Systems and methods for customizable shunt implants

Abstract

Neurovascular shunts and delivery systems and methods of using the same are described herein. The system can include a custom assembly including an introducer sheath, a catheter, an expandable shunt that can be contained in the introducer sheath or catheter, a core wire, and one or more deployment features coupled to the core wire and engaging the shunt. The custom assembly includes a tube extending along and around a distal portion of the introducer sheath. The tube is cuttable and contains a distal end of the shunt. The length of the shunt can be customized by cutting through the tube and the shunt contained therein.

Description

[0001] Cross-referencing of relevant application data

[0002] This application is a partial continuation of U.S. Patent Application No. 18 / 236,674, filed on August 22, 2023, the entire contents of which are incorporated herein by reference for all purposes.

[0003] The subject matter of this application relates to U.S. Patent Application No. 18 / 112,904, filed February 22, 2023, assigned to the assignee of this application, entitled "Systems and methods for customizable flow diverter implants"; and U.S. Provisional Patent Application No. 63 / 313,205, filed February 23, 2023, assigned to the assignee of this application, entitled "Nerovascular flow diverter and delivery systems"; and U.S. Patent Application No. 18 / 112,963, filed February 22, 2023, assigned to the assignee of this application, entitled "Nerovascular flow diverter and delivery systems". The disclosures of the above patent applications are incorporated herein by reference in their entirety. This includes: U.S. Patent Application No. 18 / 113,010, filed February 22, 2023, which has been assigned to the assignee of this application and is entitled "NEROVASCULAR FLOW DIVERTER AND DELIVERY SYSTEMS"; and U.S. Patent Application No. 18 / 236,663, filed August 22, 2023, which has been assigned to the assignee of this application and is entitled "NEROVASCULAR FLOW DIVERTER AND DELIVERY SYSTEMS". Background Technology

[0004] An aneurysm is a bulge in a blood vessel caused by a weak point in its wall, which then expands and fills with blood. Aneurysms often occur at the branches of blood vessels. As blood flows through the weakened vessel, blood pressure causes a small area to bulge outward like a balloon. While aneurysms can form in any blood vessel in the body, they are most common in arteries that carry blood from the heart, such as the aorta, or arteries in the brain.

[0005] An aneurysm that forms inside the brain is called an intracranial aneurysm or cerebral aneurysm. Cerebral aneurysms usually only cause noticeable symptoms when they rupture, burst, or leak. A ruptured or bursting cerebral aneurysm can cause a serious, life-threatening condition called subarachnoid hemorrhage. Symptoms of this bleeding include sudden and extremely painful headache, neck stiffness, nausea and vomiting, and pain when looking at light. Subarachnoid hemorrhage is life-threatening and a very serious medical emergency.

[0006] Due to the serious risks posed by this type of hemorrhage, prevention, early detection, and safe and effective treatment of cerebral aneurysms are essential. However, the complex nature of the neurovascular system, including the small diameter and tortuous anatomy of many vessels, makes such treatment challenging. Given the risks of subarachnoid hemorrhage and the challenges of treating cerebral aneurysms, improved treatment systems and methods are needed.

[0007] Aneurysms originate from vessels with a wide range of diameters. Lateral branches and / or bifurcations increase the need to select different shunt lengths for supply. Consequently, hospitals must carry a variety of shunts with different lengths and diameters, resulting in the management of a large number of SKUs. Maintaining a full range of sizes to optimally fit the shunt implant to the desired location becomes economically cumbersome. There is a need to increase the flexibility of shunt length selection while reducing the number of SKUs. Summary of the Invention

[0008] This disclosure relates to systems, devices, and methods for customizing shunts for delivery into neurovascular vessels to treat aneurysms.

[0009] The system may include an elongated tubular member having a proximal end and a distal end. The elongated tubular member includes an internal wall defining a lumen. The diverter includes a proximal end and a distal end, and defines a flow channel extending therethrough. The diverter is partially contained within the lumen of the elongated tubular member in a constrained configuration. The diverter extends beyond the distal end of the elongated tubular member by a first length. A deployable wire extends into the lumen of the elongated tubular member and into the flow channel of the diverter. The deployable wire includes a proximal end, a distal end, and a distal portion having a tapered section. The deployable wire includes at least one deployable feature coupled to the diverter, such that movement of the deployable wire relative to the elongated tubular member causes movement of the diverter relative to the elongated tubular member. A tube extends along and around the distal portion of the elongated tubular member. The tube extends beyond the distal end of the elongated tubular member by a second length. The distal end of the diverter is located within the tube. The tube is cuttable.

[0010] The splitter can be cut into variable lengths within the tube. In some embodiments, the tube includes graduation marks (gradation symbols) spaced equidistantly along the distal end of the tube for cutting the splitter and / or the tube to the desired length. In some embodiments, the first length and the second length are equal.

[0011] In some embodiments, the unfolding feature may include a pusher and at least one friction bump. Both the pusher and the at least one friction bump may be positioned along a distal portion of the unfolding wire, with the at least one friction bump located distal to the pusher. In some embodiments, the at least one friction bump is within the flow channel of the splitter and engages with a portion of the splitter. In at least some methods, an end coil extends distally from the friction bump. The unfolding wire may terminate before the distal end of the splitter, such that the distal end of the unfolding wire does not extend into the tube. The unfolding wire does not extend distally beyond the distal end of the splitter.

[0012] In some embodiments, the unfolding feature includes at least one friction bump. The at least one friction bump may be among a plurality of friction bumps. The plurality of friction bumps are spaced equidistantly.

[0013] In some embodiments, the system includes a template having a top, a bottom, a front, a rear, a first side, and a second side. The template includes equidistant scale markings along the bottom of at least one of the front and rear portions of the template. These scale markings are configured to facilitate cutting the splitter to a desired length. The template associates the scale markings with the unfolded length of the splitter.

[0014] In at least some embodiments, the template further includes a cutting notch extending through the bottom of the template. The cutting notch is located near one of the first and second sides. A scale mark is positioned between the cutting notch and the other of the first and second sides.

[0015] The template may include a first set of scale marks along the bottom of the front portion of the template and a second set of scale marks along the bottom of the rear portion of the template. One of the front and rear portions of the template is configured for right-handed users, and the other of the front and rear portions of the template is configured for left-handed users.

[0016] The tube includes a proximal end, a distal end, a first longitudinal portion having a first proximal tab, and a second longitudinal portion having a second proximal tab. Each of the first and second longitudinal portions extends from the proximal end of the tube to the distal end. By separating the first and second longitudinal portions, the tube can be peelably removed from the distal portion of the elongated tubular member. In some embodiments, the tube comprises a polymer tube. In some embodiments, the tube is transparent, making the shunt visible inside the tube.

[0017] In some embodiments, the system includes a protective sleeve extending along and around the proximal end of the splitter. The protective sleeve is configured to reduce friction and / or reduce damage to the splitter when it moves relative to the elongated tubular member.

[0018] The shunt may include a self-expanding member having a proximal end and a distal end. The self-expanding member includes a braided fabric.

[0019] In various embodiments, the system may include an inlet sheath, a catheter, a deployable shunt that may be contained within the inlet sheath or catheter, a core wire, and one or more deployment features coupled to the core wire and engaging the shunt. The core wire may be tapered. The deployment features may include a pusher, one or more friction bumps, one or more deployment coils, a self-expanding element, a support coil, an end coil, and / or a non-invasive end. These deployment features may be arranged in different combinations to facilitate the deployment of the shunt.

[0020] One aspect of this disclosure relates to systems, devices, and methods for customizing shunts for delivery into neurovascular structures to treat aneurysms. The system may include an elongated tubular member having a proximal end and a distal end. The elongated tubular member includes an internal wall defining a lumen. The shunt includes a proximal end and a distal end. The shunt is partially contained within the lumen of the elongated tubular member in a constrained configuration. The shunt extends beyond a first length of the distal end of the elongated tubular member. A deployable filament extends into the lumen of the elongated tubular member. The deployable filament includes a proximal end, a distal end, and a distal portion having a tapered portion. The deployable filament includes at least one deployable feature coupled to the shunt such that movement of the deployable filament relative to the elongated tubular member causes movement of the shunt relative to the elongated tubular member. The system includes a template having a top, a bottom, a first side, a second side, an anterior portion, and a rear portion. The template includes graduations spaced equidistantly along the bottom. The graduations are configured to facilitate cutting the shunt to variable lengths.

[0021] The shunt is cuttable. In some embodiments, the shunt includes a braided component comprising multiple strands of wire. The strands may include wire with a diameter of approximately 0.0008 inches. In some embodiments, the wire includes a drawn filler tube (DFT).

[0022] In at least some embodiments, the template further includes a cutting notch extending through the bottom of the template. The cutting notch is located near one of the first and second sides. A scale mark is positioned between the cutting notch and the other of the first and second sides.

[0023] The template includes a formula configured to facilitate cutting the splitter into variable lengths. This formula can be printed along the top portion of the template. The scale markings and formula can be printed on each of the front and rear portions of the template. In some embodiments, the template associates the scale markings with the unfolded length of the splitter.

[0024] The template may include a first set of scale marks along the bottom of the front portion of the template and a second set of scale marks along the bottom of the rear portion of the template. One of the front and rear portions of the template is configured for right-handed users, while the other is configured for left-handed users.

[0025] The system may also include a tube extending along and around the distal portion of the elongated tubular member. The tube extends beyond the distal end of the elongated tubular member. The distal end of the diverter is contained within this tube. The tube can be peeled off from the distal portion of the elongated tubular member.

[0026] The tube includes a proximal end, a distal end, a first longitudinal portion having a first proximal tab, and a second longitudinal portion having a second proximal tab. Each of the first and second longitudinal portions extends from the proximal end of the tube to the distal end. By separating the first and second longitudinal portions, the tube can be peeled off from the distal portion of the elongated tubular member.

[0027] In various embodiments, the system may include an inlet sheath, a catheter, a deployable shunt that may be contained within the inlet sheath or catheter, a core wire, and one or more deployment features coupled to the core wire and engaging the shunt. The core wire may be tapered. The deployment features may include a pusher, one or more friction bumps, one or more deployment coils, a self-expanding element, a support coil, an end coil, and / or a non-invasive end. These deployment features may be arranged in different combinations to facilitate the deployment of the shunt.

[0028] One aspect of this disclosure includes a method for customizing a shunt for delivery into a neurovascular system to treat an aneurysm. The method includes determining a desired length of the shunt in the shunt system. The system includes an elongated tubular member having a proximal end and a distal end, and an internal wall defining a lumen. The system includes a shunt comprising a proximal end and a distal end. The shunt is partially contained within the lumen of the elongated tubular member in a constrained configuration. The shunt extends beyond the distal end of the elongated tubular member by a first length. The system includes a deployable wire extending into the lumen of the elongated tubular member. The deployable wire includes a proximal end and a distal end. The deployable wire includes at least one deployable feature coupled to the shunt such that movement of the deployable wire relative to the elongated tubular member causes movement of the shunt relative to the elongated tubular member. The system also includes a tube coupled to a distal portion of the elongated tubular member, wherein the tube extends distally beyond the distal end of the elongated tubular member by a second length, wherein the distal end of the shunt is located within the tube. The method involves cutting the distributor and the pipe so that the distributor is the desired length.

[0029] The method involves retracting the splitter back into an elongated tubular member. The splitter can be retracted back into the elongated tubular member by retracting the extended wire distally.

[0030] In some embodiments, the method further includes separating the tube from a distal portion of the elongated tubular member after the splitter retracts into the elongated tubular member. The tube is separated from the distal portion of the elongated tubular member after the splitter retracts into the elongated tubular member.

[0031] The tube includes a proximal end, a distal end, a first longitudinal portion having a first proximal tab, and a second longitudinal portion having a second proximal tab. Each of the first and second longitudinal portions extends from the proximal end of the tube to the distal end. By separating the first and second longitudinal portions, the tube can be peeled away from the distal portion of the elongated tubular member. Peeling the tube away from the distal portion of the elongated tubular member includes separating the first and second longitudinal portions.

[0032] The method also includes loading the splitter into an elongated tubular component.

[0033] One aspect of this disclosure includes a method for customizing a shunt for delivery into a neurovascular system to treat an aneurysm. The method includes using a template to determine the desired length of the shunt in the shunt system. The system includes an elongated tubular member having a proximal end and a distal end, and an internal wall defining a lumen. The system includes a shunt including a proximal end and a distal end. The shunt is partially contained within the lumen of the elongated tubular member in a constrained configuration. The shunt extends beyond the distal end of the elongated tubular member by a first length. The system includes a deployable wire extending into the lumen of the elongated tubular member. The deployable wire includes a proximal end and a distal end. The deployable wire includes at least one deployable feature coupled to the shunt such that movement of the deployable wire relative to the elongated tubular member causes movement of the shunt relative to the elongated tubular member. The system also includes a tube coupled to a distal portion of the elongated tubular member, wherein the tube extends distally beyond the distal end of the elongated tubular member by a second length, wherein the distal end of the shunt is located within the tube. The method involves cutting the distributor and the pipe so that the distributor is the desired length.

[0034] The template includes a top, bottom, front, rear, first side, and second side. The template includes equidistant graduations along the bottom of at least one of the front and rear sections of the template. These graduations are configured to facilitate cutting the splitter to the desired length.

[0035] In at least some embodiments, the template further includes a cutting notch extending through the bottom of the template. The cutting notch is located near one of the first and second sides. A scale mark is positioned between the cutting notch and the other of the first and second sides.

[0036] The template may include a first set of scale marks along the bottom of the front portion of the template and a second set of scale marks along the bottom of the rear portion of the template. One of the front and rear portions of the template is configured for right-handed users, and the other of the front and rear portions of the template is configured for left-handed users.

[0037] The template includes a formula configured to facilitate cutting the splitter into variable lengths. This formula can be printed along the top portion of the template. The scale markings and formula can be printed on each of the front and rear portions of the template. In some embodiments, the template associates the scale markings with the unfolded length of the splitter.

[0038] The method involves retracting the splitter back into an elongated tubular member. The splitter can be retracted back into the elongated tubular member by retracting the extended wire distally.

[0039] The diverter system includes a tube connected to the distal portion of an elongated tubular member. The tube extends distally beyond a second length of the distal end of the elongated tubular member. The distal end of the diverter may be located within this tube.

[0040] In some embodiments, the splitter is cut such that the splitter includes cutting the pipe to the desired length.

[0041] In some embodiments, the method further includes separating the tube from the distal portion of the elongated tubular member. The tube is separated from the distal portion of the elongated tubular member after the shunt has retracted into the elongated tubular member. The tube is separated from the distal portion of the elongated tubular member by peeling it off.

[0042] The tube includes a proximal end, a distal end, a first longitudinal portion having a first proximal tab, and a second longitudinal portion having a second proximal tab. Each of the first and second longitudinal portions extends from the proximal end of the tube to the distal end. By separating the first and second longitudinal portions, the tube can be peeled away from the distal portion of the elongated tubular member. Peeling the tube away from the distal portion of the elongated tubular member includes separating the first and second longitudinal portions.

[0043] The method also includes loading the splitter into an elongated tubular component.

[0044] One aspect relates to a system for customizing a shunt for delivery into a neurovascular space to treat an aneurysm. The system includes a custom member having a proximal and a distal end. The custom member includes an internal wall defining a lumen. The system includes a shunt having a proximal and a distal end. The shunt defines a flow channel extending therethrough. The shunt is at least partially contained within the lumen of the custom member in a constrained configuration. The system includes a deployable wire extending into the lumen of the custom member and into the flow channel of the shunt. The deployable wire has a proximal end, a distal end, and a distal wire portion having a tapered portion. The deployable wire may include at least one deployable feature coupled to the shunt, such that movement of the deployable wire relative to the custom member causes movement of the shunt relative to the custom member. The deployable wire terminates in the proximal portion of the custom member.

[0045] In some embodiments, the custom component includes an inlet sheath having a proximal end and a distal end. In some embodiments, the inlet sheath is cuttable. In some embodiments, the shunt extends distally beyond the distal end of the inlet sheath. In some embodiments, the shunt is entirely contained within the custom component.

[0046] In some embodiments, the custom component further includes a tube extending along and around a distal portion of the inlet sheath. In some embodiments, the shunt extends beyond a first distal length of the inlet sheath. In some embodiments, the tube extends beyond a second distal length of the inlet sheath. In some embodiments, the distal end of the shunt is within the tube, and in some embodiments, the tube is cuttable. In some embodiments, the tube may be at least one of the following: a polymer tube; a transparent tube; or a semi-rigid tube.

[0047] In some embodiments, the tube may include graduations spaced apart along the distal end of the tube. In some embodiments, the graduations are equidistant from the distal end of the tube.

[0048] In some embodiments, the inlet sheath may include an outer inlet sheath layer. In some embodiments, the custom component further includes an inner tube. In some embodiments, the inner tube is cuttable. In some embodiments, the inner tube is insertable into the outer inlet sheath layer. In some embodiments, the shunt is entirely contained within the inner tube.

[0049] One aspect relates to a method for customizing a shunt for delivery into a neurovascular space to treat an aneurysm. The method includes determining a desired length of the shunt in a shunt system, and cutting a distal portion of the custom-made member and the shunt such that the shunt is the desired length. The shunt system includes a custom-made member having a proximal end and a distal end. The custom-made member includes an internal wall defining a lumen. The shunt system includes a shunt having a proximal end and a distal end. The shunt defines a flow channel extending therethrough. The shunt is at least partially contained within the lumen of the custom-made member in a constrained configuration. The shunt system includes a deployable wire extending into the lumen of the custom-made member and into the flow channel of the shunt. The deployable wire has a proximal end, a distal end, and a distal wire portion having a tapered portion. The deployable wire includes at least one deployable feature coupled to the shunt such that movement of the deployable wire relative to the custom-made member causes movement of the shunt relative to the custom-made member. The deployable wire terminates in the proximal portion of the custom-made member.

[0050] In some embodiments, the custom component includes an inlet sheath having a proximal end and a distal end. In some embodiments, the custom component further includes a tube extending along and around a distal portion of the inlet sheath. In some embodiments, a shunt extends beyond a first length of the distal end of the inlet sheath. In some embodiments, the shunt extends beyond a second length of the distal end of the inlet sheath. In some embodiments, the distal end of the shunt is located within the tube. In some embodiments, the tube is cuttable. In some embodiments, cutting the distal portion of the custom component and the shunt includes cutting the tube.

[0051] In some embodiments, the tube includes graduations spaced apart along the distal end of the tube. In some embodiments, cutting the tube includes cutting the tube at one of the graduations. In some embodiments, after cutting, the shunt is fully retracted into the inlet sheath by retracting the extended wire distally.

[0052] In some embodiments, the method includes separating the tube from the distal portion of the inlet sleeve. In some embodiments, the tube is separated from the distal portion of the inlet sleeve after the splitter has retracted into the inlet sleeve. In some embodiments, the tube is separated from the distal portion of the inlet sleeve by peeling the tube off from the distal portion of the inlet sleeve. In some embodiments, the inlet sleeve has an inlet length at least equal to the diverter length (splitter length) of the splitter.

[0053] In some embodiments, the tube includes a proximal end, a distal end, a first longitudinal portion having a first proximal tab, and a second longitudinal portion having a second proximal tab. In some embodiments, each of the first and second longitudinal portions extends from the proximal end of the tube to the distal end of the tube. In some embodiments, the tube can be peeled off from the distal portion of the inlet sheath by separating the first and second longitudinal portions.

[0054] This disclosure relates to systems, apparatus, and methods for customizing shunts for delivery into neurovascular vessels to treat aneurysms. The system for customizing a shunt for delivery into neurovascular vessels to treat aneurysms includes an elongated tubular member having a proximal end and a distal end. The elongated tubular member includes an internal wall defining a lumen. The system also includes a shunt having a proximal end and a distal end, wherein the shunt is partially contained within the lumen of the elongated tubular member in a constrained configuration, and wherein the shunt extends beyond a first length of the distal end of the elongated tubular member. The system also includes a deployable filament extending within the lumen of the elongated tubular member, the deployable filament having a proximal end, a distal end, and a distal portion having a tapered portion. The deployable filament includes at least one deployable feature coupled to the shunt, such that movement of the deployable filament relative to the elongated tubular member causes movement of the shunt relative to the elongated tubular member. The system also includes a housing coupled to the elongated tubular member and defining a template for customizing the shunt.

[0055] The system may include a deployable wire terminating in a proximal portion of a peelable tube. The system may also include an elongated tubular member comprising an inlet sheath having a proximal end and a distal end, wherein the inlet sheath is cuttable.

[0056] The system may further include a tube extending along and around the distal portion of the elongated tubular member, wherein the tube extends distally beyond a second length of the distal end of the elongated tubular member, wherein the distal end of the diverter is located within the tube, and wherein the tube is cuttable. The system may include a tube that can be peeled away from the distal portion of the elongated tubular member. The tube may include a proximal end, a distal end, a first longitudinal portion having a first proximal tab, and a second longitudinal portion having a second proximal tab, each of the first and second longitudinal portions extending from the proximal end of the tube to the distal end of the tube, wherein the tube can be peeled away from the distal portion of the elongated tubular member by separating the first and second longitudinal portions. The system may include a diverter that can be cut to a variable length within the tube.

[0057] The template may include equally spaced graduations configured to facilitate cutting the shunt to a variable length. The template may also include a cutting orifice, slit, or notch extending through the housing, positioned proximal to the graduations. The template may further include a cutting orifice extending through the housing with a width-binding cutting tool to facilitate cutting the shunt at a desired location or angle. The template may also include an opening extending through the housing for retraction and advance of the tube relative to the graduations, positioned proximal to the cutting orifice. The template may also include an alignment member positioned below the graduations to guide and hold the shunt stationary relative to the graduations during cutting. The template can correlate the graduations with the shunt's unfolded length. Advantageously, healthcare professionals can determine the desired length and tailor the device to that length before insertion.

[0058] At least one unfolding feature may include a pusher extending along and around a distal portion of the unfolding line, the pusher having a distal end configured to engage with a proximal end of a splitter, at least one friction bump extending distally along the unfolding line beyond the distal portion of the pusher and positioned therein, wherein the at least one friction bump is inside the splitter and engages with a portion of the splitter, and an end coil extends distally from the at least one friction bump. The system may include a splitter comprising a self-expanding member having a proximal end and a distal end. The housing may be a packaging pallet.

[0059] According to various embodiments, a method for customizing a shunt for delivery into a neurovascular space to treat an aneurysm includes providing a shunt delivery system. The system includes an elongated tubular member having a proximal end and a distal end. The elongated tubular member includes an internal wall defining a lumen. The system also includes a shunt having a proximal end and a distal end, wherein the shunt is partially contained within the lumen of the elongated tubular member in a constrained configuration, and wherein the shunt extends beyond a first length of the distal end of the elongated tubular member. The system also includes a deployable wire extending within the lumen of the elongated tubular member, the deployable wire having a proximal end, a distal end, and a distal portion having a tapered portion. The deployable wire includes at least one deployable feature coupled to the shunt, such that movement of the deployable wire relative to the elongated tubular member causes movement of the shunt relative to the elongated tubular member. The system also includes a housing coupled to the elongated tubular member and defining a template for customizing the shunt. The system also includes a tube extending along and around the distal portion of the elongated tubular member, wherein the tube extends beyond a second length of the distal end of the elongated tubular member, and wherein the distal end of the diverter is located within the tube. The method includes: determining a desired length of the diverter using a template; advancing or retracting the tube relative to the housing to align the diverter with the template; cutting the tube and the diverter such that the diverter is cut to the desired length; and retracting the diverter into the elongated tubular member or advancing the elongated tubular member over the diverter.

[0060] The method may include separating the tube from a distal portion of the elongated tubular member after retracting the splitter into the elongated tubular member or advancing the elongated tubular member over the splitter. The method may also include moving the unfolded wire relative to the elongated tubular member such that the splitter moves relative to the elongated tubular member.

[0061] Advancing or retracting the tube relative to the template may include positioning the splitter relative to scale marks spaced equally along the template, wherein the scale marks are configured to facilitate cutting the splitter to a desired length. Advancing or retracting the tube relative to the template may include positioning the tube within an alignment member disposed below the scale marks for guiding the splitter relative to the scale marks. Advancing or retracting the tube may include adjusting the tube relative to the scale marks via an opening extending through the housing and disposed proximal to the scale marks.

[0062] The cutting tube and distributor may include cutting the distributor at a desired location and / or at a desired angle using a cutting tool, via a cutting orifice, slit, or notch extending through the housing. The cutting orifice, slit, or notch may be positioned between an opening and a graduation mark and constrain the cutting tool during cutting. The template may associate the graduation mark with the deployed length of the distributor. Retracting the distributor into the elongated tubular member may include retracting the deployed wire distally. Advancing the elongated tubular member over the distributor may include keeping the deployed wire stationary while advancing the elongated tubular member. Separating the tube from the distal portion of the elongated tubular member may include peeling the tube from the distal portion of the elongated tubular member. The method may include terminating the deployed wire in the proximal portion of the peelable tube. The housing may include a packaging tray.

[0063] In one embodiment, a system for customizing a shunt for delivery to a neurovascular vessel to treat an aneurysm includes a custom member comprising a proximal and a distal end. The custom member includes an internal wall defining a lumen. The system also includes a shunt comprising a proximal and a distal end, defining a flow channel extending therethrough, wherein the shunt is at least partially contained within the lumen of the custom member in a constrained configuration. The system further includes a deployable filament extending into the lumen of the custom member and into the flow channel of the shunt, the deployable filament having a proximal end, a distal end, and a distal portion having a tapered portion, the deployable filament including at least one deployable feature coupled to the shunt such that movement of the deployable filament relative to the custom member causes movement of the shunt relative to the custom member, the deployable filament terminating in the proximal portion of the custom member. The system also includes a housing coupled to the custom member and defining an integral template for customizing the shunt. Various aspects of this disclosure provide improved flexibility in shunt length selection and specifically enable customization of the shunt length. This customization reduces the number of SKUs that hospitals must stock, reduces waste, and increases the likelihood of using shunts of appropriately determined size.

[0064] The system can include various alternative embodiments. The custom component can include an inlet sheath having a proximal end and a distal end. The inlet sheath can be cuttable. The inlet sheath can include an outer inlet sheath layer, and the custom component further includes an inner tube, wherein the inner tube is cuttable, wherein the inner tube can be inserted into the outer inlet sheath layer, and wherein the diverter is completely contained within the inner tube. The diverter can extend distally beyond the distal end of the inlet sheath. The diverter can be completely accommodated within the custom component.

[0065] According to various embodiments of the system, the custom component may further include a tube extending along and around the distal portion of the inlet sheath, wherein the shunt extends beyond a first distal length of the inlet sheath, wherein the tube extends beyond a second distal length of the inlet sheath, wherein the distal end of the shunt is within the tube, and wherein the tube is cuttable. The tube may include a polymer tube, a transparent tube, or a semi-rigid tube. The tube can be peeled off from the distal portion of the inlet sheath. The tube may include a proximal end, a distal end, a first longitudinal portion having a first proximal tab, and a second longitudinal portion having a second proximal tab, each of the first and second longitudinal portions extending from the proximal end of the tube to the distal end of the tube, wherein the tube can be peeled off from the distal portion of the inlet sheath by separating the first and second longitudinal portions.

[0066] According to at least some embodiments of the system, the distributor may be cut to a variable length within a tube. The template may include equally spaced graduations, wherein the graduations are configured to facilitate cutting the distributor to a variable length. The template may also include a cutting orifice, slit, or notch extending through the housing, wherein the orifice, slit, or notch is arranged proximal to the graduations. The template may also include a cutting orifice extending through the housing, wherein the width of the cutting orifice constrains the cutting tool to facilitate cutting the distributor at a desired location or at a desired angle. The template may include an opening extending through the housing for retraction and advance of the tube relative to the graduations, wherein the opening is arranged proximal to the cutting orifice. The template may include an alignment member arranged below the graduations to guide and hold the distributor stationary relative to the graduations during cutting. The template may associate the graduations with the unfolded length of the distributor.

[0067] According to at least some embodiments of the system, at least one deployment feature may include a pusher extending along and around a distal portion of the deployment line, the pusher having a distal end configured to engage with a proximal end of a splitter, at least one friction bump extending distally along the deployment line beyond the distal portion of the pusher and positioned therein, wherein the at least one friction bump is inside the splitter and engages with a portion of the splitter, and an end coil extends distally from the at least one friction bump. The splitter may include a self-expanding member having a proximal end and a distal end. The housing may include a packaging tray.

[0068] The embodiments disclosed herein provide several beneficial improvements. These include, for example, a reduction in system size. This reduction in system size allows for access to and treatment of smaller blood vessels. This increases the range of treatable aneurysms and thus improves patient outcomes. Furthermore, the embodiments disclosed herein increase the system's flexibility, thereby also increasing the range of treatable aneurysms.

[0069] Further applicability of this disclosure will become apparent from the detailed description provided below. It should be understood that while the detailed description and specific examples indicate various embodiments, they are intended for illustrative purposes only and are not necessarily intended to limit the scope of this disclosure. Attached Figure Description

[0070] Figure 1 This is a diagram illustrating one embodiment of a system for placing a splitter.

[0071] Figure 2 This is a diagram of the inlet sheath and the delivery of the shunt to the catheter via the inlet sheath.

[0072] Figure 3 This is a diagram of a splitter in a constrained delivery state.

[0073] Figure 4 This is a diagram of a splitter in its expanded, extended state.

[0074] Figure 5 This is an enlarged view of the braided fabric of the shunt.

[0075] Figure 6 This is a schematic diagram of a distributor delivery system.

[0076] Figure 7 This is a diagram of a delivery system in a partially unfolded structure.

[0077] Figure 8 This is a diagram of a delivery system in a partially unfolded structure.

[0078] Figure 9 This is a schematic diagram of one embodiment of a customizable splitter delivery system.

[0079] Figure 10 This is a diagram illustrating the desired length in one embodiment of a customizable splitter delivery system.

[0080] Figure 11 This is an example of a customizable splitter delivery system, showing the pipe and splitter after they have been cut to the desired length.

[0081] Figure 12 This is a diagram showing the removal of the tubing after the shunt has retracted into the sheath / conduit.

[0082] Figure 13 This is an illustration of one embodiment of a customizable shunt delivery system after the tube has been removed.

[0083] Figure 14 This is a diagram of the inlet sheath and the delivery of the shunt to the catheter via the inlet sheath.

[0084] Figure 15 This is a schematic diagram of one embodiment of a customizable splitter delivery system.

[0085] Figure 16 This is a schematic diagram of one embodiment of a customizable splitter delivery system with a protective sleeve.

[0086] Figure 17 This is a schematic diagram of one embodiment of a customizable shunt delivery system with self-expanding elements.

[0087] Figure 18 This is a schematic diagram of one embodiment of a customizable splitter delivery system.

[0088] Figure 19 This is a schematic diagram of one embodiment of a customizable splitter delivery system.

[0089] Figure 20 This is a schematic diagram of one embodiment of a customizable splitter delivery system.

[0090] Figure 21 This is a schematic diagram of one embodiment of a customizable splitter delivery system.

[0091] Figure 22 This is a schematic diagram of one embodiment of a customizable splitter delivery system.

[0092] Figure 23 This is a schematic diagram of one embodiment of a customizable splitter delivery system.

[0093] Figure 24 This is a schematic diagram of one embodiment of a customizable splitter delivery system.

[0094] Figure 25 This is a schematic diagram of one embodiment of a customizable splitter delivery system.

[0095] Figure 26 This is a schematic diagram of one embodiment of a customizable splitter delivery system.

[0096] Figure 27 This is a schematic diagram of one embodiment of packaging for a customizable diverter delivery system.

[0097] Figure 28 This is a schematic diagram of one embodiment of packaging for a customizable diverter delivery system.

[0098] Figure 29 This is a schematic diagram of one embodiment of packaging for a customizable diverter delivery system.

[0099] Figure 30This is a schematic diagram of one embodiment of packaging for a customizable diverter delivery system.

[0100] Figure 31 This is a flowchart of a method for customizing a splitter delivery system.

[0101] Figures 32A-32E Exemplary process steps for a custom splitter delivery system are shown. Detailed Implementation

[0102] This invention relates to shunts, shunt delivery systems, and methods of delivering shunts. A shunt is a device that can be placed within a vascular system to divert (redirect) flow from a portion of the vascular system covered by the shunt. As used herein, a shunt can be any device that can be positioned within a patient's blood vessel and can divert a portion of blood flow through that vessel. In some embodiments, a shunt can be an endovascular prosthesis for treating an intracranial aneurysm. A shunt can, for example, include a stent such as a laser-cut stent, a braided member, or the like. In some embodiments, a shunt may include a braided member comprising multiple braided wires, which may be, for example, a cobalt-chromium alloy, nitinol, or the like.

[0103] Shunts can be used to treat intracranial aneurysms, including, for example, saccular aneurysms, especially unruptured saccular aneurysms, or fusiform or circumferential aneurysms. A shunt can be placed in a blood vessel to extend across and cover the aneurysm. The shunt diverts blood flow from the aneurysm, thus reducing blood flow within the aneurysm. Due to the reduced blood flow, the aneurysm may close and heal over time.

[0104] While simple in principle, the practicalities of precisely placing a shunt in the often narrow and intricate vascular system of the brain can be extremely complex. Therefore, a highly flexible device is needed to navigate this vascular system. Furthermore, such a device should be capable of precisely locating the shunt within the blood vessel. Precise positioning of the shunt may include adjusting its position, and in some embodiments may include positioning multiple shunts in a fully overlapping or partially overlapping manner. Using multiple partially or fully overlapping shunts can be particularly advantageous when dealing with multiple closely spaced aneurysms or large aneurysms. In some embodiments, multiple shunts may be positioned in a fully or partially overlapping manner to further reduce blood flow to the aneurysm.

[0105] Neurovascular bundles vary widely in length and diameter. Furthermore, the diameter of a neurovascular bundle varies along its length, typically decreasing towards the distal end. Hospitals must stock shunts of varying lengths to accommodate neurovascular bundles, lateral branches, and / or bifurcations of different sizes. Additionally, the need to maintain a large inventory of shunts of various diameters necessitates managing a large number of SKUs. Such a large and diverse supply and inventory system, encompassing the full range of sizes to optimally match shunts to desired locations, becomes economically burdensome to maintain. Moreover, the need for shunts of many different diameters and lengths complicates surgery, as the optimally fitted shunt must be placed at every location. To ensure optimal fit, surgeons must have shunts of the correct length and diameter in the operating room, which can lead to waste. Furthermore, the availability of shunts of fixed lengths may force surgeons to use suboptimal lengths. The aspects of this disclosure provide improved flexibility in shunt length selection and specifically enable the customization of shunt lengths. This customization reduces the number of SKUs that hospitals must stock, reduces waste, and increases the likelihood of using shunts of appropriately determined size.

[0106] Various embodiments of this disclosure provide customizable shunts. Conventional designs provide shunts encapsulated in an introductory sheath within a delivery system, wherein the delivery wire extends beyond the implant to fix the length of the shunt. The embodiments disclosed herein do not have a deployable wire extending beyond the length of the shunt. Various embodiments of this disclosure provide customizable systems that allow users to tailor the length of the implant to match the specifications of the treatment site. Because the deployable wire does not extend distally beyond the distal end of the shunt and terminates near the distal end of the shunt, the embodiments presented herein provide a delivery system in which a user can trim the shunt to a desired length without damaging the delivery system. Specifically, in some embodiments, the user can trim the shunt at a location between the deployment wire termination position and the distal end of the shunt. In some embodiments, the deployment wire terminates in the proximal portion of the shunt, thereby providing the user with the ability to trim the shunt in a relatively distal portion of the shunt.

[0107] Furthermore, the customizable splitter delivery system disclosed herein advantageously includes a deployment mechanism that enables customization. For example, in conventional designs, the deployment mechanism is coupled to and / or configured to be used with the aforementioned deployment line, which extends distally beyond the distal end of the splitter. This mechanism would prevent customization at the distal end of the splitter because no disposable material is present up to and including the distal end of the splitter. The customizable splitter delivery system disclosed herein overcomes these obstacles by providing a proximal deployment line and deployment mechanism, allowing flexibility to adjust the length of the distal end of the splitter.

[0108] The embodiments disclosed herein provide several beneficial improvements. These include, for example, a reduction in system size. This reduction in system size allows for access to and treatment of smaller blood vessels. This increases the range of treatable aneurysms and thus improves patient outcomes. Furthermore, the embodiments disclosed herein increase the system's flexibility, thereby also increasing the range of treatable aneurysms.

[0109] However, despite the advantages of customizable shunts, the presence of a deployable wire terminating within the shunt also has drawbacks. Specifically, the lack of a deployable wire extending beyond the distal end of the shunt during deployment diminishes its ability to effectively assist in vascular navigation as a guide wire. Nevertheless, it has been found that the benefits of customizable shunts outweigh the reduced controllability.

[0110] Now refer to Figure 1 The diagram illustrates an embodiment of a system 100 for placing a shunt. System 100 may include a catheter system 102. Catheter system 102 may be configured to provide access to a patient's vascular system, and specifically, to provide access to the patient's neurovascular system. In some embodiments, catheter system 102 may be configured for insertion into the patient's vascular system at an access point and for navigation through the patient's vascular system to the location where the shunt is to be delivered.

[0111] The catheter system 102 may include a proximal end 130 and a distal end 132. The catheter system 102 may include an elongated catheter 104 that defines an inner lumen extending through all or more portions of the catheter 104. Therefore, in some embodiments, the catheter system 102 may include an elongated tubular member defining the inner lumen, and specifically, the elongated tubular member includes an internal wall defining the inner lumen. The catheter 104 may include various sizes, materials, and / or manufactures. In some embodiments, the catheter 104 may be flexible and may include biocompatible materials. The catheter 104 may include, for example, an elongated tubular member that may have a diameter of, for example, 0.005 inches, 0.01 inches, 0.017 inches, 0.02 inches, 0.021 inches, 0.027 inches, 0.03 inches, or any other diameter or intermediate diameter.

[0112] The catheter 104, which may include a catheter hub 106, can be coupled to an access device 108. This access device 108 may be a valve, such as, for example, a rotary hemostatic valve (RHV) 109. The access device 108 may be a hemostatic valve configured to provide selective and / or controllable access to the lumen of the catheter 104. In some embodiments, the access device 108 may be configured to minimize blood loss when using the catheter 104. The access device 108 may be sized to be used in conjunction with the catheter 104.

[0113] The system 100 for placing a shunt may include a deployable cable 110, which includes a proximal end 111 and a distal end 113. The deployable cable 110 may be configured to facilitate and / or control the advance of the shunt into and / or through the catheter system 102, particularly into and / or through the lumen of the catheter 104. In some embodiments, the proximal end 111 of the deployable cable 110 is configured to be controlled to advance the shunt into and / or through the catheter system 102, and the distal end 113 may be configured to be coupled to and / or interact with the shunt to advance the shunt into and / or through the catheter system 102.

[0114] The unfolded wire 110 may include a core wire 112. The core wire 112 may include an elongated wire, which may be flexible to enable navigation of the vascular system. In some embodiments, the core wire 112 may include an integrally integrated enhanced delivery wire. The core wire 112 may include various shapes and sizes and may be made of various materials. The core wire 112 may include a biocompatible wire, such as nitinol wire.

[0115] The core wire 112 may include a proximal portion 114 and a distal portion 116. Compared to the distal portion 116, the proximal portion 114 is relatively closer to the proximal end 111 of the unfolded wire 110. Similarly, compared to the proximal portion 114, the distal portion is relatively closer to the distal end 113 of the unfolded wire 110.

[0116] During the procedure, the distal end of the distal portion 116 can be inserted into the patient first. The core wire 112 can include various shapes and sizes. In some embodiments, the core wire 112 can have a constant diameter along its length, and in some embodiments, the core wire 112 can have a non-constant diameter along its length. In some embodiments, the core wire 112 includes a tapered portion having a reduced diameter. In some embodiments, the tapered portion can taper to a point, and in some embodiments, the tapered portion can taper to a flat delivery end. The tapered portion can be, for example, all or more portions of the distal portion 116 of the core wire 112. In some embodiments, the portion of the core wire 112 with a reduced diameter may be, for example, up to 5% of the distal (partial) portion of the core wire 112, up to 10% of the distal (partial) portion of the core wire 112, up to 15% of the distal (partial) portion of the core wire 112, up to 20% of the distal (partial) portion of the core wire 112, up to 25% of the distal (partial) portion of the core wire 112, up to 30% of the distal (partial) portion of the core wire 112, up to 40% of the distal (partial) portion of the core wire 112, up to 50% of the distal (partial) portion of the core wire 112, or any other portion or intermediate portion.

[0117] In some embodiments, for example, the core wire 112 may have a length that is the same as or longer than the conduit system 102. The maximum outer diameter of the core wire 112 may be, for example, up to 0.1 inches; 0.05 inches, 0.04 inches, 0.03 inches, 0.02 inches, 0.015 inches, 0.01 inches, 0.005 inches, or any other value or intermediate value.

[0118] The deployable wire 110 may include one or more deployable features 118. Deployable features 118 may be located on the distal portion 116 of the core wire 112. Deployable features 118 may include one or more features configured to interact with a shunt to enable control and / or manipulation of the core wire 112. In some embodiments, the deployable features may be configured to enable the core wire 112 to interact with a shunt to push the shunt into the lumen of the catheter 104, and / or move the shunt within the lumen of the catheter 104, and / or move the shunt through the lumen of the catheter 104. In some embodiments, the deployable features 118 may be configured to connect a shunt to the core wire 112 such that the shunt can be deployed (deployed) from the catheter 104 into the patient. Details of the deployable feature 118 will be discussed in more detail below.

[0119] The shunt placement system 100 may include an inlet sheath 120. The inlet sheath 120 may include an elongated tubular member having a proximal end 122 and a distal end 124. In some embodiments, each of the proximal end 122 and the distal end 124 of the inlet sheath 120 may be open. The inlet sheath 120 may include an inner wall defining an inner cavity extending through the inlet sheath 120.

[0120] The inlet sheath can be configured to retain the shunt before it is inserted into the catheter system 102, specifically into the proximal end 130 of the catheter system 102. In some embodiments, the inlet sheath 120 can be configured to retain the shunt within the lumen of the inlet sheath. In some embodiments, and as... Figure 2 As shown in (A), the inlet sleeve 120 holds the splitter within the cavity of the inlet sleeve 120, and the spreader wire 110 is at least partially inserted into the cavity of the inlet sleeve, which connects the spreader feature 118 of the spreader wire 110 to the splitter. Figure 2 As shown in (B), the inlet sheath 120, particularly the distal end 124 of the inlet sheath 120, can be inserted and passed through the access device 108 and inserted into the conduit 104, particularly into the conduit hub 106 of the conduit 104. In some embodiments, this may include inserting a combination of the inlet sheath containing the shunt and the unfolded wire 110 into the conduit system 102, specifically into the conduit 104.

[0121] In some embodiments, the introductory sheath 120 may advance through the access device 108 and into the catheter 104 in the direction indicated by arrow 202. The core wire 112 may be inserted into the catheter system 102, and specifically into the proximal end 130 of the catheter system 102. In some embodiments, the core wire 112 may be inserted into the introductory sheath 120, which is also inserted into the catheter system 102.

[0122] The core wire 112 can advance through the inlet sleeve 120 in the direction indicated by arrow 202, so that the shunt can advance from the inlet sleeve 120 into the conduit 104. After the shunt has advanced into the conduit 104, the inlet sleeve 120 can retract from the conduit 104 and the access device 108 in the direction indicated by arrow 204.

[0123] Now refer to Figure 3 and 4A perspective view of an embodiment of a shunt 300 is shown. The shunt 300 may be, for example, a support, a braided member, or the like. In some embodiments, the shunt may include an elongated braided member comprising a plurality of braided wires, which may be, for example, a cobalt-chromium alloy, nitinol, or the like. In some embodiments, the shunt 300 may include a tubular member defined by an outer wall 302 having a first end 304 (also referred to as a proximal end 304) and a second end 306 (also referred to herein as a distal end 306). The shunt 300 may include a proximal portion 310 and a distal portion 312. In some embodiments, the proximal portion 310 may include the proximal half of the shunt 300, while the distal portion 312 may include the distal half of the shunt 300. In some embodiments, the proximal portion 310 may include approximately one-third of the shunt 300 on its closest side, while the distal portion 312 may include approximately two-thirds of the shunt 300 distal to the proximal portion 310 of the shunt 300. In some embodiments, the proximal portion 310 may include about one-quarter of the nearest side of the splitter 300, while the distal portion 312 may include about three-quarters of the splitter 300 on the far side of the proximal portion 310 of the splitter 300.

[0124] like Figure 4 As shown, the elongated tubular member of the diverter 300 may have a central axis 400 and may extend from the proximal end 402 to the distal end 404. A flow channel 406, also referred to herein as the diverter cavity 406, may be defined by the inner wall 403 of the diverter 300 and may extend along the central axis 400 and through the diverter 300. In some embodiments, each of the proximal end 402 and the distal end 404 may include an opening into the flow channel 406, allowing fluid, particularly blood, to flow through the flow channel 406, into the proximal end 402 and out of the distal end 404.

[0125] The shunt 300 can be in the following position: Figure 3 The compressed state shown is also referred to herein as the constrained state, delivery configuration, or constrained configuration, or may be in the following state: Figure 4 The expansion state shown is also referred to herein as the unconstrained state and / or unconstrained configuration. In the constrained configuration, the shunt 300 may have a compressed outer diameter 308; in other words, the shunt 300 in the constrained configuration cannot fully expand, and / or is constrained and therefore cannot fully expand. In some embodiments, the shunt 300 may be held in the constrained state when it is contained within and / or constrained within the inlet sheath 120 and / or the conduit 104. In some embodiments, the shunt may be sized to have a compressed outer diameter 308 that fits within the inlet sheath 120 and / or the conduit.

[0126] In an unconstrained state, the shunt 300 may have an expanded outer diameter 408. The expanded diameter 408 may be larger than the compressed outer diameter 308. In some embodiments, the shunt 300 may be self-expanding, such that when the shunt 300 exits the catheter 104 and enters a patient's blood vessel, the shunt 300 automatically expands to match the inner diameter of that blood vessel. In some embodiments, the shunt 300 may be made in various sizes for use in blood vessels of different sizes. In some embodiments, the shunt 300 may have an expanded diameter 408 of up to 20 mm, up to 12 mm, up to 10 mm, up to 8 mm, up to 7 mm, up to 6 mm, up to 5 mm, up to 4 mm, between 0.5 mm and 10 mm, between 1 mm and 8 mm, between 1.25 mm and 6.5 mm, above 4.25 mm, or any other diameter or intermediate diameter or diameter range.

[0127] In some embodiments, the splitter 300 may have an unexpanded length and an expanded length. In some embodiments, when the splitter 300 expands, its length may change due to shortening, which may be associated with expansion. Therefore, as the amount of expansion of the splitter 300 increases, the splitter 300 will experience relatively more shortening. In some embodiments, the splitter 300 may have a fully expanded length that is less than about half its constrained length, between about one-third and about one-quarter of its constrained length, or any other or intermediate fully expanded length. Therefore, in some embodiments, the shortening ratio of the splitter may be greater than about 2, between about 3 and about 4, or any other or intermediate shortening ratio.

[0128] In some embodiments, the shunt 300 may have a constrained length greater than about 10 mm, greater than about 15 mm, greater than about 20 mm, greater than about 25 mm, greater than about 30 mm, greater than about 35 mm, between about 10 mm and about 400 mm, between about 25 mm and about 240 mm, or any other or intermediate length. In some embodiments, for example, the shunt may have an extended length between about 5 mm and about 60 mm.

[0129] By using Figure 1 The system 100 can deploy a shunt into a patient's blood vessel. This deployment may involve the deployment feature 118 using a deployment filament 110.

[0130] In some embodiments, the diverter 300 may include a braided member. One embodiment of the braided fabric of the diverter is 450 at... Figure 5 This is shown in detail. For example... Figure 5As shown, the braided component can be made of multiple strands 452, also referred to herein as strands 452. These strands 452 can include various shapes and sizes and can be made of various materials. In some embodiments, for example, the strands 452 can have a diameter between about 0.0002 inches and about 0.01 inches, between about 0.0005 inches and about 0.005 inches, between about 0.0007 inches and about 0.002 inches, about 0.0008 inches, about 0.001 inches, about 0.0012 inches, or any other diameter or intermediate diameter.

[0131] In some embodiments, wire 452 may include various types and / or materials. In some embodiments, wire 452 may include drawn filled tubing (DFT). In some embodiments, DFT may include an inner core and an outer tube. Each of the inner core and the outer tube may include a material, which may be the same material or may be different materials. In some embodiments, one or both of the inner core and the outer tube may be non-transparent. In some embodiments, for example, the outer tube may provide strength to the braided structure of the shunt 300, and the inner core may be non-transparent.

[0132] In some embodiments, for example, the inner core may include platinum and / or may include a platinum alloy, such as platinum and tungsten. In some embodiments, the platinum alloy may include, for example, about 28% platinum. In some embodiments, the outer tube may include an alloy, such as stainless steel, nitinol, a cobalt-chromium alloy such as 35N LT alloy, or the like.

[0133] In some embodiments, the wire may be cold-worked, and specifically may have a minimum cold work of at least 30%, at least 60%, about 60.8%, or any other amount or intermediate amount of cold work. In some embodiments, wire 452 may have a minimum tensile strength of at least about 50,000 PSI (pounds per square inch), at least about 100,000 PSI, at least 200,000 PSI, about 235,000 PSI, about 250,000 PSI, or any other minimum tensile strength or intermediate minimum tensile strength.

[0134] The braid of the shunt 300 may include any desired number of strands. In some embodiments, the braid of the shunt 300 may include between about 10 and about 200 strands, between about 20 and about 150 strands, between about 40 and about 100 strands, about 64 strands, or any other number of strands or an intermediate number of strands. Figure 5As shown, wire 452 may include wire 452-A extending in a first direction and braided together with wire 452-B extending in a second direction. Wire 452 may be braided in any desired manner, including, for example, braiding one wire on and under one wire, or braiding one wire on and under two wires, as... Figure 5 As shown, or any other weaving (method).

[0135] Now refer to Figure 6 The diagram shows a schematic of a delivery system 500. The delivery system 500 may include a shunt 300, which can be held in a constrained configuration within a lumen 502 defined by the inner wall 504 of the conduit 104 or the inlet sheath 120.

[0136] The cavity 502 may include various shapes and sizes. In some embodiments, the cavity 502 may include a cylindrical cavity, and specifically may have a circular cross-section. In some embodiments, the size of the cavity 502 may be defined by an inner diameter. In some embodiments, the inner diameter of the cavity 502 may be, for example, up to 0.2 inches, 0.1 inches; 0.05 inches, 0.04 inches, 0.03 inches, 0.025 inches, 0.021 inches, 0.02 inches, 0.017 inches, 0.015 inches, 0.01 inches, 0.005 inches, or any other value or intermediate value.

[0137] The deployable wire 110 may extend at least partially into the lumen 502 of the shunt 300 and the conduit 104 or the inlet sheath 120. The deployable wire 110 may include a core wire 112 and a deployable feature 118, the core wire 112 extending into the lumen 502 of the conduit 104 and / or the inlet sheath 120, and the deployable feature 118 shown as being completely within the lumen 502 of the conduit 104 and / or the inlet sheath 120.

[0138] exist Figure 6 In the illustrated embodiment, the unfolding feature 118 includes a pusher 505 such as a pusher coil 506 wound around a portion of the core wire 112, and one or more friction bumps 508. These one or more friction bumps may include, for example, a first friction bump 508-A, a second friction bump 508-B, and a third friction bump 508-C. In some embodiments, these one or more friction bumps 508 may include a plurality of friction bumps 508 that may be distributed along a portion of the unfolded wire 110, and specifically along a portion of the core wire 112. In some embodiments, and as... Figure 6 As shown, the friction bump 508 can be positioned within the flow channel 406 of the distributor 300 and can engage with the distributor 300.

[0139] In some embodiments, the number of friction bumps 508 in the unfolding feature 118 may vary based on the length of the splitter 300 as it is unfolded by the unfolding feature 118 including the friction bumps 508. For example, as the length of the splitter 300 being unfolded increases, the number of friction bumps 508 used to unfold the splitter 300 may increase. Thus, in embodiments with a relatively short splitter 300, a relatively small number of friction bumps 508 may be used. Similarly, in embodiments with a relatively long splitter 300, the unfolding feature 118 may include a relatively large number of friction bumps 508. In some embodiments, variations in the number of friction bumps 508 associated with the length of the splitter 300 may affect the length of the core wire 112 associated with the splitter 300, resulting in the core wire 112 terminating within the flow channel 406 of the splitter 300.

[0140] In some embodiments, and by terminating in the flow channel 406 of the diverter 300, a portion of the diverter 300 distal to the termination of the unfolded wire 110 can be trimmed without damaging the unfolded wire 110 and / or the unfolding feature 118 of the unfolded wire 110. In some embodiments, the size and position of the unfolded wire 110 are determined relative to the diverter 300 such that the unfolded wire 110 terminates in the proximal portion 310 of the diverter 300. In such embodiments, termination of the unfolded wire 110 in the proximal portion of the diverter 300 allows trimming of the distal portion 312 of the diverter 300 without damaging the unfolded wire 110, specifically without damaging the unfolding feature 118 of the unfolded wire 110.

[0141] In some embodiments, one or more friction bumps 508 may include a single friction bump. This single friction bump may extend, for example, from the pusher 505 to... Figure 6 The location of the third friction bump 508-C. Therefore, instead of having multiple friction bumps 508 along this length of the core wire 112, a single friction bump 508, also referred to herein as a "friction pad", may extend over all or more portions of this length of the core wire 112. In some embodiments, the single friction pad may extend beyond the proximal portion of the shunt 300 and into the distal portion of the shunt 300.

[0142] In some embodiments, a single long friction pad can provide better engagement with the shunt 300. However, embodiments with a plurality of spaced-apart friction bumps can provide improved flexibility of the core wire 112. In some embodiments, the single long friction pad may comprise the same material as the friction bump 508, and in some embodiments, the single long friction pad may comprise a material configured to improve flexibility.

[0143] The unfolded feature 118 also includes a support coil 510, also referred to herein as a support member coil 510, which is wound around a portion of the core wire 112, and particularly around the distal portion of the core wire 112, which may be tapered. Figure 3 As shown, the support coil 510 may extend at least partially through the pusher coil 506, and may extend along the core wire 112 between the friction bumps 508 and extend distally beyond the final friction bump 508, or as... Figure 3 As shown, it exceeds the third friction bump 508-C. Specifically, as... Figure 6 As shown, the support coil 510 may begin at a position between the proximal end 514 and the distal end 516 of the pusher 505 and / or the pusher coil 506, and may extend distally beyond the final friction bump 508. In such an embodiment, the support coil 510 may be located between at least a portion of the pusher 505 and / or the pusher coil 506 and the core wire 112. The unfolding feature 118 may also include a non-invasive end 512 at the distal end of the unfolded wire 110.

[0144] In some embodiments, such as when the shunt 300 is contained within the conduit 104 and / or the inlet sheath 120, the unfolded wire 110 and / or the core wire 112 may terminate within the shunt 300. For example, in Figure 6 In the illustrated embodiment, the atraumatic tip 512 is located within a shunt 300 contained within the catheter 104 and / or the introducer sheath 120, and thus the deployed wire 110 and / or the core wire 112 terminates within the shunt 300 contained within the catheter 104 and / or the introducer sheath 120. In some embodiments, this may include the deployed wire 110 and / or the core wire 112 terminating at a location between the proximal end 304 and the distal end 306 of the shunt 300, and specifically may include the deployed wire 110 and / or the core wire 112 terminating in the proximal portion 310 of the shunt 300.

[0145] In some embodiments, for example, when the shunt 300 has an unfolded diameter of at least about 2 mm, at least about 3 mm, at least about 4 mm, at least about 4.25 mm, at least about 5 mm, at least about 6 mm, or any other unfolded diameter or intermediate unfolded diameter, the unfolded wire 110 and / or core wire 112 may terminate within the shunt 300 when the shunt 300 is constrained, unfolded, and / or partially unfolded. In some embodiments, when the shunt 300 has a constrained length of at least about 10 mm, at least about 15 mm, at least about 20 mm, at least about 25 mm, at least about 30 mm, at least about 35 mm, or any other (constrained) length or intermediate (constrained) length, the unfolded wire 110 and / or core wire 112 may terminate within the shunt 300 when the shunt 300 is constrained, unfolded, and / or partially unfolded. In some embodiments, when the shunt 300 has at least one of an unfolded diameter greater than about 4.25 mm or a constrained length greater than about 25 mm, the unfolded wire 110 and / or core wire 112 may terminate within the shunt 300 when the shunt 300 is constrained, unfolded, and / or partially unfolded.

[0146] In some embodiments, wherein the extended wire 110 and / or core wire 112 does not extend distally beyond the distal end 306 of the shunt 300, the dimensions and / or positions of the extended wire 110 and / or core wire 112 relative to the shunt 300 in the constrained configuration can be determined such that: the extended wire 110 and / or core wire 112 terminates in a proximal portion 310 comprising half of the proximal side of the shunt 300, in a proximal portion 310 comprising one-third of the nearest side of the shunt 300, in a proximal portion 310 comprising one-quarter of the nearest side of the shunt 300, or in any other portion or intermediate portion of the shunt 300. In some embodiments, this termination position for the extended wire 110 and / or core wire 112 can be determined based on the shortening ratio of the shunt 300.

[0147] In some embodiments, and such as Figure 6 As shown, the length and / or position of the extended wire 110 and / or core wire 112 relative to the length of the shunt 300 are such that when the shunt 300 is constrained within the conduit 104 and / or the inlet sheath 120, the extended wire 110 and / or core wire 112, and specifically the distal end of the extended wire 110 and / or core wire 112, terminate within the shunt 300.

[0148] In some embodiments, a portion of the support coil 510 extending distally beyond the final friction bump 508 may support the shunt 300. Specifically, the portion of the support coil 510 extending distally beyond the final friction bump 508 may extend through at least a portion of the length of the shunt 300, and in some embodiments may reinforce those portions of the shunt 300. Specifically, and in some embodiments, the portion of the support coil 510 extending distally beyond the final friction bump 508 may prevent the shunt from collapsing and / or buckling.

[0149] The unfolded wire 110, including the unfolding feature 118, can be configured for navigation of a patient's vascular system, and specifically for navigation of a patient's neurovascular system. Thus, in some embodiments, the unfolding feature 118 can be configured to promote and / or maintain the flexibility of the core wire 112, particularly the flexibility of the distal portion 116 of the core wire 112.

[0150] The pusher coil 506 may be configured to apply force to the shunt 300 as the unfolded wire 110 advances distally to and / or through the conduit 104 and / or through the inlet sheath 120. The pusher coil 506 may comprise a coil formed of a wire winding. The wire forming the wire winding may comprise a variety of materials and sizes. In some embodiments, the wire forming the pusher coil 506 may comprise a biocompatible wire such as nitinol wire. The diameter of the wire forming the pusher coil 506 may, for example, be between 0 and 0.01 inches, between 0 and 0.005 inches, between 0 and 0.002 inches, about 0.002 inches, or any other diameter or intermediate diameter.

[0151] The actuator coil 506 may have an outer diameter sized to fit within the cavity 502 of the conduit 104 and / or the inlet sheath 120. In some embodiments, the diameter of the actuator coil 506 may be smaller than the diameter of the cavity 502 of the conduit 104 and / or smaller than the inner diameter of the cavity of the inlet sheath 120. The outer diameter of the actuator coil may be designed relative to the diameter of the cavity 502 of the conduit 104 and / or the inlet sheath 120 such that the shunt 300 does not fit between the actuator coil 506 and the inner wall 504 of the conduit 104 and / or the inlet sheath 120. In some embodiments where the inner diameter of the cavity 502 of the conduit 104 and / or the inlet sheath 120 is 0.017 inches, the outer diameter of the actuator coil 506 may be, for example, 0.015 inches. In some embodiments where the inner diameter of the lumen 502 of the conduit 104 and / or the inlet sheath 120 is 0.021 inches, the outer diameter of the pusher coil 506 may be, for example, 0.019 inches.

[0152] The pusher coil 506 may have a proximal end 514 and a distal end 516. In some embodiments, one or both of the proximal end 514 and the distal end 516 of the pusher coil 506 may be configured to attach the pusher coil 506 to the spreader wire 110. In some embodiments, one or both of the proximal end 514 and the distal end 516 of the pusher coil 506 may include solder for attaching the pusher coil 506 to the spreader wire 110, or in other words, the pusher coil 506 may be soldered to the spreader wire 110. In some embodiments, the distal end 516 of the pusher coil 506 may be further configured to provide a support surface (bearing surface) on which the pusher coil 506 can apply force to the shunt 300. In some embodiments, the support surface may be formed in the solder of the distal end 516. In some embodiments, the distal end 516 of the pusher coil 506 may include a bump portion configured to engage with the shunt 300. The bump portion may be convex to better engage with the shunt 300. In some embodiments, the bump portion may include a flat tube.

[0153] Feature 118 may include one or more friction bumps 508. In some embodiments, the friction bumps are configured to press that portion of the shunt 300 into the inner wall 504 of the conduit 104 and / or the inlet sheath 120 when a portion of the shunt 300 is within the conduit 104 and / or the inlet sheath 120. In some embodiments, the friction bumps 508 may include a material that engages with the shunt 300, particularly a material that deformably engages with the shunt 300, such that the frictional force between the shunt 300 and the friction bumps 508 is greater than the frictional force between the shunt 300 and the inner wall 504 of the conduit 104 and / or the inlet sheath 120. Due to the relatively large frictional force between the friction bumps 508 and the shunt 300, each friction bump 508 facilitates control of the shunt 300, and specifically facilitates control of the position of the shunt 300 relative to the conduit 104 and / or the inlet sheath 120. In some embodiments, the interaction between the friction bump 508 and the shunt 300 enables the unfolding wire 110 to unfold and / or retract the shunt 300 from the conduit 104, and / or partially retract the partially unfolded shunt 300 into the conduit 104.

[0154] Friction bump 508 may include, for example, a deformable material, such as an elastomer. In some embodiments, friction bump 508 may include a polymer capable of incorporating a radiopaque element such as a platinum coil and / or platinum wire. In some embodiments, friction bump 508 may include a tungsten-loaded polymer or a tungsten-loaded elastomer. In some embodiments, the friction bump may include a UV adhesive, which may, for example, be doped with a radiopaque material, such as tantalum powder. In some embodiments, some or all of the friction bump 508 may be radiopaque and / or include radiopaque elements. In some embodiments, the radiopaque element may include one or more radiopaque particles embedded in the friction bump 508, and in some embodiments, such as Figure 6 As shown, the friction bump may include a nontransparent coil 509, which may include, for example, a section of wire, such as a coil of platinum wire.

[0155] In some embodiments where the unfolded wire 110 includes a plurality of friction bumps 508, the friction bumps 508 may be spaced apart equally or unequally. In some embodiments, the friction bumps 508 may be spaced apart such that they are between 1 mm and 20 mm, between 1 mm and 15 mm, between 2 mm and 10 mm, between 3 mm and 8 mm, about 5 mm, or any other value or intermediate value.

[0156] In some embodiments, the unfolding feature 118 may include a support coil 510. The support coil 510 prevents the core wire 112 from buckling as the core wire 112 advances the shunt 300 distally within the conduit 104 and / or the inlet sheath 120. For example, to increase the flexibility of the core wire 112, it may taper at its distal portion 116. This taper may increase the flexibility of the core wire 112, but it also reduces the strength of the core wire 112. This reduction in strength of the core wire 112 can cause it to buckle when used to advance the shunt 300 distally within the conduit 103 and / or the inlet sheath 120. The support coil 510 may extend along multiple portions of the core wire 112 to prevent buckling of the core wire 112. Therefore, by combining the tapered core wire 112 and the support coil 510, the unfolded wire 110 can be flexible to navigate tortuous vascular systems, while also having sufficient strength to allow the shunt 300 to unfold.

[0157] like Figure 6 As shown, the support coil 510 may extend over a portion of the core wire 112, and specifically over all or more portions of the distal portion 116 of the core wire 112. Figure 6As further shown, the support coil 510 may extend on the core wire 112 between the friction bumps 508 and extend distally beyond the last friction bump 508, or more specifically, extend distally beyond the third friction bump 508-C.

[0158] The diameter of the wire forming the support coil can be, for example, between 0 and 0.01 inches, between 0 and 0.005 inches, between 0 and 0.002 inches, about 0.002 inches, or any other diameter or intermediate diameter. In some embodiments, the wire forming the support coil 510 can have the same diameter as the wire forming the actuator coil 506, and in some embodiments, the wire forming the support coil 510 can have a different diameter than the wire forming the actuator coil 506. In some embodiments, the outer diameter of the support coil 510 can be, for example, up to 0.04 inches, up to 0.03 inches, up to 0.02 inches, up to 0.015 inches, up to 0.01 inches, up to 0.005 inches, up to 0.001 inches, or any other value or intermediate value.

[0159] The deployable wire 110 may extend distally beyond the friction bump 508, and in some embodiments, distally beyond the third friction bump 508-C. The deployable wire 110 may terminate with a non-traumatic end 512 that may be located at the distal end of the deployable wire 110. In some embodiments, the portion of the deployable wire 110 extending distally beyond the friction bump 508 may include a portion of the support coil 510. The non-traumatic end 512 may be configured not to damage tissue that it may bump during surgical procedures, particularly during the deployment of the shunt 300 into the patient's vascular system. The non-traumatic end 512 may be attached to the distal end of the core wire 112 and / or the distal end of the support coil 510. The non-traumatic end may have a diameter that matches the outer diameter of the support coil 510. In some embodiments, the non-invasive end 512 may be spaced from the final friction bump 508 by 1 mm to 20 mm, 1 mm to 15 mm, 2 mm to 10 mm, 3 mm to 8 mm, about 5 mm, or any other value or intermediate value.

[0160] In some embodiments, the delivery system, and as Figure 6As shown, the delivery system 500 may include a retractable sleeve 520. The retractable sleeve 520 may be coupled to the deployable cable 110 and may extend over the proximal portion 522 of the shunt 300. In some embodiments, the retractable sleeve 520 may extend over the proximal portion 522 of the shunt 300 when the shunt 300 is contained within the inlet sheath 120 and / or the conduit 104. In some embodiments, the retractable sleeve 520 may extend some or all of the length of the deployable feature 118, and therefore may extend over some or all of the proximal portion 522 of the shunt 300 that engages with the deployable feature 118.

[0161] In some embodiments, the retractable sleeve 520 may be positioned midway between the proximal portion 522 of the shunt 300 and the inlet sheath 120 and / or conduit 104, thereby reducing friction between the proximal portion 522 of the shunt 300 and the inlet sheath 120 and / or conduit 104. In some embodiments, the retractable sleeve 520 not only reduces friction between the proximal portion 522 of the shunt 300 and the inlet sheath 120 and / or conduit 104, but also protects the proximal portion 522 of the shunt from damage that may be caused by movement of the shunt 300 relative to the inlet sheath 120 and / or conduit 104, such as damage that may occur during the deployment and / or retraction of the shunt 300.

[0162] The retractable sleeve 520 may include a flexible polymer that can be coupled to the unfolded wire 110. In some embodiments, such as Figure 6 As shown, the retractable sleeve 520 can be coupled to the deployable wire 110 at a location distal to all or more portions of the deployable feature 118. In some embodiments, the retractable sleeve 520 may include a heat-shrinkable polymer tube positioned over a proximal portion 522 of the splitter 300 and over a portion of the deployable wire 110 distal to the splitter 300. The retractable sleeve 520 can then be heat-shrinkable around the splitter 300 to fit snugly around the splitter 300.

[0163] The retractable sleeve 520 may also include one or more slits extending proximally from the distal end of the retractable sleeve 520. These one or more slits separate a portion of the retractable sleeve 520 extending over the proximal portion 522 of the diverter 300 into multiple segments. For example, in an embodiment of the retractable sleeve 520 including two slits, the retractable sleeve 520 may be divided into two pieces, which may be two equal halves. When the diverter 300 deploys, the one or more slits may allow the retractable sleeve 520 to open and separate from the diverter 300. Thus, as Figure 7As shown, when the retractable sleeve 520 protrudes distally beyond the conduit 104, the retractable sleeve 520 extending distally beyond the conduit 104 has separated (divided) and disconnected the shunt 300, allowing the shunt 300 to expand and allowing the retractable sleeve 520 to retract back into the conduit 104 when the shunt 300 is fully deployed.

[0164] Now refer to Figure 7 A schematic diagram of a delivery system 500 in a partially unfolded configuration is shown. Figure 7 As shown, a catheter 104, including a deployable wire 110 and a shunt 300, is located in a blood vessel 600. Figure 7 As further shown, the deploying wire 110 has advanced distally relative to the conduit 104, as indicated by arrow 602, thereby partially deploying the shunt 300. The combination of friction bumps 508 and actuating coils 506 engages with the shunt 300 to advance the shunt 300 distally into and out of the conduit 104 as the deploying wire 110 advances distally. As the deploying wire 110 advances distally, the shunt 300 unfolds from the conduit 104 and begins to expand. This distal advancement continues until the shunt 300 is fully deployed. Alternatively, if the shunt 300 has not yet fully unfolded from the conduit 104, and if at least one of the friction bumps 508 remains within the conduit 104 and engaged with the shunt 300, the shunt 300 may retract and / or partially retract into the conduit 104. In some embodiments, successful deployment of the splitter 300 can be achieved by advancing the deployment line 110 only to the distal side, and in some embodiments, successful deployment of the splitter 300 can be achieved by alternately advancing the splitter 300 to the distal side and retracting it to the proximal side until the desired positioning and / or deployment is achieved.

[0165] Now refer to Figure 8 The diagram illustrates one embodiment of a dynamic delivery system 800. System 800 may include a diverter 300 that can be held in a constrained state within the lumen 502 of a catheter 104 and / or an insertion sheath 120. In some embodiments, the diverter 300 may include an expandable braided member that defines a flow channel 406. In some embodiments, the diverter 300 may include a self-expanding braided member.

[0166] The shunt 300 may be positioned within the lumen 502 of the catheter 104 and / or the inlet sheath 120. In some embodiments, the shunt 300 may be positioned circumferentially within the lumen 502 of the catheter 104 and / or the inlet sheath 120 between the inner wall 504 defining the lumen 502 of the catheter 104 and / or the inlet sheath 120 and an expansion element, which may be a self-expanding element, as will be discussed in more detail below.

[0167] The deployable wire 110 may extend at least partially into the lumen 502 of the shunt 300 and the conduit 104 or the inlet sheath 120. The deployable wire 110 may include a core wire 112 and a deployable feature 118, the core wire 112 extending into the lumen 502 of the conduit 104 and / or the inlet sheath 120, the deployable feature 118 being shown entirely within the lumen 502 of the conduit 104 and / or the inlet sheath 120. The deployable feature 118 is coupled to the shunt such that movement of the deployable wire 110 and / or the core wire 112 relative to the conduit 104 and / or the inlet sheath 120 similarly causes movement of the shunt 300 relative to the conduit 104 and / or the inlet sheath 120.

[0168] In some embodiments, and such as Figure 8 As shown, the deployable wire 110 and core wire 112 terminate within the flow channel of the shunt 300, in other words, they do not extend distally beyond the distal end of the shunt 300. In some embodiments, the deployable wire 110 and / or core wire 112 are sized and / or configured such that neither the deployable wire 110 nor the core wire 112 extends distally beyond the distal end 306 of the shunt 300, whether the shunt 300 is in a constrained configuration or in an unconstrained configuration after being deployed from the conduit 104. Therefore, the atraumatic tip 512 at the distal end of the deployable wire 110 is located within the shunt 300 and does not extend distally beyond the distal end 306 of the shunt 300.

[0169] The unfolding feature 118 includes one or more friction bumps 508, a support coil 510, a pusher 514, an expansion element 802, an end coil 810, and a non-invasive end 512. The end coil may be a flexible end coil 810. In some embodiments, the flexible end coil 810 and / or the flexible end coil 810 and the non-invasive end 512 may facilitate navigation of the system 800 and / or the core wire 112 through the vascular system, particularly through a tortuous vascular system.

[0170] In some embodiments, some or all of these expansion features 118 are engaged with a shunt, or as... Figure 8 As shown, it engages with shunt 300. Expanded feature 118 engages with and / or can engage with shunt 300 such that movement of core wire 112 causes a corresponding movement of shunt 300.

[0171] The expansion element 802 may include a self-expanding element 802 or a controlled expansion element. In some embodiments, the self-expanding element 802 may expand upon exiting the conduit 104. In some embodiments, the controlled expansion element may expand during controlled expansion. The controlled expansion element may include, for example, a stent, a braid, a balloon, or the like. In some embodiments where the expansion element 802 includes a braided member, the thickness of the strands of the braid may vary to achieve the desired effect. For example, the strands may be thicker to provide increased expansion force, or the strands may be thinner to provide increased flexibility. In some embodiments, the strands may include various materials, including, for example, DFT, which may be, for example, radiopaque. In some embodiments, the strands may include polymers, such as high tensile strength polymers. In some embodiments, the polymer used in the strands may advantageously increase the friction between the expansion element 802 and the shunt 300, thereby increasing the ability of the expansion element 802 to retract the shunt 300. In embodiments where the strands contain a polymer, the polymer may be treated and / or doped to be radiopaque.

[0172] In some embodiments, the material of the shunt 300 and / or the expansion element 802 may be selected to minimize the compression diameter of the shunt 300 surrounding the expansion element 802. In some embodiments, for example, a high tensile strength material may be selected and used, such as a material with a tensile strength equal to or greater than 100 kpsi, 150 kpsi, 200 kpsi, 250 kpsi, etc., and the outer diameter of the fully compressed expansion element 802 may be, for example, between about 0.005 inches and 0.035 inches, between about 0.01 inches and 0.015 inches, about 0.013 inches, or any other outer diameter or intermediate outer diameter. In such an embodiment, when the shunt 300 is axially positioned around and over the expansion element 802, the outer diameter of the combination of the expansion element 802 and the shunt 300, both in a compressed state, can be, for example, between about 0.01 inches and 0.04 inches, between about 0.015 inches and 0.035 inches, about 0.017 inches, or any other outer diameter or intermediate outer diameter. As used herein, “about” means a value falling within the range of: + / - 5% of the associated value, + / - 10% of the associated value, and / or + / - 20% of the associated value. Therefore, the combination of the shunt 300 and the expansion element 802 can be fitted into a conduit 104 having an inner diameter, for example, between about 0.01 inches and 0.04 inches, between about 0.015 inches and 0.035 inches, about 0.017 inches, or any other inner diameter or intermediate inner diameter.

[0173] In some embodiments, the controlled expansion element may include one or more features configured to enable control of the expansion of the controlled expansion element. These features may include one or more wires, conduits, rods, or the like. In some embodiments, the controlled expansion element may be expanded by axially compressing it, bringing its proximal end closer to its distal end. Although the following discussion focuses on the use of the self-expanding element 802, it will be understood that the self-expanding element 802 may be replaced by the controlled expansion element.

[0174] like Figure 8 As shown, the self-expanding element 802 includes a proximal end 804 and a distal end 806, the proximal end also referred to herein as the first end 804, and the distal end also referred to herein as the second end 806. The proximal end 804 of the self-expanding element 802 can be coupled to the distal end 113 of the unfolded wire 110, more specifically to the distal end 113 of the core wire 112. Figure 8 As shown, the self-expanding element 802 can extend from the proximal end 804 to the distal end 806.

[0175] The self-expanding element 802 may include a support or braided member. In some embodiments, the self-expanding element includes a laser-cut support. The self-expanding element 802 may include various shapes and sizes and may be made of various materials. In some embodiments, the self-expanding element 802 may be made of nitinol, and the drawn filler tube may include, for example, nitinol, a cobalt-chromium exterior and a platinum interior, such as a mixture of nitinol and cobalt-chromium. In some embodiments, the self-expanding element 802 may include a plurality of braided strands, at least some of which may be non-transparent.

[0176] The self-expanding element 802 can be configured to engage with the shunt 300 when the shunt is contained within the catheter 104 and / or the insertion sheath 120, such that movement of the deploying wire 110, particularly the core wire 112, causes a corresponding movement of the shunt 300. When the self-expanding element 802 has been deployed from the catheter 104, it expands to a fully expanded state, or to the maximum expansion allowed by the vessel containing the self-expanding element 802. In some embodiments, the self-expanding element 802 can be advanced distally and / or retracted proximally through the shunt 300.

[0177] In some embodiments, the dilation element 802, such as a controlled dilation element or a self-dilation element 802, can generate a radial force that can cause the shunt 300 to dilate to a greater extent than would occur under other conditions. For example, even if the shunt 300 is self-dilation, the dilation element 802, such as a controlled dilation element or a self-dilation element 802, can generate a greater radial dilation force than that generated by the shunt 300. By moving the dilation element 802 through the shunt 300, these greater radial dilation forces generated by the dilation element 802 can be applied to the shunt 300 and can cause the shunt 300 to dilate further. This increased dilation can increase and / or improve the contact between the shunt 300 and the blood vessel 600. In some embodiments, the dilation element 802 is used, such as a controlled dilation element or as a self-dilation element.

[0178] In some embodiments, the diameter of the dilator 802 may be larger than the diameter of the unconstrained shunt 300 when unconstrained, while in other embodiments, the diameter of the dilator 802 may be smaller than the diameter of the unconstrained shunt 300 when unconstrained. Therefore, in some embodiments, and when unconstrained, the diameter of the dilator 802 may be larger or smaller than the diameter of the vessel 600. In some embodiments, when the shunt 300 is deployed, twisting, torsion, compression, or bending occurs within the shunt 300, which prevents the shunt 300 from expanding. In some embodiments, the dilator 802 can be expanded to a diameter smaller than the diameter of the vessel 600 to straighten, remedy (correct), and / or eliminate these twists, torsions, compressions, or bending in the shunt 300. In such embodiments, the expansion of the dilator 802 to a diameter smaller than the diameter of the vessel 600 can straighten, remedy (correct), and / or eliminate these twists, torsions, compressions, or bending in the shunt 300, causing the shunt 300 to self-expand to engage with the wall of the vessel 600. In such embodiments, although the dilating element 802 may not force the shunt 300 to dilate to engage the wall of the blood vessel, the dilating element 802 may force the shunt 300 to dilate sufficiently to eliminate, straighten, and / or remedy (correct) such twists, torsions, compressions, or bends in the shunt 300, so that the shunt 300 can self-dilate to engage the wall of the blood vessel 600. Therefore, in some embodiments, the dilating element 802 initiates dilation, which is then continued and completed by the shunt 300.

[0179] Alternatively, in some embodiments, the diameter of the dilator 802 may be such that the dilator 802 forces the deployed shunt 300 to expand by movement of the deployed shunt 300 to engage with the wall of the blood vessel 600. In such embodiments, the dilator 802 may expand to a diameter equal to and / or greater than the diameter of the blood vessel wall 600.

[0180] In some embodiments, expansion of the dilator 802 may result in shortening of the dilator 802. This shortening may cause the distal end 113 of the core wire 112 to move proximally. This may specifically involve proximally moving the atraumatic end 512. This proximal movement of the distal end 113 of the core wire 112 and / or the atraumatic end 512 may reduce the distal extension of those portions of the core wire 112 that enter the blood vessel, thereby reducing the risk of vascular injury.

[0181] One or more friction bumps 508 may be coupled to the unfolded wire 110, and specifically to the core wire 112 and / or the support coil 510. In some embodiments, one or more friction bumps 508 may be directly coupled to the unfolded wire 110 and specifically to the core wire 112, and in some embodiments, one or more friction bumps 508 may be indirectly coupled to the unfolded wire 110 and specifically to the core wire 112 via, for example, a self-expanding element. In some embodiments, the friction bumps 508 may be directly coupled to the support coil 510. In some embodiments, the friction bumps 508 may be soldered to the support coil 510, and solder penetration into the support coil 510 may further couple the friction bumps 508 to the core wire 112.

[0182] In some embodiments, one or more friction bumps 508 may be located at one or both ends of the self-expanding element. Therefore, in some embodiments, at least one of the friction bumps 508 is located at one of the proximal end 804 and the distal end 806. In some embodiments, at least one of the friction bumps 508 is located at one of the proximal end 804 and the distal end 806, and another friction bump is located at the other of the proximal end 804 and the distal end 806. Figure 8As shown, the friction bump 508 includes a first friction bump 508-A and a second friction bump 508-B. The first friction bump 508-A is located at, adjacent to, and / or on the proximal end 804 of the self-expanding element 802, while the second friction bump 508-B is located at, adjacent to, and / or on the distal end 806 of the self-expanding element 802. In some embodiments, the friction bump 508 may extend across and / or over a portion of the self-expanding element 802. In some embodiments, one or more friction bumps 508 may be radiopaque and / or may include radiopaque elements such as coil 509. In some embodiments, one or both of the expansion element 802 and / or friction bumps 508 may facilitate the complete or partial retraction of the partially deployed shunt 300 back into the conduit 104. In some embodiments, compared to the expansion element 802 and the second friction bump 508-B which are positioned on the more distal side, the first friction bump 508-A can be optimally retracted into the conduit 404 by the position of the diverter 300 on the more distal side.

[0183] In some embodiments, the first friction bump 508-A may be coupled to the proximal end 804 of the expansion element 802 and / or the distal end of the core wire 112. In some embodiments, the first friction bump 508-A may be coupled to the support coil 510. Specifically, in some embodiments, the first friction bump 508-A may be directly coupled to the support coil 510. In some embodiments, the first friction bump 508-A may be soldered to the support coil 510, the solder may penetrate the support coil 510, and the first friction bump 508-A may further be coupled to the core wire 112, specifically to the distal end of the core wire 112. In some embodiments, the solder may form all or part of the first friction bump 508-A.

[0184] In some embodiments, the second friction bump 508-B may be coupled to the distal end 806 of the expansion element 802 and / or to the end coil 810. In some embodiments, the second friction bump 508-B may be soldered to the distal end 806 of the expansion element 802 and / or to the end coil 810. In some embodiments, the solder may form all or part of the second friction bump 508-B.

[0185] The system may include a support coil 510. The support coil 510 may extend around and / or along at least a portion of the distal portion 116 of the core wire 112, including extending along and / or around the distal end 113 of the core wire 112. In some embodiments, the support coil 510 may extend from a location proximal to the self-expanding element 802 and / or from a location proximal to the first friction bump 508-A. In some embodiments, the support coil 510 may extend at least partially into the first friction bump 508-A.

[0186] In some embodiments, the core wire 112 terminates at and / or within the first friction bump 508-B. Therefore, in some embodiments, the distal end 806 of the expansion element 802 is not directly coupled to the distal end of the core wire 112, but is indirectly coupled to the distal end of the core wire 112 via the distal end 804 of the expansion element 802. Therefore, in some embodiments, the core wire 112 does not extend through the expansion element 802. In some embodiments, this connection of only the proximal end 804 of the expansion element 802 to the core wire 112 achieves a shortening of the expansion element 802 associated with its radial expansion. In some embodiments, the lack of a core wire 112 extending through the expansion element 802 increases the flexibility of the expansion element 802.

[0187] In some embodiments where the core wire 112 terminates at the proximal end 804 of the expansion element 802, the connecting wire 820 may be connected to the distal end 806 of the expansion element 802, to the end coil 810, and / or to the atraumatic end 512. In some embodiments, the connecting wire 820 may be configured to prevent loss of the distal portion of the unfolded wire 110 in the event of, for example, breakage of the expansion element 802, the end coil 810, and / or the atraumatic end 512. In such embodiments, the connecting wire 820 allows the distal portion of the unfolded wire 110 to be retracted from the patient.

[0188] In some embodiments, the connecting wire 820 may be connected to the distal end of the core wire 112, while in some embodiments the connecting wire 820 may extend parallel to and / or through the core wire 112, and in some embodiments it may be used as a pull wire for controlling expansion and / or facilitating the expansion of the expansion element 802.

[0189] In some embodiments, the connecting wire 820 may be tensioned when the expansion element 802 is contained within the conduit 104 and / or the inlet sheath 120, and the connecting wire 820 may be relaxed when the expansion element 802 is deployed from the conduit 104 and / or in an expanded configuration.

[0190] In some embodiments, system 800 may include an end coil 810, which may be a flexible end coil 810. The end coil 810 may extend distally from the self-expanding element 802, and specifically from the distal end 802 of the self-expanding element 806. The end coil 810 may extend distally beyond the self-expanding element 802 and may terminate at a non-invasive end 512. In some embodiments, the non-invasive end 512 may be located at the most distal point of the end coil 810. In some embodiments, the flexible end coil 810 and / or the flexible end coil 810 and the non-invasive end 512 may facilitate navigation of system 800 and / or core wire 112 through vascular systems, particularly through tortuous vascular systems.

[0191] Figure 8 An embodiment of the shunt deployed by system 800 is shown. Catheter 104 has been inserted into the vascular system and advanced to a position close to, near, or beyond treatment site 812. In some embodiments, the catheter position can be determined by imaging, such as by fluoroscopy.

[0192] As shown, the deploying filament 110 and shunt 300 are advanced distally in the direction indicated by arrow 814 until the shunt 300 exits the catheter 104. As the shunt 300 exits the catheter 104, it can begin to dilate and can begin to engage the interior of the blood vessel 600. In some embodiments, the distal advancement of the deploying filament 110 and shunt 300 can continue until the shunt 300 is fully deployed. Alternatively, if the shunt 300 has not yet fully deployed from the catheter 104, it can be retracted and / or partially retracted into the catheter 104. In some embodiments, the shunt 300 can be retracted and / or partially retracted into the catheter 104 until the friction bump 508 and / or the dilation element 802 exit the catheter 104 on the proximal side. In some embodiments, the positions of the shunt 300, conduit 104, friction bump 508, and / or self-expanding element 802 can be determined by imaging, particularly by imaging multiple portions of the transmissive element and / or conduit 104, friction bump 508, and / or self-expanding element 802. In some embodiments, and based on the results of this imaging, it can be determined whether the shunt 300 can be retracted and / or partially retracted into the conduit 104.

[0193] When the self-expanding element 802 exits the conduit 104, it expands and applies a radially outward force to the shunt 300, causing the shunt 300 to expand further. Alternatively, when using a controlled expansion element, opening the conduit 104 may cause the controlled expansion element to expand.

[0194] The self-expanding element 802 may continue to advance distally relative to the catheter 104 until the shunt 300 is fully deployed. When the shunt 300 is fully deployed, the self-expanding element 802 may advance distally through the shunt 300 to fully and / or maximally expand the shunt 300, at which point the self-expanding element 802 may retract proximally through the shunt 300 and then return to the catheter 104. In some embodiments, the distal advancement and proximal retraction of the dilator 802 through the shunt 300 may be repeated multiple times before retracting the dilator 802 back into the catheter 104. In some embodiments, the repeated movement of the dilator 802 through the deployed shunt 300 may help achieve full deployment of the shunt 300, particularly when all or more portions of the shunt 300 are not yet fully deployed. This movement of the self-expanding element 802 through the shunt 300, first distally and then proximally, can increase the dilation of the shunt 300 and improve the connection between the shunt and the vessel 600.

[0195] Once the self-expanding element 802 has retracted into the catheter 104, the catheter can be retracted and / or one or more additional shunts can be delivered to the treatment site.

[0196] like Figure 8 The illustration shows an embodiment of a shunt 300 for delivery into a blood vessel 600 to treat an aneurysm. In some embodiments, the blood vessel may be a neurovascular vessel, or in other words, a blood vessel in or around the patient's brain. In some embodiments, delivery of the shunt 300 into the blood vessel 600 may include partially unfolding the shunt 300 from the catheter 104 and / or fully or partially retracting the shunt 300 into the catheter 104. As used herein, full retraction occurs when the shunt 300 is retracted until it is completely contained within the catheter 104, while partial retraction occurs when a portion of the shunt 300 remains outside the catheter 104 after retraction.

[0197] In some embodiments, the shunt can be fully or partially deployed after the shunt 300 retracts into the conduit 104. In some embodiments, the shunt 300 can be partially deployed and retracted once, while in some embodiments, the shunt 300 can be repeatedly partially deployed and retracted into the conduit 104.

[0198] In some embodiments, the shunt 300 may be retracted into the catheter 104 and removed from the blood vessel. In some embodiments, the shunt 300 may be replaced by another shunt 300 of a different size, for example, a shunt with a larger or smaller diameter. In some embodiments, the shunt 300 may be retracted and re-deployed to improve the expansion of the shunt 300. In some embodiments, for example, retracting and re-deploying the shunt 300 may result in a more complete opening of the shunt 300 and / or improved contact between all or more portions of the shunt 300 and the blood vessel in which it is deployed.

[0199] In some embodiments, the shunt 300 can be retracted and / or re-deployed to affect the portion of the vessel covered by the deployed shunt 300. In some embodiments, for example, and by controlling the positioning and / or movement of both the catheter 104 and the core wire 112 during deployment, the coverage of the shunt 300 in the treatment position can be affected. For example, and after the distal portion of the shunt 300 has been engaged with the vessel to attach the shunt 300 to the vessel, the length of the deployed shunt can be affected by retracting the catheter 104 while deploying the shunt 300. Specifically, the relative speed of the retraction of the catheter 104 relative to the deployment of the shunt 300 can affect the length of the shunt 300. For example, by retracting the catheter 104 relatively slowly relative to the deployment of the shunt 300, the length of the deployed shunt can be reduced. Alternatively, by retracting the catheter 104 relatively quickly relative to the deployment of the shunt 300, the shunt 300 can be stretched during deployment, and the length of the deployed shunt 300 can be increased.

[0200] In some embodiments, and by controlling the length of the deployed shunt 300, the surgeon can influence the diameter of the deployed shunt 300. Specifically, as the length of the deployed shunt increases, the deployed, unconstrained diameter of the shunt decreases. Thus, in some embodiments where the shunt 300 is deployed into a vessel with a large diameter, the surgeon can reduce the length of the deployed shunt to achieve the desired deployed diameter of the shunt 300.

[0201] Now refer to Figure 9 A schematic diagram of a customizable delivery system 900 is shown. (As shown) Figure 9 As shown, the unfolded cable 110 and the shunt 300 are at least partially positioned within the inlet sheath 120. Figure 9 As shown, in some embodiments, no portion of the extended wire 110 extends distally beyond the distal end 307 of the shunt 300. For example... Figure 9As further seen, in some embodiments, prior to the custom shunt 300, no portion of the extended cable 110 extends distally beyond the distal end 124 of the inlet sheath 120.

[0202] like Figure 9 As further seen, the unfolded wire 110, including the tapered core wire 112, is the connecting unfolded feature 118, such as Figure 9 As shown, the unfolding feature includes a pusher 505 and a friction protrusion 508, as described in detail above. Although Figures 9 to 16 An embodiment with friction bumps 508 and / or pushers 505 is shown, but these embodiments may include Figure 8 The unfolding feature 118 shown is, for example, the expansion element 802 and the friction bumps 508-A, 508-B.

[0203] The combination of friction bump 508 and pusher 505 engages with shunt 300 to advance shunt 300 distally into and out of conduit 104 as the deploying wire 110 advances distally. As the deploying wire 110 advances distally, shunt 300 unfolds from conduit 104 and begins to expand. This distal advancement continues until shunt 300 is fully unfolded. Alternatively, if shunt 300 has not yet fully unfolded from conduit 104, and while friction bump 508 is still within conduit 104 and engaged with shunt 300, shunt 300 may retract and / or partially retract into conduit 104. In some embodiments, successful unfolding of shunt 300 can be achieved by advancing only the deploying wire 110 distally, while in some embodiments, successful unfolding of shunt 300 can be achieved by alternately advancing shunt 300 distally and retracting proximally until the desired positioning and / or unfolding is achieved. Figure 9 In the system 900 shown, the shunt 300 extends a first length 902 beyond the distal end 124 of the inlet sleeve 120.

[0204] like Figure 9 The system 900 shown also includes a customization component 901 that enables customization of the shunt 300. In some embodiments, the customization component 901 enables customization of the shunt 300 before it is inserted into the conduit 104.

[0205] Custom component 901 may include an elongated tubular member having a proximal end and a distal end. In some embodiments, the elongated tubular member of custom component 901 includes an internal wall defining an inner cavity. In some embodiments, custom component 901 may include one or more cuttable portions that allow cutting to realize a custom diverter 300.

[0206] Custom component 901 may include a proximal portion 930 and a distal portion 932. In some embodiments, the proximal portion 930 may include the proximal half of custom component 901, while the distal portion 932 may include the distal half of custom component 901. In some embodiments, the proximal portion 930 may include approximately one-third of the proximal side of custom component 901, while the distal portion 932 may include approximately two-thirds of custom component 901 located distal to the proximal portion 930. In some embodiments, the proximal portion 930 may include approximately one-quarter of the proximal side of custom component 901, while the distal portion 932 may include approximately three-quarters of custom component 901 located distal to the proximal portion 930.

[0207] In some embodiments, the custom component 901 may include one or more components. The custom component 901 may include an inlet sleeve 120. In some embodiments, the inlet sleeve 120 may be cuttable to customize the splitter 300. In some embodiments, the custom component 901 may include an inlet sleeve 120 coupled to and / or coupled to another cuttable feature for customizing the splitter 300. For example, in some embodiments, the custom component 901 may include a tubular component, such as the inlet sleeve 120, and a cuttable support extending along and around the distal end 124 of the elongated tubular component (e.g., the inlet sleeve 120). In some embodiments, the cuttable support may be a tube 904 extending along and around the distal end 124 of the elongated tubular component (e.g., the inlet sleeve 120). The tube 904 may be a polymer tube attached to the distal end 306 of the splitter 300. The tube 904 preferably comprises a polymer tube comprising heat-shrinkable PTFE, polyetheramide, polyolefin, or FEP. In at least some embodiments, tube 904 is transparent, partially transparent, or opaque. For example, in at least some methods, shunt 300 is visible or partially visible within tube 904.

[0208] In some embodiments, and such as Figures 9 to 17 As shown, the deployable feature 118 and / or deployable wire 110 do not extend distally into the tube 904, but terminate in the inlet sleeve 120. In some embodiments, the deployable feature and / or deployable wire 110 terminate in the proximal portion 930 of the custom member 901. Thus, in some embodiments, the deployable feature terminates in the proximal portion 310 of the diverter 300, which is contained within the inlet sleeve 120 rather than in the tube 904.

[0209] The tube 904 extends beyond the distal end 124 of the inlet sleeve 120 by a second length 906. (As...) Figure 9As seen, the distal end 306 of the splitter 300 may be contained within the tube 904. The tube 904 is preferably cuttable and configured such that the length of the splitter 300 can be customized by cutting the tube 904 and the splitter 300 contained therein. In at least some embodiments, the tube is semi-rigid and peelable.

[0210] In at least some methods, the first length 902 and the second length 906 are equal, such that the shunt 300 and the tube 904 extend distally beyond the distal end 124 of the inlet sheath 120 by the same length. In other methods, the second length 906 (e.g., the length by which the tube 904 extends beyond the distal end 124 of the inlet sheath 120) may be greater than or less than the first length 902 (e.g., the length by which the shunt 300 extends beyond the distal end 124 of the inlet sheath 120). In at least some embodiments, the spreader wire 110 terminates before the distal end 306 of the shunt 300, such that the distal end of the spreader wire 110 does not extend into the tube 904. The spreader wire 110 does not extend distally beyond the distal end 306 of the shunt 300.

[0211] In some embodiments, the splitter 300 can be cut to a desired length within the tube 904. Specifically, in some embodiments, the size and composition of the individual strands in the splitter 300, as well as the combination of the braiding of the fabric, can make the splitter 300 cuttable. In some embodiments, this may include, for example, a braiding that does not unravel when the splitter 300 is cut. A heat-shrinkable tube constrains and holds the braid in a constrained configuration. In various methods, the braid has been heat-treated to maintain its shape and tubular configuration.

[0212] The desired length of the shunt 300 can be customized by cutting it, allowing the physician to tailor the length of the shunt 300 to match the specifications of the treatment site. For example, the physician can trim the shunt 300 to the desired length within the tube 904 without damaging the delivery system 900. The tube 904 facilitates the on-demand trimming process of the shunt 300 (on-demand trimming).

[0213] In at least some embodiments, the tube 904 includes graduation marks 908 that are equidistantly spaced along a portion of the tube 904, and specifically along the distal portion 910 of the tube 904. In various embodiments, the splitter 300 may include graduation marks 904 equidistantly spaced along a portion of the splitter 300 such that the graduation marks 908 are visible through the tube 904. The graduation marks 908 can serve as a ruler for guiding cuts to the splitter 300 and / or the tube 904 to a desired length.

[0214] The tube 904 includes a proximal end 912 and a distal end 914 opposite to the proximal end 912, a first longitudinal portion 916 having a first proximal tab 918, and a second longitudinal portion 920 having a second proximal tab 922. In some embodiments, the first longitudinal portion 916 is coupled to the second longitudinal portion 920 via a connecting portion that is relatively thinner than each of the first longitudinal portion 916 and the second longitudinal portion 920. Each of the first longitudinal portion 916 and the second longitudinal portion 920 extends from the proximal end 912 of the tube 904. In various embodiments, the tube 904 can be peelably removed from the distal portion of the introduction sleeve 120 by separating the first longitudinal portion 916 from the second longitudinal portion 920 using the first proximal tab 918 and the second proximal tab 922 in a manner that will be understood by those skilled in the art. Specifically, in some embodiments, peeling the tube 904 from the introduction sleeve may include separating the first longitudinal portion 916 from the second longitudinal portion 920 along the connecting portion.

[0215] like Figure 10 As seen herein, system 900 can be used to customize the length of splitter 300 to a desired length 1000. In at least some embodiments, discard section 1002 can be removed (e.g., cut) from pipe 904 having splitter 300 located within pipe 904. Scale markings 908 can be used to measure the desired length 1000 and / or to measure discard section 1002 to determine where cut 1004 should be formed. Referring now to... Figure 11 The discarded section 1002 has been removed, and the expected length 1000 is retained.

[0216] like Figure 12 As shown, the first longitudinal portion 916 of the tube 904 having a first proximal pull tab 918 and the second longitudinal portion 920 having a second proximal pull tab 922 can be peelably removed from the distal portion of the inlet sleeve 120 by separating the first longitudinal portion 916 from the second longitudinal portion 920 using the first proximal pull tab 918 and the second proximal pull tab 922 in a manner that will be understood by those skilled in the art. For example, the first longitudinal portion 916 is pulled by the pull tab 918 in a first direction 1200 that is substantially perpendicular to the longitudinal axis 1202 of the inlet sleeve 120. Similarly, the second longitudinal portion 920 is pulled by the pull tab 922 in a second direction 1204 that is substantially perpendicular to the longitudinal axis 1202 of the inlet sleeve 120 and opposite to the first direction 1200.

[0217] In at least some embodiments, before or during the peelable removal of the tube 904, the desired length 1000 of the shunt 300 retracts into the inlet sleeve 120, such that the shunt 300 is substantially within the inlet sleeve 120. In some embodiments, the inlet sleeve 120 has a length such that the entire shunt 300 can be retracted from the tube 904 into the inlet sleeve 120, whether the shunt 300 is trimmed or undressed. In some such embodiments, the inlet sleeve 120 has a length greater than or equal to the length of the undressed shunt 300. Therefore, in some embodiments, the combined length of the inlet sleeve 120 and the attached tube is longer than that of the undressed shunt. As described in detail above, the shunt 300 can be retracted into the inlet sleeve 120 via actuation of the unfolded wire 110 and movement relative to the inlet sleeve 120. For example, the splitter 300 is retracted into the inlet sheath 120 by retracting the extended wire 110 to the distal side.

[0218] Peelable removal of tube 904 includes separating tube 904 from the distal portion of the inlet sleeve 120. As described above, tube 904 can be separated from the distal portion of the inlet sleeve 120 by peeling tube 904 from the distal portion of the inlet sleeve 120, wherein peeling tube 904 includes separating the first longitudinal portion 916 from the second longitudinal portion 920. However, separation of tube 904 from the distal portion of the inlet sleeve 120 can be performed in other ways, for example, using only a pull tab to separate tube 904. In some methods, tube 904 is separated from the distal portion of the inlet sleeve 120 after the shunt 300 has retracted into the inlet sleeve.

[0219] Now refer to Figure 13 After tube 904 is removably removed from the distal portion of the inlet sheath 120 and the desired length 1000 of the shunt 300 is retracted into the inlet sheath 120, the remaining system 1300 can be loaded into the conduit system 102, and specifically, into the conduit 104 of the conduit system 102 via actuation of the unfolding wire 110, as... Figure 14 As shown. The shunt 300 can then be delivered to the neurovascular vessel (e.g., vessel 600). This may include moving the distal end 132 of the catheter system 102 near the treatment location, for example, advancing the catheter system 102 proximal to the treatment location within the neurovascular vessel, advancing the core wire through the microcatheter, and deploying the shunt from the microcatheter and into the neurovascular vessel 600 to treat the aneurysm by advancing the pusher and at least one friction bump via the advancement of the core wire.

[0220] In some embodiments, the catheter system 102 may be positioned distally, and in some embodiments, only distally to the treatment location. In some embodiments, advancing the deployable filament 110 distally relative to the catheter system 102 may also cause the shunt 300 to advance distally relative to the catheter system 102. In some embodiments, the shunt 300 may be deployed by advancing the deployable filament 110 relative to the catheter system 102. In some embodiments, such advancement of the deployable filament 110 relative to the catheter system 102 may include: retracting the catheter system 102 within the vessel 600 while maintaining the position of the deployable filament 110 relative to the vessel 600; advancing the deployable filament 110 relative to the vessel 600 while maintaining the position of the catheter system 102 relative to the vessel 600; or simultaneously retracting the catheter system 102 relative to the vessel 600 while advancing the deployable filament 110 relative to the vessel 600.

[0221] In some embodiments, as the shunt 300 exits the conduit system 102, the shunt 300 expands and / or begins to expand. The shunt 300 may continue to expand via further distal advancement of the deployed wire 110 and thus via further distal advancement of the shunt, and the shunt 300 may be fully expanded.

[0222] After the shunt 300 has been fully deployed, the deployed filament 110 can be retracted distally into the catheter system 102, and the catheter can be retracted from the treatment position and from the patient's vascular system. In some embodiments, one or more additional shunts 300 may be deployed to the treatment position. This may include placing an additional shunt on top of one or more previously deployed shunts 300. Alternatively, one or more additional shunts 300 may be positioned in a partially overlapping manner to increase the length of the treated vessel 600. In such embodiments, the distal end of the additional shunt may be placed overlapping the proximal end or on top of a previously placed shunt 300.

[0223] In some embodiments, at least one of the pusher and at least one friction bump is radiopaque. Delivery of the catheter system 102 may include imaging of the pusher and at least one friction bump to determine the location of the shunt in the neurovascular bundle and the position of the pusher and / or at least one friction bump relative to the microcatheter.

[0224] In some embodiments, the shunt retracts into the microcatheter before at least one of the at least one friction bump has left the microcatheter. In at least some aspects, the positioning of the microcatheter is adjusted based on imaging relative to the treatment location.

[0225] In various aspects, the shunt is loaded into the catheter system 102. In some embodiments, loading the shunt into the microcatheter includes inserting an inlet sheath containing the shunt into the microcatheter via an access device and advancing a deployable wire through the inlet sheath to advance the shunt from the inlet sheath into the microcatheter.

[0226] like Figure 15 As shown, the second customizable diverter delivery system 1500 includes a template 1502. Template 1502 includes a top 1504, a bottom 1506, a front 1508, a rear 1510, a first side 1512, and a second side 1514. Template 1502 includes features similar to at least... Figure 9 The scale mark 1516 is shown as scale mark 908. Scale mark 1516 is configured to assist in cutting the splitter 300 to the desired length in a manner similar to that described above. Scale mark 1516 is preferably associated with the unfolded length of the splitter 300.

[0227] In some embodiments, tube 904 may include graduation markings, such as at least at Figure 9 The scale markings shown are illustrated in the diagram. The second customizable shunt delivery system 1500 depicts alternative and / or supplementary methods to guide a physician in cutting the shunt 300 within the peelable removable tube 904 to the desired length. In at least some of these methods, scale markings may be set on both the tube 904 and the template 1502 on which the shunt delivery system is provided.

[0228] In various embodiments, template 1502 includes a cutout, slit, or recess 1518 extending through a bottom 1506 of template 1502. The cutout, slit, or recess 1518 is located near one of the first side portion 1512 and the second side portion 1514. A graduation mark 1516 may be positioned between the cutout, slit, or recess 1518 and the other of the first side portion 1512 and the second side portion 1514. For example, the graduation mark 1516 is positioned between the cutout, slit, or recess 1518 and the first side portion 1512. In another example, the graduation mark 1516 is positioned between the cutout, slit, or recess 1518 and the second side portion 1514, such as... Figure 15 As shown.

[0229] In some embodiments, template 1502 includes a first set of scale marks along the bottom 1506 of the front portion 1508 of template 1502 and a second set of scale marks along the bottom 1506 of the rear portion 1510 of template 1502. In one embodiment, one of the front portion 1508 and the rear portion 1510 of template 1502 is configured for right-handed users, while the other of the front portion 1508 and the rear portion 1510 of template 1502 is configured for left-handed users.

[0230] In various embodiments, template 1502 includes a formula (scheme, criterion), not shown, configured to facilitate cutting the splitter 300 to a desired length. This formula may be printed along the top 1504 of template 1502. For example, the formula may be printed along the top portion of template 1502. In other examples, the formula may be centered on the front 1508 and / or rear 1510 of template 1502. The formula may be printed at any position along either side of template 1502. In a preferred embodiment, the formula and scale markings 1516 are printed on each of the front 1508 and rear 1510 of template 1502.

[0231] In at least one embodiment, the formula includes:

[0232] L T =L I -L D R

[0233] R = 0.27D + 1.2

[0234] in:

[0235] L T = Trimming length

[0236] L D =Expanded length

[0237] L I =Inner length of the sheath

[0238] R = ratio

[0239] D = implant diameter

[0240] In one embodiment, the implant diameter (D) is 4 mm, the desired unfolded length (LD) is 25 mm, and the in-sleeve length (L) is... I It is 80mm.

[0241] calculate:

[0242] R = 0.27(4) + 1.2 = 2.28

[0243] L T =800-25(2.28)=23mm

[0244] Therefore, in order to achieve an unfolded length of 25mm, the operator needs to trim off 23mm.

[0245] like Figure 16As shown, the second customizable diverter delivery system 1500 includes a protective sleeve 1600 extending along and around the proximal end 304 of the diverter 300, wherein the protective sleeve 1600 is configured to reduce friction and / or reduce damage to the diverter 300 as the diverter 300 moves relative to an elongated tubular member (e.g., an inlet sleeve 120). In various methods, the protective sleeve 1600 extends beyond the proximal end 304 of the diverter 300 and / or the pusher 505, such as... Figure 16 As shown.

[0246] The protective sleeve 1600 may be a heat-shrinkable plastic. In some embodiments, the protective sleeve 1600 may include a flexible polymer coupled to the deployable wire 110. In some embodiments, the protective sleeve 1600 may be coupled to the deployable wire 110 at a location distal to all or part of the deployable features (e.g., friction bumps 508, support coils 510, etc.). In some embodiments, the protective sleeve 1600 may include a heat-shrinkable polymer tube positioned over the proximal end 304 of the shunt 300 and over a portion of the deployable wire 110 distal to the shunt 300. The protective sleeve 1600 may then be heat-shrinkable around the shunt 300 to fit snugly around the shunt 300. The protective sleeve 1600 is coupled to the pusher 505 and / or the core wire 112.

[0247] The protective sleeve 1600 may also include one or more slits (not shown) extending proximally from the distal end of the protective sleeve 1600. The one or more slits will separate a portion of the protective sleeve 1600 extending over the proximal end 304 of the shunt 300 into multiple parts. For example, in an embodiment of the protective sleeve 1600 including two slits, the protective sleeve 1600 may be divided into two pieces, which may be two equal halves. As the shunt 300 deploys, the one or more slits may allow the protective sleeve 1600 to open and separate from the shunt 300. The protective sleeve 1600 may extend distally beyond the conduit 104 and split (split) such that the protective sleeve 1600 separates from the shunt 300, allowing the shunt 300 to expand and allowing the protective sleeve 1600 to retract into the conduit 104 when the shunt 300 is fully deployed.

[0248] like Figure 17As shown, the second customizable shunt delivery system 1500 includes a custom component 901 and an expansion element 1700, wherein the expansion element 1700 is configured to reduce friction and / or damage to the shunt 300 as the shunt 300 moves relative to an elongated tubular component (e.g., an inlet sheath 120). The expansion element 1700 may be a self-expanding element or a controlled expansion element. In some embodiments, a self-expanding element may expand upon exiting the conduit 104. In some embodiments, a controlled expansion element may expand when controlled to expand. The expansion element 1700 may include, for example, a stent, a braid, a balloon, etc. In some embodiments where the expansion element 1700 includes a braided component, the thickness of the strands of the braid may be varied to achieve a desired effect. For example, the strands may be thicker to provide increased expansion force, or the strands may be thinner to provide increased flexibility. In some embodiments, the strands may include various materials, including, for example, a DFT, which may be, for example, radiopaque. In some embodiments, the strands may include polymers, such as high tensile strength polymers. In some embodiments, the polymer used in the strands can advantageously increase the friction between the expansion element 1700 and the shunt 300, thereby increasing the ability of the expansion element 1700 to retract the shunt 300. In embodiments where the strands include a polymer, the polymer may be treated and / or doped to be non-transmissive.

[0249] Now refer to Figure 18 A customizable shunt delivery system 1800 can be implemented without tubing. In such an embodiment, the custom component 901 does not include a cutable tube attached distally as shown in the previous embodiment. In this alternative embodiment, the shunt 300 can extend beyond the distal end 124 of the inlet sheath 120 by a length 1802. As further shown, in such an embodiment, the deployable wire 110 terminates within the inlet sheath 120 such that the deployable wire 110 does not extend distally beyond the distal end 124 of the inlet sheath 120. A physician can use a template (not shown) to measure the shunt 300 and cut the shunt 300 1804 to the desired length 1806, and the shunt 300 can retract into the inlet sheath 120, as described in detail above. In such an embodiment, and as described above regarding Figures 9 to 17 The introduced sheath 120 may have sufficient length to accommodate the entire shunt 300, whether trimmed or undone.

[0250] Now refer to Figure 19The customizable flow delivery system 1900 includes a custom component 901, which includes a cuttable inlet sheath 1902. The cuttable inlet sheath 1902 includes an outer inlet sheath layer 1904 and an inner cuttable tube 1906 surrounding the diverter 300. In some methods, the outer inlet sheath layer 1904 is rigid, while the inner cuttable tube 1906 is semi-rigid (e.g., similar to the tube 904 described in detail above). In some embodiments, the outer inlet sheath layer 1904 may have sufficient length to receive the entire diverter 300, whether trimmed or undone.

[0251] In various methods, the introducer sleeve 1902 (e.g., outer introducer sleeve layer 1904) may taper distally. In other methods, the introducer sleeve 1902 is not tapered and includes a constant diameter throughout the length of the introducer sleeve 1902.

[0252] In an alternative embodiment (not shown), the inlet sheath 1902 is integral and cuttable. For example, it includes an outer inlet sheath layer 1904 and an inner cuttable tube 1906, and as shown... Figure 19 Unlike the embodiments shown, the inlet sheath 1902 comprises only a relatively thin and rigid material. In some embodiments, the single (integral), cutable inlet sheath 1902 is semi-rigid to allow cutting of the inlet sheath 1902, but rigid enough to engage with the conduit hub 106 to allow the shunt 300 to transfer from the inlet sheath 1902 to the conduit 104.

[0253] The outer sheath 1904 defines the outer sheath cavity 1908, and the inner cutable tube 1906 defines the inner tube cavity 1910. For example... Figure 19 As shown, the diverter (e.g., the diverter 300 described in detail above) is contained in the inner tube cavity 1910 in a constrained position.

[0254] In various embodiments, system 1900 includes a deployable wire (such as deployable wire 110 described in detail above) extending into the inner lumen 1910 of the inner tube and into a flow channel of the shunt 300. As deployable wire 110 advances distally, shunt 300 deploys from conduit 104 and begins to expand. This distal advancement continues until shunt 300 is fully deployed.

[0255] like Figure 20 As shown, according to any aspect described in detail above, the internally cuttable tube 1906 and the shunt 300 can be cut 2002 to the desired length 2004. (As...) Figures 20 to 26As shown, the spreader wire 110 and / or spreader feature 118 terminates proximally at the distal end of the splitter 300, specifically, proximally at the location where the splitter 300 may be cut 2002, such that cutting the splitter 300 will not cut the spreader wire 110 and / or spreader feature 118.

[0256] In some embodiments, the shunt 300 may be cut 2002 to a desired length 2004. For example, the internally cutable tube 1906 may include graduations and / or be provided with a template having graduations to enable a physician to determine and measure the desired length 2004. Figure 21 As shown, after cutting 2002 (e.g., after cutting the cutable tube 1906 and the shunt 300), the remaining portion 2006 can be discarded.

[0257] In some embodiments, such as Figure 22 As shown, after cutting the inner cutable tube 1906 and the shunt 300, the outer inlet sheath 1904 can be advanced distally by 2200 to position the inner tube within the outer sheath, such that the distal end of the inner tube is located within the inner cavity of the outer sheath. In another embodiment, the outer inlet sheath 1904 can be advanced distally by 2200 to align the distal end 2202 of the outer inlet sheath 1904 with the distal end 2204 of the inner cutable tube 1906 and / or the distal end 2206 of the shunt 300. In another embodiment, the inner cutable tube 1906 and the shunt can be retracted into the outer inlet sheath 1904. In another embodiment, the inner cutable tube 1906 and the diverter 300 are provided separately from the outer inlet sheath 1904, and after cutting, the trimmed inner cutable tube 1906 and diverter 300 are inserted into the outer inlet sheath 1904, as exemplarily Figure 23-26 As shown in the image.

[0258] In such Figure 23 In the alternative embodiment shown, the custom component 901 includes an inner cutable tube 1906 and an outer inlet sheath layer 1904. Figure 23 In some embodiments, the inner cutable tube 1906 and the diverter 300 are provided separately from the outer inlet sheath layer 1904. The inner cutable tube 1906 includes one or more locking elements 2302. The one or more locking elements 2302 may be spaced apart around the periphery of the inner cutable tube 1906. In one exemplary aspect, the inner cutable tube 1906 includes at least two locking elements 2302 located on opposite sides of the inner cutable tube 1906, as shown.

[0259] In some aspects, locking elements 2302 are located on the outer lead sheath layer 1904. One or more locking elements 2302 may be spaced apart around the periphery of the outer lead sheath layer 1904. In one exemplary aspect, the outer lead sheath layer 1904 includes at least two locking elements 2302 located on opposite sides of the outer lead sheath layer 1904.

[0260] In various embodiments, after cutting the inner cutable tube 1906 and the diverter 300, the trimmed inner cutable tube 1906 and diverter 300 are inserted into the outer inlet sleeve 1904, and each locking element 2302 is wedged between the outer inlet sleeve layer 1904 and the inner cutable tube 1906, and configured to lock the positioning of the outer inlet sleeve layer 1904 relative to the inner cutable tube 1906, such as... Figure 24 As shown.

[0261] In another embodiment, the inner cutable tube 1906 and the diverter 300 are disposed within the outer inlet sheath layer 1904, and the distal ends of the inner cutable tube 1906 and the diverter 300 extend beyond the distal end of the outer inlet sheath layer 1904 for cutting to a desired length. After cutting the inner cutable tube 1906 and the diverter 300, the outer inlet sheath layer 1904 can be retracted, causing the locking element 2302 to wedge into the outer inlet sheath layer 1904.

[0262] In alternative, such as Figure 25 As shown, the internally cuttable tube 1906 includes a flared end 2502 surrounding the periphery of the proximal end 2504 of the internally cuttable tube 1906.

[0263] In various embodiments, the flared end 2502 is wedged between the inner cutable tube 1906 and the outer inlet sheath layer 1904 and configured to lock the position of the outer inlet sheath layer 1904 relative to the inner cutable tube 1906.

[0264] In various embodiments, after cutting the inner cutable tube 1906 and the diverter 300, the trimmed inner cutable tube 1906 and diverter 300 are inserted into the outer inlet sheath 1904, and the flared end 2502 is wedged between the outer inlet sheath layer 1904 and the inner cutable tube 1906, and configured to lock the position of the outer inlet sheath layer 1904 relative to the inner cutable tube 1906, such as... Figure 26 As shown.

[0265] In another embodiment, the inner cutable tube 1906 and the diverter 300 are disposed within the outer inlet sheath 1904, and the distal ends of the inner cutable tube 1906 and the diverter 300 extend beyond the distal end of the outer inlet sheath 1904 for cutting to a desired length. After cutting the inner cutable tube 1906 and the diverter 300, the outer inlet sheath 1904 can be retracted over the flared end 2502 of the outer inlet sheath 1904.

[0266] Figure 27 This is a schematic diagram of one embodiment of packaging for a customizable diverter delivery system. In various embodiments, unless otherwise stated herein, "packaging" may be interchangeably referred to as "shell". System 2700 includes packaging 2702, which is either primary packaging or packaging in direct contact with diverter delivery device 2704. Packaging 2702 may provide a backing (support) for supporting diverter delivery device 2704 during transport, storage, or similar processes. For example, packaging 2702 may include a packaging pallet. In particular, diverter delivery device 2704 may be removably coupled to packaging 2702 via fastening members 2706 such as adhesives, straps, clips, kinks, or the like. Packaging 2702 may be made of any material, including but not limited to paper, plastic, corrugated cardboard, glass, metal, wood, foam, etc., or any combination thereof. Fastening members 2706 may be integrally formed with packaging 2702, and / or fastening members 2706 may be formed independently and used with packaging 2702.

[0267] According to various embodiments, the diverter delivery device 2704 may include an elongated tubular member 2708, such as an inlet, including any of the embodiments described with respect to the other figures. For example, the elongated tubular member 2708 is a cutable inlet. The diverter delivery device 2704 may include a diverter 2710 that is at least partially contained within the cavity of the elongated tubular member 2708 in a constrained configuration. Figure 27 As shown, the diverter 2710 extends a first length L1 beyond the distal end of the elongated tubular member 2708. The diverter delivery device 2704 may include a deployable wire 2712 that extends into the cavity of the elongated tubular member 2708, and movement of the deployable wire 2712 relative to the elongated tubular member 2708 causes movement of the diverter 2710 relative to the elongated tubular member 2708, as described in detail above.

[0268] The diverter delivery device 2704 may further include a peelable tube 2715 extending along and around the distal portion of the elongated tubular member 2708. The cutable, peelable tube 2715 may include peelable FEP. In other embodiments, the cutable, peelable tube 2715 may include any polymer tubing material. In various embodiments, the tube 2715 extends beyond the distal second length L2 of the elongated tubular member 2708. In an exemplary embodiment, the distal end of the diverter 2710 is within the tube 2715, and the tube 2715 is cutable, as described in detail above. The tube 2715 can be peelably removed from the elongated tubular member 2708.

[0269] like Figure 27 As further shown, package 2702 includes an integrated template 2714. Template 2714 may include scale marks 2716. Scale marks 2716 are configured to facilitate cutting the splitter 2710 to a desired length. Template 2714 may associate the scale marks 2716 with the unfolded length of the splitter 2710. According to various embodiments, the scale marks 2716 may be equally spaced. For example, the scale marks 2716 may increase along a scale. In other embodiments, the scale marks 2716 are not equally spaced. For example, various lengths may be predetermined and marked on template 2714. In some embodiments, template 2714 may be printed directly on package 2702. In other embodiments, template 2714 is an adhesive or insert attached to package 2702 in a manner known in the art. Package 2702 may also include alignment members 2718 disposed below the scale marks 2716. Alignment member 2718 may be a transparent tube, an inner cavity, etc., used to align the splitter delivery device 2704 relative to the scale mark 2716, for example to ensure that the splitter delivery device 2704 is straight and parallel to the scale mark 2716, for accurately determining the desired length of the splitter 2710. Figure 27 The inserted thumbnail highlights the position of the alignment member 2718 relative to the scale mark 2716 and the cut hole, slit or notch 2720.

[0270] In various embodiments, the alignment member 2718 may include a friction surface that engages with the shunt delivery device 2704 to hold the shunt delivery device 2704 in place during cutting. Furthermore, the alignment member 2718 frictionally engages with the shunt delivery device 2704 to prevent healthcare personnel from unintentionally pulling the shunt delivery device 2704 too far and too fast (e.g., beyond the desired length).

[0271] According to at least some embodiments, the template 2714, including the scale markings 2716, may not be a physical template. For example, the template 2714 may be projected onto or otherwise visually positioned on the packaging 2702 or its components. The template 2714 may be visible to healthcare professionals via a microscope, mobile phone, or other imaging device to help cut the shunt 2710 into variable lengths.

[0272] The package 2702, including template 2714, also includes a cutting orifice, slit, or notch 2720 extending through the package 2702. The cutting orifice, slit, or notch 2720 may be arranged proximal to the scale mark 2716. In various embodiments, the cutting orifice, slit, or notch 2720 is a slot for inserting scissors, blades, trimmers, shears, cutters, or other cutting tools into it for cutting the distributor delivery device 2704. In at least some embodiments, the size and shape of the cutting orifice, slit, or notch 2720 are determined to ensure alignment of the scissors within the cutting orifice, slit, or notch 2720, and accuracy of the cut (notch) relative to the scale mark 2716. For example, the size and shape of the cutting orifice, slit, or notch 2720 are designed such that the scissors do not laterally (laterally) shift upon insertion into the cutting orifice, slit, or notch 2720 (e.g., thereby changing the length of the distributor delivery device 2704). In other words, the width of the cutting orifice, slit, or notch 2720 constrains the cutting tool to facilitate cutting the shunt at the desired location and / or at the desired angle. For example, according to various embodiments, healthcare professionals may cut the shunt at a right angle (e.g., perpendicular) to its axis. In other embodiments, a 45-degree angle may be required.

[0273] In some embodiments, the package 2702 may further include an opening 2722 for retraction and advancement of the shunt delivery device 2704 relative to the scale mark 2716. The opening 2722 may be a clamping opening for a healthcare professional to pass through and clamp, allowing the shunt delivery device 2704 to be laterally translated relative to the template 2714 and the scale mark 2716. Once aligned, the healthcare professional can clamp and hold the shunt delivery device 2704 through the opening 2722 to maintain its position during cutting. In an exemplary embodiment, the opening 2722 is arranged proximal to the cutting orifice, slit, or notch 2720 such that the cutting orifice, slit, or notch 2720 is positioned between the opening 2722 and the alignment member 2718 and / or the scale mark 2716.

[0274] Package 2702 may also include a pair of scissors 2724 (or any cutting tool) for performing the cut. Thus, the size and shape of the cutting opening, slit, or notch 2720 can be designed to accommodate the scissors 2724 provided with the diverter delivery device 2704 to ensure the accuracy of the cut.

[0275] In various embodiments, package 2702 may include torque converter 2726 and / or various other components for use with shunt delivery device 2704. Package 2702 may include more or fewer components than those shown herein, as will be understood by one of ordinary skill in the art upon reading this disclosure.

[0276] Figures 28-30 Various embodiments of packaging for customizable diverter delivery systems are shown. Figures 28-30 An alternative construction with additional openings such as opening 2804 and opening 3004 is shown, providing additional handles for handling package 2702. Unless otherwise stated herein, the components may have similar forms and functions. Therefore, components with similar forms and functions can be used with… Figures 28-30 Similarly, number them. Figure 28 Package 2802 is shown, which has an exemplary alternative cutout, slit, or notch 2806 extending through the bottom edge of package 2802. Figure 29 A simplified embodiment is shown, which does not include any openings in the package 2902 and a cut-out, slit, or notch 2904 extending through the bottom edge of the package 2902. Figure 30 Package 3002 is shown, which includes an additional opening 3004 and a flap 3006 for covering the tip of the scissors 2724. Figure 30 It also includes exemplary alternative cutouts, slits, or notches 3008 that extend through the bottom edge of the package 3002.

[0277] Figure 31 This is a flowchart of a method for customizing a shunt delivery system. Method 3100 includes various embodiments for customizing a shunt for delivery into a neurovascular space to treat an aneurysm. Method 3100 includes providing a shunt system comprising any of the embodiments described in detail above. In particular, method 3100 includes using [the shunt system described above]. Figure 27-30The packaged shunt system. Method 3100 includes step 3102. Step 3102 includes determining the desired length of the shunt in the shunt system using a template for customizing the shunt. Advantageously, healthcare professionals can determine the desired length and customize the device to the desired length before insertion. In various embodiments, the template associates the scale markings with the unfolded length of the shunt. Various embodiments of method 3100 describe a housing for the shunt, which can be referenced regarding... Figure 27-30 Any of the packaging embodiments described herein.

[0278] Step 3104 includes advancing or retracting the tube relative to the housing to align the distributor with the template. Advancing or retracting the tube relative to the template may include positioning the distributor relative to graduations spaced equally along the template. These graduations are configured to facilitate cutting the distributor to the desired length. Step 3104 may also include positioning the tube within an alignment member disposed below the graduations to guide and hold the distributor stationary relative to the graduations during cutting. An opening at the nearest end of the graduations disposed within the housing may be used to advance or retract the tube relative to the template.

[0279] Step 3106 includes cutting the tube and shunt using a cutting orifice, slit, or notch disposed within the housing, such that the shunt is cut to a desired length. In various embodiments, the cutting orifice, slit, or notch is positioned between an opening and a graduation mark. Cutting the shunt to the desired length may include cutting the tube provided with the shunt system. Cutting may also include using a cutting tool such as the provided scissors to cut the shunt at a desired location and / or at a desired angle via a cutting orifice, slit, or notch extending through the housing.

[0280] Step 3108 includes retracting the distributor into the elongated tubular member or advancing the elongated tubular member over the distributor. After cutting, the distributor can be fully retracted into the elongated tubular member. According to various embodiments, the distributor is retracted into the elongated tubular member by retracting the unfolded wire coupled to the distributor distally. In various embodiments, method 3100 may include step 3110, which includes moving the unfolded wire relative to the elongated tubular member such that the distributor is moved relative to the elongated tubular member. Advancing the elongated tubular member over the distributor may include keeping the unfolded wire stationary while advancing the elongated tubular member.

[0281] In various embodiments, method 3100 further includes step 3112, which includes separating the tube from the distal portion of the elongated tubular member. For example, the tube can be separated from the distal portion of the elongated tubular member after the shunt has retracted into the elongated tubular member. According to the various embodiments described herein, the tube can be separated from the distal portion of the elongated tubular member by peeling it off. As will be understood by those skilled in the art upon reading this disclosure, method 3100 can accommodate a shunt within the elongated tubular member into a microcatheter or similar device for insertion into a patient's blood vessel.

[0282] Figures 32A-32E Exemplary process steps for customizing a shunt using a shunt delivery system as described herein are illustrated. According to various embodiments, healthcare professionals can inject contrast agent into a patient's blood vessel to perform fluorescence path mapping, thereby measuring and estimating the diameter of the target vessel and / or the neck width of the aneurysm. The desired length of the shunt can then be determined.

[0283] Figure 32A A customizable shunt prepared according to an embodiment of this disclosure is shown. Figure 32A It shows about Figure 31 An embodiment of at least step 3104 of the method 3100. Specifically, Figure 32A A device 3202 positioned within an opening 3204 is shown. The device 3202 can be translated 3206 such that its distal end is aligned 3208 with the template 3211 and with the scale markings corresponding to the desired length of the deployed splitter. For example, Figure 32A The device 3202 shown will have a final unfolded length of 30 mm. In some embodiments, at least a portion of the device 3202 is positioned within the alignment member 3203 to maintain the device 3202 in a straight configuration and parallel to the template 3211 for accurate measurements, etc. Healthcare workers can align the device 3202 and clamp it through the opening 3204 for [specific procedures / operations]. Figure 32B The cut shown is 3210.

[0284] Figure 32B The device 3202 is shown to be cut to the desired length by inserting scissors 3212 through a cutting orifice, slit, or notch 3214, as described in detail above. Figure 32B It shows about Figure 31 An embodiment of at least step 3106 of the method 3100.

[0285] Figure 32CThe device 3202 is shown being removed from its packaging to expose the sheath 3216. Healthcare workers should inspect both the device 3202 and the sheath 3216 for any damage. The device 3202 retracts into the sheath 3216 by advancing the sheath 3220 while holding the deployed wire 3218 in place. The sheath 3216 may be advanced forward 3220 until the device 3202 is fully retracted into the sheath 3216. Figure 32C It shows at least about Figure 31 An embodiment of step 3108 of method 3100.

[0286] Figure 32D The illustration shows the removal of the peelable tube 3222 from the sheath 3216 retracted within the device 3202 by pulling one or more tabs 3224. Figure 32E The illustration shows the insertion of a retractable sheath 3216 into a rotary hemostatic valve (RHV) 3226. The distal end of the sheath 3216 can be seated at the distal end of a microcatheter hub (not shown), and the RHV 3226 can be closed around the sheath 3216 to secure the RHV 3226 to the sheath 3216. The device 3202 can then be advanced until it is fully inserted into the microcatheter, and according to at least some embodiments, the sheath 3216 can be removed. Further embodiments of deploying the device 3202 may include any of the embodiments described in this disclosure.

[0287] Various embodiments of this disclosure advantageously reduce the number of sizes that healthcare providers must maintain in stock (e.g., reduce inventory). For example, instead of carrying multiple lengths of shunts for each diameter, a customizable shunt delivery system with only three sizes as described herein and shown in Table 1 below can provide 26 different lengths and diameters. In other words, instead of three different products, healthcare providers must maintain, track, and store 26 different products. Thus, the embodiments of the customizable technology described herein provide the longest possible length for each desired diameter (which can be customized to a shorter length as needed), thereby reducing the number of SKUs in inventory by 75% (from 158 SKUs to 26 SKUs, as shown in Table 1 below).

[0288] Table 1: Size Supply Matrix of Customizable Diverters

[0289]

[0290] In the foregoing description, the invention has been described with reference to specific embodiments thereof; however, those skilled in the art will recognize that the invention is not limited thereto. Various features and aspects of the invention described above may be used alone or in combination. Furthermore, the invention can be used in any number of environments and applications beyond those described herein without departing from the broader spirit and scope of this specification. Therefore, this specification and the accompanying drawings should be considered illustrative rather than restrictive. It should be understood that the terms “comprising,” “including,” and “having” as used herein are specifically intended to be understood as open-ended terms.

Claims

1. A system for customizing a shunt for delivery into a neurovascular space to treat an aneurysm, the system comprising: An elongated tubular member having a proximal end and a distal end, wherein the elongated tubular member includes an internal wall defining an inner cavity; A diverter including a proximal end and a distal end, wherein the diverter is partially contained within the lumen of the elongated tubular member in a constrained configuration, wherein the diverter extends beyond the first length of the distal end of the elongated tubular member. A spreader wire extends within the cavity of the elongated tubular member, the spreader wire having a proximal end, a distal end, and a distal portion having a tapered portion, the spreader wire including at least one spreader feature coupled to the diverter, such that movement of the spreader wire relative to the elongated tubular member causes movement of the diverter relative to the elongated tubular member. A housing, the housing being coupled to the elongated tubular member and defining a template for customizing the diverter; and A tube extending along and around the distal portion of the elongated tubular member, wherein the tube extends beyond the distal second length of the elongated tubular member, wherein the distal end of the diverter is located within the tube, and wherein the tube is cutable.

2. The system according to claim 1, characterized in that, The elongated tubular member includes an inlet sheath having a proximal end and a distal end, wherein the inlet sheath is cuttable.

3. The system according to claim 1, characterized in that, The tube is removable from the distal portion of the elongated tubular member.

4. The system according to claim 3, characterized in that, The unfolded wire terminates in the proximal portion of the peelable tube.

5. The system according to claim 1, characterized in that, The tube includes a proximal end, a distal end, a first longitudinal portion having a first proximal tab, and a second longitudinal portion having a second proximal tab, each of the first and second longitudinal portions extending from the proximal end of the tube to the distal end of the tube, wherein the tube is peelably removable from the distal portion of the elongated tubular member by separating the first and second longitudinal portions.

6. The system according to claim 1, characterized in that, The distributor can be cut into variable lengths within the pipe.

7. The system according to claim 1, characterized in that, The template includes equally spaced scale marks, wherein the scale marks are configured to facilitate cutting the splitter into variable lengths.

8. The system according to claim 7, characterized in that, The template also includes a cutting opening, slit, or notch extending through the housing, wherein the cutting opening, slit, or notch is arranged on the proximal side of the scale mark.

9. The system according to claim 7, characterized in that, The template also includes a cutting orifice extending through the housing, wherein the width of the cutting orifice constrains the cutting tool to facilitate cutting the splitter at a desired location or at a desired angle.

10. The system according to claim 9, characterized in that, The template also includes an opening extending through the housing for retraction and advance of the tube relative to the scale markings, wherein the opening is arranged proximal to the cutting orifice.

11. The system according to claim 7, characterized in that, The template also includes an alignment member disposed below the scale marks to guide the splitter relative to the scale marks and keep the splitter stationary during cutting.

12. The system according to claim 7, characterized in that, The template associates the scale markings with the spread length of the splitter.

13. The system according to claim 1, characterized in that, The shunt includes a self-expanding member having a proximal end and a distal end.

14. The system according to claim 1, characterized in that, The housing includes a packaging pallet.

15. A system for customizing a shunt for delivery into a neurovascular space to treat an aneurysm, the system comprising: An elongated tubular member having a proximal end and a distal end, wherein the elongated tubular member includes an internal wall defining an inner cavity; A diverter including a proximal end and a distal end, wherein the diverter is partially contained within the lumen of the elongated tubular member in a constrained configuration, wherein the diverter extends beyond the first length of the distal end of the elongated tubular member. A spreader wire extending within the cavity of the elongated tubular member, the spreader wire having a proximal end, a distal end, and a distal portion having a tapered portion, the spreader wire including at least one spreading feature coupled to the diverter, such that movement of the spreader wire relative to the elongated tubular member causes movement of the diverter relative to the elongated tubular member; and A housing, the housing being connected to the elongated tubular member and defining a template for customizing the diverter; Wherein, the at least one unfolding feature includes: A pusher extending along and around the distal portion of the unfolded wire, the pusher having a distal end configured to engage with the proximal end of the shunt; At least one friction bump, the at least one friction bump extending distally along the unfolded wire beyond the distal portion of the pusher and positioned therein, wherein the at least one friction bump is located inside the splitter and engages with a portion of the splitter; and An end coil that extends distally from the at least one friction bump.

16. A method for customizing a shunt for delivery into a neurovascular space to treat an aneurysm, the method comprising: Provide a splitter delivery system, the splitter delivery system comprising: An elongated tubular member having a proximal end and a distal end, the elongated tubular member including an internal wall defining an inner cavity; A diverter, comprising a proximal end and a distal end, wherein the diverter is partially contained within the lumen of the elongated tubular member in a constrained configuration, wherein the diverter extends beyond a first length of the distal end of the elongated tubular member. A spreader wire extends within the cavity of the elongated tubular member, the spreader wire having a proximal end, a distal end, and a distal portion having a tapered portion, the spreader wire including at least one spreader feature connected to the splitter; A housing, the housing being coupled to the elongated tubular member and defining a template; and A tube extending along and around the distal portion of the elongated tubular member, wherein the tube extends beyond a second length of the distal end of the elongated tubular member, wherein the distal end of the diverter is located within the tube; The template is used to determine the desired length of the splitter; The tube is advanced or retracted relative to the housing to align the distributor with the template. Cut the pipe and the distributor, thereby cutting the distributor to the desired length; and The diverter is retracted into the elongated tubular member or the elongated tubular member is advanced over the diverter.

17. The method as described in claim 16, characterized in that... It also includes separating the tube from the distal portion of the elongated tubular member after the diverter is retracted into the elongated tubular member or the elongated tubular member is advanced over the diverter.

18. The method as described in claim 17, characterized in that, Separating the tube from the distal portion of the elongated tubular member includes peeling the tube from the distal portion of the elongated tubular member.

19. The method as described in claim 18, characterized in that, The unfolded wire terminates in the proximal portion of the tube and within the constrained shunt.

20. The method as described in claim 16, characterized in that... It also includes moving the unfolded wire relative to the elongated tubular member, such that the distributor moves relative to the elongated tubular member.

21. The method as described in claim 16, characterized in that, Advancing or retracting the tube relative to the template includes positioning the splitter relative to scale marks spaced equally along the template, wherein the scale marks are configured to facilitate cutting the splitter to the desired length.

22. The method as described in claim 21, characterized in that, Advancing or retracting the tube relative to the template includes positioning the tube within an alignment member arranged below the scale marks to guide the splitter relative to the scale marks and keep the splitter stationary during cutting.

23. The method as described in claim 21, characterized in that, Advancing or retracting the tube involves adjusting the tube relative to the graduation mark via an opening extending through the housing and arranged proximal to the graduation mark.

24. The method as described in claim 23, characterized in that, Cutting the tube and the distributor includes cutting the distributor at a desired location or at a desired angle via a cutting orifice, slit, or notch extending through the housing, or by using a cutting tool.

25. The method as described in claim 24, characterized in that, The cutting orifice, slit, or notch is positioned between the opening and the scale mark, and constrains the cutting tool during cutting.

26. The method as described in claim 21, characterized in that, The template associates the scale markings with the spread length of the splitter.

27. The method as described in claim 21, characterized in that, Retracting the splitter into the elongated tubular member includes retracting the unfolded wire distally.

28. The method as described in claim 21, characterized in that, Advancing the elongated tubular member on the distributor involves keeping the unfolded wire stationary while advancing the elongated tubular member.

29. The method as described in claim 16, characterized in that, The housing includes a packaging pallet.

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