Removing material from a body lumen

Abstract

By using a distal element comprising an expandable mesh, retrieval of material from a blood vessel lumen can be improved. A treatment device includes an elongated member having a proximal portion and a distal portion configured to be positioned intravascularly at a treatment site at or near a thrombus. A distal element comprising an expandable mesh is coupled to the distal portion of the elongated member by a connection assembly. In an expanded state, at least a portion of the mesh is configured to be juxtaposed with a vessel wall at the treatment site to anchor or stabilize the elongated member relative to the vessel. The distal element can be electrically coupled to an extracorporeal current generator.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of priority to U.S. Patent Application No. 16 / 439,642, filed June 12, 2019; U.S. Patent Application No. 16 / 439,647, filed June 12, 2019; U.S. Patent Application No. 16 / 439,645, filed June 12, 2019; and U.S. Patent Application No. 16 / 439,651, filed June 12, 2019, all of which are hereby incorporated herein by reference in their entirety.

[0003] This application is also incorporated in its entirety by reference each of the following commonly owned applications: U.S. Patent Application No. 12 / 427,620, filed April 21, 2009; U.S. Patent Application No. 12 / 942,209, filed November 9, 2010; U.S. Patent Application No. 15 / 838,214, filed December 11, 2017; U.S. Patent Application No. 15 / 838,230, filed December 11, 2017; U.S. Patent Application No. 16 / 024,367, filed June 29, 2018; U.S. Patent Application No. 16 / 024,388, filed June 29, 2018; U.S. Patent Application No. 16 / 024,408, filed June 29, 2018; and U.S. Patent Application No. 16 / 024,429, filed June 29, 2018. Technical Field

[0004] This invention generally relates to apparatus and methods for removing obstructions from the cavities of the human body. Some embodiments of this invention relate to apparatus and methods for removing clotted material from blood vessels. Background Technology

[0005] Many medical procedures use one or more medical devices to remove obstructions (such as clotted material) from internal cavities, blood vessels, or other organs. An inherent risk of such procedures is that if the obstruction or fragments thereof are removed from the removal device, moving or otherwise interfering with the obstruction can potentially cause further harm. If all or part of the obstruction detaches from the device and flows downstream, it is highly likely that the free material will remain trapped in smaller and more convoluted anatomical structures. In many cases, the physician will no longer be able to remove the obstruction again using the same removal device because the device may be too large and / or immobile to be moved to the site of a new obstruction.

[0006] Surgical treatments for ischemic stroke by restoring blood flow within the brain's vascular system are constrained by the aforementioned concerns. The brain relies on its arteries and veins to supply oxygenated blood to the heart and lungs and to remove carbon dioxide and cellular waste from brain tissue. Blockages that interfere with this blood supply eventually cause brain tissue to cease functioning. If the disruption of blood flow persists long enough, the continued lack of nutrients and oxygen can lead to irreversible cell death. Therefore, the need for immediate medical intervention for ischemic stroke is paramount.

[0007] To access the cerebral vascular system, physicians typically advance a catheter from the distal part of the body (usually the leg) through the abdominal vascular system and into the brain region of the vascular system. During the procedure, guidewires are used to facilitate navigation of the catheter (and / or associated therapeutic device) to the vascular portion near the target thrombus. For example, a physician can use a guidewire to navigate the vascular system to the treatment site, and then advance one or more catheters or other devices through the guidewire to said site. Guidewires can also be used to facilitate device replacement. For example, a physician can replace the original catheter with another catheter or a separate device with different characteristics or better suited to the intended procedure (e.g., better fit, better navigation, better support, etc.).

[0008] Once within the cerebral vascular system, the physician deploys a device to remove the obstruction causing the blockage. Concern for the migration of the removed obstruction or debris increases the duration of the procedure when restoring blood flow is crucial. Furthermore, the physician may not be aware of one or more fragments removed from the initial obstruction that could cause blockages in smaller, more distal vessels.

[0009] Many physicians currently use stents to perform thrombectomy (i.e., clot removal) to address ischemic stroke. Typically, the physician deploys a stent into the clot in an attempt to push the clot to the side of the vessel and restore blood flow. Tissue plasminogen activator (“tPA”) is usually injected into the bloodstream via an intravenous line to break down the clot. However, it takes time for tPA to reach the clot, as it must travel through the vascular system and only begins to break down the clot upon reaching the clot material. tPA is also frequently administered to supplement the effectiveness of the stent. However, if attempts to dissolve the clot are ineffective or incomplete, the physician may attempt to remove the stent while it is expanding against or embedded within the clot. In doing so, the physician must effectively drag the clot proximally through the vascular system into a guiding catheter located within a vessel in the patient's neck (usually the carotid artery). While this procedure has shown to be clinically effective and easy for physicians to perform, several significant drawbacks remain with this approach.

[0010] For example, one drawback is that the stent may not adequately retain the clot as it is pulled into the catheter. In this case, some or all of the clot may remain in the vascular system. Another risk is that as the stent moves the clot from the initial blockage site, the clot may not adhere to the stent when it is withdrawn toward the catheter. This is a particular risk when traversing bifurcation and tortuous anatomy. Furthermore, blood flow can carry the clot (or fragments of the clot) into the branch vessels at the bifurcation. If the clot is successfully brought to the tip of the guiding catheter in the carotid artery, yet another risk is that the clot can be “peeled” or “shorn” from the stent as it enters the guiding catheter.

[0011] Given the above, there is still a need for improved devices and methods that can remove occlusions from the body's cavities and / or blood vessels. Summary of the Invention

[0012] This invention generally relates to apparatus and methods for removing obstructions from cavities within the human body. Aspects of this invention include therapeutic systems for removing clot material from blood vessels. In some embodiments, the therapeutic system includes a therapeutic device and one or more catheters. The therapeutic device may include an elongated member and an expandable distal element coupled to a distal region of the elongated member. The distal element can provide several functions throughout the procedure to facilitate clot retraction. For example, deployment of the distal element within the blood vessel can anchor the distal region of the therapeutic device at the deployed location. Such anchoring can facilitate navigation of tortuous vascular systems (such as cerebral vascular systems) to the site of the thrombus and can also help align, straighten, or stabilize one or more delivery system components associated with the therapeutic device, such as a microcatheter or aspiration catheter. Additionally, the distal element of this invention can be used in conjunction with an aspiration catheter to push clot material toward the aspiration catheter and also serves as a distal embolism filter.

[0013] For example, the present invention is illustrated by various aspects described below. For convenience, various examples of the aspects of the present invention are described as numbered clauses (1, 2, 3, etc.). These clauses are provided as examples but do not limit the present invention. It should be noted that any of the dependent clauses may be combined in any combination and placed in the corresponding independent clauses, such as clauses (1, 73, 77, etc.). Other clauses may be presented in a similar manner.

[0014] 1. A treatment device comprising:

[0015] An elongated member having a proximal portion and a distal portion, the distal portion being configured to be positioned at or near a treatment site within a blood vessel thrombus.

[0016] A distal element, coupled to the distal portion of the elongated member via a connecting assembly, the distal element comprising an expandable mesh having a constrained state for delivery to the treatment site and an expanded state, wherein in the expanded state at least a portion of the mesh is configured to juxtapose with the vessel wall at the treatment site.

[0017] The distal element is configured to extend to contact the vessel wall at the treatment site and to anchor and / or stabilize the elongated member within the vessel.

[0018] 2. The treatment device according to any one of the preceding clauses, wherein the distal element is configured to rotate about the elongated member.

[0019] 3. The treatment device according to any one of the preceding clauses, wherein the connecting assembly is configured to rotate about the elongated member.

[0020] 4. The treatment device according to any one of the preceding clauses, wherein the connecting assembly and / or the distal element is configured to rotate approximately 360 degrees around the circumference of the elongated member.

[0021] 5. The treatment device according to any one of the preceding clauses, wherein the distal element has a first end and a second end and is configured to rotate about the elongated member, and wherein at least one of the first end or the second end is substantially fixed at a location along the length of the elongated member.

[0022] 6. The treatment device according to any one of the preceding clauses, wherein the distal element has a first end and a second end and is configured to rotate about the elongated member, and wherein at least one of the first end or the second end is configured to move axially along the elongated member.

[0023] 7. The treatment device according to any one of the preceding clauses, wherein the distal element has a first end and a second end and is configured to rotate about the elongated member, and wherein the first end and the second end are configured to move axially along the elongated member.

[0024] 8. The treatment device according to any one of the preceding clauses, wherein the distal element is configured to move axially along the elongated member.

[0025] 9. The treatment device according to any one of the preceding clauses, wherein the distal element has a first end and a second end, and wherein both the first end and the second end of the distal element are axially movable along the elongated member.

[0026] 10. The treatment device according to any one of the preceding clauses, wherein the distal element is rotatably and slidably coupled to the elongated member.

[0027] 11. The treatment device according to any one of the preceding clauses, further comprising a stop that is proximal to the elongated member of the connecting assembly, wherein the stop inhibits the connecting assembly from moving proximally along the elongated member beyond the stop.

[0028] 12. The treatment device according to any one of the preceding clauses, further comprising a stop coupled distally to the elongated member of the connecting assembly, wherein the stop inhibits movement of the connecting assembly distally along the elongated member beyond the stop.

[0029] 13. The treatment device according to any one of the preceding clauses, further comprising:

[0030] A first stop, the first stop being coupled proximally to the elongated member of the connecting assembly, wherein the first stop inhibits the connecting assembly from moving proximally along the elongated member beyond the first stop; and

[0031] A second stop is coupled to the elongated member on the distal side of the connecting assembly, wherein the second stop prevents the connecting assembly from moving beyond the second stop along the distal side of the elongated member.

[0032] 14. The treatment device according to any one of the preceding clauses, wherein the distance between the first stop and the second stop along the elongated member is greater than the length of the connecting assembly, such that the connecting assembly is configured to translate along the elongated member between the first stop and the second stop.

[0033] 15. The treatment device according to any one of the preceding clauses, wherein the elongated member extends through at least a portion of the cavity of the distal element.

[0034] 16. The treatment device according to any one of the preceding clauses, wherein the distal element has a hole at its distal portion, and wherein the elongated member extends through the hole.

[0035] 17. The treatment device according to any one of the preceding clauses, wherein the elongated member is a solid metal wire.

[0036] 18. The treatment device according to any one of the preceding clauses, wherein the elongated member comprises an elongated tubular element having an inner lumen extending therethrough.

[0037] 19. The treatment device according to Clause 18, wherein the elongated tubular element is a hypotube.

[0038] 20. The treatment device according to Clause 18, wherein the distal portion of the elongated tubular element is connected to the proximal portion of the connecting assembly.

[0039] 21. The treatment device according to any one of the preceding clauses, further comprising a coil positioned around the elongated member in a region proximal to the connecting assembly.

[0040] 22. The treatment device according to any one of the preceding clauses, further comprising a coil positioned around the elongated member in a region distal to the connecting assembly.

[0041] 23. The treatment device according to Clause 22, wherein the proximal end of the coil is located distal to the distal element.

[0042] 24. The treatment device according to Clause 22, wherein the proximal end of the coil is located proximal to the distal end of the distal element, such that at least a portion of the coil and the distal element overlap.

[0043] 25. The treatment device according to any one of the preceding clauses, further comprising: (a) a proximal coil positioned about the length of the elongated member proximal to the connecting assembly, and (b) a distal coil positioned about the length of the elongated member distal to the connecting assembly.

[0044] 26. The treatment device according to any one of the preceding clauses, wherein the elongated member is a first elongated member and has a groove extending along its length, and wherein the treatment device further includes a second elongated member configured to be positioned along and within the groove.

[0045] 27. The treatment device according to Clause 26, wherein the groove is a helical-cut groove.

[0046] 28. The treatment device according to any one of the preceding clauses, wherein the connecting assembly includes a tubular band surrounding a proximal portion of the expandable mesh.

[0047] 29. The treatment device according to any one of the preceding clauses, wherein the band comprises a radiopaque material.

[0048] 30. The treatment device according to any one of the preceding clauses, wherein the connecting assembly comprises an outer strap and an inner strap.

[0049] 31. The treatment device according to Clause 30, wherein the proximal portion of the expandable mesh is positioned between the outer band and the inner band.

[0050] 32. The treatment device according to Clause 30 or Clause 31, wherein the inner band surrounds a portion of the elongated member, and wherein the inner band is configured to rotate around the elongated member.

[0051] 33. The treatment device according to any one of the preceding clauses, wherein the distal element is secured to the elongated member at the connection assembly.

[0052] 34. The treatment device according to any one of the preceding clauses, wherein the distal element includes the most distal element of the treatment device.

[0053] 35. The treatment device according to any one of the preceding clauses, wherein the connecting assembly is coupled to the distal end of the elongated member.

[0054] 36. The treatment device according to any one of the preceding clauses, wherein the expandable mesh comprises a plurality of braided filaments, the plurality of braided filaments having a predetermined three-dimensional shape in the expanded state.

[0055] 37. The treatment device according to any one of the preceding clauses, wherein the expandable mesh comprises a weave formed of 24, 32, 36, 48, 64 or 72 filaments.

[0056] 38. The treatment device according to any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of a plurality of wires, wherein some or all of the wires have a diameter of about 0.001 inches (0.00254 cm).

[0057] 39. The treatment device according to any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of a plurality of wires, wherein some or all of the plurality of wires have the same diameter.

[0058] 40. The treatment device according to any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of a plurality of wires, wherein at least some of the plurality of wires have different diameters.

[0059] 41. The treatment device according to any one of the preceding clauses, wherein the expandable mesh forms a closed spherical shape in the expanded state, the mesh having a hole at the distal portion.

[0060] 42. The treatment device according to any one of the preceding clauses, wherein in the extended state, the expandable mesh forms one of a sphere, an elongated sphere, or an oblate spheroid.

[0061] 43. The treatment device according to any one of the preceding clauses, wherein the expandable mesh comprises an inner layer and an outer layer.

[0062] 44. The treatment device according to any one of the preceding clauses, wherein the expandable mesh comprises an inner layer and an outer layer, the inner layer and the outer layer meeting at a fold at a distal portion of the mesh.

[0063] 45. The treatment device according to clause 44, wherein the expandable mesh includes a hole at the distal portion, the hole being defined by a fold.

[0064] 46. ​​The treatment device according to any one of the preceding clauses, wherein the maximum cross-sectional dimension of the expandable mesh is 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm or 8.0 mm.

[0065] 47. The treatment device according to any one of the preceding clauses, wherein the expandable mesh is formed of a plurality of filaments having a first end and a second end fixed at the connecting assembly.

[0066] 48. The treatment device according to any one of the preceding clauses, wherein the expandable mesh is formed of a plurality of filaments, the plurality of filaments being formed of an inner core material surrounded by an outer material.

[0067] 49. The treatment device according to Clause 48, wherein the inner core material is a radiopaque material and the outer layer material is a hyperelastic material.

[0068] 50. The treatment device according to any one of the preceding clauses, wherein the expandable mesh is a laser cutting tube.

[0069] 51. The treatment device according to any one of the preceding clauses, wherein the expandable mesh extends longitudinally along the elongated member and / or the distal coil.

[0070] 52. The treatment device according to any one of the preceding clauses, wherein the expandable mesh comprises a plurality of filaments.

[0071] 53. The treatment device according to Clause 52, wherein the filaments are interwoven.

[0072] 54. The treatment device according to Clause 52 or Clause 53, wherein the filaments are woven.

[0073] 55. The treatment device according to any one of clauses 52 to 54, wherein each of the filaments has a first end and a second end opposite to the first end, and wherein both the first end and the second end of the filament are fixed relative to each other at the connecting assembly.

[0074] 56. The treatment device according to any one of clauses 52 to 55, wherein each of the filaments terminates at only one end of the distal element.

[0075] 57. The treatment device according to clause 56, wherein the filament forms an opening at the end of the distal element opposite to the only end.

[0076] 58. The treatment device according to Clause 57, wherein the inverted portion of each of the filaments defines the opening.

[0077] 59. The treatment device according to Clause 58, wherein the inverted portions of the filament are configured to move relative to each other.

[0078] 60. The treatment device according to any one of clauses 56 to 59, wherein the elongated member and / or distal coil extends through the opening.

[0079] 61. The treatment device according to any one of clauses 56 to 60, wherein the filament is slidable on the elongated member at one end of the distal element opposite to the only end thereon.

[0080] 62. The treatment device according to any one of clauses 56 to 61, wherein the filament is not attached to the elongated member at the end of the distal element opposite to the only end thereon.

[0081] 63. The treatment device according to any one of clauses 56 to 62, wherein the distal element is configured to be positioned at the treatment site such that only one end of the distal element is positioned between the thrombus and the other end of the distal element.

[0082] 64. The treatment device according to any one of clauses 56 to 63, wherein the distal element is substantially curved along its entire length.

[0083] 65. The treatment device according to any one of clauses 52 to 64, wherein each of the filaments extends distally and radially inwardly from the middle portion of the expandable mesh to the distal end of the expandable mesh.

[0084] 66. The treatment device according to any one of clauses 52 to 64, wherein each of the filaments extends distally and radially inwardly from the middle portion of the expandable mesh to the flat distal side of the expandable mesh.

[0085] 67. A treatment system comprising:

[0086] The treatment device according to any one of clauses 1 to 66; and

[0087] A catheter having an inner lumen extending through it, wherein the treatment device is configured to be slidably disposed within the inner lumen.

[0088] 68. A treatment system comprising:

[0089] Treatment device according to any one of clauses 1 to 66;

[0090] A first catheter having a first lumen extending therethrough, wherein the treatment device is configured to be slidably disposed within the lumen; and

[0091] A second catheter having a second lumen extending therethrough, wherein the first catheter is configured to be slidably disposed within the second lumen.

[0092] 69. The treatment system according to Clause 68, further comprising a negative pressure source configured to be coupled to the second cavity to aspirate material through the second cavity.

[0093] 70. The treatment system according to Clause 68, wherein the first catheter is a microcatheter and the second catheter is an aspiration catheter.

[0094] 71. The treatment system according to Clause 68, wherein the first catheter is a microcatheter and the second catheter is a guiding catheter.

[0095] 72. The treatment system according to Clause 68, wherein the first catheter is a microcatheter and the second catheter is a balloon-guided catheter.

[0096] 73. A treatment system comprising:

[0097] Treatment device according to any one of clauses 1 to 66;

[0098] A first catheter having a first lumen extending therethrough, wherein the treatment device is configured to be slidably disposed within the lumen;

[0099] A second catheter having a second lumen extending therethrough, wherein the first catheter is configured to be slidably disposed within the second lumen; and

[0100] A third catheter having a third lumen extending therethrough, wherein the second catheter is configured to be slidably disposed within the second lumen.

[0101] 74. The treatment system according to Clause 73, further comprising a negative pressure source configured to be coupled to the second cavity to aspirate material from the treatment site through the second cavity.

[0102] 75. The treatment system according to Clause 73, wherein the first catheter is a microcatheter, the second catheter is a suction catheter, and the third catheter is a guiding catheter.

[0103] 76. The treatment system according to Clause 73, wherein the first catheter is a microcatheter, the second catheter is a suction catheter, and the third catheter is a balloon-guided catheter.

[0104] 77. A method for treating blood vessels, the method comprising:

[0105] The first catheter is positioned intravascularly within the lumen of a blood vessel such that the distal end of the first catheter is distal to the target thrombus, wherein the first catheter contains a treatment device comprising an elongated member and a distal element coupled to the elongated member, the distal element comprising an expandable mesh.

[0106] The first catheter is moved relative to the distal element to release the distal element, such that the distal element extends from its location distal to the target thrombus to be juxtaposed with the vessel wall;

[0107] The distal end of the second catheter is positioned intravascularly within the lumen of the vessel at a location proximal to the target thrombus; and

[0108] A portion of the thrombus near the lumen of the blood vessel is aspirated through the second catheter.

[0109] 78. The method according to Clause 77, further comprising moving the distal element proximally relative to the distal end of the second catheter, such that the proximal portion of the distal element engages the distal portion of the thrombus.

[0110] 79. The method according to Clause 77, further comprising, while aspirating the portion of the vascular lumen, pushing the thrombus toward the distal end of the second catheter using the distal element.

[0111] 80. The method according to Clause 77, further comprising pushing the distal element toward the distal end of the second catheter to push the thrombus into the opening at the distal end of the second catheter while aspirating the portion of the vascular lumen.

[0112] 81. The method according to Clause 77, further comprising inhibiting proximal movement of the treatment device while the distal element extends within the blood vessel.

[0113] 82. The method according to Clause 77, wherein the distal element is rotatably coupled to the elongated member.

[0114] 83. The method according to Clause 77, wherein the treatment device is any one of the treatment devices according to Clauses 1 to 66.

[0115] 84. A treatment device comprising:

[0116] An elongated member having a proximal portion and a distal portion, the distal portion being configured to be positioned at or near a treatment site within a blood vessel thrombus; and

[0117] A distal element, coupled to the distal portion of the elongated member via a connecting assembly, the distal element comprising an expandable mesh having a constrained state and an extended state for delivery to the treatment site, wherein in the extended state the distal element has a hole at its distal portion, and wherein the elongated member extends through the hole.

[0118] In the extended state, the distal element is configured to extend to contact the vessel wall at the treatment site and anchor and / or stabilize the elongated member within the vessel.

[0119] 85. The treatment device according to clause 84, wherein the edge of the hole is formed by the mesh.

[0120] 86. The treatment device according to clause 85, wherein the edge of the hole is formed by the grid surrounding the entire perimeter of the hole.

[0121] 87. The treatment device according to clause 85, wherein the mesh comprises filaments, and the filaments form the edges of the aperture.

[0122] 88. The treatment device according to clause 84, wherein the distal element is configured to rotate about the elongated member.

[0123] 89. The treatment device according to clause 84, wherein the elongated member extends through at least a portion of the cavity of the distal element.

[0124] 90. The treatment device according to Clause 84, wherein the elongated member comprises an elongated tubular element having an inner lumen extending therethrough.

[0125] 91. The treatment device according to Clause 84, wherein the elongated tubular element is a hypotube.

[0126] 92. The treatment device according to Clause 84, wherein the distal portion of the elongated tubular element is connected to the proximal portion of the connecting assembly.

[0127] 93. The treatment device according to Clause 84, further comprising a coil positioned around the elongated member in a region proximal to the connecting assembly.

[0128] 94. The treatment device according to clause 84, further comprising a coil positioned around the elongated member in a region distal to the connecting assembly.

[0129] 95. The treatment device according to Clause 84, wherein the expandable mesh comprises a plurality of filaments.

[0130] 96. The treatment device according to Clause 95, wherein each of the filaments has a first end and a second end opposite to the first end, and wherein both the first end and the second end of the filament are fixed relative to each other at the connecting assembly.

[0131] 97. The treatment device according to Clause 95, wherein each of the filaments terminates at only one end of the distal element.

[0132] 98. The treatment device according to Clause 97, wherein the filament forms an opening at the end of the distal element opposite to the only end.

[0133] 99. A method for treating blood vessels, the method comprising:

[0134] The catheter is positioned intravascularly within the lumen of a blood vessel such that the distal end of the catheter is distal to the target thrombus, wherein the catheter contains a treatment device comprising an elongated member and a distal element coupled to the elongated member, the distal element comprising an expandable mesh having pores at its distal portion;

[0135] The catheter is moved relative to the distal element to release the distal element, such that the distal element expands at a location distal to the target thrombus to be juxtaposed with the vessel wall, wherein the expansion of the distal element causes the apertures of the expandable mesh to move along the elongated member.

[0136] Aspirate a portion of the blood vessel lumen near the thrombus; and

[0137] The distal element is moved proximally relative to the distal end of the catheter, such that the proximal portion of the distal element engages the distal portion of the thrombus.

[0138] 100. The method according to Clause 99, wherein the catheter is a first catheter, and the method further comprises positioning the distal end of a second catheter intravascularly within the lumen of the vessel at a location proximal to the target thrombus, and wherein a portion of the lumen of the vessel is aspirated through the second catheter.

[0139] 101. The method according to Clause 100, further comprising, while aspirating the portion of the vascular lumen, pushing the thrombus toward the distal end of the second catheter using the distal element.

[0140] 102. The method according to Clause 100, further comprising pushing the distal element toward the distal end of the second catheter to push the thrombus into an opening at the distal end of the second catheter while aspirating the portion of the vascular lumen.

[0141] 103. The method according to Clause 99, further comprising inhibiting proximal movement of the treatment device while the distal element extends within the blood vessel.

[0142] 104. The method according to clause 99, wherein the distal element is rotatably coupled to the elongated member.

[0143] 105. A treatment device comprising:

[0144] An elongated member having a proximal portion and a distal portion, the distal portion being configured to be positioned at or near a treatment site within a blood vessel thrombus; and

[0145] A distal element, coupled to the distal portion of the elongated member via a connecting assembly, the distal element comprising an expandable mesh having a constrained state for delivery to the treatment site and an expanded state, wherein in the expanded state at least a portion of the mesh is configured to juxtapose with the vessel wall at the treatment site, wherein the distal element has a hole at its distal portion, and wherein the elongated member extends through the hole.

[0146] The distal element is configured to extend to contact the vessel wall at the treatment site and to anchor and / or stabilize the elongated member within the vessel.

[0147] 106. The treatment device according to clause 105, wherein the edge of the hole is formed by the mesh.

[0148] 107. The treatment device according to clause 106, wherein the edge of the hole is formed by the grid surrounding the entire perimeter of the hole.

[0149] 108. The treatment device according to clause 106, wherein the mesh comprises filaments, and the filaments form the edges of the aperture.

[0150] 109. The treatment device according to Clause 105, wherein the distal element is configured to rotate about the elongated member.

[0151] 110. The treatment device according to Clause 105, wherein the elongated member extends through at least a portion of the cavity of the distal element.

[0152] 111. The treatment device according to Clause 105, wherein the elongated member comprises an elongated tubular element having an inner lumen extending therethrough.

[0153] 112. The treatment device according to Clause 105, wherein the elongated tubular element is a hypotube.

[0154] 113. The treatment device according to clause 105, wherein the distal portion of the elongated tubular element is connected to the proximal portion of the connecting assembly.

[0155] 114. The treatment device according to clause 105, further comprising a coil positioned around the elongated member in a region proximal to the connecting assembly.

[0156] 115. The treatment device according to clause 105, further comprising a coil positioned around the elongated member in a region distal to the connecting assembly.

[0157] 116. The treatment device according to Clause 105, wherein the expandable mesh comprises a plurality of filaments.

[0158] 117. The treatment device according to Clause 116, wherein each of the filaments has a first end and a second end opposite to the first end, and wherein both the first end and the second end of the filament are fixed relative to each other at the connecting assembly.

[0159] 118. The treatment device according to Clause 116, wherein each of the filaments terminates at only one end of the distal element.

[0160] 119. The treatment device according to Clause 118, wherein the filament forms an opening at the end of the distal element opposite to the only end.

[0161] 120. A method for treating blood vessels, the method comprising:

[0162] The catheter is positioned intravascularly within the lumen of a blood vessel such that the distal end of the catheter is distal to the target thrombus, wherein the catheter contains a treatment device comprising an elongated member and a distal element coupled to the elongated member, the distal element comprising an expandable mesh having pores at its distal portion;

[0163] The catheter is moved relative to the distal element to release the distal element, such that the distal element expands at a location distal to the target thrombus to be juxtaposed with the vessel wall, wherein the expansion of the distal element causes the apertures of the expandable mesh to move along the elongated member.

[0164] Aspirate a portion of the blood vessel lumen near the thrombus; and

[0165] The distal element is moved proximally relative to the distal end of the catheter, such that the proximal portion of the distal element engages the distal portion of the thrombus.

[0166] 121. The method according to Clause 120, wherein the catheter is a first catheter, and the method further comprises positioning the distal end of a second catheter intravascularly within the lumen of the vessel at a location proximal to the target thrombus, and wherein a portion of the lumen of the vessel is aspirated through the second catheter.

[0167] 122. The method according to Clause 121, further comprising, while aspirating the portion of the lumen of the blood vessel, pushing the thrombus toward the distal end of the second catheter with the distal element.

[0168] 123. The method according to Clause 121, further comprising pushing the distal element toward the distal end of the second catheter to push the thrombus into an opening at the distal end of the second catheter while aspirating the portion of the vascular lumen.

[0169] 124. The method according to Clause 120, further comprising inhibiting proximal movement of the treatment device while the distal element extends within the blood vessel.

[0170] 125. The method according to clause 120, wherein the distal element is rotatably coupled to the elongated member.

[0171] 126. A treatment device comprising:

[0172] An elongated member comprising a distal portion configured to be positioned at or near a treatment site within a blood vessel thrombus.

[0173] A distal element, the distal element comprising a first expandable mesh and configured to expand from a constrained configuration to an extended configuration, in which at least a portion of the distal element is juxtaposed with the vessel wall at the treatment site or other desired location; and

[0174] An interventional element configured to engage the thrombus at the treatment site, the interventional element extending longitudinally over the distal portion of the elongated member and including a second expandable mesh, wherein the interventional element is configured to extend from a constrained configuration to an extended configuration in which at least a portion of the interventional element is juxtaposed with the vessel wall at the treatment site.

[0175] 127. The apparatus according to Clause 126, wherein the distal element is located distal to the intervention element.

[0176] 128. The device according to clause 126, wherein the distal element is located proximal to the interventional element.

[0177] 129. The apparatus according to any one of the preceding clauses, wherein the interventional element is coupled to the elongated member such that the interventional element is longitudinally fixed relative to the elongated member.

[0178] 130. The apparatus according to any one of the preceding clauses, wherein the distal element is coupled to the elongated member such that the distal element is longitudinally fixed relative to the elongated member.

[0179] 131. The device according to any one of the preceding clauses, wherein the intervention element is rotatably coupled to the elongated member.

[0180] 132. The device according to any one of the preceding clauses, wherein the distal element is rotatably coupled to the elongated member.

[0181] 133. The device according to any one of the preceding clauses, wherein at least one of the interventional element or the distal element is rotatably coupled to the elongated member.

[0182] 134. The device according to any one of the preceding clauses, further comprising a stop that is proximal to the elongated member of the interventional element, wherein the interventional element is slidably coupled to the elongated member and movable between the stop and the distal element.

[0183] 135. The device according to Clause 132, wherein the stop is a first stop, and the device further includes a second stop coupled between the interventional element and the distal element to the elongated member, wherein the interventional element is movable between the first stop and the second stop.

[0184] 136. The device according to clause 135, further comprising a third stop coupled distally to the elongated member of the distal element, wherein the distal element is slidably coupled to the elongated member and movable between the second stop and the third stop.

[0185] 137. The device according to any one of the preceding clauses, further comprising a stop coupled distally to the elongated member of the distal element, wherein the distal element is slidably coupled to the elongated member and movable between the intervention element and the stop.

[0186] 138. The device according to Clause 137, wherein the stop is a first stop, and the device further includes a second stop coupled between the intervening element and the distal element to the elongated member, wherein the distal element is movable between the first stop and the second stop.

[0187] 139. The device according to any one of the preceding clauses, wherein the distal element is a first distal element, and the device further includes a second distal element proximal to the intervention element.

[0188] 140. The apparatus according to clause 139, wherein the second distal element is coupled to the elongated member such that the second distal element is longitudinally fixed relative to the elongated member.

[0189] 141. The apparatus according to Clause 139 or Clause 140, wherein the second distal element is rotatably coupled to the elongated member.

[0190] 142. The device according to any one of clauses 139 to 141, further comprising a stop that is proximal to the elongated member on the second distal element, wherein the second distal element is slidably coupled to the elongated member and is movable between the stop and the intervention element.

[0191] 143. The device according to any one of clauses 139 to 142, wherein the intervention element is slidably coupled to the elongated member and movable between the first distal element and the second distal element.

[0192] 144. The apparatus according to any one of clauses 139 to 143, wherein the first distal element and the second distal element are substantially the same.

[0193] 145. The device according to any one of the preceding clauses, further comprising a tube extending longitudinally over the elongated member.

[0194] 146. The device according to clause 145, wherein the tube is coupled to the proximal portion of the interventional element.

[0195] 147. The device according to Clause 67 or Clause 146, further comprising a proximal stop or coupling member coupled to the elongated member, the tube extending longitudinally between the proximal stop or coupling member and the intervention element.

[0196] 148. The apparatus according to any one of clauses 145 to 147, wherein the tube is coupled to the proximal portion of the distal element.

[0197] 149. The apparatus according to any one of clauses 145 to 148, wherein the tube comprises a helical cut extending along at least a portion of the length of the tube.

[0198] 150. The device according to Clause 149, wherein the helical cut extends only a portion of the length of the tube.

[0199] 151. The apparatus according to Clause 149 or Clause 150, wherein the proximal end of the spiral cut is located at the middle portion of the tube.

[0200] 152. The device according to clause 149, wherein the spiral cut extends substantially the entire length of the tube.

[0201] 153. The apparatus according to any one of clauses 149 to 152, wherein the helical cut comprises a first portion having a first pitch and a second portion having a second pitch different from the first pitch.

[0202] 154. The device according to any one of the preceding clauses, wherein the interventional element comprises a plurality of braided filaments, and the device further comprises a connecting assembly extending over the elongated member and coupled to a proximal portion of the plurality of braided filaments.

[0203] 155. The device according to any one of the preceding clauses, wherein the plurality of braided filaments of the intervention element include a free distal portion.

[0204] 156. The apparatus according to Clause 154 or Clause 155, wherein the plurality of braided filaments of the interventional element include exposed braided ends.

[0205] 157. The device according to any one of the preceding clauses, wherein the interventional element comprises a working length portion and a non-working length portion, the working length portion being configured to interlock, capture, and / or engage the thrombus.

[0206] 158. The device according to clause 157, wherein the distal end of the working length portion is proximal to the distal end of the interventional element.

[0207] 159. The device according to any one of the preceding clauses, wherein the working length portion is spaced apart from the distal end of the interventional element.

[0208] 160. The apparatus according to any one of clauses 157 to 159, wherein the non-working length portion is disposed between the distal end of the elongated member and the proximal end of the working length portion.

[0209] 161. The device according to any one of the preceding clauses, wherein the interventional element comprises a thrombectomy device.

[0210] 162. The device according to any one of the preceding clauses, wherein the interventional element includes a stent remover.

[0211] 163. The apparatus according to any one of the preceding clauses, wherein the interventional element includes a removal device.

[0212] 164. The apparatus according to any one of the preceding clauses, wherein the intervention element is a mesh.

[0213] 165. The device according to any one of the preceding clauses, wherein the interventional element is a laser cutting bracket.

[0214] 166. The device according to any one of the preceding clauses, wherein the distal element is any one of the distal elements of the treatment device according to clauses 1 to 66.

[0215] 167. The device according to any one of the preceding clauses, wherein the elongated member is a first elongated member, and the system further includes a second elongated member extending within the catheter and comprising a distal region configured to be positioned within the blood vessel at or near a thrombus.

[0216] 168. The apparatus according to Clause 167, wherein the first elongated member is coupled to one of the interventional element or the distal element, and wherein the second elongated member is coupled to the other of the interventional element or the distal element.

[0217] 169. The device according to any one of the preceding clauses, wherein the distal element comprises a plurality of braided filaments.

[0218] 170. The device according to any one of the preceding clauses, wherein the distal element includes an attachment region configured to engage with the thrombus.

[0219] 171. The apparatus according to clause 170, wherein the attachment region includes the proximal side of the distal element.

[0220] 172. The apparatus according to Clause 170 or Clause 171, wherein the proximal portion of the distal element includes the attachment region, and wherein the distal portion of the distal element includes a non-attachment region.

[0221] 173. The apparatus according to any one of the preceding clauses, wherein the distal element is coupled to the elongated member at its distal end.

[0222] 174. A treatment system comprising:

[0223] Treatment device according to any one of clauses 1 to 66;

[0224] A catheter having an inner lumen extending through it, wherein the treatment device is configured to be slidably disposed within the inner lumen.

[0225] 175. The system according to Clause 174, wherein the catheter is a first catheter, and the system further includes a second catheter configured to be slidably received by the lumen of the first catheter.

[0226] 176. The system according to Clause 175, wherein the first catheter is a guiding catheter and the second catheter is a microcatheter.

[0227] 177. The system according to Clause 175 or Clause 176, further comprising a third catheter configured to be slidably received through the lumen of the first catheter.

[0228] 178. The system according to Clause 177, wherein the first catheter is a guiding catheter and the third catheter is a distal access catheter.

[0229] 179. The system according to Clause 177, wherein the first catheter is a guiding catheter, the second catheter is a microcatheter, and the third catheter is a distal access catheter.

[0230] 180. The system according to Clause 177, wherein the third catheter is a suction catheter.

[0231] 181. The system according to Clause 177, wherein the first catheter is a balloon-guided catheter and the third catheter is a distal access catheter.

[0232] 182. The system according to Clause 177, wherein the first catheter is a guiding catheter and the third catheter is a distal entry catheter, wherein the distal entry catheter includes a flow-stopping element configured to extend within the lumen of the blood vessel and at least partially block blood flow proximal to the thrombus.

[0233] 183. The system according to Clause 182, wherein the distal access catheter is a suction catheter.

[0234] 184. The system according to any one of clauses 174 to 183, wherein:

[0235] The first catheter includes a flow-stopping element configured to extend into an extended state within the blood vessel and at least partially block blood flow proximal to the thrombus.

[0236] The third catheter is a suction catheter configured to apply negative pressure at the treatment site.

[0237] 185. A method comprising:

[0238] The catheter is advanced intravascularly to a treatment site near the thrombus, such that the distal end of the catheter is positioned distal to the thrombus, wherein the catheter contains a treatment device comprising an elongated member, an extendable distal element, and an interventional element.

[0239] The catheter is withdrawn proximally beyond the proximal end of the distal element, thereby allowing the distal element to self-extend at its location distal to the thrombus to juxtapose with the vessel wall;

[0240] Continue withdrawing the catheter proximally beyond the proximal end of the interventional element, causing the interventional element to self-expand, wherein at least a portion of the interventional element self-expands within the thrombus.

[0241] 186. The method according to clause 185, wherein the treatment device is any of the treatment devices described in clauses 1 to 49.

[0242] 187. The method according to Clause 185, wherein at least one of the distal element or the interventional element is rotatable relative to the elongated member.

[0243] 188. The method according to Clause 185, wherein one of the interventional element and the distal element is fixedly coupled to the elongated member, and the other of the interventional element and the distal element is free to rotate about the elongated member and / or translate along the elongated member.

[0244] 189. The method according to Clause 185, wherein both the interventional element and the distal element are configured to translate along the elongated member.

[0245] 190. The method according to Clause 185, wherein the treatment device further includes an elongated shaft having an inner lumen extending therethrough, and wherein the interventional element is coupled to a distal portion of the elongated shaft and the distal element is coupled to a distal portion of the elongated member, and wherein the elongated member and the elongated shaft are axially movable relative to each other.

[0246] 191. The method according to Clause 185, wherein the interventional element is a laser cutting tube.

[0247] 192. The method according to clause 185, wherein the distal element is a braid.

[0248] 193. The method according to Clause 185, further comprising aspirating the thrombus.

[0249] 194. A treatment device comprising:

[0250] An elongated member comprising a distal portion configured to be positioned at or near a treatment site within a blood vessel thrombus.

[0251] A distal element, the distal element including a first expandable mesh and configured to expand from a constrained configuration to an extended configuration, in which at least a portion of the distal element is juxtaposed with the vessel wall at the treatment site or other desired location, the distal element being rotatably coupled to the elongated member; and

[0252] An interventional element configured to engage the thrombus at the treatment site, the interventional element extending longitudinally over the distal portion of the elongated member and including a second expandable mesh, wherein the interventional element is configured to extend from a constrained configuration to an extended configuration in which at least a portion of the interventional element is juxtaposed with the vessel wall at the treatment site.

[0253] 195. The treatment device according to Clause 194, further comprising a stop that is proximal to the elongated member of the interventional element, wherein the interventional element is slidably coupled to the elongated member and movable between the stop and the distal element.

[0254] 196. The treatment device according to Clause 195, wherein the stop is a first stop, and the device further includes a second stop coupled between the interventional element and the distal element to the elongated member, wherein the interventional element is movable along the elongated member between the first stop and the second stop.

[0255] 197. The treatment device according to Clause 196, further comprising a third stop coupled distally to the elongated member of the distal element, wherein the distal element is slidably coupled to the elongated member and movable along the elongated member between the second stop and the third stop.

[0256] 198. The treatment device according to Clause 194, wherein the distal element is a first distal element distal to the interventional element, and the device further includes a second distal element proximal to the interventional element.

[0257] 199. The treatment device according to Clause 194, further comprising a tube extending longitudinally over the elongated member.

[0258] 200. The treatment device according to Clause 199, wherein the tube is coupled to the proximal portion of the interventional element.

[0259] 201. The treatment device according to Clause 199, further comprising a proximal stop or coupling member coupled to the elongated member, the tube extending longitudinally between the proximal stop or coupling member and the interventional element.

[0260] 202. The treatment device according to Clause 199, wherein the tube is coupled to the proximal portion of the distal element.

[0261] 203. The treatment device according to Clause 199, wherein the tube includes a helical cut extending along at least a portion of the length of the tube.

[0262] 204. The treatment device according to Clause 194, wherein the interventional element includes a thrombectomy device.

[0263] 205. The treatment device according to Clause 194, wherein the interventional element includes a stent remover.

[0264] 206. The treatment device according to Clause 194, wherein the interventional element is a laser-cutting stent.

[0265] 207. A treatment system comprising:

[0266] An elongated member comprising a distal portion configured to be positioned at or near a treatment site within a blood vessel thrombus.

[0267] A distal element, the distal element being configured to extend from a constrained configuration to an extended configuration, in which at least a portion of the distal element is juxtaposed with the vessel wall at the treatment site or other desired location;

[0268] Interventional element, the interventional element including a stent remover; and

[0269] A tube that extends longitudinally over the elongated member.

[0270] 208. The system according to Clause 207, wherein the distal element is configured to prevent or inhibit a portion of the thrombus from migrating distally thereto.

[0271] 209. The system according to Clause 207, further comprising a catheter having an inner lumen extending therethrough, wherein the distal element and the interventional element are configured to be slidably disposed within the inner lumen.

[0272] 210. The system according to clause 209, wherein the catheter is a first catheter, and the system further includes a second catheter configured to be slidably received by the lumen of the first catheter.

[0273] 211. The system according to Clause 210, wherein the first catheter is a guiding catheter and the second catheter is a microcatheter.

[0274] 212. The system according to Clause 207 further includes a proximal stop or coupling member coupled to the elongated member, wherein the tube is coupled to the proximal portion of the interventional element and extends longitudinally between the interventional element and the proximal stop or coupling member.

[0275] 213. The system according to Clause 207, further comprising:

[0276] A first stop, the first stop being fixedly coupled to the elongated member proximal to the distal element; and

[0277] A second stop is fixedly coupled to the elongated member on the distal side of the distal element.

[0278] in--

[0279] The distal element is slidably coupled to the elongated member and is movable along the elongated member between the first stop and the second stop.

[0280] The intervention element is proximal to the distal element and rotatably coupled to the elongated member.

[0281] 214. A thrombectomy system comprising:

[0282] A catheter having an inner lumen and a distal portion configured to locate a thrombus in an adjacent blood vessel;

[0283] A distal element, coupled to a distal portion of an elongated member configured to be electrically coupled to a first terminal of a power source and slidably advanced through the lumen of the conduit; and

[0284] An electrode, which is electrically coupled to the second terminal of the power supply.

[0285] 215. The system according to Clause 194, wherein the distal element comprises any distal element according to any of the preceding clauses.

[0286] 216. The system according to any one of the preceding clauses, wherein the distal element includes an attachment portion configured to electrostatically engage with the thrombus.

[0287] 217. The system according to Clause 196, wherein at least a portion of the attachment portion extends along the elongated member.

[0288] 218. The system according to any one of clauses 196 to 197, wherein at least a portion of the attachment portion extends along the elongated member on the proximal side of the distal element.

[0289] 219. The system according to any one of clauses 196 to 198, wherein the attachment portion is configured to serve as an electrode surface.

[0290] 220. The system according to any one of clauses 196 to 199, wherein the attachment portion defines a conductivity gradient as it extends in a proximal to distal direction.

[0291] 221. The system according to Clause 200, wherein the conductivity gradient includes an increase in conductivity as it extends distally.

[0292] 222. The system according to Clause 200, wherein the conductivity gradient includes a decrease in conductivity as it extends distally.

[0293] 223. The system according to any one of clauses 196 to 202, wherein the attachment portion is configured to define a charge density gradient as it extends in a proximal to distal direction.

[0294] 224. The system according to clause 203, wherein the charge density gradient includes an increase in charge density as it extends distally.

[0295] 225. The system according to clause 203, wherein the charge density gradient includes a decrease in charge density as it extends distally.

[0296] 226. The system according to any one of clauses 196 to 205, wherein the attachment portion is at least partially coated with a conductive material.

[0297] 227. The system according to Clause 206, wherein the coating has a varying thickness or concentration over the attachment portion.

[0298] 228. The system according to any one of clauses 196 to 207, wherein the attachment portion comprises a coil on the proximal side of the distal element.

[0299] 229. The system according to any one of the preceding clauses, wherein the catheter is a first catheter, and the system further includes a second catheter and a third catheter, wherein the first catheter is configured to be slidably disposed within the lumen of the second catheter, and the second catheter is configured to be slidably disposed within the lumen of the third catheter.

[0300] 230. The system according to any one of the preceding clauses, further comprising an inhalation source configured to supply negative pressure through the catheter to aspirate a region adjacent to the distal portion of the catheter.

[0301] 231. The system according to any one of the preceding clauses, wherein the attachment portion includes the proximal side of the distal element.

[0302] 232. The system according to any one of the preceding clauses, wherein the proximal portion of the distal element includes the attachment portion, and wherein the distal portion of the distal element includes a non-attached portion.

[0303] 233. The system according to any one of the preceding clauses, wherein the attachment portion is more conductive than the other portions of the distal element.

[0304] 234. The system according to any one of the preceding clauses, wherein the attachment portion is at least partially coated with a conductive material.

[0305] 235. The system according to Clause 214, wherein the conductive material comprises gold.

[0306] 236. The system according to Clause 214, wherein the coating has a varying thickness or concentration over the attachment portion.

[0307] 237. The system according to any one of the preceding clauses, wherein the non-attached portions are coated with an insulating material.

[0308] 238. The system according to any one of the preceding clauses, wherein the attachment portion includes a coil on the proximal side of the distal element.

[0309] 239. The system according to any one of the preceding clauses further includes a coil disposed around the elongated member in a region proximal to the distal element.

[0310] 240. The system according to Clause 219, wherein the coil is conductive.

[0311] 241. The system as described in Clause 194, wherein:

[0312] The electrode includes a thiopancreatic tube coupled to the second electrical terminal, the thiopancreatic tube having a proximal portion, a distal portion, and an inner cavity extending therethrough;

[0313] The elongated member extends through the inner cavity of the hyaluronic acid tube;

[0314] An insulating material is disposed between the wave tube and the elongated member, the insulating material extending from the proximal portion of the wave tube to the distal portion of the wave tube; and

[0315] The distal element is electrically connected to the elongated member.

[0316] 242. The system according to Clause 221, further comprising a second insulating material disposed around the outer surface of the proximal portion of the hysteresis tube.

[0317] 243. The system according to Clause 222, wherein the outer surface of the distal portion of the sodium hypochlorite tube is not covered by the second insulating material.

[0318] 244. The system according to any one of clauses 221 to 223, wherein the insulating material comprises PTFE, polyimide, ETFE or a dielectric polymer.

[0319] 245. The system according to any one of clauses 221 to 224, wherein the elongated member is fixed relative to the hyaluronic acid tube.

[0320] 246. The system according to any one of clauses 221 to 225, wherein current flows from the distal element to the hypotube when an electrolytic medium is present in the distal element and a voltage is supplied to the first and second electrical terminals of the external power supply.

[0321] 247. The system according to any one of the preceding clauses, wherein the electrode is disposed at the distal portion of the catheter.

[0322] 248. The system according to Clause 227, wherein the electrode is electrically connected to a conductive lead extending proximally along the conduit.

[0323] 249. The system according to any one of the preceding clauses, wherein the electrode includes a conductive strip that extends at least partially circumferentially around the distal portion of the conduit.

[0324] 250. The system according to Clause 229, wherein the conductive strip is disposed on the inner surface of the conduit.

[0325] 251. The system according to Clause 229, wherein the conductive strip is disposed on the outer surface of the conduit.

[0326] 252. The system according to any one of the preceding clauses, wherein the electrode includes an interventional element coupled to the distal portion of the elongated member and configured to be slidably advanced through the lumen of the catheter, the interventional element being electrically isolated from the distal element.

[0327] 253. The system according to clause 232, wherein the interventional element includes the interventional element according to any one of the preceding clauses.

[0328] 254. The system according to clause 232 or 233, wherein at least a portion of the intervention element is coated with a conductive material.

[0329] 255. The system according to Clause 232, wherein at least a portion of the intervention element is coated with an insulating material.

[0330] 256. The system according to any one of the preceding clauses, wherein the catheter includes a suction catheter.

[0331] 257. The system according to any one of the preceding clauses further includes an inhalation source configured to supply negative pressure through the catheter to aspirate a region adjacent to the distal portion of the catheter.

[0332] 258. The system according to any one of the preceding clauses, further comprising the power supply, wherein the first terminal is a positive terminal and the second terminal is a negative terminal.

[0333] 259. The system according to any one of the preceding clauses, wherein current flows from the distal element to the electrode when an electrolytic medium is present in the distal element and voltage is supplied to the first and second electrical terminals.

[0334] 260. The system according to any one of the preceding clauses, wherein the electrode comprises an external needle or a grounding pad.

[0335] 261. The system according to any one of the preceding clauses, wherein the electrode includes a distal portion of the distal element that is electrically isolated from the attachment portion of the distal element.

[0336] 262. The system according to Clause 241, wherein the distal element comprises a plurality of individual conductive filaments, and wherein a first subset of filaments is electrically connected to the first terminal and a second subset of filaments is electrically connected to the second terminal, the first subset of filaments and the second subset of filaments being electrically isolated from each other along their respective lengths.

[0337] 263. The system according to clause 241 or 242, wherein when the distal element has an electrolytic medium and a voltage is supplied to the first and second electrical terminals, current flows through the electrolytic medium from the first filament subset to the second filament subset.

[0338] 264. A thrombectomy system comprising:

[0339] Current generator;

[0340] A wire pusher, electrically coupled to the current generator, is configured to be slidably advanced through the blood vessel to the site of spread of a nearby thrombus; and

[0341] A distal element, which is coupled to the distal portion of the push wire, such that the distal element is electrically connected to the current generator.

[0342] 265. The system according to clause 244, wherein the distal element includes the distal element according to any one of the preceding clauses.

[0343] 266. The system according to any one of the preceding clauses, wherein the distal element includes an attachment portion configured to electrostatically engage with the thrombus.

[0344] 267. The system according to Clause 246, wherein the attachment portion includes the proximal side of the distal element.

[0345] 268. The system according to Clause 246, wherein at least a portion of the attachment portion extends along the elongated member.

[0346] 269. The system according to Clause 248, wherein at least a portion of the attachment portion extends along the elongated member proximal to the distal element.

[0347] 270. The system according to any one of clauses 246 to 249, wherein the attachment portion is configured to serve as an electrode surface.

[0348] 271. The system according to any one of clauses 246 to 250, wherein the attachment portion is configured to define a conductivity gradient as it extends in a proximal to distal direction.

[0349] 272. The system according to any one of clauses 246 to 251, wherein the attachment portion is configured to define a charge density gradient as it extends in a proximal to distal direction.

[0350] 273. The system according to any one of clauses 246 to 252, further comprising a return electrode electrically connected to the current generator.

[0351] 274. The system according to any one of clauses 246 to 253, wherein the proximal portion of the distal element includes the attachment portion and wherein the distal portion of the distal element includes the non-attached portion.

[0352] 275. The system according to any one of clauses 246 to 254, wherein the attachment portion is more conductive than the other portions of the distal element.

[0353] 276. The system according to any one of clauses 246 to 255, wherein the attachment portion is at least partially coated with a conductive material.

[0354] 277. The system according to Clause 256, wherein the conductive material comprises gold.

[0355] 278. The system according to Clause 256, wherein the coating has a varying thickness or concentration over the attachment portion.

[0356] 279. The system according to any one of clauses 246 to 258, wherein the non-attached portion of the distal element is coated with an insulating material.

[0357] 280. The system according to any one of the preceding clauses, wherein the wire pusher comprises a coil on the proximal side of the distal element.

[0358] 281. The system according to any one of the foregoing clauses further includes a coil disposed around the pusher wire in a region proximal to the distal element.

[0359] 282. The system according to Clause 261, wherein the coil is conductive.

[0360] 283. The system according to any one of the foregoing clauses further includes a return electrode, the return electrode being electrically connected to the current generator.

[0361] 284. The system as described in Clause 263, wherein:

[0362] The return electrode includes a thiopancreatic tube coupled to the second electrical terminal, the thiopancreatic tube having a proximal portion, a distal portion, and an inner cavity extending therethrough;

[0363] The push wire extends through the inner cavity of the sodium hypochlorite tube;

[0364] An insulating material is disposed between the sodium hypochlorite tube and the push wire, the insulating material extending from the proximal portion of the sodium hypochlorite tube to the distal portion of the sodium hypochlorite tube; and

[0365] The distal element is electrically connected to the pusher wire.

[0366] 285. The system according to any one of the preceding clauses, further comprising a second insulating material disposed around the outer surface of the proximal portion of the hysteresis tube.

[0367] 286. The system according to Clause 265, wherein the outer surface of the distal portion of the sodium hypochlorite tube is not covered by the second insulating material.

[0368] 287. The system according to any one of the preceding clauses, wherein the insulating material comprises PTFE, polyimide, ETFE or a dielectric polymer.

[0369] 288. The system according to any one of the preceding clauses, wherein the pusher wire is fixed relative to the hyaluronic acid tube.

[0370] 289. The system according to any one of the preceding clauses, wherein current flows from the distal element to the hypotube when an electrolytic medium is present in the distal element and current is supplied through the current generator.

[0371] 290. The system according to Clause 263, wherein the return electrode is disposed at the distal portion of the catheter.

[0372] 291. The system according to Clause 270, wherein the return electrode is electrically connected to a conductive lead extending proximally along the conduit.

[0373] 292. The system according to clause 270 or 271, wherein the return electrode includes a conductive strip extending circumferentially at least partially around the distal portion of the conduit.

[0374] 293. The system according to Clause 272, wherein the conductive strip is disposed on at least one of the inner or outer surfaces of the conduit.

[0375] 294. The system according to any one of clauses 263 to 273, wherein current flows from the distal element to the return electrode when an electrolytic medium is present in the distal element and current is supplied through the current generator.

[0376] 295. The system according to Clause 263, wherein the return electrode comprises an external needle or a grounding pad.

[0377] 296. The system according to Clause 263, wherein the return electrode includes a distal portion of the distal element that is electrically isolated from the attachment portion of the distal element.

[0378] 297. The system according to Clause 276, wherein the distal element comprises a plurality of individual conductive filaments, and wherein a first subset of filaments is electrically connected to the first terminal and a second subset of filaments is electrically connected to the second terminal, the first subset of filaments and the second subset of filaments being electrically isolated from each other along their respective lengths.

[0379] 298. The system according to clause 276 or 277, wherein when the distal element has an electrolytic medium and a voltage is supplied to the first and second electrical terminals, current flows through the electrolytic medium from the first filament subset to the second filament subset.

[0380] 299. A thrombectomy device, comprising:

[0381] An elongated member configured to be slidably pushed through a body cavity, the elongated member being configured to be electrically coupled to a first electrical terminal of a current generator;

[0382] A delivery electrode, the delivery electrode including a distal element coupled to a distal portion of the elongated member; and

[0383] A return electrode is configured to be electrically coupled to a second electrical terminal of the current generator.

[0384] 300. The apparatus according to Clause 279 further includes a current generator having a first electrical terminal coupled to the elongated member and a second electrical terminal coupled to the return electrode.

[0385] 301. The apparatus according to any one of the preceding clauses, wherein the distal element includes the distal element according to any one of the preceding clauses.

[0386] 302. The device according to any one of the preceding clauses, wherein the distal element includes an attachment portion configured to electrostatically engage with a thrombus.

[0387] 303. The device according to clause 282, wherein at least a portion of the attachment portion extends along the elongated member.

[0388] 304. The device according to clause 283, wherein at least a portion of the attachment portion extends along the elongated member proximal to the distal element.

[0389] 305. The apparatus according to any one of clauses 282 to 284, wherein the attachment portion is configured to serve as an electrode surface of the delivery electrode.

[0390] 306. The apparatus according to any one of clauses 282 to 285, wherein the attachment portion is configured to define a conductivity gradient as it extends in a proximal to distal direction.

[0391] 307. The apparatus according to any one of clauses 282 to 286, wherein the attachment portion is configured to define a charge density gradient as it extends in a proximal to distal direction.

[0392] 308. The device according to any one of the preceding clauses, further comprising a first conduit configured to slidably receive the elongated member passing therethrough.

[0393] 309. The device according to Clause 288, further comprising an inhalation source configured to supply negative pressure through the catheter to aspirate a region adjacent to the distal portion of the catheter.

[0394] 310. The device according to any one of clauses 282 to 290, wherein the attachment portion further comprises a coil coupled to the elongated member in a region proximal to the distal element.

[0395] 311. The device according to any one of clauses 282 to 291, wherein the attachment portion includes the proximal side of the distal element.

[0396] 312. The apparatus according to any one of clauses 282 to 292, wherein the proximal portion of the distal element includes the attachment portion and wherein the distal portion of the distal element includes a non-attached portion.

[0397] 313. The device according to clause 292, wherein the non-attached portion is coated with an insulating material.

[0398] 314. The device according to any one of clauses 282 to 293, wherein the attachment portion is more conductive than the other portions of the distal element.

[0399] 315. The device according to any one of clauses 282 to 295, wherein the attachment portion is at least partially coated with a conductive material.

[0400] 316. The apparatus according to clause 295, wherein the conductive material comprises gold.

[0401] 317. The apparatus according to Clause 295, wherein the conductive material has a varying thickness or concentration over the attachment portion.

[0402] 318. The apparatus according to any one of the preceding clauses, wherein the elongated member comprises a coil on the proximal side of the distal element.

[0403] 319. The device according to any one of the preceding clauses, further comprising a coil disposed around the elongated member in a region proximal to the distal element.

[0404] 320. The apparatus according to clause 299, wherein the coil is conductive.

[0405] 321. A method comprising:

[0406] An elongated member is advanced through a catheter to a treatment site near a thrombus in a blood vessel, the elongated member having a distal element coupled to a distal portion of the elongated member;

[0407] The distal element is positioned at least partially distal to the thrombus, the distal element extending to be juxtaposed with the vessel wall; and

[0408] Current is supplied to the distal element through the elongated member.

[0409] 322. The method according to clause 301 further includes stopping the supply of current to the second electrical terminal after the first time period.

[0410] 323. The method according to clause 302 further includes retracting the elongated member proximally relative to the conduit after the current supply is stopped.

[0411] 324. The method according to clause 302, wherein the first time period is less than about 5 minutes.

[0412] 325. The method according to clause 302, wherein the first time period is less than about 2 minutes.

[0413] 326. The method according to any one of the preceding clauses, wherein the total energy delivered by the current is between 0.75 mJ and 24,000 mJ, or between 120 mJ and 24,000 mJ, and wherein the peak current delivered by the current is between 0.5 mA and 5 mA.

[0414] 327. The method according to any one of the preceding clauses, wherein the total energy delivered by the current is between 120 mJ and 5000 mJ.

[0415] 328. The method according to any one of the preceding clauses, wherein the total charge delivered by the current is between 30 mC and 1200 mC.

[0416] 329. The method according to any one of the preceding clauses, wherein the total charge delivered by the current is between 120mC and 160mC.

[0417] 330. The method according to any one of the preceding clauses, wherein the frequency of the current is between 1 Hz and 1 MHz.

[0418] 331. The method according to any one of the preceding clauses, wherein the frequency of the current is between 1 Hz and 1 kHz.

[0419] 332. The method according to any one of the preceding clauses, wherein the duty cycle of said current is between 5% and 99%.

[0420] 333. The method according to any one of the preceding clauses, wherein the duty cycle of the current is between 5% and 20%.

[0421] 334. The method according to any one of the preceding clauses, wherein the peak current delivered by the current is between 0.5 mA and 5 mA.

[0422] 335. The method according to any one of the preceding clauses, wherein delivering the current to the distal element substantially does not form a thrombus.

[0423] 336. The method according to any one of the preceding clauses, wherein the current includes a non-square waveform.

[0424] 337. The method according to any one of the preceding clauses, wherein the current comprises a composite waveform, the composite waveform comprising a superposition of square waveforms and non-square waveforms.

[0425] 338. The method according to clause 317, wherein the non-square waveform includes a triangular waveform.

[0426] 339. The method according to any one of the preceding clauses, wherein the distal element comprises a conductive self-expanding device.

[0427] 340. The method according to any one of the preceding clauses, wherein the distal element comprises a plurality of braided filaments.

[0428] 341. The method according to any one of the preceding clauses, wherein the distal element includes an attachment portion configured to engage with the thrombus.

[0429] 342. The method according to clause 321, wherein the attachment portion is more conductive than the other portions of the distal element.

[0430] 343. The method according to clause 321, wherein the attachment portion is at least partially coated with a conductive material.

[0431] 344. The method according to clause 323, wherein the conductive material comprises gold.

[0432] 345. The method according to any one of the preceding clauses, further comprising removing the thrombus from the blood vessel.

[0433] 346. The method according to any one of the preceding clauses, further comprising retracting the distal element to displace the thrombus.

[0434] 347. A thrombectomy system comprising:

[0435] A catheter having an inner lumen and a distal portion configured to locate a thrombus in an adjacent blood vessel;

[0436] An interventional element coupled to a distal portion of an elongated member, the elongated member being configured to be electrically coupled to a first terminal of an external power source and slidably advanced through the lumen of the catheter; and

[0437] A distal element, which is configured to be disposed distal to the interventional element and electrically coupled to a second terminal of the external power source.

[0438] 348. The system according to clause 327, wherein the distal element is coupled to the distal portion of the elongated member at a location distal to the intervention element.

[0439] 349. The system according to clause 328, wherein the elongated member includes a first conductive path coupled to the intervention element and a second conductive path coupled to the distal element, the first conductive path and the second conductive path being electrically insulated from each other along their respective lengths.

[0440] 350. The system according to clause 329, wherein the first conductive path is configured to be electrically coupled to a first terminal of an external power source, and the second conductive path is configured to be electrically coupled to a second terminal of the external power source.

[0441] 351. The system according to any one of the preceding clauses, wherein the first conductive path comprises a conductive tube having an inner cavity, and the second conductive path comprises a push wire extending through the inner cavity of the conductive tube, wherein an insulating material is disposed between the conductive tube and the push wire.

[0442] 352. The system according to clause 331, further comprising a second insulating material disposed around the outer surface of the proximal portion of the hysteresis tube.

[0443] 353. The system according to clause 331 or clause 332, wherein the insulating material comprises PTFE, polyimide, ETFE or dielectric polymer.

[0444] 354. The system according to any one of clauses 331 to 333, wherein the pusher wire is fixed relative to the conductive tube.

[0445] 355. The system according to any one of the preceding clauses, wherein the distal element is coupled to the distal portion of a second elongated member, the second elongated member being configured to be slidably advanced through the lumen of the catheter.

[0446] 356. The system according to any one of the preceding clauses, wherein the distal element comprises the distal element according to any one of the preceding clauses.

[0447] 357. The system according to any one of the preceding clauses, wherein the interventional element includes the interventional element according to any one of the preceding clauses.

[0448] 358. The system according to any one of the preceding clauses, wherein at least a portion of the intervention element is coated with a conductive material.

[0449] 359. The system according to any one of the preceding clauses, wherein at least a portion of the intervention element is coated with an insulating material.

[0450] 360. The system according to any one of the preceding clauses, wherein at least a portion of the distal element is coated with a conductive material.

[0451] 361. The system according to any one of the preceding clauses, wherein at least a portion of the distal element is coated with an insulating material.

[0452] 362. The system according to any one of the preceding clauses, wherein current flows from the interventional element to the distal element when an electrolytic medium is present in the interventional element and the distal element and power is supplied to the first and second terminals of the external power source.

[0453] 363. The system according to any one of the preceding clauses further includes a power source, wherein the first terminal is a positive terminal and wherein the second terminal is a negative terminal.

[0454] 364. The system according to any one of the preceding clauses, wherein the catheter includes a suction catheter.

[0455] 365. The system according to any one of the preceding clauses further includes an inhalation source configured to supply negative pressure through the catheter to aspirate a region adjacent to the distal portion of the catheter.

[0456] 366. A thrombectomy device, comprising:

[0457] An elongated member configured to be slidably advanced through a body cavity, the elongated member having a distal portion configured to be adjacent to the location of a thrombus;

[0458] A first conductive path extends along the elongated member and is configured to be electrically coupled to an external current generator.

[0459] A second conductive path extends along the elongated member and is configured to be electrically coupled to an external current generator, the second conductive path being electrically isolated from the first conductive path along its length.

[0460] An interventional element coupled to the distal portion of the elongated member, such that the interventional element is electrically connected to the first conductive path;

[0461] A distal element is coupled to the distal portion of the elongated member at a location distal to the intervention element, such that the distal element is electrically connected to the second conductive path.

[0462] 367. The apparatus according to any one of the preceding clauses, wherein the second conductive path comprises a conductive tube having an inner cavity, and the first conductive path comprises a push wire extending through the inner cavity of the conductive tube, wherein an insulating material is disposed between the conductive tube and the push wire.

[0463] 368. The device according to any one of the preceding clauses, further comprising a second insulating material disposed around the outer surface of the proximal portion of the conductive tube.

[0464] 369. The apparatus according to any one of the preceding clauses, wherein the insulating material comprises PTFE, polyimide, ETFE or a dielectric polymer.

[0465] 370. The device according to any one of the preceding clauses, wherein the elongated member is fixed relative to the conductive tube.

[0466] 371. The apparatus according to any one of the preceding clauses, wherein the distal element comprises the distal element according to any one of the preceding clauses.

[0467] 372. The apparatus according to any one of the preceding clauses, wherein the intervention includes an intervention element according to any one of the preceding clauses.

[0468] 373. The apparatus according to any one of the preceding clauses, wherein when an electrolytic medium is present in the interventional element and the distal element and current is supplied through the extracorporeal current generator, current flows from the interventional element to the distal element.

[0469] 374. The apparatus according to any one of the preceding clauses, further comprising a current generator, wherein the first terminal is a positive terminal and wherein the second terminal is a negative terminal.

[0470] 375. A method comprising:

[0471] An elongated member is advanced through a catheter to a treatment site near a thrombus in a blood vessel, the elongated member having a distal element coupled to a distal portion of the elongated member;

[0472] The interventional element is positioned at or near the thrombus, and the interventional element is electrically connected to the first electrical terminal of the external current generator.

[0473] The distal element is positioned at least partially distal to the thrombus, the distal element extending to be juxtaposed with the vessel wall; and

[0474] Current is supplied to the intervention element through the current generator.

[0475] 376. The method according to any one of the preceding clauses further includes stopping the supply of current after the first time period.

[0476] 377. The method according to any one of the preceding clauses further includes retracting the elongated member proximally relative to the conduit after the current supply is stopped.

[0477] 378. The method according to any one of the preceding clauses, wherein the first time period is less than about 5 minutes.

[0478] 379. The method according to any one of the preceding clauses, wherein the first time period is less than about 2 minutes.

[0479] 380. The method according to any one of the preceding clauses, wherein supplying current includes the steps according to any one of the preceding clauses.

[0480] 381. The method according to any one of the preceding clauses, wherein the distal element is electrically connected to the second electrical terminal of the external current generator.

[0481] 382. The method according to any one of the preceding clauses, wherein the first electrical terminal is a positive terminal and the second electrical terminal is a negative terminal.

[0482] 383. The method according to any one of the preceding clauses, wherein the distal element comprises the distal element according to any one of the preceding clauses.

[0483] 384. The method according to any one of the preceding clauses, wherein the interventional element comprises the interventional element according to any one of the preceding clauses.

[0484] 385. A thrombectomy system comprising:

[0485] A catheter having an inner lumen and a distal portion configured to locate a thrombus in an adjacent blood vessel;

[0486] An elongated member configured to be electrically coupled to a first terminal of a power source and slidably advanced through the lumen of a conduit;

[0487] A distal element, coupled to a distal portion of the elongated member, the distal element including an attachment portion configured to electrostatically engage with the thrombus; and

[0488] An electrode, which is configured to be electrically coupled to a second terminal of the power supply.

[0489] 386. The system according to clause 385, wherein at least a portion of the attachment portion extends along the elongated member.

[0490] 387. The system according to clause 385, wherein at least a portion of the attachment portion extends along the elongated member proximal to the distal element.

[0491] 388. The system according to clause 385, wherein the attachment portion is configured to serve as an electrode surface.

[0492] 389. The system according to clause 385, wherein the attachment portion defines a conductivity gradient as the attachment portion extends in a proximal to distal direction.

[0493] 390. The system according to clause 389, wherein the conductivity gradient includes an increase in conductivity as the attachment portion extends distally.

[0494] 391. The system according to clause 389, wherein the conductivity gradient includes a decrease in conductivity as the attachment portion extends distally.

[0495] 392. The system according to clause 385, wherein the attachment portion is configured to define a charge density gradient as the attachment portion extends in a proximal to distal direction.

[0496] 393. The system according to clause 392, wherein the charge density gradient includes an increase in charge density as the attachment portion extends distally.

[0497] 394. The system according to clause 392, wherein the charge density gradient includes a decrease in charge density as the attachment portion extends distally.

[0498] 395. The system according to clause 385, wherein the attachment portion is at least partially coated with a conductive material.

[0499] 396. The system according to clause 395, wherein the conductive material has a varying thickness or concentration over the attachment portion.

[0500] 397. The system according to clause 385, wherein the attachment portion includes a coil on the proximal side of the distal element.

[0501] 398. A thrombectomy system comprising:

[0502] Current generator;

[0503] An elongated member electrically coupled to the current generator, the elongated member being configured to be slidably advanced through the blood vessel to the site of spread of a nearby thrombus; and

[0504] A distal element coupled to a distal portion of the elongated member such that the distal element is electrically connected to the current generator, the distal element including an attachment portion configured to electrostatically engage with the thrombus.

[0505] 399. The system according to clause 398, wherein at least a portion of the attachment portion extends along the elongated member.

[0506] 400. The system according to clause 398, wherein at least a portion of the attachment portion extends along the elongated member proximal to the distal element.

[0507] 401. The system according to clause 398, wherein the attachment portion is configured to serve as an electrode surface.

[0508] 402. The system according to clause 398, wherein the attachment portion is configured to define a conductivity gradient as the attachment portion extends in a proximal to distal direction.

[0509] 403. The system according to clause 398, wherein the attachment portion is configured to define a charge density gradient as the attachment portion extends in a proximal to distal direction.

[0510] 404. The system according to Clause 398 further includes a return electrode electrically connected to the current generator.

[0511] 405. The system according to clause 404, wherein:

[0512] The return electrode includes a conductive tube electrically coupled to the current generator, the conductive tube having a proximal portion, a distal portion, and an inner cavity extending through it;

[0513] The elongated member extends through the inner cavity of the conductive tube;

[0514] An insulating material is disposed between the conductive tube and the elongated member, the insulating material extending from the proximal portion of the conductive tube to the distal portion of the conductive tube; and

[0515] The distal element is electrically connected to the elongated member.

[0516] 406. A thrombectomy device, comprising:

[0517] An elongated member configured to be slidably pushed through a body cavity, the elongated member being configured to be electrically coupled to a first electrical terminal of a current generator;

[0518] A delivery electrode, the delivery electrode including a distal element coupled to a distal portion of the elongated member, wherein the distal element includes an attachment portion configured to electrostatically engage with a thrombus; and

[0519] A return electrode is configured to be electrically coupled to a second electrical terminal of the current generator.

[0520] 407. The device according to clause 406, wherein at least a portion of the attachment portion extends along the elongated member.

[0521] 408. The device according to clause 406, wherein at least a portion of the attachment portion extends along the elongated member proximal to the distal element.

[0522] 409. The apparatus according to clause 406, wherein the attachment portion is configured to serve as an electrode surface of the delivery electrode.

[0523] 410. The apparatus according to claim 406, wherein the attachment portion is configured to define a conductivity gradient as the attachment portion extends in a proximal to distal direction.

[0524] 411. The apparatus according to claim 406, wherein the attachment portion is configured to define a charge density gradient as the attachment portion extends in a proximal to distal direction.

[0525] 412. The device according to clause 406, further comprising a conduit configured to slidably receive the elongated member passing therethrough.

[0526] 413. The device according to clause 412, further comprising an inhalation source configured to supply negative pressure through the catheter to aspirate a region adjacent to a distal portion of the catheter.

[0527] 414. The apparatus according to clause 406, wherein the attachment portion further comprises a coil coupled to the elongated member in a region proximal to the distal element.

[0528] 415. A thrombectomy system comprising:

[0529] A catheter having an inner lumen and a distal portion configured to locate a thrombus in an adjacent blood vessel;

[0530] An interventional element coupled to a distal portion of an elongated member, the elongated member being configured to be slidably advanced through the lumen of the catheter and electrically coupled to a first terminal of an external power source via a first conductive path; and

[0531] A distal element, which is located distal to the interventional element and electrically coupled to a second terminal of the external power source via a second conductive path.

[0532] 416. The system according to clause 415, wherein the first conductive path includes a conductive tube having an inner cavity, the elongated member includes a second conductive path extending through the inner cavity of the conductive tube, and an insulating material is disposed between the conductive tube and the elongated member.

[0533] 417. The system according to clause 415, wherein the distal element is coupled to the distal portion of the elongated member at a location proximal to the interventional element.

[0534] 418. The system according to clause 415, wherein the elongated element is a first elongated member, and wherein the distal element is coupled to a distal portion of a second elongated member, the second elongated member being configured to be slidably advanced through the lumen of the catheter.

[0535] 419. The system according to claim 415, wherein the distal element comprises an expandable mesh having a low-profile state for delivery to the unfolding site and an expanded state, wherein in the expanded state at least a portion of the mesh is configured to be juxtaposed with the vessel wall at the unfolding site.

[0536] 420. The system according to clause 415, wherein the distal element comprises a plurality of braided filaments.

[0537] 421. The system according to clause 415, wherein the distal element comprises a woven ball.

[0538] 422. The system according to clause 415, wherein the distal element is configured to deploy distal to the thrombus to prevent distal embolism.

[0539] 423. The system according to clause 415, wherein the interventional element includes a thrombectomy device.

[0540] 424. The system according to clause 415, wherein the interventional element includes a stent remover.

[0541] 425. The system according to clause 415, wherein current flows from the interventional element to the distal element when an electrolytic medium is present in the interventional element and the distal element and power is supplied to the first and second terminals of the external power source.

[0542] 426. The system according to Clause 415 further includes an external power source, wherein the first terminal is a positive terminal and the second terminal is a negative terminal.

[0543] 427. The system according to clause 415 further includes an inhalation source configured to supply negative pressure through the catheter to aspirate a region adjacent to the distal portion of the catheter.

[0544] 428. A thrombectomy device comprising:

[0545] An elongated member configured to be slidably advanced through a body cavity, the elongated member having a distal portion configured to be adjacent to the location of a thrombus;

[0546] A first conductive path extends along the elongated member and is configured to be electrically coupled to an external current generator.

[0547] A second conductive path extends along the elongated member and is configured to be electrically coupled to an external current generator, the second conductive path being electrically isolated from the first conductive path.

[0548] An interventional element coupled to the distal portion of the elongated member, such that the interventional element is electrically connected to the first conductive path; and

[0549] A distal element, coupled at a location distal to the intervention element to the distal portion of the elongated member, such that the distal element is electrically connected to the second conductive path.

[0550] When an electrolytic medium is present in both the interventional element and the distal element, and current is supplied through the external current generator, current flows from the interventional element to the distal element.

[0551] 429. The apparatus according to claim 428, wherein the first conductive path includes a conductive tube having an inner cavity, and the second conductive path extends through the inner cavity of the conductive tube, wherein an insulating material is disposed between the conductive tube and the elongated member.

[0552] 430. The apparatus of claim 428, wherein the distal element comprises an expandable mesh having a low-profile state for delivery to the unfolding site and an expanded state, wherein in the expanded state at least a portion of the mesh is configured to juxtapose with the vessel wall at the unfolding site.

[0553] 431. The device according to clause 428, wherein the distal element comprises a plurality of braided filaments.

[0554] 432. The device according to clause 428, wherein the distal element comprises a woven ball.

[0555] 433. The device according to clause 428, wherein the interventional element includes a stent remover.

[0556] 434. The apparatus according to clause 428, wherein the interventional element includes a removal device.

[0557] 435. The device according to clause 428, wherein the interventional element is a laser cutting bracket.

[0558] 436. The apparatus according to clause 428, wherein at least a portion of the distal element is coated with a conductive material.

[0559] 437. The apparatus according to clause 428, further comprising the external current generator, wherein the positive terminal of the external current generator is coupled to the first conductive path, and the negative terminal of the external current generator is coupled to the second conductive path.

[0560] Further features and advantages of the present invention are described below, and will be apparent in part from the description, or may be learned by practicing the present invention. The advantages of the present invention will be realized and obtained through the structures specifically pointed out in the written description and its claims and drawings. Attached Figure Description

[0561] Many aspects of the invention can be better understood by referring to the following accompanying drawings. The components in the drawings are not necessarily to scale; rather, the focus is on clearly illustrating the principles of this disclosure.

[0562] Figure 1 A perspective view of a treatment system for removing material from a human body cavity, according to one or more embodiments of the present invention, is shown.

[0563] Figure 2A It shows Figure 1 A schematic side view of a portion of the treatment system shown.

[0564] Figure 2B It shows along Figure 2A The treatment device is a cross-sectional view taken by line 2B-2B in the figure.

[0565] Figure 2C A cross-sectional view of another embodiment of the treatment device is shown.

[0566] Figure 3-8A A side view of a treatment device according to various aspects of the technology of the present invention is shown.

[0567] Figure 8B yes Figure 8A A detached view of a portion of the slender member shown.

[0568] Figure 8C The section cut along line 8B-8B is shown. Figure 8A A cross-sectional view of the treatment device.

[0569] Figures 9A-9F Embodiments of distal elements according to various aspects of the present invention are shown.

[0570] Figures 10A-10E A method for removing clot material from the lumen of a blood vessel according to one or more embodiments of the present invention is shown.

[0571] Figure 11 A perspective view of a treatment system for removing material from a human body cavity, according to one or more embodiments of the present invention, is shown.

[0572] Figure 12-17 A schematic side view of a treatment system according to an embodiment of the present invention is shown.

[0573] Figures 18A-18D The illustration depicts a method for removing clot material from the lumen of a blood vessel according to one or more embodiments of the present invention.

[0574] Figure 19A A perspective view of an electro-enhanced therapeutic system for removing material from a human body cavity, according to one or more embodiments of the present invention, is shown.

[0575] Figure 19B and 19C yes Figure 19A Schematic diagrams of different embodiments of the current generator shown.

[0576] Figure 20A yes Figure 19A A side view of a part of the treatment system.

[0577] Figure 20B yes Figure 20A A schematic side-view cross-section of a portion of the treatment system shown.

[0578] Figure 20C This is a side cross-sectional schematic diagram as part of another embodiment of the treatment system.

[0579] Figure 21 A perspective view of an electro-enhanced therapeutic system for removing material from a human body cavity, according to one or more embodiments of the present invention, is shown.

[0580] Figure 22 yes Figure 21 A side view of a portion of the treatment system shown.

[0581] Figure 23A–23E illustrates a sample waveform for electrically enhanced removal of material from a blood vessel lumen according to one or more embodiments of this disclosure. Detailed Implementation

[0582] This invention provides apparatus, systems, and methods for removing clots and / or other materials from the lumen of blood vessels. Although numerous embodiments are described below with respect to apparatus, systems, and methods for treating cerebral embolism or intracranial embolism, other applications and embodiments besides those described herein are also within the scope of this invention. For example, the treatment systems and methods of this invention can be used to remove emboli from cavities other than blood vessels (e.g., the digestive tract, etc.) and / or can be used to remove emboli from blood vessels outside the brain (e.g., blood vessels in the lungs, abdomen, cervix, or chest, or peripheral blood vessels including those in the legs or arms, etc.). Additionally, the treatment systems and methods of this invention can be used to remove cavities obstructing the lumen other than clot material (e.g., plaque, excised tissue, foreign bodies, etc.).

[0583] I. Overview of the treatment system of the present invention

[0584] Figure 1 A view of a treatment system 10 according to one or more embodiments of the present invention is shown. Figure 1 As shown, the treatment system 10 has a proximal portion 10a and a distal portion 10b, the proximal portion being configured for external positioning during treatment, and the distal portion being configured for intravascular positioning at or near a treatment site within a blood vessel (e.g., an intracranial vessel). The treatment system 10 may include a handle 16 at the proximal portion 10a, a treatment device 100, and a plurality of elongated shafts or members extending between the proximal portion 10a and the distal portion 10b. For example, in some embodiments, such as... Figure 1 In the illustrated embodiment, the treatment system 10 may include one, some, or all of the following: a first catheter 200 (e.g., a guiding catheter or a balloon guiding catheter), a second catheter 210 (e.g., a distal access catheter or a suction catheter), the second catheter being configured to be slidably disposed within the lumen of the first catheter 200, and a third catheter 220 (e.g., a microcatheter), the third catheter being configured to be slidably disposed within the lumen of the second catheter 210. In some embodiments, the first catheter 200 is coupled to a handle 16, the handle providing proximal access to the second catheter 210, the third catheter 220, and / or the treatment device 100. The treatment device 100 may be configured to be slidably disposed within the lumen of the first catheter 200, the second catheter 210, and / or the third catheter 220.

[0585] like Figure 1As shown, the treatment device 100 has a proximal portion 100a, a distal portion 100b, an elongated member 120 extending from the proximal portion 100a to the distal portion 100b, and an expandable distal element 140 coupled to the distal portion of the elongated member 120. The distal element 140 may include an expandable mesh having a low profile or constrained state while positioned within a catheter for delivery to a deployment location, and an expanded state in which at least a portion of the mesh is configured to juxtapose with the vessel wall. The distal element 140 is configured to extend along the intravascular pathway to the desired location at the treatment site and to contact the vessel wall at the treatment site to anchor and / or stabilize any portion of the elongated member 120 and / or the treatment device 100 and / or the treatment system 10 at the desired location. As detailed below, the distal element 140 may also be configured to facilitate thrombus removal from the treatment site.

[0586] In some embodiments, the treatment system 10 includes an inhalation source 25 (e.g., a syringe, pump, etc.) configured to be fluidly coupled (e.g., via connector 23) to a proximal portion of one or more of a first catheter 200, a second catheter 210, and / or a third catheter 220 to apply negative pressure therethrough. In some embodiments, the treatment system 10 includes a fluid source 27 (e.g., a fluid reservoir, syringe, pump, etc.) configured to be fluidly coupled (e.g., via connector 23) to a proximal portion of one or more of the first catheter 200, the second catheter 210, and / or the third catheter 220 to supply fluid (e.g., saline, contrast agent, medication such as a thrombolytic agent, etc.) to the treatment site.

[0587] According to some embodiments, such as Figure 1 As shown, each of the first catheter 200, the second catheter 210, and the third catheter 220 can be formed as a generally tubular member extending along and around a central axis and terminating at a corresponding distal end. The size of the first catheter 200 can be set and configured to slidably accommodate both the second catheter 210 and the third catheter 220 passing through it. In some embodiments, the first catheter 200 is a balloon-guided catheter having an inflatable balloon or other expandable member that can be used to anchor the first catheter 200 relative to a peripheral blood vessel and / or to block blood flow at the location of the balloon.

[0588] The second catheter 210 can be sized and configured to slidably accommodate a third catheter 220 passing through it. The second catheter 210 can be coupled at its proximal portion to an inhalation source 25, such as a pump or syringe, to supply negative pressure to the treatment site. In some embodiments, the working length of the second catheter 210 can be from about 100 cm to about 140 cm, for example, about 105 cm, about 120 cm, or about 132 cm. The inner diameter of the second catheter 210 can be about 0.068 inches (0.172 cm) or about 0.071 inches (0.180 cm).

[0589] According to some embodiments, the third catheter 220 is typically configured to follow a conventional guidewire within the cervical anatomy and enter a cerebral blood vessel associated with the brain, and can also be selected according to several standard designs commonly available. Thus, the length of the third catheter 220 can be at least 125 cm, and more specifically, can be between about 125 cm and about 175 cm. In some embodiments, the inner diameter of the third catheter 220 can be about 0.015 inches (0.0381 cm), 0.017 inches (0.043 cm), about 0.021 inches (0.053 cm), or about 0.027 inches (0.069 cm). Other designs and sizes are contemplated.

[0590] The following text is about Figures 10A-10E More specifically, in operation, firstly, a first catheter 200 may be advanced through the blood vessel and a balloon may be expanded to anchor the first catheter 200 in place and / or block blood flow from a region proximal to the balloon. Next, a second catheter 210 may be advanced through the first catheter 200 until its distal end extends distally beyond the distal end of the first catheter 200. The second catheter 210 may be positioned such that its distal end is close to or adjacent to the treatment site (e.g., the site of a blood clot within the blood vessel). Then, a third catheter 220 may be advanced through the second catheter 210 until its distal end extends distally beyond the distal end of the second catheter 210.

[0591] According to some embodiments, the bodies of conduits 200, 210, and 220 can be made of various thermoplastics, such as polytetrafluoroethylene (PTFE) or... Materials such as fluorinated ethylene propylene (FEP), high-density polyethylene (HDPE), and polyether ether ketone (PEEK) can be optionally lined with a hydrophilic material, such as polyvinylpyrrolidone (PVP), or some other plastic coating, on the inner or adjacent surfaces of the conduit. Alternatively, any surface can be coated with various combinations of different materials, depending on the desired result. Any one or more conduits 200, 210, and 220 can incorporate reinforcing structures in their construction, such as layering between an inner lubricating liner and an outer polymer jacket. Such reinforcing structures can be metallic and / or polymeric and include tubular braids, coils, thiourea tubes (e.g., helically cut or slotted thiourea tubes), or combinations thereof. Suitable metals for constructing reinforcing structures include, but are not limited to, stainless steel, nitinol, and cobalt-chromium alloys.

[0592] II. Example treatment device and usage method

[0593] Figure 2A yes Figure 1 Side view of some embodiments of the treatment device 100 shown. (See attached image.) Figure 2A As shown, the treatment device 100 may include an elongated member 120 (such as a wire or guidewire) and an expandable distal element 140 coupled to the distal portion of the elongated member 120 via a connecting assembly 130. Figure 2A In the illustrated embodiment, the elongated member 120 extends distally from the connecting assembly 130 through the entire length of the distal element 140 and protrudes distally beyond the distal element 140. In some embodiments, the elongated member 120 may terminate at the connecting assembly 130 and not extend into the internal cavity and / or not coexist with any portion of the distal element 140. In some embodiments, the elongated member 120 terminates at a location along the length of the distal element 140 but does not extend distally beyond the distal element 140.

[0594] The elongated member 120 can move within a catheter and / or microcatheter to position the distal element 140 at a desired location. The elongated member 120 can be flexible enough to allow manipulation of the treatment device 100 through a tortuous channel, such as advance and / or retraction. The tortuous channel can include, for example, a catheter lumen, a microcatheter lumen, a blood vessel, a urinary tract, a biliary tract, and an airway. The elongated member 120 can be formed of any material and size suitable for the task to which the system is to be used. In some embodiments, the elongated member 120 may include a solid metal wire. In some embodiments, the elongated member 120 may include any other suitable form of shaft, such as an elongated tubular shaft, as referenced below. Figure 7 The subject of discussion.

[0595] In some embodiments, the elongated member 120 may comprise stainless steel, nitinol, or other metals or alloys. In some embodiments, the elongated member 120 may be coated with, for example, polytetrafluoroethylene along part or all of its length. The distal portion or tip 120b of the elongated member 120 may have a curved shape, for example, as shown in the figure. Figure 2A As shown, the distal portion 120b of the elongated member 120 can be used to guide the advancement of the distal end of the elongated member 120. The elongated member 120 may have a diameter that is substantially constant along its length, or the elongated member 120 may have a diameter that tapers radially inward along at least a portion of its length as it extends in the distal direction. In some embodiments, the diameter of the elongated member 120 is 0.008 inches (0.020 cm), 0.010 inches (0.254 cm), 0.014 inches (0.036 cm), 0.018 inches (0.046 cm), or greater.

[0596] The proximal end of the distal element 140 can be coupled to the elongated member 120 via the connecting assembly 130. For example, as Figure 2B As shown in the cross-sectional end view of the connecting assembly 130, the connecting assembly 130 may include an outer strap 132 positioned proximally around the distal element 140 and an inner strap 131 positioned around the elongated member 120. Therefore, the proximally end of the distal element 140 can be sandwiched between the outer strap 132 and the inner strap 131, and the connecting assembly 130 can be rolled downwards onto the elongated member 120 to secure the connecting assembly 130 to the elongated member 120 at a desired positioning. Figure 2C As shown, in some embodiments, the proximal end of the distal element 140 can be directly attached to the elongated member 120 via a single strap 133.

[0597] In some embodiments, such as Figure 3 and 4 As depicted, the treatment device 100 may include a stop on either side of the connecting assembly 130 for limiting axial movement of the distal element 140 along the elongated member 120. Figure 3As shown, in some embodiments of the technology, the treatment device 100 includes a first stop 134 fixed to the proximal side of an elongated member 120 of the connecting assembly 130 and a second stop 136 fixed to the distal side of the elongated member 120 of the connecting assembly 130. The first stop 134 and the second stop 136 can be of any shape or size that prevents or inhibits movement of the connecting assembly 130 along the elongated member 120. Each of the first stop 134 and / or the second stop 136 can be integrally formed with the elongated member 120 or formed as a separate component. The first stop 134 and the second stop 136 can be positioned adjacent to the proximal and distal ends of the connecting assembly 130 such that the connecting assembly 130 cannot translate along the elongated member 120. In such embodiments, the second stop 136 can be positioned precisely distal to the connecting assembly 130 at a location within the inner region of the distal element 140. In such embodiments, although the connecting assembly 130 and the distal element 140 are substantially prevented from axial movement, the connecting assembly 130 and the distal element 140 can still rotate freely about the elongated member 120, thereby allowing the physician to twist the elongated member 120 when the distal element 140 is in the extended state.

[0598] In some embodiments, the first stop 134 and the second stop 136 may be spaced apart from corresponding adjacent ends of the connecting assembly 130, for example, as shown in the figure. Figure 4 As shown. In this embodiment, the connecting assembly 130 is freely translatable along the length of the elongated member 120, the length of which is equal to the distance between the first stop 134 and the second stop 136. Therefore, the connecting assembly 130 and the distal element 140 are free to both: rotate about the elongated member 120 and translate along the elongated member.

[0599] In some embodiments, the treatment device 100 may include one or more flexible helical coils wound around one or more portions of the elongated member 120. The coils may be formed from small-diameter wires (e.g., 0.003-inch wires). In some embodiments, the coils may be gold-plated tungsten coils, platinum coils, or other suitable radiopaque materials for facilitating visualization via radiographic imaging. Figure 5AAs shown, the treatment device 100 may include a proximal coil 150 extending proximally to the connecting assembly 130 and / or the distal element 140 along the length of the elongated member 120. The proximal coil 150 may extend over the entire length of the elongated member 120 proximal to the connecting assembly 130, or it may extend only a portion of the length of the elongated member 120 proximal to the connecting assembly 130 (e.g., a short length of the elongated member 120 just proximal to the connecting assembly 130). In some embodiments, the distal end of the proximal coil 150 may be adjacent to or connected to the proximal portion of the connecting assembly 130 and / or the distal element 140. In other embodiments, the distal end of the proximal coil 150 is spaced apart from the proximal end of the connecting assembly 130 and / or the proximal end of the distal element 140.

[0600] like Figure 5B As shown, the treatment device 100 may include a distal coil 160 extending along the length of the elongated member 120 distal to the connecting assembly 130, and the distal coil 160 may extend distally therefrom, passing through some or all of the interior of the distal element 140, and optionally extending distally beyond the distal element 140. The proximal end of the distal coil 160 may abut or be connected to the distal end of the connecting assembly 130. In some embodiments, the proximal end of the distal coil 160 is spaced apart from the distal end of the connecting assembly 130 such that a portion of the elongated member 120 extends distally toward the coil. The distal coil 160 may serve as a distal tip coil of the elongated member 120, providing tip flexibility and navigation. In some such embodiments, the most distal portion of the elongated member 120 may extend into the lumen of the distal coil 160, reaching the distal end of the coil, wherein the elongated member may be attached to the coil end by welding or laser welding.

[0601] In some aspects of the technology, the treatment device 100 may include a proximal coil 150 and a distal coil 160, such as Figure 6 As depicted. In any of the foregoing embodiments, the proximal coil 150, the distal coil 160, or both may be supplemented or replaced by a braid.

[0602] Figure 7 A therapeutic device 100 according to the present invention is shown, the therapeutic device including an elongated shaft 170 and a distal element 140 carried by the elongated shaft 170. The elongated shaft 170 may define an inner cavity configured to slidably receive an elongated member 120 therethrough. The distal end of the elongated shaft 170 may be abutted or end-to-end connected to the proximal end of a connecting assembly 130 and / or the proximal end of the distal element 140. The distal element 140 may be positioned over the elongated member 120. Figure 7In this configuration, the elongated member 120 may optionally slide within the elongated shaft 170, allowing the member and shaft to move independently of each other. For example, the shaft 170 may advance over the elongated member 120, which may function in a manner similar to a guidewire to enhance navigation. Alternatively, when positioned in a tortuous or narrow vascular system, if it is desired to shorten the distal extension of the device 100, the elongated member 120 may be partially or completely retracted into the elongated shaft 170.

[0603] In some embodiments, such as those depicted in Figure 8A, the treatment device 100 may include a slotted wire 180, a distal element 140, and an elongated member 120. Figure 8B A partial view of a slotted wire 180 is shown, the slotted wire 180 may include a groove 182 that spirals (or extends in a straight, non-spiral manner) along the wire body and is configured to receive an elongated member 120 therein. Figure 8C As shown in the cross-sectional view, the elongated member 120 can be positioned within the groove 182. The elongated member 120 can extend distally beyond the distal end of the slotted wire 180, optionally passing through the distal element 140 and extending distally beyond the distal element to its distal end 120b. The distal element 140 can be connected to the slotted wire 180 at or near the distal end of the slotted wire 180. For example, the connecting assembly 130 and / or the distal element 140 itself can be coupled to the outer diameter of the slotted wire 180. Alternatively, the distal end of the slotted wire 180 can be adjacent to or end-to-end connected to the proximal end of the connecting assembly 130 and / or the distal element 140.

[0604] Examples of the distal element selected in this invention

[0605] In some embodiments, the distal element 140 may be made of a plurality of filaments or struts. In some embodiments, the distal element 140 may be woven, braided, molded, or cut from sheet or tube. The filaments or struts may be formed of known flexible materials, including shape memory materials (e.g., nitinol), cobalt-chromium, platinum, stainless steel, other metals, other metal alloys, or combinations thereof. In some embodiments, the filaments may be wires having circular, oval, square, rectangular, or other cross-sectional shapes. Further, the filaments or struts may be configured such that the distal element 140 is self-expanding. In some embodiments, at least a portion of the distal element 140 will tend to elastically present an expanded configuration without a reaction force. In some embodiments, the distal element 140 may consist of a first set of filaments formed of platinum or a platinum alloy (e.g., platinum / 8% tungsten) and a set of filaments formed of cobalt-nickel or cobalt-chromium alloys (e.g., 35N LT). TMThe second set of filaments, available from FortWayne Metals of Fort Wayne, Ind., USA, is used to create the mesh 142. The filaments comprise metal and / or polymer wires. One, some, or all of the filaments 144 forming the mesh 142 may be formed from stretched-filled tubular wires comprising a core material surrounded by an outer material. The core material may be a radiopaque material, such as platinum, and the outer material may be a shape memory alloy, such as nitinol, chromium-cobalt (“CrCo”) alloy, stainless steel alloy, etc.

[0606] The wire filaments can be braided into a final lattice structure. In at least one embodiment, the filaments can be braided using a 1-up-2-down-2 pattern during the braiding or winding of the distal element 140. However, in other embodiments, other braiding methods may be followed without departing from the scope of this disclosure. Such other braiding methods may include 1-up-1-down-1 patterns and 2-up-2-down-2 patterns. In some embodiments, the distal element 140 can be heat-set into a desired shape, for example, by placing the distal element 140 in contact with a molding surface of a molding element that defines all or part of the desired shape of the distal element 140.

[0607] The distal element 140 may include an aperture. In some embodiments, when the distal element 140 is in an expanded state, the aperture may have a size sufficient to allow fluids such as blood, saline, or contrast agents to pass through it. In some embodiments, the distal element 140 may exhibit porosity configured to reduce hemodynamic flow through the distal element 140 to a desired degree. For example, if the distal element 140 is formed of a braid, the aperture size can be controlled by adjusting the number of wires in the braid and the weft and pitch of the braid. As will be understood, and as is known in the art, the porosity of the distal element 140 can be adjusted by longitudinally “packing” the distal element 140 during unfolding. In some embodiments, the distal element 140 may substantially impede flow or may be substantially flow-transparent.

[0608] In some embodiments, the distal element 140, whether or not it comprises multiple filaments, may be coated or surface-treated with one or more compounds such as antithrombotic agents.

[0609] Figure 9A This is a perspective view of the distal element 140 according to several embodiments of the present invention. Figure 9AAs shown, the distal element 140 may include a mesh 142 formed by a plurality of braided filaments 144, which, when the mesh 142 is in an expanded, unconstrained state, have been heat-set to present a spherical shape. Examples of spherical shapes include spheres, elongated spheres (such as...). Figure 9A (as shown), an oblate spheroid, etc. The mesh 142 may have an inner layer and an outer layer, their proximal ends fixed relative to each other at the connecting assembly 130 and meeting distally at a distal fold 146 surrounding the hole 148. The edge of the hole 148 (e.g., 146) may be formed by the mesh 142. In some embodiments, the edge of the hole 148 may be formed by the mesh 142 surrounding the entire circumference of the hole 148.

[0610] The inner and outer layers can be in the distal portion 140b (e.g., as shown in the image). Figure 9A The outer and inner layers are aligned with each other at the points shown to form a curved distal surface. For example, at least at the distal portion 140b of the distal element 140, the inner and outer layers may extend distally and radially inward toward the hole 148. In some embodiments, the outer and / or inner layers extend distally and radially outward from the connecting assembly 130 and then distally and radially inward to the distal end of the distal element 140 (e.g., fold 146). The distal element 140 and / or its layers may be curved along its entire length or may have one or more generally straight portions (e.g., as shown). Figure 9B , 9C (as shown in 9E and 9F and elsewhere herein). In some embodiments, the curved surface transforms into a substantially flat, distal surface surrounding the hole 148. In any case, the proximal portion 140a and distal portion 140b of the mesh 142 can form a generally closed surface. However, unlike at the proximal portion 140a of the mesh 142, portions of the filaments 144 at or near the fold 146 at the distal portion 140b of the mesh 142 can move relative to each other. Thus, the distal portion 140b of the mesh 142 has the characteristics of a closed end and also some characteristics of an open end (such as a conventional support), such as some degrees of freedom of movement of the distal portion of the filaments and an opening through which guidewires, conduits, or other elongated members can pass.

[0611] In some embodiments, each of the plurality of filaments 144 has a first end positioned at a proximal portion 140a of the mesh 142 and a second end also positioned at a proximal portion 140a of the mesh 142. Each filament 144 may extend distally from its corresponding first end along the body of the mesh 142 to a fold 146, fold, and then proximally along the mesh body to its corresponding second end at the proximal portion 140a of the mesh 142. Thus, each of the plurality of filaments has a first length forming an inner layer of the mesh 142, a second length forming an outer layer of the mesh 142, and a first end and a second end fixed at the proximal portion 140a of the mesh 142. In some embodiments, the distal element 140 may comprise a mesh formed of a single layer or a mesh formed of three or more layers.

[0612] Therefore, in some embodiments, the distal element 140 may include a plurality of filaments forming a mesh extending longitudinally along the elongated member 120, the elongated axis 170, and / or the distal coil 160, and the filaments 144 may terminate at only one end of the distal element 140, such as Figure 3-8A At the proximal or distal end shown. The filament may form an opening (e.g., hole 148) at the end opposite to the filament end / terminus. The distal element 140 or its mesh may not be attached to the elongated member 120 and / or the elongated shaft 170 at the end where the opening is located or otherwise at the end opposite to the filament end / terminus (and may slide thereon). The elongated member 120 and / or the elongated shaft 170 may pass through the opening. Thus, under radial compressive force, the opening (e.g., hole 148) allows the distal portion 140b of the distal element 140 to slide and / or move along the elongated member 120, thereby allowing the distal element 140 to compress and elongate radially with minimal resistance. This promotes a self-expanding but also sufficiently flexible and compressible distal element 140 to avoid damage to fragile blood vessels (such as the neurovascular system). Thus, the distal element 140 can sufficiently self-expand to effectively move or capture thrombi without the risk of damaging surrounding blood vessels. In some embodiments, as the distal element 140 extends, the extension of the distal element causes the hole to move along the elongated member 120.

[0613] In some embodiments, the distal surface of the mesh 142 is completely closed (i.e., does not contain holes). In some embodiments, the filament is fixed relative to the elongated member 120 or the elongated shaft 170 at the junction at both the proximal and distal ends of the distal element 140.

[0614] Mesh 142 can be formed from 24, 32, 36, 48, 64, 72, 96, 128, or 144 filaments. Mesh 142 can be formed from a range of filament or wire sizes, such as wires with diameters from about 0.0004 inches to about 0.0020 inches, or from about 0.0009 inches to about 0.0012 inches. In some embodiments, the diameter of each wire or filament in the conductor or filament is approximately 0.0004 inches, approximately 0.0005 inches, approximately 0.0006 inches, approximately 0.0007 inches, approximately 0.0008 inches, approximately 0.0009 inches, approximately 0.001 inches, approximately 0.0011 inches, approximately 0.0012 inches, approximately 0.0013 inches, approximately 0.0014 inches, approximately 0.0015 inches, approximately 0.0016 inches, approximately 0.0017 inches, approximately 0.0018 inches, approximately 0.0019 inches, or approximately 0.0020 inches. In some embodiments, all filaments 144 of the braided mesh 142 may have the same diameter. For example, in some embodiments, all filaments 144 have a diameter of approximately 0.001 inches. In some embodiments, some filaments of the filaments 144 may have different cross-sectional diameters. For example, some of the filaments 144 may have a slightly thicker diameter to impart additional strength to the braided layer. In some embodiments, some of the filaments may have a diameter of about 0.001 inches, and some of the filaments may have a diameter greater than 0.001 inches. Thicker filaments can impart greater strength to the braid without significantly increasing the delivery profile of the device, where thinner wires provide some strength while filling the braid matrix density.

[0615] The distal element 140 can have different shapes and sizes in its extended, unconstrained state. For example, the distal element 140 can have a projectile shape ( Figure 9B ), barrel-shaped, egg-shaped, top-shaped (for example, Figure 9C ), bowl-shaped (e.g., Figure 9D ), disc-shaped (e.g., Figure 9E ), cylindrical or substantially cylindrical (e.g., Figure 9F )wait.

[0616] The distal element 140 of the present invention may include a range of sizes. For example, the maximum cross-sectional dimension of the distal element 140 of the present invention may be at least 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm or 8.00 mm.

[0617] Figures 10A-10E A method for removing clotted material CM from the lumen of a blood vessel V using the treatment system 10 as described above is demonstrated. Figure 10AAs shown, the first catheter 200 can be advanced through the vascular system and positioned within the blood vessel, such that the distal portion of the first catheter 200 is located proximal to the clot material CM. Figure 10B As shown, a second catheter 210 can be advanced through the first catheter 200 until the distal portion of the second catheter 210 is located at or near the clot material CM. The first catheter 200 can be secured in place using a balloon 1001 or other expandable member configured to engage the vessel wall. Next, a third catheter 220 can be advanced through the second catheter 210 such that the distal portion of the third catheter 220 is positioned at or near the clot material CM. In some embodiments, the third catheter 220 can pass through the clot material CM and be positioned such that the distal end 221 of the third catheter 220 is located distal to the clot material CM. Then, a distal element 140 can be advanced through the third catheter 220 in a low-profile configuration until the distal end of the distal element 140 is located at or near the distal end of the third catheter 220.

[0618] like Figure 10C As shown, the third catheter 220 can be withdrawn proximally relative to the distal element 140 to release the distal element 140, thereby allowing the distal element 140 to self-expand at least partially away from the clot material CM. In some embodiments, the distal element 140 can expand distally to the clot material CM such that no portion of the distal element 140 engages the clot material CM during its expansion toward the vessel wall. In some embodiments, the distal element 140 is configured to expand to contact the wall of the vessel V, or the distal element 140 can expand to a diameter smaller than the diameter of the vessel lumen such that the distal element 140 does not engage the entire circumference of the vessel wall.

[0619] like Figure 10D As shown, aspiration can be applied to the treatment site via the second catheter 210. For example, after the distal element 140 is deployed, the third catheter 220 can be retracted and removed from the lumen of the second catheter 210. The treatment site can then be aspirated through the second catheter 210, for example, via an aspiration source, such as a pump or syringe, coupled to the proximal portion of the second catheter 210.

[0620] In some embodiments, suction is applied as the distal element 140 is retracted into the second conduit 210. During retraction, the proximal side of the distal element 140 may engage with and push the clotted material CM proximally toward the distal end of the second conduit 210. Suction at this stage and / or the presence of the distal element 140 distal to the clotted material CM helps to hold the clotted material CM within the second conduit 210 and prevents any displaced portion of the clotted material CM from escaping from the second conduit 210 and being released back into the container V.

[0621] refer to Figure 10EWhen the distal element 140 engages with the clot material CM, the clot material CM can be removed. For example, if the clot material CM is grasped and / or thus pushed, the distal element 140 can be retracted proximally (e.g., together with the second catheter 210, and optionally the third catheter 220). The second catheter 210, the distal element 140, and the associated clot material CM can then optionally be withdrawn from the patient through one or more larger peripheral catheters such as the first catheter 200.

[0622] exist Figure 10E In this process, the clot material CM has been moved to at least partially enter the second catheter 210. In some embodiments, the clot material CM can substantially block the lumen of the second catheter 210, thereby creating a "corking" effect that may be noticeable to the clinician supplying negative pressure to the second catheter 210. Once the second catheter 210 is corked with the clot material CM, it becomes increasingly difficult to supply sustained negative pressure to the second catheter 210. This corking effect can indicate to the clinician that the clot material CM has been engaged with the second catheter 210 and that the clot material CM and the second catheter 210 can retract through the vessel V and enter the first catheter 200 or other peripheral catheters.

[0623] III. Examples of treatment systems employing interventional elements having the distal elements disclosed herein.

[0624] Figure 11 A view is shown of a treatment system 11 for removing material from a human body cavity according to one or more embodiments of the present invention. Several features of the treatment system 11 may be similar to... Figure 1 The treatment system 10 shown and described elsewhere in this document. Figure 11 As shown, the treatment system 11 includes a treatment device 101 having a proximal portion 101a and a distal portion 101b. The proximal portion is configured for external positioning during treatment, and the distal portion is configured for intravascular positioning at or near a treatment site within a blood vessel (e.g., an intracranial vessel) at or near a thrombus. The treatment system 11 may include a handle 16 at the proximal portion 101a, a distal element 140, an interventional element 300, and a plurality of elongated shafts or members extending between the proximal and distal portions 101a and 101b. For example, in some embodiments, such as Figure 11In the illustrated embodiment, the treatment system 11 may include one, some, or all of the following: a first catheter 200 (e.g., a guiding catheter or a balloon guiding catheter), a second catheter 210 (e.g., a distal access catheter or a suction catheter), the second catheter being configured to be slidably disposed within the lumen of the first catheter 200, and a third catheter 220 (e.g., a microcatheter), the third catheter being configured to be slidably disposed within the lumen of the second catheter 210. In some embodiments, the first catheter 200 is coupled to a handle 16, the handle providing proximal access to the second catheter 210, the third catheter 220, the distal element 140, and / or the interventional element 300. Each of the distal element 140 and the interventional element 300 may be configured to be slidably disposed within the lumen of the first catheter 200, the second catheter 210, and / or the third catheter 220. References herein Figure 1 Any embodiment or version of the components described above in the treatment system 10 may also be used in conjunction with the treatment system 11.

[0625] In some embodiments, the treatment system 11 includes an inhalation source 25 (e.g., a syringe, pump, etc.) configured to be fluidly coupled (e.g., via connector 23) to a proximal portion of one or more of the first catheter 200, second catheter 210, and / or third catheter 220 to apply negative pressure therethrough. In some embodiments, the treatment system 11 includes a fluid source 27 (e.g., a fluid reservoir, syringe, pump, etc.) configured to be fluidly coupled (e.g., via connector 23) to a proximal portion of one or more of the first catheter 200, second catheter 210, and / or third catheter 220 to supply fluid (e.g., saline, contrast agent, drug such as a thrombolytic agent, etc.) to the treatment site.

[0626] According to some embodiments, such as Figure 11 As shown, each of catheters 200, 210, and 220 can be formed as a generally tubular member extending along and around a central axis and terminating at a corresponding distal end. According to some embodiments, the third catheter 220 is typically configured to follow a conventional guidewire in the cervical anatomy and enter a cerebral blood vessel associated with the brain, and can also be selected according to several standard designs commonly available. Thus, the length of the third catheter 2202 can be at least 125 cm, and more specifically, can be between about 125 cm and about 175 cm. Other designs and sizes are conceivable.

[0627] The second catheter 210 can be sized and configured to slidably accommodate the third catheter 220 passing through it. As described above, the second catheter 210 can be coupled at its proximal portion to an inhalation source 25, such as a pump or syringe, to supply negative pressure to the treatment site. The first catheter 200 can be sized and configured to slidably accommodate both the second catheter 210 and the third catheter 220 passing through it. In some embodiments, the first catheter 200 is a balloon-guided catheter having an inflatable balloon or other expandable component that can be used to anchor the first catheter 200 relative to a peripheral blood vessel. As previously discussed... Figures 10A-10E More specifically, in operation, firstly, a first catheter 200 may be advanced through the blood vessel, and then a balloon may be expanded to anchor the first catheter 200 in place and / or block blood flow from a region proximal to the balloon. Next, a second catheter 210 may be advanced through the first catheter 200 until its distal end extends distally beyond the distal end of the first catheter 200. The second catheter 210 may be positioned such that its distal end is adjacent to the treatment site (e.g., the site of a blood clot within the blood vessel). Then, a third catheter 220 may be advanced through the second catheter 210 until its distal end extends distally beyond the distal end of the second catheter 210.

[0628] According to some embodiments, the bodies of conduits 200, 210, and 220 can be made of various thermoplastics, such as polytetrafluoroethylene (PTFE) or... Materials such as fluorinated ethylene propylene (FEP), high-density polyethylene (HDPE), and polyether ether ketone (PEEK) can be optionally lined with a hydrophilic material, such as polyvinylpyrrolidone (PVP), or some other plastic coating, on the inner or adjacent surfaces of the conduit. Alternatively, any surface can be coated with various combinations of different materials, depending on the desired result. Any one or more conduits 200, 210, and 220 can incorporate reinforcing structures in their construction, such as layering between an inner lubricating liner and an outer polymer jacket. Such reinforcing structures can be metallic and / or polymeric and include tubular braids, coils, thiourea tubes (e.g., helically cut or slotted thiourea tubes), or combinations thereof. Suitable metals for constructing reinforcing structures include, but are not limited to, stainless steel, nitinol, and cobalt-chromium alloys.

[0629] Figure 12 yes Figure 11 A side view of an embodiment of the system 11 and treatment device 101 shown. The system 11 and / or treatment device 101 includes a distal element 140, an interventional element 300, and an elongated member 120 extending from the body of the first catheter 200 and passing through at least a portion of the interventional element 300 and the distal element 140. Figure 12As shown, the distal element 140 is located distal to the intervention element 300 and spaced apart from the distal portion 120b (e.g., distal tip or end) of the elongated member 120. In some embodiments, the distal element 140 may be located at the distal portion 120b or the distal end of the elongated member 120. Instead of the foregoing, the distal element 140 may be located proximal to the intervention element 300 in some embodiments.

[0630] like Figure 12 As shown, the distal element 140 includes a proximal portion 140a, a distal portion 140b, and a connecting assembly 130 disposed on the elongated member 120. As described in more detail elsewhere herein, the distal element 140 (e.g., the proximal portion of the distal element 140) can be slidably coupled, rotatably coupled, or fixedly coupled to the elongated member 120, for example, via the connecting assembly 130. Figure 12 In the illustrated embodiment, the distal element 140 is fixedly coupled to the elongated member 120 via a connecting assembly 130, such that the distal element 140 cannot move longitudinally relative to the elongated member 120. In such embodiments, the distal element 140 may be rotatably and / or slidably coupled to the elongated member 120.

[0631] The distal element 140 may include an expandable mesh having a low-profile state or configuration for delivery to deployment positioning and an expanded state or configuration in which at least a portion of the mesh is configured to juxtapose with the vessel wall. The distal element 140 is configured to extend along the intravascular path to the desired location at the treatment site and to contact the vessel wall at the treatment site to anchor and / or stabilize any portion of the elongated member 120 or the treatment system 11 at the desired location. As previously described, the distal element 140 may also be configured to facilitate thrombus removal from the treatment site. (Refer to above) Figure 1-9F Any of the distal elements in the disclosed distal element 140 can be used in this document regarding Figure 11-17 The disclosed treatment device 101.

[0632] like Figure 12 As shown, the interventional element 300 includes a proximal portion 300a, a distal portion 300b, and a connecting assembly 302 at the proximal portion 300a. As described in more detail below, the interventional element 300 (e.g., the proximal portion 300a of the interventional element 300) can be slidably coupled, rotatably coupled, or fixedly coupled to the elongated member 120, for example, via the connecting assembly 302. Figure 12 As shown, the interventional element 300 is fixedly coupled to the elongated member 120 via a connecting assembly 302, such that the interventional element 300 cannot move longitudinally relative to the elongated member 120. In such embodiments, the interventional element 300 may be rotatably coupled to the elongated member 120.

[0633] The interventional element 300 further includes an open unit frame or strut and a body of unit extending distally from the connecting assembly 302. In some embodiments, the distal portion 300b of the interventional element 300 may be generally tubular (e.g., cylindrical), and the proximal portion 300a of the interventional element 300 may taper proximally toward the connecting assembly 302. In some embodiments, the distal portion 300b (e.g., distal end) coincides with the distal portion 120b of the elongated member 120 or the treatment device 101. The interventional element 300 has a low-profile configuration (not shown) when confined within the first catheter 200 and in extended configurations for securing and / or engaging clot material or other obstructions within a vascular lumen (e.g., a cerebral vascular lumen) and / or for restoring blood flow within a vessel.

[0634] In some embodiments, the interventional element 300 is a mesh structure formed of a hyperelastic material (e.g., nitinol) or other elastic or self-expanding material, configured to self-expand upon release from the delivery catheter. For example, in some embodiments, the interventional element 300 may be a stent and / or a stent remover, such as Medtronic's Solitaire. TM Vascular reconstruction devices, Stryker Neurovascular intervention ProVue TM A stent remover or other suitable device. In other embodiments, the interventional element 300 may comprise a plurality of braided wires. Examples of suitable interventional elements 300 include those disclosed in the following: U.S. Patent No. 7,300,458, filed November 5, 2007; U.S. Patent No. 8,940,003, filed November 22, 2010; U.S. Patent No. 9,039,749, filed October 1, 2010; U.S. Patent No. 8,066,757, filed December 28, 2010; and U.S. Publication No. 2018 / 0325534, filed May 12, 2017, each of which is incorporated herein by reference in its entirety.

[0635] Figure 13-17 yes Figure 12 The diagram shows a side view of an embodiment of the system 11 and treatment device 101, wherein the distal element 140 and / or interventional element 300 are movable relative to each other and / or the elongated member 120. Unless otherwise stated, Figure 13-17In any of the embodiments shown, each of the distal element 140 and / or interventional element 300 may be rotatably and / or slidably coupled to the elongated member 120 (or fixedly mounted without rotation or sliding). Therefore, any rotation of the distal element 140 and / or interventional element 300 that occurs during the movement of the treatment device 101 through a catheter in a tortuous vascular system will not transfer to the elongated member 120 (or only a reduced portion of such rotation will transfer to the elongated member). By reducing or preventing rotation or “rolling up” of the elongated member 120, the rotatable coupling feature helps reduce the force required to move the treatment device 101 through the catheter, and any “whipping” effect that may occur when the distal element 140 and / or interventional element 300 suddenly reverses rotation upon exiting the catheter. Additionally, this capability allows the elongated member 120 to rotate to facilitate pointing the distal end 120b of the elongated member 120 in a desired direction of travel (e.g., at a vascular junction or bend) without correspondingly rotating the interventional element 300 and / or distal element 140 within the vessel or catheter. In cases where the elongated member 120 cannot be rotated relative to elements 300, 140, it is necessary to rotate the entire system 11 to navigate it as needed, which may be physically difficult if elements 300, 140 are compressed within the catheter or if the elements expand within the blood vessel.

[0636] exist Figure 13-17 In some embodiments, where one or both of the distal element 140 and / or interventional element 300 are not fixedly coupled to the elongated member 120 (e.g., rotatably and / or slidably coupled to the elongated member 120), the system 11 and treatment device 101 may include a second elongated member 120. In such embodiments, the distal element 140 and interventional element 300 may be disposed on separate elongated members 120 (e.g., corresponding first and second elongated members), such that the movement of one of the distal element 140 or interventional element 300 is individually controlled by the movement of the corresponding elongated member 120 in relation to the movement of the other of the distal element 140 and interventional element 300.

[0637] Figure 13This is a side view of an embodiment of system 11 and treatment device 101, wherein an interventional element 300 is slidably coupled to an elongated member 120 via a slidable connection assembly 302 positioned on the elongated member 120. At least one stop 304 is fixedly coupled to the elongated member 120 proximally of the interventional element 300 and / or the connection assembly 302. In such embodiments, the interventional element 300 can move longitudinally relative to the elongated member 120 and / or the distal element 140 between the stop 304 and the distal element 140. The stop 304 can comprise any shape and / or size that prevents or inhibits movement of the interventional element 300 proximally. In some embodiments, the stop 304 can be integrally formed with the elongated member 120 or formed as a separate component. The distal element 140 can be fixedly and / or slidably / rotatably coupled to the elongated member 120 via the connection assembly 130.

[0638] Figure 13 The system 11 and treatment device 101 may optionally include a stop 306 (e.g., a second stop) fixedly coupled to the elongated member 120 between the interventional element 300 (e.g., its connection assembly 302) and the distal element 140. In such embodiments, the interventional element 300 may be slidably / rotatably coupled to the elongated member 120, for example, via the connection assembly 302, and may be longitudinally movable relative to the elongated member 120 between stops 304 and 306.

[0639] Figure 14 This is a side view of another embodiment of system 11 and treatment device 101, wherein the distal element 140 is slidably coupled to the elongated member 120 via a slidable connection assembly 130 positioned on the elongated member 120. At least one stop 308 is fixedly coupled to the elongated member 120 distal to the distal element 140. In such embodiments, the distal element 140 can move longitudinally relative to the elongated member 120 between the stop 308 and the interventional element 300. The stop 308 may comprise any shape and / or size that inhibits movement of the distal element 140 distally thereto. In some embodiments, the stop 308 may be integrally formed with the elongated member 120 or formed as a separate component. The interventional element 300 may be fixedly and / or rotatably coupled to the elongated member 120, for example, via a connection assembly 302.

[0640] Figure 14The system 11 and / or treatment device 101 may optionally include a stop 310 (e.g., a second stop) fixedly coupled to the elongated member 120 between the interventional element 300 (e.g., the distal portion 300b of the interventional element 300) and a connection assembly 130 of the distal element 140. In such embodiments, the distal element 140 may be slidably coupled to the elongated member 120, for example, via the connection assembly 130, and may be longitudinally movable relative to the elongated member 120 between stops 308 and 310.

[0641] Figure 15 This is a side view of another embodiment of system 11 and treatment device 101, wherein the distal element 140 and interventional element 300 are each slidably coupled to the elongated member 120 via their respective slidable connection assemblies 130, 302 positioned on the elongated member 120. A stop 304 (e.g., a first stop) may be fixedly coupled to the elongated member 120 proximally to the interventional element 300, a stop 308 (e.g., a second stop) may be fixedly coupled to the elongated member 120 distally to the distal element 140, and a stop 310 (e.g., a third stop) may be fixedly coupled to the elongated member 120 between the interventional element 300 (e.g., the distal portion 300b of the interventional element 300) and the distal element 140. In such embodiments, (a) the distal element 140 may be slidably coupled to the elongated member 120, for example, via a connecting assembly 130, and is longitudinally movable relative to the elongated member 120 between stops 308 and 310, and (b) the intervention element 300 may be slidably coupled to the elongated member 120, for example, via a connecting assembly 302, and is longitudinally movable relative to the elongated member 120 between stops 304 and 310.

[0642] Figure 16 This is a side view of another embodiment of system 11 and treatment device 101, wherein the distal element 140 is slidably coupled to the elongated member 120. (As shown) Figure 14As shown, system 11 and / or treatment device 101 includes an interventional element 300 and a distal element 140 disposed on an elongated member 120, a stop 308 fixedly coupled to the distal end of the elongated member 120, and a tube 312 disposed on the elongated member 120 and coupled to the interventional element 300 (e.g., the proximal portion 300a of the interventional element 300). In some embodiments, the elongated member 120 is longitudinally movable within the lumen of the tube 312. Thus, the elongated member 120 and the distal element 140 can be slidably moved together relative to the interventional element 300 and the tube 312. Alternatively or additionally, the distal element 140 can be slidably coupled to the elongated member 120, for example, via a connecting assembly 130, such that the distal element 140 is longitudinally movable relative to the elongated member 120 at least between the stop 308 and the interventional element 300. The tube 312 may extend to the proximal end or portion 100a of the treatment device 100 (and / or to the proximal end or portion 10a of the treatment system 10), for example, to allow the user to manipulate the tube and elongated member 120 independently from each other. Therefore, this configuration allows some slidability of the distal element 140 relative to the elongated member 120, and also allows the interventional element 300 and the distal element 140 to move independently slidably and / or rotatably from each other. In some cases, it may be useful to controllably change the longitudinal distance between the distal portion 300b (e.g., distal end) of the interventional element 300 and the proximal portion 140a (e.g., proximal end) of the distal element 140. For example, after deploying the interventional element 300 into or near a thrombus, the distal element 140 can be slidably retracted or advanced relative to the interventional element 300 and / or the thrombus, as needed by the clinician. Among other advantages, this capability also allows for the adjustability of the system 100 to adapt to different vascular systems in different patients.

[0643] like Figure 16 As shown, in some embodiments, system 11 and / or treatment device 101 may optionally include a stop 310 (e.g., a second stop) fixedly coupled to the elongated member 120 between the interventional element 300 (e.g., the distal portion 300b of the interventional element 300) and the distal element 140. In such embodiments, the distal element 140 may be slidably coupled to the elongated member 120, for example, via a connecting assembly 130, and may be longitudinally movable relative to the elongated member 120 between stops 308 and 310.

[0644] Figure 17 This is a side view of another embodiment of system 11 and treatment device 101. (See diagram below.) Figure 17As shown, system 11 and / or treatment device 101 includes an interventional element 300, a distal element 140 (e.g., a first distal element) located distal to the interventional element 300, and a distal element 141 (e.g., a second distal element) located proximal to the interventional element 300. These components are slidably coupled to the elongated member 120 via their respective connecting assemblies 302, 130. System 11 and treatment device 101 may further include a stop 308 (e.g., a first stop) fixedly coupled distally to the elongated member 120 of the distal element 140, a stop 314 (e.g., a second stop) fixedly coupled proximally to the elongated member 120 of the distal element 141, and a stop 310 (e.g., a third stop) fixedly coupled between the distal element 140 and the interventional element 300 (e.g., the distal portion 300b of the interventional element 300) and the elongated member 120. In such embodiments, one or more of the distal element 140, distal element 141, and intervention element 300 may be rotatably and / or slidably coupled to the elongated member 120. For example, only distal element 140, only intervention element 300, only distal element 141, both distal element 140 and intervention element 300, both distal element 141 and intervention element 300, both distal element 140 and 141, or all of distal element 140, intervention element 300, and distal element 141 may be rotatably and / or slidably coupled to the elongated member. For example, as... Figure 17 As shown: (a) the distal element 140 can be slidably coupled to the elongated member 120, for example, via the connecting assembly 130, and is longitudinally movable relative to the elongated member 120 between the stops 308 and 310; (b) the intervention element 300 can be slidably coupled to the elongated member 120, for example, via the connecting assembly 302, and is longitudinally movable relative to the elongated member 120 between the distal element 141 and the stop 310; and (c) the distal element 141 can be slidably coupled to the elongated member 120, for example, via the connecting assembly 130, and is longitudinally movable relative to the elongated member 120 between the stop 314 and the intervention element 300.

[0645] In another embodiment of system 11 and treatment device 101, the distal element 140 may be omitted and the interventional element 300 is rotatably (or rotatably and slidably) mounted on the elongated member 120. This embodiment will provide the advantage of allowing access to the treatment area via the rotatable distal portion 120b of the elongated member 120 and the third catheter 220 (together with and when positioned within the distal portion of the third catheter 220).

[0646] Figure 13-17The illustrated embodiment of the treatment device 101 offers a useful advantage by allowing relative movement of the device's moving components during treatment, which helps accommodate variations in the vascular system of different patients. Thus, considering the vascular system of the specific patient being treated, the physician is given some freedom to position any distal extensions of the interventional element 300, distal element 140, and / or elongated member 120 to ensure they will deploy most effectively and / or safely. Similarly, these embodiments may allow the physician to adjust (e.g., shorten) the effective length of any distal extension of the elongated member and avoid unnecessarily jeopardizing the vascular system distal to the treatment site.

[0647] Figures 18A-18D A method for removing clotted material CM from the lumen of a blood vessel V using a treatment system 11, according to an embodiment of the present invention, is illustrated. Similar to the above description... Figure 10A and 10B The described method allows the first catheter 200 to be advanced through the vascular system and positioned within a blood vessel V, such that the distal portion of the first catheter 200 is proximal to the clot material CM (e.g., as shown in the image). Figure 10A (As shown). A second catheter 210 can be advanced through the first catheter 200 until the distal portion of the second catheter 210 is located at or near the clot material CM. In some embodiments, the first catheter 200 can be secured in place using a balloon 1001 or other expandable member configured to engage the vessel wall. Next, a third catheter 220 can be advanced through the second catheter 210 such that the distal portion of the third catheter 220 is positioned at or near the clot material CM. In some embodiments, the third catheter 220 can be positioned such that its distal end 221 is distal to the clot material CM. Figure 18A As shown, the interventional element 300 and / or the distal element 140 can be advanced through the third catheter 220 in a low-profile configuration until the distal end of the distal element 140 is located at or near the distal end of the third catheter 220. In some embodiments, the interventional element 300 and the distal element 140 can be delivered together or separately to the vessel V via the same delivery or via separate delivery. In such embodiments where the interventional element 300 and the distal element 140 are delivered separately, the distal element is deployed distal to the clot material CM, for example from the third catheter 220 via a first delivery, and then the interventional element 300 is deployed distal to or in the clot material CM, for example from the third catheter 220 via a second delivery.

[0648] like Figure 18AAs shown, the third catheter 220 can be retracted proximally relative to the distal element 140 and the interventional element 300 to release the distal element 140 and the interventional element 300. This allows the distal element 140 to self-extend to juxtapose with the vessel wall distal to the clot material CM and the interventional element 300, and allows the interventional element 300 to self-extend within the clot material CM. As the interventional element 300 extends, it engages and / or secures the surrounding clot material CM, and in some embodiments, blood flow through the clot material CM can be restored or improved by pushing aside a blood flow path that may extend through the extended distal element 140. In some embodiments, both the distal element 140 and the interventional element 300 may extend distal to the clot material CM such that neither the distal element 140 nor any portion of the interventional element 300 engages the clot material CM during the process of extending toward the vessel wall. In some embodiments, one or both of the distal element 140 and the interventional element 300 are configured to extend to contact the wall of the blood vessel V, or the distal element 140 and / or the interventional element 300 may extend to a diameter smaller than the diameter of the blood vessel lumen, such that the distal element 140 and / or the interventional element 300 do not engage the entire circumference of the blood vessel wall.

[0649] Once the interventional element 300 has extended to engage with the clot material CM (and the distal element 140 has extended at a location away from the clot material CM), the interventional element 300 can grasp the clot material CM by means of its ability to mechanically interlock with it. The distally positioned distal element 140 can block, collect, or otherwise engage with any portion of the clot material CM migrating downstream from the interventional element 300, thereby reducing the risk of additional vascular occlusion in more difficult-to-reach distal regions of the brain.

[0650] Now for reference Figure 18B In some embodiments, aspiration can be applied to the treatment site, for example, through the second catheter 210. For example, after the distal element 140 and interventional element 300 have deployed, the third catheter 220 can be retracted and removed from the lumen of the second catheter 210. The treatment site can then be aspirated through the second catheter 210, for example, through an aspiration source, such as a pump or syringe, coupled to the proximal portion of the second catheter 210. In some embodiments, aspiration is applied while the interventional element 300 is retracted into the second catheter 210. Aspiration at this stage can help secure the clot material CM within the second catheter 210 and prevent any displaced portions of the clot material CM from escaping from the second catheter 210 and being released back into the vessel V. In various embodiments, the treatment site can be aspirated continuously before, during, or after the interventional element 300 is retracted into the second catheter 210.

[0651] refer to Figure 18Cand 18D When the interventional element 300 engages with the clot material CM, the clot material CM can be removed. For example, with the clot material CM held, the interventional element 300 and the distally positioned distal element 140 can be retracted proximally (e.g., together with the second catheter 210, and optionally together with the first catheter 200, or into the second catheter 210). When the interventional element 300 and the clot material CM are retracted into the second catheter 210, the distal element 140 can help push the clot material CM into the lumen of the second catheter 210 and subsequently aspirate it into the catheter, or maintain an extended configuration, with the distal side of the catheter 210 acting as a filter / pusher. Figure 18D The second catheter 210, distal element 140, interventional element 300, and the conjoined clot material CM can then optionally be withdrawn from the treatment site via one or more larger peripheral catheters. During this withdrawal, any portion of the clot material CM removed from the interventional element 300 can be captured by the distal element 140, thereby preventing such clot material CM fragments from migrating downstream. Figure 18D As shown, retraction may optionally continue until the distal element 140 is adjacent to the distal end of the second catheter 210 and is retracted into the lumen of the second catheter 210. In some embodiments, the interventional element 300 and the clot material CM form a removable, integrated thrombus device clump.

[0652] In some embodiments, the distal element 140 can be used to extend other expandable devices, such as diverters or supports. In some embodiments, all or part of the distal element 140 can be covered with a polymer and used for proximal flow control. If the distal half of the distal element 140 is covered, it can be used like a sail for flow guidance and navigation. This can be helpful for navigating winding arches or other bifurcations.

[0653] IV. Example of an electro-enhanced therapy device and its usage

[0654] Figure 19A A view of an electro-enhanced therapy system 12 according to one or more embodiments of the present invention is shown. Several features of the therapy system 12 may be similar to... Figure 1 The features of the treatment system 10 shown and described above. For example, catheters 200, 210, 220, elongated member 120, and distal element 140 may include those described above. Figure 1-1 Some or all of the features described in 8E. For example... Figure 19AAs shown, the treatment system 12 may include a current generator 20 and a treatment device 102 having a proximal portion 102a and a distal portion 102b. The proximal portion is configured to be coupled to the current generator 20, and the distal portion is configured to be positioned intravascularly at a treatment site at or near a thrombus (e.g., an intracranial vessel). The treatment device 102 includes a distal element 140 at the distal portion 102b, a handle 16 at the proximal portion 102a, and a plurality of coaxially arranged catheters 200, 210, and 220, as previously described. The current generator 20 may be coupled to the proximal portion of one or more of an elongated member 120, a third catheter 220, a second catheter 210, and / or a first catheter 200 to provide a charged environment at the distal portion 102b of the treatment device 102, as described in more detail below. References Figure 1 The treatment system 10 or Figure 11 Any embodiment or version of the components described above in the treatment system 11 may also be used in conjunction with the treatment system 12.

[0655] As previously described herein, the distal element 140 may include an expandable mesh having a low-profile state for delivery to deployment positioning and an expanded state in which at least a portion of the mesh is configured to juxtapose with the vessel wall. The distal element 140 is configured to expand at the treatment site to contact the vessel to anchor and / or stabilize any portion of the elongated member 120 or the treatment system 12 at the desired location. As detailed elsewhere herein, the distal element 140 may also be configured to facilitate thrombus removal from the treatment site. In some embodiments, the distal element 140 may be a woven mesh having a tapered or closed distal and / or proximal end, and a central portion having a radial dimension larger than the ends.

[0656] In some embodiments, the treatment system 12 includes an inhalation source 25 (e.g., a syringe, pump, etc.) configured to be fluidly coupled (e.g., via connector 23) to a proximal portion of one or more catheters 200, 210, 220 to apply negative pressure therethrough. In some embodiments, the treatment system 12 includes a fluid source 27 (e.g., a fluid reservoir, syringe, pump, etc.) configured to be fluidly coupled (e.g., via connector 23) to a proximal portion of one or more catheters 200, 210, 220 to supply fluid (e.g., saline, contrast agent, medication such as a thrombolytic agent, etc.) to the treatment site.

[0657] According to some embodiments, the current generator 20 can be configured to output a medically useful current. Figure 19B and 19C This is a schematic diagram of different embodiments of the current generator 20. (Reference) Figure 19B The current generator 20 may include a power supply 1922, a first terminal 1924, a second terminal 1926, and a controller 1928. The controller 1928 includes a processor 1930 coupled to a memory 1932 storing instructions (e.g., in the form of processor- or controller-executable software, code, or program instructions) for causing the power supply 1922 to deliver current according to certain parameters provided by software, code, etc. The power supply 1922 of the current generator 20 may include a DC power supply, an AC power supply, and / or a power supply switchable between DC and AC. The current generator 20 may include a suitable controller for controlling various parameters (such as intensity, amplitude, duration, frequency, duty cycle, and polarity) of the energy output by the power supply or generator. For example, the current generator 20 may provide a voltage of about 2 volts to about 28 volts and a current of about 0.5 mA to about 20 mA.

[0658] Figure 19C Another embodiment of the current generator 20 is shown, in which Figure 19B The controller 1928 is replaced by a drive circuit system 1934. In this embodiment, the current generator 20 may include hardwired circuitry elements that provide the desired waveform delivery, instead of... Figure 19B A software-based generator. The drive circuit system 1934 may include, for example, analog circuit elements (e.g., resistors, diodes, switches, etc.) configured to cause the power supply 1922 to deliver current through the first terminal 1924 and the second terminal 1926 according to desired parameters. For example, the drive circuit system 1934 may be configured to cause the power supply 1922 to deliver a periodic waveform through the first terminal 1924 and the second terminal 1926.

[0659] As described above, the current generator 20 can be coupled to the proximal portion of the elongated member 120 and / or the conduits 200, 210, 220. Figure 19A One or more catheters in the proximal portion are used to supply current to the distal element 140. For example, in some embodiments, two terminals 1924, 1926 of the current generator 20 are coupled to the elongated member 120, such that the elongated member 120 acts as a delivery electrode or conductive path (i.e., transferring current from the current generator 20 to the treatment site) and a return electrode or conductive path (i.e., transferring current from the treatment site back to the current generator 20) (see below). Figure 20B (More detailed description) Both. In other embodiments, the return electrode may be separable from the elongated member 120. For example, the return electrode may be carried by one or more of the conduits 200, 210, 220. In some embodiments, the return electrode may be carried by one or more optional external electrodes 1929 ( Figure 19AThis can be provided, such as by a needle piercing the patient or by a grounding pad applied to the patient's skin. In some embodiments, the return electrode may be an insulated wire with an exposed conductive portion at its distal end.

[0660] Figure 20A yes Figure 19A The diagram shows a portion of the system 12 and treatment device 102. System 12 may include multiple (e.g., two or more) distinct conductive paths or channels for transmitting current along system 12. The distal element 140 may serve as an electrode (e.g., a delivery electrode) electrically connected to a conductive path integrated into the elongated member 120. Another conductive path in the system 12 may be electrically connected to another electrode (e.g., a return electrode). Various embodiments of the elongated member 120 may be sized for insertion into a human body cavity (e.g., a blood vessel) and may be configured to unfold, push, and pull devices such as the distal element 140 along the human body cavity.

[0661] As described above, the distal element 140 (or a portion thereof) can be used as a delivery electrode and can be electrically coupled to the positive terminal of the current generator 20. Figure 19A ).like Figure 20B As shown, in some embodiments, the elongated member 120 may include an elongated conductive shaft 2011 (e.g., a wire pusher) extending along the length of the elongated member 120. The shaft 2011 may be connected to the current generator 20 at its proximal end. Figure 19A The shaft 2011 is electrically connected to the current generator 20 and to the distal element 140 at its distal end. The shaft 2011 may be insulated along at least a portion of its length, wherein the exposed portion allows electrical connection to the current generator 20 and the distal element 140.

[0662] In different embodiments, one or more return electrodes can be configured in various ways. For example, in some embodiments, the return electrode is an external electrode 29. Figure 19A Such as a needle or grounding pad applied to the patient's skin. The needle or grounding pad can be coupled to the current generator 20 via one or more leads to complete the circuit. In some embodiments, the return electrode is carried by a peripheral conduit (e.g., a third conduit 220, a second conduit 210, and / or a first conduit 200), as described in more detail elsewhere herein.

[0663] According to some embodiments, such as Figure 20AAs shown, catheters 200, 210, and 220 can each be formed as generally tubular members extending along and around a central axis and terminating at corresponding distal ends 2001, 2002, and 2003. According to some embodiments, the first catheter 200 is typically configured to follow a conventional guidewire in the cervical anatomy and enter a cerebral blood vessel associated with the brain, and can also be selected according to several standard designs commonly available. Thus, the length of the first catheter 200 can be at least 125 cm, and more specifically, can be between about 125 cm and about 175 cm. Other designs and sizes are conceivable.

[0664] The size of the second catheter 210 can be set and configured to slidably extend through the first catheter 200. As described above, the second catheter 210 can be coupled to the inhalation source 25 at its proximal portion. Figure 19A A third catheter 220, such as a pump or syringe, is used to supply negative pressure to the treatment site. The size of the third catheter 220 can be set and configured to slidably extend through the second catheter 210 and the first catheter 200. In some embodiments, the first catheter 200 is a balloon-guided catheter having an inflatable balloon or other expandable component that can be used to anchor the first catheter 200 relative to a surrounding blood vessel. As described in more detail below, in operation, the first catheter 200 can first be advanced through the blood vessel and then the balloon can be expanded to anchor the first catheter 200 in place and / or block blood flow from a region proximal to the balloon. Next, the second catheter 210 can be advanced through the first catheter 200 until its distal end 2002 extends distally beyond the distal end 2003 of the first catheter 200. The second catheter 210 can be positioned such that its distal end 2002 is adjacent to the treatment site (e.g., the site of a blood clot within the blood vessel). The third catheter 220 can then be advanced through the second catheter 210 until its distal end 2001 extends distally beyond the distal end 2002 of the second catheter 210. The distal element 140 can then be advanced through the third catheter 220 via the elongated member 120 for delivery to the treatment site.

[0665] According to some embodiments, electrode 2004 is disposed at the distal region of third conduit 220. Electrode 2004 may be formed in an annular loop that extends circumferentially around the central axis of third conduit 220. Alternatively or in combination, electrode 2004 may extend less circumferentially around third conduit 220. For example, electrode 2004 may be positioned entirely on one radial side of the central axis. By further examples, electrode 2004 may provide multiple discrete, discontinuous electrode portions around the central axis. These portions of electrode 2004 may be electrically connected to a common conductive path to collectively act as a single electrode, or to multiple separate such paths to allow these portions to function independently when needed. Electrode 2004 may be a strip, wire, or coil embedded in the wall of third conduit 220. According to some embodiments, electrode 2004 may be longitudinally separated from the distal end 2001 of third conduit 220 by a non-conductive portion of third conduit 220. Alternatively, the distal portion of electrode 2004 may extend to the distal end 2001 of third conduit 220, such that electrode 2004 forms part of distal end 2001. According to some embodiments, the inner surface of electrode 2004 may be flush with the inner surface of third conduit 220. Alternatively or in combination, the inner surface of electrode 2004 may extend more radially inward relative to the inner surface of third conduit 220 (e.g., providing a “step”). Alternatively or in combination, the inner surface of electrode 2004 may extend less radially inward relative to the inner surface of third conduit 220 (e.g., recessed into a body). According to some embodiments, electrode 2004 may be radially surrounded by the outer portion of third conduit 220 to provide insulation from the external environment. In some embodiments, the outer surface of electrode 2004 may be flush with the outer surface of third conduit 220 and may provide an exposed radially outward-facing electrode surface. In this case, the radially inner portion of third conduit 220 may provide insulation from the environment within the lumen of third conduit 220.

[0666] Electrode 2004 may comprise one or more rings, one or more coils, or other suitable conductive structures, and may each form at least one surface (e.g., an inner or outer surface) that is exposed and configured to be electrically active or conductive. Electrode 2004 may have a fixed inner diameter or size, or a radially expandable inner diameter or size. In some embodiments, electrode 2004 is a deposited or “painted” electrode. Electrode may comprise platinum, platinum alloys (e.g., 92% platinum and 8% tungsten, 90% platinum and 10% iridium), gold, cobalt-chromium, stainless steel, nitinol, or combinations thereof, or any suitable conductive material, metal, or alloy.

[0667] In some embodiments, electrode 2004 may be a separate expandable component coupled to the outer surface of the third conduit 220, such as a braid, support, or other conductive element coupled to the outer surface of the distal portion of the third conduit 220. In some embodiments, electrode 2004 may be part of a flow-stopping element, such as an expandable braid coupled to an occlusion balloon.

[0668] According to some embodiments, electrode 2004 can be electrically connected to current generator 20 via conductive lead 2005. Conductive lead 2005 may extend proximally along or within the wall of third conduit 220 or beyond the proximal end of third conduit 220. Conductive lead 2005 may include more than one conductive path extending within the wall of third conduit 220. According to some embodiments, conductive lead 2005 may form a helical coil along or within at least a portion of third conduit 220. Alternatively or in combination, conductive lead 2005 may form a braided fabric or lattice structure along or within at least a portion of third conduit 220. In some embodiments, conductive lead 2005 may be a conductive element (e.g., wire, coil, etc.) wound around the outer surface of third conduit 220. In this case, conductive lead 2005 may be coated with an insulating material along at least a portion of its length. The insulating material may be, for example, parylene, PTFE, or other suitable insulating materials.

[0669] In some embodiments, instead of or in addition to the third conduit 220 or the elongated member 120, the second conduit 210 and / or the first conduit 200 may be similarly equipped with corresponding electrodes. For example, the second conduit 210 may include an electrode 2006 disposed at a distal region of the second conduit 210. The electrode 2006 may be electrically connected to the current generator 20 via a conductive lead 2007 extending proximally along the second conduit 210. Figure 19A The configuration of electrode 2006 and the corresponding conductive lead 2007 can be similar to any variation described above with respect to electrode 2004 and conductive lead 2005 of the first conduit 200.

[0670] In some embodiments, the first conduit 200 includes an electrode 2008 disposed at a distal region of the first conduit 200. The electrode 2008 can be electrically connected to a current generator 20 via a conductive lead 2009 extending proximally along the first conduit 200. Figure 19A The configuration of electrode 2008 and the corresponding conductive lead 2009 can be similar to any variation described above with respect to electrode 2004 and conductive lead 2005 of third conduit 220.

[0671] In various embodiments, the system may include any combination of the electrodes 2004, 2006, and 2008 described above. For example, the system may include an electrode 2004 and a corresponding conductive lead 2005 for the third conduit 220, while the second conduit 210 and the first conduit 200 may not have electrodes or conductive leads therein. In some embodiments, the system may include only the electrode 2006 for the second conduit 210, while the first conduit 200 and the third conduit 220 may not have electrodes or conductive leads therein. In some embodiments, the system may include only the electrode 2008 for the first conduit 200, while the third conduit 220 and the second conduit 210 may not have electrodes or corresponding conductive leads therein. In some embodiments, any two of the conduits 200, 210, and 220 may have electrodes and corresponding leads, while the remaining conduits may not have electrodes or conductive leads therein.

[0672] exist Figure 20A In the illustrated configuration, one or more of electrodes 2004, 2006, or 2008 can be coupled to the negative terminal of current generator 20, while distal element 140 can be coupled to the positive terminal of current generator 20 via elongated member 120. Therefore, when a voltage is applied to the terminal and distal element 140 in the presence of blood (or any other electrolyte medium), current flows from distal element 140 through the blood or other medium and to the return electrode. The return electrode can be a conductive element carried by one or more of the conduits 200, 210, 220 as described above, or in some embodiments, the return electrode can be an external electrode 29 (…). Figure 19A ), such as a needle or a grounding pad.

[0673] In some embodiments, one or more conduits carrying the electrodes may be used without an electrically coupled distal element 140. In various embodiments, the distal element 140 may be omitted entirely, or it may be included but not electrically coupled to the current generator 20. In this case, conduit-based electrodes (e.g., electrode 2004 carried by the third conduit 220, electrode 2006 carried by the second conduit 210, or electrode 2008 carried by the first conduit 200) may serve as delivery electrodes, and a separate return electrode may be provided in the form of another conduit-based electrode (carried by the same conduit or by another conduit) or as an external electrode (e.g., a needle or grounding pad). In cases where a single conduit carries two electrodes, one electrode may be disposed on the outer surface of the conduit, while the other electrode may be disposed on the inner surface of the conduit. For example, in addition to a return electrode in the form of a conductive strip disposed on the outer surface of conduit 210, the second conduit 210 may include a delivery electrode in the form of a conductive strip disposed on the inner surface of conduit 210.

[0674] As in Figure 20B As described in more detail below, in some embodiments, the return electrode may be integrated into an elongated member 120 of the treatment system 12, such that the elongated member 120 carries two separate conductive paths along its length. Figure 20B This is an embodiment of the technology according to the present invention. Figure 20A A schematic cross-sectional side view of a portion of the treatment system 12 shown. Figure 20B As shown, the elongated member 120 includes an elongated conductive shaft 2011 and an elongated tubular member 2012, the tubular member having an inner cavity through which the shaft 2011 extends. The shaft 2011 has a distal portion 2010, and the tubular member 2012 has a distal portion 2018. Both the shaft 2011 and the tubular member 2012 are conductive along their respective lengths. In some embodiments, the shaft 2011 and the tubular member 2012 are positioned fixed relative to each other. For example, in some embodiments, the shaft 2011 is not slidable or rotatable relative to the tubular member 2012, such that the elongated member 120 can be pushed or pulled without relative movement between the shaft 2011 and the tubular member 2012 and / or other individual components of the elongated member 120.

[0675] In some embodiments, the shaft 2011 may be a solid wire, such as a conductor made of nitinol, stainless steel, or other metals or alloys. The shaft 2011 can be thinner than otherwise required due to the additional structural column strength provided by the surrounding tubular member 2012. The tubular member 2012 may be a hollow conductive tube, a hyaluronic acid tube, a braid, a coil, or other suitable one or more components, or a combination of one or more conductors, one or more tubes, one or more braids, one or more coils, etc. In some embodiments, the tubular member 2012 may be a laser-cut hyaluronic acid tube having a helical cut pattern (or other cut-slot pattern) formed in its sidewalls along at least a portion of its length. The tubular member 2012 may be made of stainless steel (e.g., 304SS), nitinol, and / or other alloys. In at least some embodiments, the tubular member 2012 may have a laser-cut pattern to achieve desired mechanical properties (e.g., column strength, flexibility, kink resistance, etc.).

[0676] The elongated member 120 may also include an adhesive or mechanical coupler, such as a coiled tape or marker tape 2020 disposed at the distal end of the elongated member 120, and the marker tape 2020 may optionally couple the distal end of the elongated member 120 to the distal element 140. The marker tape 2020 may be radiopaque, for example comprising platinum or other radiopaque materials, thereby enabling observation of the proximal end of the distal element 140 under fluorescence fluoroscopy. In some embodiments, additional radiopaque markers may be disposed at different locations along the treatment system 12, such as along the axis 2011, the tubular member 2012, or the distal element 140 (e.g., at the distal end of the distal element 140 or along the length of the distal element).

[0677] In at least some embodiments, the elongated member 120 further includes a first insulating layer or material 2022 extending between the shaft 2011 and the surrounding tubular member 2012. The first insulating material 2022 may be, for example, PTFE (polytetrafluoroethylene or TEFLON). TM Or any other suitable electrically insulating coating (e.g., polyimide, oxide, ETFE-based coating, or any suitable dielectric polymer). In some embodiments, the first insulating material 2022 extends substantially along the entire length of the shaft 2011. In some embodiments, the first insulating material 2022 separates and electrically insulates the shaft 2011 from the tubular member 2012 along the entire length of the tubular member 2012. In some embodiments, the first insulating material 2022 does not cover the nearest side portion of the shaft 2011, thereby providing the shaft current generator 20 ( Figure 19A The exposed area can be electrically coupled. In some embodiments, for example, the first insulating material 2022 terminates proximally at the proximal end of the shaft, and the current generator 20 ( Figure 19A A coaxial connector can be used, for example, to electrically couple the shaft to the near end of the shaft 2011.

[0678] The elongated member 120 may additionally include a second insulating layer or material 2024 surrounding the tubular member 2012 along at least a portion of its length. The second insulating material 2024 may be, for example, PTFE or any other suitable electrically insulating coating (e.g., polyimide, oxide, ETFE-based coating, or any suitable dielectric polymer). In some embodiments, the distal portion 2018 of the tubular member 2012 is not covered by the second insulating material 2024, thereby leaving an exposed conductive surface at the distal portion 2018. In some embodiments, the length of the exposed distal portion 2018 of the tubular member 2012 may be at least (or equal to) 1 inch, 2 inches, 3 inches, 4 inches, 5 inches, 6 inches, or greater. In some embodiments, the length of the exposed distal portion 2018 of the tubular member 2012 may be between at least 1 inch and 10 inches, between 2 inches and 8 inches, between 3 inches and 7 inches, between 4 inches and 6 inches, or about 5 inches. This exposed portion of the distal portion 2018 of the tubular member 2012 provides a return path for the current supplied to the delivery electrodes (e.g., all or part of the distal element 140), as described in more detail below. In some embodiments, the second insulating material 2024 does not cover the proximal portion of the tubular member 2012, thereby providing the current generator 20 of the tubular member 2012 ( Figure 19A The exposed area can be electrically coupled. In some embodiments, the second insulating material 2024 terminates proximally at the proximal end of the tubular member 2012, and the current generator 20 can be electrically coupled to the tubular member 2012 at the proximal end, for example, using a coaxial connector.

[0679] In some embodiments, the elongated member 120 further includes a retraction mark in the proximal portion of the tubular member 2012. The retraction mark can be a visual indicator used to guide a clinician as the overlying catheter is retracted proximally relative to the elongated member 120. For example, the retraction mark can be positioned such that when the proximal end of the overlying catheter is retracted to be positioned at or near the retraction mark, the distal portion 2018 of the tubular member 2012 is distally positioned beyond the distal end of the catheter. In this positioning, the exposed distal portion 2018 of the tubular member 2012 is exposed to the surrounding environment (e.g., blood, tissue, etc.) and can be used as a return electrode for the elongated member 120.

[0680] The proximal end of shaft 2011 can be electrically coupled to the positive terminal of current generator 20, and the proximal end of tubular member 2012 can be electrically coupled to the negative terminal of current generator 20. During operation, treatment system 12 provides a circuit in which current flows distally from the positive terminal of current generator 20 through shaft 2011, distal element 140, and surrounding medium (e.g., blood, tissue, thrombus, etc.) before returning to the exposed distal portion 2018 of tubular member, proximally through tubular member 2012, and returns to the negative terminal of current generator 20. Figure 19A ).

[0681] As described above, current generator 20 ( Figure 19A The device may include a power supply and a processor or hardwired circuit element, the processor being coupled to a memory storing instructions for the power supply to deliver current according to certain parameters, and the hardwired circuit element being configured to deliver current according to desired parameters. The current generator 20 may be integrated into the elongated member 120 or may be removably coupled to the elongated member 120, for example, via clips, wires, plugs, or other suitable connectors. (See other sections of this document for more information.) Figures 23A-23E A more detailed description is given of the specific parameters of the energy provided by the current generator 20.

[0682] In some embodiments, the polarity of the current generator 20 can be switched such that the negative terminal is electrically coupled to the shaft 2011 and the positive terminal is electrically coupled to the tubular member 2012. This can be advantageous, for example, when attempting to attract predominantly positively charged material to the distal element 140, or when attempting to break up a clot rather than holding it with an interventional element. In some embodiments, an alternating current (AC) signal can be used instead of a DC signal. In certain situations, an AC signal can advantageously aid in breaking up thrombi or other materials.

[0683] like Figure 20A and 20C As depicted, the distal element 140 may include an attachment portion 2030 extending only over a portion of the distal element 140 (or the attachment portion 2030 may completely exclude the distal element 2030). For example, the attachment portion 2030 may extend only over a proximal portion (e.g., proximal side, proximal half, proximal third, proximal quarter, etc.) of the distal element 140. The attachment portion 2030 of the distal element 140 may be configured to interlock with, capture, mediate, and / or engage a thrombus. The portion of the distal element 140 outside the attachment portion may or may not contact the thrombus-forming material during use, but is configured to perform functions that render it ineffective or less effective than the attachment portion for interlocking, capturing, and / or engaging a thrombus. In some embodiments, such as Figure 20AIn the embodiment shown, the distal end of the attachment portion is located proximal to the distal end of the distal end of the distal element 140 (i.e., the attachment portion is spaced apart from the distal end of the distal element 140), and the proximal end of the attachment portion 2030 is located at or adjacent to the band 2020.

[0684] In some embodiments, the “non-attached portion” of the distal element 140 (e.g., the entire distal element 140 other than the attachment portion) may be coated with a non-conductive or insulating material (e.g., parylene, PTFE, or other suitable non-conductive coating) such that the coated area is not in electrical contact with the surrounding medium (e.g., blood). Therefore, the current carried to the distal element 140 by the elongated member 120 is exposed to the surrounding medium only along the attachment portion 2030 of the distal element 140. This can advantageously concentrate the electrically enhanced attachment effect along the attachment portion 2030 of the distal element 140, where this effect is most useful, and thereby combine both mechanical contact / interlocking with the electrical enhancement provided by the delivered electrical signal. In some embodiments, the distal portion 140b of the distal element 140 (e.g., the distal side of the attachment portion 2030) may also be coated with a non-conductive material (e.g., parylene, PTFE, or other suitable non-conductive coating), leaving only the proximal region of the distal element 140 or the attachment portion 2030 with exposed conductive surfaces.

[0685] In some embodiments, the distal element 140 may comprise a conductive material positioned on some or all of its outer surfaces. The conductive material may be, for example, gold and / or another suitable conductor with a conductivity greater than (or less than) that of the material comprising the distal element 140. The conductive material can be applied to the distal element 140 by electrochemical deposition, sputtering, vapor deposition, dip coating, and / or other suitable methods. In various embodiments, the coating may be applied only to the outward-facing portion of the filament, only to the inward-facing portion of the filament, only to one of the side portions, or to any combination of surface portions.

[0686] In some embodiments, the conductive coating (e.g., disposed over the attachment portion 2030) or the insulating coating (e.g., disposed over the non-attached portion of the distal element 140) may be provided with different thicknesses or concentrations. For example, in some embodiments, the conductive coating is provided according to a gradient, wherein the concentration or thickness of the conductive material is maximized near the central (or proximal) region of the attachment portion 2030, and the concentration or thickness of the conductive material gradually decreases toward the edges of the attachment portion 2030. Since current tends to concentrate in the more conductive portions of the distal element 140, such a gradient can increase the charge density in desired areas of the distal element 140 (e.g., providing increased charge density in the central (or proximal) region of the attachment portion 2030).

[0687] In some aspects of the invention, the conductive material is disposed only on the attachment portion 2030 of the distal element 140, while the distal portion 140b of the distal element 140 is exposed. Because the resistance of the conductive material is much lower than that of the underlying material including the distal element 140, the current delivered to the distal element 140 is concentrated along the attachment portion 2030. In several embodiments of this type, the conductive material may be disposed only on the outer portion of the support surface along the attachment portion 2030. In other embodiments, the conductive material may be disposed on all or part of the length of the distal element 140 on all or part of the filament surface.

[0688] like Figure 20C As shown, part or all of the attachment portion 2030 may be positioned on (or formed therefrom) the elongated member 120, for example, in the form of a coil 2032 positioned proximal to the proximal side of the marking strip 2020 and the distal element 140. The coil 2032 may be conductive, for example, made of metal (e.g., stainless steel (e.g., 304SS), nitinol / or other alloys) or other suitable conductive materials. In some embodiments, the coil 2032 is a separate element mounted on the shaft 2011 of the elongated member 120. In other embodiments, the shaft 2011 itself may be formed into a coiled shape to provide the coil 2032. In some embodiments, in addition to the helical coil 2032, other shapes and structures may be provided in the same positioning, such as wavy curves, a series of bends, helical cuts or slotted cut tubes, or other suitable shapes or structures. The coil 2032 (or other suitable structure) may provide increased electrode surface area in this region. When current is applied to shaft 2011, the increased surface area provided by coil 2032 can enhance the electrode's ability to contact, engage, and / or hold the clump material CM, thereby increasing electrostatic attachment. Therefore, in some embodiments, attachment portion 2030 extends proximally to (and / or excludes) distal element 140 and may include coil 2032 and a portion of elongated member 120.

[0689] In some embodiments, individual filaments or groups of filaments of the distal element 140 may be individually electrically addressable. For example, a first group of filaments may be electrically addressable, for example, coupled to a first terminal of a power supply, while a second group of filaments may be individually electrically addressable, for example, coupled to a second terminal of a power supply. Within the distal element 140, the first and second groups of filaments may have insulating and non-insulating portions such that exposed conductive portions of the first group do not directly contact exposed conductive portions of the second group of filaments. For example, the first group of filaments may be coated with an insulating material along the proximal portion 140a of the distal element 140 and exposed (or coated with a conductive material) along the distal portion 140b of the distal element 140. The second group of filaments may have the opposite configuration, wherein the filaments are coated with an insulating material along the distal portion 140b of the distal element 140 and exposed (or coated with a conductive material) along the proximal portion 140a of the distal element 140. In operation, when current is supplied and an electrolytic medium is present at the distal element 140, one set of filaments can serve as delivery electrodes (e.g., with a positive charge) and another set of filaments can serve as return electrodes (e.g., with a negative charge). In some embodiments, three, four, five, six, or more individually addressable filaments or groups of filaments may be present. Such filaments may extend proximally along the length of the elongated member 120, for example, along the distal portion of the elongated member 120, to provide individually addressable electrodes in the region.

[0690] In operation, delivering current to the distal element 140 can enhance the removal of the clump material. For example, return to reference. Figures 10A-10E You can use the above information about Figure 19A-20C The described method of enhancing the power supply to the treatment system 12 involves a current generator 20 electrically coupled to one or more elements of the treatment system 12. For example, the current generator 20 may be electrically coupled to the proximal end of the elongated member 120 and configured as such. Figure 10C The diagram illustrates that current is delivered to the distal element 140 (or to its attachment portion 2030, or to the attachment portion 2030 but not to the distal element 140) before or after the distal element 140 has been released from the third catheter 220 into the blood vessel and / or extended into or adjacent to the clot material CM. Upon delivery of the electrical signal, the distal element 140 can be retained in place within the blood vessel V or manipulated for the desired duration. The positively charged distal element 140 / attachment portion 2030 can attract the negatively charged components of the clot material CM, thereby enhancing the grip of the distal element 140 and / or attachment portion 2030 on the clot material CM. This allows the distal element 140 to be used to remove the clot material CM and push (and / or aspirate) it into the first or second catheter 200 / 210, while reducing the risk of losing grip on the thrombus or a portion thereof, which may migrate downstream and cause further vascular occlusion in more difficult-to-reach areas of the brain.

[0691] like Figure 10D As shown, aspiration can be applied to the treatment site via the second catheter 210. For example, after the distal element 140 has been deployed, the first catheter 200 can be retracted and removed from the lumen of the second catheter 210. The treatment site can then be aspirated through the second catheter 210, for example, via an aspiration source, such as a pump or syringe, coupled to the proximal portion of the second catheter 210. In some embodiments, after the distal element 140 has been deployed, the treatment site is aspirated via the current generator 20 while electrical energy is supplied to the distal element 140 (or its attachment portion 2030, or to the attachment portion 2030 but not the distal element 140). By combining aspiration with the application of electrical energy, any newly formed clots (e.g., any clots formed that are at least partially attributable to the application of electrical energy) or any clot fragments that have broken and loosened during the procedure can be pulled into the second catheter 210, thereby preventing any such clots from being released downstream of the treatment site. Thus, simultaneous aspiration allows for the use of higher power or current levels delivered to the distal element 140 without the risk of the harmful effects of new clot formation. Additionally, suction can capture along the distal element 140 or the marker strip 2020 during the application of electrical energy to the distal element 140. Figure 20A Any air bubbles formed can improve patient safety during surgery.

[0692] In some embodiments, aspiration is applied as the distal element 140 is retracted into the second catheter 210. During retraction, the proximal side of the distal element 140 may engage with and push the clot material CM proximally toward the distal end of the second catheter 210. Aspiration at this stage helps to secure the clot material CM within the second catheter 210 and prevents any displaced portion of the clot material CM from escaping from the second catheter 210 and being released back into the vessel V. In various embodiments, the treatment site may be aspirated continuously before, during, or after the delivery of an electrical signal to the distal element 140 (and / or the attachment portion 2030) and before, during, or after the distal element 140 is retracted into the second catheter 210.

[0693] At least when the distal element 140 deploys and engages the thrombus CM, an electric current can be delivered to the distal element 140 (and / or attachment portion 2030) to positively charge the distal element 140 or attachment portion 2030, thereby enhancing clot adhesion to the distal element 140 or attachment portion 2030. In some cases, electrically enhanced clot adhesion can be improved even in the absence of blood flow. Therefore, it may be particularly beneficial to block blood flow when the distal element 140 or attachment portion 2030 is charged and when the distal element 140 and thrombus CM are withdrawn proximally (e.g., via the balloon 1001 of the first catheter 200 or the flow-stopping element on the second catheter 210). Instead of or in addition to such flow blocking, a saline flow can be supplied to the distal element 140 from the fluid source 27 via the second catheter 210 and / or the first catheter 200.

[0694] refer to Figure 10E When the distal element 140 engages with the clot material CM, the clot material CM can be removed. For example, if the clot material CM is grasped or thus adjacent, the distal element 140 can be retracted proximally (e.g., into or together with the second catheter 210, and optionally together with the first catheter 200). The second catheter 210, the distal element 140, and the associated clot material CM can then optionally be withdrawn from the patient through one or more larger peripheral catheters such as the first catheter 200. During this retraction, the distal element 140 and / or the attachment portion 2030 can grasp the clot material CM, for example, by applying an electric current and / or electrostatic current from a current generator as discussed herein. (As used herein with reference to devices for grasping or removing thrombi or other vascular / luminal materials or for this purpose, "electrical" and its derivatives shall be understood to include "electrostatic" and its derivatives.) Therefore, the distal element 140 and / or attachment portion 2030 can maintain enhanced or electrically and / or electrostatically enhanced grip on the clot material CM during retraction. In other embodiments, the current generator 20 can stop delivering electrical signals to the distal element 140 and / or attachment portion 2030 before the distal element 140 retracts relative to the blood vessel V. In some embodiments, the distal element 140 and the clot material CM form a removable, integrated thrombus device clump, wherein the connection between the thrombus and the device is electrically enhanced, for example, by the application of current as discussed herein.

[0695] exist Figure 10EIn this process, the clotted material CM has been moved to at least partially enter the second catheter 210. In some embodiments, as previously described, the clotted material CM can substantially block the lumen of catheter 210, thereby creating a "corking" effect that may be noticeable to clinicians supplying negative pressure to catheter 210. In some embodiments, current generator 20 can continue to supply electrical signals to distal element 140 and return electrode during retraction, while in other embodiments, current generator 20 can stop supplying electrical signals during retraction of catheter 210 and clotted material CM.

[0696] In some cases, instead of delivering current to the distal element 140 or attachment portion 2030, current can be delivered to an electrode carried by one or more conduits (e.g., the second conduit 210). For example, an electrical signal can be supplied to the second conduit 210 by a current generator 20 to charge the distal portion of the conduit 210. For example, as described above regarding Figure 20A As described, in some embodiments, the second conduit 210 may include an electrode disposed at its distal portion. The electrode may be any conductive element, such as a conductive strip extending around the inner or outer surface of the conduit 210, a support engaging with the inner surface of the second conduit 210, etc. The first electrode may be electrically coupled to a conductive lead extending proximally along the conduit 210 and coupled at its proximal end to the positive terminal of the current generator 20. The conductive lead may be, for example, a wire, a coil, or other conductive element carried by and / or coupled to the conduit 210. In some embodiments, the conductive lead is embedded within the wall of the second conduit 210. In other embodiments, the conductive lead is disposed along the outer surface of the conduit 210 (e.g., spirally wound around the outer surface of the conduit along the length of the conduit 210). The conductive lead may be covered along a portion of its length with an insulating material, such as parylene, PTFE, or other suitable insulating coating.

[0697] The negative terminal of the current generator 20 can be coupled to a return electrode to complete the circuit, wherein the first electrode is disposed on the catheter 210. In some embodiments, the return electrode may be an external electrode (e.g., a needle or grounding pad coupled to the patient's skin). In other embodiments, the return electrode may be carried by a separate catheter. In some embodiments, the return electrode may be carried by the catheter 210 at a location spaced apart from the first electrode. For example, the first electrode may be a conductive element, such as a band or loop, disposed at a location spaced apart from the first electrode. In some embodiments, the first electrode may be exposed along the radially inner surface of the catheter 210, while the return electrode may be exposed along the radially outer surface of the catheter 210. In some embodiments, the return electrode may be a separate expandable component (e.g., a balloon or other expandable component having a conductive element such as a metal braid therein) coupled to the outer surface of the catheter 210.

[0698] In some methods of this invention, a guidewire (not shown) may be advanced to the treatment site and pushed through the clot material CM until the distal portion of the guidewire is located distal to the clot material CM. The guidewire may be advanced through one or more of catheters 200, 210, 220 and / or one or more of catheters 200, 210, 220 may be advanced over the guidewire. The guidewire may be insulated (e.g., using parylene, PTFE, etc.) along at least a portion of its length, wherein the exposed portion allows electrical communication with the current generator 20 and the distal element 140. For example, in some embodiments, the distal portion of the guidewire may be exposed, and the guidewire may be positioned at the treatment site such that the exposed portion of the guidewire is distal to the clot material CM. The proximal end of the guidewire may be coupled to the current generator 20, such that the exposed portion of the guidewire acts as a return electrode. In some embodiments, the guidewire may be coupled to the positive terminal of a power source, and the exposed portion acts as a delivery electrode. The guidewire can serve as a delivery electrode or a return electrode, wherein any delivery electrode or return electrode is carried by any component of the treatment system (e.g., one or more of the first catheter 200, the second catheter 210, the third catheter 220, the distal element 140, etc.).

[0699] Figure 21-22 A treatment system 13 is shown, comprising a distal element 140, an interventional element 300, and a current generator 20 for supplying charge to selected components of the system 13. The distal element 140 (or its attachment portion 2030) and the interventional element 300 can be used as electrodes in operation of the system 13, having opposite polarities, wherein the interventional element 300 is positively charged and the distal element 140 serves as a negatively charged return electrode (or vice versa), or having common polarities, wherein both the interventional element 300 and the distal element are positively charged, and some other component (e.g., a second catheter 210, or any other suitable component) provides a negatively charged return electrode. Alternatively, the interventional element 300 can be electrically neutral or separate from the rest of the treatment system 13. Several features of the treatment system 13 may be similar to... Figure 11 The treatment system 11 shown and described above. For example, catheters 200, 210, 220, elongated member 120, distal element 200, and interventional element 300 may include the components described above. Figure 1-1 Some or all of the features described in 8E. For example... Figure 22 As shown, both the distal element 140 and the intervention element 300 are coupled to the distal portion of the elongated member 120. The elongated member 120 may be coupled to a current generator at its proximal end (not shown), as previously discussed regarding... Figure 20A As described, the distal element 140 can be electrically connected to a conductive shaft 2011 surrounded along its length by an insulating material 2022. (References herein) Figure 1Treatment system 10 Figure 11 The treatment system 11 or Figure 19A Any embodiment or version of the components described above in the treatment system 12 may also be used with the treatment system 13.

[0700] Continue to refer to Figure 22 A conductive tubular member 2012 extends over a shaft 2011 and is itself covered along its length with an insulating material 2024. As shown, the shaft 2011 extends distally beyond the distal end of the tubular member 2012. In some embodiments, the shaft 2011 is not slidable or rotatable relative to the tubular member 2012, such that the elongated member 120 can be pushed or pulled without relative movement between the shaft 2011 and the tubular member 2012 and / or other individual components of the elongated member 120.

[0701] The elongated member 120 may also include an adhesive or mechanical coupler, such as the coiled or marking tape 2020 disposed at the distal end of the elongated member 120 as previously described. Additionally, the elongated member 120 may include a second marking tape 2034 (or other suitable mechanical coupler or adhesive) disposed at the distal end of the tubular member 2012. The second tape 2034 may couple the distal end of the tubular member 2012 to the proximal end of the interventional element 300, such that the interventional element 300 is electrically connected to the second tape 2034 and to the tubular member 2012.

[0702] As previously described herein, interventional element 300 may be generally tubular (e.g., cylindrical), and the proximal portion of interventional element 300 may taper proximally, here coupled to the second band 2034. In various embodiments, interventional element 300 may take many forms, such as a removal device, a thrombectomy device, or other suitable medical device. For example, in some embodiments, interventional element 300 may be a stent and / or stent remover, such as Medtronic's Solitaire. TM Vascular reconstruction devices, Stryker Neurovascular intervention ProVue TM A stent remover or other suitable device. In some embodiments, the interventional element 300 may be a coiled wire, fabric, and / or braid formed of a plurality of braided filaments. In some embodiments, the interventional element 300 may be a mesh structure (e.g., braid, stent, etc.) formed of a hyperelastic material (e.g., nitinol) or other elastic material or a self-expanding material configured to self-expand upon release from a peripheral catheter. The mesh structure may include a plurality of struts and open spaces between the struts. In some embodiments, the struts and spaces may be positioned along the longitudinal direction, the radial direction, or both of the interventional element 300.

[0703] like Figure 22 As depicted, the interventional element 300 may include a working length (WL) portion and a non-working length (NWL) portion. The portion of the interventional element 300 within the working length (WL) may be configured to interlock, capture, and / or engage thrombi. The portion of the interventional element 300 within the non-working length (NWL) may contact thrombus-forming material during use, but is configured to perform functions that render it ineffective or less effective than the working length (WL) portion for interlocking, capturing, and / or engaging thrombi. In some embodiments, such as Figure 22 As shown, the distal end of the working length WL portion is located proximal to the distal end of the interventional element 300 (i.e., the working length WL portion is spaced apart from the distal end of the interventional element 300), and the non-working length NWL portion is disposed between the working length WL and the distal end of the band 2034 and / or the tubular member 2012.

[0704] In some embodiments where the interventional element 300 is used as an electrode, the non-working length NWL portion of the interventional element 300 may be coated with a non-conductive or insulating material (e.g., parylene, PTFE, or other suitable non-conductive coating) such that the coated area is not in electrical contact with the surrounding medium (e.g., blood). Therefore, the current carried to the interventional element 300 by the tubular member 2012 is exposed to the surrounding medium only along the working length WL portion of the interventional element 300. This can advantageously concentrate the electrical enhancement attachment effect along the working length WL of the interventional element 300, where this effect is most useful, and thereby combine the mechanical interlocking provided by the working length WL with the electrical enhancement provided by the delivered electrical signal. In some embodiments, the distal region of the interventional element 300 (e.g., the distal side of the working length WL) may also be coated with a non-conductive material (e.g., parylene, PTFE, or other suitable non-conductive coating), leaving only the central portion of the interventional element 300 or the working length WL with exposed conductive surfaces.

[0705] In some embodiments, the intervention element 300 may include additional conductive material positioned on some or all of its outer surfaces. The conductive material may be, for example, gold and / or another suitable conductor with a conductivity greater than (or less than) that of the material comprising the intervention element 300. The conductive material may be applied to the intervention element 300 by electrochemical deposition, sputtering, vapor deposition, dip coating, and / or other suitable methods. In some embodiments, the conductive material may be disposed only on the outward-facing surface, the inward-facing surface, one or more side surfaces of the side of the support, or any combination of surface portions.

[0706] In some embodiments, a first portion of the interventional element 300 is covered by a conductive material, and a second portion of the interventional element 300 is covered by an insulating or dielectric material (e.g., parylene). In some embodiments, the working length WL portion of the interventional element 300 may be covered by a conductive material, while the non-working length NWL portion may be covered by an insulating material. In some embodiments, the conductive material may be disposed on all or part of the length of the interventional element 300 along all or part of the support surface, and the insulating material may be disposed on the support surface and / or on those portions of the working length not covered by the conductive material.

[0707] The proximal end of shaft 2011 can be electrically coupled to the negative terminal of current generator 20, and the proximal end of tubular member 2012 can be electrically coupled to the positive terminal of current generator 20. During operation, treatment system 13 provides a circuit in which current flows distally from the positive terminal of current generator 20 through tubular member 2012, intervention element 300, and surrounding medium (e.g., blood, tissue, thrombus, etc.) before returning to distal element 140, and proximally along tubular member 2012, and returns to the negative terminal of current generator 20. Figure 21 ).

[0708] In some embodiments, the distal element 140 and the interventional element 300 can be delivered using separate shafts, push wires, or other elongated members. For example, the distal element 140 can be coupled to the distal portion of the elongated member 120, while the interventional element 300 is coupled to the distal portion of a separate elongated member or shaft (e.g., an elongated shaft 170 with a lumen in which the elongated member 120 is housed). The two elongated members can be advanced individually through the surrounding catheter, allowing the distal element 140 and the interventional element 300 to move rotationally and longitudinally relative to each other. Each of the elongated members can be individually coupled to a terminal of the current generator 20, allowing the interventional element 300 to be used as a delivery electrode and the distal element 140 to be used as a return electrode, or vice versa.

[0709] In operation, delivering current to the intervention element 300 and the distal element 140 (and / or its attachment portion 2030) can enhance the removal of clotted material. For example, return to reference. Figures 18A-18D You can use the above information about Figure 22 The described method of enhancing the power supply to the treatment system involves a current generator 20 electrically coupled to one or more elements of the treatment system 13. For example, the current generator 20 may be electrically coupled to the proximal end of the elongated member 120 and configured as follows: Figure 18AThe diagram illustrates the delivery of current to the interventional element 300 and / or distal element 140 (and / or their attachments 2030) before or after the interventional element 300 and / or distal element 140 have been released from the third catheter 220 into the blood vessel and / or extended into or adjacent to the clot material CM. Upon delivery of the electrical signal, the interventional element 300 and distal element 140 can be retained in the appropriate position within the blood vessel V or manipulated for the desired duration. The positively charged interventional element 300 (and, in this case, the positively charged distal element 140) can attract the negatively charged components of the clot material CM, thereby enhancing the grip of the interventional element 300 (and, when positively charged, the distal element 140) on the clot material CM. This allows the interventional element 300 (and possibly the distal element 140) to be used to remove the clot material CM while reducing the risk of losing grip on the thrombus or a portion thereof, which may migrate downstream and cause further vascular occlusion in more difficult-to-reach areas of the brain. Additionally, the distal element 140 can be used as an additional filter (its function is electrostatically enhanced when the distal element is positively charged) to prevent any detached thrombus or clot material CM from migrating downstream relative to the interventional element 300.

[0710] like Figure 18B As shown, aspiration can be applied to the treatment site via the second catheter 210. For example, after the interventional element 300 and distal element 140 have been deployed, the first catheter 200 can be retracted and removed from the lumen of the second catheter 210. The treatment site can then be aspirated through the second catheter 210, for example, via an aspiration source, such as a pump or syringe, coupled to the proximal portion of the second catheter 210. In some embodiments, after the deployment of the interventional element 300 and distal element 140, the treatment site is aspirated while electrical energy is supplied to the interventional element 300 (and / or distal element 140, having the same or opposite polarity as the interventional element 300) via a current generator 20. By combining aspiration with the application of electrical energy, any newly formed clots (e.g., any clots formed that are at least partially attributable to the application of electrical energy) or any clot fragments that have broken and loosened during the procedure can be pulled into the second catheter 210, thereby preventing any such clots from being released downstream of the treatment site. Therefore, simultaneous aspiration allows for the use of higher power or current levels delivered to the interventional element 300 without the risk of the harmful effects of new clot formation. Additionally, aspiration can capture clots along the interventional element 300 or marker band 2034 during the application of electrical energy to the interventional element 300. Figure 22 Any air bubbles formed can improve patient safety during surgery.

[0711] In some embodiments, aspiration is applied as the interventional element 300 and distal element 140 are retracted into the second catheter 210. During retraction, the proximal side of the distal element 140 (and / or the engagement portion 2030) may engage with and push the clot material CM proximally toward the distal end of the second catheter 210. Aspiration at this stage helps to secure the clot material CM within the second catheter 210 and prevents any displaced portion of the clot material CM from escaping from the second catheter 210 and being released back into the vessel V. In various embodiments, the treatment site may be aspirated continuously before, during, or after the delivery of an electrical signal to the interventional element 300 (and / or distal element 140) and before, during, or after the interventional element 300 is retracted into the second catheter 210.

[0712] At least when the interventional element 300 is deployed and engages the thrombus CM, an electric current can be delivered to the interventional element 300 to make it positively charged, thereby enhancing clot adhesion to the interventional element 300. In some cases, electrically enhanced clot adhesion can be improved even in the absence of blood flow. Therefore, it may be particularly beneficial to block blood flow when the interventional element 300 is charged and during proximal withdrawal of the thrombus (e.g., via the balloon 1001 of the first catheter 200 or the flow-stopping element of the second catheter 210). Instead of or in addition to such flow blocking, a saline flow can be supplied to the interventional element 300 from the fluid source 27 via the second catheter 210 and / or the first catheter 200.

[0713] refer to Figure 18C-18D When the interventional element 300 and / or distal element 140 engage with the clot material CM, the clot material CM can be removed. For example, with the clot material CM held, the interventional element 300 can be retracted proximally (e.g., together with the second catheter 210, and optionally the first catheter 200). The second catheter 210, distal element 140, interventional element 300, and associated clot material CM can then optionally be withdrawn from the patient through one or more larger peripheral catheters. During this retraction, the interventional element 300 can hold the clot material CM electrically and / or electrostatically, for example, by applying current from a current generator. Thus, the interventional element 300 can maintain enhanced or electrically and / or electrostatically enhanced holding of the clot material CM during retraction. In other embodiments, the current generator 20 can stop delivering electrical signals to the interventional element 300 before the interventional element 300 is retracted relative to the vessel V. In some embodiments, the interventional element 300 and the clot material CM form a removable, integrated thrombus device mass, wherein the connection between the thrombus and the device is electrically enhanced, for example, by the application of an electric current as discussed herein.

[0714] exist Figure 18C-18DIn this process, the clotted material CM has been moved to at least partially enter the second catheter 210. In some embodiments, as previously described, the clotted material CM can substantially block the lumen of the second catheter 210, thereby creating a "corking" effect that may be noticeable to clinicians supplying negative pressure to the second catheter 210. In some embodiments, the current generator 20 can continue to supply electrical signals to the interventional element 300 and the distal element 140 during retraction, while in other embodiments, the current generator 20 can stop supplying electrical signals during the retraction of the catheter 210 and the clotted material CM.

[0715] V. Example of waveform selection for electrical enhancement extraction

[0716] Figures 23A-23E Different electrical waveforms are shown for use with the treatment system of the present invention. Although the waveforms and other power delivery parameters disclosed herein may differ from those described above... Figure 19A-22 The described apparatus and methods are used together, but the waveforms and other parameters are also applicable to other apparatus configurations and techniques. For example, a return electrode can be disposed along the catheter wall as a separate conductive member extending within the catheter lumen, as a needle electrode disposed at other sites in the body, etc. In each of these apparatus configurations, the power delivery parameters and waveforms can be advantageously used to promote clot adhesion without damaging surrounding tissues. Furthermore, although the waveforms and other power delivery parameters disclosed herein can be used to treat cerebral embolism or intracranial embolism, other applications and embodiments beyond those described herein are also within the scope of the invention. For example, the waveforms and power delivery parameters disclosed herein can be used for electrically enhanced removal of emboli from cavities other than blood vessels (e.g., the digestive tract, etc.), and / or can be used for electrically enhanced removal of emboli from blood vessels outside the brain (e.g., pulmonary vessels, vessels in the legs, etc.).

[0717] Although a continuous uniform direct current (DC) electrical signal is applied (such as...) Figure 23E As shown, positively charging interventional elements and / or aspiration catheters can improve thrombus adhesion, but this may carry the risk of damaging surrounding tissue (e.g., ablation), and relatively high levels of continuous current can also lead to thrombus formation (i.e., the potential generation of new clots). Periodic waveforms have been found particularly useful for achieving effective clot capture without ablating tissue or generating a large amount of new clots at the treatment site. Without being bound by theory, the clot adhesion effect appears to be most closely related to the peak current of the delivered electrical signal. Periodic waveforms can advantageously deliver the desired peak current without delivering excessive total energy or charge. Specifically, periodic non-square waveforms are well-suited for delivering the desired peak current while reducing the amount of total delivered energy or charge compared to uniformly applied current or square waveforms.

[0718] Figures 23A-23D This demonstrates what can be related to the above text. Figure 19A-22 The described apparatus and method, as well as various periodic waveforms used in conjunction with other apparatuses and techniques. Figure 23E A continuous, uniform DC signal, which can also be used in some embodiments, is shown. (Reference) Figures 23A-23D Electricity can be delivered in the form of pulsed DC based on these waveforms. Figure 23A and 23B The diagrams show periodic square and triangular waveforms. Both waveforms have the same amplitude, but the triangular waveform delivers the same peak current as the square waveform, but only half the total charge and less total energy. Figure 23C This illustrates another pulsed DC or periodic waveform, which is a composite of square and triangular waveforms. Figure 23B Compared to the triangular waveform, Figure 23C The superposition of the triangular and square waveforms shown delivers additional effects while still delivering more... Figure 23A A square waveform delivers less total energy. This is because the delivered energy is proportional to the square of the current, and Figure 23C The brief peaks in the composite waveform ensure that current is supplied without distributing too much energy. Figure 23D Another non-square waveform (in this case, a trapezoidal waveform) is shown, where the "rising" and "falling" portions at the beginning and end of each pulse provide a period of reduced current compared to a square waveform. In other embodiments, different non-square waveforms may be used, including superpositions of square waveforms with any non-square waveform, depending on the desired power delivery characteristics.

[0719] The waveform shape (e.g., pulse width, duty cycle, amplitude) and duration can each be selected to achieve desired power delivery parameters, such as the total charge, total energy, and peak current delivered to the interventional element and / or catheter. In some embodiments, the total charge delivered to the distal element, interventional element, and / or catheter can be between about 30-1200 mC, or between about 120-600 mC. According to some embodiments, the total charge delivered to the distal element, interventional element, and / or catheter can be less than 600 mC, less than 500 mC, less than 400 mC, less than 300 mC, less than 200 mC, or less than 100 mC.

[0720] In some embodiments, the total energy delivered to the distal element, interventional element, and / or aspiration catheter may be between about 0.75-24,000 mJ, between about 120-24,000 mJ, or between about 120-5000 mJ. According to some embodiments, the total energy delivered to the distal element, interventional element, and / or aspiration catheter may be less than 24,000 mJ, less than 20,000 mJ, less than 15,000 mJ, less than 10,000 mJ, less than 5,000 mJ, less than 4,000 mJ, less than 3,000 mJ, less than 2,000 mJ, less than 1,000 mJ, less than 900 mJ, less than 800 mJ, less than 700 mJ, less than 600 mJ, less than 500 mJ, less than 400 mJ, less than 300 mJ, less than 200 mJ, less than 120 mJ, less than 60 mJ, less than 48 mJ, less than 30 mJ, less than 12 mJ, less than 6 mJ, or less than 1.5 mJ.

[0721] In some embodiments, the delivered peak current may be between about 0.5-20 mA or between about 0.5-5 mA. According to some embodiments, the delivered peak current may be greater than 0.5 mA, greater than 1 mA, greater than 1.5 mA, greater than 2 mA, greater than 2.5 mA, or greater than 3 mA.

[0722] The duration of power delivery is another important parameter, which can be controlled to achieve the desired clot adhesion effect without damaging tissue at the treatment site or creating new clots. In at least some embodiments, the total energy delivery time may not exceed 1 minute, 2 minutes, 3 minutes, 4 minutes, or 5 minutes. According to some embodiments, the total energy delivery time may be less than about 30 seconds, less than about 1 minute, less than about 90 seconds, or less than about 2 minutes. As used herein, “total energy delivery time” refers to the time period of the waveform supplied by the interventional element and / or catheter (including those time periods between current pulses).

[0723] The duty cycle of the applied electrical signal can also be selected to achieve desired clot adhesion properties without ablating tissue or promoting new clot formation. In some embodiments, the duty cycle may be between about 5% and about 99% or between about 5% and about 20%. According to some embodiments, the duty cycle may be about 10%, about 20%, about 30%, about 40%, or about 50%. In yet other embodiments, a constant current may be used, wherein the duty cycle is 100%. For embodiments with a 100% duty cycle, a lower time or current may be used to avoid delivering excessive total energy to the treatment site.

[0724] Table 1 presents the range of values ​​for the power delivery parameters for different waveforms. For each condition described in Table 1, a 1 kΩ resistor and a 1 kHz frequency are used (for square, triangular, and composite conditions). The constant condition represents a continuous, steady current applied over the duration (i.e., 100% duty cycle). Column 1, Peak Current, represents the peak current of the corresponding waveform. For the composite condition, Column 2, Peak Current, represents the peak current of the second portion of the waveform. For example, refer to the reference... Figure 23C Peak current 1 will correspond to the current at the top of the triangular portion of the waveform, while peak current 2 will correspond to the current at the top of the square portion of the waveform.

[0725]

[0726]

[0727] Table 1

[0728] As shown in Table 1, the periodic waveforms (square, triangular, and combined conditions) achieve higher peak currents with lower total delivered charge compared to the corresponding constant conditions. For example, in constant condition 4, a peak current of 20 mA corresponds to a total delivered energy of 24,000 mJ, while condition square 3 delivers a peak current of 20 mA with a total energy of only 4,800 mJ. Conditions triangular 2 and combined 1 similarly deliver lower total energy while maintaining a peak current of 20 mA. Since clot adhesion appears to be driven by peak current, these periodic waveforms can provide improved clot adhesion while reducing the risk of damaging tissue at the treatment site or promoting new clot formation. Table 1 also shows that the triangular and combined conditions achieve higher peak currents with lower total delivered charge compared to the corresponding square condition. For example, condition square 3 has a peak current of 20 mA and delivers a total charge of 240 mC, while condition triangle 2 has a peak current of 20 mA but delivers a total charge of only 120 mC, and condition compound 1 has a peak current of 20 mA and delivers a total charge of only 144 mC. Thus, these non-square waveforms provide additional benefits by delivering the desired peak current while reducing the total charge delivered to the treatment site.

[0729] Although Table 1 represents a series of waveforms with a single frequency (1 kHz), in some embodiments, the frequency of the pulsed DC waveform can be controlled to achieve the desired effect. For example, in some embodiments, the frequency of the waveform can be between 1 Hz and 1 MHz, between 1 Hz and 1 kHz, or between 500 Hz and 1 kHz.

[0730] IV. in conclusion

[0731] This disclosure is not intended to be exhaustive or to limit the invention to the precise forms disclosed herein. While specific embodiments have been disclosed herein for illustrative purposes, various equivalent modifications are possible without departing from the invention, as will be recognized by those skilled in the art. In some instances, well-known structures and functions have not been shown and / or described in detail to avoid unnecessarily obscuring the description of embodiments of the invention. Although steps of a method may be presented in a particular order herein, in alternative embodiments, the steps may have another suitable order. Similarly, in other embodiments, certain aspects of the invention disclosed in the context of a particular embodiment may be combined or omitted. Furthermore, while advantages associated with certain embodiments have been disclosed in the context of those embodiments, other embodiments may also exhibit these advantages, and not all embodiments are required to exhibit such advantages or other advantages disclosed herein to fall within the scope of the invention. Therefore, this disclosure and associated techniques may cover other embodiments not explicitly shown and / or described herein.

[0732] Throughout this disclosure, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” include plural referents. Similarly, unless the word “or” is explicitly limited to meaning only a single item other than those in a list having two or more items, its use in such a list should be interpreted as including any single item in list (a), all items in list (b), or any combination of items in list (c). Furthermore, the terms “comprising,” etc., throughout this disclosure are used to mean including at least one or more of the listed features, such that no further number of one or more of the same features and / or one or more features of another type are excluded. Directional terms such as “up,” “down,” “front,” “back,” “vertical,” and “horizontal” may be used herein to express and clarify relationships between various elements. It should be understood that such terms do not indicate absolute orientation. References herein to “an embodiment,” “embodiment,” or similar expressions mean that a particular feature, structure, operation, or characteristic described in connection with an embodiment may be included in at least one embodiment of the inventive technique. Therefore, the appearance of such phrases or expressions herein does not necessarily refer to the same embodiment. Furthermore, specific features, structures, operations, or characteristics can be combined in one or more embodiments in any suitable manner.

Claims

1. A treatment device comprising: an elongated member having a proximal portion and a distal portion, the distal portion configured to be positioned within a blood vessel at a treatment site at or near a thrombus; and a distal element having a proximal end and a distal end, the distal end directly coupled to the distal portion of the elongated member by a connection assembly, the distal end comprising a curved distal surface, wherein the distal end is not coupled to the elongated member such that the distal end is freely movable relative to the elongated member, and wherein the distal element comprises an expandable mesh having an inner layer and an outer layer that coincide with one another at the distal end to form the curved distal surface, wherein the expandable mesh has a constrained state for delivery to the treatment site and an expanded state in which the distal element has an aperture at its distal portion and wherein the elongated member extends through the aperture, wherein in the expanded state, the distal element is configured to expand into contact with a blood vessel wall at the treatment site and anchor and / or stabilize the elongated member within the blood vessel.

2. The treatment device of claim 1, wherein edges of the aperture are formed by the mesh.

3. The treatment device of claim 2, wherein edges of the aperture are formed by the mesh around an entire perimeter of the aperture.

4. The treatment device of claim 2, wherein the mesh comprises filaments and the filaments form the edges of the aperture.

5. The treatment device of claim 1, wherein the distal element is configured to rotate around the elongated member.

6. The treatment device of claim 1, wherein the elongated member extends through at least a portion of a cavity of the distal element.

7. The treatment device of claim 1, wherein the elongated member comprises an elongated tubular element having an inner lumen extending therethrough.

8. The treatment device of claim 7, wherein the elongated tubular element is a hypotube.

9. The treatment device of claim 7, wherein a distal portion of the elongated tubular element is connected to a proximal portion of the connection assembly.

10. The treatment device of claim 1, further comprising a coil positioned around a region of the elongated member proximal of the connection assembly.

11. The treatment device of claim 1, further comprising a coil positioned around a region of the elongated member distal of the connection assembly.

12. The treatment device of claim 1, wherein the expandable mesh comprises a plurality of filaments.

13. The treatment device of claim 12, wherein each of the filaments has a first end and a second end opposite the first end, and wherein both the first and second ends of the filaments are fixed relative to one another at the connection assembly.

14. The treatment device of claim 12, wherein each of the filaments terminates at only one end of the distal element.

15. The treatment device of claim 14, wherein the filaments form an opening at an end of the distal element opposite the only one end.

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