Expandable device and associated systems and methods

Abstract

Expandable devices are disclosed herein. Several of the embodiments relate to expandable devices that include a mesh configured to expand at a vessel bifurcation of a human patient. The mesh can include a tubular body portion and one or more circumferentially discontinuous hinged portions. The mesh can expand such that the one or more hinged portions are positioned at an angle to the tubular body portion.

Description

Technical Field

[0001] This technology relates to scalable devices and associated systems and methods. In certain embodiments, this technology relates to devices for shunting blood flow in a blood vessel. In some embodiments, this technology relates to devices for preventing blood from flowing into an aneurysm at a blood vessel bifurcation, and associated systems and methods of use. Background Technology

[0002] An aneurysm is an abnormal bulge or dilation of a blood vessel, which may be caused by disease, injury, or congenital abnormalities that weaken the vessel wall. Aneurysms have thin and fragile walls and are prone to rupture, which can lead to stroke, death, disability, etc. Aneurysms can be treated by placing an occlusive device (e.g., coil, braid, fluid embolization, etc.) within the aneurysm to reduce blood flow and promote thrombus formation and embolization within the aneurysm. However, intrasac occlusive devices can reposition the aneurysm and enter vessels with wide-necked aneurysms, which can lead to arterial occlusion, stroke, and / or death.

[0003] Another method for treating aneurysms involves inserting a shunt stent or braid into the carrier vessel containing the aneurysm to be treated. Such stents or braids can be inserted into the vessel in a radially constrained state, positioned close to the neck of the aneurysm, and extended to be juxtaposed with the vessel wall. If the stent or braid has a sufficiently low porosity, it can act to prevent blood from flowing through the device and into the aneurysm, thereby causing embolization of the aneurysm. A shunt device can be placed within two vessels (e.g., the carrier vessel and a first branch vessel, or the first branch vessel and a second branch vessel) to treat a bifurcation aneurysm between vessels. However, shunt devices typically contain tubular structures. Therefore, when such shunt devices are placed across the neck of the aneurysm, a portion of the device is positioned across the junction with the other vessel and interferes with blood flow to that vessel. Therefore, there is a need for improved shunt devices for treating bifurcation aneurysms. Summary of the Invention

[0004] This technology relates to devices, systems, and methods for treating bifurcation aneurysms. According to some embodiments, the expandable device of this technology includes an expandable mesh having circumferentially discontinuous hinged portions, configured to be angularly positioned relative to the tubular body portion of the mesh when the device is expanded. The expandable device of this technology is particularly advantageous for treating bifurcation aneurysms located where the parent vessel branches into two or more branch vessels. For example, the expandable mesh of this technology can be configured to be positioned adjacent to the bifurcation aneurysm such that the tubular body portion of the mesh is positioned within a first branch vessel, one of the hinged portions is positioned within a second branch vessel, and another of the hinged portions is positioned within the parent vessel, such that one or more portions of the expandable mesh are positioned across the neck of the bifurcation aneurysm and prevent blood flow into the aneurysm.

[0005] The present invention is illustrated, for example, according to various aspects described below, including with reference to Figures 1A-10. For convenience, various examples of aspects of the present invention are described using numbered clauses (1, 2, 3, etc.). These clauses are provided as examples and do not limit the scope of the invention.

[0006] Clause 1. An expandable device configured for neck localization of an aneurysm across a bifurcation of a patient's blood vessel, the device comprising:

[0007] A generally tubular mesh having a first end portion and a second end portion, the second end portion comprising a first hinge region and a second hinge region.

[0008] The first hinge region and the second hinge region are separated by first and second slits, which extend along the longitudinal axis of the mesh.

[0009] When the mesh is in an expanded state, the first hinged area is positioned at a first angle relative to the first end portion, and the second hinged area is positioned at a second angle relative to the first end portion.

[0010] Clause 2. The apparatus according to Clause 1, wherein the length of the first slit is equal to the length of the second slit.

[0011] Clause 3. The device according to Clause 1 or Clause 2, wherein the first slit and the second slit are circumferentially spaced about 180 degrees apart.

[0012] Clause 4. The apparatus according to Clause 1 or Clause 2, wherein the width of the first hinge region is less than the width of the second hinge region.

[0013] Clause 5. The device according to any one of Clauses 1 to 4, wherein the first angle is about 0 degrees and the second angle is between about 30 degrees and 150 degrees.

[0014] Clause 6. The device according to any one of Clauses 1 to 4, wherein the first angle is substantially equal to the second angle.

[0015] Clause 7. The device according to any one of Clauses 1 to 6, wherein the first and second slits are formed by mechanical or laser cutting.

[0016] Clause 8. The device according to any one of Clauses 1 to 7, wherein the longitudinal edges of the first and second hinged regions adjacent to the first and second slits have been brazed, melted, welded or glued.

[0017] Clause 9. The apparatus according to any one of Clauses 1 to 8 further includes a third slit extending circumferentially between the first slit and the second slit.

[0018] Clause 10. The device according to any one of Clauses 1 to 9 further comprises a plurality of transmissive marks circumferentially positioned around a first end portion of the mesh.

[0019] Clause 11. The device according to any one of Clauses 1 to 10, further comprising a first plurality of radiopaque markings attached to a first hinge region and a second plurality of radiopaque markings attached to a second hinge region.

[0020] Clause 12. The apparatus according to Clause 11, wherein the first plurality of transmissive marks comprises fewer transmissive marks than the second plurality of transmissive marks.

[0021] Clause 13. A device configured to locate the neck of an aneurysm across a bifurcation of a patient's blood vessel, the device comprising:

[0022] An expandable mesh having a generally tubular body portion and circumferentially discontinuous arm portions extending from the body portion, wherein when the expandable mesh is in a low-profile configuration, the longitudinal axis of the arm portions is generally parallel to the longitudinal axis of the body portion, and wherein when the expandable mesh is in an extended configuration, the longitudinal axis of the arm portions is angularly positioned relative to the longitudinal axis of the body portion.

[0023] Clause 14. The device according to Clause 13, wherein the angle is between about 30 degrees and about 150 degrees.

[0024] Clause 15. The device according to Clause 13 or Clause 14, wherein the main body portion is configured to be positioned within a first blood vessel and the arm portion is configured to be placed within a second blood vessel.

[0025] Clause 16. The device according to any one of Clauses 13 to 15, wherein the arm portion is a first arm portion, and the mesh further includes a second arm portion extending from the body portion, wherein when the expandable mesh is in an extended configuration, the longitudinal axis of the first arm portion is positioned at a first angle to the longitudinal axis of the body portion, and the longitudinal axis of the second arm portion is positioned at a second angle to the longitudinal axis of the body portion.

[0026] Clause 17. The device according to any one of Clauses 13 to 16, wherein the mesh is configured to divert blood flow away from the aneurysm.

[0027] Clause 18. The apparatus according to any one of Clauses 13 to 17, wherein the mesh comprises a woven material.

[0028] Clause 19. The apparatus according to any one of Clauses 13 to 18, wherein the mesh is self-expanding.

[0029] Clause 20. The device according to any one of Clauses 13 to 19, wherein the mesh is formed of a shape memory alloy.

[0030] Clause 21. The device according to any one of Clauses 16 to 20, wherein the main body portion is configured to be positioned within a first branch vessel, the first arm portion is configured to be placed within a second branch vessel, and the second arm portion is configured to be placed within a tumor-carrying vessel.

[0031] Clause 22. The device according to any one of Clauses 13 to 21, wherein the mesh is configured to anchor to the patient's blood vessel wall.

[0032] Clause 23. A device for reducing blood flow within an aneurysm in a blood vessel, the device comprising:

[0033] A scalable mesh comprising a circumferentially discontinuous first section, a circumferentially discontinuous second section, and a generally tubular third section; the scalable device has radially constrained configurations and extended configurations.

[0034] When the scalable mesh is in a radially constrained configuration, the device comprises a substantially tubular shape.

[0035] When the expandable mesh is in the expanded configuration, the first portion is configured to be positioned within the tumor-bearing vessel, the second portion is configured to be positioned within the first branch vessel, and the third portion is configured to be positioned within the second branch vessel.

[0036] When located across the neck of an aneurysm, the device is configured to substantially block blood flow into the aneurysm and allow blood flow from the carrier vessel to the first and second branch vessels.

[0037] Clause 24. The device according to Clause 23, wherein the second and third portions are configured to substantially cover the neck of the aneurysm.

[0038] Clause 25. The device according to Clause 23, wherein the first and third portions are configured to substantially cover the neck of the aneurysm.

[0039] Clause 26. The device according to Clause 23, wherein the first and second portions are configured to substantially cover the neck of the aneurysm.

[0040] Clause 27. A device for reducing blood flow within an aneurysm in a blood vessel, the device comprising:

[0041] A scalable mesh comprising a first portion, a second portion, and a third portion, wherein at least one of the portions is circumferentially discontinuous, and the scalable device has a radially constrained configuration and an extended configuration.

[0042] When the scalable mesh is in a radially constrained configuration, the device comprises a substantially tubular shape.

[0043] When the expandable mesh is in the expanded configuration, the first portion is configured to be positioned within the tumor-bearing vessel, the second portion is configured to be positioned within the first branch vessel, and the third portion is configured to be positioned within the second branch vessel.

[0044] When located across the neck of an aneurysm, the device is configured to substantially block blood flow into the aneurysm and allow blood flow from the carrier vessel to the first and second branch vessels.

[0045] Clause 28. The device according to Clause 27, wherein the third portion is substantially tubular and the first and second portions are circumferentially discontinuous.

[0046] Clause 29. The device according to Clause 27, wherein the first and third portions are substantially tubular and the second portion is circumferentially discontinuous.

[0047] Clause 30. The apparatus according to any one of Clauses 27 to 29, wherein at least one of the said portions faces an angle of about 30 degrees to about 330 degrees.

[0048] Clause 31. The apparatus according to any one of Clauses 27 to 29, wherein at least one of the said portions faces an angle of about 180 degrees.

[0049] Clause 32. A method for fabricating a scalable device, comprising:

[0050] A tubular mesh having a porosity configured for the flow of diverted blood, the tubular mesh comprising a first end portion, a second end portion, and an intermediate portion therebetween;

[0051] A circumferentially discontinuous arm portion is formed from the second end portion of the tubular mesh, the arm portion being movable relative to the first end portion of the mesh;

[0052] Manipulate the mesh into an extended configuration; and

[0053] In the extended configuration, set the shape of the mesh.

[0054] Clause 33. The method according to Clause 32, wherein the forming arm portion comprises establishing at least two slits in the tubular mesh.

[0055] Clause 34. The method according to Clause 32 or Clause 33, wherein manipulating the mesh into an extended configuration includes obtaining a clamp and attaching the mesh to the clamp.

[0056] Clause 35. The method according to any one of Clauses 32 to 34, wherein the mesh shape is configured in an extended configuration to include a heat-treated mesh.

[0057] Clause 36. The method according to any one of Clauses 33 to 35, wherein establishing at least two slits comprises laser-cut tubular mesh.

[0058] Clause 37. The method according to any one of Clauses 33 to 36, wherein the first end portion is a proximal end portion, the second end portion is a distal end portion, and each of at least two slits extends along the longitudinal axis of the device from the distal end of the distal end portion toward the proximal end.

[0059] Clause 38. The method according to any one of Clauses 33 to 36, wherein each of at least two slits extends along the longitudinal axis of the device within the intermediate portion.

[0060] Clause 39. The method according to any one of Clauses 33 to 38, wherein the arm portion is a first arm portion, the method further comprising forming a second arm portion.

[0061] Clause 40. A scalable device delivery system comprising:

[0062] A core member configured for advancement within a body cavity, the core member comprising a distal portion, a first proximal portion, and a second proximal portion, the first and second proximal portions being radially spaced apart;

[0063] A first pusher element fixed to a first proximal portion of a core member and a second pusher element fixed to a second proximal portion of a core member, wherein each of the first and second pusher elements includes a mating surface facing distally;

[0064] An orientation member connected to a first proximal portion of the core member, the orientation member being configured to rotate the first proximal portion of the core member; and

[0065] An expandable device comprising a distal end portion and two arm portions extending proximally from the distal end portion, wherein each of the two arm portions includes a proximal edge.

[0066] The distal engagement surface of the first actuating element is adjacent to the proximal edge of the first arm portion, and the distal engagement surface of the second actuating element is adjacent to the proximal edge of the second arm portion.

[0067] Clause 41. The system according to Clause 40, wherein the first and second actuating elements are configured to transmit a force directed to the distal side to the expandable device.

[0068] Clause 42. The system described in Clause 40 or Clause 41 further includes a plate rotatably positioned around the core member.

[0069] Clause 43. The system according to Clause 42, wherein the plate is configured to transmit forces directed proximal or radially outward to the expandable device.

[0070] Clause 44. The system according to any one of Clauses 40 to 43 further includes a sheath or catheter, wherein the core member, first and second actuating elements, and an expandable device are positioned within the lumen of the sheath or catheter.

[0071] Clause 45. The system according to any one of Clauses 40 to 44, wherein each of the first and second actuating elements includes a proximal restraint member.

[0072] Clause 46. The system according to any one of Clauses 40 to 46 further includes a distal restraint member coupled to the core member.

[0073] Clause 47. The system according to any one of Clauses 40 to 46, wherein the orientation member is rotatably positioned around the second proximal portion of the core member.

[0074] Clause 48. A method for treating an aneurysm located at a vascular bifurcation comprising a first vessel, a second vessel, and a third vessel, between the first and second vessels, the method comprising:

[0075] Provides a scalable device for diverting blood flow away from an aneurysm, the scalable device comprising:

[0076] An expandable mesh comprising multiple arm portions including a first arm portion, a second arm portion, and a third arm portion, wherein at least one of the portions is circumferentially discontinuous, the expandable mesh having a generally tubular radially constrained state for delivery within a microcatheter, and an expanded state wherein the second arm portion is positioned at a first angle to the longitudinal axis of the first arm portion, and the third arm portion is positioned at a second angle to the longitudinal axis of the first arm portion;

[0077] The first arm portion of the expandable device is advanced into the first blood vessel and the first arm portion is extended to contact the wall of the first blood vessel; and

[0078] The second arm portion is advanced into the second vessel and extended to contact at least a portion of the wall of the second branch vessel, such that at least a portion of the second arm portion is positioned across the neck of the aneurysm; and

[0079] The third arm is extended to contact at least a portion of the wall of the third blood vessel.

[0080] Clause 49. The method described in accordance with Clause 48, wherein the first arm portion is circumferentially continuous.

[0081] Clause 50. The method described in accordance with Clause 48 or Clause 49, wherein the second arm portion is circumferentially discontinuous.

[0082] Clause 51. The method according to any one of Clauses 48 to 50, wherein at least a portion of the third arm portion is circumferentially discontinuous. Attached Figure Description

[0083] Many aspects of this disclosure can be better understood by referring to the following figures. The components in the figures are not necessarily to scale; rather, the focus is on clearly illustrating the principles of this disclosure.

[0084] Figure 1A depicts an example of a bifurcation aneurysm located between two branch vessels at the bifurcation of the carrier vessel.

[0085] Figure 1B depicts a coil protrusion of an example bifurcation aneurysm from Figure 1A.

[0086] Figure 2A An isometric view of an expandable device in a tubular configuration, configured according to an embodiment of the present technology.

[0087] Figure 2B For extended configurations configured according to embodiments of this technology Figure 2A An isometric view of the expandable device shown.

[0088] Figure 3 An scalable device configured in an extended configuration and positioned at a blood vessel bifurcation according to an embodiment of the present technology is shown.

[0089] Figure 4A An isometric view of an scalable device configured according to an embodiment of the present technology.

[0090] Figure 4B For the section along line 4B-4B Figure 4A An axial cross-sectional view of the expandable device shown.

[0091] Figure 4C For the section taken along line 4C-4C Figure 4A An axial cross-sectional view of the expandable device shown.

[0092] Figure 5A An isometric view of an scalable device configured according to an embodiment of the present technology.

[0093] Figure 5B Section 5B-5B along the line Figure 5A An axial cross-sectional view of the expandable device shown.

[0094] Figure 6A and 6B An isometric view of an scalable device configured according to an embodiment of the present technology, shown in tubular and extended configurations, respectively.

[0095] Figure 7A and 7B An isometric view of an scalable device configured according to an embodiment of the present technology, shown in tubular and extended configurations, respectively.

[0096] Figure 8 An example of an extendable device configured in an extended configuration and positioned at a vascular bifurcation, and an example of an intra-sac occlusion device positioned within an aneurysm, are shown according to embodiments of the present technology.

[0097] Figure 9 An isometric view of an expandable device in a tubular configuration according to an embodiment of the present technology.

[0098] Figure 10 This is a schematic side view of the delivery system of this technology. Detailed Implementation

[0099] This technology relates to scalable devices and associated systems and methods. For example, some embodiments of this technology relate to shunt scalable meshes configured to be positioned within one or more vessels at a vascular bifurcation and across the neck of a bifurcation aneurysm. Specific details of several embodiments of this technology are described below with reference to Figures 1A-10.

[0100] Regarding the terms "distal" and "proximal" in this specification, unless otherwise stated, these terms may refer to the relative position of a portion of an interventional device, such as a shunt device and / or an associated delivery device, with respect to the operator and / or the vascular system. For example, when referring to a delivery system that includes the scalable shunt device described herein, "proximal" may refer to a location closer to the operator of the device or to an incision in the vascular system, while "distal" may refer to a location further away from the operator of the device or further away from the incision along the vascular system (e.g., the distal end of a catheter).

[0101] As used herein, “radially constrained configuration” refers to the unextended configuration of an expandable device, wherein the expandable device is configured to be delivered via catheter to and from the treatment site. As used herein, “extended configuration” refers to a configuration in which the expandable device is partially or fully extended. An extended configuration may be achieved by actuation only (e.g., via balloon inflation), only via self-expansion, or both. Unless otherwise specified herein, “fully extended” as used to describe a configuration of an expandable device refers to a configuration in which a portion of the expandable device is positioned relative to other portions of the expandable device as needed for treatment or to facilitate treatment. For example, a fully extended configuration of an expandable device may include an articulated portion of the expandable device positioned at an angle to the tubular body portion of the expandable device, such that the articulated portion is configured to be positioned within the lumen of a branch vessel and across the neck of a bifurcation aneurysm, and the tubular body portion is configured to be positioned within the lumen of a second branch vessel. As used herein, “intermediate extended configuration” refers to a configuration of the expandable device between a radially constrained configuration and a fully extended configuration.

[0102] As used herein, the term "longitudinal" can refer to the direction along the axis extending through the cavity of the expandable device and / or support when in a tubular configuration, and the term "circumferential" can refer to the direction extending in a plane orthogonal to the longitudinal axis and around the circumference of the device when in a tubular configuration. As used herein, "circumferentially continuous" can refer to a portion of a device having a closed circumference such that the axial cross-sectional shape of the device is a complete circle. As used herein, "circumferentially discontinuous" can refer to a portion of a device having an open circumference such that the axial cross-sectional shape of the device is an arc with an angle of less than 360 degrees.

[0103] As used in this article, "vascular bifurcation" refers to the location where the carrier vessel branches into two or more branch vessels. A bifurcation aneurysm is an aneurysm located between two branch vessels or between the carrier vessel and a branch vessel.

[0104] As used herein, the terms “generally,” “basically,” “about,” and similar terms are used as approximate terms rather than as terms of degree, and are intended to take into account the inherent biases of the measured or calculated values ​​that would be recognized by a person of ordinary skill in the art.

[0105] The device of this technology can be configured to treat a bifurcation aneurysm located at a bifurcation in a patient's vascular system, wherein the parent vessel P divides into two or more branch vessels B1, B2 (e.g., aneurysm A illustrated in Figure 1A). The branch vessels of the bifurcation may be at substantially different angles, have substantially different sizes, and / or be of different quantities (e.g., three or more) compared to the bifurcation depicted in Figure 1A. The bifurcation aneurysm A may be offset relative to the junction (e.g., having a neck substantially open to one branch vessel), tilted relative to the plane established by the vessel (e.g., entering or leaving the page), etc. Fluid inflow into the aneurysm can cause rupture of aneurysm A, which can lead to stroke, death, disability, etc. Therefore, treating the aneurysm to reduce blood flow into it, thereby reducing the risk of adverse prognoses, may be advantageous.

[0106] Intrasac occlusion devices, including but not limited to embolization coil 101, can be used to treat aneurysm A. However, if aneurysm A has a wide neck, it may be difficult to treat it alone with an intrasac device (e.g., embolization coil 101) because the intrasac device may be easily repositioned through the aneurysm neck into the parent vessel, as illustrated in Figure 1B. Repositioning or protrusion of the coil can lead to arterial occlusion, stroke, and / or death. Shunt devices can be used alone or in combination with intrasac devices to prevent blood from flowing into the aneurysm. However, tubular shunt devices may not adequately cover the neck of the aneurysm and may undesirably prevent blood from flowing into one of the vessels at the bifurcation. Therefore, one or more devices, systems, and methods of the present art relate to shunt devices configured to locate across a bifurcation aneurysm to prevent blood from flowing into the aneurysm while allowing blood to flow from the parent vessel into two or more branch vessels.

[0107] Figure 2A and 2B This is an isometric view of a scalable shunt device (“device 200”) configured according to the present technology. Device 200 may include a scalable shunt mesh (“mesh 202”) configured to interfere with blood flow to a degree sufficient to cause aneurysm thrombosis. For example, mesh 202 may have sufficiently low porosity to prevent or reduce blood flow across the thickness of mesh 202. Although Figure 2A and 2BThe device 200 is depicted comprising a single mesh 202, but in some embodiments, the device 200 includes multiple occlusion devices (e.g., a support, a braid, etc.). A second occlusion may be radially positioned within the mesh 202, radially positioned above the mesh 202, across the mesh 202, and / or end-to-end with the mesh 202. For example, the device of the present technology may include a first tubular mesh radially positioned within a second tubular mesh, such that the device comprises a combined porosity less than that of either the first or second mesh. In some embodiments, the device of the present technology may include a mesh configured to shunt blood flow and a support configured to provide structural support to the mesh. Additional occlusion devices may be formed integrally with or separately from the mesh.

[0108] According to some embodiments, such as Figure 2A As shown, the mesh 202 encompasses the entire length and / or circumference of the device. However, for example, when combined with a second occlusion device, the mesh 202 may only encompass a portion of the length and / or circumference of the device 200. In some embodiments, the length of the mesh 202 is at least partially based on the length of the neck of the aneurysm to be treated. In some embodiments, the properties of the mesh 202 (e.g., porosity, thickness, material properties) may be the same throughout the device. However, the properties of the mesh 202 may also vary throughout the device 200. For example, a scalable device of the present technology may include a portion configured to be positioned adjacent to the neck of the aneurysm and comprising a low-porosity mesh, and other portions configured to be anchored to the vessel wall and having a porosity greater than that of the mesh.

[0109] Figure 2A A device 200 configured for delivery in a radially constrained state is shown. In the radially constrained state, the device 200 may have a generally tubular shape. The device 200 may include a first end portion 204, a second end portion 206, and a longitudinal axis L extending between the first and second end portions 204, 206. In some embodiments, the first end portion 204 is a distal end portion, and the second end portion 206 is a proximal end portion. The device may include an outer surface, an inner surface, a thickness between the inner and outer surfaces, and a cavity defined by the inner surface and extending from the first end portion 204 to the second end portion 206. One or more ends of the device may be open (i.e., the cavity extends through one or more ends of the device).

[0110] According to some embodiments, the diameter and / or length of the device 200 in a tubular configuration may be at least partially based on the anatomy to be treated. For example, in some cases, it may be advantageous to select a diameter of the device 200 slightly larger than the diameter of the blood vessel in which the device is configured to be positioned. An excessively large diameter of the device 200 may facilitate anchoring of the device 200 to the vessel wall. In some embodiments, the diameter of the device 200 varies along its length. For example, the first terminal portion 204 and / or the second terminal portion 206 may taper gradually in a distal or proximal direction. Alternatively or additionally, the first terminal portion 204 and / or the second terminal portion 206 may flare out in a distal or proximal direction. In some embodiments, the diameter of the device 200 is substantially constant along its length. According to some embodiments, the length of the device may be configured based on the length of the carrier vessel, the length of branch vessels, the angle between the two vessels, the length of the aneurysm neck, etc. In some embodiments, the device 200 does not comprise a tubular shape in a radially constrained state. The device 200 may contain any suitable hollow shape, including but not limited to circular, oval, elliptical, rectangular, prismatic, etc.

[0111] According to some embodiments, the second end portion 206 of the mesh 202 may include one or more hinged portions movable relative to the first end portion 204 of the mesh 202. The hinged portions may be separated by one or more slits. For example, such as... Figure 2A As shown, the second end portion 206 of the mesh 202 may include circumferentially discontinuous first and second hinge portions 208a, 208b (collectively referred to as "hinge portions 208"). Hinge portions 208 may be separated by first and second slits 210. Each hinge portion 208 may include an edge 212 formed by the slits (e.g., longitudinal edges 212a, 212b). According to some embodiments, the number of hinge portions is proportional to the number of slits. For example, two slits may form two hinge portions, three slits may form three hinge portions, four slits may form four hinge portions, and so on. In some embodiments, the number of slits is greater than or less than the number of hinge portions.

[0112] In some embodiments, such as Figure 2AAs depicted, slits 210 extend along the longitudinal axis L of device 200. Slits 210 may also extend circumferentially along the device and / or in a direction inclined to the longitudinal and / or circumferential directions. Each of the slits 210 may have a first end, a second end, and a length therebetween. The first and / or second ends of one of the slits 210 may be substantially longitudinally aligned with the first and / or second ends of the other slits (one or more). In some embodiments, the first end of slit 210 is longitudinally offset. In some embodiments, the second end of slit 210 is longitudinally offset. Slits 210 may contain the same length. In some embodiments, the length of the first slit 210a may be different from or the same as the length of the second slit 210b. Figure 2A and 2B As shown, in some embodiments, slit 210 extends through one end of device 200. The slit may extend through one, both, or neither end of device 200.

[0113] The width of each of the slits 210 may define an opening between an edge 212 of the first hinge portion 208a and a corresponding edge 212 of the second hinge portion 208b adjacent to the slit. In some embodiments, such as... Figure 2A As shown, the slit width is negligible, such that when the device 200 is in a tubular configuration, adjacent edges 212 of the first and second hinge portions are disconnected but in contact. The slit width may be greater than zero, such that the edges 212 of adjacent first and second hinge portions are disconnected and spaced apart by at least the width of the slit.

[0114] According to some embodiments, the device of this technology can be configured in an extended state, wherein the hinged portion is positioned at a desired angle to the main body of the device. For example, Figure 2B The device 200 is depicted in an extended configuration. In this extended configuration, the first hinge portion 208a and the second hinge portion 208b are separable from each other. The first hinge portion 208a (e.g., the longitudinal axis of the first hinge portion 208a) is positioned at a first angle θ1 with the longitudinal axis L of the device. Figure 2B As shown, the first angle may be approximately zero, such that the first hinge portion 208a is substantially parallel to the longitudinal axis L. The second hinge portion 208b may form a second angle θ with the longitudinal axis L of the device. In some embodiments, the second angle θ is between approximately 30 degrees and approximately 150 degrees. In some embodiments, the first angle is substantially non-zero, such that the first hinge portion 208a is not substantially parallel to the first end portion 204. The first angle may be between approximately 30 degrees and approximately 270 degrees. According to some embodiments, the first angle and / or the second angle θ is between approximately 90 degrees and approximately 120 degrees.

[0115] Each of the first terminal portion 204, the first hinge portion 208a, and the second hinge portion 208b can be configured to be positioned within the lumen of the blood vessel at the treatment site of the bifurcation aneurysm, such as Figure 3 As shown. The first terminal portion 204 can be configured to be positioned within the lumen of the first branch vessel B1. The device 200 can be extended to a fully extended configuration. Figure 3 The second hinge portion 208b is positioned within the second branch vessel B2, and the first hinge portion 208a extends within the tumor-bearing vessel P. Figure 3 As shown, the first terminal portion 204 and / or the second hinged portion 208b can be configured to be positioned across the neck of the aneurysm A. The shunt properties of these portions of the mesh 202 can be configured to prevent blood from flowing into the aneurysm. In some embodiments, any single portion or multiple portions of the device 200 can be configured to be positioned across the neck of the aneurysm.

[0116] Each portion of the device 200 (e.g., the first end portion 204, the first hinge portion 208a, and the second hinge portion 208b) can be configured to anchor to the vessel wall. The degree of anchoring can be based at least in part on the surface area of ​​the portion contacting the vessel wall, the radial force exerted by said portion on the vessel wall, the diameter of said portion relative to the diameter of the vessel wall, the material of said portion, etc. For example, the tubular first end portion 204 may contact the entire circumference of the wall of the first branch vessel B1. In contrast, the circumferentially discontinuous second hinge portion 208b may contact only a portion of the circumference of the wall of the second branch vessel B2, and therefore may be anchored to the second branch vessel B2 to a lesser extent than the first end portion 204 is anchored to the first branch vessel B1.

[0117] One or more portions of the device in this technology may be circumferentially discontinuous, so that the device can be anchored to each vessel at the bifurcation, fully covering the neck of the aneurysm, and allowing minimal disruption to blood flow from the carrier vessel to both branches, such as... Figure 3 As shown. Each of the hinged portions may have a width defined by the angle between the hinged portions, said width being based on the radial spacing of the slits separating adjacent hinged portions. For example, Figure 4A The drawing device 400 has first and second hinged portions 408a, 408b separated by first and second slits 410a, 401b extending along the longitudinal axis of the device. Figure 4B This shows an axial cross-sectional view of the first end portion 404 of the mesh taken along line 4B-4B. (See attached image.) Figure 4B As shown, the axial cross-sectional shape of the circumferentially continuous first end portion 404 is a complete circle. The circumferentially discontinuous first and second hinge portions 408a and 408b may each have an axial cross-sectional shape of an arc with opposing angles (see...). Figure 4C For example, such as Figure 4C As shown, the first hinge portion 408a faces the first angle. And the second hinge portion 408b faces the second angle. The first and second slits 410a and 410b are spaced approximately 180 degrees apart, therefore, and Both are approximately 180 degrees, and the first and second hinge portions 408a and 408b contain approximately equal widths (and opposite angles).

[0118] In some embodiments, the hinged portions face different angles and have different widths. For example, Figure 5A and 5B Isometric and cross-sectional views of the device 500 are shown, wherein the first hinge portion 508a faces the first angle. Furthermore, the second hinge portion 508b is greater than the opposite side. The second angle In some embodiments, angle and The size can be based on the radial spacing of the slits 510. In embodiments where the device includes more than two hinge portions, some or all of the hinge portions may have the same width. In some embodiments, some or all of the hinge portions may have different widths. The width of the hinge portion can be selected based on the intended location of the hinge portion at the treatment site. For example, in some embodiments, the hinge portion is configured to be positioned at least partially across the aneurysm neck to have a larger width to ensure that complete coverage of the aneurysm neck may be advantageous.

[0119] The scalable device according to this technology can have any suitable number of hinged sections. For example, Figure 6A and 6B The device 600 depicted includes a tubular first end portion 604 and a hinge portion 608 extending from the first end portion 604. The circumferentially discontinuous hinge portion 608 may be oriented at an angle as described above. In some embodiments, the hinge portion 608 is oriented at an angle of approximately 180 degrees to form a semi-tubular shape, such as... Figure 6A and 6BAs shown. According to some embodiments, the hinge portion 608 is oriented at an angle between about 10 degrees and about 350 degrees, between about 20 degrees and about 340 degrees, between about 20 degrees and about 330 degrees, between about 30 degrees and about 320 degrees, between about 40 degrees and about 310 degrees, between about 50 degrees and about 300 degrees, between about 60 degrees and about 290 degrees, between about 70 degrees and about 280 degrees, between about 80 degrees and about 270 degrees, between about 90 degrees and about 260 degrees, between about 100 degrees and about 250 degrees, between about 110 degrees and about 240 degrees, between about 120 degrees and about 230 degrees, between about 130 degrees and about 220 degrees, between about 140 degrees and about 210 degrees, between about 150 degrees and about 200 degrees, or between about 160 degrees and about 190 degrees.

[0120] When device 600 is in a radially constrained state, such as Figure 6A As shown, the longitudinal axis of the hinge portion 608 may be generally parallel to the longitudinal axis L of the device 600. In the extended state, the hinge portion 608 may be configured such that the longitudinal axis of the hinge portion 608 is at an angle θ relative to the longitudinal axis L of the device 600. According to some embodiments, the device 600 may be configured to locate aneurysms between branch vessels, between the carrier vessel and the first branch vessel, and / or between the carrier vessel and the second branch vessel. The angle θ between the longitudinal axis L of the device 600 and the hinge portion 608 may be partially based on the treatment site. For example, the first distal portion 604 may be configured to be located within the first branch vessel, and the hinge portion 608 may be configured to be located within the second branch vessel, and the angle θ may be based on the angle between the first and second branch vessels. In some embodiments, the angle θ is between about 30 degrees and about 270 degrees. According to some embodiments, the angle θ is between about 90 degrees and about 120 degrees.

[0121] According to some embodiments, such as Figure 7A As shown, the device 700 of this technology may include a mesh 702 having a tubular first end portion 704 and a second end portion 706 including a first hinge portion 708a and a second hinge portion 708b. The first hinge portion 708a may include a circumferentially discontinuous portion as previously described and a circumferentially continuous tubular portion. In some embodiments, the tubular first end portion is a distal end portion configured to be positioned within a first branch vessel, and the tubular portion of the first hinge portion 708a is a proximal portion configured to be positioned within a tumor-bearing vessel. The second hinge portion 708b may include three edges that are disconnected from the first hinge portion 708a by three slits 710. Figure 7AAs shown, two slits 710a and 710b can extend longitudinally, and a slit 710c can extend circumferentially between the two longitudinal slits 710a and 710b. The two longitudinal slits 710a and 710b can extend only along a portion of the second end portion 706 and do not extend through the end of the device 700. The second hinge portion can be oriented at approximately 180 degrees, such as... Figure 7A and 7B As shown. In some embodiments, as previously described, the second hinge portion 708b may be oriented at an angle between about 10 degrees and about 350 degrees. In extended configurations ( Figure 7B The first hinge portion 708a can be configured to be substantially parallel to the first end portion 704, or the first hinge portion 708a can be configured to be positioned relative to the first end portion 704 at a non-zero first angle. In an extended configuration, the second hinge portion 708b can be positioned relative to the first end portion 704 at a second angle θ. As previously described, the angle θ can be between about 30 degrees and about 270 degrees. According to some embodiments, the angle θ is between about 90 degrees and about 120 degrees.

[0122] According to some embodiments, such as Figure 8 As shown, the scalable shunt device of this technology, such as device 700, can be used with an additional occlusion device to treat aneurysm A. Embolization coil 101 can be placed within the aneurysm before device 700 is deployed at the treatment site. In the extended configuration, at least one portion of device 700 (e.g., Figure 8 The first terminal portion 704 and the second hinge portion 708b) of the device 700 are configured to be positioned across the neck of the aneurysm. One or more portions of the device 700 covering the neck of the aneurysm prevent the embolization coil 101 from dislodging from the aneurysm and entering branches and / or carrier vessels. The occlusion device can be any suitable occlusion device, such as an embolization coil, a fluid embolization device, a braid, etc.

[0123] This technology can be expanded into devices such as Figure 9The illustrated device 900 may incorporate radiopaque materials (e.g., platinum, platinum-iridium, tantalum, gold, tungsten) to improve visualization of the device 900 within a patient's vascular system. For example, the device 900 may include one or more radiopaque markers 950 attachable to a mesh 902. The radiopaque markers 950 may comprise coils, strips, electroplated materials, etc. The radiopaque markers 950 may be permanently attached to the device 900 by welding, mechanical attachment, adhesive, or another suitable bonding method. In some embodiments, the radiopaque markers are detachably attached to the device 900. The radiopaque markers may be positioned on the outer surface of the device 900, the inner surface of the device 900, and / or between the inner and outer surfaces of the device 900. In some embodiments, one or more portions of the mesh 902 of the device 900 (e.g., one or more mesh supports, one or more mesh lines) are formed of a radiopaque material.

[0124] like Figure 9 As described, radiopaque markers 950 can be specifically patterned and attached to device 900 to visualize and / or distinguish certain portions of the device. For example, radiopaque markers 950 can be attached to device 900 in a longitudinal region adjacent to the second end portion 906 of device 900. Multiple radiopaque markers 950 can be attached around the circumference of device 900 in the longitudinal region. Radiopaque markers 950 can be spaced evenly or unevenly around the circumference of device 900. Additionally or alternatively, radiopaque markers 950 can be attached to hinge portions (one or more) 908. When device 900 includes multiple hinge portions 908, one hinge portion 908 may include a larger number of radiopaque markers 950 and / or different arrangements of radiopaque markers 950 than other hinge portions 908 to facilitate identification of the hinge portion 908 when device 900 is within a patient's vascular system. For example, Figure 9 The first hinge portion 908a shown includes a radiopaque marker, while the second hinge portion 908b includes four radiopaque markers. The radiopaque markers 950 are spaced apart circumferentially around each of the hinge portions 908. Although Figure 9 Eight radiopaque markers are shown, but any suitable number and distribution of radiopaque markers 950 can be used. In various embodiments, the distribution of radiopaque markers 950 along the device 900 may be circumferentially asymmetrical, such that the first and second hinge portions 908a and 908b can be distinguished from each other under fluorescence inspection.

[0125] The scalable devices disclosed herein can be manufactured using any suitable technology or materials. The scalable devices forming this technology may include obtaining a scalable mesh formed of one or more metals, polymers, composite materials, and / or biomaterials. In some embodiments, the scalable mesh may be made of one or more metals or alloys, including hyperelastic metals / alloys (e.g., nickel-titanium alloys, such as nitinol) or other metals / alloys, such as stainless steel, cobalt-chromium alloys, cobalt-nickel alloys (e.g., 35N LT from Fort Wayne Metals, Fort Wayne, Indiana, USA). TM The expandable mesh is formed from materials such as platinum, platinum-tungsten alloys, gold, magnesium, iridium, chromium, zinc, titanium, tantalum, and / or an alloy of any of the aforementioned metals or any combination thereof. In several embodiments, the expandable mesh may be highly polished and / or surface-treated to further improve blood compatibility. The expandable mesh may be constructed solely of metallic materials without any polymeric materials, or may include a combination of polymeric and metallic materials. Some or all of the expandable mesh may be at least partially formed of radiopaque materials, metals, or alloys.

[0126] In some embodiments, some or all of the mesh may be formed of strands or threads that have been braided or woven together. The strands may have a two-component (or multi-component) configuration comprising an inner core material surrounded by an outer shell material. The core material may include any of the materials disclosed in the preceding paragraphs, and the outer material may include any of the materials disclosed in the preceding paragraphs. In some embodiments, the core material may differ from the outer material. For example, in some embodiments, the core material is a radiopaque material (e.g., platinum, platinum-tungsten alloy, tantalum, gold, tungsten, etc., or a material that is substantially less radiopaque than the outer material), and the outer material is an elastic or highly elastic and / or hyperelastic material (e.g., nitinol, 35N LT, etc., or a material with a substantially higher Young's modulus than the outer material). The cross-sectional area of ​​the core material (in terms of cross-sectional dimension dc) may be approximately 5% to approximately 50%, approximately 10% to approximately 45%, approximately 15% to approximately 40%, approximately 10%, approximately 15%, approximately 20%, approximately 25%, approximately 30%, approximately 35%, approximately 40%, and approximately 45% of the total cross-sectional area of ​​the single strand (this measurement is referred to as the "fill percentage" of the core material 22 to the strand 18).

[0127] Suitable materials and combinations for strands used in scalable meshes include: (a) all strands in a coaxial bicomponent configuration having a cobalt-nickel outer material and a platinum or platinum-tungsten (or other opaque) core material; (b) all strands in a coaxial bicomponent configuration having a nickel-titanium outer material and a platinum or platinum-tungsten (or other opaque) core material; (c) combinations of coaxial bicomponent strands having a cobalt-nickel outer material and a platinum or platinum-tungsten (or other opaque) core material, and some cobalt-nickel single-component strands; (d) combinations of coaxial bicomponent strands having a nickel-titanium outer material and a platinum or platinum-tungsten (or other opaque) core material, and some nickel-titanium single-component strands; and (e) combinations of cobalt-nickel or nickel-titanium single-component strands with some platinum or platinum-tungsten (or other opaque) single-component strands.

[0128] In some embodiments, the mesh may be formed from sheets or tubes of any suitable material, such as, but not limited to, materials described elsewhere herein. Any suitable cutting process, such as cutting, laser cutting, milling, chemical etching, electrical discharge wire cutting (EDM), water jetting, stamping (imprinting), chemical etching, etc., can be used to cut the mesh from the material. The sheet or tube of material may have a thickness selectively chosen to achieve the desired material properties of the resulting mesh. In various embodiments, the thickness of the sheet or tube of material may be uniform or variable (e.g., thinning in specific areas using etching, grinding, etc., or thickening in specific areas using deposition, etc.). In some embodiments, the mesh is formed directly as a sheet or tube by additive processes such as thin film deposition, 3D printing, etc.

[0129] In some embodiments, the mesh can be bent or otherwise manipulated to create a tubular configuration of the mesh (e.g., a radially constrained configuration). For example, in embodiments where the mesh is initially formed from a flat sheet of material (e.g., by laser cutting, by thin film deposition, etc.), the tubular configuration can be created by removably attaching the mesh to a tubular mold or jig and subjecting the mesh to a heat treatment process as described elsewhere herein. In some embodiments, the tubular configuration is formed by deforming a flat sheet of material into a generally tubular shape such that the longitudinal edges of the flat pattern are positioned adjacent to or contacting each other. The longitudinal edges may be joined along all or part of their respective length (e.g., via laser welding). In some embodiments, the edges may overlap such that the overlapping portion comprises radial layers of two meshes.

[0130] The hinge portion of this technology can be formed by creating slits in a mesh. In some embodiments, the slits can be formed by a suitable cutting process, such as, but not limited to, the cutting processes described above. The cut edges of the mesh can be fastened by welding, pressing, melting, gluing, weaving, clamping, or another suitable fastening method. In some embodiments, the various portions of the mesh (e.g., the first end portion, the hinge portion) can be formed separately and then joined together. The portions of the mesh can be joined by any suitable joining method, such as, but not limited to, welding, pressing, melting, gluing, etc. In some embodiments, the hinge portion can be formed by extruding the material forming the first end portion of the mesh.

[0131] In some embodiments, the mesh may be bent or otherwise manipulated via a shape-setting process to establish an expanded configuration of the mesh, wherein one or more hinged portions are angled relative to a first end portion of the device. In some embodiments, the shape-setting process includes manipulating the mesh into a desired expanded configuration (e.g., by coupling to a mold or fixture) and subjecting the mesh to heat treatment. One example of a heat treatment procedure may include heating the mesh to a selected temperature and holding it for a selected time period, followed by rapid cooling. Rapid cooling may be achieved by any suitable cooling procedure, such as, but not limited to, water quenching or air cooling. In certain instances, the heat treatment procedure may be performed in an air or vacuum furnace, a salt bath, a fluidized sand bed, or other suitable system. In other instances, other suitable heat treatment procedures may be employed, including but not limited to resistance heating or heating by flowing an electric current through the metal of the appliance structure. After the initial shape setting, one or more additional post-treatment operations may be provided on the mesh, including but not limited to sandblasting, shot peening, polishing, chemical etching, electropolishing, electroplating, coating, ultrasonic cleaning, sterilization, or other cleaning or decontamination procedures.

[0132] In some embodiments, a single shape-setting step may be performed to deform the mesh into its desired extended configuration. However, in some embodiments, shape setting may include two or more shape-setting steps (e.g., two or more heat treatment processes, possibly using two or more different fixtures). In such cases, the amount of deformation imparted to the mesh in each shape-setting step may be limited, with each subsequent shaping step moving the mesh further toward the desired extended configuration.

[0133] This disclosure also includes any of the methods for treating vascular conditions, such as aneurysms, using embodiments of the scalable device disclosed herein. The scalable device can be deployed across the neck of the aneurysm, and its shunt properties are used to reduce blood flow between the aneurysm and the parent vessel, causing thrombus formation within the aneurysm and / or leading to aneurysm healing.

[0134] Figure 10A side view of an example of a delivery system 1001 according to the present technology is shown. The delivery system may include an elongated tube 1012 (e.g., a microcatheter) having a proximal distal portion 1016, a distal distal portion 1018, a lumen 1020 extending from the proximal distal portion 1016 to the distal distal portion 1018, and an inner surface 1022 defining the lumen 1020. At the distal distal portion 1018, the elongated tube 1012 may be open. The elongated tube 1012 may be configured to slidably receive a core member 1013 configured to carry an expandable device 1000. The core member 1013 may be configured to advance beyond the distal portion 1018 to expand or deploy the expandable device 1000 within a blood vessel. In operation, the core member 1013 may advance distally relative to the tube 1012, or the tube 1012 may retract proximally relative to the core member 1013. The elongated tube 1012 may be defined in a generally longitudinal dimension extending between the proximal end portion 1016 and the distal end portion 1018. When the delivery system 1001 is in use, the longitudinal dimension does not need to be straight along some or any of its length.

[0135] The core member 1013 may include a distal portion 1013a configured to extend generally longitudinally through a cavity in the elongated tube 1012. The core member 1013 may also include a first proximal portion 1013b and a second proximal portion 1013c. The first and second proximal portions 1013b and 1013c may be radially spaced apart, such as... Figure 10 As shown. The first proximal portion 1013b may be configured to move the entire expandable device 1000 and / or the first hinged portion of the expandable device 1000 through the elongated tube 1012, while the second proximal portion 1013c may be configured to move and / or deploy the second hinged portion 1008b of the expandable device 1000. The core member 1013 may substantially comprise any member(s) having sufficient flexibility and column strength to move the expandable device 1000 through the elongated tube 1012. Thus, the core member 1013 may comprise wire, tubing (e.g., a thiourea tube), braid, coil, or other suitable member(s), or a combination of wire(s), tubing(s), braid, coil, etc.

[0136] The delivery system 1001 may also include a coupling assembly 1026 or a re-sheathing assembly 1026 configured to releasably retain the expandable device 1000 relative to the core member 1013. The coupling assembly 1026 may be configured to engage the expandable device 1000 via abutment of a proximal end or edge of the expandable device 1000, mechanical interlocking with the orifices and filaments of the expandable device 1000, frictional engagement with the inner wall of the expandable device 1000, any combination of these modes of action, or another suitable mode of action. Thus, the coupling assembly 1026 may engage with the inner surface 1022 of the elongated tube 1012 to grip and / or abut the expandable device 1000, such that the coupling assembly 1026 can move the expandable device 1000 along and within the elongated tube 1012, for example, movement of the core member 1013 relative to the distal and / or proximal side of the elongated tube 1012 causes corresponding distal and / or proximal movement of the expandable device 1000 within the elongated lumen 1020.

[0137] In some embodiments, the coupling assembly 1026 may include one or more proximal restrictors 1028 and distal restrictors 1030. The proximal and distal restrictors 1028, 1030 may be secured to the core member(s) 1013 to prevent or limit movement of the coupling assembly 1026 proximal or distally along the longitudinal dimension of the core member 1013. For example, the proximal and distal restrictors 1028, 1030 may be brazed or secured to the core member(s) 1013 using an adhesive. In some embodiments, as described further in detail below, the proximal restrictor 1028 may be sized to abut the proximal end of the expandable device 1000 and to be used to push the device distally during delivery. The distal restrictor 1030 may taper distally toward the core member 1013. This taper reduces the risk of the distal restrictor 1030 contacting the inner surface of the expandable device 1000, particularly during navigation of a tortuous vascular system, where the system 1001 may be in a highly tortuous configuration.

[0138] like Figure 10As depicted, the proximal limiter 1028 may be configured to abut a proximal end or proximal edge of the expandable device 1000. The proximal limiter 1028 may include a first portion 1028a fixed to a first proximal portion 1013b of the core member 1013 and a second portion 1028b fixed to a second proximal portion 1013c of the core member 1013. The second portion 1028b of the proximal limiter is movable relative to the first portion 1028a of the proximal limiter. The first portion 1028a of the proximal limiter 1028 may be configured to abut a first hinge portion 1008a of the expandable device 1000, and the second portion 1028b of the proximal limiter 1028 may be configured to abut a second hinge portion 1008b of the expandable device 1000. In this arrangement, each portion of the proximal limiter 1028 may be used to move (e.g., push) a corresponding hinge portion of the expandable device 1000. A thrust can be applied to the first proximal portion 1013b of the core member 1013, such that the first portion 1028a of the proximal limiter 1028 abuts the first hinge portion 1008a of the expandable device 1000, and moves the entire expandable device 1000 or only the first hinge portion 1008a distally through the elongated tube 1012. A thrust can be applied to the second proximal portion 1013c of the core member 1013, such that the second portion 1028b of the proximal limiter 1028 abuts the second hinge portion 1008b of the expandable device 1000, and moves the second hinge portion 1008b distally through the elongated tube 1012.

[0139] The coupling assembly 1026 may also include a re-sheathing member 1032 positioned around the core member 1013 between proximal and distal limiters 1028, 1030. The re-sheathing member 1032 may be a rigid plate, sprocket, pad, or other suitable member having a central aperture of the core member 1013 configured to receive it. The re-sheathing member 1032 may be configured to frictionally engage, mechanically interlock, or otherwise engage with the expandable device 1000 such that the re-sheathing member 1032 restricts longitudinal movement of the expandable device 1000 relative to the core member 1013. One or more spacers (not shown) may be positioned around the core member 1013 between the re-sheathing member and the proximal limiter 1028, distal limiter 1030, and / or additional re-sheathing member 1032 to define relative longitudinal positioning between components at either end of the spacer. The spacer may comprise a coil, a solid tube, or other structural element that can be mounted on the core member 1013. In some embodiments, the spacer may be a zero-pitch coil with flat ends. In some embodiments, the spacer may be a solid tube (e.g., a laser-cut tube) rotatably mounted or non-rotatably fixed (e.g., brazed) to the core member 1013. The outermost radial dimension of the spacer may be smaller than the outermost radial dimension of the re-sheath member 1032, such that the spacer does not contact the expandable device 1000 during normal operation of the system 1001. Although Figure 10 The embodiments described herein include a single re-sheathing member 1032 without spacers, but the re-sheathing member and spacers can vary. In at least one embodiment, the coupling assembly 1026 includes only a single re-sheathing member 1032 without any spacers. In other embodiments, the number of re-sheathing members can vary, for example, two, three, four, five, six or more re-sheathing members separated by spacers.

[0140] When the proximal limiter 1028 is configured to push the expandable device 1000 distally, the proximal limiter accordingly transfers some, most, or all of the distal longitudinal (thrust) force to the expandable device 1000, completely or partially replacing the re-sheathing member(s) 1032. In this configuration, as the expandable device 1000 is delivered distally along the length of the elongated tube 1012, the re-sheathing member 1032 may transfer a small amount of thrust to the expandable device 1000, or none at all. Advantageously, this reduces or eliminates the tendency of the re-sheathing member(s) 1032 to cause porosity deformation of the expandable device 1000. Moving the expandable device 1000 in this manner using the proximal limiter 1028 also reduces or eliminates longitudinal movement of the expandable device 1000 relative to the core member 1013, which is sometimes accompanied by the porosity deformation described above. In most cases, the majority of the travel of the expandable device 1000 within the elongated tube 1012 during delivery to the treatment location is in the distal or "push" direction, compared to the relatively short travel involved in resheathing the expandable device 1000 proximally or in a "pull" direction. Therefore, configuring the proximal limiter 1028 to transfer most or all of the thrust to the expandable device 1000 can significantly reduce or substantially eliminate such deformation and / or relative longitudinal movement of the stent.

[0141] therefore, Figure 10 The coupling assembly 1026 may employ a proximal limiter 1028 as a push element to transmit at least some, most, or all of a distal thrust to the expandable device 1000 during delivery. In such a coupling assembly 1026, a re-sheathing member (one or more) 1032 does not transmit any distal thrust to the expandable device 1000 during delivery (or transmits only a small portion of such force, or only intermittently). The re-sheathing member (one or more) 1032 may transmit a proximal pull to the expandable device 1000 during retraction or re-sheathing, and the proximal limiter 1028 may not transmit a proximal pull to the support (or the proximal limiter may transmit such a pull occasionally or intermittently, for example, when a portion of the expandable device 1000 is recessed between the outer edge of the proximal limiter 1028 and the inner wall of the elongated tube 1012).

[0142] In some embodiments, re-sheathing members (one or more) 1032 are used for distal and proximal movement of the expandable device 1000 relative to the elongated tube 1012. The re-sheathing members (one or more) 1032 can transmit distally directed forces to the expandable device 1000 to move it distally within the elongated tube 1012 during delivery, and transmit proximally directed forces to the expandable device 1000 to move it proximally within the elongated tube 1012 during re-sheathing. In such embodiments, the proximal limiter 1028 may be configured to have a relatively small outer diameter and / or positioned sufficiently proximal to the proximal end of the expandable device 1000 to prevent the proximal limiter 1028 from transmitting distally directed thrust to the expandable device 1000 during delivery.

[0143] The re-insertion member 1032 may be fixed to the core member 1013 so that it cannot move longitudinally / slidingly and / or radially / rotatably relative to the core member 1013. Alternatively, the re-insertion member 1032 may be coupled to (e.g., mounted on) the core member 1013 such that the re-insertion member 1032 can rotate about the longitudinal axis of the core member 1013 and / or move or slide longitudinally along the core member 1013. In such embodiments, the re-insertion members 1032 may each have an inner cavity or aperture in which the core member 1013 is received, such that the re-insertion member 1032 can slide and / or rotate relative to the core member 1013.

[0144] In some embodiments, the re-sheathing member 1032 may be mounted to the core member 1013 to allow not only rotational movement of the re-sheathing member 1032 but also tilting relative to the longitudinal axis of the core member 1013 to a certain degree. For example, the aperture in the re-sheathing member 1032 may be larger than the outer diameter of the corresponding portion of the core member 1013, thereby allowing rotational movement and tilting relative to the core member 1013. As used herein, "tilt" means that the long axis of the re-sheathing member 1032 (i.e., the axis extending along the longest dimension of the re-sheathing member 1032, substantially parallel to the proximal and distal end faces of the re-sheathing member 1032) is not orthogonal to the longitudinal axis of the core member 1013. For example, in a tilted configuration, the long axis of the re-sheathing member 1032 may intersect the core member 1013 at approximately 85 degrees, indicating a tilt of 5 degrees. The permissible degree of tilt may vary depending on the dimensions of the re-sheathing member 1032 and the core member 1013. In some embodiments, one or both of the re-insertion members 1032 may be tilted relative to the core member 1013 by 30 degrees or less, 20 degrees or less, 10 degrees or less, or 5 degrees or less. In some embodiments, one or both of the re-insertion members 1032 may be tilted relative to the core member by at least 5 degrees, at least 10 degrees, at least 20 degrees or more.

[0145] Proper positioning of the expandable device of this technology requires the articulated portion to be oriented adjacent to the blood vessel to which it is intended to expand. Delivery system 1001 may include an orientation member 1034 to facilitate proper rotation of the expandable device 1000 during delivery. The orientation member 1034 may be coupled to a first and / or second proximal portion 1013a, 1013b of core member 1013. In some embodiments, the orientation member 1034 is fixed to the first proximal portion 1013b of core member 1013 and is slidable over a second proximal portion 1013c of core member 1013. As a result, the first and second proximal portions 1013b and 1013c are slidably movable relative to each other.

[0146] In operation, the expandable device 1000 can be moved distally or proximally within the elongated tube 1012 via the core member 1013 and the coupling assembly 1026. To remove the expandable device 1000 from the elongated tube 1012, one or both proximal portions of the core member 1013 move distally while the elongated tube 1012 remains stationary, or one or more proximal portions of the core member 1013 remain stationary while the elongated tube 1012 is retracted proximally. As the proximal portions (one or more) of the core member 1013 move distally, the distal side of the proximal limiter 1028 abuts against the proximal end of the expandable device 1000, causing the expandable device to advance distally and ultimately exit the distal portion 1018 of the elongated tube 1012. In embodiments where the re-sheathing member(s) 1032 is used to transmit thrust to the expandable device 1000, in response to the application of a distally directed force to the core member 1013, a mechanical engagement or interlock between the re-sheathing member 1032 and the expandable device 1000 causes the expandable device 1000 to move distally through and away from the elongated tube 1012. Conversely, to re-sheath or otherwise move the expandable device 1000 into the elongated tube 1012, the relative movement between the core member 1013 and the elongated tube 1012 is opposite to the movement of the expandable device 1000 out of the elongated tube, such that the proximal region of the distal limiter 1030 abuts against the distal end of the expandable device, thereby causing the re-sheathing member 1032 to retract relative to the elongated tube 1012. The mechanical engagement between the re-sheathing member 1032 and the expandable device 1000 accordingly retains the expandable device 1000 relative to the core member 1013, such that proximal movement of the expandable device 1000 relative to the elongated tube 1012 allows the re-sheathing of the expandable device 1000 to return to the distal portion 1018 of the elongated tube 1012. This can be useful when the expandable device 1000 has been partially deployed and a portion of the expandable device 1000 is held between at least one re-sheathing member 1032 and the inner surface 1022 of the elongated tube 1012, because the expandable device 1000 can be retracted into the distal opening of the elongated tube 1012 by moving the core member 1013 proximal relative to the elongated tube 1012 (and / or moving the elongated tube 1012 distal relative to the core member 1013). Reinsertion in this manner is still possible until the reinsertion member 1032 and / or the elongated tube 1012 have been moved beyond the distal opening of the elongated tube 1012 and the expandable device 1000 is released from between the reinsertion member 1032 and the elongated tube 1012.

[0147] In some embodiments, the delivery of the scalable device of this technology may begin by obtaining a percutaneous access point into the patient's arterial system, typically via a major vessel in the leg or arm. A guidewire may be placed and advanced through the percutaneous access point to a treatment site, which may be in an intracranial artery or any neurovascular artery, peripheral artery, or coronary artery. A slender tube 1012 (e.g., a microcatheter) may be advanced over the guidewire to a treatment site with an aneurysm at the bifurcation of the vessel. The distal portion 1018 of the slender tube 1012 may be advanced into a first branch vessel. The guidewire may then be withdrawn from the slender tube 1012, along with the core member 1013 and core assembly 1026, together with the scalable device 1000 mounted thereon or supported thereon, which may be advanced through the slender tube 1012 to the distal portion 1018. Radiopaque markings of the scalable device 1000 may be visualized using fluorescence examination to identify the orientation and / or location of the scalable device 1000 at the treatment site. Orientation member 1034 can be used to rotate expandable device 1000 within elongated tube 1012 and / or blood vessel to achieve proper rotational orientation. A first (e.g., distal) distal portion 1004 of expandable device 1000 can be extended within a first branch vessel as previously described by applying thrust to a first proximal portion 1013b of core member 1013. Expandable device 1000 can self-extend to juxtapose with the inner wall of the first branch vessel. In some embodiments, additional extension devices (e.g., balloons, power sources) can be used to facilitate or cause expansion of device 1000. In some embodiments, once the first distal portion 1004 of expandable device 1000 is deployed, a second hinge portion 1008b can be deployed into the second branch vessel. Force can be applied to the second proximal portion 1013c of core member 1013 to cause the second portion 1028b of proximal restrictor 1028 to move the second hinge portion 1008b into the second branch vessel. For example, the second portion 1028b of the proximal restrictor 1028 may advance distally relative to the first portion 1028a. Due to this distal advancement, the second portion 1028b of the proximal restrictor may radially push the second hinge portion 1008b radially outward. The second hinge portion 1008b may extend to juxtapose with the inner wall of the second branch vessel, such that at least a portion of the first distal portion 1004 and / or the second hinge portion 1008b is positioned across the neck of the aneurysm between the first and second branch vessels. The first hinge portion 1008a may advance away from the elongated tube 1012 and extend to juxtapose with the inner wall of the carrier vessel. The delivery system 1001 may be removed from the patient, leaving an implantable, expandable device 1000 positioned within the carrier and branch vessels and across the neck of the bifurcation aneurysm.

[0148] in conclusion

[0149] Although numerous embodiments of systems, apparatuses, and methods for treating cerebral aneurysms have been described above, the techniques are also applicable to other applications and / or other methods, such as pulmonary or cardiac applications. Furthermore, other embodiments besides those described herein are within the scope of the technology. Additionally, several other embodiments of the technology may have different configurations, components, or procedures than those described herein. Therefore, those skilled in the art will accordingly appreciate that the technology may have other embodiments with additional elements, or that the technology may have other embodiments that do not have some of the features shown and described above with reference to Figures 1A-10.

[0150] The description of embodiments of this technology is not intended to be exhaustive or to limit the technology to the exact forms disclosed above. Singular or plural terms may also include plural or singular terms, respectively, where context permits. As those skilled in the art will recognize, although specific embodiments and examples of this technology have been described above for illustrative purposes, various equivalent modifications can be made within the scope of this technology. For example, while the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0151] Furthermore, unless the word “or” is explicitly limited to referring only to a single item that is exclusive to other items in a list of two or more items, the use of “or” in such lists can be understood to include: (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term “comprising” is used throughout to mean at least one or more of the enumerated features, such that no larger number of the same features and / or other features of additional types are excluded. It should also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications may be made without departing from the present technology. Furthermore, while advantages associated with certain embodiments of the present technology have been described in the context of those embodiments, other embodiments may also present such advantages, and not all embodiments are required to present such advantages to fall within the scope of the present technology. Therefore, this disclosure and associated technology may cover other embodiments not explicitly shown or described herein.

Claims

1. An expandable device configured to locate the neck of an aneurysm at the bifurcation of a patient's blood vessel for preventing blood flow into the aneurysm, said blood vessel including a parent vessel, a first branch vessel, and a second branch vessel, said expandable device comprising: A generally tubular mesh having a first end portion and a second end portion, the second end portion comprising a first hinge region and a second hinge region. The first hinge region and the second hinge region are separated by first and second slits, which extend along the longitudinal axis of the mesh. When the mesh is in an expanded state, the first hinge region and the second hinge region are configured to be positioned across the neck of the aneurysm. The first hinge region is positioned at a first angle relative to the first end portion and is configured to be anchored to the wall of the aneurysm-bearing vessel. The second hinge region is positioned at a second angle relative to the first end portion and is configured to be anchored to the wall of the second branch vessel. The first end portion is configured to be anchored to the first branch vessel.

2. The expandable device of claim 1, wherein the length of the first slit is equal to the length of the second slit.

3. The expandable device of claim 1, wherein the first slit and the second slit are circumferentially spaced about 180 degrees apart.

4. The expandable device according to claim 1, wherein the width of the first hinge region is smaller than the width of the second hinge region.

5. The expandable device of claim 1, wherein the first angle is about 0 degrees and the second angle is between 30 degrees and 150 degrees.

6. The scalable device of claim 1, wherein the first angle is substantially equal to the second angle.

7. The expandable device of claim 1, wherein the longitudinal edges of the first and second hinge regions adjacent to the first and second slits have been brazed, melted, welded, or glued.

8. The expandable device of claim 1, wherein the mesh further comprises a third slit extending circumferentially between the first slit and the second slit.

9. The expandable device of claim 1, further comprising a first plurality of opaque markers attached to the first hinge region and a second plurality of opaque markers attached to the second hinge region.

10. The scalable device of claim 9, wherein the first plurality of transmissive markers comprises fewer transmissive markers than the second plurality of transmissive markers.

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