, 208, 208, 210, 212, 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, f¾04§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, however, 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. Upon assembl of the microcoil implant 200 into the vasoocclusive implant system 100, 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. For example, 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. In addition, the diameter .of the wire 144, if 92/8 F¾/W, 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. In microcoil implants 200 having a diameter D2 or 6 mm or larger, additional framing microcoil models may be mad having .013" or larger embolic coils 130 wound with .002" and larger wire 144. it .should b noted that the 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.

[D047J Turning to. FIG. 10A, 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 wound around a first arm 502, the second loop 204 is wound around a second arm 504, the third loop 206 is wound around a third arm 508, the fourth loop 208 is wound around a fourth arm 503, the fifth loop 210 is wound around a fifth arm 510, and a sixth loop 212 is wound around a sixth arm Si 2, The wi e 144 of the embolic coil 130 is pulled into a straight extension 516 for length at the first end 214 (FIG. 4) of the embolic coil 130, and is secured info a securing element 5 4 at an end 518 of the first arm 502, 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). When the forming of the microcoii Implant 200 on the mandrel 500 is complete, 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. After cooling to room temperature, 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. In the specific case of the microcoii Implant 200, 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,

|8048] 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

Engage. The diameter of the tethe 132 formed from Engage may range from .002" to

,00275" and more particularly, may he ,0022". 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

.00225", 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). In addition to tjhe use of 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. These 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.

|004S| 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. However, the diameter f¾ 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. The complex of three-dimensional structure in many clinical situations can aid In better engagement of the finishing microeoil implant with the rest of the coil mass, due to its ability to interlock. There is thus less chance of the finishing microeoil implant migrating out of the aneurysm, Into the parent artery,

[C OSS!J 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. Thus, as described in accordance with FIGS, 1 1-13. 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.

[00511 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.

[00521 ^ 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. f¾SS3J Turning to FIG. 12, a circuit diagram 800 of the electrical power suppl 700 of FIG. 1 , 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). As shown in the graph 900 in FIG. 13, 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,

PS$4! 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. Using this coaxial arrangement, a stiff zone of between .015" and .030" can he created, and more particularly, between .020" and .025". This creates significantly increased flexibility of the microcoil Implant 1102 as it is being delivered Into an aneurysm from a microcatheter, and is much less likely to cause the microcatheter to lose its position at the neck of the aneurysm. [8055] FIGS. 1SA through 1 SG illustrate use of the vasoocciusive implant system of FIG, 1 to implant a microcoil implant 16, 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. As the microcoil implant 18 exists the microcatheter 12, it assumes It secondary shape as shown in FIG. 15C. 0S8J 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.

If additional microcoil implants 18 are to be implanted, the steps of FIGS. 15B through 15F are repeated. The method is repeated for each additional microcoil implant 16 need to sufficiently fill the aneurysm A. Once the aneurysm is fully occluded, the microcatheter 12 is removed, as seen in FIG, 15G. fOOSOJ FIGS. 16A-188 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. Once the implant device 10 is pushed out of the distal port of the microcatheter 51 , or th radial constraint is otherwise removed, 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. I other method embodiments, 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. Once the distal tip or deployment port of the delivery system is positioned in a desirabl location adjacent or within a vascular defect, 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. As the implant device 10 emerges from the distal end of the delivery apparatus 92 or microcathefer 51 , 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. [00611 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.. For example, a variety of 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.

Claims

HAT 18 CLAIMED:

1. A vasoocctewe implant comprising:

an elongate helical coil comprising a metallic wire and having a proximal end and a distal end;

an elongate stretch-resistant member extending axlaJly within th helical coil and having a proximal end and a distal end, the proximal end of the stretch- resistant member secured to the proximal end of the helical coil, and the distal end of the stretch-resistant member secured to the distal end of the helical coil; a coupling coil wrapped around the distal end of a core wire, the coupling coil positioned coaxial!y within the helical coil; and

a cylindrical region of insulation material situated between the helical coil and the coupling coll, configured to electrically insulate the helical coil from the core wire.

2. The implant of claim 1 , wherein the core wire further comprises an uninsulated eleetrQlytically detachable zone extending proximally from the cylindrical insulation region, wherein the implant is configured to he electro!yticaliy detachable from a pusher member at the electrolyiioally detachable zone,

^•3. The system of claim 1 , wherein the helical coil has a first primary outer diameter adjacent to the proximal end and a reduced diameter portion at or adjacent the proximal end, and a second primary outer diameter adjacent to the distal end and a reduced diameter portion at or adjacent to the distal end.

4, The system of claim 1, wherein the stretch-resistant member is secured to the reduced diameter portions of the helical coil.

5. The system of claim 1 , wherein the insulation material surrounds at least a

portion of the elongate stretch-resistant member.

8, The system of claim 1 , wherein the insulative material comprises an ultraviolet- curable adhesive, a two-part epoxy, or a thermoplastic.

7. The system of claim 1 , wherei the cor wire comprises stainless steel.

8. A vasooccluslve implant system comprising:

a pusher member having a proximal and a distal end, the pusher member composing an elongate core wire and a polymeric cover surrounding the core wire, wherein a distal portion of the core wire extends from the distal end of the pusher member; and

an implant comprising:

an elongate helical coil comprising a metallic wire and having a proximal end and a distal and;

an elongate stretch-resistant member extending axial ly within the helical coil and having a proximal end and a distal end, the proximal end of the stretch-resistant member secured to the proximal end of the helical coil, and the distal end of the stretch-resistant member secured to the distal end of the helical coil; and

a coupling coil wrapped around a distal end of the cure wire, the coupling col! positioned coaxially within the helical coil: and

a cylindrical region of insulation material situated between the helical coil and the coupling coil, configured to electrically insulate the helical coil from the core wire.

9. The system of claim 8, wherein the portion of the core wire extending from the distal end of the pusher member comprises an electrolyticaily detachable zone, wherein the implant is configured to be elecfioiylically detachable from the pusher member at the electrolyticaily detachable zone.

10. The system of claim 8, wherein the core wire is electrically insulated along its length except for the electrolyticaily detachable zone and a terminal zone at the proximal end of the pushing member.

11.The system of ciaim 8, wherein the core wire has a diameter at the electrolyticaily detachable zone of between .0015" and .0025". and wherein the electrolyticaily detachable zone has a length of between .002" and ,008"

12. Th system of claim 8, wherein the core wire has a diameter at the electroiyticaliy detachable zone of between ,0017" and .0023", and wherein the electrolyticaily detachable zone has a length of between .002^:: and .003".

13. The system of claim 8, wherein a portion of the core wire immediately proximal to the proximal end of the insulation material has an electrically non-insulated outer surface.

14. The system of claim 8, further comprising an electrical power supply electrically coupled to the implant assembly at the proximal end of the pushing member.

15 The system of claim 14 herein the electrical power supply has a voltage

between 13.0 V and 17,0 V.

16. The system of claim 14, wherein the electrical power supply has a voltage

between 16.0 V and 17.0 V.

17. The system of claim 14, wherein the electrical power supply is configured to

operate at a current between 1.4mA and 2,4mA.

18. The system of claim 14, wherein the electrical power supply is configured to

operate at a current between 1.8mA and 2,2mA.

19. The system of claim 14, wherein the electrical power supply comprises a direct current source.

20. The system of claim 8, wherein the helical coil has a first primary outer diameter adjacent to the proximal end and a reduced diameter portion at or adjacent the proximal end, and a second primary outer diameter adjacent to the distal end and a reduced diameter portion at or adjacent to the distal end.

21. The system of claim 20, wherein the stretch-resistant member is secured to the reduced diameter portions of the helical coil.

22. The system of claim 8, wherein the insulation material surrounds at least a

portion of the elongate 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 an electropositive tantalum metal vapor deposited which is radiopaque.

25. The system of claim 8, wherein the cor wire comprises stainless steel.

28. The vascular Implant system of claim 8, wherein the core wire has a diameter of between at least ,008" and .018^* at the proximal end of the elongate pushing member.

27. The system of claim S, wherein the polymeric cover comprises polyethylene

terephfhalafe or polyethylene ferephfhalate shrink tubing.

28. The system of claim S, wherein the insufative material comprises an uitraviolet- curable adhesive, a two-part epoxy, or a thermoplastic.

29. The system of claim 1 , further comprising a sterite cable configured to connect the electrical power supply to the implant assembly, the sterile cable comprising a sterite button, v tierein tactile operation of the sterile button activates the electrical power supply.

30. A method for creating an aneurysm, the method comprising:

providing a vasooeclusive implant system comprising:

a pusher member having a proximal and a distal end, the pusher member comprising an elongate core wire and a polymeric cover surrounding the core wire, wherein a distal portion of the core wire extends from the distal end of the pusher member; and

an implant comprising having an elongate helical coil comprising a metallic wire and having 3_. roximal end and a distal ^'end; an elongate stretch-resistant member extending axially within the helical coil and having a proximal end and a distal end, the proximal end of the stretch- resistant member secured to the proximal end of the helical coil, and the distal end of the stretch-resistant member secured to the distal end of the helical coil; a coupling coif wrapped around the distal end of the core wire, the coupling coll positioned .coaxislly within the helical coil; and a cylindrical region of insulation material situated between the helical coil and the coupling coil, configured to electrically insulate the helical coil from the core wire;

introducing a microcatheter containing the vasooeclusive implant system into a vasculature of a patient;

advancing the microcatheter to the aneurysm;

pushing the implant out of the distal end of the microcatheter and info the aneurysm until the detachment zone is positioned just outside the microcatheter; and eieetroiyticaH detaching the implant from the pusher member.

31.The method of claim 30, further comprising; pushing a second implant out of a distal end of the mierocatheter and into the aneurysm until a detachment zone on the second implant is positioned just outside the m crocatheter; and efectrolytieaily detaching th second implant

32. The method of claim 30, further comprising implanting a three-dimensional

framing mlcrocoi in the aneurysm.

33. The method of claim 30, wherein the implant is detached electronically via a remote detachment module.