Vascular embolization implant

Abstract

According to some embodiments, a vascular embolization implant (e.g., a vascular occlusion implant or device) includes a coil configured to assume a radially-contracted shape for delivery into a subject, and configured to assume an implanted or non-elongated shape when positioned into a target vascular defect of the subject, wherein the coil is configured to form six sides when in the implanted or non-elongated (e.g., inflated or three-dimensional) shape, wherein at least one side formed by the implanted or non-elongated (e.g., inflated, three-dimensional or non-linear) coil includes a large collar, and wherein at least one side formed by the implanted or non-elongated (e.g., radially-inflated) coil includes two or more small collars.

Description

[0001] Related applications This application claims priority to U.S. Provisional Application No. 63,057,016, the entire contents of which are hereby incorporated herein by reference. Technical Field

[0002] This application generally relates to medical devices, and more specifically, to devices, systems, and methods for the treatment of aneurysms and other vascular abnormalities. Background Technology

[0003] Implantable medical devices exist for treating a wide range of diseases and conditions associated with body cavities. Occlusive devices can be used to at least partially fill or occupy certain blood vessels or other anatomical spaces (e.g., aneurysms). For example, aneurysms, which can develop due to weakening of the arterial wall, can lead to internal bleeding. Occlusion of aneurysms and other such spaces using implanted devices can be used to treat these potentially dangerous and fatal conditions. Summary of the Invention

[0004] According to some embodiments, a vascular embolization implant (e.g., a vascular occlusion implant or device) includes a coil configured to present an elongated or generally straight or linear shape for delivery into a subject, and configured to present an implanted or non-elongated (e.g., inflated or three-dimensional) shape when positioned in a target vascular defect of the subject, wherein the coil is configured to form six sides when in a non-elongated (e.g., inflated, three-dimensional, or non-linear) shape, wherein at least one side formed by the implanted coil includes a large loop, and wherein at least one side formed by the implanted coil includes two or more small loops.

[0005] According to some embodiments, the diameter of the large loop is at least 70% of the width of the corresponding side of the implant. In some embodiments, the diameter of the large loop is at least 75% of the width of the corresponding side of the implant. In some embodiments, the diameter of the large loop is at least 80% of the width of the corresponding side of the implant.

[0006] According to some embodiments, the diameter of each of the small loops is less than 50% of the width of the corresponding side of the implant. In some embodiments, the diameter of each of the small loops is less than 40% of the width of the corresponding side of the implant. In some embodiments, the diameter of each of the small loops is less than 30% of the width of the corresponding side of the implant. In some embodiments, the diameter of each of the small loops is less than 20% of the width of the corresponding side of the implant.

[0007] According to some embodiments, the implant includes three sides containing a large loop and three sides containing two or more small loops. In other embodiments, the implant includes two sides containing a large loop and four sides containing two or more small loops, or vice versa. In other embodiments, the implant includes one side containing a large loop and five sides containing two or more small loops, or vice versa.

[0008] According to some embodiments, the coil is configured to transition from a first side to an adjacent side for all sides of the implant. In some embodiments, the transition includes a 90-degree transition with respect to an adjacent side. In some embodiments, the six-sided implant includes a coil comprising five consecutive adjacent (e.g., 90-degree or approximately 90-degree) transitions. According to some embodiments, two or more sides of the implant may be configured to daisy-link to a single side. In some embodiments, such a configuration may increase the length of the implant.

[0009] According to some embodiments, at least one side comprising two or more small loops includes at least three loops. In some embodiments, at least one side comprising two or more small loops includes at least four loops (e.g., 4, 5, more than 5, etc.).

[0010] According to some embodiments, the coil includes a shape memory material. In some embodiments, the shape memory material includes a platinum-tungsten alloy.

[0011] According to some embodiments, the coil is configured to be delivered to a target vascular defect of a subject using a delivery tool. In some embodiments, the delivery tool includes a pusher component and a tether component.

[0012] According to some embodiments, the tethering component is configured to be releasably secured to a portion of the coil. In some embodiments, the tethering component is configured to be damaged to release from the coil after the implant has been delivered to a target vascular defect of the subject. In some embodiments, the tethering component is configured to be damaged mechanically, thermally, chemically, or electrolytically. Attached Figure Description

[0013] These and other features, aspects, and advantages of this application are described with reference to the accompanying drawings of certain embodiments, which are intended to illustrate and not limit the invention. It will be understood that these drawings are for illustrating the various concepts disclosed herein and are not to scale.

[0014] Figure 1 A perspective view of a vascular occlusion device according to one embodiment is shown; Figure 2 for Figure 1 Different perspective views of a vascular occlusion device; Figure 3 and Figure 4 Show Figure 1 and Figure 2 Different perspective views of the side of a vascular occlusion device; Figures 5A to 5F Show Figure 1 and Figure 2 Different plan views of various sides of the device; Figure 6 An implant releasably secured to a delivery device is illustrated according to one embodiment; Figure 7 The coil or component of the implant is shown in the winding orientation; and Figure 8A and Figure 8B Side and cross-sectional views of an embodiment including an implanted coil are shown. Detailed Implementation

[0015] While various embodiments of the handheld component are specifically relevant to vascular occlusion devices for treating cerebral aneurysms and other vascular abnormalities, the features, advantages, and other characteristics disclosed herein can be applied directly or indirectly to other applications, such as, for example, medical devices, mechanical devices, and / or similar devices.

[0016] Several embodiments of the invention disclosed herein are particularly advantageous because they include one, several, or all of the following benefits: providing a vascular occlusion implantation device with enhanced shape, providing a vascular occlusion implantation device with greater strength properties, and the implant being designed to have enhanced shape memory properties, for example, the implant having the necessary stiffness so that it can more predictably, reliably, and in an improved manner form a cage-like structure in the aneurysm with respect to its predetermined shape. In some embodiments, the implant is shaped, designed, and otherwise configured to have more loops for increased neck coverage. In some configurations, smaller loops of the implant combined with enhanced shape memory properties can result in improved coverage of the target anatomical region (e.g., the neck or other portion of the aneurysm).

[0017] Treatment of intracranial aneurysms and / or other aneurysms using microcoils and / or other implants offers certain advantages over other approaches (e.g., surgical clamping). In some embodiments, a microcatheter or other endovascular device is advanced within the object to position its tip adjacent to the neck of the aneurysm. Subsequently, the microcoil or other implant can be delivered into the aneurysm or other vascular defect through the lumen of the microcatheter or other endovascular device.

[0018] This application discloses various embodiments of microcoil devices or other implants, and the manner in which they are delivered to aneurysms or other defects. Details regarding the shape, size, construction, and / or other aspects of the implant can help ensure that the implant remains within the desired aneurysm after implantation.

[0019] The microcoil and / or other implant embodiments disclosed herein can be used as desired or required for defects of any size and / or for the treatment of any indication. Furthermore, as mentioned above, the implants can be delivered and released within the target anatomy of the subject using any desired protocol or technique.

[0020] Figure 1 An embodiment of a vascular occlusion implant 10 is shown, which includes a generally three-dimensional shape when deployed into a subject. As shown, the implant 10 includes a complex shape formed by a coil component 100. The shape of the coil component 100 may define an internal region 50.

[0021] Continue to refer to Figure 1 In some embodiments, implant 10 may comprise a generally cubic shape, wherein the implant includes six sides. As shown, implants in their implanted or non-elongated (e.g., inflatable, three-dimensional, or non-linear) shape may comprise multiple rings. In some embodiments, the inflatable component or portion 100 forming the ring may be oriented generally (e.g., substantially) along one of the six sides of a cube or other three-dimensional hexahedral device. In some embodiments, the implant has a generally or substantially cubic shape, wherein all six sides are identical or substantially identical in cross-sectional shape. For example, in some arrangements, each of the “sides” of implant 10 is approximately within 100% to 125% of the area of ​​any other side (e.g., 100 to 125%, 100 to 105%, 105 to 110%, 110 to 115%, 115 to 120%, 120 to 125%, 100 to 110%, 110 to 120%, 115 to 125%, percentages between the aforementioned ranges and values, etc.).

[0022] like Figure 2 As shown (e.g., schematically), each of the sides (e.g., represented by vertical or orthogonal arrows A, B, C, D, E, F) is offset by 90 degrees or nearly 90 degrees relative to each other to form a hexagonal cube shape. For clarity, the different “sides” A, B, C, D, E, F of the implant 10 are... Figure 3 It is shown schematically in the middle.

[0023] Implant 10 may include a single component 100 configured to take on a depicted shape upon release into the anatomy of a subject. Component 100 may include a helical component comprising a platinum-tungsten alloy. For example, in some embodiments, the platinum-tungsten alloy comprises an alloy of 92% platinum and 8% tungsten (92 / 8Pt / W), other alloys, and / or other shape memory materials with hyperelastic properties. However, in some embodiments, component 100 may, as desired or required, include non-helical shapes and / or materials that are not shape memory materials.

[0024] According to some embodiments, component 100 includes an inner or core component surrounded by an outer wire component. In some embodiments, the outer wire component is wound (e.g., spirally) around the outside of the core component. In some arrangements, one or more outer layers or coatings may be positioned along the outside of both the outer wire component and the core component. According to some embodiments, such as Figure 8A and Figure 8B As shown, component 100 may include helical wound components comprising continuous loops or windings. In some embodiments, such loops or windings are angled relative to the longitudinal and / or radial axes of component 100. For example, as desired or required, the component may include loops or windings at angles of 0 to 90 degrees (e.g., 0 to 90 degrees, 10 to 70 degrees, 20 to 60 degrees, angles between the aforementioned degrees, etc.) relative to the longitudinal and / or radial axes of component 100. In some embodiments, the component may comprise only a single alloy or other components wound around an axis. However, in other configurations, as mentioned above, component 100 may include internal components and / or one or more external components, coatings, and / or coverings.

[0025] Continue to refer to Figure 8A and Figure 8B The length L, diameter or other cross-sectional dimension D, and / or the gap G between continuous loops or windings G can be modified to suit a particular design and / or application or use. In some embodiments, the diameter or other cross-sectional dimension D of component 100 is 0.005 to 0.050 inches (e.g., 0.005 to 0.050 inches, 0.010 to 0.015 inches, 0.008 to 0.035 inches, 0.0125 to 0.00325 inches, values ​​between the foregoing, etc.).

[0026] According to some embodiments, the implant 10 is configured to present as shown in the figure. Figure 7 The winding shape is shown in the figure. In some arrangements, the component 100 of the implant is wound around a single cylindrical mandrel (not shown). The component 100 of the implant 10 may be formed of an embolization coil component 100 having a first end 102 and a second end 104.

[0027] Continue to refer to Figure 1 and Figure 2 As mentioned above, the implant 10 may include six sides (e.g., A to F) defining an internal region 50. In some embodiments, the implant 10 includes a single coil or component 100 extending from a first end 102 to a second end 104. Figure 1 and Figure 2 Shown in and in Figure 4The coil or component 100, schematically highlighted by the arrow, can form one or more desired shapes along each "side" of the implant 10 before transitioning to the adjacent "side" of the implant.

[0028] In some embodiments, such as Figure 4 As schematically depicted, the coils or other components 100 of the device are configured to transition from one “side” of the implant 10 to an adjacent “side” when in an implanted or non-elongated (e.g., inflated) configuration. As shown, the transition between sides may include a transition with respect to an adjacent side (e.g., a side offset by approximately 90 degrees relative to the first side). Thus, each of the transitions A to B, B to C, C to D, D to E, and E to F of component 100, as shown, may be with respect to an adjacent side. However, in other configurations, the transition may occur in a different manner as desired or required (e.g., from one “side” to a non-adjacent “side”).

[0029] like Figure 1 and Figure 2 As shown, implants, whether in implanted or non-elongated (e.g., inflatable or non-linear) form, may include one or more loops, curves, and / or other shapes along each side. Thus, the coils or other components 100 of implant 10 may be configured to present a desired configuration when implanted or non-elongated (e.g., inflatable or unrestrained radially). The loops or other shapes formed by the coils or components may vary along one or more sides of the implant. Alternatively, the coils or other components 100 of the implant may form similar loops or shapes along two or more sides as desired or required.

[0030] Figures 5A to 5F Show Figure 1 and Figure 2 The following is a front view of each of the six sides of the implant embodiment. As shown, some of the sides (such as, for example, sides A, C, and E) are characterized by a larger loop or curve 110 formed by a coil or component 100. However, other sides (such as, for example, sides B, D, and F) contain two or more (e.g., 2, 3, 4, more than 4, etc.) smaller loops or curves 120.

[0031] According to some embodiments, the constructions disclosed herein can result in greater neck or other coverage for the target aneurysm. Furthermore, the increased or enhanced shape memory properties resulting from the expansion (e.g., non-linear) shape of the implant can refine the cage morphology to a predetermined shape.

[0032] Therefore, as illustrated herein, the six-sided implant 10 may include three sides comprising a larger collar 110 and three sides comprising a smaller collar 120. In some embodiments, each side formed by the larger collar 110 (e.g., sides A, C, and E) may contain only a single collar 110. Furthermore, in some embodiments, each side formed by the smaller collar 120 (e.g., sides B, D, and F) may contain multiple collars 120.

[0033] However, in alternative arrangements, the side with the larger collar 110 may contain more than one collar 110. Similarly, the side with the smaller collar 120 may contain only a single collar, or it may contain multiple collars 120. Thus, depending on the expectation or need for a particular application or use, the side may contain one, two, three, four or more larger or smaller collars 110, 120.

[0034] In some embodiments, the larger collar 110 is a collar comprising a diameter that is at least 70% to 80% of the width or other cross-sectional dimension of the side on which the collar or curve 110 is located (e.g., along the collar or curve). Furthermore, in some arrangements, the smaller collar 120 is a collar comprising a diameter that is less than 50% (e.g., less than 50%, less than 45%, less than 40%, less than 35%, less than 30%, less than 25%, less than 20%, etc.) of the width or other cross-sectional dimension of the side on which the collar or curve 120 is located (e.g., along the collar or curve).

[0035] In the illustrated embodiment, implant 10 includes three sides (sides A, C, and E) with a larger loop or curve 110, and three sides (sides B, D, and F) with a smaller loop or curve 120. However, in other arrangements, implant 10 may include more or fewer sides with a larger loop or curve 110, and / or more or fewer sides with a smaller loop or curve 120, as desired or required. For example, in one embodiment, implant 10 may include one or two sides with a larger loop or curve 110, and five or four sides with a smaller loop or curve 120, or vice versa.

[0036] like Figure 6 As schematically illustrated, a vascular occlusion device or implant 10 may include a tether 220, which is made of one or more of a variety of materials (including, for example, one or more thermoplastic elastomers). The tether 220 may be included as part of a delivery device 200 and positioned along the distal end of a pusher component 210 of such device 200. In some embodiments, the implant 10 is detachably coupled to the pusher component 210 of the delivery device 200 via a coupling joint or the tether 220.

[0037] In some arrangements, the tether 220 comprises a thermoplastic elastomer, such as, for example, Engage®, polyester thread (e.g., polyethylene terephthalate (PET)), and / or any other material. The diameter of the tether 220 may be from 0.00075 inches to 0.0030 inches (e.g., 0.0015 to 0.0030 inches, 0.0020 to 0.0025 inches, 0.00075 to 0.0015 inches, 0.0010 inches, 0.0022 inches, values ​​between the foregoing ranges, etc.).

[0038] The coil or other component 100 of the implant 10 may have a diameter or other cross-sectional dimension of 0.010 inches to 0.030 inches (e.g., 0.010 to 0.030 inches, 0.010 to 0.020 inches, 0.010 inches to 0.015 inches, 0.011 to 0.013 inches, 0.012 inches, etc.). The length of the coil or other component 100 (when straight) may be 0.5 cm to 100 cm (e.g., 0.5 to 100 cm, 0.5 to 75 cm, 0.5 to 50 cm, 1 to 40 cm, or values ​​between the foregoing values, etc.), depending on preference or need.

[0039] According to some embodiments, delivery and deployment of the implantation device 10 can be achieved by first compressing the implantation device 10 for intravascular delivery through the subject. When placed within a microcatheter or other intraluminal device, the filamentous element layer of the implant can exhibit an elongated, non-elongated structure that is generally parallel to each other and parallel to the longitudinal axis of the microcatheter.

[0040] In some embodiments, once the implantable device 10 is withdrawn from the distal end of a microcatheter or other endoluminal device (or the radially constrained wire or component 100 of the device 10 is otherwise removed), the distal ends of the filamentous elements may then contract axially toward each other to present a three-dimensional configuration within an aneurysm or other vascular defect. However, any other method or technique may be used, as desired or required, to deliver the implant 10 to the desired anatomical location of the subject. The distal end of the microcatheter or endoluminal device may be positioned such that the distal port of the microcatheter is directed toward or disposed within the vascular defect (e.g., aneurysm) to be treated, and the delivery component (e.g., the delivery wire) is removed. The implantable device 10 secured to the delivery device may be inserted (e.g., in an elongated or generally straight, linear, or constrained orientation) into the proximal portion of the lumen of the microcatheter or other endoluminal device.

[0041] The implant 10 can then be advanced distally through the lumen of the delivery device to the vascular defect. In some embodiments, once the distal end or deployment port of the delivery system is positioned at a desired location adjacent to or within the vascular defect, the implant 10 can deploy beyond the distal end of the microcatheter, thus allowing the device to begin taking on a three-dimensional or implantable shape. As the implant 10 emerges from the distal end of the delivery device and the microcatheter, the implant 10 can begin to take on a non-elongated or implantable (e.g., non-linear) state within the vascular defect. In some embodiments, to release the implant 10 within an aneurysm or other vascular defect, the implant 10 can be detached from the delivery device by damaging the tether. Such detachment can be accomplished using any known method, such as using thermal or electrical energy to melt the tether, cutting or otherwise mechanically damaging the tether, chemically damaging the tether, and / or similar methods.

[0042] As mentioned above, the microcoils and / or other implants disclosed herein may be removable for delivery and implantation into the desired anatomical site. Any of a variety of known removal methods or techniques may be used, as desired or required, to deliver the implant into the desired anatomical site. While removal systems may involve some dynamic processes, some systems involve more physical movement of the system than others. For example, mechanical removal systems using pressure, unscrewing, axial piston release, and / or similar methods tend to cause a limited amount of movement of the implant at the aneurysm during removal.

[0043] In some setups, non-mechanical disassembly systems (e.g., chemical, temperature, electrolytic, etc.) may involve less movement. However, in other setups, such systems often suffer from less consistency. For example, when using such systems, short, consistent periods of coil disassembly may be experienced. While the electrical insulation of the implanted coil itself helps reduce the average coil disassembly time, some inconsistency remains regarding how quickly the coil will disassemble. In larger aneurysms that may have ten or more implanted coils, large or unpredictable disassembly times multiply, delaying surgery. Additionally, large single disassembly times can be risky during disassembly due to patient movement with the catheter system. Even systems that indicate disassembly has occurred (e.g., by measuring current below a certain threshold) are not entirely trusted by users.

[0044] Many detachable systems include specific structures at the junction between the propeller wire and the detachably coupled microcoil implant. Of course, the delivery system and / or implant can be sized, shaped, and otherwise constructed to allow safe, predictable, and reliable detachment to occur.

[0045] In some embodiments, one or more implants 10 may be positioned within a target aneurysm or other vascular defect. In some arrangements, the implant(s) may be used to fill or otherwise occupy the desired volume of the aneurysm. For example, the size, shape, number, and / or details of the implant(s) may be selected to fill as much of the volume of the target defect as possible. In some arrangements, 80% to 100% of the target defect may be filled by the implant(s). However, in other embodiments, less than 80% of the defect may be filled by the implant(s). The relatively soft nature of the implant 10 allows a sufficient amount of filling to achieve the desired level of thrombosis and occlusion without creating potentially dangerous stress on the wall of the aneurysm, which may potentially rupture (or re-rupture).

[0046] Although several embodiments and examples are disclosed herein, this application extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the invention, as well as modifications and equivalents thereof. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments can be made and still fall within the scope of the invention. Therefore, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for each other to form different modes of the disclosed invention. Therefore, it is intended that the scope of the invention disclosed herein should not be limited by the particularly disclosed embodiments described above, but should be determined only by a reasonable reading of the following claims.

[0047] While the invention is susceptible to various modifications and alternatives, specific examples are shown in the accompanying drawings and described in detail herein. However, it should be understood that the invention is not limited to the specific forms or methods disclosed, but rather, the invention will cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order listed. The methods summarized above and further elaborated below describe certain actions taken by a practitioner; however, it should be understood that they may also include instructions from another party to those actions. The methods summarized above and further elaborated below describe certain actions taken by a user (e.g., a professional in some cases); however, it should be understood that they may also include instructions from another party to those actions. Thus, actions such as “inserting an implant” or “delivering an implant” include “commanding the insertion of an implant” and “commanding the delivery of an implant.” The scope disclosed herein also includes any and all overlapping, sub-scopes, and combinations thereof. Languages ​​such as “up to,” “at least,” “greater than,” “less than,” “between,” etc., contain enumerated numbers. Numbers preceded by terms (such as "approximately" or "about") include listed numbers. For example, "approximately 10mm" includes "10mm". Terms or phrases preceded by terms (such as "roughly") include listed terms or phrases. For example, "roughly parallel" includes "parallel".

Claims

1. A vascular occlusion implant, comprising: A coil component capable of expanding from an elongated shape to an implantable shape, the elongated shape being for delivery into an object, and the coil component having the implantable shape when positioned in a target vascular defect of the object. When in the implanted shape, the coil component forms six sides; In the implantation shape, three sides of the coil component include large loops, and in the implantation shape, the other three sides of the coil component each include two or more small loops.

2. The vascular occlusion implant according to claim 1, wherein, The diameter of the large loop is at least 70% of the width of the corresponding side of the six sides of the vascular occlusion implant.

3. The vascular occlusion implant according to claim 1, wherein, The diameter of each of the small loops is less than 50% of the width of the corresponding side of the six sides of the vascular occlusion implant.

4. The vascular occlusion implant according to any one of the preceding claims, wherein, With respect to all sides of the coil component in the implanted shape, the coil component transitions from the first side to the immediately adjacent side.

5. The vascular occlusion implant according to claim 1, wherein, The coil includes shape memory material.

6. The vascular occlusion implant according to claim 5, wherein, The shape memory material includes a platinum-tungsten alloy.

7. The vascular occlusion implant according to claim 1, further comprising a tether releasably secured to the coil component, wherein, The coil component can be delivered to the target vascular defect of the object using the tether and pusher components.

8. The vascular occlusion implant according to claim 7, wherein, The tether is capable of damaging the target vascular defect of the object to release the tether from the coil component.

9. The vascular occlusion implant according to claim 8, wherein, The tether is constructed to be damaged mechanically, thermally, chemically, or electrolytically.

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