Implant and system for vascular treatment

Abstract

According to one aspect, an implant for vascular treatment may include a wire having a first section and a second section, each movable from a delivery state to a deployed state in response to removal of external pressure on the wire, the first section in the deployed state includes at least one loop securable to a target anatomical location of the subject, and the second section in the deployed state has a non-linear shape positionable to at least partially occupy an anatomical vessel with the first section secured to the target anatomical location, and the first section is stiffer than the second section.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 366,233, filed June 10, 2022, the entire contents of which are hereby incorporated by reference herein. Background Art

[0002] Implantable medical devices can be used to treat many diseases and conditions associated with the body's lumens. For example, a weakening in the arterial wall can develop into a vascular aneurysm and ultimately lead to internal bleeding and / or other conditions. Implant devices can be used to occlude blood vessels, aneurysms, and other anatomical spaces to treat such potentially dangerous conditions and / or for vascular sacrifice. For example, an implant device can be used to block (e.g., completely or partially) flow in a blood vessel, such as a location around or adjacent to an aneurysm or other vascular abnormality. However, the time associated with the accurate and stable placement of such implant devices at the treatment site is generally crucial. Therefore, there is a need for an implant device that can be quickly and reliably placed to occlude blood vessels, aneurysms, and other anatomical locations. Summary of the Invention

[0003] According to one aspect, an implant for vascular treatment may include a wire having a first segment and a second segment, both of which are capable of moving from a delivery state to a deployed state in response to removal of external pressure on the wire, the first segment including at least one ring capable of being secured to a target anatomical location of an object in the deployed state, the second segment having a nonlinear shape in the deployed state, which is capable of being positioned to at least partially occupy an anatomical vessel when the first segment is secured to the target anatomical location, and the first segment is stiffer than the second segment.

[0004] In some implementations, the first section of the wire can have a first spring constant greater than approximately 10 N / m and less than approximately 20 N / m.

[0005] In certain implementations, the second section of the wire can have a second spring constant greater than approximately 1 N / m and less than approximately 10 N / m.

[0006] In some implementations, the first section of the wire can have a first spring constant, the second section of the wire has a second spring constant, and the first spring constant is 2 to 20 times greater than the second spring constant.

[0007] In some embodiments, the first section of wire and the second section of wire can be coupled to each other at a coupling location. In some cases, the first section of wire can have a first proximal portion and a first distal portion, the second section of wire has a second proximal portion and a second distal portion, and the first distal portion of the first section of wire is coupled to the second proximal portion of the second section of wire at a coupling location. In some cases, the first section of wire and the second section of wire can be coupled to each other at a coupling location using one or more of welding, adhesive, or a sleeve. In some cases, the first section of wire and the second section of wire can form a continuous outer surface along the coupling location.

[0008] In some implementations, the first section of the wire and the second section of the wire can be collectively unitary.

[0009] In certain implementations, in the absence of external pressure on the wire, the at least one ring may include at least three rings. For example, the at least three rings may collectively form a spiral shape.

[0010] In some implementations, in the expanded state of the wire, at least one loop of the first section of the wire can have a maximum outer diameter greater than about 2 mm and less than about 25 mm.

[0011] In certain implementations, in the expanded state of the wire, the second section of the wire can be configured to collapse upon itself to at least partially occupy an anatomical vessel with the first section secured at the target anatomical location.

[0012] In some implementations, in the expanded state of the wire, the second section of the wire may have a predetermined three-dimensional shape. For example, the predetermined three-dimensional shape may define a cavity. Additionally or alternatively, the predetermined three-dimensional shape of the at least one loop of the first section of the wire and the second section of the wire may each have respective maximum external dimensions that are substantially equal to one another. Additionally or alternatively, the predetermined three-dimensional shape may have a maximum external dimension that is greater than approximately 2 mm and less than approximately 25 mm.

[0013] In certain embodiments, at least one of the first section of wire and the second section of wire may include a main winding, which defines a longitudinal axis surrounded by the main winding. The main winding may define a plurality of gaps therebetween. In some cases, when there is no external pressure on the wire, the plurality of gaps defined between the main windings may be tilted relative to the longitudinal axis surrounded by the main winding. In addition, or alternatively, in the expanded state, at least some of the plurality of gaps may have an axial dimension greater than about 12 microns and less than about 130 microns. In certain embodiments, the first section of wire and the second section of wire may both include a main winding, the main winding of the first section of wire having a first outer diameter, the main winding of the second section of wire having a second outer diameter, and the first outer diameter being different from the second outer diameter.

[0014] In some implementations, the wire can have a first length in the delivery state and a second length in the deployed state, and the first length is greater than the second length. As an example, the first length of the wire can be greater than about 0.5 cm and less than about 100 cm.

[0015] In certain implementations, a first section of the wire can be formed from a first material and a second section of the wire can be formed from a second material, where the first material is different from the second material.

[0016] In some implementations, at least one of the first section of the wire or the second section of the wire can include tungsten and platinum. As an example, at least one of the first section of the wire or the second section of the wire can include 92% platinum by weight and 8% tungsten by weight.

[0017] In certain implementations, the first section of the wire can have a first wire diameter and the second section of the wire has a second wire diameter, and at least one of the first wire diameter or the second wire diameter is greater than about 25 microns and less than about 260 microns.

[0018] In some implementations, in the expanded state of the wire, at least one of the first section of the wire or the second section of the wire can have a maximum outer dimension that is greater than approximately 0.25 mm and less than approximately 0.5 mm.

[0019] According to another aspect, a system for vascular treatment may include: a catheter defining an inner lumen and a distal opening that are fluidly connected to each other; an implant comprising a wire having a first segment and a second segment, both of which are capable of being positioned in the inner lumen in a delivery state, and the first segment of the wire is stiffer than the second segment of the wire; a tether coupled to the second segment of the implant; and a pusher member releasably coupled to the second segment of the wire via the tether, the pusher member being capable of advancing in a distal direction in the inner lumen toward the distal opening of the catheter, the first segment of the wire being capable of moving through the distal opening of the catheter to an expanded state including at least one ring in response to the distal advancement of the pusher member in the inner lumen.

[0020] In some embodiments, at least one of the first section of the wire and the second section of the wire may include a main winding that defines a gap, and when the first section of the wire and the second section of the wire are positioned in a lumen of the catheter in a delivery state, the main winding surrounds a longitudinal axis defined by the lumen.

[0021] In certain implementations, the first section of the wire can be movable from the delivery state within the lumen of the catheter to the deployed state while the second section of the wire remains within the lumen of the catheter in the delivery state.

[0022] In some embodiments, with the second section of the wire in a delivery state within the lumen and the first section of the wire in an expanded state, the pusher member may be capable of further advancing in a distal direction toward the distal opening, and in response to further distal advancement of the pusher member within the lumen, the second section of the wire may be capable of moving through the distal opening to an expanded state comprising a nonlinear shape.

[0023] In certain implementations, the pusher member can include one or more markings that indicate advancement of the implant relative to the lumen of the catheter.

[0024] In some implementations, the pusher member can be releasable from the tether with the first section of wire and the second section of wire both in a deployed state outside the lumen of the catheter.

[0025] In certain implementations, the tether may be formed from one or more thermoplastic elastomers.

[0026] In some implementations, the system can further include a rotary hemostasis valve, wherein the rotary hemostasis valve is in fluid communication with the lumen of the catheter and is actuatable into tension about the pusher member to constrain movement of the pusher member within the lumen of the catheter.

[0027] In certain implementations, the system can further include a one-way valve in fluid communication with the distal opening of the catheter via the lumen of the catheter, and the one-way valve is actuatable to control fluid delivery via the lumen of the catheter through the distal opening.

[0028] According to yet another aspect, a vascular treatment method may include advancing an implant comprising a wire in a delivery state through the vasculature of a subject to a target anatomical location within the vasculature; releasing a first segment of the wire from the delivery state to an expanded state comprising at least one ring; securing the at least one ring to the target anatomical location; and, with the at least one ring secured to the target anatomical location, releasing a second segment of the wire from the delivery state to an expanded state, the second segment of the wire having a nonlinear shape in the expanded state that at least partially occupies an anatomical vessel, and the first segment of the wire being stiffer than the second segment of the wire.

[0029] In some implementations, advancing the implant through the vasculature of the subject can include moving the implant through a lumen defined by a catheter.

[0030] In some implementations, advancing the implant through the vasculature of the subject can include moving the pusher in a distal direction to push the implant in an axial direction through the lumen of the catheter. In some cases, releasing the second segment of the wire from the delivery state to the deployed state can include disconnecting the pusher from a tether coupled to the second segment of the wire.

[0031] In some implementations, advancing the implant through the vasculature can include moving the implant to a blood vessel having an aneurysm.

[0032] In some cases, one or more implants may be positioned within the target vessel location. In some arrangements, (multiple) implants may be used to fill or otherwise occupy the desired volume of the target vessel. For example, the size, shape, number and / or details of (multiple) implants may be selected to fill as much volume as possible of the target vessel. In some implementations, 80% to 100% of the cross-sectional area of the target vessel may be filled by (multiple) implants. However, in other implementations, less than 80% of the cross-sectional area of the target vessel may be filled by (multiple) implants. In some embodiments, the relatively soft nature of the second section of the implant may promote contraction to achieve desired thrombosis and occlusion levels while reducing the possibility of generating potentially dangerous stresses on the wall of the vascular system or vascular defect, which may potentially lead to rupture (or re-rupture).

[0033] Other aspects, features, and advantages will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1A is a schematic diagram of a system for vascular treatment including a catheter, implant, tether, and pusher components.

[0035] Figure 1B When the pusher member moves the implant distally through the catheter Figure 1A Schematic diagram of the distal portion of the system.

[0036] Figure 1C yes Figure 1A Side view of the implant.

[0037] Figure 1D yes Figure 1A A cross-sectional side view of an implant, wherein the cross section is along Figure 1C 1D-1D interception in.

[0038] Figure 1E yes Figure 1A Schematic diagram of a first section of a wire of an implant in an expanded state, wherein Figure 1A The second section of the wire of the implant is in a delivery state within the catheter.

[0039] Figure 1F It is in the expanded state when there is no external pressure on the wire Figure 1A Schematic diagram of a first section and a second section of an implant.

[0040] Figures 2A-2His a schematic diagram of the time sequence of vascular treatment, which includes the release of Figure 1A The implant is fixed at a target anatomical position within a blood vessel and at least partially occupies the anatomical vessel.

[0041] Figure 3 is a schematic diagram of a vascular treatment that involves releasing Figure 1A The implant is fixed at a target anatomical position within an aneurysm of an anatomical blood vessel and allows the implant to at least partially occupy the aneurysm of the anatomical blood vessel.

[0042] Figure 4A is a perspective view of an implant including a wire having a first section and a second section, the wire shown in an expanded state with no external force on the wire, wherein the first section of the wire includes at least one loop and the second section of the wire has a predetermined three-dimensional shape.

[0043] Figure 4B yes Figure 4A A perspective view of a first section of a wire of an implant of FIG. 1 , the first section of the wire being shown in an expanded state with no external force on the wire.

[0044] Figure 4C yes Figure 4A A perspective view of a second segment of a wire of an implant of FIG. 1 , the second segment of the wire being shown in an expanded state with no external force on the wire.

[0045] Like reference numbers in the various drawings indicate like elements. Specific implementation

[0046] Embodiments will now be described with reference to the accompanying drawings.The foregoing may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

[0047] All documents mentioned herein are hereby incorporated by reference in their entirety. Unless expressly stated otherwise or clear from the context, references to items in the singular should be understood to include the plural items, and vice versa. Grammatical conjunctions are intended to express any and all disjunctive and conjunctive combinations of the linked clauses, sentences, words, and the like, unless otherwise stated or clear from the context. Thus, the term "or" should generally be understood to mean "and / or," and similarly, the term "and" should generally be understood to mean "and / or."

[0048] The description of numerical ranges herein is not intended to limit, but refers to any and all numerical values falling within the range, unless otherwise indicated herein, and each individual value within such a range is incorporated into the specification as if it were individually described herein. When accompanied by numerical values, the words "about", "approximately" or the like will be interpreted as indicating a deviation that satisfactorily operates for the intended purpose as will be appreciated by those skilled in the art. Value ranges and / or numerical values are provided herein only as examples and do not constitute a limitation on the scope of the embodiments described. The use of any and all examples or exemplary language ("for example", "such as" or the like) provided herein is only intended to better describe the embodiments and does not result in limitation on the scope of the embodiments. Any language in the specification should not be interpreted as indicating that any unclaimed element is essential for the practice of the embodiments.

[0049] In the following description, it is understood that terms such as “first,” “second,” and the like are words of convenience and are not to be construed as limiting terms.

[0050] As used herein, unless otherwise indicated or clear from the context, the term "physician" should be understood to include surgeons or other interventional specialists who prepare and / or perform any one or more of the medical procedures described herein, and more broadly, should be understood to include any medical personnel, such as nurses, who assist such surgeons or interventional specialists in preparing for or performing any one or more of the medical procedures described herein. Furthermore, as used herein, the term "subject" should be understood to include any type of mammal (including humans) on which a medical procedure (such as, but not limited to, thrombectomy) may be performed.

[0051] In addition, as used herein, implants and portions thereof are described as having a "delivery state" and an "expanded state". It will be appreciated that the "delivery state" refers to the shape and orientation of an implant or portion thereof under external pressure (such as pressure applied by a catheter to an implant or portion thereof disposed in an inner cavity defined by the catheter), as indicated by the context. In addition, or alternatively, it will be appreciated that the "expanded state" refers to the shape and orientation of an implant or portion thereof when the external pressure is removed from the implant or portion thereof, as indicated by the context. Given that the shape and orientation of an implant in an anatomical vessel of an object can be deformed in any of a variety of different ways by external pressure on the implant from one or more anatomical features of the object, the shape of the final shape of the implant in the anatomical vessel can be unpredictable and therefore difficult to describe. Therefore, for the sake of clarity and effective description, the expanded state of an implant or portion thereof should be understood to refer to the shape and orientation of the implant or portion thereof in the absence of external pressure from a catheter and / or anatomical features of the object, as indicated by the context. To the extent that certain aspects of the expanded state of an implant are described in the context of its shape and orientation in an anatomical vessel, it should be recognized that such description assumes that the implant is sized relative to the anatomical vessel to achieve certain characteristics of the implant in the expanded state in the absence of external pressure on the implant.

[0052] In the following description, the implant is described as having a first segment and a second segment. It should be appreciated that this is for clarity and efficiency of description and should not be construed as limiting unless expressly indicated or the contrary intention is clear from the context. Thus, any one or more of the implants of the present disclosure may have two or more segments that are distinct from one another, as may be useful for achieving rapid and reliable placement of an implant for vascular treatment.

[0053] While various embodiments disclosed herein refer specifically to vascular occlusive devices (e.g., for blocking blood flow in a specific blood vessel, for treating cerebral aneurysms and other vascular abnormalities, etc.), it should be understood that this is for the sake of clarity and efficiency of description. Accordingly, the implants, systems, and methods disclosed herein should be understood to be useful with other types of medical devices and / or other types of medical treatments, unless expressly indicated or clear from the context to the contrary. By way of example, unless otherwise specified or clear from the context, the implants described herein can be used with defects of any size and / or for treating any indication, as desired or required. Furthermore, while the present disclosure describes coil implants (e.g., microcoils) or other devices capable of being implanted (e.g., permanently, temporarily, retractably, etc.) within a blood vessel, it should be understood that such implants can be implanted in other luminal structures, aneurysms or other defects, and / or any other location within the subject's anatomy. Furthermore, while the implants are described as being delivered using a catheter, it should be understood that the implants described herein can be delivered to and released at the target anatomical location of a subject using any desired protocol or technique.

[0054] Now refer to Figures 1A-1F , a system 100 for vascular treatment may include a catheter 102, an implant 104, a tether 106, and a pusher member 108. The catheter 102 may define a lumen 110 and a distal opening 112 in fluid communication with each other. The implant 104 may include a wire 114 having a first segment 116 and a second segment 118, each of which is positionable in the lumen 110 of the catheter 102 in a delivery state. The tether 106 may be coupled to the second segment of the implant 104, and the pusher member 108 may be detachably coupled to the second segment 118 of the wire 114 via the tether 106. Additionally, or alternatively, the pusher member 108 may be configured to advance in a distal direction within the lumen 110 toward the distal opening 112 of the catheter 102. In response to distal advancement of pusher member 108 within lumen 110 , first section 116 of wire 114 may be configured to move through distal opening 112 of lumen 110 to a deployed state including at least one loop 120 .

[0055] In general, the first segment 116 of the wire 114 and the second segment 118 of the wire 114 can differ from each other with respect to one or more properties or characteristics such that the first segment 116 of the wire 114 and the second segment 118 of the wire 114 can facilitate performing different aspects of a vascular treatment using only a single implant. The differences in the properties or characteristics of the first segment 116 of the wire 114 and the second segment 118 of the wire 114 can facilitate performing the vascular treatment using fewer implants (e.g., in some cases, a single implant) as compared to using multiple implants (e.g., multiple coils) to achieve the differences in the properties or characteristics, thereby reducing the time of the implantation procedure, simplifying the implantation procedure, improving safety, and / or providing one or more other benefits or advantages.

[0056] In certain implementations, the first section 116 of the wire 114 can be stiffer than the second section 118 of the wire 114, such that the spring constant of the first section 116 of the wire 114 is greater than the spring constant of the second section 118 of the wire 114. For example, the spring constant of the first section 116 of the wire 114 can be up to about 40% greater than the spring constant of the second section 118 of the wire 114. Additionally or alternatively, the first spring constant can be 2 to 20 times greater than the second spring constant. In certain implementations, the first section 116 of the wire 114 can have a first spring constant greater than about 10 N / m and less than about 20 N / m, which can be useful for retaining shape to secure the first section 116 of the wire 114 to a target anatomical location. Additionally or alternatively, the second section 118 of the wire 114 can have a second spring constant greater than about 1 N / m and less than about 10 N / m, as can be useful for collapsing the second section 118 of the wire 114 in the deployed state into a nonlinear shape to at least partially occupy an anatomical vessel, wherein the first section 116 of the wire 114 is secured at a target anatomical location. The greater stiffness of the first section 116 of the wire 114 in the deployed state can facilitate anchoring or otherwise securing the implant 104 within the target anatomical location of the subject, while the lower stiffness of the second section 118 of the wire 114 in the deployed state can facilitate achieving a nonlinear shape to at least partially occupy an anatomical vessel, wherein the first section 116 of the wire 114 is secured at the target anatomical location. Additionally, or alternatively, the shapes, sizes (e.g., diameter or other cross-sectional dimensions, length, etc.) of first segment 116 of wire 114 and second segment 118 of wire 114 may differ from each other, as may be useful for performing vascular treatment using wire 114.

[0057] In some implementations, in the deployed state, the first section 116 of the wire 114 can include at least one loop 120, such as can be useful for surrounding a target anatomical location within a blood vessel, wherein the radial force of the at least one loop 120 abuts the target anatomical location, facilitating securing the implant 104 in place. In this context, the at least one loop 120 should be understood to include any one or more shapes of revolution upon release of external pressure on the first section 116 of the wire 114. That is, upon release of external pressure on the first section 116 of the wire 114, the at least one loop 120 need not necessarily be geometrically circular, provided that the shape of the at least one loop 120 facilitates securing the implant 104 at the target anatomical location within the subject to perform vascular treatment. While the at least one loop 120 can include a complete revolution, the at least one loop 120 can further or alternatively include a partial loop (e.g., 1 / 4, 1 / 2, 3 / 4, etc.). As an example, the at least one loop 120 of the first section 116 of the wire 114 in the deployed state can include at least three loops (e.g., 3 to 3 1 / 4 rings), and in some cases, at least three rings can collectively form a helical shape.

[0058] At least one ring 120 may have an outer diameter DIMB that is equal to or substantially equal to the inner diameter of the target vessel (e.g., an anatomical vessel adjacent to a vascular anomaly, a section of a subject's vessel expected to undergo vascular sacrifice, etc.), wherein in this context, substantially equal is understood to allow the anatomical structure to deviate from a uniform circular shape at certain locations. In some embodiments, the outer diameter DIMB of at least one ring 120 may be larger than the diameter of the target vessel (e.g., 0 to 1, 1 to 2, 2 to 3, 3 to 4, 4 to 5, 5 to 10%, more than 10%, a percentage between the aforementioned values and ranges, etc.). In such a configuration, the first segment 116 of the wire 114 may be sized, shaped, and / or otherwise adapted to apply force to the target anatomical location to help anchor or secure the implant 104 within the target vessel. According to some implementations, DIMB may be modified or otherwise adjusted to accommodate particular design requirements and / or applications or uses. The DIM B of the first section 116 of the wire 114 can be greater than about 2 mm and less than about 25 mm (e.g., 2 to 25, 3 to 20, 4 to 15, 5 to 10 mm, values between the aforementioned values, etc.), allowing for dimensional tolerances associated with manufacturing. Although the at least one ring 120 may be substantially circular in some cases, it should be recognized that the at least one ring 120 may be non-circular in other cases, and in the case where the at least one ring 120 is non-circular, the DIM B should be understood to refer to the maximum outer dimension of the non-circular shape.

[0059] Generally, the second section 118 of the wire 114 remains in the lumen 110 of the catheter 102 in a delivery state (e.g., Figure 1E), the first section 116 of the wire 114 may be capable of being removed from the delivery state (e.g., in the lumen 110 of the catheter 102) within the lumen 110. Figure 1B Additionally, or alternatively, the second section 118 of the wire 114 is in the delivery state within the lumen 110, and the first section 116 of the wire 114 is in the deployed state (e.g., Figure 1E ), pusher member 108 may be configured to be further advanced in a distal direction toward distal opening 112. In response to further distal advancement of pusher member 108 within lumen 110 of catheter 102, second section 118 of wire 114 may be configured to move through the distal opening to an expanded state comprising a nonlinear shape of second section 118 of wire 114.

[0060] In general, the second section 118 of the wire 114 may have any one or more of a variety of different nonlinear shapes associated with performing vascular treatment at a target location within a blood vessel of a subject. In particular, the nonlinear shape of the second section of the wire 114 in the deployed state may occupy at least a portion of the anatomical vessel. For example, in the deployed state of the wire 114, and with the first section 116 of the wire 114 secured at the target anatomical location, the second section 118 of the wire 114 may be capable of collapsing on itself to at least partially occupy the anatomical vessel. In other words, with the first section 116 of the wire 114 secured in place at the target anatomical location, the nonlinear shape of the second section 118 of the wire 114 may collapse on itself such that the second section 118 of the wire 114 acts as a collapsing coil.

[0061] In certain embodiments, the first section 116 of the wire 114 and / or the second section 118 of the wire 114 may include a main winding 122 that defines a first longitudinal axis A1 encompassed by the main winding 122. The main winding 122 may include a helically wound component having continuous turns or coils. In some embodiments, such turns or coils may be angled relative to the first longitudinal axis A1 and / or relative to a radial axis of the main winding 122. For example, the turns or coils may be angled from 0 to 90 degrees (e.g., from 0 to 90 degrees, from 10 to 80 degrees, from 20 to 60 degrees, angles between the aforementioned angles, etc.) relative to the first longitudinal axis A1 and / or the radial axis. In addition, or alternatively, with the first segment 116 of the wire 114 and the second segment 118 of the wire 114 positioned in the lumen 110 of the catheter 102 in a delivery state, the main winding 122 may surround a second longitudinal axis L2 defined by the lumen 110 of the catheter 102, as may be useful for delivering the implant 104 to a target anatomical location via the catheter 102.

[0062] The main windings 122 may define a plurality of gaps G therebetween. As an example, in the absence of external pressure on the wire 114, the plurality of gaps G defined between the main windings 122 may be inclined relative to the first longitudinal axis A1 surrounded by the main windings 122. Additionally or alternatively, in the case where the plurality of gaps G are along the first section 116 of the wire 114, the plurality of gaps G may facilitate providing a greater rigidity (and therefore, a greater spring constant) to the first section 116 of the wire 114 than the rigidity of the second section 118 of the wire 114. Additionally or alternatively, the plurality of gaps G along the first section 116 of the wire 114 may improve the gripping properties of the first section 116 of the wire 114 to facilitate anchoring the implant 104 to the adjacent tissue of the blood vessel. For example, in some arrangements where the plurality of gaps G are along the first section 116 of the wire, the plurality of gaps G may act as a clip-like feature, providing an increased surface area along the plurality of gaps G and / or providing another benefit of assisting anchoring. In some implementations, the plurality of gaps G of the first section 116 of the wire 114 can be equal or substantially equal (allowing for dimensional tolerances) for each instance of the plurality of gaps G. However, in other implementations, the sizes of the plurality of gaps G can vary along the sections of the implant 104 as desired or required. Any other features or characteristics can be used to alter the stiffness and / or other aspects of the first section 116 of the wire 114 and / or the second section 118 of the wire 114, as an alternative or in addition to including a plurality of gaps G along corresponding portions of the wire 114.

[0063] According to some arrangements (e.g., those in which the plurality of gaps G are arranged along the first section 116 of the wire 114), at least some of the plurality of gaps G may have an axial dimension greater than about 12 microns and less than about 130 microns. In some cases, a gap size of about 38 microns may provide advantageous features for the first section 116 of the implant 104. In some cases, the second section 118 of the wire 114 may include a plurality of gaps G, while in other cases, the second section 118 of the wire 114 may not include any gaps. Furthermore, in the case in which both the first section 116 of the wire 114 and the second section 118 of the wire 114 include a main winding 122, the main winding 122 of the first section 116 of the wire 114 may have a first outer diameter D1, and the main winding 122 of the second section 118 of the wire 114 may have a second outer diameter D2. Although the first outer diameter D1 and the second outer diameter D2 may be equal to each other in some cases, it should be appreciated that in other cases, the first outer diameter D1 may be different from (e.g., greater than or less than) the second outer diameter D2. In the case where the first segment 116 of the wire 114 is non-circular, the first outer diameter D1 should be understood to refer to the maximum outer cross-sectional dimension of the first segment 116 in the transport state. Similarly, in the case where the second segment 118 of the wire 114 is non-circular, the second outer diameter D2 should be understood to refer to the maximum outer dimension of the second segment 118 in the transport state.

[0064] In some arrangements, the first segment 116 of the wire 114 and the second segment 118 of the wire 114 can be wound around a single cylindrical mandrel (not shown). The first segment 116 of the wire 114 can have a first proximal portion 126 and a first distal portion 128, the second segment 118 of the wire 114 can have a second proximal portion 130 and a second distal portion 132, and the first distal portion 128 can be coupled to the second proximal portion 130 at the coupling location 124 to form a single, unitary implant from the first proximal portion 126 of the first segment 116 of the wire 114 to the second distal portion 132 of the second segment 118 of the wire 114. The first segment 116 of the wire 114 and the second segment 118 of the wire 114 can be secured to each other using any one or more connection methods or techniques. For example, the first section 116 of the wire 114 and the second section 118 of the wire 114 may be secured to each other at the coupling location 124 using one or more of welding (e.g., laser welding), adhesives, or sleeves. Welding may be particularly useful because it does not introduce any new materials or material interactions and does not alter the aging of any existing materials in the first section 116 and / or the second section 118. Additionally, or alternatively, the first section 116 of the wire 114 and the second section 118 of the wire 114 may form a continuous outer surface along the coupling location 124. That is, at the coupling location 124, the connection between the first section 116 of the wire 114 and the second section 118 of the wire 114 may form a smooth transition between the first section 116 of the wire 114 and the second section 118 of the wire 114.

[0065] Generally, the first section 116 of the wire 114 can be formed from a first material, and the second section 118 of the wire 114 can be formed from a second material, which can be the same as or different from the first material. In some implementations, the first section 116 of the wire 114 can include a platinum-tungsten alloy. For example, the platinum-tungsten alloy can include an alloy of 92% platinum and 8% tungsten (92 / 8Pt / W), a shape memory material having superelastic properties, other metals or alloys, and / or any other material. Additionally or alternatively, the first section 116 of the wire 114 can include a material that is not a helical shape and / or a shape memory material, as desired or required. Additionally or alternatively, the second section 118 of the wire 114 can include a platinum-tungsten alloy and / or any other material. For example, the second section 118 of the wire 114 can include a platinum-tungsten alloy that includes an alloy of 92% platinum and 8% tungsten (92 / 8Pt / W). However, in other implementations, the implant 104 can include other alloys having superelastic properties and / or other shape memory materials in addition to or in place of platinum and tungsten.

[0066] In some embodiments, the first outer diameter D1 of the first section 116 of the wire 114 and / or the second outer diameter D2 of the second section 118 of the wire 114 (when the implant 104 is in the delivery state, such as before the release in the object body) can be approximately 0.25mm to approximately 0.51mm inch, allowing the variation associated with manufacturing tolerances. However, in other implementations, the first outer diameter D1 and / or the second outer diameter D2 can be less than approximately 0.25mm or greater than approximately 0.51mm.

[0067] In some embodiments, the first section 116 of the wire 114 may have a first wire diameter WD1, and the second section 118 of the wire 114 may have a second wire diameter WD2, which are approximately equal in size (allowing for differences associated with manufacturing tolerances), while in other embodiments, the first wire diameter WD1 and the second wire diameter WD2 may be different from each other. In some cases, the first wire diameter WD1 of the first section 116 of the wire 114 may be greater than about 25 microns and less than about 260 microns. However, in other arrangements, the first wire diameter WD1 of the first section 116 of the wire 114 may be less than about 25 microns or greater than about 260 microns. By way of example, in some cases, the first wire diameter WD1 of the first section 116 of the wire 114 may be about 70 microns to about 76 microns. In addition, or alternatively, the second wire diameter WD2 of the second section 118 may be greater than about 25 microns and less than about 260 microns. In some cases, second wire diameter WD2 of second section 118 of wire 114 may be approximately 51 microns, approximately 64 microns, or approximately 76 microns.

[0068] In some cases, the wire 114 may have a first length L1 in a transport state within the lumen 110 of the catheter 102 and a second length L2 in an expanded state when there is no external pressure on the wire 114. The first length L1 may be greater than the second length L2. In addition, or alternatively, the first length L1 may vary based on the type of vascular abnormality being treated, the target peripheral blood vessel (e.g., blood vessel diameter), the intended surgery, the age, health status, or other characteristics of the subject and / or the like. In some implementations, the first length L1 of the wire 114 may be 0.5 cm to 100 cm (e.g., 0.5 to 100, 0.5 to 75, 0.5 to 50, 1 to 40 cm, values between the aforementioned values, etc.).

[0069] In some implementations, the first length L1 of the wire 114 in the delivered state can vary proportionally (e.g., linearly, nonlinearly, etc.) to the outer diameter DIM B of the at least one loop 120 formed by the first segment 116 of the wire 114 in the absence of external pressure (in the deployed state). For example, a larger value of DIM B for treating larger blood vessels can correspond to a larger value of the first length L1. In some implementations, the outer diameter DIM B of the at least one loop 120 and the first length L1 of the implant 104 can be selected to at least partially occlude blood flow in a target blood vessel location surrounding a vascular defect.

[0070] Generally, the pusher member 108 can be movable within the lumen 110 of the catheter 102 to push the implant 104 in a direction parallel to the second longitudinal axis A2 defined by the lumen 110 of the catheter 102. In some cases, the pusher member 108 can include one or more markings 134 that indicate advancement of the implant 104 relative to the lumen 110 of the catheter 102.

[0071] The pusher member 108 can be releasable from the tether 106 with the first section 116 of the wire 114 and the second section 118 of the wire 114 in an expanded state outside the lumen 110 of the catheter 102. For example, the tether 106 can be formed from one or more thermoplastic elastomers. In some arrangements, the tether 106 can include a thermoplastic elastomer such as, for example, Engage TM Polyolefin elastomer (available from Dow, Midland, Michigan, USA), polyester thread (eg, polyethylene terephthalate (PET)), and / or any other material. The diameter of the tether 106 may be 19 microns to 76 microns.

[0072] In some implementations, the system 100 can include one or more valves. For example, the system 100 can include a rotary hemostasis valve 136 in fluid communication with the lumen 110 of the catheter 102. The rotary hemostasis valve 136 can facilitate controlling the position of the pusher member 108. For example, the rotary hemostasis valve 136 can be actuated to tighten around the pusher member to constrain movement of the pusher member 108 within the lumen 110 of the catheter 102. As a more specific example, the pusher member 108 can include a proximal fluorescent safety marker, and when the proximal fluorescent safety marker reaches the hub of the catheter 102 (e.g., a microcatheter) used to deliver the implant 104, the RHV can tighten around the pusher member 108 to constrain any further distal movement of the pusher member 108. Additionally, or alternatively, the system 100 can include a one-way valve 138 in fluid communication with the distal opening 112 of the catheter via the lumen 110 of the catheter 102, and the one-way valve 138 can be actuated to control delivery of a fluid (e.g., saline) via the lumen 110 of the catheter 102 through the distal opening 112.

[0073] As an example, the system 100 can provide a solution (e.g., saline) flush. Flushing (e.g., continuous or intermittent flushing) can advantageously reduce friction between the implant 104 and the lumen 110 of the catheter 102 and / or reduce the likelihood of clot formation and / or provide one or more other benefits. To prepare the system 100 for continuous flushing, a rotary hemostasis valve 136 can be attached to the hub 140 of the guide catheter 142. A three-way stopcock 144 can be attached to the side arm of the rotary hemostasis valve 136, and a line can be connected for continuous infusion of the flushing solution. Another example of a rotary hemostasis valve 136 can be attached to the hub 146 of the catheter 102. A one-way valve 138 (e.g., a one-way stopcock) can be attached to the side arm of the rotary hemostasis valve 136 attached to the hub 146 of the catheter 102, and a line for continuous flushing with an appropriate solution can be connected to the one-way valve 138.

[0074] The one-way valve 138 can be opened and the catheter 102 can be flushed with a sterile flush solution before closing the one-way valve 138. In some implementations, to minimize or at least reduce the risk of thromboembolic complications, it can be useful to maintain a continuous infusion of an appropriate sterile flush solution into the guide catheter 142, the introducer sheath 148, and the catheter 102. In certain implementations, continuous or substantially continuous flushing (e.g., with the flush solution) can be provided via a pressurized bag or other pressurized source, for example, at a predetermined pressure (e.g., 300 mmHg).

[0075] Having described various aspects of system 100, attention is now directed to exemplary methods of vascular treatment using system 100. In particular, Figures 2A-2H is a schematic diagram of a time sequence of an exemplary method of vascular treatment that includes releasing an implant 104 and securing the implant at a target anatomical location within a blood vessel so that it at least partially occupies the anatomical vessel.

[0076] Now refer to Figures 1A-1F2A-2H, an exemplary method of vascular treatment using system 100 may include advancing implant 104 in a delivery state through the vasculature of a subject to a target anatomical location. The target location may include a peripheral vasculature location at or near a vascular abnormality (such as an aneurysm A) (e.g., to completely or at least partially block, occlude, redirect, etc., blood flow in a vascular abnormality of a peripheral vessel), a segment of the vasculature requiring vascular sacrifice, and / or any other location within the anatomical structure of the subject. According to some arrangements, when disposed within catheter 102, the filamentous elements of the layers of implant 104 may assume an elongated, non-everted configuration that is substantially parallel to each other and to the second longitudinal axis A2 of the lumen 110 of catheter 102. Additionally, or alternatively, advancing implant 104 through the vasculature may include compressing (e.g., radially compressing) implant 104 into lumen 110 of catheter 102 for intravascular delivery through the subject.

[0077] In some implementations, during surgery, high-quality digital subtraction fluoroscopic path mapping can be used to determine and achieve correct guidance and placement of the implant 104 within a target location in the vasculature or other target location of the subject's anatomy. For example, in some arrangements, the guide catheter 142 can have an inner diameter that is large enough to allow injection of a contrast agent while the catheter 102 (e.g., a microcatheter) is advanced to perform fluoroscopic path mapping during surgery. Additionally, or alternatively, any other type of imaging or other technology can be used to assist in determining the correct placement of the implant 104.

[0078] In some embodiments, the catheter 102 can be introduced into the vasculature of the subject using a percutaneous access point. The catheter 102 can be advanced to the cerebral vasculature of the subject, the peripheral vascular network of the subject, and / or any other anatomical location of the subject as desired or required. The catheter 102 can be, for example, a reinforced catheter (e.g., a wire-reinforced microcatheter). In addition, or alternatively, the catheter 102 can include one or more coatings, layers, and / or other features. For example, in some cases, the catheter 102 can include an inner surface coating such as polytetrafluoroethylene (PTFE) and / or other thermoplastic coatings. In addition, or alternatively, the catheter 102 can include one or more (e.g., 1, 2, 3, more than 3, etc.) radiopaque markers to assist in the advancement of the catheter 102 through the vasculature or other portion of the anatomical structure of the subject.

[0079] In some cases, a guide catheter 142 and / or a guidewire can be used to facilitate advancement of the catheter 102 through the subject's anatomical structure to the target location. The catheter 102 can be advanced within the subject's intravascular network until the distal opening 112 of the catheter 102 is located at or near the target location in the subject's vasculature. The target location can be past the aneurysm A (e.g., distally thereof). That is, at the target location, the distal opening 112 of the catheter 102 can be directed downstream of the peripheral blood vessels of the aneurysm A. Once the catheter 102 is positioned, the guide catheter 142 can be removed.

[0080] After performing fluoroscopic path mapping, the physician can use, for example, pre-treatment angiography (e.g., angiographic assessment of the diameter of the parent vessel, peripheral vessel, lesion, and / or the like) and / or any other technique to measure and / or estimate the size of the lesion or vessel to be treated. In some cases, this information can be used (e.g., with or without consideration of other data, factors, etc.) to select the size of the implant 104. The implant 104 can be advanced through the microcatheter 212 to a target vessel position distal to the aneurysm A. In some implementations, the implant 104, which is secured to the pusher member 108, can be pre-positioned within the catheter 102 (e.g., when the implant 104 is in a delivery state) before the catheter 102 is introduced into the vascular system. Alternatively, after the catheter 102 is positioned within the subject's body, the implant 104 can enter the proximal opening of the lumen 110 of the catheter 102.

[0081] The implant 104 can be advanced distally through the distal opening 112 of the lumen 110 of the catheter 102 toward the target blood vessel location. The implant 104 can be advanced by advancing the pusher member 108 in a smooth, continuous motion within the lumen 110 of the catheter 102. For example, the implant 104 can be advanced until the proximal end of the pusher member 108 contacts or otherwise engages the proximal end of the introducer sheath 148. After the correct position of the pusher member 108 is confirmed, the rotary hemostasis valve can be released and the introducer sheath 148 can be retracted from the rotary hemostasis valve 136.

[0082] In some implementations, the physician can position a marker (e.g., a fluorescent safety marker) toward the proximal end of the pusher member 108. The implant 104 can be further advanced until the pusher member 108 is at least partially located within the rotary hemostasis valve 136 on the hub 146 of the catheter 102. The pusher member 108 can be further advanced until the fluorescent safety marker approaches the rotary hemostasis valve 136. In some arrangements, the fluorescent safety marker reaching the rotary hemostasis valve 136 can indicate that the implant 104 is located at or near the distal opening 112 of the catheter 102, and fluoroscopic guidance can be initiated.

[0083] An exemplary method of vascular treatment using the system 100 may include releasing the first segment 116 of the wire 114 from a delivery state to a deployed state including the at least one loop 120. For example, once the distal opening 112 of the catheter 102 is positioned adjacent to the vascular defect, the implant 104 may be advanced distally beyond the distal opening 112 of the catheter 102, thereby allowing the first segment 116 of the wire 114 to begin assuming a three-dimensional or implanted shape including the at least one loop 120. For example, using fluoroscopic guidance, the implant 104 may be slowly advanced out of the catheter 102 until a desired placement of the first segment 116 of the wire 114 in the deployed state is achieved.

[0084] In addition, or alternatively, an exemplary method of vascular treatment using the system 100 may include securing at least one ring 120 at a target anatomical location. That is, as the implant 104 emerges from the distal opening 112 under the axial force of the pusher member 108 moving distally along the lumen 110, the implant 104 may begin to assume a non-stretched or implanted (e.g., non-linear) state within the target vascular location. In some embodiments, the first segment 116 of the catheter 102 may emerge from the distal opening 112 of the catheter 102 and begin to form at least one ring 120 in an expanded state, such that the first segment 116 of the wire 114 in the expanded state can act as an anchor at the target vascular location, passing through the vascular defect (e.g., through the aneurysm A) to prevent or reduce the likelihood that the implant 104 will detach from the target vascular location and / or otherwise move (e.g., migrate) undesirably (even in high flow scenarios).

[0085] Additionally or alternatively, an exemplary method of vascular treatment using the system 100 may include, with the at least one ring 120 secured at the target anatomical location, releasing the second segment 118 of the wire 114 from a delivery state to a deployed state such that the second segment 118 of the wire 114 assumes a nonlinear shape that at least partially occupies the anatomical vessel. That is, once the first segment 116 of the wire 114 is anchored, the pusher member 108 may be further distally advanced within the lumen 110 of the catheter 102 such that the second segment 118 of the implant 104 may begin to assume a nonlinear shape associated with the deployed state of the second segment 118 of the implant 104. As the implant 104 is further advanced in the distal direction, the relative flexibility of the second segment 118 of the implant 104 may facilitate at least partially “collapse” or occupying the volume of the anatomical vessel at or near the target vascular location. In some cases, catheter 102 may be retracted proximally until implant 104 at least partially occupies a target vascular position outside of the vascular defect (e.g., a position outside of aneurysm A). However, in other embodiments, catheter 102 is not retracted upon deployment of implant 104 as desired or required for a particular application or use.

[0086] According to some embodiments, the implant 104 can be advanced until the breakaway region (eg, tether 106) is positioned outside of the catheter 102 (eg, immediately outside of the distal opening 112) (see, e.g., Figure 2E When imaging techniques are used, there may be some visual indication of this location. For example, one or more markers 134 on the pusher member 210 may be adjacent to the distal side of the proximal radiopaque marker 150 on the catheter 102.

[0087] In some embodiments, once the implant 104 is pushed out of the distal opening 112 of the catheter 102, the second distal portion 132 of the second segment 118 of the wire 114 can be axially contracted (e.g., toward the second proximal portion 130) such that the second segment 118 assumes a nonlinear shape (e.g., a three-dimensional configuration) within the target anatomical vessel. However, any other method or technique can be used to advance, deliver, and / or deploy the implant 104 to the desired anatomical location of the subject, as desired or required. Once the implant 104 is intravascularly blocked or occluded blood flow in the target anatomical vessel, the catheter 102 can be removed from the subject, as described in the accompanying drawings. Figure 2G Displayed in.

[0088] With the implant 104 positioned at the target location with the detachment zone positioned outside the catheter 102, the rotary hemostasis valve 136 can be tightened around the pusher member 108 to prevent or reduce the likelihood of movement of the implant 104. The operator can verify (e.g., once, repeatedly, etc.) that the distal end of the pusher member 108 is not under stress before the coil is detached. This verification may be desirable or necessary to reduce or eliminate the possibility that axial compression or tension may cause the distal end of the catheter 102 to move during detachment of the implant 104, thereby causing a vascular defect (e.g., aneurysm A) or a vascular rupture.

[0089] Additionally, in some implementations, the implant 104 can be observed (e.g., under fluoroscopy or other imaging techniques) after placement and before the implant 104 is detached from the tether 106. This can help reduce or eliminate the possibility of undesirable movement of the implant 104 after the procedure is complete. In some cases, undesirable movement can indicate that the size of the implant 104 is inappropriate. In those cases, the implant 104 can be removed and replaced with another example of the implant 104 that is more appropriately sized for the particular procedure.

[0090] Once placement of the implant 104 is resolved, in some arrangements, the pusher member 108 can be detached from the tether 106 coupled to the second section 118 of the wire 114. Such detachment can be achieved using any known method, such as, for example, melting the tether using heat or electrical energy, cutting or otherwise mechanically damaging the tether, chemically damaging the tether, and / or the like. After detachment, the pusher member 108 can be removed from the catheter 102. For example, before removing the pusher member 108, the rotary hemostasis valve 136 can be released and the pusher member 108 can be retracted (e.g., slowly) while confirming (e.g., under fluoroscopy or using other imaging techniques) that there is no movement of the implant 104 (e.g., or that any movement is within an acceptable tolerance).

[0091] As mentioned above, the microcoil and / or other implants disclosed herein may be detachable for delivery and implantation in a desired anatomical position. Any of the various known detachment methods or techniques can be used to deliver the implant to the desired anatomical position according to expectations or requirements. Although the detachment system may include some dynamic processes, some systems involve more physical movement of the system than other systems. For example, a mechanical detachment system using pressure, unscrewing, axial piston release and / or the like may cause a limited amount of movement of the implant 104 at the target anatomical position during detachment. In some arrangements, non-mechanical detachment systems (e.g., chemical, temperature, electrolysis, etc.) may include less movement, but may result in lower consistency in some cases. However, in some arrangements, such systems often suffer from lower consistency. Although the electrical isolation of the implant 104 itself may help reduce the average detachment times of the implant 104, there may still be some inconsistencies in how quickly the implant 104 can detach. Additionally, or alternatively, a single long detachment time may risk instability during detachment of the implant 104 (eg, due to subject movement, other factors, etc.) Some detachable systems may include special features at the junction between the pusher member 108 and the implant 104 .

[0092] Although certain aspects of implants, systems, and methods of vascular treatment are described, other aspects of implants, systems, and methods of vascular treatment may additionally or alternatively be possible.

[0093] As an example, although the implant is described as being deployed wherein the first section of wire at least partially occupies the volume of an anatomical vessel, other types of deployment are additionally or alternatively possible. For example, referring now to Figure 3 , the first section 116 of the wire 114 can be deployed within the aneurysm A itself such that the at least one ring 120 can be anchored within the aneurysm A. Additionally, or alternatively, it will be appreciated that the implant 104 can be delivered to other vascular locations, such as an organ or the like.

[0094] As another example, while the segments of the implant 104 are described as being formed from a single alloy wound about the first longitudinal axis A1, it should be recognized that any one or more of the segments of the implant may include internal components and / or one or more external components, coatings and / or coverings.

[0095] In certain embodiments, implant 104 can only comprise single alloy or other parts wound around axis.Yet, in other configurations, as mentioned above, the first section 116 of wire 114 and / or the second section 118 of wire 114 can comprise interior components and / or one or more exterior components, coating and / or covering.For example, the first section 116 of wire 114 and / or the second section 118 of wire 114 can comprise interior core or wire component and exterior wire component or covering.Exterior wire component can at least partially wrap around and cover interior or core wire component.In some cases, exterior wire component can be wound around the outside of core wire (for example, spirally).In some arrangements, one or more exterior layers or coating can be located along the outside of exterior wire component and core wire.

[0096] As yet another example, although the implant is described as including a collapsible second section, other configurations of the second section are additionally or alternatively possible. For example, referring now to Figure 4A 、 4B and 4C, the implant 402 may include a wire 414 having a first segment 416 and a second segment 418. For clarity and efficiency of description, the above description and having the same Figures 4A-4C 100 series elements with the same last two digits in the associated description sections of the 400 series elements should be understood to be similar or interchangeable with each other unless otherwise clearly indicated from the context, and therefore, are not described separately from each other except to note differences or emphasize certain features. Thus, for example, the first section 416 of the wire 414 should be understood to be similar to the above description of Figures 1A-1F and Figures 2A-2H A first section 116 of wire 114 is depicted.

[0097] In the deployed state of the wire 414, the first section 416 of the wire 414 can secure the implant 104 at the target anatomical location according to various techniques described herein, and the second section 418 of the wire 414 can have a predetermined three-dimensional shape in the absence of external forces on the second section 418 of the wire 414. For example, the predetermined three-dimensional shape of the second section 418 of the wire 414 can include one or more loops 458. For example, the predetermined three-dimensional shape formed by the one or more loops 458 of the second section 418 of the wire 414 in the deployed state can define a cavity 460 such that the second section 418 in the deployed state acts as a frame.

[0098] In some implementations, by way of example, the one or more loops 458 of the second section 418 of the wire 414 in the deployed state can have a diameter DIM A, while the first section 416 of the wire 414 can have at least one loop 120 in the deployed state with a diameter DIM B. In some embodiments, the diameter DIMA of the one or more loops 458 in the second section 418 of the wire 414 can be 2 to 25 mm (e.g., 2 to 25, 3 to 20, 4 to 15, 5 to 10 mm, values in between, etc.). In some implementations, the diameter DIMA of the one or more loops 458 of the wire 414 can be equal to or substantially equal to (e.g., within 0 to 5%, within 0 to 10%, within + / - 1 mm or 2 mm, etc.) the diameter DIMB of the at least one loop 120 of the first section 416 of the wire 414.

[0099] As another example, while the implant is described as having a first segment and a second segment connected to each other at a connection location 124, it should be recognized that the first segment of the wire and the second segment of the wire of any one or more of the various different implants described herein may be collectively unitary, i.e., without a connection location, such that the implant is a single component.

[0100] The method steps of the implementation described herein are intended to include any suitable method that causes such method steps to be performed in accordance with the patentability of the following claims, unless a different meaning is explicitly provided or otherwise clear from the context. Thus, for example, performing step X includes any suitable method for causing another party (such as a remote user, a remote processing resource (e.g., a server or cloud computer) or a machine) to perform step X. Similarly, performing steps X, Y, and Z may include any method that directs or controls any combination of such other individuals or resources to perform steps X, Y, and Z to obtain the benefits of such steps. Thus, the method steps of the implementation described herein are intended to include any suitable method that causes one or more other parties or entities to perform steps in accordance with the patentability of the following claims, unless a different meaning is explicitly provided or otherwise clear from the context. Such parties or entities do not need to be directed or controlled by any other party or entity and do not need to be located within a particular jurisdiction.

[0101] It will be appreciated that the methods and systems described above are set forth by way of example and not limitation. Many variations, additions, omissions and other modifications will be apparent to those skilled in the art. In the absence of clear indications to the contrary, the disclosed steps may be modified, supplemented, omitted and / or reordered without departing from the scope of the present disclosure. In addition, the order or presentation of the method steps in the above description and accompanying drawings is not intended to require that the steps depicted be performed in that order unless a particular order is expressly required or otherwise clear from the context. Thus, although particular embodiments are shown and described, it will be apparent to those skilled in the art that various changes and modifications in form and detail may be made therein without departing from the spirit and scope of the present disclosure, and are intended to form part of the present invention as defined by the following claims.

Claims

1. An implant for vascular treatment, comprising: a wire having a first section and a second section, The first segment and the second segment are each movable from a delivery state to a deployed state in response to removal of external pressure on the wire, The first section comprises, in the expanded state, at least one ring capable of being secured to a target anatomical location of a subject, The second segment has a non-linear shape in the expanded state that is positionable to at least partially occupy an anatomical vessel with the first segment secured at the target anatomical location, and The first section is stiffer than the second section.

2. The implant according to claim 1, wherein The first section of the wire has a first spring constant greater than about 10 N / m and less than about 20 N / m.

3. An implant according to any one of the preceding claims, wherein The second section of the wire has a second spring constant greater than about 1 N / m and less than about 10 N / m.

4. An implant according to any one of the preceding claims, wherein The first section of the wire has a first spring constant, the second section of the wire has a second spring constant, and the first spring constant is 2 to 20 times greater than the second spring constant.

5. An implant according to any one of the preceding claims, wherein The first section of the wire and the second section of the wire are coupled to each other at a coupling location.

6. The implant according to claim 5, wherein The first segment of the wire has a first proximal portion and a first distal portion, the second segment of the wire has a second proximal portion and a second distal portion, and the first distal portion of the first segment of the wire is coupled to the second proximal portion of the second segment of the wire at the coupling location.

7. The implant according to any one of claims 5 or 6, wherein The first section of the wire and the second section of the wire are coupled to each other at the coupling location using one or more of welding, adhesive, or a sleeve.

8. The implant according to any one of claims 5 to 7, wherein The first section of the wire and the second section of the wire form a continuous outer surface along the coupling location.

9. An implant according to any one of the preceding claims, wherein The first section of the wire and the second section of the wire are collectively unitary.

10. An implant according to any one of the preceding claims, wherein In the absence of external pressure on the wire, the at least one ring comprises at least three rings.

11. The implant according to claim 10, wherein The at least three rings collectively form a helical shape.

12. An implant according to any one of the preceding claims, wherein In the expanded state of the wire, the at least one loop of the first section of the wire has a maximum outer diameter greater than about 2 mm and less than about 25 mm.

13. An implant according to any one of the preceding claims, wherein In the expanded state of the wire, the second section of the wire can collapse upon itself to at least partially occupy the anatomical vessel, with the first section secured at the target anatomical location.

14. An implant according to any one of the preceding claims, wherein In the expanded state of the wire, the second section of the wire has a predetermined three-dimensional shape.

15. The implant according to claim 14, wherein The predetermined three-dimensional shape defines a cavity.

16. The implant according to any one of claims 14 or 15, wherein The at least one loop of the first section of the wire and the predetermined three-dimensional shape of the second section of the wire each have respective maximum outer dimensions that are substantially equal to one another.

17. An implant according to any one of claims 14 to 16, wherein The predetermined three-dimensional shape has a maximum outer dimension greater than about 2 mm and less than about 25 mm.

18. An implant according to any one of the preceding claims, wherein At least one of the first section of the wire and the second section of the wire includes a main winding defining a longitudinal axis encompassed by the main winding.

19. The implant according to claim 18, wherein The main windings define a plurality of gaps therebetween.

20. The implant of claim 19, wherein In the absence of external pressure on the wire, the gap defined between the main windings is inclined relative to the longitudinal axis encompassed by the main windings.

21. The implant according to any one of claims 19 or 20, wherein In the expanded state, at least some of the plurality of gaps have an axial dimension greater than about 12 microns and less than about 130 microns.

22. An implant according to any one of claims 18 to 21, wherein The first section of the wire and the second section of the wire each include the main winding, the main winding of the first section of the wire has a first outer diameter, the main winding of the second section of the wire has a second outer diameter, and the first outer diameter is different from the second outer diameter.

23. An implant according to any one of the preceding claims, wherein The wire has a first length in the delivery state, and has a second length in the deployed state, and the first length is greater than the second length.

24. The implant of claim 23, wherein The first length of the wire is greater than about 0.5 cm and less than about 100 cm.

25. An implant according to any one of the preceding claims, wherein The first section of the wire is formed of a first material, the second section of the wire is formed of a second material, and the first material is different from the second material.

26. An implant according to any one of the preceding claims, wherein At least one of the first section of the wire or the second section of the wire includes tungsten and platinum.

27. The implant of claim 26, wherein At least one of the first section of the wire or the second section of the wire includes 92% by weight platinum and 8% by weight tungsten.

28. An implant according to any one of the preceding claims, wherein The first section of the wire has a first wire diameter and the second section of the wire has a second wire diameter, and at least one of the first wire diameter or the second wire diameter is greater than about 25 microns and less than about 260 microns.

29. Implant according to the preceding claim, wherein In the expanded state of the wire, at least one of the first section of the wire or the second section of the wire has a maximum outer dimension greater than about 0.25 mm and less than about 0.5 mm.

30. A system for vascular treatment, the system comprising: a catheter defining a lumen and a distal opening in fluid communication with each other; an implant comprising a wire having a first section and a second section, the first section and the second section both being positionable within the lumen in a delivered state, and the first section of the wire being stiffer than the second section of the wire; a tether coupled to the second section of the implant; as well as a pusher member releasably coupled to the second section of the wire via the tether, the pusher member being advanceable in a distal direction within the lumen toward the distal opening of the catheter, the first section of the wire being moveable through the distal opening of the catheter to an expanded state including at least one loop in response to distal advancement of the pusher member within the lumen.

31. The system of claim 30, wherein: At least one of the first segment of the wire and the second segment of the wire includes a main winding that defines a gap, and when the first segment of the wire and the second segment of the wire are positioned in the inner cavity of the catheter in the delivery state, the main winding surrounds the longitudinal axis defined by the inner cavity.

32. The system according to any one of claims 30 or 31, wherein The first section of the wire is movable from the delivery state within the lumen of the catheter to the deployed state while the second section of the wire is retained within the lumen of the catheter in the delivery state.

33. A system according to any one of claims 30 to 32, wherein: With the second section of the wire in the delivery state within the lumen and the first section of the wire in the deployed state, the pusher member can be further advanced in the distal direction toward the distal opening, and in response to further distal advancement of the pusher member within the lumen, the second section of the wire can be moved through the distal opening to an deployed state comprising a nonlinear shape.

34. A system according to any one of claims 30 to 33, wherein The pusher component includes one or more markings that indicate advancement of the implant relative to the lumen of the catheter.

35. A system according to any one of claims 30 to 34, wherein The pusher member is releasable from the tether with the first section of wire and the second section of wire both in the deployed state outside the lumen of the catheter.

36. A system according to any one of claims 30 to 35, wherein The tether is formed from one or more thermoplastic elastomers.

37. The system of any one of claims 30 to 36, further comprising a rotary hemostatic valve, wherein The rotary hemostasis valve is in fluid communication with the lumen of the catheter and is actuatable to be tensioned about the pusher member to constrain movement of the pusher member within the lumen of the catheter.

38. The system of any one of claims 30 to 37, further comprising a one-way valve in fluid communication with the distal opening of the catheter via the lumen of the catheter, and the one-way valve actuatable to control fluid delivery via the lumen of the catheter through the distal opening.

39. A method of vascular treatment, comprising: advancing an implant comprising the wire in a delivery state through the vasculature of the subject to a target anatomical location within the vasculature; releasing the first section of wire from the conveyed state to an expanded state including at least one loop; securing the at least one ring to the target anatomical location; as well as With the at least one ring secured at the target anatomical location, the second section of the wire is released from the delivery state to the deployed state, the second section of the wire having a nonlinear shape in the deployed state that at least partially occupies an anatomical vessel, and the first section of the wire being stiffer than the second section of the wire.

40. The method of claim 39, wherein Advancing the implant through the vasculature of the subject includes moving the implant through a lumen defined by a catheter.

41. The method according to claim 40, wherein Advancing the implant through the vasculature of the subject includes moving the pusher in a distal direction to push the implant in an axial direction through the lumen of the catheter.

42. The method according to claim 41, wherein Releasing the second section of the wire from the delivery state to the deployed state includes disconnecting the pusher from a tether coupled to the second section of the wire.

43. The method according to any one of claims 39 to 42, wherein Advancing the implant through the vasculature includes moving the implant to a blood vessel having an aneurysm.

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