Detection of electrolytic separation of vascular obstructions

Abstract

An electrolytic separation device for use with a delivery wire connected to a vaso-occlusive device via an electrolytically severable joint. The separation device is configured to evaluate whether a successful electrolytic separation event has occurred based on electrical parameter information and to reset the electrical parameter information when a measured elapsed time reaches an elapsed time threshold. The separation device is also configured to evaluate whether a successful electrolytic separation event has occurred within a fixed period of an electrolytic separation cycle based on the generated electrical parameter information and to extend the electrolytic separation cycle only if a successful electrolytic separation event has not occurred within the fixed period. The separation device is further configured to incrementally increase electrolytic work thresholds, which can be compared to the measured electrolytic work value to evaluate whether an electrolytic separation event has occurred.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical devices and intravascular medical procedures, and more particularly to devices and methods for detecting electrolytic detachment of vaso-occlusive devices. [Background technology]

[0002] An aneurysm is a localized, blood-filled blood vessel dilation, usually in the shape of a sac or balloon extending from the vessel, caused by disease, intravascular blood flow / pressure, and / or weakening of the vessel wall. The aneurysm can rupture, causing hemorrhage, stroke (e.g., intracranial aneurysm), and other adverse outcomes for the patient. Approximately 25,000 intracranial aneurysms rupture each year in North America.

[0003] There are various approaches to treating ruptured or unruptured aneurysms, including endovascular approaches that deliver vaso-occlusive devices into the aneurysm via an intravascular catheter. Vascular occlusive devices are generally constructed of self-expanding materials, and upon deployment from a delivery system to a target site in a patient, the unconstrained device expands without assistance. Self-expanding vaso-occlusive devices may be biased to expand when released from a delivery catheter or may contain shape-memory components that allow the device to expand when exposed to preset conditions. Some vaso-occlusive devices may also be characterized as hybrid devices, possessing properties of both self-expanding and non-self-expanding materials.

[0004] A typical endovascular approach involves two major steps. The first step is introducing a catheter into the aneurysm site using a device such as those described in U.S. Pat. Nos. 4,739,768 and 4,884,575, which are expressly incorporated herein by reference. The second step involves loading a vaso-occlusive device into the catheter via a delivery device (e.g., a delivery wire) in a collapsed or radially compressed delivery configuration and then introducing it into the aneurysm sac. In some embodiments, multiple vaso-occlusive devices (e.g., two) can be loaded simultaneously and introduced sequentially into the aneurysm sac. Once delivered into the aneurysm sac, the vaso-occlusive devices can be expanded to fill and occlude the aneurysm sac. Additional vaso-occlusive devices can then be sequentially placed into the catheter via the delivery device and delivered into the aneurysm sac until the aneurysm sac is completely filled with vaso-occlusive devices.

[0005] Vaso-occlusive devices can have a variety of sizes and shapes, but vaso-occlusive devices for treating aneurysms typically assume a spherical secondary shape upon placement within the aneurysm sac. Once placed within the aneurysm sac, the vaso-occlusive device can further reinforce the inner wall of the aneurysm sac while occluding the aneurysm, thereby reducing the likelihood of rupture or preventing further aneurysm rupture. Vaso-occlusive devices can be constructed from a variety of materials, including polymers (e.g., non-bioerodible and bioerodible plastics) and metals. Vaso-occlusive devices can be fabricated from shape-memory or superelastic materials, such as shape-memory metals (e.g., shape-memory nitinol) and polymers (e.g., polyurethane). Such shape-memory vaso-occlusive devices can be induced (e.g., by temperature, electric field, magnetic field, or light) to assume a predetermined shape (e.g., a radially expanded shape) after delivery to the treatment site. Superelastic embolic materials, such as superelastic nitinol, assume a predetermined shape after delivery without the need for an inducing stimulus. Other commonly used materials include stainless steel, platinum, and Elgiloy. Drug delivery vaso-occlusive devices can carry bioactive or therapeutic agents (eg, pro-thrombogenic agents) or can be coated onto the surface of the device.

[0006] Commonly used vaso-occlusive devices include flexible, helically wound coils formed by winding platinum (or platinum alloy) wire strands around a "primary" mandrel. The coil is then wound around a larger "secondary" mandrel and heat-treated to impart a secondary shape. For example, U.S. Pat. No. 4,994,069 (expressly incorporated herein by reference) describes a vaso-occlusive device that assumes a straight, helical primary shape when stretched for placement within the lumen of a delivery catheter and a collapsed, spiral secondary shape when released from the delivery catheter and deployed within a blood vessel. Complex three-dimensional secondary shapes may be imparted to the vaso-occlusive device to tailor its stiffness / flexibility to better border and fill an aneurysm. Other three-dimensional embolic coils are described in U.S. Patent Nos. 5,624,461 (a three-dimensionally filled embolic coil), 5,639,277 (a vaso-occlusive coil having a twisted helical shape), and 5,649,949 (a conical vaso-occlusive coil of variable cross-section). U.S. Patent Nos. 5,690,666 and 5,826,587 also describe vaso-occlusive coils with little or no inherent secondary shape. U.S. Patent No. 5,645,558 describes a spherical vaso-occlusive device that is wound with one or more strands to form a substantially hollow sphere or ovoid shape containing overlapping strands when deployed within an aneurysm. As other vaso-occlusive devices that assume a spherical shape upon deployment, U.S. Patent No. 8,998,947 discloses a tubular mesh with petal-like portions that, when deployed within an aneurysm, forms an approximately spherical shape with overlapping petal-like portions, and U.S. Patent Application Publication No. 2014 / 020060 discloses a hemispherical dome-shaped scaffold that inverts when an opposing force is applied to the aneurysm dome and is then filled with a vaso-occlusive material.

[0007] Vaso-occlusive coils, such as those described in U.S. Pat. No. 4,994,069, are delivered into the aneurysm sac in a variety of ways, with three to ten coils typically delivered into a single aneurysm sac. One highly desirable means of delivering vaso-occlusive coils into the aneurysm sac is to employ an electrolytic detachment procedure, such as that described in U.S. Pat. No. 5,122,136 (expressly incorporated herein by reference). This procedure involves loading a conductive delivery wire (e.g., stainless steel) with a vaso-occlusive coil attached into a delivery catheter, advancing the delivery wire distally to insert the vaso-occlusive coil into the aneurysm sac, and then passing a small current through the delivery wire at the electrolytically severable junction between the vaso-occlusive coil and the distal end of the delivery wire, thereby detaching the vaso-occlusive coil from the distal end of the delivery wire and permanently delivering the detached vaso-occlusive coil into the aneurysm sac.

[0008] If the vaso-occlusive coil is electrolytically detached from the delivery wire (a "successful electrolytic detachment event"), it is desirable to report such a successful electrolytic detachment event at the time of its occurrence, thereby prompting the physician to remove the delivery wire from the delivery catheter and load the next vaso-occlusive coil and its associated delivery wire into the delivery catheter for electrolytic detachment and delivery into the aneurysm sac. Alternatively, if a successful electrolytic detachment event does not occur within a reasonable time, it is desirable to report such non-occurrence (non-detachment) of a successful electrolytic detachment event to the physician so that the physician can make another attempt to electrolytically detach the vaso-occlusive coil from the delivery wire. To this end, typical electrolytic detachment devices include a means for reporting to the physician whether a successful electrolytic detachment event has occurred. Some known electrolytic detachment detection systems determine the likelihood of a successful electrolytic detachment event by measuring one or more direct current (DC) and / or alternating current (AC) electrical parameters (e.g., impedance, voltage, etc.) while passing a small current through the electrolytically severable junction and analyzing sudden changes in these electrical parameters. Examples of such electrolytic separation detection systems are described in US Pat. Nos. 5,643,254 and 6,397,850, which are expressly incorporated herein by reference.

[0009] A handheld electrolytic separation device, such as the InZone® Detachment System manufactured by Stryker® Neurovascular, can be used to apply a small current to the electrolytically severable junction between the vaso-occlusive coil and the distal end of the delivery wire to detect and report detachment of the vaso-occlusive coil from the delivery wire. One embodiment of such a handheld electrolytic separation device includes a power terminal to which the proximal end of the delivery wire is connected (e.g., by insertion into a power port) and a ground terminal to which a ground electrode placed in contact with the patient (e.g., via percutaneous insertion into the patient's body) is connected via an electrical cable (e.g., by inserting the electrical cable's connector into the ground port).

[0010] The handheld electrolytic separation device can be operated on the handle (e.g., by pressing a button) to perform one or more electrolytic separation cycles (i.e., deliver one or more current cycles) to the electrolytically severable junction between the vaso-occlusive coil and the distal end of the delivery wire. During each electrolytic separation cycle, the handheld electrolytic separation device measures the cumulative current delivered to the electrolytically severable junction (in lieu of the electrolytic work performed by the handheld electrolytic separation device) and compares it to a threshold value to determine the likelihood that the vaso-occlusive coil has electrolytically detached from the delivery wire. That is, if a predetermined amount of electrolytic work is performed by the handheld electrolytic separation device, the vaso-occlusive coil is presumed to have electrolytically detached from the delivery wire.

[0011] Although desirable, there is no guarantee that all vaso-occlusive coils will be electrolytically detached from the delivery wire within the first electrolytic detachment cycle. In particular, the electrolytic detachment process is highly dependent on the environment surrounding the vaso-occlusive coil, and therefore the elapsed time between the initial application of current to the electrolytically severable junction and the electrolytic detachment of the vaso-occlusive coil from the delivery wire can vary. For example, the presence of high concentrations of non-ionic contrast media, the presence of other embolic agents, contact between the electrolytically severable junction and a previously delivered vaso-occlusive coil, the presence of thrombus on the electrolytically severable junction, misalignment of the delivery wire and delivery catheter such that the electrolytically severable junction is not exposed to blood to the extent necessary for electrolysis to occur, and grounding issues such as corroded electrical cables or poor electrical contact between the ground electrode and the patient can adversely affect the elapsed time required for successful detachment of the vaso-occlusive coil from the delivery wire. If environmental electrolytic conditions are ideal, initiating an electrolytic detachment cycle will rapidly and successfully detach the vaso-occlusive coil from the delivery wire. With a particular vaso-occlusive coil set, initiating an electrolytic detachment cycle may result in successful detachment of the vaso-occlusive coil from the delivery wire within 5 seconds.

[0012] However, if one or more environmental conditions are not ideal, a longer elapsed time may be required, sometimes even exceeding 5 seconds. Indeed, empirical studies have shown that 30% of successful electrolytic detachments of certain types of vaso-occlusive coils from their corresponding delivery wires occur after 5 seconds or less. Thus, in approximately 30% of electrolytic detachment cases, if the electrolytic detachment cycle is only 5 seconds long, at least one additional electrolytic detachment cycle must be performed to successfully separate the vaso-occlusive device from the delivery wire. Electrolytic detachment devices can also be designed for electrolytic detachment cycle times longer than 5 seconds (e.g., 1 minute) to ensure that the vaso-occlusive coil is separated from the delivery wire at the end of the electrolytic detachment cycle. However, extending the electrolytic detachment cycle time would unnecessarily prolong many (if not most) of the electrolytic detachment procedures, with the electrolytic detachment cycle successfully separating the vaso-occlusive coil well before the electrolytic detachment cycle time. Therefore, a 5-second electrolytic detachment cycle has been determined to be optimal for certain types of vaso-occlusive coils.

[0013] Thus, electrolytic detachment of the vaso-occlusive coil from the delivery wire may require multiple successive operations of the electrolytic separation device. For example, in the example of FIG. 1 , the handheld electrolytic separation device is operated (e.g., by repeatedly pressing a button) to perform an exemplary sequence of electrolytic separation cycles (i.e., sequentially supplying current cycles to the electrolytically severable junction between the vaso-occlusive coil and the distal end of the delivery wire for a fixed period of time (e.g., 5 seconds)), the final electrolytic separation cycle successfully electrolytically separating the vaso-occlusive coil from the delivery wire. Prior to initiating such an exemplary electrolytic separation sequence, it is assumed that the vaso-occlusive coil is inserted into the patient's aneurysm sac as briefly described above, the proximal end of the delivery wire is inserted into the power port of the handheld electrolytic separation device, and an electrical cable connected to a ground electrode positioned in contact with the patient is inserted into the ground port of the handheld electrolytic separation device.

[0014] During each electrolytic separation cycle, the handheld electrolytic separation device measures and analyzes one or more electrical parameters in the electrical circuit between the delivery wire and the ground electrode, and then determines and reports, at the end of the electrolytic separation cycle, whether the vaso-occlusive coil has been successfully electrolytically detached from the delivery wire. As described above, the measured electrical parameters include at least cumulative current (although other types of electrical parameters, such as mean moving impedance, can also be measured and analyzed), which can be compared to a threshold value to determine the likelihood that the vaso-occlusive coil has been electrolytically detached from the delivery wire. Based on the results of this comparison, the handheld electrolytic separation device reports to the physician, at the end of the electrolytic separation cycle, whether a successful electro-detachment event has occurred.

[0015] 1, at the end of each electrolytic separation cycle prior to the final electrolytic separation cycle, the handheld electrolytic separation device may assess that the vaso-occlusive coil has not electrolytically separated from the delivery wire and report to the physician that successful electrolytic separation has not occurred, thereby prompting the physician to initiate the next electrolytic separation cycle by operating an electrolytic separation cycle. On the other hand, at the end of the final electrolytic separation cycle, the handheld electrolytic separation device may assess that the vaso-occlusive coil has electrolytically separated from the delivery wire and report to the physician that successful electrolytic separation has occurred, thereby prompting the physician to perform a new vaso-occlusive coil electrolytic separation procedure.

[0016] Because electrolytic detachment of the vaso-occlusive coil from the delivery wire does not necessarily occur at the end of an electrolytic detachment cycle, prudent practice dictates that the physician always verify after completion of each electrolytic detachment cycle whether the vaso-occlusive coil has in fact been electrolytically detached from the delivery wire.

[0017] For example, if the handheld electrolytic separation device detects and reports to the physician that a successful electrolytic separation event has not occurred at the end of a particular electrolytic separation cycle, the physician can confirm that the vaso-occlusive coil has not actually been electrolytically separated from the delivery wire. Specifically, the physician can remove the proximal end of the delivery wire from the handheld electrolytic separation device, pull the delivery wire slightly proximally (e.g., 1-2 mm), and confirm under fluoroscopy that the vaso-occlusive coil has moved with the delivery wire, thereby preventing successful electrolytic separation from the delivery wire. Notably, movement of the vaso-occlusive coil during this confirmation procedure may favorably change the environmental electrolytic conditions, thereby increasing the likelihood of successful electrolytic separation of the vaso-occlusive coil from the delivery wire during the next electrolytic separation attempt. The physician can then take other corrective actions, such as ensuring that the delivery wire is properly aligned with the delivery catheter to fully expose the electrolytically severable junction to blood, activating a flushing system to remove contrast media surrounding the vaso-occlusive device, and ensuring that the ground electrode is in stable contact with the patient.

[0018] If the handheld electrolytic separation device detects and reports that a successful electrolytic detachment event has occurred at the end of a particular electrolytic detachment cycle, the physician can verify that the vaso-occlusive coil has indeed detached from the delivery wire even when the handheld electrolytic separation device evaluates and reports the success of the electrolytic detachment event to the physician. For example, the physician can disconnect the proximal end of the delivery wire from the handheld electrolytic separation device, pull the delivery wire slightly proximally (e.g., 1-2 mm), and verify under fluoroscopy that the vaso-occlusive coil has not moved with the delivery wire and has therefore indeed been electrolytically detached from the delivery wire.

[0019] Thus, as shown in FIG. 1, the physician can perform a fluoroscopic visualization check and take corrective action immediately after each electrolytic separation cycle in which the handheld electrolytic separation device reports that no successful electrolytic separation event occurred, and can perform only a fluoroscopic visualization check (without taking corrective action) after the last electrolytic separation cycle in which the handheld electrolytic separation device reports that a successful electrolytic separation event occurred.

[0020] If fluoroscopic visualization reveals that the vaso-occlusive coil has in fact moved with the delivery wire and thus electrolytic detachment from the delivery wire has not been successful (i.e., a false-positive detection of electrolytic detachment has occurred), the physician can slightly push the delivery wire distally to fully reposition the vaso-occlusive coil within the aneurysm sac, reinsert the proximal end of the delivery wire into the power port of the handheld electrolytic detachment device, and again operate the handheld electrolytic detachment device to perform another electrolytic detachment cycle. Thus, instead of only performing a fluoroscopic visualization check at the end of the last electrolytic detachment cycle as shown in FIG. 1, the physician can perform a fluoroscopic visualization check immediately after the current electrolytic detachment cycle to take corrective action and then operate the handheld electrolytic detachment device to continue the electrolytic detachment procedure.

[0021] If the handheld electrolytic separation device detects and reports to the physician that a successful electrolytic separation event has occurred at the end of the current electrolytic separation cycle (whether this positive detection of electrolytic separation is correct or not), the "double-handed" physician may, out of an overly cautious attitude, re-operate the handheld electrolytic separation device to perform an additional electrolytic separation cycle without confirming by fluoroscopic visualization that the vaso-occlusive coil has been successfully electrolytically separated from the delivery wire. In such a case, the "double-handed" physician may disconnect the proximal end of the delivery wire from the handheld electrolytic separation device and then quickly reconnect the proximal end of the delivery wire to the handheld electrolytic separation device (without confirming by fluoroscopic visualization), as shown in FIG. 2.

[0022] If the handheld electrolytic separation device detects and reports to the physician that a successful electrolytic separation event has not occurred at the end of the current electrolytic separation cycle (whether or not this negative detection of electrolytic separation is correct), the physician can confirm that the vaso-occlusive coil has not actually detached from the delivery wire. Again, the physician can remove the proximal end of the delivery wire from the handheld electrolytic separation device, pull the delivery wire slightly proximally (e.g., 1–2 mm), and confirm under fluoroscopy that the vaso-occlusive coil has moved with the delivery wire and thus has not actually electrolytically detached from the delivery wire. Simply physically manipulating the vaso-occlusive coil is a corrective action to modify the electrolytic conditions to a favorable state. The physician can also take other corrective actions, such as ensuring that the delivery wire is properly aligned with the delivery catheter so that the electrolytically severable junction is fully exposed to blood, operating the flushing system to remove contrast media around the vaso-occlusive device, or ensuring stable contact of the ground electrode with the patient. A "dual action" physician may simply operate the handheld electrolytic separation device again to perform additional electrolytic separation cycles rather than immediately performing fluoroscopic visualization confirmation or taking corrective action. Similarly, in this case, a "dual action" physician may disconnect the proximal end of the delivery wire from the handheld electrolytic separation device and then quickly reconnect the proximal end of the delivery wire to the handheld electrolytic separation device (without performing fluoroscopic visualization confirmation and / or corrective action), as shown in FIG. 2.

[0023] If the vaso-occlusive coil has not been successfully separated from the delivery wire (e.g., after fluoroscopic visualization reveals that there has been a false-positive electrolytic detachment detection or a true-negative electrolytic detachment detection), the physician can reconnect the proximal end of the delivery wire to the handheld electrolytic detachment device and again operate the handheld electrolytic detachment device to perform an electrolytic detachment cycle, thereby continuing the electrolytic detachment procedure in another attempt to electrolytically detach the vaso-occlusive coil from the delivery wire. Such electrolytic detachment attempts may be repeated until the vaso-occlusive coil is, in fact, electrolytically detached from the delivery wire.

[0024] Because fluoroscopic confirmation of successful electrolytic detachment of the vaso-occlusive coil from the delivery wire (if electrolytic detachment is reported as successful) or unsuccessful electrolytic detachment from the delivery wire (if electrolytic detachment is reported as unsuccessful) can be time-consuming and can increase procedure time, it is recommended that fluoroscopic confirmation be performed only once for each vaso-occlusive coil and that manipulation of the delivery wire to improve environmental conditions be minimized, if not eliminated entirely.

[0025] The electrolytic separation device can be designed to have a variable electrolytic separation cycle time (e.g., the electrolytic separation cycle time does not have to be a fixed time, such as 5 seconds), thereby terminating current delivery to the electrolytically severable junction when successful electrolytic detachment of the vaso-occlusive coil from the delivery wire is detected and reported, thereby minimizing the number of required electrolytic separation cycles (in most cases, only one) and the associated fluoroscopic visualization confirmation. However, the use of a fixed electrolytic separation cycle minimizes the occurrence of false-positive electrolytic separation detections (i.e., detecting successful electrolytic detachment of the vaso-occlusive coil from the delivery wire when, in fact, the vaso-occlusive coil has not been electrolytically detached from the delivery wire). That is, supplying current to the electrolytically severable junction for the entire fixed electrolytic separation cycle increases the likelihood that the vaso-occlusive coil will actually electrolytically detach from the delivery wire, compared to terminating current delivery to the electrolytically severable junction once successful electrolytic detachment of the vaso-occlusive coil from the delivery wire is detected and reported during a variable electrolytic separation cycle.

[0026] Furthermore, when using a variable electrolytic separation cycle, in certain cases where environmental electrolytic conditions are not ideal, it may not be desirable to wait until the vaso-occlusive coil is electrolytically separated from the delivery wire. That is, rather than continuing to deliver current to the electrolytically severable joint under non-ideal environmental electrolytic conditions, it may be desirable to use a fixed electrolytic separation cycle that unconditionally terminates at a known end point, thereby allowing the physician to change the environmental electrolytic conditions, e.g., by adjusting the position of the delivery wire and delivery catheter to make the environmental electrolytic conditions more ideal, and then attempt another fixed electrolytic separation cycle under the more ideal environmental electrolytic conditions. In this manner, having a fixed electrolytic separation cycle with an appropriate unconditional end point can prompt the physician to take corrective action (i.e., attempt to make the environmental electrolytic conditions more ideal) at the end of the fixed electrolytic separation cycle before continuing to deliver current to the electrolytically severable joint.

[0027] Thus, there remains a need to minimize the number of electrolytic detachment cycles required to successfully electrolytically detach a given vaso-occlusive coil from a delivery wire, as well as to minimize the number of false-positive electrolytic detachment detections, prompting a physician to take corrective action if necessary.

[0028] Because the vaso-occlusive coil is estimated to electrolytically detach from the delivery wire by the end of the first electrolytic detachment cycle (notwithstanding the fact that a small number of vaso-occlusive coils may not electrolytically detach from the delivery wire by the end of the first electrolytic detachment cycle), the handheld electrolytic detachment device predicts that the next electrolytic detachment cycle will be applied to the newly distally attached vaso-occlusive coil. To prevent electrolytic detachment detection information (e.g., measured cumulative current and threshold) associated with the current vaso-occlusive coil from being sent to the new vaso-occlusive coil, the handheld electrolytic detachment device can automatically reset the electrolytic detachment detection information used to detect the electrolytic detachment of the new vaso-occlusive coil from the delivery wire. Such a reset may occur when the proximal end of the delivery wire associated with the new vaso-occlusive coil is connected to the handheld electrolytic detachment device or when the handheld electrolytic detachment device is operated to deliver another electrolytic detachment cycle. In this way, the handheld electrolytic detachment device recognizes that no electrolytic work has been performed at the start of the next electrolytic detachment cycle, which is performed in an attempt to electrolytically detach the new vaso-occlusive coil from the delivery wire.

[0029] This is not a problem if the vasoocclusive coil actually electrolytically detaches from the delivery wire during the current electrolytic separation cycle and such successful electrolytic separation is confirmed; however, if the current vasoocclusive coil does not actually electrolytically detach from the delivery wire during the current electrolytic separation cycle, resetting the electrolytic separation detection information too early may adversely affect the ability of the handheld electrolytic separation device to accurately determine whether the current vasoocclusive coil electrolytically detached from the delivery wire during the next electrolytic separation cycle. For example, if the measured cumulative current state is not carried over to the next electrolytic separation cycle, the measured cumulative current that the handheld electrolytic separation device compares with the cumulative current threshold may be too small to satisfy the cumulative current threshold to prevent the handheld electrolytic separation device from detecting successful electrolytic separation of the vasoocclusive coil from the delivery wire during the next electrolytic separation cycle, resulting in an erroneous report to the physician that a successful electrolytic separation event did not occur (i.e., a false-negative electrolytic separation detection). Such premature resetting of the electrical parameter information can occur by reconnecting the same delivery wire to the handheld electrolytic separation device (e.g., in the case of a false-positive electrolytic separation detection, when fluoroscopic visualization does not confirm that the vasoocclusive device has successfully separated from the delivery wire, or in the case of a true-negative electrolytic separation detection, when fluoroscopic visualization confirms that the vasoocclusive device has not successfully separated from the delivery wire), or by simply operating the handheld electrolytic separation device again to perform another electrolytic separation cycle without confirming with fluoroscopic visualization (e.g., in the case of a "double operation event" in the case of a true-negative electrolytic separation detection or a false-positive electrolytic separation cycle detection).

[0030] In cases where the current vaso-occlusive coil has actually electrolytically detached from the delivery wire during the current electrolytic detachment cycle, if the same delivery wire is immediately reconnected to the handheld electrolytic detachment device (without fluoroscopic visualization confirmation) and the handheld electrolytic device is operated again to perform another electrolytic detachment cycle on the now-detached vaso-occlusive coil (e.g., in a dual-operation event in the case of a true-positive electrolytic detachment detection or a false-negative electrolytic detachment cycle detection), a premature reset of the electrical parameter information may still occur, resulting in the handheld electrolytic detachment device failing to detect that the vaso-occlusive coil has been successfully electrolytically detached from the delivery wire during the next electrolytic detachment cycle and erroneously reporting to the physician that a successful electrolytic detachment event did not occur (i.e., resulting in a false-negative electrolytic detachment detection).

[0031] Furthermore, if a successful electrolytic detachment event is reported to have occurred during the current electrolytic detachment cycle (regardless of whether the current vaso-occlusion coil has actually been electrolytically detached from the delivery wire during the current electrolytic detachment cycle), the sequence of first reporting that a successful electrolytic detachment event has occurred followed by reporting that successful electrolytic detachment has not occurred, as shown in Figure 2, may be confusing to the physician.

[0032] One solution to preventing premature resetting of the electrolytic detachment detection information is to provide the handheld electrolytic detachment device with a control (e.g., a button) that the physician can manually operate to reset the electrolytic detachment detection information, thereby ensuring that the electrolytic detachment detection information is reset only after it has been confirmed that the current vaso-occlusive coil has been electrolytically detached from the delivery wire. However, this requires an additional step in the electrolytic detachment procedure that the physician may forget or be unwilling to perform.

[0033] Therefore, a need remains to provide an electrolytic separation device that automatically resets the electrolytic separation information only after a successful electrolytic separation event is deemed to have actually occurred.

[0034] The handheld electrolytic separation device assumes that the electrolytic work required to electrolytically separate the vaso-occlusive coil from the delivery wire remains the same throughout the electrolytic separation procedure, and therefore the threshold against which the handheld electrolytic separation device compares the measured cumulative current is constant. However, it has been found that a significant portion of the electrolytic work (i.e., the cumulative current) is consumed in side reactions near the vaso-occlusive coil, and this side reaction increases as the electrolytic separation procedure progresses over time. However, because the threshold against which the measured cumulative current is compared is constant, it is possible that the measured cumulative current reaches that threshold prematurely, resulting in the handheld electrolytic separation device detecting and reporting a false-positive electrolytic separation detection (i.e., erroneously detecting and reporting that the vaso-occlusive coil has electrolytically separated from the delivery wire).

[0035] Therefore, there remains a need to minimize the possibility of false-positive electrolytic separation detection based on measurements of the electrolytic work performed by a handheld electrolytic separation device (i.e., the measured cumulative current). Summary of the Invention

[0036] In accordance with the present invention, an electrolytic separation device is provided for use with an electrically conductive delivery wire having a distal end to which a vaso-occlusive device is respectively attached and an electrolytically severable joint located proximal to the vaso-occlusive device.

[0037] The electrolytic isolation device includes a power terminal configured to electrically connect to and disconnect from the proximal end of the delivery wire. The power terminal may be, for example, a power port configured for insertion of the proximal end of the delivery wire. In one embodiment, the electrolytic isolation device further includes a ground terminal configured to electrically connect to a ground electrode in electrical contact with the patient via an electrical cable.

[0038] The electrolytic separation device further comprises a current supply circuit configured to supply current to the electrolytically severable joint of the vaso-occlusive assembly while the vaso-occlusive device is positioned within the patient's vasculature so as to electrolytically detach the vaso-occlusive device from the distal end of the delivery wire. The electrolytic separation device further comprises an electrolytic separation detection circuit configured to generate electrical parameter information indicative of a successful electrolytic detachment event (e.g., a measured cumulative electrical parameter such as a measured cumulative current, or a measured electrolytic work value performed by the current supply circuit).

[0039] The electrolytic separation device further comprises a controller configured to evaluate whether a successful electrolytic separation event has occurred based on the generated electrical parameter information. In one embodiment, the controller is configured to generate a first user-identifiable notification if it is evaluated that a successful electrolytic separation event has occurred, and the controller is configured to generate a second user-identifiable notification different from the first user-identifiable notification if it is evaluated that a successful electrolytic separation event has not occurred. In another embodiment, the electrolytic separation device further comprises a current supply actuator, wherein the controller is configured to operate the current supply circuit in response to one actuation of the current supply actuator to supply current to the electrolytically severable joint during an electrolytic separation cycle and to operate the current supply circuit in response to another actuation of the current supply actuator to supply current to the electrolytically severable joint during another electrolytic separation cycle.

[0040] According to a first aspect of the present invention, the electrolytic separation device further comprises a timer configured to measure an elapsed time between a delivery wire detachment event and a subsequent delivery wire attachment event. The controller is further configured to reset the electrical parameter information when the measured elapsed time reaches a first elapsed time threshold (e.g., 3 seconds or more, e.g., in a range of 25 to 45 seconds). In one embodiment, the controller is configured to reset the electrical parameter information when the measured elapsed time reaches the first elapsed time threshold and a successful electrolytic separation event is evaluated to have occurred, and to reset the electrical parameter information when the measured elapsed time reaches a second elapsed time threshold greater than the first elapsed time threshold and a successful electrolytic separation event is evaluated not to have occurred. In this case, the first elapsed time threshold is, for example, in a range of 3 to 10 seconds, and the second elapsed time threshold is, for example, in a range of 25 to 45 seconds.

[0041] According to a second aspect of the present invention, the controller is configured to operate the current supply circuit to supply current to the electrolytically severable joint during an electrolytic separation cycle having a fixed duration, and to extend the electrolytic separation cycle only if it is assessed that a successful electrolytic separation event has not occurred during the fixed duration.

[0042] In one embodiment, the fixed period is an initial fixed period, in which case the controller is configured to extend the electrolytic separation cycle by a subsequent variable period. The controller may be configured to incrementally evaluate whether a successful electrolytic separation event has occurred during the subsequent variable period, and to terminate the electrolytic separation cycle if it is determined that a successful electrolytic separation event has occurred. The subsequent variable period may have multiple time increments, each time increment being shorter than the initial fixed period of the electrolytic separation cycle. In this case, the controller may be configured to incrementally evaluate whether a successful electrolytic separation event has occurred during each of the multiple time increments, and to terminate the electrolytic separation cycle at the end of the time increment in which it is determined that a successful electrolytic separation event has occurred.

[0043] In another embodiment, the controller is configured to determine whether an electrolytic anomaly occurred during the supply of current to the electrolytically severable joint, and to extend the electrolytic separation cycle only if it is determined that an electrolytic anomaly did not occur during the supply of current to the electrolytically severable joint. For example, if the electrical parameter information includes measured electrolytic work performed by the current supply circuit, the controller may be configured to determine that an electrolytic anomaly occurred during the supply of current to the electrolytically severable joint if the measured electrolytic work is outside an electrolytic work range defined by a minimum electrolytic work limit and a maximum electrolytic work limit.

[0044] In yet another embodiment, the electrolytic separation device further comprises a counter configured to track the number of completed electrolytic separation cycles, in which case the controller may be configured to not extend the electrolytic separation cycles if the tracked number of completed electrolytic separation cycles exceeds a preset number of electrolytic separation cycles.

[0045] According to a third aspect of the present invention, the electrolytic separation detection circuit is configured to incrementally measure the electrolytic work performed by the current supply circuit over time (e.g., by incrementally measuring the cumulative current supplied by the current supply circuit over time), thereby generating a plurality of measured electrolytic work values, and the controller is further configured to incrementally increase the electrolytic work threshold over time to generate a plurality of electrolytic work thresholds, compare the plurality of measured electrolytic work values ​​with the plurality of electrolytic work thresholds, respectively, and evaluate whether a successful electrolytic separation event has occurred based on the comparison result.

[0046] In accordance with the present invention, a vascular occlusion treatment system is provided.

[0047] The vascular occlusion treatment system includes a delivery catheter configured to be introduced into a patient's vascular system, the delivery catheter including an elongate sheath body, an inner lumen extending through the elongate sheath body, and a distal port each in communication with the inner lumen.

[0048] The vascular occlusion treatment system further includes a vascular occlusion assembly configured to be disposed within the inner lumen of the delivery catheter. The vascular occlusion assembly includes a delivery wire and a vascular occlusion device (e.g., a vasoocclusion coil) detachably connected to the delivery wire via an electrolytically severable joint. The vasoocclusion device is configured to be deployed within the patient's vasculature from a distal port of the delivery catheter.

[0049] The vascular occlusion treatment system further includes an electrolytic separation device (e.g., a handheld electrolytic separation device) configured to electrically connect and electrically disconnect the proximal end of the delivery wire of the vascular occlusion assembly, the electrolytic separation device supplying current to the electrolytically severable joint of the vascular occlusion assembly while the vascular occlusion device is positioned within the patient's vasculature so as to electrolytically separate the vascular occlusion device from the distal end of the delivery wire, generating electrical parameter information indicative of a successful electrolytic separation event (e.g., a measured cumulative electrical parameter such as a measured cumulative current, or a measured electrolytic work value performed by the electrolytic separation device), and evaluating whether a successful electrolytic separation event has occurred based on the generated electrical parameter information.

[0050] In one embodiment, the vascular occlusion treatment system further comprises a ground electrode positioned in electrical contact with the patient and configured to be electrically connected to the electrolytic isolation device via an electrical cable.

[0051] In another embodiment, the electrolytic separation device is configured to generate a first user-identifiable notification when a successful electrolytic separation event is assessed to have occurred and to generate a second user-identifiable notification different from the first user-identifiable notification when a successful electrolytic separation event is assessed to have not occurred. In yet another embodiment, the electrolytic separation device is configured to supply current to the electrolytically severable joint during an electrolytic separation cycle in response to one actuation of the electrolytic separation device and to supply current to the electrolytically severable joint during another electrolytic separation cycle in response to another actuation of the electrolytic separation device.

[0052] According to a fourth aspect of the present invention, the electrolytic separation device is further configured to measure an elapsed time between a delivery wire separation event and a subsequent delivery wire connection event, and to reset the electrical parameter information if the measured elapsed time reaches a first elapsed time threshold (e.g., 3 seconds or more, e.g., in the range of 25 to 45 seconds).

[0053] In one embodiment, the electrolytic separation device is configured to reset the electrical parameter information when the measured elapsed time reaches a first elapsed time threshold and a successful electrolytic separation event is evaluated to have occurred, and to reset the electrical parameter information when the measured elapsed time reaches a second elapsed time threshold greater than the first elapsed time threshold and a successful electrolytic separation event is evaluated not to have occurred. In this case, the first elapsed time threshold is, for example, within a range of 3 to 10 seconds, and the second elapsed time threshold is, for example, within a range of 25 to 45 seconds. In one example, the delivery catheter can include another inner lumen extending through the elongate sheath body and another distal port each communicating with the other inner lumen. The vascular occlusion treatment system can further include another vascular occlusion assembly configured to be disposed within the inner lumen of the delivery catheter, the another vascular occlusion assembly including a delivery wire and a vascular occlusion device detachably connected to the delivery wire via an electrolytically severable joint, the another vascular occlusion device configured to be deployed into the patient's vasculature from the another distal port of the delivery catheter. The proximal end of the delivery wire of another vasoocclusive assembly may be configured to be electrically connected to an electrolytic separation device, and the proximal end of the delivery wire of another vasoocclusive assembly may be configured to be electrically isolated from the electrolytic separation device. The electrolytic separation device may be configured to supply current to the electrolytically severable joint of the vasoocclusive assembly such that the vasoocclusive device electrolytically separates from the distal end of the delivery wire while the other vasoocclusive assembly is positioned within the patient's vasculature. The delivery wire detachment event includes detaching the delivery wire of the vasoocclusive assembly from the electrolytic separation device, and the subsequent delivery wire connection event includes reconnecting the delivery wire of the vasoocclusive assembly to the electrolytic separation device or connecting the delivery wire of the other vasoocclusive assembly to the electrolytic separation device.

[0054] According to a fifth aspect of the present invention, the electrolytic separation device is configured to supply current to an electrolytically severable joint of the vaso-occlusive assembly during an electrolytic separation cycle having a fixed duration while the vaso-occlusive device is positioned within a patient's blood vessel so as to electrolytically separate the vaso-occlusive device from the distal end of the delivery wire, and to extend the electrolytic separation cycle only if it is assessed that no successful electrolytic separation event has occurred during the fixed duration.

[0055] In one embodiment, the fixed period is an initial fixed period, in which case the electrolytic separation device is configured to extend the electrolytic separation cycle by a subsequent variable time. The electrolytic separation device may be configured to incrementally evaluate whether a successful electrolytic separation event has occurred during the subsequent variable period, and to terminate the electrolytic separation cycle if it is determined that a successful electrolytic separation event has occurred. The subsequent variable period may have multiple time increments, each time increment being shorter than the initial fixed period of the electrolytic separation cycle. In this case, the electrolytic separation device may be configured to incrementally evaluate whether a successful electrolytic separation event has occurred during each of the multiple time increments, and to terminate the electrolytic separation cycle at the end of the time increment in which it is determined that a successful electrolytic separation event has occurred.

[0056] In another embodiment, the electrolytic separation device is configured to determine whether an electrolytic anomaly occurred during the supply of current to the electrolytically severable joint, and to extend the electrolytic separation cycle only if it is determined that an electrolytic anomaly did not occur during the supply of current to the electrolytically severable joint. For example, if the electrical parameter information includes measured electrolytic work values ​​performed by the current supply circuit, the electrolytic separation device may be configured to determine that an electrolytic anomaly occurred during the supply of current to the electrolytically severable joint if the measured electrolytic work value is outside an electrolytic work value range defined by a minimum electrolytic work limit value and a maximum electrolytic work limit value.

[0057] In yet another embodiment, the electrolytic separation device may be configured to track the number of completed electrolytic separation cycles, in which case the electrolytic separation device may be configured not to extend the electrolytic separation cycles if the tracked number of completed electrolytic separation cycles exceeds a preset number of electrolytic separation cycles.

[0058] According to a sixth aspect of the present invention, the electrolytic separation device is configured to incrementally measure the electrolytic work performed by the electrolytic separation device over time (e.g., by incrementally measuring the cumulative current supplied by the electrolytic separation device over time), thereby generating a plurality of measured electrolytic work values, and the electrolytic separation device is further configured to incrementally increase the electrolytic work threshold over time to generate a plurality of electrolytic work thresholds, compare the plurality of measured electrolytic work values ​​with the plurality of electrolytic work thresholds, respectively, and evaluate whether a successful electrolytic separation event has occurred based on the comparison results.

[0059] In accordance with the present invention, a method is provided for occluding a patient's vasculature using a vaso-occlusion assembly, the vaso-occlusion assembly comprising a delivery wire and a vaso-occlusion device (e.g., a vaso-occlusion coil) detachably connected to a distal end of the delivery wire via an electrolytically severable joint.

[0060] The method includes the steps of: introducing the configured delivery catheter into a patient's vasculature; disposing a vaso-occlusive assembly within the delivery catheter such that the vaso-occlusive device is positioned outside the delivery catheter within the patient's vasculature (e.g., an aneurysmal sac of the patient's vasculature); electrically connecting a proximal end of a delivery wire of the vaso-occlusive assembly to a power source; applying current from the power source to an electrolytically severable joint of the vaso-occlusive assembly while the vaso-occlusive device is positioned within the patient's vasculature; generating electrical parameter information indicative of a successful electrolytic detachment event (e.g., a measured cumulative electrical parameter, such as a measured cumulative current, or a measured electrolytic work performed by the power source); and evaluating whether a successful electrolytic detachment event has occurred based on the generated electrical parameter information. One method further includes contacting a ground electrode to the patient and electrically connecting the ground electrode to the power source such that current is applied between the delivery wire and the ground electrode. Another method further includes generating a first user-identifiable notification if it is determined that a successful electrolytic detachment event has occurred, and generating a second user-identifiable notification different from the first user-identifiable notification if it is determined that a successful electrolytic detachment event has not occurred. In yet another method, electrical current is supplied to the electrolytically severable joint during an electrolytic separation cycle and to the electrolytically severable joint during another electrolytic separation cycle.

[0061] According to a seventh aspect of the present invention, the method further includes measuring an elapsed time between a delivery wire separation event and a subsequent delivery wire connection event, and resetting the electrical parameter information if the measured elapsed time reaches a first elapsed time threshold (e.g., 3 seconds or more, e.g., in the range of 25 to 45 seconds).

[0062] In one method, the electrical parameter information is reset when the measured elapsed time reaches a first elapsed time threshold and a successful electrolytic separation event is evaluated to have occurred, and the electrical parameter information is reset when the measured elapsed time reaches a second elapsed time threshold that is greater than the first elapsed time threshold and a successful electrolytic separation event is evaluated not to have occurred, where the first elapsed time threshold is, for example, in the range of 3 to 10 seconds and the second elapsed time threshold is, for example, in the range of 25 to 45 seconds.

[0063] In one example, the method further includes disposing a separate vaso-occlusive assembly within the delivery catheter, wherein both the vaso-occlusive device and the separate vaso-occlusive device are disposed outside the delivery catheter within the patient's vasculature, the separate vaso-occlusive assembly including a delivery wire and a vaso-occlusive device detachably connected to a distal end of the delivery wire via an electrolytically severable junction. The method further includes, after evaluating whether a successful electrolytic detachment event has occurred, electrically connecting a proximal end of the delivery wire of the separate vaso-occlusive assembly to a power source, and resetting the electrical parameter information after the proximal end of the delivery wire of the separate vaso-occlusive assembly is electrically connected to the power source.

[0064] According to an eighth aspect of the present invention, while the vaso-occlusive device is positioned within the vasculature of a patient, an electrical current is supplied from a power source to an electrolytically severable joint of the vaso-occlusive assembly during an electrolytic separation cycle having a fixed duration, the method including the steps of evaluating whether a successful electrolytic separation event has occurred during the fixed duration of the electrolytic separation cycle based on the generated electrical parameter information, and extending the electrolytic separation cycle only if it is evaluated that a successful electrolytic separation event has not occurred during the fixed duration.

[0065] In one method, the fixed period is an initial fixed period, in which case the electrolytic separation cycle can be extended by a subsequent variable time. The method can further include incrementally evaluating whether a successful electrolytic separation event has occurred during the subsequent variable period, and terminating the electrolytic separation cycle when it is determined that a successful electrolytic separation event has occurred. The subsequent variable period can have multiple time increments, each time increment being shorter than the initial fixed period of the electrolytic separation cycle, in which case it is incrementally evaluated whether a successful electrolytic separation event has occurred during each of the multiple time increments, and the electrolytic separation cycle is terminated at the end of the time increment in which it is determined that a successful electrolytic separation event has occurred.

[0066] Another method further includes determining whether an electrolytic anomaly occurred during the supply of current to the electrolytically severable joint, in which case the electrolytic separation cycle is extended only if it is determined that an electrolytic anomaly did not occur during the supply of current to the electrolytically severable joint. For example, if the electrical parameter information includes a measured electrolysis work value performed by the power supply, it may be determined that an electrolysis anomaly occurred during the supply of current to the electrolytically severable joint when the measured electrolysis work value is outside an electrolysis work value range defined by a minimum electrolysis work limit value and a maximum electrolysis work limit value.

[0067] Yet another method further includes tracking the number of completed electrolytic separation cycles, wherein the electrolytic separation cycles are not extended when the tracked number of completed electrolytic separation cycles exceeds a preset limit number of electrolytic separation cycles.

[0068] According to a ninth aspect of the present invention, the method includes the steps of incrementally measuring the electrolytic work performed by the power source over time (e.g., by incrementally measuring the cumulative current supplied by the power source over time), thereby generating a plurality of measured electrolytic work values; incrementally increasing an electrolytic work threshold over time, thereby generating a plurality of electrolytic work thresholds; comparing the plurality of measured electrolytic work values ​​with a plurality of electrolytic work thresholds, respectively; and assessing whether a successful electrolytic separation event has occurred based on the comparison results.

[0069] Other and further aspects and features of the embodiments will become apparent from the following detailed description, taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0070] The drawings illustrate the design and utility of preferred embodiments of the disclosed invention, with similar elements designated by common reference numerals. Note that the drawings are not drawn to scale, and elements of similar structure or function are designated by similar reference numerals throughout the drawings. Note also that the drawings are intended only to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention, nor are they intended to limit the scope of the invention, which is defined solely by the appended claims and their equivalents. Furthermore, an exemplary embodiment of the disclosed invention need not possess all disclosed aspects or advantages. Furthermore, an aspect or advantage described in connection with a particular embodiment of the disclosed invention is not necessarily limited to that embodiment, and may be implemented in any other embodiment, even if not so shown.

[0071] In order to better understand how the above-mentioned and other advantages and objects of the disclosed invention are obtained, a more particular description of the briefly above-disclosed invention will be rendered by reference to specific embodiments thereof which are illustrated in the accompanying drawings, the invention being described and explained with additional specificity and detail using the accompanying drawings, with the understanding that the drawings illustrate only typical embodiments of the invention and are therefore not to be considered as limiting its scope. [Figure 1] FIG. 1 is a plan view of an electrolytic separation procedure performed by a conventional electrolytic separation device to electrolytically separate a vaso-occlusive device from a delivery wire. [Figure 2] FIG. 2 is a plan view of another electrolytic separation procedure performed by a conventional electrolytic separation device to electrolytically separate a vaso-occlusive device from a delivery wire. [Figure 3] FIG. 3 is a plan view of a vaso-occlusive treatment system constructed in accordance with one embodiment of the disclosed invention, particularly showing a vaso-occlusive device in a delivery configuration. [Figure 4] FIG. 4 is a plan view of the vaso-occlusive treatment system of FIG. 3, particularly showing the vaso-occlusive device in a deployed configuration. [Figure 5] 5 is an enlarged, partially cut-away cross-sectional view of the distal end of the vaso-occlusion assembly of the vaso-occlusion treatment system of FIG. 3. FIG. [Figure 6] 6 is a cross-sectional view of the single lumen delivery catheter and vascular occlusion assembly of the vascular occlusion treatment system of FIG. 3. [Figure 7] 7 is a cross-sectional view of an alternative embodiment of a dual lumen delivery catheter and two vascular occlusion assemblies usable in the vascular occlusion treatment system of FIG. 3. [Figure 8] 8 is a top view of the handheld electrolytic separation device of the vascular occlusion treatment system of FIG. 3. FIG. [Figure 9] FIG. 9 is a block diagram of the electronic components included in the handheld electrolytic separation device of FIG. [Figure 10]FIG. 10 is a plan view illustrating the delivery of a vaso-occlusive device into an aneurysm sac of a patient using the vaso-occlusive treatment system of FIG. 3, prior to electrolytic detachment of the vaso-occlusive device from the delivery wire. [Figure 11] FIG. 11 is a plan view illustrating the delivery of a vaso-occlusive device into a patient's aneurysm sac using the vaso-occlusive treatment system of FIG. 3, showing the state after electrolytic detachment of the vaso-occlusive device from the delivery wire. [Figure 12] FIG. 12 is a plan view of an extended electrolytic separation cycle performed by the handheld electrolytic separation device of FIG. [Figure 13] 13A-13G are plan views of progressively extended electrolytic separation cycles performed by the handheld electrolytic separation device of FIG. [Figure 14] FIG. 14 is one sequence of an electrolytic separation cycle that may be performed by the handheld electrolytic separation device of FIG. [Figure 15] FIG. 15 is another sequence of an electrolytic separation cycle that may be performed by the handheld electrolytic separation device of FIG. [Figure 16] FIG. 16 is a plan view of an extended electrolytic separation cycle performed by the handheld electrolytic separation device of FIG. 8, particularly showing the timing of the sequence of electrolytic separation event evaluations performed during the extended electrolytic separation cycle. [Figure 17] FIG. 17 is a timing diagram illustrating the incrementally increasing electrolytic work threshold over time used by the handheld electrolytic separation device of FIG. 8 in assessing the occurrence of an electrolytic separation event during an extended electrolytic separation cycle. [Figure 18] FIG. 18 is a plot showing the fit of the step-increasing electrolytic work thresholds of FIG. 17 to the experimental electrolytic separation points. [Figure 19] FIG. 19 is a flow diagram illustrating one method of performing an electrolytic separation procedure with the handheld electrolytic separation device of FIG. [Figure 20]FIG. 20 is a flow diagram illustrating another method of performing an electrolytic separation procedure with the handheld electrolytic separation device of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0072] The present disclosure relates to electrolytic separation devices for use in vaso-occlusive treatment systems that deliver vaso-occlusive devices (e.g., vaso-occlusive coils) into a patient's vasculature (e.g., into an aneurysm sac) via an electrolytic separation procedure.

[0073] The electrolytic detachment devices described herein minimize the number of electrolytic detachment cycles (and accompanying fluoroscopic visualization confirmation) required to successfully electrolytically detach a given vaso-occlusive coil from a delivery wire, and can minimize the number of false-positive electrolytic detachments, prompting the physician to take corrective action if necessary.

[0074] In particular, if a successful electrolytic detachment event (i.e., electrolytic detachment of the vaso-occlusive device from the delivery wire) has not been detected and reported at the end of an electrolytic detachment cycle, the electrolytic detachment device automatically extends such electrolytic detachment cycle (if extending the cycle is assessed to facilitate electrolytic detachment of the vaso-occlusive device from the delivery wire), predicting that a successful electrolytic detachment event will occur soon without manipulating the delivery wire to change the environmental electrolytic conditions to a favorable state. In this manner, an extended electrolytic detachment cycle can have an initial fixed duration followed by a variable duration. Such an electrolytic detachment cycle can be extended incrementally by multiple time increments, each time increment being significantly shorter than the duration by which the electrolytic detachment cycle is extended. In this manner, electrolytic detachment of the vaso-occlusive device from the delivery wire can be assessed during each time increment, and if a successful electrolytic detachment event is assessed to have occurred, the extended electrolytic detachment cycle is promptly terminated (i.e., the electrolytic detachment cycle is not further extended). In some embodiments, the electrolytic detachment device can extend multiple electrolytic detachment cycles up to a certain limit, beyond which such extension is deemed not beneficial.

[0075] The length of the initial fixed period of the extended electrolytic separation cycle can be selected (e.g., 5 seconds) to minimize the possibility of false-positive electrolytic separation (i.e., by setting a minimum time for which current is supplied by the electrolytic separation device). In other words, if a successful electrolytic separation event is detected and reported, the initial fixed period of the extended electrolytic separation cycle functions as a fixed electrolytic separation cycle, with its advantages, and such an electrolytic separation cycle is not automatically extended. The length of the subsequent variable period of the extended electrolytic separation cycle can be selected to be long enough (e.g., up to 5 seconds) to result in a significant number of successful electrolytic separation events that did not occur during the initial fixed period of the extended electrolytic separation cycle, while being short enough to allow the extended electrolytic separation cycle to be completed within a reasonable time if continuing the extended electrolytic separation cycle is futile due to unfavorable environmental electrolytic conditions. Thus, it will be appreciated that if a successful electrolytic separation event that did not occur during the initial fixed period of an extended electrolytic separation cycle occurs within a variable time period of a subsequent electrolytic separation cycle, the physician will not be prompted to take corrective action when not necessary, but will only be prompted to perform a single fluoroscopic confirmation check when a successful electrolytic separation event is reported, thereby shortening the duration of the electrolytic separation procedure. By providing an upper limit on the extended electrolytic separation cycle, the extended electrolytic separation cycle will eventually terminate, thereby prompting the physician to take corrective action when necessary.

[0076] The electrolytic separation devices described herein can also automatically reset electrolytic separation detection information (i.e., information used to evaluate whether a successful electrolytic separation event has occurred) only if a successful electrolytic separation event is deemed to have actually occurred. Such a successful electrolytic separation event can be deemed to have occurred based on the measured elapsed time between a delivery wire detachment event (i.e., the time when the delivery wire is detached from the electrolytic separation device) and a subsequent delivery wire connection event (i.e., the time when the delivery wire is connected to the electrolytic separation device (either the current delivery wire is reconnected or a new delivery wire is connected)). In essence, the electrolytic separation device uses such measured elapsed time as a surrogate indicator for a physician's treatment of whether a successful electrolytic separation event has occurred. Such measured elapsed time can be compared to one or more elapsed time thresholds, and a successful electrolytic separation event can be deemed to have occurred if the measured elapsed time reaches the elapsed time thresholds.

[0077] In one embodiment, the measured elapsed time between a delivery wire detachment event and a subsequent delivery wire attachment event can be compared to a single elapsed time threshold, regardless of whether a successful electrolytic detachment event was detected and reported.

[0078] In this case, if the measured elapsed time between the delivery wire detachment event and the subsequent delivery wire attachment event is less than the elapsed time threshold, the physician visually assesses via fluoroscopy that a successful electrolytic separation event has not occurred and possibly takes additional corrective action, either quickly reconnecting the proximal end of the delivery wire to the electrolytic separation case, or the physician quickly disconnects the proximal end of the delivery wire from the electrolytic separation device and reconnects it to the electrolytic separation device before initiating the next electrolytic separation cycle of the current vaso-occlusion device (i.e., a double operation event occurs). In those cases (i.e., when the physician performs a fluoroscopic check and / or takes corrective action, or when the physician performs a double operation event), the measured elapsed time does not reach the elapsed time threshold. As a result, the electrolytic separation device does not automatically reset the electrolytic separation detection information, thereby minimizing the possibility of a false-negative electrolytic separation being detected and reported for the current vascular occlusion device at the end of the next electrolytic separation cycle (in the case of a fluoroscopic check and / or corrective action, or a double operation event), or preventing a misleading false-negative electrolytic detection from being detected and reported after a true-positive electrolytic detection has already been detected and reported (in the case of a double operation event).

[0079] On the other hand, if the measured elapsed time between a delivery wire detachment event and a subsequent delivery wire connection event reaches an elapsed time threshold, the electrolytic separation device assumes that the physician has assessed the occurrence of a successful electrolytic separation event through fluoroscopic visualization, loaded a new delivery wire with a new vasoocclusion device into the delivery catheter, and then connected the new delivery wire to the electrolytic separation device. Therefore, the electrolytic separation device automatically resets the electrolytic separation detection information for the new vasoocclusion device. Therefore, the single elapsed time threshold should be selected to temporally distinguish between a simple fluoroscopic visualization check and a fluoroscopic visualization check followed by the loading of a delivery wire with a new vasoocclusion coil into the delivery catheter. For example, such a single elapsed time threshold can be in the range of 25 to 45 seconds, e.g., 30 seconds.

[0080] In another embodiment, the measured elapsed time between a delivery wire detachment event and a subsequent delivery wire attachment event can be compared to two different elapsed time thresholds depending on whether a successful electrolytic detachment event was detected and reported.

[0081] In particular, if a successful electrolytic detachment event has been detected and reported, the electrolytic separation device assumes that the physician quickly disconnected and then reconnected the proximal end of the delivery wire from the electrolytic separation device (i.e., a double operation event has occurred) before initiating the next electrolytic detachment cycle for the current vasoocclusion device if the measured elapsed time between the delivery wire detachment event and the subsequent delivery wire connection event is less than a relatively short elapsed time threshold. Therefore, the electrolytic separation device does not automatically reset the electrolytic detachment detection information to prevent a misleading false-negative electrolytic detection from being detected and reported after a true-positive electrolytic detection has already been detected and reported. On the other hand, if the measured elapsed time between the delivery wire detachment event and the subsequent delivery wire connection event reaches a relatively short elapsed time threshold, the electrolytic separation device assumes that the physician did not disconnect and reconnect the delivery wire with the current vasoocclusion device from the electrolytic separation device (i.e., a double operation event has not occurred) and instead assumes that the physician performed a fluoroscopic visualization check (with or without loading one or more new vasoocclusion devices into the delivery catheter). Therefore, the electrolytic separation device automatically resets the electrolytic detachment detection information for the new vasoocclusion device. In the embodiments described below, a relatively short elapsed time threshold is selected to distinguish between quickly connecting and reconnecting the same delivery wire to an electrolytic isolation device and performing a fluoroscopic visualization check. For example, such a relatively short elapsed time threshold can be 3 to 10 seconds, e.g., 5 seconds.

[0082] If a successful electrolytic detachment event is not detected and reported, the electrolytic separation device assumes that the physician visually confirmed via fluoroscopy that a successful electrolytic detachment event did not occur, possibly performed additional corrective action, and quickly reconnected the proximal end of the delivery wire to the electrolytic separation case if the measured elapsed time between the delivery wire detachment event and the subsequent delivery wire connection event is less than the elapsed time threshold. In this case, the measured elapsed time would not have reached the relatively long elapsed time threshold. Therefore, the electrolytic separation device does not automatically reset the electrolytic detachment detection information, thereby minimizing the possibility of detecting and reporting a false-negative electrolytic detachment for the current vasoocclusion device at the end of the next electrolytic separation cycle. On the other hand, if the measured elapsed time between the delivery wire detachment event and the subsequent delivery wire connection event reaches the relatively long elapsed time threshold, the electrolytic separation device assumes that the physician visually confirmed via fluoroscopy that a successful detachment event did occur, loaded a new delivery wire and a new vasoocclusion device into the delivery catheter, and then coupled the new delivery wire to the electrolytic separation device. Therefore, the electrolytic separation device automatically resets the electrolytic detachment detection information for the new vasoocclusion device. Therefore, a relatively long elapsed time threshold should be selected to distinguish between a mere fluoroscopic visualization check and the subsequent loading of the delivery wire and new vaso-occlusive coil into the delivery catheter. For example, such a relatively long elapsed time threshold may be in the range of 25 to 45 seconds, e.g., 30 seconds.

[0083] The electrolytic separation devices described herein can also minimize the likelihood of false-positive electrolytic separations based on measurements of the electrolytic work performed by the electrolytic separation device (i.e., as indicated by the measured cumulative current). In particular, the electrolytic separation device can incrementally increase an electrolytic work threshold (e.g., a cumulative current threshold) over time and compare it to a measured electrolytic work value to assess whether a successful electrolytic separation event has occurred. The electrolytic work threshold can be incrementally increased over an entire electrolytic separation cycle or a portion thereof (e.g., at the beginning of each variable period of an extended electrolytic separation cycle), and the measured electrolytic work value can be compared to the increased electrolytic work threshold at the end of the electrolytic separation cycle to assess whether an electrolytic separation event has occurred. In this way, the incremental increase in the electrolytic work threshold corresponds to the increase in electrolytic work required to successfully separate the vaso-occlusive device from the delivery wire, thereby reducing the detection and reporting of false-positive electrolytic separations.

[0084] 3-6, one embodiment of a vascular occlusion treatment system 10 constructed in accordance with the disclosed invention is described. The vascular occlusion treatment system 10 includes a delivery catheter 12, a vaso-occlusion assembly 14 slidably disposed within the delivery catheter 12, a ground electrode 16 configured for placement in contact with a patient, an electrical cable 18 configured for removably attachment to the ground electrode 16, and a power source in the form of an electrolytic separation device 20 to which the vaso-occlusion assembly 14 is removably attached and to which the ground electrode 16 is removably attached via the electrical cable 18. As described in further detail below, the vaso-occlusion assembly 14 includes a delivery wire 22 and a vaso-occlusion device 24 detachably connected to the delivery wire 22 via an electrolytically severable junction 26.

[0085] The delivery catheter 12 has a tubular configuration and can take the form of, for example, a microcatheter, a sheath, or the like. The delivery catheter 12 includes an elongate sheath body 28 having a proximal portion 30 and a distal portion 32, and an inner lumen 34 (shown partially in phantom) extending through the sheath body 28 between the proximal portion 30 and the distal portion 32, with the vascular occlusion assembly 14 housed within the inner lumen. The free end of the proximal portion 30 of the sheath body 28 remains outside the patient's body and is accessible to an operator (e.g., a clinician or physician), while the remainder of the sheath body 28, including the distal portion 32, is sized and dimensioned to reach remote locations in the patient's vasculature. The sheath body 28 has a length suitable for accessing a target tissue site within the patient's body from a vascular access point. The target tissue site will vary depending on the medical procedure for which the delivery catheter 12 is being used. For example, if the delivery catheter 12 is used to access the vasculature in a patient's brain through a femoral artery access point in the patient's groin, the overall length of the sheath body 28 may be between 125 cm and 200 cm. The outer diameter of the sheath body 28 may be within a range of 3F to 10F. In one embodiment, the outer diameter of the sheath body 28 may be uniform along its entire length. In another embodiment, the outer diameter of the sheath body 28 tapers gradually or in steps from a first outer diameter at the proximal portion 30 to a second outer diameter at the distal portion 32, thereby facilitating navigation through tortuous vasculature. While the sheath body 28 is depicted as having a generally circular cross-sectional shape, it should be understood that the sheath body 28 may include other cross-sectional shapes or combinations of shapes, such as an oval, a rectangle, a triangle, a polygon, or the like.

[0086] The delivery catheter 12 can include one or more regions or regions along its length having different configurations and / or properties. For example, the outer diameter of the distal section 32 of the sheath body 28 can be smaller than the outer diameter of the proximal section 30 of the sheath body 28, thereby reducing the profile of the distal section 32 and facilitating navigation through tortuous vasculature. Additionally, the distal section 32 can be more flexible than the proximal section 30. Generally, the proximal section 30 is formed of a stiffer material than the distal section 32 of the sheath body 28, providing sufficient pushability for advancement through a patient's vasculature, while the distal section 32 is formed of a more flexible material, allowing the distal section 32 to remain flexible and more easily track over a guidewire to access remote sites within tortuous regions of the vasculature. The sheath body 28 can be constructed from a suitable polymeric material, metal and / or alloy, such as polyethylene, stainless steel, other suitable biocompatible materials, or a combination thereof. In some cases, the proximal portion 30 may include a reinforcing layer, such as a braided or coiled layer, to enhance the pushability of the sheath body 28. The sheath body 28 may include a transition region between the proximal portion 30 and the distal portion 32.

[0087] The delivery catheter 12 includes a distal port 36 that communicates with the inner lumen 34 of the delivery catheter 12, through which the vaso-occlusive device 24 is deployed. The delivery catheter 12 further includes a proximal adapter 38 that is secured to the proximal portion 30 of the sheath body 28 using suitable means, such as adhesive, welding, or the like. The proximal adapter 38 includes a central bore 40 (shown in phantom) that communicates with the lumen 34 of the delivery catheter 12. The central bore 40 terminates in a proximal port 42 for loading the vaso-occlusive assembly 14 into the delivery catheter 12. The proximal adapter 38 further includes a side port 44 in fluid communication with the central bore 40, which side port can be used to introduce fluid into the inner lumen 34 of the delivery catheter 12, e.g., into the vaso-occlusion assembly 14, introduce contrast agent into the patient's vasculature, and / or introduce saline into the patient's vasculature to flush out contrast agent, e.g., prior to electrolytic isolation and delivery of the vaso-occlusion device 24 into the patient's vasculature.

[0088] The delivery catheter 12 further includes one or more radiopaque marker bands 46 (in this case, two distal bands 46a and a proximal band 46b) located near the distal port 36 of the distal section 32 of the delivery catheter 12, which marker bands can be identified using medical imaging techniques (e.g., fluoroscopy). The distal band 46a can be used to position the distal tip of the delivery catheter 12 within the patient's vasculature, while the proximal band 46b can be used to position the delivery catheter 12 relative to the partially or fully deployed vaso-occlusive device 24. As a result, the delivery catheter 12 and the delivery wire 22 can be longitudinally aligned, thereby ensuring that the electrolytically severable junction 26 is positioned immediately distal to the distal port 36 of the delivery catheter 12 and in contact with bodily fluids within the patient's vasculature, facilitating electrolytic separation of the vaso-occlusive device 24 from the delivery wire 22, as described in more detail below. The radiopaque marker band 46 may be constructed of any suitable radiopaque material, such as gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, or the like.

[0089] As shown in FIG. 7, an alternative embodiment of a delivery catheter 12′ is similar to the delivery catheter 12 shown in FIG. 6, except that the delivery catheter 12′ includes two inner lumens 34′ into which two vascular occlusion assemblies 14 can be respectively positioned, and two distal ports (not shown) into which the two vascular occlusion assemblies 14 can respectively be deployed.

[0090] Generally, the vaso-occlusive device 24 has a delivery configuration when constrained within the delivery catheter 12 (FIG. 3) (or alternatively, the delivery catheter 12′), and a deployed configuration that conforms to the internal shape of the aneurysm sac 100 (FIGS. 10 and 11) when deployed from the delivery catheter 12 (FIG. 4) (or alternatively, the delivery catheter 12′) into the aneurysm sac 100. The vaso-occlusive device 24 can be pre-biased to form a cylindrical, conical, or other desired shape. The vaso-occlusive device 24 is highly flexible, and its overall shape can be easily deformed. In the illustrated embodiment, the vaso-occlusive device 24 is shown as a helical coil formed from wire having a suitable diameter, e.g., 2 to 6 mils. The diameter of the vaso-occlusive device 24 in the delivery configuration can be, e.g., 10 to 30 mils. The length of the vaso-occlusive device 24 can be any desired and appropriate length, e.g., 1 to 50 cm, depending on the site to be occluded. In alternative embodiments, the vaso-occlusive device 24 can take the form of a structure other than a coil, e.g., a braid. The vaso-occlusive device 24 may optionally be covered with or connected to a fibrous material tied to the outside of the coil or braid. The vaso-occlusive device 24 may be constructed of a suitable biocompatible, radiopaque material, such as platinum, gold, tungsten, iridium, or alloys thereof, or other metals. In the illustrated embodiment, the vaso-occlusive device 24 has an end cap or tip that prevents puncture of the aneurysm sac 100 when delivered therein.

[0091] The delivery wire 22 may be a coil, wire, tendon, or the like (e.g., a conventional guidewire, a torqueable cable tube, or a hypotube) that has sufficient column strength to push the vaso-occlusive device 24 into the aneurysm sac 100. The delivery wire 22 may have an appropriate outer diameter (e.g., 10-30 mils) and an appropriate length (e.g., 50-300 cm). The materials used to construct the delivery wire 22 are selected to impart different flexibility and stiffness characteristics to different portions of the delivery wire 22. For example, the delivery wire 22 may be formed of different materials along its length, e.g., materials with different elastic moduli, resulting in differential flexibility.

[0092] In the illustrated embodiment, the delivery wire 22 generally comprises a core wire 48 constructed of an electrically conductive material, such as stainless steel, and a sleeve 50 constructed of an electrically insulating material, such as polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, or other suitable polymeric material. The core wire 48 has a proximal section 52 extending proximally from the proximal section 30 of the delivery catheter 12 for manipulation by a physician, a distal section 54 to which the vaso-occlusive device 24 is attached, and an intermediate section 56 located between the proximal section 52 and the distal section 54. The proximal section 52 of the core wire 48 is enlarged to ergonomically facilitate manipulation of the delivery wire 22 by a physician. The proximal section 52 of the core wire 48 tapers distally to the intermediate section 56. The distal section 54 of the core wire 48 extends from the intermediate section 56 and further tapers distally to provide flexibility to the distal end of the delivery wire 22. The delivery wire 22 can include a coil (not shown) secured around the distal portion 54 of the core wire 48, thereby providing some column strength to the distal end of the delivery wire 22 without adversely affecting the flexibility of the tapered distal portion 54 of the core wire 48. The sleeve 50 is disposed over the distal portion 54 of the core wire 48 and serves to electrically insulate the portion of the distal portion 54 of the core wire 48 proximal to the electrolytically severable junction 26 and the coil of the delivery wire 22 from blood in the patient's vasculature, as described below. The delivery wire 22 further includes a radiopaque marker band 58 disposed on the sleeve 50, which can be identified using medical imaging techniques (e.g., fluoroscopy). The marker band 58 can be used to position the delivery catheter 12 relative to a partially or fully deployed vaso-occlusive device 24 (by aligning it with the proximal marker 46b on the delivery catheter 12), thereby longitudinally aligning the delivery catheter 12 and delivery wire 22, thereby ensuring that the electrolytically severable junction 26 is positioned just distal to the distal port 36 of the delivery catheter 12 and in contact with bodily fluids within the patient's vasculature, so that the vaso-occlusive device 24 can be easily electrolytically separated from the delivery wire 22, as described below.The radiopaque marker band 58 may be constructed from any suitable radiopaque material, such as, for example, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like.

[0093] The vaso-occlusive device 24 is secured to the distal portion 56 of the core wire 48 via an electrolytically resistant bushing 60. The electrolytically severable joint 26 is in the form of an electrolytically degradable segment for separating the vaso-occlusive device 24 from the delivery wire 22 by electrolysis and is located on the core wire 48 between the electrically insulating sleeve 50 and the vaso-occlusive device 24. Thus, when current is applied to the core wire 48, the current flows through the electrolytically severable joint 26. However, because the electrolytically severable joint 26 is not electrically insulated, it is more susceptible to electrolytic dissolution in blood than the portion of the core wire 48 covered by the electrically insulating sleeve 50 and the vaso-occlusive device 24. Thus, the electrolytically severable joint 26 will substantially or completely dissolve upon release of the vaso-occlusive device 24. Preferably, the length of the electrolytically severable joint 26 is not significantly greater than the diameter of the electrolytically severable joint 26. For example, the length of the electrolytically severable joint 26 can be as short as 0.010 inches, and typically 0.15 inches or less.

[0094] In the illustrated embodiment, the ground electrode 16 takes the form of a metal clip configured to be removably attached to a hypodermic needle (not shown) that is inserted percutaneously into the patient's body, for example, into the patient's thigh or groin, and the ground electrode 16 is electrically connected to the patient to complete an electrical circuit electrically connecting the vaso-occlusion assembly 14 and the ground electrode 16 through the electrically conductive patient.

[0095] 8, electrolytic separation device 20 can be manipulated by a physician to perform an electrolytic separation procedure. Electrolytic separation device 20 includes an outer case 62, a power terminal 64 to which core wire 48 is electrically connected, a ground terminal 66 to which ground electrode 16 is electrically connected via electrical cable 18, electronic components 68 (shown in FIG. 9) housed within outer case 62 for supplying electrical current to electrolytically severable joint 26 of vaso-occlusion assembly 14 in a controlled manner, and an electrolytic separation actuator 70 secured to outer case 62 for manually initiating the flow of electrical current from electrolytic separation device 20 to electrolytically severable joint 26 of vaso-occlusion assembly 14.

[0096] The outer case 62 is constructed of a suitable material, such as acrylonitrile butadiene styrene (ABS) or polycarbonate, and is shaped and sized to be ergonomically held in one hand by a physician. In the illustrated embodiment, the power terminal 64 takes the form of a port (e.g., a funnel) through which the proximal portion 52 of the core wire 48 can be selectively inserted and removed, while the ground terminal 66 takes the form of a port through which a corresponding plug 88 ( FIGS. 3 and 4 ) of the electrical cable 18 can be selectively inserted and removed. Inserting the proximal portion 52 of the core wire 48 into the power port 64 (or, broadly, connecting the delivery wire 22 to the power terminal 64) constitutes a “delivery wire connection event,” while removing the proximal portion 52 of the core wire 48 from the power port 64 (or, broadly, disconnecting the delivery wire 22 from the power terminal) constitutes a “delivery wire separation event.” As described in further detail below, electronics 68 is configured to supply current to electrolytically severable joint 26 of vaso-occlusive assembly 14 during one or more electrolytic detachment cycles until vaso-occlusive device 24 electrolytically detaches from delivery wire 22, and to report various events occurring during the electrolytic detachment procedure to the physician.

[0097] In the illustrated embodiment, the electrolytic separation actuator 70 takes the form of a push button that can be pressed to manually instruct the electrolytic separation device 20 to perform an electrolytic separation cycle (i.e., a period of time during which current is supplied from the electronics 68 to the electrolytically severable joints 26 of the vaso-occlusive assembly 14). A single actuation (i.e., a quick press and release) of the push button 70 initiates an electrolytic separation cycle. The push button 70 can be actuated multiple times to initiate a series of electrolytic separation cycles. That is, the push button 70 is actuated to initiate a first electrolytic separation cycle, and after the first electrolytic separation cycle is completed, the push button 70 is actuated again to initiate a second electrolytic separation cycle, and after the second electrolytic separation cycle is completed, the push button 70 is actuated again to initiate a third electrolytic separation cycle, and so on.

[0098] Referring to FIG. 9, the electronics 68 generally include a controller 72, a power supply 74, a current supply circuit 76, an electrolytic isolation detection circuit 78, a timer 80, a counter 82, a memory 84, and a plurality of indicators 86.

[0099] The controller 72 is configured to perform various functions of the electrolytic separation device 20, including performing electrolytic separation cycles by operating the current supply circuit 76 to initiate and terminate the supply of current to the vaso-occlusion assembly 14, evaluating the occurrence of a successful electrolytic separation event based on electrical parameter information generated by the electrolytic separation detection circuit 78 and stored in memory 84, and notifying a physician of events related to the operation of the electrolytic separation device 20 and events that occur during an electrolytic separation cycle (e.g., the occurrence or non-occurrence of a successful electrolytic separation event). The controller 72 may also be configured to monitor the operation of the electronic components 68 (e.g., by monitoring the status of various nodes or other points in the electronic components 68, e.g., power supply voltage, temperature, battery voltage, etc.) and perform self-diagnostic tests on the electronic components 68. Importantly, as described in more detail below, the controller 72 is also configured to extend the electrolytic separation cycle under certain conditions, reset the electrical parameter information stored in memory 84, including the measured electrolytic work value (indicated by the measured cumulative current), under certain conditions, and adjust the electrolytic work threshold (in this case, the cumulative current threshold) during or between adjacent electrolytic separation cycles.

[0100] The functions of controller 72 may be performed using one or more suitable computing devices or digital processors, including, but not limited to, a microcontroller, a microprocessor, a digital signal processor, a graphics processing unit, a central processing unit, an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), and / or a programmable logic unit (PLU). Such computing devices or digital processors may be associated with non-transitory computer- or processor-readable media that store executable logic or instructions and / or data or information that, when executed, perform the functions of those components. The non-transitory computer- or processor-readable media may be formed, for example, as one or more registers of the microprocessor, FPGA, or ASIC, or may be a type of computer-readable medium, i.e., a computer-readable storage medium.

[0101] Power supply 74 is configured to store and provide electrical power to electronic components 68. Power supply 74 may be, for example, a non-rechargeable battery having an expected life of a certain number of electrolytic separation cycles (e.g., 20 cycles) that powers electronic components 68, although in alternative embodiments, the power supply may be, for example, a rechargeable battery (e.g., a lithium ion battery or a lithium ion polymer battery).

[0102] The current supply circuit 76 is configured to supply current to the vaso-occlusion assembly 14. The current supply circuit 76 is electrically connected between the power port 64 (FIG. 8) to which the vaso-occlusion assembly 14 is electrically connected and the ground port 66 (FIG. 8) to which the ground electrode 16 is electrically connected, and is configured to supply a certain amperage (e.g., 0.5 mA or 1.0 mA) of current to the vaso-occlusion assembly 14. To that end, the current supply circuit 76 may include one or more current sources, a patient isolation capacitor, or the like.

[0103] The electrolytic detachment detection circuit 78 is configured to measure electrical parameters that generate electrical parameter information indicative of a successful electrolytic detachment event, and in particular, is configured to measure the electrolytic work performed by the current supply circuit 76 (in this case, the cumulative current supplied to the vasoocclusion assembly 14 by the current supply circuit 76). The electrolytic detachment detection circuit 78 is electrically connected between the power supply port 64 (FIG. 8) to which the vasoocclusion assembly 14 is electrically connected and the ground port 66 (FIG. 8) to which the ground electrode 16 is electrically connected, and can take the form of any prior art circuit capable of measuring the instantaneous amperage of current over time. The controller 74 can derive a value of the cumulative current supplied to the vasoocclusion assembly 14 by the current supply circuit 76 (i.e., a value of the electrolytic work performed by the current supply circuit 76) by integrating with respect to time the instantaneous amperage of current measured by the electrolytic detachment detection circuit 78.

[0104] Timer 80 is configured to measure the elapsed time between a delivery wire connection event and a subsequent delivery wire separation event, while one of counters 82 is configured to track the number of electrolytic separation cycles extended by electrolytic separation device 20, and another of counters 82 is configured to count the number of time increments of extended electrolytic separation cycles, as described below. Although timer 80 and counter 82 are shown as being external to controller 72, in alternative embodiments, either timer 80 or counter 82, or both, are internal to controller 76.

[0105] Memory 84 is configured to store information data including, for example, electrical parameter information such as measured cumulative current obtained from electrolytic separation detection circuit 78 and a cumulative current threshold against which the measured cumulative current is compared by controller 72, as described below. Memory 84 may include, but is not limited to, RAM, ROM, EEPROM, flash memory, or other memory technology, CD-ROM, digital versatile disk ("DVD") or other optical storage device, magnetic cassette, magnetic tape, magnetic disk storage device, or other magnetic storage device, or other medium usable to store desired information and accessible by a computing device. Those skilled in the art will be familiar with the term "controller," which may be implemented in software, firmware, hardware, or any suitable combination thereof.

[0106] The indicators 86 are configured to report various events to the physician during the electrolytic separation procedure. In the illustrated embodiment, the indicators 86 are located on the outer case 62 to notify the physician of various events during the electrolytic separation procedure, as shown in FIG. 8 . In the illustrated embodiment, the electrolytic separation device 20 automatically powers on when the proximal portion 52 of the core wire 48 is inserted into the power terminal 64 of the electrolytic separation device 20. In the illustrated embodiment, the indicators 72 include a system ready indicator 86 a, a current indicator 86 b, a cycle complete indicator 86 c, a ground indicator 86 d, and a low battery indicator 86 e. At least some of the indicators 72 provide both visual and audible notifications to the physician.

[0107] The system ready indicator 86a illuminates a green light and emits one beep when the electrolytic separation device 20 is powered on and the patient 15 is successfully grounded via the ground electrode 16 and electrical cable 18, thereby informing the physician that the electrolytic separation device 20 is ready to electrolytically separate the vaso-occlusive device 24 from the delivery wire 22. The current indicator 86b illuminates a green light and emits three short beeps, thereby informing the physician that the electrolytic separation device 20 has assessed that a successful electrolytic separation event has occurred, and flashes a green light and emits one long beep, thereby informing the physician that the electrolytic separation device 20 has assessed that a successful electrolytic separation event has not occurred. The ground indicator 86d flashes an amber light until the patient 15 is properly grounded via the ground electrode 16 and electrical cable 18, after which the ground indicator 86d illuminates an amber light. When push button 70 is pressed, ground indicator 86d turns off. Low battery indicator 86e flashes an amber light to notify the physician that the battery in electrolytic separation device 20 is low. Of course, electrolytic separation device 20 can be equipped with any combination of indicators other than the combination of indicators 86 shown in FIG. 8.

[0108] 10 and 11, one procedure for delivering a vascular occlusion device 24 into an aneurysm sac 100 to treat a cerebral aneurysm 102 will be described. The delivery catheter 12 (or the delivery catheter 12' shown in FIG. 7) can be introduced into the patient using a transfemoral approach, specifically by inserting the delivery catheter 12 into the femoral artery near the patient's groin. A physician can then guide the delivery catheter 12 through the patient's vasculature under fluoroscopic guidance until the distal port 36 of the delivery catheter 12 is located at a target site within a blood vessel 104 just proximal to the aneurysm sac 100 (specifically, near the neck 106 of the cerebral aneurysm 102), as shown in FIG.

[0109] The physician then introduces the vascular occlusion assembly 14 through the inner lumen 34 of the single-lumen delivery catheter 12 until the vascular occlusion device 24 is positioned within the aneurysm sac 100, longitudinally aligning the delivery catheter 12 and delivery wire 22 so that the electrolytically severable joint 26 is positioned in contact with the blood in the blood vessel 104 just distal to the distal port 36 of the single-lumen delivery catheter 12 (or alternatively, inserts two vascular occlusion assemblies 14 each through the inner lumen 34' of the dual-lumen delivery catheter 12' until both vascular occlusion devices 24 are positioned within the aneurysm sac 100, longitudinally aligning the dual-lumen delivery catheter 12' and delivery wire so that the electrolytically severable joints of both vascular occlusion assemblies 14 are positioned in contact with the blood in the blood vessel 104 just distal to the distal port of the dual-lumen delivery catheter 12'). Under fluoroscopic visualization, such longitudinal alignment between the delivery catheter 12 (or delivery catheter 12') and the delivery wire 22 (or the delivery wire of the vascular occlusion assembly 14) can be ensured by aligning the marker band 58 located on the vascular occlusion assembly 14 (or marker bands located on both vascular occlusion assemblies 14) with the proximal marker 46b located on the delivery catheter 12, as shown in FIG. 4.

[0110] The ground electrode 16 is attached to the patient (in this case, a hypodermic needle (not shown) is inserted into the patient's body and the ground electrode 16 is clipped onto the hypodermic needle). Then, as shown in FIGS. 3-5 , the proximal portion 52 of the core wire 48 (either the proximal portion 52 of the only delivery wire 22 if only one vaso-occlusion assembly 14 is introduced through the inner lumen 34 of the single-lumen delivery catheter 12, or one of the two delivery wires 22 if two vaso-occlusion assemblies 14 are introduced through the two inner lumens 34 of the dual-lumen delivery catheter 12′) is connected to the power terminal 64 of the electrolytic separation device 20 (e.g., inserted into the power port 64), while the plug 88 of the electrical cable 18 is connected to the ground terminal 66 (e.g., inserted into the ground port 66). As a result, the electrolytic separation device 20 is powered on, the system ready indicator 86a illuminates a green light, and a single beep sounds. Meanwhile, the ground indicator 86d changes from flashing amber to a solid amber. The physician can then operate the electrolytic separation device 20 by actuating the electrolytic separation actuator, specifically by pressing the push button 70 once, which provides current to the electrolytically severable joint 24 during an electrolytic separation cycle. The current indicator 86b will illuminate a green light and all other indicators 86 will be off. At the end of the electrolytic separation cycle, the cycle complete indicator 86c will illuminate a green light.

[0111] Optimally, the vaso-occlusive device 24 will be electrolytically detached from the delivery wire 22 by the end of the electrolytic detachment cycle, as shown in Figure 11. When the electrolytic detachment device 20 detects that a successful electrolytic detachment event has occurred, the cycle complete indicator 86c will emit three short beeps, after which the physician can disconnect the proximal portion 52 of the core wire 48 from the power terminal 64 of the electrolytic detachment device 20 (specifically, remove it from the power port 64) and perform a fluoroscopic visualization check (including pulling on the proximal portion 52 of the core wire 48 to slightly retract the delivery wire 22 within the single-lumen delivery catheter 12 (or dual-lumen delivery catheter 12')) to confirm that the vaso-occlusive device 24 has indeed been electrolytically detached from the delivery wire 22.

[0112] If the electrolytic separation device 20 does not detect the occurrence of a successful electrolytic separation event, the cycle completion indicator 86c will emit one long beep, after which the physician can take corrective action, such as disconnecting the proximal portion 52 of the core wire 48 from the power terminal 64 of the electrolytic separation device 20 (specifically, removing it from the power port 64) and physically manipulating the vaso-occlusive device 24 (e.g., by slightly pulling on the proximal portion 52 of the core wire 48), properly aligning the delivery wire 22 with the single-lumen delivery catheter 12 (or dual-lumen delivery catheter 12') so that the electrolytically severable junction is fully exposed to blood, operating the flushing system to remove contrast agent around the vaso-occlusive device 24, and checking the ground electrode 16 to ensure stable contact with the patient.

[0113] Assuming that vaso-occlusive device 24 has not actually electrolytically detached from delivery wire 22 (after a fluoroscopic visualization check does not confirm the occurrence of a successful electrolytic detachment event despite the detection of a successful electrolytic detachment event by electrolytic detachment device 20, or after no successful electrolytic detachment is detected by electrolytic detachment device 20), the physician can again operate electrolytic detachment device 20 to supply current to electrolytically severable joint 26 during another electrolytic detachment cycle by actuating the electrolytic detachment actuator, specifically by again depressing push button 70.

[0114] After it has been determined that the vaso-occlusive device 24 has been electrolytically detached from the delivery wire 22, the above-described electrolytic detachment procedure can be repeated for the next vaso-occlusive device 24.

[0115] For example, when using the single-lumen delivery catheter 12 shown in FIG. 6 , a new vaso-occlusive assembly 14 can be introduced through the inner lumen 34 of the delivery catheter 12 until a new vaso-occlusive device 24 is positioned within the aneurysm sac 100, with the delivery catheter 12 and delivery wire 22 longitudinally aligned so that the electrolytically severable junction 26 is positioned in contact with the blood in the blood vessel 104 just distal to the distal port 36 of the delivery catheter 12. The proximal portion 52 of the core wire 48 of the next vaso-occlusive device 24 can then be connected to the power terminal 64 of the electrolytic separation device 20 (specifically, inserted into the power port 64), and the above-described electrolytic separation procedure can be repeated to deliver the new vaso-occlusive device 24 into the aneurysm sac 100.

[0116] As another example, if the dual-lumen delivery catheter 12′ shown in FIG. 7 is used and only one vaso-occlusive device 24 of the vaso-occlusive assemblies 14 disposed within the respective inner lumens of the delivery catheter 12′ has been electrolytically separated from its delivery wire, the proximal portion 52 of the core wire 48 of the other vaso-occlusive assembly 14 disposed within the respective inner lumen 34′ of the delivery catheter 12′ can be connected to the power terminal 64 of the electrolytic separation device 20 (specifically, inserted into the power port 64), and the electrolytic separation procedure described above can be repeated to deliver a new vaso-occlusive device 24 into the aneurysm sac 100.

[0117] As yet another example, if a dual-lumen delivery catheter 12′ as shown in FIG. 7 is used and the vaso-occlusive devices 24 of both vaso-occlusive assemblies 14 disposed within the respective inner lumens of the delivery catheter 12′ have both been electrolytically separated from the delivery wire, two new vaso-occlusive assemblies 14 can be introduced respectively through the inner lumens 34′ of the delivery catheter 12′ until two new vaso-occlusive devices 24 are disposed within the aneurysm sac 100, with the delivery catheter 12′ and the delivery wire longitudinally aligned so that the electrolytically severable junction 26 is disposed in contact with the blood within the blood vessel 104 just distal to the distal port of the delivery catheter 12′, after which the proximal portion 52 of the core wire 48 of one of the two vaso-occlusive devices 24 can be connected to the power terminal 64 of the electrolytic separation device 20 (specifically, inserted into the power port 64), and the electrolytic separation procedure described above can be repeated to deliver the new vaso-occlusive device 24 into the aneurysm sac 100.

[0118] After all of the vaso-occlusive devices 24 have been delivered into the aneurysm sac 100 and electrolytically separated from the delivery wire 22, the aneurysm sac 100 is sealed off from the blood vessel 104. As a result, as shown in FIG. 11 , the blood and vaso-occlusive devices 24 within the aneurysm sac 100 coagulate into a solid mass 108, thereby preventing the aneurysm sac 100 from rupturing in response to the blood pressure within the blood vessel 104.

[0119] Importantly, as briefly discussed above, the electrolytic separation device 20 automatically extends an electrolytic separation cycle if a successful electrolysis event is not detected and reported to a physician at the end of the electrolytic separation cycle. Such an extension of the electrolytic separation cycle may be performed, for example, in an electrolytic separation procedure for either the vaso-occlusion assembly 14 loaded into the single-lumen delivery catheter 12 of FIG. 6 or the vaso-occlusion assembly 14' loaded into the dual-lumen delivery catheter 12' of FIG. 7.

[0120] In one embodiment, shown in FIG. 12 , the electrolytic separation cycle 90 has an initial fixed period 92 followed by a variable period 94. The length of the initial fixed period 92 can be selected to minimize the possibility of false-positive electrolytic separation (i.e., by setting a minimum period for which current is supplied by the electrolytic separation device 20). In essence, the initial fixed period 92 functions as a fixed electrolytic separation cycle if a successful electrolytic separation event occurs and is reported, with the same benefits as a fixed electrolytic separation cycle; such an electrolytic separation cycle is not automatically extended. The length of the subsequent variable period 94 can be selected to be long enough to result in a large number of successful electrolytic separation events (that did not occur during the initial fixed period 92), yet short enough to allow the extended electrolytic separation cycle 90 to be completed within a reasonable period if unfavorable environmental electrolytic conditions make continuing the extended electrolytic separation cycle 90 futile. In one embodiment, the length of the initial fixed period 92 is, for example, 5 seconds, the length of the subsequent variable period 94 is, for example, 5 seconds, and the length of the electrolytic separation cycle 90 can vary from 5 to 10 seconds. Thus, if a successful electrolytic separation event does not occur during the initial fixed period 92, but does occur during the subsequent variable period 94, the physician will not be prompted to take corrective action when not necessary and will only be prompted to perform a single fluoroscopic confirmation check upon reporting of the successful electrolytic separation event, thereby shortening the duration of the electrolytic separation procedure. By providing an upper limit on the extended electrolytic separation cycle 90, the extended electrolytic separation cycle 90 can eventually be terminated, prompting the physician to take corrective action if necessary.

[0121] The controller 72 is configured to evaluate whether a successful electrolytic detachment event occurred during the initial fixed period 92 (in this case, at the end of the initial fixed period 92) based on the electrical parameter information generated by the detachment detection circuit 78, in which case the value of the electrolytic work performed by the current supply circuit 76, W meas (using the measured cumulative current supplied by the current supply circuit 76 as a proxy index) is used as the electrolytic work threshold W thThe controller 72 is only activated if it is determined that no successful electrolytic separation event has occurred during the initial fixed period 92 (e.g., the measured electrolytic work value W meas is the electrolytic work threshold W th , if the electrolytic separation cycle 90 is not reached, the electrolytic separation cycle 90 is further configured to automatically extend the electrolytic separation cycle 90 by a subsequent variable period 94.

[0122] The controller 72 is configured to incrementally evaluate whether a successful electrolytic separation event has occurred during the subsequent variable period 94, and terminate the electrolytic separation cycle 90 when it is determined that a successful electrolytic separation event has occurred. In the illustrated embodiment, the subsequent variable period 94 includes multiple fixed time increments 96, each shorter than the initial fixed period 92. In this case, the controller 72 incrementally evaluates whether a successful electrolytic separation event has occurred during each fixed time increment 96 (and reports to the physician whether a successful electrolytic separation event has occurred via the cycle completion indicator 86c), and terminates the electrolytic separation cycle 90 at the end of the fixed time increment 96 during which it is determined that a successful electrolytic separation event has occurred. In this manner, the controller 72 evaluates whether a successful electrolytic separation event has occurred during each fixed time increment 96, and immediately terminates the extended electrolytic separation cycle 90 (i.e., the electrolytic separation cycle 90 is not further extended) when it is determined that a successful electrolytic separation event has occurred. In the illustrated embodiment, the fixed time increments 96 are the same length, however, in alternative embodiments, the fixed time increments 96 may be different lengths.

[0123] 13A, the controller 72 determines that a successful electrolytic separation event occurred during the initial fixed period 92. Therefore, the controller 72 does not automatically extend the electrolytic separation cycle 90 by a subsequent variable period 94, but instead immediately terminates the electrolytic separation cycle 90 at the end of the initial fixed period 92 and reports to the physician that a successful electrolytic separation event occurred. As a result, the completed electrolytic separation cycle 90 will have only the initial fixed period 92.

[0124] 13B , on the other hand, the controller 72 determines that a successful electrolytic separation event did not occur during the initial fixed time period 92 of the electrolytic separation cycle 90. Therefore, the controller 72 does not report whether a successful electrolytic separation event occurred, but instead automatically extends the electrolytic separation cycle 90 by a subsequent variable time period 94. As further shown in FIG. 13B , the controller 72 determines that a successful electrolytic separation event did not occur during the initial fixed time period 92, but that a successful electrolytic separation event occurred during the first fixed time increment 96-1 of the subsequent variable time period 94. Therefore, the controller 72 immediately terminates the electrolytic separation cycle 90 at the end of the first fixed time increment 96 and reports to the physician that a successful electrolytic separation event occurred. As a result, the completed electrolytic separation cycle 90 will have only the initial fixed time period 92 and the first fixed time increment 96 of the subsequent variable time period 94.

[0125] 13C, the controller 72 determines that a successful electrolytic separation event did not occur during the initial fixed period 92 and the first fixed time increment 96-1 of the subsequent variable period 94, but determines that a successful electrolytic separation event occurred during the second fixed time increment 96-2 of the subsequent variable period 94. Therefore, the controller 72 immediately terminates the electrolytic separation cycle 90 at the end of the second fixed time increment 96 and reports to the physician that a successful electrolytic separation event occurred. As a result, the completed electrolytic separation cycle 90 includes the initial fixed period 92 and the first and second fixed time increments 96-1 and 96-2 of the subsequent variable period 94.

[0126] 13D, the controller 72 determines that a successful electrolytic separation event did not occur during the initial fixed period 92 and the first and second fixed time increments 96-1, 96-2 of the subsequent variable period 94, but determines that a successful electrolytic separation event occurred during the third fixed time increment 96-3 of the subsequent variable period 94. Therefore, the controller 72 immediately terminates the electrolytic separation cycle 90 at the end of the third fixed time increment 96-3 and reports to the physician that a successful electrolytic separation event occurred. As a result, the completed electrolytic separation cycle 90 includes the initial fixed period 92 and the first through third fixed time increments 96-1 through 96-3 of the subsequent variable period 94.

[0127] 13E, the controller 72 determines that a successful electrolytic separation event did not occur during the initial fixed period 92 and the first through third fixed time increments 96-1 through 96-3 of the subsequent variable period 94, but determines that a successful electrolytic separation event occurred during the fourth fixed time increment 96-4 of the subsequent variable period 94. Therefore, the controller 72 immediately terminates the electrolytic separation cycle 90 at the end of the fourth fixed time increment 96-4 and reports to the physician that a successful electrolytic separation event occurred. As a result, the completed electrolytic separation cycle 90 includes the initial fixed period 92 and the first through fourth fixed time increments 96-1 through 96-4 of the subsequent variable period 94.

[0128] 13F, the controller 72 determines that a successful electrolytic separation event did not occur during the initial fixed period 92 and the first through fourth fixed time increments 96-1 through 96-4 of the subsequent variable period 94, but determines that a successful electrolytic separation event occurred during the fifth fixed time increment 96-5 of the subsequent variable period 94. Therefore, the controller 72 immediately terminates the electrolytic separation cycle 90 at the end of the fifth fixed time increment 96-5 and reports to the physician that a successful electrolytic separation event occurred. As a result, the completed electrolytic separation cycle 90 includes the initial fixed period 92 and all of the first through fifth fixed time increments 96-1 through 96-5 of the subsequent variable period 94.

[0129] The controller 72 is configured to extend the electrolytic separation cycle 90 only up to a preset limit of fixed time increments 96 (in this case, five fixed time increments 96-1 through 96-5). In particular, as briefly mentioned above, one of the counters 82 keeps track of the number N of fixed time increments extended in the current electrolytic separation cycle 90. TI Regardless of the occurrence of a successful electrolytic separation event, the controller 72 determines whether the number of tracked extended fixed time increments 96 in the current electrolytic separation cycle 90 exceeds a preset limit value N of fixed time increments. TI-lim (i.e., if the electrolytic separation cycle is extended by a further fixed time increment 96, the tracking number N of fixed time increments by which the current electrolytic separation cycle 90 is extended will be equal to TI is a fixed time increment with a preset limit N TI-lim would be exceeded, the electrolytic separation cycle 90 is not extended by a further fixed time increment).

[0130] For example, in Figure 13G, the controller 72 assesses that a successful electrolytic separation event has not occurred by the end of the fifth fixed time increment 96-5. Therefore, the controller 72 determines that the tracking number N of fixed time increments already extended in the current electrolytic separation cycle 90 has not yet occurred. TI is the preset limit value N of the electrolytic separation cycle. cycle-lim = 5, the electrolytic separation cycle 90 is terminated immediately at the end of the fifth fixed time increment 96-5 and the physician is notified that a successful electrolytic separation event has not occurred.

[0131] The controller 72 is configured to automatically extend a particular electrolytic detachment cycle 90 only when it is assessed that extending the electrolytic detachment cycle would significantly facilitate the electrolytic detachment of the vaso-occlusive device 24 from the delivery wire 22, for example, when a successful electrolytic detachment event is expected to occur soon without the need for corrective action.

[0132] For example, controller 72 can take into account the presence of an electrolytic anomaly when evaluating whether automatically extending another electrolytic detachment cycle 90 would significantly facilitate the electrolytic detachment of vaso-occlusive device 24 from delivery wire 22. In one embodiment, controller 72 is configured to determine whether an electrolytic anomaly occurred during the application of current to electrolytically severable joint 26, and to automatically extend electrolytic detachment cycle 90 only if it is not determined that an electrolytic anomaly occurred during the application of current to electrolytically severable joint 26.

[0133] An electrolytic anomaly is the electrolytic work value W measured at the end of the initial fixed period 92 of the electrolytic separation cycle 90. meas is minimal, indicating that not enough electrolytic work is being done to electrolytically separate the vaso-occlusive device 24 from the delivery wire 22, such as when there is an open circuit between the core wire 48 and the ground electrode 16. The controller 72 calculates the electrolytic work value W measured at the end of the initial fixation period 92. meas The minimum electrolytic work limit value W lim-min Compared with the measured electrolytic work value W meas is the minimum electrolytic work limit value W lim-min If it is smaller, it can be determined that an electrolysis abnormality has occurred.

[0134] Another electrolytic anomaly can occur when the cumulative current measured at the end of the initial fixation period 92 of the electrolytic detachment cycle 90 is excessive, indicating that too much current is being used to perform something other than electrolytic work, such as when the electrolytically severable joint 26 is in physical contact with the mass of the vaso-occlusive device within the aneurysm sac 100. The controller 72 calculates the electrolytic work value W measured at the end of the initial fixation period 92. meas The maximum electrolytic work limit value W lim-max Compared with the measured electrolytic work value W meas is the maximum electrolytic work limit value W lim-max If it exceeds this value, it can be determined that an electrolysis abnormality has occurred.

[0135] Therefore, the measured electrolytic work value W meas is the electrolytic work threshold W th Whether or not the measured electrolytic work value W is reached, the controller 72 may, in response to the assessed electrolytic anomaly, assess that a successful electrolytic separation event has not occurred (in this case, the measured electrolytic work value W meas is the minimum electrolytic work limit value W lim-min and maximum electrolytic work limit W lim-max and outside the scope specified by

[0136] 14, the controller 72 can execute a series of electrolytic separation cycles 90 with a single press of the push button 70. The controller 72 may detect an electrolysis anomaly during a first electrolytic separation cycle 90-1 and, instead of automatically extending the first electrolytic separation cycle 90-1, may report that a successful electrolytic separation event has not occurred, prompt the physician to perform a fluoroscopic visualization check and take corrective action, and then initiate a second electrolytic separation cycle 90-2. The controller 72 may then not detect an electrolysis anomaly during the second electrolytic separation cycle 90-2, but may determine that a successful electrolytic separation event has not occurred at the end of the initial fixed duration 92 of the second electrolytic separation cycle 90-2 and, therefore, automatically extend the second electrolytic separation cycle 90-2 by a subsequent variable duration 94. At the end of the second electrolytic separation cycle 90-2, the controller 72 again evaluates and reports that a successful electrolytic separation event has not occurred, again prompting the physician to perform a fluoroscopic visualization check and take corrective action, and then begins the third electrolytic separation cycle 90-3. Thereafter, the controller 72 evaluates that a successful electrolytic separation event has occurred at the end of the initial fixed period 92 of the third electrolytic separation cycle 90-3, and thus, rather than automatically extending the third electrolytic separation cycle 90-3, reports that a successful electrolytic separation event has occurred, thereby prompting the physician to perform a fluoroscopic visualization check to confirm the reported successful electrolytic separation event.

[0137] As another example, controller 72 may take into account the number of electrolytic detachment cycles that have already been performed when evaluating whether automatically extending an additional electrolytic detachment cycle 90 would significantly facilitate electrolytic detachment of vaso-occlusive device 24 from delivery wire 22. In one embodiment, controller 72 is configured to limit the number of electrolytic detachment cycles 90 that can be completed. In particular, as briefly mentioned above, another one of counters 82 may count the number N of completed electrolytic detachment cycles. cycle Whether or not there is an electrolysis anomaly, the controller 72 keeps track of the number N of completed electrolytic separation cycles. cycle is a preset limit value N of completed electrolytic separation cycles. cycle-lim If the electrolytic separation cycle 90 exceeds 100 kJ / s, the electrolytic separation cycle 90 is not automatically extended.

[0138] 15, a series of electrolytic separation cycles 90 can be executed by the controller 72 in response to a single actuation of the push button 70. In this example, a preset limit N of completed electrolytic separation cycles is reached. cycle-lim = 2, so the controller 72 automatically extends the first and second electrolytic separation cycles 90-1, 90-2, but does not automatically extend the third and fourth electrolytic separation cycles 90-3, 90-4.

[0139] In particular, the controller 72 determines that a successful electrolytic separation event has not occurred at the end of the initial fixed period 92 of the first electrolytic separation cycle 90-1, and determines that the tracking number N of completed electrolytic separation cycles has not occurred. cycle is a preset limit value N of completed electrolytic separation cycles. cycle-lim=2, the first electrolytic separation cycle 90-1 is automatically extended by a subsequent variable period 94. At the end of the first electrolytic separation cycle 90-1, the controller 72 evaluates and reports that a successful electrolytic separation event has not occurred, prompting the physician to perform a fluoroscopic visualization check and take corrective action before initiating a second electrolytic separation cycle 90-2. At the end of the initial fixed period 92 of the second electrolytic separation cycle 90-2, the controller 72 again evaluates that a successful electrolytic separation event has not occurred, and also reports that the tracking number N of completed electrolytic separation cycles has not occurred. cycle is a preset limit value N of completed electrolytic separation cycles. cycle-lim =2 has still not been exceeded, automatically extending the second electrolytic separation cycle 90-2 by a subsequent variable period 94. At the end of the second electrolytic separation cycle 90-2, the controller 72 evaluates and reports that a successful electrolytic separation event has not occurred, prompting the physician to perform another fluoroscopic visualization check and take corrective action before initiating a third electrolytic separation cycle 90-3. Thereafter, the controller 72 again evaluates that a successful electrolytic separation event has not occurred at the end of the initial fixed period 92 of the third electrolytic separation cycle 90-3. However, the tracking number N of completed electrolytic separation cycles remains unchanged. cycle is a preset limit value N of completed electrolytic separation cycles. cycle-lim =2, the controller 72 does not automatically extend the third electrolysis cycle 90-3, reports that a successful electrolytic separation event has not occurred, and prompts the physician to perform a fluoroscopic visualization check and take corrective action before initiating the fourth electrolytic separation cycle 90-4. The controller 72 then evaluates that a successful electrolytic separation event has occurred at the end of the initial fixed period 92 of the fourth electrolytic separation cycle 90-4, and therefore does not automatically extend the fourth electrolysis cycle 90-4, reports that a successful electrolytic separation event has occurred, and prompts the physician to perform a fluoroscopic visualization check to confirm the reported successful electrolytic separation event.

[0140] Importantly, as briefly mentioned above, the electrolytic detachment device 20 generates electrolytic detachment detection information (in this case, the measured electrolytic work value W ) that is subsequently used to detect the electrolytic detachment of the new vaso-occlusive device 24 from the delivery wire 22. meas and electrolytic work threshold W th ) The electrolytic separation device 20 resets the electrolytic separation detection information only in response to a delivery wire connection event and after a certain amount of time has elapsed since the delivery wire separation event.

[0141] Specifically, as briefly mentioned above, timer 80 measures the elapsed time T between a delivery wire connect event and a subsequent delivery wire disconnect event. meas The controller 72 is configured to measure the measured elapsed time T between a delivery wire connect event and a subsequent delivery wire disconnect event. meas is one or more elapsed time thresholds T th (e.g., 3 seconds or more), the measured electrolytic work value W meas and electrolytic work threshold W th In one embodiment, the timer 80 is configured to reset the time threshold T th The controller 72 determines the measured elapsed time T when the timer 80 expires. meas is the elapsed time threshold T th It can be determined that this has been reached.

[0142] In one embodiment of the electrolytic separation device 20, such as for use in a single lumen delivery catheter 12 as shown in FIG. 6, the controller 72 determines the measured elapsed time T meas is a single elapsed time threshold T th When the measured electrolytic work value W meas and electrolytic work threshold W th (These will change over time as briefly mentioned above).

[0143] Elapsed time threshold T this selected to temporally distinguish between: 1) a physician action that simply involves quickly disconnecting and reconnecting the current delivery wire 22 from the electrolytic separation device 20 (indicating a double operation event in which the current vaso-occlusive device 24 has electrolytically detached from the delivery wire 22 but is also subjected to another electrolytic separation cycle), or a physician action that involves only a fluoroscopic visualization check and / or corrective action (and the accompanying disconnection and reconnection of the current delivery wire 22 to the electrolytic separation device 20) (indicating that the current vaso-occlusive device 24 has not electrolytically detached from its delivery wire 22 and therefore that at least one more electrolytic separation cycle needs to be performed on the current vaso-occlusive device 24); and (2) a physician action that involves a fluoroscopic check and the loading of a new vaso-occlusive device 24 into the delivery catheter 12 (and the accompanying disconnection of the current delivery wire 22 from the electrolytic separation device 20 and the connection of the new delivery wire 22 to the electrolytic separation device 20) (indicating that the current vaso-occlusive device 24 has electrolytically detached from its delivery wire 22 and that the next electrolytic separation cycle is applied to the new vaso-occlusive device 24).

[0144] Generally, a physician's procedure that includes a fluoroscopic visualization check followed by loading a new vaso-occlusive device 24 into the delivery catheter 12 (and the accompanying disconnection of the current delivery wire 22 from the electrolytic separation device 20 and connection of the new delivery wire 22 to the electrolytic separation device 20) will take longer than a physician's procedure that simply involves quickly disconnecting and reconnecting the current delivery wire 22 from the electrolytic separation device 20 (in the case of a double operation event) or a physician's procedure that only involves a fluoroscopic visualization check and / or corrective action (and the accompanying disconnection and reconnection of the current delivery wire 22 to the electrolytic separation device 20).

[0145] Therefore, a single elapsed time threshold T th can be selected (e.g., in the range of 25 to 45 seconds), specifically the measured elapsed time T between a delivery wire separation event and a subsequent delivery wire connection event. meas is a single elapsed time threshold T th, it can be assumed that the physician's action will only include a quick disconnection and reconnection of the delivery wire 22 to the electrolytic separation device 20 (in the case of a double operation event), or a fluoroscopic visualization check and / or corrective action (and the accompanying disconnection and reconnection of the current delivery wire 22 to the electrolytic separation device 20), while the measured elapsed time T between the delivery wire disconnection event and the subsequent delivery wire connection event meas is a single elapsed time threshold T th A single elapsed time threshold may be selected such that if greater than , it can be assumed that the physician's procedure includes a fluoroscopic check and the loading of a new vasoocclusive device 24 into the delivery catheter 12 (and the accompanying detachment of the current delivery wire 22 from the electrolytic separation device 20 and connection of the new delivery wire 22 to the electrolytic separation device 20).

[0146] Therefore, the controller 72 determines the measured elapsed time T meas is a single elapsed time threshold T th Measure the electrolytic work value W only when it reaches meas and electrolytic work threshold W th Reset (for example, the measured electrolytic work value W meas to zero, the electrolytic work threshold W th to a default value), and then when evaluating whether a successful electrolytic detachment event has occurred for the putative new vaso-occlusive device 24, the reset measured electrolytic work value W meas and electrolytic work threshold W th Therefore, the controller 72 determines whether the measurement elapsed time T meas is a single elapsed time threshold T th If the measured electrolytic work value W meas and electrolytic work threshold W th does not automatically reset, thereby minimizing the possibility of a false negative electrolytic separation being detected and reported for the current vaso-occlusive device 24 at the end of the next electrolytic separation cycle.

[0147] For example, in another embodiment of the electrolytic separation device 20 used in the dual lumen delivery catheter 12 shown in FIG. 7, the controller 72 determines whether a successful electrolytic separation event has occurred by evaluating and reporting the measured elapsed time T meas is a relatively short elapsed time threshold T th1 When the electrolytic work value W is reached, meas and electrolytic work threshold W th resets the measured elapsed time T if it is evaluated and reported that no successful electrolytic separation event has occurred. meas is the second relatively long elapsed time threshold T th2 When the electrolytic work value W is reached, meas and electrolytic work threshold W th is configured to reset

[0148] A relatively short elapsed time threshold T th1 is selected to temporally distinguish between 1) a physician action that simply involves quickly disconnecting and reconnecting the current delivery wire 22 to the electrolytic separation device 20 (indicating a dual operation event in which the current vaso-occlusive device 24 has electrolytically separated from its delivery wire 22, but is subjected to one more electrolytic separation cycle), and 2) a physician action that involves a fluoroscopic visualization check (and associated disconnection of the current delivery wire 22 from the electrolytic separation device 20, and connection of a new delivery wire 22 to the electrolytic separation device 20) (indicating that the current vaso-occlusive device 24 has electrolytically separated from its delivery wire 22, and that the next electrolytic separation cycle will be applied to the new vaso-occlusive device 24).

[0149] Generally, a physician action that includes a fluoroscopic visualization check (and the associated disconnection of the current delivery wire 22 from the electrolytic separation device 20 and connection of a new delivery wire 22 to the electrolytic separation device 20) will take longer than a physician action that only involves quickly disconnecting and reconnecting the current delivery wire 22 to the electrolytic separation device 20 (in the case of a dual operation event). Notably, the fluoroscopic visualization check may be followed by loading a new vaso-occlusive device into the single-lumen delivery catheter 12 and connecting its delivery wire 22 to the electrolytic separation device 20, or by loading two new vaso-occlusive devices into the dual-lumen delivery catheter 12′ and connecting one of their delivery wires 22 to the electrolytic separation device 20; however, if a new vaso-occlusive device 24 has already been loaded into the dual-lumen delivery catheter 12′ as the second vaso-occlusive device 24, the fluoroscopic visualization check may be followed simply by connecting the delivery wire 22 to the electrolytic separation device 20. However, the first relatively short elapsed time threshold T th1 When selecting , only the alternative case where a new vaso-occlusive device 24 is not loaded into the delivery catheter after the fluoroscopic visualization check needs to be considered (in this case, only the first vaso-occlusive device 24 previously loaded into the dual-lumen delivery catheter 12' has been electrolytically detached from its delivery wire 12, and the next electrolytic detachment cycle is applied to the second vaso-occlusive device 24 previously loaded into the dual-lumen delivery catheter 12').

[0150] Therefore, a relatively short elapsed time threshold T th1 can be selected (e.g., in the range of 3 to 10 seconds), and specifically, the measured elapsed time T between a delivery wire separation event and a subsequent delivery wire connection event meas is a relatively short elapsed time threshold T th1 , it can be assumed that the physician's procedure involves only a quick disconnection and reconnection of the delivery wire 22 to the electrolytic separation device 20 (in the case of a double operation event), while the measured elapsed time T between the delivery wire disconnection event and the subsequent delivery wire connection event measis a relatively short elapsed time threshold T th1 If greater than , a relatively short elapsed time threshold can be selected such that a fluoroscopic visualization check (and the accompanying detachment of the current delivery wire 22 from the electrolytic separation device 20 and attachment of a new delivery wire 22 to the electrolytic separation device 20) can be assumed to be included in the physician's procedure.

[0151] Thus, if a successful electrolytic separation event is evaluated and reported to have occurred, the controller 72 may determine whether the measured elapsed time T meas is a relatively short elapsed time threshold T th1 Measure the electrolytic work value W only when it reaches meas and electrolytic work threshold W th and the resulting reset measured electrolytic work value W meas and electrolytic work threshold W th will be applied when later evaluating whether a successful electrolytic detachment event has occurred for a potential new vaso-occlusive device 24. To this end, controller 72 may use the measured elapsed time T meas is a relatively short elapsed time threshold T th1 If the measured electrolytic work value W meas and electrolytic work threshold W th does not automatically reset, thereby preventing a misleading false negative electrolytic detection from being evaluated and reported after a true positive electrolytic detection has already been detected and reported (e.g., in a double operation event).

[0152] A relatively long elapsed time threshold T th2is selected to temporally distinguish between: 1) a physician action that includes only a quick disconnection and reconnection of the current delivery wire 22 to the electrolytic separation device 20 (indicating a double operation event in which the current vaso-occlusive device 24 has been electrolytically detached from its delivery wire 22 but is subjected to one more electrolytic separation cycle), or a physician action that includes only a fluoroscopic visualization check and / or corrective action (and accompanying disconnection and reconnection of the current delivery wire 22 to the electrolytic separation device 20) (indicating that the current vaso-occlusive device 24 has not been electrolytically detached from its delivery wire 22 and therefore that at least one more electrolytic separation cycle needs to be performed on the current vaso-occlusive device 24); and 2) a physician action that includes a fluoroscopic check and the loading of a new vaso-occlusive device 24 into the delivery catheter 12 (and accompanying disconnection of the current delivery wire 22 from the electrolytic separation device 20 and connection of the new delivery wire 22 to the electrolytic separation device 20) (indicating that the current vaso-occlusive device 24 has been electrolytically detached from the delivery wire 22 and that the next electrolytic separation cycle will be applied to the new vaso-occlusive device 24).

[0153] Generally, a physician's procedure that includes a fluoroscopic visualization check followed by loading a new vaso-occlusive device 24 into the delivery catheter 12 (and the accompanying disconnection of the current delivery wire 22 from the electrolytic separation device 20 and connection of the new delivery wire 22 to the electrolytic separation device 20) will take longer than a physician's procedure that includes only a quick disconnection and reconnection of the current delivery wire 22 to the electrolytic separation device 20 (in the case of a double operation event), or a physician's procedure that includes only a fluoroscopic visualization check and / or corrective action (and the accompanying disconnection and reconnection of the current delivery wire 22 to the electrolytic separation device 20).

[0154] Therefore, a relatively long elapsed time threshold T th2 can be selected (e.g., in the range of 25 to 45 seconds), specifically the measured elapsed time T between a delivery wire separation event and a subsequent delivery wire connection event. meas is a relatively long elapsed time threshold T th2, it can be assumed that the physician's action only involves a quick disconnection and reconnection of the delivery wire 22 to the electrolytic separation device 20 (in the case of a double operation event), or a fluoroscopic visualization check and / or corrective action (and the accompanying disconnection and reconnection of the current delivery wire 22 to the electrolytic separation device 20), while the measured elapsed time T between the delivery wire disconnection event and the subsequent delivery wire connection event meas is a relatively long elapsed time threshold T th2 A relatively long elapsed time threshold can be selected such that if it is greater than , it can be assumed that the physician's treatment will include a fluoroscopic visualization check and the insertion of a new vasoocclusive device 24 into the delivery catheter 12 (and the associated detachment of the current delivery wire 22 from the electrolytic separation device 20 and the connection of the new delivery wire 22 to the electrolytic separation device 20).

[0155] Thus, if a successful electrolytic separation event is evaluated and reported as not occurring, the controller 72 may reset the measured elapsed time T meas is a relatively long elapsed time threshold T th2 Measure the electrolytic work value W only when it reaches meas and electrolytic work threshold W th and the resulting reset measured electrolytic work value W meas and electrolytic work threshold W th will be applied when later evaluating whether a successful electrolytic detachment event has occurred for a potential new vaso-occlusive device 24. To this end, controller 72 may use the measured elapsed time T meas is a relatively long elapsed time threshold T th2 If the measured electrolytic work value W meas and electrolytic work threshold W th does not automatically reset, thereby minimizing the possibility of a false negative electrolytic separation being detected and reported for the current vaso-occlusive device 24 at the end of the next electrolytic separation cycle.

[0156] Importantly, as briefly mentioned above, the electrolytic separation device 20 reduces over time the electrolytic work threshold W th is increased stepwise, and the measured electrolytic work value W meas are compared to assess whether a successful electrolytic separation event has occurred.

[0157] In particular, the electrolytic isolation detection circuit 78, under the control of the controller 72, measures the electrolytic work performed by the current supply circuit 76 stepwise over time to generate a plurality of measured electrolytic work values ​​W meas-1 ~W meas-n (Where, meas-1 is the first measured electrolytic work value during the electrolytic separation cycle 90, and W meas-n is the last measured electrolytic work value), while the controller 72 is configured to generate an electrolytic work threshold W th By gradually increasing the value of W, multiple electrolytic work thresholds th-1 ~W th-n (Where, th-1 is the first electrolytic work threshold, and W th-n is the final electrolytic work threshold) and measure the electrolytic work value W meas-1 ~W meas-n The electrolytic work threshold W th-1 ~W th-n and evaluate whether a successful electrolytic separation event has occurred based on the comparison result. th The gradual increase in corresponds to the increasing electrolytic work required to successfully detach the vaso-occlusive device 24 from the delivery wire 22, thereby reducing false-positive electrolytic detachment detections and reports.

[0158] In the embodiment shown in FIG. 16, the electrolytic separation detection circuit 78 measures the electrolytic work performed by the current supply circuit 76 at the end of an initial fixed period 92 of the electrolytic separation cycle 90 (5 seconds in this case), and also at the end of each fixed time increment 96 of a subsequent variable period 94 of the electrolytic separation cycle 90 (6 seconds, 7 seconds, etc. in this case, until the end of the subsequent variable period 94) if the electrolytic separation cycle 90 is extended, thereby determining the relatively short measured electrolytic work value W corresponding to the initial fixed period 92. meas-1 , a second measured electrolytic work value W corresponding to the first fixed time increment 96 meas-2 , a third measured electrolytic work value W corresponding to the second fixed time increment 96 meas-3 and so on until the end of the subsequent variable period 94. If the electrolytic separation cycle 90 is extended, the controller 72 incrementally increases the electrolytic work threshold for each fixed time increment 96 of the subsequent variable period 94 of the electrolytic separation cycle 90, until a first electrolytic work threshold W th-1 , a second electrolytic work threshold W corresponding to the first fixed time increment 96 th-2 , a third electrolytic work threshold W corresponding to the second fixed time increment 96 th-3 and so on until the end of the subsequent variable period 94 to produce an electrolytic work threshold.

[0159] Therefore, the controller 72 calculates the first measured electrolytic work value W meas-1 is the first electrolytic work threshold W th-1 If the value of the second measured electrolytic work value W is reached, it is evaluated whether a successful electrolytic separation event has occurred by the end of the initial fixed period 92. meas-2 is the second electrolytic work threshold W th-2 If the value of the first fixed time increment 96-1 of the subsequent variable period 94 is reached, then the system evaluates whether a successful electrolytic separation event has occurred by the end of the first fixed time increment 96-1 of the subsequent variable period 94 (assuming that a successful electrolytic separation event has not been evaluated to have occurred by the end of the initial fixed period 92), and calculates a third measured electrolytic work value W meas-3 is the third electrolytic work threshold W th-3If the second fixed time increment 96-2 is reached, the system evaluates whether a successful electrolytic separation event has occurred by the end of the second fixed time increment 96-2 of the subsequent variable period 94 (assuming that a successful electrolytic separation event has not been evaluated to have occurred by the end of the second fixed time increment 96-2), and calculates a third measured electrolytic work value W meas-3 is the third electrolytic work threshold W th-3 If the value of the second fixed time increment 96-2 is reached, the system evaluates whether a successful electrolytic separation event has occurred by the end of a third fixed time increment 96-3 of the subsequent variable period 94 (assuming that a successful electrolytic separation event has not been evaluated to have occurred by the end of the second fixed time increment 96-2), and calculates a fourth measured electrolytic work value W meas-4 is the fourth electrolytic work threshold W th-4 If the value of the fifth measured electrolytic work value W is reached, the system evaluates whether a successful electrolytic separation event has occurred by the end of the fourth fixed time increment 96-4 of the subsequent variable period 94 (assuming that a successful electrolytic separation event has not been evaluated to have occurred by the end of the third fixed time increment 96-3), and calculates a fifth measured electrolytic work value W. meas-5 is the fifth electrolytic work threshold W th-5 If the time limit is reached, it is evaluated whether a successful electrolytic separation event has occurred by the end of the fifth fixed time increment 96-5 of the subsequent variable period 94 (assuming that a successful electrolytic separation event has not been evaluated to have occurred by the end of the fourth fixed time increment 96-4).

[0160] Measured electrolytic work value W meas-1 ~W meas-n will naturally increase over time as more electrolytic work is performed by current supply circuit 76 to electrolytically separate vaso-occlusive device 24 from its delivery wire 22, while the electrolytic work threshold W th-1 ~W th-ncan be selected according to a known electrolytic work-time separation curve 98 (shown by the dashed line in FIG. 17 ), which generally increases with time. Such an electrolytic work-time separation curve 98 includes the magnitude of electrolytic work (in this case, cumulative current) required (with tolerances) to electrolytically separate a particular type of vaso-occlusive device 24 from its delivery wire 22 as a function of time. The electrolytic work-time separation curve 98 is obtained by experimentally testing a relatively large number (e.g., 100) of a particular type of vaso-occlusive assembly (i.e., passing a current through each vaso-occlusive assembly while visualizing the vaso-occlusive device, and recording the electrolytic work value and elapsed time when the vaso-occlusive device electrolytically separates from the delivery wire) to generate a set of points 99, as shown in FIG. 18 . The electrolytic work-time separation curve 98 is then generated by fitting a continuous curve to the set of points 99, and the discrete electrolytic work thresholds W th-1 ~W th-n can be fitted to the electrolytic work-time separation curve 98. It is worth noting that the discrete electrolytic work threshold W th-1 ~W th-n Since the value of electrolytic work can be applied with some tolerance, the discrete electrolytic work threshold W th-1 ~W th-n is typically higher than the electrolysis work-time separation curve 98 by a predetermined magnitude. th-1 ~W th-n is a conservative estimate of the success of the electrolytic separation event, thereby minimizing false-positive electrolytic separation detections.

[0161] Having described the structure and function of the electrolytic separation device 20, a method 150 for operating the electrolytic separation device 20 to perform a series of electrolytic separation cycles 90 to electrolytically separate the vaso-occlusive device 24 from its delivery wire 22 will now be described with reference to FIGS. 16 and 19.

[0162] Before commencing method 150, assume that vaso-occlusion assembly 14 is disposed within delivery catheter 12, vaso-occlusion device 24 is deployed within aneurysm sac 100, and electrolytically severable junction 26 is positioned distal to distal port 36 of delivery catheter 22 and exposed to blood within blood vessel 104, as shown in FIG. 10, while proximal portion 52 of core wire 48 of delivery wire 22 is electrically connected to the power terminal of electrolytic separation device 20 (specifically, inserted into power port 64), and ground electrode 16 is in firm contact with the patient and electrically connected to the ground terminal of electrolytic separation device 20 via electrical cable 18 (specifically, inserted into ground port 66), as shown in FIGS. 3 and 4.

[0163] First, the electrolytic separation device 20 is actuated once (in this case, by quickly pressing and releasing the push button 70 (FIG. 8)) to initiate the electrolytic separation cycle 90 (step 152), which causes the electrolytic separation device 20 to supply current to the electrolytically severable junction 26 for the initial fixed period 92 of the electrolytic separation cycle 90 (step 154).

[0164] The electrolytic separation device 20 then evaluates whether a successful electrolytic separation event occurred by the end of the initial fixed period 92 of the electrolytic separation cycle 90. If a successful electrolytic separation event is assessed to have occurred by the end of the initial fixed period 92 of the electrolytic separation cycle 90, the electrolytic separation device 20 reports the result to the physician. If a successful electrolytic separation event is not assessed to have occurred by the end of the initial fixed period 92 of the electrolytic separation cycle 90, the electrolytic separation device 20 may extend the electrolytic separation cycle 90 by a subsequent variable period 94, if such an extension is deemed useful, and re-evaluates whether a successful electrolytic separation event was assessed to have occurred during the subsequent variable period 94 of the electrolytic separation cycle 90, and reports the result to the physician at the end of the extended electrolytic separation cycle 90.

[0165] Specifically, the electrolytic separation device 20 calculates the electrolytic work W performed by the electrolytic separation device 20 during an initial fixed period 92 of the electrolytic separation cycle 90. meas(in this case, the cumulative current delivered by electrolytic separation device 20 through delivery wire 22) is measured (step 156). As a result, a first measured electrolytic work value W meas-1 is generated.

[0166] The electrolytic separation device 20 then determines whether an electrolytic anomaly occurred during the application of current to the electrolytically severable joint 26 during the initial fixed period 92 of the electrolytic separation cycle 90, and, in particular, determines the measured electrolytic work value W meas (In this case, the first measured electrolytic work value W meas-1 ) is the minimum electrolytic work limit value W lim-min and maximum electrolytic work limit W lim-max It is determined whether the measured electrolysis work value is within the electrolysis work value range defined by the minimum electrolysis work limit value W (step 158). lim-min and maximum electrolytic work limit W lim-max If the measured electrolytic work value is outside the electrolytic work value range defined by the minimum electrolytic work limit W, then the electrolytic separation device 20 evaluates and reports (via the cycle completion indicator 86c) that a successful electrolytic separation event has not occurred during the initial fixed period 92 of the electrolytic separation cycle 90 (step 160). lim-min and maximum electrolytic work limit W lim-max If the measured electrolytic work value W is within the range of electrolytic work values ​​defined by meas (In this case, the measured electrolytic work value W meas-1 ) is the electrolytic work threshold W th (In this case, the first electrolytic work threshold W th-1 ) is reached (step 162). meas is the first electrolytic work threshold W th If so, the electrolytic separation device 20 evaluates and reports (via the cycle completion indicator 86c) that a successful electrolytic separation event occurred during the electrolytic separation cycle 90 (step 164).

[0167] Measured electrolytic work value W meas is the electrolytic work threshold W this not reached, the electrolytic separation device 20 continues to count the number N of completed electrolytic separation cycles (tracked via one of the counters 82). cycle is a preset limit value N of completed electrolytic separation cycles. cycle-lim (Step 166) to determine whether the tracking number N of completed electrolytic separation cycles has exceeded cycle is a preset limit value N of completed electrolytic separation cycles. cycle-lim If so, the electrolytic separation device 20 does not extend the electrolytic separation cycle 90 (step 168) and evaluates and reports (via the cycle completion indicator 86c) that a successful electrolytic separation event did not occur during the initial fixed period 92 of the electrolytic separation cycle 90 (step 160).

[0168] Tracking number of completed electrolytic separation cycles N cycle is a preset limit value N of completed electrolytic separation cycles. cycle-lim If not, the electrolytic separation device 20 progressively evaluates whether a successful electrolytic separation event occurred during each subsequent time increment 96 of the variable period 94, terminates the electrolytic separation cycle 90 at the end of the time increment 96 in which a successful electrolytic separation event is evaluated to have occurred, and reports the results to the physician.

[0169] Specifically, the electrolytic separation device 20 extends the electrolytic separation cycle 90 by a subsequent variable duration 94, and specifically extends the electrolytic separation cycle 90 by one fixed time increment 96 (step 170). As a result, the electrolytic separation device 20 continues to supply current to the electrolytically severable joint 26 of the vaso-occlusive assembly 14 during the fixed time increment 96 of the variable duration 94 of the electrolytic separation cycle 90 (step 172). The electrolytic separation device 20 then continues to supply current to the electrolytically severable joint 26 of the vaso-occlusive assembly 14 for the fixed time increment 96 of the variable duration 94 of the electrolytic separation cycle 90 by a tracking number N of fixed time increments that have been extended in the current electrolytic separation cycle 90. TI (i.e., via another one of the counters 82) by one (step 174).

[0170] The electrolytic separation device 20 then measures the electrolytic work W performed by the electrolytic separation device 20 from the beginning of the initial fixed time period 92 of the electrolytic separation cycle 90 to the end of the current fixed time increment 96 of the subsequent variable time period 94. meas (in this case, the cumulative current supplied by the electrolytic separation device 20 through the delivery wire 22) is measured (step 176) to determine the electrolytic work threshold W th Specifically, the second through sixth measured electrolytic work values ​​W corresponding to the current fixed time increment 96 of the subsequent variable period 94 of the electrolytic separation cycle 90 are increased (step 178). meas-2 ~W meas-6 , which corresponds to the now fixed time increment 96 of the subsequent variable period 94 of the electrolytic separation cycle 90. th-2 ~W th-6 One of the thresholds (for example, the stepwise increased electrolytic work threshold W shown in FIG. 17) th-2 ~W th-6 (according to

[0171] Thus, if the electrolytic separation cycle 90 is first extended, the trailing number N of fixed time increments extended in the current electrolytic separation cycle 90 is TI increases from 0 to 1 (i.e., the current fixed time increment 96 becomes the first fixed time increment 96-1), and the second measured electrolytic work value W meas-2 is generated, and the second electrolytic work threshold W th-2 In the next iteration, the number of traces N of fixed time increments extended in the current electrolysis cycle 90 is selected. TI increases from 1 to 2 (i.e., the current fixed time increment 96 becomes the second fixed time increment 96-2), and the third measured electrolytic work value W meas-3 is generated, and the third electrolytic work threshold W th-3 In the next iteration, the number of traces N of fixed time increments extended in the current electrolysis cycle 90 is selected. TI increases from 2 to 3 (i.e., the current fixed time increment 96 becomes the third fixed time increment 96-3), and the fourth measured electrolytic work value W meas-4 is generated, and the fourth electrolytic work threshold W th-4In the next iteration, the number of traces N of fixed time increments extended in the current electrolysis cycle 90 is selected. TI increases from 3 to 4 (i.e., the current fixed time increment 96 becomes the fourth fixed time increment 96-4), and the fifth measured electrolytic work value W meas-5 is generated, and the fifth electrolytic work threshold W th-5 In the next iteration, the number of traces N of fixed time increments extended in the current electrolysis cycle 90 is selected. TI increases from 4 to 5 (i.e., the current fixed time increment 96 becomes the fifth fixed time increment 96-5), and the sixth measured electrolytic work value W meas-6 is generated, and the sixth electrolytic work threshold W th-6 is selected.

[0172] The electrolytic separation device 20 then measures the electrolytic work value W meas (Measured electrolytic work value W meas-2 ~W meas-6 The value currently generated is the electrolytic work threshold (electrolytic work threshold W th-2 ~W th-6 The measured electrolytic work value W is then calculated (step 178). meas The selected electrolytic work threshold W th If N is reached, the electrolytic separation device 20 terminates the electrolytic separation cycle 90 (step 180) and waits for a tracked number N of fixed time increments (tracked via one of the counters 82). TI (step 182), and evaluates and reports (via cycle completion indicator 86c) that a successful electrolytic separation event occurred during electrolytic separation cycle 90 (step 164). meas The selected electrolytic work threshold W th is not reached, the electrolytic separation device 20 continues to count the number N of fixed time increments (tracked by one of the counters 82) extended in the current electrolysis cycle 90. TI is a fixed time increment with a preset limit N TI-lim It is determined whether or not it is equal to (step 184).

[0173] The current electrolysis cycle 90 is extended by a fixed time increment to track the number NTI is a fixed time increment with a preset limit N TI-lim If so, the electrolytic separation device 20 terminates the electrolytic separation cycle 90 (step 186) and terminates the tracked number N of fixed time increments (tracked via one of the counters 82). TI (step 188), and evaluates and reports (via cycle completion indicator 86c) (step 160) that no successful electrolytic separation events have occurred during the electrolytic separation cycle 90. The tracking number N of extended fixed time increments in the current electrolytic cycle 90 TI is a fixed time increment with a preset limit N TI-lim If so, the method 150 returns to step 170 .

[0174] After an electrolytic separation cycle 90 (whether extended or not) is completed and the occurrence or non-occurrence of a successful electrolysis event is reported to the physician in step 160 or 164, the electrolytic separation device 20 keeps track of the number N of completed electrolytic separation cycles. cycle (step 190), and detects whether a delivery wire detachment event has occurred (i.e., whether the proximal end of delivery wire 22 has been detached from electrolytic separation device 20) (step 192) before re-activating electrolytic separation device 20 (i.e., initiating another electrolytic separation cycle). If a delivery wire detachment event has not occurred before re-activating electrolytic separation device 20, the measured electrolytic work value W meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycle The electrical parameter information is retained (i.e., not reset) (step 194), including:

[0175] If a delivery wire detachment event occurs, the electrolytic separation device 20 detects (step 196) the occurrence of a subsequent delivery wire connection event (i.e., whether the proximal end of a delivery wire 22 (either the previous delivery wire 22 or the next delivery wire 22) is connected to the electrolytic separation device 20) and determines whether the measured elapsed time T measFor example, the countdown timer 80 is started and the elapsed time threshold T th The electrolytic separation device 20 may begin counting down the measured elapsed time T by determining whether the countdown timer 80 has expired prior to the delivery wire connection event. meas is the elapsed time threshold T th 19, the method 150 may determine whether the electrolytic separation device 20 has reached a measured elapsed time T meas is a single elapsed time threshold T th Thus, the method 150 is suitable for the single lumen delivery catheter 12 shown in FIG.

[0176] Measurement elapsed time T meas is the elapsed time threshold T th is not reached (i.e., the countdown timer 80 does not expire before the delivery wire connection event), the electrolytic separation device 20 meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycle and retain (i.e., do not reset) the electrical parameter information (step 194), including: and . In such a case, it is assumed that either the physician has not performed any action immediately prior to the delivery wire connection event (indicating a double operation event in which the current vaso-occlusive device 24 has been electrolytically detached from its delivery wire 22 but is subjected to one more electrolytic detachment cycle), or the physician is performing a fluoroscopic visualization check and / or corrective action without loading a new vaso-occlusive device 24 into the delivery catheter 12 (indicating that the current vaso-occlusive device 24 has not been electrolytically detached from its delivery wire 22 and therefore needs to be subjected to at least one more electrolytic detachment cycle). Thus, the measured electrolytic work value W meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycle Resetting and is not desirable in this case.

[0177] Measurement elapsed time T meas is the elapsed time threshold T th is reached (i.e., the countdown timer 80 expires before the delivery wire connection event), the electrolytic separation device 20 calculates the measured electrolytic work value W meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycle and reset the electrical parameter information (step 200), including: (a) the measured electrolytic work value W meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycle It is desirable to reset the

[0178] Measured electrolytic work value W meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycle After the electrical parameter information, including , is maintained in step 194 or reset in step 200, the method 150 returns to step 152 to begin another electrolytic separation cycle 90.

[0179] 20, an alternative method 150' is similar to the method 150 shown in FIG. 19, except that the electrolytic separation device 20 determines whether a successful electrolytic separation event has occurred after a measured elapsed time T meas is a relatively short elapsed time threshold T th1 , and if a successful electrolytic separation event has not been evaluated and reported, the measured elapsed time T meas is a relatively long elapsed time threshold T th2For example, countdown timer 80 may be configured to determine whether a relatively short elapsed time threshold T th1 or a relatively long elapsed time threshold T th2 The electrolytic separation device 20 then determines whether the countdown timer 80 has expired before the delivery wire connection event, thereby determining the measured elapsed time T meas is a relatively short elapsed time threshold T th1 or a relatively long elapsed time threshold T th2 The method 150' is suitable for the dual lumen delivery catheter 12' shown in FIG.

[0180] A successful electrolytic separation event is evaluated and reported (step 197), and the measured elapsed time T meas is a relatively short elapsed time threshold T th1 is not reached (i.e., the countdown timer 80 does not expire before the delivery wire connection event) (step 198a), the electrolytic separation device 20 calculates the measured electrolytic work value W meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycle The electrical parameter information is retained (i.e., not reset) (step 194), including the measured electrolytic work value W. In such a case, it is assumed that the physician performed no action immediately prior to the delivery wire connection event (indicating a dual operation event in which the current vaso-occlusive device 24 is electrolytically detached from its delivery wire 22, but is also subjected to another electrolytic detachment cycle). meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycle Resetting and is not desirable in this case.

[0181] A successful electrolytic separation event is evaluated and reported (step 197), and the measured elapsed time T meas is a relatively short elapsed time threshold T th1is reached (i.e., the countdown timer 80 expires before the delivery wire connection event) (step 198a), the electrolytic separation device 20 calculates the measured electrolytic work value W meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycle and reset (step 200). In such a case, it is assumed that just prior to the delivery wire connection event, the physician performed a fluoroscopic visualization check (indicating that the current vaso-occlusive device 24 has been electrolytically detached from its delivery wire 22 and that the next electrolytic detachment cycle will be applied to the new vaso-occlusive device 24 already loaded within the delivery catheter 12'). Thus, the measured electrolytic work value W meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycle In this case, it is desirable to reset

[0182] If a successful electrolytic separation event has not been evaluated and reported (step 197) and the measured elapsed time T meas is a relatively long elapsed time threshold T th2 has not been reached (i.e., the countdown timer 80 did not expire before the delivery wire connection event) (step 198b), the electrolytic separation device 20 calculates the measured electrolytic work value W meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycleand retain (i.e., do not reset) (step 194). In such a case, it can be assumed that the physician did not perform any action immediately prior to the delivery wire connection event (indicating a double operation event in which the current vaso-occlusive device 24 is electrolytically detached from its delivery wire 22 but is subjected to one more electrolytic detachment cycle), or that the physician is performing a fluoroscopic visualization check and / or corrective action without loading a new vaso-occlusive device 24 into the delivery catheter 12 (indicating that the current vaso-occlusive device 24 is not electrolytically detached from its delivery wire 22 and therefore needs to be subjected to at least one more electrolytic detachment cycle). Thus, the measured electrolytic work value W meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycle Resetting and is not desirable in this case.

[0183] If a successful electrolytic separation event has not been evaluated and reported (step 197) and the measured elapsed time T meas is a relatively long elapsed time threshold T th2 is reached (i.e., the countdown timer 80 expires before the delivery wire connection event) (step 198b), the electrolytic separation device 20 calculates the measured electrolytic work value W meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycle and reset the electrical parameter information (step 200), including: (a) the measured electrolytic work value W meas and electrolytic work threshold W th and the tracking number of completed electrolytic separation cycles N cycleIn this case, it is desirable to reset

[0184] While particular embodiments have been disclosed and described herein, those skilled in the art will understand that they are not intended to limit the disclosed invention. Moreover, it will be apparent to those skilled in the art that various changes, substitutions, and alterations (e.g., various dimensions of parts, combinations of parts) can be made without departing from the scope of the disclosed invention, which is defined solely by the following claims and their equivalents. Accordingly, the specification and drawings should be interpreted in an illustrative, and not a restrictive, sense. The various embodiments disclosed and described herein are intended to cover all such alternatives, modifications, and equivalents of the disclosed invention, which may fall within the scope of the appended claims.

[0185] Numbered Embodiments of the Invention [Claim 1] 1. An electrolytic separation device for use with an electrically conductive delivery wire, the delivery wire having a distal end to which a vaso-occlusive device is attached and an electrolytically severable junction located proximal to the vaso-occlusive device, the electrolytic separation device comprising: a power terminal configured to electrically connect to and disconnect from a proximal end of the delivery wire; and a current supply circuit configured to supply current to the electrolytically severable joint of the vaso-occlusive assembly while the vaso-occlusive device is positioned within the patient's vasculature, such that the vaso-occlusive device electrolytically detaches from the distal end of the delivery wire; and an electrolytic detachment detection circuit configured to generate electrical parameter information indicative of a successful electrolytic detachment event; a timer configured to measure the elapsed time between a delivery wire disconnection event and a subsequent delivery wire connection event; and a controller configured to evaluate whether the successful electrolytic separation event occurred based on the generated electrical parameter information, and to reset the electrical parameter information if the measured elapsed time reaches a first elapsed time threshold. [Claim 2] 2. The electrolytic separation device according to claim 1, 1. An electrolytic isolation device, further comprising a ground terminal configured to be electrically connected via an electrical cable to a ground electrode that is in electrical contact with a patient. [Claim 3] 2. The electrolytic separation device according to claim 1, The electrolytic separation device, wherein the power terminal is a power port configured to receive the proximal end of the delivery wire. [Claim 4] 2. The electrolytic separation device according to claim 1, The electrolytic separation device, wherein the electrical parameter information includes a measured cumulative electrical parameter. [Claim 5] 5. The electrolytic separation device according to claim 4, The electrolytic separation device, wherein the cumulative electrical parameter comprises a measured cumulative current. [Claim 6] 2. The electrolytic separation device according to claim 1, Electrolytic separation device, wherein the electrical parameter information includes measured electrolytic work performed by the current supply circuit. [Claim 7] 2. The electrolytic separation device according to claim 1, 10. An electrolytic separation device, wherein the first elapsed time threshold is 3 seconds or greater. [Claim 8] 2. The electrolytic separation device according to claim 1, 10. An electrolytic separation device, wherein the first elapsed time threshold is within a range of 25 to 45 seconds. [Claim 9] 2. The electrolytic separation device according to claim 1, the controller is configured to reset the electrical parameter information when the measured elapsed time reaches the first elapsed time threshold and the successful electrolytic separation event is evaluated to have occurred; the controller is configured to reset the electrical parameter information when the measured elapsed time reaches a second elapsed time threshold that is greater than the first elapsed time threshold and it is determined that a successful electrolytic separation event has not occurred. [Claim 10] 10. The electrolytic separation device according to claim 9, 1. An electrolytic separation device, wherein the first elapsed time threshold is within a range of 3 to 10 seconds, and the second elapsed time threshold is within a range of 25 to 45 seconds. [Claim 11] 2. The electrolytic separation device according to claim 1, the controller is configured to generate a first user-identifiable notification when the successful electrolytic separation event is assessed to have occurred; the controller is configured to generate a second user-identifiable notification different from the first user-identifiable notification if it is determined that the successful electrolytic separation event has not occurred. [Claim 12] 2. The electrolytic separation device according to claim 1, 10. The electrolytic separation device according to claim 9, wherein the electrical parameter information includes a measured electrolytic work value performed by the current supply circuit, and the controller is configured to evaluate that the successful electrolytic separation event has not occurred if the measured electrolytic work value does not reach an electrolytic work threshold, and to evaluate that the successful electrolytic separation event has occurred if the measured electrolytic work value reaches the electrolytic work threshold. [Claim 13] 13. The electrolytic separation device of claim 12, 10. An electrolytic separation device, wherein the controller is configured to incrementally increase the electrolytic work threshold over time. [Claim 14] 2. The electrolytic separation device according to claim 1, 10. The electrolytic separation device of claim 9, further comprising a current supply actuator, wherein the controller is configured to supply current to the electrolytically severable junction during the electrolytic separation cycle by operating the current supply circuit in response to a single actuation of the current supply actuator. [Claim 15] 15. The electrolytic separation device of claim 14, the controller is configured to supply current to the electrolytically severable joint during another electrolytic separation cycle by operating the current supply circuit in response to another actuation of the current supply actuator. [Claim 16] 15. The electrolytic separation device of claim 14, 10. The electrolytic separation device of claim 9, wherein the electrolytic separation cycle has a fixed duration, and the controller is configured to evaluate whether the successful electrolytic separation event occurred during the fixed duration. [Claim 17] 17. The electrolytic separation device of claim 16, the controller is further configured to extend the electrolytic separation cycle only if it is determined that the successful electrolytic separation event has not occurred during the fixed period of time. [Claim 18] 18. The electrolytic separation device of claim 17, the fixed period is an initial fixed period, and the controller is configured to evaluate whether the successful electrolytic separation event has occurred by the end of the initial fixed period, and to extend the electrolytic separation cycle by a subsequent variable period only if it is determined that the successful electrolytic separation event has not occurred during the initial fixed period. [Claim 19] 19. The electrolytic separation device of claim 18, the controller is configured to incrementally evaluate whether the successful electrolytic separation event has occurred during the subsequent variable period of time, and to terminate the electrolytic separation cycle if it is evaluated that the successful electrolytic separation event has occurred. [Claim 20] 20. The electrolytic separation device of claim 19, the subsequent variable period of time comprises a plurality of time increments, each time increment being shorter than the initial fixed period of the electrolytic separation cycle, and the controller is configured to progressively evaluate whether the successful electrolytic separation event occurred during each of the plurality of time increments, and to terminate the electrolytic separation cycle at the end of a time increment in which the successful electrolytic separation event is evaluated to have occurred. [Claim 21] 18. The electrolytic separation device of claim 17, the controller is configured to determine whether an electrolytic anomaly has occurred during the supply of current to the electrolytically separable joint, and to extend the electrolytic separation cycle only when it is determined that an electrolytic anomaly has not occurred during the supply of current to the electrolytically separable joint. [Claim 22] 22. The electrolytic separation device of claim 21, the electrical parameter information includes a measured electrolytic work value performed by the current supply circuit, and the controller is configured to determine that an electrolytic anomaly has occurred during the supply of current to the electrolytically severable joint if the measured electrolytic work value is outside an electrolytic work value range defined by a minimum electrolytic work limit value and a maximum electrolytic work limit value. [Claim 23] 18. The electrolytic separation device of claim 17, 12. The electrolytic separation device of claim 11, further comprising a counter configured to track a number of completed electrolytic separation cycles, wherein the controller is configured to not extend the electrolytic separation cycles if the tracked number of completed electrolytic separation cycles exceeds a preset number of electrolytic separation cycles. [Claim 24] A vascular occlusion treatment system, comprising: a delivery catheter configured to be introduced into a patient's vascular system, the delivery catheter including an elongate sheath body, an inner lumen extending through the elongate sheath body, and a distal port each in communication with the inner lumen; a vaso-occlusive assembly configured to be disposed within the inner lumen of the delivery catheter, the vaso-occlusive assembly comprising a delivery wire and a vaso-occlusive device detachably connected to the delivery wire via an electrolytically severable joint, the vaso-occlusive device configured to be deployed into the patient's vasculature from a distal port of the delivery catheter; 1. A vascular occlusion treatment system comprising: an electrolytic separation device configured to electrically connect and electrically disconnect a proximal end of a delivery wire of the vascular occlusion assembly; the electrolytic separation device configured to supply current to an electrolytically severable joint of the vascular occlusion assembly while the vascular occlusion device is positioned within a patient's vasculature so as to electrolytically separate the vascular occlusion device from the distal end of the delivery wire; generate electrical parameter information indicative of a successful electrolytic detachment event; evaluate whether the successful electrolytic detachment event has occurred based on the generated electrical parameter information; measure an elapsed time between a delivery wire detachment event and a subsequent delivery wire connection event; and reset the electrical parameter information when the measured elapsed time reaches a first elapsed time threshold. [Claim 25] 25. The vascular occlusion treatment system according to claim 24, 10. A vascular occlusion treatment system, further comprising a ground electrode positioned in electrical contact with a patient and configured to be electrically connected to the electrolytic separation device via an electrical cable. [Claim 26] 25. The vascular occlusion treatment system according to claim 24, A vascular occlusion treatment system, wherein the electrolytic separation device is a handheld electrolytic separation device. [Claim 27] 25. The vascular occlusion treatment system according to claim 24, The vascular occlusion treatment system, wherein the electrical parameter information includes a measured cumulative electrical parameter. [Claim 28] 28. The vascular occlusion treatment system according to claim 27, The vascular occlusion treatment system, wherein the cumulative electrical parameter comprises a measured cumulative current. [Claim 29] 25. The vascular occlusion treatment system according to claim 24, The vascular occlusion treatment system, wherein the electrical parameter information includes measured electrolytic work performed by the electrolytic separation device. [Claim 30] 25. The vascular occlusion treatment system according to claim 24, A vascular occlusion treatment system, wherein the first elapsed time threshold is 3 seconds or more. [Claim 31] 25. The vascular occlusion treatment system according to claim 24, A vascular occlusion treatment system, wherein the first elapsed time threshold is within a range of 25 to 45 seconds. [Claim 32] 25. The vascular occlusion treatment system according to claim 24, the electrolytic separation device is configured to reset the electrical parameter information when the measured elapsed time reaches the first elapsed time threshold and it is determined that the successful electrolytic separation event has occurred, and to reset the electrical parameter information when the measured elapsed time reaches a second elapsed time threshold that is greater than the first elapsed time threshold and it is determined that the successful electrolytic separation event has not occurred. [Claim 33] 33. The vascular occlusion treatment system according to claim 32, A vascular occlusion treatment system, wherein the first elapsed time threshold is within a range of 3 to 10 seconds, and the second elapsed time threshold is within a range of 25 to 45 seconds. [Claim 34] 33. The vascular occlusion treatment system according to claim 32, the delivery catheter further comprising another inner lumen extending through the elongate sheath body and another distal port respectively communicating with the other inner lumen; the vascular occlusion treatment system further includes another vascular occlusion assembly configured to be disposed within the inner lumen of the delivery catheter, the another vascular occlusion assembly including a delivery wire and a vascular occlusion device detachably connected to the delivery wire via an electrolytically severable joint, the another vascular occlusion device configured to be deployed into the patient's vasculature from another distal port of the delivery catheter; a proximal end of a delivery wire of another vaso-occlusive assembly configured to be electrically connected to said electrolytic separation device, and a proximal end of a delivery wire of another vaso-occlusive assembly configured to be electrically isolated from said electrolytic separation device; the electrolytic separation device is configured to supply current to the electrolytically severable joint of the vaso-occlusive assembly such that the vaso-occlusive device electrolytically separates from the distal end of the delivery wire while another vaso-occlusive device is positioned within the patient's vasculature; 1. A vascular occlusion treatment system, comprising: a delivery wire disconnection event comprising disconnecting a delivery wire of the vasoocclusion assembly from the electrolytic separation device; and a subsequent delivery wire connection event comprising reconnecting a delivery wire of the vasoocclusion assembly to the electrolytic separation device or connecting a delivery wire of another vasoocclusion assembly to the electrolytic separation device. [Claim 35] 25. The vascular occlusion treatment system according to claim 24, The electrolytic separation device is configured to generate a first user-identifiable notification when it is determined that the successful electrolytic separation event has occurred, and to generate a second user-identifiable notification different from the first user-identifiable notification when it is determined that the successful electrolytic separation event has not occurred. [Claim 36] 25. The vascular occlusion treatment system according to claim 24, 10. A vascular occlusion treatment system, comprising: a first electrolytic separation device configured to: determine whether a successful electrolytic separation event has occurred; a second electrolytic separation device configured to determine whether a successful electrolytic separation event has occurred; a second electrolytic separation device configured to determine whether a successful electrolytic separation event has occurred; and a third electrolytic separation device configured to determine whether a successful electrolytic separation event has occurred; [Claim 37] 37. The vascular occlusion treatment system according to claim 36, 10. A vascular occlusion treatment system, wherein the electrolytic separation device is configured to incrementally increase the electrolytic work threshold over time. [Claim 38] 25. The vascular occlusion treatment system according to claim 24, 1. A vascular occlusion treatment system, comprising: an electrolytic separation device configured to supply an electric current to the electrolytically severable joint during the electrolytic separation cycle in response to a single actuation of the electrolytic separation device. [Claim 39] 39. The vascular occlusion treatment system according to claim 38, the electrolytic separation device is configured to supply current to the electrolytically severable joint during another electrolytic separation cycle in response to another single actuation of the electrolytic separation device. [Claim 40] 39. The vascular occlusion treatment system according to claim 38, 10. A vascular occlusion treatment system, comprising: an electrolytic separation cycle having a fixed duration; and an electrolytic separation device configured to evaluate whether the successful electrolytic separation event occurred during the fixed duration. [Claim 41] 41. The vascular occlusion treatment system according to claim 40, the electrolytic separation device is further configured to extend the electrolytic separation cycle only if it is determined that the successful electrolytic separation event has not occurred during the fixed period of time. [Claim 42] 42. The vascular occlusion treatment system according to claim 41, the fixed period is an initial fixed period, and the electrolytic separation device is configured to evaluate whether the successful electrolytic separation event has occurred by the end of the initial fixed period, and to extend the electrolytic separation cycle by a subsequent variable period only if it is determined that the successful electrolytic separation event has not occurred during the initial fixed period. [Claim 43] 43. The vascular occlusion treatment system according to claim 42, the electrolytic separation device is configured to incrementally evaluate whether the successful electrolytic separation event has occurred during the subsequent variable time period, and to terminate the electrolytic separation cycle if it is determined that the successful electrolytic separation event has occurred. [Claim 44] 44. The vascular occlusion treatment system according to claim 43, the subsequent variable period of time comprises a plurality of time increments, each time increment being shorter than the initial fixed period of the electrolytic separation cycle; and the electrolytic separation device is configured to progressively evaluate whether the successful electrolytic separation event occurred during each of the plurality of time increments, and to terminate the electrolytic separation cycle at the end of a time increment in which the successful electrolytic separation event was evaluated to have occurred. [Claim 45] 42. The vascular occlusion treatment system according to claim 41, the electrolytic separation device is configured to determine whether an electrolytic anomaly has occurred during the supply of current to the electrolytically severable joint, and to extend the electrolytic separation cycle only if it is determined that an electrolytic anomaly has not occurred during the supply of current to the electrolytically severable joint. [Claim 46] 46. ​​The vascular occlusion treatment system according to claim 45, 10. A vascular occlusion treatment system comprising: a first electrolytic separation device configured to: determine that an electrolytic anomaly has occurred during the supply of current to the electrolytically severable joint when the electrical parameter information includes a measured electrolytic work value performed by the electrolytic separation device; and a second electrolytic separation device configured to determine that an electrolytic anomaly has occurred during the supply of current to the electrolytically severable joint when the measured electrolytic work value is outside an electrolytic work range defined by a minimum electrolytic work limit value and a maximum electrolytic work limit value. [Claim 47] 42. The vascular occlusion treatment system according to claim 41, 1. A vascular occlusion treatment system, comprising: the electrolytic separation device configured to track a number of completed electrolytic separation cycles; and the electrolytic separation device configured to not extend the electrolytic separation cycle if the tracked number of completed electrolytic separation cycles exceeds a preset limit number of electrolytic separation cycles. [Claim 48] 48. The vascular occlusion treatment system according to claim 47, A vascular occlusion treatment system, wherein the vascular occlusion device is a vascular occlusion coil. [Claim 49] 1. A method of occluding a patient's vasculature using a vaso-occlusion assembly, comprising: The vaso-occlusive assembly comprises a delivery wire and a vaso-occlusive device detachably connected to a distal end of the delivery wire via an electrolytically severable joint, and the method comprises: introducing the configured delivery catheter into the patient's vasculature; placing the vaso-occlusive assembly within the delivery catheter such that the vaso-occlusive device is positioned outside of the delivery catheter within the patient's vasculature; electrically connecting a proximal end of a delivery wire of the vaso-occlusive assembly to a power source; applying an electrical current from the power source to an electrolytically severable joint of the vaso-occlusive assembly while the vaso-occlusive device is positioned within the patient's vasculature; generating electrical parameter information indicative of a successful electrolytic separation event; evaluating whether a successful electrolytic separation event has occurred based on the generated electrical parameter information; measuring the elapsed time between a delivery wire detachment event and a subsequent delivery wire attachment event; and resetting the electrical parameter information when the measured elapsed time reaches a first elapsed time threshold. [Claim 50] 50. The method of claim 49, contacting a ground electrode to a patient; and electrically connecting the ground electrode to the power source such that an electrical current is provided between the delivery wire and the ground electrode. [Claim 51] 50. The method of claim 49, The method, wherein the electrical parameter information includes measured cumulative electrical parameters. [Claim 52] 52. The method of claim 51, The method, wherein the cumulative electrical parameter comprises a measured cumulative current. [Claim 53] 50. The method of claim 49, The method, wherein the electrical parameter information includes measured electrolytic work performed by the power supply. [Claim 54] 50. The method of claim 49, The method, wherein the first elapsed time threshold is greater than or equal to 3 seconds. [Claim 55] 50. The method of claim 49, The method, wherein the first elapsed time threshold is within a range of 25 seconds to 45 seconds. [Claim 56] 50. The method of claim 49, wherein the electrical parameter information is reset when the measured elapsed time reaches the first elapsed time threshold and it is determined that the successful electrolytic separation event has occurred, and wherein the electrical parameter information is reset when the measured elapsed time reaches a second elapsed time threshold that is greater than the first elapsed time threshold and it is determined that the successful electrolytic separation event has not occurred. [Claim 57] 57. The method of claim 56, 10. The method of claim 1, wherein the first elapsed time threshold is in a range of 3 to 10 seconds, and the second elapsed time threshold is in a range of 25 to 45 seconds. [Claim 58] 57. The method of claim 56, placing another vaso-occlusive assembly within the delivery catheter, wherein both the vaso-occlusive device and another vaso-occlusive device are positioned outside the delivery catheter within the patient's vasculature, the another vaso-occlusive assembly including a delivery wire and a vaso-occlusive device detachably connected to a distal end of the delivery wire via an electrolytically severable joint; after assessing whether the successful electrolytic detachment event has occurred, electrically connecting a proximal end of a delivery wire of another vaso-occlusive assembly to the power source; and resetting the electrical parameter information after the proximal end of a delivery wire of another vaso-occlusion assembly is electrically connected to the power source. [Claim 59] 50. The method of claim 49, generating a first user-identifiable notification if the successful electrolytic separation event is evaluated to have occurred; and if it is determined that the successful electrolytic separation event has not occurred, generating a second user-identifiable notification that is different from the first user-identifiable notification. [Claim 60] 50. The method of claim 49, the electrical parameter information includes a measured electrolytic work value performed by the power source, and the electrolytic separation device is configured to evaluate the successful electrolytic separation event as not occurring if the measured electrolytic work value does not reach an electrolytic work threshold, and to evaluate the successful electrolytic separation event as occurring if the measured electrolytic work value reaches the electrolytic work threshold. [Claim 61] 61. The method of claim 60, The method further comprising the step of gradually increasing the electrolytic work threshold over time. [Claim 62] 50. The method of claim 49, a current is applied to said electrolytically severable joint during an electrolytic separation cycle. [Claim 63] 63. The method of claim 62, a method wherein an electric current is applied to said electrolytically severable joint during another electrolytic separation cycle; [Claim 64] 63. The method of claim 62, The method, wherein the electrolytic separation cycle has a fixed duration, and the occurrence of the successful electrolytic separation event during the fixed duration is evaluated. [Claim 65] 65. The method of claim 64, The method further comprising extending the electrolytic separation cycle only if it is determined that the successful electrolytic separation event has not occurred during the fixed period of time. [Claim 66] 66. The method of claim 65, the fixed period is an initial fixed period, the occurrence of the successful electrolytic separation event is evaluated through the end of the initial fixed period, and the electrolytic separation cycle is extended by a subsequent variable period only if it is evaluated that the successful electrolytic separation event has not occurred during the initial fixed period. [Claim 67] 67. The method of claim 66, evaluating stepwise whether the successful electrolytic separation event occurred during the subsequent variable time period; and terminating the electrolytic separation cycle if it is determined that a successful electrolytic separation event has occurred. [Claim 68] 68. The method of claim 67, the subsequent variable period of time comprises a plurality of time increments, each time increment being shorter than the initial fixed period of the electrolytic separation cycle, the method comprising: evaluating in a stepwise manner whether the successful electrolytic separation event occurred during each of the plurality of time increments; and terminating the electrolytic separation cycle at the end of a time increment in which the successful electrolytic separation event was evaluated to have occurred. [Claim 69] 66. The method of claim 65, the method further comprising the step of determining whether an electrolytic anomaly has occurred during the application of current to the electrolytically severable joint, and wherein the electrolytic separation cycle is extended only if it is determined that an electrolytic anomaly has not occurred during the application of current to the electrolytically severable joint. [Claim 70] 70. The method of claim 69, the electrical parameter information includes measured electrolysis work performed by the power supply, and if the measured electrolysis work is outside an electrolysis work range defined by a minimum electrolysis work limit and a maximum electrolysis work limit, it is determined that an electrolysis anomaly has occurred during the supply of current to the electrolytically severable joint. [Claim 71] 66. The method of claim 65, The method further comprising the step of tracking the number of completed electrolytic separation cycles, wherein if the tracked number of extended electrolytic separation cycles exceeds a preset limit of electrolytic separation cycles, the electrolytic separation cycles are not extended. [Claim 72] 50. The method of claim 49, The method, wherein the vaso-occlusive device is a vaso-occlusive coil. [Claim 73] 50. The method of claim 49, The method, wherein the vaso-occlusive device is placed within an aneurysmal sac in the patient's vasculature. [Claim 74] 1. An electrolytic separation device for use with an electrically conductive delivery wire, the delivery wire having a distal end to which a vaso-occlusive device is attached and an electrolytically severable junction located proximal to the vaso-occlusive device, the electrolytic separation device comprising: a power terminal configured to electrically connect to a proximal end of each of the delivery wires; a current supply circuit configured to supply current to the electrolytically severable joint of the vaso-occlusive assembly when positioned within a patient's vasculature such that the vaso-occlusive device electrolytically separates from the distal end of the delivery wire; an electrolytic detachment detection circuit configured to generate electrical parameter information indicative of an electrolytic detachment event; and a controller configured to operate the current supply circuit to supply current to the electrolytically severable junction during an electrolytic separation cycle having a fixed duration, to evaluate whether a successful electrolytic separation event has occurred during the fixed duration based on the generated electrical parameter information, and to extend the electrolytic separation cycle only if it is determined that a successful electrolytic separation event has not occurred during the fixed duration. [Claim 75] 75. The electrolytic separation device of claim 74, 1. An electrolytic isolation device, further comprising a ground terminal configured to be electrically connected via an electrical cable to a ground electrode that is in electrical contact with a patient. [Claim 76] 75. The electrolytic separation device of claim 74, The electrolytic separation device, wherein the power terminal is a power port configured to receive the proximal end of the delivery wire. [Claim 77] 75. The electrolytic separation device of claim 74, The electrolytic separation device, wherein the electrical parameter information includes a measured cumulative electrical parameter. [Claim 78] 78. The electrolytic separation device of claim 77, The electrolytic separation device, wherein the cumulative electrical parameter comprises a measured cumulative current. [Claim 79] 75. The electrolytic separation device of claim 74, Electrolytic separation device, wherein the electrical parameter information includes measured electrolytic work performed by the current supply circuit. [Claim 80] 75. The electrolytic separation device of claim 74, 10. The electrolytic separation device of claim 9, wherein the fixed period is an initial fixed period, and the controller is configured to extend the electrolytic separation cycle by a subsequent variable period. [Claim 81] 81. The electrolytic separation device of claim 80, the controller is configured to incrementally evaluate whether the successful electrolytic separation event has occurred during the subsequent variable period of time, and to terminate the electrolytic separation cycle if it is evaluated that the successful electrolytic separation event has occurred. [Claim 82] 82. The electrolytic separation device of claim 81, the subsequent variable period of time comprises a plurality of time increments, each time increment being shorter than the initial fixed period of the electrolytic separation cycle, and the controller is configured to progressively evaluate whether the successful electrolytic separation event occurred during each of the plurality of time increments, and to terminate the electrolytic separation cycle at the end of a time increment in which the successful electrolytic separation event is evaluated to have occurred. [Claim 83] 75. The electrolytic separation device of claim 74, the controller is configured to determine whether an electrolytic anomaly has occurred during the supply of current to the electrolytically separable joint, and to extend the electrolytic separation cycle only when it is determined that an electrolytic anomaly has not occurred during the supply of current to the electrolytically separable joint. [Claim 84] 84. The electrolytic separation device of claim 83, the electrical parameter information includes a measured electrolytic work value performed by the current supply circuit, and the controller is configured to determine that an electrolytic anomaly has occurred during the supply of current to the electrolytically severable joint if the measured electrolytic work value is outside an electrolytic work value range defined by a minimum electrolytic work limit value and a maximum electrolytic work limit value. [Claim 85] 75. The electrolytic separation device of claim 74, 10. The electrolytic separation device of claim 9, further comprising a current supply actuator, wherein the controller is configured to supply current to the electrolytically severable joint during the electrolytic separation cycle by operating the current supply circuit in response to a single actuation of the current supply actuator. [Claim 86] 86. The electrolytic separation device of claim 85, the controller is configured to, in response to another actuation of the current supplying actuator, operate the current supplying circuit to supply current to the electrolytically severable junction during another electrolytic separation cycle having an initial fixed duration. [Claim 87] 75. The electrolytic separation device of claim 74, 12. The electrolytic separation device of claim 11, further comprising a counter configured to track a number of completed electrolytic separation cycles, wherein the controller is configured to not extend the electrolytic separation cycles if the tracked number of completed electrolytic separation cycles exceeds a preset number of electrolytic separation cycles. [Claim 88] 75. The electrolytic separation device of claim 74, 10. The electrolytic separation device of claim 9, further comprising a timer configured to measure an elapsed time between a delivery wire detachment event and a subsequent delivery wire connection event, wherein the controller is configured to reset the electrical parameter information when the measured elapsed time reaches a first elapsed time threshold. [Claim 89] 89. The electrolytic separation device of claim 88, 10. An electrolytic separation device, wherein the first elapsed time threshold is 3 seconds or greater. [Claim 90] 89. The electrolytic separation device of claim 88, 10. An electrolytic separation device, wherein the first elapsed time threshold is within a range of 25 to 45 seconds. [Claim 91] 89. The electrolytic separation device of claim 88, the controller is configured to reset the electrical parameter information when the measured elapsed time reaches the first elapsed time threshold and the successful electrolytic separation event is evaluated to have occurred; the controller is configured to reset the electrical parameter information when the measured elapsed time reaches a second elapsed time threshold that is greater than the first elapsed time threshold and it is determined that a successful electrolytic separation event has not occurred. [Claim 92] 92. The electrolytic separation device of claim 91, 1. An electrolytic separation device, wherein the first elapsed time threshold is within a range of 3 to 10 seconds, and the second elapsed time threshold is within a range of 25 to 45 seconds. [Claim 93] 75. The electrolytic separation device of claim 74, the controller is configured to generate a first user-identifiable notification when the successful electrolytic separation event is assessed to have occurred; the controller is configured to generate a second user-identifiable notification different from the first user-identifiable notification if it is determined that the successful electrolytic separation event has not occurred. [Claim 94] 75. The electrolytic separation device of claim 74, 10. The electrolytic separation device according to claim 9, wherein the electrical parameter information includes a measured electrolytic work value performed by the current supply circuit, and the controller is configured to evaluate that the successful electrolytic separation event has not occurred during a fixed period of the electrolytic separation cycle if the measured electrolytic work value does not reach an electrolytic work threshold, and to evaluate that the successful electrolytic separation event has occurred during a fixed period of the electrolytic separation cycle if the measured electrolytic work value reaches the electrolytic work threshold. [Claim 95] 95. The electrolytic separation device of claim 94, 10. An electrolytic separation device, wherein the controller is configured to incrementally increase the electrolytic work threshold over an extended electrolytic separation cycle. [Claim 96] A vascular occlusion treatment system, comprising: a delivery catheter configured to be introduced into a patient's vascular system, the delivery catheter including an elongate sheath body, an inner lumen extending through the elongate sheath body, and a distal port each in communication with the inner lumen; a vaso-occlusive assembly configured to be disposed within the inner lumen of the delivery catheter, the vaso-occlusive assembly comprising a delivery wire and a vaso-occlusive device detachably connected to the delivery wire via an electrolytically severable joint, the vaso-occlusive device configured to be deployed into the patient's vasculature from a distal port of the delivery catheter; 1. A vascular occlusion treatment system comprising: an electrolytic separation device configured to electrically connect and electrically disconnect a proximal end of a delivery wire of the vaso-occlusion assembly; wherein the electrolytic separation device supplies current to an electrolytically severable joint of the vaso-occlusion assembly during an electrolytic separation cycle having a fixed duration while the vaso-occlusion device is positioned within a patient's vasculature so as to electrolytically separate the vaso-occlusion device from the distal end of the delivery wire; generates electrical parameter information indicative of a successful electrolytic separation event; evaluates whether the successful electrolytic separation event has occurred during the fixed duration based on the generated electrical parameter information; and extends the electrolytic separation cycle only if it is determined that the successful electrolytic separation event has not occurred during the fixed duration. [Claim 97] 97. The vascular occlusion treatment system of claim 96, 10. A vascular occlusion treatment system, further comprising a ground electrode positioned in electrical contact with a patient and configured to be electrically connected to the electrolytic separation device via an electrical cable. [Claim 98] 97. The vascular occlusion treatment system of claim 96, A vascular occlusion treatment system, wherein the electrolytic separation device is a handheld electrolytic separation device. [Claim 99] 97. The vascular occlusion treatment system of claim 96, The vascular occlusion treatment system, wherein the electrical parameter information includes a measured cumulative electrical parameter. [Claim 100] 100. The vascular occlusion treatment system of claim 99, The vascular occlusion treatment system, wherein the cumulative electrical parameter comprises a measured cumulative current. [Claim 101] 97. The vascular occlusion treatment system of claim 96, The vascular occlusion treatment system, wherein the electrical parameter information includes measured electrolytic work performed by the electrolytic separation device. [Claim 102] 97. The vascular occlusion treatment system of claim 96, 10. A vascular occlusion treatment system, wherein the fixed period is an initial fixed period, and the electrolytic separation device is configured to extend the electrolytic separation cycle for a subsequent variable period. [Claim 103] 103. The vascular occlusion treatment system of claim 102, the electrolytic separation device is configured to incrementally evaluate whether the successful electrolytic separation event has occurred during the subsequent variable time period, and to terminate the electrolytic separation cycle if it is determined that the successful electrolytic separation event has occurred. [Claim 104] 104. The vascular occlusion treatment system of claim 103, the subsequent variable period of time comprises a plurality of time increments, each time increment being shorter than the initial fixed period of the electrolytic separation cycle; and the electrolytic separation device is configured to progressively evaluate whether the successful electrolytic separation event occurred during each of the plurality of time increments, and to terminate the electrolytic separation cycle at the end of a time increment in which the successful electrolytic separation event was evaluated to have occurred. [Claim 105] 97. The vascular occlusion treatment system of claim 96, the electrolytic separation device is configured to determine whether an electrolytic anomaly has occurred during the supply of current to the electrolytically severable joint, and to extend the electrolytic separation cycle only if it is determined that an electrolytic anomaly has not occurred during the supply of current to the electrolytically severable joint. [Claim 106] 106. The vascular occlusion treatment system of claim 105, 10. A vascular occlusion treatment system comprising: a first electrolytic separation device configured to: determine that an electrolytic anomaly has occurred during the supply of current to the electrolytically severable joint when the electrical parameter information includes a measured electrolytic work value performed by the electrolytic separation device; and a second electrolytic separation device configured to determine that an electrolytic anomaly has occurred during the supply of current to the electrolytically severable joint when the measured electrolytic work value is outside an electrolytic work range defined by a minimum electrolytic work limit value and a maximum electrolytic work limit value. [Claim 107] 97. The vascular occlusion treatment system of claim 96, 1. A vascular occlusion treatment system, comprising: an electrolytic separation device configured to supply an electric current to the electrolytically severable joint during the electrolytic separation cycle in response to a single actuation of the electrolytic separation device. [Claim 108] 108. The vascular occlusion treatment system of claim 107, the electrolytic separation device is configured to supply current to the electrolytically severable junction during another electrolytic separation cycle having an initial fixed duration in response to another single actuation of the electrolytic separation device. [Claim 109] 97. The vascular occlusion treatment system of claim 96, 10. A vascular occlusion treatment system, comprising: an electrolytic separation device configured to track the number of completed electrolytic separation cycles and not extend the electrolytic separation cycles if the tracked number of completed electrolytic separation cycles exceeds a preset limit number of electrolytic separation cycles. [Claim 110] 97. The vascular occlusion treatment system of claim 96, 1. A vascular occlusion treatment system, comprising: a first electrolytic isolation device configured to measure an elapsed time between a delivery wire detachment event and a subsequent delivery wire connection event; and to reset the electrical parameter information when the measured elapsed time reaches a first elapsed time threshold. [Claim 111] 111. The vascular occlusion treatment system of claim 110, A vascular occlusion treatment system, wherein the first elapsed time threshold is 3 seconds or more. [Claim 112] 111. The vascular occlusion treatment system of claim 110, A vascular occlusion treatment system, wherein the first elapsed time threshold is within a range of 25 to 45 seconds. [Claim 113] 111. The vascular occlusion treatment system of claim 110, the controller is configured to reset the electrical parameter information when the measured elapsed time reaches the first elapsed time threshold and the successful electrolytic separation event is evaluated to have occurred; the controller is configured to reset the electrical parameter information when the measured elapsed time reaches a second elapsed time threshold that is greater than the first elapsed time threshold and when it is determined that the successful electrolytic detachment event has not occurred. [Claim 114] 114. The vascular occlusion treatment system of claim 113, A vascular occlusion treatment system, wherein the first elapsed time threshold is within a range of 3 to 10 seconds, and the second elapsed time threshold is within a range of 25 to 45 seconds. [Claim 115] 114. The vascular occlusion treatment system of claim 113, the delivery catheter further comprising another inner lumen extending through the elongate sheath body and another distal port respectively communicating with the other inner lumen; the vascular occlusion treatment system further includes another vascular occlusion assembly configured to be disposed within the inner lumen of the delivery catheter, the another vascular occlusion assembly including a delivery wire and a vascular occlusion device detachably connected to the delivery wire via an electrolytically severable joint, the another vascular occlusion device configured to be deployed into the patient's vasculature from another distal port of the delivery catheter; a proximal end of a delivery wire of another vaso-occlusive assembly configured to be electrically connected to said electrolytic separation device, a proximal end of a delivery wire of another vaso-occlusive assembly configured to be electrically isolated from said electrolytic separation device, and applying an electric current to the electrolytically severable joint of the vaso-occlusive assembly while the other vaso-occlusive assembly is positioned within the vasculature of the patient such that the other vaso-occlusive device is electrolytically isolated from the distal end of said delivery wire; 1. A vascular occlusion treatment system, comprising: a delivery wire disconnection event comprising disconnecting a delivery wire of the vasoocclusion assembly from the electrolytic separation device; and a subsequent delivery wire connection event comprising reconnecting a delivery wire of the vasoocclusion assembly to the electrolytic separation device or connecting a delivery wire of another vasoocclusion assembly to the electrolytic separation device. [Claim 116] 97. The vascular occlusion treatment system of claim 96, The electrolytic separation device is configured to generate a first user-identifiable notification when it is determined that the successful electrolytic separation event has occurred, and to generate a second user-identifiable notification different from the first user-identifiable notification when it is determined that the successful electrolytic separation event has not occurred. [Claim 117] 97. The vascular occlusion treatment system of claim 96, 10. A vascular occlusion treatment system, comprising: a device for treating a vascular occlusion, the device being further configured to: determine that a successful electrolytic separation event has not occurred during a fixed period of the electrolytic separation cycle if the measured electrolytic work value does not reach an electrolytic work threshold; and determine that a successful electrolytic separation event has occurred during a fixed period of the electrolytic separation cycle if the measured electrolytic work value reaches the electrolytic work threshold. [Claim 118] 118. The vascular occlusion treatment system of claim 117, 10. A vascular occlusion treatment system, wherein the electrolytic separation device is configured to incrementally increase the electrolytic work threshold over an extended electrolytic separation cycle. [Claim 119] 97. The vascular occlusion treatment system of claim 96, A vascular occlusion treatment system, wherein the vascular occlusion device is a vascular occlusion coil. [Claim 120] 1. A method of occluding a patient's vasculature using a vaso-occlusion assembly, comprising: The vaso-occlusive assembly comprises a delivery wire and a vaso-occlusive device detachably connected to a distal end of the delivery wire via an electrolytically severable joint, and the method comprises: introducing the configured delivery catheter into the patient's vasculature; placing the vaso-occlusive assembly within the delivery catheter such that the vaso-occlusive device is positioned outside of the delivery catheter within the patient's vasculature; electrically connecting a proximal end of a delivery wire of the vaso-occlusive assembly to a power source; applying electrical current from the power source to the electrolytically severable joints of the vaso-occlusive assembly during an electrolytic detachment cycle having a fixed duration while the vaso-occlusive device is positioned within the patient's vasculature; generating electrical parameter information indicative of a successful electrolytic separation event; evaluating whether the successful electrolytic separation event occurred during a fixed period of the electrolytic separation cycle based on the generated electrical parameter information; and extending the electrolytic separation cycle only if it is determined that the successful electrolytic separation event has not occurred during the fixed period of time. [Claim 121] 121. The method of claim 120, contacting a ground electrode to a patient; and electrically connecting the ground electrode to the power source such that an electrical current is provided between the delivery wire and the ground electrode. [Claim 122] 121. The method of claim 120, The method, wherein the electrical parameter information includes measured cumulative electrical parameters. [Claim 123] 123. The method of claim 122, The method, wherein the cumulative electrical parameter comprises a measured cumulative current. [Claim 124] 121. The method of claim 120, The method, wherein the electrical parameter information includes measured electrolytic work performed by the power supply. [Claim 125] 121. The method of claim 120, The method wherein the fixed period is an initial fixed period and the electrolytic separation cycle is extended by a subsequent variable period. [Claim 126] 126. The method of claim 125, evaluating stepwise whether the successful electrolytic separation event occurred during the subsequent variable time period; and terminating the electrolytic separation cycle when it is determined that a successful electrolytic separation event has occurred. [Claim 127] 127. The method of claim 126, the subsequent variable period of time comprises a plurality of time increments, each time increment being shorter than the initial fixed period of the electrolytic separation cycle, the method comprising: evaluating in a stepwise manner whether the successful electrolytic separation event occurred during each of the plurality of time increments; and terminating the electrolytic separation cycle at the end of a time increment in which the successful electrolytic separation event was evaluated to have occurred. [Claim 128] 126. The method of claim 125, the method further comprising the step of determining whether an electrolytic anomaly has occurred during the application of current to the electrolytically severable joint, and wherein the electrolytic separation cycle is extended only if it is determined that an electrolytic anomaly has not occurred during the application of current to the electrolytically severable joint. [Claim 129] 129. The method of claim 128, the electrical parameter information includes measured electrolysis work performed by the power supply, and if the measured electrolysis work is outside an electrolysis work range defined by a minimum electrolysis work limit and a maximum electrolysis work limit, it is determined that an electrolysis anomaly has occurred during the supply of current to the electrolytically severable joint. [Claim 130] 121. The method of claim 120, 10. The method of claim 9, further comprising the step of applying an electric current to an electrolytically severable joint of the vaso-occlusive assembly during another electrolytic detachment cycle having a fixed duration while the vaso-occlusive device is positioned within the patient's vasculature. [Claim 131] 121. The method of claim 120, The method further comprising the step of tracking the number of completed electrolytic separation cycles, wherein the electrolytic separation cycles are not extended if the tracked number of completed electrolytic separation cycles exceeds a preset limit of electrolytic separation cycles. [Claim 132] 121. The method of claim 120, measuring the elapsed time between a delivery wire detachment event and a subsequent delivery wire attachment event; and resetting the electrical parameter information if the measured elapsed time reaches a first elapsed time threshold. [Claim 133] 133. The method of claim 132, The method, wherein the first elapsed time threshold is greater than or equal to 3 seconds. [Claim 134] 133. The method of claim 132, The method, wherein the first elapsed time threshold is within a range of 25 seconds to 45 seconds. [Claim 135] 133. The method of claim 132, wherein the electrical parameter information is reset when the measured elapsed time reaches the first elapsed time threshold and it is determined that the successful electrolytic separation event has occurred, and wherein the electrical parameter information is reset when the measured elapsed time reaches a second elapsed time threshold that is greater than the first elapsed time threshold and it is determined that the successful electrolytic separation event has not occurred. [Claim 136] 136. The method of claim 135, 10. The method of claim 1, wherein the first elapsed time threshold is in a range of 3 to 10 seconds, and the second elapsed time threshold is in a range of 25 to 45 seconds. [Claim 137] 136. The method of claim 135, placing another vaso-occlusive assembly within the delivery catheter, wherein both the vaso-occlusive device and another vaso-occlusive device are positioned outside the delivery catheter within the patient's vasculature, the another vaso-occlusive assembly including a delivery wire and a vaso-occlusive device detachably connected to a distal end of the delivery wire via an electrolytically severable joint; after assessing whether the successful electrolytic detachment event has occurred, electrically connecting a proximal end of a delivery wire of another vaso-occlusive assembly to the power source; and resetting the electrical parameter information after the proximal end of a delivery wire of another vaso-occlusion assembly is electrically connected to the power source. [Claim 138] 121. The method of claim 120, generating a first user-identifiable notification if the successful electrolytic separation event is evaluated to have occurred; and if it is determined that the successful electrolytic separation event has not occurred, generating a second user-identifiable notification that is different from the first user-identifiable notification. [Claim 139] 121. The method of claim 120, The method, wherein the electrical parameter information includes measured electrolytic work values ​​performed by the electrolytic separation device, and the successful electrolytic separation event is evaluated as not occurring during a fixed period of the electrolytic separation cycle if the measured electrolytic work value does not reach an electrolytic work threshold, and is evaluated as occurring during a fixed period of the electrolytic separation cycle if the measured electrolytic work value reaches the electrolytic work threshold. [Claim 140] 121. The method of claim 120, The method further comprising the step of gradually increasing the electrolytic work threshold over an extended electrolytic separation cycle. [Claim 141] 121. The method of claim 120, The method, wherein the vaso-occlusive device is a vaso-occlusive coil. [Claim 142] 121. The method of claim 120, The method, wherein the vaso-occlusive device is placed within an aneurysmal sac in the patient's vasculature. [Claim 143] 1. An electrolytic separation device for use with an electrically conductive delivery wire, the delivery wire having a distal end to which a vaso-occlusive device is attached and an electrolytically severable junction located proximal to the vaso-occlusive device, the electrolytic separation device comprising: a power terminal configured to electrically connect to a proximal end of each of the delivery wires; a current supply circuit configured to supply current to the electrolytically severable joint of the vaso-occlusive assembly when positioned within a patient's vasculature such that the vaso-occlusive device electrolytically separates from the distal end of the delivery wire; an electrolytic isolation detection circuit configured to incrementally measure the electrolytic work performed by the current supply circuit over time, thereby generating a plurality of measured electrolytic work values; a controller configured to operate the current supply circuit to supply current to the electrolytically severable joint, to generate a plurality of electrolytic work thresholds by incrementally increasing the electrolytic work threshold over time, to compare the plurality of measured electrolytic work values ​​with the plurality of electrolytic work thresholds, and to evaluate whether a successful electrolytic separation event has occurred based on the comparison results. [Claim 144] 144. The electrolytic separation device of claim 143, 1. An electrolytic isolation device, further comprising a ground terminal configured to be electrically connected via an electrical cable to a ground electrode that is in electrical contact with a patient. [Claim 145] 144. The electrolytic separation device of claim 143, The electrolytic separation device, wherein the power terminal is a power port configured to receive the proximal end of the delivery wire. [Claim 146] 144. The electrolytic separation device of claim 143, 10. An electrolytic separation device, comprising: an electrolytic separation detection circuit configured to incrementally measure the cumulative current supplied by the current supply circuit over time, thereby incrementally measuring the electrolytic work performed by the current supply circuit over time. [Claim 147] 144. The electrolytic separation device of claim 143, 10. The electrolytic separation device of claim 9, further comprising a current supply actuator, wherein the controller is configured to supply current to the electrolytically severable joint during the electrolytic separation cycle by operating the current supply circuit in response to a single actuation of the current supply actuator. [Claim 148] 148. The electrolytic separation device of claim 147, the controller is configured to supply current to the electrolytically severable joint during another electrolytic separation cycle by operating the current supply circuit in response to another actuation of the current supply actuator. [Claim 149] 148. The electrolytic separation device of claim 147, 10. The electrolytic separation device, wherein the electrolytic separation cycle has an initial fixed period, and the controller is configured to evaluate whether the successful electrolytic separation event occurred during the initial fixed period based on at least one of the comparison results. [Claim 150] 150. The electrolytic separation device of claim 149, the controller is configured to extend the electrolytic separation cycle only if it is determined that the successful electrolytic separation event has not occurred during the initial fixed period, and to determine whether the successful electrolytic separation event has occurred after the initial fixed period based on at least another one of the comparison results. [Claim 151] 151. The electrolytic separation device of claim 150, the initial fixed period is an initial fixed period, the controller is configured to evaluate whether the successful electrolytic separation event has occurred during the initial fixed period, and extend the electrolytic separation cycle by a subsequent variable period only if it is determined that the successful electrolytic separation event has not occurred during the initial fixed period, and the controller is configured to evaluate whether the successful electrolytic separation event has occurred during the subsequent variable period based on at least another one of the comparison results. [Claim 152] 152. The electrolytic separation device of claim 151, and wherein at least one of the comparison results includes a plurality of stepwise comparison results, and the controller is configured to stepwise evaluate whether the successful electrolytic separation event has occurred during the subsequent variable period based on the plurality of stepwise comparison results, and to terminate the electrolytic separation cycle when it is evaluated that the successful electrolytic separation event has occurred. [Claim 153] 153. The electrolytic separation device of claim 152, The subsequent variable period has a plurality of time increments, each time increment being shorter than the initial fixed period of the electrolytic separation cycle, and the controller is configured to evaluate in a stepwise manner whether the successful electrolytic separation event occurred during each of the plurality of time increments based on the results of the stepwise comparisons, and to terminate the electrolytic separation cycle at the end of a time increment in which it is evaluated that the successful electrolytic separation event occurred. [Claim 154] 151. The electrolytic separation device of claim 150, the controller is configured to determine whether an electrolytic anomaly has occurred during the supply of current to the electrolytically separable joint, and to extend the electrolytic separation cycle only when it is determined that an electrolytic anomaly has not occurred during the supply of current to the electrolytically separable joint. [Claim 155] 155. The electrolytic separation device of claim 154, the controller is configured to determine that an electrolytic anomaly has occurred during the supply of current to the electrolytically severable joint when the measured electrolytic work value is outside an electrolytic work value range defined by a minimum electrolytic work limit value and a maximum electrolytic work limit value. [Claim 156] 151. The electrolytic separation device of claim 150, 12. The electrolytic separation device of claim 11, further comprising a counter configured to track a number of completed electrolytic separation cycles, wherein the controller is configured to not extend the electrolytic separation cycles if the tracked number of completed electrolytic separation cycles exceeds a preset number of electrolytic separation cycles. [Claim 157] 144. The electrolytic separation device of claim 143, 1. The electrolytic separation device, further comprising: a timer configured to measure an elapsed time between a delivery wire separation event and a subsequent delivery wire connection event; and wherein the controller is configured to reset the incrementally measured electrolytic work value and the incrementally increased electrolytic work threshold when the measured elapsed time reaches a first elapsed time threshold. [Claim 158] 158. The electrolytic separation device of claim 157, 10. An electrolytic separation device, wherein the first elapsed time threshold is 3 seconds or greater. [Claim 159] 158. The electrolytic separation device of claim 157, 10. An electrolytic separation device, wherein the first elapsed time threshold is within a range of 25 to 45 seconds. [Claim 160] 158. The electrolytic separation device of claim 157, the controller is configured to reset the incrementally measured electrolytic work value and the incrementally increased electrolytic work threshold when the measured elapsed time reaches the first elapsed time threshold and the successful electrolytic separation event is evaluated to have occurred; the controller is configured to reset the incrementally measured electrolytic work value and the incrementally increased electrolytic work threshold when the measured elapsed time reaches a second elapsed time threshold that is greater than the first elapsed time threshold and it is determined that the successful electrolytic separation event has not occurred. [Claim 161] 161. The electrolytic separation device of claim 160, 1. An electrolytic separation device, wherein the first elapsed time threshold is within a range of 3 to 10 seconds, and the second elapsed time threshold is within a range of 25 to 45 seconds. [Claim 162] 144. The electrolytic separation device of claim 143, the controller is configured to generate a first user-identifiable notification when the successful electrolytic separation event is assessed to have occurred; the controller is configured to generate a second user-identifiable notification different from the first user-identifiable notification if it is determined that the successful electrolytic separation event has not occurred. [Claim 163] A vascular occlusion treatment system, comprising: a delivery catheter configured to be introduced into a patient's vascular system, the delivery catheter including an elongate sheath body, an inner lumen extending through the elongate sheath body, and a distal port each in communication with the inner lumen; a vaso-occlusive assembly configured to be disposed within the inner lumen of the delivery catheter, the vaso-occlusive assembly comprising a delivery wire and a vaso-occlusive device detachably connected to the delivery wire via an electrolytically severable joint, the vaso-occlusive device configured to be deployed into the patient's vasculature from a distal port of the delivery catheter; 1. A vascular occlusion treatment system comprising: an electrolytic separation device configured to electrically connect and electrically disconnect a proximal end of a delivery wire of the vasoocclusion assembly; wherein the electrolytic separation device supplies current to an electrolytically severable joint of the vasoocclusion assembly while the vasoocclusion device is positioned within a patient's vasculature so as to electrolytically separate the vasoocclusion device from the distal end of the delivery wire; incrementally measures the electrolytic work performed by the electrolytic separation device over time, thereby generating a plurality of measured electrolytic work values; incrementally increases an electrolytic work threshold over time, thereby generating a plurality of electrolytic work thresholds; compares the plurality of measured electrolytic work values ​​with the plurality of electrolytic work thresholds; and evaluates whether a successful electrolytic separation event has occurred based on the comparison results. [Claim 164] 164. The vascular occlusion treatment system of claim 163, 10. A vascular occlusion treatment system, further comprising a ground electrode positioned in electrical contact with a patient and configured to be electrically connected to the electrolytic separation device via an electrical cable. [Claim 165] 164. The vascular occlusion treatment system of claim 163, A vascular occlusion treatment system, wherein the electrolytic separation device is a handheld electrolytic separation device. [Claim 166] 164. The vascular occlusion treatment system of claim 163, 10. A vascular occlusion treatment system, comprising: an electrolytic separation device configured to incrementally measure the electrolytic work performed by the electrolytic separation device over time by incrementally measuring the cumulative current delivered by the electrolytic separation device over time. [Claim 167] 164. The vascular occlusion treatment system of claim 163, 1. A vascular occlusion treatment system, comprising: an electrolytic separation device configured to supply an electric current to the electrolytically severable joint during the electrolytic separation cycle in response to a single actuation of the electrolytic separation device. [Claim 168] 168. The vascular occlusion treatment system of claim 167, the electrolytic separation device is configured to supply current to the electrolytically severable joint during another electrolytic separation cycle in response to another single actuation of the electrolytic separation device. [Claim 169] 168. The vascular occlusion treatment system of claim 167, the electrolytic separation cycle having an initial fixed period, and the electrolytic separation device configured to evaluate whether the successful electrolytic separation event occurred during the initial fixed period based on at least one of the comparison results. [Claim 170] 170. The vascular occlusion treatment system of claim 169, the electrolytic separation device is configured to extend the electrolytic separation cycle only if it is determined that the successful electrolytic separation event did not occur during the initial fixation period, and to evaluate whether the successful electrolytic separation event occurred after the initial fixation period based on at least another one of the comparison results. [Claim 171] 171. The vascular occlusion treatment system of claim 170, the initial fixed period is an initial fixed period, the electrolytic separation device is configured to evaluate whether the successful electrolytic separation event occurred during the initial fixed period and extend the electrolytic separation cycle by a subsequent variable period only if it is determined that the successful electrolytic separation event did not occur during the initial fixed period, and the electrolytic separation device is configured to evaluate whether the successful electrolytic separation event occurred during the subsequent variable period based on at least another one of the comparison results. [Claim 172] 172. The vascular occlusion treatment system of claim 171, and wherein at least one of the comparison results includes a plurality of stepwise comparison results, and the electrolytic separation device is configured to stepwise evaluate whether the successful electrolytic separation event has occurred during the subsequent variable period of time based on the plurality of stepwise comparison results, and to terminate the electrolytic separation cycle when it is evaluated that the successful electrolytic separation event has occurred. [Claim 173] 173. The vascular occlusion treatment system of claim 172, the subsequent variable period of time comprises a plurality of time increments, each time increment being shorter than the initial fixed period of the electrolytic separation cycle; and the electrolytic separation device is configured to evaluate, in a stepwise manner, whether or not the successful electrolytic separation event occurred during each of the plurality of time increments based on the results of the stepwise comparisons, and to terminate the electrolytic separation cycle at the end of a time increment in which it is evaluated that the successful electrolytic separation event occurred. [Claim 174] 171. The vascular occlusion treatment system of claim 170, the electrolytic separation device is configured to determine whether an electrolytic anomaly has occurred during the supply of current to the electrolytically severable joint, and to extend the electrolytic separation cycle only if it is determined that an electrolytic anomaly has not occurred during the supply of current to the electrolytically severable joint. [Claim 175] 175. The vascular occlusion treatment system of claim 174, The electrolytic separation device is configured to determine that an electrolytic abnormality has occurred during the supply of current to the electrolytically severable joint when the measured electrolytic work value is outside an electrolytic work value range defined by a minimum electrolytic work limit value and a maximum electrolytic work limit value. [Claim 176] 171. The vascular occlusion treatment system of claim 170, 10. A vascular occlusion treatment system, comprising: an electrolytic separation device configured to track the number of completed electrolytic separation cycles and not extend the electrolytic separation cycles if the tracked number of completed electrolytic separation cycles exceeds a preset limit number of electrolytic separation cycles. [Claim 177] 164. The vascular occlusion treatment system of claim 163, 1. A vascular occlusion treatment system, comprising: an electrolytic separation device configured to measure an elapsed time between a delivery wire detachment event and a subsequent delivery wire connection event; and to reset the incrementally measured electrolytic work value and the incrementally increased electrolytic work threshold when the measured elapsed time reaches a first elapsed time threshold. [Claim 178] 178. The vascular occlusion treatment system of claim 177, A vascular occlusion treatment system, wherein the first elapsed time threshold is 3 seconds or more. [Claim 179] 178. The vascular occlusion treatment system of claim 177, A vascular occlusion treatment system, wherein the first elapsed time threshold is within a range of 25 to 45 seconds. [Claim 180] 178. The vascular occlusion treatment system of claim 177, the electrolytic separation device is configured to reset the incrementally measured electrolytic work value and the incrementally increased electrolytic work threshold when the measured elapsed time reaches the first elapsed time threshold and the successful electrolytic separation event is assessed to have occurred; the electrolytic separation device is configured to reset the incrementally measured electrolytic work value and the incrementally increased electrolytic work threshold when the measured elapsed time reaches a second elapsed time threshold that is greater than the first elapsed time threshold and it is determined that the successful electrolytic separation event has not occurred. [Claim 181] 181. The vascular occlusion treatment system of claim 180, A vascular occlusion treatment system, wherein the first elapsed time threshold is within a range of 3 to 10 seconds, and the second elapsed time threshold is within a range of 25 to 45 seconds. [Claim 182] 181. The vascular occlusion treatment system of claim 180, the delivery catheter further comprising another inner lumen extending through the elongate sheath body and another distal port respectively communicating with the other inner lumen; the vascular occlusion treatment system further includes another vascular occlusion assembly configured to be disposed within the inner lumen of the delivery catheter, the another vascular occlusion assembly including a delivery wire and a vascular occlusion device detachably connected to the delivery wire via an electrolytically severable joint, the another vascular occlusion device configured to be deployed into the patient's vasculature from another distal port of the delivery catheter; a proximal end of a delivery wire of another vaso-occlusive assembly configured to be electrically connected to said electrolytic separation device, a proximal end of a delivery wire of another vaso-occlusive assembly configured to be electrically isolated from said electrolytic separation device, and applying an electric current to the electrolytically severable joint of said vaso-occlusive assembly while another vaso-occlusive assembly is positioned within the patient's vasculature so as to electrolytically separate said another vaso-occlusive device from the distal end of said delivery wire; 1. A vascular occlusion treatment system, comprising: a delivery wire disconnection event comprising disconnecting a delivery wire of the vasoocclusion assembly from the electrolytic separation device; and a subsequent delivery wire connection event comprising reconnecting a delivery wire of the vasoocclusion assembly to the electrolytic separation device or connecting a delivery wire of another vasoocclusion assembly to the electrolytic separation device. [Claim 183] 164. The vascular occlusion treatment system of claim 163, the electrolytic separation device is configured to generate a first user-identifiable notification when the successful electrolytic separation event is assessed to have occurred; the electrolytic separation device is configured to generate a second user-identifiable notification different from the first user-identifiable notification if it is determined that the successful electrolytic separation event has not occurred. [Claim 184] 1. A method of occluding a patient's vasculature using a vaso-occlusion assembly, comprising: The vaso-occlusive assembly comprises a delivery wire and a vaso-occlusive device detachably connected to a distal end of the delivery wire via an electrolytically severable joint, and the method comprises: introducing the configured delivery catheter into the patient's vasculature; placing the vaso-occlusive assembly within the delivery catheter such that the vaso-occlusive device is positioned outside of the delivery catheter within the patient's vasculature; electrically connecting a proximal end of a delivery wire of the vaso-occlusive assembly to a power source; applying an electrical current from the power source to the electrolytically severable joint of the vaso-occlusive assembly while the vaso-occlusive device is positioned within the patient's vasculature; measuring incrementally the electrolytic work performed by the power supply over time, thereby generating a plurality of measured electrolytic work values; increasing the electrolytic work threshold in stages over time, thereby generating a plurality of electrolytic work thresholds; comparing the plurality of measured electrolysis work values ​​to the plurality of electrolysis work thresholds, respectively; and evaluating whether a successful electrolytic separation event occurred based on the comparison. [Claim 185] 185. The method of claim 184, contacting a ground electrode to a patient; and electrically connecting the ground electrode to the power source such that an electrical current is provided between the delivery wire and the ground electrode. [Claim 186] 185. The method of claim 184, 10. A method according to claim 9, wherein the electrolytic work value is measured incrementally over time by measuring incrementally the cumulative current supplied by said power supply over time. [Claim 187] 185. The method of claim 184, a power source applying an electric current to the electrolytically severable junction during an electrolytic separation cycle. [Claim 188] 188. The method of claim 187, and applying current from said power source to said electrolytically severable joint during another electrolytic separation cycle. [Claim 189] 188. The method of claim 187, The method, wherein the electrolytic separation cycle has a fixed duration, and the occurrence of a successful electrolytic separation device during the fixed duration is evaluated based on at least one of the comparison results. [Claim 190] 190. The method of claim 189, the electrolytic separation cycle is extended only if it is determined that the successful electrolytic separation event has not occurred during the fixed period of time, the method further comprising the step of determining whether the successful electrolytic separation event has occurred after the fixed period of time based on at least another one of the comparison results. [Claim 191] 191. The method of claim 190, the fixed period is an initial fixed period, and whether the successful electrolytic separation event has occurred is evaluated by the end of the initial fixed period, and the electrolytic separation cycle is extended by a subsequent variable period only if it is evaluated that the successful electrolytic separation event has not occurred during the initial fixed period. [Claim 192] 192. The method of claim 191, wherein at least one of the comparison results includes a plurality of stepwise comparison results, the method further comprising: a step of stepwise evaluating whether the successful electrolytic separation event occurred during the subsequent variable period based on the plurality of stepwise comparison results; and a step of terminating the electrolytic separation cycle when it is evaluated that the successful electrolytic separation event occurred. [Claim 193] 193. The method of claim 192, the subsequent variable period of time comprises a plurality of time increments, each time increment being shorter than the initial fixed period of the electrolytic separation cycle; and the electrolytic separation device is configured to incrementally evaluate whether the successful electrolytic separation event occurred during each of the plurality of time increments based on the results of the incremental comparisons, and to terminate the electrolytic separation cycle at the end of a time increment in which it is evaluated that the successful electrolytic separation event occurred. [Claim 194] 190. The method of claim 189, the method further comprising the step of determining whether an electrolytic anomaly has occurred during the application of current to the electrolytically severable joint, and wherein the electrolytic separation cycle is extended only if it is determined that an electrolytic anomaly has not occurred during the application of current to the electrolytically severable joint. [Claim 195] 195. The method of claim 194, and determining that an electrolytic anomaly has occurred during the supply of current to the electrolytically severable joint if the measured electrolytic work value is outside an electrolytic work value range defined by a minimum electrolytic work limit value and a maximum electrolytic work limit value. [Claim 196] 190. The method of claim 189, 10. The method of claim 9, further comprising the step of tracking the number of completed electrolytic separation cycles, wherein the electrolytic separation cycles are not extended if the tracked number of completed electrolytic separation cycles exceeds a preset limit number of electrolytic separation cycles. [Claim 197] 185. The method of claim 184, measuring the elapsed time between a delivery wire detachment event and a subsequent delivery wire attachment event; and resetting the incrementally measured electrolytic work value and incrementally increased electrolytic work threshold when the measured elapsed time reaches a first elapsed time threshold. [Claim 198] 15. The method of claim 14, The method, wherein the first elapsed time threshold is greater than or equal to 3 seconds. [Claim 199] 15. The method of claim 14, The method, wherein the first elapsed time threshold is within a range of 25 seconds to 45 seconds. [Claim 200] 15. The method of claim 14, resetting the measured electrolytic work value when the measured elapsed time reaches the first elapsed time threshold and the successful electrolytic separation event is evaluated to have occurred; resetting the measured electrolytic work value when the measured elapsed time reaches a second elapsed time threshold that is greater than the first elapsed time threshold and the successful electrolytic separation event is assessed not to have occurred. [Claim 201] 201. The method of claim 200, 10. The method of claim 1, wherein the first elapsed time threshold is in a range of 3 to 10 seconds, and the second elapsed time threshold is in a range of 25 to 45 seconds. [Claim 202] 201. The method of claim 200, placing another vaso-occlusive assembly within the delivery catheter, wherein both the vaso-occlusive device and another vaso-occlusive device are positioned outside the delivery catheter within the patient's vasculature, the another vaso-occlusive assembly including a delivery wire and a vaso-occlusive device detachably connected to a distal end of the delivery wire via an electrolytically severable joint; after assessing whether the successful electrolytic detachment event has occurred, electrically connecting a proximal end of a delivery wire of another vaso-occlusive assembly to the power source; and resetting the measured electrolytic work value after the proximal end of the delivery wire of the other vaso-occlusive assembly is electrically connected to the power source. [Claim 203] 185. The method of claim 184, generating a first user-identifiable notification if the successful electrolytic separation event is evaluated to have occurred; and if it is determined that the successful electrolytic separation event has not occurred, generating a second user-identifiable notification that is different from the first user-identifiable notification. [Claim 204] 185. The method of claim 184, The method, wherein the vaso-occlusive device is a vaso-occlusive coil. [Claim 205] 185. The method of claim 184, The method, wherein the vaso-occlusive device is placed within an aneurysmal sac in the patient's vasculature.

Claims

1. 1. An electrolytic separation device for use with an electrically conductive delivery wire, the delivery wire having a distal end to which a vaso-occlusive device is attached and an electrolytically severable junction located proximal to the vaso-occlusive device, the electrolytic separation device comprising: a power terminal configured to electrically connect to and disconnect from a proximal end of the delivery wire; and a current supply circuit configured to supply current to the electrolytically severable joint of the vaso-occlusive assembly while the vaso-occlusive device is positioned within the patient's vasculature, such that the vaso-occlusive device electrolytically detaches from the distal end of the delivery wire; and an electrolytic detachment detection circuit configured to generate electrical parameter information indicative of a successful electrolytic detachment event; a timer configured to measure the elapsed time between a delivery wire disconnection event and a subsequent delivery wire connection event; and a controller configured to evaluate whether the successful electrolytic separation event occurred based on the generated electrical parameter information, and to reset the electrical parameter information if the measured elapsed time reaches a first elapsed time threshold.

2. 10. The electrolytic separation device of claim 1, 1. An electrolytic isolation device, further comprising a ground terminal configured to be electrically connected via an electrical cable to a ground electrode that is in electrical contact with a patient.

3. 10. The electrolytic separation device of claim 1, The electrolytic separation device, wherein the power terminal is a power port configured to receive the proximal end of the delivery wire.

4. 10. The electrolytic separation device of claim 1, The electrolytic separation device, wherein the electrical parameter information includes a measured cumulative electrical parameter.

5. 5. The electrolytic separation device of claim 4, The electrolytic separation device, wherein the cumulative electrical parameter comprises a measured cumulative current.

6. 10. The electrolytic separation device of claim 1, Electrolytic separation device, wherein the electrical parameter information includes measured electrolytic work performed by the current supply circuit.

7. 10. The electrolytic separation device of claim 1, 10. An electrolytic separation device, wherein the first elapsed time threshold is greater than or equal to 3 seconds.

8. 10. The electrolytic separation device of claim 1, The electrolytic separation device, wherein the first elapsed time threshold is within a range of 25 to 45 seconds.

9. 10. The electrolytic separation device of claim 1, the controller is configured to reset the electrical parameter information when the measured elapsed time reaches the first elapsed time threshold and the successful electrolytic separation event is evaluated to have occurred; the controller is configured to reset the electrical parameter information when the measured elapsed time reaches a second elapsed time threshold that is greater than the first elapsed time threshold and it is determined that the successful electrolytic separation event has not occurred.

10. 10. The electrolytic separation device of claim 9, 1. An electrolytic separation device, wherein the first elapsed time threshold is within a range of 3 to 10 seconds, and the second elapsed time threshold is within a range of 25 to 45 seconds.

11. 10. The electrolytic separation device of claim 1, the controller is configured to generate a first user-identifiable notification when the successful electrolytic separation event is assessed to have occurred; the controller is configured to generate a second user-identifiable notification different from the first user-identifiable notification when it is determined that the successful electrolytic separation event has not occurred.

12. 10. The electrolytic separation device of claim 1, 10. The electrolytic separation device according to claim 9, wherein the electrical parameter information includes a measured electrolytic work value performed by the current supply circuit, and the controller is configured to evaluate that the successful electrolytic separation event has not occurred if the measured electrolytic work value does not reach an electrolytic work threshold, and to evaluate that the successful electrolytic separation event has occurred if the measured electrolytic work value reaches the electrolytic work threshold.

13. 13. The electrolytic separation device of claim 12, 10. An electrolytic separation device, wherein the controller is configured to incrementally increase the electrolytic work threshold over time.

14. 10. The electrolytic separation device of claim 1, 10. The electrolytic separation device of claim 9, further comprising a current supply actuator, wherein the controller is configured to supply current to the electrolytically severable joint during the electrolytic separation cycle by operating the current supply circuit in response to a single actuation of the current supply actuator.

15. 15. The electrolytic separation device of claim 14, the controller is configured to operate the current supply circuit in response to another actuation of the current supply actuator to supply current to the electrolytically severable joint during another electrolytic separation cycle.

16. 15. The electrolytic separation device of claim 14, 10. The electrolytic separation device of claim 9, wherein the electrolytic separation cycle has a fixed duration, and the controller is configured to evaluate whether the successful electrolytic separation event occurred during the fixed duration.

17. 17. The electrolytic separation device of claim 16, the controller is further configured to extend the electrolytic separation cycle only if it is determined that the successful electrolytic separation event has not occurred during the fixed period of time.

18. 18. The electrolytic separation device of claim 17, the fixed period is an initial fixed period, and the controller is configured to evaluate whether the successful electrolytic separation event has occurred by the end of the initial fixed period, and to extend the electrolytic separation cycle by a subsequent variable period only if it is determined that the successful electrolytic separation event has not occurred during the initial fixed period.

19. 20. The electrolytic separation device of claim 18, the controller is configured to incrementally evaluate whether the successful electrolytic separation event has occurred during the subsequent variable period of time, and to terminate the electrolytic separation cycle if it is evaluated that the successful electrolytic separation event has occurred.

20. 20. The electrolytic separation device of claim 19, the subsequent variable period of time comprises a plurality of time increments, each time increment being shorter than the initial fixed period of the electrolytic separation cycle, and the controller is configured to progressively evaluate whether the successful electrolytic separation event occurred during each of the plurality of time increments, and to terminate the electrolytic separation cycle at the end of a time increment in which the successful electrolytic separation event is evaluated to have occurred.

21. 18. The electrolytic separation device of claim 17, the controller is configured to determine whether an electrolytic anomaly has occurred during the supply of current to the electrolytically separable joint, and to extend the electrolytic separation cycle only when it is determined that an electrolytic anomaly has not occurred during the supply of current to the electrolytically separable joint.

22. 22. The electrolytic separation device of claim 21, the electrical parameter information includes a measured electrolytic work value performed by the current supply circuit, and the controller is configured to determine that an electrolytic anomaly has occurred during the supply of current to the electrolytically severable joint if the measured electrolytic work value is outside an electrolytic work value range defined by a minimum electrolytic work limit value and a maximum electrolytic work limit value.

23. 18. The electrolytic separation device of claim 17, 12. The electrolytic separation device of claim 11, further comprising a counter configured to track a number of completed electrolytic separation cycles, wherein the controller is configured to not extend the electrolytic separation cycles if the tracked number of completed electrolytic separation cycles exceeds a preset number of electrolytic separation cycles.

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