Systems and methods for customizable flow diverter implants - Patents.com

Abstract

Neurovascular flow diverters and delivery systems, as well as methods for using them, are described herein. The system can include an introducer sheath, a catheter, a deployable flow diverter that can be housed in the introducer sheath or catheter, a core wire, and one or more deployment features coupled to the core wire and engaging the flow diverter. The system includes a tubular body extending along and around a distal portion of the introducer sheath. The tubular body is cuttable and houses the distal end of the flow diverter. The length of the flow diverter can be customized by cutting the tubular body and the flow diverter housed within the tubular body.

Description

[Background technology]

[0001]

[0001] An aneurysm is a bulge in a blood vessel caused by a weak blood vessel wall expanding and filling with blood. Aneurysms frequently occur where blood vessels branch. As blood passes through the weakened vessel, blood pressure causes the small area to bulge outward like a balloon. Aneurysms can form in any blood vessel in the body, but are most common in arteries that carry blood away from the heart, such as the aorta, or in the brain.

[0002]

[0002] Aneurysms that form inside the brain are called intracranial or cerebral aneurysms. Cerebral aneurysms typically cause noticeable symptoms only if they rupture, rupture, or leak. The rupture or rupture of a cerebral aneurysm causes a serious, life-threatening condition known as subarachnoid hemorrhage. Symptoms of such hemorrhage include sudden, severe headache, neck stiffness, nausea and vomiting, and pain when looking at light. Subarachnoid hemorrhage is life-threatening and a very serious medical emergency.

[0003]

[0003] Due to the significant risks posed by such hemorrhage, prevention, early detection, and safe and effective treatment of cerebral aneurysms are desirable. However, the complex nature of the neurovasculature, including the small diameter and tortuous anatomical structure of many blood vessels, makes such treatment difficult. In light of the risks posed by subarachnoid hemorrhage and the challenges in treating cerebral aneurysms, improved treatment systems and methods are desirable.

[0004]

[0004] Aneurysms arise from blood vessels with a wide range of diameters. Side branches and / or bifurcations increase the need to stock a variety of flow diverter options in various lengths. Hospitals must therefore maintain a wide variety of flow diverters in different lengths and diameters, resulting in many SKUs to manage. Maintaining a full range of sizes to optimally fit a flow diverter implant to a desired location is economically burdensome. It is desirable to improve the flexibility in flow diverter length selection while reducing the number of SKUs. Summary of the Invention

[0005] The present disclosure relates to systems, devices, and methods for customizing a flow diverter for delivery into a neurovasculature 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 a lumen. The flow diverter includes a proximal end and a distal end and defines a flow path extending through the flow diverter. The flow diverter is partially contained within the lumen of the elongated tubular member in a constrained configuration. The flow diverter extends a first length beyond the distal end of the elongated tubular member. A deployment wire extends within the lumen of the elongated tubular member and within the flow path of the flow diverter. The deployment wire includes a proximal end, a distal end, and a distal portion having a tapered portion. The deployment wire includes at least one deployment feature coupled to the flow diverter such that movement of the deployment wire relative to the elongated tubular member moves the flow diverter relative to the elongated tubular member. The tubular body extends along and around a distal portion of the elongate tubular member. The tubular body extends a second length beyond the distal end of the elongate tubular member. The distal end of the flow diverter is within the tubular body. The tubular body is severable.

[0006] The flow diverter is cuttable to a desired length within the tubing. In some embodiments, the tubing includes equally spaced markings along the distal end of the tubing for cutting the flow diverter and / or the tubing to a desired length. In some embodiments, the first length and the second length are equal.

[0007] In some embodiments, the deployment feature can include a pusher and at least one friction bump. Both the pusher and the at least one friction bump can be disposed along a distal portion of the deployment wire, with the at least one friction bump being disposed distal to the pusher. In some embodiments, the at least one friction bump is inside the flow path of the flow diverter and engages a portion of the flow diverter. In at least some approaches, a tip coil extends distally from the friction bump. The deployment wire can terminate before the distal end of the flow diverter such that the distal end of the deployment wire does not extend into the tubular body. The deployment wire does not extend distally beyond the distal end of the flow diverter.

[0008] In some embodiments, the deployment feature includes at least one friction bump. The at least one friction bump may be among a plurality of friction bumps. The plurality of friction bumps are evenly spaced apart.

[0009] In some embodiments, the system includes a template having a top, a bottom, a front, a back, a first side, and a second side. The template includes evenly spaced graduations along a bottom of at least one of the front side of the template and the back side of the template. The graduations are configured to assist in cutting the flow diverter to a desired length. The template correlates the graduations to a deployed length of the flow diverter.

[0010] In at least some embodiments, the template further includes a cutting notch extending through a bottom portion of the template, the cutting notch being adjacent to one of the first and second sides, and the scale being disposed between the cutting notch and the other of the first and second sides.

[0011] The template may include a first set of graduations along a bottom of a front surface of the template and a second set of graduations along a bottom of a back surface of the template, wherein one of the front surface of the template and the back surface of the template is configured for a right-handed user and the other of the front surface of the template and the back surface of the template is configured for a left-handed user.

[0012] The tubular body 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 tubular body to the distal end of the tubular body. The tubular body is peelable and removable from the distal portion of the elongate tubular member by separating the first longitudinal portion from the second longitudinal portion. In some embodiments, the tubular body comprises a polymeric tube. In some embodiments, the tubular body is transparent so that the flow diverter is visible within the tubular body.

[0013] In some embodiments, the system includes a protective sleeve extending around and along the proximal end of the flow diverter, the protective sleeve configured to reduce friction and / or reduce damage to the flow diverter as the flow diverter moves relative to the elongate tubular member.

[0014]

[0014] The flow diverter may include a self-expanding member having a proximal end and a distal end. The self-expanding member includes a braid.

[0015] In various embodiments, the system can include an introducer sheath, a catheter, a deployable flow diverter that can be housed in the introducer sheath or the catheter, a core wire, and one or more deployment features coupled to the core wire and engaging the flow diverter. The core wire can be tapered. The deployment features can include a pusher, one or more frictional bumps, one or more deployment coils, a self-expanding element, a support coil, a tip coil, and / or an atraumatic tip. These deployment features can be arranged in different combinations to facilitate deployment of the flow diverter.

[0016] One aspect of the present disclosure relates to systems, devices, and methods for customizing a flow diverter for delivery into a neurovasculature to treat an aneurysm. The system can include an elongate tubular member having a proximal end and a distal end. The elongate tubular member includes an inner wall defining a lumen. The flow diverter includes a proximal end and a distal end. The flow diverter is partially contained within the lumen of the elongate tubular member in a constrained configuration. The flow diverter extends a first length beyond the distal end of the elongate tubular member. A deployment wire extends within the lumen of the elongate tubular member. The deployment wire includes a proximal end, a distal end, and a distal portion having a tapered portion. The deployment wire includes at least one deployment feature coupled to the flow diverter such that movement of the deployment wire relative to the elongate tubular member moves the flow diverter relative to the elongate tubular member. The system can include a template having a top, a bottom, a first side, a second side, a front surface, and a back surface. The template includes evenly spaced graduations along the bottom, which are configured to assist in cutting the flow distributor to the desired length.

[0017] The flow diverter is cuttable. In some embodiments, the flow diverter comprises a braided member including a plurality of strands. The strands can comprise wire having a diameter of about 0.0008 inches. In some embodiments, the wire comprises stretch-filled tubing (DFT).

[0018] In at least some embodiments, the template further includes a cutting notch extending through a bottom portion of the template, the cutting notch being adjacent to one of the first and second sides, and the scale being disposed between the cutting notch and the other of the first and second sides.

[0019] The template includes a formula configured to assist in cutting the flow diverter to a desired length. The formula may be printed along the top of the template. The scale and formula may be printed on each of the front and back sides of the template. In some embodiments, the template correlates the scale to the deployed length of the flow diverter.

[0020] The template may include a first set of graduations along a bottom of a front surface of the template and a second set of graduations along a bottom of a back surface of the template, wherein one of the front surface of the template and the back surface of the template is configured for a right-handed user and the other of the front surface of the template and the back surface of the template is configured for a left-handed user.

[0021] The system may further include a tubular body extending along and around a distal portion of the elongate tubular member. The tubular body extends beyond the distal end of the elongate tubular member. The distal end of the flow diverter is housed within the tubular body. The tubular body is peelable and removable from the distal portion of the elongate tubular member.

[0022] The tubular body 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 tubular body to the distal end of the tubular body. The tubular body is peelable and removable from the distal portion of the elongate tubular member by separating the first longitudinal portion from the second longitudinal portion.

[0023] In various embodiments, the system can include an introducer sheath, a catheter, a deployable flow diverter that can be housed in the introducer sheath or the catheter, a core wire, and one or more deployment features coupled to the core wire and engaging the flow diverter. The core wire can be tapered. The deployment features can include a pusher, one or more frictional bumps, one or more deployment coils, a self-expanding element, a support coil, a tip coil, and / or an atraumatic tip. These deployment features can be arranged in different combinations to facilitate deployment of the flow diverter.

[0024] One aspect of the present disclosure includes a method for customizing a flow diverter for delivery into a neurovasculature to treat an aneurysm. The method includes determining a desired length of a flow diverter for a flow diverter system. The system includes an elongate tubular member having proximal and distal ends and an inner wall defining a lumen. The system includes a flow diverter including the proximal and distal ends. The flow diverter is partially contained within the lumen of the elongate tubular member in a constrained configuration. The flow diverter extends a first length beyond the distal end of the elongate tubular member. The system includes a deployment wire extending within the lumen of the elongate tubular member. The deployment wire includes a proximal and distal end. The deployment wire includes at least one deployment feature coupled to the flow diverter such that movement of the deployment wire relative to the elongate tubular member moves the flow diverter relative to the elongate tubular member. The system further includes a tubular body coupled to a distal portion of the elongate tubular member, the tubular body extending distally a second length beyond the distal end of the elongate tubular member, and the distal end of the flow diverter residing within the tubular body. The method includes cutting the flow diverter and the tubular body so that the flow diverter is of a desired length.

[0025]

[0025] The method includes retracting the flow diverter within the elongate tubular member. The flow diverter can be retracted within the elongate tubular member by distally retracting the deployment wire.

[0026] In some embodiments, the method further includes separating the tubular body from the distal portion of the elongate tubular member after the flow diverter has been retracted into the elongate tubular member. The tubular body is separated from the distal portion of the elongate tubular member after the flow diverter has been retracted into the elongate tubular member.

[0027] The tubular body 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 tubular body to the distal end of the tubular body. The tubular body is peelable and removable from the distal portion of the elongate tubular member by separating the first longitudinal portion from the second longitudinal portion. Peeling the tubular body from the distal portion of the elongate tubular member includes separating the first longitudinal portion from the second longitudinal portion.

[0028] The method further includes loading the flow diverter into the elongated tubular member.

[0029] One aspect of the present disclosure includes a method for customizing a flow diverter for delivery into a neurovasculature to treat an aneurysm. The method includes using a template to determine a desired length of a flow diverter for a flow diverter system. The system includes an elongate tubular member having proximal and distal ends and an inner wall defining a lumen. The system includes a flow diverter including the proximal and distal ends. The flow diverter is partially contained within the lumen of the elongate tubular member in a constrained configuration. The flow diverter extends a first length beyond the distal end of the elongate tubular member. The system includes a deployment wire extending within the lumen of the elongate tubular member. The deployment wire includes a proximal and distal end. The deployment wire includes at least one deployment feature coupled to the flow diverter such that movement of the deployment wire relative to the elongate tubular member moves the flow diverter relative to the elongate tubular member. The system further includes a tubular body coupled to a distal portion of the elongate tubular member, the tubular body extending distally a second length beyond the distal end of the elongate tubular member, and the distal end of the flow diverter residing within the tubular body. The method includes cutting the flow diverter and the tubular body so that the flow diverter is of a desired length.

[0030] The template includes a top, a bottom, a front, a back, a first side, and a second side. The template includes evenly spaced graduations along a bottom of at least one of the front and back sides of the template. The graduations are configured to assist in cutting the flow distributor to a desired length.

[0031] In at least some embodiments, the template further includes a cut notch extending through a bottom portion of the template. The cut notch is proximate one of the first side and the second side. The scale is disposed between the cut notch and the other of the first side and the second side.

[0032] The template may include a first set of graduations along a bottom of a front surface of the template and a second set of graduations along a bottom of a back surface of the template, wherein one of the front surface of the template and the back surface of the template is configured for a right-handed user and the other of the front surface of the template and the back surface of the template is configured for a left-handed user.

[0033] The template includes a formula configured to assist in cutting the flow diverter to a desired length. The formula may be printed along the top of the template. The scale and formula may be printed on the front and back of the template, respectively. In some embodiments, the template correlates the scale to the deployed length of the flow diverter.

[0034]

[0034] The method includes retracting the flow diverter within the elongate tubular member. The flow diverter can be retracted within the elongate tubular member by distally retracting the deployment wire.

[0035] The flow diverter system includes a tubular body coupled to a distal portion of the elongate tubular member. The tubular body extends a second length distally beyond the distal end of the elongate tubular member. A distal end of the flow diverter can be within the tubular body.

[0036] In some embodiments, cutting the flow diverter to the desired length includes cutting the tubing.

[0037] In some embodiments, the method further includes separating the tubular body from the distal portion of the elongate tubular member. The tubular body is separated from the distal portion of the elongate tubular member after the flow diverter is retracted into the elongate tubular member. The tubular body is separated from the distal portion of the elongate tubular member by peeling the tubular body from the distal portion of the elongate tubular member.

[0038] The tubular body 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 tubular body to the distal end of the tubular body. The tubular body is peelable and removable from the distal portion of the elongate tubular member by separating the first longitudinal portion from the second longitudinal portion. Peeling the tubular body from the distal portion of the elongate tubular member includes separating the first longitudinal portion from the second longitudinal portion.

[0039]

[0039] The method further includes loading the flow diverter into the elongated tubular member.

[0040] 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 explanation of the drawings]

[0041] [Figure 1] FIG. 1 illustrates an embodiment of a system for positioning a flow diverter. [Figure 2] FIG. 10 illustrates an introducer sheath and delivery of a flow diverter through the introducer sheath to a catheter. [Figure 3] FIG. 13 illustrates the constrained delivery state of the flow diverter. [Figure 4] FIG. 10 is a diagram showing the expanded deployed state of the flow divider. [Figure 5] FIG. 10 is an enlarged view of the braid of the current shunt. [Figure 6] FIG. 1 is a diagram of a flow diverter delivery system. [Figure 7] FIG. 1 illustrates a partially deployed configuration of the delivery system. [Figure 8] FIG. 10 is another view showing the delivery system in a partially deployed configuration. [Figure 9] FIG. 1 illustrates an embodiment of a customizable flow diverter delivery system. [Figure 10] FIG. 10 illustrates the desired length of one embodiment of a customizable flow diverter delivery system. [Figure 11] FIG. 10 illustrates one embodiment of a customizable flow diverter delivery system after the tubing and flow diverter have been cut to a desired length. [Figure 12] FIG. 10 shows removal of the tubular body after the flow diverter has been retracted into the sheath / catheter. [Figure 13] FIG. 10 illustrates one embodiment of a customizable flow diverter delivery system after the tubing has been removed. [Figure 14] FIG. 1 illustrates an introducer sheath and delivery of a flow diverter to a catheter through the introducer sheath. [Figure 15] FIG. 1 illustrates one embodiment of a customizable flow diverter delivery system. [Figure 16] FIG. 1 illustrates one embodiment of a customizable flow diverter delivery system with a protective sleeve. [Figure 17] 1A-1C illustrate an embodiment of a customizable flow diverter delivery system with self-expanding elements. [Figure 18] FIG. 1 illustrates one embodiment of a customizable flow diverter delivery system. [Figure 19] FIG. 1 illustrates one embodiment of a customizable flow diverter delivery system. [Figure 20] FIG. 1 illustrates one embodiment of a customizable flow diverter delivery system. [Figure 21] FIG. 1 illustrates one embodiment of a customizable flow diverter delivery system. [Figure 22] FIG. 1 illustrates one embodiment of a customizable flow diverter delivery system. [Figure 23] FIG. 1 illustrates one embodiment of a customizable flow diverter delivery system. [Figure 24] FIG. 1 illustrates one embodiment of a customizable flow diverter delivery system. [Figure 25]FIG. 1 illustrates one embodiment of a customizable flow diverter delivery system. [Figure 26] FIG. 1 illustrates one embodiment of a customizable flow diverter delivery system. DETAILED DESCRIPTION OF THE INVENTION

[0042]

[0067] The present invention relates to a flow diverter, a flow diverter delivery system, and a method for delivering a flow diverter. A flow diverter is a device that can be placed within a vasculature and divert flow away from a portion of the vasculature covered by the flow diverter. As used herein, a flow diverter can be any device that can be placed within a patient's blood vessel and divert a portion of blood flow through that vessel. In some embodiments, the flow diverter can be an endovascular prosthesis used to treat intracranial aneurysms. The flow diverter can include, for example, a stent, such as a laser-cut stent, a braided member, or the like. In some embodiments, the flow diverter can include a braided member including a plurality of braided wires, which can be, for example, cobalt chromium, nitinol, or the like.

[0043]

[0068] Flow diverters can be used to treat intracranial aneurysms, including, for example, saccular aneurysms, particularly unruptured saccular aneurysms, or fusiform or circumferential aneurysms. The flow diverter can be placed within a blood vessel to extend across and cover the aneurysm. The flow diverter can divert blood flow away from the aneurysm, thereby reducing blood flow within the aneurysm. Over time, reduced blood flow can lead to the aneurysm closing and healing.

[0044]

[0069] While simple in principle, the reality of accurately placing a flow diverter in the often small and tortuous cerebral vasculature can be quite complex. Therefore, it is desirable for the device to have high flexibility to allow passage through this vasculature. Furthermore, such a device should be capable of accurately placing the flow diverter within the vessel. Accurate placement of the flow diverter can include adjusting the position of the flow diverter, and in some embodiments, placing multiple flow diverters in a fully or partially overlapping manner. The use of multiple, partially or fully overlapping flow diverters can be particularly beneficial when addressing multiple closely spaced or larger aneurysms. In some embodiments, multiple flow diverters can be placed in a fully or partially overlapping manner to further reduce blood flow to the aneurysm.

[0045]

[0070] Neurovasculature has a wide range of lengths and diameters. Furthermore, the diameter of a neurovasculature varies along its length, typically decreasing distally. Hospitals must stock flow diverters of various lengths to accommodate different sizes of neurovasculature, side branches, and / or bifurcations. Furthermore, hospitals must stock flow diverters of different diameters, resulting in a large number of SKUs to manage. Such a large, diverse supply and inventory system, including a full range of sizes to optimally fit a flow diverter to a desired location, is economically burdensome to maintain. Furthermore, the need to have multiple flow diverters of different diameters and lengths complicates surgery, as the best-fitting flow diverter must be placed at each location. To ensure the best fit, surgeons must have multiple flow diverters of the correct length and diameter in the operating room, which can lead to waste. Furthermore, because flow diverters are provided in fixed lengths, surgeons may be forced to use flow diverters of suboptimal lengths. Various aspects of the present disclosure improve flexibility in flow diverter length selection, particularly allowing for customization of flow diverter lengths. This customization reduces the number of SKUs hospitals must stock, reduces waste, and increases the likelihood of using the right size diverter.

[0046]

[0071] Various embodiments of the present disclosure provide a customizable flow diverter. Conventional designs provide a flow diverter packaged within the introducer sheath of a delivery system, where a delivery wire extends beyond the implant, thereby fixing the length of the flow diverter. The embodiments disclosed herein do not have a deployment wire extending beyond the length of the flow diverter. The embodiments of the present disclosure provide a customizable system that allows the user to adjust the length of the implant to meet the specifications of the treatment site. The embodiments presented herein provide a delivery system that allows the user to trim the flow diverter to a desired length without compromising the delivery system, since the deployment wire does not extend distally beyond the distal end of the flow diverter.

[0047]

[0072] Additionally, the customizable flow diverter delivery system of the present disclosure advantageously includes a deployment mechanism that allows for customization. For example, in conventional designs, the deployment mechanism is coupled to and / or configured for use with the aforementioned deployment wire that extends distally beyond the distal end of the flow diverter. Such mechanisms preclude customization at the distal end of the flow diverter because there is no disposable material up to and including the distal end of the flow diverter. The customizable flow diverter delivery system of the present disclosure overcomes these obstacles by providing a proximally located deployment wire and deployment mechanism, leaving the flexibility to adjust the length of the distal end of the flow diverter.

[0048]

[0073] The embodiments disclosed herein offer several beneficial improvements. These include, for example, a reduced system size. The reduced system size allows for access and treatment of smaller vessels. This expands the range of treatable aneurysms and therefore improves patient outcomes. Additionally, the embodiments disclosed herein improve the flexibility of the system, which also expands the range of treatable aneurysms.

[0049]

[0074] 1 , a diagram of one embodiment of a system 100 for placing a flow diverter is shown. The system 100 can include a catheter system 102. The catheter system 102 can be configured to provide access to a patient's vasculature, particularly the patient's neurovasculature. In some embodiments, the catheter system 102 can be configured to be inserted into the patient's vasculature at an access point and passed through the patient's vasculature to a location where the flow diverter is to be delivered.

[0050]

[0075] The catheter system 102 can include a proximal end 130 and a distal end 132. The catheter system 102 can include an elongated catheter 104 defining a lumen extending through all or a portion of the catheter 104. Thus, in some embodiments, the catheter system 102 can include an elongated tubular member defining a lumen, specifically, an elongated tubular member including an inner wall defining the lumen. The catheter 104 can include a variety of sizes, materials, and / or manufacturers. In some embodiments, the catheter 104 is flexible and can include a biocompatible material. The catheter 104 can include, for example, an elongated tubular member and can have, for example, a diameter of 0.005 inches, 0.01 inches, 0.017 inches, 0.02 inches, 0.021 inches, 0.027 inches, 0.03 inches, or any other or intermediate diameter.

[0051]

[0076] The catheter 104, which may include a catheter hub 106, can be coupled to an access device 108. The access device 108 can be a valve, such as, for example, a rotary hemostatic valve (RHV) 109. The access device 108 can be a hemostatic valve that can be configured to provide selectable and / or controllable access to a lumen of the catheter 104. In some embodiments, the access device 108 can be configured to minimize blood loss while the catheter 104 is in use. The access device 108 can be sized for use in connection with the catheter 104.

[0052]

[0077] The system 100 for deploying a flow diverter can include a deployment wire 110 having 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 flow diverter into and / or through the catheter system 102, specifically into and / or through the lumen of the catheter 104. In some embodiments, the proximal end 111 of the deployment wire 110 can be configured to be controlled to control the advancement of the flow diverter into and / or through the catheter system 102, and the distal end 113 can be coupled to and / or configured to interact with the flow diverter to advance the flow diverter into and / or through the catheter system 102.

[0053]

[0078] The deployment wire 110 can include a core wire 112. The core wire 112 can include an elongated wire that can be flexible to allow passage through the vasculature. In some embodiments, the core wire 112 can include a unitary reinforced delivery wire. The core wire 112 can include a variety of shapes and sizes and can be made from a variety of materials. The core wire 112 can include a biocompatible wire, which can be, for example, a nitinol wire.

[0054]

[0079] Core wire 112 can include a proximal portion 114 and a distal portion 116. Compared to distal portion 116, proximal portion 114 is relatively closer to proximal end 111 of deployment wire 110. Similarly, compared to proximal portion 114, distal portion 116 is relatively closer to distal end 113 of deployment wire 110.

[0055]

[0080] During a procedure, the distal end of the distal portion 116 can be inserted into the patient first. The core wire 112 can include a variety of 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 variable diameter along its length. In some embodiments, the core wire 112 comprises a tapered core wire 112, which includes a portion of 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 tip. The tapered portion can be, for example, all or part of the distal portion 116 of the core wire 112. In some embodiments, the portion of the core wire 112 that has a reduced diameter may be, for example, up to the distal 5% of the core wire 112, up to the distal 10% of the core wire 112, up to the distal 15% of the core wire 112, up to the distal 20% of the core wire 112, up to the distal 25% of the core wire 112, up to the distal 30% of the core wire 112, up to the distal 40% of the core wire 112, up to the distal 50% of the core wire 112, or any other portion or intermediate portion.

[0056]

[0081] In some embodiments, for example, the core wire 112 can have a length that is the same as or longer than the catheter system 102. The maximum outer diameter of the core wire 112 can be, for example, up to 0.1 inches, i.e., 0.05 inches, 0.04 inches, 0.03 inches, 0.02 inches, 0.015 inches, 0.01 inches, 0.005 inches, or any other value or intermediate value.

[0057]

[0082] The deployment wire 110 can include one or several deployment features 118. The deployment feature 118 can be disposed on the distal portion 116 of the core wire 112. The deployment feature 118 can include one or several features configured to interact with the flow diverter to allow the core wire 112 to control and / or manipulate the core wire 112. In some embodiments, the deployment feature can be configured to allow the core wire 112 to interact with the flow diverter to push the flow diverter into a lumen of the catheter 104 and / or move the flow diverter into and / or through a lumen of the catheter 104. In some embodiments, the deployment feature 118 can be configured to couple the flow diverter to the core wire 112 so that the flow diverter can be deployed from the catheter 104 into the patient. Details of the deployment feature 118 are described in more detail below.

[0058]

[0083] The flow diverter 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 inner wall defining a lumen extending therethrough.

[0059]

[0084] The introducer sheath 120 can be configured to hold the flow diverter before the flow diverter is inserted into the catheter system 102, specifically into the proximal end 130 of the catheter system 102. In some embodiments, the introducer sheath 120 can be configured to hold the flow diverter within its lumen. In some embodiments, as shown in FIG. 2A , the introducer sheath 120 holds the flow diverter within its lumen, and the deployment wire 110 is at least partially inserted into the lumen of the introducer sheath, coupling the deployment feature 118 of the deployment wire 110 with the flow diverter. As shown in FIG. 2B , the introducer sheath 120, specifically the distal end 124 of the introducer sheath 120, can be inserted through the access device 108 into the catheter 104, specifically into the catheter hub 106 of the catheter 104. In some embodiments, this insertion may include inserting the combination of an introducer sheath containing the flow diverter and deployment wire 110 into the catheter system 102, and specifically into the catheter 104.

[0060]

[0085] In some embodiments, the introducer sheath 120 can be advanced through the access device 108 and into the catheter 104 in the direction indicated by arrow 202. The core wire 112 can be inserted into the catheter system 102, specifically into the proximal end 130 of the catheter system 102. In some embodiments, the core wire 112 can be inserted into the introducer sheath 120, and the introducer sheath 120 can be inserted into the catheter system 102.

[0061]

[0086] The core wire 112 can be advanced through the introducer sheath 120 in the direction indicated by arrow 202, and the flow diverter can be advanced from the introducer sheath 120 into the catheter 104. After the flow diverter has been advanced into the catheter 104, the introducer sheath 120 can be retracted from the catheter 104 and access device 108 in the direction indicated by arrow 204.

[0062]

[0087] 3 and 4, a perspective view of one embodiment of a flow diverter 300 is shown. The flow diverter 300 can be, for example, a stent, a braided member, or the like. In some embodiments, the flow diverter can include an elongated braided member including a plurality of braided wires, which can be, for example, cobalt chrome, nitinol, or the like. In some embodiments, the flow diverter 300 can include a tubular member defined by an outer wall 302 having a first end 304, also referred to herein as the proximal end 304, and a second end 306, also referred to herein as the distal end 306. As seen in FIG. 4, the elongated tubular member of the flow diverter 300 can have a central axis 400 and can extend from the proximal end 402 to the distal end 404. A flow path 406, also referred to herein as the flow diverter lumen 406, can be defined by an inner wall 403 of the flow diverter 300 and can extend through the flow diverter 300 along the central axis 400. In some embodiments, the proximal end 402 and the distal end 404 can each include an opening to the flow channel 406 so that fluid, specifically blood, can flow through the flow channel 406, entering the proximal end 402 and exiting the distal end 404.

[0063]

[0088] The flow diverter 300 can be in a compressed state, also referred to herein as a constrained state, delivery configuration, or constrained configuration, as shown in FIG. 3 , or in an expanded state, also referred to herein as an unconstrained state and / or unconstrained configuration, as shown in FIG. 4 . In the constrained configuration, the flow diverter 300 can have a compressed outer diameter 308; in other words, the flow diverter 300 in the constrained configuration is not fully expanded and / or is constrained so that it cannot fully expand. In some embodiments, the flow diverter 300 can be held in a constrained state when the flow diverter is contained and / or constrained within the introducer sheath 120 and / or catheter 104. In some embodiments, the flow diverter can be sized to have a compressed outer diameter 308 that fits within the introducer sheath 120 and / or catheter.

[0064]

[0089] In an unconstrained state, the flow diverter 300 can have an expanded outer diameter 408. The expanded diameter 408 can be larger than the compressed outer diameter 308. In some embodiments, the flow diverter 300 can be self-expanding, such that when the flow diverter 300 exits the catheter 104 and enters the patient's blood vessel, the flow diverter 300 automatically expands to match the inner diameter of the blood vessel. In some embodiments, the flow diverter 300 can be made in a variety of sizes for use with different sized blood vessels. In some embodiments, the expanded diameter 408 of the flow diverter 300 can be 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, 0.5 mm to 10 mm, 1 mm to 8 mm, 1.25 mm to 6.5 mm, or any other or intermediate diameter or range of diameters.

[0065]

[0090] The flow diverter can be deployed within a patient's blood vessel using the system 100 of Figure 1. Deployment can include the use of deployment features 118 on the deployment wire 110.

[0066]

[0091] In some embodiments, the flow diverter 300 can include a braided member. One embodiment of a flow diverter braid is shown in detail at 450 in FIG. 5. As seen in FIG. 5, the braided member can be made from a plurality of wires 452, also referred to herein as strands 452. These wires 452 can include a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, for example, the diameter of the wires 452 can be from about 0.0002 inches to about 0.01 inches, from about 0.0005 inches to about 0.005 inches, from about 0.0007 inches to about 0.002 inches, about 0.0008 inches, about 0.001 inches, about 0.0012 inches, or any other or intermediate diameter.

[0067]

[0092] In some embodiments, the wire 452 can comprise various types and / or materials. In some embodiments, the wire 452 can comprise a stretch-filled tubing (DFT). In some embodiments, the DFT can comprise an inner core and an outer tube. The inner core and the outer tube can each comprise a material, which can be the same material or different materials. In some embodiments, one or both of the inner core and the outer tube can be radiopaque. In some embodiments, for example, the outer tube can provide strength to the braided member of the flow diverter 300, and the inner core can be radiopaque.

[0068]

[0093] In some embodiments, for example, the inner core can include platinum and / or a platinum alloy, which can include, for example, 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, for example, stainless steel, nitinol, a cobalt-chromium alloy such as 35N LT alloy, etc.

[0069]

[0094] In some embodiments, the wire can be cold worked, specifically having a minimum cold work of at least 30%, at least 60%, about 60.8%, or any other or intermediate amount of cold work. In some embodiments, the wire 452 can have a minimum tensile strength of at least about 50,000 PSI, at least about 100,000 PSI, at least 200,000 PSI, about 235,000 PSI, about 250,000 PSI, or any other or intermediate minimum tensile strength value.

[0070]

[0095] The braid of the flow diverter 300 can include any desired number of strands. In some embodiments, the braid of the flow diverter 300 can include about 10 to about 200 strands, about 20 to about 150 strands, about 40 to about 100 strands, about 64 strands, or any other or intermediate number of strands. As seen in FIG. 5, the wires 452 can include wires 452-A extending in a first direction and braided with wires 452-B extending in a second direction. The wires 452 can be braided in any desired manner, including, for example, a braid of one wire over another and one wire under another, a braid of one wire over two wires and one wire under two wires, or any other braid.

[0071]

[0096] 6, there is shown a schematic diagram of a delivery system 500. The delivery system 500 can include a flow diverter 300 that can be held in a constrained configuration within a lumen 502 defined by an inner wall 504 of the catheter 104 or introducer sheath 120.

[0072]

[0097] The lumen 502 can include a variety of shapes and sizes. In some embodiments, the lumen 502 can include a cylindrical lumen, and specifically can have a circular cross-section. The size of the lumen 502 can be defined by an inner diameter in some embodiments. 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.

[0073]

[0098] The deployment wire 110 can extend at least partially through both the flow diverter 300 and the lumen 502 of the catheter 104 or introducer sheath 120. The deployment wire 110 can include a core wire 112 that can extend within the lumen 502 of the catheter 104 and / or introducer sheath 120, and a deployment feature 118 that is shown entirely within the lumen 502 of the catheter 104 and / or introducer sheath 120.

[0074]

[0099] In the embodiment shown in FIG. 6 , the deployment feature 118 includes a pusher 505, such as a pusher coil 506, that wraps around a portion of the core wire 112, and one or more frictional bumps 508. These one or more frictional bumps may include, for example, a first frictional bump 508-A, a second frictional bump 508-B, and a third frictional bump 508-C. In some embodiments, these one or more frictional bumps 508 may include multiple frictional bumps 508 that may be distributed along a portion of the deployment wire 110, and specifically, along a portion of the core wire 112. In some embodiments, the frictional bumps 508 may be disposed inside the flow path 406 of the flow diverter 300 and may engage the flow diverter 300, as shown in FIG. 6 .

[0075]

[0100] In some embodiments, the one or more friction bumps 508 can include a single friction bump. This single friction bump can extend, for example, from the pusher 505 to the location of the third friction bump 508-C in FIG. 6. Thus, instead of having multiple friction bumps 508 along the length of the core wire 112, a single friction bump 508, also referred to herein as a friction pad, can extend along all or part of the length of the core wire 112. In some embodiments, this single friction pad can extend beyond the proximal portion of the flow diverter 300 to the distal portion of the flow diverter 300.

[0076]

[0101] In some embodiments, a single long friction pad can provide better engagement with the flow diverter 300. However, embodiments having multiple spaced friction bumps can improve flexibility of the core wire 112. In some embodiments, the single long friction pad can include the same material as the friction bumps 508, and in some embodiments, the single long friction pad can include a material configured to improve flexibility.

[0077]

[0102] Deployment feature 118 further includes a support coil 510, also referred to herein as support coil 510, wrapped around a portion of core wire 112, particularly a distal portion of core wire 112, which may be tapered. As seen in FIG. 6 , support coil 510 may extend at least partially through pusher coil 506, along core wire 112 between frictional bumps 508, and distally beyond the last frictional bump 508, i.e., beyond third frictional bump 508-C as shown in FIG. 6 . Specifically, as seen in FIG. 6 , support coil 510 may begin at a location between proximal end 514 and distal end 516 of pusher 505 and / or pusher coil 506 and extend distally to a location distally beyond the last frictional bump 508. In such embodiments, the support coil 510 can be between at least a portion of the pusher 505 and / or 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.

[0078]

[0103] In some embodiments, the portion of the support coil 510 that extends distally beyond the last friction bump 508 can support the flow diverter 300. Specifically, the portion of the support coil 510 that extends distally beyond the last friction bump 508 can extend through at least a portion of the length of the flow diverter 300 and, in some embodiments, can strengthen those portions of the flow diverter 300. Specifically, in some embodiments, the portion of the support coil 510 that extends distally beyond the last friction bump 508 can prevent the flow diverter from collapsing and / or buckling.

[0079]

[0104] Deployment wire 110, including deployment features 118, can be configured for passage through a patient's vasculature, and particularly for navigation through the patient's neurovascular system. Thus, in some embodiments, deployment features 118 can be configured to promote and / or maintain flexibility of core wire 112, and particularly distal portion 116 of core wire 112.

[0080]

[0105] The pusher coil 506 can be configured to apply a force to the flow diverter 300 as the deployment wire 110 advances distally into and / or through the catheter 104 and / or introducer sheath 120. The pusher coil 506 can include a coil formed by wire windings. The wire forming the wire windings can include a variety of 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, about 0.002 inches, or any other or intermediate diameter.

[0081]

[0106] 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 pusher coil 506 can have a diameter 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 so that the flow diverter 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 may be, for example, 0.019 inches.

[0082]

[0107] The pusher coil 506 can 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 can be configured to attach the pusher coil 506 to the deployment wire 110. In some embodiments, one or both of the proximal end 514 and the distal end 516 of the pusher coil 506 can include solder that secures the pusher coil 506 to the deployment wire 110; in other words, the pusher coil 506 can be soldered to the deployment wire 110. In some embodiments, the distal end 516 of the pusher coil 506 can be further configured to provide a support surface against which the pusher coil 506 can apply a force to the current shunt 300. In some embodiments, the support surface can be formed in the solder of the distal end 516. In some embodiments, the distal end 516 of the pusher coil 506 can include a bumper portion configured to engage the current shunt 300. The bumper portion may be convex to better engage with the flow diverter 300. In some embodiments, the bumper portion may comprise a flat tube.

[0083]

[0108] The deployment feature 118 can include one or more frictional bumps 508. In some embodiments, the frictional bumps are configured to press a portion of the flow diverter 300 against the inner wall 504 of the catheter 104 and / or introducer sheath 120 when the portion of the flow diverter 300 is within the catheter 104 and / or introducer sheath 120. In some embodiments, the frictional bumps 508 can include a material that engages, specifically, deformably engages, the flow diverter 300 such that the frictional force between the flow diverter 300 and the frictional bump 508 is greater than the frictional force between the flow diverter 300 and the inner wall 504 of the catheter 104 and / or introducer sheath 120. Due to the relatively greater frictional force between the frictional bumps 508 and the flow diverter 300, each frictional bump 508 facilitates control of the flow diverter 300, specifically, the position of the flow diverter 300 relative to the catheter 104 and / or introducer sheath 120. In some embodiments, the interaction between the friction bumps 508 and the flow diverter 300 can allow the deployment wire 110 to deploy the flow diverter 300 from the catheter 104 and / or to retract and / or partially retract a partially deployed flow diverter 300 back into the catheter 104.

[0084]

[0109] The frictional bumps 508 can comprise a deformable material such as, for example, an elastomer. In some embodiments, the frictional bumps 508 can comprise a polymer that can house a radiopaque element, such as, for example, a platinum coil and / or platinum wire. In some embodiments, the frictional bumps 508 can comprise a tungsten-filled polymer or a tungsten-filled elastomer. In some embodiments, the frictional bumps can comprise a UV adhesive that can be doped with a radiopaque material, such as, for example, tantalum powder. In some embodiments, some or all of the frictional bumps 508 can be radiopaque and / or can include a radiopaque element. In some embodiments, the radiopaque element can include one or more radiopaque particles embedded in the frictional bumps 508, and in some embodiments, as shown in FIG. 6, the frictional bumps can include a radiopaque coil 509 that can include, for example, a piece of wire, such as a coil of platinum wire.

[0085]

[0110] In some embodiments where the deployment wire 110 includes multiple friction bumps 508, the friction bumps 508 can be evenly or unevenly spaced. In some embodiments, the friction bumps 508 can be spaced apart by 1 mm to 20 mm, 1 mm to 15 mm, 2 mm to 10 mm, 3 mm to 8 mm, about 5 mm, or any other value or intermediate value.

[0086]

[0111] In some embodiments, the deployment feature 118 can include a support coil 510. The support coil 510 can prevent the core wire 112 from buckling as the core wire 112 advances the flow diverter 300 distally within the catheter 104 and / or introducer sheath 120. For example, to increase the flexibility of the core wire 112, the core wire 112 can be tapered at its distal portion 116. This tapered portion can increase the flexibility of the core wire 112, but it can also decrease the strength of the core wire 112. This decrease in strength of the core wire 112 can result in buckling of the core wire 112 as the core wire 112 is used to advance the flow diverter 300 distally within the catheter 104 and / or introducer sheath 120. The support coil 510 can extend along a portion of the core wire 112 to prevent the core wire 112 from buckling. Thus, the combination of the tapered core wire 112 and the support coil 510 allows the deployment wire 110 to be flexible enough to navigate through tortuous vasculature while also having sufficient strength to deploy the flow diverter 300.

[0087]

[0112] 6, the support coil 510 can extend over a portion of the core wire 112, specifically over all or part of the distal portion 116 of the core wire 112. As further seen in FIG. 6, 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, more specifically, beyond the third friction bump 508-C.

[0088]

[0113] The diameter of the wire forming the support coil can be, for example, between 0 and 0.01 inches, between 0 and 0.005 inches, between 0 and 0.002 inches, about 0.002 inches, or any other or intermediate diameter. In some embodiments, the diameter of the wire forming the support coil 510 can be the same as the wire forming the pusher coil 506, and in some embodiments, the diameter of the wire forming the support coil 510 can be different from 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, or any other value or intermediate value.

[0089]

[0114] The deployment wire 110 can extend distally beyond the frictional bump 508, and in some embodiments, beyond the third frictional bump 508-C. The deployment wire 110 can terminate in an atraumatic tip 512, which can be disposed at the distal end of the deployment wire 110. In some embodiments, the portion of the deployment wire 110 that extends distally beyond the frictional bump 508 can include a portion of the support coil 510. The atraumatic tip 512 can be configured to avoid damaging tissue that may be impinged upon during the procedure, particularly during deployment of the flow diverter 300 in the patient's vasculature. 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 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.

[0090]

[0115] 6 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 flow diverter 300. In some embodiments, the retraction sleeve 520 can extend over the proximal portion 522 of the flow diverter 300 when the flow diverter 300 is housed within the introducer sheath 120 and / or catheter 104. In some embodiments, the retraction sleeve 520 can extend part way or the entire length of the deployment feature 118 and, therefore, can extend over part or the entire proximal portion 522 of the flow diverter 300 that engages the deployment feature 118.

[0091]

[0116] In some embodiments, the retracting sleeve 520 can be positioned between the proximal portion 522 of the flow diverter 300 and the introducer sheath 120 and / or catheter 104, thereby reducing friction between the proximal portion 522 of the flow diverter 300 and the introducer sheath 120 and / or catheter 104. In some embodiments, the retracting sleeve 520 can not only reduce friction between the proximal portion 522 of the flow diverter 300 and the introducer sheath 120 and / or catheter 104, but can also protect the proximal portion 522 of the flow diverter 300 from damage that may result from movement of the flow diverter 300 relative to the introducer sheath 120 and / or catheter 104, such as may occur during deployment and / or retraction of the flow diverter 300.

[0092]

[0117] The retraction sleeve 520 can comprise a flexible polymer that can be coupled to the deployment wire 110. In some embodiments, the retraction sleeve 520 can be coupled to the deployment wire 110 at a location distal to all or a portion of the deployment feature 118, as shown in FIG. 6. In some embodiments, the retraction sleeve 520 can comprise a heat-shrink polymer tube that can be placed over the proximal portion 522 of the flow diverter 300 and over a portion of the deployment wire 110 distal to the flow diverter 300. The retraction sleeve 520 can then be heat-shrunk around the flow diverter 300 to form a snug fit around the flow diverter 300.

[0093]

[0118] The retracting sleeve 520 may further include one or more slits extending proximally from the distal end of the retracting sleeve 520. The one or more slits separate the portion of the retracting sleeve 520 that extends over the proximal portion 522 of the flow diverter 300 into multiple sections. For example, in one embodiment of the retracting sleeve 520 including two slits, the retracting sleeve 520 may be split into two sections, which may be two equal halves. The one or more slits allow the retracting sleeve 520 to open and separate from the flow diverter 300 when the flow diverter 300 is deployed. Thus, as seen in FIG. 7 , the retracting sleeve 520 protrudes distally beyond the catheter 104. As can be seen, the retracting sleeve 520 that extends distally beyond the catheter 104 is split and separated from the flow diverter 300, allowing the flow diverter 300 to expand and allowing the retracting sleeve 520 to be retracted into the catheter 104 upon full deployment of the flow diverter 300.

[0094]

[0119] Referring now to FIG. 7 , a schematic diagram of the delivery system 500 is shown in a partially deployed configuration. As seen in FIG. 7 , the catheter 104 containing the deployment wire 110 and flow diverter 300 is within a blood vessel 600. As further seen in FIG. 7 , the deployment wire 110 has been advanced distally relative to the catheter 104, as indicated by arrow 602, thereby partially deploying the flow diverter 300. The combination of friction bumps 508 and pusher coils 506 engage the flow diverter 300, advancing it distally into and out of the catheter 104 as the deployment wire 110 advances distally. As the deployment wire 110 advances distally, the flow diverter 300 begins to expand, deploying from the catheter 104. This distal advancement continues until the flow diverter 300 is fully deployed. Alternatively, if the flow diverter 300 is not fully deployed from the catheter 104, and if at least one of the frictional bumps 508 is still within the catheter 104 and engaged with the flow diverter 300, the flow diverter 300 can be retracted and / or partially retracted into the catheter 104. In some embodiments, successful deployment of the flow diverter 300 can be achieved by advancing the deployment wire 110 only distally, and in some embodiments, successful deployment of the flow diverter 300 can be achieved by alternately advancing the flow diverter 300 distally and retracting it proximally until the desired positioning and / or deployment is achieved.

[0095]

[0120] 8, a schematic diagram of one embodiment of a dynamic delivery system 800 is shown. The system 800 can include a flow diverter 300 that can be held in a constrained state within the lumen 502 of the catheter 104 and / or introducer sheath 120. In some embodiments, the flow diverter 300 can include an expandable braided member that can define the flow path 406. In some embodiments, the flow diverter 300 can include a self-expanding braided member.

[0096]

[0121] The flow diverter 300 can be disposed in the lumen 502 of the catheter 104 and / or introducer sheath 120. In some embodiments, the flow diverter 300 can be disposed circumferentially within the lumen 502 of the catheter 104 and / or introducer sheath 120 between an inner wall 504 defining the lumen 502 of the catheter 104 and / or introducer sheath 120 and an expanding element, which can be a self-expanding element, as described more fully below.

[0097]

[0122] The deployment wire 110 can extend at least partially through both the flow diverter 300 and a lumen 502 of the catheter 104 or introducer sheath 120. The deployment wire 110 can include a core wire 112 that can extend within the lumen 502 of the catheter 104 and / or introducer sheath 120, and a deployment feature 118 that is shown entirely within the lumen 502 of the catheter 104 and / or introducer sheath 120. The deployment feature 118 is coupled to the flow diverter such 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 flow diverter 300 relative to the catheter 104 and / or introducer sheath 120.

[0098]

[0123] The deployment feature 118 includes one or more frictional bumps 508, a support coil 510, an expansion element 802, a tip coil 810, and an atraumatic tip 512. The tip coil can be a flexible tip coil 810. In some embodiments, the flexible tip coil 810 and / or the flexible tip coil 810 and atraumatic tip 512 can facilitate passage of the system 800 and / or the core wire 112 through the vasculature, particularly through tortuous vasculature.

[0099]

[0124] In some embodiments, some or all of these deployment features 118 engage with the flow diverter 300, i.e., are engaged with the flow diverter 300 as shown in Figure 8. The deployment features 118 engage and / or can be engaged with the flow diverter 300 such that movement of the core wire 112 results in corresponding movement of the flow diverter 300.

[0100]

[0125] The expansion element 802 can comprise a self-expanding element 802 or a controlled expansion element. In some embodiments, the self-expanding element 802 can expand upon exiting the catheter 104. In some embodiments, the controlled expansion element can expand when controlled to expand. The controlled expansion element can comprise, for example, a stent, a braid, a balloon, etc. In some embodiments, the expansion element 802 comprises a braided member, the thickness of the strands of the braid can be varied to achieve a desired effect. For example, thicker strands can provide increased expansion force or thinner strands can provide increased flexibility. In some embodiments, the strands can comprise various materials, including, for example, DFT, which can be radiopaque. In some embodiments, the strands can comprise a polymer, such as a high tensile strength polymer. In some embodiments, the polymer used in the strands can advantageously increase friction between the expansion element 802 and the flow diverter 300, thereby improving the ability of the expansion element 802 to retract the flow diverter 300. In embodiments, the strands comprise a polymer, the polymer can be treated and / or doped to be radiopaque.

[0101]

[0126] In some embodiments, the materials of the flow diverter 300 and / or the expansion element 802 can be selected to minimize the compressed diameter of the flow diverter 300 around the expansion element 802. In some embodiments, in selecting and using high tensile strength materials, such as materials having a tensile strength of 100 kpsi, 150 kpsi, 200 kpsi, 250 kpsi, or greater, the outer diameter of the fully compressed expansion element 802 can be, for example, about 0.005 inches to 0.035 inches, about 0.01 inches to 0.015 inches, about 0.013 inches, or any other or intermediate outer diameter. In such embodiments, when the flow diverter 300 is axially disposed around and over the expansion element 802, the outer diameter of the combination of the expansion element 802 and flow diverter 300, both in a compressed state, can be, for example, about 0.01 inches to 0.04 inches, about 0.015 inches to 0.035 inches, about 0.017 inches, or any other or intermediate outer diameter. As used herein, "about" indicates a value that is within a range of + / - 5% of the relevant value, + / - 10% of the relevant value, and / or + / - 20% of the relevant value. Thus, the flow diverter 300 and dilating element 802 combination can fit into a catheter 104 having an inner diameter of, for example, about 0.01 inch to 0.04 inch, about 0.015 inch to 0.035 inch, about 0.017 inch, or any other or intermediate diameter.

[0102]

[0127] In some embodiments, the controlled expansion element can include one or more features configured to allow for control of the expansion of the controlled expansion element. These features can include one or more wires, catheters, rods, etc. In some embodiments, the controlled expansion element can be expanded by axially compressing the controlled expansion element such that the proximal end of the controlled expansion element approaches the distal end of the controlled expansion element. While the following description focuses on the use of a self-expanding element 802, it will be understood that the self-expanding element 802 can be replaced with a controlled expansion element.

[0103]

[0128] 8, the self-expanding element 802 includes a proximal end 804, also referred to herein as a first end 804, and a distal end 806, also referred to herein as a 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. The self-expanding element 802 can extend distally from the proximal end 804 to the distal end 806 of the self-expanding element 802, as shown in FIG.

[0104]

[0129] The self-expanding element 802 can include a stent or a braided member. In some embodiments, the self-expanding element includes a laser-cut stent. The self-expanding element 802 can include a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, the self-expanding element 802 can be made from a nitinol stretch-filled tube, which can include, for example, nitinol, a cobalt chrome exterior and a platinum interior, or a mixture of nitinol and cobalt chrome. In some embodiments, the self-expanding element 802 can include a plurality of braided strands, at least a portion of which can be radiopaque.

[0105]

[0130] The self-expanding element 802 can be configured to engage the flow diverter 300 when the flow diverter is housed within the catheter 104 and / or introducer sheath 120 such that movement of the deployment wire 110, particularly the core wire 112, leads to corresponding movement of the flow diverter 300. When the self-expanding element 802 is deployed from the catheter 104, the self-expanding element 802 expands to a fully expanded state, or to a maximum expanded state allowed by the vessel in which the self-expanding element 802 is housed. In some embodiments, the self-expanding element 802 can be advanced distally and / or retracted proximally through the flow diverter 300.

[0106]

[0131] In some embodiments, the expansion element 802, such as a controlled expansion element or a self-expanding element 802, can generate a radial force that can expand the flow diverter 300 more than would otherwise occur. For example, even if the flow diverter 300 is self-expanding, the expansion element 802, such as a controlled expansion element or a self-expanding element 802, may generate a radial expansion force greater than that generated by the flow diverter 300. By moving the expansion element 802 through the flow diverter 300, these greater radial expansion forces generated by the expansion element 802 can be applied to the flow diverter 300, causing the flow diverter 300 to further expand. This further expansion can increase and / or improve contact between the flow diverter 300 and the blood vessel 600. In some embodiments, the use of an expansion element 802, such as a controlled expansion element or a self-expanding element.

[0107]

[0132] In some embodiments, the expansion element 802, when unconstrained, can have a diameter larger than the diameter of the unconstrained flow diverter 300; in some embodiments, the expansion element 802, when unconstrained, can have a diameter smaller than the diameter of the unconstrained flow diverter 300. Thus, in some embodiments, when unconstrained, the expansion element 802 can have a diameter larger or smaller than the diameter of the blood vessel 600. In some embodiments, when deploying the flow diverter 300, kinks, twists, compression, or bends may occur in the flow diverter 300, which may hinder the expansion of the flow diverter 300. In some embodiments, the expansion element 802 can straighten, ameliorate, and / or eliminate these kinks, twists, compression, or bends in the flow diverter 300 by expanding to a diameter smaller than the diameter of the blood vessel 600. In such embodiments, expansion by the expansion element 802 smaller than the diameter of the blood vessel 600 can correct, ameliorate, and / or eliminate these kinks, kinks, compressions, or bends in the flow diverter 300, allowing the flow diverter 300 to self-expand and engage the wall of the blood vessel 600. Thus, in some embodiments, the expansion element 802 initiates expansion, which is then continued and completed by the flow diverter 300.

[0108]

[0133] In some embodiments, expansion of the expandable element 802 can result in shortening of the expandable element 802. This shortening can cause the distal end 113 of the core wire 112 to move proximally, which can in particular cause the atraumatic tip 512 to move proximally. This proximal movement of the distal end 113 of the core wire 112 and / or the atraumatic tip 512 can reduce the distal extension of these portions of the core wire 112 into the blood vessel, thereby reducing the risk of damage to the blood vessel.

[0109]

[0134] One or more frictional bumps 508 can be coupled to the deployment wire 110, and specifically, can be coupled to the core wire 112. In some embodiments, the one or more frictional bumps 508 can be directly coupled to the deployment wire 110, and specifically, the core wire 112, and in some embodiments, the one or more frictional bumps 508 can be indirectly coupled to the deployment wire 110, and specifically, the core wire 112, for example, via a self-expanding element.

[0110]

[0135] In some embodiments, one or more frictional bumps 508 can be disposed on one or both ends of the self-expanding element. Thus, in some embodiments, at least one of the frictional bumps 508 is disposed on one of the proximal end 804 and the distal end 806. In some embodiments, at least one of the frictional bumps 508 is disposed on one of the proximal end 804 and the distal end 806, and another frictional bump is disposed on the other of the proximal end 804 and the distal end 806. As seen in FIG. 8 , the frictional bumps 508 include a first frictional bump 508-A disposed adjacent to and / or on the proximal end 804 of the self-expanding element 802 and a second frictional bump 508-B disposed adjacent to and / or on the distal end 806 of the self-expanding element 802. In some embodiments, the frictional bumps 508 can 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 wire coil 509 .

[0111]

[0136] The system can include a support coil 510. The support coil 510 can extend around and / or along at least a portion of the distal portion 116 of the core wire 112, including along and / or around the distal end 113 of the core wire 112. The support coil 510, in some embodiments, can extend from a location proximal to the self-expanding element 802 to the self-expanding element 802 and / or from a location proximal to the first frictional bump 508-A to the first frictional bump 508-A. In some embodiments, the support coil 510 can extend at least partially within the first frictional bump 508-A.

[0112]

[0137] The system 800, in some embodiments, can include a tip coil 810, which can be a flexible tip coil 810. The tip coil 810 can extend distally from the self-expanding element 802, and specifically, can extend distally from the distal end 806 of the self-expanding element 802. The tip coil 810 can extend distally beyond the self-expanding element 802 and can terminate in an atraumatic tip 512. The atraumatic tip 512 can be at the distal-most point of the tip coil 810, in some embodiments. In some embodiments, the flexible tip coil 810 and / or the flexible tip coil 810 and the atraumatic tip 512 can facilitate passage of the system 800 and / or the core wire 112 through a vasculature, particularly through tortuous vasculature.

[0113]

[0138] One embodiment of deploying a flow diverter using system 800 is shown in Figure 8. A catheter 104 is inserted into the vasculature and advanced to a position proximate to a treatment site 812, which may be at, near, or beyond the treatment site 812. In some embodiments, the position of the catheter may be determined by imaging, such as fluoroscopy.

[0114]

[0139] As seen in this figure, the deployment wire 110 and flow diverter 300 are advanced distally in the direction indicated by arrow 814 until the flow diverter 300 exits the catheter 104. Once the flow diverter 300 exits the catheter 104, the flow diverter 300 may begin to expand and begin to engage the interior of the blood vessel 600. In some embodiments, the distal advancement of the deployment wire 110 and flow diverter 300 may continue until the flow diverter 300 is fully deployed. Alternatively, if the flow diverter 300 is not fully deployed from the catheter 104, the flow diverter 300 may be retracted and / or partially retracted within the catheter 104. In some embodiments, the flow diverter 300 may be retracted and / or partially retracted within the catheter 104 until the frictional bumps 508 and / or the proximal-most portions of the self-expanding elements 802 exit the catheter 104. In some embodiments, the position of the flow diverter 300, the catheter 104, the frictional bumps 508, and / or the self-expanding elements 802 can be determined by imaging, specifically by imaging portions of the radiopaque elements and / or the catheter 104, the frictional bumps 508, and / or the self-expanding elements 802. In some embodiments, based on the results of this imaging, it can be determined whether the flow diverter 300 can be retracted and / or partially retracted into the catheter 104.

[0115]

[0140] As the self-expanding element 802 exits the catheter 104, the self-expanding element 802 expands and applies a radially outward force to the flow diverter 300, further expanding the flow diverter 300. Alternatively, if a controlled expansion element is used, the controlled expansion element can be expanded upon exiting the catheter 104.

[0116]

[0141] The self-expanding element 802 can continue to advance distally relative to the catheter 104 until the flow diverter 300 is fully deployed. Once the flow diverter 300 is fully deployed, the self-expanding element 802 can be advanced distally through the flow diverter 300 to fully and / or maximally expand the flow diverter 300, at which point the self-expanding element 802 can be retracted proximally through the flow diverter 300 and then returned to the catheter 104. In some embodiments, the distal advancement and proximal retraction of the expanding element 802 through the flow diverter 300 can be repeated multiple times until the expanding element 802 is retracted into the catheter 104. In some embodiments, repeated movement of the expanding element 802 through the deployed flow diverter 300 can facilitate achieving full deployment of the flow diverter 300, particularly if all or part of the flow diverter 300 is not fully deployed. This movement of the self-expanding element 802 through the flow diverter 300, first distally and then proximally, can increase the expansion of the flow diverter 300 and improve the connection between the flow diverter and the blood vessel 600.

[0117]

[0142] Once the self-expanding element 802 is retracted into the catheter 104, the catheter can be retracted and / or one or several additional flow diverters can be delivered to the treatment site.

[0118]

[0143] As shown in FIG. 8 , a graphic depiction of an embodiment for delivering a flow diverter 300, specifically, into a blood vessel 600 to treat an aneurysm, is shown. In some embodiments, the blood vessel can be a neurovascular vessel, in other words, a blood vessel in or around the patient's brain. In some embodiments, delivery of the flow diverter 300 into the blood vessel 600 can include partial deployment of the flow diverter 300 from the catheter 104 and / or full or partial retraction of the flow diverter 300 into the catheter 104. As used herein, full retraction occurs when the flow diverter 300 is retracted until it is fully housed in the catheter 104, and partial retraction occurs when a portion of the flow diverter 300 remains outside of the catheter 104 after retraction of the flow diverter 300.

[0119]

[0144] In some embodiments, the flow diverter 300 can be fully or partially deployed after being retracted into the catheter 104. In some embodiments, the flow diverter 300 can be partially deployed and retracted once, and in some embodiments, the flow diverter 300 can be repeatedly partially deployed and retracted into the catheter 104.

[0120]

[0145] In some embodiments, the flow diverter 300 can be retracted into the catheter 104 and removed from the blood vessel. In some embodiments, the flow diverter 300 can be replaced with another flow diverter 300 of a different size, e.g., a flow diverter having a larger or smaller diameter. In some embodiments, the flow diverter 300 can be retracted and redeployed to improve the expansion of the flow diverter 300. In some embodiments, for example, retracting and redeploying the flow diverter 300 can result in more complete opening of the flow diverter 300 and / or improved contact between all or part of the flow diverter 300 and the blood vessel in which the flow diverter 300 is deployed.

[0121]

[0146] In some embodiments, the flow diverter 300 is retracted and / or redeployed to affect the portion of the blood vessel covered by the deployed flow diverter 300. In some embodiments, the blood vessel coverage of the flow diverter 300 at the treatment location can be affected, for example, by controlling the position and / or movement of both the catheter 104 and the core wire 112 during deployment. For example, after the distal portion of the flow diverter 300 engages the blood vessel, thereby coupling the flow diverter 300 to the blood vessel, the length of the deployed flow diverter can be affected by retracting the catheter 104 while deploying the flow diverter 300. Specifically, the relative speed of retraction of the catheter 104 relative to the deployment of the flow diverter 300 can affect the length of the flow diverter 300. For example, the length of the deployed flow diverter can be shortened by retracting the catheter 104 relatively slowly relative to the deployment of the flow diverter 300. Alternatively, the flow diverter 300 can be stretched while being deployed by retracting the catheter 104 relatively quickly relative to the deployment of the flow diverter 300, thereby increasing the length of the deployed flow diverter 300.

[0122]

[0147] In some embodiments, by controlling the length of the deployed flow diverter 300, the surgeon can influence the diameter of the deployed flow diverter 300. Specifically, as the deployed length of the flow diverter increases, the diameter of the deployed, unconstrained flow diverter decreases. Thus, in some embodiments in which the flow diverter 300 is deployed in a vessel having a larger diameter, the surgeon may decrease the length of the deployed flow diverter to obtain the desired deployed diameter of the flow diverter 300.

[0123]

[0148] 9, a schematic diagram of a customizable delivery system 900 is shown. As can be seen in FIG. 9, the deployment wire 110 and the flow diverter 300 are at least partially disposed within the introducer sheath 120. As can be seen in FIG. 9, in some embodiments, no portion of the deployment wire 110 extends distally beyond the distal end 306 of the flow diverter 300.

[0124]

[0149] As further seen in FIG. 9 , the deployment wire 110, which includes the tapered core wire 112, is coupled to a deployment feature 118, which, as shown in FIG. 9 , includes a pusher 505 and frictional bumps 508, as described in detail above. The combination of the frictional bumps 508 and the pushers 505 engage the flow diverter 300, advancing it distally into and out of the catheter 104 as the deployment wire 110 advances distally. As the deployment wire 110 advances distally, the flow diverter 300 begins to deploy and expand from the catheter 104. This distal advancement continues until the flow diverter 300 is fully deployed. Alternatively, if the flow diverter 300 is not fully deployed from the catheter 104, the flow diverter 300 can be retracted and / or partially retracted into the catheter 104 if the frictional bump 508 is still within the catheter 104 and engaged with the flow diverter 300. In some embodiments, successful deployment of the flow diverter 300 can be achieved by advancing the deployment wire 110 only distally, and in some embodiments, successful deployment of the flow diverter 300 can be achieved by alternately advancing the flow diverter 300 distally and retracting it proximally until the desired positioning and / or deployment is achieved. According to the system 900 shown in FIG. 9 , the flow diverter 300 extends a first length 902 beyond the distal end 124 of the introducer sheath 120.

[0125]

[0150] The system 900 shown in FIG. 9 further includes a severable support extending along and around the distal end 124 of the elongate tubular member (e.g., introducer sheath 120). In some embodiments, the severable support can be a tubular body 904 extending along and around the distal end 124 of the elongate tubular member (e.g., introducer sheath 120). The tubular body 904 can be a polymer tube attached to the distal end 306 of the flow diverter 300. The tubular body 904 preferably comprises a polymer tube including heat-shrinkable PTFE, Pebax, polyolefin, or FEP. In at least some embodiments, the tubular body 904 is transparent, partially transparent, or opaque. For example, in at least some approaches, the flow diverter 300 is visible or partially visible within the tubular body 904.

[0126]

[0151] The tubular body 904 extends a second length 906 beyond the distal end 124 of the introducer sheath 120. As seen in FIG. 9 , the distal end 306 of the flow diverter 300 can be housed within the tubular body 904. The tubular body 904 is preferably cuttable and configured to allow customization of the length of the flow diverter 300 by cutting the tubular body 904 and the flow diverter 300 housed within the tubular body 904. In at least some embodiments, the tubular body is semi-rigid and peelable.

[0127]

[0152] In at least some approaches, the first length 902 and the second length 906 are the same, such that the flow diverter 300 and the tubular body 904 extend distally the same distance beyond the distal end 124 of the introducer sheath 120. In other approaches, the second length 906 (e.g., the length that the tubular body 904 extends beyond the distal end 124 of the introducer sheath 120) may be longer or shorter than the first length 902 (e.g., the length that the flow diverter 300 extends beyond the distal end 124 of the introducer sheath 120). In at least some embodiments, the deployment wire 110 terminates before the distal end 306 of the flow diverter 300, such that the distal end of the deployment wire 110 does not extend into the tubular body 904. The deployment wire 110 does not extend distally beyond the distal end 306 of the flow diverter 300.

[0128]

[0153] In some embodiments, the flow diverter 300 is cuttable to a desired length within the tubular body 904. Specifically, in some embodiments, the size and composition of the individual strands of the flow diverter 300, in combination with the weave of the braid, allows the flow diverter 300 to be cuttable. In some embodiments, this can include, for example, a braid weave that does not unravel when the flow diverter 300 is cut. The heat shrink tubing restrains the braid and maintains the braid in a restrained configuration. In various approaches, the braid is heat treated to maintain its shape and tubular configuration.

[0129]

[0154] The desired length of the flow diverter 300 may be customizable by cutting the flow diverter 300, allowing a physician to adjust the length of the flow diverter 300 to meet the specifications of the treatment site. For example, a physician may trim the flow diverter 300 within the tubular body 904 to the desired length without compromising the delivery system 900. The tubular body 904 assists in the process of trimming the flow diverter 300 as needed.

[0130]

[0155] In at least some embodiments, the tubular body 904 includes graduations 908 evenly spaced along a portion of the tubular body 904, particularly along a distal portion 910 of the tubular body 904. For example, the graduations 908 may be used as a ruler to guide cutting of the flow diverter 300 and / or the tubular body 904 to a desired length.

[0131]

[0156] The tubular body 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 connected to the second longitudinal portion 920 via a connecting portion that is relatively narrower 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 tubular body 904. In various embodiments, the tubular body 904 is peelable and removable 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, as will be understood by one skilled in the art. Specifically, in some embodiments, peeling the tubular body 904 from the introducer sheath can include separating the first longitudinal portion 916 from the second longitudinal portion 920 along a connecting portion.

[0132]

[0157] As shown in FIG. 10 , system 900 can be used to customize the length of flow diverter 300 to a desired length 1000. In at least some embodiments, waste section 1002 may be removed (e.g., cut) from tubing 904 with flow diverter 300 disposed therein. Graduations 908 may be used to measure the desired length 1000 and / or waste section 1002 and to determine where to make cuts 1004. Referring now to FIG. 11 , waste section 1002 has been removed, leaving the desired length 1000.

[0133]

[0158] 12 , the first longitudinal portion 916 of the tubular body 904 having a first proximal pull tab 918 and the second longitudinal portion 920 having a second proximal pull tab 922 can be peeled and 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, as will be understood by one skilled in the art. For example, the first longitudinal portion 916 is pulled by the pull tab 918 in a first direction 1200 that is 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 the first direction 1200.

[0134]

[0159] In at least some embodiments, before or during peelable removal of the tubular body 904, the desired length 1000 of the flow diverter 300 is retracted into the introducer sheath 120 so that the flow diverter 300 resides substantially within the introducer sheath 120. The flow diverter 300 may be retracted into the introducer sheath 120 by actuation of the deployment wire 110 and movement relative to the introducer sheath 120 in the manner described in detail above. For example, retraction of the flow diverter 300 into the introducer sheath 120 is accomplished by distally retracting the deployment wire 110.

[0135]

[0160] Peelably removing the tubular body 904 includes separating the tubular body 904 from the distal portion of the introducer sheath 120. As described above, the tubular body 904 can be separated from the distal portion of the introducer sheath 120 by peeling the tubular body 904 from the distal portion of the introducer sheath 120, and peeling the tubular body 904 includes separating the first longitudinal portion 916 from the second longitudinal portion 920; however, separating the tubular body 904 from the distal portion of the introducer sheath 120 may be accomplished in other ways, such as, for example, separating the tubular body 904 using only a single pull tab. In some approaches, the tubular body 904 is separated from the distal portion of the introducer sheath 120 after the flow diverter 300 is retracted into the introducer sheath.

[0136]

[0161] 13 , after the tubular body 904 has been peelably detached from the distal portion of the introducer sheath 120 and the desired length 1000 of the flow diverter 300 has been retracted into the introducer sheath 120, the remaining system 1300 may be loaded into the catheter system 102, specifically into the catheter 104 of the catheter system 102, via actuation of the deployment wire 110, as shown in FIG. 14 . The flow diverter 300 may then be delivered to the neurovasculature (e.g., blood vessel 600). This delivery may include moving the distal end 132 of the catheter system 102 proximate to the treatment location, e.g., advancing the catheter system 102 proximal to the treatment location within the neurovasculature, advancing a core wire through the microcatheter, and advancing a pusher and at least one friction bump via the advancement of the core wire, thereby deploying the flow diverter from the microcatheter into the neurovasculature 600 to treat the aneurysm.

[0137]

[0162] In some embodiments, the catheter system 102 can be positioned distal, and in some embodiments, just distal, to the treatment location. In some embodiments, distal advancement of the deployment wire 110 relative to the catheter system 102 can similarly advance the flow diverter 300 distally relative to the catheter system 102. In some embodiments, the flow diverter 300 can be deployed by advancing the deployment wire 110 relative to the catheter system 102. In some embodiments, this advancement of the deployment wire 110 relative to the catheter system 102 can include retracting the catheter system 102 into 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 advancing the deployment wire 110 relative to the blood vessel 600 while simultaneously retracting the catheter system 102 relative to the blood vessel 600.

[0138]

[0163] In some embodiments, the flow diverter 300 expands and / or begins to expand as the flow diverter 300 exits the catheter system 102. The flow diverter 300 can continue to be deployed by further distal advancement of the deployment wire 110, and thus the flow diverter, until the flow diverter 300 is fully deployed.

[0139]

[0164] After the flow diverter 300 is fully deployed, the deployment wire 110 can be retracted distally within the catheter system 102, allowing the catheter to be retracted from the treatment location and from the patient's vasculature. In some embodiments, one or several additional flow diverters 300 can be deployed at the treatment location. This deployment can include placing the additional flow diverter on top of one or several previously deployed flow diverters 300. Alternatively, one or several additional flow diverters 300 can be placed in a partially overlapping manner to increase the length of the blood vessel 600 being treated. In such embodiments, the distal end of the additional flow diverter can be placed overlapping the proximal end of the previously placed flow diverter 300.

[0140]

[0165] 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 at least one of the pusher and the at least one friction bump to determine the location of the flow diverter within the neurovasculature and the location of the pusher and / or the at least one friction bump relative to the microcatheter.

[0141]

[0166] In some embodiments, the flow diverter is retracted into the microcatheter when at least one of the at least one friction bump does not extend from the microcatheter. In at least some aspects, the positioning of the microcatheter is adjusted relative to the treatment location based on the imaging.

[0142]

[0167] In various aspects, the flow diverter is loaded into the catheter system 102. In some embodiments, loading the flow diverter into the microcatheter includes inserting an introducer sheath containing the flow diverter through the access device and into the microcatheter, and advancing a deployment wire through the introducer sheath to advance the flow diverter from the introducer sheath into the microcatheter.

[0143]

[0168] As shown in FIG. 15 , the second customizable flow diverter delivery system 1500 includes a template 1502. The template 1502 includes an upper portion 1504, a lower portion 1506, a front portion 1508, a back portion 1510, a first side 1512, and a second side 1514. The template 1502 has at least markings 1516 similar to the markings 908 shown in FIG. 9 . The markings 1516 are configured to assist in cutting the flow diverter 300 to a desired length in a manner similar to that described above. The markings 1516 preferably correlate to the deployed length of the flow diverter 300.

[0144]

[0169] In some embodiments, the tubular body 904 may include at least graduations as shown in Figure 9. The second customizable flow diverter delivery system 1500 illustrates an alternative and / or complementary approach to guiding the physician in cutting the flow diverter 300 within the peel-away, removable tubular body 904 to the desired length. In at least some approaches, the graduations may be provided on both the tubular body 904 and the template 1502 provided with the flow diverter delivery system.

[0145]

[0170] In various embodiments, the template 1502 includes a cut notch 1518 extending through the bottom 1506 of the template 1502. The cut notch 1518 is proximate one of the first side 1512 and the second side 1514. The graduations 1516 may be located between the cut notch 1518 and the other of the first side 1512 and the second side 1514. For example, the graduations 1516 are located between the cut notch 1518 and the first side 1512. In another example, the graduations 1516 are located between the cut notch 1518 and the second side 1514, as shown in FIG. 15 .

[0146]

[0171] In some embodiments, the template 1502 includes a first set of markings along a bottom 1506 of a front surface 1508 of the template 1502 and a second set of markings along a bottom 1506 of a back surface 1510 of the template 1502. In one embodiment, one of the front surface 1508 of the template 1502 and the back surface 1510 of the template 1502 is configured for a right-handed user, and the other of the front surface 1508 of the template 1502 and the back surface 1510 of the template 1502 is configured for a left-handed user.

[0147]

[0172] In various embodiments, the template 1502 includes a formula (not shown) configured to assist in cutting the flow diverter 300 to the desired length. The formula may be printed along the top 1504 of the template 1502. For example, the formula may be printed along the top of the template 1502. In other examples, the formula may be centered on either the front 1508 and / or back 1510 of the template 1502. The formula may be printed anywhere on either side along the template 1502. In a preferred embodiment, the formula and graduations 1516 are printed on each of the front 1508 and back 1510 of the template 1502.

[0148]

[0173] In at least one embodiment, the formula includes: L T =L I -L D R R=0.27D+1.2 where: L T = trimmed length L D = Development length L I = Inner sheath length R=ratio D = implant diameter is.

[0149]

[0174] In one example, the implant diameter (D) is 4 mm and the desired deployment length (L D) is 25 mm, and the inner sheath length (L I ) is 80mm.

[0150]

[0175] Doing the calculation, R = 0.27(4) + 1.2 = 2.28 L T =80-25(2.28)=23mm This becomes:

[0151]

[0176] Therefore, to achieve a deployed length of 25 mm, the operator must cut off 23 mm.

[0152]

[0177] 16, the second customizable flow diverter delivery system 1500 includes a protective sleeve 1600 extending along and around the proximal end 304 of the flow diverter 300, the protective sleeve 1600 being configured to reduce friction and / or reduce damage to the flow diverter 300 as the flow diverter 300 moves relative to the elongate tubular member (e.g., the introducer sheath 120). In various approaches, the protective sleeve 1600 extends beyond the proximal end 304 of the flow diverter 300 and / or beyond the pusher 505, as shown in FIG.

[0153]

[0178] The protective sleeve 1600 may be heat-shrinkable plastic. In some embodiments, the protective sleeve 1600 may comprise 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 location distal to all or a portion of the deployment features (e.g., friction bump 508, support coil 510, etc.). In some embodiments, the protective sleeve 1600 may comprise a heat-shrink polymer tube that can be positioned over the proximal end 304 of the flow diverter 300 and over a portion of the deployment wire 110 distal to the flow diverter 300. The protective sleeve 1600 can then be heat-shrunk around the flow diverter 300 to form a snug fit around the flow diverter 300. The protective sleeve 1600 is coupled to the pusher 505 and / or core wire 112.

[0154]

[0179] The protective sleeve 1600 may further 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 that extends over the proximal end 304 of the flow diverter 300 into multiple sections. For example, in one embodiment of the protective sleeve 1600 including two slits, the protective sleeve 1600 may be split into two sections, which may be two equal halves. The one or more slits allow the protective sleeve 1600 to open and separate from the flow diverter 300 when the flow diverter 300 is deployed. The protective sleeve 1600 may extend distally beyond the catheter 104 and split to separate from the flow diverter 300, allowing the flow diverter 300 to expand and allowing the protective sleeve 1600 to be retracted into the catheter 104 when the flow diverter 300 is fully deployed.

[0155]

[0180] As shown in FIG. 17 , the second customizable flow diverter delivery system 1500 includes an expansion element 1700 configured to reduce friction and / or damage to the flow diverter 300 as it moves relative to the elongated tubular member (e.g., the introducer sheath 120). The expansion element 1700 may be a self-expanding element or a controlled expansion element. In some embodiments, a self-expanding element can expand upon exiting the catheter 104. In some embodiments, a controlled expansion element can expand when controlled to do so. The expansion element 1700 may include, for example, a stent, a braid, a balloon, etc. In some embodiments in which the expansion element 1700 includes a braided member, the thickness of the strands in the braid can be varied to achieve a desired effect. For example, thicker strands can provide increased expansion force or thinner strands can provide increased flexibility. In some embodiments, the strands can include various materials, including, for example, DFT, which can be radiopaque, for example. In some embodiments, the twisting threads can include a polymer, such as a high tensile strength polymer. In some embodiments, the polymer used in the twisting threads can advantageously increase friction between the dilating element 1700 and the flow diverter 300, thereby improving the ability of the dilating element 1700 to retract the flow diverter 300. In embodiments in which the twisting threads include a polymer, the polymer can be treated and / or doped to be radiopaque.

[0156]

[0181] 18 , a customizable flow diverter delivery system 1800 may be implemented without a tubular body. In this alternative embodiment, the flow diverter 300 may extend a length 1802 beyond the distal end 124 of the introducer sheath 120. Using a template (not shown), the physician may measure and cut 1804 the flow diverter 300 to the desired length 1806, and the flow diverter 300 may be retracted into the introducer sheath 120 as described in detail above.

[0157]

[0182] 19, a customizable flow diverter delivery system 1900 includes a cuttable introducer sheath 1902. The cuttable introducer sheath 1902 includes an outer introducer sheath layer 1904 and an inner cuttable tubular body 1906 that surrounds the flow diverter 300. In some approaches, the outer introducer sheath layer 1904 is rigid and the inner cuttable tubular body 1906 is semi-rigid (e.g., similar to the tubular body 904 described in detail above).

[0158]

[0183] In various approaches, the introducer sheath 1902 (e.g., the outer introducer sheath layer 1904) may be tapered distally. In other approaches, the introducer sheath 1902 is not tapered, but rather has a constant diameter throughout its length.

[0159]

[0184] In an alternative embodiment, not shown, the introducer sheath 1902 is a one-piece cuttable feature. For example, the introducer sheath 1902 comprises only a relatively thin, rigid material, as opposed to an embodiment including an outer introducer sheath layer 1904 and an inner cuttable tubular body 1906, as shown in FIG. 19. In some embodiments, the one-piece cuttable introducer sheath 1902 is semi-rigid to allow cutting of the introducer sheath 1902, yet is rigid enough to engage the catheter hub 106 and allow transfer of the flow diverter 300 from the introducer sheath 1902 to the catheter 104.

[0160]

[0185] The outer introducer sheath layer 1904 defines an outer sheath layer lumen 1908, and the inner cuttable tubular body 1906 defines an inner tubular body lumen 1910. A flow diverter (such as flow diverter 300 described in detail above) is housed within the inner tubular body lumen 1910 in a constrained configuration, as shown in FIG.

[0161]

[0186] In various embodiments, the system 1900 includes a deployment wire (such as the deployment wire 110 detailed above) that extends within the inner tubular body lumen 1910 and the flow path of the flow diverter 300. As the deployment wire 110 advances distally, the flow diverter 300 begins to deploy and expand from the catheter 104. This distal advancement continues until the flow diverter 300 is fully deployed.

[0162]

[0187] 20 , the inner cuttable tubular body 1906 and flow diverter 300 may be cut 2002 to a desired length 2004 according to any of the embodiments detailed above. For example, the inner cuttable tubular body 1906 may include markings and / or a template with markings may be provided to allow a physician to determine and measure the desired length 2004. The remaining portion 2006 may be discarded after cutting 2002 (e.g., after cutting the inner cuttable tubular body 1906 and flow diverter 300), as shown in FIG.

[0163]

[0188] 22 , after the inner cuttable tubular body 1906 and the flow diverter 300 are cut, the outer introducer sheath layer 1904 may be advanced 2200 distally to position the inner tubular body within the outer sheath layer such that the distal end of the inner tubular body is within the outer sheath layer lumen. In another embodiment, the outer introducer sheath layer 1904 may 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 tubular body 1906 and / or the distal end 2206 of the flow diverter 300. In another embodiment, the inner cuttable tubular body 1906 and the flow diverter may be retracted into the outer introducer sheath layer 1904. In yet another embodiment, as shown in exemplary Figures 23 to 26, the inner cuttable tubular body 1906 and flow diverter 300 are provided separately from the outer introducer sheath layer 1904, and after cutting, the trimmed inner cuttable tubular body 1906 and flow diverter 300 are inserted into the outer introducer sheath 1904.

[0164]

[0189] 23 , the inner cuttable tubular body 1906 and the flow diverter 300 are provided separately from the outer introducer sheath layer 1904. The inner cuttable tubular body 1906 includes one or more locking elements 2302. The one or more locking elements 2302 may be spaced apart around the circumference of the inner cuttable tubular body 1906. In one exemplary embodiment, the inner cuttable tubular body 1906 includes at least two locking elements 2302, positioned on opposite sides of the inner cuttable tubular body 1906, as shown.

[0165]

[0190] In some embodiments, the locking elements 2302 are disposed on the outer introducer sheath layer 1904. One or more locking elements 2302 may be spaced apart around the circumference of the outer introducer sheath layer 1904. In one exemplary embodiment, the outer introducer sheath layer 1904 includes at least two locking elements 2302 disposed on opposite sides of the outer introducer sheath layer 1904, as shown.

[0166]

[0191] In various embodiments, after cutting the inner cuttable tubular body 1906 and the flow diverter 300, the trimmed inner cuttable tubular body 1906 and flow diverter 300 are inserted into the outer introducer sheath 1904, and the locking element 2302 is pushed between the outer introducer sheath layer 1904 and the inner cuttable tubular body 1906, as shown in FIG. 24, and is configured to lock the position of the outer introducer sheath layer 1904 relative to the inner cuttable tubular body 1906.

[0167]

[0192] In another embodiment, the inner cuttable tubular body 1906 and flow diverter 300 are disposed within the outer introducer sheath layer 1904, with the distal ends of the inner cuttable tubular body 1906 and flow diverter 300 extending beyond the distal end of the outer introducer sheath layer 1904 for cutting to a desired length. After cutting the inner cuttable tubular body 1906 and flow diverter 300, the outer introducer sheath layer 1904 may be retracted such that the locking element 2302 is wedged into the outer introducer sheath layer 1904.

[0168]

[0193] Alternatively, as shown in FIG. 25, the inner cuttable tubular body 1906 includes a flared end 2502 around the proximal end 2504 of the inner cuttable tubular body 1906 .

[0169]

[0194] In various embodiments, the flared end 2502 is configured to be wedged between the inner cuttable tubular body 1906 and the outer introducer sheath layer 1904 and lock the position of the outer introducer sheath layer 1904 relative to the inner cuttable tubular body 1906.

[0170]

[0195] In various embodiments, after cutting the inner cuttable tubular body 1906 and the flow diverter 300, the trimmed inner cuttable tubular body 1906 and flow diverter 300 are inserted into the outer introducer sheath 1904, and the flared end 2502 is configured to be pushed between the outer introducer sheath layer 1904 and the inner cuttable tubular body 1906, as shown in FIG. 26, to lock the position of the outer introducer sheath layer 1904 relative to the inner cuttable tubular body 1906.

[0171]

[0196] In another embodiment, the inner cuttable tubular body 1906 and flow diverter 300 are disposed within the outer introducer sheath layer 1904, with the distal ends of the inner cuttable tubular body 1906 and flow diverter 300 extending beyond the distal end of the outer introducer sheath layer 1904 for cutting to a desired length. After cutting the inner cuttable tubular body 1906 and flow diverter 300, the outer introducer sheath layer 1904 may be retracted over the flared end 2502, which is wedged into the outer introducer sheath layer 1904.

[0172]

[0197] While the present invention has been described in the foregoing specification with reference to specific embodiments thereof, those skilled in the art will recognize that the present invention is not limited thereto. Various features and aspects of the above-described invention can be used individually or together. Moreover, the present invention can be utilized in any number of environments and applications beyond those described herein without departing from the broader spirit and scope of the present specification. Accordingly, the specification and drawings should be regarded as illustrative rather than restrictive. It will be recognized that the terms "comprising," "including," and "having," as used herein, are specifically intended to be read as open-ended terms of art.

Claims

1. 1. A system for customizing a flow diverter for delivery into a neurovasculature to treat an aneurysm, comprising: an elongated tubular member having a proximal end and a distal end, the elongated tubular member including an inner wall defining a lumen; a flow diverter having a proximal end and a distal end, the flow diverter defining a flow path extending therethrough, the flow diverter being partially contained within the lumen of the elongate tubular member in a constrained configuration, and extending a first length beyond the distal end of the elongate tubular member; a deployment wire extending within the lumen of the elongate tubular member and within the flow channel of the flow diverter, the deployment wire having a proximal end, a distal end, and a distal portion having a tapered portion, the deployment wire comprising at least one deployment feature coupled to the flow diverter such that movement of the deployment wire relative to the elongate tubular member moves the flow diverter relative to the elongate tubular member; a tubing extending along and around the distal portion of the elongate tubular member, the tubing extending a second length beyond the distal end of the elongate tubular member, the distal end of the flow diverter being within the tubing, the tubing being severable; and A system comprising:

2. The system of claim 1 , wherein the flow diverter is cuttable to a desired length within the tubing.

3. The system of claim 1 , wherein the tubular body includes equally spaced graduations along the distal end of the tubular body.

4. The system of claim 1 , wherein the first length and the second length are equal.

5. The at least one deployment feature: 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 flow diverter; at least one friction bump disposed along the distal portion of the deployment wire that extends distally beyond the pusher, the at least one friction bump being inside the flow channel of the flow diverter and engaging a portion of the flow diverter; a tip coil extending distally from the friction bump; The system of claim 1 , comprising:

6. 3. The system of claim 2, further comprising a template having a top, a bottom, a front, a back, a first side, and a second side, the template including equally spaced markings along the bottom of at least one of the front and back sides, the markings configured to assist in cutting the flow distributor to the desired length.

7. 7. The system of claim 6, wherein the template further comprises a cut notch extending through the bottom portion of the template, the cut notch being adjacent one of the first and second sides, and the scale being located between the cut notch and the other of the first and second sides.

8. 8. The system of claim 7, wherein the template comprises a first set of markings along the bottom of the front surface of the template and a second set of markings along the bottom of the back surface of the template, one of the front surface of the template and the back surface of the template being configured for a right-handed user and the other of the front surface of the template and the back surface of the template being configured for a left-handed user.

9. The system of claim 6 , wherein the template correlates the graduations to a deployed length of the flow diverter.

10. 2. The system of claim 1, wherein the tubular body 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 tubular body to the distal end of the tubular body, and wherein the tubular body is peelably removable from the distal portion of the elongate tubular member by separating the first longitudinal portion from the second longitudinal portion.

11. The system of claim 1 , wherein the tubular body comprises a polymeric tube.

12. The system of claim 1 , wherein the tubular body is transparent.

13. The system of claim 12 , wherein the tubular body is a semi-rigid tube.

14. The system of claim 1 , wherein the flow diverter is visible within the tubing.

15. The system of claim 1 , wherein the at least one deployment feature comprises at least one friction bump.

16. The system of claim 15 , wherein the at least one friction bump comprises a plurality of friction bumps, the plurality of friction bumps being equally spaced apart.

17. 10. The system of claim 1, further comprising a protective sleeve extending along and around the proximal end of the flow diverter, the protective sleeve configured to reduce friction and / or reduce damage to the flow diverter when the flow diverter is moved relative to the elongate tubular member.

18. The system of claim 1 , wherein the flow diverter comprises a self-expanding member having a proximal end and a distal end.

19. The system of claim 18 , wherein the self-expanding member comprises a braid.

20. The system of claim 1 , wherein the deployment wire terminates before the distal end of the flow diverter such that the distal end of the deployment wire does not extend into the tubular body.

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