Systems and methods for customizable shunt implants

Abstract

Neurovascular shunts and delivery systems and methods of using the same are described herein. The system may include a custom member including an introducer sheath, a catheter, a deployable shunt that may be included 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 member 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 diverter. The length of the diverter may be tailored by cutting through the tube and the diverter contained therein.

Description

Cross-references to related application data

[0001] This application is a continuation-in-part 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.

[0002] The subject matter of this application is related to U.S. patent application No. 18 / 112,904, filed on February 22, 2023, which has been assigned to the assignee of this application and is entitled: SYSTEMS AND METHODS FOR CUSTOMIZABLE FLOW DIVERTER IMPLANTS; and U.S. Provisional Patent Application No. 63 / 313,205, filed on February 23, 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 / 112,963, filed on February 22, 2023, which has been assigned to the assignee of this application and is entitled: NEROVASCULAR FLOW DIVERTER AND DELIVERY SYSTEMS. SYSTEMS); and U.S. patent application No. 18 / 113,010 filed on February 22, 2023, which has been assigned to the assignee of the present application and is entitled: NEROVASCULAR FLOW DIVERTER AND DELIVERY SYSTEMS; and U.S. patent application No. 18 / 236,663 filed on August 22, 2023, which has been assigned to the assignee of the present application and is entitled: NEROVASCULAR FLOW DIVERTER AND DELIVERY SYSTEMS, the entire text of the disclosure of the above patent applications is incorporated herein by reference for all purposes. Background Art

[0003] An aneurysm is a bulge in a blood vessel caused by a weakness in the vessel wall that expands and fills with blood. Aneurysms often occur where a blood vessel branches. As blood passes through the weakened vessel, the blood pressure causes a small area to bulge outward like a balloon. Although aneurysms can form in any blood vessel in the body, they are most common in arteries that carry blood away from the heart, such as the aorta or arteries in the brain.

[0004] Aneurysms that form inside the brain are called intracranial aneurysms or brain aneurysms. Brain aneurysms usually cause no noticeable symptoms until they rupture, burst, or leak. A ruptured or burst brain aneurysm can cause a serious, life-threatening condition called a subarachnoid hemorrhage. Symptoms of this type of bleeding include sudden and extremely painful headaches, a stiff neck, nausea and vomiting, and pain when looking at light. A subarachnoid hemorrhage is life-threatening and is a very serious medical emergency.

[0005] Due to the serious risks posed by such hemorrhage, there is a need for prevention, early detection, and safe and effective treatment of brain aneurysms. However, the complex nature of the neurovasculature, including the small diameter of many vessels and the tortuous anatomy, makes such treatment difficult. Given the risks posed by subarachnoid hemorrhage and the challenges of treating brain aneurysms, there is a need for improved treatment systems and methods.

[0006] Aneurysms arise from blood vessels with a wide range of diameters. Side branches and / or bifurcations increase the need to choose different shunt lengths in terms of supply. Therefore, hospitals must carry a variety of shunts with different lengths and diameter sizes, resulting in a large number of SKUs that need to be managed. Maintaining a full range of sizes to optimally match 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

[0007] The present disclosure relates to systems, devices, and methods for customizing flow shunts for delivery into a neurovasculature to treat an aneurysm.

[0008] The system may include an elongated tubular member having a proximal end and a distal end. The elongated tubular member includes an inner wall defining an inner cavity. The shunt includes a proximal end and a distal end and defines a flow channel extending therethrough. The shunt is partially contained in the inner cavity of the elongated tubular member in a constrained configuration. The shunt extends beyond the distal first length of the elongated tubular member. An unfolding wire extends into the inner cavity of the elongated tubular member and into the flow channel of the shunt. The unfolding wire includes a proximal end, a distal end, and a distal portion having a tapered portion. The unfolding wire includes at least one unfolding feature coupled to the shunt so that movement of the unfolding wire relative to the elongated tubular member causes the shunt to move relative to the elongated tubular member. The tube extends along and around the distal portion of the elongated tubular member. The tube extends beyond the distal second length of the elongated tubular member. The distal end of the shunt is located within the tube. The tube is cuttable.

[0009] The shunt can be cut into variable lengths within the tube. In some embodiments, the tube includes graduated markings (gradient symbols) equally spaced along the distal end of the tube for cutting the shunt and / or the tube into desired lengths. In some embodiments, the first length and the second length are equal.

[0010] In some embodiments, the deployment 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 deployment wire, wherein at least one friction bump is located distal to the pusher. In some embodiments, at least one friction bump is within a flow channel of the shunt and engages with a portion of the shunt. In at least some methods, the end coil extends distally from the friction bump. The deployment wire may terminate before the distal end of the shunt so that the distal end of the deployment wire does not extend into the tube. The deployment wire does not extend distally beyond the distal end of the shunt.

[0011] In some embodiments, the deployment feature includes at least one friction bump. The at least one friction bump may be in a plurality of friction bumps. The plurality of friction bumps are equally spaced apart.

[0012] 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 scale markings spaced equidistantly along the bottom of at least one of the front and rear of the template. The scale markings are configured to facilitate cutting the shunt to a desired length. The template associates the scale markings with an expanded length of the shunt.

[0013] 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 side and the second side. The scale mark is positioned between the cutting notch and the other of the first side and the second side.

[0014] The template may include a first set of scale markings along the bottom of the front portion of the template and a second set of scale markings along the bottom of the back portion of the template. One of the front portion of the template and the back portion of the template is configured for a right-handed user, and the other of the front portion of the template and the back portion of the template is configured for a left-handed user.

[0015] The tube comprises a proximal end, a distal end, a first longitudinal portion having a first proximal pull tab, and a second longitudinal portion having a second proximal pull tab. Each of the first longitudinal portion and the second longitudinal portion extends from the proximal end of the tube to the distal end of the tube. The tube can be peelably removed from the distal portion of the elongated tubular member by separating the first longitudinal portion from the second longitudinal portion. In some embodiments, the tube comprises a polymer tube. In some embodiments, the tube is transparent so that the shunt is visible inside the tube.

[0016] In some embodiments, the system includes a protective sleeve extending along and around the proximal end of the shunt. The protective sleeve is configured to reduce friction and / or reduce damage to the shunt when the shunt moves relative to the elongated tubular member.

[0017] The shunt may include a self-expanding member having a proximal end and a distal end. The self-expanding member includes a braid.

[0018] In various embodiments, the system may include an introducer sheath, a catheter, a deployable shunt that may 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 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 an atraumatic end. The deployment features may be arranged in different combinations to facilitate deployment of the shunt.

[0019] One aspect of the present disclosure relates to systems, devices and methods for customizing a flow diverter for delivery into a neurovascular vessel to treat an aneurysm. The system may include an elongated tubular member having a proximal end and a distal end. The elongated tubular member includes an inner wall defining an inner cavity. The flow diverter includes a proximal end and a distal end. The flow diverter is partially contained in the inner cavity of the elongated tubular member in a constrained configuration. The flow diverter extends beyond a distal first length of the elongated tubular member. An expansion wire extends into the inner cavity of the elongated tubular member. The expansion wire includes a proximal end, a distal end and a distal portion having a tapered portion. The expansion wire includes at least one expansion feature coupled to the flow diverter so that movement of the expansion wire relative to the elongated tubular member causes the flow diverter to move relative to the elongated tubular member. The system includes a template having a top, a bottom, a first side, a second side, a front and a rear. The template includes graduated markings spaced equidistantly along the bottom. The graduated markings are configured to facilitate cutting the flow diverter into variable lengths.

[0020] The shunt is cuttable. In some embodiments, the shunt comprises a braided member comprising a plurality of strands. The strands may comprise a wire having a diameter of approximately 0.0008 inches. In some embodiments, the wire comprises a drawn fill tube (DFT).

[0021] 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 side and the second side. The scale mark is positioned between the cutting notch and the other of the first side and the second side.

[0022] The template includes a formula configured to facilitate cutting the shunt into variable lengths. The formula can be printed along a top portion of the template. The scale markings and formula can be printed on each of the front and back portions of the template. In some embodiments, the template associates the scale markings with the expanded length of the shunt.

[0023] The template may include a first set of scale markings along the bottom of the front portion of the template and a second set of scale markings along the bottom of the back portion of the template. One of the front portion of the template and the back portion of the template is configured for a right-handed user, and the other of the front portion of the template and the back portion of the template is configured for a left-handed user.

[0024] 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 shunt is contained in the tube. The tube can be peeled off and removed from the distal portion of the elongated tubular member.

[0025] The tube comprises a proximal end, a distal end, a first longitudinal portion having a first proximal pull tab, and a second longitudinal portion having a second proximal pull tab. Each of the first longitudinal portion and the second longitudinal portion extends from the proximal end of the tube to the distal end of the tube. The tube can be peelably removed from the distal portion of the elongated tubular member by separating the first longitudinal portion from the second longitudinal portion.

[0026] In various embodiments, the system may include an introducer sheath, a catheter, a deployable shunt that may 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 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 an atraumatic end. The deployment features may be arranged in different combinations to facilitate deployment of the shunt.

[0027] One aspect of the present disclosure includes a method for customizing a shunt for delivery into a neurovascular vessel to treat an aneurysm. The method includes determining a desired length of a shunt of a shunt system. The system includes an elongated tubular member having a proximal end and a distal end and an inner wall defining an inner cavity. The system includes a shunt, the shunt including a proximal end and a distal end. The shunt is partially contained in the inner cavity of the elongated tubular member in a constrained configuration. The shunt extends beyond a distal first length of the elongated tubular member. The system includes an expansion wire extending into the inner cavity of the elongated tubular member. The expansion wire includes a proximal end and a distal end. The expansion wire includes at least one expansion feature coupled to the shunt, so that movement of the expansion wire relative to the elongated tubular member causes the shunt to move 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 a distal second length of the elongated tubular member, wherein the distal end of the shunt is located within the tube. The method includes cutting the flow splitter and the tube so that the flow splitter is a desired length.

[0028] The method includes retracting the shunt into the elongated tubular member. The shunt can be retracted into the elongated tubular member by retracting the deployment wire distally.

[0029] In some embodiments, the method further comprises separating the tube from the distal portion of the elongated tubular member after the shunt is retracted into the elongated tubular member.After the shunt is retracted into the elongated tubular member, the tube is separated from the distal portion of the elongated tubular member.

[0030] The tube includes a proximal end, a distal end, a first longitudinal portion having a first proximal pull tab, and a second longitudinal portion having a second proximal pull tab. Each of the first longitudinal portion and the second longitudinal portion extends from the proximal end of the tube to the distal end of the tube. The tube can be peelably removed from the distal portion of the elongated tubular member by separating the first longitudinal portion from the second longitudinal portion. Peeling the tube from the distal portion of the elongated tubular member includes separating the first longitudinal portion from the second longitudinal portion.

[0031] The method also includes loading a flow diverter into the elongated tubular member.

[0032] One aspect of the present disclosure includes a method for customizing a shunt for delivery into a neurovascular vessel to treat an aneurysm. The method includes determining a desired length of a shunt of a shunt system using a template. The system includes an elongated tubular member having a proximal end and a distal end and an inner wall defining an inner cavity. The system includes a shunt, the shunt including a proximal end and a distal end. The shunt is partially contained in the inner cavity 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. The system includes an expansion wire extending into the inner cavity of the elongated tubular member. The expansion wire includes a proximal end and a distal end. The expansion wire includes at least one expansion feature coupled to the shunt, so that movement of the expansion wire relative to the elongated tubular member causes the shunt to move 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 a second length of the distal end of the elongated tubular member, wherein the distal end of the shunt is located within the tube. The method includes cutting the flow splitter and the tube so that the flow splitter is a desired length.

[0033] The template includes a top, a bottom, a front, a rear, a first side, and a second side. The template includes scale markings equally spaced along the bottom of at least one of the front and rear of the template. The scale markings are configured to facilitate cutting the shunt into a desired length.

[0034] 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 side and the second side. The scale mark is positioned between the cutting notch and the other of the first side and the second side.

[0035] The template may include a first set of scale markings along the bottom of the front portion of the template and a second set of scale markings along the bottom of the back portion of the template. One of the front portion of the template and the back portion of the template is configured for a right-handed user, and the other of the front portion of the template and the back portion of the template is configured for a left-handed user.

[0036] The template includes a formula configured to facilitate cutting the shunt into variable lengths. The formula can be printed along a top portion of the template. The scale markings and formula can be printed on each of the front portion of the template and the rear portion of the template. In some embodiments, the template associates the scale markings with the expanded length of the shunt.

[0037] The method includes retracting the shunt into the elongated tubular member. The shunt can be retracted into the elongated tubular member by retracting the deployment wire distally.

[0038] The shunt system includes a tube coupled to a distal portion of an elongated tubular member. The tube extends distally beyond a distal second length of the elongated tubular member. The distal end of the shunt may be located within the tube.

[0039] In some embodiments, cutting the flow splitter so that the flow splitter is a desired length includes cutting the tube.

[0040] In some embodiments, the method further comprises separating the tube from the distal portion of the elongated tubular member. After the shunt is retracted into the elongated tubular member, the tube is separated from the distal portion of the elongated tubular member. The tube is separated from the distal portion of the elongated tubular member by peeling the tube from the distal portion of the elongated tubular member.

[0041] The tube includes a proximal end, a distal end, a first longitudinal portion having a first proximal pull tab, and a second longitudinal portion having a second proximal pull tab. Each of the first longitudinal portion and the second longitudinal portion extends from the proximal end of the tube to the distal end of the tube. The tube can be peelably removed from the distal portion of the elongated tubular member by separating the first longitudinal portion from the second longitudinal portion. Peeling the tube from the distal portion of the elongated tubular member includes separating the first longitudinal portion from the second longitudinal portion.

[0042] The method also includes loading a flow diverter into the elongated tubular member.

[0043] One aspect relates to a system for customizing a flow diverter for delivery into a neurovascular vessel to treat an aneurysm. The system includes a custom component having a proximal end and a distal end. The custom component includes an inner wall defining an inner cavity. The system includes a flow diverter having a proximal end and a distal end. The flow diverter defines a flow channel extending therethrough. The flow diverter is at least partially contained within the inner cavity of the custom component in a constrained configuration. The system includes a deployment wire extending into the inner cavity of the custom component and extending into the flow channel of the flow diverter. The deployment wire has a proximal end, a distal end, and a distal wire portion having a tapered portion. The deployment wire may include at least one deployment feature coupled to the flow diverter so that movement of the deployment wire relative to the custom component causes the flow diverter to move relative to the custom component. The deployment wire terminates in a proximal portion of the custom component.

[0044] In some embodiments, the custom component comprises an introducer sheath having a proximal end and a distal end. In some embodiments, the introducer sheath is cuttable. In some embodiments, the shunt extends distally beyond the distal end of the introducer sheath. In some embodiments, the shunt is completely contained within the custom component.

[0045] In some embodiments, the custom component also includes a tube extending along and around the distal portion of the introducer sheath. In some embodiments, the shunt extends beyond the distal first length of the introducer sheath. In some embodiments, the tube extends beyond the distal second length of the introducer 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 can be at least one of the following tubes: a polymer tube; a transparent tube; or a semi-rigid tube.

[0046] In some embodiments, the tube may include graduated markings spaced apart along the distal end of the tube. In some embodiments, the graduated markings are equally spaced apart along the distal end of the tube.

[0047] In some embodiments, the introducer sheath may include an outer introducer sheath layer. In some embodiments, the custom component also includes an inner tube. In some embodiments, the inner tube is cuttable. In some embodiments, the inner tube is insertable into the outer introducer sheath layer. In some embodiments, the shunt is completely contained within the inner tube.

[0048] One aspect relates to a method for customizing a shunt for delivery into a neurovascular vessel to treat an aneurysm. The method includes determining the desired length of a shunt of a shunt system, and cutting a distal portion of a custom component and the shunt so that the shunt is the desired length. The shunt system includes a custom component having a proximal end and a distal end. The custom component includes an inner wall defining an inner cavity. The shunt system includes a shunt, which includes a proximal end and a distal end. The shunt defines a flow channel extending therethrough. The shunt is at least partially contained in the inner cavity of the custom component in a constrained configuration. The shunt system includes a deployment wire extending into the inner cavity of the custom component and extending into the flow channel of the shunt. The deployment wire has a proximal end, a distal end, and a distal wire portion having a tapered portion. The deployment wire includes at least one deployment feature coupled to the shunt, so that movement of the deployment wire relative to the custom component causes the shunt to move relative to the custom component. The deployment wire terminates in the proximal portion of the custom component.

[0049] In some embodiments, the customized component includes an introducer sheath having a proximal end and a distal end. In some embodiments, the customized component also includes a tube extending along and around the distal portion of the introducer sheath. In some embodiments, the shunt extends beyond a distal first length of the introducer sheath. In some embodiments, the shunt extends beyond a distal second length of the introducer 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 customized component and the shunt includes cutting the tube.

[0050] In some embodiments, the tube includes scale markings spaced apart along the distal end of the tube. In some embodiments, cutting the tube includes cutting the tube at one of the scale markings. In some embodiments, after cutting, the shunt is fully retracted into the introducer sheath by retracting the deployment wire distally.

[0051] In some embodiments, the method includes separating the tube from the distal portion of the introducer sheath. In some embodiments, after the shunt is retracted into the introducer sheath, the tube is separated from the distal portion of the introducer sheath. In some embodiments, by peeling off the tube from the distal portion of the introducer sheath, the tube is separated from the distal portion of the introducer sheath. In some embodiments, the introducer sheath has an introducer length that is at least equal to the diverter length (shunt length) of the shunt.

[0052] In some embodiments, the tube comprises a proximal end, a distal end, a first longitudinal portion having a first proximal pull tab, and a second longitudinal portion having a second proximal pull tab. In some embodiments, each of the first longitudinal portion and the second longitudinal portion extends from the proximal end of the tube to the distal end of the tube. In some embodiments, the tube can be peelably removed from the distal portion of the introducer sheath by separating the first longitudinal portion from the second longitudinal portion.

[0053] The present disclosure relates to systems, devices and methods for customizing a flow diverter for delivery to a neurovascular vessel to treat an aneurysm. A system for customizing a flow diverter for delivery to a neurovascular vessel to treat an aneurysm includes an elongated tubular member having a proximal end and a distal end. The elongated tubular member includes an inner wall defining an inner cavity. The system also includes a flow diverter including a proximal end and a distal end, wherein the flow diverter is partially contained in the inner cavity of the elongated tubular member in a constrained structure, and wherein the flow diverter extends beyond a distal first length of the elongated tubular member. The system also includes an expansion wire extending in the inner cavity of the elongated tubular member, the expansion wire having a proximal end, a distal end and a distal portion having a tapered portion. The expansion wire includes at least one expansion feature connected to the flow diverter, so that the movement of the expansion wire relative to the elongated tubular member causes the flow diverter to move relative to the elongated tubular member. The system also includes a housing connected to the elongated tubular member and defining a template for customizing the flow diverter.

[0054] The system may include the deployment wire terminating in a proximal portion of the peelable tube. The system may include the elongated tubular member including an introducer sheath having a proximal end and a distal end, wherein the introducer sheath is cuttable.

[0055] The system may also include a tube extending along and around the 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, and wherein the tube is cuttable. The system may include that the tube is peelably removable 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 pull tab, and a second longitudinal portion having a second proximal pull tab, each of the first longitudinal portion and the second longitudinal portion 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 longitudinal portion from the second longitudinal portion. The system may include that the shunt is cuttable into variable lengths within the tube.

[0056] The template may include equally spaced graduation marks, wherein the graduation marks are configured to help cut the shunt into variable lengths. The template may also include a cutting orifice, slit or notch extending through the housing, wherein the cutting orifice, slit or notch is arranged on the proximal side of the graduation marks. The template may also include a cutting orifice extending through the housing, wherein the width of the cutting orifice bundles the cutting tool to help cut the shunt at a desired position or at a desired angle. The template may also include an opening extending through the housing for the retraction and advancement of the tube relative to the graduation marks, wherein the opening is arranged on the proximal side of the cutting orifice. The template may also include an alignment member, which is arranged below the graduation marks, for guiding the shunt relative to the graduation marks during cutting and keeping the shunt stationary. The template may associate the graduation marks with the expansion length of the shunt. Advantageously, a medical professional can determine the desired length before inserting the device and customize the device to the desired length.

[0057] At least one deployment feature may include a pusher extending along and around a distal portion of the deployment wire, the pusher having a distal end configured to engage with a proximal end of the shunt, at least one friction lug positioned along a distal portion of the deployment wire extending distally beyond the pusher, wherein at least one friction lug is inside the shunt and engages with a portion of the shunt, and the end coil extends distally from the at least one friction lug. The system may include a shunt including a self-expanding member having a proximal end and a distal end. The housing may be a packaging tray.

[0058] According to various embodiments, a method for customizing a shunt for delivery into a neurovascular vessel 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 inner wall defining an inner cavity. The system also includes a shunt, the shunt including a proximal end and a distal end, wherein the shunt is partially contained in the inner cavity of the elongated tubular member in a constrained structure, and wherein the shunt extends beyond the distal first length of the elongated tubular member. The system also includes an expansion wire extending in the inner cavity of the elongated tubular member, the expansion wire having a proximal end, a distal end, and a distal portion having a tapered portion. The expansion wire includes at least one expansion feature connected to the shunt, so that the movement of the expansion wire relative to the elongated tubular member causes the shunt to move relative to the elongated tubular member. The system also includes a housing connected 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 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 includes: determining a desired length of the shunt using a template, advancing or retracting the tube relative to the housing to align the shunt with the template, cutting the tube and shunt so that the shunt is cut to the desired length, and retracting the shunt into the elongated tubular member or advancing the elongated tubular member over the shunt.

[0059] The method may include, after retracting the shunt into the elongated tubular member or advancing the elongated tubular member over the shunt, detaching the tube from the distal portion of the elongated tubular member. The method may include moving the deployment wire relative to the elongated tubular member such that the shunt moves relative to the elongated tubular member.

[0060] Advancing or retracting the tube relative to the template may include positioning the shunt relative to scale markings equally spaced along the template, wherein the scale markings are configured to facilitate cutting the shunt 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 markings for guiding the shunt relative to the scale markings. Advancing or retracting the tube may include adjusting the tube relative to the scale markings via an opening extending through the housing and disposed proximal to the scale markings.

[0061] Cutting the tube and shunt can include cutting the shunt at a desired position and / or at a desired angle using a cutting tool, via a cutting aperture, slit or notch extending through the housing. The cutting aperture, slit or notch can be positioned between the opening and the scale mark and constrain the cutting tool during cutting. The template can associate the scale mark with the expansion length of the shunt. Retracting the shunt into the elongated tubular member can include retracting the expansion wire distally. Advancing the elongated tubular member on the shunt can include keeping the expansion wire stationary while advancing the elongated tubular member. Separating the tube from the distal portion of the elongated tubular member can include stripping the tube from the distal portion of the elongated tubular member. The method can include that the expansion wire terminates in the proximal portion of the peelable tube. The housing can include a packaging tray.

[0062] In one embodiment, a system for customizing a flow diverter for delivery to a neurovascular vessel to treat an aneurysm includes a custom component, the custom component includes a proximal end and a distal end. The custom component includes an inner wall defining an inner cavity. The system also includes a flow diverter, the flow diverter includes a proximal end and a distal end, the flow diverter defines a flow channel extending therethrough, wherein the flow diverter is at least partially contained in the inner cavity of the custom component with a constrained structure. The system also includes a deployment wire, the deployment wire extends into the inner cavity of the custom component and extends into the flow channel of the flow diverter, the deployment wire has a proximal end, a distal end and a distal portion with a tapered portion, the deployment wire includes at least one deployment feature connected to the flow diverter, so that the movement of the deployment wire relative to the custom component causes the flow diverter to move relative to the custom component, and the deployment wire terminates in the proximal portion of the custom component. The system also includes a housing connected to the custom component and defining an integral template for customizing the flow diverter. Various aspects of the present disclosure provide improved flexibility in the selection of flow diverter lengths, and specifically enable the flow diverter length to be customized. This customization reduces the number of SKUs that hospitals must stock, reduces waste, and increases the likelihood that an appropriately sized shunt will be used.

[0063] The system may include various optional embodiments. The custom component may include an introducer sheath having a proximal end and a distal end. The introducer sheath may be cuttable. The introducer sheath may include an outer introducer sheath layer, and wherein the custom component further includes an inner tube, wherein the inner tube is cuttable, and wherein the inner tube may be inserted into the outer introducer sheath layer, and wherein the shunt is completely contained within the inner tube. The shunt may extend distally beyond the distal end of the introducer sheath. The shunt may be completely contained within the custom component.

[0064] According to various embodiments of the system, the custom component may further include a tube extending along and around the distal portion of the introducer sheath, wherein the shunt extends beyond the distal first length of the introducer sheath, wherein the tube extends beyond the distal second length of the introducer 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 may be peelably removed from the distal portion of the introducer sheath. The tube may include a proximal end, a distal end, a first longitudinal portion having a first proximal pull tab, and a second longitudinal portion having a second proximal pull tab, each of the first longitudinal portion and the second longitudinal portion extending from the proximal end of the tube to the distal end of the tube, wherein the tube may be peelably removed from the distal portion of the introducer sheath by separating the first longitudinal portion from the second longitudinal portion.

[0065] According to at least some embodiments of the system, the shunt can be cut into variable lengths within the tube. The template may include equally spaced scale marks, wherein the scale marks are configured to facilitate cutting the shunt into variable lengths. The template may also include a cutting orifice, slit, or notch extending through the housing, wherein the cutting orifice, slit, or notch is arranged on the proximal side of the scale marks. 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 shunt at a desired position or at a desired angle. The template may include an opening extending through the housing for retraction and advancement of the tube relative to the scale marks, wherein the opening is arranged on the proximal side of the cutting orifice. The template may include an alignment member arranged below the scale marks for guiding the shunt relative to the scale marks during cutting and keeping the shunt stationary. The template may associate the scale marks with the expanded length of the shunt.

[0066] 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 wire, the pusher having a distal end configured to engage with a proximal end of the shunt, at least one friction lug positioned along a distal portion of the deployment wire extending distally beyond the pusher, wherein the at least one friction lug is inside the shunt and engages with a portion of the shunt, and the end coil extends distally from the at least one friction lug. The shunt may include a self-expanding member having a proximal end and a distal end. The housing may include a packaging tray.

[0067] The embodiments disclosed herein provide a variety of beneficial improvements. These include, for example, a reduction in system size. This reduction in system size enables access to and treatment of smaller blood vessels. This increases the range of treatable aneurysms and thus improves patient outcomes. In addition, the embodiments disclosed herein increase the flexibility of the system, thereby also increasing the range of treatable aneurysms.

[0068] Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter.It should be understood that the detailed description and specific examples, while indicating various embodiments, are intended for purposes of illustration only and are not intended to necessarily limit the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0069] Figure 1 is a diagram of one embodiment of a system for placing a shunt.

[0070] Figure 2 is an illustration of an introducer sheath and delivery of a shunt via the introducer sheath to a catheter.

[0071] Figure 3 is an illustration of a shunt in a constrained delivery state.

[0072] Figure 4 is an illustration of a shunt in an expanded, deployed state.

[0073] Figure 5 It is a magnified picture of the braid of the shunt.

[0074] Figure 6 is a schematic diagram of a shunt delivery system.

[0075] Figure 7 is an illustration of the delivery system in a partially deployed configuration.

[0076] Figure 8 is an illustration of the delivery system in a partially deployed configuration.

[0077] Fig. 9 is a schematic diagram of one embodiment of a customizable shunt delivery system.

[0078] Fig.10 is an illustration of desired lengths in one embodiment of a customizable shunt delivery system.

[0079] Fig.11 is an illustration of one embodiment of a customizable shunt delivery system after the tube and shunt have been cut to desired lengths.

[0080] Fig.12 is an illustration of the tube being removed after the shunt has been retracted into the sheath / catheter.

[0081] Fig.13 is an illustration of one embodiment of a customizable shunt delivery system after removal of the tube.

[0082] Fig.14 is an illustration of an introducer sheath and delivery of a shunt via the introducer sheath to a catheter.

[0083] Fig.15 is a schematic diagram of one embodiment of a customizable shunt delivery system.

[0084] Fig.16 is a schematic diagram of one embodiment of a customizable shunt delivery system with a protective sleeve.

[0085] Fig.17 is a schematic diagram of one embodiment of a customizable shunt delivery system having a self-expanding element.

[0086] Fig.18 is a schematic diagram of one embodiment of a customizable shunt delivery system.

[0087] Fig.19 is a schematic diagram of one embodiment of a customizable shunt delivery system.

[0088] Fig. 20 is a schematic diagram of one embodiment of a customizable shunt delivery system.

[0089] Fig.21 is a schematic diagram of one embodiment of a customizable shunt delivery system.

[0090] Fig. 22 is a schematic diagram of one embodiment of a customizable shunt delivery system.

[0091] Fig.23 is a schematic diagram of one embodiment of a customizable shunt delivery system.

[0092] Fig.24 is a schematic diagram of one embodiment of a customizable shunt delivery system.

[0093] Fig.25 is a schematic diagram of one embodiment of a customizable shunt delivery system.

[0094] Fig.26 is a schematic diagram of one embodiment of a customizable shunt delivery system.

[0095] Fig. 27 is a schematic diagram of one embodiment of packaging for a customizable shunt delivery system.

[0096] Fig.28 is a schematic diagram of one embodiment of packaging for a customizable shunt delivery system.

[0097] Fig.29 is a schematic diagram of one embodiment of packaging for a customizable shunt delivery system.

[0098] Fig.30is a schematic diagram of one embodiment of packaging for a customizable shunt delivery system.

[0099] Fig.31 is a flow chart of a method for customizing a shunt delivery system.

[0100] Figures 32A-32E Exemplary process steps for customizing a shunt delivery system are shown. DETAILED DESCRIPTION

[0101] The present invention relates to shunts, shunt delivery systems, and methods for delivering shunts. A shunt is a device that can be placed in a vascular system to shunt (divert away) 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 in a patient's blood vessel and can shunt a portion of the blood flow through the vessel. In some embodiments, the shunt can be an intravascular prosthesis for treating intracranial aneurysms. The shunt can, for example, include a stent such as a laser cut stent, a braided component, or the like. In some embodiments, the shunt can include a braided component that includes a plurality of braided wires that can be, for example, cobalt-chromium alloys, nitinol, or the like.

[0102] Flow diverters can be used to treat intracranial aneurysms, including, for example, saccular aneurysms, particularly unruptured saccular aneurysms, or fusiform or circumferential aneurysms. Flow diverters can be placed in a blood vessel to extend across and cover an aneurysm. Flow diverters can divert blood flow away from an aneurysm, thereby reducing blood flow in the aneurysm. Due to the reduced blood flow, the aneurysm may close and heal over time.

[0103] Although simple in principle, the practical aspects of precisely placing a shunt in the often delicate and tortuous vasculature of the brain can be very complex. Therefore, a device with high flexibility is needed to enable navigation of this vasculature. In addition, such a device should be able to accurately position the shunt within the blood vessel. Precise positioning of the shunt may include adjusting the position of the shunt, and in some embodiments may include positioning multiple shunts to completely overlap or partially overlap. The use of multiple partially overlapping or completely overlapping shunts may be particularly beneficial when dealing with multiple closely spaced aneurysms or larger aneurysms. In some embodiments, multiple shunts may be positioned to completely overlap or partially overlap to further reduce blood flow to the aneurysm.

[0104] The range of length and diameter of the neurovascular is very wide. In addition, the diameter of the neurovascular varies along its length, wherein the diameter is generally reduced at the gradually distal position of the neurovascular. Hospitals must have shunts of different lengths to accommodate neurovascular vessels of different sizes, side branches, and / or bifurcations. In addition, hospitals must stock shunts of various diameter sizes, resulting in the need to manage a large number of SKUs. Such a large and diverse supply and inventory system that includes a full range of sizes to best match the shunt to the desired position becomes economically burdensome to maintain. In addition, the need to have shunts of many different diameters and lengths complicates surgery because the best-fit shunt must be placed in each position. In order to ensure the best fit, the surgeon must have a shunt of the correct length and diameter in the operating room, which may result in waste. In addition, due to the provision of fixed-length shunts, the surgeon may be forced to use a shunt of suboptimal length. Various aspects of the present disclosure provide improved flexibility in shunt length selection, and specifically enable customization of shunt length. This customization reduces the number of SKUs that a hospital must stock, reduces waste, and increases the likelihood that an appropriately sized shunt will be used.

[0105] Various embodiments of the present disclosure provide customizable shunts. Conventional designs provide shunts encapsulated in an introducer sheath on a delivery system, wherein the delivery wire extends past (exceeds) the implant, thereby fixing the length of the shunt. The embodiments disclosed herein do not have a deployment wire extending beyond the length of the shunt. The various embodiments of the present disclosure provide a customizable system that allows the user to customize the length of the implant to match the specifications of the treatment site. Because the deployment 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 the 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 position 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 the relatively distal portion of the shunt.

[0106] In addition, the customizable shunt delivery system disclosed herein advantageously includes an unfolding mechanism that enables customization. For example, in conventional designs, the unfolding mechanism is connected to the aforementioned unfolding wire and / or is configured to be used with the aforementioned unfolding wire, which extends distally beyond the distal end of the shunt. Such a mechanism will prevent customization at the distal end of the shunt because there will not be any disposable materials until and including the distal end of the shunt. The customizable shunt delivery system disclosed herein overcomes these obstacles by providing a unfolding wire and unfolding mechanism located proximally, leaving flexibility for adjusting the length of the distal end of the shunt.

[0107] The embodiments disclosed herein provide a variety of beneficial improvements. These include, for example, a reduction in system size. This reduction in system size enables access to and treatment of smaller blood vessels. This increases the range of treatable aneurysms and thus improves patient outcomes. In addition, the embodiments disclosed herein increase the flexibility of the system, thereby also increasing the range of treatable aneurysms.

[0108] However, despite the benefits of being able to customize the shunt, having a deployment wire that terminates inside the shunt also has disadvantages. Namely, the lack of the deployment wire extending beyond the distal end of the shunt during shunt deployment impairs the ability of the deployment wire to effectively assist in navigating the vessel as a guide wire. However, it has been found that the benefits of customizing the shunt outweigh the impaired controllability.

[0109] Now refer to Figure 1 , a schematic diagram of one embodiment of a system 100 for placing a shunt is shown. System 100 may include a catheter system 102. Catheter system 102 may be configured to provide access to a patient's vasculature, and specifically to provide access to a patient's neurovasculature. In some embodiments, catheter system 102 may be configured for insertion into a patient's vasculature at an access point, and for navigating through the patient's vasculature to a location where a shunt is to be delivered.

[0110] 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 cavity extending through all or a plurality of portions of the catheter 104. Therefore, in some embodiments, the catheter system 102 may include an elongated tubular member that defines an inner cavity, and in particular, the elongated tubular member includes an inner wall that defines an inner cavity. 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, for example, a diameter of 0.005 inch, 0.01 inch, 0.017 inch, 0.02 inch, 0.021 inch, 0.027 inch, 0.03 inch or any other diameter or intermediate diameter.

[0111] The catheter 104, which may include a catheter hub 106, may be coupled to an access device. The 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 that may be configured to provide selectable 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 the catheter 104 is in use. The access device 108 may be sized to be used in conjunction with the catheter 104.

[0112] The system 100 for placing a shunt can include a deployment wire 110 including a proximal end 111 and a distal end 113. The deployment wire 110 can be configured to facilitate and / or control the advancement 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 deployment wire 110 is configured to be controlled to control the advancement of the shunt into and / or through the catheter system 102, and the distal end 113 can be configured to couple to and / or interact with the shunt to advance the shunt into and / or through the catheter system 102.

[0113] The deployment wire 110 may include a core wire 112. The core wire 112 may include an elongated wire that may be flexible to enable navigation of the vascular system. In some embodiments, the core wire 112 may include an integrated enhanced delivery wire. The core wire 112 may include a variety of shapes and sizes and may be made of a variety of materials. The core wire 112 may include a biocompatible wire that may be, for example, a nitinol wire.

[0114] The core wire 112 may include a proximal portion 114 and a distal portion 116. The proximal portion 114 is relatively closer to the proximal end 111 of the deployment wire 110 than the distal portion 116. Likewise, the distal portion is relatively closer to the distal end 113 of the deployment wire 110 than the proximal portion 114.

[0115] During surgery, the distal end of the distal portion 116 can be inserted into the patient's body 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 core wire 112 that includes a portion with 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 multiple portions of the distal portion 116 of the core wire 112. In some embodiments, the portion of the core wire 112 having a reduced diameter can be, for example, up to 5% of the distal side (portion) of the core wire 112, up to 10% of the distal side (portion) of the core wire 112, up to 15% of the distal side (portion) of the core wire 112, up to 20% of the distal side (portion) of the core wire 112, up to 25% of the distal side (portion) of the core wire 112, up to 30% of the distal side (portion) of the core wire 112, up to 40% of the distal side (portion) of the core wire 112, up to 50% of the distal side (portion) of the core wire 112, or any other portion or intermediate portion.

[0116] In some embodiments, for example, core wire 112 can have a length as long as or longer than catheter system 102. Core wire 112 can have a maximum outer diameter of, 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 values.

[0117] The deployment wire 110 may include one or more deployment features 118. The deployment feature 118 may be located on the distal portion 116 of the core wire 112. The deployment feature 118 may include one or more features that are configured to interact with the shunt so that the core wire 112 can control and / or manipulate the core wire 112. In some embodiments, the deployment feature can be configured to enable the core wire 112 to interact with the shunt to push the shunt into the lumen of the catheter 104, and / or move the shunt in the lumen of the catheter 104, and / or move the shunt through the lumen of the catheter 104. In some embodiments, the deployment feature 118 can be configured to connect the shunt to the core wire 112 so that the shunt can be deployed (deployed) from the catheter 104 into the patient's body. The details of the deployment feature 118 will be discussed in more detail below.

[0118] The shunt placement system 100 can include an introducer sheath 120. The introducer sheath 120 can 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 introducer sheath 120 can be open. The introducer sheath 120 can include an interior wall that defines a lumen extending through the introducer sheath 120.

[0119] The introducer sheath can be configured to retain the shunt before the shunt is inserted into the catheter system 102, and in particular, into the proximal end 130 of the catheter system 102. In some embodiments, the introducer sheath 120 can be configured to retain the shunt within the lumen of the introducer sheath. Figure 2 As shown in (A), the introducer sheath 120 holds the shunt in the lumen of the introducer sheath 120, and the deployment wire 110 is at least partially inserted into the lumen of the introducer sheath, which couples the deployment feature 118 of the deployment wire 110 to the shunt. Figure 2 (B), introducer sheath 120, in particular the distal end 124 of introducer sheath 120, can be inserted through access device 108 and into catheter 104, in particular into catheter hub 106 of catheter 104. In some embodiments, this can include inserting a combination of an introducer sheath including a shunt and deployment wire 110 into catheter system 102, and in particular into catheter 104.

[0120] In some embodiments, introducer sheath 120 can be advanced through access device 108 and into catheter 104 in the direction indicated by arrow 202. Core wire 112 can be inserted into catheter system 102, and specifically into proximal end 130 of catheter system 102. In some embodiments, core wire 112 can be inserted into introducer sheath 120, which can be inserted into catheter system 102.

[0121] Core wire 112 may be advanced through introducer sheath 120 in the direction indicated by arrow 202 to advance the shunt from introducer sheath 120 into catheter 104. After the shunt is advanced into catheter 104, introducer sheath 120 may be retracted from catheter 104 and access device 108 in the direction indicated by arrow 204.

[0122] Now refer to Figure 3 and 4, a stereoscopic view of an embodiment of a shunt 300 is shown. The shunt 300 may be, for example, a stent, a braided member, or the like. In some embodiments, the shunt may include an elongated braided member including a plurality of braided wires, which may be, for example, cobalt-chromium alloys, 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 half of the proximal side of the shunt 300, and the distal portion 312 may include half of the distal side of the shunt 300. In some embodiments, the proximal portion 310 may include about one-third of the proximal side of the shunt 300, and the distal portion 312 may include about 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 approximately one-quarter of the most proximal portion of the shunt 300 , while the distal portion 312 may include approximately three-quarters of the shunt 300 distal to the proximal portion 310 of the shunt 300 .

[0123] like Figure 4 As shown, the elongated tubular member of the shunt 300 can have a central axis 400 and can extend from a proximal end 402 to a distal end 404. A flow channel 406, also referred to herein as a shunt lumen 406, can be defined by an inner wall 403 of the shunt 300 and can extend along the central axis 400 and through the shunt 300. In some embodiments, each of the proximal end 402 and the distal end 404 can include an opening into the flow channel 406 so that a fluid, particularly blood, can flow through the flow channel 406, into the proximal end 402 and out of the distal end 404.

[0124] The shunt 300 may be in a Figure 3 The compressed state shown, also referred to herein as the constrained state, delivery configuration or constrained configuration, may be in a Figure 4 104. The expanded state shown in the figure is also referred to as the unconstrained state and / or unconstrained structure herein. In the constrained structure, the shunt 300 can have a compressed outer diameter 308. In other words, the shunt 300 in the constrained structure cannot be fully expanded, and / or is constrained so as not to be fully expanded. In some embodiments, when the shunt is contained and / or constrained in the introducer sheath 120 and / or in the catheter 104, the shunt 300 can remain in the constrained state. In some embodiments, the size of the shunt can be designed to have a compressed outer diameter 308 that fits in the introducer sheath 120 and / or the catheter.

[0125] In the unconstrained state, the shunt 300 can have an expanded outer diameter 408. The expanded diameter 408 can be greater than the compressed outer diameter 308. In some embodiments, the shunt 300 can be self-expanding so that when the shunt 300 leaves the catheter 104 and enters the patient's blood vessel, the shunt 300 automatically expands to match the inner diameter of the blood vessel. In some embodiments, the shunt 300 can be made in various sizes for use in blood vessels of different sizes. In some embodiments, the shunt 300 can 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, more than 4.25 mm, or any other diameter or intermediate diameter or diameter range.

[0126] In some embodiments, the shunt 300 can have an undeployed length and an deployed length. In some embodiments, when the shunt 300 is deployed, the length of the shunt 300 can change due to the shortening of the shunt 300, which can be associated with the expansion of the shunt 300. Therefore, as the amount of expansion of the shunt 300 increases, the shunt 300 will experience relatively more shortening. In some embodiments, the shunt 300 can have a fully expanded length that is less than about one-half of its constrained length, between about one-third to about one-quarter of its constrained length, or any other or intermediate fully expanded length. Therefore, in some embodiments, the shunt can have a shortening ratio that is greater than about 2, between about 3 to about 4, or any other or intermediate shortening ratio.

[0127] In some embodiments, the diverter 300 can 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 diverter can have an expanded length between about 5 mm and about 60 mm.

[0128] By using Figure 1 The system 100 can deploy the shunt into the patient's blood vessel. The deployment can involve using the deployment feature 118 of the deployment wire 110.

[0129] In some embodiments, the shunt 300 may include a braided member. One embodiment of the braid of the shunt is 450 in Figure 5 As shown in detail in Figure 5As shown, the braided member can be made of multiple wires 452, also referred to herein as strands 452. These wires 452 can include various shapes and sizes and can be made of various materials. In some embodiments, for example, wire 452 can have a diameter of about 0.0002 inches to about 0.01 inches, about 0.0005 inches to about 0.005 inches, about 0.0007 inches to about 0.002 inches, about 0.0008 inches, about 0.001 inches, about 0.0012 inches, or any other diameter or intermediate diameter.

[0130] In some embodiments, the wire 452 may include various types and / or materials. In some embodiments, the wire 452 may include a drawn fill tube (DFT). In some embodiments, the 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 a different material. In some embodiments, one or both of the inner core and the outer tube may be radiopaque. In some embodiments, for example, the outer tube may provide strength to the braided member of the shunt 300, and the inner core may be radiopaque.

[0131] In some embodiments, for example, the inner core can include platinum and / or can include a platinum alloy such as platinum and tungsten. In some embodiments, the platinum alloy can include, for example, about 28% platinum. In some embodiments, the outer tube can include an alloy such as stainless steel, nitinol, a cobalt-chromium alloy such as 35N LT alloy, or the like.

[0132] In some embodiments, the wire can be cold worked, and specifically can 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, the wire 452 can have at least about 50,000 PSI (pounds force 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 (at) intermediate minimum tensile strength.

[0133] The braid of the flow splitter 300 may include any desired number of strands. In some embodiments, the braid of the flow splitter 300 may include between about 10 strands and about 200 strands, between about 20 strands and about 150 strands, between about 40 strands and about 100 strands, about 64 strands, or any other number of strands or intermediate numbers of strands. Figure 5As shown, wire 452 may include wire 452-A extending in a first direction and braided with wire 452-B extending in a second direction. Wire 452 may be braided in any desired manner, including, for example, braiding 1 wire on 1 wire and under 1 wire, braiding 1 wire on 2 wires and under 2 wires, such as Figure 5 as shown, or any other weaving (method).

[0134] Now refer to Figure 6 , shows a schematic diagram of a delivery system 500. The delivery system 500 can include a shunt 300 that can be retained within a lumen 502 defined by an interior wall 504 of a catheter 104 or introducer sheath 120 in a constrained configuration.

[0135] The lumen 502 can include various shapes and sizes. In some embodiments, the lumen 502 can include a cylindrical lumen, and can specifically have a circular cross-section. In some embodiments, the size of the lumen 502 can be defined by an inner diameter. In some embodiments, the inner diameter of the lumen 502 can 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.

[0136] The deployment wire 110 can extend at least partially into the lumen 502 of the shunt 300 and the catheter 104 or introducer sheath 120. The deployment wire 110 can include a core wire 112 that can extend into the lumen 502 of the catheter 104 and / or introducer sheath 120 and a deployment feature 118 that is shown completely within the lumen 502 of the catheter 104 and / or introducer sheath 120.

[0137] exist Figure 6 In the illustrated embodiment, the unfolding feature 118 includes a pusher 505, such as a pusher coil 506 wrapped 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, which may be distributed along a portion of the unfolding wire 110, and specifically may be distributed along a portion of the core wire 112. In some embodiments, and as Figure 6 As shown, friction tabs 508 may be positioned within flow passage 406 of flow splitter 300 and may engage flow splitter 300 .

[0138] In some embodiments, the number of friction tabs 508 in the deployment feature 118 can vary based on the length of the flow splitter 300 when the deployment feature 118 including the friction tabs 508 is deployed. For example, as the length of the flow splitter 300 being deployed increases, the number of friction tabs 508 used to deploy the flow splitter 300 can increase. Thus, in embodiments with a relatively short flow splitter 300, a relatively small number of friction tabs 508 can be used. Similarly, in embodiments with a relatively long flow splitter 300, a relatively large number of friction tabs 508 can be included in the deployment feature 118. In some embodiments, the change in the number of friction tabs 508 associated with the length of the flow splitter 300 can affect the length of the core wire 112 associated with the flow splitter 300, thereby causing the core wire 112 to terminate within the flow channel 406 of the flow splitter 300.

[0139] In some embodiments, and by terminating in the flow channel 406 of the shunt 300, a portion of the shunt 300 distal to the termination of the deployment wire 110 can be trimmed without damaging the deployment wire 110 and / or the deployment feature 118 of the deployment wire 110. In some embodiments, the deployment wire 110 is sized and positioned relative to the shunt 300 such that the deployment wire 110 terminates in the proximal portion 310 of the shunt 300. In such embodiments, the termination of the deployment wire 110 in the proximal portion of the shunt 300 allows the distal portion 312 of the shunt 300 to be trimmed without damaging the deployment wire 110, and in particular without damaging the deployment feature 118 of the deployment wire 110.

[0140] In some embodiments, the one or more friction bumps 508 may include a single friction bump. The single friction bump may extend from the pusher 505 to the Figure 6 Thus, instead of having multiple friction tabs 508 over the length of the core wire 112, a single friction tab 508, also referred to herein as a "friction pad," may extend over all or multiple portions of the 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.

[0141] In some embodiments, a single long friction pad may provide better engagement with the diverter 300. However, embodiments with multiple friction tabs spaced apart may provide improved flexibility of the core wire 112. In some embodiments, the single long friction pad may include the same material as the friction tabs 508, and in some embodiments, the single long friction pad may include a material configured to improve flexibility.

[0142] The deployment feature 118 also includes a support coil 510, also referred to herein as a support coil 510, which is wrapped around a portion of the core wire 112, and in particular, is wrapped around a distal portion of the core wire 112, which may be tapered. Figure 3 As shown, the support member coil 510 can extend at least partially through the pusher coil 506 and can extend along the core wire 112 between the friction bumps 508 and extend distally beyond the final friction bump 508, or as shown in FIG. Figure 3 As shown, it exceeds the third friction protrusion 508-C. Specifically, as Figure 6 As shown, the support coil 510 can start at a position between the proximal end 514 and the distal end 516 of the pusher 505 and / or the pusher coil 506 and can extend distally to a position distally beyond the final friction bump 508. In such an embodiment, the support coil 510 can be located between at least a portion of the pusher 505 and / or the pusher coil 506 and the core wire 112. The deployment feature 118 can also include an atraumatic tip 512 at the distal-most end of the deployment wire 110.

[0143] In some embodiments, for example, when the shunt 300 is contained within the catheter 104 and / or the introducer sheath 120, the deployment wire 110 and / or the core wire 112 can terminate within the shunt 300. Figure 6 In the illustrated embodiment, the atraumatic tip 512 is located within the shunt 300 contained within the catheter 104 and / or the introducer sheath 120, and thus the deployment wire 110 and / or the core wire 112 terminate within the shunt 300 contained within the catheter 104 and / or the introducer sheath 120. In some embodiments, this can include the deployment 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 can include the deployment wire 110 and / or the core wire 112 terminating in the proximal portion 310 of the shunt 300.

[0144] In some embodiments, for example, when the shunt 300 has an expanded 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 expanded diameter or intermediate expanded diameter, the expansion wire 110 and / or the core wire 112 can terminate within the shunt 300 when the shunt 300 is constrained, expanded, and / or partially expanded. 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 expansion wire 110 and / or the core wire 112 can terminate within the shunt 300 when the shunt 300 is constrained, expanded, and / or partially expanded. In some embodiments, when the shunt 300 has at least one of an expanded diameter greater than about 4.25 mm or a constrained length greater than about 25 mm, the expansion wire 110 and / or the core wire 112 can terminate within the shunt 300 when the shunt 300 is constrained, expanded, and / or partially expanded.

[0145] In some embodiments, wherein the deployment wire 110 and / or core wire 112 do not extend distally beyond the distal end 306 of the shunt 300, the deployment wire 110 and / or core wire 112 may be sized and / or positioned relative to the shunt 300 in the constrained configuration such that: the deployment wire 110 and / or core wire 112 terminates in a proximal portion 310 that includes the proximal half of the shunt 300, terminates in a proximal portion 310 that includes the proximal-most third of the shunt 300, terminates in a proximal portion 310 that includes the proximal-most quarter of the shunt 300, or terminates in any other portion or intermediate portion of the shunt 300. In some embodiments, this termination position for the deployment wire 110 and / or core wire 112 may be determined based on a shortening ratio of the shunt 300.

[0146] In some embodiments, and as Figure 6 As shown, the length and / or position of the deployment 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 catheter 104 and / or the introducer sheath 120, the deployment wire 110 and / or core wire 112, and specifically the distal end of the deployment wire 110 and / or core wire 112 terminates within the shunt 300.

[0147] In some embodiments, the portion of the support coil 510 that extends distally beyond the final friction bump 508 can support the shunt 300. Specifically, the portion of the support coil 510 that extends distally beyond the final friction bump 508 can extend through at least a portion of the length of the shunt 300, and in some embodiments can reinforce those portions of the shunt 300. Specifically, and in some embodiments, the portion of the support coil 510 that extends distally beyond the final friction bump 508 can prevent the shunt from collapsing and / or buckling.

[0148] The deployment wire 110 including the deployment feature 118 can be configured to navigate the vasculature of the patient, and in particular to navigate the neurovasculature of the patient. Therefore, in some embodiments, the deployment feature 118 can be configured to promote and / or maintain the flexibility of the core wire 112, in particular the flexibility of the distal portion 116 of the core wire 112.

[0149] The pusher coil 506 can be configured to apply force to the shunt 300 when the unfolding wire 110 is advanced distally to and / or through the catheter 104, and / or through the introducing member sheath 120. The pusher coil 506 can include a coil formed by a wire winding. The wire forming the wire winding can include various materials and sizes. In some embodiments, the wire forming the pusher coil 506 can include a biocompatible wire such as a nitinol wire. The diameter of the wire forming the pusher coil 506 can be, for example, between 0 and 0.01 inches, between 0 and 0.005 inches, between 0 and 0.002 inches, a diameter of about 0.002 inches, or any other diameter or intermediate diameter.

[0150] The pusher coil 506 can have an outer diameter sized to fit within the lumen 502 of the catheter 104 and / or introducer sheath 120. In some embodiments, the diameter of the pusher coil 506 can be smaller than the diameter of the lumen 502 of the catheter 104 and / or smaller than the inner diameter of the lumen of the introducer sheath 120. The outer diameter of the pusher coil can be sized relative to the diameter of the lumen 502 of the catheter 104 and / or introducer sheath 120 such that the shunt 300 does not fit between the pusher coil 506 and the inner wall 504 of the catheter 104 and / or introducer sheath 120. In some embodiments where the inner diameter of the lumen 502 of the catheter 104 and / or introducer sheath 120 is 0.017 inches, the outer diameter of the pusher coil 506 can be, for example, 0.015 inches. In some embodiments where the inner diameter of the lumen 502 of the catheter 104 and / or introducer sheath 120 is 0.021 inches, the outer diameter of the pusher coil 506 can be, for example, 0.019 inches.

[0151] 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 unfolding 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 that attaches the pusher coil 506 to the unfolding wire 110, or in other words, the pusher coil 506 may be soldered to the unfolding wire 110. In some embodiments, the distal end 516 of the pusher coil 506 may be further configured to provide a bearing surface (bearing surface), which the pusher coil 506 can use to apply force to the shunt 300. In some embodiments, the bearing 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.

[0152] The deployment feature 118 may include one or more friction bumps 508. In some embodiments, the friction bumps are configured to press a portion of the shunt 300 into the inner wall 504 of the catheter 104 and / or the introducer sheath 120 when the portion of the shunt 300 is within the catheter 104 and / or the introducer 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 friction between the shunt 300 and the friction bumps 508 is greater than the friction between the shunt 300 and the inner wall 504 of the catheter 104 and / or the introducer sheath 120. Due to the relatively large friction between the friction bumps 508 and the shunt 300, each friction bump 508 facilitates control of the shunt 300, and in particular facilitates control of the position of the shunt 300 relative to the catheter 104 and / or the introducer sheath 120. In some embodiments, the interaction between the friction bumps 508 and the shunt 300 may enable the deployment wire 110 to deploy and / or retract the shunt 300 from the catheter 104 , and / or partially retract a partially deployed shunt 300 into the catheter 104 .

[0153] The friction bumps 508 may include, for example, a deformable material, such as an elastomer. In some embodiments, the friction bumps 508 may include a polymer capable of encapsulating a radiopaque element, such as a platinum coil and / or a platinum wire. In some embodiments, the friction bumps 508 may include a tungsten loaded polymer or a tungsten loaded elastomer. In some embodiments, the friction bumps may include a UV glue, which may, for example, be doped with a radiopaque material, such as tantalum powder. In some embodiments, some or all of the friction bumps 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 bumps 508, and in some embodiments, such as Figure 6 As shown, the friction bump may include a radiopaque coil 509, which may include, for example, a coil of a length of wire, such as platinum wire.

[0154] In some embodiments where the unfolded wire 110 includes a plurality of friction bumps 508, each friction bump 508 may be spaced apart at equal or unequal intervals. In some embodiments, each friction bump 508 may be spaced apart at 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.

[0155] In some embodiments, the deployment feature 118 may include a support coil 510. When the core wire 112 advances the shunt 300 distally in the catheter 104 and / or the introducer sheath 120, the support coil 510 can prevent the core wire 112 from buckling. For example, in order to increase the flexibility of the core wire 112, the core wire 112 can be tapered at its distal portion 116. The tapering can increase the flexibility of the core wire 112, but also reduces the strength of the core wire 112. When the core wire 112 is used to advance the shunt 300 distally in the catheter 103 and / or the introducer sheath 120, this reduction in the strength of the core wire 112 can cause the core wire 112 to buckle. The support coil 510 can extend along multiple portions of the core wire 112 to prevent the core wire 112 from buckling. Thus, through the combination of the tapered core wire 112 and the support coil 510 , the deployment wire 110 may be flexible to navigate the tortuous vasculature while also having sufficient strength to enable the shunt 300 to be deployed.

[0156] like Figure 6 As shown, the support coil 510 can extend over a portion of the core wire 112, and specifically over all or multiple portions of the distal portion 116 of the core wire 112. Figure 6As further shown, the support coil 510 can extend over 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.

[0157] 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 in diameter, 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 pusher coil 506, and in some embodiments, the wire forming the support coil 510 can have a different diameter than the wire forming the pusher 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.

[0158] The deployment wire 110 can extend distally beyond the friction bump 508, and in some embodiments, extend distally beyond the third friction bump 508-C. The deployment wire 110 can terminate with an atraumatic tip 512 that can be located at the distal end of the deployment wire 110. In some embodiments, the portion of the deployment wire 110 that extends distally beyond the friction bump 508 can include a portion of the support coil 510. The atraumatic tip 512 can be configured not to damage the tissue that may be hit during the performance of the surgical procedure, particularly during the deployment of the shunt 300 in the patient's vascular system. The atraumatic tip 512 can be attached to the distal end of the core wire 112 and / or the distal end of the support coil 510. The atraumatic tip can have a diameter that matches the outer diameter of the support coil 510. In some embodiments, the atraumatic tip 512 can be spaced from the last friction bump 508 by between 1 mm and 20 mm, between 1 mm and 15 mm, between 2 mm and 10 mm, between 3 mm and 8 mm, approximately 5 mm, or any other value or intermediate values.

[0159] In some embodiments, the delivery system, and as Figure 6As shown, the delivery system 500 can include a retraction sleeve 520. The retraction sleeve 520 can be coupled to the deployment wire 110 and can extend over a proximal portion 522 of the shunt 300. In some embodiments, the retraction sleeve 520 can extend over the proximal portion 522 of the shunt 300 when the shunt 300 is contained within the introducer sheath 120 and / or the catheter 104. In some embodiments, the retraction sleeve 520 can extend over some or all of the length of the deployment feature 118, and thus can extend over some or all of the proximal portion 522 of the shunt 300 that is engaged with the deployment feature 118.

[0160] In some embodiments, the retraction sleeve 520 can be positioned intermediate between the proximal portion 522 of the shunt 300 and the introducer sheath 120 and / or the catheter 104, and thereby can reduce friction between the proximal portion 522 of the shunt 300 and the introducer sheath 120 and / or the catheter 104. In some embodiments, the retraction sleeve 520 can not only reduce friction between the proximal portion 522 of the shunt 300 and the introducer sheath 120 and / or the catheter 104, but can also protect the proximal portion 522 of the shunt from damage that may be caused by movement of the shunt 300 relative to the introducer sheath 120 and / or the catheter 104, such as damage that may occur during deployment and / or retraction of the shunt 300.

[0161] The retraction sleeve 520 may include a flexible polymer that may be coupled to the deployment wire 110. Figure 6 As shown, the retraction sleeve 520 can be coupled to the deployment wire 110 at a location distal to all or portions of the deployment feature 118. In some embodiments, the retraction sleeve 520 can include a heat shrink polymer tube that can be positioned over a proximal portion 522 of the shunt 300 and over a portion of the deployment wire 110 distal to the shunt 300. The retraction sleeve 520 can then be heat shrunk around the shunt 300 to fit snugly around the shunt 300.

[0162] The retraction sleeve 520 may also include one or more slits extending proximally from the distal end of the retraction sleeve 520. The one or more slits separate the portion of the retraction sleeve 520 extending above the proximal portion 522 of the shunt 300 into a plurality of sections. For example, in an embodiment of the retraction sleeve 520 including two slits, the retraction sleeve 520 may be divided into two pieces, which may be two equal halves. When the shunt 300 is deployed, the one or more slits may allow the retraction sleeve 520 to open and separate from the shunt 300. Thus, as Figure 7104. As shown, when the retraction sleeve 520 protrudes distally beyond the catheter 104. As shown, the retraction sleeve 520 extending distally beyond the catheter 104 has divided (split) and separated from the shunt 300, allowing the shunt 300 to expand, and allowing the retraction sleeve 520 to be retracted into the catheter 104 when the shunt 300 is fully deployed.

[0163] Now refer to Figure 7 , shows a schematic diagram of the delivery system 500 in a partially deployed configuration. Figure 7 As shown, the catheter 104 including the deployment wire 110 and the shunt 300 is positioned in the blood vessel 600. Figure 7 As further shown, the deployment wire 110 has been advanced distally relative to the catheter 104, as shown by arrow 602, thereby partially deploying the shunt 300. The combination of the friction bump 508 and the pusher coil 506 engages with the shunt 300 to advance the shunt 300 distally into and out of the catheter 104 when the deployment wire 110 advances distally. When the deployment wire 110 advances distally, the shunt 300 is deployed from the catheter 104 and begins to expand. This advancement to the distal side continues until the shunt 300 is fully deployed. Alternatively, if the shunt 300 has not yet been fully deployed from the catheter 104, and at least one of the friction bumps 508 is still in the catheter 104 and engaged with the shunt 300, the shunt 300 can be retracted and / or partially retracted into the catheter 104. In some embodiments, successful deployment of the shunt 300 can be achieved by advancing only the deployment wire 110 distally, and in some embodiments, successful deployment of the shunt 300 can be achieved by alternately advancing the shunt 300 distally and retracting it proximally until the desired positioning and / or deployment is achieved.

[0164] Now refer to Figure 8 , a schematic diagram of one embodiment of a dynamic delivery system 800 is shown. The system 800 may include a shunt 300 that may be retained in a constrained state within the lumen 502 of the catheter 104 and / or the introducer sheath 120. In some embodiments, the shunt 300 may include an expandable braided member that may define a flow channel 406. In some embodiments, the shunt 300 may include a self-expanding braided member.

[0165] The shunt 300 can be positioned within the lumen 502 of the catheter 104 and / or introducer sheath 120. In some embodiments, the shunt 300 can be positioned within the lumen 502 of the catheter 104 and / or introducer sheath 120 circumferentially between an interior wall 504 defining the lumen 502 of the catheter 104 and / or introducer sheath 120 and an expansion element, which can be a self-expanding element, as will be discussed in more detail below.

[0166] The deployment wire 110 can extend at least partially into the lumen 502 of the shunt 300 and the catheter 104 or introducer sheath 120. The deployment wire 110 can include a core wire 112 that can extend into the lumen 502 of the catheter 104 and / or introducer sheath 120 and a deployment feature 118 that is shown completely within the lumen 502 of the catheter 104 and / or introducer sheath 120. The deployment feature 118 is coupled to the shunt so that movement of the deployment wire 110 and / or core wire 112 relative to the catheter 104 and / or introducer sheath 120 similarly moves the shunt 300 relative to the catheter 104 and / or introducer sheath 120.

[0167] In some embodiments, and as Figure 8 As shown, the deployment wire 110 and the core wire 112 terminate within the flow channel of the shunt 300, in other words, do not extend distally beyond the distal end of the shunt 300. In some embodiments, the deployment wire 110 and / or the core wire 112 are sized and / or configured such that: when the shunt 300 is in a constrained configuration, or in an unconstrained configuration after being deployed from the catheter 104, neither the deployment wire 110 nor the core wire 112 extends distally beyond the distal end 306 of the shunt 300. Therefore, the atraumatic tip 512 at the distal end of the deployment wire 110 is located within the shunt 300 and does not extend distally beyond the distal end 306 of the shunt 300.

[0168] The deployment 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 an atraumatic tip 512. The end coil can be a flexible end coil 810. In some embodiments, the flexible end coil 810 and / or the flexible end coil 810 and the atraumatic tip 512 can facilitate navigation of the system 800 and / or the core wire 112 through the vasculature, particularly through tortuous vasculature.

[0169] In some embodiments, some or all of these deployment features 118 are engaged with a flow diverter, or as Figure 8 As shown, the deployment feature 118 is engaged with the diverter 300 . The deployment feature 118 is engaged with the diverter 300 and / or can be engaged with the diverter 300 such that movement of the core wire 112 results in corresponding movement of the diverter 300 .

[0170] 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 when leaving the catheter 104. In some embodiments, the controlled expansion element may expand when 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 include a polymer, the polymer may be treated and / or doped to be radiopaque.

[0171] In some embodiments, the materials of the shunt 300 and / or the expansion element 802 can be selected to minimize the compressed diameter of the shunt 300 around the expansion element 802. In some embodiments, for example, by selecting and using a high tensile strength material, such as a material having a tensile strength equal to or greater than 100 kpsi (thousand pounds per square inch), 150 kpsi, 200 kpsi, 250 kpsi, etc., the outer diameter of the fully compressed expansion element 802 can 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 that falls within the following ranges: + / - 5% of the associated value, + / - 10% of the associated value, and / or + / - 20% of the associated value. Thus, the combination of the shunt 300 and the expansion element 802 can be fitted in a catheter 104 having an inner diameter of, 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.

[0172] 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, catheters, rods, or the like. In some embodiments, the controlled expansion element may be expanded by axially compressing the controlled expansion element so that the proximal end of the controlled expansion element is closer to the distal end of the controlled expansion element. Although the following discussion focuses on the use of self-expanding element 802, it will be understood that the self-expanding element 802 can be replaced by a controlled expansion element.

[0173] like Figure 8 As shown, the self-expanding element 802 includes a proximal end 804 and a distal end 806, the proximal end is also referred to herein as the first end 804, and the distal end is 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 deployment 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 distally from a proximal end 804 of the self-expanding element 802 to a distal end 806 .

[0174] The self-expanding element 802 may include a stent or a braided member. In some embodiments, the self-expanding element includes a laser cut stent. 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 fill tube may include, for example, nitinol, cobalt chromium exterior and platinum interior, for example, a mixture of nitinol and cobalt chromium, etc. In some embodiments, the self-expanding element 802 may include a plurality of braided strands, at least some of which may be radiopaque.

[0175] The self-expanding element 802 can be configured to engage the shunt 300 when the shunt is contained within the catheter 104 and / or within the introducer sheath 120, such that movement of the deployment wire 110, and in particular movement of the core wire 112, results in corresponding movement of the shunt 300. When the self-expanding element 802 has been deployed from the catheter 104, the self-expanding element 802 expands to a fully expanded state, or to a maximum expanded state permitted by the vessel housing the self-expanding element 802. In some embodiments, the self-expanding element 802 can be advanced distally through the shunt 300 and / or retracted proximally.

[0176] In some embodiments, expansion elements 802, such as controlled expansion elements or self-expanding elements 802, can generate radial forces that can cause shunt 300 to expand to a greater extent than would otherwise occur. For example, expansion elements 802, such as controlled expansion elements or self-expanding elements 802, can generate greater radial expansion forces than would otherwise be generated by shunt 300, even if shunt 300 is self-expanding. By moving expansion elements 802 through shunt 300, these greater radial expansion forces generated by expansion elements 802 can be applied to shunt 300 and can cause shunt 300 to expand further. This increased expansion can increase and / or improve contact between shunt 300 and vessel 600. In some embodiments, expansion elements 802 are used, such as controlled expansion elements or as self-expanding elements.

[0177] In some embodiments, when unconstrained, the diameter of the expansion element 802 can be larger than the diameter of the unconstrained shunt 300, while in some embodiments, when unconstrained, the diameter of the expansion element 802 can be smaller than the diameter of the unconstrained shunt 300. Thus, in some embodiments, and when unconstrained, the diameter of the expansion element 802 can be larger or smaller than the diameter of the vessel 600. In some embodiments, when the shunt 300 is deployed, kinks, twists, compressions, or bends can occur in the shunt 300, which can prevent expansion of the shunt 300. In some embodiments, the expansion element 802 can straighten, remedy (correct), and / or eliminate these kinks, twists, compressions, or bends in the shunt 300 by expanding to a diameter that is smaller than the diameter of the vessel 600. In such embodiments, expansion of the expansion element 802 that is smaller than the diameter of the vessel 600 can straighten, remedy (correct), and / or eliminate these kinks, twists, compressions, or bends in the shunt 300, which can cause the shunt 300 to self-expand to engage the wall of the vessel 600. In such embodiments, while the expansion element 802 may not force the shunt 300 to expand to engage the wall of the vessel, the expansion element 802 may force the shunt 300 to expand sufficiently to eliminate, straighten, and / or remedy (correct) these kinks, twists, compressions, or bends in the shunt 300 so that the shunt 300 may self-expand to engage the wall of the vessel 600. Thus, in some embodiments, the expansion element 802 begins (initiates) expansion, which is then continued and completed by the shunt 300.

[0178] Alternatively, in some embodiments, the diameter of the expansion element 802 can be such that movement of the expansion element 802 through the deployed shunt 300 forces the deployed shunt 300 to expand to engage the wall of the vessel 600. In such embodiments, the expansion element 802 can expand to a diameter equal to and / or greater than the diameter of the vessel wall 600.

[0179] In some embodiments, expansion of expansion element 802 may result in shortening of expansion element 802. Such shortening may cause distal end 113 of core wire 112 to move proximally. This may specifically move atraumatic tip 512 proximally. Such proximal movement of distal end 113 of core wire 112 and / or atraumatic tip 512 may reduce distal extension of those portions of core wire 112 that enter a blood vessel, thereby reducing the risk of vascular damage.

[0180] One or more friction bumps 508 may be coupled to the deployment wire 110, and in particular may be coupled 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 deployment wire 110, and in particular to the core wire 112, and in some embodiments, one or more friction bumps 508 may be indirectly coupled to the deployment wire 110, and in particular 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 welded to the support coil 510, and the solder may penetrate into the support coil 510 to further couple the friction bumps 508 to the core wire 112.

[0181] In some embodiments, one or more friction bumps 508 may be located at one or both ends of the self-expanding element. Thus, 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 of the friction bumps is located at the other of the proximal end 804 and the distal end 806. Figure 8As shown, the friction bumps 508 include a first friction bump 508-A and a second friction bump 508-B, the first friction bump 508-A being located at, adjacent to, and / or on the proximal end 804 of the self-expanding element 802, and the second friction bump 508-B being located at, adjacent to, and / or on the distal end 806 of the self-expanding element 802. In some embodiments, the friction bumps 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 a radiopaque element such as a coil 509. In some embodiments, the expansion element 802 and / or one or both of the friction bumps 508 may facilitate fully or partially retracting the partially deployed shunt 300 into the catheter 104. In some embodiments, the first friction lug 508-A can optimally facilitate full or partial retraction of the shunt 300 into the catheter 404 due to its relatively proximal position compared to the relatively more distally positioned expansion element 802 and the second friction lug 508-B.

[0182] In some embodiments, the first friction bump 508-A can 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 can be coupled to the support coil 510. Specifically, in some embodiments, the first friction bump 508-A can be directly coupled to the support coil 510. In some embodiments, the first friction bump 508-A can be welded to the support coil 510, the solder can penetrate the support coil 510 and can further couple the first friction bump 508-A to the core wire 112 and specifically to the distal end of the core wire 112. In some embodiments, the solder can form all or part of the first friction bump 508-A.

[0183] In some embodiments, the second friction bump 508-B can 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 can be welded to the distal end 806 of the expansion element 802 and / or to the end coil 810. In some embodiments, the weld can form all or part of the second friction bump 508-B.

[0184] The system may include support coil 510. Support coil 510 may extend around and / or along at least a portion of distal portion 116 of core wire 112, including extending along and / or around distal end 113 of core wire 112. In some embodiments, support coil 510 may extend from a location proximal to self-expanding element 802 to self-expanding element 802 and / or from a location proximal to first friction bump 508-A to first friction bump 508-A. In some embodiments, support coil 510 may extend at least partially into first friction bump 508-A.

[0185] In some embodiments, core wire 112 terminates at and / or in first friction bump 508-B. Thus, in some embodiments, distal end 806 of expansion element 802 is not directly coupled to the distal end of core wire 112, but is indirectly coupled to the distal end of core wire 112 via distal end 804 of expansion element 802. Thus, in some embodiments, core wire 112 does not extend through expansion element 802. In some embodiments, such coupling of only proximal end 804 of expansion element 802 to core wire 112 enables shortening of expansion element 802 associated with radial expansion of expansion element 802. In some embodiments, the lack of core wire 112 extending through expansion element 802 increases the flexibility of expansion element 802.

[0186] In some embodiments where core wire 112 terminates at proximal end 804 of expansion element 802, coupling wire 820 can be connected to distal end 806 of expansion element 802, to end coil 810, and / or to atraumatic tip 512. In some embodiments, coupling wire 820 can be configured to prevent loss of a distal portion of deployment wire 110 in the event of, for example, breakage of expansion element 802, end coil 810, and / or atraumatic tip 512. In such embodiments, coupling wire 820 allows the distal portion of deployment wire 110 to be retracted from the patient.

[0187] In some embodiments, the connecting wire 820 can be connected to the distal end of the core wire 112, and in some embodiments, the connecting wire 820 can extend parallel to and / or through the core wire 112, and in some embodiments can be used as a pulling wire to control expansion and / or facilitate expansion of the expansion element 802.

[0188] In some embodiments, the coupling wire 820 can be tensioned when the expansion element 802 is contained within the catheter 104 and / or the introducer sheath 120, and the coupling wire 820 can be relaxed when the expansion element 802 is deployed from the catheter 104 and / or is in an expanded configuration.

[0189] In some embodiments, the system 800 can include an end coil 810, which can be a flexible end coil 810. The end coil 810 can extend distally from the self-expanding element 802, and in particular can extend distally from the distal end 802 of the self-expanding element 806. The end coil 810 can extend distally beyond the self-expanding element 802 and can terminate at an atraumatic tip 512. In some embodiments, the atraumatic tip 512 can be 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 atraumatic tip 512 can facilitate navigation of the system 800 and / or the core wire 112 through the vasculature, particularly through tortuous vasculature.

[0190] Figure 8 An embodiment of a shunt is shown deployed with system 800. Catheter 104 has been inserted into the vascular system and has been advanced to a position proximate to treatment site 812, which may be at, near, or beyond treatment site 812. In some embodiments, the position of the catheter may be determined via imaging, such as via fluoroscopy.

[0191] As shown, the deployment wire 110 and the shunt 300 are advanced distally in the direction indicated by the arrow 814 until the shunt 300 exits the catheter 104. As the shunt 300 exits the catheter 104, the shunt 300 may begin to expand and may begin to engage the interior of the blood vessel 600. In some embodiments, the distal advancement of the deployment wire 110 and the shunt 300 may continue until the shunt 300 is fully deployed. Alternatively, if the shunt 300 has not yet been fully deployed from the catheter 104, the shunt 300 may be retracted and / or partially retracted into the catheter 104. In some embodiments, the shunt 300 may be retracted and / or partially retracted into the catheter 104 until the friction bump 508 and / or the self-expanding element 802 exit the catheter 104 at the most proximal side. In some embodiments, the position of shunt 300, catheter 104, friction bumps 508, and / or self-expanding element 802 can be determined via imaging, particularly via imaging of radiopaque elements and / or portions of catheter 104, friction bumps 508, and / or self-expanding element 802. In some embodiments, and based on the results of this imaging, it can be determined whether shunt 300 can be retracted and / or partially retracted into catheter 104.

[0192] When self-expanding element 802 exits catheter 104, self-expanding element 802 expands and applies a radially outward force to shunt 300, causing further expansion of shunt 300. Alternatively, where a controlled expansion element is used, the opening exits catheter 104 and the controlled expansion element may expand.

[0193] The self-expanding element 802 may continue to be advanced 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 be advanced distally through the shunt 300 to fully and / or maximally expand the shunt 300, at which point the self-expanding element 802 may be retracted proximally through the shunt 300 and then back into the catheter 104. In some embodiments, the distal advancement and proximal retraction of the expansion element 802 through the shunt 300 may be repeated multiple times before the expansion element 802 is retracted into the catheter 104. In some embodiments, repeated movement of the expansion element 802 through the deployed shunt 300 may help achieve full deployment of the shunt 300, particularly in situations where all or multiple portions of the shunt 300 have not yet been fully deployed. This movement of the self-expanding element 802 first distally and then proximally through the shunt 300 may increase expansion of the shunt 300 and improve the connection between the shunt and the blood vessel 600.

[0194] Once the self-expanding element 802 has been retracted into the catheter 104, the catheter may be retracted and / or one or more additional shunts may be delivered to the treatment site.

[0195] like Figure 8 , a diagram of an embodiment of delivering a shunt 300 is shown, specifically, the shunt 300 is used to deliver the shunt 300 into a blood vessel 600 to treat an aneurysm. In some embodiments, the blood vessel can be a neurovascular vessel, or in other words, can be a blood vessel in or around the patient's brain. In some embodiments, delivering the shunt 300 into the blood vessel 600 can include partially deploying 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 fully contained within the catheter 104, while partial retraction occurs when a portion of the shunt 300 remains outside the catheter 104 after the shunt 300 is retracted.

[0196] In some embodiments, the shunt can be fully deployed or partially deployed after the shunt 300 is retracted into the catheter 104. In some embodiments, the shunt 300 can be partially deployed and retracted once, while in some embodiments, the shunt 300 can be partially deployed and retracted into the catheter 104 repeatedly.

[0197] In some embodiments, the shunt 300 can be retracted into the catheter 104 and removed from the vessel. In some embodiments, the shunt 300 can be replaced with another shunt 300 of a different size, for example, a shunt with a larger or smaller diameter. In some embodiments, the shunt 300 can be retracted and redeployed to improve expansion of the shunt 300. In some embodiments, for example, retracting and redeploying the shunt 300 can result in a more complete opening of the shunt 300 and / or result in improved contact between all or multiple portions of the shunt 300 and the vessel in which it is deployed.

[0198] In some embodiments, the shunt 300 can be retracted and / or redeployed 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 of the vessel 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 couple 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 when deployed, and the length of the deployed shunt 300 can be increased.

[0199] In some embodiments, and by controlling the length of the deployed shunt 300, the surgeon can affect 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 having a larger diameter, the surgeon can reduce the length of the deployed shunt to achieve the desired deployed diameter of the shunt 300.

[0200] Now refer to Fig. 9 , a schematic diagram of a customizable delivery system 900 is shown. Fig. 9 As shown, the deployment wire 110 and the shunt 300 are at least partially positioned within the introducer sheath 120. Fig. 9 As shown, in some embodiments, no portion of the deployment wire 110 extends distally beyond the distal end 307 of the shunt 300. Fig. 9As further seen in FIG. 1 , in some embodiments, prior to customization of the shunt 300 , no portion of the deployment wire 110 extends distally beyond the distal end 124 of the introducer sheath 120 .

[0201] like Fig. 9 As further seen in FIG. 1 , the unfolded wire 110 including the tapered core wire 112 is coupled to the unfolding feature 118, such as Fig. 9 As shown, the deployment feature includes a pusher 505 and a friction bump 508 as described in detail above. Figures 9 to 16 An embodiment with friction bumps 508 and / or pushers 505 is shown, but these embodiments may include Figure 8 The deployment features 118 shown are specifically, for example, expansion elements 802 and friction bumps 508 -A, 508 -B.

[0202] The combination of the friction bump 508 and the pusher 505 engages the shunt 300 to advance the shunt 300 distally into and out of the catheter 104 as the deployment wire 110 advances distally. As the deployment wire 110 advances distally, the shunt 300 deploys from the catheter 104 and begins to expand. This distal advancement continues until the shunt 300 is fully deployed. Alternatively, if the shunt 300 has not yet been fully deployed from the catheter 104, and with the friction bump 508 still within the catheter 104 and engaged with the shunt 300, the shunt 300 can be retracted and / or partially retracted into the catheter 104. In some embodiments, successful deployment of the shunt 300 can be achieved by only advancing the deployment wire 110 distally, while in some embodiments, successful deployment of the shunt 300 can be achieved by alternately advancing the shunt 300 distally and retracting it proximally until the desired positioning and / or deployment is achieved. According to the embodiment of the present invention, the shunt 300 can be deployed distally and / or partially deployed. Fig. 9 In the illustrated system 900 , the shunt 300 extends a first length 902 beyond the distal end 124 of the introducer sheath 120 .

[0203] like Fig. 9 The illustrated system 900 also includes a customization component 901 that can enable customization of the shunt 300. In some embodiments, the customization component 901 can enable customization of the shunt 300 prior to inserting the shunt 300 into the catheter 104.

[0204] Customized component 901 can include an elongated tubular member having a proximal end and a distal end. In some embodiments, the elongated tubular member of customized component 901 includes an inner wall defining an inner cavity. In some embodiments, customized component 901 can include one or more cuttable portions that allow cutting to achieve customized shunt 300.

[0205] Customized component 901 may include a proximal portion 930 and a distal portion 932. In some embodiments, proximal portion 930 may include the proximal half of customized component 901, while distal portion 932 may include the distal half of customized component 901. In some embodiments, proximal portion 930 may include approximately one-third of the most proximal side of customized component 901, while distal portion 932 may include approximately two-thirds of customized component 901 distal to proximal portion 930 of customized component 901. In some embodiments, proximal portion 930 may include approximately one-quarter of the most proximal side of customized component 901, while distal portion 932 may include approximately three-quarters of customized component 901 distal to proximal portion 930 of customized component 901.

[0206] In some embodiments, the customized component 901 may include one or more components. The customized component 901 may include an introducer sheath 120. In some embodiments, the introducer sheath 120 may be cuttable to customize the shunt 300. In some embodiments, the customized component 901 may include an introducer sheath 120 that is coupled to and / or can be coupled to another introducer sheath 120 that can be cut to customize the features of the shunt 300. For example, in some embodiments, the customized component 901 may include a tubular member, such as an introducer sheath 120 and a cuttable support extending along and around the distal end 124 of the elongated tubular member (e.g., the introducer sheath 120). In some embodiments, the cuttable support may be a tube 904 extending along and around the distal end 124 of the elongated tubular member (e.g., the introducer sheath 120). The tube 904 may be a polymer tube attached to the distal end 306 of the shunt 300. The tube 904 preferably includes a polymer tube that includes heat-shrinkable PTFE, polyetheramide, polyolefin, 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.

[0207] In some embodiments, and as Figures 9 to 17 As shown, the deployment feature 118 and / or deployment wire 110 do not extend distally into the tube 904, but terminate in the introducer sheath 120. In some embodiments, the deployment feature and / or deployment wire 110 terminates in the proximal portion 930 of the custom component 901. Thus, in some embodiments, the deployment feature terminates in the proximal portion 310 of the shunt 300, while the proximal portion of the shunt 300 is contained in the introducer sheath 120 rather than in the tube 904.

[0208] Tube 904 extends a second length 906 beyond distal end 124 of introducer sheath 120. Fig. 9, the distal end 306 of the shunt 300 can be contained within a tube 904. The tube 904 is preferably cuttable and configured such that the length of the shunt 300 can be customized via cutting of the tube 904 and the shunt 300 contained therein. In at least some embodiments, the tube is semi-rigid and peelable.

[0209] In at least some approaches, the first length 902 and the second length 906 are equal, such that the shunt 300 and the tube 904 extend distally the same length beyond the distal end 124 of the introducer sheath 120. In other approaches, the second length 906 (e.g., the length that the tube 904 extends beyond the distal end 124 of the introducer sheath 120) can be greater than or less than the first length 902 (e.g., the length that the shunt 300 extends beyond the distal end 124 of the introducer sheath 120). In at least some embodiments, the deployment wire 110 terminates prior to the distal end 306 of the shunt 300, such that the distal end of the deployment wire 110 does not extend into the tube 904. The deployment wire 110 does not extend distally beyond the distal end 306 of the shunt 300.

[0210] In some embodiments, the diverter 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 diverter 300 and the combination of the braiding of the braid can make the diverter 300 cuttable. In some embodiments, this can include, for example, the braiding of the braid that does not unravel when the diverter 300 is cut. The heat shrink tube constrains the braid and maintains the braid in a constrained configuration. In various methods, the braid has been heat treated to maintain its shape and tubular configuration.

[0211] The desired length of the shunt 300 can be customizable via cutting of the shunt 300, allowing the physician to customize 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 trimming process of the shunt 300 as needed (trim-on-demand processing).

[0212] In at least some embodiments, tube 904 includes graduation markings 908 that are equally spaced along a portion of tube 904, and specifically along a distal portion 910 of tube 904. In various embodiments, shunt 300 can include graduation markings 904 that are equally spaced along a portion of shunt 300 in a manner such that graduation markings 908 are visible through tube 904. Graduation markings 908 can be used as a ruler to guide cutting of shunt 300 and / or tube 904 to a desired length.

[0213] The tube 904 includes a proximal end 912 and a distal end 914 opposite the proximal end 912, a first longitudinal portion 916 having a first proximal pull tab 918, and a second longitudinal portion 920 having a second proximal pull tab 922. In some embodiments, the first longitudinal portion 916 is coupled to the second longitudinal portion 920 via a coupling 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 strippably removed from the distal portion of the introducer sheath 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 one of ordinary skill in the art. Specifically, in some embodiments, stripping the tube 904 from the introducer sheath can include separating the first longitudinal portion 916 from the second longitudinal portion 920 along the coupling portion.

[0214] like Fig.10 As seen in FIG. 1 , system 900 can be used to customize the length of shunt 300 to a desired length 1000. In at least some embodiments, discard section 1002 can be removed (e.g., cut) from tube 904 having shunt 300 positioned therein. Graduation markings 908 can be used to measure desired length 1000 and / or measure discard section 1002 to determine where cutout 1004 should be formed. Referring now to FIG. Fig.11 , the discarded section 1002 has been removed, and the desired length 1000 remains.

[0215] like Fig.12 As shown, the first longitudinal portion 916 of the tube 904 having the first proximal pull tab 918 and the second longitudinal portion 920 having the second proximal pull tab 922 can be peelably removed from the distal portion of the introducer sheath 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 one of ordinary skill in the art. For example, the first longitudinal portion 916 is pulled by the pull tab 918 in a first direction 1200 that is generally perpendicular to the longitudinal axis 1202 of the introducer sheath 120. Similarly, the second longitudinal portion 920 is pulled by the pull tab 922 in a second direction 1204 that is generally perpendicular to the longitudinal axis 1202 of the introducer sheath 120 and opposite to the first direction 1200.

[0216] In at least some embodiments, before or during the strippable removal of the tube 904, the desired length 1000 of the shunt 300 is retracted into the introducer sheath 120 so that the shunt 300 is substantially within the introducer sheath 120. In some embodiments, the introducer sheath 120 has a length such that the entire shunt 300 can be retracted from the tube 904 into the introducer sheath 120 regardless of whether the shunt 300 is modified or untrimmed. In some such embodiments, the introducer sheath 120 has a length greater than or equal to the length of the untrimmed shunt 300. Therefore, in some embodiments, the combined length of the introducer sheath 120 and the attached tube is longer than the untrimmed shunt. In the manner described in detail above, the shunt 300 can be retracted into the introducer sheath 120 via the actuation of the deployment wire 110 and the movement relative to the introducer sheath 120. Retracting the shunt 300 into the introducer sheath 120 is performed, for example, by retracting the deployment wire 110 distally.

[0217] Peelably removing the tube 904 includes separating the tube 904 from the distal portion of the introducer sheath 120. As described above, the tube 904 can be separated from the distal portion of the introducer sheath 120 by peeling the tube 904 from the distal portion of the introducer sheath 120, wherein peeling the tube 904 includes separating the first longitudinal portion 916 from the second longitudinal portion 920, however, separating the tube 904 from the distal portion of the introducer sheath 120 can be performed in other ways, for example, using only one pull tab to separate the tube 904. In some methods, the tube 904 is separated from the distal portion of the introducer sheath 120 after the shunt 300 is retracted into the introducer sheath.

[0218] Now refer to Fig.13 , after the tube 904 is releasably removed from the distal portion of the introducer sheath 120 and the desired length 1000 of the shunt 300 is retracted into the introducer sheath 120, the remaining system 1300 can be loaded into the catheter system 102, and specifically, loaded into the catheter 104 of the catheter system 102 via actuation of the deployment wire 110, as shown. Fig.14 As shown. The shunt 300 can then be delivered to a neurovascular vessel (e.g., vessel 600). This can include moving the distal end 132 of the catheter system 102 to the vicinity of 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.

[0219] In some embodiments, the catheter system 102 can be positioned distally, and in some embodiments, only distally of the treatment location. In some embodiments, the advancement of the deployment wire 110 distally relative to the catheter system 102 can also cause the shunt 300 to advance distally relative to the catheter system 102. In some embodiments, the shunt 300 can be deployed by advancing the deployment wire 110 relative to the catheter system 102. In some embodiments, such advancement of the deployment wire 110 relative to the catheter system 102 can include: retracting the catheter system 102 in the blood vessel 600 while maintaining the position of the deployment wire 110 relative to the blood vessel 600; advancing the deployment wire 110 relative to the blood vessel 600 while maintaining the position of the catheter system 102 relative to the blood vessel 600; or simultaneously retracting the catheter system 102 relative to the blood vessel 600 while advancing the deployment wire 110 relative to the blood vessel 600.

[0220] In some embodiments, the shunt 300 expands and / or begins to expand as the shunt 300 exits the catheter system 102. The shunt 300 can continue to deploy via further distal advancement of the deployment wire 110 and thus the shunt, and the shunt 300 can be fully deployed.

[0221] After the shunt 300 has been fully deployed, the deployment wire 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 can be deployed to the treatment position. This can include placing additional shunts on top of one or more previously deployed shunts 300. Alternatively, one or more additional shunts 300 can be placed to partially overlap to increase the length of the treated blood vessel 600. In such an embodiment, the distal end of the additional shunt can be placed overlappingly on the proximal end or on the previously placed shunt 300.

[0222] In some embodiments, at least one of the pusher and the at least one friction bump is radiopaque. Delivery of the catheter system 102 may include imaging the at least one of the pusher and the at least one friction bump to determine the position of the shunt in the neurovascular vessel and the position of the pusher and / or the at least one friction bump relative to the microcatheter.

[0223] In some embodiments, the shunt is retracted into the microcatheter when at least one of the at least one friction bump has not exited the microcatheter. In at least some aspects, positioning of the microcatheter is adjusted relative to the treatment location based on the imaging.

[0224] In various aspects, the shunt is loaded into the catheter system 102. In some embodiments, loading the shunt into the microcatheter includes inserting an introducer sheath containing the shunt into the microcatheter through an access device, and advancing a deployment wire through the introducer sheath to advance the shunt from the introducer sheath into the microcatheter.

[0225] like Fig.15 As shown, a second customizable shunt delivery system 1500 includes a template 1502. The template 1502 includes a top portion 1504, a bottom portion 1506, a front portion 1508, a rear portion 1510, a first side portion 1512, and a second side portion 1514. The template 1502 includes a plurality of Fig. 9 Scale markings 1516 of scale markings 908 are shown in FIG. Scale markings 1516 are configured to assist in cutting the shunt 300 to a desired length in a manner similar to that described above. Scale markings 1516 are preferably associated with the expanded length of the shunt 300.

[0226] In some embodiments, tube 904 may include graduated markings, such as at least Fig. 9 The second customizable shunt delivery system 1500 depicts an alternative and / or supplemental method to guide a physician in cutting the shunt 300 within the peelably removable tube 904 to a desired length. In at least some methods, the graduation markings may be provided on both the tube 904 and the template 1502 provided with the shunt delivery system.

[0227] In various embodiments, the template 1502 includes a cutting aperture, slit, or notch 1518 extending through the bottom 1506 of the template 1502. The cutting aperture, slit, or notch 1518 is located adjacent one of the first side 1512 and the second side 1514. The scale markings 1516 can be positioned between the cutting aperture, slit, or notch 1518 and the other of the first side 1512 and the second side 1514. For example, the scale markings 1516 are positioned between the cutting aperture, slit, or notch 1518 and the first side 1512. In another example, the scale markings 1516 are positioned between the cutting aperture, slit, or notch 1518 and the second side 1514, as shown in FIG. Fig.15 shown.

[0228] In some embodiments, the template 1502 includes a first set of scale markings along a bottom 1506 of a front portion 1508 of the template 1502 and a second set of scale markings along a bottom 1506 of a rear portion 1510 of the template 1502. In one embodiment, one of the front portion 1508 of the template 1502 and the rear portion 1510 of the template 1502 is configured for a right-handed user, and the other of the front portion 1508 of the template 1502 and the rear portion 1510 of the template 1502 is configured for a left-handed user.

[0229] In various embodiments, the template 1502 includes a formula (scheme, guideline) not shown that is configured to help cut the diverter 300 into a desired length. The formula can be printed along the top 1504 of the template 1502. For example, the formula can be printed along the top portion of the template 1502. In other examples, the formula can be centered on the front 1508 and / or rear 1510 of the template 1502. The formula can be printed anywhere on either side along the template 1502. In a preferred embodiment, the formula and scale marks 1516 are printed on each of the front 1508 and rear 1510 of the template 1502.

[0230] In at least one embodiment, the formula includes: L T =L I -L D R R=0.27D+1.2 in: L T = Trimming length L D = Expanded length L I = Length inside the sheath R = Ratio D = implant diameter

[0231] In one embodiment, the implant diameter (D) is 4 mm, the desired deployed length (LD) is 25 mm, and the length within the sheath (L I ) is 80mm.

[0232] calculate: R = 0.27(4) + 1.2 = 2.28 L T =800-25(2.28)=23mm

[0233] Therefore, to achieve an extended length of 25 mm, the operator needs to trim off 23 mm.

[0234] like Fig.16 As shown, the second customizable shunt delivery system 1500 includes a protective sleeve 1600 extending along and around the proximal end 304 of the shunt 300, wherein the protective sleeve 1600 is configured to reduce friction and / or reduce damage to the shunt 300 when the shunt 300 moves relative to the elongated tubular member (e.g., the introducer sheath 120). In various methods, the protective sleeve 1600 extends beyond the proximal end 304 of the shunt 300 and / or the pusher 505, such as Fig.16 shown.

[0235] The protective sleeve 1600 can be a heat shrink plastic. In some embodiments, the protective sleeve 1600 can include a flexible polymer coupled to the deployment wire 110. In some embodiments, the protective sleeve 1600 can be coupled to the deployment wire 110 at a position distal to all or part of the deployment features (e.g., friction bumps 508, support coils 510, etc.). In some embodiments, the protective sleeve 1600 can include a heat shrink polymer tube that can be positioned on the proximal end 304 of the shunt 300 and on the portion of the deployment wire 110 distal to the shunt 300. The protective sleeve 1600 can then be heat shrunk 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.

[0236] 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 separate the portion of the protective sleeve 1600 extending above 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 is deployed, 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 catheter 104 and separate (split) so that the protective sleeve 1600 is separated from the shunt 300, allowing the shunt 300 to expand, and allowing the protective sleeve 1600 to retract into the catheter 104 when the shunt 300 is fully deployed.

[0237] like Fig.17As shown, the second customizable shunt delivery system 1500 includes a custom component 901 expansion element 1700, wherein the expansion element 1700 is configured to reduce friction and / or reduce damage to the shunt 300 when the shunt 300 moves relative to the elongated tubular component (e.g., the introducer sheath 120). The expansion element 1700 can be a self-expanding element or a controlled expansion element. In some embodiments, the self-expanding element can expand when leaving the catheter 104. In some embodiments, the controlled expansion element can expand when controlled to expand. The expansion element 1700 can 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 can vary to achieve the desired effect. For example, the strands can be thicker to provide an increased expansion force, or the strands can be thinner to provide increased flexibility. In some embodiments, the strands can include various materials, including, for example, DFT, which can be, for example, radiopaque. In some embodiments, the strands can include polymers, such as high tensile strength polymers. In some embodiments, the polymer used in the strands can advantageously increase friction between the dilation element 1700 and the shunt 300, thereby increasing the ability of the dilation element 1700 to retract the shunt 300. In embodiments where the strands include a polymer, the polymer can be treated and / or doped to be radiopaque.

[0238] Now refer to Fig.18 , a customizable shunt delivery system 1800 can be implemented without a tube. In such an embodiment, the custom component 901 does not include a cuttable tube attached distally as shown in the previous embodiment. In this alternative embodiment, the shunt 300 can extend a length 1802 beyond the distal end 124 of the introducer sheath 120. As further shown, in such an embodiment, the deployment wire 110 terminates within the introducer sheath 120 so that the deployment wire 110 does not extend distally beyond the distal end 124 of the introducer sheath 120. The physician can use a template (not shown) to measure the shunt 300 and cut 1804 the shunt 300 to a desired length 1806, and the shunt 300 can be retracted into the introducer sheath 120, as described in detail above. In such an embodiment, and as described above with respect to Figures 9 to 17 Discussed. The introducer sheath 120 can be of sufficient length to receive the entirety of the shunt 300, whether trimmed or untrimmed.

[0239] Now refer to Fig.19, a customizable flow delivery system 1900 includes a custom component 901, which includes a cuttable introducer sheath 1902. The cuttable introducer sheath 1902 includes an outer introducer sheath layer 1904 and an inner cuttable tube 1906 surrounding the shunt 300. In some methods, the outer introducer 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 introducer sheath layer 1904 can have a sufficient length to accommodate the entirety of the shunt 300, whether it is trimmed or untrimmed.

[0240] In various approaches, introducer sheath 1902 (eg, outer introducer sheath layer 1904 ) can taper distally. In other approaches, introducer sheath 1902 is not tapered and includes a constant diameter throughout the length of introducer sheath 1902 .

[0241] In an alternative embodiment not shown, the introducer sheath 1902 is a unitary, cuttable feature. For example, with an outer introducer sheath layer 1904 and an inner cuttable tube 1906 and as shown in FIG. Fig.19 Unlike the illustrated embodiment, introducer sheath 1902 comprises only a relatively thin and rigid material. In some embodiments, a single (integral), cuttable introducer sheath 1902 is semi-rigid to allow cutting of introducer sheath 1902, but rigid enough to engage with catheter hub 106 to allow transfer of shunt 300 from introducer sheath 1902 to catheter 104.

[0242] The outer introducer sheath layer 1904 defines an outer sheath layer lumen 1908, and the inner cuttable tube 1906 defines an inner tube lumen 1910. Fig.19 As shown, a shunt (such as shunt 300 described in detail above) is contained within inner tube lumen 1910 in a constrained position.

[0243] In various embodiments, system 1900 includes a deployment wire (such as deployment wire 110 described in detail above) extending into inner tube lumen 1910 and into the flow channel of shunt 300. As deployment wire 110 is advanced distally, shunt 300 is deployed from catheter 104 and begins to expand. This distal advancement continues until shunt 300 is fully deployed.

[0244] like Fig. 20 As shown, the inner cuttable tube 1906 and the flow diverter 300 can be cut 2002 to a desired length 2004 according to any of the aspects described in detail above. Figures 20 to 26As shown, the deployment wire 110 and / or deployment feature 118 terminate proximal to the distal end of the shunt 300, specifically, terminate proximal to the location where the shunt 300 may be cut 2002, so that cutting the shunt 300 will not cut the deployment wire 110 and / or deployment feature 118.

[0245] In some embodiments, the shunt 300 may be cut 2002 to a desired length 2004. For example, the inner cuttable tube 1906 may include graduated markings and / or be provided with a template having graduated markings to enable a physician to determine and measure the desired length 2004. Fig.21 As shown, after the cut 2002 is performed (eg, after cutting the inner cuttable tube 1906 and the flow diverter 300), the remaining portion 2006 may be discarded.

[0246] In some embodiments, Fig. 22 As shown, after cutting the inner cuttable tube 1906 and the shunt 300, the outer introducer sheath layer 1904 can be advanced 2200 distally to position the inner tube within the outer sheath layer so that the distal end of the inner tube is located within the lumen of the outer sheath layer. In another embodiment, the outer introducer sheath layer 1904 can be advanced 2200 distally to align the distal end 2202 of the outer introducer sheath layer 1904 with the distal end 2204 of the inner cuttable tube 1906 and / or the distal end 2206 of the shunt 300. In another embodiment, the inner cuttable tube 1906 and the shunt can be retracted into the outer introducer sheath layer 1904. In yet another embodiment, the inner cuttable tube 1906 and the flow diverter 300 are provided separately from the outer introducer jacket layer 1904, and after cutting, the trimmed inner cuttable tube 1906 and the flow diverter 300 are inserted into the outer introducer jacket 1904, as shown in the exemplary Figure 23-26 as shown in .

[0247] In such Fig.23 In the illustrated alternative embodiment, the custom component 901 includes an inner cuttable tube 1906 and an outer introducer jacket layer 1904. Fig.23 In an embodiment of the present invention, the inner cuttable tube 1906 and the flow diverter 300 are provided separately from the outer introducer jacket layer 1904. The inner cuttable tube 1906 includes one or more locking elements 2302. The one or more locking elements 2302 can be spaced around the periphery of the inner cuttable tube 1906. In an exemplary aspect, the inner cuttable tube 1906 includes at least two locking elements 2302 located on opposite sides of the inner cuttable tube 1906, as shown.

[0248] In some aspects, locking elements 2302 are located on outer introducer jacket layer 1904. One or more locking elements 2302 can be spaced around the perimeter of outer introducer jacket layer 1904. In an exemplary aspect, outer introducer jacket layer 1904 includes at least two locking elements 2302 located on opposite sides of outer introducer jacket layer 1904.

[0249] In various embodiments, after cutting the inner cuttable tube 1906 and the flow diverter 300, the trimmed inner cuttable tube 1906 and the flow diverter 300 are inserted into the outer introducer sheath 1904, and each locking element 2302 is wedged between the outer introducer sheath layer 1904 and the inner cuttable tube 1906 and is configured to lock the positioning of the outer introducer sheath layer 1904 relative to the inner cuttable tube 1906, as shown in FIG. Fig.24 shown.

[0250] In another embodiment, the inner cuttable tube 1906 and the shunt 300 are disposed in the outer introducer jacket layer 1904, and the distal ends of the inner cuttable tube 1906 and the shunt 300 extend beyond the distal end of the outer introducer jacket layer 1904 for cutting into a desired length. After cutting the inner cuttable tube 1906 and the shunt 300, the outer introducer jacket layer 1904 can be retracted so that the locking element 2302 is wedged into the outer introducer jacket layer 1904.

[0251] Alternatively, if Fig.25 As shown, the inner cuttable tube 1906 includes a flared end 2502 around the periphery of the proximal end 2504 of the inner cuttable tube 1906 .

[0252] In various embodiments, flared end 2502 is wedged between inner cuttable tube 1906 and outer introducer jacket layer 1904 and is configured to lock the position of outer introducer jacket layer 1904 relative to inner cuttable tube 1906 .

[0253] In various embodiments, after cutting the inner cuttable tube 1906 and the flow splitter 300, the trimmed inner cuttable tube 1906 and the flow splitter 300 are inserted into the outer introducer jacket 1904, and the flared end 2502 is wedged between the outer introducer jacket layer 1904 and the inner cuttable tube 1906 and is configured to lock the position of the outer introducer jacket layer 1904 relative to the inner cuttable tube 1906, as shown in FIG. Fig.26 shown.

[0254] In another embodiment, the inner cuttable tube 1906 and the flow diverter 300 are disposed in the outer introducer jacket layer 1904, and the distal ends of the inner cuttable tube 1906 and the flow diverter 300 extend beyond the distal end of the outer introducer jacket layer 1904 for cutting to a desired length. After cutting the inner cuttable tube 1906 and the flow diverter 300, the outer introducer jacket layer 1904 can be retracted over the flared end 2502 wedged into the outer introducer jacket layer 1904.

[0255] Fig. 27 Schematic diagram of an embodiment of a package for a customizable shunt delivery system. In various embodiments, unless otherwise specified herein, "package" can be interchangeably referred to as "shell". System 2700 includes package 2702, which is a primary package or a package that directly contacts a shunt delivery device 2704. Package 2702 can provide a backing (support) for supporting a shunt delivery device 2704 during transportation, storage or similar processes. For example, package 2702 can include a packaging tray. In particular, shunt delivery device 2704 can be removably coupled to package 2702 via a fastening member 2706 such as an adhesive, tie, clip, kink or the like. Package 2702 can be made of any material including but not limited to paper, plastic, corrugated cardboard, glass, metal, wood, foam, etc. or any combination thereof. Fastening member 2706 can be formed integrally with package 2702, and / or fastening member 2706 can be independently formed and used with package 2702.

[0256] According to various embodiments, the shunt delivery device 2704 may include an elongated tubular member 2708, such as an introducer, including any of the various embodiments described with respect to the other figures. For example, the elongated tubular member 2708 is a cuttable introducer. The shunt delivery device 2704 may include a shunt 2710 at least partially contained within the lumen of the elongated tubular member 2708 in a constrained configuration. Fig. 27 As shown, the shunt 2710 extends a first length L1 beyond the distal end of the elongated tubular member 2708. The shunt delivery device 2704 can include a deployment wire 2712 that extends into the lumen of the elongated tubular member 2708, and movement of the deployment wire 2712 relative to the elongated tubular member 2708 moves the shunt 2710 relative to the elongated tubular member 2708, as described in detail above.

[0257] The shunt delivery device 2704 can also include a peelable tube 2715 extending along and around the distal portion of the elongated tubular member 2708. The cuttable, peelable tube 2715 can include peelable FEP. In other embodiments, the cuttable, peelable tube 2715 can include any polymer tube 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 shunt 2710 is within the tube 2715, and the tube 2715 is cuttable, as described in detail above. The tube 2715 can be peelably removed from the elongated tubular member 2708.

[0258] like Fig. 27 As further shown in the figure, the package 2702 includes an integrated template 2714. The template 2714 may include scale marks 2716. The scale marks 2716 are configured to help cut the diverter 2710 into a desired length. The template 2714 can associate the scale marks 2716 with the expansion length of the diverter 2710. According to various embodiments, the scale marks 2716 can be spaced equidistantly. For example, the scale marks 2716 can be incremented along the scale. In other embodiments, the scale marks 2716 are spaced unequally. For example, various lengths can be predetermined and marked on the template 214. In some embodiments, the template 2714 can be directly printed on the package 2702. In other embodiments, the template 2714 is a sticker or insert connected to the package 2702 in a manner known in the art. The package 2702 can also include an alignment member 2718 arranged below the scale marks 2716. The alignment member 2718 can be a transparent tube, inner cavity, etc., which is used to align the shunt delivery device 2704 relative to the scale mark 2716, for example to ensure that the shunt delivery device 2704 is straight and parallel to the scale mark 2716, for accurately determining the desired length of the shunt 2710. Fig. 27 The inset image highlights the position of the alignment member 2718 relative to the scale marking 2716 and the cut aperture, slit or notch 2720.

[0259] In various embodiments, the alignment member 2718 can include a friction surface that engages the shunt delivery device 2704 for holding the shunt delivery device 2704 in place during cutting. Additionally, the alignment member 2718 frictionally engages the shunt delivery device 2704 for preventing a healthcare provider from inadvertently pulling the shunt delivery device 2704 out too far and too quickly (e.g., beyond a desired length).

[0260] According to at least some embodiments, the template 2714 including the graduation markings 2716 may not be a physical template. For example, the template 2714 may be projected onto, or otherwise visually disposed on, the package 2702 or a component thereof. The template 2714 may be visible to a medical professional via a microscope, cell phone, or other imaging device to assist in cutting the shunt 2710 into variable lengths.

[0261] The package 2702 including the template 2714 also includes a cutting aperture, slit, or notch 2720 extending through the package 2702. The cutting aperture, slit, or notch 2720 can be disposed proximal to the graduation markings 2716. In various embodiments, the cutting aperture, slit, or notch 2720 is a slot for scissors, blades, trimmers, shears, shears, or other cutting tools to be inserted therein for cutting the shunt delivery device 2704. In at least some embodiments, the cutting aperture, slit, or notch 2720 is sized and shaped to ensure alignment of the scissors within the cutting aperture, slit, or notch 2720, and accuracy of the cut (incision) relative to the graduation markings 2716. For example, the cutting aperture, slit, or notch 2720 is sized and shaped so that the scissors do not translate laterally (laterally) (e.g., thereby changing the length of the shunt delivery device 2704) once inserted into the cutting aperture, slit, or notch 2720. In other words, the width of the cutting aperture, slit or notch 2720 constrains the cutting tool to facilitate cutting the shunt at a desired location and / or at a desired angle. For example, according to various embodiments, a healthcare provider may cut the shunt at right angles (e.g., perpendicular) to the axis of the shunt. In other embodiments, a 45 degree angle may be desired.

[0262] In some embodiments, the package 2702 may also include an opening 2722 for retracting and advancing the shunt delivery device 2704 relative to the graduation marks 2716. The opening 2722 may be a gripping opening for a healthcare provider to grip through and laterally translate the shunt delivery device 2704 relative to the template 2714 and the graduation marks 2716. Once aligned, the healthcare provider may grip and hold the shunt delivery device 2704 through the opening 2722 to maintain the position of the shunt delivery device 2704 during cutting. In an exemplary embodiment, the opening 2722 is disposed proximal to the cutting orifice, slit, or notch 2720 such that the cutting orifice, slit, or notch 2720 is disposed between the opening 2722 and the alignment member 2718 and / or the graduation marks 2716.

[0263] The package 2702 may also include a pair of scissors 2724 (or any cutting tool) for performing the cutting. Thus, the size and shape of the cutting aperture, slit or notch 2720 may be designed to accommodate the scissors 2724 provided with the shunt delivery device 2704 to ensure precision of the cutting.

[0264] In various embodiments, the package 2702 can include a torquer 2726 and / or various other components for use with the shunt delivery device 2704. The package 2702 can include more or fewer components than those shown herein, as will be appreciated by one of ordinary skill in the art upon reading this disclosure.

[0265] Figure 28-30 Various embodiments of packaging for a customizable shunt delivery system are shown. Figure 28-30 An alternative configuration is shown with additional openings such as opening 2804 and opening 3004, which provide additional handles for carrying package 2702. Unless otherwise specified herein, the various elements may have similar form and function. Therefore, elements having similar form and function may be used interchangeably. Figure 28-30 Numbered similarly. Fig.28 A package 2802 is shown having an exemplary alternative cut aperture, slit, or notch 2806 extending through a bottom edge of the package 2802 . Fig.29 A simplified embodiment of a package 2902 that does not include any openings and a cut aperture, slit, or notch 2904 extending through a bottom edge of the package 2902 is shown. Fig.30 A package 3002 is shown that includes an additional opening 3004 and a flap 3006 for covering the tips of the scissors 2724. Fig.30 Also included is an exemplary alternative cut aperture, slit or notch 3008 extending through the bottom edge of the package 3002.

[0266] Fig.31 is a flow chart of a method for customizing a flow shunt delivery system. Method 3100 includes various embodiments for customizing a flow shunt for delivery into a neurovascular vessel to treat an aneurysm. Method 3100 includes providing a flow shunt system including any of the embodiments described in detail above. In particular, method 3100 includes using a flow shunt including a flow shunt as described in detail with respect to Figure 27-30The method 3100 includes step 3102. Step 3102 includes determining a desired length of a shunt of the shunt system using a template for customizing the shunt. Advantageously, a healthcare provider can determine the desired length prior to inserting the device and customize the device to the desired length. In various embodiments, the template associates the scale markings with the expanded length of the shunt. Various embodiments of the method 3100 describe a housing for a shunt that can be referred to with reference to Figure 27-30 Any of the packaging embodiments described.

[0267] Step 3104 includes advancing or retracting the tube relative to the housing to align the shunt with the template. Advancing or retracting the tube relative to the template may include positioning the shunt relative to scale marks spaced equidistantly along the template. The scale marks are configured to facilitate cutting the shunt to a desired length. Step 3104 may also include positioning the tube within an alignment member disposed below the scale marks for guiding the shunt relative to the scale marks and keeping the shunt stationary during cutting. An opening disposed at the proximal end of the scale marks in the housing may be used to advance or retract the tube relative to the template.

[0268] Step 3106 includes cutting the tube and the shunt using a cutting orifice, slit or notch arranged in the housing so that the shunt is cut to a desired length. In various embodiments, the cutting orifice, slit or notch is positioned between the opening and the scale mark. Cutting the shunt so that the shunt is the desired length may include cutting the tube provided with the shunt system. Cutting may also include using a cutting tool such as provided scissors to cut the shunt at a desired position and / or at a desired angle via a cutting orifice, slit or notch extending through the housing.

[0269] Step 3108 includes retracting the shunt into the elongated tubular member or advancing the elongated tubular member over the shunt. After cutting, the shunt can be completely retracted into the elongated tubular member. According to various embodiments, the shunt is retracted into the elongated tubular member by retracting the deployment wire connected to the shunt distally. In various embodiments, method 3100 may include step 3110, which includes moving the deployment wire relative to the elongated tubular member so that the shunt moves relative to the elongated tubular member. Advancing the elongated tubular member over the shunt may include keeping the deployment wire stationary while advancing the elongated tubular member.

[0270] In various embodiments, the method 3100 also includes step 3112, which includes separating the tube from the distal portion of the elongated tubular member. For example, after the shunt is retracted into the elongated tubular member, the tube can be separated from the distal portion of the elongated tubular member. According to various embodiments described herein, the tube can be separated from the distal portion of the elongated tubular member by peeling the tube from the distal portion of the elongated tubular member. As will be understood by those of ordinary skill in the art upon reading this disclosure, the method 3100 can load the shunt within the elongated tubular member into a microcatheter or similar device for insertion into a patient's blood vessel.

[0271] Figures 32A-32E Exemplary process steps for customizing a flow shunt using a flow shunt delivery system as described herein are shown. According to various embodiments, a healthcare provider can inject a contrast agent into a patient's blood vessel to perform fluorescent path mapping to measure and estimate the diameter of the target blood vessel and / or the neck width of the aneurysm. From this, the desired length of the flow shunt can be determined.

[0272] Fig.32A Preparation of a customizable shunt according to an embodiment of the present disclosure is shown. Fig.32A Shows about Fig.31 An embodiment of at least step 3104 of method 3100 is described. In particular, Fig.32A Device 3202 is shown positioned within opening 3204. Device 3202 can be translated 3206 so that the distal end of device 3202 is aligned 3208 with template 3211 and a scale mark corresponding to the desired length of the deployed shunt. For example, Fig.32A The device 3202 shown in FIG. 32 will have a final deployed 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. A medical professional can align the device 3202 and clamp the device 3202 through the opening 3204 for Fig.32B Cut 3210 shown.

[0273] Fig.32B The device 3202 is shown being cut 3210 to a desired length by inserting scissors 3212 through the cutting aperture, slit, or notch 3214, as described in detail above. Fig.32B Shows about Fig.31 An embodiment of at least step 3106 of method 3100 is described.

[0274] Fig.32CThe device 3202 is shown removed from the packaging to expose the sheath 3216. The medical professional should inspect the device 3202 and sheath 3216 for any damage. The device 3202 is retracted into the sheath 3216 by advancing 3220 the sheath 3216 forward while holding the deployment wire 3218 in place. The sheath 3216 can be advanced 3220 forward until the device 3202 is fully retracted into the sheath 3216. Fig.32C Shows at least about Fig.31 An embodiment of step 3108 of method 3100 is described.

[0275] Fig.32D The peelable tube 3222 is shown removed from the sheath 3216 into which the device 3202 is retracted by pulling one or more tabs 3224. Fig.32E The sheath 3216 into which the device 3202 is retracted is shown inserted into a rotary hemostatic valve (RHV) 3226. The distal tip 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 the device 3202 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 can include any of the embodiments described in the present disclosure.

[0276] Various embodiments of the present disclosure advantageously reduce the number of sizes that a healthcare provider must maintain in stock (e.g., reduce inventory). For example, rather than carrying multiple lengths of shunts for each diameter, a healthcare provider is able to provide 26 different lengths and diameters by stocking only 3 sizes of customizable shunt delivery systems as described herein and shown in Table 1 below. In other words, a healthcare provider must maintain, track, and store 26 different products, compared to 3 different products. Thus, embodiments of the customizable technology described herein provide the longest length for each desired diameter (which can be customized to a desired shorter length), thereby reducing the number of SKUs in inventory by 75% (from 158 SKUs to 26 SKUs, as shown in Table 1 below).

[0277] Table 1: Dimensional supply matrix of customizable shunts

[0278] In the foregoing description, the present invention has been described with reference to specific embodiments of the present invention, but those skilled in the art will recognize that the present invention is not limited thereto. The various features and aspects of the above invention may be used alone or in combination. In addition, without departing from the broader spirit and scope of this specification, the present invention may be used in any number of environments and applications outside those described herein. Therefore, this specification and the accompanying drawings should be considered illustrative, rather than restrictive. It should be recognized that the terms "including", "comprising" and "having" used herein are particularly intended to be understood as open-ended terms.

Claims

1. A system for customizing a flow diverter for delivery into a neurovascular vessel to treat an aneurysm, the system comprising: an elongated tubular member having a proximal end and a distal end, the elongated tubular member including an interior wall defining a lumen; a shunt including 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, wherein the shunt extends beyond the distal end of the elongated tubular member by a first length; a deployment wire extending within the lumen of the elongated tubular member, the deployment wire having a proximal end, a distal end, and a distal portion having a taper, the deployment wire including at least one deployment feature coupled to the shunt such that movement of the deployment wire relative to the elongated tubular member moves the shunt relative to the elongated tubular member; and A housing is coupled to the elongated tubular member and defines a template for customizing the flow diverter.

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

3. The system according to claim 1, characterized in that Also included is a tube extending along and around a 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 shunt is located within the tube, and wherein the tube is cuttable.

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

5. The system according to claim 4, characterized in that The deployment wire terminates in a proximal portion of the peelable tube.

6. The system according to claim 3, characterized in that The tube comprises a proximal end, a distal end, a first longitudinal portion having a first proximal pull tab, and a second longitudinal portion having a second proximal pull tab, each of the first longitudinal portion and the second longitudinal portion extending from the proximal end of the tube to the distal end of the tube, wherein the tube is removably removable from the distal portion of the elongated tubular member by separating the first longitudinal portion from the second longitudinal portion.

7. The system according to claim 3, characterized in that The flow divider can be cut to variable lengths within the tube.

8. The system according to claim 1, characterized in that The template includes equally spaced graduation markings, wherein the graduation markings are configured to facilitate cutting the shunt into variable lengths.

9. The system according to claim 8, characterized in that The template further comprises a cutting aperture, slit or notch extending through the housing, wherein the cutting aperture, slit or notch is arranged on a proximal side of the scale markings.

10. The system according to claim 1, characterized in that The template also includes a cutting aperture extending through the housing, wherein a width of the cutting aperture constrains a cutting tool to facilitate cutting the diverter at a desired location or at a desired angle.

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

12. The system according to claim 8, characterized in that The template also includes an alignment member disposed below the graduation mark for guiding the shunt relative to the graduation mark and holding the shunt stationary during cutting.

13. The system according to claim 8, characterized in that The template relates the scale markings to the deployed length of the diverter.

14. The system according to claim 1, characterized in that The at least one expansion feature comprises: a pusher extending along and around the distal portion of the deployment wire, the pusher having a distal end configured to engage the proximal end of the shunt; at least one friction tab positioned along a distal portion of the deployment wire extending distally beyond the distal portion of the pusher, wherein the at least one friction tab is located inside the diverter and engages a portion of the diverter; and A terminal coil extends distally from the at least one friction bump.

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

16. The system according to claim 1, characterized in that The housing includes a packaging tray.

17. A method for customizing a flow diverter for delivery into a neurovascular vessel to treat an aneurysm, the method comprising: A shunt delivery system is provided, the shunt delivery system comprising: an elongated tubular member having a proximal end and a distal end, the elongated tubular member including an interior wall defining a lumen; a shunt including 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, wherein the shunt extends beyond the distal end of the elongated tubular member by a first length; a deployment wire extending within the lumen of the elongated tubular member, the deployment wire having a proximal end, a distal end, and a distal portion having a taper, the deployment wire including at least one deployment feature coupled to the shunt; a housing coupled to the elongated tubular member and defining a template; and a tube extending along and around a distal portion of the elongated tubular member, wherein the tube extends a second length beyond the distal end of the elongated tubular member, wherein the distal end of the shunt is within the tube; determining a desired length of the shunt using the template; advancing or retracting the tube relative to the housing to align the flow diverter with the template; cutting the tube and the flow splitter so that the flow splitter is cut to the desired length; and The shunt is retracted into the elongated tubular member or the elongated tubular member is advanced over the shunt.

18. The method according to claim 17, characterized in that After retracting the shunt into the elongated tubular member or advancing the elongated tubular member over the shunt, the tube is detached from the distal portion of the elongated tubular member.

19. The method according to claim 18, 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.

20. The method according to claim 19, characterized in that The deployment wire terminates in a proximal portion of the tube and within the constrained shunt.

21. The method according to claim 17, characterized in that Also included is moving the deployment wire relative to the elongated tubular member such that the shunt moves relative to the elongated tubular member.

22. The method according to claim 17, characterized in that Advancing or retracting the tube relative to the template includes positioning the shunt relative to graduation markings equally spaced along the template, wherein the graduation markings are configured to facilitate cutting the shunt to the desired length.

23. The method according to claim 22, characterized in that Advancing or retracting the tube relative to the template includes positioning the tube within an alignment member disposed below the graduation markings for guiding the shunt relative to the graduation markings and holding the shunt stationary during cutting.

24. The method according to claim 22, characterized in that Advancing or retracting the tube includes adjusting the tube relative to the graduation markings via an opening extending through the housing and disposed proximal to the graduation markings.

25. The method according to claim 22, characterized in that Cutting the tube and shunt includes cutting the shunt at a desired location or at a desired angle using a cutting tool via a cutting aperture, slit, or notch extending through the housing.

26. The method according to claim 25, characterized in that The cutting aperture, slit or notch is positioned between the opening and the scale markings and constrains the cutting tool during cutting.

27. The method according to claim 22, characterized in that The template relates the scale markings to the deployed length of the diverter.

28. The method according to claim 22, characterized in that Retracting the shunt into the elongated tubular member includes distally retracting the deployment wire.

29. The method according to claim 22, characterized in that Advancing the elongated tubular member over the shunt includes maintaining the deployment wire stationary while advancing the elongated tubular member.

30. The method according to claim 17, characterized in that The housing includes a packaging tray.

31. A system for customizing a flow diverter for delivery into a neurovascular vessel to treat an aneurysm, the system comprising: a custom component having a proximal end and a distal end, the custom component including an interior wall defining an interior lumen; a flow diverter including a proximal end and a distal end, the flow diverter defining a flow passage extending therethrough, wherein the flow diverter is at least partially contained within the lumen of the custom component in a constrained configuration; a deployment wire extending into the lumen of the custom component and into the flow passage of the shunt, the deployment wire having a proximal end, a distal end, and a distal portion having a taper, the deployment wire including at least one deployment feature coupled to the shunt such that movement of the deployment wire relative to the custom component moves the shunt relative to the custom component, the deployment feature terminating in a proximal portion of the custom component; and A housing is coupled to the custom component and defines an integrated template for customizing the diverter.

32. The system according to claim 31, characterized in that The custom component includes an introducer sheath having a proximal end and a distal end.

33. The system according to claim 32, characterized in that The introducer sheath is cuttable.

34. The system according to claim 32, characterized in that The introducer sheath comprises an outer introducer sheath layer, and wherein, The custom component further includes an inner tube, wherein the inner tube is cuttable, and wherein the inner tube is insertable into an outer introducer jacket layer, and wherein the flow diverter is completely contained within the inner tube.

35. The system according to claim 32, characterized in that The shunt extends distally beyond the distal end of the introducer sheath.

36. The system according to claim 32, characterized in that The flow diverter is completely contained within the custom component.

37. The system according to claim 32, characterized in that The custom structure also includes a tube extending along and around a distal portion of the introducer sheath, wherein the shunt extends beyond a distal first length of the introducer sheath, wherein the tube extends beyond a distal second length of the introducer sheath, wherein the distal end of the shunt is within the tube, and wherein the tube is cuttable.

38. The system according to claim 37, characterized in that The tube comprises at least one of the following tubes: polymer tubes; Transparent tube; or Semi-rigid tube.

39. The system according to claim 37, characterized in that The tube is peelably removable from the distal portion of the introducer sheath.

40. The system of claim 37, wherein: The tube comprises a proximal end, a distal end, a first longitudinal portion having a first proximal pull tab, and a second longitudinal portion having a second proximal pull tab, each of the first longitudinal portion and the second longitudinal portion extending from the proximal end of the tube to the distal end of the tube, wherein the tube is removably removable from the distal portion of the introducer sheath by separating the first longitudinal portion from the second longitudinal portion.

41. The system according to claim 37, characterized in that The flow divider can be cut to variable lengths within the tube.

42. The system according to claim 37, characterized in that The template includes equally spaced graduation markings, wherein the graduation markings are configured to facilitate cutting the shunt into a desired length.

43. The system according to claim 42, characterized in that The template further comprises a cutting aperture, slit or notch extending through the housing, wherein the cutting aperture, slit or notch is arranged proximal to the scale markings.

44. The system according to claim 42, characterized in that The template also includes a cutting aperture extending through the housing, wherein the cutting aperture constrains a cutting tool to facilitate cutting the shunt at a desired location or at a desired angle.

45. The system according to claim 44, characterized in that The template also includes an opening extending through the housing for retraction and advancement of the tube relative to the graduation markings, wherein the opening is disposed proximal to the cutting orifice.

46. ​​The system of claim 42, wherein: The template also includes an alignment member disposed below the graduation mark for guiding the shunt relative to the graduation mark and holding the shunt stationary during cutting.

47. The system according to claim 42, characterized in that The template relates the scale markings to the deployed length of the diverter.

48. The system of claim 31, wherein: The at least one expansion feature comprises: a pusher extending along and around the distal portion of the deployment wire, the pusher having a distal end configured to engage the proximal end of the shunt; at least one friction tab positioned along a distal portion of the deployment wire extending distally beyond the distal portion of the pusher, wherein the at least one friction tab is located inside the diverter and engages a portion of the diverter; and A terminal coil extends distally from the at least one friction bump.

49. The system according to claim 31, characterized in that The shunt includes a self-expanding member having a proximal end and a distal end.

50. The system of claim 31, wherein: The housing includes a packaging tray.

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