Electrical endoluminal enhancement of material retrieval

Abstract

Material retrieval from a blood vessel lumen can be improved by the attachment of an electrical enhancement material to a medical device. The device can include an elongate core member having a treatment site configured to be positioned within a blood vessel lumen within a blood vessel, and an interventional element coupled to a distal portion of the elongate core member. The interventional element includes a body expandable from a first configuration to a second configuration and a conductive radiopaque marker coupled to the body. A conductive lead has a distal portion electrically coupled to the radiopaque marker and a proximal portion configured to be electrically coupled to a current source.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Patent Application No. 16 / 711,862, filed December 12, 2019, and U.S. Patent Application No. 16 / 711,858, filed December 12, 2019, each of which is incorporated herein by reference in its entirety. Technical Field

[0003] 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 vascular electroreduction. Background Technology

[0004] 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 breaks free from the device and flows downstream, the free material is highly likely to become lodged in smaller and more convoluted anatomical structures. In many cases, the physician will not 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.

[0005] Surgery intended to treat ischemic stroke by restoring blood flow within the brain's vascular system is affected by the aforementioned issues. 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 blood interruption persists long enough, the continued lack of nutrients and oxygen can lead to irreversible cell death. Therefore, providing immediate medical treatment for ischemic stroke is desirable.

[0006] 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 region of the cerebral vascular system. Once within the cerebral vascular system, the physician deploys devices to remove the obstruction causing the blockage. The focus on removing the obstruction or the migration of removed fragments increases the duration of the procedure, especially when restoring blood flow is critical. Furthermore, the physician may not be aware of one or more fragments removed from the initial obstruction that are causing blockages in smaller, more distal vessels.

[0007] Many physicians now use stents for thrombectomy (i.e., clot removal) to address ischemic stroke. Typically, a 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 traverse the vascular system and only begins to break down the clot upon reaching the clot material. tPA is also frequently administered to supplement stent effectiveness. However, if attempts to dissolve the clot are ineffective or incomplete, the physician may attempt to remove the stent while it expands against or embeds in 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.

[0008] For example, one drawback is that the stent may not adequately contain the clot as it is being 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 navigating bifurcated and tortuous anatomy. Furthermore, blood flow can carry the clot (or fragments of the clot) into the branch vessels of 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.

[0009] 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

[0010] Mechanical thrombectomy (i.e., grabbing and removing clots) has been effectively used to treat ischemic stroke. While most clots can be removed in a single pass, there are cases where multiple attempts are required to completely remove the clot and restore blood flow through the vessel. Additionally, complications arise when the interventional element and clot traverse tortuous intracranial vascular anatomy, due to clot detachment from the interventional element during the removal process. For example, detached clots or clot fragments may obstruct other arteries, leading to secondary stroke. Failure modes leading to clot release during removal include: (a) boundary conditions at bifurcations; (b) changes in vessel diameter; and (c) vessel tortuosity, etc.

[0011] Certain blood components, such as platelets and clotting proteins, exhibit a negative charge. The therapeutic system of this invention provides an interventional element carrying one or more electrodes and a current generator configured to positively charge the interventional element during one or more stages of a thrombectomy procedure. For example, the current generator may apply a constant or pulsating direct current (DC) to the electrodes. The positively charged electrodes and / or interventional element attract negatively charged blood components, thereby improving the adhesion of the thrombus to the interventional element and reducing the number of passes or attempts required to completely remove the clot.

[0012] One method of delivering current to an interventional element is to conduct the current along the core wire coupled to the proximal end of the interventional element. However, the inventors have found that this method can lead to unfavorable charge concentration along the proximal portion of the interventional element, while the charge density is insufficient in the more distal portions of the interventional element (e.g., along some or all of the working length of the interventional element). This is particularly true for interventional elements with a proximal portion that tapers towards the connection point with the core wire. Since mechanical clot adhesion occurs primarily away from the region of highest charge density, this current concentration in the proximal portion can reduce the effectiveness of electrostatic enhancement of clot adhesion. Furthermore, delivering current in this manner may require a hypotube or other additional structural elements coupled to the core wire, thereby stiffening the core assembly and making navigation of tortuous vascular systems more difficult.

[0013] To overcome these and other problems, in some aspects of this technology, the treatment system may include one or more electrodes carried by or otherwise coupled to the interventional element. The electrodes may take the form of radiopaque markers fixed to a portion of the interventional element and may be arranged to improve charge distribution on the surface of the interventional element during treatment. For example, by delivering current to the electrodes fixed to the interventional element, charge may be concentrated in selected areas of the interventional element (e.g., areas adjacent to the delivery electrodes).

[0014] Current can flow to the delivery electrode via multiple leads extending between the current generator (which may be placed externally) and the electrode. One or more return electrodes may also be coupled to the interventional element and optionally serve as radiopaque markers. Alternatively or additionally, the return electrode may be positioned in other locations (e.g., needles, grounding pads, conductive elements carried by one or more catheters of the treatment system, wires, and / or any other suitable conductive elements configured to complete the circuitry with the delivery electrode and the externally positioned current generator). When the interventional element is placed in the presence of blood (or any other electrolytic medium) and a voltage is applied at the terminals of the current generator, current flows along the leads to the delivery electrode and the interventional element, through the blood, and to the return electrode, thereby positively charging at least a portion of the interventional element and adhering clot material to the interventional element.

[0015] The treatment systems and methods of this technology can further improve clot adhesion to the interventional element by positioning delivery electrodes relative to the interventional element in a manner that improves charge distribution and / or by altering the characteristics of the interventional element. For example, in some embodiments, some or all of the interventional element may be coated with one or more highly conductive materials such as gold to improve clot adhesion. In some aspects of the present invention, the working length of the interventional element may be coated with a conductive material, while the non-working length of the interventional element may be coated with an insulating material.

[0016] For example, the present invention is illustrated by various aspects described below. For convenience, various embodiments of the various 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 dependent clauses may be combined in any combination and are placed in the corresponding independent clauses. Other clauses may be presented in a similar manner.

[0017] 1. A medical device comprising:

[0018] An elongated core member having a distal portion configured to be positioned intravascularly at a treatment site within the lumen of a blood vessel; and

[0019] An interventional element coupled to a distal portion of a core member, the interventional element comprising:

[0020] The main body, which can be extended from the first configuration to the second configuration;

[0021] A non-transparent element coupled to the body, the non-transparent element comprising a conductive material;

[0022] A conductive lead having a distal portion electrically coupled to a nontransmissive element and a proximal portion configured to be electrically coupled to a current source.

[0023] 2. The apparatus of Clause 1, wherein the body comprises a conductive material.

[0024] 3. The apparatus according to any one of the preceding clauses, wherein the body is electrically connected to the non-transmissive element.

[0025] 4. The apparatus according to any one of the preceding clauses, wherein at least a portion of the conductive lead along its length is electrically insulated.

[0026] 5. The apparatus according to any one of the preceding clauses, wherein the conductive lead extends proximally along the core member.

[0027] 6. The apparatus according to any one of the preceding clauses, wherein the conductive lead and the core member are coupled together along at least a portion of their respective lengths.

[0028] 7. The apparatus according to any one of the preceding clauses, wherein the conductive lead comprises at least one of the following: copper or nitinol.

[0029] 8. The device according to any one of the preceding clauses, wherein the conductive lead comprises a wire with a diameter between about 0.005 and 0.02 mm.

[0030] 9. The apparatus according to any one of the preceding clauses, wherein the non-transmissive element includes a coil coupled to a portion of the body.

[0031] 10. The apparatus according to any one of the preceding clauses, wherein the non-transmissive element is coupled to the distally extending tip of the body.

[0032] 11. The apparatus according to any one of the preceding clauses, wherein the body comprises a plurality of pillars forming a plurality of units, and wherein the non-transparent element is coupled to one of the pillars.

[0033] 12. The apparatus according to any one of the preceding clauses, wherein the body comprises a plurality of pillars forming a plurality of units, and wherein the non-transparent element is coupled to a protrusion extending from one of the pillars.

[0034] 13. The apparatus according to any one of the preceding clauses, wherein the non-transmissive element comprises a strip.

[0035] 14. The apparatus according to any one of the foregoing clauses, further comprising:

[0036] Multiple transmissive elements coupled to the body, each element comprising a conductive material; and

[0037] Multiple conductive leads, each having a distal portion electrically coupled to one of the multiple transmissive elements and a proximal portion configured to be electrically coupled to a current source.

[0038] 15. The apparatus according to any one of the preceding clauses, wherein the plurality of conductive leads are bundled together along at least a portion of their respective lengths.

[0039] 16. The apparatus according to any one of the preceding clauses, wherein a first group of the plurality of transmissive elements is configured as a delivery electrode, and wherein a second group of the plurality of transmissive elements is configured as a return electrode.

[0040] 17. The apparatus according to any one of the preceding clauses, wherein the delivery electrode is arranged within the working length of the body, and wherein the return electrode is arranged within the non-working length of the body.

[0041] 18. The apparatus according to any one of the preceding clauses, wherein the delivery electrode is arranged near the return electrode.

[0042] 19. The apparatus according to any one of the preceding clauses, wherein the plurality of transmissive elements are configured to serve as delivery electrodes, the apparatus further comprising a return electrode configured to be coupled to the current source.

[0043] 20. The apparatus according to any one of the preceding clauses, wherein the transmissive element is configured to serve as a delivery electrode, and wherein the conductive lead is a first conductive lead, the apparatus further comprising:

[0044] Return electrode; and

[0045] The second conductive lead has a distal portion electrically coupled to the return electrode and a proximal portion configured to be electrically coupled to the current source.

[0046] 21. The apparatus according to any one of the preceding clauses, wherein the return electrode comprises a needle or a grounding pad.

[0047] 22. The apparatus according to any one of the preceding clauses, wherein the return electrode includes an exposed conductive member disposed near the proximal portion of the interventional element.

[0048] 23. The apparatus according to any one of the preceding clauses, wherein the exposed conductive components are not carried by the main body.

[0049] 24. The apparatus according to any one of the preceding clauses, wherein the transmissive element is a first transmissive element, and the return electrode includes a second transmissive element coupled to the body and comprising a conductive material.

[0050] 25. The apparatus according to any one of the preceding clauses, wherein the first nontransparent element is arranged within the working length of the body, and wherein the second nontransparent element is arranged within the non-working length of the body.

[0051] 26. The apparatus according to any one of the preceding clauses, wherein the first nontransparent element and the second nontransparent element are each arranged within the working length of the body.

[0052] 27. The apparatus according to any one of the preceding clauses, wherein the first transmissive element is disposed within the central portion of the body, and wherein the second transmissive element is disposed in the distal portion of the body.

[0053] 28. The apparatus according to any one of the preceding clauses, wherein the first conductive lead and the second conductive lead each extend proximally along the core member.

[0054] 29. The apparatus according to any one of the preceding clauses, wherein the first conductive lead, the second conductive lead, and the core member are non-sliply coupled together along at least a portion of their respective lengths.

[0055] 30. The apparatus according to any one of the preceding clauses, wherein the first conductive lead, the second conductive lead, and the core member are bundled together along at least a portion of their respective lengths.

[0056] 31. The apparatus according to any one of the preceding clauses, wherein the radiopaque element includes a radiopaque marker.

[0057] 32. The apparatus according to any one of the preceding clauses, wherein the current source comprises a current generator.

[0058] 33. The device according to any one of the preceding clauses, wherein the interventional element comprises a thrombectomy device.

[0059] 34. The device according to any one of the preceding clauses, wherein the interventional element comprises a stent retriever.

[0060] 35. The apparatus according to any one of the preceding clauses, wherein the interventional element includes a removal device.

[0061] 36. The device according to any one of the preceding clauses, wherein a portion of the intervention element is coated with a conductive material.

[0062] 37. The apparatus according to any one of the preceding clauses, wherein the conductive material comprises gold.

[0063] 38. The device according to any one of the preceding clauses, wherein a portion of the intervention element is coated with a conductive material.

[0064] 39. The apparatus according to any one of the preceding clauses, wherein the non-conductive material comprises parylene.

[0065] 40. A system comprising:

[0066] The apparatus according to any one of the foregoing clauses; and

[0067] A current source, electrically coupled to the conductive lead.

[0068] 41. A medical device comprising:

[0069] Thrombolysis element, comprising:

[0070] The main body, configured to bind the thrombus; and

[0071] A conductive, non-transmissive element coupled to the body; and

[0072] A conductive lead, which is electrically connected to the non-transmissive element, is configured to be electrically coupled to a current source.

[0073] 42. The apparatus according to any one of the preceding clauses, wherein the body comprises a conductive material.

[0074] 43. The apparatus according to any one of the preceding clauses, wherein the body is electrically connected to the non-transmissive element.

[0075] 44. The apparatus according to any one of the preceding clauses, wherein at least a portion of the conductive lead along its length is electrically insulated.

[0076] 45. The apparatus according to any one of the preceding clauses, wherein the radiopaque element includes a radiopaque marker.

[0077] 46. ​​The apparatus according to any one of the preceding clauses, wherein the non-transmissive element comprises a coil wound around a portion of the body.

[0078] 47. The apparatus according to any one of the preceding clauses, wherein the non-transmissive element is coupled to the distal tip of the body.

[0079] 48. The apparatus according to any one of the preceding clauses, wherein the body comprises a plurality of pillars forming a plurality of units, and wherein the non-transparent element is coupled to one of the pillars.

[0080] 49. The apparatus according to any one of the preceding clauses, wherein the body comprises a plurality of pillars forming a plurality of units, and wherein the non-transparent element is coupled to a protrusion extending from one of the pillars.

[0081] 50. The apparatus according to any one of the preceding clauses, wherein the non-transmissive element comprises a strip.

[0082] 51. The apparatus according to any one of the preceding clauses, further comprising:

[0083] Multiple conductive, non-transmissive elements coupled to the main body; and

[0084] Multiple conductive leads, each electrically coupled to one of the multiple non-transmissive elements and configured to be electrically coupled to a current source.

[0085] 52. The apparatus according to any one of the preceding clauses, wherein the plurality of conductive leads are bundled together along at least a portion of their respective lengths.

[0086] 53. The apparatus according to any one of the preceding clauses, wherein a first group of the plurality of transmissive elements is configured as a delivery electrode, and wherein a second group of the plurality of transmissive elements is configured as a return electrode.

[0087] 54. The apparatus according to any one of the preceding clauses, wherein the delivery electrode is arranged within the working length of the body, and wherein the return electrode is arranged within the non-working length of the body.

[0088] 55. The apparatus according to any one of the preceding clauses, wherein the plurality of transmissive elements are configured to serve as delivery electrodes, the apparatus further comprising a return electrode configured to be coupled to the current source.

[0089] 56. The apparatus according to any one of the preceding clauses, wherein the transmissive element is configured to serve as a delivery electrode, and wherein the conductive lead is a first conductive lead, the apparatus further comprising:

[0090] Return electrode; and

[0091] The second conductive lead has a distal portion electrically coupled to the return electrode and a proximal portion configured to be electrically coupled to the current source.

[0092] 57. The apparatus according to any one of the preceding clauses, wherein the return electrode comprises a needle or a grounding pad.

[0093] 58. The device according to any one of the preceding clauses, wherein the return electrode includes an exposed conductive member disposed near the proximal portion of the thrombectomy element.

[0094] 59. The apparatus according to any one of the preceding clauses, wherein the exposed conductive component is not carried by the main body.

[0095] 60. The apparatus according to any one of the preceding clauses, wherein the transmissive element is a first transmissive element, and the return electrode includes a second transmissive element coupled to the body and comprising a conductive material.

[0096] 61. The apparatus according to any one of the preceding clauses, wherein the first nontransparent element is arranged within the working length of the body, and wherein the second nontransparent element is arranged within the non-working length of the body.

[0097] 62. The apparatus according to any one of the preceding clauses, wherein the first nontransparent element and the second nontransparent element are each arranged within the working length of the body.

[0098] 63. The apparatus according to any one of the preceding clauses, wherein the first transmissive element is disposed within the central portion of the body, and wherein the second transmissive element is disposed in the distal portion of the body.

[0099] 64. The apparatus according to any one of the preceding clauses, wherein the current source comprises a current generator.

[0100] 65. The device according to any one of the preceding clauses, wherein the thrombectomy element comprises a stent thrombectomy device.

[0101] 66. The device according to any one of the preceding clauses, wherein a portion of the thrombectomy element is coated with a conductive material.

[0102] 67. The device according to any one of the preceding clauses, wherein a portion of the thrombectomy element is coated with a non-conductive material.

[0103] 68. A method comprising:

[0104] The thrombectomy device is advanced via a catheter to an intravascular treatment site, the thrombectomy device comprising:

[0105] The main body, which can be extended from the first configuration to the second configuration;

[0106] A non-transparent element coupled to the body, the non-transparent element comprising a conductive material; and

[0107] Current is supplied to the non-transparent element.

[0108] 69. The method according to any one of the preceding clauses, wherein current is supplied to the non-transmissive element such that the current is transmitted to the thrombectomy device.

[0109] 70. The method according to any one of the preceding clauses, wherein the thrombectomy device comprises a conductive material.

[0110] 71. The method according to any one of the preceding clauses, wherein the thrombectomy device further comprises a plurality of radiopaque elements coupled to the body and comprising a conductive material, the method further comprising supplying current to the plurality of radiopaque elements.

[0111] 72. The method according to any one of the preceding clauses, wherein the transmissive element is coupled to a protrusion extending from the strut of the body.

[0112] 73. The method according to any one of the preceding clauses, wherein the transmissive element is coupled to the distally extending tip of the body.

[0113] 74. The method according to any one of the preceding clauses, wherein the non-transmissive element comprises at least one of the following: a coil or a strip.

[0114] 75. The method according to any one of the preceding clauses, wherein the radiopaque element includes a radiopaque marker.

[0115] 76. The method according to any one of the preceding clauses, wherein the supply current generates a positive charge along at least a portion of the body.

[0116] 77. The method according to any one of the preceding clauses, further comprising concentrating the positive charge along a working length of the body, wherein the proximal end of the working length is located distal to the proximal end of the body, and the distal end of the working length is located proximal to the distal end of the body.

[0117] 78. The method according to any one of the preceding clauses, wherein supplying current includes supplying direct current to the non-transmissive element.

[0118] 79. The method according to any one of the preceding clauses, wherein supplying current includes delivering pulsating current to a nontransmissive element.

[0119] 80. The method according to any one of the preceding clauses, wherein supplying current comprises supplying current to a nontransmissive element, said current having an amplitude between about 0.5 mA and about 5 mA.

[0120] 81. The method according to any one of the preceding clauses, wherein supplying current comprises supplying current to a nontransparent element having an amplitude of about 2 mA.

[0121] 82. The method according to any one of the preceding clauses, wherein the thrombectomy device includes a stent thrombectomy device.

[0122] 83. The method according to any one of the preceding clauses, wherein the thrombectomy device is a laser-cutting stent or mesh.

[0123] 84. A thrombectomy device, comprising:

[0124] A main body, which can be extended from a first configuration to a second configuration, the main body having a working length portion and a non-working length portion arranged proximal to the working length portion;

[0125] One or more electrodes coupled to the body within the working length portion;

[0126] One or more conductive leads electrically coupled to one or more electrodes, the conductive leads being configured to be electrically coupled to a current source.

[0127] The electrodes are configured such that when current is supplied to the conductive lead via the current source, the charge density in the working length portion is greater than the charge density in the non-working length portion.

[0128] 85. The apparatus according to any one of the preceding clauses, wherein the non-working length portion includes a proximal tapered section, and wherein the working length portion includes a non-tapered section.

[0129] 86. The device according to any one of the preceding clauses, wherein the working length portion includes a segment of the body configured to mechanically engage with a thrombus.

[0130] 87. The apparatus according to any one of the preceding clauses, wherein the one or more electrodes are non-transmissive.

[0131] 88. The apparatus according to any one of the preceding clauses, wherein the one or more electrodes comprise platinum, gold, or copper.

[0132] 89. The apparatus according to any one of the preceding clauses, wherein the one or more electrodes comprise a coil, a strip, a cap, or a tube.

[0133] 90. The apparatus according to any one of the preceding clauses, wherein the body comprises a plurality of pillars forming a plurality of units, and wherein one or more of the electrodes are coupled to one of the pillars.

[0134] 91. The apparatus according to any one of the preceding clauses, wherein the body includes a plurality of pillars forming a plurality of units, and wherein one or more of the electrodes are coupled to a protrusion extending from one of the pillars.

[0135] 92. The apparatus according to any one of the preceding clauses, wherein the body comprises a conductive material.

[0136] 93. The apparatus according to any one of the preceding clauses, wherein the body is electrically connected to the one or more electrodes.

[0137] 94. The apparatus according to any one of the preceding clauses, wherein the body comprises a conductive material.

[0138] 95. The apparatus according to any one of the preceding clauses, wherein the one or more electrodes are electrically coupled to the body within the working length portion.

[0139] 96. The apparatus according to any one of the preceding clauses, wherein at least a portion of the conductive lead along its length is electrically insulated.

[0140] 97. The apparatus according to any one of the foregoing clauses, further comprising:

[0141] Multiple electrodes coupled to the body; and

[0142] Multiple conductive leads, each electrically coupled to one of the multiple electrodes and configured to be electrically coupled to the current source.

[0143] 98. The apparatus according to any one of the preceding clauses, wherein the plurality of conductive leads are bundled together along at least a portion of their respective lengths.

[0144] 99. The apparatus according to any one of the preceding clauses, wherein a first set of the plurality of electrodes is configured to serve as a delivery electrode, and wherein a second set of the plurality of electrodes is configured to serve as a return electrode.

[0145] 100. The apparatus according to any one of the preceding clauses, wherein the delivery electrode is arranged within the working length of the body, and wherein the return electrode is arranged within the non-working length of the body.

[0146] 101. The apparatus according to any one of the preceding clauses, wherein the plurality of electrodes are configured to serve as delivery electrodes, the apparatus further comprising a return electrode configured to be coupled to the current source.

[0147] 102. The apparatus according to any one of the preceding clauses, wherein the one or more electrodes are configured to serve as delivery electrodes, and wherein the conductive lead is a first conductive lead, the apparatus further comprising:

[0148] Return electrode; and

[0149] The second conductive lead has a distal portion electrically coupled to the return electrode and a proximal portion configured to be electrically coupled to the current source.

[0150] 103. The apparatus according to any one of the preceding clauses, wherein the return electrode comprises a needle or a grounding pad.

[0151] 104. The apparatus according to any one of the preceding clauses, wherein the return electrode includes an exposed conductive member disposed near the proximal portion of the body.

[0152] 105. The apparatus according to any one of the preceding clauses, wherein the exposed conductive components are not carried by the body.

[0153] 106. The apparatus according to any one of the preceding clauses, wherein the return electrode includes a radiopaque marker coupled to the body and includes a conductive material.

[0154] 107. The apparatus according to any one of the preceding clauses, wherein the delivery electrode is arranged within the working length of the body, and wherein the return electrode is arranged within the non-working length of the body.

[0155] 108. The apparatus according to any one of the preceding clauses, wherein the delivery electrode and the return electrode are each arranged within the working length of the body.

[0156] 109. The apparatus according to any one of the preceding clauses, wherein the body comprises a stent removal device.

[0157] 110. The apparatus according to any one of the preceding clauses, wherein a portion of the body is coated with a conductive material.

[0158] 111. The device according to any one of the preceding clauses, wherein a portion of the body is coated with a non-conductive material.

[0159] 112. A thrombectomy device, comprising:

[0160] A body that can be extended from a first configuration to a second configuration, the body having a proximal conical portion and a distal portion;

[0161] Multiple electrodes coupled to the body;

[0162] Multiple conductive leads are electrically coupled to the electrode, and the conductive leads are configured to be electrically coupled to a current source.

[0163] The electrodes are configured such that when current is supplied to the conductive lead via the current source, the charge density in the distal portion is greater than the charge density in the proximal tapered portion.

[0164] 113. The apparatus according to any one of the preceding clauses, wherein the electrode is non-transmissive.

[0165] 114. The apparatus according to any one of the preceding clauses, wherein the electrode comprises platinum, gold or copper.

[0166] 115. The apparatus according to any one of the preceding clauses, wherein each of the electrodes comprises a coil, a strip, a cap, or a tube.

[0167] 116. The apparatus according to any one of the preceding clauses, wherein the electrode is coupled to the body in the distal portion.

[0168] 117. The apparatus according to clause 112, wherein the electrode is electrically coupled to the body.

[0169] 118. The apparatus according to any one of the preceding clauses, wherein the body comprises a plurality of pillars forming a plurality of units, and wherein at least one of the electrodes is coupled to one of the pillars.

[0170] 119. The apparatus according to any one of the preceding clauses, wherein the body includes a plurality of pillars forming a plurality of units, and wherein at least one of the electrodes is coupled to a protrusion extending from one of the pillars.

[0171] 120. The apparatus according to any one of the preceding clauses, wherein the body comprises a conductive material.

[0172] 121. The apparatus according to any one of the preceding clauses, wherein the body is electrically connected to the electrode.

[0173] 122. The apparatus according to any one of the preceding clauses, wherein at least a portion of the conductive leads along their respective lengths is electrically insulated.

[0174] 123. The apparatus according to any one of the preceding clauses, wherein the plurality of conductive leads are bundled together along at least a portion of their respective lengths.

[0175] 124. The apparatus according to any one of the preceding clauses, wherein a first group of the plurality of electrodes is configured to serve as a delivery electrode, and wherein a second group of the plurality of electrodes is configured to serve as a return electrode.

[0176] 125. The apparatus according to any one of the preceding clauses, wherein the delivery electrode is arranged within the working length of the body, and wherein the return electrode is arranged within the non-working length of the body.

[0177] 126. The apparatus according to any one of the preceding clauses, wherein the plurality of electrodes are configured to serve as delivery electrodes, the apparatus further comprising a return electrode configured to be coupled to the current source.

[0178] 127. The apparatus according to any one of the preceding clauses, wherein the plurality of electrodes are configured to serve as delivery electrodes, the apparatus further comprising:

[0179] Return electrode; and

[0180] A conductive return lead having a distal portion electrically coupled to the return electrode and a proximal portion configured to be electrically coupled to the current source.

[0181] 128. The apparatus according to any one of the preceding clauses, wherein the return electrode comprises a needle or a grounding pad.

[0182] 129. The apparatus according to any one of the preceding clauses, wherein the return electrode includes an exposed conductive member disposed near a proximal portion of the body.

[0183] 130. The apparatus according to any one of the preceding clauses, wherein the exposed conductive component is not carried by the body.

[0184] 131. The apparatus according to any one of the preceding clauses, wherein the return electrode includes a radiopaque marker coupled to the body and includes a conductive material.

[0185] 132. The apparatus according to any one of the preceding clauses, wherein the delivery electrode is arranged within the working length of the body, and wherein the return electrode is arranged within the non-working length of the body.

[0186] 133. The apparatus according to any one of the preceding clauses, wherein the delivery electrode and the return electrode are each arranged within the working length of the body.

[0187] 134. The apparatus according to any one of the preceding clauses, wherein the body comprises a stent removal device.

[0188] 135. The apparatus according to any one of the preceding clauses, wherein a portion of the body is coated with a conductive material.

[0189] 136. The apparatus according to any one of the preceding clauses, wherein a portion of the body is coated with a non-conductive material.

[0190] 137. A medical device comprising:

[0191] The intervention element includes a body that can be extended from a first configuration to a second configuration, the body having a working length;

[0192] A shaft, which is coupled to the proximal end of the body and extends longitudinally therefrom;

[0193] At least one electrode is located within the working length and configured to be connected to a current source such that when at least one electrode is energized, the charge density around the body is maximized within the working length.

[0194] 138. The apparatus according to any one of the preceding clauses, wherein the at least one electrode is electrically coupled to the body.

[0195] 139. The apparatus according to any one of the preceding clauses, wherein the at least one electrode comprises a nontransparent element coupled to the body and comprises a conductive material.

[0196] 140. The apparatus according to any one of the preceding clauses, wherein the body comprises a plurality of pillars forming a plurality of units, and wherein the at least one electrode is coupled to one of the pillars.

[0197] 141. The apparatus according to any one of the preceding clauses, wherein the body includes a plurality of pillars forming a plurality of units, and wherein at least one of the electrodes is coupled to a protrusion extending from one of the pillars.

[0198] 142. The apparatus according to any one of the preceding clauses, wherein the at least one electrode includes a delivery electrode, and the apparatus further includes at least one return electrode.

[0199] 143. The apparatus according to any one of the preceding clauses, wherein the at least one return electrode is arranged within the non-working length of the body.

[0200] 144. The apparatus according to any one of the preceding clauses, wherein the at least one return electrode is electrically insulated from the body.

[0201] 145. The apparatus according to any one of the preceding clauses, wherein the return electrode comprises a nontransparent element coupled to the body and comprises a conductive material.

[0202] 146. The apparatus according to any one of the preceding clauses, wherein the interventional element comprises a stent retriever.

[0203] 147. A method comprising:

[0204] The thrombectomy device is advanced via a catheter to a target site on the body, the thrombectomy device comprising:

[0205] Expandable component, having a working length and a non-working length;

[0206] One or more delivery electrodes coupled to the expandable member within the working length;

[0207] Current is supplied to the delivery electrode such that the charge density along the working length of the expandable member is greater than the charge density along the non-working length of the expandable member.

[0208] 148. The method according to any one of the preceding clauses, wherein the supply current causes hydrogen to form at the target site.

[0209] 149. The method according to any one of the preceding clauses, wherein current is supplied to the delivery electrode such that current is transmitted to the thrombectomy device.

[0210] 150. The method according to any one of the preceding clauses, wherein the thrombectomy device comprises a conductive material.

[0211] 151. The method according to any one of the preceding clauses, wherein the thrombectomy device further includes a plurality of delivery electrodes coupled to the expandable member, and the method further includes supplying current to the plurality of delivery electrodes.

[0212] 152. The method according to any one of the preceding clauses, wherein the delivery electrode is coupled to a protrusion extending from the strut of the expandable member.

[0213] 153. The method according to any one of the preceding clauses, wherein the delivery electrode is coupled to the distally extending tip of the expandable member.

[0214] 154. The method according to any one of the preceding clauses, wherein the delivery electrode comprises at least one of the following: a coil or a strip.

[0215] 155. The method according to any one of the preceding clauses, wherein the supply current generates a positive charge along at least a portion of the expandable member.

[0216] 156. The method according to any one of the preceding clauses, wherein the proximal end of the working length is distal to the proximal end of the expandable member, and the distal end of the working length is proximal to the distal end of the expandable member.

[0217] 157. The method according to any one of the preceding clauses, wherein supplying current includes delivering direct current to the delivery electrode.

[0218] 158. The method according to any one of the preceding clauses, wherein supplying current includes delivering a pulsed current to the delivery electrode.

[0219] 159. The method according to any one of the preceding clauses, wherein supplying current comprises supplying current to the delivery electrode, the current having an amplitude of about 0.5 mA to about 5 mA.

[0220] 160. The method according to any one of the preceding clauses, wherein the supply current comprises supplying a current to the delivery electrode having an amplitude of about 2 mA.

[0221] 161. The method according to any one of the preceding clauses, wherein the thrombectomy device includes a stent thrombectomy device.

[0222] 162. The method according to any one of the preceding clauses, wherein the thrombectomy device is a laser-cutting stent or mesh.

[0223] 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

[0224] 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.

[0225] Figure 1A A perspective view of an electro-enhanced therapy system for removing material from a body cavity, according to one or more embodiments of the technology of the present invention, is shown.

[0226] Figure 1B and 1C yes Figure 1A Schematic diagrams showing different implementations of the current generator.

[0227] Figure 2 yes Figure 1A A side view of the distal portion of the treatment system.

[0228] Figure 3A An interventional element carrying multiple electrodes in an deployed state, according to an embodiment of the present technology, is shown.

[0229] Figure 3B The illustration shows another embodiment of an interventional element carrying multiple electrodes in its deployed state.

[0230] Figure 4 yes Figure 3A Detailed view of section 4-4 shown.

[0231] Figure 5 yes Figure 3ADetailed view of section 5-5 shown.

[0232] Figure 6 yes Figure 3B Detailed view of section 6-6 shown.

[0233] Figure 7-10 A cross-sectional view of an electrode mounted on an interventional element according to an embodiment of the present technology is shown.

[0234] Figure 11-13 Another embodiment of the interventional element carrying the electrode is shown.

[0235] Figure 14A This is a side sectional view of a lead bundle assembly according to an embodiment of the present technology.

[0236] Figure 14B yes Figure 14A A cross-sectional view of the lead wire bundle assembly.

[0237] Figure 15A This is a side sectional view of a lead bundle assembly according to an embodiment of the present technology.

[0238] Figure 15B yes Figure 15A A cross-sectional view of the lead wire bundle assembly.

[0239] Figure 16A This is a side sectional view of a lead bundle assembly according to an embodiment of the present technology.

[0240] Figure 16B yes Figure 16A A cross-sectional view of the lead wire bundling assembly.

[0241] Figures 17A-17D A method for removing clot material from the lumen of a blood vessel using an electro-enhanced therapy system is shown.

[0242] Figure 18A –18E 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

[0243] This invention provides apparatus, systems, and methods for removing clot material from the lumen of blood vessels. Although many 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) 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). 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.).

[0244] I. Overview of Electro-Enhanced Therapy Systems

[0245] Figure 1A A view of an electro-enhanced therapy system 10 according to one or more embodiments of the present invention is shown. Figure 1A As shown, the treatment system 10 may include a current generator 20 and a treatment device 40 having a proximal portion 40a and a distal portion 40b. 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 within a blood vessel (e.g., an intracranial vessel), at or near a thrombus. The treatment device 40 includes an interventional element 100 at the distal portion 10b, a handle 16 at the proximal portion 10a, and a plurality of elongated shafts or members extending therebetween. For example, in some embodiments, such as Figure 1A As shown, the treatment device 40 includes a first catheter 14 (e.g., a balloon-guided catheter); a second catheter 13 (e.g., a distal access catheter or aspiration catheter) configured to slide within the lumen of the first catheter 14; a third catheter 12 (e.g., a microcatheter) configured to slide within the lumen of the second catheter 13; and a core member 11 configured to slide within the lumen of the third catheter 12. In some embodiments, the treatment device 40 does not include the second catheter 13. The first catheter 14 may be coupled to a handle 16 that provides proximal access to the core member 11, which engages the interventional element 100 at its distal end. A current generator 20 may be coupled to the proximal portion of one or more leads (not shown) to deliver current to the interventional element 100, thereby providing an electrified environment at the distal portion 40b of the treatment device 40, as described in more detail below.

[0246] In some embodiments, the treatment system 10 includes an aspiration 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 14, second catheter 13, and / or third catheter 12 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 14, second catheter 13, and / or third catheter 12 to supply fluid (e.g., saline, contrast agent, medication such as a thrombolytic agent, etc.) to the treatment site.

[0247] According to some embodiments, catheters 12, 13, and 14 may each be formed as generally tubular members extending along and about a central axis. According to some embodiments, the third catheter 12 is typically configured to follow a conventional guidewire in the cervical anatomy and enter a cerebral blood vessel associated with the brain, and may also be selected according to several standard designs commonly available. Thus, the length of the third catheter 12 may be at least 125 cm, and more specifically, may be between about 125 cm and about 175 cm. Other designs and sizes are contemplated.

[0248] The size of the second catheter 13 can be set and configured to slidably accommodate the third catheter 12 passing through it. As described above, the second catheter 13 can be coupled to the suction source 25 at its proximal portion. Figure 1A (e.g., a pump or syringe) to supply negative pressure to the treatment site. The size of the first catheter 14 can be set and configured to slidably accommodate both the second catheter 13 and the third catheter 12 passing through it. In some embodiments, the first catheter 14 is a balloon guiding catheter having an inflatable balloon or other expandable member surrounding the catheter axis at or near its distal end. (See below for more details.) Figures 17A-17D In a more detailed description, during the procedure, the first catheter 14 may first be advanced through the blood vessel, and its balloon may then be inflated to anchor the first catheter 14 in place and / or block blood flow from a region proximal to the balloon, for example to enhance the effectiveness of aspiration performed through the first catheter 14 and / or other catheters. Next, the second catheter 13 may be advanced through the first catheter 14 until its distal end extends distally beyond the distal end of the first catheter 14. The second catheter 13 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, the third catheter 12 may be advanced through the second catheter 13 until its distal end extends distally beyond the distal end of the second catheter 13. The interventional element 100 may then be advanced through the third catheter 12 for delivery to the treatment site.

[0249] According to some embodiments, the bodies of conduits 12, 13, and 14 can be made of various thermoplastics, such as polytetrafluoroethylene (PTFE or TEFLON®), fluorinated ethylene propylene (FEP), high-density polyethylene (HDPE), polyetheretherketone (PEEK), etc., which may optionally be lined with a hydrophilic material, such as polyvinylpyrrolidone (PVP), or some other plastic coating on the inner or adjacent surfaces of the conduits. Furthermore, depending on the desired outcome, any surface may be coated with various combinations of different materials.

[0250] According to some embodiments, the current generator 20 may include a generator configured to output a medically useful current. Figure 1B and 1C This is a schematic diagram of different implementations of the current generator 20. (Reference) Figure 1B The current generator 20 may include a power supply 22, a first terminal 24, a second terminal 26, and a controller 28. The controller 28 includes a processor 30 coupled to a memory 32 that stores instructions (e.g., in the form of processor- or controller-executable software, code, or program instructions) for causing the power supply 22 to deliver current according to certain parameters provided by software, code, etc. The power supply 22 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 that can be used to control 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.

[0251] Figure 1C Another embodiment of the current generator 20 is shown, wherein Figure 1B The controller 28 is replaced by a drive circuit system 34. In this embodiment, the current generator 20 may include hardwired circuit elements that provide the desired waveform delivery, instead of... Figure 1B A software-based generator. The drive circuit system 34 may include, for example, analog circuit elements (e.g., resistors, diodes, switches, etc.) configured to cause the power supply 22 to deliver current through the first terminal 24 and the second terminal 26 according to desired parameters. For example, the drive circuit system 34 may be configured to cause the power supply 22 to deliver a periodic waveform through the first terminal 24 and the second terminal 26. The following section discusses... Figures 18A-18E A more detailed description is given of the specific parameters of the energy provided by the current generator 20.

[0252] In some embodiments, one or more electrodes may be carried, coupled to, or mounted on the interventional element 100 (or the electrodes may include conductive elements or surfaces other than radiopaque elements / markers, if any). The electrodes may optionally take the form of radiopaque elements or marks attached to a portion of the interventional element 100 and may be arranged to provide and / or improve charge distribution on the surface of the interventional element 100 during treatment. Current may be delivered to the electrodes via a plurality of corresponding electrical leads extending between the current generator 20 and the electrodes attached to the interventional element 100. The electrodes may include delivery electrodes and one or more return electrodes, which may also be coupled to or formed on the interventional element 100, or may be located elsewhere (e.g., as external electrode 29 or others, which will be explained in more detail below). When the interventional element 100 is placed in the presence of blood (or thrombus, and / or any other electrolyte medium that may be present, such as saline) and a voltage is applied at the terminals of the current generator 20, current flows out of the generator along the leads to the delivery electrode (and, optionally, to the interventional element 100 itself) and through the blood (and / or other medium) to the return electrode, thereby making at least a portion of the interventional element 100 positively charged and promoting clot adhesion.

[0253] Figure 2 yes Figure 1A The diagram shows a side view of the distal portion 40b of the treatment device 40. As shown, the interventional element 100 may include a plurality of electrodes 202 disposed thereon. The electrodes 202 may take the form of conductive members or surfaces coupled to or integrated into the body of the interventional element 100 at different locations. For example, each electrode 202 may be coupled to a strut, a protrusion extending away from the strut, a distally extending tip, or any other suitable portion of the interventional element 100. In some embodiments, the electrodes 202 may be radiopaque so that they are visible under fluorescence fluoroscopy. (Generally, as used herein, "radiopaque" means an element or component that is more visible under fluorescence fluoroscopy than an adjacent portion of the interventional element 100 itself.) In such a configuration, the electrodes 202 may serve as both radiopaque markers and electrodes. According to some embodiments, some or all of the electrodes 202 may take the form of coils, tubes, strips, plates, traces, or any other suitable conductive structure, or a structure that is both conductive and radiopaque. Exemplary materials for the electrode include copper, stainless steel, nitinol, platinum, gold, iridium, tantalum, alloys thereof, or any other suitable conductive material, or a material that is both conductive and non-transparent. In some embodiments, electrode 202 is not non-transparent, and a separate non-transparent marker may or may not be used in conjunction with such a non-transparent electrode 202.

[0254] Electrodes 202 can each be coupled to a corresponding electrical lead 204, which may extend alongside, and / or be coupled to, wrapped around, or incorporated into the core member 11. Thus, when the thrombectomy device is used with the catheter 12, the leads can extend through the lumen of the catheter 12. The electrical leads 204 may be bundled together or otherwise combined in a lead bundle assembly 205 that extends proximally through the catheter 12 to the adjacent core member 11. The bundle assembly 205 may be coupled at its proximal portion to a current generator (e.g., current generator 20); Figure 1A Each individual lead 204 is electrically coupled to a current generator to deliver current to the corresponding electrode 202. Although Figure 2 A single electrical lead 204 coupled to each individual electrode 202 is shown, but in some embodiments, any subset of electrodes 202 may share an electrical connection via one or more leads 204. For example, a lead may extend between two electrodes 202, thereby electrically communicating with each other and with a generator or other current source when coupled thereto.

[0255] In some embodiments, a first subset of electrodes 202 may be electrically coupled to the positive terminal of current generator 20 via their respective leads 204, and thus serve as delivery electrodes. Simultaneously, a second subset of electrodes 202 may be electrically coupled to the negative terminal of current generator 20 via their respective leads 204, and accordingly serve as return electrodes. In some embodiments, some or all of the delivery electrodes 202 may be electrically connected to (or electrically insulated from) the body of interventional element 100, and may be conductive themselves. When some or all of the delivery electrodes 202 are electrically connected to the (conductive) body of interventional element 100, the positive / delivery lead 204 (e.g., a single such lead) may be electrically coupled to the body of interventional element 100 (e.g., at or near its proximal end), thereby being electrically connected to some or all of the delivery electrodes 202. Therefore, the current carried by the delivery electrode 202 can flow into the interventional element 100, thereby generating positive charge along at least a portion of the interventional element 100 (and any delivery electrode 202 coupled to the body of the interventional element; in some embodiments, a separate delivery electrode 202 may be omitted and the body of the interventional element (or its exposed portion) may be used as a delivery electrode). In some embodiments, one or more regions of the interventional element 100 may be coated with an insulating material such that the current transmitted from the delivery electrode 202 to the interventional element 100 will not be carried by the surface of the interventional element 100 in the coated region. As a result, the charge distribution on the surface of the interventional element 100 or along its length may be located in the regions of the interventional element 100 that are not coated with insulating material.

[0256] In some embodiments, the return electrode 202 may be carried by the interventional element 100 but electrically insulated from the body of the interventional element 100. For example, the return electrode 202 may be mounted on a portion of the interventional element 100, with an electrically insulating material disposed between them, such that the current carried by the return electrode 202 is coupled to the return electrode 202 via a corresponding lead 204 instead of passing through the body of the interventional element 100. In some embodiments, the return electrode 202 may be electrically connected to at least a portion of the interventional element 100.

[0257] During operation, the treatment system 10 can provide circuitry in which current flows distally from the positive terminal of the current generator 20 via delivery lead 204 to delivery electrode 202 and (optionally) to interventional element 100. The current then travels from the surface of interventional element 100 (when properly configured) through and to the surrounding medium (e.g., blood, tissue, thrombus, etc.), and then proximally through return lead 204 to the negative terminal of the current generator via return electrode 202 carried by interventional element 100.

[0258] Instead of the return electrode 202 carried as the intervention element 100, the return electrode can be configured in a variety of different ways. For example, in some embodiments, the return electrode is an external electrode 29. Figure 1A Such as a needle or grounding pad applied to the patient's skin. The needle or grounding pad may 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 12, a second conduit 13, and / or a first conduit 14). In some embodiments, the return electrode may be an insulated wire with an exposed conductive portion at its distal end, or an exposed conductive portion with a core member 11 near its distal end.

[0259] II. Selected Implementations of Interventional Elements for Use with the Treatment Systems Disclosed herein

[0260] Still referencing Figure 2In some embodiments, interventional element 100 may be a metallic or conductive thrombectomy device. For example, interventional element 100 may include or be made of stainless steel, nitinol, cobalt-chromium, platinum, tantalum, their alloys, or any other suitable material. Interventional element 100 may have a low-profile, restrained, or compressed configuration (not shown) for delivery into the treatment site vessel within the third catheter 12, and an extended configuration for securing and / or engaging clot material and / or for restoring blood flow at the treatment site. In some embodiments, interventional element 100 is a mesh structure (e.g., braid, stent, etc.) formed of a hyperelastic material (e.g., nitinol) or other elastic or self-expanding material configured to self-expand upon release from the third catheter 12. Interventional element 100 has a proximal portion 100a and a distal portion 100b, the proximal portion being coupled to core member 11. Interventional element 100 further includes an open cell framework or body 208 and a coupling region 210 extending proximally from body 208. In some embodiments, the body 208 of the interventional element 100 may be generally tubular (e.g., cylindrical), and the proximal portion 100a of the interventional element 100 may taper proximally within the coupling region 210.

[0261] In various embodiments, the interventional element 100 can take many forms, such as a removal device, a thrombectomy device, or other suitable medical device. For example, in some embodiments, the interventional element 100 may be a stent and / or a stent thrombectomy device, such as Medtronic's Solitaire. TM Trevo® ProVue, a vascular reconstruction device from Stryker Neurovascular. TM A stent remover or other suitable device. In some embodiments, the interventional element 100 may be a coiled wire, fabric, and / or braid formed of multiple braided filaments. Examples of suitable interventional elements 100 include any of the interventional elements disclosed in 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; and U.S. Patent No. 8,066,757, filed December 28, 2010, each of which is incorporated herein by reference in its entirety.

[0262] The core component 11 may include a shaft, for example, having sufficient column strength and tensile strength to facilitate movement of the thrombectomy device through the catheter. The core component 11 may include a wire, which may taper to a smaller diameter as it extends distally, if desired. This taper may be implemented as a gradual or continuous taper, or in multiple separate tapered sections separated by a constant diameter portion. Alternatively, the core component 11 may include a tube, such as a hypotube, and the tube / hypotube may be laser-cut in a helical or slotted manner (or other manner) to impart additional flexibility where needed. The core component may also include combinations of wires, tubes, braided shafts, etc.

[0263] For ease of understanding, Figure 3A An exemplary interventional element 100, on which multiple electrodes 202 are carried, is shown in a "planar" view. Figure 3A The interventional element 100 shown includes a working length WL and a non-working length NWL located proximal to the working length WL. For example, as... Figure 3A As shown, the non-working length NWL is arranged between the working length WL and the connection with the core member 11. In some embodiments, the intervention element 100 may include a frame or body having a plurality of struts 302 and a plurality of units 304 located between the struts, forming a mesh. Combinations of longitudinally and serially interconnected struts 302 may form a corrugated member 306 extending in a generally longitudinal direction. The struts 302 may be interconnected via connectors 308. While the struts are shown in a particular corrugated or zigzag configuration, in some embodiments the struts may have other configurations. In a rolled-up configuration, the frame of the intervention element 100 may have a generally tubular or generally cylindrical shape in some embodiments, while in other embodiments the frame may have a shape that is neither tubular nor cylindrical.

[0264] Figure 3A The working length WL of the interventional element shown includes a number of units 304. In embodiments where the interventional element 100 includes units, the dimensions and shapes of the units 304 in the working length and the interventional element portions forming them can be designed such that they penetrate, capture, or both of the thrombus as the working length expands into the thrombus. In some embodiments, portions of the interventional element 100 in the working length can capture the thrombus with a single unit 304 and / or with the exterior or radial exterior of the expanded interventional element 100. Additionally or alternatively, in some embodiments, portions of the interventional element 100 in the working length can contact, interlock, capture, or engage portions of the thrombus with a single unit 304 and / or with the interior or radial interior of the expanded interventional element 100.

[0265] like Figure 3AAs shown, for example, the non-working length (NWL) may include a tapered proximal portion 310 of the interventional element 100. The proximal portion 310 of the interventional element 100 may taper towards the proximal end of the interventional element 100. In some embodiments, the tapering of the proximal non-working portion 310 may advantageously facilitate retraction and repositioning of the treatment device 40 and the interventional element 100. For example, in some embodiments, the non-working length (NWL) facilitates retraction of the interventional element 100 into the catheter 12.

[0266] The intervention element 100 may include a first edge 314 and a second edge 316. For example, the first edge 314 and the second edge 316 may be formed by cutting sheet or tubing. Although the first and second edges are shown as having a wavy or zigzag configuration, in some embodiments, the first and second edges may have a straight or linear configuration or other configurations. In some embodiments, edges 314, 316 may be curved, straight, or a combination thereof along the proximal portion 310 of the tapered shape.

[0267] Figure 3A Multiple protrusions 318 are also shown, on which electrodes 202 or radiopaque markers may be mounted. Each protrusion 318 may be attached to a portion of the interventional element 100 that may come into contact with a thrombus during use of the interventional element. In some embodiments, the protrusions 318 may be attached to a portion of the interventional element 100 in its working length WL. In embodiments where the interventional element includes a strut 302, the protrusions 318 may be attached to the strut 302. If present, the protrusions 318 may be arranged within a unit 304 or on another surface of the interventional element 100. In some embodiments, multiple protrusions 318 may be attached to multiple struts 302 respectively. In some embodiments, some or all of the protrusions 318 may be attached to and / or only to a single strut 302. In some embodiments, the protrusions 318 may be attached to and / or at a connector 308. In some embodiments, in a fully expanded configuration of the interventional element 100, the protrusions 318 may be separated from all other protrusions 318 by a distance, for example, at least 2 mm or at least 3 mm. In some embodiments, protrusion 318 may be separated from all other protrusions 318 by the width of a unit or the length of a strut (e.g., the entire length of the strut separates adjacent protrusions). One or more protrusions 318 may be located at some or all of the proximal end 320, the distal end 322, or the intermediate region of the working length WL between the proximal end 322 and the distal end 322. The working length WL may extend continuously or intermittently between the proximal end 320 and the distal end 322.

[0268] In some embodiments, the interventional element 100 may include one or more distally extending tips 324 extending from the distal end of the interventional element 100. For example, Figure 3A The illustrated device includes five elongated, distally extending tips 324 extending from the distal end of the interventional element 100. For example, as Figure 3A As shown, in some embodiments where the interventional element includes a strut, these distal tips 324 may extend from a row at the far end of the strut. In some embodiments, one or more electrodes 202 and / or one or more radiopaque markers may be attached to the distal tips 324, if present. For example, as Figure 3A As shown, in some embodiments where one or more markers or electrodes are attached to the distal tip, one or more markers or electrodes 202 on the distal tip 324 may be positioned at the distal end 322 of the working length WL.

[0269] like Figure 3A As shown, multiple electrodes 202 can be coupled to the body of the intervention element 100. Each electrode 202 can be coupled to an electrical lead 204, which in turn can be coupled to a current generator (e.g., current generator 20). Figure 1A (e.g., copper, platinum, gold, their alloys, or any other suitable current source). Some or all of the electrodes 202 may take the form of conductive elements fixed to a portion of the interventional element 100. For example, some or all of the electrodes 202 may be metallic, conductive, and optionally radiopaque (e.g., including copper, platinum, gold, their alloys, or any other suitable material). In some embodiments, some or all of the electrodes 202 may take the form of coils, strips, tubes, caps, or any other suitable structural elements that can be mounted to the interventional element 100 and positioned in electrical communication with the corresponding lead 204. In some embodiments, the electrodes 202 may be welded, soldered, crimped, adhesively mounted, or otherwise adhered to the interventional element 100. As described in more detail elsewhere herein, in some embodiments, at least some (or all) of the electrodes 202 may be in electrical communication with the body of the interventional element 100, and may themselves include conductive materials (e.g., nitinol, stainless steel, etc.) such that current flows through the electrodes 202 and into the interventional element 100. In some embodiments, at least some (or all) of the electrodes 202 may be carried by the interventional element 100, but remain electrically insulated from the interventional element, for example by arranging an electrically insulating material between the electrodes 202 and the body of the interventional element 100. In such a configuration, current flowing through such insulated electrodes 202 is not transmitted to the interventional element 100 below, which is mounted or otherwise coupled to the interventional element 100 below.

[0270] As indicated, each of the electrodes 202 may be electrically connected to the electrical lead 204. Some or all of the lead 204 may take the form of an elongated conductive member that is partially or entirely insulated along its length. For example, some or all of the lead 204 may take the form of a wire with an insulating coating at least a portion of its length. Some or all of the lead may include other conductive structures, such as traces (e.g., printed or deposited traces), tubes, buses, strips, coils, doped polymer chains, etc. As an embodiment, the lead 204 may take the form of a metallic wire (e.g., nitinol, copper, stainless steel, etc.). In some embodiments, the wire may have a thickness or diameter between about 0.005 mm and about 0.125 mm or between about 0.005 mm and about 0.05 mm (e.g., 58 AWG wire). Such a wire may have a substantially uniform thickness along its length, or it may taper gradually toward the distal or proximal side. Leads 204 can have lengths greater than approximately 125 cm, approximately 150 cm, approximately 175 cm, or approximately 200 cm. The insulating coating surrounding the leads can include any suitable electrical insulating material (e.g., polyimide, parylene, PTFE, etc.). Leads 204 can be soldered, welded, or otherwise adhered to their respective electrodes 202. Although some leads 204 are... Figure 3A The leads 204 are schematically shown extending beyond the body or lumen of the interventional element 100, but in various embodiments, some or all of the leads 204 may be routed along the radially inward or radially outward surface of the interventional element 100, or optionally through one or more units 304, for example, in a wavy manner, such that the leads 204 are braided in an up-and-down pattern through alternating units 304. In some embodiments, the leads 204 may be wound (once or multiple times) around each of one or more supports 302 located proximal to the electrode coupled to the leads, to more securely attach the leads 204 to the body of the interventional element 100.

[0271] The individual leads 204a-d can be coupled together at the proximal junction and converge in a lead bundle assembly (not shown), as elsewhere in this document (e.g., regarding...). Figure 14A-16B (For more detailed description) Whether arranged in a lead bundle assembly or as separate and independent elements, leads 204a-d may extend proximally through a surrounding conduit (and / or couple to or integrate into the core component 11) to electrically couple to a current generator or other current source.

[0272] exist Figure 3AIn the illustrated embodiment, the first and second electrodes 202a and 202b are coupled to a distally extending tip 324, and the first and second electrodes 202a and 202b are electrically coupled to a first electrical lead 204a, which extends proximally along the length of the intervention element 100. Figure 4 A detailed view of a first electrode 202a mounted on a distally extending tip 324 is shown. The electrode 202a may be in the form of a coil, strip, cap, or tube, mounted on the distally extending tip 324. In various embodiments, the electrode 202a may extend around some or all of the circumference of the distally extending tip 324. In some embodiments, the length of the electrode 202a may be between about 0.5 and 2.0 mm, or about 0.85 mm. In some embodiments, the width of the electrode 202a may be between about 0.05 and 0.4 mm, or about 0.20 mm. A first lead 204a may be electrically coupled to the electrode 202a. For example, the first lead 204a may be soldered, welded, or otherwise adhered to and electrically communicated with the electrode 202a. In some embodiments, the distal portion of the lead 204a extends into the space between the electrode 202a and the distally extending tip 324. According to some embodiments, electrode 202a and / or lead 204a may be electrically connected to the material of distal extension tip 324. In other embodiments, insulating material may be disposed between electrode 202a and distal extension tip 324 (and / or insulating material may be disposed between lead 204a and distal extension tip 324) such that current flowing through electrode 202a and / or lead 204a is suppressed from being transmitted to distal extension tip 324 below intervention element 100.

[0273] Return to reference Figure 3A The third and fourth electrodes 202c and 202d can similarly take the form of a conductive (and optionally non-transmissive) element coupled to a distally extending tip 324. In the illustrated embodiment, the third and fourth electrodes 202c and 202d are electrically coupled to a second electrical lead 204b extending proximally along the length of the intervention element 100.

[0274] Continue to refer to Figure 3A The fifth and sixth electrodes 202e and 202f take the form of conductive members mounted on a protrusion 318 that extends away from (and / or beside) the support 302 of the intervention element 100 (and / or within the unit 304), and a third electrical lead 204c is electrically coupled to the fifth and sixth electrodes 202e and 202f. Figure 5A detailed view of a fifth electrode 202e mounted on a protrusion 318 is shown. The electrode 202e may be in the form of a coil or strip mounted on the protrusion 318. In various embodiments, the electrode 202e may extend around some or all of the circumference of the protrusion 318. In some embodiments, the length of the electrode 202e may be between approximately 0.5 mm and approximately 2 mm, for example, approximately 0.80 mm. In some embodiments, the width of the electrode 202e may be between approximately 0.05 and 0.2 mm, or approximately 0.11 mm. A third lead 204c may be electrically coupled to the electrode 202e. For example, the lead 204c may be soldered, welded, or otherwise adhered to and electrically communicated with the electrode 202e. In some embodiments, the distal portion of the lead 204c extends into the space between the electrode 202e and the protrusion 318. According to some embodiments, the electrode 202e and / or the lead 204c may be electrically communicated with the material of the protrusion 318. In other embodiments, insulating material may be disposed between electrode 202e and protrusion 318 (and / or insulating material may be disposed between lead 204c and protrusion 318) such that current flowing through electrode 202e and / or lead 204c is suppressed to be transmitted to protrusion 318 below intervention element 100.

[0275] Return to reference Figure 3A The seventh and eighth electrodes 202g and 202h can similarly take the form of conductive (and optionally non-transmissive) elements coupled to the protrusion 318. In the illustrated embodiment, the seventh and eighth electrodes 202g and 202h are electrically coupled to a fourth electrical lead 204d extending proximally along the length of the intervention element 100.

[0276] exist Figure 3A In the illustrated embodiment, there are four separate electrical leads 204, each coupled to two electrodes 202, for a total of eight addressable electrodes 202. This configuration is merely exemplary; in other embodiments, there may be fewer or more electrodes (e.g., 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, or more electrodes carried by the intervention element 100). Similarly, there may be fewer or more leads 204.

[0277] By selecting the location of each electrode 202, the charge distribution on the interventional element 100 can be adjusted to achieve the desired outcome during treatment. For example, by coupling electrodes 202e, 202f, 202g, and 202h to the positive terminal of a current generator (e.g., by coupling leads 204c and 204d to the positive terminal of the current generator), these electrodes 202e, 202f, 202g, and 202h can deliver positive charge to corresponding portions of the interventional element 100. Thus, these can be used as delivery electrodes. If any of these electrodes is electrically connected to the interventional element 100, a positive current can flow into the interventional element 100, thereby making a large portion of the surface of the interventional element 100 positively charged. In some embodiments, a portion of the interventional element 100 may be coated with an electrically insulating material to selectively concentrate the charge in certain areas (e.g., within the working length WL). According to some embodiments, some or all of the delivery electrodes 202e, 202f, 202g and 202h are not electrically connected to the intervention element 100 (e.g., due to the presence of insulating material disposed between the delivery electrodes and their respective protrusions 318).

[0278] In some embodiments, the electrode 202 coupled to the protrusion 318 located at the proximal end 320 of the working length WL may be arranged proximally or distally within 5 mm, 4 mm, 3 mm, 2 mm, or 1 mm of the proximal end 320. In some embodiments, the electrode 202 coupled to the protrusion 318 located at the proximal end 320 may be arranged proximally or distally within the length of a unit or a strut of the proximal end 322.

[0279] In some embodiments, the electrode 202 coupled to the protrusion 318 located at the distal end 322 of the working length WL may be arranged proximally or distally within 5 mm, 4 mm, 3 mm, 2 mm, or 1 mm of the distal end 322. In some embodiments, the electrode connected to the protrusion 318 located at the distal end 322 may be arranged proximally or distally within the length of a unit or a strut of the distal end 322.

[0280] In addition to electrode positioning, charge distribution is also affected by the configuration of the delivery electrodes (e.g., material, size, surface area), the delivery leads (e.g., material, cross-sectional dimensions), and the amount of current delivered. For example, a reduction in the number of electrodes or surface area leads to an increase in charge density at the electrodes. If the charge density is too high, it may pose health risks when used in the human body. However, at certain thresholds of charge density, hydrogen can be generated at electrode 202 or on other parts of interventional element 100. In some cases, hydrogen can be neuroprotective, and therefore providing a selectively high enough charge density to generate hydrogen within the patient's neurovascular system may be advantageous.

[0281] In the illustrated embodiment, the distal electrodes 202a, 202b, 202c, and 202d are coupled to the negative terminal of the current generator (e.g., by coupling leads 204a and 204b to the negative terminal of the current generator) and thus these electrodes serve as return electrodes. In some embodiments, the return electrodes may be electrically insulated from the intervention element 100, for example by arranging insulating material between the distally extending tip 324 and the respective electrodes 202a, 202b, 202c, and / or 202d.

[0282] In operation, a circuit is provided in which current flows distally from the positive terminal of the current generator through delivery leads 204c and 204d to delivery electrodes 202e, 202f, 202g, and 202h, and then to interventional element 100 (if one or more delivery electrodes are electrically connected to interventional element 100). The current then travels from the surface of interventional element 100 and / or from the delivery electrodes to the surrounding medium (e.g., blood, tissue, thrombus, etc.) and then returns to return electrodes 202a, 202b, 202c, and 202d. The current then flows proximally through return leads 204a and 204b and returns to the negative terminal of the current generator. Alternatively, the return electrodes may be provided elsewhere, such as via an external needle or grounding pad, via an insulated wire having an exposed distal portion of the core member 11 or an exposed electrode portion coupled to the distal portion of the catheter, etc. In this case, the return electrodes may optionally be omitted from interventional element 100.

[0283] In some embodiments, the non-working length NWL portion of the interventional element 100 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 by the delivery electrode 202 to the interventional element 100 is exposed to the surrounding medium only along the working length WL portion of the interventional element 100. This can advantageously concentrate the electrical enhancement attachment effect along the working length WL of the interventional element 100, 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 100 (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 100 or the working length WL with exposed conductive surfaces.

[0284] In some embodiments, the proximal end of the working length may be located at the nearest side of the interventional element forming a complete circumference. In some embodiments, the proximal end of the working length may be located at the nearest side of the interventional element having its maximum lateral dimension in the fully dilated state. In some embodiments, the proximal end of the working length may be located at the nearest side of the interventional element having a peak, crown, or ridge in the lateral dimension in the fully dilated state.

[0285] In some embodiments, the distal end of the working length may be located at the farthest point where the interventional element forms a complete circumference. In some embodiments, the distal end of the working length may be located at the farthest point where the interventional element has its maximum lateral dimension in its fully dilated state. In some embodiments, the distal end of the working length may be located at the farthest point where the interventional element has a peak, crown, or ridge in its lateral dimension in its fully dilated state.

[0286] In some embodiments, the interventional element 100 may include 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 interventional element 100. The conductive material can be applied to the interventional element 100 by electrochemical deposition, sputtering, vapor deposition, dip coating, and / or other suitable methods. In some aspects of the invention, the conductive material is disposed only on the working length WL portion of the interventional element 100, for example, such that the proximal and distal portions of the interventional element 100 are exposed or not covered by the conductive material. In this configuration, because the resistance of the conductive material is much lower than the resistance of the material below comprising the interventional element 100, the current delivered to the interventional element 100 is concentrated along the working length WL portion. In several such embodiments, the conductive material may be disposed only on the radially outward-facing support surface along the working length WL portion. In other embodiments, the conductive material may be disposed on all or a portion of the support surface along the entire length of the interventional element 100.

[0287] In some embodiments, a first portion of the interventional element 100 is covered by a conductive material, and a second portion of the interventional element 100 is covered by an insulating or dielectric material (e.g., parylene). For example, in some embodiments, the radially outward-facing surface of the support surface is covered by a conductive material, while the radially inward-facing surface of the support surface is covered by an insulating material. In some embodiments, the working length WL portion of the interventional element 100 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 along all or part of the length of the interventional element 100 on 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.

[0288] For ease of understanding, Figure 3B Another exemplary interventional element 100, on which multiple electrodes 202 are carried, is shown in a "planar" view. Figure 3B The configuration shown can be similar to the previous one. Figure 3A The described configuration, in addition to, Figure 3B As shown, four leads 204a-d are coupled to four electrodes 202a-d respectively. The first electrode 202a and the fourth electrode 202d are in the form of conductive members coupled to the support 302 of the intervention element 100, while the second electrode 202b and the third electrode 202c are in the form of conductive members coupled to the protrusion 318, similar to those mentioned above. Figure 3A It has been described.

[0289] A detailed view of the fourth electrode 202d mounted on the support column 302 is shown below. Figure 6 As shown. Electrode 202d may take the form of a coil, strip, cap, or tube mounted on post 302. In various embodiments, electrode 202d may extend around some or all of the circumference of post 302. Fourth lead 204d may be electrically coupled to fourth electrode 202d. For example, lead 204d may be soldered, welded, or otherwise adhered to and electrically connected to electrode 202d. In some embodiments, the distal portion of lead 204d extends into the space between electrode 202d and post 302. According to some embodiments, electrode 202d and / or lead 204d may be electrically connected to the material of post 302. In other embodiments, insulating material may be arranged between electrode 202d and post 302 (and / or insulating material may be arranged between lead 204d and post 302) such that current flowing through electrode 202d and / or lead 204d is suppressed from propagating to post 302 below intervention element 100.

[0290] Return to reference Figure 3B Electrodes 202 can be coupled to terminals of the current generator via their respective leads 204, such that the second electrode 202b and the fourth electrode 202d serve as delivery electrodes (e.g., coupled to the positive terminal) and the first electrode 202a and the third electrode 202c serve as return electrodes (e.g., coupled to the negative terminal). Figure 3A The configuration is the opposite, wherein the delivery electrode is arranged in the central portion of the interventional element 100 and the return electrode is positioned along the distal tip. Figure 3B In the illustrated embodiment, both the return electrode and the delivery electrode are positioned on the central portion of the interventional element 100 (e.g., within the working length WL). This configuration can provide a different charge distribution on the surface of the interventional element 100, for example, by providing a shorter path between the delivery electrode and the return electrode. Additionally, as... Figure 3B As shown, at least one delivery electrode 202d is located far from at least one return electrode 202c, while at least one delivery electrode 202b is located near at least one return electrode 202a.

[0291] Figure 3A and 3B The illustrated embodiment describes an exemplary configuration of electrode 202 and lead 204; however, various other configurations are possible. For example, some or all of the electrodes can be mounted to the intervention element 100 at any suitable location, such as along the post 302, protrusion 318, distally extending tip 324, or any other suitable location. Similarly, the number of electrodes 202, their respective polarities, and their relative positioning can be selected to achieve a desired charge distribution and other operating parameters.

[0292] Figure 7 and 8 A cross-sectional view is shown of the electrode 202 mounted on the interventional element 100 in each case, with interventional insulating material 702 disposed between the electrode 202 and the portion below the interventional element. Figure 7 In one embodiment, the portion of the intervention element 100 below the electrode 202 has a rectangular cross-section (e.g., a support 302), while... Figure 8 In some embodiments, the portion of the interventional element 100 below the electrode 202 has a circular cross-section (e.g., a distally extending tip 324). These shapes are merely exemplary, and in various embodiments, the interventional element 100 can present any suitable cross-sectional shape. Figure 7 and Figure 8 In this configuration, electrodes 202 surround a segment of the intervention element 100, with insulating material 702 disposed between them. The insulating material 702 can be, for example, parylene, PTFE, polyimide, or any suitable electrical insulating material. As a result, the current carried by the electrodes 202 is not transmitted to the support 302 or to the distal tip 324. This insulating configuration can be used for either delivering or returning electrodes, if needed.

[0293] Figure 9 and 10A cross-sectional view of an electrode 202 mounted on an interventional element 100 for electrical communication with the interventional element 100 is shown. No interventional insulating material is present, allowing the electrode 202 to be in direct contact and thus electrically connected to the lower support 302 or the distal extension tip 324 of the interventional element 100. In some embodiments, one or more non-insulating (e.g., conductive) coatings may be disposed between the electrode 202 and the support 302 or distal extension tip 324 of the interventional element 100. In this configuration, the current delivered to the electrode 202 is transmitted to the lower support 302 or distal extension tip 324 of the interventional element 100, particularly if the interventional element 100 is made of a conductive material such as stainless steel or nitinol. This electrical coupling configuration can be used as needed for electrode delivery or return.

[0294] Unless otherwise specified, Figure 11-13 Further embodiments of interventional elements 1100, 1200, 1300 carrying multiple electrodes 202 are shown. These interventional elements and electrode arrangements can be similar to various embodiments of interventional element 100 and associated electrode arrangements described herein. As described elsewhere herein, multiple leads (not shown) can be electrically coupled to the electrodes 202 to provide an electrical connection between the current generator and the individual electrodes 202. Figure 11-13 As shown, the intervention element can take many different forms, while benefiting from the electro-enhanced adhesion to the agglomerate material provided by electrode 202. For example, regarding Figure 11 The intervention element 1100 is a clot removal device having an internal tubular member and an external expandable member with a diameter larger than the internal tubular member. The external member may have radially outwardly extending struts defining an inlet configured to receive clotted material therein. (Regarding...) Figure 12 Interventional element 1200 is another embodiment of a clot removal device, in which it includes a plurality of interconnected cages having damage-resistant guiding surfaces and configured to expand radially outward to engage the thrombus. Figure 13 Another exemplary interventional element 1300 in the form of a clot removal device is shown, which includes a loop or spiral member configured to expand into or distal to the thrombus, thereby engaging the thrombus between the turns of the loop and facilitating its removal from the body. In addition to these illustrative examples, the interventional element 100 may take other forms, such as a removal device, a thrombectomy device, a retrieval device, a braid, a mesh, a laser-cutting stent, or any suitable structure.

[0295] II. Preferred embodiments of the lead bundle assembly for use with the treatment system disclosed herein

[0296] As described above, the electrode 202 carried by the intervention element 100 can be electrically coupled to the external current generator 20 via a longitudinally extending lead 204, which can be coupled or joined together via a proximal-extending lead bundle assembly 205. In various embodiments, the lead bundle assembly 205 may extend parallel to but separately from the core member 11, or in some embodiments, the lead bundle assembly may be coupled to or integrated with the core member 11. The leads 204 may be configured to be electrically coupled to the current generator (e.g., current generator 20) at their respective proximal portions; Figure 1A This can be achieved by using a current generator or other current source, and coupling its respective distal end to one or more electrodes 202 coupled to the interventional element 100 as described elsewhere herein. In some embodiments, lead 204 includes delivery electrode leads and return electrode leads, while in other embodiments, lead 204 includes only delivery electrode leads, in which case one or more return electrodes may be coupled to a current generator (e.g., via an external needle or grounding pad, by coupling to a catheter, or any other suitable configuration). Similarly, in some embodiments, lead 204 includes only return electrode leads, with only the return electrode 202 carried by the interventional element 100. In such configurations, delivery electrodes may be provided elsewhere, such as coupled to a distal portion of a catheter, carried by another portion of the interventional element, or any other suitable arrangement.

[0297] Figure 14A This is a side sectional view of the lead bundle assembly 205 according to some embodiments, and Figure 14B yes Figure 14A A cross-sectional view of component 205 is shown. (See attached image.) Figure 14A As shown in Figure -B, the lead bundle assembly 205 includes four leads 204a-d extending longitudinally along the assembly 205. Although four leads are shown, more or fewer leads may be present in various embodiments, such as 1, 2, 3, 5, 6, 7, 8, 9, 10, or more leads. The lead bundle assembly 205 may have a length sufficient to extend between an external current generator at the proximal end and an endovascular treatment site at the distal end. For example, the lead bundle assembly 205 may have a length of at least about 100 cm, at least about 125 cm, at least about 150 cm, or at least about 175 cm, or between about 100 cm and 200 cm, or between about 150 cm and about 190 cm.

[0298] Leads 204 may each be exposed at the proximal end of component 205 (e.g., not covered with insulating material) for coupling to a current generator (e.g., current generator 20). Figure 1AIn the distal portion of the lead bundle assembly 205, leads 204 may extend individually distally away from the bundle assembly 205, each lead 204 extending toward a different electrode. This distally extending portion of the lead 204 (not shown here) may include insulating material disposed on the individual lead 204, with its exposed distal portion (e.g., leaving approximately 0.5-5 mm of exposure) facilitating coupling of the individual lead 204 to a single electrode, as described above regarding... Figure 3A-6 As stated above.

[0299] In at least some embodiments, the lead bundle assembly 205 includes a first insulating layer or material 1402 extending around each lead 204. For example, the first insulating material 1402 may be polyimide or any other suitable electrically insulating coating (e.g., PTFE, oxide, ETFE-based coating, or any suitable dielectric polymer). For example, the first insulating material 1402 may circumferentially surround each lead 204 with a thickness between approximately 0.00005” and approximately 0.0005”, or approximately 0.0002”. In some embodiments, the first insulating material 1402 extends substantially along the entire length of the lead 204 and the assembly 205. In some embodiments, the first insulating material 1402 separates and electrically insulates the leads 204 from each other substantially along the entire length of the assembly 205. In some embodiments, the first insulating material 1402 does not cover the nearest side portion of the lead 204, thereby providing the current generator 20 ( Figure 1A The exposed area of ​​the lead 204 can be electrically coupled to. In some embodiments, the first insulating material 1402 does not cover the farthest portion of the lead 204, thereby providing the electrode 202 ( Figure 3A The exposed area of ​​lead 204 can be electrically coupled to.

[0300] The lead bundle assembly 205 may additionally include a second insulating layer or material 1404 that surrounds some or all of the respective leads 204 along at least a portion of their length. For example, the second insulating material 1404 may be polyimide or any other suitable electrically insulating coating (e.g., PTFE, oxide, ETFE-based coating, or any suitable dielectric polymer). The insulating material 1404 may be in the form of a generally tubular member with a wall thickness between about 0.00005” and about 0.0005”, or about 0.0002”. In some embodiments, the second insulating material 1404 does not cover the nearest side portion of the leads 204, thereby providing the current generator 20 ( Figure 1A The exposed area of ​​the lead 204 can be electrically coupled to. As previously described, on the distal side of the distal end of the second insulating material 1404, the single lead 204 (and optionally the surrounding first insulating material 1404) can extend distally toward the single electrode 202.

[0301] exist Figure 14A In embodiment -B, the second insulating material 1404 defines the outer surface of the bundling assembly 205, which may be substantially cylindrical. In use, the bundling assembly 205 can be slidably advanced through a conduit (e.g., a third conduit 12) adjacent to the core member 11. Figure 1A In some embodiments, the bundling assembly 205 may be coupled to the core member 11, for example, by bonding them together at one or more locations to prevent relative sliding movement. In other embodiments, the bundling assembly 205 and the core member 11 may remain separate and may slide and / or rotate relative to each other.

[0302] Figure 15A This is a side sectional view of a lead bundle assembly 205 according to another embodiment, and Figure 15B yes Figure 15A The diagram shows a cross-sectional view of component 205. In this embodiment, two leads 204a and 204b are embedded within an insulating strip 1502. This strip can be made of an electrically insulating material, such as polyimide, parylene, PTFE, or any other suitable electrically insulating material, and can expose the proximal and distal portions of leads 204a and 204b, as previously described. Figure 15B As shown, the strip may have a substantially rectangular cross-section. The strip may have a thickness between about 0.0005” and about 0.001” and a width less than about 0.002”.

[0303] generally, Figures 14A-14B The lead bundle assembly depicted in 15A-15B can be used as core member 11 without any additional structure or component, or with additional structures such as non-conductive core wires or spools, braided spools, or surrounding (or central) tubes, coils, or braids. Such tubes can be laser-cut in a spiral or slotted manner (or other manner) to impart additional flexibility where needed.

[0304] Figure 16A This is a side sectional view of a lead bundle assembly 205 according to another embodiment. Figure 16B yes Figure 16A The diagram shows a cross-sectional view of component 205. Except that component 205 is coaxially arranged around core member 11 (which may include wires, tubes, braided spools, etc. as described above), this embodiment can be similar to... Figures 14A-14B The implementation method is as follows. For example, each lead 204a-d may be coated with a first insulating material 1402, as described above regarding... Figures 14A-14BHowever, in this embodiment, the lead wire 204 is arranged radially around the core member 11, and the second insulating material 1404 surrounds the lead wire 204 and the core member 11. As a result, the core member 11 and the lead wire 204 can be fixed to each other and can be slidably pushed through the surrounding conduit as a whole.

[0305] IV. Selected Usage Methods

[0306] Figures 17A-17D A method for removing clotted material CM from the lumen of a blood vessel V using the treatment system 10 of the present invention is demonstrated. For example... Figure 17A As shown, the first catheter 14 can be advanced through the vascular system and positioned within the blood vessel, such that the distal portion of the first catheter 14 is located proximal to the clot material CM. Figure 17B As shown, the second catheter 13 can be advanced through the first catheter 14 until the distal portion of the second catheter 13 is located at or near the clotted material CM. Next, the third catheter 12 can be advanced through the second catheter 13 such that the distal portion of the third catheter 12 is positioned at or near the clotted material CM. In some embodiments, the third catheter 12 can be positioned such that its distal end is distal to the clotted material CM. The interventional element 100 can then be advanced through the third catheter 12 in a low-profile configuration until the distal end of the interventional element 100 is located at or near the distal end of the third catheter 12.

[0307] like Figure 17C As shown, the third catheter 12 can be withdrawn proximally relative to the interventional element 100 to release the interventional element 100, thereby allowing the interventional element 100 to self-expand within the clot material CM. As the interventional element 100 expands, 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 blood flow paths through it. In some embodiments, the interventional element 100 can expand distally to the clot material CM such that no portion of the interventional element 100 engages the clot material CM during expansion toward the vessel wall. In some embodiments, the interventional element 100 is configured to expand to contact the wall of the vessel V, or the interventional element 100 can expand to a diameter smaller than the diameter of the vessel lumen, such that the interventional element 100 does not engage the entire circumference of the vessel wall.

[0308] Once the interventional element 100 has been extended to engage with the clot material CM, it can grasp the clot material CM by means of its mechanically interlocking ability. A current generator 20, electrically coupled to the proximal end of the lead 204, can deliver current to the electrode 202 carried by the interventional element 100 before or after the interventional element 100 has been released from the third catheter 12 into the blood vessel and / or extended into the clot material CM. While the electrical signal is delivered, the interventional element 100 can be held in place within the blood vessel V or manipulated for a desired duration. The positive current delivered to the interventional element 100 via the electrode 202 can attract the negatively charged components of the clot material CM, thereby enhancing the grasp of the clot material CM by the interventional element 100. This allows the interventional element 100 to be used to remove the clot material CM while reducing the risk of losing grasp of the thrombus or a portion thereof, which may migrate downstream and cause further vascular occlusion in more difficult-to-reach areas of the brain.

[0309] 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 distal to the clot material CM. The guidewire may be advanced through one or more of catheters 12-14 and / or one or more of catheters 12-14 may be advanced over the guidewire. The guidewire may be insulated along at least a portion of its length (e.g., using parylene, PTFE, etc.), wherein the exposed portion allows electrical communication with the current generator 20 and the interventional element 100. 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, 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 catheters of the first catheter 14, the second catheter 13, the third catheter 12, the interventional element 100, etc.).

[0310] In some methods, fluid can be delivered to the treatment site via the second catheter 13 and / or the third catheter 12 while current is being delivered to the interventional element 100. Fluid delivery can occur before or simultaneously with the interventional element 100 engaging the thrombus, and can coincide with the entire duration of the current delivery or only a portion thereof. In some cases, aspiration can be applied to the treatment site via the second catheter 13. For example, after the interventional element 100 has been deployed, the third catheter 12 can be retracted and removed from the lumen of the second catheter 13. The treatment site can then be aspirated via the second catheter 13, for example, via an aspiration source, such as a pump or syringe, coupled to the proximal portion of the second catheter 13. In some embodiments, the treatment site is aspirated simultaneously with the supply of electrical energy to the interventional element 100 via the current generator 20 after the interventional element 100 has been deployed. 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 loosened clot fragments that have broken off during the procedure can be pulled into the second catheter 13, 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 100 without the risk of the harmful effects of new clot formation. Additionally, aspiration can capture any air bubbles that form along the interventional element 100 during the application of electrical energy, which can improve patient safety during the procedure.

[0311] In some embodiments, aspiration is applied as the interventional element 100 is retracted into the second catheter 13. Aspiration at this stage helps to hold the clot material CM within the second catheter 13 and prevents any displaced portion of the clot material CM from escaping from the second catheter 13 and being released back into the vessel V. In various embodiments, the treatment site can be aspirated continuously before, during, or after the delivery of an electrical signal to the interventional element 100, and before, during, or after the interventional element 100 is retracted into the second catheter 13.

[0312] At any time before, during, and / or after the deployment of interventional element 100, a clotting element (e.g., a balloon of a balloon catheter or other suitable clotting element) may be deployed within the vessel proximal to the clot material CM to partially or completely block blood flow to the treatment site. In some methods, the clotting element may be deployed at a location along the vessel proximal to the clot material CM (e.g., at the proximal portion of the internal carotid artery) and may remain inflated during deployment of interventional element 100 and eventual withdrawal to remove the thrombus.

[0313] At least when the interventional element 100 is deployed and adhering to the thrombus CM, current can be supplied to the interventional element 100 (e.g., via lead 204 and electrode 202) to give the interventional element 100 a positive charge, thereby enhancing the adhesion of the clot to the interventional element 100. Reference Figure 17DWhen the interventional element 100 engages with the clot material CM, the clot material CM can be removed. For example, with the clot material CM being grasped, the interventional element 100 can be retracted proximally (e.g., together with the second catheter 13, and optionally the third catheter 12). The second catheter 13, the interventional element 100, and the associated clot material CM can then optionally be withdrawn from the patient through one or more larger peripheral catheters. During this withdrawal, the interventional element 100 can grasp the clot material CM electrically or electrostatically, for example, by applying an electric current or electrostatic force from a current generator as discussed herein. (As used herein with reference to grasping or removing thrombi or other vascular / luminal materials or devices for this purpose, "electrical" and its derivatives shall be understood to include "electrostatic" and its derivatives). Thus, the interventional element 100 can maintain enhanced or electrically and / or electrostatically enhanced grasping of the clot material CM during withdrawal. In other embodiments, the current generator 20 may stop supplying electrical signals to the electrode 202 carried by the interventional element 100 before the interventional element 100 retracts relative to the blood vessel V. In some embodiments, the interventional element 100 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 current as discussed herein.

[0314] V. Selected Implementation Methods for Waveform Extraction by Electrical Enhancement

[0315] Figures 18A-18E 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 1A-17D The devices and methods described herein are used together, but the waveforms and other parameters are also applicable to other device configurations and techniques. For example, the return electrode can be disposed along the catheter wall as a separate conductive member extending within the catheter lumen. In each of these device configurations disposed elsewhere in the body, 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 implementations 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 outside the body (e.g., the digestive tract, etc.), and / or can be used for electrically enhanced removal of emboli from vessels outside the brain (e.g., pulmonary vessels, vessels in the legs, etc.).

[0316] As described above, the treatment system may include multiple delivery electrodes and / or multiple return electrodes carried by the interventional element. In some embodiments, two or more delivery electrodes may be driven with the same waveform. However, in some embodiments, two or more delivery electrodes may be driven with different waveforms to achieve desired charge distribution characteristics at the interventional element 100.

[0317] Although a continuous uniform direct current (DC) signal is applied (such as...) Figure 18E As shown, applying a positive charge to the interventional element 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). To achieve effective clot capture without ablating tissue or generating a large number of new clots at the treatment site, periodic waveforms have been found particularly useful. 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 a uniformly applied current or a square waveform.

[0318] Figures 18A-18D This shows what can be related to the above about Figure 1A-17D The described apparatus and method, as well as various periodic waveforms used in conjunction with other apparatuses and techniques. Figure 18E A continuous, uniform DC signal, which can also be used in some implementations, is shown. (Reference) Figures 18A-18D Electricity can be transmitted in the form of pulsed DC based on these waveforms. Figure 18A and 18B The diagrams show periodic square and triangular waveforms. Both waveforms have the same amplitude, but the triangular waveform can deliver the same peak current as the square waveform, but only half the total charge, and delivers less total energy. Figure 18C This illustrates another pulsed DC or periodic waveform, which is a composite of square and triangular waveforms. Figure 18B Compared to the triangular waveform, Figure 18C The superposition of the triangular and square waveforms shown delivers additional benefits while still providing a higher efficiency. Figure 18A A square waveform requires less total energy. This is because the energy delivered is proportional to the square of the current, and Figure 18C The brief peaks in the composite waveform ensure that current is supplied without distributing too much energy. Figure 18DAnother 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 implementations, different non-square waveforms can be used, including superpositions of square waveforms with any non-square waveform, depending on the desired power delivery characteristics.

[0319] 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 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 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.

[0320] In some implementations, the total energy delivered to the 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 implementations, the total energy delivered to the 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.

[0321] 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.

[0322] 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).

[0323] The duty cycle of the applied electrical signal can also be selected to achieve the desired clot adhesion properties without ablating tissue or promoting new clot formation. In some embodiments, the duty cycle can be between about 5% and about 99% or between about 5% and about 20%. According to some embodiments, the duty cycle can be about 10%, about 20%, about 30%, about 40%, or about 50%. In yet other embodiments, a constant current can be used, wherein the duty cycle is 100%. For embodiments with a 100% duty cycle, a lower time or current can be used to avoid delivering excessive total energy to the treatment site.

[0324] Table 1 presents the value range of power transmission 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 combined conditions). Constant conditions represent 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 combined conditions, Column 2, Peak Current, represents the peak current of the second portion of the waveform. For example, refer to the reference... Figure 18C 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.

[0325]

[0326] Table 1

[0327] As shown in Table 1, the periodic waveforms (square, triangular, and combined conditions) achieve higher peak currents with lower total charge delivered compared to the corresponding constant conditions. For example, in constant condition 4, a peak current of 20 mA corresponds to a total energy delivered 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 charge delivered 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 WL 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.

[0328] Although Table 1 represents a series of waveforms with a single frequency (1 kHz), in some implementations, the frequency of the pulsed DC waveform can be controlled to achieve the desired effect. For example, in some implementations, 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.

[0329] VI. Conclusion

[0330] 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 appreciated by those skilled in the art. In some cases, 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 the 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.

[0331] Unless otherwise stated, all numerical values ​​used in the specification and claims should be understood to be modified by the term "about" in all cases, and therefore, unless indicated otherwise, the numerical parameters set forth in the specification and appended claims are approximations that may vary depending on the desired properties sought to be obtained by this technique. To a minimum, and without attempting to limit the application of the equivalence principle to the scope of the claims, each numerical parameter should be interpreted at least according to the number of significant digits reported and by applying general rounding techniques. Furthermore, all ranges disclosed herein should be understood to encompass any and all subranges contained herein. For example, the range "1 to 10" encompasses (and includes) any and all subranges between (and including) the minimum value of 1 and the maximum value of 10, i.e., any and all subranges having a minimum value equal to or greater than 1 and a maximum value equal to or less than 10, such as 5.5 to 10.

[0332] 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, throughout this disclosure, the use of terms such as “comprising” indicates at least the inclusion of the stated features, such that no further number of the same features and / or one or more additional types of features are excluded. Directional terms such as “up,” “down,” “front,” “back,” “vertical,” and “horizontal” are 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,” “implementation,” 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 invention. 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 implementations in any suitable manner.

Claims

1. A medical device comprising: An elongated core member having a distal portion configured to be positioned intravascularly at a treatment site within the lumen of a blood vessel; and An interventional element coupled to a distal portion of a core member, the interventional element comprising: A main body, which can be extended from a first configuration to a second configuration, the main body having a working length portion and a non-working length portion arranged proximal to the working length portion; A non-transparent element coupled to the body, the non-transparent element comprising a conductive material; A conductive lead having a distal portion electrically coupled to a non-transmissive element and a proximal portion configured to be electrically coupled to a current source. The charge distribution on the interventional element can be adjusted by positioning the non-transparent element. The non-transparent element is configured such that when current is supplied to the conductive lead via the current source, the charge density in the working length portion is greater than the charge density in the non-working length portion, and the polarity of the charge in the working length portion is opposite to the polarity of the charge carried by the human tissue at the treatment site.

2. The medical device according to claim 1, wherein, The main body includes a conductive material.

3. The medical device according to claim 1, wherein, The main body is electrically connected to the non-transmissive element.

4. The medical device according to claim 1, wherein, The conductive lead extends proximally along the core component.

5. The medical device according to claim 1, further comprising: Multiple transmissive elements coupled to the body, each transmissive element comprising a conductive material; and Multiple conductive leads, each conductive lead having a distal portion electrically coupled to one of the multiple transmissive elements and a proximal portion configured to be electrically coupled to a current source.

6. The medical device according to claim 5, wherein, The first group of the plurality of transmissive elements is configured to serve as a delivery electrode, and the second group of the plurality of transmissive elements is configured to serve as a return electrode.

7. The medical device according to claim 6, wherein, The delivery electrode is arranged within the working length portion of the body, and the return electrode is arranged within the non-working length portion of the body.

8. The medical device according to claim 5, wherein, The plurality of transmissive elements are configured to serve as delivery electrodes, and the medical device further includes a return electrode configured to be coupled to the current source.

9. The medical device according to claim 1, wherein, The radiopaque element is configured to serve as a delivery electrode, and wherein the conductive lead is a first conductive lead, the medical device further comprising: Return electrode; and The second conductive lead has a distal portion electrically coupled to the return electrode and a proximal portion configured to be electrically coupled to the current source.

10. The medical device according to claim 9, wherein, The radiopaque element is a first radiopaque element, and the return electrode includes a second radiopaque element coupled to the body and comprising a conductive material.

11. The medical device according to claim 10, wherein, The first nontransparent element is arranged within the working length portion of the body, and wherein the second nontransparent element is arranged within the non-working length portion of the body.

12. The medical device according to claim 1, wherein, The radiopaque element includes a radiopaque marker.

13. The medical device of claim 1, wherein the interventional element comprises a thrombectomy device.

14. A medical system comprising: The medical device according to any one of claims 1-13; and A current source, electrically coupled to the conductive lead.

15. A thrombectomy device, comprising: A body having multiple pillars defining multiple units and forming a mesh, the body being extendable from a first configuration to a second configuration, the body having a working length portion and a non-working length portion disposed proximal to the working length portion, wherein, in the working length portion, when the body is extended to the second configuration, the multiple units are configured to penetrate and / or capture thrombi; One or more electrodes coupled to the body within the working length portion; One or more conductive leads electrically coupled to one or more electrodes, the conductive leads being configured to be electrically coupled to a current source. The electrode is positioned such that the charge distribution on the main body can be adjusted. The electrode is configured such that when current is supplied to the conductive lead via the current source, the charge density in the working length portion is greater than the charge density in the non-working length portion, and the polarity of the charge in the working length portion is opposite to the polarity of the charge carried by the thrombus to be removed.

16. The thrombectomy device according to claim 15, wherein, The non-working length portion includes a proximal tapered section, and the working length portion includes a non-tapered section.

17. The thrombectomy device according to claim 15, characterized in that, in, The working length portion includes a section of the body configured to mechanically engage with a thrombus.

18. The thrombectomy device according to claim 15, wherein, The one or more electrodes are non-transmissive.

19. The thrombectomy device according to claim 15, wherein, The main body includes a conductive material.

20. The thrombectomy device according to claim 15, wherein, The main body is electrically connected to the one or more electrodes.

21. The thrombectomy device according to claim 15, wherein, The one or more electrodes are electrically coupled to the body within the working length portion.

22. The thrombectomy device according to claim 15, wherein, The one or more electrodes are configured to serve as delivery electrodes, and wherein the conductive lead is a first conductive lead, the thrombectomy device further includes: Return electrode; and The second conductive lead has a distal portion electrically coupled to the return electrode and a proximal portion configured to be electrically coupled to the current source.

23. The thrombectomy device according to claim 22, wherein, The return electrode includes a radiopaque marker coupled to the body and comprises a conductive material.

24. The thrombectomy device according to claim 22, wherein, The delivery electrode is arranged within the working length portion of the main body, and the return electrode is arranged within the non-working length portion of the main body.

25. The thrombectomy device according to claim 22, wherein, The delivery electrode and the return electrode are each arranged within the working length portion of the main body.

26. The thrombectomy device according to claim 15, wherein, The main body includes a stent removal device.

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