Intervention Systems and Associated Devices and Methods - Patent application

Abstract

According to some embodiments, the technology includes devices and systems for removing occlusive material from a vascular lumen. For example, the system can include a first elongate member, a second elongate member, and a cutting element configured to cut the occlusive material at a treatment site. Rotation of the second elongate member relative to the first elongate member (or vice versa) can cause the cutting element to expand away from a longitudinal axis of the second elongate member. The system can further include an expandable positioning element configured to be delivered intravascularly to the treatment site, where the positioning element can be configured to expand into apposition with the vascular wall and position the cutting element closer to the occlusive material than prior to expansion of the positioning element.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to U.S. Provisional Application No. 63 / 269,169, filed March 10, 2022, which is incorporated by reference in its entirety herein.

[0002] The present technology relates generally to interventional systems and associated devices and methods. [Background technology]

[0003] Deep vein thrombosis (DVT) is a disease consisting of blood clots in deep veins, usually in the legs, but they can also occur in the veins of the arms. Symptoms include pain, swelling, tenderness, and / or discoloration in the affected limb. If untreated, this can lead to worsening symptoms and complications such as post-thrombotic syndrome, with symptoms of chronic pain, swelling, and skin discoloration, or pulmonary embolism (PE), a very serious and life-threatening disease. Pharmacological treatments include anticoagulant or thrombolytic drugs. More recently, percutaneous catheters have been developed for more rapid removal of clots to clear blockages and prevent PE. These include catheters that can deliver thrombolytic agents to the site of the clot, in some cases in combination with aspiration and / or fragmentation of the clot into smaller pieces. Other catheters mechanically capture and remove the clot without thrombolytic agents, thereby reducing the bleeding risk caused by these drugs. An early example of this is the Fogarty Balloon Thrombectomy Catheter. More recent examples include the ClotTriever® (Inari Medical, Irvine, Calif.) and ReVene® Thrombectomy Catheters (Vetex Medical, Galway, Ireland).

[0004] Unfortunately, many of these therapies have limited success with partial or complete blockages caused by chronic thrombi (i.e., thrombi older than 1 or 2 months). As the clot remains in the limb over a period of several months, the initial thrombus transforms into a fibrin and / or collagen structure, which is stronger and more firmly attached to the wall. Chronic thrombi may take the form of fibrous trabeculae or membranes that extend across and into the venous lumen (also known as venous adhesions). Furthermore, the thrombus becomes more firmly attached to the wall. Catheter-based thrombolysis or thrombus removal devices have a lower success rate in removing these blockages. Venous adhesions may also prevent optimal treatment of venous obstruction by balloon angioplasty or stent placement, as the fibrous structure prevents permanent stretching of the vessel wall. There is a need for improved endovascular thrombus removal devices that can successfully remove chronic thrombi. Summary of the Invention [Means for solving the problem]

[0005] The subject technology is illustrated according to various aspects described below, including, for example, with reference to Figures 1-52. Various examples of aspects of the subject technology are described as numbered annotations (1, 2, 3, etc.) for convenience. These are provided as examples and are not limiting of the subject technology. 1. A device for modifying and / or removing occlusive material from the lumen of a blood vessel, comprising: an elongate member having a proximal portion and a distal portion configured to be intravascularly positioned at a treatment site within a blood vessel adjacent the occlusive material; a cutting portion disposed on a distal portion of the elongate member, the cutting portion including a cutting element, the cutting portion having a collapsed low profile state for delivery to a treatment site and a deployed state for severing occlusive material at the treatment site, the cutting element extending radially away from a longitudinal axis of the elongate member in the deployed state; a capturing portion disposed on a distal portion of the elongate member, the capturing portion configured to collect occlusive material dislodged by the cutting portion; A device comprising: 2. The device of claim 1, wherein the capture portion is positioned distal to the cutting portion along the elongate member. 3. The device of claim 1 or claim 2, wherein the capture device is self-expandable. 4. The device of any one of claims 1-3, wherein the elongate member comprises a first elongate member and a second elongate member, the cutting portion being disposed at a distal portion of the first elongate member, and the capturing portion being disposed at a distal portion of the second elongate member. 5. The device of claim 4, wherein the first and second elongate members are configured to rotate and / or translate relative to one another. 6. The device of claim 4 or claim 5, wherein the second elongate member is configured to be slidably disposed within the lumen of the first elongate member. 7. The device of claim 4 or claim 5, wherein the first elongate member is configured to be slidably disposed within the lumen of the second elongate member. 8. The device of any one of clauses 1-7, wherein the cutting portion comprises a blade disposed along a portion of the cutting element. 9. The device of claim 8, wherein the blades are positioned only along a proximally-facing surface of the cutting element. 10. The device of any one of clauses 1-9, wherein the cutting edge of the cutting element is approximately linear. 11. The device of any one of claims 1-9, wherein the cutting element is wrapped around the longitudinal axis of the shaft. 12. The device of any one of clauses 1-9, wherein the cutting element is a first cutting element, and the device further comprises a second cutting element configured to extend radially away from the longitudinal axis of the elongate shaft in the deployed state. 13. The device of claim 12, wherein the angle between the first cutting element and the second cutting element in the deployed state is less than 180 degrees. 14. The device of claim 12, wherein the angle between the first cutting element and the second cutting element in the deployed state is between about 135 degrees and about 180 degrees. 15. The device of any one of clauses 1-14, wherein the capturing portion and the cutting portion are independently deployable. 16. The device of any one of claims 1-15, wherein the capture portion has a closed distal end portion and an open proximal end portion. 17. The device of any one of claims 1-16, wherein the capture portion comprises a mesh. 18. The device of any one of statements 1-17, wherein the capture portion has a first region comprising a braid and a second region comprising a stent. 19. The device of any one of clauses 1-18, wherein in the deployed state, the cutting element has a proximally facing portion and a distally facing portion, and the sharpened edge of the cutting element is disposed only along the proximally facing portion. 20. The device of any one of clauses 1-18, wherein in the deployed state, the cutting element has a proximally facing portion and a distally facing portion, and the sharpened edge of the cutting element is disposed only along the distally facing portion. 21. A system for modifying and / or removing occlusive material from a lumen of a blood vessel, comprising: a first elongate member having a proximal portion and a distal portion configured to be intravascularly positioned at a treatment site within a blood vessel adjacent the occlusive material; a second elongate member having a proximal portion and a distal portion configured to be positioned intravascularly at the treatment site; a cutting portion disposed on a distal portion of the first elongate member, the cutting portion including a cutting element, the cutting portion having a collapsed low profile state for delivery to a treatment site and a deployed state for severing occlusive material at the treatment site, the cutting element extending radially away from a longitudinal axis of the first elongate member in the deployed state; a capturing portion disposed on a distal portion of the second elongate member, the capturing portion configured to collect occlusive material dislodged by the cutting portion; A system comprising: 22. The system of claim 21, wherein the second elongate member is slidably disposed within the lumen of the first elongate member. 23. The system of claim 21, wherein the first elongate member is slidably disposed within the lumen of the second elongate member. 24. The system of any one of claims 21-23, wherein a distal region of the cutting portion is axially fixed to a distal portion of the second elongate member and a proximal region of the cutting portion is configured to move axially along the second elongate member. 25. The system of any one of claims 21-14, wherein in the deployed state, the cutting element has a proximally facing portion and a distally facing portion, and the sharpened edge of the cutting element is disposed only along the proximally facing portion. 26. The system of any one of claims 21-24, wherein in the deployed state, the cutting element has a proximally facing portion and a distally facing portion, and the sharpened edge of the cutting element is disposed only along the distally facing portion. 27. The system of any one of claims 21-26, further comprising an introducer sheath, wherein the first and second elongate members are configured to be slidably disposed within a lumen of the introducer sheath. 28. A device for modifying and / or removing occlusive material from the lumen of a blood vessel, comprising: a first elongate member having a proximal portion and a distal portion configured to be intravascularly positioned at a treatment site within a blood vessel adjacent the occlusive material, the first elongate member defining a lumen extending therethrough; a second elongate member having a proximal portion and a distal portion configured to be intravascularly positioned at a treatment site, the second elongate member configured to be rotatably disposed within a lumen of the first elongate member; a cutting element configured to cut occlusive material at the treatment site, the cutting element having a proximal end region at a distal portion of the first elongate member and a distal end region at a distal portion of the second elongate member, wherein rotation of the second elongate member relative to the first elongate member (or vice versa) causes the cutting element to expand away from a longitudinal axis of the second elongate member; A device comprising: 29. The device of claim 28, wherein the cutting element wraps at least partially around the longitudinal axis of the second elongate member as the cutting element extends between the first elongate member and the second elongate member. 30. The device of claim 28 or 29, wherein the cutting element is a ribbon. 31. The device of any one of clauses 28-30, wherein the cutting element has longitudinally extending edges, and one or both longitudinally extending edges are sharpened. 32. A device described in any one of clauses 28-30, wherein the cutting element has a proximally facing longitudinal edge and a distally facing longitudinal edge, and only one of the proximally facing or distally facing longitudinal edges is sharpened. 33. The device of any one of clauses 28-32, wherein the cutting element is a first cutting element and the device comprises a second cutting element. 34. The device of claim 33, wherein the second cutting element is positioned radially inward of the first cutting element. 35. The device of claim 33, wherein the second cutting element is positioned radially outward of the first cutting element. 36. The device of any one of clauses 33-35, wherein the second cutting element is generally linear. 37. The device of any one of clauses 33-35, wherein the second cutting element wraps at least partially around the longitudinal axis of the second elongate member. 38. The device of any one of clauses 33-37, further comprising a third elongate member positioned between the first elongate member and the second elongate member, wherein the second cutting element is at a distal portion of the third elongate member. [Brief description of the drawings]

[0006] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure.

[0007] [Figure 1]FIG. 1 diagrammatically depicts a treatment system configured in accordance with some embodiments of the present technology.

[0008] [Diagram 2] FIG. 2 diagrammatically depicts a distal portion of a treatment system configured in accordance with some embodiments of the present technology.

[0009] [Figure 3A] 3A and 3B are top views of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in a collapsed and expanded state, respectively. [Figure 3B] 3A and 3B are top views of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in a collapsed and expanded state, respectively.

[0010] [Figure 4] FIG. 4 diagrammatically depicts an end view of a cutting portion of a treatment assembly, configured in accordance with some embodiments of the present technology, shown positioned within a blood vessel lumen in an expanded state.

[0011] [Diagram 5] FIG. 5 is a side view of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in an expanded state.

[0012] [Figure 6] 6 and 7 are side views of a treatment assembly configured in accordance with some embodiments of the present technology. [Figure 7] 6 and 7 are side views of a treatment assembly configured in accordance with some embodiments of the present technology.

[0013] [Figure 8] 8 and 9A are side views of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in an expanded state. [Figure 9A]8 and 9A are side views of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in an expanded state.

[0014] [Figure 9B] FIG. 9B is a side view of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in a collapsed state.

[0015] [Figure 10] FIG. 10 is a side view of a treatment assembly configured in accordance with some embodiments of the present technology.

[0016] [Figure 11] FIG. 11 is a side view of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in an expanded state.

[0017] [Figure 12A] 12A-12C are side views of a treatment system having a treatment device and an introducer sheath with a proximal funnel, configured in accordance with some embodiments of the present technology. [Figure 12B] 12A-12C are side views of a treatment system having a treatment device and an introducer sheath with a proximal funnel, configured in accordance with some embodiments of the present technology. [Figure 12C] 12A-12C are side views of a treatment system having a treatment device and an introducer sheath with a proximal funnel, configured in accordance with some embodiments of the present technology.

[0018] [Figure 13] 13-16 are side views of a capture portion configured in accordance with certain embodiments of the present technology. [Figure 14] 13-16 are side views of a capture portion configured in accordance with certain embodiments of the present technology. [Figure 15] 13-16 are side views of a capture portion configured in accordance with certain embodiments of the present technology. [Figure 16] 13-16 are side views of a capture portion configured in accordance with certain embodiments of the present technology.

[0019] [Figure 17A] FIG. 17A is an isometric view of a treatment assembly with a cutting portion constructed in accordance with the present technology shown in an expanded state.

[0020] [Figure 17B] FIG. 17B is an end view of the treatment assembly with the cutting portion shown in FIG. 17A shown positioned within a blood vessel lumen in an expanded state.

[0021] [Figure 18A] FIG. 18A is an isometric view of a treatment assembly with a cutting portion constructed in accordance with the present technology shown in an expanded state.

[0022] [Figure 18B] FIG. 18B is an end view of the treatment assembly with the cutting portion shown in FIG. 18A shown positioned within a blood vessel lumen in an expanded state.

[0023] [Figure 19A] FIG. 19A is an exploded view of a blade assembly, configured in accordance with certain embodiments of the present technology.

[0024] [Figure 19B] FIG. 19B is an assembled view of a blade assembly, configured in accordance with certain embodiments of the present technology.

[0025] [Figure 20A] 20A and 20B are perspective views of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in a collapsed state and an expanded state, respectively. [Figure 20B]20A and 20B are perspective views of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in a collapsed state and an expanded state, respectively.

[0026] [Figure 21A] 21A and 21B are perspective views of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in a collapsed state and an expanded state, respectively. [Figure 21B] 21A and 21B are perspective views of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in a collapsed state and an expanded state, respectively.

[0027] [Figure 22A] 22A, 22B, and 22C are perspective views of a treatment assembly, configured in accordance with some embodiments of the present technology, shown with various components removed for ease of illustration. [Figure 22B] 22A, 22B, and 22C are perspective views of a treatment assembly, configured in accordance with some embodiments of the present technology, shown with various components removed for ease of illustration. [Figure 22C] 22A, 22B, and 22C are perspective views of a treatment assembly, configured in accordance with some embodiments of the present technology, shown with various components removed for ease of illustration.

[0028] [Figure 23A] 23A and 23B are perspective views of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in a collapsed state and an expanded state, respectively. [Figure 23B] 23A and 23B are perspective views of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in a collapsed state and an expanded state, respectively.

[0029] [Figure 24]FIG. 24 is a perspective view of a treatment assembly, configured in accordance with some embodiments of the present technology, shown in an expanded state.

[0030] [Diagram 25] FIG. 25 is a perspective view of a treatment assembly with a cutting portion, configured in accordance with some embodiments of the present technology, shown in an expanded state.

[0031] [Figure 26] FIG. 26 is a perspective view of a treatment assembly configured in accordance with some embodiments of the present technology.

[0032] [Figure 27A] 27A and 27B are isometric views of a treatment assembly with a cutting portion, configured in accordance with some embodiments of the present technology. Fig. 27A shows the cutting portion in a collapsed state. Fig. 27B shows the cutting portion in an expanded state. [Figure 27B] 27A and 27B are isometric views of a treatment assembly with a cutting portion, configured in accordance with some embodiments of the present technology. Fig. 27A shows the cutting portion in a collapsed state. Fig. 27B shows the cutting portion in an expanded state.

[0033] [Figure 27C] 27C and 27D are side views of the arms of the cutting portion shown in FIGS. 27A and 27B shown isolated from the treatment assembly and configured in accordance with some embodiments of the present technology. [Figure 27D] 27C and 27D are side views of the arms of the cutting portion shown in FIGS. 27A and 27B shown isolated from the treatment assembly and configured in accordance with some embodiments of the present technology.

[0034] [Figure 28A]28A and 28B are isometric views of a treatment assembly with a cutting portion, configured in accordance with some embodiments of the present technology. Fig. 28A shows the cutting portion in a collapsed state. Fig. 28B shows the cutting portion in an expanded state. [Figure 28B] 28A and 28B are isometric views of a treatment assembly with a cutting portion, configured in accordance with some embodiments of the present technology. Fig. 28A shows the cutting portion in a collapsed state. Fig. 28B shows the cutting portion in an expanded state.

[0035] [Figure 29A] 29A and 29B show a treatment assembly configured in accordance with certain embodiments of the present technology. [Figure 29B] 29A and 29B show a treatment assembly configured in accordance with certain embodiments of the present technology.

[0036] [Figure 30A] 30A and 30B show a treatment assembly configured in accordance with certain embodiments of the present technology. [Figure 30B] 30A and 30B show a treatment assembly configured in accordance with certain embodiments of the present technology.

[0037] [Diagram 31] FIG. 31 shows a treatment assembly configured in accordance with some embodiments of the present technology.

[0038] [Figure 32A] 32A and 32B show a treatment assembly configured in accordance with certain embodiments of the present technology. [Figure 32B] 32A and 32B show a treatment assembly configured in accordance with certain embodiments of the present technology.

[0039] [Diagram 33] FIG. 33 shows a treatment assembly configured in accordance with some embodiments of the present technology.

[0040] [Diagram 34] FIG. 34 shows a treatment assembly configured in accordance with some embodiments of the present technology.

[0041] [Diagram 35] FIG. 35 shows a treatment assembly configured in accordance with some embodiments of the present technology.

[0042] [Figure 36A] 36A and 36B show a treatment assembly configured in accordance with certain embodiments of the present technology. [Figure 36B] 36A and 36B show a treatment assembly configured in accordance with certain embodiments of the present technology.

[0043] [Figure 37A] 37A and 37B are isometric and side views of another treatment assembly with features for directing tissue. [Figure 37B] 37A and 37B are isometric and side views of another treatment assembly with features for directing tissue.

[0044] [Figure 38A] 38A and 38B show a treatment assembly configured in accordance with certain embodiments of the present technology. [Figure 38B] 38A and 38B show a treatment assembly configured in accordance with certain embodiments of the present technology.

[0045] [Figure 39A] 39A and 39B show a treatment assembly configured in accordance with certain embodiments of the present technology. [Figure 39B] 39A and 39B show a treatment assembly configured in accordance with certain embodiments of the present technology.

[0046] [Diagram 40]FIG. 40 is a perspective view of a treatment assembly with a locator element configured in accordance with some embodiments of the present technology.

[0047] [Figure 41A] 41A-41F show different positioning device and treatment device arrangements configured in accordance with certain embodiments of the present technology. [Figure 41B] 41A-41F show different positioning device and treatment device arrangements configured in accordance with certain embodiments of the present technology. [Figure 41C] 41A-41F show different positioning device and treatment device arrangements configured in accordance with certain embodiments of the present technology. [Figure 41D] 41A-41F show different positioning device and treatment device arrangements configured in accordance with certain embodiments of the present technology. [Figure 41E] 41A-41F show different positioning device and treatment device arrangements configured in accordance with certain embodiments of the present technology. [Fig.41F] 41A-41F show different positioning device and treatment device arrangements configured in accordance with certain embodiments of the present technology.

[0048] [Diagram 42] 42 and 43 show a positioning device and treatment device arrangement configured in accordance with some embodiments of the present technology. [Diagram 43] 42 and 43 show a positioning device and treatment device arrangement configured in accordance with some embodiments of the present technology.

[0049] [Diagram 44] 44 and 45 show a positioning device and treatment device arrangement configured in accordance with some embodiments of the present technology. [Diagram 45]44 and 45 show a positioning device and treatment device arrangement configured in accordance with some embodiments of the present technology.

[0050] [Figure 46A] 46A and 46B are perspective and end views, respectively, of a treatment assembly with a locator element configured in accordance with some embodiments of the present technology. [Figure 46B] 46A and 46B are perspective and end views, respectively, of a treatment assembly with a locator element configured in accordance with some embodiments of the present technology.

[0051] [Figure 47A] 47A-47D show different positioning device and treatment assembly arrangements configured in accordance with certain embodiments of the present technology. [Figure 47B] 47A-47D show different positioning device and treatment assembly arrangements configured in accordance with certain embodiments of the present technology. [Figure 47C] 47A-47D show different positioning device and treatment assembly arrangements configured in accordance with certain embodiments of the present technology. [Figure 47D] 47A-47D show different positioning device and treatment assembly arrangements configured in accordance with certain embodiments of the present technology.

[0052] [Figure 48] 48 and 49 show a positioning device and treatment assembly arrangement configured in accordance with some embodiments of the present technology. [Figure 49] 48 and 49 show a positioning device and treatment assembly arrangement configured in accordance with some embodiments of the present technology.

[0053] [Figure 50A] 50A and 50B depict a distal capture device configured in accordance with some embodiments of the present technology. [Figure 50B] 50A and 50B depict a distal capture device configured in accordance with some embodiments of the present technology.

[0054] [Figure 51A] 51A and 51B diagrammatically depict a treatment system including a capture device, configured in accordance with some embodiments of the present technology. [Figure 51B] 51A and 51B diagrammatically depict a treatment system including a capture device, configured in accordance with some embodiments of the present technology.

[0055] [Figure 52] FIG. 52 diagrammatically depicts a treatment system including a treatment device, a capture device, and an introducer sheath, configured in accordance with some embodiments of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0056] Detailed Description FIG. 1 diagrammatically depicts a treatment system 10 (also referred to herein as “system 10”) configured in accordance with the present technology. Treatment system 10 is configured to access a body lumen (such as a vein or artery) and modify, capture, and / or remove occlusive material from the body lumen. As used herein, “occlusion” or “occlusive material” can comprise, for example, clot material, atherosclerotic plaque, and / or other flow-occlusive structures, including those derived from clot material, such as fibrous clot material, venous adhesions, fibrinous structures, collagenous structures, fibrous trabeculae, and / or others. As shown in FIG. 1, system 10 may comprise a treatment device 101 (or “device 101”) having a proximal portion 101a configured to be positioned outside the body during a procedure, a distal portion 101b configured to be positioned at a treatment site within a blood vessel, and one or more elongate members 102 extending between the proximal portion 101a and the distal portion 101b. The treatment device 101 can also include a handle 12 and a sleeve 112 extending distally from the handle 12. The elongated member 102 can be configured to be slidably disposed within a lumen of the sleeve 112. In some embodiments, the treatment device 101 does not include one of the sleeve 112 or the elongated member 102. In these and other embodiments, the treatment device 101 includes two or more elongated members. In some of such embodiments, the treatment device 101 does not include a sleeve 112 and the elongated member 102 includes at least a first and a second elongated member 111, 108 (described below with reference to FIG. 2).

[0057] The treatment device 101 may include at least one lumen configured to receive a guidewire (not shown) or other guide rail so that the device 101 may be positioned at a treatment site over the guidewire. The lumen may extend along the elongate member 102 (or any components thereof, including one or both of the first and second elongate members 111, 108, discussed with reference to FIG. 2) and terminate distally at a distal opening. The lumen may also be configured to receive a visualization device therethrough.

[0058] The treatment device 101 further includes a treatment assembly 100 (or "assembly 100") carried by a distal portion of the elongate member 102. The treatment assembly 100 can comprise a capturing portion 200 and a cutting portion 300, which can be integral with one another or separate components. The cutting portion 300 can comprise one or more cutting elements configured to cut through occlusive material within the vessel lumen as the treatment assembly 100 is moved axially along the lumen, thereby separating and / or releasing the occlusive material from the vessel wall and / or from other occlusive material. The capturing portion 200 can comprise one or more expandable mesh structures configured to engage, confine, or otherwise become engaged with the occlusive material at the treatment site before, during, or after engagement by the cutting portion 300. The capturing portion 200 can comprise any of the capturing portions 200 described herein, and the cutting portion 300 can comprise any of the cutting portions 300 described herein. In some embodiments, the treatment system 10 includes only the cutting portion and can be used in conjunction with a separate off-the-shelf capture device. Additional details regarding the capture portion 200 and the cutting portion 300 are described below.

[0059] The treatment assembly 100 is transformable between a low-profile state for delivery to a vascular lumen and a deployed (e.g., expanded) state, as detailed herein. As used herein with reference to the treatment assembly 100, "expanded" and "deployed" refer to the configuration of the treatment assembly 100 when one or both of the capturing portion 200 and the cutting portion 300 are in a partially or fully expanded state. According to some embodiments described herein, the capturing portion 200 and the cutting portion 300 are integrated into a single expandable device. In some of such embodiments, the treatment assembly 100 is self-expanding and is coupled to a distal end portion of a single elongate member 102. In other embodiments in which the capturing portion 200 and the cutting portion 300 are integrated into a single expandable device, the treatment assembly 100 (whether the treatment assembly 100 is self-expanding or requires activation) is coupled to at least two elongate members 108, 111, as shown in FIG. 2. The sleeve 112 may be positioned over the treatment assembly 100 to radially restrain and / or protect the treatment assembly 100 during introduction into the vascular lumen. In such embodiments, the sleeve 112 is retracted proximally to expose the treatment assembly 100 and allow one or more portions of the treatment assembly 100 to expand.

[0060] In accordance with some aspects of the present technology, the capturing portion 200 and the cutting portion 300 are independently deployable. In such embodiments, the capturing portion 200 and the cutting portion 300 are both self-expanding and can be coupled to the same elongation member 102 or may be coupled to separate elongation members.

[0061] In some embodiments, the capturing portion 200 and the cutting portion 300 comprise separately formed components, both carried by the distal region of the elongate member 102. One of many examples of such an embodiment is shown in Figures 3A and 3B. In these embodiments, the capturing portion 200 and the cutting portion 300 can be configured to collapse and expand independently of one another or via the same actuation mechanism. For example, the capturing portion 200 can be a resilient structure configured to self-expand in response to removal of the sleeve 112, while the expansion of the cutting portion 300 may require an additional actuation step by the operator (as described in more detail herein). Similarly, the cutting portion 300 can be a resilient structure configured to self-expand in response to removal of the sleeve 112, while the expansion of the capturing portion 200 may require an additional actuation step by the operator (as described in more detail herein). According to some examples, both the capturing portion 200 and the cutting portion 300 are resilient self-expanding structures.

[0062] Still referring to FIG. 1 , the handle 12 at the proximal portion 101a of the treatment device 101 can be permanently or removably coupled to one or more of the elongate members (sleeve 112, elongate member 102, inner member 108, outer member 111, etc.). The handle 12 can include one or more actuators for controlling the movement of one or more portions of the treatment assembly 100. For example, the handle 12 can include a first actuator 14 that is mechanically (e.g., via a push rod, push tube, and / or pull wire) and / or electrically (e.g., via one or more wires) coupled to the capturing portion 200 and a second actuator 16 that is mechanically (e.g., via a push rod, push tube, and / or pull wire) and / or electrically (e.g., via one or more wires) coupled to the cutting portion 300. Activation of the first actuator 14 can, for example, control the movement of one or more of the capturing portions 200. In some embodiments, the first actuator 14 controls the axial, rotational, and / or radial expansion / contraction of part or all of the capturing portion 200. In some embodiments, the second actuator 16 controls the axial, rotational, and / or radial expansion / contraction of part or all of the cutting portion 300. In accordance with some aspects of the present technology, the first and / or second actuators 14, 16 and / or a third actuator (not shown) control the axial, rotational, and / or radial expansion / contraction of part or all of the capturing portion 200 and part or all of the cutting portion 300. For example, the handle 12 can include an actuator configured to move the cutting portion 300 axially relative to the capturing portion 200 (or vice versa).

[0063] In some embodiments, the first and / or second actuators 14, 16 or additional actuators (not shown) in the handle 12 are coupled to the sleeve 112 and configured to control axial and / or rotational movement of the sleeve 112. Such actuators can be configured, for example, to axially advance or retract the sleeve 112 to selectively expose or cover all or a portion of the treatment assembly 100. In some embodiments, the first and / or second actuators 14, 16 or additional actuators (not shown) in the handle 12 are coupled to the elongated member 102 and configured to control axial and / or rotational movement of the elongated member 102. In some embodiments, the first and / or second actuators 14, 16 or additional actuators (not shown) in the handle 12 are coupled to the inner member 108 and configured to control axial and / or rotational movement of the inner member 108. In some embodiments, the first and / or second actuators 14, 16 or additional actuators (not shown) in the handle 12 are coupled to the outer member 111 and configured to control axial and / or rotational movement of the outer member 111. The handle 12 can include more or less than two actuators (e.g., one actuator, three actuators, four actuators, five actuators, six actuators, etc.).

[0064] In accordance with some aspects of the present technology, the treatment system 10 optionally includes an introducer 103 for facilitating delivery of the treatment device 101 into the vascular lumen. The introducer 103 can include a proximal portion 103a, a distal portion 103b, a hub 105 at the proximal portion 103a, and an elongated sheath 110 extending distally from the hub 105 to the distal portion 103b of the introducer 103. In some embodiments, the hub 105 is configured to be coupled to the suction source 18 and / or the fluid source 20 (e.g., via one or more ports). The hub 105 and the sheath 110 can be configured to receive a portion of the treatment device 101 therethrough. For example, the treatment assembly 100, the elongated member 102, and / or the sleeve 112 can be configured to be inserted through the hub 105 and slidably positioned within the lumen of the sheath 110. In some embodiments, the hub 105 includes a hemostasis valve. According to some embodiments, introducer 103 includes a funnel at the distal end portion of sheath 110. Examples of such embodiments are depicted in Figures 12A-12C and 52. The funnel can be configured to expand into apposition with the vessel wall proximate the distal end portion of sheath 110, thereby preventing released occlusive material from progressing proximally of introducer 103. In some embodiments, system 10 does not include introducer 103.

[0065] Treatment system 10 may optionally include a suction or aspiration source 18 (e.g., a syringe, a pump, etc.) fluidly coupled to a proximal portion of one or more of introducer 103, sleeve 112, and / or elongated member 102 (and / or one or more subcomponents thereof) and configured to apply negative pressure therethrough. In some embodiments, treatment system 10 includes a fluid source 20 (e.g., a fluid reservoir, a syringe, a pump, etc.) fluidly coupled to a proximal portion of one or more of introducer 103, sleeve 112, and / or elongated member 102 (and / or one or more subcomponents thereof) and configured to supply fluid to the treatment site. The fluid may be, for example, saline, a contrast agent, a drug such as a thrombolytic agent, etc.

[0066] An actuator on the handle 12 or a separate actuator connected directly to the suction source 18 and / or fluid source 20 may control the application of suction and / or irrigation to the treatment site through the system 10. In some embodiments, a single actuator controls both suction and irrigation. In some embodiments, the suction level from the suction source 18 and the fluid flow level from the fluid source 20 are coupled to be at the same level or nearly the same level so that there is no fluid accumulation at the treatment site. A single actuator can raise or lower this same level.

[0067] In some embodiments, the treatment system 10 may include a positioning element configured to position the treatment assembly and / or cutting portion in close proximity to the occlusive material within the blood vessel (or other body lumen) to improve efficiency of cutting. The positioning element can additionally or alternatively be utilized to offset the cutting portion from the vessel wall to protect the vessel wall. The positioning element can be part of a separate device over, adjacent to, or through which the treatment device 101 and / or treatment assembly 100 are delivered, or can be incorporated onto the treatment device 101 itself (e.g., disposed on the sleeve 112, elongated member 102, first elongated member 111, second elongated member 108, etc.). The positioning element can be porous (e.g., expandable cage, struts, etc.) or substantially impermeable to blood flow (e.g., balloon, covered stent, etc.). Additional details regarding the positioning elements are discussed herein.

[0068] In some methods of use, system 10 can be introduced into the venous system from a proximal site (e.g., the common femoral vein, femoral vein, or internal jugular vein) and advanced in a retrograde direction (against normal blood flow) to a treatment site within the veins of a patient's leg. System 10 can also be introduced into the venous system from a distal site (e.g., the popliteal vein or a more distal vein) and advanced in an antegrade direction (the same direction as blood flow) toward a target treatment site. In some embodiments, system 10 is introduced into a patient's artery for treatment within the artery.

[0069] 3A and 3B are top views of a distal portion 101b of a treatment device 101 with a treatment assembly 100 in various states of deployment, in accordance with an embodiment of the present technology. As shown in FIGs. 3A and 3B, the treatment assembly 100 can include a capturing portion 200 and a cutting portion 300. The capturing portion 200 and the cutting portion 300 can be independently deployable. For example, the capturing portion 200 is shown in a deployed (e.g., expanded) state in FIGs. 3A and 3B, and the cutting portion 300 is shown in a collapsed state in FIG. 3A and in a deployed state in FIG. 3B.

[0070] The cutting portion 300 can comprise one or more cutting elements 302 configured to cut through occlusive material within the vessel lumen, thereby separating and / or releasing the occlusive material from the vessel wall and / or other occlusive material, as the treatment assembly 100 is moved axially along the lumen. FIG. 4 diagrammatically depicts the device positioned within a blood vessel. The arms 304 of the cutting portion 300 may be angled toward each other (rather than extending 180 degrees apart) when extended, such that the arms 304 and attached blades 302 are at an angle θ that better approximates the curvature of the vessel wall. This geometry facilitates cutting occlusive material (such as chronic thrombotic material) away from the curved vessel wall. In some embodiments, the angle between the two arms is less than 180 degrees. In some embodiments, the angle is between 135 and 180 degrees.

[0071] The capturing portion 200 can comprise one or more expandable mesh structures configured to engage, trap, or otherwise become engaged with occlusive material at the treatment site. In some embodiments, for example, as shown in Figures 3A and 3B, the cutting portion 300 can be positioned proximal to some or all of the capturing portion 200 along the longitudinal axis of the assembly 100 and / or device 101 such that a portion of the occlusive material separated from the vessel wall by axial movement of the cutting portion 300 is subsequently trapped within and / or engaged with the capturing portion 200 for subsequent removal from the patient's body. For example, in some embodiments, all or a portion of the cutting portion 300 is positioned distal to the occlusive material and moves proximally, and in some embodiments, all or a portion of the cutting portion 300 is positioned proximal to the occlusive material and moves distally toward the capturing portion 200.

[0072] As depicted in Figures 3A and 3B, in some embodiments, the capturing portion 200 and the cutting portion 300 comprise separately formed components, both carried by a distal region of the elongate member 102. In such embodiments, the capturing portion 200 and the cutting portion 300 can be configured to collapse and expand independently of one another or via the same actuation mechanism. For example, the capturing portion 200 can be a resilient structure configured to self-expand in response to removal of the sleeve 112, while the expansion of the cutting portion 300 may require an additional actuation step by an operator (as described in more detail herein). Similarly, the cutting portion 300 can be a resilient structure configured to self-expand in response to removal of the sleeve 112, while the expansion of the capturing portion 200 may require an additional actuation step by an operator (as described in more detail herein). According to some embodiments, both the capturing portion 200 and the cutting portion 300 are resilient self-expanding structures.

[0073] In some embodiments of the present technology, for example, as shown in FIGS. 3A and 3B, the elongate member 102 can comprise an outer member 111 and an inner member 108 positioned through a lumen of the outer member 111. The proximal ends of each of the outer member 111 and the inner member 108 can be disposed in a handle such that the inner and outer members 108, 111 can be manipulated by an operator. In some embodiments, the distal end portion 200b of the capturing portion 200 is coupled to a distal region of the inner member 108. In the embodiment shown in FIGS. 3A and 3B, for example, only the distal end portion 200b of the capturing portion 200 is coupled to a distal region of the inner member 108, and the proximal end portion 200a is free to radially expand away from the inner member 108 when the sleeve 112 is removed. As a result, when the capturing portion 200 is in the expanded state, the proximal end portion 200a defines a proximal opening 206 through which occlusive material separated by the cutting portion 300 may pass, trapping the occlusive material within an interior cavity defined by the capturing portion 200. In some embodiments, only the proximal end portion 200a of the capturing portion 200 is coupled to the inner member 108, while the distal end portion 200b is free and defines a distal opening in the expanded state. In some embodiments, both the proximal end portion 200a and the distal end portion 200b are coupled to the inner member 108.

[0074] 3A and 3B, the distal end portion 300b of the cutting portion 300 can be coupled to the inner member 108, and the proximal end portion 300a of the cutting portion 300 can be coupled to the distal end portion of the outer member 111. The distal end portion 300b of the cutting portion 300 can be coupled to the inner member 108 at a location distal to, generally aligned with, or proximal to the proximal end of the capturing portion 200. In some embodiments, the distal end portion 300b is slidable along the inner member 108. In such embodiments, the inner member 108 may optionally include distal and / or proximal stops to limit distal and / or proximal axial movement of the cutting portion 300 along the inner member 108, respectively. In either case, movement of the outer member 111 relative to the inner member 108 can cause the cutting portion 300 to radially expand and collapse. For example, axial movement of the outer member 111 relative to the inner member 108 in the distal direction can cause the cutting portion 300 to expand radially, while axial movement of the outer member 111 relative to the inner member 108 in the proximal direction can cause the cutting portion 300 to collapse radially.

[0075] According to some embodiments of the present technology, the cutting portion 300 may comprise a tube with one or more regions removed along a distal portion to form expandable arms 304 (individually labeled as 304a and 304b). In some embodiments, the tube forming the outer member 111 and the cutting portion 300 are different portions of the same continuous tube. As explained above, distal movement of the outer member 111 relative to the inner member 108 causes the arms 304 to buckle and / or bend outwardly away from the longitudinal axis of the extension member 102, as shown in FIG. 3B.

[0076] Arm 304 can include one or more sections 306a, 306b, 308a, and 308b (collectively referred to as "sections 309") and one or more joints 310. Joints 310 can be positioned along arm 304 between sections 309 and / or between individual arms 304 and the remaining portion of the tube from which the arm 304 is severed (e.g., the proximal and distal end portions of arm 304). Joint 310 can be a portion of arm 304 that is configured to flex or bend preferentially relative to sections 309 and / or the proximal and distal end portions of the tube. In some embodiments, one or more of the joints 310 can be formed by opposing recesses (e.g., living hinges) at desired locations along the arm 304, while in other embodiments, one or more of the joints 310 can be one or more small pins, elastic polymer elements, mechanical hinges, and / or other devices that allow one section to pivot or bend relative to another.

[0077] 3A and 3B, each arm 304 includes a distal joint at its distal end portion, a proximal joint at its proximal end portion, and an intermediate joint located along the length of the respective arm 304 between the distal and proximal joints. In response to longitudinal stress caused by relative axial movement of the inner and outer members 108, 110, the arms 304 deform to a predetermined shape biased by the configuration and / or relative position of the joints 310. For example, in the illustrated embodiment, each arm 304 includes a generally linear distal section 306a, 306b and a generally linear proximal section 308a, 308b when deployed. In some embodiments, each arm 304 includes a generally curvilinear distal section 306a, 306b and / or a generally curvilinear proximal section 308a, 308b when deployed.

[0078] The cutting portion 300 can include one or more cutting elements, such as blades 302, fixedly coupled to one or more sections of the arms. In the embodiment shown in FIGS. 3A and 3B, the blades 302 each have a sharpened edge that faces proximally when the cutting portion 300 is in a deployed and / or expanded state. The blades 302 may be made of a first material, while the arms 304 and / or the cutting portion 300 may be made of a second material that is different from the first material. For example, the blades 302 may be made of stainless steel, while the arms 304 and / or the cutting portion 300 may be made of a resilient and / or superelastic metal alloy, such as Nitinol, cobalt chromium alloy, and others. In some embodiments, the blades 302 are made of the same material as the arms 304. According to some embodiments, the cutting elements are not separately formed structures, but are instead formed from sharpened edges of structural elements of the cutting portion 300.

[0079] 5 is a side view of a distal portion 101b of a treatment device 101 configured in accordance with some embodiments of the present technology, with the treatment assembly 100 shown in an expanded state. The assembly 100 may generally comprise an elongate member 102 and a cutting portion 300 similar to the elongate member 102 and cutting portion 300 discussed above with reference to FIGS. 3A and 3B. The capturing portion 200 shown in FIG. 5 may generally be similar to the capturing portion 200 shown in FIG. 3A and 3B, except that the capturing portion 200 shown in FIG. 5 includes a flexible braided distal region 202 and a more rigid proximal region 204 formed from a laser cut tube or sheet of material. The tube forming the proximal region 204 may be continuous with or separate from the distal region of the cutting portion 300. The proximal region 204 may have a greater long term outward force and / or radial resistance compared to the distal region 202, which may be beneficial to maintain patency of the proximal opening 206 once the capturing portion 200 of the assembly 100 and / or device 101 is deployed. In some embodiments, the cutting portion 300 may be fixed to or integral with the capturing portion 200. For example, the proximal open end region 204 of the capturing portion 200 may be constructed from a cut Nitinol tube. The main structure of the cutting portion 300 may also be constructed from a cut Nitinol tube, as described above. The Nitinol tubes of the region 204 and the cutting portion 300 may be the same Nitinol tube with two sections of the cut pattern. Alternatively, the Nitinol tubes of the region 204 and the cutting portion 300 may be two separate tubes that are mechanically bonded, glued, soldered, or welded to fixedly couple the capturing portion 200 with the cutting portion 300.

[0080] 6 and 7 show a distal portion of the device 101 configured according to some embodiments of the present technology. As shown in FIGS. 6 and 7, in some embodiments, the cutting portion 300 and the capturing portion 200 are separate components that are spaced apart and slidably coupled. In this embodiment, the blades of the cutting portion 300 of the assembly 100 and / or the device 101 can face proximally or face distally depending on how the capturing portion 200 and the cutting portion 300 are configured to be used relative to one another. In one variation, shown in FIG. 6, the cutting element 302 (e.g., a blade, etc.) is oriented to face proximally, e.g., attached to the proximal arms 306a and 306b of the cutting portion 300. According to some methods of use, the treatment assembly 100 is initially positioned within the vessel lumen such that the capturing portion 200 and the cutting portion 300 are both distal to the occlusive material. The two portions 200, 300 can be expanded, for example, by retraction of the sheath or by any of the expansion mechanisms described herein. The cutting portion 300 can be retracted proximally to cut through the occlusive material, and subsequently, the capturing portion 200 can be retracted proximally to collect the cut occlusive material. In some embodiments, the cutting portion 300 and the capturing portion 200 can be retracted alternately and / or simultaneously to cut and capture the occlusive material.

[0081] In another variation, as shown in FIG. 7, the blade 302 on the cutting portion faces distally. For example, the blade 302 can be attached to the distal arms 304a and 304b of the cutting portion 300. According to some methods of use, the treatment assembly 100 is initially positioned within the vessel lumen such that the capturing portion 200 is distal to the occlusive material and the cutting portion 300 is proximal to the occlusive material. In use, the cutting portion 300 can be moved axially toward the capturing portion 200 to separate the occlusive material from the wall and push the occlusive material into the capturing portion 200.

[0082] In some embodiments, the cutting portion 300 of the assembly 100 may be an expandable tubular structure with integrated cutting elements. FIG. 8, for example, illustrates the assembly 100 with a cutting portion 300 comprising a generally tubular stent-like portion 502 and a plurality of arms 504 extending away from the stent-like portion 502 in a distal direction. The cutting portion 300 may further include a plurality of cutting elements 302, each disposed at an end portion of a corresponding arm 502. For example, in some embodiments, the cutting portion 300 is constructed from a cut Nitinol tube with integrated cutting elements 302 (such as blades) arranged in a circular array. The arms 504 and cutting elements 302 may be spaced about the circumference of the cutting portion 300 such that the cutting portion 300 is configured to create a cut that extends circumferentially around the vessel wall. Such a feature may be advantageous in some situations due to the amount of occlusive material in the vessel and / or the difficulty of separating the occlusive material from the vessel wall. The cutting edges of the cutting elements 302 may be sharpened and configured to mechanically cut and / or otherwise modify the occlusive material. Additionally or alternatively, the cutting edges of the cutting elements may be configured to chemically cut and / or otherwise modify the occlusive material.

[0083] In some embodiments, one, some, or all of the arms 504 are tapered. In some embodiments, the arms 504 are not tapered and / or have a substantially constant width and / or arc length along their length. In the collapsed state (not shown), the distal end portions can be circumferentially spaced apart while the intermediate portions of the projections circumferentially overlap with circumferentially adjacent projections. In the expanded state (FIG. 8), the end portions of the arms 504 can be circumferentially spaced apart by an arc length greater than when the device was in the collapsed state, with the intermediate portions overlapping circumferentially to a lesser extent than in the collapsed state, or not at all.

[0084] As shown in FIG. 8 , the arms 504 and / or the cutting element 302 can be directed distally towards the capturing portion 200. In some of such embodiments, the cutting portion 300 can be configured to move axially relative to the capturing portion 200. For example, the cutting portion 300 can be slidably coupled to the outer extension member 111 while the capturing portion 200 can be coupled to the inner extension member 108. Other configurations allowing independent movement of the capturing portion 200 and the cutting portion 300 are also possible. In use, the cutting portion 300 can be deployed and / or otherwise positioned proximal to the occlusive material with all or a portion of the capturing portion 200 positioned distal to the occlusive material. The cutting portion 300 can be pushed distally to cut the occlusive material and separate it from the vessel wall and / or from other occlusive material.

[0085] Figure 9A shows a treatment assembly 100 that is generally similar to the treatment assembly 100 of Figure 8, except that in Figure 9A, multiple arms 504 extend in a proximal direction away from the stent-like portion 502. In use, the capturing portion 200 and the cutting portion 300 can be deployed and / or otherwise positioned distal to the occlusive material and retracted proximally to cut the occlusive material. Figure 9B depicts the treatment assembly 100 in a collapsed state within the sleeve 112 (shown in cross-section).

[0086] In some embodiments where the capturing portion 200 and the cutting portion 300 are separately formed components, the capturing portion 200 and the cutting portion 300 can be fixed to one another such that axial and / or rotational movement of one of the portions 200, 300 causes axial movement of all or a portion of the other portion 200, 300. For example, the distal end portion 300b of the cutting portion 300 can be fixedly coupled to the proximal end region 200a of the capturing portion 200. If the cutting portion 300 and the capturing portion 200 are both fairly rigid structures with high column strength (such as laser cut tubes or sheets of material), axial movement of the cutting portion 300 will cause axial movement of the entire capturing portion 200, and vice versa. If one of the capture portion 200 or the cutting portion 300 is a more flexible structure (such as a braid) with low column strength while the other is a more rigid structure, axial movement of the more rigid structure may cause the end region of the more flexible structure to collapse axially, while axial movement of the flexible structure may not cause any axial movement of the more rigid structure.

[0087] According to some embodiments, the capturing portion 200 and the cutting portion 300 can be rotated and / or axially moved independently of one another. For example, the elongate member 102 can comprise a first elongate member coupled to the capturing portion 200 and a second elongate member coupled to the cutting portion 300. The first and second elongate members can be configured to move axially relative to one another and / or rotate relative to one another (e.g., when one elongate member is received within a lumen of the elongate member), thereby causing axial movement and / or rotation of the corresponding attached capturing and cutting portions 200, 300. In some embodiments, the capturing portion 200 and the cutting portion 300 can be mounted to the same elongate member, but one of the capturing portion 200 or the cutting portion 300 is axially and / or rotationally fixed to the elongate member, while the other is free to slide along and / or rotate about the elongate member. In some embodiments, both the capturing portion 200 and the cutting portion 300 are axially and / or rotationally fixed to the elongate member.

[0088] In any of the embodiments in which the capturing portion 200 and the cutting portion 300 are separately formed components, the capturing portion 200 and the cutting portion 300 may be configured to radially expand and collapse independently of one another or via the same actuation mechanism, as discussed herein.

[0089] In some embodiments of the technology, the cutting portion 300 is integrated into the structure of the capturing portion 200, or vice versa. For example, as shown in FIG. 10, the capturing portion 200 can have one or more cutting elements 302 oriented proximally along the capturing portion's proximal surface and configured to cut occlusive material as the device is retracted. The cutting elements may be angled relative to the longitudinal axis of the elongate member 102 to optimize the blade's ability to slide through tough material as the device is retracted proximally. The cutting elements can be one or more separately formed blades that are coupled to the capturing portion 200's proximal surface. For example, the cutting elements can be separately formed blades 302 that are mechanically attached to the capturing portion 200 (e.g., via a latching configuration described with respect to FIGS. 19A and 19B). In such embodiments, the posts defining the proximal opening 206 of the capturing portion 200 may have slots or other features to mechanically lock the blade 302 in place relative to the posts. Additionally, or alternatively, the cutting element may be formed from the same material and / or structure as the capturing portion 200. For example, the cutting element may be formed from a sharpened proximally-facing surface of the capturing portion 200.

[0090] In some embodiments, for example as shown in Figure 11, the cutting elements and / or the projections carrying the cutting elements are constructed from the same metal tube that makes up the proximal portion 204 of the capturing portion 200 and include protruding tapered elements that fold together when collapsed, similar to Figures 8-9B. Although the assembly 100 in Figure 11 shows the capturing portion 200 comprising a braid, in some embodiments the capturing portion 200 may comprise a laser cut stent.

[0091] 8, 9A, 9B, 11, 27A, 27B, 28A, and 28B, one, some, or all of the protrusions (arm 504, arm 652, protrusion 1502, etc.) can include cutting element 302. The cutting element can be coupled to the protrusion (blade, etc.) or the cutting element can be formed from the protrusion, for example, by sharpening one edge / surface of the protrusion. In some embodiments, the cutting element is positioned at a distal end portion of the protrusion. In these and other embodiments, the cutting element may be positioned along all or a portion of one or both side surfaces of a given protrusion.

[0092] When the treatment assembly 100 is in the collapsed state, the protrusions can be compressed together, and when the treatment assembly 100 is in the expanded state, the protrusions can expand outwardly to contact and / or conform to the vessel wall. As the treatment assembly is pulled into and through the occlusive material, the cutting elements cut the occlusive material away from the vessel wall. The cutting elements may be configured to be angled such that pulling the device causes the cutting surface to slice across the occlusive material to improve the cutting action. The distal and / or side edges of one, some, or all of the protrusions and / or blades can be generally linear, generally curved, serrated, and have other suitable configurations.

[0093] As mentioned above, the devices and systems of the present technology can optionally include an introducer 103. The introducer comprises a hub 105 and an elongated sheath 110 with a self-expanding funnel configured to extend distally from a distal opening of the sheath 110. Such a feature can be beneficial to contain occlusive material trapped within the sheath 110 as the treatment assembly 100 is withdrawn into the sheath 110. An exemplary system 10 including a funnel 700 is shown in FIGS. 12A and 12B. As shown in FIG. 12A, the treatment device 101 with the treatment assembly 100 can be delivered in a collapsed state through the sheath 110 with the funnel 700 in an expanded state. Once positioned, the sleeve 112 can be retracted to expand the treatment assembly. FIG. 12B shows the sleeve 112 partially retracted to show the captured portion 200 of the expanded treatment assembly 100. 12C shows the sleeve 112 fully retracted to show the cutting portion 300 of the expanded treatment assembly 100. Additionally or alternatively, suction may be applied to the hub 105 of the introducer 103, with or without a funnel, to further reduce the risk of embolism. The funnel 700 can be used with any of the systems detailed herein. A. Exemplary Capture Moieties

[0094] Several capturing portion configurations are shown and described with respect to Figures 13-16. The cutting portion 300 is not shown in Figures 13-16 for easy viewing of the capturing portion 200. It should be understood that the present disclosure is not limited to the capturing portion 200 depicted in the drawings.

[0095] 13 shows a capturing portion comprising a braided or woven capturing portion 200 having a closed distal end portion and an opening 206 at its proximal end portion. The braid has a tapered shape with a cross-sectional dimension that decreases in the distal direction. The distal end of the braid may be clamped together with a tip component 254 that constrains the ends of the braided wires together. The tip component 254 may have a tapered or rounded distal edge to reduce trauma to the vessel wall and facilitate traversing the device through the treatment site when the assembly 100 and / or device 101 are delivered to the treatment site. The tip component 254 may also affix an actuation member 102 to the distal end of the capturing device.

[0096] FIG. 14 shows a capturing portion 200 comprising a cut mesh structure having a closed distal end portion and an opening at its proximal end portion. The expanded mesh structure has a tapered shape with a cross-sectional dimension that decreases in the distal direction. The closed distal portion may be clamped closed with a tip component 254 that constrains the ends of the cut tube pattern together. As described above, the tip component 254 may have a tapered or rounded distal end and may also be used to affix the elongate member 102 to the closed end of the capturing portion 200. In some embodiments, the mesh structure may have a cut pattern that naturally creates a tapered profile when expanded without the tip component 254. The tip component 254 may still be present in this embodiment to present a tapered or rounded distal end and / or to affix the elongate member 102 to the closed end of the capturing portion 200.

[0097] 15 illustrates a capturing portion 200 comprising a flexible, tapered distal region 202 coupled to a stiffer proximal region 204. The distal region 202 may comprise a braid and the proximal region 204 may comprise a laser cut tube or sheet of material. The proximal region 204 may have a greater long term outward force and / or radial resistance compared to the distal region 202, which may be beneficial to maintain patency of the proximal opening 206 once the capturing portion 200 is deployed within a vessel lumen.

[0098] In any of the embodiments disclosed herein, the capturing portion 200 may include an open cell framework or body. According to some embodiments, the inlet 206 to the capturing portion 200 is angled to facilitate capture of occlusive material within the capturing portion 200. In some embodiments, the proximal end portion 200a of the capturing portion 200 may be generally tubular (including cylindrical) and the distal portion 200b of the capturing portion 200 tapers distally to the elongate member 102 (or a component thereof). Similarly, the distal portion 200b of the capturing portion 200 is generally tubular (e.g., cylindrical) and the proximal end portion 200a of the capturing portion 200 tapers proximally to the elongate member 102 (or a component thereof).

[0099] In some embodiments, the capturing portion 200 can have an open proximal end and a closed distal end. In some embodiments, the capturing portion 200 has an open proximal end and an open distal end. In some embodiments, the capturing portion has a closed proximal end and an open distal end. In some embodiments, referring to 200a in FIG. 16, the capturing portion has a closed proximal end and a closed distal end.

[0100] In some embodiments, the capturing portion 200 comprises a single expandable mesh structure. In some embodiments, the capturing portion 200 comprises multiple expandable structures 200a, 200b, for example as depicted in Figure 16. The different structures can have the same or different shapes, can expand to the same or different maximum cross-sectional dimensions, and / or can comprise the same or different types of mesh structures (e.g., braids, laser cut tubes, laser cut sheets, woven fabrics, etc.).

[0101] In some embodiments, the capturing portion 200 comprises a mesh structure formed from a resilient or spring material (e.g., stainless steel or cobalt chromium alloy), a superelastic material (e.g., nitinol), or other resilient or self-expanding material configured to self-expand upon release from the restraining sleeve 112. For example, in some embodiments, the mesh is a self-expanding stent and / or stent retriever. According to some embodiments, the mesh structure is a laser cut tube or sheet of material. The material can be comprised of, for example, a resilient, elastic, and / or superelastic metal alloy or polymer. In some embodiments, the mesh structure comprises a plurality of braided wires (e.g., filaments, threads, sutures, fibers, or the like) woven together to form a structure having openings. The mesh and / or braid can be comprised of metal, polymer, composite, and / or biological material. The polymeric materials may include Dacron, polyester, polypropylene, nylon, Teflon, polytetrafluoroethylene (PTFE), tetrafluoroethylene, polyethylene terephthalate, polylactic acid (PLA) silicone, polyurethane, polyethylene, polycarbonate, styrene, polyimide, PEBAX, Hytrel, polyvinyl chloride, high density polyethylene, low density polyethylene, polyetheretherketone (PEEK), rubber, latex, and / or other suitable polymers known in the art. Other materials known in the art of elastic implants may also be used. Metallic materials may include, but are not limited to, nickel titanium alloys (e.g., Nitinol), platinum, cobalt chromium alloys, stainless steel, tungsten or titanium, or alloys of any of these metals. In certain embodiments, the metallic filaments may be highly polished and / or surface treated to further improve their hemocompatibility. The capture portion 200 may be constructed solely from metallic materials without the inclusion of any polymeric materials, solely from polymeric materials without the inclusion of any metallic materials, or from a combination of polymeric and metallic materials.

[0102] In some embodiments, some or all of the wires of the capture portion 200 are drawn-filled tube ("DFT") wires having a radiopaque core (e.g., platinum, tantalum, gold, tungsten, etc.) surrounded by an elastic or superelastic material (e.g., nitinol, cobalt chromium alloy, etc.). The radiopaque core may comprise about 5% to about 50% (e.g., 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%) of the total cross-sectional area of ​​the individual wires. Also, some or all of the wires may have a wire diameter of about 0.003 inches to about 0.015 inches (e.g., 0.008 inches, 0.009 inches, 0.01 inches, etc.). In some embodiments, all of the wires have the same diameter, and in other embodiments, some of the wires have different diameters. B. Exemplary Cleavage Moieties

[0103] According to some embodiments of the present technology, the cutting portion 300 may comprise a separate cutting element, such as a blade, attached to an expandable structure forming the cutting portion 300. As explained above, the cutting portion may be oriented proximally or distally, as shown in Figs. 6 and 7, respectively, and Figs. 8 and 9A, respectively. The cutting portion may also be a capturing portion, as shown in Figs. 10 and 11, and may be secured thereto. The expandable structure may be configured to angle the cutting element such that as the device is drawn toward and then through the occlusive material, the cutting element cuts the occlusive material away from the vessel wall. Continued removal of the device and / or drawing the capturing portion through the blood flow and / or treatment site then draws the occlusive material into the capturing portion 200. An example of such an expandable structure is shown in Fig. 17A. 3A and 3B, the cutting portion 300 of FIG. 17A can be formed from a tube having two or more longitudinally extending slots that create at least two arms 304 that are configured to bend radially outward when the tube is shortened. The longitudinal slots can be formed such that the arms 304 have joints 310 that bend to form segments 309 in the arms 304 when the arms 304 are expanded.

[0104] As shown in FIG. 17B, the arms 304 of the cutting portion 300 may be angled toward each other (rather than extending 180 degrees apart) when extended so that the arms 304 and attached blade 302 are at an angle θ that better approximates the curvature of the vessel wall. This geometry facilitates cutting occlusive material (such as chronic thrombotic material) away from the curved vessel wall. In some embodiments, the angle between the two arms is less than 180 degrees. In some embodiments, the angle is between 135 and 180 degrees.

[0105] As shown in Figure 18A, in some embodiments, the cutting portion 300 can include a locating arm 314 that is circumferentially disposed between two arms 304 carrying the cutting elements. As depicted in Figure 18B, when the cutting portion 300 is in an expanded state, the locating arm 314 presses against a portion of the vessel wall opposite the elongate member 102 to improve the position of the cutting element for severing and / or separating occlusive material from the vessel wall.

[0106] 19A and 19B are exploded and assembled views, respectively, of an exemplary blade attachment assembly configured in accordance with some embodiments of the present technology. The assembly includes a portion of the arm 304, e.g., the distal portion 306 or the proximal portion 308 (or other portions of the cutting portion 300 and / or the capturing portion 200), the blade 302, and the coupler 1400. Any portion of the cutting portion 300 and the capturing portion 200 described herein can include one or more openings, such as the opening 324 shown extending through the arm 304. The opening 324 can be configured to receive a corresponding tab 320 extending from the blade 302 in a direction away from the sharpened edge of the blade 302. The tab 320 can have one or more openings 322 configured to receive a corresponding protrusion 1302 positioned along the latch 1400. The tab 320 on the blade 302 is positioned through the opening 324 on the arm 304 such that the opening 322 on the tab 320 is exposed on the non-receiving side of the arm opening 324, as shown in FIG. 19B. The protrusion 1302 on the latch 1400 is then positioned through the tab opening 322, thereby locking the blade 302 onto the arm 304. The protrusion 1302 may also include features that allow the width of the protrusion 1302 to increase and lock after insertion through the slot 324, further securing the latch 1400 and blade 302 to the arm 304.

[0107] In some embodiments, as shown in Figures 20A and 20B, the treatment assembly 100 includes an elongate shaft 102 including a first and a second elongate member 111, 108, and a cutting portion 300 including a cutting element 2010 that extends helically and / or spirally around a longitudinal axis of the elongate shaft 102. The second elongate member 108 can be configured to be positioned within the lumen of the first elongate member 111 and extends distally beyond the distal end of the first elongate member 111. In some embodiments, the axial positions of the first and second elongate members 111, 108 are fixed, and in some embodiments, the first and second elongate members 111, 108 are longitudinally slidably disposed relative to one another. In either case, the first and second elongate members 111, 108 may be configured to rotate relative to one another. The treatment assembly 100 may optionally include a tapered distal tip 2020 at the distal end portion 108 b of the second elongate member 108 .

[0108] The cutting element 2010 can have a proximal end portion 2010a at the distal end portion 111b of the first elongate member 111, a distal end portion 2010b at the distal end portion 108b of the second elongate member 108, and an intermediate portion 2010c extending between the proximal end portion 2010a and the distal end portion 2010b. The intermediate portion 2010c wraps around the longitudinal axis of the treatment assembly 100. The cutting element 2010 is deformable between a collapsed configuration (FIG. 20A) and an expanded configuration (FIG. 20B). In the collapsed configuration, the cutting element 2010 is wrapped around the second elongate member 108 and has an outer diameter slightly larger than that of the second elongate member 108. The cutting element 2010 may wrap less than one turn (360 degrees) or more than one turn (including multiple turns) around the longitudinal axis. When the second elongate member 108 is rotated relative to the first elongate member 111 in a first direction (or vice versa), the cutting element 2010 unwinds and expands radially outward, as shown in FIG. 20B. Rotation of the second elongate member 108 relative to the first elongate member 111 in a second direction opposite the first direction (or vice versa) forces the cutting element 2010 to wrap onto the second elongate member 108, thereby radially collapsing the cutting element 2010. The amount of rotation controls the amount of expansion, and the actual percentage of expansion depends, for example, on the initial diameter of the elongate shaft 102, the length of the cutting element 2010, and the angle at which the cutting element 2010 is coupled to the elongate shaft 102.

[0109] In some embodiments, the cutting element 2010 comprises a ribbon having a width w (labeled in FIG. 20A ) and longitudinal sides 2012a, 2012b (collectively referred to as “longitudinal sides 2012”). The width may be constant or may vary along the length of the ribbon. One of the longitudinal sides 2012 may face proximally (2012a) and one of the longitudinal sides may face distally (2012b). The ribbon may be made, for example, from one or more elastic and / or superelastic metals or polymers. One or both longitudinal sides 2012 of the ribbon may be configured to cut occlusive material within the vessel lumen. For example, in some embodiments, one or both longitudinal sides 2012 of the ribbon are sharpened. Additionally or alternatively, one or both longitudinal sides 2012 of the ribbon may be serrated. One or both longitudinal sides 2010 may have both serrated and sharpened portions to enhance the cutting ability of the cutting element 2010 as it is moved (e.g., rotated and / or translated) through occlusive material. In some cases, it may be beneficial to have the proximally facing longitudinal side 2012a sharpened and / or serrated and the distally facing longitudinal side 2012b atraumatic and / or rounded. This configuration allows the device to cut through occlusive material as it is retracted and / or rotated proximally while reducing the risk of trauma to the vessel wall during advancement of the treatment assembly 100 to the treatment site. According to some embodiments, only the portion of the proximally facing longitudinal side 2012a that is proximal to the maximum diameter of the cutting element 2010 (when the cutting element 2010 is in an expanded state) is configured to cut through occlusive material. This configuration can reduce trauma to the native vessel wall as the treatment assembly 100 is pulled proximally and / or rotated through the treatment site.

[0110] Once the cutting element 2010 is expanded, the treatment assembly 100 can be rotated, translated, or both to cut the occlusive material. In some embodiments, expansion of the cutting element 2010 can cut the occlusive material. The cutting element 2010 can be repeatedly expanded and collapsed to engage and cut the occlusive material. Movement of the cutting element 2010 to cut the occlusive material may be performed manually by a user, facilitated by an actuator on the handle 12, or performed automatically with a motor on the handle 12.

[0111] Although only a single cutting element 2010 is shown in Figures 20A and 20B, the present technology includes treatment assemblies with more than one wrapped cutting element (e.g., two wrapped cutting elements, three wrapped cutting elements, four wrapped cutting elements, etc.) By way of example only, Figures 21A and 21B show a treatment assembly 100 having first and second cutting elements 2010 and 2014. The treatment assembly 100 is shown in a collapsed state in Figure 21A and in an expanded state in Figure 21B. The cutting elements 2010, 2014 each have a proximal end portion 2010a, 2014a (2010a is not visible in FIGS. 21A and 21B) disposed at the distal end portion 111b of the first elongate member 111 and a distal end portion 2010b, 2014b, respectively, disposed at the distal end portion 108b of the second elongate member 108. The proximal end portions 2010a, 2014a can be coupled to the first elongate member 111 at different circumferential locations spaced apart about the circumference of the first elongate member 111. Whether two or more than two cutting elements are utilized, the spacing may be the same or different between adjacent cutting elements 2010. In some embodiments, the proximal end portions 2010a, 2014a are coupled to the first elongate member 111 at diametrically opposed locations. In other embodiments, the proximal end portions 2010a, 2014a have other circumferential spacings. Similarly, the distal end portions 2010b, 2014b can be coupled to the second elongate member 108 at different circumferential locations spaced about the circumference of the second elongate member 108. The spacing can be the same or different between adjacent cutting elements 2010. In some embodiments, the distal end portions 2010b, 2014b are coupled to the second elongate member 108 at diametrically opposed locations. In other embodiments, the distal end portions 2010b, 2014b have other circumferential spacings. In those embodiments having two or more cutting elements 2010, the different cutting elements 2010 can have the same or different widths.

[0112] The diameter of the elongated shaft 102 (and / or one or more components thereof), the number of cutting elements 2010, the angle at which the cutting element 2010 is coupled to the elongated shaft 102 (and / or one or more components thereof), the number of turns, and the width of the cutting element 2010 may be varied to create a desired expanded cutting configuration. As used herein with respect to a wrapped cutting element, "length" is measured along the longitudinal axis of the cutting element 2010 that extends through the cross section of the cutting element 2010. In some embodiments, the elongated shaft 102 is 3 mm in diameter, the length of the cutting element 2010 is 22 mm, the width of the cutting element 2010 is 2 mm, and the cutting element 2010 is coupled to the elongated shaft 102 at a 60 degree angle. In the collapsed state, the cutting element 2010 can be tightly wrapped around the elongated shaft 102 two times. In the expanded state (e.g., after rotation of the second elongate member 108), the cutting element 2010 unwinds until it has only one turn around the elongate shaft 102, which nearly doubles the maximum diameter of the cutting element 2010 (in this case, to about 6 mm). According to some embodiments, the cutting element 2010 is coupled to the elongate shaft 102 at a 60 degree angle, is 33 mm long, and is wrapped about three times around the elongate shaft 102. In the expanded state, the cutting element 2010 unwinds until it has one turn around the elongate shaft 102, which nearly triples the maximum diameter of the cutting element 2010 (in this case, to about 9 mm). In some embodiments, the cutting element 2010 has a length of 40 mm, is coupled to the elongate shaft 102 at a 45 degree angle, and is wrapped about three times around the elongate shaft 102. In one embodiment, the cutting element 2010 has a length of 57 mm, is coupled to the elongated shaft 102 at an angle of 30 degrees, and is wound about three times around the elongated shaft 102. In the latter two examples, the cutting element 2010 can be unwound to its fully expanded diameter, where it has one turn and a diameter that is about three times its starting diameter (e.g., about 9 mm). However, the angle of attachment is less acute (compared to the previous examples), but over a longer length due to the less acute angle of attachment.For example, at a 60 degree mounting angle, the spiral length is approximately 16 mm, for a 45 degree mounting angle, the spiral length is approximately 28 mm, and for a 30 degree mounting angle, the spiral length is 49 mm, all with more than 3 turns.

[0113] The fully expanded diameter of the cutting element 2010 also depends on the design of the attachment of the proximal and distal end portions 2010a, 2010b of the cutting element 2010 to the first and second elongated members 111, 108 of the elongated shaft 102, respectively. For example, if the ends of the cutting element 2010 are fixedly welded or soldered to the corresponding first or second elongated members 111, 108, the cutting element 2010 will remain tangent or nearly tangent to the elongated shaft 102 when it is unwound, creating one bevel angle of the helical taper on each end of the cutting element 2010. On the other hand, if the cutting element 2010 is allowed to angle away from the elongated shaft 102 to some extent, or is allowed to hinge freely to the elongated shaft 102, the helical taper will be at another bevel angle. Each type of helical taper will modify the fully unwound diameter to some extent.

[0114] In some embodiments, the width of the cutting element 2010 can be selected based on the desired gap length g (see FIG. 20A) between turns when the cutting element 2010 is fully wound (e.g., in a collapsed state). Additionally or alternatively, the width w (see FIG. 20A) of the cutting element 2010 can depend on the number of cutting elements 2010 present in the treatment assembly 100. If the treatment assembly 100 has more than one cutting element, the width of the individual cutting elements 2010 will be less than if only a single cutting element 2010 were used over a given length of the treatment assembly 100. The greater the width w of a given cutting element 2010, the greater the resistance it will have to bending strain when under load, which can more effectively cut occlusive material. As will be demonstrated, there is a tradeoff between the number of cutting elements 2010 and the performance of each cutting element 2010. In some embodiments, the width w of the cutting element 2010 may vary over the length of the cutting element. For example, width w may be smaller at ends 2010a and 2010b but wider at middle portion 2010c. Additionally or alternatively, the widths of the cutting elements may be varied, e.g., see Figures 21A and 21B, cutting element 2010 may have a width w1 and cutting element 2014 may have a second width w2.

[0115] As discussed, the second elongate member 108 may rotate relative to the first elongate member 111 when expanding the treatment assembly 100, and in some embodiments, the second elongate member 108 may also translate relative to the first elongate member 111 to axially compress or extend the cutting element 2010. The ability of the cutting element 2010 to be axially compressed or extended depends, in part, on how the proximal and distal end portions 2010a, 2010b of the cutting element 2010 are coupled to the first and second elongate members 111, 108 of the elongate shaft 102 and whether the attachment allows for the attachment angle to vary as axial compression or extension of the cutting element 2010 increases or decreases the angle of attachment. The ability to axially compress and extend the cutting element 2010 while in an expanded state improves the cutting efficiency of the treatment assembly 100. For example, the treatment assembly 100 may separate and capture occlusive material from a combination of one or more expanded wrapped cutting elements that rotate, translate, expand, and / or compress through the occlusive material at the treatment site. In addition, the cutting element 2010 may be partially unwound for a first cutting pass, then further unwound to a more expanded and / or fully expanded state for a second cutting pass, and so on for multiple cutting passes until the desired effect is achieved.

[0116] In some variations, the cutting element 2010 is integral to the first elongate member 111. For example, the first elongate member 111 can comprise a tubular member cut in a helical and / or spiral pattern at its distal portion to create one or more helical strips. Thus, the first elongate member 111 and the cutting element 2010 can be made of the same material. The distal end portion 2010b of the cutting element 2010 / the distal end portion 111b of the first elongate member 111 can be fixed to the distal end portion 108b of the second elongate member 108. When the second elongate member 108 is rotated relative to the first elongate member 111, the cutting strip (here the cutting element 2010) unrolls and expands outward. The above-described embodiment advantageously does not require any attachment design, thus reducing the number of manufacturing processes.

[0117] In another variation, the cutting element 2010 is formed from one material having the required mechanical properties, including the ability to retain sufficient rigidity to have an effective cutting action when wound and unwound, sharpened, and manipulated as described above, and the first elongated member 111 is formed from a separate tube. The first elongated member 111 is then attached to a second tube that extends proximally from the treatment assembly 100 and has suitable properties for the catheter shaft components, e.g., cost, flexibility, etc.

[0118] There are many possible methods for attaching the proximal end portion 2010a of the cutting element 2010 to the first elongate member 111 and the distal end portion 2010b to the second elongate member 108, for example, via soldering, welding, glueing, mechanical attachment, or some combination thereof. As described above, the method of attachment can affect the strength of the attachment and the specific expansion performance of the cutting element 2010 when it is expanded and used to remove occlusive material.

[0119] In some embodiments, for example, as shown in FIGS. 22A, 22B, and 22C, the distal end portion 2010b of the cutting element 2010 is mechanically captured between the distal end portion of the second elongate member 108 and the anchoring element 2220. The distal end portion 2010b of the cutting element 2010 can be coupled to a cylindrical coupler 2210 (e.g., a dowel, tube, or other cylindrical component) and extend from the coupler 2210 at an angle. The angle between the coupler 2210 and the cutting element 2010 forms the angle at which the cutting element 2010 extends from the second elongate member 108. In some embodiments, the coupler 2210 is integral with the cutting element 2010. For example, the coupler 2210 can be constructed by rolling the cutting element 2010 at the distal end portion 2010b into a tight cylinder. In some embodiments, the coupler 2210 is a separate component that is attached to the distal end portion 2010b of the cutting element 2010. In either case, the coupler 2210 can be configured to be received within a groove 2230 that extends along a distal portion of the second elongate member 108. The anchoring element 2220 can be a band configured to be slidably disposed across an outer surface of the second elongate member 108. The anchoring element 2220 can have a slot 2225 that extends along less than its entire length. The slot 2225 can be continuous with an opening at the distal end of the anchoring element 2220.

[0120] 22B, the cutting element 2010 can be mechanically captured at a distal end portion of the second elongate member 108 by inserting the coupler 2210 into a groove 830 in the second elongate member 108 and sliding the anchoring element 2220 upward, capturing the coupler 2210 in the slot 2225. The slot 2225 in the anchoring element 2220 is wide enough to allow the cutting element 2010 to extend radially outward therethrough, but is too narrow to allow passage of the coupler 2210. The coupler 2210 is configured to rotate within the groove 2230, thereby allowing the extension angle of the cutting element 2010 (relative to the second elongate member 108) to vary. The width of the slot 2225 may be varied to allow for various ranges of motion of the coupler 2210 (and thus the cutting element 2010) within the groove 2230 as the treatment assembly 100 is expanded. In FIG. 22C, the groove 830 is shown extending proximally beyond the anchoring element 2220, although in other embodiments, the groove 830 may terminate at a more distal location (including aligned with or distal to the proximal end of the anchoring element 2220). In some embodiments, the coupler 2210 is fixed within the groove 2230 such that it cannot rotate relative to the second elongate member 108.

[0121] The second elongate member 108 can have a tapered distal tip 2020 at its distal end. The tapered distal tip 2020 is removed from the view of FIG. 22B to show the coupler 2210 in the groove 2230, but is shown in FIG. 22C to illustrate how the coupler 2210 and cutting element 2010 are mechanically captured. The distal tip 2020 can prevent distal axial movement of the anchoring element 2220 and coupler 2210, thereby anchoring the coupler 2210 within the slot 2225 in the anchoring element 2220. In some embodiments, the distal tip 2020 has a maximum diameter that is greater than the diameter of the second elongate member 108. In some embodiments, the coupler 2210 is anchored within the slot 2225 via other means, such as a non-tapered distal cap, tube, or other component, to prevent the anchoring element from sliding out of the slot 2225. In these and any embodiments disclosed herein, the second elongate member 108 can have a lumen 22 extending therethrough. The distal tip 2020 can also include a lumen that is an extension of the lumen 22. The lumen 22 may be used to accommodate a guidewire or other guide element (e.g., the shaft of a separate capture element component) to allow advancement and positioning of the treatment assembly 100 at the treatment site.

[0122] The anchoring element 2220 and / or the second elongate member 108 can include one or more anchoring means such that when the anchoring element 2220 is in position over the coupler 2210, the axial and rotational position of the anchoring element 2220 (and thus the axial position of the coupler 2210) is fixed relative to the second elongate member 108. For example, the anchoring element 2220 can have one or more side holes (not shown) and the second elongate member 108 can have one or more protrusions that project radially outward into the side holes when the side holes are aligned with the protrusions. In some embodiments, the anchoring element 2220 includes one or more tabs (not shown) that can be pushed radially inward to lock into one or more receptacles in the second elongate member 108. Additionally or alternatively, the fastening element 2220 can be soldered, welded, or glued to the second elongate member 108 to hold the fastening element 2220 in place.

[0123] The proximal end portion 2010a of the cutting element 2010 may be mechanically captured in the distal portion of the first elongate member 111. For example, the first elongate member 111 may include a groove similar to the slot 2225 on the anchoring element 2220. In such an embodiment, the second elongate member 108 may have a recess in its outer surface such that the second elongate member 108 may be free to rotate relative to the first elongate member 111, causing the cutting element 2010 to expand and collapse. As mentioned above, in some embodiments, the cutting element 2010 is integral with and is an extension of the first elongate member 111.

[0124] The coupler 2210 can have other shapes and configurations. For example, in some embodiments, the distal end portion 2010b of the cutting element 2010 may be cut (e.g., laser cut) to have a T-shaped distal end configured to be received within the slit 2225 of the anchoring element 2220. The T-shaped distal end (or a portion thereof) is then trapped in a fixed position between the anchoring element 2220 and the second elongate member 108. The treatment assembly 100 can include a distal tip for anchoring the T-shaped distal end in place.

[0125] In any of the embodiments including one or more cutting elements 2010, the treatment assembly 100 may optionally include an expandable member (e.g., a balloon) (not shown) disposed radially inward of the cutting element 2010. The expandable member can be configured to expand under an already expanded (partially or fully) cutting element 2010 to add a radial force to the cutting element 2010 and prevent or reduce distortion of the cutting element 2010 as the treatment assembly 100 is translated and / or rotated through the treatment site. The expandable member may be aligned with only the middle and / or distal portions (i.e., not the proximal portions) of the cutting element 2010 so as not to interfere with the cutting action of the cutting element 2010 on the proximal side of the treatment assembly 100.

[0126] In some embodiments, for example, as shown in Figures 23A and 23B, the treatment device includes an elongate shaft 102 including first and second elongate members 111, 108, and a cutting portion 300. The distal portion of the first elongate member 111 includes an elongate tube 2320, a distal band 2330, and two or more strips 2350 connecting the proximal tube 2320 to the distal band 2330. In a collapsed state, the strips 2350 may be parallel to the axis of the elongate shaft 102 or may be at a slight angle (e.g., 0-20 degrees) from the axis of the elongate shaft 102 (as shown in Figure 23A). The second elongate member 108 can be configured to be slidably disposed within the lumen of the first elongate member 111. The second elongate member 108 can extend distally through the proximal tube 2320 and the underlying portion of the strip 2350 and beyond the distal band 2330. The treatment assembly 100 can include a distal tip 2020 coupled to a distal end of the second elongate member 108 and having a maximum diameter greater than a diameter of the distal band 2330. In some embodiments, the distal tip 2020 is locked to the distal band 2330 of the first elongate member 111 with locking elements on the second elongate member 108 and the distal band 2330. For example, the distal band 2330 can have a side hole and the second elongate member 108 can have a protrusion that projects outwardly into the side hole. In some embodiments, the distal band 2330 has a tab that can be pushed radially inward to lock into a receptacle in the second elongate member 108. Additionally or alternatively, the second elongate member 108 and the distal band 2330 can be attached via welding, glue, or soldering, for example.

[0127] In either case, when the second elongate member 108 is retracted proximally, the distance between the distal band 2330 and the distal end of the proximal tube 2320 is shortened and the strip 2350 on the first elongate member 111 is deflected radially outward to form an expanded arm, as shown in FIG. 23B. In those embodiments where the strip 2350 is attached to the first elongate member 111 at an angle (as shown in FIGS. 23A and 23B), the arm is twisted slightly in a plane perpendicular to the elongate shaft 102. The strip 2350 may have one or more edges that are sharpened and / or serrated. When expanded, the treatment assembly 100 may be rotated and / or translated to act as a rotating blade to remove occlusive material from the treatment site. The amount of expansion depends on the amount of translation of the second elongate member 108 relative to the first elongate member 111. In use, the arms may be extended partially outward for a first pass, then further expanded for a second pass, etc., to more effectively remove occlusive material.

[0128] The strips 2350 may be integral to the tube 2320 of the first elongate member 111. As seen in FIG. 23A, the first elongate member 111 can be cut (e.g., laser cut) at the distal end to create one or more strips parallel to the axis of the elongate shaft 102 or at a slight angle thereto. Optionally, the cut pattern includes a recessed portion 2360 along the length of one, some, or all of the strips 2350 to urge the strips 2350 to bend preferentially at the recessed portion 2360. The recessed portion 2360 may be at the midpoint of the strip 2350 to create a symmetrical expansion geometry, or may be biased toward the distal end of the strip 2350 to create an asymmetrical expansion geometry, as illustrated in FIG. 24. The latter configuration may allow for a better cut angle of the strip cut edge against the occlusive material.

[0129] In some embodiments, the strips 2350 are not cutting elements. Instead, as seen in FIG. 25, the strips 2350 contain tabs or other features that allow a second cutting element, such as the blade 1010, to be attached to each strip 2350. In this variation, the first elongated member 111 may be made of one material configured to be expanded and crushed, and the blade 1010 may be made of a second material that is adapted to have a sharpened blade edge. The blade 1010 may be secured to the strip 2350 with a separate latch component (not shown). Additionally or alternatively, the blade 1010 may be soldered or welded to the strip 2350.

[0130] In some cases, it may be desirable to have additional cutting elements oriented in the opposite direction of the existing cutting elements to provide a counterforce during cutting of the occlusive material. For example, in some embodiments, the device may include one or more inner cutting elements positioned inside one or more outer cutting elements. The inner cutting elements may be generally linear (e.g., as shown in FIG. 23) or may be helical and / or spiral (e.g., as shown in FIGS. 20A and 20B). The outer cutting elements may be generally linear (e.g., as shown in FIG. 23) or may be helical and / or spiral (e.g., as shown in FIGS. 20A and 20B). In some embodiments, the device 101 may include an inner extension member 108, an outer extension member 111 with one or more cutting elements 2010, and an extension member located between the inner extension member 108 and the outer extension member 111 that includes one or more cutting elements. In such embodiments, the cutting elements may be integral to the outer and intermediate extension members, or may be separate elements attached to the outer and intermediate extension members. The handle 12 (FIG. 1) of the device 101 may have an actuator that controls the rotational movement of the outer and intermediate extension members. For example, the actuator on the handle 12 may be configured to pivot the first extension member 111 in one direction while either holding the inner cutting element (carried by the intermediate extension member) stationary or rotating the inner cutting element in the opposite direction. In some embodiments, as shown, for example, in FIG. 26, the cutting portion 300 of the treatment assembly 100 comprises an inner extension member 108, an outer extension member 111 with one or more attached or integral cutting elements 2010, and an intermediate member 2323 located between the inner extension member 108 and the outer extension member 111 with corresponding cutting elements 2326 (individually labeled as 2326a-2326d in FIG. 26).In such an embodiment, the handle 12 (FIG. 1) can include one or more actuators for rotating the outer extension member 111 in one direction relative to the inner extension member 108 while shortening the intermediate extension member 2323 to expand the cutting element 2326 radially outward during deployment. The handle 12 can be configured to further actuate the outer and intermediate extension members 111, 2326 to rotate and / or translate to cut the occlusive material. One, some, or all of the cutting elements 2010 can have sharpened edges and one, some, or all of the cutting elements 2326 can have sharpened edges. In some embodiments, only the outer cutting element 2010 or only the inner cutting element 2326 may have sharpened edges. In those embodiments including inner and outer cutting elements with sharpened edges, the sharpened edges can be configured to face each other. Thus, the inner and outer cutting elements 2326, 2010 can be configured to confine the occlusive material as they move toward one another to cut the occlusive material. The inner and outer cutting elements 2326, 2010 can thus provide a counter force to the cutting force (or any force) imparted by the other to the occlusive material.

[0131] In a similar manner, the embodiment shown in Figures 23A and 23B may have one or more expandable cutting elements located inside the outer cutting element. The treatment assembly 100 may have an intermediate extension member located between the inner extension member 108 and the outer extension member 111 with a corresponding expandable cutting element. The inner and outer cutting elements may be configured such that when expanded, the cutting edge of the inner cutting element is angled in one direction and the cutting edge of the outer cutting element is angled in the opposite direction. As described above, the handle 12 may have an actuator that controls the rotational movement of the outer and intermediate extension members. For example, the handle 12 may be configured to pivot the outer extension member 111 in one direction while either holding the intermediate member stationary or rotating the intermediate member in the opposite direction.

[0132] In some embodiments, the cutting portion 300 can be configured as provided in Figures 27A-27D. In such embodiments, the cutting portion 300 can be made from a superelastic tube, such as Nitinol or other, with a cutting pattern that forms multiple (two or more) arms 1502 that protrude from the distal end of the Nitinol tube. The arms 1502 can be heat set so that once the sleeve 112 is retracted, they expand outwardly at a larger diameter than the base tube. One, some, or all of the arms 1502 can be shaped to assume the shape shown in the side views of Figures 27C and 27D. As shown in FIG. 27C, the arm 1502 can have a first generally linear portion 1502a extending from the vessel, a second portion 1502b extending distally and radially outward from the first portion 1502a, and a third, most distal portion 1502c extending distally and radially inward from the second portion 1502b. The curve between the second portion 1502b and the third portion 1502c forms an atraumatic surface that can slide along the vessel wall. In such an embodiment, the cutting element 302 can project distally from the distal end 1504 of the arm 1502 along a dimension that is generally parallel to the vessel axis and along the direction of movement of the arm 1502 (indicated by arrow A). In some embodiments, for example, as represented by FIG. 27D , one, some, or all of the arms 1502 include a fourth portion 1502d that extends distally from the third portion 1502c along a dimension that is generally parallel to the vascular axis and along the direction of movement of the arm 1502 (indicated by arrow A).

[0133] One, some, or all of the arms 1502 can have beveled and sharpened points. Like the cutting portion 300 of Figures 8-9B, the cutting portion in the embodiment represented by Figures 27A-27D forms a circumferential pattern, but because the blades do not overlap in the collapsed configuration, the cuts will not be as close together. However, because they are not required to overlap in the collapsed configuration, the collapsed profile takes up less space, which can be advantageous for an intravascular device.

[0134] 28A and 28B are isometric views of a cutting portion configured in accordance with some embodiments of the present technology. FIG. 28A shows the cutting portion in a collapsed state. FIG. 28B shows the cutting portion in an expanded state. The system 10 and / or assembly 100 of FIGS. 28A and 28B may generally be similar to the system 10 and / or assembly 100 of FIGS. 27A-27D, except that in FIGS. 28A and 28B, the system 10 includes a cover 1600 positioned over all or a portion of the cutting portion 300. The cover 1600 may be braided, woven, fabric, polymeric material, or the like. The cover 1600 may protect the native vessel wall from the cutting portion while allowing the cutting portion to remove occlusive material within the lumen of the treatment site. The cover 1600 may also assist in capturing separated occlusive material instead of or in addition to the use of the capture device 200 and / or suction via the suction source 18.

[0135] The cover 1600 may also be applied to other cutting portions described herein for the same or other purposes. C. Illustrative Uses

[0136] Various approaches may be used to gain intravascular access to occlusive material within a vascular lumen. In some embodiments, the method includes percutaneously accessing a vascular lumen (such as a vein) with a guidewire, advancing an introducer sheath (such as any of the introducers disclosed herein) over the guidewire and through the access site, and inserting a treatment device (such as any of the treatment devices disclosed herein) through the lumen of the introducer sheath and into the vascular lumen. A distal portion of the treatment device containing the treatment assembly can be advanced to a target treatment site within the vascular lumen. The access site may be, for example, in the femoral, internal jugular, or popliteal vein to treat a venous site, or the femoral or radial artery to treat an arterial site. In some embodiments, the method includes aspirating or injecting a thrombolytic agent from or into the blood vessel before, during, or after extraction of the occlusive material.

[0137] In some embodiments, a guidewire may first be inserted into the vascular lumen and advanced through the occlusive material such that a distal end of the guidewire is distal to the occlusive material. Next, an introducer 103 (FIG. 1) may be delivered over the guidewire such that a distal portion of the introducer 103 (FIG. 1) is positioned within the vascular lumen proximal to the occlusive material. In those embodiments in which the introducer includes a funnel at the distal end of the sheath 110, the funnel 700 may be expanded to appose the vascular wall. The method may continue by inserting a treatment device 101 over the guidewire, through the introducer 103, and into the vascular lumen. In some embodiments, the treatment device 101 may be advanced through the occlusive material such that a portion or all of the treatment assembly 100 of the treatment device 101 is distal to the occlusive material. In some embodiments, the treatment assembly 100 may be advanced to a location within the blood vessel such that a portion or all of the treatment assembly 100 is proximal to the occlusive material.

[0138] According to some embodiments, the treatment assembly 100 may be contained within the sleeve 112 during delivery. Once the distal portion of the treatment device 101 is positioned at a desired location relative to the occlusive material at the treatment site, the sleeve 112 of the device 101 may be pulled proximally relative to the treatment assembly 100 (or the treatment assembly may be pushed distally relative to the sleeve 112) to release one or both of the cutting and capturing portions of the treatment assembly 100, thereby allowing the capturing portion 200 and / or the cutting portion 300 to self-expand. In some embodiments, the treatment assembly 100 may be expanded distal to the occlusive material such that no portion of the capturing portion 200 and no portion of the cutting portion 300 engages the occlusive material during and / or immediately after expansion. In some embodiments, at least a portion of one or both of the capturing portion 200 and the cutting portion 300 self-expands within the occlusive material. In some embodiments, the capturing portion 200 is distal to the occlusive material and the cutting portion 300 is proximal to the occlusive material. As described elsewhere herein, in some embodiments, one or both of the capturing portion 200 and the cutting portion 300 are not self-expanding and require mechanical actuation.

[0139] While the capturing and cutting portions 200, 300 are in the expanded configuration, the cutting portion 300 can be pushed toward the capturing portion 200 and / or the capturing portion 200 can be pushed distally toward the cutting portion 300 (either sequentially, simultaneously, or before and after). Alternatively, the capturing and cutting portions 200 and 300 can be pulled proximally to simultaneously or sequentially cut and capture the occlusive material. Before, during, or after such movement, the entire treatment assembly 100 can be pushed distally or pulled proximally toward the sheath 110. As the assembly 100 and / or device 101 are pulled proximally, the blades 302 of the cutting portion 300 cut through the occlusive material in a direction generally parallel to the longitudinal axis of the blood vessel, thereby separating the occlusive material from the vessel wall and / or other occlusive material. The capturing portion 200 collects the separated occlusive material and is then pulled into the sheath 110 for removal from the patient. As mentioned above, in some embodiments, the system 10 does not include an introducer sheath. In this embodiment, the treatment device 10 may be introduced into the vasculature via a standard introducer sheath. In embodiments with a funnel 700 on the distal end of the sheath 110, the funnel serves to capture all occlusive material as the treatment device is pulled therefrom into the sheath and out of the blood vessel. In embodiments with suction capabilities, suction can be applied to one, some, or all of the elongated shafts associated with the treatment system (e.g., the sheath 110 via a connection in the hub 105, or the sleeve 112, outer member 111, etc. via a connection in the handle 12) to reduce the possibility of embolic complications.

[0140] As mentioned above, both capturing portion 200 and cutting portion 300 may be self-expanding such that when sleeve 112 is retracted, the capturing and cutting portions self-expand to an expanded state. For example, sleeve 112 may be partially retracted to expand the capturing portion and then further retracted to expand the cutting portion. Additionally or alternatively, the capturing and / or cutting portions may be expanded by active actuation. For example, one or both of capturing portion 200 and cutting portion 300 may be coupled to an actuation member that, when actuated by an operator (via a handle at a proximal portion of treatment device 101), causes capturing portion 200 and / or cutting portion 300 to partially or fully expand. For example, in some embodiments, the treatment device includes an actuation member coupled to a distal end region of a corresponding one of capturing portion 200 or cutting portion 300, which, when pulled, has the effect of shortening the length of that component and expanding that component. In those embodiments in which the capturing portion 200 and the cutting portion 300 are integrated into a single expandable component, a single actuation member may expand and / or collapse both together. Similarly, in those embodiments in which the capturing portion 200 and the cutting portion 300 are separate components, a single actuation member may expand and / or collapse only one portion. In some embodiments in which the capturing portion 200 and the cutting portion 300 are separate components, the capturing portion 200 and the cutting portion 300 may each be independently actuable, whether by separate actuation members or by different mechanisms or timing via the same actuation member.

[0141] According to various embodiments, one of the capturing portion 200 or the cutting portion 300 is self-expanding and the other of the capturing portion 200 or the cutting portion 300 requires active expansion. For example, the capturing portion 200 can self-expand when the sleeve 112 is retracted, while the cutting portion 300 requires expansion with an actuation member. In this example, the cutting portion 300 may be expanded for only the first portion of the thrombus removal step to facilitate initial removal of the thrombus from the wall, but then retracted during the remaining portion of the thrombus removal step as this is no longer required.

[0142] According to some embodiments, the treatment assembly 100 of the treatment device 101 is positioned distal to the occlusive material, expanded, and then manipulated, such as rotated, translated, or both, to separate the occlusive material from the wall. For example, the treatment assembly can include one or more cutting elements (FIGS. 20A, 20B, 21A, etc.), and the inner extension member is rotated to expand the cutting element to some or all of its expanded amount, and then manipulated to separate the occlusive material from the treatment site. The treatment device can be re-advanced for further expansion and manipulation, in some cases to a greater expanded amount, for additional separation of the occlusive material.

[0143] At any time before, during, or after the aforementioned methods, suction may be applied at the treatment site to further reduce the risk of embolism.

[0144] At any time before, during, or after the aforementioned method, the treatment area may be flushed, with or without suction, to aid in separating and capturing obstructive material. Irrigation may be applied through the treatment device via a fluid line connected to a irrigation source. Alternatively, irrigation may be applied from a side arm of the introducer sheath.

[0145] In some embodiments, both suction and irrigation may be applied to the treatment site. For example, a suction source may be connected to the treatment device and an irrigation source may be connected to the introducer 103. Conversely, a suction source may be connected to the introducer 103 and an irrigation source may be connected to the treatment device 101. Alternatively, both are connected to the treatment device 101 or both are connected to the introducer 103.

[0146] During separation and / or removal of occlusive material from the treatment site by the treatment assembly, the distal capture sheath may capture and contain any material that is not aspirated or otherwise removed by the treatment device.

[0147] During or after detachment and / or removal of occlusive material from the treatment site by the treatment assembly, the treatment device can be removed from the introducer 103 (FIG. 1). Suction applied through the introducer 103 can reduce embolic particles during device removal. The inclusion of a funnel 700 on the introducer sheath 110 can also reduce the likelihood that embolic particles will remain within the vessel when the treatment device is removed.

[0148] At any time before, during, or after engagement of the cutting element with the occlusive material, the treatment device and / or treatment assembly can be configured to deliver energy at the treatment site. For example, the treatment device and / or treatment assembly may be configured to vibrate and / or emit ultrasonic energy. All of the methods detailed above apply equally to the embodiments discussed below.

[0149] In some embodiments, for example, as shown in FIGS. 29A and 29B, the treatment assembly 100 comprises a cutting portion 300 including a housing 2910 and a rotating member 2905 having one or more spiral cutting edges 2908 disposed within the housing 2910. The housing 2910 can be or be carried by a distal portion of the second elongate member 108, and the rotating member 2905 can be or be carried by a distal portion of the first elongate member 111. The housing 2910 can comprise a tubular sidewall having one or more windows 2912 for exposing the inner rotating member 2905. FIG. 29A shows the assembly 100 with the rotating member 2910 and the housing 2905, while FIG. 29B shows the housing 2910 removed to better illustrate the rotating member 2905. The edge 2915 of the window 2912 provides a fixed edge against which the helical cutting edge 2908 shears as it is rotated, thus facilitating the cutting action along the shear line on any material that comes into contact with the shear line. The edge 2915 of the window 2912 may be sharpened to increase the cutting action. The edge 2915 may also be oriented slightly inward to impart a shear force against the cutting edge 2908 of the rotating member 2905 to further increase the shear force. Alternatively, the helical cutting edge 2908 may be oriented slightly outward for the same purpose. The housing 2910 may be made from laser cut hypotube. The sharpened edge and / or the inward orientation of the edge 2915 may be a secondary action relative to the hypotube. As shown in FIGS. 29A and 29B, the treatment assembly 100 may also include a lumen 20 and a tapered tip 620 to allow for atraumatic positioning of the treatment device 101 at the treatment site over the guide rail.

[0150] The helical cutting edge 2908 may be formed by a helical groove in the rotating member 2905, where the edges of the groove are sharpened, similar to a fluted cutter such as a drill bit. As shown in FIG. 29B, the rotating member 2905 can have one or more cutting flutes.

[0151] In some embodiments, as illustrated in Figures 30A and 30B, the treatment assembly 100 comprises a first tubular housing 3010 and a second tubular housing 3005 disposed within the first housing 3010. The first housing 3010 can be or be carried by a distal portion of the second elongate member 108, and the second housing 3005 can be or be carried by a distal portion of the first elongate member 111. Figure 30A shows the treatment assembly 100 with the second housing 3005 and the first housing 3010, while Figure 301B shows the treatment assembly 100 with the first housing 3010 removed to better illustrate the second housing 3005. The first housing 3010 can have a tubular sidewall having one or more windows 3012 exposing the second housing 3005, and the second housing 3005 can have a tubular sidewall having one or more windows 3006.

[0152] At least some of the sides (e.g., including the longitudinal sides) of the window 3012 can include a longitudinally extending edge 3015, which can be blunt or sharpened. At least some of the sides (e.g., including the longitudinal sides) of the window 3006 can include a cutting edge 3008. The cutting edge 3008 can be straight or helical. In some embodiments, the longitudinally extending side of the window 3006 is not parallel to the longitudinal axis of the second housing 3005 (e.g., the side is inclined). The second housing 3005 can be configured to rotate relative to the first housing 3010 (e.g., via rotation of the second elongated member 108 relative to the first elongated member 111, etc.) such that the cutting edge 3008 of the window 3006 of the second housing 3005 and the fixed edge 3015 of the first housing 3010 form a shear edge. One or both of the edges 3008 and 3015 can be sharpened in a manner that optimizes the cutting force on material that contacts the shearing edge. For example, the cutting edge 3008 of the rotating member 3005 can be sharpened with a sharp edge on its outer surface and the cut-out edge 3015 of the outer member is sharpened with a sharp edge on its inner surface. The distal tapered tip 620 and inner lumen 20 facilitate atraumatic advancement of the device over the guide rails to and through the treatment area.

[0153] The size of the window 3012 (both width and thickness) can determine the size of the cutting surface. The number of windows determines the number of cutting surfaces and shear edges. A larger cutout or more than one cutting surface will increase the size of the cutting surface available to remove occlusive material. As mentioned above, in some embodiments, the treatment system 10 includes a suction source configured to be fluidly coupled to the treatment device 101. In some of such embodiments, the suction source can be configured to be fluidly connected to the annular space between the first housing 3010 and the second housing 3005. In use, if the housing window becomes blocked by a material, the material will create a vacuum seal and the suction source will apply an inward force against the material through the window 3012. In such embodiments, it may be preferable to limit the number and size of the windows to one to facilitate the creation of a vacuum seal. In some embodiments, the outer edge of the window has a raised bead or flange to optimize the vacuum seal.

[0154] In some embodiments, for example as shown in FIG. 31 , the treatment assembly 100 comprises a cutting portion 300 including a housing 3110 and a rotating member 3105 having one or more cutting edges 3108 disposed within the housing 3110. The housing 3110 can be or be carried by a distal portion of the second elongate member 108, and the rotating member 3105 can be or be carried by a distal portion of the first elongate member 111. The housing 3010 includes a distal opening 3107 through which the rotating member 3105 protrudes a fixed or variable distance. The rotating element 3105 can have a cutting edge 3108 on a distal end. In the version shown in FIG. 31 , the cutting edge 3108 is formed by cutting a spiral groove into the distal face of the rotating member 3105 and sharpening one or more edges of each groove. The grooves can be cut from a relatively flat distal surface, as shown, to provide a more planar cutting surface, or can be cut from a tapered front surface to provide a tapered or pointed cutting surface, similar to the front of a drill bit. The edge 3115 of the housing 3110 surrounding the distal opening 3107 may also be sharpened or blunt. In some embodiments, the cutting edge 3108 contacts the edge 3115 of the distal opening 3107, creating a circular shear edge as the rotating member 3105 is rotating.

[0155] In some embodiments, the rotating member 3105 defines a lumen therethrough to allow the device to be advanced over a guide rail. The guide rail may be retracted into the device during the cutting step to maximize the cutting surface against the obstructive material. In some embodiments, the rotating member 3105 does not include an inner lumen.

[0156] In some embodiments, for example as shown in Figs. 32A and 32B, the treatment assembly 100 comprises an inner rotating tube 1405 and an outer stationary tube 1410, both with a crenulated patterned leading edge. The crenulated pattern of the inner tube has a diagonal or helical edge 1408. The crenulated edge 1415 of the outer tube is either straight or diagonal in the cross direction and when rotated serves as a stationary edge against which the helical cutting edge of the inner tube shears, thus facilitating the cutting action on any material that comes into contact with the shear line. The cutting crenulated edge 1415 of the outer tube may be sharpened to increase the cutting force. The edge 1415 may also be oriented slightly inward to impart a shear force against the rotating member 1405 to further increase the cutting force. Alternatively or in addition, the crenulated edge 1408 of the inner tube may be oriented slightly outward for the same effect. FIG. 32A shows the assembly, and FIG. 32B shows the outer tube 1410 removed to better illustrate the inner tube 1405.

[0157] According to some embodiments, the treatment assembly 100 can include combined end and side cutters. For example, as shown in FIG. 33, the treatment assembly 100 includes an inner rotating member 1505 and an outer tube 1510. The inner rotating member 1505 has a sharpened spiral edge 1508 on a side surface and a sharpened edge 1528 on a front surface. The outer tube 1510 has both a side cutout 1512 with edge 1515 and an open end with an outer edge 1525 at the front, exposing the side surfaces and front end of the treatment assembly 100 to the cutting edges 1508 and 1528 of the rotating cutting member 1505.

[0158] In another embodiment, the treatment assembly 100 has an inner rotating tube and an outer stationary tube, where the inner tube has both cutouts with spiral cutting edges on the sides and small crenulated cutting edges on the ends. The outer stationary tube has cutouts on the sides with fixed edges and a small crenulated pattern on the ends, which in combination with the inner tube side and end cutting edges form shear cut lines on both the sides and ends of the treatment assembly when the inner tube is rotated.

[0159] In any of these embodiments, the cutting edge may be a sharpened edge. Alternatively, the cutting edge may be a serrated edge. As shown in FIG. 34, for example, the inner rotating member 3405 of the side cutting assembly may have a sawtooth pattern on the cutout, creating a serrated cutting edge 3408. The edge may be both serrated and sharpened. In another example, as shown in FIG. 35, the inner rotating member 3505 of the end cutter may have a sawtooth pattern on the crenellations, creating a serrated cutting edge 3508.

[0160] In any of the side-cutting, end-cutting, or combination cutting configurations described above, the inner rotating member may be driven by a motor. In these embodiments, the handle 12 (FIG. 1) may include an actuator (e.g., the first actuator 14, the second actuator 16, or another) that may turn the motor on and off. The handle itself may contain the motor. Alternatively, the handle includes a connection to an external motor. In these and other embodiments, the inner rotating member may alternatively or additionally be rotated manually by a user via an actuator on the handle 12.

[0161] In any of the treatment assemblies described above, the treatment assembly 100 may include a guide element that guides the occlusive material toward the cutting surface and / or cutting edge as the treatment device 101 is advanced within the vessel toward or through the occlusive material. For example, as shown in FIGS. 36A and 36B, the treatment assembly 100 may include two or more arms 1810 that extend outward and act to direct or "gather" tissue toward a side window 1812 to facilitate cutting of the tissue as the device 101 is advanced. FIG. 36A is an isometric view. FIG. 36B is a side view to better illustrate the shape of the arms 1810. The arms 1810 may be formed from a cut pattern in the outer tube 1801 and heat set in an open position. The shape of the arms 1810 may be configured to minimize the possibility of the arms getting caught on the wall of the vessel. For example, as shown, the ends 1820 of the arms 1810 are inwardly curved. During delivery of the device to the target site, the arms 1810 may be retracted with a constraining sheath (not shown). When the treatment assembly 100 is near or at the target site, the constraining sheath is retracted, allowing the arms 1810 to expand outward and function to direct tissue. The arms 1810 may also be formed from separate elements that are attached to the outer tube 1801.

[0162] 36A and 36B, the treatment assembly 100 may also include a side opening 1830 proximal to the cutting surface. In embodiments in which the treatment device 101 is connected to a suction source 201, the opening 1830 may serve to collect occlusive material that has been separated from the vascular target site and remove the material from the patient.

[0163] As shown in Figures 37A and 37B, the arms 1910 may be oriented in the opposite direction. In this embodiment, the treatment assembly 100 is positioned through the obstructive area with the arms 1910 restrained inside an outer restraining sleeve (not shown). Once positioned, the sheath is retracted to allow the arms to expand outward. As the device is pulled back, the arms direct the obstructive material towards the cutting window 1912.

[0164] In some embodiments, the treatment assembly 100 comprises a coring cutter. For example, as shown in Figs. 38A and 38B, the cutting portion 300 can comprise an outer tube 2010 with a side cutout window 2012 and an inner tube 2005 with a sharpened end 2008. The distal edge 2015 of the outer side cutout window 2012 may also be sharpened. As shown in Fig. 38A, when the treatment assembly is positioned against the obstructive material, the inner tube 2005 is recessed proximally of the window 2012 of the outer tube 2010, allowing the obstructive material to enter the recessed space through the window 2012. During the cutting step, as shown in Fig. 38B, the inner tube is forced forward, pushing the inner tube edge 2008 towards the outer tube edge 2015, thereby cutting the obstructive material in the recessed space in a punch-like manner. In the first case, the inner tube has a sharpened edge on the distal end of the inner tube opening. One or more of the sharpened edges 2008 and 2015 may also be serrated.

[0165] Cutting of the occlusive material may be performed by the user with a manual actuator on the handle 12 that slides the inner member 2005 forward and then rebounds. Alternatively, the inner tube 2005 may be connected to a spring in the handle 12 that is configured to push the inner tube forward. The spring can be released by the user to apply additional force against the tissue during the cutting step. In an embodiment, a single actuator movement propels the inner member forward and then resets the inner member in the recessed position.

[0166] In some variations, for example as shown in Figures 39A and 39B, the leading edge 2108 of the inner tube 2105 is beveled. Similarly, the outer tube edge 2115 may also be beveled in the opposite direction. In this way, during the cutting step as the inner tube is pushed forward, the cutting step has both a slicing and punching action. Figure 39A shows the inner member 2105 almost completely recessed. In use, the inner member may be fully recessed during the positioning step to maximize the recession space. Figure 39B shows the inner member at almost the end of travel in the cutting configuration.

[0167] Any of the treatment systems herein may include a positioning element configured to position the treatment assembly and / or cutting portion in close proximity to the occlusive material within the blood vessel (or other body lumen) to improve efficiency of cutting. This is particularly beneficial in embodiments where the cutting surface is on one side of the elongated member 102 and / or where an amount of opposing force would increase the efficiency of the cutting action. For example, the positioning element may orient the cutting portion of the treatment assembly (either on the side or end of the treatment assembly, or both) against one side of the vessel lumen. The positioning element may additionally or alternatively be utilized to offset the cutting portion from the vessel wall to protect the vessel wall. In either case, the positioning element may be incorporated into the treatment device 101 (e.g., on the elongated member 102, the first elongated member 111, the second elongated member 108, or the sleeve 112) or may be disposed on a separate device that may be delivered over, through, and / or alongside the treatment device 101. As used herein, a "positioning device" refers to a separate device on which a positioning element is disposed. The positioning elements of the present technology can provide benefits to any of the treatment devices or assemblies disclosed herein, but may be particularly advantageous for treatment assemblies in which the cutting elements do not extend outwardly within the lumen of the treatment vessel (such as side cutters, end cutters, and coring cutters).

[0168] In some embodiments, the locating element can comprise an expandable structure. For example, as shown in FIG. 40, the locating element can comprise an inflatable balloon 4080 carried by a distal portion of the elongate shaft 4020. The elongate shaft 4020 can comprise a tubular sidewall defining a lumen therethrough and including a window 4030 at the distal portion of the elongate shaft 4020. The balloon 4080 can be positioned about a circumference of the elongate shaft 4020 opposite the window 4030. In some embodiments, all or a portion of the balloon 4080 is longitudinally aligned with all or a portion of the cutting portion 300 of the treatment assembly 100 (as shown in FIG. 40). In other embodiments, the balloon 4080 is longitudinally adjacent to or spaced apart from the cutting portion 300, as shown in, for example, FIGS. 41A-41F (discussed below). The balloon 4080 can be proximal to the cutting portion 300 (as shown in FIGS. 41A-41F), aligned with the cutting portion 300 (as shown in FIG. 40), or distal to the cutting portion 300 (not shown) along the longitudinal axis of the system. Still referring to FIG. 40, the elongate shaft 4020 optionally includes a distal tip 620 at its distal end. In other embodiments, the distal tip 620 is coupled to the distal end of the elongate member 102 (or components thereof, such as the first and / or second elongate members 108, 111), or neither the elongate shaft 4020 nor the elongate member 102 includes a distal tip 620.

[0169] The elongate shaft 4020 can be configured for use with the treatment device 101. For example, in some embodiments, the lumen of the elongate shaft 4020 is configured to receive therein the elongate member 102 of the treatment device 101 (which may be a single elongate member or may comprise multiple elongate members, such as first and second elongate members 108 and 111). The treatment device 101 can be positioned relative to the elongate shaft 4020 such that the cutting portion 300 of the treatment device 101 is longitudinally aligned with (and exposed through) the window 4030 of the elongate shaft 4020. The treatment device 101 can be longitudinally fixed within the elongate shaft 4020 or can be slidably disposed within the elongate shaft 4020. Similarly, the treatment device 101 can be rotationally fixed relative to the elongate shaft 4020 or can be configured to rotate within the elongate shaft 4020. In some embodiments, one or more components of the treatment device 101 can rotate relative to the elongate shaft 4020 and / or the balloon 4080, but cannot translate relative to the elongate shaft 4020 and / or the balloon 4080.

[0170] According to some methods of use, the distal portion of the treatment device 101 and the distal portion of the elongate shaft 4020 are delivered together to a treatment site. During delivery, the balloon 4080 is in a contracted and / or low-profile state. Once at the treatment site, the balloon 4080 can be expanded to position the cutting portion 300 at a desired location relative to the occlusive material and / or vessel wall. The treatment assembly 100 and / or the cutting portion 300 can then be actuated to remove the occlusive material. The balloon 4080 can be contracted, repositioned, and re-inflated as necessary for further occlusive material removal.

[0171] In some embodiments, the positioning element can be configured as a quasi-selective guide for delivering the treatment assembly 100 to the treatment site. For example, the positioning device can first be accessed and positioned at the treatment site with a dilator (not shown). The dilator can then be removed and replaced with the treatment device 101. In some embodiments, the positioning device and the treatment device can first be positioned together (as mentioned above). In either scenario, the treatment device 101 can be removed from the positioning device and replaced with an alternative treatment device. For example, a treatment device with a treatment assembly including a side cutter may be used to separate occlusive material from the treatment site, and then a treatment device with a treatment assembly including an end cutter may be replaced at the treatment site and used to separate additional occlusive material therefrom. In this manner, any combination of treatment devices, treatment assemblies, and / or cutting portions may be used in a single procedure.

[0172] The positioning element of FIG. 40 can be used with any of the treatment devices, treatment assemblies, cutting portions, and / or capturing portions disclosed herein. By way of further example only, FIGS. 41A-41F show different combinations of the positioning device shown in FIG. 40 with the cutting portion 300 shown and described with respect to FIGS. 20A and 20B. In any of these variations, at least a portion of the treatment device 101 can be longitudinally and / or rotationally fixed relative to the elongated shaft 4020. For example, the first elongated member 111 may be longitudinally and / or rotationally fixed relative to the elongated shaft 4020, while the second elongated member 108 is free to rotate and / or translate relative to the elongated shaft 4020 (thereby allowing the expansion / collapse of the cutting element 2010). As another example, the second elongate member 108 may be longitudinally and / or rotationally fixed relative to the elongate shaft 4020, while the first elongate member 111 is free to rotate and / or translate relative to the elongate shaft 4020 (thereby allowing expansion / collapse of the cutting element 2010).

[0173] As shown in FIG. 41A, the treatment device 101 and positioning device can be arranged such that the cutting portion 300 is longitudinally adjacent to the balloon 4080 and the cutting element 2010 is configured to predominantly expand in the direction of the expanded balloon 4080. FIG. 41B shows an example in which the cutting portion 300 is longitudinally adjacent to the balloon 4080, but the cutting element is configured to predominantly expand in a different direction than (including opposite to) that of the expanded balloon 4080. In FIG. 41C, the cutting portion 300 is longitudinally spaced from the balloon 4080 (e.g., by advancement of the treatment device 101 relative to the positioning device (or vice versa)) and the cutting element 2010 is configured to predominantly expand in a different direction than (including opposite to) that of the expanded balloon 4080. In FIG. 41D, the cutting portion 300 is longitudinally spaced from the balloon 4080 (e.g., by advancement of the treatment device 101 relative to the positioning device (or vice versa)), and the cutting element 2010 is configured to expand predominantly in the direction of the expanded balloon 4080.

[0174] The balloon 4080 (or other positioning element) can be expanded to a radial distance from the central longitudinal axis L of the treatment system (labeled only in FIG. 41E) that is less than, the same as, or greater than the maximum radial expansion distance of the cutting element 2010. The expansion of the balloon 4080 can be adjusted depending on the desired degree of expansion of the cutting element 2010. FIGS. 41A-41D provide examples of smaller and / or less expanded balloons, while FIGS. 41E and 41F provide examples of larger and / or more expanded balloons.

[0175] While the balloon 4080 shown in FIGS. 40 and 41A-41F is eccentrically and / or positioned on one side of the elongated shaft 4020, in some embodiments, the balloon 4080 (or any of the positioning elements of the present technology) may be configured to expand concentrically and / or extend around the entire circumference of the elongated shaft 4020 (e.g., as shown in FIGS. 44 and 45). The concentric positioning balloon may be partially or fully inflated to prevent the cutting element 300 from damaging the native wall during advancement, and / or may be further inflated to protect the native vessel wall and guide the cutting element to remain within the vessel central lumen while cutting the occlusive material. The positioning provided by such embodiments may be beneficial, especially when used in conjunction with a helical cutting element, since centering the longitudinal axis of the elongated shaft 4020 within the vessel doubles the effective treatment diameter of the cutting portion 300. For example, a spiral cutting element 2010 with an expanded diameter of 8 mm may be used to treat a 16 mm vessel if centered within the lumen and allowed to rotate 360 ​​degrees. It should be understood that other cutting element diameters and vessel sizes are also possible. As shown in FIGS. 42 and 43, in some embodiments, the balloon 4080 comprises multiple lobes 4081 that are independently inflatable / expandable. Different lobes 4081 may be selectively inflated for off-center device positioning or all inflated for centering (as shown). In some embodiments, the balloon 4080 includes multiple lobes 4081, but the lobes do not surround the entire circumference of the elongated shaft 4020 (e.g., at least two of the lobes are spaced around the circumference of the elongated shaft 4020).

[0176] The positioning element can comprise other expandable structures. For example, as shown in FIG. 46A, the positioning element can comprise a plurality of expandable struts 4622 carried on a distal portion of an elongated shaft 4620. In some embodiments, the struts 4622 are cut from the sidewall of the elongated shaft 4620. The struts 4620 can have preferential bends and / or living hinges along their respective lengths such that the struts 4622 flex and expand outwardly when the elongated member 4620 is shortened, for example, by pulling back an elongated member (not shown) coupled to the distal end of the struts 4622 while holding the proximal end of the elongated shaft 4620 stationary, or by advancing the proximal end of the elongated shaft 4620 while holding the distal end of the struts 4622 stationary. The struts 4622 may have sections with cutouts to form hinge locations 4650. The hinge location may be at the midpoint of the strut 4622 or elsewhere along the length of the strut 4622. For example, as shown in FIG. 46A, the hinge location may be toward the distal end of the strut 4622, forming an asymmetric bend when the locator element 4680 is expanded. In some embodiments, the strut 4622 is part of a separate expandable structure that is coupled to a distal portion of the elongated shaft 4620 (rather than being disconnected from the elongated shaft 4620).

[0177] In either case, the struts 4622 may be positioned only along a portion of the circumference of the treatment assembly 100 (as shown in FIG. 46B) so as to push the treatment assembly 100 to one side of the vessel lumen when the struts 4622 engage the vessel wall on the different side. This asymmetry allows the user to direct the cutting portion 300 of the treatment assembly 100 (in this case an end cutter, although other cutting portions 300 can also be used in conjunction with the positioning element 4680) toward a desired location within the vessel to remove obstructive material. The struts 4622 may be approximately parallel to the axis of the elongated shaft 4620 in the low-profile state and flex outward in a planar arc when the elongated shaft 4620 is shortened (as described above), or the struts 4622 may be oriented diagonally in the low-profile state such that they form an expanding helix when the elongated shaft 4620 is shortened.

[0178] The positioning elements of Figures 46A and 46B can be used with any of the treatment devices 101, treatment assemblies 100, cutting portions 300, and / or capturing portions 200 disclosed herein. By way of further example only, Figures 47A-47D show different combinations of the positioning device shown in Figure 46A with the cutting portion 300 shown and described with respect to Figures 20A and 20B. In any of these variations, at least a portion of the treatment device 101 can be longitudinally and / or rotationally fixed relative to the elongated shaft 4620. For example, the first elongated member 111 may be longitudinally and / or rotationally fixed relative to the elongated shaft 4620, while the second elongated member 108 is free to rotate and / or translate relative to the elongated shaft 4620 (thereby allowing the expansion / collapse of the cutting element 2010). As another example, the second elongate member 108 may be longitudinally and / or rotationally fixed relative to the elongate shaft 4620, while the first elongate member 111 is free to rotate and / or translate relative to the elongate shaft 4620 (thereby allowing expansion / collapse of the cutting element 2010).

[0179] As shown in FIG. 47A, the treatment device 101 and positioning device can be arranged such that the cutting portion 300 is expanded at a location longitudinally adjacent to the expanded positioning elements 4680. In FIG. 47A, the cutting portion 300 is rotationally oriented such that the cutting elements 2010 predominantly radially expand in the same direction as the expansion of the struts 4680. FIG. 47B shows an example in which the cutting portion 300 is expanded at a location longitudinally adjacent to the expanded positioning elements 4680. In FIG. 47B, the cutting portion 300 is rotationally oriented such that the cutting elements 2010 predominantly radially expand in a different direction than that of the expanded struts 4680 (including vice versa). In FIG. 47C, the cutting portion 300 is expanded at a location spaced longitudinally from the positioning element 4680 (e.g., by advancement of the treatment device 101 relative to the positioning device, or vice versa), and the cutting portion 300 is oriented such that it predominantly expands in a different direction than that of the expanded struts 4680 (including the opposite direction). In FIG. 47D, the cutting portion 300 is expanded at a location spaced longitudinally from the positioning element 4680 (e.g., by advancement of the treatment device 101 relative to the positioning device, or vice versa), and the cutting element 2010 is configured to predominantly expand in the direction of expansion of the expanded struts 4680. Expansion of any of the positioning elements herein can occur before, during, or after expansion and / or activation of the cutting portion.

[0180] Similar to the balloon 4080, the positioning element 4280 shown in FIGS. 46A-47D is positioned eccentrically and / or on one side of the elongate shaft 4220, however, in some embodiments, the positioning element 4280 (or any of the positioning elements of the present technology) may be configured to expand concentrically and / or extend around the entire circumference of the elongate shaft 4220 (e.g., as shown in FIGS. 48 and 49).

[0181] 40-49 are part of a separate positioning device, the same positioning element can be incorporated directly into the treatment device. To use FIG. 41A as an example, in some embodiments, the positioning element is disposed directly on the second elongate member 108 and the treatment device 101 can include an inflation lumen that extends from a proximal portion of the treatment device 101 to an interior region of the balloon 4080.

[0182] Any of the positioning elements disclosed herein (including the balloon 4080 and the expandable struts 4680) may be configured to partially or completely occlude a blood vessel lumen (or other body lumen) when expanded. A positioning element comprising multiple expandable struts may, for example, include an impermeable covering over all or a portion of the struts. This functionality has the secondary effect of reducing or eliminating the risk of embolic particles traveling toward the heart (if the treatment vessel is a vein) or toward a limb or end organ (if the treatment vessel is an artery).

[0183] As mentioned above, various approaches may be used to gain intravascular access to occlusive material within a vascular lumen. In some embodiments, the method includes percutaneously accessing a vascular lumen (such as a vein) with a guidewire, advancing an introducer sheath (such as any of the introducers disclosed herein) over the guidewire and through the access site, and inserting a treatment device (such as any of the treatment devices disclosed herein, including treatment device 101) through the lumen of the introducer sheath and into the vascular lumen. A distal portion of treatment device 101 containing treatment assembly 100 can be advanced to a target treatment site within the vascular lumen. The access site may be, for example, in the femoral vein, internal jugular vein, or popliteal vein. In some embodiments, the method includes aspirating occlusive material from the blood vessel or injecting a thrombolytic agent therein before, during, or after extraction of the occlusive material with the treatment device.

[0184] In some embodiments, a guidewire may first be inserted into the vascular lumen and advanced through the occlusive material such that a distal end of the guidewire is distal to the occlusive material. An introducer (such as, for example, introducer 103) may then be delivered over the guidewire such that a distal portion of the introducer is positioned within the vascular lumen proximal to the occlusive material. In those embodiments in which the introducer includes a funnel at the distal portion of the introducer, the funnel is expanded to appose the vascular wall. The method may continue by inserting a treatment device 101 over the guidewire, through the introducer, and into the vascular lumen. In some embodiments, the treatment device 101 may be advanced through the occlusive material such that a portion or all of the treatment assembly 100 of the treatment device 101 is distal to the occlusive material. In some embodiments, the treatment assembly 100 may be advanced to a location within the blood vessel such that a portion or all of the treatment assembly 100 is proximal to the occlusive material. In some embodiments, the treatment assembly 100 can be advanced to a location within the blood vessel such that part or all of the treatment assembly 100 is within the occlusive material. In some embodiments, a distal capture assembly can be positioned distal to the occlusive material prior to positioning of the treatment assembly 100. In other embodiments, the distal capture assembly can be positioned simultaneously with the positioning of the treatment assembly.

[0185] In some methods of use, the cutting portion 300 and / or treatment assembly 100 are positioned distal to the occlusive material, expanded, and then manipulated (e.g., rotated, translated, or both) to separate the occlusive material from the vessel wall. In those embodiments in which the cutting portion is a ribbon cutter, the inner member can be rotated to expand the ribbon to some or all of its expanded amount, and then manipulated to separate the occlusive material from the treatment site. The treatment device can be re-advanced for further expansion and manipulation, in some cases to a greater expanded amount, for additional separation of the occlusive material.

[0186] In some methods of use, the cutting portion 300 and / or the treatment assembly 100 can be positioned within the occlusive material. For example, the positioning elements of the present technology can push the cutting portion 300 of the treatment assembly 100 against the occlusive material, either by, for example, expanding struts, inflating a balloon, or other methods. The cutting portion 300 can be actuated, for example, by powering a motor or by manual rotation of the cutting portion and / or cutting element. The treatment assembly 100 can be rotationally moved back and forth or around to separate additional occlusive material from the target area. The positioning elements can be collapsed so that the treatment assembly 100 can be reoriented or translated at the treatment site, and then re-expanded for further separation of occlusive material by the treatment assembly 100. For treatment assemblies with end cutting elements (e.g., as depicted in Figures 31, 32A-32B, 33, 36A-36B, and others), the treatment assembly may be pushed forward into the occlusive material to separate the material from the treatment site.

[0187] In some embodiments, as shown in Figures 50A and 50B, for example, the treatment system 10 may include a separate distal capture device 301. The distal capture device 301 may comprise an expandable basket 310 coupled to an elongate member 320. A restraining sheath 330 can be positioned over the basket 310 and the elongate member 320 during positioning of the distal capture device 301, as shown in Figure 50A. Once at the desired site, the restraining sleeve is retracted to allow the basket 310 to expand, as shown in Figure 50B.

[0188] 51A and 51B show an exemplary configuration of using the distal capture device 301 with the treatment device 101. In use, as shown in FIG. 51A, the distal capture device is first positioned at a distance distal to the treatment site. Once positioned, the restraining sheath 330 is retracted to expand the basket 310. The treatment device may be loaded onto the extension member 320, advanced, and positioned at the treatment site proximal to the distal capture basket 310. In this manner, the extension member 320 acts as a guide rail. In this configuration, the extension member is sized to fit within the inner lumen 20 of the treatment device 101. In an alternative configuration, the distal capture device is positioned at a location distal to the treatment site, and then the treatment site is positioned using a separate guide rail, such as a guidewire to the treatment site. The extension member 320 of the distal capture device 301 and the shaft 102 of the treatment device 101 are side-by-side within the introducer sheath. Alternatively, the distal capture assembly and the treatment device 101 are slidably or fixedly connected and positioned together at the treatment site.

[0189] Alternatively, as shown in FIG. 51B, a distal capture device 301 is positioned side-by-side within the blood vessel with the treatment device 101 and extended distally of the treatment area.

[0190] Further embodiments of the distal capture device 301 are provided in PCT Application No. PCT / US2022 / 071076, filed March 10, 2022, which is incorporated by reference in its entirety into this specification.

[0191] In some embodiments, the treatment system may include an introducer sheath 103, as shown, for example, in FIG. 52. The introducer sheath may include features for aspiration of bulky material, for example, large diameter tubing and fluid lines with valves connected to a suction source, such as a large syringe or suction pump. The introducer sheath may also include an expandable distal section 5200 to act as a funnel during removal of the treatment device 101 from the introducer sheath 103 in a manner to capture as much of the obstructive material as possible to be removed and captured by the treatment assembly 100 of the treatment device 101.

[0192] Any of the embodiments of the treatment assembly 100 may be further enhanced with the addition of suction to remove material separated from the treatment area using the various cutting actions described. In an embodiment, the treatment device 101 includes a fluid line 230 that fluidly connects the treatment assembly 100 to a Y-adapter 210 on the handle 12. In use, a suction pump is connected to a port on the handle 12, thus connecting suction to the treatment assembly 100. The suction pump may be manually controlled by the user, for example, using a manual or foot-actuated valve 220 that is opened or closed depending on whether suction is desired at the treatment site. In another embodiment, the suction pump may be automatically turned on, for example, when a motor is turned on to rotate the internal cutter. In another embodiment, the suction source may be turned on only when it senses an increase in resistance to suction due to an obstruction to the treatment assembly, indicating that the treatment assembly is in contact with a surface such as an occlusive material. The suction source 201 may be a pump, a syringe, a connection to a suction source such as a wall suction, or other suction source.

[0193] As mentioned above, in some embodiments, the treatment system 10 includes a flushing source, such as a syringe, fluid pump, or pressurized fluid bag, that is fluidly connected to a lumen of the treatment device 101. The flushing solution may be a saline solution. In use, the flushing may be used to continuously or intermittently direct occlusive material that has been separated from the treatment site toward a distal collection basket, such as the capture portion 200 of the treatment device 101 or a separate distal capture device 310.

[0194] In one variation, the treatment system 10 includes both a suction source 201 and a flushing source (not shown). In this embodiment, the flushing source and the suction source can be turned on and off in coordination to minimize blood loss when aspirating occlusive material that has been separated from the treatment site by aspirating fluid that has flowed from the flushing source to the treatment site, rather than aspirating blood.

[0195] At any time before, during, or after the aforementioned method, suction may be applied at the treatment site to remove detached material from the treatment site. Suction may be applied through the treatment device via a fluid line connected to a suction source. Alternatively, suction may be applied from a side arm of the introducer sheath.

[0196] At any time before, during, or after the aforementioned method, the treatment area may be flushed, with or without suction, to aid in separating and capturing obstructive material. Irrigation may be applied through the treatment device via a fluid line connected to a irrigation source. Alternatively, irrigation may be applied from a side arm of the introducer sheath.

[0197] In certain embodiments, both suction and irrigation may be applied to the treatment site. For example, a suction source may be connected to the treatment device and an irrigation source may be connected to the introducer sheath. Conversely, a suction source may be connected to the sheath and an irrigation source may be connected to the treatment device. Alternatively, both are connected to the treatment device or both are connected to the sheath.

[0198] During separation and / or removal of occlusive material from the treatment site by the treatment assembly, the distal capture sheath may capture and contain any material that is not aspirated or otherwise removed by the treatment device.

[0199] During or after separation and / or removal of occlusive material from the treatment site by the treatment assembly, the treatment device is removed from the introducer sheath 103. Suction applied to the introducer sheath reduces embolic particles during device removal. A funnel on the introducer sheath may also reduce the likelihood of embolic particles remaining within the vessel when the treatment device is removed. conclusion

[0200] Although many of the embodiments are described above with respect to systems, devices, and methods for retrieving clot material from a blood vessel lumen, the technology is also applicable to other applications and / or other approaches, such as removal and / or modification of other structures within any body lumen. Other embodiments in addition to those described herein are also within the scope of the technology. In addition, some other embodiments of the technology can have different configurations, components, or procedures than those described herein. Those skilled in the art will therefore accordingly understand that the technology can have other embodiments with additional elements, or that the technology can have other embodiments without some of the features shown and described above with reference to FIGS. 1-52.

[0201] The description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include plural or singular terms, respectively. Specific embodiments of the present technology and examples thereof are described above for illustrative purposes, but as one skilled in the art would recognize, various equivalent modifications are possible within the scope of the present technology. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0202] As used herein, the terms "generally," "substantially," "about," and similar terms are used as terms of approximation, not degree, and are intended to take into account inherent variations in measurements or calculations that will be recognized by one of ordinary skill in the art.

[0203] Also, unless the word "or" is expressly limited in relation to a list of two or more items to mean only a single item exclusively from the other items, the use of "or" in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. In addition, the term "comprising" is used throughout to mean including at least the recited features, so as not to exclude any greater number of the same features and / or other features of additional types. Also, it should be understood that specific embodiments have been described herein for illustrative purposes, and that various modifications may be made without departing from the technology. Furthermore, while advantages associated with certain embodiments of the technology are described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily need to exhibit such advantages to fall within the scope of the technology. Thus, the present disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

1. 1. A system for modifying and / or removing occlusive material from a lumen of a blood vessel, the system comprising: a first elongate member having a proximal portion and a distal portion configured to be intravascularly positioned at a treatment site within a blood vessel adjacent the occlusive material, the first elongate member defining a lumen extending therethrough; a second elongate member having a proximal portion and a distal portion configured to be intravascularly positioned at the treatment site, the second elongate member configured to be rotatably disposed within the lumen of the first elongate member; a cutting element configured to cut occlusive material at the treatment site, the cutting element having a proximal end region at the distal portion of the first elongate member and a distal end region at the distal portion of the second elongate member, wherein rotation of the second elongate member relative to the first elongate member, or vice versa, causes the cutting element to expand away from a longitudinal axis of the second elongate member; an expandable locator element configured to be delivered intravascularly to the treatment site, the locator element configured to expand into apposition with a vessel wall and position the cutting element closer to the occlusive material than before expansion of the locator element; and A system comprising:

2. 10. The system of claim 1, wherein the locator element is disposed on an elongate shaft defining a lumen therethrough, and the first elongate member, second elongate member, and cutting element are configured to be positioned within the lumen of the elongate shaft.

3. The system of claim 2 , wherein the elongate shaft comprises a tubular sidewall having a proximal portion and a distal portion, the sidewall comprising a window in the distal portion.

4. The system of claim 3 , wherein the cutting element is configured to be positioned within the elongated shaft such that at least a portion of the locator element is exposed through the window.

5. The system of claim 2 , wherein the locator element is positioned along only a portion of the circumference of the elongate shaft.

6. The system of claim 1 , wherein the locator element is translatable and / or rotatable relative to the first elongate member.

7. The system of claim 1 , wherein the locator element is translatable and / or rotatable relative to the second elongate member.

8. The system of claim 1 , wherein the positioning element comprises a balloon.

9. The system of claim 1 , wherein the positioning element comprises a plurality of posts.

10. 2. The system of claim 1, wherein the locator element is configured to expand a maximum first radial distance away from a central longitudinal axis of the elongate shaft and the cutting element is configured to expand a maximum second radial distance away from the longitudinal axis of the second elongate member that is less than the first radial distance.

11. 10. The system of claim 1, wherein the cutting element wraps at least partially around the longitudinal axis of the second elongate member as the cutting element extends between the first elongate member and the second elongate member.

12. The system of claim 11 , wherein the cutting element is a ribbon.

13. 13. The system of claim 12, wherein the cutting element has longitudinally extending edges, and one or both longitudinally extending edges are sharpened.

14. 14. The system of claim 13, wherein the cutting element has a proximally facing longitudinal edge and a distally facing longitudinal edge, and only one of the proximally facing or distally facing longitudinal edge is sharpened.

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